Attached files
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EX-5.1 - SignPath Pharma, Inc. | v196685_ex5-1.htm |
EX-23.2 - SignPath Pharma, Inc. | v196685_ex23-2.htm |
As
filed with the Securities and Exchange Commission on September 15,
2010
Registration
No. 333-______
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
20549
FORM
S-1
REGISTRATION
STATEMENT
UNDER
THE SECURITIES ACT
OF 1933
SIGNPATH
PHARMA INC.
(Exact Name of
Registrant as specified in its charter)
Delaware
|
2834
|
20-5079533
|
||
(State
or other jurisdiction
of
incorporation or organization)
|
(Primary
Standard Industrial
Classification
Code Number)
|
(I.R.S.
Employer
Identification
No.)
|
1375
California Road
Quakertown,
PA 18951
Telephone:
(215) 538-9996
Telecopier:
(215) 538-1245
(Address and
telephone number of principal executive offices)
Dr.
Lawrence Helson
Chief
Executive Officer
1375
California Road
Quakertown,
PA 18951
Telephone:
(215) 538-9996
Telecopier:
(215) 538-1245
(Name, address and
telephone number of agent for service)
Copy
to:
Elliot H.
Lutzker, Esq.
Phillips
Nizer LLP
666 Fifth
Avenue, 28th
Floor
New York,
New York 10103-0084
Telephone:
(212) 841-0707
Telecopier:
(212) 262-5152
Approximate Date of Proposed Sale to
the Public: As soon as practicable after the effective date of
this registration statement.
If any of
the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, check
the following box. x
If this
Form is filed to register additional securities for an offering pursuant to
Rule 462(b) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering. o
If this
Form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. o
If this
Form is a post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
accelerated filer
|
o
|
Accelerated
filer
|
o
|
|
Non-accelerated
filer
|
o
|
Smaller
reporting company
|
x
|
|
(Do
not check if a smaller reporting company)
|
o
|
CALCULATION
OF REGISTRATION FEE
Title of Each Class of Securities to be Registered
|
Amount to be
Registered (1)
|
Proposed Maximum
Aggregate Offering
Price per Security
|
Proposed Maximum
Aggregate
Offering Price
|
Amount of
Registration
Fee
|
||||||||||||
Common
Stock, par value $.001
|
1,307,500 | $ | 1.00 | $ | 1,307,500 | $ | 72.96 | (2) | ||||||||
Common
Stock, par value $.001
|
200,000 | $ | 1.00 | $ | 200,000 | $ | 14.26 | |||||||||
Common
Stock, par value $.001, issuable upon conversion of Series A Preferred
Stock
|
1,683,364 | $ | 1.00 | $ | 1,683,364 | $ | 93.93 | (2) | ||||||||
Common
Stock, par value $.001, issuable upon exercise of Common Stock Purchase
Warrants
|
1,683,364 | $ | 1.27 | (3) | $ | 2,137,872 | $ | 119.29 | (2) | |||||||
Common
Stock, par value $.001, issuable upon conversion of Series A Preferred
Stock
|
643,610 | $ | 1.00 | $ | 643,610 | $ | 45.89 | |||||||||
Common
Stock, par value $.001, issuable upon exercise of Common Stock Purchase
Warrants
|
643,610 | $ | 1.27 | (3) | $ | 817,385 | $ | 58.28 | ||||||||
TOTAL
|
6,161,448 | - | $ | 6,789,731 | $ | 404.61 |
(1)
|
Pursuant
to Rule 416 under the Securities Act of 1933, these shares include an
indeterminate number of shares of Common Stock issuable as a result of
stock splits, stock dividends, recapitalizations or similar
events.
|
(2)
|
This
amount was paid on April 7, 2009 and August 6, 2009, upon the filing of
Registration Statement (No.
333-158474).
|
(3)
|
Estimated
solely for purposes of calculating the registration fee pursuant to
Securities Act Rule 457(g), based on the exercise price of the
warrants.
|
(4)
|
Of
this amount, $118.43 is being paid with the filing of this Registration
Statement and the balance was paid as set forth in Note (2)
above.
|
This
Registration hereby amends this Registration Statement on such date or dates as
may be necessary to delay its effective date until the Registrant shall file a
further amendment which specifically states that this Registration Statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until the Registration Statement shall become
effective on such date as the commission, acting pursuant to said Section 8(a),
may determine.
Pursuant
to Rule 429(b) under the Securities Act this Registration Statement shall also
serve as a Post-Effective Amendment No. 1 to the Company’s Registration
Statement on Form S-1 (No. 333-158474) declared effective on August 10,
2009.
SUBJECT
TO COMPLETION – DATED SEPTEMBER 15, 2010
The
information contained in this prospectus is not complete and may be changed.
These securities may not be sold until the registration statement filed with the
Securities and Exchange Commission (the “SEC”) is effective. This prospectus is
not an offer to sell these securities and it is not soliciting an offer to buy
these securities in any state where the offer or sale is not
permitted.
PROSPECTUS
SIGNPATH
PHARMA INC.
6,161,448
Shares of common stock
This
prospectus relates to the public offering of up to 6,161,448 shares of our
common stock consisting of 1,507,500 shares issued to seventeen (17) retail
accredited investors in a bridge financing and 4,653,948 shares issuable upon
conversion and exercise of securities sold to 33 different retail
accredited investors in private equity offerings. The shares will be offered
from time to time for the account of the stockholders identified in the “Selling
Stockholders” section of this prospectus. The selling stockholders and any
broker-dealers that participate in the distribution of the securities are
“underwriters” as that term is defined in Section 2(11) of the Securities Act of
1933, as amended.
The
shares will be sold by the selling stockholders on an immediate and continuing
basis at a fixed price of $1.00 per share. We intend to seek a listing of our
common stock on the Over-The-Counter Bulletin Board (“OTCBB”), which is
maintained by the Financial Industry Regulatory Authority, Inc.
(“FINRA”).
The
shares being offered pursuant to this prospectus involve a high degree of risk.
Persons should not invest unless they can afford to lose their entire
investment. You should carefully read the “Risk Factors” section commencing on
page 6 for information that should be considered in determining whether to
purchase any of the shares.
NEITHER
THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS
APPROVED OR DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE ADEQUACY OR
ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL
OFFENSE.
The date
of this Prospectus is __________, 2010
1
ADDITIONAL
INFORMATION
You
should rely only on the information contained or incorporated by reference in
this prospectus and in any accompanying prospectus supplement. No one has been
authorized to provide you with different information. The shares are not being
offered in any jurisdiction where the offer is not permitted. You should not
assume that the information in this prospectus or any prospectus supplement is
accurate as of any date other than the date on the front of such
documents.
TABLE
OF CONTENTS
Page No.
|
|
INTRODUCTORY COMMENTS
|
3
|
SUMMARY INFORMATION
|
3
|
WHERE YOU CAN FIND MORE
INFORMATION
|
6
|
RISK FACTORS
|
6
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DETERMINATION OF OFFERING PRICE
|
22
|
DILUTION AND OTHER COMPARATIVE PER SHARE
DATA
|
22
|
PRICE RANGE OF COMMON STOCK, RELATED STOCKHOLDER
MATTERS AND ISSUER PURCHASES OF EQUITY
SECURITIES
|
23
|
CAPITALIZATION
|
25
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USE OF PROCEEDS
|
25
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
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26
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BUSINESS
|
31
|
MANAGEMENT
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45
|
EXECUTIVE AND CONSULTANT
COMPENSATION
|
48
|
CERTAIN RELATIONSHIPS AND RELATED
TRANSACTIONS
|
49
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PRINCIPAL STOCKHOLDERS
|
50
|
SELLING STOCKHOLDERS
|
51
|
DESCRIPTION OF SECURITIES
|
57
|
SHARES ELIGIBLE FOR FUTURE
SALE
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60
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INDEMNIFICATION
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61
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PLAN OF DISTRIBUTION
|
62
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EXPERTS
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63
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LEGAL MATTERS
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63
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INDEX TO CONSOLIDATED FINANCIAL
STATEMENTS
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64
|
2
INTRODUCTORY
COMMENTS
Use
of Names
Throughout
this prospectus, the terms “we,” “us,” “our,” “registrant,” “Company” refer to
SignPath Pharma Inc.
SUMMARY
INFORMATION
Our
Company
SignPath
is a development stage biotechnology company founded in May 2006 to develop
proprietary formulations of curcumin, a naturally occurring compound found in
the root of the
Curcuma longa (tumeric) plant, for applications
in malignant diseases.
Curcumin
has an extensive history as an oral medicinal product with safe human use, but
its potential therapeutic benefits have been limited by its low absorption when
taken orally, as well as its inactivation in the liver (due to hepatic
glucuronidation). SignPath intends to develop Investigative New Drug (“IND”)
applications and clinical trials for parenterally (taken into the body in a
manner other than the digestive tract) administered curcumin. We believe that
the liposomal and nano-sized formulations we have licensed could overcome
absorption and hepatic inactivation problems associated with oral administration
of unmodified curcumin extract, based on management’s experience and the
opinions of our consultants to expand its use for concerns, Parkinson’s Disease
and parasitic diseases the Company is developing three different intravenous
nano-particle sized formulations. Proof of efficacy of these formulations
against human tumor xenografts in mice was published. During IND pre-clinical
toxicity trials in dogs with lipsomil curcumin, a dose-dependent hemolysis was
observed, indicating specific dose/schedules of administration will be required
for trials in humans.
SignPath
has licensed two proprietary intravenous formulations containing curcumin as the
active therapeutic agent. The first is a liposomal version licensed from
University of Texas MD Anderson Cancer Center (“UTMDACC”); the second is a
nanosized version licensed from The Johns Hopkins University (“JHU”). The
Company’s near term (next 6 to 12 months) goals are to complete preclinical
development of the first two lead compounds, liposomal curcumin and
nanocurcumin, and file an IND with the FDA to begin Phase I safety studies. The
Company believes its licensed formulations of curcumin change the product from a
naturally occurring one to novel chemical entities making them potentially
patentable. The Company seeks to develop these new products which potentially
will give SignPath proprietary
curcumin preparations with applications in a broad spectrum of malignant
diseases.
The
Company has assembled leaders experienced in pharmacologic development of
natural products to advise it on the development of its curcumin formulations.
This Scientific Advisory Board is comprised of individuals with specific
experience with natural products, formulation development, and malignant
diseases. Expertise in chemistry will come from commercially based product
chemists. Drug development will overseen by Lawrence Helson MD, Chief Executive
Officer, an oncologist with 20 years of pharmaceutical development experience;
Arniban Maitra, Phd, MPPH, of JHU, who has expertise in
nanotechnology, development of nanocurcumin, and testing for antitumor effects;
and Judith
A. Smith, PhD, director of the UTMDACC pre-clinical development group for the
liposomal formulation.
The
Company’s Scientific Advisory Board members all bring relevant experience to the
Company. Professor Tauseef Ahmad, MD is an experienced principal investigator
for lymphoma, myeloma and solid tumor studies. See “Management” below
for more information about our management team and Scientific Advisory Board
members.
Clinical
application strategies will be based upon the advice of the individuals serving
on the Scientific Advisory Board, all of whom have academic and practical
experience in biopharmaceutical fields. We expect that our Phase I and II
clinical trials, if and when conducted, will be run by clinical research
organizations with whom we expect to establish collaborative
relationships.
Our
pre-clinical IND development of liposomal curcumin is scheduled to be run
by the UTMDACC group which has functional pre-clinical IND development
procedures and experience. The JHU group is experienced with non-clinical
development of nanocurcumin; however, the nanocurcumin pre-clinical aspects will
be run by the UTMDACC research and development group. The
latter has experience with curcumin and the capability of
guiding us through the IND development process of both
formulations.
3
During
the fiscal years ended December 31, 2009 and 2008, the Company expended $215,938
and $263,886, respectively, for net research and development. None of these
expenses were borne by customers as the final products are not commercially
available. They consisted primarily of payments made to JHU and Brookwood
Pharmaceuticals under agreements described below.
SignPath
is a publicly held non-listed Delaware corporation with offices in Quakertown,
Pennsylvania in a building owned by our CEO. The Company does not pay rent or
have a lease for its space.
SignPath’s
executive office is located at 1375 California Road, Quakertown, Pennsylvania,
18951. Our telephone number is 215-538-9996.
The
Offering
Securities Issued and
Outstanding:
Common
Stock
|
11,740,000
shares, $.001 par value (“Common Stock”)
|
|
Series
A Convertible Preferred Stock
|
2,412
shares, $.10 par value (“Preferred Stock”) convertible at $.85 per share
into 2,838,924 shares of Common Stock.
|
|
Warrants
|
Exercisable
at $1.27 per share into 2,838,924 of Common Stock
(“Warrants”).
|
|
Placement
Agent Warrants
|
Exercisable
at $.85 per share into 969,335 shares of Common Stock (“Placement Agent
Warrants”).
|
|
Options
|
100,000
shares
|
|
Common
Stock Fully Diluted
|
18,487,183
shares
|
Shares
Offered Hereby:
Between
August 2007 and April 2008, the Registrant completed a Bridge Financing with 15
accredited investors pursuant to which it received total gross proceeds of
$847,500 from the sale of 10% promissory notes and an aggregate of 1,365,000
shares of Common Stock (the “Bridge Shares”). An aggregate of 1,307,500 Bridge
Shares (all except those held by Bruce Meyers, the principal of the placement
agent for the Bridge Financing and the Registrant’s founder, are being
registered for resale hereby.
As of
November 28, 2008, SignPath sold 1451.88 units of its securities at a price of
$1,000 per Unit. Each Unit consists of (i) one share of 6.5% Series A
Convertible Preferred Stock (“Preferred Stock”) convertible into 1,177 shares of
common stock (equivalent to $.85 per share of common stock, hereinafter, the
“Conversion Rate”) following the effective date of this Registration Statement
(the “Effective Date”) subject to adjustment, and (ii) one Warrant to purchase
1,177 shares of common stock at $1.27 per share (the “Warrant Exercise Price”)
for a five-year period following the Effective Date. Between February 19, 2009
and February 11, 2010, pursuant to a new offering dated December 12, 2008,
SignPath sold 835 additional Units of Preferred Stock and Warrants on the same
terms as described above, for gross proceeds of $785,000. Between May 21, 2010
and September 6, 2010, pursuant to a new offering dated April 29, 2010, SignPath
sold 125 additional Units of Preferred Stock and Warrants on the same terms as
described above, for gross proceeds of $125,000 (collectively, the “Preferred
Stock Offering”).
The
Preferred Stock shall be convertible following the Effective Date, at the
Company’s option, into common stock, and the Warrants shall be subject to
redemption, upon 30 days’ written notice, if the Company’s common stock trades
above 200% of the Conversion Rate in the case of the Preferred Stock and $1.70
per share in the case of the Warrants, for 20 consecutive trading
days.
4
This
registration statement of the Company is for the purpose of allowing Selling
Stockholders to resell their shares at their own discretion. The Company’s
initial registration statement on Form S-1 (No. 333-158474) was declared
effective by the SEC on August 10, 2009. This Registration Statement also serves
as a post-effective amendment to its initial registration statement pursuant to
Rule 429(b) under the Securities Act. No founders’ shares or any other shares of
common stock held by affiliates are being registered for resale. The selling
stockholders are the retail accredited investors in the Company’s Bridge
Financing and Preferred Stock Offering, for whom the Company agreed to file this
registration statement. None of the Units or Bridge Shares purchased by
affiliates of the Company are being registered. Thus, an aggregate of 1,507,500
Bridge Shares, 2,326,974 shares of common stock issuable upon conversion of
Preferred Stock and 2,326,974 shares of common stock issuable upon exercise of
Warrants, or an aggregate of 6,161,448 shares of Common Stock are registered for
resale hereby.
The
Company shall receive no consideration, directly or indirectly, in connection
with the future sale of the shares registered under this Registration Statement
by selling stockholders. There is no dilutive impact of this Offering until any
warrants are exercised at 150% of the Conversion Rate of the Preferred Stock.
See “Description of Securities” below.
Summary
Financial Information
The summary financial information set
forth below is derived from the more detailed audited and unaudited financial
statements of the Company appearing elsewhere in this prospectus. This
information should be read in conjunction with such financial statements,
including the notes to such financial statements.
Statement
of Operations Data:
From
Inception
|
||||||||||||||||||||
Six Months Ended
|
Years Ended
|
May 15, 2006
|
||||||||||||||||||
June 30,
|
December 31,
|
Through
|
||||||||||||||||||
2010
|
2009
|
2009
|
2008
|
June 30,
|
||||||||||||||||
(Unaudited)
|
(Unaudited)
(Restated)
|
(Restated)
|
2010
|
|||||||||||||||||
Revenue
|
$ | - | $ | - | $ | - | $ | - | $ | - | ||||||||||
Total
Operating Expenses
|
(690,415 | ) | (445,896 | ) | (612,098 | ) | (1,631,771 | ) | (3,461,115 | ) | ||||||||||
Grant
income
|
40,784 | - | 40,773 | - | 81,557 | |||||||||||||||
Loss
on derivative liability
|
(137,560 | ) | (115,580 | ) | (159,418 | ) | - | (340,786 | ) | |||||||||||
Interest
Expense
|
- | - | - | (63,995 | ) | (63,995 | ) | |||||||||||||
Net
Loss
|
$ | (787,191 | ) | $ | (561,476 | ) | $ | (730,743 | ) | $ | (1,695,766 | ) | $ | (3,784,339 | ) | |||||
Basic
and Diluted
|
||||||||||||||||||||
Loss
Per Share
|
$ | (0.07 | ) | $ | (0.05 | ) | $ | (0.06 | ) | $ | (0.15 | ) | ||||||||
Weighted
Average Number
|
||||||||||||||||||||
of
Shares Outstanding
|
11,373,149 | 11,340,000 | 11,340,000 | 11,174,651 |
Balance
Sheet Data:
June 30,
|
December 31,
|
|||||||||||||||
2010
|
2009
|
2008
|
2007
|
|||||||||||||
(Unaudited)
|
(Restated)
|
|||||||||||||||
Current
Assets
|
$ | 64,699 | $ | 295,418 | $ | 181,128 | $ | 2,854 | ||||||||
Total
Assets
|
68,005 | 297,818 | 184,328 | 6,854 | ||||||||||||
Accounts
payable and accrued expenses
|
162,784 | 117,967 | 76,999 | 304,812 | ||||||||||||
Derivative
liability
|
3,027,055 | 2,824,603 | - | - | ||||||||||||
Additional
Paid-In Capital
|
650,535 | 340,831 | 2,318,442 | 218,617 | ||||||||||||
Accumulated
Deficit
|
(3,784,341 | ) | (2,997,150 | ) | (2,222,599 | ) | (526,833 | ) | ||||||||
Stockholders’
Equity (Deficit)
|
(3,121,834 | ) | (2,644,752 | ) | 107,329 | (297,958 | ) | |||||||||
Total
Liabilities and Stockholders’ Equity
|
$ | 68,005 | $ | 297,818 | $ | 184,328 | $ | 6,854 |
5
WHERE
YOU CAN FIND MORE INFORMATION
We
will distribute annual reports to our stockholders, including financial
statements examined and reported on by independent certified public accountants.
We also will provide you without charge, upon your request, with a copy of any
or all reports and other documents we file with the SEC, as well as any or all
of the documents incorporated by reference in this prospectus or the
registration statement we filed with the SEC registering for resale the shares
of our common stock being offered pursuant to this prospectus, other than
exhibits to such documents unless such exhibits are specifically incorporated by
reference into such documents. Requests for such copies should be directed to
Dr. Lawrence Helson, the Company’s Chief Executive Officer, at SignPath Pharma
Inc., 1375 California Road, Quakertown, PA 18951; telephone (215) 538-9946; fax:
215-538-1245; URL:www.signpathpharma.com.
We have
filed a registration statement on Form S-1 with the SEC registering under
the Securities Act the common stock that may be distributed under this
prospectus. This prospectus, which is a part of such registration statement,
does not include all of the information contained in the registration statement
and its exhibits. For further information regarding us and our common stock, you
should consult the registration statement and its exhibits.
Statements
contained in this prospectus concerning the provisions of any documents are
summaries of those documents, and we refer you to the documents filed with the
SEC for more information. The registration statement and any of its amendments,
including exhibits filed as a part of the registration statement or an amendment
to the registration statement, are available for inspection and copying as
described above.
RISK
FACTORS
The
securities offered hereby are speculative, involve a high degree of risk and
should only be purchased by persons who can afford to lose their entire
investment. Prospective purchasers should carefully consider, among other
things, the following risk factors relating to the business of the Company and
this offering prior to making any investment. You are strongly urged to consult
with professional financial advisors, accountants, and lawyers in evaluating
this investment and making an independent and informed decision about whether or
not to invest your money in this offering.
Risks
Related to Our Company
History
of significant losses and risk of losing entire investment.
The
Company’s financial statements reflect that it has incurred significant losses
since inception, including net losses of $730,743 and $1,695,766 for the years
ended December 31, 2009 and 2008 and a loss from inception through June 30, 2010
of $3,784,341. The Company expects to continue to have losses and negative cash
flows for the foreseeable future, and it is possible that the Company may never
reach profitability. Therefore, there is a significant risk that public
investors may lose some or all of their investment.
Our
financial statements have been prepared assuming that the Company will continue
as a going concern.
Our
audited financial statements for the fiscal year ended December 31, 2009
have been prepared assuming the Company will continue as a going concern. As
discussed in Note 1 to the financial statements for the period ended December
31, 2009, the continuation of the Company as a going concern is dependent upon
the continued financial support from its shareholders, the ability to raise
equity or debt financing, and the attainment of profitable operations from the
Company’s planned business. Our independent registered public accounting firm
has included an explanatory paragraph expressing substantial doubt about our
ability to continue as a going concern in their audit report for the fiscal year
ended December 31, 2009. If we are unable to raise additional capital or borrow
money we will not be able to complete and file INDs with the FDA in order to
commence clinical trials. If that were to occur the Company would be forced to
suspend or terminate operations and, in all likelihood cause investors to lose
their entire investment.
6
We
are a development stage company, making it difficult for you to evaluate our
business and your investment.
We are in
the development stage and our operations and the development of our proposed
products are subject to all of the risks inherent in the establishment of a new
business enterprise, including:
|
·
|
the
absence of an operating history;
|
|
·
|
the
lack of commercialized products;
|
|
·
|
an
expected reliance on third parties for the development and
commercialization of some of our proposed
products;
|
|
·
|
uncertain
market acceptance of our proposed products;
and
|
|
·
|
reliance
on key personnel
|
Because
we are subject to these risks, you may have a difficult time evaluating our
business and your purchase of our securities.
No
revenue for the foreseeable future, with substantial losses and no guarantee of
profitability.
At this
stage of its growth cycle, the Company has a limited operating history and no
revenues, products ready for market, customers or marketing
resources.
As a
development stage company, the Company has a limited relevant operating history
upon which an evaluation of its prospects can be made. Such prospects must be
considered in light of the risks, expenses and difficulties frequently
encountered in establishing a new business in the evolving and heavily-regulated
pharmaceuticals industry, which is characterized by an ever-increasing number of
market entrants, intense competition and high failure rate. In addition,
significant challenges are often encountered in shifting from developmental to
commercial activities.
In
addition, we are subject to many business risks, including but not limited to,
unforeseen capital requirements, failure of market acceptance, failure to
establish business relationships, and competitive disadvantages against larger
and more established companies. In addition, there can be no assurance that the
Company will ever be able to generate revenues or, if the Company generates
revenues, that it will ever be profitable, or that the Company will be able to
obtain sufficient additional funds to continue its planned activities.
Therefore, prospective investors may lose all or a portion of their investment.
The Company does not anticipate that it will have any revenues for the
foreseeable future.
Concentration
of ownership by a Founder and its affiliates raises a potential conflict of
interest between the Company, a Founder and certain of their
employees.
Bruce
Meyers, a Founder of the Company and President of Meyers Associates, owns
2,657,500 shares (22.6%) and Meyers Associates owns 2,200,000 shares (18.7%) of
the 11,740,000 outstanding shares of the Company’s common stock and Imtiaz Khan,
Managing Director of Meyers Associates owns 2,450,000 shares (20.9% of the
Company). This concentration of ownership may not be in the best interests of
the Company’s stockholders and Meyers Associates and may be subject to potential
conflicts of interest. As a result of Meyers Associates’ ownership of the
Company, it is likely that in the event the Company becomes a publicly-traded
company, Meyers Associates’ would not be able to serve as a market maker in the
Company’s common stock. See “Principal Stockholders.”
The
Company does not have the financing resources necessary to successfully complete
development and market any formulations of curcumin.
As of
June 30, 2010, the Company had $64,699 cash on hand. The Company does not have
any current sources of financing, to complete product development and marketing.
If the Company is unable to attract sufficient additional capital, it will not
be able to realize its growth plans. If the Company does find such financing, it
may be on terms that are unfavorable or dilutive, to owners of the Company’s
equity securities.
7
Our drug
development program will require substantial additional capital to successfully
complete it, arising from costs to:
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complete
research, preclinical testing and human
studies;
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establish
pilot scale and commercial scale manufacturing processes;
and
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establish
and develop quality control, regulatory, marketing, sales and
administrative capabilities to support these
programs.
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Our
future operating and capital needs will depend on many factors,
including:
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the
pace of scientific progress in our research and development programs and
the magnitude of these programs;
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the
scope and results of preclinical testing and human
studies;
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the
time and costs involved in obtaining regulatory
approvals;
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the
time and costs involved in preparing, filing, prosecuting, maintaining and
enforcing patent claims;
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competing
technological and market
developments;
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our
ability to establish additional
collaborations;
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changes
in our existing collaborations;
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the
cost of manufacturing scale-up; and
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the
effectiveness of our commercialization
activities.
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We base
our outlook regarding the need for funds on many uncertain variables. Such
uncertainties include regulatory approvals, the timing of events outside our
direct control such as negotiations with potential strategic partners and other
factors. Any of these uncertain events can significantly change our cash
requirements as they determine such one-time events as the receipt of major
milestones and other payments.
We cannot
be certain that additional funding will be available on acceptable terms, or at
all. To the extent that we raise additional funds by issuing equity securities,
our stockholders may experience significant dilution. Any debt financing, if
available, may involve restrictive covenants that impact our ability to conduct
our business. If we are unable to raise additional capital, when required, or on
acceptable terms, we may have to significantly delay, scale back or discontinue
the development and/or the commercialization of one or more of our product
candidates. Accordingly, any failure to raise adequate capital in a timely
manner would have a material adverse effect on our business, operating results,
financial condition and future growth prospects.
Additional
funds are required to support our operations but we may be unable to obtain them
on favorable terms, we would be required to cease or reduce further development
or commercialization of our potential products.
We
will need to increase the size of our organization, and we may experience
difficulties in managing growth.
We are a
small company with one full-time employee, our CEO, as of
the date of this prospectus. To conduct our clinical trials and commercialize
our product candidates, we will need to expand our employee base for managerial,
operational, financial and other resources. Future growth will impose
significant added responsibilities on members of management, including the need
to identify, recruit, maintain and integrate additional employees. Our future
financial performance and our ability to commercialize our product candidates
and to compete effectively will depend, in part, on our ability to manage any
future growth effectively.
8
The
Company’s success is highly dependent on attracting and retaining key scientific
and management personnel, but the Company may be unable to do so.
The
Company’s future depends on the service of its scientific and management teams
and other key personnel. The Company may be unable to attract highly qualified
personnel, especially if it is unable to demonstrate to those individuals that
it has sufficient funding to adequately compensate them either through current
cash salary or with equity that could eventually have substantial value. If the
Company is unable to attract highly qualified individuals, the Company may be
unable to continue development or commercialization efforts of its proposed
products which would have a material adverse effect on the Company’s
operations.
We
have no experience in manufacturing, sales, marketing or distribution
capabilities.
The
Company has no experience in manufacturing, selling, marketing or distributing
any formulations of curcumin or any other product. The Company has outsourced
production of raw materials for production of liposomal curcumin and will
outsource production of good manufacturing practice (“GMP”) grade of liposomal
curcumin and nanocurcumin to commercial facilities. There can be no assurance
that the Company will be able successfully to sell, market, commercialize or
distribute any formulation of curcumin or any other products at any time in the
future.
Provisions
in our charter documents and Delaware law could discourage or prevent a
takeover, even if an acquisition would be beneficial to our
stockholders.
Provisions
of our certificate of incorporation and by-laws, as well as provisions of
Delaware law, could make it more difficult for a third party to acquire us, even
if doing so would be beneficial to our stockholders. These provisions
include:
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authorizing
the issuance of “blank check” preferred that could be issued by our Board
of Directors to increase the number of outstanding shares and thwart a
takeover attempt;
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prohibiting
cumulative voting in the election of directors, which would otherwise
allow less than a majority of stockholders to elect director candidates;
and
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advance
notice provisions in connection with stockholder proposals that may
prevent or hinder any attempt by our stockholders to bring business to be
considered by our stockholders at a meeting or replace our board of
directors.
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If
we lose the services of our Chief Executive Officer, our operations would be
disrupted and our business could be harmed
Our
business plan relies significantly on the continued services of our CEO, Dr.
Larry Helson, age 77. If we were to lose his services, our ability to continue
to execute our business plan would be materially impaired. While we have entered
into an employment agreement with Dr. Helson, the agreement would not prevent
him from terminating his employment with us. Dr. Helson has not indicated he
intends to leave the Company, and we are not currently aware of any facts or
circumstances that suggest he might leave us.
Risks
Related to Our Business
We
are devoting our efforts to a limited number of product candidates, and there is
no assurance of product success.
The
Company is an early stage biopharmaceutical company and, since its inception,
has focused mainly on research and development. There can be no assurance that
the Company will ever successfully develop liposomal curcumin, nanocurcumin, or
any other formulation of curcumin or any product whatsoever, or obtain FDA
approval for clinical testing in the United States or any other
country.
9
Our two
curcumin formulations in development will require extensive additional
development, including preclinical testing and human studies, as well as
regulatory approvals, before we can commercialize and market them. We cannot
predict if or when any of the product candidates we are developing will be
approved for marketing. There are many reasons that we may fail in our efforts
to develop our potential products, including the possibility that:
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preclinical
testing or human studies may show that our potential products are
ineffective or cause harmful side
effects;
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the
products may fail to receive necessary regulatory approvals from the FDA
in a timely manner, or at all;
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the
products, if approved, may not be produced in commercial quantities or at
reasonable costs;
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the
potential products, once approved, may not achieve commercial
acceptance;
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regulatory
or governmental authorities may apply restrictions to our potential
products, which could adversely affect their commercial success;
or
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the
proprietary rights of other parties may prevent us from marketing our
potential products.
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Given our
limited focus on two product candidates, if these product candidates do not
prove successful in clinical trials, and are not approved or are not
commercialized because we have insufficient resources for continued development
or for any other reason, we may be required to suspend or discontinue our
operations and our business could be materially harmed.
SignPath
depends on intellectual property licensed from third parties which it may not be
able to maintain.
The
Company’s business plan depends on developing products based on intellectual
property licensed from The Johns Hopkins University (“JHU”) and The University
of Texas MD Anderson Cancer Center (“UTMDACC”). See “Business - Intellectual
Property.” The Company’s license agreements require the Company to
make payments to the licensors in the future. The Company currently does not
have sufficient resources to make all of such payments, and there can be no
assurance that the Company will be able to make such payments in the
future.
The
Company’s exclusive license with UTMDACC is for the life of patent rights or, if
no patent rights are issued, for up to 30 years; however, is terminable upon 30
days’ written notice if the Company fails to cure a breach of payment or funding
requirement, or upon up to 90 days’ written notice for any other breach of
contract by the Company.
The
Company’s license agreement with JHU is for the life of the last patent to
expire or 20 years if no patents issue. It is terminable for a breach of
contract by SignPath not cured within 30 days after receipt of
notice.
Additional
patents and pending patent applications filed by third parties, if issued, may
cover aspects of products the Company intends to develop or may develop and test
in the future. As a result, the Company may be required to obtain additional
licenses from third-party patent holders in order to use, manufacture or sell
the Company’s product candidates.
There can
be no assurance that the Company’s current arrangements with JHU or UTMDACC, or
any future arrangements will lead to the development of any products with any
commercial potential, that the Company will be able to obtain proprietary rights
or licenses for proprietary rights with respect to any technology development in
connection with these arrangements or that the Company will be able to ensure
the confidentiality of any proprietary rights and information developed with JHU
or UTMDACC will prevent the public disclosure thereof. The Company is not aware
of any litigation, threatened litigation, or challenge to intellectual property,
however, once any patents are issued to the Company, we may be subject to future
litigation.
There can
be no assurance that the Company will be able to maintain its existing license
agreements or obtain additional necessary licenses on reasonably acceptable
terms or at all. The Company’s inability to maintain its existing licenses or
obtain additional licenses on acceptable terms would have a material adverse
effect on the Company’s business, financial condition and results of
operations.
10
The
US FDA regulatory process is costly, lengthy and requires specific
expertise.
The
Company will rely initially on consultants and service organizations with prior
experience working with the FDA to guide the product through the regulatory
process. The Company expects to hire experienced employees and/or consultants to
analyze, prepare and present Investigational New Drug (“IND”) applications to
the FDA and conduct clinical trials. The process of obtaining regulatory
approvals can be extremely costly and time-consuming, and there is no guarantee
of success. If the Company does not receive approval of any of its IND
applications, it will not be able to proceed with Phase I clinical testing. In
addition, clinical testing is not predictable. Even if the FDA approves an IND
application, the Company cannot guarantee that the FDA will approve Phase I
clinical results. The Company’s failure to obtain required regulatory approvals
would have a material adverse effect on the Company’s business, financial
condition and results of operations and could require the Company to curtail or
cease its operations.
Delays
in clinical testing could result in increased cost to us and delay our ability
to generate revenue.
We may
experience delays in clinical testing of our product candidates. We do not know
whether planned clinical trials will need to be redesigned or will be completed
on schedule, if at all. Clinical trials can be delayed for a variety of reasons,
including delays in obtaining regulatory approval to commence a trial, in
reaching agreement on acceptable clinical trial terms with prospective sites, in
obtaining institutional review board approval to conduct a trial at a
prospective site, in recruiting patients to participate in a trial or in
obtaining sufficient supplies of clinical trial materials. Many factors affect
patient enrollments, including the size of the patient population, the proximity
of patients to clinical sites, the eligibility criteria for the trial, competing
clinical trials and new drugs approved for the conditions we are investigating.
Prescribing physicians will also have to decide to use our product candidates
over existing drugs that have established safety and efficacy profiles. Any
delays in completing our clinical trials will increase our cost, slow down our
product development and approval process and delay our ability to generate
revenue.
We
may be required to suspend or discontinue clinical trials due to unexpected side
effects or other safety risks that could preclude approval of our product
candidates.
Our
clinical trials may be suspended at any time for a number of reasons. For
example, we may voluntarily suspend or terminate our clinical trials if at any
time we believe that they present an unacceptable risk to the clinical trial
patients. In addition, regulatory agencies may order the temporary or permanent
discontinuation of our clinical trials at any time if they believe that the
clinical trials are not being conducted in accordance with requirements or that
they present an unacceptable safety risk to the clinical trial
patients.
The
Company has not encountered any adverse effects in mice or rats with liposomal
curcumin or nanocurcumin. However, studies in humans have not yet been initiated
by the Company. Administering any product candidates to humans may produce
undesirable side effects. These side effects could interrupt, delay or halt
clinical trials of our product candidates and could result in the FDA or other
regulatory authorities denying further developments or approval of our product
candidates for any or all targeted indications. Ultimately, some or all of our
product candidates may prove to be unsafe for human use. Moreover, we could be
subject to significant liability if any volunteer or patient suffers, or appears
to suffer, adverse health effects as a result of participating in our clinical
trials.
If
testing of a particular product candidate does not yield successful results,
then we will be unable to commercialize that product.
Our
product candidates in clinical trials must meet rigorous testing standards. We
must demonstrate the safety and efficacy of our potential products through
extensive preclinical and clinical testing. Clinical trials are subject to
continuing oversight by governmental regulatory authorities, such as the FDA,
and institutional review boards and must meet the requirements of these
authorities in the United States, including those for informed consent and good
clinical practices. We may not be able to comply with these requirements, which
could disqualify completed or ongoing clinical trials. We may experience
numerous unforeseen events during, or as a result of, the testing process that
could delay or prevent commercialization of our product candidates, including
the following:
11
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safety
and efficacy results from human clinical trials may show the product
candidate to be less effective or safe than desired or those results may
not be replicated in later clinical
trials;
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the
results of preclinical studies may be inconclusive or they may not be
indicative of results that will be obtained in human clinical
trials;
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after
reviewing relevant information, including preclinical testing or human
clinical trial results, we may abandon or substantially restructure
projects that we might previously have believed to be
promising;
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we
or the FDA may suspend or terminate clinical trials if the participating
patients are being exposed to unacceptable health risks or for other
reasons; and
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the
effects of our product candidates may not be the desired effects or may
include undesirable side effects or other characteristics that interrupt,
delay or cause us or the FDA to halt clinical trials or cause the FDA or
foreign regulatory authorities to deny approval of the product candidate
for any or all target indications.
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Data from
our completed clinical trials, when and if completed, may not be sufficient to
support approval by the FDA. The clinical trials of our product candidates may
not be completed as or when planned, and the FDA may not approve any of our
product candidates for commercial sale. If we fail to demonstrate the safety or
efficacy of a product candidate to the satisfaction of the FDA, this will delay
or prevent regulatory approval of that product candidate. Therefore, any delay
in obtaining, or inability to obtain, FDA approval of any of our product
candidates could materially harm our business and cause our stock price to
decline.
Even
if we receive regulatory approval for our product candidates, we will be subject
to ongoing significant regulatory obligations and oversight.
If we
receive regulatory approval to sell our product candidates, the FDA and foreign
regulatory authorities may, nevertheless, impose significant restrictions on the
indicated uses or marketing of such products, or impose ongoing requirements for
post-approval studies. If we fail to comply with applicable regulatory
requirements, we may be subject to fines, suspension or withdrawal of regulatory
approvals, product recalls, seizure of products, operating restrictions and
criminal prosecution. Any of these events could harm or prevent sales of the
affected products or could substantially increase the costs and expenses of
commercializing and marketing these products. In addition, if any of our product
candidates receive marketing approval and we or others later identify
undesirable side effects caused by the product, we could face one or more of the
following:
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a
change in the labeling statements or withdrawal of FDA or other regulatory
approval of the product;
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a
change in the way the product is administered;
or
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the
need to conduct additional clinical
trials.
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Discovery
after approval of previously unknown problems with our products, manufacturers
or manufacturing processes, or failure to comply with regulatory requirements,
may result in actions such as:
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restrictions
on such products’ manufacturers or manufacturing
processes;
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restrictions
on the marketing of a product;
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warning
letters;
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withdrawal
of the products from the market;
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refusal
to approve pending applications or supplements to approved applications
that we submit;
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recall
of products;
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12
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fines,
restitution or disgorgement of profits or
revenue;
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suspension
or withdrawal of regulatory
approvals;
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refusal
to permit the import or export of our
products;
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product
seizure;
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injunctions;
or
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imposition
of civil or criminal penalties.
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Our
potential products face significant regulatory hurdles prior to
commercialization and marketing which could delay or prevent sales;
No assurance of FDA approval.
The FDA
and comparable agencies in foreign countries impose substantial requirements
upon the introduction of therapeutic and diagnostic pharmaceutical and
biological products through lengthy and detailed laboratory and clinical testing
procedures, sampling activities and other costly and time-consuming procedures.
Satisfaction of these requirements typically takes several years or more and
varies substantially based upon the type, complexity and novelty of the product.
The regulatory review may result in extensive delay in the regulatory approval
process. Regulatory requirements ultimately imposed could adversely affect the
Company’s ability to clinically test, manufacture or market potential products.
Government regulation also applies to the manufacture of pharmaceutical and
biological products.
Before we
obtain the approvals necessary to sell any of our potential products, we must
show through preclinical studies and human testing that each potential product
is safe and effective. Failure to show any potential product’s safety and
effectiveness would delay or prevent regulatory approval of the product and
could adversely affect our business. The clinical trials process is complex and
uncertain. The results of preclinical studies and initial clinical trials may
not necessarily predict the results from later large-scale clinical trials. In
addition, clinical trials may not demonstrate a potential product’s safety and
effectiveness to the satisfaction of the regulatory authorities. A number of
companies have suffered significant setbacks in advanced clinical trials or in
seeking regulatory approvals, despite promising results in earlier
trials.
The rate
at which we complete our clinical trials depends on many factors, including our
ability to obtain adequate supplies of the potential products to be tested and
patient enrollment. Patient enrollment is a function of many factors, including
the size of the patient population, the proximity of patients to clinical sites
and the eligibility criteria for the trial. Delays in patient enrollment may
result in increased costs and longer development times. In addition, under our
license agreements with UTMDACC and JHU, these universities have certain rights
to control product development and clinical programs for products developed
under the collaborations. As a result, the universities may conduct these
programs more slowly or in a different manner than we had expected. Even if
clinical trials are completed, we or the universities still may not apply for
FDA approval in a timely manner or the FDA still may not grant
approval.
We
will not have our own manufacturing facilities and will depend on third
parties.
The
Company has entered into a manufacturing agreement with Polymun Scientific
Immunbiologische Forschung GmBh, Vienna, Austria, to encapsulate pure synthetic
curcumin with lipid particles. We have also entered into a contract with
Brookwood Pharmaceutical Inc. (now known as Surmodics Pharmaceuticals, Inc.) to
synthesize polymer for noncurcumin. Notwithstanding the foregoing, the Company
cannot guarantee that it will be able to obtain adequate supplies of liposomal
curcumin or nanocurcumin that will remain stable for clinical trials and in
amounts that will be sufficient for clinical trials and post-approval commercial
production, if any. If the Company fails to source adequate amounts of curcumin,
or if there is poor manufacturing performance on the part of the above-stated
third party manufacturers, we may not be able to complete development of our
product candidates, which could have an adverse effect on the Company’s
business, financial condition and results of operations and could require the
Company to curtail or cease its operations.
13
Competition
in the biotechnology and pharmaceutical industries is intense, and if SignPath
fails to compete effectively its financial results will suffer.
SignPath’s
business environment is characterized by extensive research efforts, rapid
developments and intense competition. Its competitors may have or may develop
superior technologies or approaches to the development of competing products,
which may provide them with competitive advantages. The Company’s potential
curcumin product candidates may not compete successfully. The Company believes
that successful competition in its industry depends on product efficacy, safety,
reliability, availability, timing, scope of regulatory approval, acceptance and
price, among other things. Important factors to SignPath’s success also include
speed in developing product candidates, completing clinical development and
laboratory testing, obtaining regulatory approvals and manufacturing and selling
commercial quantities of potential products to the market.
The
Company expects competition to increase as technological advances are made and
commercial applications broaden. In the event it develops its initial product
candidates and any additional product candidates, the Company anticipates it
will face substantial competition from pharmaceutical, biotechnology and other
companies, universities and research institutions. The Company is aware of other
companies and academic groups that focus on cellular signal transduction
pathways and are developing specific pathway or related kinase inhibitors. These
competitors include Exelixis Inc., Onyx Pharmaceuticals, and several major
pharmaceutical companies.
Many of
the Company’s competitors have substantially greater capital resources, research
and development staffs, facilities and experience in conducting clinical trials
and obtaining regulatory approvals, as well as in manufacturing and marketing
pharmaceutical products. In addition, many of SignPath’s competitors may achieve
product commercialization or patent protection earlier than SignPath achieves
commercialization or patent protection, if at all.
If we or
our collaborators receive regulatory approvals for our product candidates, some
of our products will compete with well-established, FDA-approved therapies that
have generated substantial sales over a number of years. In addition, we will
face competition based on many different factors, including:
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the
safety and effectiveness of our
products;
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the
timing and scope of regulatory approvals for these
products;
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the
availability and cost of manufacturing, marketing and sales
capabilities;
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the
effectiveness of our marketing and sales
capabilities;
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the
price of our products;
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the
availability and amount of third-party reimbursement;
and
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the
strength of our patent position.
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We also
anticipate that we will face increased competition in the future as new
companies enter our target markets and scientific developments surrounding
cancer therapies and drugs for treatment of inflammatory conditions continue to
accelerate. Competitors may develop more effective or more affordable products,
or may achieve patent protection or commercialize products before us or our
collaborators. In addition, the health care industry is characterized by rapid
technological change. New product introductions, technological advancements, or
changes in the standard of care for our target diseases could make some or all
of our products obsolete.
The
Company may be unable to defend or protect its intellectual
property.
The
Company intends to protect its intellectual property through patents and
trademarks. The patent positions of biotechnology companies generally are highly
uncertain and involve complex legal and factual questions that will determine
who has the right to develop a particular product or process. As a result, the
Company cannot predict which of its patent applications will result in the
granting of patents or the timing of the granting of the patents. Additionally,
many of the Company’s competitors have significantly greater capital with which
to pursue patent litigation. There can be no assurance that the
Company would have the resources to defend its patents in the face of a
lawsuit.
14
Further,
the Company relies on trade secrets, know-how and other proprietary information.
The Company seeks to protect this information, in part, through the use of
confidentiality agreements with employees, consultants, advisors and others.
Nonetheless, there can be no assurance that those agreements will provide
adequate protection for the Company’s trade secrets, know-how or other
proprietary information and prevent their unauthorized use or disclosure. While
the Company is not aware of any challenges to its intellectual property, once
any patents are issued to the Company litigation may ensue. There is also the
risk that the Company’s employees, consultants, advisors or others will not
maintain confidentiality of such trade secrets or proprietary information, or
that this information may become known in some other way or be independently
developed by the Company’s competitors.
SignPath
is exposed to product liability risks.
The
Company’s business exposes it to potential product liability risks that are
inherent in the testing, including testing in human clinical trials,
manufacturing, marketing and sale of biotechnology products. There can be no
assurance that product liability claims will not be asserted against the
Company.
We plan
to have product liability insurance covering our clinical trials which we
currently believe will be adequate to cover any product liability exposure we
may have. Clinical trial and product liability insurance is becoming
increasingly expensive. As a result, we may be unable to obtain sufficient
insurance coverage at a reasonable cost to protect us against losses that could
have a material adverse effect on our business. An individual may bring a
product liability claim against us if one of our products or product candidates
causes, or is claimed to have caused, an injury or is found to be unsuitable for
consumer use. Any product liability claim brought against us, with or without
merit, could result in:
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liabilities
that substantially exceed our product liability insurance, which we would
then be required to pay from other sources, if
available;
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an
increase of our product liability insurance rates or the inability to
maintain insurance coverage in the future on acceptable terms, or at
all;
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withdrawal
of clinical trial volunteers or
patients;
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damage
to our reputation and the reputation of our products, resulting in lower
sales;
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regulatory
investigations that could require costly recalls or product
modifications;
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litigation
costs; and
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the
diversion of management’s attention from managing our
business.
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A
successful product liability claim or series of claims brought against the
Company could have a material adverse effect on the Company’s business,
financial condition and results of operation.
The
Company may be sued by third parties who claim that its products infringe on
their intellectual property rights.
The
Company may be exposed to future litigation by third parties based on claims
that its patents, products or activities infringe on the intellectual property
rights of others or that the Company has misappropriated the trade secrets of
others. Any litigation or claims against the Company, whether or not valid,
could result in substantial costs, could place a significant strain on the
Company’s financial and managerial resources, and could harm the Company’s
reputation. In addition, intellectual property litigation or claims could force
the Company to do one or more of the following, any of which could have a
material adverse effect on the Company or cause the Company to curtail or cease
its operations:
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Cease
testing, developing, using and/or commercializing liposomal curcumin,
nanocurcumin, or other formulations of curcumin or other products that it
may develop; or
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Obtain
a license from the holder of the infringed intellectual property right,
which could also be costly or may not be available on reasonable
terms.
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15
SignPath
may be subject to damages resulting from claims that it or its employees have
wrongfully used or disclosed alleged trade secrets of their former
employers.
The
Company’s current employee and/or future employees have been previously employed
by other biotechnology or pharmaceutical companies. Although no claims against
the Company are currently pending or threatened, the Company may be subject to
claims that these employees or the Company have inadvertently or otherwise used
or disclosed trade secrets or other proprietary information of their former
employers. Litigation may be necessary to defend against these claims. Even if
SignPath is successful in defending against these claims, litigation could
result in substantial costs and be a distraction to management. If the Company
fails in defending such claims, in addition to paying money claims, it may lose
valuable intellectual property rights or personnel. A loss of key research
personnel or their work product could hamper or prevent its ability to
commercialize certain product candidates, which could severely harm SignPath’s
business.
Governmental
and third-party payors may impose sales and pharmaceutical pricing restrictions
or controls on SignPath’s potential products that could limit its future product
revenues and adversely affect profitability.
The
commercial success of the Company’s potential products is substantially
dependent on whether third-party reimbursement is available for the ordering of
its products by the medical profession for use by their patients. Medicare,
Medicaid, health maintenance organizations and other third-party payors may not
cover or provide adequate payment for SignPath’s potential products. They may
not view the Company’s potential products as cost-effective and reimbursement
may not be available to consumers or may not be sufficient to allow its
potential products to be marketed on a competitive basis. Likewise, legislative
or regulatory efforts to control or reduce health care costs or reform
government health care programs could result in lower prices or rejection of its
potential products. Changes in reimbursement policies or health care cost
containment initiatives that limit or restrict reimbursement for the Company’s
products may cause its revenue to decline.
Rapid
technological change could make any products that SignPath eventually develops
obsolete.
Biopharmaceutical
technologies have undergone rapid and significant change and the Company expects
that they will continue to do so. Any compounds, products or processes that
SignPath develops may become obsolete or uneconomical before the Company
recovers any expenses incurred in connection with their
development.
We
expect to rely heavily on third party relationships and termination of any of
these programs could reduce the financial resources available to us, including
research funding and milestone payments.
Our
strategy for developing and commercializing many of our potential product
candidates, including products aimed at larger markets, includes entering into
collaborations with research partners, licensors, licensees and others. These
collaborations will provide us with research and development resources for
potential products. These agreements also will give our collaborative partners
significant discretion when deciding whether or not to pursue any development
program. Our collaborations may not be successful. Currently, we have
collaborative relationships with JHU and UTMDACC. See “Business – Intellectual
Property”.
In
addition, JHU and UTMDACC may develop products, either alone or with others,
that compete with the types of drugs they currently are developing with us. This
would result in less support and increased competition for our programs. If
either of our two licensors breach or terminate their agreements with us or
otherwise fail to conduct their collaborative activities successfully, our
product development under these agreements will be delayed or
terminated.
We may
have disputes in the future with JHU and UTMDACC, including disputes concerning
who owns the rights to any technology developed. These and other possible
disagreements between us and our licensors could delay our ability and the
ability of the universities to achieve milestones or our receipt of other
payments. In addition, any disagreements could delay, interrupt or terminate the
collaborative research, development and commercialization of certain potential
products, or could result in litigation or arbitration. The occurrence of any of
these problems could be time-consuming and expensive and could adversely affect
our business.
16
In
general, collaborative agreements provide that they may be terminated under
certain circumstances. There can be no assurance that the Company will be able
to extend either of its agreements with the universities upon their termination
or expiration, or that the Company will be able to enter into new collaborative
agreements with existing or new partners in the future. To the extent the
Company chooses not to or is unable to establish any additional third party
arrangements, it would require substantially greater capital to undertake
research, development and marketing of its proposed products at its own expense.
In addition, the Company may encounter significant delays in introducing its
proposed products into certain markets or find that the development, manufacture
or sale of it proposed products in such markets is adversely affected by the
absence of such third party agreements.
We
will rely on third parties to supply and manufacture our product candidates,
without any direct control over the timing for the supply, production and
delivery of our product candidates, thereby possibly adversely affecting any
future revenues.
We will
rely exclusively and be dependent on certain third party source suppliers to
supply pure synthetic curcumin for our product candidates. Liposomal curcumin is
manufactured in Vienna, Austria under contract with Polymun Scientific
Immunbiologische Forschung GmbH. We have obtained initial quantities of
liposomal curcumin from Sigma Aldrich Fine Chemicals (“SAFC”) and/or Sabinsa,
Inc. of New Jersey. Nanocurcumin will be manufactured by either SAFC or Sabinsa.
The polymer is manufactured by Brookwood Pharmaceuticals in Birmingham, Alabama.
See “Business – Potential Commercialization of Liposomal Curcumin and
Nanocurcumin; and Raw Materials; Supplies.”
If any of
these arrangements terminate, locating additional or replacement suppliers for
these materials may take a substantial amount of time. In addition, we may have
difficulty obtaining similar supplies from other suppliers that are acceptable
to the FDA. If we have to switch to a replacement supplier, we may face
additional regulatory delays and the manufacture and delivery of our product
candidates could be interrupted for an extended period of time, which may delay
completion of our clinical trials or commercialization of our product
candidates. As a result, regulatory approval of our product candidates may not
be received at all. All these delays could cause delays in commercialization of
our product candidates, delays in our ability to generate revenue, and increase
our costs.
Further,
our contract manufacturers must comply with current Good Manufacturing
Practices, or cGMPs, and other government regulations, which may limit the
available sources of our needed supplies. The FDA periodically inspects
manufacturing facilities, including third parties who manufacture products or
active ingredients for us. The FDA may not believe that the chosen manufacturers
have sufficient experience making the dosage forms that we have contracted with
them to produce, and may subject those manufacturers to increased scrutiny.
Pharmaceutical manufacturing facilities must comply with applicable cGMPs, and
manufacturers usually must invest substantial funds, time and effort to ensure
full compliance with these standards. We will not have control over our contract
manufacturers’ compliance with these regulations and standards. Failure to
comply with applicable regulatory requirements can result in sanctions, fines,
delays or suspensions of approvals, seizures or recalls of products, operating
restrictions, manufacturing interruptions, costly corrective actions,
injunctions, adverse publicity against us and our products and possible criminal
prosecutions.
We
will rely on third parties to conduct our clinical trials. If these third
parties do not successfully carry out their contractual duties or meet expected
deadlines, we may not be able to seek or obtain regulatory approval for or
commercialize our product candidates.
We will
need to retain a third party clinical research organization, or CRO, to
implement, provide monitors and manage data for our clinical programs. We and
our CRO are required to comply with current Good Clinical Practices, or GCPs,
regulations and guidelines enforced by the FDA for all of our products in
clinical development. The FDA enforces GCPs through periodic inspections of
trial sponsors, principal investigators and trial sites. In the future, if we or
our CRO fails to comply with applicable GCPs, the clinical data generated in our
clinical trials may be deemed unreliable and the FDA may require us to perform
additional clinical trials before approving our marketing applications. We
cannot assure you that, upon inspection, the FDA will determine that any of our
clinical trials for products in clinical development comply with GCPs. In
addition, our clinical trials must be conducted with products produced under
cGMP regulations, and will require a large number of test subjects. Our failure
to comply with these regulations may require us to repeat clinical trials, which
would delay the regulatory approval process.
17
If CROs
do not successfully carry out their contractual duties or obligations or meet
expected deadlines, if they need to be replaced, or if the quality or accuracy
of the clinical data they obtain is compromised due to the failure to adhere to
our clinical protocols, regulatory requirements or for other reasons, our
clinical trials may be extended, delayed or terminated, and we may not be able
to obtain regulatory approval for or successfully commercialize our product
candidates. As a result, our financial results and the commercial prospects for
our product candidates would be harmed, our costs could increase, and our
ability to generate revenue could be delayed.
The
Orphan Drug Act may provide a competitor with up to seven years of market
exclusivity.
The
Orphan Drug Act was created to encourage companies to develop therapies for rare
diseases by providing incentives for drug development and commercialization. One
of the incentives provided by the act is seven years of market exclusivity for
the first product in a class licensed for the treatment of a rare disease. We
intend to target indications that would be covered by the Orphan Drug Act, and
companies may obtain orphan drug status for therapies that are developed for
this indication. In the event that any competitor of ours is first to obtain FDA
licensure for a competitive product, we could be prevented from obtaining
licensure and marketing our product candidates.
The
commercial success of our product candidates will depend upon the degree of
market acceptance of these products among physicians, patients, health care
payors and the medical community.
Even if a
product candidate is approved for sale by the appropriate regulatory
authorities, physicians may not prescribe our product candidates, in which case
we could not generate revenue or become profitable. Market acceptance by
physicians, healthcare payors and patients will depend on a number of factors,
including:
|
·
|
acceptance
by physicians and patients of each such product as a safe and effective
treatment;
|
|
·
|
cost
effectiveness;
|
|
·
|
adequate
reimbursement by third parties;
|
|
·
|
potential
advantages over alternative
treatments;
|
|
·
|
relative
convenience and ease of administration;
and
|
|
·
|
prevalence
and severity of side effects.
|
We
are subject to critical accounting policies, and we may interpret or implement
required policies incorrectly.
We follow
generally accepted accounting principles for the United States in preparing our
financial statements. As part of this work, we must make many estimates and
judgments about future events. These affect the value of the assets and
liabilities, contingent assets and liabilities, and revenue and expenses that we
report in our financial statements. We believe these estimates and judgments are
reasonable, and we make them in accordance with our accounting policies based on
information available at the time. However, actual results could differ from our
estimates, and this could require us to record adjustments to expenses or
revenues that could be material to our financial position and results of
operations in future periods.
The
obligations associated with being a public company require significant resources
and management attention, which may divert from our business
operations.
We are
subject to the reporting requirements of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”), and the Sarbanes-Oxley Act of 2002, or the
Sarbanes-Oxley Act. The Exchange Act requires that we file annual, quarterly and
current reports with respect to our business and financial condition. The
Sarbanes-Oxley Act requires, among other things, that we establish and maintain
effective internal controls and procedures for financial reporting. As a result,
we will incur significant legal, accounting and other expenses. Furthermore, the
need to establish the corporate infrastructure demanded of a public company may
divert management's attention from implementing our growth strategy, which could
prevent us from improving our business, results of operations and financial
condition. We have made, and will continue to make, changes to our internal
controls and procedures for financial reporting and accounting systems to meet
our reporting obligations as a stand-alone public company. However, the measures
we take may not be sufficient to satisfy our obligations as a public company. In
addition, we cannot predict or estimate the amount of additional costs we may
incur in order to comply with these requirements. We anticipate that these costs
will materially increase our selling, general and administrative
expenses.
18
Section
404 of the Sarbanes-Oxley Act requires annual management assessments of the
effectiveness of our internal control over financial reporting, starting
with the second annual report that we would expect to file with the Securities
and Exchange Commission in March 2011, and may require in the same report,
a report by our independent registered public accounting firm on
the effectiveness of our internal control over financial reporting.
In connection with the implementation of the necessary procedures and
practices related to internal control over financial reporting, we may identify
additional deficiencies. We may not be able to remediate any future
deficiencies in time to meet the deadline imposed by the Sarbanes-Oxley Act for
compliance with the requirements of Section 404. In addition, failure to
achieve and maintain an effective internal control environment could have
a material adverse effect on our business and stock price.
Risks
Related to this Offering
The
value of the Company’s common stock is not certain.
The
conversion price of the Company’s outstanding Preferred Stock and the exercise
price of the warrants were arbitrarily determined through negotiations between
the Company and Meyers Associates and bear no relationship to book value,
assets, earnings, or any other accepted criteria of value. Accordingly, such
prices should not be considered as indications of the actual value of our
securities. The Company cannot assure that these prices will accurately reflect
the value of the Company’s common stock once it is publicly traded or that these
prices will be realized upon disposition of the Company’s common
stock.
Absence
of a public market for the securities offered hereby will lack
liquidity.
There is
currently no public market for any of the Company’s securities and there can be
no assurance that a public market will develop in the future. Once this
Registration Statement is declared effective, in the event there is no active
trading market for the Company’s securities, an investor may be unable to
liquidate an investment in the shares and, therefore, should be prepared to bear
the economic risk of an investment in the shares for an indefinite period and to
withstand a total loss of investment. Rule 144 promulgated under the Securities
Act requires, among other conditions, a six month holding period prior to the
resale of securities acquired in a non-public offering without having to satisfy
the registration requirements of the Securities Act. In the event we do not have
sufficient financial and human resources in the future, we may not be able to
fulfill our reporting requirements under the Exchange Act or disseminate to the
public any current financial or other information concerning the Company, as
required by Rule 144 as one of the conditions of its availability. In such event
we will not be absolved from liability for our failure to file these
reports.
If
our common stock is traded on the OTC Bulletin Board, which is not a national
securities exchange, it may be detrimental to investors
We intend
to seek to have our shares of common stock traded on the OTC Bulletin Board
maintained by FINRA. Although there is currently no market for our securities,
securities traded on the OTC Bulletin Board, as compared to the national
securities exchanges, generally have limited trading volume and exhibit a wide
spread between the bid/ask quotations. We cannot predict whether a more active
market for our common stock will develop in the future. In the absence of an
active trading market: investors may have difficulty buying and selling our
common stock or obtaining market quotations; market visibility for our common
stock may be limited; and a lack of visibility for our common stock may have a
depressive effect on the mark price for our common stock.
Preferred
Stock as an anti-takeover device
We are
authorized to issue 5,000,000 shares of preferred stock, $0.10 par value. The
preferred stock may be issued in series from time to time with such designation,
voting and other rights, preferences and limitations as our Board of Directors
may determine by resolution. Unless the nature of a particular transaction and
applicable status require such approval, the Board of Directors has the
authority to issue these shares without stockholder approval subject to approval
of the holders of our preferred stock. The issuance of preferred stock may have
the effect of delaying or preventing a change in control of the Company without
any further action by our stockholders.
19
Series
A Preferred Stock may make it difficult to obtain additional
funding
The
approval of the holders of a majority of the Series A Preferred Stock is
required for the Company to issue any capital stock with rights on parity with
or senior to Series A Preferred Stock. While this limitation is designed to
protect existing investors in a liquidation or dissolution of the Company, it
would also make it more difficult to obtain additional funding in the event the
Company’s financial or business condition has deteriorated.
Our
common stock will be subject to restrictions on sales by broker-dealers and
penny stock rules, which may be detrimental to investors.
Our
common stock will be subject to Rules 15g-1 through 15g-9 under the
Exchange Act, which imposes certain sales practice requirements on
broker-dealers who sell our common stock to persons other than established
customers and “accredited investors” (as defined in Rule 501(a) of the
Securities Act). For transactions covered by this rule, a broker-dealer must
make a special suitability determination for the purchaser and have received the
purchaser’s written consent to the transaction prior to the sale. This
rule adversely affects the ability of broker-dealers to sell our common
stock and purchasers of our common stock to sell their shares of our common
stock.
Additionally,
our common stock is subject to SEC regulations applicable to “penny stocks.”
Penny stocks include any non-exchange listed equity security that has a market
price of less than $5.00 per share, subject to certain exceptions. The
regulations require that prior to any non-exempt buy/sell transaction in a penny
stock, a disclosure schedule proscribed by the SEC relating to the penny stock
market must be delivered by a broker-dealer to the purchaser of such penny
stock. This disclosure must include the amount of commissions payable to both
the broker-dealer and the registered representative and current price quotations
for our common stock. The regulations also require that monthly statements be
sent to holders of a penny stock that disclose recent price information for the
penny stock and information of the limited market for penny stocks. These
requirements adversely affect the market liquidity of our common
stock.
A
significant number of our shares are eligible for sale, and their sale could
depress the market price of our stock.
Sales of
a significant number of shares of common stock in the public market pursuant to
a current prospectus could harm the market price of our common stock. Pursuant
to our registration statement (No. 333-158474), an aggregate of 4,674,228 shares
of common stock were registered in August 10, 2009 and subject to the
effectiveness of this registration statement together with an additional
1,487,220 shares of Common Stock, or an aggregate of 6,161,448 shares, will all
be free-trading. As additional shares of our common stock become available for
resale in the public market pursuant to this prospectus and otherwise, the
supply of our common stock will increase, which could decrease its price. Some
or all of the shares of our common stock may be offered from time to time in the
open market pursuant to Rule 144, and these sales may have a depressive
effect on the market for the shares of our common stock. In general, a
non-affiliated person who has held restricted shares for a period of six months,
under Rule 144, may sell into the market our common stock all of their shares,
subject to the Company being current in its periodic reports filed with the SEC.
An affiliate may sell an amount equal to the greater of 1% of the outstanding
shares or, if listed on Nasdaq or another national securities exchange, the
average weekly number of shares sold in the last four weeks prior to such sale.
Such sales may be repeated once every three months, and any of the restricted
shares may be sold by a non-affiliate without any restriction after they have
been held the year.
Investors
may experience substantial dilution of their ownership in the
future.
Pursuant
to the Stock Option Plan to be adopted, employees, directors and independent
contractors may acquire up to an aggregate of 500,000 shares of the Company’s
common stock through the exercise of stock options that may be granted in the
future. The Company’s stockholders will incur dilution upon exercise of such
options. In addition, three are currently outstanding warrants to purchase
approximately 2,721,224 shares of common stock and Series A Convertible Stock to
purchase approximately 2,721,224 shares of Common Stock plus placement agent
warrants to purchase approximately 1,381,948 shares of common stock. The mere
existence of these derivative securities may have a depressive effect on any
market for our common stock which may develop. Furthermore, if the Company
issues or sells shares of common stock or any derivative securities for less
than the $0.85 per share initial conversion price, the initial conversion price
of the above-described Preferred Stock will be reset to such conversion price
and the Warrants to 150% of the Preferred Stock conversion price, as adjusted,
which will result in substantial dilution of new investors.
20
In
addition, if the Company raises additional funds by issuing additional stock in
one or more additional financings, further dilution to stockholders will result,
and new investors may have rights superior to existing
stockholders.
The
Company’s officers, directors and principal stockholders may be able
significantly to influence matters requiring stockholder approval because they
will own a large percentage of the Company’s outstanding shares, even after this
Offering.
The
Company’s founder, Bruce Meyers, who is a principal of Meyers Associates, a
FINRA member firm, Dr. Lawrence Helson, CEO, and Dr. Arthur Bollon, Director,
beneficially own 4,857,500, 1,800,000 and 800,000 shares, respectively, of the
11,740,000 shares of Common Stock currently issued and outstanding, or
approximately 63.5% of the 11,740,000 outstanding shares of the Company’s common
stock. After giving effect to the conversion of all 2,412 outstanding shares of
Preferred Stock, but not the exercise of the warrants, those persons will
beneficially own in the aggregate 7,906,720 shares, or approximately 54% of the
14,578,924 outstanding shares of the Company’s common stock. These stockholders
will be able to exercise control over substantially all matters requiring
approval by the Company’s stockholders, including the election of directors and
the approval of significant corporate transactions, which includes their ability
to amend the Certificate of Incorporation, approve a merger or consolidation of
the Company with another company or approve the sale of substantially all of the
assets of the Company without the agreement of minority stockholders. This
concentration of ownership may not be in the best interests of all of the
Company’s stockholders. See “Principal Stockholders.”
Limitations
on ability to pay dividends.
The
Company does not currently expect to pay cash dividends on any of its common
stock for the foreseeable future. The ability of the Company to pay dividends on
the Company’s common stock will depend upon, among other things, future
earnings, if any, the success of the Company’s business activities, capital
requirements, the general financial condition of the Company, and general
business conditions. There can be no assurance that the Company will ever be in
a financial position to declare and pay dividends on the Company’s capital stock
or that the Board of Directors would otherwise ever declare or pay such a
dividend.
The
public offering price was arbitrarily determined and does not reflect our
value.
The
public offering price of the shares was arbitrarily determined and does not bear
any relationship to our book value, assets, prospective earnings or any other
recognized criteria of value.
You
will incur immediate dilution as a result of this offering.
If you
purchase common stock in this offering, you will pay more for your shares than
the amounts paid by existing stockholders for their shares. As a result, you
will incur immediate dilution of $1.27 per share, representing the difference
between the initial public offering price of $1.00 per share and our as adjusted
net tangible book value deficit per share as of June 30, 2010. See “Dilution and
Other Comparative Per Share Data.”
Forward
Looking Statements
This
prospectus contains forward-looking statements in "Summary," "Risk Factors,"
"Business" and elsewhere. These statements relate to future events or future
predictions, including events or predictions relating to our future financial
performance, and are generally identifiable by use of the words "may," "will,"
"should," "expect," "plan," "anticipate," "believe," "feel," "confident,"
"estimate," "intend," "predict," "potential" or "continue" or the negative of
such terms or other variations on these words or comparable terminology. These
statements are only predictions and involve known and unknown risks,
uncertainties and other factors, including the risks described under "Risk
Factors" that may cause the Company's or its industry's actual results, levels
of activity, performance or achievements to be materially different from any
future results, levels of activity, performance or achievements expressed or
implied by such forward-looking statements. In addition to the risks described
in Risk Factors, important factors to consider and evaluate in such
forward-looking statements include: (i) the general economic recession and
changes in the external competitive market factors which might impact the
Company's results of operations; (ii) unanticipated working capital or other
cash requirements including those created by the failure of the Company to
adequately anticipate the costs associated with clinical trials, manufacturing
and other critical activities; (iii) changes in the Company's business strategy
or an inability to execute its strategy due to unanticipated changes in the
therapeutic drug industry; (iv) the inability or failure of the Company's
management to devote sufficient time and energy to the Company's business; and
(v) the failure of the Company to complete any or all of the transactions
described herein on the terms currently contemplated. In light of these risks
and uncertainties, many of which are described in greater detail elsewhere in
this Risk Factors discussion, there can be no assurance that the forward-looking
statements contained in this prospectus will in fact transpire.
21
Although
the Company believes that the expectations reflected in the forward-looking
statements are reasonable, the Company cannot guarantee future results, levels
of activity, performance or achievements. Moreover, neither the Company nor any
other person assumes responsibility for the accuracy and completeness of such
statements. We do not undertake any duty to update any of the forward-looking
statements after the date of this prospectus to conform such statements to
actual results or changes in our expectations.
DETERMINATION
OF OFFERING PRICE
The
public offering price was arbitrarily determined based primarily on the
Company’s operations since the completion of the Company’s Private Placement.
The price does not bear any relationship to our book value, assets, prospective
earnings or any other recognized criteria of value.
DILUTION
AND OTHER COMPARATIVE PER SHARE DATA
General
The
following tables summarize as of June 30, 2010;
|
·
|
the
number of shares of common stock
outstanding;
|
|
·
|
the
number of shares of Common Stock issuable upon conversion of preferred
stock as a percentage of our total outstanding
shares;
|
|
·
|
the
aggregate consideration for such
shares;
|
|
·
|
the
aggregate consideration as a percentage of total consideration;
and
|
|
·
|
the
average consideration per share for such shares by Common Stockholders and
Preferred Stockholders.
|
Shares of
common
stock
purchased
|
% of total
shares
|
Aggregate
consideration
|
% of total
consideration
|
Average
consideration
per share
|
||||||||||||||||
Common
Stockholders
|
11,740,000 | 81.2 | % | $ | 1,137,660 | 33 | % | $ | .08 | |||||||||||
Preferred
Stockholders
|
2,721,224 | 18.8 | % | 2,312,000 | 67 | % | $ | .85 | ||||||||||||
Total
|
14,461,224 | 100.0 | % | $ | 3,449,660 | 100.0 | % |
If you
purchase shares offered hereby, your ownership interest will be diluted.
“Dilution” is the difference between the public offering price of the common
stock and the net tangible book value per share immediately after the Offering.
“Net tangible book value” is the amount that results from subtracting our total
liabilities and intangible assets from our total assets. As of June 30, 2010, we
had a net tangible book value deficit for our 11,740,000 shares of common stock
outstanding of $(3,121,834), or approximately $(.27) per share. There will be
no change in our net tangible book value as a result of the Offering, as we will
not receive any proceeds from the sale of shares offered hereby. However, there
will be an immediate dilution of approximately $1.27 per share to public
investors, as the difference between the $1.00 per share public offering price
and the $(.27) per share net tangible book value deficit.
22
The
following table illustrates the dilution described above:
Public
offering price per share
|
$ | 1.00 | ||
Net
tangible book value deficit per share before offering
|
$ | (.27 | ) | |
Net
tangible book value per share after offering
|
$ | (.27 | ) | |
Dilution
to public investors
|
$ | 1.27 |
PRICE
RANGE OF COMMON STOCK, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF
EQUITY SECURITIES
(a) Market
Information
Our
common stock is not publicly traded We intend to seek a listing of
our common stock on the Over-The-Counter Bulletin Board (“OTCBB”), which is
maintained by the Financial Industry Regulatory Authority, Inc.
(“FINRA”).
As of the
date of this prospectus there are outstanding: options to purchase
100,000 shares of common stock; approximately 2,412 shares of Series A
Convertible Preferred Stock exercisable for approximately 2,838,924 shares of
common stock; common stock purchase warrants to purchase approximately 2,838,924
shares of Common Stock, and placement agent warrants to purchase approximately
969,335 shares of Common Stock or an aggregate of 13,487,183 shares of Common
Stock.
Upon
completion of this offering, we will have issued and outstanding 11,740,000
shares of common stock. Of this amount, 10,000,000 Founders Shares issued on May
12, 2008 and 1,365,000 Bridge Shares issued between August 2007 and April 2008
will all qualify for resale under Rule 144, commencing 90 days from the
effective date of this prospectus.
The
1,507,500 shares of common stock which are issued and outstanding and registered
on this registration statement, as well as the 2,326,974 shares of common stock
issuable upon conversion of preferred stock and 2,326,974 shares of common stock
issuable upon exercise of warrants will be freely tradable without restriction
under the Securities Act unless purchased by our “affiliates,” as that term is
defined in Rule 144 under the Securities Act.
(b) Holders of
Record
As of
August 30, 2010, there were 24 holders of record of our common
stock.
(c) Dividend
Policy
We have
never declared or paid dividends on our shares of common stock. We currently
intend to retain future earnings for use in our business and, therefore, do not
anticipate paying any cash dividends on our shares of common stock in the
foreseeable future. Any future determination as to the payment of cash dividends
on our common stock will be at the discretion of our Board of Directors and will
depend on our earnings, operating and financial condition, capital requirements
and other factors deemed relevant by our Board of Directors including the
General Corporation Law of the State of Delaware, which provides that cash
dividends are only payable out of retained earnings or if certain minimum
rations of assets to liabilities are satisfied. The declaration of cash
dividends on our common stock also may be restricted by the provisions of credit
agreements that we may enter into from time to time.
(d) Securities Authorized For
Issuance Under Equity Compensation Plans
EQUITY
COMPENSATION PLAN INFORMATION
The
following table provides information regarding the status of our existing equity
compensation plans at December 31, 2009.
23
Plan category
|
Number of shares of common
stock to be issued on exercise of
outstanding options, warrants
and rights
|
Weighted-average exercise
price of outstanding
options, warrants and
rights
|
Number of securities remaining
available for future issuance
under equity compensation plans
(excluding securities reflected in
the previous columns)
|
|||||||||
Equity
compensation plans
approved by security
holders (1)
|
-0- | -0- | -0- | |||||||||
Equity
compensation plans not approved by security holders
|
-0- | -0- | -0- | |||||||||
Total
|
-0- | -0- | -0- |
(1)
Consists of our 2009 Employee Stock Incentive Plan.
24
CAPITALIZATION
The
following table sets forth the Company’s capitalization as of June 30,
2010(1):
Actual
|
||||
Cash
|
$ | 64,699 | ||
Total
Assets
|
$ | 68,005 | ||
Accounts
payable and accrued expenses
|
$ | 162,784 | ||
Derivative
liability
|
$ | 3,027,055 | ||
Stockholders’
equity:
|
||||
Preferred
Stock, $0.10 par value, 5,000,000 shares authorized; 2,312 outstanding
shares of Series A Preferred Stock
|
231 | |||
Common
Stock, $0.001 par value, 45,000,000 shares authorized; 11,740,000 shares
issued and outstanding(2)
|
11,741 | |||
Additional
Paid-In Capital
|
$ | 650,535 | ||
Accumulated
deficit
|
$ | (3,784,341 | ) | |
Total
stockholders’ equity (deficit)
|
$ | (3,121,834 | ) | |
Total
Capitalization
|
$ | 68,005 |
(1) The
capitalization table is based on the Company’s historical financial information
as of the period ended June 30, 2010. This table was not prepared and has not
been reviewed or compiled by certified public accountants nor by an independent
accounting firm. The financial information contained in this table was prepared
by the Company’s management.
(2)
Does not include: 500,000 shares of Common Stock reserved for issuance under the
Company’s 2009 Employee Stock Incentive Plan of which 100,000 options have been
granted; 2,838,924 shares of Common Stock reserved for issuance upon conversion
of 2,412 shares of Series A Convertible Preferred Stock; 2,838,924 shares of
Common Stock reserved for issuance upon exercise of outstanding warrants;
368,894 shares reserved for issuance pursuant to the potential issuance of
dividend shares (at $.85 per share) on the 2,412 shares of preferred stock for
the next two years; and 969,335 shares reserved for issuance upon exercise of
placement agent’s warrants.
USE
OF PROCEEDS
We will
not receive proceeds from the sale of shares offered hereby by the Selling
Stockholders, except upon the exercise of all of the warrants offered hereby for
$2,659,700 (net of a 10% warrant exercise fee). Any warrant proceeds will be
used by the Company for working capital purposes.
25
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The
following discussion should be read in conjunction with the financial statements
and notes thereto included in this prospectus. Except for the historical
information contained herein, the discussion in this prospectus contains certain
forward-looking statements that involve risk and uncertainties, such as
statements of the Company’s plans, objectives, expectations and intentions as of
the date of this filing. The cautionary statements made in this document should
be read as being applicable to all related forward-looking statements wherever
they appear in this document. The Company’s actual results could differ
materially from those discussed here. Factors that could cause differences
include those discussed in the “Risk Factors” section as well as discussed
elsewhere herein.
Liquidity
and Capital Resources
June
30, 2010 as Compared With December 31, 2009
As of
June 30, 2010 and December 31, 2009, the Company had $64,699 and $295,418,
respectively, of cash on hand. The Company’s working capital deficit increased
from $(2,647,152) at December 31, 2009 to a deficit of ($3,125,140), as of June
30, 2010 as a result of a decrease in cash resulting from a loss from operations
and an increase in derivative liability for preferred stock and warrants.
SignPath had a deficit accumulated during the development stage of $3,784,341,
as of June 30, 2010.
Since
January 1, 2010 (the “2010 Private Placement”), SignPath sold 50 Units
consisting of the same securities sold in the 2008 and 2009 Private Placement.
The Company received gross proceeds of $50,000 and incurred stock offering costs
of $8,000 related to this offering.
The
Company has no agreements, arrangements or understandings with any officer,
director or shareholder as to any future financing, either equity or debt. The
Company expects to continue to incur losses for the foreseeable future and it is
possible the Company may never reach profitability. Therefore, the Company will
require additional capital resources and financing to implement its business
plan and continue its operations. The Company’s current burn rate for salaries,
research programs and professional fees averages about $15,000 per month. Thus,
it is expected that the Company currently has sufficient cash on hand to operate
through December 31, 2010. Management believes it has enough funds to complete
its pre-clinical trials. If the Company receives favorable results, Management
believes it will have the ability to raise additional funds to complete INDs. In
view of general economic conditions, there can be no assurance that any
additional financing will be available to us, that any affiliate will provide
additional investments in the Company or that adequate funds for our operations
will otherwise be available when needed or on terms acceptable to
us.
Cash used
in operating activities during the six months ended June 30, 2010 (“Fiscal
2010”) was $(264,329) compared to cash used of $(355,223) during the comparable
period in 2009 (“Fiscal 2009”). This resulted from a net loss of $787,191 in
Fiscal 2010, offset by adjustments for non cash expenses of $340,000 for stock
issued for services and $137,560 related to changes in the carrying value of
derivative liabilities along with an increase in accounts payable and accrued
expenses of $44,818. This is compared to a loss of $(561,476) during Fiscal 2009
what was offset by adjustments for non cash expenses of $115,580 related to
changes in the carrying value of derivative liabilities along with an increase
in accounts payable and accrued expenses of $90,273.
The
Company had net cash provided by financing activities of $35,000 in Fiscal 2010
as a result of the $50,000 received in the 2010 Private Placement described
above, reduced by $15,000 of offering costs. During the Fiscal 2009 Period, the
Company had $432,446 of net cash provided by financing activities as a result of
the $560,000 received from the 2009 Private Placement of Preferred Stock less
the stock offering costs of $127,554.
As a
result of the foregoing, the Company’s cash decreased by $230,719 during Fiscal
2010 from $295,418 to $64,699.
The
financial statements included in this report have been prepared in conformity
with generally accepted accounting principles that contemplate our continuance
as a going concern. The Company has had no revenues and has generated losses
from operation. As set forth in Note 1 to the audited Financial Statements, the
continuation of the Company as a going concern is dependant upon the continued
financial support from its shareholders, the ability to raise equity or debt
financing, and the attainment of profitable operations from the Company’s
planned business. The financial statements do not include any adjustments to the
recoverability and classification of recorded asset amounts and classification
of liabilities that might be necessary should the Company be unable to continue
as a going concern.
26
December
31, 2009 as Compared With December 31, 2008
As of
December 31, 2009 and December 31, 2008, the Company had $295,418 and $181,128,
respectively, of cash on hand. The Company’s working capital decreased from
$104,129 at December 31, 2008, to $(2,647,152) at December 31, 2009, as a result
of the adoption of ASC 815 which required a reclassification of the Company’s
preferred stock from permanent equity into current liabilities. Absent this
reclass, the Company’s working capital would have increased to $179,851 as a
result of the sale of $810,000 securities to 13 different accredited investors
offset, in part, by an increase of $40,968 in accounts payable and accrued
expenses. The Company is a development stage company with a limited operating
history. SignPath had a deficit accumulated during the development stage of
$2,997,150, as of December 31, 2009.
Net cash
used in operating activities during Fiscal 2009 decreased to $529,556 from
$745,653 during Fiscal 2008. This resulted from a decreased net loss from
$1,695,766 in Fiscal 2008 to a net loss of $730,743 in Fiscal 2009, offset by an
increase in accounts payable and accrued expenses of $40,968.
The
Company had net cash provided by financing activities of $643,846 in Fiscal 2009
as a result of the $810,000 received in the 2009 Private Placement described
above, reduced by $166,154 of offering costs. During Fiscal 2008, the Company
had $923,927 of net cash provided by financing activities as a result of the
$562,000 received from the 2008 Private Placement of Preferred Stock less the
stock offering costs of $270,948 plus the $632,875 raised through bridge
financing.
As a
result of the foregoing, the Company’s cash increased by $114,290 during Fiscal
2009 from $181,128 to $295,418.
Results
of Operations
Six
months ended June 30, 2010, as compared with six months ended June 30,
2009
The
Company does not expect to receive any operating revenues prior to 2012. Total
operating expenses during the six months ended June 30, 2010 (the “2010 Period”)
increased to $690,415, as compared with $445,896 during the six months ended
June 30, 2009 (the “2009 Period”) primarily as a result of $340,000 of
consulting expenses related to Common Stock issuances. General and
administrative expenses decreased to $126,329 in the 2010 Period from $260,639
in the 2009 Period primarily as a result of a reduction in payroll
expenses.
A
research grant of approximately $80,000 from the Michael J. Fox Parkinson’s
Disease Foundation to measure parenteral liposomal curcumin passage across the
blood brain barrier and focal distributions in mice/rate brains in collaboration
with D.S. Chiou at the University of Western Ontario, Canada. Data, to date, has
revealed intravenous curcumin localized in specific brain regions associated
with Parkinson’s Disease and memory processing. As of June 30, 2010, the Company
has expended $81,857 to manufacture nanocucumin for this study and is funding
animal studies with Dr. Chiou with the remaining funds. This is reflected on the
Company’s Statement of Operations as $40,784 of grant income during the 2010
Period.
The
Company paid $10,600 in licensing fees in the 2010 Period as compared with
$50,000 of license fees in the 2009 Period.
The
Company paid an aggregate of $224,086 in research and development fees in the
2010 Period as compared to $185,257 in the 2009 Period. This included $19,370 to
University of Texas, MD Anderson Cancer Center (“UTMDACC”) for non-clinical and
mouse pre-clinical non-GLP studies of lipsomal curcumin. Payments in the 2009
Period included $32,575 paid to Surmodics Pharmaceuticals, Inc. (f/n/a Brookwood
Pharmaceuticals, Inc. (“Surmodics”) for polymer for the production of
nanocurcumin under the Johns Hopkins University Agreement (the “JHU Agreement”)
and for the production of clinical GMP grade curcumin under the UTMDACC
agreement.
27
The
Company also paid Topaz Technology, Inc. (“Topaz”) an aggregate of $8,000 during
the 2009 Period to provide FDA/EMEA Compliance and validation audits relating to
the synthetic curcumin manufacturing facility in India.
The
amount paid for research and development in the 2010 Period consisted of
payments for overhead and patent fees for non-clinical studies and pre-clinical
studies in the nanocurcumin compound and to produce polymer under the JHU
Agreement for animal studies of nanocurcumin. During the 2009 Period, the
Company paid UTMDACC for non-clinical and mouse pre-clinical pre-GLP studies of
lipomal curcumin. It also includes expenses relating to development of
depotcurcumin, a slow release formulation. Depotcurcumin was originally made at
UNT under non-GLP conditions from curcumin extract (and PLGA, a chemical
surrounding the curcumin) originally purchased from a U.S. chemical supplier.
Sigma Aldrich Fine Chemicals (“SAFC”).
As a
result of the foregoing, the Company had a net loss of $(787,191) in the 2010
Period as compared to a net loss of $(561,476) in the 2009 period. This
translates to a loss per share of $(0.07) in the 2010 Period compared to $(0.05)
in the 2009 Period.
Results
of Operations for the Year Ended December 31, 2009, as Compared with the Year
Ended December 31, 2008
The
Company has not received any revenues since its inception on May 15, 2006. We do
not expect to receive any revenues prior to 2012. Our total operating expenses
during the year ended December 31, 2009 (“Fiscal 2009”) decreased to $612,098,
as compared with $1,631,771 during the year ended December 31, 2008 (“Fiscal
2008”). General and administrative expense increased to $243,492 in Fiscal 2009
from $101,406 in Fiscal 2008, primarily as a result of increased activity in the
Company in pursuing its manufacture and preclinical development of its lead
curcumin formulations.
Legal and
professional expenses decreased from $143,527 in Fiscal 2008 to $74,794 in
Fiscal 2009, as a result of the completion of the Company’s business plan during
Fiscal 2008, offset by expense related to the Company’s Registration Statement
being declared effective in Fiscal 2009.
There
were no advertising expenses and only $2,782 of consulting expenses paid in
Fiscal 2009, as compared with $79,481 of consulting fees paid in Fiscal 2008 to
our financial advisers and $49,175 of advertising expenses paid in Fiscal 2008
to create public awareness of the Company.
The
Company paid $102,347 in licensing fees in Fiscal 2008 as compared with $75,092
of license fees in Fiscal 2009. Fees in Fiscal 2008 included payments
of $99,412 to the
Anderson Cancer Center while licensing fees of $20,000 in Fiscal 2009
related to payments to the Anderson Cancer Center and the remaining $55,000 were
payments made to the University of Texas Health Science.
The
Company paid an aggregate of $215,938 in research and development fees in Fiscal
2009 as compared to $263,886 in Fiscal 2008. This included an annual fee of
$10,000 paid to UTMDACC for non-clinical and mouse pre-clinical non-GLP studies
of lipsomal curcumin. Payments in Fiscal 2009 included a $10,000 annual license
fee paid to JHU under the JHU Agreement, as well as payment of approximately
$66,000 paid to Surmodics for polymer for the production of nanocurcumin under
the JHU Agreement and $697 for the production of clinical GMP grade curcumin
under the UTMDACC agreement. During Fiscal 2009, the Company paid approximately
$33,000 to Dr. Maitra under the Company’s sponsored research agreement to fund
the costs of non-clinical and pre-clinical studies of nanocurcumin at JHU;
approximately $21,000 paid for overhead under the JHU Agreement and a $1,100
patent fee paid under the JHU Agreement; and a $30,000 payment to University of
North Texas (“UNT”) Health Science Center under an agreement entered into on
August 18, 2008 for sponsored research. During Fiscal 2009, the Company paid
UTMDACC approximately $32,000 for non-clinical and mouse pre-clinical non-GLP
Studies of lipsomal curcumin as well as payments to Polymun Scientific
Immunbiologische Fonschung GmbH under the UTMDACC agreement.
The
amount paid for research and development in Fiscal 2008 consisted of
payments for overhead and patent fees for non-clinical studies and
pre-clinical studies of the nanocurcumin compound and to produce polymer under
the JHU Agreement for animal studies of nanocurcumin. During Fiscal 2008, the
Company paid UTMDACC for non-clinical and mouse pre-clinical non-GLP studies of
lipsomal curcumin and a $10,000 annual fee. It also includes expenses relating
to development of depotcurcumin, a slow release formulation. Depotcurcumin was
originally made at UNT under non-GLP conditions from circumin extract (and PLGA,
a chemical surrounding the curcumin) originally purchased from
SAFC.
28
The
Company recognized a loss of $(159,418) due to the change in fair value of the
Company’s derivative liabilities. The Company also received a total of $40,773
in grant income during the year ended December 31, 2009. This is compared to
$-0- and $-0- in derivate gain(loss) and grant income in 2008, respectively. The
Company did recognize a total of $63,995 of interest expense in
2008.
As a
result of the foregoing, the Company had a net loss of $(730,743) in Fiscal
2009, as compared with a net loss of $(1,695,766) in Fiscal 2008. This
translates to a loss per share of $(0.06) in Fiscal 2009 compared to $(0.15) in
Fiscal 2008.
Critical
Accounting Policies
We have
identified the policies outlined below as critical to our business operations
and an understanding of our results of operations. The list is not intended to
be a comprehensive list of all of our accounting policies. In many cases, the
accounting treatment of a particular transaction is specifically dictated by
accounting principles generally accepted in the United States, with no need for
management’s judgment in their application. The impact and any associated risks
related to these policies on our business operations is discussed throughout
Management’s Discussion and Analysis of Financial Condition and Results of
Operations where such policies affect our reported and expected financial
results. Note that our preparation of the financial statements requires us to
make estimates and assumptions that affect the reported amount of assets and
liabilities, disclosure of contingent assets and liabilities at the date of our
financial statements, and the reported amounts of revenue and expenses during
the reporting period. There can be no assurance that actual results will not
differ from those estimates.
Basis
of Presentation
These
consolidated financial statements and related notes are presented in accordance
with accounting principles generally accepted in the United States, and are
expressed in U.S. dollars. The Company’s fiscal year-end is December
31.
Use
of Estimates
The
preparation of these consolidated financial statements in conformity with
generally accepted accounting principles in the United States requires
management to make estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and liabilities at
the date of the consolidated financial statements and the reported amounts of
revenues and expenses during the reporting period. The Company regularly
evaluates estimates and assumptions related to valuation and amortization
policies on property and equipment and valuation allowances on deferred income
tax losses. The Company bases its estimates and assumptions on current facts,
historical experience and various other factors that it believes to be
reasonable under the circumstances, the results of which form the basis for
making judgments about the carrying values of assets and liabilities and the
accrual of costs and expenses that are not readily apparent from other sources.
The actual results experienced by the Company may differ materially and
adversely from the Company’s estimates. To the extent there are material
differences between the estimates and the actual results, future results of
operations will be affected.
Derivative
Financial Instruments
The
Company generally does not use derivative financial instruments to hedge
exposures to cash-flow risks or market-risks that may affect the fair values of
its financial instruments. The Company utilizes various types of financing to
fund our business needs, including preferred stock with warrants attached and
other instruments not indexed to our stock. The Company is required to record
its derivative instruments at their fair value. Changes in the fair value of
derivatives are recognized in earnings in accordance with ASC 815.
29
Revenue
Recognition
As of the
date of this disclosure, the Company has yet to recognize revenues. As the
Company continues to develop and implement its business plan, revenue from the
performance of services or sale of products will be recognized in accordance
with FASB codification standards. Revenue will be recognized only when the price
is fixed or determinable, persuasive evidence of an arrangement exists, the
service is provided, and collectability is assured.
Basic
and Diluted Net Income (Loss) Per Share
The
Company computes net income (loss) per share in accordance with FASB
codification standards. The standard requires presentation of both basic and
diluted earnings per share (EPS) on the face of the income statement. Basic EPS
is computed by dividing net income (loss) available to common shareholders
(numerator) by the weighted average number of shares outstanding (denominator)
during the period. Diluted EPS gives effect to all dilutive potential common
shares outstanding during the period using the treasury stock method and
convertible preferred stock using the if-converted method. In computing Diluted
EPS, the average stock price for the period is used in determining the number of
shares assumed to be purchased from the exercise of stock options or warrants.
Diluted EPS excludes all dilutive potential shares if their effect is
anti-dilutive.
Income
Taxes
Potential
benefits of income tax losses are not recognized in the accounts until
realization is more likely than not. The Company has adopted FASB codification
regarding the required tax asset benefit computations for net operating losses
carry forward. The potential benefits of net operating losses have not been
recognized in these consolidated financial statements because the Company cannot
be assured it is more likely than not it will utilize the net operating losses
carried forward in future years.
Stock-Based
Compensation
The
Company records stock-based compensation in accordance with FASB codification
starndards, using the fair value method. All transactions in which goods or
services are the consideration received for the issuance of equity instruments
are accounted for based on the fair value of the consideration received or the
fair value of the equity instrument issued, whichever is more reliably
measurable. Equity instruments issued to employees and the cost of the services
received as consideration are measured and recognized based on the fair value of
the equity instruments issued.”
Plan
of Operations
The
Company's current focus is on the manufacture and preclinical development of its
lead curcumin formulations (intravenous liposomal curcumin, oral and intravenous
nanocurcumin) with a view toward filing two IND applications with the FDA. The
Company's product candidates are still in the preclinical development
phase.
The
Company believes that a novel pharmaceutical preparation with enhanced
absorption of the active compound with resistance to hepatic inactivation could
potentially have greater clinical efficacy than the oral versions. The
laboratory and oral administration studies by other researchers to date suggest
that curcumin has high potency. The Company believes that an alternate route for
administering this compound, such as the Company's parenteral (taken into the
body other than through the digestive canal) formulation, could be more
effective at lower dosages. SignPath intends to develop a parenteral liposomal
formulation, and a nanoparticle formulation, nanocurcumin, to overcome the
limitations of the oral form.
SignPath
believes that the dual development and comparison of liposomal curcumin and
nanocurcumin could expose potential differences in biological effects and
distribution to different tissues. The Company intends to manufacture good
manufacturing practice (GMP) grade of liposomal curcumin and nanocurcumin. Both
formulations will require outsourcing production to one or more commercial
facilities. Our initial goals are to obtain sufficient material for in vitro and
animal analysis and to develop these formulations in order to submit INDs to the
FDA. Determination of safety, dosage, and efficacy of these formulations in a
quantifiable manner will permit us to pursue clinical registration trials for a
variety of malignant diseases. Following submission of the INDs, the Company
plans to initially run Phase I studies with both of the parenteral formulations
in patients with treatment refractory malignant disease. Subsequently, if the
Phase I trials are successful, the Company plans to seek FDA authorization to
run Phase II trials in selected malignancies.
30
Liposomal
curcumin: The Company has agreements with contract manufacturers for the
manufacture, chemistry. and controls for supplies of the drugs to be tested.
Liposomal curcumin is manufactured by our contract manufacturer, Polymun, Inc.
Initial quantities of GMP grade liposomal curcumin to conduct preclinical
studies to corroborate previously published data from other researchers were
obtained from Sigma Aldrich Fine Chemicals ("SAFC") or from Sabinsa. Final
production of liposmal curcumin GMP was completed at Polymun in Vienna, Austria
during 2009. Using Iipocurc, anti-cancer activity without toxicity in human
colon and pancreatic cancer xenograft models were published. Following the
determination of safety and the optimum dosage and schedule in the most
sensitive of the three species, we will be able to estimate starting dosages for
Phase I trials in humans. We plan to outsource corroborative studies of
Iiposomal absorption, distribution, metabolism, and excretion (ADME), and
pharmacokinetics in rats with the aim of estimating optimum dosage schedules, as
well as dosage and safety in mice, rats and dogs to satisfy IND regulations to
GLP laboratories in M.D. Anderson Cancer Center in Houston, Texas.
Nanocurcumin:
The Company intends to obtain commercial volumes of purified curcumin from third
party manufacturers, SAFC and/or Sabinsa, in quantities suitable to satisfy
preclinical and clinical demands. The Company believes that the manufacture of
Iiposomal curcumin and nanocurcumin can also be scaled up as necessary since
these additional substances are readily available from commercial sources
utilizing established production technologies. We plan to outsource nanocurcumin
pre-clinical development to M.D. Anderson. We will continue non-clinical and
preclinical analyses of nanocurcumin at the NCI Nanocharacterization Laboratory.
The nanocurcumin program will be managed by M.D. Anderson through the filing of
the Company's IND. However, we intend to develop direct injection nanocurc, a
new clinical entity at Johns Hopkins Cancer Center for preventive therapy of
inducted curcumin in situ in rats. Nanocurc, a parenteral formulation of
nanocurcumin in human pancreatic cancer xenografts in nude mice has demonstrated
anti-cancer effects. This formulation has activity against breast cancer-DCIS
and passes the blood brain barrier. During late 2010, we intend to conduct a
European Phase I dose funding in Parkinson's Disease for volunteers in
collaboration with Polymun, Vienna, Austria. Upon completion, we will also
continue studies of nanocurcumin, PLGA-nanocurcumin and lipsomal curcumin
against L-DOPA induced dyskinesias in dogs. We will measure inhibiting effects
of curcumin on disease progression in Parkinson's Disease patients at the
University of Western Ontario, Canada. Contracts with these institutions will be
initiated upon receipt of manufactured nanocurcumin.
Quantitative
and Qualitative Disclosures About Market Risk
In the
normal course of business, our financial position is routinely subject to a
variety of risks, including market risk associated with interest rate movement.
We regularly assess these risks and have established policies and business
practices intended to protect against these and other exposures. As a result, we
do not anticipate material potential losses in these areas.
As of
June 30, 2010, we had cash and cash equivalents of $64,699.
BUSINESS
Company
Overview
SignPath
is a development stage biotechnology company founded in May 2006 to develop
proprietary formulations of curcumin, a naturally occurring compound found in
the root of the
Curcuma longa (tumeric) plant, for applications
in malignant diseases.
Curcumin
has an extensive history as an oral medicinal product with safe human use, but
its potential therapeutic benefits have been limited by its low absorption when
taken orally, as well as its inactivation in the liver (due to hepatic
glucuronidation). SignPath intends to develop Investigative New Drug (“IND”)
applications and clinical trials for parenterally (taken into the body in a
manner other than the digestive tract) administered curcumin. We believe that
the liposomal and nano-sized formulations we have licensed could overcome
absorption and hepatic inactivation problems associated with oral administration
of unmodified curcumin extract, based on management’s experience and the
opinions of our consultants to expand its use for concerns, Parkinson’s Disease
and parasitic diseases the Company is developing three different intravenous
nano-particle sized formulations. Proof of efficacy of these formulations
against human tumor xenografts in mice was published. During IND pre-clinical
toxicity trials in dogs with lipsomil curcumin, a dose-dependent hemolysis was
observed, indicating specific dose/schedules of administration will be required
for trials in humans.
31
SignPath
has licensed two proprietary intravenous formulations containing curcumin as the
active therapeutic agent. The first is a liposomal version licensed from
University of Texas MD Anderson Cancer Center (“UTMDACC”); the second is a
nanosized version licensed from The Johns Hopkins University (“JHU”). The
Company’s near term (next 6 to 12 months) goals are to complete preclinical
development of the first two lead compounds, liposomal curcumin and
nanocurcumin, and file an IND with the FDA to begin Phase I safety studies. The
Company believes its licensed formulations of curcumin change the product from a
naturally occurring one to novel chemical entities making them potentially
patentable. The Company seeks to develop these new products which potentially
will give SignPath proprietary
curcumin preparations with applications in a broad spectrum of malignant
diseases.
The
Company has assembled leaders experienced in pharmacologic development of
natural products to advise it on the development of its curcumin formulations.
This Scientific Advisory Board is comprised of individuals with specific
experience with natural products, formulation development, and malignant
diseases. Expertise in chemistry will come from commercially based product
chemists. Drug development will overseen by Lawrence Helson MD, Chief Executive
Officer, an oncologist with 20 years of pharmaceutical development experience;
Arniban Maitra, Phd, MPPH, of JHU, who has expertise in
nanotechnology, development of nanocurcumin, and testing for antitumor effects;
and Judith
A Smith, PhD, director of the UTMDACC pre-clinical development group for the
liposomal formulation.
The
Company’s Scientific Advisory Board members all bring relevant experience to the
Company. Professor Tauseef Ahmad, MD is an experienced principal investigator
for lymphoma, myeloma and solid tumor studies. See “Management” below for
more information about our management team and Scientific Advisory Board
members.
Clinical
application strategies will be based upon the advice of the individuals serving
on the Scientific Advisory Board, all of whom have academic and practical
experience in biopharmaceutical fields. We expect that our Phase I and II
clinical trials, if and when conducted, will be run by clinical research
organizations with whom we expect to establish collaborative
relationships.
Our
pre-clinical IND development of liposomal curcumin is scheduled to be run
by the UTMDACC group which has functional pre-clinical IND development
procedures and experience. The JHU group is experienced with non-clinical
development of nanocurcumin; however, the nanocurcumin pre-clinical
aspects will be run by the UTMDACC research and development group. The
latter has experience with curcumin and the capability of
guiding us through the IND development process of both formulations.
During
the fiscal years ended December 31, 2009 and 2008, the Company expended $215,938
and $263,886, respectively, for net research and development. This consisted
primarily of payments made to JHU and Brookwood Pharmaceuticals under agreements
described below.
SignPath
is a publicly-held non-listed Delaware corporation with offices in Quakertown,
Pennsylvania in a building owned by our CEO. The Company does not pay rent or
have a lease for its space.
32
Target
Markets
The
anticipated markets for therapeutic curcumin are diseases for which current
therapeutic alternatives are not satisfactory. There are several malignant
diseases which are classified as orphan indications, defined by the FDA as
conditions with less than 200,000 patients in the United States. Some of these
conditions exhibit
dependency upon NFκB (NF kappa-B, a family of intracellular proteins), a
signaling pathway component inhibited by curcumin. (1) Two such
indications are multiple myeloma and pancreatic cancer. The Company currently
plans to pursue the development and testing of therapies with
parenterally-administered curcumin to address multiple myeloma and pancreatic
cancer, two forms of cancer in which current treatment is only marginally
effective or could be greatly improved.
Preclinical
studies conducted by other scientists of curcumin-based treatments in cancer
(2) therapy suggest it may
have an application as a parenteral drug for both prophylaxis and therapy. There
are current trials with oral curcumin for these diseases by other research
groups at various stages of clinical development. While these preclinical data
show potentially beneficial activity and follow well-defined mechanisms of
action, (2) the
parenteral route has not yet been substantiated as effective in controlled
clinical trials. The Company’s goal is to establish the efficacy of parenterally
administered curcumin.
Pancreatic
cancer is the fifth leading cause of cancer deaths, accounting for an estimated
30,000 deaths annually in the United States, according to published reports
found in Burro, H.A. et al (Item 5, Appendix B). This cancer is largely
resistant to the current approved drug, gemcitabene, and results in an objective
tumor response in only 5% of patients resulting in a minor impact on
survival. (3)
Pancreatic cancer, thus, remains an unmet clinical need. We believe
that most patients with this diagnosis could be candidates for controlled
clinical trials alone or in combination with gemcitabene in clinical
trials.
Other
potential susceptible tumor types are primary and metastatic brain tumors and
multiple myeloma in adults. The market for glioblastoma multiforme and other
malignant gliomas has an incidence of about 17,000 per year, or 59 per million
of the population, according to the scientific literature. (4) Although this
represents just 2% of cancer deaths in the United States, survival rates are
quite low and cost of treatment is high. Following standard therapy, the median
survival of glioblastoma patients is 9 to 11 months with less than 5% of
patients alive after 5 years. In addition, metastases to the brain from other
sites affect an estimated 75,000 patients per year and have very poor survival
rates, making primary and metastatic brain tumors a clear unmet need. The annual
incidence of multiple myeloma is 15,000 cases in the United States. Multiple
myeloma is responsible for 10% to 20% of the hematological malignancies, with
skeletal involvement in about 80% of the patients. (5) This disease
has been shown by other non-Company researchers to have an increased expression
of the curcumin-sensitive signaling pathway, which the Company believes may make
it susceptible to therapy with our product candidates. Based upon pre-clinical
studies conducted by other scientists with curcumin, we believe the potential
patient population could include the majority of these patients following
failure of standard treatment, or as testing advances, in combination therapy or
as a first line single-agent.
The
Company believes that its parenteral formulations of curcumin can be compared
with standard of care when used in combination with front line standard
chemotherapy in a number of diseases. Given the aging of the population with
annual incremental growth in the number of prospective patients in chronic and
acute disease categories, the Company believes a potentially effective and
potentially minimally toxic agent like curcumin could gain wide acceptance and
usage.
1 Ahn
KS, Aggarwal BB., 2005 Transcription factor NF-(kappa)B; A sensor for smoke and
stress Signals. Ann N.Y. Acad Sci 1056:218-233.
2 Aggarwal
B.B., Kumar A, Bharti C 2003. Anticancer potential of curcumin. Pre-clinical and
clinical studies. Anticancer Research 23:363-398.
3 Burris
H.A. et al. 1997 Improvements in survival and clinical benefit with gemcitabine
as first line therapy for patients with advanced pancreatic cancer: a randomized
trial. J Clinical Oncology 15:2403-2413.
4 Schouten
L.J. et al 2003, Incidence of brain metastases in a cohort of patients with
carcinoma of the breast, colon, kidney, lung and melanomas. Cancer
94:2698-2705.
5 Sung
B. Kunnumakkara AB, Sethi G. Anand P., Guha S., Aggarwal BB. Mol Cancer ther.,
Ap 8(4): 959-70. 2009, Curcumin circumvents chemoresistence in vitro and
potentiates the effect of thalidomide and bortezomib against human multiple
myeloma in nude mice model.
33
Product
Overview
Background
on Curcumin
Curcumin
has been used primarily in its natural state in tumeric as an ingredient in
foods for hundreds of years in India and the Asian subcontinent where it grows
naturally. It also has a history of use as a medicinal extract.(3)
Curcumin’s
history includes oral human use for a variety of benign and malignant diseases.
A body of published research explaining curcumin’s mechanisms of action at the
cellular level supports its potential application in humans. (6), (1), (2), (7)
In addition, there have been parenteral curcumin toxicology studies
in animals published by other researchers which support a finding of curcumin’s
safety. (7)
One
problem that has limited the therapeutic potential of curcumin is that orally
delivered curcumin has limited bioavailability. Further, curcumin is broken down
when it passes through in the intestinal tract and when it reaches the liver.
Studies of oral curcumin by other researchers have attributed to its low
efficacy to low levels of active drug reaching the bloodstream. Yet,
uncontrolled trials conducted by third parties have shown that oral curcumin,
nonetheless, appears to have some detectable clinical activity in a variety of
diseases.
To
address this problem, SignPath intends to develop parenteral formulations
(administration that bypasses the gastrointestinal system) in the form of a
liposomal version and a nanosized version. Predicated upon the dosage schedules,
needs, and population demographics of different disease entities, the Company
believes these curcumin-based treatments will be applicable for a broad spectrum
of proliferative malignant diseases. In addition, curcumin is believed to work
as a chemopreventive agent in cancers of the colon, stomach, and skin based upon
its established antioxidant and anti-inflammatory properties. (1)
Brief
Technology Background: Signal Transduction and Cellular
Pathways
Cells
carry out many of their functions by responding to signals transmitted from the
external environment. The surface of a cell has receptor proteins that span or
cross the cell surface and bind to their targets with high specificity. When an
external molecule binds to a surface receptor, it provides the signal to
activate (turn on or turn off) critical cell processes. Recent scientific
breakthroughs have enabled these surface receptors and the internal pathways
they control to become targets for drug development. Several other companies
have used these mechanisms to develop products that have reached the market or
advanced to late stage clinical trials.
Once a
cell signaling pathway is activated, a series of reactions (or cascade) occurs
within the cell. Each step activates a specific protein in the pathway, and its
active products initiate the activation of the next protein in the process. Some
of the cellular processes that are controlled in this manner include
inflammatory pathways, cell proliferation, cell survival, and cell death
(apoptosis). Elevated levels of activated inflammatory survival
pathways.
1 Ahn
KS, Aggarwal BB., 2005 Transcription factor NF-(kappa)B; A sensor for smoke and
stress Signals. Ann N.Y. Acad Sci 1056:218-233.
2 Aggarwal
B.B., Kumar A, Bharti C 2003. Anticancer potential of curcumin. Pre-clinical and
clinical studies. Anticancer Research 23:363-398.
3 Burris
H.A. et al. 1997 Improvements in survival and clinical benefit with gemcitabine
as first line therapy for patients with advanced pancreatic cancer: a randomized
trial. J Clinical Oncology 15:2403-2413.
6 Reddy
RC, Vatsala PG, Keshamouni VG et al, 2005. Curcumin for Malaria Therapy
Biochemical and Biophysical Research Communications 326:472-474.
7 Li,L.,
Brairteh, F. Kurzrock,R 2005. Liposome Encapsulated Curcumin. In Vitro Effects
on proliferation, apoptosis, signaling and angiogenesis. Cancer,
104:1322-1331.
34
have been
correlated with many types of tumors, (8) and can also be
markers for more severe disease and/or poor prognosis. Some pathways are
associated with resistance to chemotherapy, defined as tumor cell survival in
the presence of conventional toxic chemotherapy. These are some of the tumor
cell characteristics that can make cancer a fatal disease.
SignPath
is developing curcumin, a compound for which
there are early indicators that it may be a compound that inhibits several cell
survival pathways via blockade of specific signaling proteins called activating
kinases. Two established pathway targets are known as NFκB and AKT. (1) The net effect
when these pathways are inactivated is to turn off signals leading to cell
metabolism, protein synthesis, proliferation and activate signals leading to
cell death via activation of downstream processes. These changes also alter
other pathways, including STAT3, survivin, and pathways conferring resistance to
chemotherapy.
SignPath
believes inhibition of these critical intracellular survival pathways are good
targets for drug development, and our management believes that curcumin is an
attractive lead
compound for further development due to its inhibition of major survival
pathways and collateral effects of activating death pathways. It also
prohibits inflammation and release of inflammatory cytokines such as tumor
necrosis factor-ά (alpha), inflammatory cells such as macrophages which are
required for the development and spread of tumors. Recently it has been shown
that activation of NFκB (an intracellular protein) is a critical component in
cellular responses to TOLL-receptor ligands (receptors that activate
immune cell responses) and Interleukin-1 (a cytokine). The latter are implicated
in the innate immune response promoting murine hepatocellular and colon
carcinoma. (2) One of the
established effects of curcumin is to inhibit NFκB and subsequent
TOLL-receptor ligand activity. Scientific studies have suggested that a drug
that can inhibit these activated survival and inflammatory pathways should be
able to stop the growth of cancer cells. Blocking inhibitors of death pathways
are believed to shorten the cell’s ability to survive. (8)
Liposome
Encapsulation and Nanocurcumin
SignPath
is developing liposomal and nanosized versions of curcumin. The liposomal
version is a lipid-protein coating that encases the molecule. This helps prevent
the drug from being removed from the bloodstream by the liver, increases
solubility in serum, and increases the drug’s circulation time allowing more
drug to reach tumor sites. Micellar aggregates or nanoformulations of curcumin
with unique polymeric chemical coatings will be synthesized and contain similar
solubility characteristics to liposomal formulations; however, we believe these
nano-formulations may have discrete clinical applications compared to the
liposomal formulation. For these reasons, SignPath intends to develop both
formulations.
Nanocurc,
a polymeric parenteral formulation of nanocurcumin, in human pancreatic cancer
xenografts in nude mice has been found by the Company to have anti-cancer
effects which are synergistic when co-administered with Gemcitabine. This
formulation has activity against breast cancer and passes the blood brain
barrier. Non-clinical and pre-clinical studies of tumor targeted PLGA curcumin
have been completed at the University of Texas (see below) and
published.
1 Ahn KS,
Aggarwal BB., 2005 Transcription factor NF-(kappa)B; A sensor for smoke and
stress Signals. Ann N.Y. Acad Sci 1056:218-233
2 Aggarwal
B.B., Kumar A, Bharti C 2003. Anticancer potential of curcumin. Pre-clinical and
clinical studies. Anticancer Research 23:363-398.
8
Rakoff-Nahoum Seth, and Medzitof, Rusian 2007 Regulation of Spontaneous
Intestinal Tumorigenesis Through the Adaptor
Protein MyD88. Science 317: 124-127.
35
Mechanism
of Action
Curcumin’s
molecular mechanisms of action involve direct and indirect inhibition or
activation of multiple biochemical targets in tumor cells. These include genes,
enzymes, proteins, and, particularly, many components of up-regulated cell
survival and down-regulated cell death pathways. These activities result in
decreased inflammatory and/or oxidative damage, decreased migration,
proliferation and invasion of tumor cells, decreased radio- and chemoresistance,
and increased chemosensitivity to cytotoxic drugs. While not incorporated in
SignPath’s initial efforts, the Company may also develop curcumin applications
to target malaria or other parasitic diseases. These observations suggest the
potential to treat several diseases with large potential markets if the Company
can develop an economically feasible product.
Cancer: Only
1% of an oral dose of curcumin is absorbed; yet in spite of this extreme
limitation, there are publications that suggest anti-cancer activity of orally
administered curcumin. (2)
Additional evidence for anticancer activity is suggested
from in
vitro and
animal experiments. Its anticancer effects include promoting apoptosis (cell
death pathways) and down regulation of major pro-survival factors, including
AKT, NFκB, STAT-3, and Survivin signaling pathways. We, therefore, believe that
commercial application of parenteral curcumin formulations for cancers which
depend upon NFκB (such as multiple myeloma and pancreatic cancer) represent
prime candidates for Phase II trials assuming successful preclinical and Phase I
trials. Many other cancers such as brain tumors are also dependent upon AKT,
NFκB, and survival pathways which may render them additional potential clinical
targets. (3)
Government
Regulation
Regulation
by governmental authorities in the United States and other countries is a
significant factor in the development, manufacture and marketing of
pharmaceuticals, and in our ongoing research and development activities. All of
our products will require regulatory approval by governmental agencies prior to
commercialization. In particular, pharmaceutical drugs are subject to rigorous
preclinical testing and clinical trials and other pre-marketing approval
requirements by the U.S. Food and Drug Administration (“FDA”) and regulatory
authorities in other countries. In the United States, various federal, and in
some cases, state statutes and regulations also govern or impact upon the
manufacturing, safety, labeling, storage, record-keeping and marketing of
pharmaceutical products. The lengthy process of seeking required approvals and
the continuing need for compliance with applicable statutes and regulations,
require the expenditure of substantial resources.
Regulatory
approval, when and if obtained for any of our product candidates, may be limited
in scope which may significantly limit the indicated uses for which our product
candidates may be marketed. Further, approved drugs and manufacturers are
subject to ongoing review and discovery of previously unknown problems that may
result in restrictions on their manufacture, sale or use or in their withdrawal
from the market.
FDA
Approval & Developmental Milestones
There are
three primary phases of FDA clinical trials for an FDA new drug application
(NDA) and approval for commercial sale. Before these can begin,
non-clinical/pre-clinical laboratory studies are conducted and an
Investigational New Drug application (IND) is submitted to the FDA. After FDA
approval, the Company may begin Phase I clinical safety and dosage estimation
studies, followed by Phase II studies to evaluated clinical efficacy in selected
diseases, then Phase III testing to demonstrate statistically significant safety
and efficacy.
3 Burris
H.A. et al. 1997 Improvements in survival and clinical benefit with gemcitabine
as first line therapy for patients with advanced pancreatic cancer: a randomized
trial. J Clinical Oncology 15:2403-2413.
36
During
the pre-clinical phase (non-clinical and pre-clinical) a compound is
studied ex-vivo in a
laboratory and in-vivo
in laboratory animals to establish its stability, manufacturing
feasibility, bioavailability, absorption, distribution, metabolism and
elimination. This phase of testing establishes pre-clinical parameters for
clinical safety and efficacy. Results of these pre-clinical trials comprise the
IND that is submitted to the FDA for review before the drug is tested in humans.
Phase I testing is a basic safety study to determine if the drug is safe enough
to be tested in humans. During Phase I, the drug can be tested in both healthy
human volunteers and/or patients with malignant disease to determine a tolerable
dosage regimen that is sufficiently safe to proceed with further testing in a
larger group of diseased patients. Testing in disease-free volunteers can supply
accurate estimates of safety and tolerability for application in persons with
non-cancer indications, while testing in patients with pre-treated cancers can
indicate different degrees of tolerance depending upon their past medical
history.
In Phase
II studies, the drug is tested in small number of patients with benign and/or
malignant forms of the disease to determine the doses at which the drug has
clinical activity and to characterize the drug’s effects on the body. These
effects include the drug’s dosage, efficacy, and side effect
profiles.
Drugs
that have a clinical benefit in Phase II trials move forward to additional
clinical testing with a larger number of patients in Phase III trials. These
trials verify Phase II results in a larger patient sample and must demonstrate
statistically significant benefits in the drug’s safety and efficacy. Trial
endpoints are designed to show a meaningful clinical effect over a predetermined
timeframe. These timeframes depend on the disease being tested and can be in
days, weeks, or years of treatment.
The drug
being tested is typically compared with a placebo or the current standard of treatment to show
that the drug is equal to (or an improvement upon) existing treatments. Once
those studies have been completed, the new drug application (NDA) is prepared
and submitted to the FDA for approval. Under FDA guidelines, the NDA should be
answered within 10 months. At such time, the FDA may inform the Company
that drug is approved, the application is approvable pending resolution of
certain issues, or may require additional studies to be completed for
approval.
Other
Regulatory Requirements
Any
products that we manufacture or distribute under FDA approvals are subject to
pervasive and continuing regulation by the FDA, including record-keeping
requirements and reporting of adverse experiences with the products. Drug
manufacturers and their subcontractors are required to register with the FDA
and, where appropriate, state agencies, and are subject to periodic unannounced
inspections by the FDA and state agencies for compliance with cGMP regulations
which impose procedural and documentation requirements upon us and any third
party manufacturers we utilize. Before approving a biologics license
application, the FDA will inspect the facilities at which the product is
manufactured (including both those of the applicant and any third-party
component manufacturers) and will not approve the product unless the
manufacturing facilities are in compliance with FDA’s cGMP, which are
regulations that govern the manufacture, storage and distribution of a product.
Manufacturers of biologics also must comply with FDA’s general biological
product standards.
Following
approval, the FDA periodically inspects drug and biologic manufacturing
facilities to ensure continued compliance with the cGMP regulations. We must
ensure that any third-party manufacturers continue to expend time, money and
effort in the areas of production, quality control, record keeping and reporting
to ensure full compliance with those requirements. Failure to comply with these
requirements subjects the manufacturer to possible legal or regulatory action,
such as suspension of manufacturing or recall or seizure of product. Adverse
experiences with the product must be reported to the FDA and could result in the
imposition of marketing restrictions through labeling changes or market removal.
Product approvals may be withdrawn if compliance with regulatory requirements is
not maintained or if problems concerning safety or efficacy of the product occur
following approval.
The FDA
also closely regulates the marketing and promotion of drugs. A company can make
only those claims relating to safety and efficacy that are approved by the FDA.
Failure to comply with these requirements can result in adverse publicity,
warning letters, corrective advertising and potential civil and criminal
penalties. Physicians may prescribe legally available drugs for uses that are
not described in the product's labeling and that differ from those tested by us
and approved by the FDA. Such off-label uses are common across medical
specialties. Physicians may believe that such off-label uses are the best
treatment for many patients in varied circumstances. The FDA does not regulate
the behavior of physicians in their choice of treatments. The FDA does, however,
restrict manufacturer’s communications on the subject of off-label
use.
37
The FDA’s
policies may change and additional government regulations may be enacted which
could prevent or delay regulatory approval of our product candidates or approval
of new indications for our existing products. We cannot predict the likelihood,
nature or extent of adverse governmental regulations that might arise from
future legislative or administrative action, either in the United States or
abroad.
In
addition, the labeling, advertising, promotion, marketing and distribution of a
drug or biologic product also must be in compliance with FDA and U.S. Federal
Trade Commission (“FTC”) requirements which include, among others, standards and
regulations for off-label promotion, industry sponsored scientific and
educational activities, promotional activities involving the internet, and
direct-to-consumer advertising. The FDA and FTC have very broad enforcement
authority, and failure to abide by these regulations can result in penalties,
including the issuance of a warning letter directing the Company to correct
deviations from regulatory standards and enforcement actions that can include
seizures, injunctions and criminal prosecution.
Other
Uses of Curcumin
There are
other potential uses of curcumin in addition to our initial focus on multiple
myeloma and pancreatic cancer. Following our clinical trials in these two
categories, we will seek to study other cancer candidates which have an AKT or
NFkB requirement for survival and proliferation, such as breast and prostate
cancers. The unique activity of curcumin also suggests its use with other cancer
treatment modalities. For example, it may increase tumor cell susceptibility to
standard treatment with radiation or chemotherapy.
Because
of the protean nature of curcumin’s interaction with different cell components,
and based upon data derived from traditional use and non-clinical and
pre-clinical laboratory studies, we believe it may have a therapeutic role in
numerous non-cancer indications.
To expand
its use for other cancers, Parkinson’s Disease and parasitic diseases, the
Company is developing three different (liposomal, polymeric and slow release
PLGA) intravenous nanoparticle size formulations. Proof of efficacy of these
formulations against human tumor xenografts in mice was published. During IND
pre-clinical toxicity trials in dogs, with liposomal curcumin, a dose-dependant
hemolysis was observed, indicating specific dose/schedules of administrations
will be required for trials in humans.
A
research grant of approximately $80,000 from the Michael J. Fox Parkinson’s
Disease Foundation to measure parenteral liposomal curcumin passage across the
blood brain barrier and focal distributions in mice/rat brains in collaboration
with D. S. Chiou at the University of Western Ontario, Canada. Data, to date,
has revealed intravenous curcumin localized in specific brain regions associated
with Parkinson’s Disease and memory processing. The Company has expended
approximately $30,000 to manufacture nanocurcumin for this study and is funding
animal studies with Dr. Chiou with the remaining funds.
To
broaden the intellectual property profile of parenteral curcumin, additional
clinical uses of curcumin have been incorporated in a CIP (continuation in
progress) application. This application has been submitted to the Patent and
Trademark Office by MD Anderson and contains claims for additional therapeutic
uses of curcumin. There is sufficient published data on curcumin and autoimmune
diseases, degenerative diseases of the joints and the nervous system,
inflammatory based diseases, aging, diabetes and cerebral malaria to envision
addressing these conditions with parenteral curcumin when final dosage and
safety data from cancer trials in cancer patients becomes
available.
Clinical
Trials
The
Company expects to submit an IND to begin human clinical trials upon completion
of the preclinical work, which is expected to be in the third quarter of 2010.
The Company expects to initiate Phase I clinical trials within three months of
regulatory clearance. Clinical trials for liposomal curcumin and nanocurcumin
will use curcumin formulations made under GMP conditions by contract
manufacturers. As described below, the Company has entered into agreements with
manufacturers of curcumin, liposomal curcumin, and polymers for
nanocurcumin to produce sufficient quantities to complete all
pre-clinical requirements for submission of an IND. Agreements for additional
quantities of both formulations for Phase 1 clinical trials will be
initiated depending upon human dosage estimates generated in
pre-clinical studies. The Company plans to pursue four Phase I liposomal
curcumin and nanocurcumin parenteral trials in cancer patients.
38
We have
had preliminary discussions regarding participation in Phase I and II clinical
trials during direct meetings with responsible physician investigators at
three cancer centers. All have had extensive experience with drug trials
anticancer drugs and are willing to participate in the proposed clinical
studies.
These investigators
include:
|
·
|
M.D.Anderson
Cancer Center, Houston Texas. Dr. R. Kurzrock has already evaluated oral
curcumin in over 40 patients with pancreatic
cancer.
|
|
·
|
New
York Medical College, Dr. T. Ahmad has had extensive experience as a
Phase I, II, and III clinical trial
investigator.
|
|
·
|
At
the Algemeine Krankenhaus, in Vienna Austria, Dr. Michael Wolzt would be
in charge of Phase I and II clinical trials following initial toxicity
data from either New York Medical College (Valhalla, NY) or M.D. Anderson
Cancer Center. Our CEO inspected these facilities in December 2007,
however, no agreements were entered into and management will determine
whether to pursue a clinical study of this finding depending on cost and
feasibility, when regulatory approval is
obtained.
|
Additional Phase
I trials in normal volunteers may be initiated if deemed necessary by the
FDA, if a non-toxic but therapeutic dose is determined in Phase I
cancer studies. These studies are expected to be carried out by Dr.
Wolzt in Vienna, Austria and at The Johns Hopkins Hospital, Baltimore,
Maryland.
Tentative
sites for these Phase I trials include the following:
|
·
|
We
expect that the SP01 (liposomal curcumin) formulation will be tested for
pharmacokinetics, safety and dosage estimation in a Phase I trial in three
centers: MD Anderson Cancer Center, Houston, Texas; Westchester
Medical Center, Valhalla, New York; and Medical University of Vienna,
Allgemeines Krankenhaus, Vienna,
Austria.
|
|
·
|
We
expect that the SP02 (nanocurcumin) formulation will be tested for
pharmacokinetics, safety, and dosage estimates in Phase I trials in three
centers: M.D. Anderson Medical Center, Houston, Texas;
Westchester Medical Center, Valhalla, New York; and Medical University of
Vienna, Allgemeines Krankenhaus, Vienna,
Austria.
|
In both
cases above, the Company expects that the trials’ subjects will be cancer
patients who have failed standard of care therapy and elected experimental
therapy.
Provided
that the safety results of Phase I trials are satisfactory and the FDA approves
the Phase II studies, the Company anticipates launching the following Phase II
trials:
|
·
|
Liposomal
curcumin: Intravenous administration to pancreatic cancer
patients who fail standard therapy.
|
|
·
|
Liposome
curcumin: Intravenous administration to multiple myeloma cancer patients
who fail standard therapy.
|
|
·
|
Nanocurcumin: Intravenous
administration to pancreatic cancer patients who fail standard
therapy.
|
|
·
|
Nanocurcumin: Intravenous
administration to multiple myeloma patients who fail standard
therapy.
|
39
Market
Analysis
The
anticipated markets for therapeutic curcumin include populations with unmet
medical needs, or as combinations with established drugs to enhance their
activity in the presence of drug resistance. The preclinical studies of curcumin
in cancer suggest its potential application as a parenteral drug for both
prophylaxis and therapy.
Given the
aging of the population with an annual increment in the number of prospective
patients in chronic disease categories, the Company believes a potentially
effective and presumably minimally toxic agent like oral or parenteral curcumin
could gain wide acceptance and usage.
As stated
earlier, the Company is aware of pre-clinical data from other research
suggesting that parenteral curcumin may have anti-cancer activity. (8) The new cases of cancer
in the United States in 2009 were estimated at approximately 1,400,000 per year,
according to the American Cancer Society, Inc. Surveillance Research. This is a
large market with substantial room for improvement over current
therapies.
Curcumin
may also prove to be effective as prevention for high-risk individuals and as a
therapeutic for established disease when used alone or in combination with other
agents. As an initial approach we anticipate treating diseases with unmet needs.
These include multiple myeloma and pancreatic cancer. While there are current
clinical trials with oral preparation of curcumin, we currently know of no
competitors with publicly known plans to develop parenteral forms of curcumin.
Management believes that the Company is positioned to leverage its rights to its
licensed intellectual property of these parenteral products in the United States
and worldwide.
Potential
Commercialization of Liposomal Curcumin and Nanocurcumin
Because
the liposomal formulation has been demonstrated by other researchers to be
effective in animal studies, (8) we anticipate that this
modification of curcumin could be more effective than the natural extract from
turmeric when administered parenterally. Assuming we obtain positive results
from our preclinical trials, clinical trials and ultimately receive FDA
approval, the Company believes that these formulations of curcumin may be
accepted by physicians for treating cancer and other diseases that fit within
the efficacy profile established by the Company.
Modification
of water-insoluble drugs such as curcumin as liposomes or nanoparticles is a
novel formulation process. We cannot predict at this time the biological
activity of a liposomal curcumin product compared to the nanocurcumin
formulation due to possible differences in effectiveness, pharmacokinetics, and
pharmacodynamics. There may be specific pharmacological advantages for either
formulation which could confer clinical and/or commercial value. The final cost
of drug production will depend upon usage and economies of scale; however, we
intend to adopt a strategy, if possible, to result in our products having a cost
competitive with current medications for the intended applications.
The
Company also expects to evaluate conducting potential additional development
initiatives based on its licensed curcumin formulation to treat patients with
degenerative, arthritic and parasitic diseases, such as malaria, depending upon
the results of the Phase 1 trials, clinical imperatives, and financial resources
to carry them out.
Clinical
application of parenteral administration of liposomal curcumin or nanosized
curcumin may induce varied responses in the same disease or in different disease
states. In addition, we anticipate different development and manufacturing
costs, and ultimately different commercial remuneration in the different
applications. These variations are attributed to demographic differences in
applications such as pancreatic cancer and multiple myeloma.
8
Rakoff-Nahoum Seth, and Medzitof, Rusian 2007 Regulation of Spontaneous
Intestinal Tumorigenesis Through the Adaptor Protein MyD88. Science 317:
124-127.
40
The
Company entered into a Liposomal Formulation Manufacturing Agreement with
Polymun Scientific Immunbiologische Forschung GmbH (“Polymun”), Vienna, Austria,
dated as of September 6, 2007, which has been filed as an exhibit to the
Company’s SEC filings. Pursuant to this agreement, Polymun will apply their GLP
process and experience to encapsulate pure synthetic curcumin provided
by the Company with a layer of lipid particles (making a liposome
formulation which can be injected intravenously). After testing for size, and
stability, Polymun will deliver the liposomal curcumin to the MD Anderson Cancer
Center for intravenous animal toxicity testing. During this
developmental process they have invented and developed a special assay to
simultaneously quantify the content of lipids and curcumin in all batches they
prepare. Polymun completed scaled-up GMP manufacture of the lipocurc
formulation. The Company’s obligation to Polymun totaled €280,000 through the
first two development stages and thereafter a €130,000 per production fee. Our
agreement with Polymun expired on December 31, 2009 although the parties are
continuing work under the terms of the agreement.
On
January 30, 2008, the Company contracted with Brookwood Pharmaceuticals, Inc.,
n/k/a Surmodics Pharmaceuticals, Inc. (“Surmodics”) an Alabama based polymer
manufacturer, to synthesize a quantity of polymer for nanocurcumin development.
The polymer is designed to surround the pure curcumin to render it soluble
and ready for intravenous administration in mice, rats, and dogs which
constitutes the "nanocurcumin formulation". The total cost for producing
sufficient polymer for animal studies is $81,000. Surmodics will provide
quantities of output to the Company’s designated manufacturer in order to
fulfill final product requirements.
Both
Polymun and Surmodics are agreeable to proceed with this second phase of
development to produce clinical GMP grade curcumin. The Company will decide
between the two companies based upon their capacity and experience. Since
liposomal curcumin is an advanced stage of development (pre-clinical) and
nearing completion of FDA requirements, the Company’s interest is to proceed
with that product in its Phase 1 clinical studies. The nanocurcumin to be
developed by The Johns Hopkins University is expected to take 8 to 12 months
before it can be submitted for trials. Ultimately, the final GMP product will be
shipped to Dr. Anirban Maitra at The Johns Hopkins University, who will complete
the pre-clinical aspects of the IND. Additional batches will be sent to
J.A.Smith at MD Anderson for GLP production.
Raw
Materials; Supplies
Liposomal
curcumin was manufactured for the Company by Polymun, Inc., of
Vienna, Austria under the agreement described in the prior section. It was
obtained initially from a U.S. chemical supplier, Sigma Aldrich Fine Chemicals
(“SAFC”) and then from Sabinsa Inc., New Jersey. The Company obtained one batch
of 200 grams of GMP manufactured liposomal curcumin under an agreement dated
June 30, 2007 with SAFC, which has been filed as an exhibit to the Company’s SEC
filings. The total cost to the Company was $98,350 for scaled-up manufacture of
98.2% pure curcumin under GMP for human use is in process at Sabinsa/Sami Labs,
Bangalore, India. FDA and EMEA (European Medicines Agency) compliance and
validations audits relating to the curcumin manufacturing facility in India was
performed by Topaz Technology, Inc. of Bryn Mawr, PA under an agreement with the
Company dated June 30, 2009, at a total cost of $24,500 which has been paid.
Analysis of the 0.1% residue is being done at Chimic Labs, Massachusetts.
Nanocurcumin is manufactured for the Company by either SAFC or Sabinsa. The
Company’s purchases from Sabinsa were made pursuant to purchase orders without a
contract. There are very stringent new regulations concerning GMP by the EMEA
and the FDA. The polymer used for nanocurcumin development is manufactured by
Surmodics under the above-described agreement.
At
UTMDCC, GLP pharmacokinetic and toxicity studies of single and multi-dose
intravenous liposomal curcumin in mice and rats were without evidence of
toxicity at a maximal injectible volume. Dog pharmacokinetics and single
ascending dose toxicity studies identified reversible hemolysis at a maximum
tolerated dose (MTD) and irreversible hemolysis at a significantly higher dose
limiting level. In vitro studies with dog and human RBCs corroborated these
observations three anmexin V biomarker (a biochemical feature
used to measure the progress of diseases or the effects of treatment). Multidose canine
studies are planned at MTD dosages based upon these studies.
SignPath
is collaborating with Gibralter Labs, Surmodic Pharma, Johns Hopkins University
and the NCI Nanocharacterization Laboratory for corroborative non-clinical and
pre-clinical studies of polymeric nanocurcumin. GMP production is being explored
at a facility in Calcutta, India.
Intellectual
Property
The
Company has three pending patent applications for lipocurc, nanocurc and
depocurc. The U.S. Patent Office has returned office action on all three
applications. A fourth provisional patent submission concerning curcumin
infusions was submitted in November 2009, a six-month extension request for a
fifth provisional patent applications concerning a new medical application was
submitted in or about March 2010.
41
Internet
domains have been established for Signpathpharma.com; depocorc.com,
lipocurc.com; nanocurc.com and nanocurcumin.com. The trademark “Nanocurc” (Sept.
15, 2009) has been registered with a six-month extension to use in
commerce.
Agreement
With University of Texas MD Anderson Cancer Center
A patent
is pending for liposomal curcumin. It was submitted in 2005 by the University of
Texas MD Anderson Cancer Center (the “UTMDACC”) with the title “Liposomal
Curcumin for Treatment of Cancer.” On February 21, 2007, SignPath,
the UTMDACC and the Board of Regents of the University of Texas System (the
“Board”) entered into an exclusive license for this pending patent (the “UTMDACC
License Agreement”). Pursuant to the UTMDACC License Agreement, SignPath has a
royalty-bearing exclusive, worldwide license to manufacture, use, import and
sell for human and animal use inventions and discoveries covered by the pending
patent and associated technologies. SignPath may sublicense its rights under the
UTMDACC License Agreement.
SignPath
has agreed to pay all of UTMDACC’s reasonable out-of-pocket expenses of filing,
prosecuting, enforcing and maintaining its patent rights. In addition, SignPath
is obligated to pay a $15,000 license documentation fee and an annual
maintenance fee of $10,000 for the first seven years of the UTMDACC License
Agreement. If a patent is issued during the first seven years of the license,
this annual fee will increase to $15,000. After the seventh anniversary of the
UTMDACC License Agreement, the annual fee will increase to $30,000 a
year.
In
addition, SignPath is obligated to pay running royalties of 2.5% on net sales of
less than $250 million for products covered by an issued patent licensed under
the UTMDACC License Agreement. This royalty rate increases to 3% for sales equal
to, or greater than, $250 million. A royalty of 1.5% of net sales is payable by
SignPath for products covered under the license which are not protected by an
issued patent. After sales to the public begin, SignPath must pay a minimum
annual royalty $75,000 which can be deducted from the royalties on net sales due
under the agreement. In addition, SignPath is obligated to pay 20% to 25% of all
non-royalty consideration received under sublicensing agreements.
The
Company will also be responsible for the following milestone payments upon the
occurrence of specified events. These consist of: (1) $10,000 upon dosing the
first patent with a licensed product in a Phase 1 Study; (2) $25,000 upon dosing
the first patient within a licensed product in a Phase 2 study; (3) $50,000 upon
dosing the first patient with a licensed product in a Phase 3 Study, or $40,000
if no product has issued when this milestone is achieved; (4) $400,000 upon the
first regulatory approval of a licensed product, or $200,000 if no patent has
issued and (5) $15,000 upon issuance of a patent. The Company expects to fund
the milestone payments when they come due from the private placement of equity
securities to the extent funds are available. Further the Company has agreed to
provide a minimum of $250,000 in funding for the completion of pre-clinical
studies subject to completion of final reports.
The
UTMDACC License Agreement survives for the period that patent rights covering
the licensed intellectual property are in place, or if no patent rights are
issued, 15 years with an automatic extension of 15 years upon regulatory
approval of a licensed product. UTMDACC will, as part of a SignPath sponsored
research agreement, prosecute an IND for the pegylated liposomal curcumin
product. UTMDACC and/or the Board has the right to terminate the agreement in
any jurisdiction if SignPath fails to cure within 90 days of receipt of written
notice its failure to commercialize and actively attempt to commercialize sales
in such jurisdiction. The UTMDACC License Agreement is terminable by UTMDACC
upon 30 days’ written notice if SignPath fails to cure a breach of payment
and/or fails to fund completion of pre-clinical studies or file an IND or upon
90 days’ written notice for any other breach of contract.
42
Agreement
With The Johns Hopkins University
In
October, 2007, SignPath and The Johns Hopkins University (“JHU”) entered into an
exclusive license agreement under a provisional patent application (Serial No.
60,866/516) entitled “Biocompatible ‘Smart’ Nanogels as carriers for Hydrophobic
drugs”. This application was submitted on November 20, 2006 by JHU for a
nano-sized curcumin formulation called nano curcumin. Pursuant to the JHU
License Agreement, SignPath has an exclusive worldwide license to manufacture,
use, import and sell inventions and discoveries covered by the pending patent
and associated technologies. SignPath may sublicense its rights under the JHU
License Agreement, subject to terms and conditions set forth in the Agreement.
The JHU License Agreement shall continue until its expiration of the last to
expire patent in each country, or if no patents issue, then for 20 years from
the commencement of the agreement. The agreement is terminable for a breach
which is not cured within 30 days after receipt of notice or by SignPath upon 90
days’ prior written notice. Title to all inventions and discoveries made by each
party resulting from their research shall belong to each respective party with
joint ownership of inventions and discoveries which are made
jointly.
Under the
terms of the JHU License Agreement, SignPath has agreed to exercise its best
efforts file an IND with the FDA and to exercise reasonable efforts to develop
and introduce the licensed products and services into the commercial market. In
addition, the Company entered into a sponsored research agreement (the “SRA”)
with Dr. Anirban Maitra of JHU pursuant to which we will provide $100,000 of
funding for the continuation of non-clinical and pre-clinical studies of the
nanocurcumin compound will pay JHU indirect costs of $64,000. The SRA was
entered into by the Company on October 2, 2007. Payment of the $100,000 fee
under the SRA was due in three equal installments beginning 30 days after
execution of the agreement and at 4 month intervals from development of an IND
for nanocurcumin all of which has been paid as of December 31, 2009. The term of
the SRA was one year ending on September 18, 2008 which was not extended.
Subject to current research activity, new opportunities and the availability of
funds, Dr. Maitra’s contract may be renewed for additional programs. All
inventions which would be filed as a continuation patent under JHU’s patent
application shall be subject to the JHU License Agreement.
SignPath
was obligated under the JHU License Agreement to pay $50,000 in license fees
which have been paid, plus minimum annual royalties increasing from $10,000 in
the first two years to $25,000 in the third and fourth years and $30,000 in the
fifth year. An aggregate of approximately $241,000 has been paid under this
license agreement as of June 30, 2010. The JHU License Agreement also provides
that we will be obligated to pay JHU running royalty rates of two percent (2%)
of net sales less than $250 million for licensed products covered by one or more
claims in an issued patent, and three percent (3%) of net sales equal to or
greater than $250 million for licensed products covered by one or more claims in
an issued patent, or one and one half percent (1.5%) of net sales of licensed
products not covered by an issued patent. The running royalties payable under
the agreement are subject to a minimum annual rate. SignPath is also subject to
other substantial payments, including all reasonable costs of patent
reimbursement. The Company is obligated to make the following payments upon
development milestones to JHU regardless of whether the milestone is achieved by
the Company, a sublicensee or an affiliate: (1) $25,000 upon dosing the first
patient with a licensed product in a Phase I clinical trial at a site other
than JHU; (2) $50,000 upon dosing the first patient with a licensed patent in a
Phase II clinical trial at a site other than JHU; (3) $25,000 upon dosing
the first patient with the licensed patent in a Phase III clinical trial at
a site other than JHU; (4) $250,000 upon first regulatory approval of the
licensed patent, or $100,000 if no patent has issued; (5) $10,000 upon issuance
of a patent sublicense fees (if applicable), and reimbursement of costs
reasonably incurred by JHU in connection with the patent.
Agreements
with the University of North Texas
On August
18, 2008, the Company entered into a Patent and Technology License Agreement
with the University of North Texas (“UNT”) Health Science Center (the “UNT
Agreement”). UNT granted the Company a royalty-bearing exclusive license to
manufacture and sell products developed at UNT from depot curcumin. In
consideration of the license, the Company agreed to pay an upfront license fee
of $15,000, reasonable out-of-pocket expenses for patent rights; an annual
maintenance fee of $10,000 commencing on the first anniversary date of when the
UNT Agreement was signed until the first to occur of (i) the seventh anniversary
date of the contract signing; (ii) the first sale of a product to a
non-affiliated third party; or (iii) the issuance of a patent. The annual fee
increases to $30,000 after the seventh anniversary date of the agreement being
signed until the first sale. The annual maintenance fee shall increase from
$10,000 to $15,000 following the issuance of a patent until the earlier of first
sale or the seventh anniversary date. Upon the first sale, the annual
maintenance fee shall convert into a minimum annual royalty of $75,000. Running
royalties of 2.5% of net sales less than $250 million for licensed products
covered by an issued patent; 3% of net sales equal to or greater than $250
million; and 1% of net sales of licensed products not covered by an issued
patent may be credited against the minimum annual royalty next
due.
43
The
Company or a sublicensee shall pay milestone payments to UNT of (i) $10,000 upon
the first dosing of a patient with a licensed product in a Phase 1 Study; (ii)
$25,000 upon the first dosing of a patient with a licensed product in a Phase 2
Study; (iii) $50,000 upon the first dosing of a patient with a licensed product
in a Phase 3 Study, the latter of which shall be reduced from $50,000 to $40,000
if no patent has been issued; $400,000 upon first regulatory approval of each
licensed product unless a patent has not been issued; $15,000 upon issuance of a
U.S. or European patent; $200,000 upon regulatory approval of a licensed patent
for each indication other than cancer, which shall be reduced to $100,000 if no
patent has been issued.
Certain
payments to the Company by a sub-licensee prior to initiation of a Phase 2 Study
shall not be included in fees paid to UNT in the amount of 25% and 20% if the
sublicense is executed after initiation of a Phase 2 Study. UNT shall also
be paid a $100,000 assignment fee.
The
Company agreed to spend at least $250,000 towards pre-clinical studies,
exclusive of overhead costs of UNT. At least $100,000 must be funded within 18
months of the contract signing and an aggregate of $200,000 within 2 ½ years of
the contract signing. The Company also agreed to pay all costs of filing for
patents, or otherwise lose its rights under the patent and agreed to enforce
patent rights against infringement.
The UNT
Agreement shall terminate the later of the expiration of any patent rights or 15
years or if no patent is issued, the agreement shall end 15 years after
regulatory approval of any licensed product. The Company must evidence to UNT
within three years that it is actively and effectively attempting to
commercialize a licensed product. The UNT Agreement will terminate if the
Company is unable to cure a payment default after 60 days notice from UNT or
upon 30 days notice if the Company fails to fund completion of pre-clinical
studies or to file an IND, or 90 days after default by the Company of any other
obligation under the agreement.
The
Company entered into a Sponsored Research Agreement, effective June 1, 2009,
with UNT to sponsor additional research and obtain certain patent rights and
technology resulting from such additional research. The research under this
agreement, as amended on September 8, 2009, will be carried out through November
8, 2011, under the direction of Dr. Jamboor Vishwanatha. Total payments to UNT
consist of $167,212, with a $30,000 payment due upon signing; $30,000 due on
December 1, 2009, $55,000 due on May 31, 2010 and $52,121 due on November 8,
2011.
Legal
Proceedings
As of the
date hereof, there are no material legal proceedings pending or threatened to be
taken against the Company. SignPath has retained legal counsel to evaluate and
advise on our intellectual property and patent strategy.
Employees
The
Company currently has one employee, Dr. Lawrence Helson, its Chief Executive
Officer. The Company expects to continue to use subcontractors and independent
consultants and will hire a business development director when funds are
available.
Properties
The
Company’s executive offices are located in a building owned by Dr. Lawrence
Helson, Chief Executive Officer, and are located at 1375 California Road,
Quarkertown, Pennsylvania, 18951. The Company does not pay rent at this
location. The Company owned $3,306 in office equipment in its headquarters and
administrative offices as of June 30, 2010.
44
MANAGEMENT
Set forth
below is also a brief description of the relevant business and/or scientific
experience and background of each person named below.
Officers,
Directors and Other Key Staff
Our
current officers, directors, and other key advisors to the Company consist
of:
Name
|
Age
|
Position
|
||
Lawrence
Helson, BSci, BMed,
|
77
|
Chief
Executive Officer, Director, and President
|
||
M.Sci,
MD
|
||||
Arthur
P. Bollon, Ph.D.
|
67
|
Director
|
||
Jack
Levine, CPA
|
60
|
Director
|
Dr.
Helson has served as Chief Executive Officer, Director and President of the
Company since May 28, 2008. From 1967 to 1986, Dr. Helson was employed at
Memorial Sloan Kettering Cancer Center NYC, the last 12 years as attending
physician. From 1982 to 1986, he was an associate attending pediatrician at
Cornell University Medical School, New York City. From 1986-1987 he was director
of Phase III clinical trials of Zoladex ICI in Delaware. From 1987 to 1997 he
was Professor of Pediatric and Adult Oncology at New York Medical College,
Valhalla, NY. From 1997 to 2007 he was a founder-scientist at Onconova Inc, a
biotechnology company in Princeton, New Jersey, and since 1993 has also been
part-time Vice President of Bio-Research at Napro Biotherapeutics, Boulder,
Colorado. He has held oncology consulting positions from 1985 to 1997 at Bambino
Jesu Hospital, Vatican City, Metaxa Hospital; Pireaus, Greece; and for the
Brazilian Consulate in New York City. From 2003 until present, he has provided
unpaid informal consulting services to HemoBiotech Inc, in Dallas, Texas. He ran
various research laboratories at Sloan Kettering Institute from 1975-1985, from
1987 to 1997 at New York Medical College, and from 2002 to 2005 for Napro
Biotherapeutics (now Tapestry Pharmaceuticals) in Allentown, Pennsylvania. Dr.
Helson has over 185 peer reviewed publications and 4 Issued Patents. He
initiated the bone marrow transplant program at Memorial Sloan Kettering
Hospital in 1973, and published the first peer reviewed paper in the journal
Nature on Tumor Necrosis Factor in 1975. His laboratory research also developed
six human neural tumor cell lines which are in the ATCC and English repositories
and are distributed worldwide. He also edits the journal Anticancer
Research , published in Athens, Greece and was an editor for
Nude Mouse Heterotransplantation Research, published by Karger and
Co.
Dr.
Arthur P. Bollon has served as a director of the Company since May 28, 2008. Dr.
Bollon has more than 25 years of experience in biotechnology as a scientist,
executive and entrepreneur. From October 2003, until August 2010, he was the
Chairman, President and Chief Executive Officer and since August 2010, he is a
director and consultant to HemoBioTech, Inc. which is developing HemoTech, a
potential substitute for human blood. He is a founder and had served as Chairman
and Chief Executive Officer of Wadley Biosciences Inc./LPL, a
joint venture between Wadley Cancer Center and Phillips
Petroleum which focused on cancer and immune disease therapeutics
from 1987 to 1991. From 1992 to 2000, he was a founder, Chairman and Chief
Executive Officer of Cytoclonal Pharmaceutics Inc. which focused on cancer and
infectious disease therapeutics. While at Cytoclonal, he completed an initial
public offering. In addition, he has completed research contracts with multiple
universities including UCLA, Montana State University, University of California
at San Diego, Texas Tech University and University of British
Columbia.
From 1979
through 1987, Dr. Bollon served as Chairman of the Department of Molecular
Genetics and Director of Genetic Engineering at the Wadley Cancer Center
focusing on the cloning of human cytokine genes for treatment of cancer. Prior
to Wadley, he was a faculty member at the University of Texas Southwestern
Medical School and Adjunct Professor in the Department of Molecular and Cell
Biology at the University of Texas at Dallas. He is the author of multiple
scientific communications including Editor of “Recombinant DNA Products:
Insulin, Interferon and Growth Hormone,” by CRC Press. Dr. Bollon received his
Ph.D. in molecular genetics from the Waxman Institute of Microbiology at Rutgers
University and was a Post-Doctoral Fellow at Yale University.
45
Jack
Levine was appointed to the Board of Directors of the Company on July 12, 2010.
Mr. Levine, a Certified Public Accountant, has been advising private companies
for over 30 years. From 1999 to 2007 he served as an Independent Board Member to
Pharmanet, Inc. (Nasdaq) where from 2006-2007, he served as Chairman of the
Board; in 2005, was a member of the Nominating Committee, Lead Director in 2004;
a member of the Compensation Committee in 2003, a Chairman of the Audit
Committee in 1999. Pharmanet is a global drug development services company
providing a comprehensive range of services to pharmaceutical biotechnology,
generic drug and medical device companies. From 2004-2008, Mr. Levine served as
Chairman of the Audit Committee of Grant Life Sciences (OTCBB), an R&D
company focused on early detection of cervical cancer and also providing medical
diagnostic kits. From 2000-2006, Mr. Levine was Chairman either of the Audit
Committee, Executive Committee or ALCO Committee of Beach Bank, Miami Beach,
Florida. He also served as Chairman of the Audit Committees of Prairie Fund
(2000-2006) and Bankers Savings Bank (1996-1998). From 2004-2006, Mr. Levine was
a member of the Audit Committee of Miami Dade County School Board, the nation’s
third largest school system with an annual budget exceeding $5
Billion.
Mr.
Levine has been a licensed CPA in Florida since 1983 and in New York since 2009.
He has been a Committee member of the State of Florida – Florida Bar since 1993
and a Board Member of the Southeast Region of the American Friends of Bar-Ilan
University since 2002.
Director
Independence
The
Company presently does not have any committees of the Board of Directors, which
acts together on all matters. We are not required to comply with the director
independence requirement of any securities exchange. In determining whether our
directors are independent, however, we intend to comply with the independent
rules of Nasdaq provided by Rule 4200(a)(15). As of the date of this report, Dr.
Arthur Bollon and Jack Levine, two of our three directors, are non-officer
independent members of the Board of Directors. Jack Levine is an Audit Committee
Financial Expert as defined in Item 407(d)(5)(i) of Regulation S-K.
Arthur
Bollon is also an executive officer of HemoBioTech Inc., however there have been
no transactions between the Company and HemoBioTech Inc.
Scientific
Advisory Board
SignPath
has established a Scientific Advisory Board (“SAB”) to review the research
projects of SignPath and of partnerships in which SignPath is a partner and
analyze the progress and direction of the research projects; to consider and
advise SignPath with respect to any proposed or future research projects; and to
consider and suggest general areas of research to be pursued or significant
products that should be developed.
Members
of the SAB, acting as independent contractors, shall provide consulting services
to the Company from time to time as requested. Members are expected to attend at
least one meeting per year and be available for telephonic conversations and for
review of proposed products from time to time. The consulting agreements are
renewable on an annual basis and are subject to termination on 30 days prior
written notice by either party. Members will be paid $5,000 per meeting of the
SAB (a maximum of two) attended by each adviser following the completion of a
private placement of at least $3 million. The Company will pay its SAB members a
reasonable royalty, to be negotiated on a case by case basis, from revenues
derived by the Company as a result of any inventions, improvements or projects
submitted by the advisors. The current members of the SAB and their biographical
information are as follows:
Lawrence
Helson, MD, See “Management” above.
Arthur
Bollon, Ph.D., See “Management” above.
Anirban
Maitra, MBBS, is its recipient of the Sponsored Research Agreement Johns Hopkins
Hospital Preclinical nanocurcumin development. Dr. Maitra holds a Medical
degree from All India Institute of Medical Sciences at New Delhi,
India in 1996. He then had a residency in Anatomic Pathology from University of
Texas Southwestern Medical Center Dallas followed by a Fellowship in Pediatric
Pathology Dallas Childrens Medical Center and Gastrointestinal/liver
Pathology clinical research fellowship at Johns Hopkins in 2001, with a faculty
appointment in 2002. Currently, he is Associate Professor of Pathology and
Oncology, and on the faculty of McKusick-Nathans Institute of Genetic Medicine.
He is associate editor of Current Molecular Medicine and has five major awards
for his research contributions. His research activities include mechanism-based
cancer-specific therapies for pancreatic cancer exploring small molecule
inhibitors of developmental signaling pathways, high-throughput approaches for
identification of abnormal pancreatic cancer genes, and using targeted
nanoparticles as novel drug delivery systems to enhance therapeutic efficacy
while restricting side effects. This latter research is supported by a Sponsored
Research Agreement with SignPath Pharma Inc.
46
Tauseef
Ahmed, MD, is the medical director of the Zalman A. Arlin Cancer Institute at
Westchester County Medical Center. He also serves as Chief to the division of
oncology at New York Medical College as well as Professor of Medicine. He stands
on 11 cancer-related committees including serving as Chair of the Cancer
Committee and the Oncology Steering Committee at Westchester Medical
Center. Dr. Ahmed is widely published with over 130 peer reviewed articles
appearing in various medical journals.
Eric K.
Rowinsky, MD, is the Executive Vice President and Chief Medical Officer,
Imclone, Inc., New York, NY. Prior to joining ImClone in 2005, Dr. Rowinsky was
Director of Clinical Research and later Director of the Institute for Drug
Development of the Cancer Therapy and Research Center in San Antonio from
1996-2005. He is a Clinical Professor of Medicine in the Division of
Medical Oncology at the University of Texas Health Science Center at San
Antonio. Dr. Rowinsky received his B.A. degree from New York University and his
M.D. from the Vanderbilt University School of Medicine. Following his residency
in internal medicine at the University of California, he completed fellowship
training in medical oncology at The Johns Hopkins University School of
Medicine.
Judith A.
Smith, Pharm.D. FCCP, BCOP, is Asst. Professor Dept. Gynecology, Division of
Surgery, MD Anderson Director, Translational Research Fellowship Division of
Pharmacy and Head, Curcumin Group UT MD Anderson Cancer Center. Dr. Smith
received a Bachelor of Science in Pharmacy from Union University Albany College
of Pharmacy in 1996 and completed a Doctor of Pharmacy degree in 1997. She
completed a residency in Oncology Pharmacy Practice with a Pharmacy Practice
equivalent at the National Institutes of Health. After residency, Dr. Smith
completed a two-year fellowship in Clinical Pharmacology at the University of
Texas M.D. Anderson Cancer Center (MDACC), then joined the Faculty at UT MD
Anderson Cancer Center. Currently, Dr. Smith is Director of Pharmacology
Research and an Associate Professor in the Department of Gynecologic Oncology,
Division of Surgery at MDACC. In addition, she has a joint-faculty appointment
as an Assistant Professor in the Department of Obstetrics and Gynecology at the
University of Texas Health Science Center (UTHSC) at Houston Medical School and
also in the Department of Clinical Sciences and Administration at the University
of Houston College of Pharmacy where Dr. Smith is the course coordinator for two
graduate elective courses. She is an active clinical pharmacist in the
Gynecology Oncology Center at MDACC as well as the Core Pharmacology Laboratory
Director at UTHSC Medical School at Houston. Her research focus is on drug
development for gynecologic cancers and conditions with a specific focus on drug
interactions/drug resistance with a focus on integration of herbal and
nutritional supplements for treatment of cancer.
Muhammad
Majeed, Ph.D., is the Founder, President, and Chief Executive Officer, Sabinsa
Corporation, a manufacturer of fine chemicals for nutritional, pharmaceutical
and food industries. Dr. Majeed received a B. Pharm. from Trivandrum
Medical College, India; MS in Pharmacy and PhD in Industrial Pharmacy
in New York in 1975. He worked in Pfizer, Carter Wallace and other
major companies on drug formulations prior to
establishing Sabinsa Corp. whose goal was to integrate modern
pharmaceutical technology with Ayurveda medicine. He
developed methods to extract and synthesize medicinal
products such as Boswellin, curcuminoids, gugulipids, bioperine,
citrine, petro Selenic acid, and 50 other standardized products which
are marketed globally with the US and Japan as the major
markets. Currently Sabinsa manufactures synthetic intermediates used in
pharmaceutical herb powders. Manufacturing, Research and Development is in
India. His company has 32 U.S. and international patents.
Contingency
Plan
In the
event that Dr. Helson, our current CEO is unable to fulfill his duties, the
Company expects that Dr. Tauseef Ahmed will serve as acting CEO until a
permanent replacement is found.
47
EXECUTIVE
AND CONSULTANT COMPENSATION
The
Company has entered into an employment contract with Dr. Lawrence Helson to
secure his services as President and Chief Executive Officer. The two-year
period of the contract, as extended, ends May 31, 2011. Dr. Helson will receive
a base salary of $200,000 per annum plus bonuses at the discretion of the Board.
During the calendar years ended December 31, 2009 and 2008, Dr. Helson was paid
approximately $85,000 and $50,000 and the remainder of his salary was written
off pursuant to Dr. Helson’s waiver. On June 16, 2010, the Board of Directors
awarded Dr. Helson a one-time bonus of 300,000 restricted Shares of Common
Stock. Dr. Helson may terminate the agreement upon 30 days’ prior written
notice. If the Company terminates without Cause (as defined) or Dr. Helson
terminates for Good Reason (as defined) or a Disability, the Company shall pay
Dr. Helson in addition to all accrued compensation, a severance payment equal to
six (6) months of the greater of (A) Dr. Helson’s then current base salary and
(B) the highest base salary in effect that any time during the 90 days prior to
termination. The Company shall also pay the severance payment in the event it
fails to notify Dr. Helson of its intentions to continue employment past the
expiration date no less than 90 days prior to the expiration date, or if they
fail to reach an agreement on a new employment agreement prior to the expiration
date. Dr. Helson’s employment agreement provides for a non-compete for one year
following termination of employment with any business primarily involved in
developing proprietary formulations of curcumin for application in malignant
disorders. The shares of Common Stock issued to Dr. Helson were subject to a
one-year vesting period which has expired.
Members
of the Scientific Advisory Board (SAB) are reimbursed for reasonable expenses
incurred in connection with travel to attend SAB meetings. We expect a maximum
of two SAB meetings will be held per year. Advisors will be paid $2,000 for
attending each meeting called by SignPath. Options to purchase common shares of
SignPath may be made available to the Advisor under the 2009 Option
Plan.
The
following table sets forth, with respect to the Company’s fiscal years ended
December 31, 2009 and December 31, 2008, all compensation earned by each person
who is required to be listed pursuant to Item 402(m)(2) of Regulation
S-K.
Name and
Principal Position
|
Year
|
Salary ($)
|
Bonus($)
|
Stock
Awards
($)(1)(2)
(3)
|
Option
Awards
($)
|
Non-Equity
Incentive Plan
Compensation
($)(4)
|
All Other
Compensation
($)(5)
|
Total
($)
|
||||||||||||||||||||||
Lawrence
Helson
|
2009
|
$
|
85,000
|
0
|
0
|
0
|
0
|
0
|
$
|
85,000
|
||||||||||||||||||||
President
and Chief
|
2008
|
$
|
50,000
|
(1)
|
0
|
0
|
0
|
0
|
0
|
$
|
50,000
|
|||||||||||||||||||
Executive
Officer
|
(1) Under
Dr. Helson’s employment contract he is to receive a base salary of $200,000 per
annum. He received $85,000 and $50,000 during 2009 and 2008 and Dr. Helson
waived the remainder due under his employment contract which amount was written
off.
Director’s
Compensation
Members
of the Board of Directors are reimbursed for reasonable expenses incurred in
connection with travel to attend board meetings. Options to purchase common
shares of SignPath will be made available to independent directors under the
2009 Option Plan, however, no cash compensation will be paid initially. See
“2009 Employee Stock Incentive Plan” below.
Pursuant
to the terms of a Letter Agreement dated July 12, 2010, Jack Levine was granted
options to purchase 100,000 shares of common stock at $0.85 per share upon his
joining the Board of Directors. The option vests in three equal installments on
each of the first three anniversary dates of the date of grant and is
exercisable for ten (10) years from the date of grant. He will be reimbursed for
reasonable expenses incurred, however will not receive any other cash
compensation.
48
2009
Employee Stock Incentive Plan
The
Company’s 2009 Employee Stock Incentive Plan (the “2009 Option Plan”) was
adapted by the Company’s Board of Directors on February 9, 2009 in order to
motivate participants by means of stock options and restricted stock to achieve
the Company’s long-term performance goals and enable our employees, officers,
directors and consultants to participate in our long term growth and financial
success. The 2009 Plan, which is administered by our Board of Directors,
authorizes the issuance of a maximum of 500,000 shares of our common stock,
which may be authorized and unissued shares or treasury shares. Employee options
shall be deemed Incentive Stock Options (as defined in the 2009 Option Plan) to
the maximum extent permitted by Section 422 of the Internal Revenue Code
including a five-year limit on exercise for 10% or greater stockholders with any
excess grant to the above individuals over the limits set by Section 422
being Non-Qualified Stock Options as defined in the 2009 Option Plan. Both the
Incentive Stock Options or any Non-Qualified Stock Options must be granted at an
exercise price of not less than the fair market value of shares of common stock
at the time the option is granted and Incentive Stock Options granted to 10% or
greater stockholders must be granted at an exercise price of not less than 110%
of the fair market value of the shares on the date of grant. If any award under
the 2009 Plan terminates, expires unexercised, or is cancelled, the shares of
common stock that would otherwise have been issuable pursuant thereto will be
available for issuance pursuant to the grant of new awards. The 2009 Plan will
terminate on February 9, 2019.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
As
described elsewhere in this prospectus, the Company and Meyers Associates LP,
the placement agent for its Preferred Stock Offering, have numerous
relationships and related transactions. Mr. Bruce Meyers, the Principal and
Chief Executive Officer of Meyers Associates LP, founded our Company. Mr. Meyers
beneficially owns approximately 42% of the Company’s common stock and therefore,
has influence in the affairs and operations of the Company which may present a
conflict of interest between the Company and the Placement Agent.
On May
12, 2008, the Company sold an aggregate of 10,000,000 Founders Shares of Common
Stock, $.001 par value, to the following five (5) persons: Bruce Meyers, the
Company’s founder (2,600,000 shares); Meyers Associates, L.P. (2,600,000
shares); Imtiaz Khan, Managing Director of Meyers Associates (2,500,000 shares);
Dr. Arthur Bollon, a Director (800,000 shares) and Dr. Lawrence Helson, Chief
Executive Officer (1,500,000 shares). The shares were issued in consideration of
par value of $.001 per share and services rendered.
Between
August 2007 and April 2008, the Company completed five separate private
financings (collectively, the “Bridge Financing”) with certain accredited
investors of units, each unit consisting of $1 in principal amount of 10%
promissory notes (referred to herein as the “Bridge Notes”) and shares of Common
Stock (the “Bridge Shares”). The Company raised gross proceeds of approximately
$847,500 in the Bridge Financing and the holders of the Bridge Note also
received for an aggregate of 1,365,000 shares of Bridge Shares. The holders of
$889,876 of Bridge Notes (including accrued and unpaid interest) converted their
Bridge Notes into Units in the Company’s November 28, 2008 financing described
below. Mr. Meyers, the principal of Meyers Associates, L.P. which acted as the
placement agent and is the Company’s founder, was the holder of $57,500 in
principal amount of Bridge Notes which he exchanged for Units in the November
28, 2008 financing and retained his 57,500 Bridge Shares.
On
November 28, 2008, SignPath sold 1501.88 units (“Units”) of its securities at a
price of $1,000 per Unit. Each Unit consists of (i) one share of 6.5% Series A
Convertible Preferred Stock convertible into 1,177 shares of common stock
(equivalent to $.85 per share of common stock) following the effective date of
this Registration Statement, subject to adjustment, and (ii) one Warrant to
purchase, 1,177 shares of common stock at $1.27 per share for a five-year period
following the effective date. The Units were sold to 21 accredited investors,
including Meyers Associates, L.P., which purchased 117 Units as placement agent.
Bruce Meyers, Founder of the Company, President and CEO of Meyers Associates,
purchased 264.67 units. Meyers Associates received sales and commissions of 10%
of the gross proceeds of $1,501,876 from the sale of Units, as well as a
non-accountable expense allowance equal to 3% of the gross proceeds of the
offering, and a Unit Purchase Option to purchase 15% of the securities sold in
the offering.
Between
February 19, 2009 and February 11, 2010, the Company sold 785 Units (the same as
described in the prior paragraph) pursuant to a new offering dated December 12,
2008. The Units were sold to 13 accredited investors. Meyers Associates L.P.,
received sales commissions of 10% ($78,500) of the gross proceeds of $785,000
from the sale of Units, as well as a non-accountable expense allowance equal to
3% of the gross proceeds of the offering, and a Unit Purchase Option to purchase
15% of the securities sold in the offering.
49
Between
May 21, 2010 and August 30, 2010 the Company sold 125 Units (the same as
described in the prior paragraph) pursuant to a new offering dated April 29,
1010 (the “2010 Private Placement”). The Units were sold to two investors.
Meyers Associates L.P., received sales commissions of 10% ($12,500) of the gross
proceeds of $125,000 from the sale of Units, as well as a non-accountable
expense allowance equal to 3% of the gross proceeds of the offering, and a Unit
Purchase Option to purchase 15% of the securities sold in the
offering.
Dr.
Lawrence Helson, our chief executive officer, is an unpaid consultant to Meyers
Associates LP and is a member of the Board of Directors of HemoBiotech, of which
Dr. Arthur Bollon, a member of the Company’s Board of Directors, is a director
and consultant.
In
addition, as described further under “2009 Employee Stock Option Plan” above,
Dr. Bollon may be eligible for certain stock options under the Company’s 2009
Option Plan.
Otherwise,
none of our directors or officers, nor any person who beneficially owns,
directly or indirectly, shares carrying more than 5% of the voting rights
attached to all of our outstanding shares, nor any promoter, nor any relative or
spouse of any of the foregoing persons has any material interest, direct or
indirect, in any presently proposed transaction which, in either case, has or
will materially affect us.
Our
management is involved in other business activities and may, in the future,
become involved in other business opportunities. If a specific business
opportunity becomes available, such persons may face a conflict in selecting
between our business and their other business interests. In the event that a
conflict of interest arises at a meeting of our directors, a director who has
such a conflict will disclose his interest in a proposed transaction and will
abstain from voting for or against the approval of such
transaction.
PRINCIPAL
STOCKHOLDERS
The
following table sets forth certain information regarding the beneficial
ownership of the Company’s common stock as of date of this prospectus by (i)
each person which is known by the Company to beneficially own more than 5% of
the Company’s common stock, (ii) by each of the Company’s directors, (iii) by
each executive officer of the Company, and (iv) by all executive officers and
directors as a group.
The
address of each of the persons listed below, unless otherwise noted, is c/o
Signpath Pharma Inc. 1375 California Road, Quakertown, PA 18951.
Name of Beneficial Owner
|
Number of Shares of
common stock
Beneficially
Owned (1)
|
Percentage of common
stock Beneficially Owned
|
||||||
Dr.
Lawrence Helson (2)
|
1,800,000 | 15.3 | % | |||||
Dr.
Arthur Bollon
|
800,000 | 6.8 | % | |||||
Jack
Levine
|
-0- | (3) | -0- | |||||
Meyers
Associates, L.P. (4)
|
3,772,366 | (5) | 28.2 | % | ||||
Bruce
Meyers (4)
|
8,406,000 | (6) | 60.0 | % | ||||
Imtiaz
Khan (4)(7)
|
2,450,000 | 20.9 | % | |||||
All
Executive Officers and Directors as a Group
(3 persons)
|
2,600,000 | 22.1 | % |
(1) Except
as otherwise noted in the footnotes to this table, the named person owns
directly and exercises sole voting and investment power over the shares listed
as beneficially owned by such person. Includes any securities that such person
has the right to acquire within sixty days pursuant to options, warrants,
conversion privileges or other rights. As of the date of this prospectus, there
were 11,740,000 shares of our common stock issued and outstanding. As of that
date, (i) 500,000 shares of common stock were reserved for issuance under
our 2009 Option Plan of which no options had been granted;
(ii) approximately 2,838,924 shares of our common stock were reserved for
issuance pursuant to conversion of preferred stock; (iii) approximately
2,838,924 shares were reserved for issuance pursuant to exercise of warrants to
purchase common stock; (iv) 368,894 shares of our common stock were reserved for
issuance pursuant to the issuance of Dividend Shares; and (v) there were
Placement Agent Warrants to purchase approximately 969,335 shares of common
stock equal to 15% of the securities sold in the 2008, 2009 and 2010 Private
Placements.
50
(2) Dr.
Helson, our CEO, is also an unpaid consultant to Meyers Associates,
L.P.
(3) Does
not include options to purchase 100,000 shares of common stock granted on July
12, 2010 which vest in three equal installments on the first three anniversary
dates from the date of grant.
(4) The
address of each of these persons is 45 Broadway, 2nd Fl.,
New York, NY 10006.
(5)
Includes 2,200,000 shares of Common Stock, an aggregate of 1,381,948 shares of
common stock issuable upon exercise of Meyers Associates’ Unit Purchase
Options and 275,418 shares of common stock underlying 117 units purchased by
Meyers Associates in the 2008 Private Placement; but does not include additional
shares of common stock beneficially owned by Bruce Meyers, the President of
Meyers Associates. Bruce Meyers has the power to vote and dispose of the Shares
owned by Meyers Associates.
(6) Mr.
Meyers is Principal and Chief Executive Officer of Meyers Associates. This
amount includes 2,657,500 shares of common stock and an aggregate of
623,033 shares of common stock issuable underlying 264.67 Units purchased by Mr.
Meyers in the 2008 Private Placement, as well as the shares owned by Meyers
Associates set forth in note (3) above.
(7) Mr.
Kahn is an employee of Meyers Associates.
Unless
otherwise indicated in the foregoing table (or the footnotes thereto), the
persons named in the table have sole voting and dispositive power with respect
to the shares of the Company’s common stock and/or options owned by such person,
subject to community property laws where applicable.
SELLING
STOCKHOLDERS
This
offering consists of an aggregate of 1,507,500 shares of Common Stock issued and
outstanding held by 17 non-affiliated bridge lenders (“Bridge Shares”);
2,326,974 shares of common stock issuable upon the conversion of Preferred
Stock; 2,326,974 shares issuable upon the exercise of Warrants, all of which
6,161,448 shares of common stock may be offered for sale and sold pursuant to
this prospectus by the selling stockholders. The shares are to be offered by and
for shares of common stock the respective accounts of the selling stockholders.
We have agreed to register all of the shares under the Securities Act for resale
by the selling stockholders and to pay all of the expenses in connection with
such registration and sale of the shares, other than underwriting discounts and
selling commissions and the fees and expenses of counsel and other advisors to
the selling stockholders. We will not receive any proceeds from the sale of the
shares by the selling stockholders, other than the exercise price of the
Warrants.
Information
with respect to the selling stockholders and the shares of our common stock held
by them and those shares being offered for sale pursuant to this prospectus is
set forth in the following table. None of the selling stockholders has had any
material relationship with us within the past three years, except as noted above
or in the notes to the following table.
Number of
Shares Owned
|
Number of
Shares Underlying
Preferred Stock and
Warrants Being
|
Amount and Nature
of Beneficial
Ownership
Before and After the
Sale of the
Shares Being Offered
Percentage(2)
|
||||||||||||||
Selling Stockholder
|
Prior to Sale
|
Offered for Sale (1)
|
Before
|
After
|
||||||||||||
Howard
Heller
|
117,700 | 117,700 | (3) | 1.0 | % | - | ||||||||||
Silverman
Roberts 44 Pipe LLC(4)
|
175,586 | 175,586 | (5) | 1.5 | % | - | ||||||||||
SP
Mort Westhampton(6)
|
925,680 | 925,680 | (7) | 7.7 | % | - | ||||||||||
Mitchell
Blatt
|
175,586 | 175,586 | (5) | 1.5 | % | - |
51
Number of
Shares Owned
|
Number of
Shares Underlying
Preferred Stock and
Warrants Being
|
Amount and Nature
of Beneficial
Ownership
Before and After the
Sale of the
Shares Being Offered
Percentage(2)
|
||||||||||||||
Selling Stockholder
|
Prior to Sale
|
Offered for Sale (1)
|
Before
|
After
|
||||||||||||
Gregory
Cohen
|
87,794 | 87,794 | (8) | * | - | |||||||||||
Marcio
Fainziliber
|
353,100 | 353,100 | (9) | 2.9 | % | - | ||||||||||
Eric
Fessler
|
175,586 | 175,586 | (5) | 1.5 | % | - | ||||||||||
Mitchell
Goldberg
|
87,794 | 87,794 | (8) | * | - | |||||||||||
Shelton
J. Spike Lee
|
263,384 | 263,384 | (10) | 2.3 | % | - | ||||||||||
Terry
& Deborah S. Lynne
|
58,580 | 58,850 | (11) | * | - | |||||||||||
Brian
Miller
|
175,586 | 175,586 | (5) | 1.5 | % | - | ||||||||||
James
Nigro
|
87,288 | 87,288 | (8) | * | - | |||||||||||
Wayne
& Bonnie Pensentadler
|
47,080 | 47,080 | (13) | * | - | |||||||||||
Nicholas
Primpas
|
322,686 | 322,686 | (12) | 2.7 | % | - | ||||||||||
Robert
Seguso
|
460,824 | 460,824 | (14) | 3.8 | % | - | ||||||||||
Gary
M. Simeone
|
58,850 | 58,850 | (11) | * | - | |||||||||||
Michael
Stone
|
360,824 | 360,824 | (15) | 3.0 | % | - | ||||||||||
Liza
Torkan
|
87,288 | 87,288 | (16) | * | - | |||||||||||
Gordon
H. Twedt
|
58,850 | 58,850 | (11) | * | - | |||||||||||
Ronald
Weaver
|
174,550 | 174,550 |
(17)
|
1.5 | % | - | ||||||||||
Amin
Adjmi
|
58,850 | 58,850 | (11) | * | - | |||||||||||
Harry
Adjmi
|
117,700 | 117,700 | (3) | * | - | |||||||||||
Richard
Adjmi
|
141,240 | 141,240 | (18) | 1.2 | % | - | ||||||||||
Michael
J. Marino
|
176,550 | 176,550 | (19) | 1.5 | % | - | ||||||||||
Amin
J. Tebele
|
117,700 | 117,700 | (3) | * | - | |||||||||||
Abraham
J. Sultan
|
82,390 | 82,390 | (20) | * | - | |||||||||||
Rick
Schafer
|
35,310 | 35,130 | (21) | * | - | |||||||||||
Tom
Flack
|
58,850 | 58,850 | (11) | * | - | |||||||||||
Dale
Feitz
|
58,850 | 58,850 | (11) | * | - | |||||||||||
Rodney
A. and Andria A. Blume
|
117,700 | 117,700 | (3) | * | - | |||||||||||
H.
Newcombe Eldredge 1997 Revocable Trust
|
353,100 | 353,100 | (10) | 2.9 | % | - | ||||||||||
Meir
Duke
|
470,800 | 470,800 | (22) | 3.9 | % | - | ||||||||||
Donald
Mudd Jr. Revocable Trust
|
117,700 | 117,700 | (3) | * | - | |||||||||||
Total
|
6,161,448 |
* Less
than 1% of the issued and outstanding shares.
(1)
|
Except
where noted in footnotes, includes one share of common stock, issuable
upon exercise of Warrants issued for every share of common stock issuable
upon conversion of Preferred Stock. By way of example, for each unit sold
at $1,000, 1,177 shares of common stock are issuable upon conversion of
one share of Preferred Stock and 1,177 shares of common stock are issuable
upon exercise of Warrants.
|
(2)
|
Except
as otherwise noted in the footnotes to this table, the named person owns
directly and exercises sole voting and investment power over the shares
listed as beneficially owned by such person. Includes any securities that
such person has the right to acquire within sixty days pursuant to
options, warrants, conversion privileges or other rights. For purposes of
this table, a person or group of persons is: (a) deemed to have
“beneficial ownership” of any shares as of a given date which such person
has the right to acquire within 60 days after such date and (b) assumed to
have sold all shares registered hereby in this offering. For purposes of
computing the percentage of outstanding shares held by each person or
group of persons named above on a given date, any security which such
person or persons has the right to acquire within 60 days after such date
is deemed to be outstanding for the purpose of computing the percentage
ownership of such person or persons, but is not deemed to be outstanding
for the purpose of computing the percentage ownership of any other
person.
|
52
As of the
date of this prospectus, there were 11,740,000 shares of our common stock issued
and outstanding. As of that date, (i) 500,000 shares of common stock were
reserved for issuance under our 2009 Option Plan of which 100,000 options had
been granted; (ii) approximately 2,721,224 shares of our common stock were
reserved for issuance pursuant to conversion of preferred stock; (iii)
approximately 2,721,224 shares reserved for issuance pursuant to exercise of
warrants to purchase common stock; (iv) approximately 353,600 shares of common
stock were reserved for issuance pursuant to the issuance of dividend shares;
and (v) there were Placement Agent Warrants to purchase approximately 1,381,948
shares of common stock equal to 15% of the securities sold in the 2008 and 2009
Private Placements.
(3)
|
Includes
58,850 shares of common stock issuable upon conversion of Preferred Stock
and 58,850 shares of common stock issuable upon exercise of
Warrants.
|
(4)
|
Voting
and disposition power with respect for the shares are held by Marc
Roberts, Managing Member.
|
(5)
|
Includes
50,000 Bridge Shares and 62,793 shares of common stock issuable upon
conversion of Preferred Stock and 62,793 shares of common stock issuable
upon exercise of Warrants.
|
(6)
|
Voting
and disposition power with respect for the shares are held by Nicole
Locantro, President.
|
(7)
|
Includes
632,500 Bridge Shares and 146,590 shares of common stock issuable upon
conversion of Preferred Stock and 146,590 shares of common stock issuable
upon exercise of Warrants.
|
(8)
|
Includes
25,000 Bridge Shares and 31,397 shares of common stock issuable upon
conversion of Preferred Stock and 31,397 shares of common stock issuable
upon exercise of Warrants.
|
(9)
|
Includes
176,550 shares of common stock issuable upon conversion of Preferred Stock
and 176,550 shares of common stock issuable upon exercise of
Warrants.
|
(10)
|
Includes
75,000 Bridge Shares and 94,192 shares of common stock issuable upon
conversion of Preferred Stock and 94,192 shares of common stock issuable
upon exercise of Warrants.
|
(11)
|
Includes
29,425 shares of common stock issuable upon conversion of Preferred Stock
and 29,425 shares of common stock issuable upon exercise of
Warrants.
|
(12)
|
Includes
25,000 Bridge Shares and 148,843 shares of common stock issuable upon
conversion of Preferred Stock and 148,844 shares of common stock issuable
upon exercise of Warrants.
|
(13)
|
Includes
23,540 shares of common stock issuable upon conversion of Preferred Stock
and 23,540 shares of common stock issuable upon exercise of
Warrants.
|
(13)
|
Includes
23,540 shares of common stock issuable upon conversion of Preferred Stock
and 23,540 shares of common stock issuable upon exercise of
Warrants.
|
(14)
|
Includes
200,000 Bridge Shares and 130,412 shares of common stock issuable upon
conversion of Preferred Stock and 130,412 shares of common stock issuable
upon exercise of Warrants.
|
(15)
|
Includes
100,000 Bridge Shares and 130,412 shares of common stock issuable upon
conversion of Preferred Stock and 130,412 shares of common stock issuable
upon exercise of Warrants.
|
(16)
|
Includes
25,000 Bridge Shares and 31,144 shares of common stock issuable upon
conversion of Preferred Stock and 31,144 shares of common stock issuable
upon exercise of Warrants.
|
(17)
|
Includes
50,000 Bridge Shares and 62,275 shares of common stock issuable upon
conversion of Preferred Stock and 66,275 shares of common stock issuable
upon exercise of
Warrants.
|
53
(18)
|
Includes
70,620 shares of common stock issuable upon conversion of Preferred Stock
and 70,620 shares of common stock issuable upon exercise of
Warrants.
|
(19)
|
Includes
88,275 shares of common stock issuable upon conversion of Preferred Stock
and 88,275 shares of common stock issuable upon exercise of
Warrants.
|
(20)
|
Includes
41,195 shares of common stock issuable upon conversion of Preferred Stock
and 41,195 shares of Common Stock issuable upon exercise of
Warrants.
|
(21)
|
Includes
17,655 shares of common stock issuable upon conversation of Preferred
Stock and 17,655 shares of common stock issuable upon exercise of
Warrants.
|
(22)
|
Includes
235,400 shares of common stock issuable upon conversion of Preferred Stock
and 235,400 shares of common stock issuable upon exercise of
Warrants.
|
Additional
Disclosures
Payments
Made in Connection with the Financing
Since the
registration statement (No. 333-158474) of which this prospectus forms a part
was not timely filed or declared effective within 120 days following the
April 7, 2009 Initial Filing Date for the 2008 Private Placement, we must pay to
each selling stockholder an amount equal to 2% of the dollar amount invested
($1,430,210), with respect to shares being registered for resale herein
(pro-rated for partial months) for a maximum of eight months beyond the
Scheduled Filing Date and/or 120 days from the Initial Filing Date. Such
penalty may be paid in cash or shares of Common Stock solely at the discretion
of the Company. Thus, since the registration statement was not filed by January
27, 2009, the total possible payments we would have to make pursuant to these
liquidated damages to selling shareholders under this prospectus is 69 days or
an aggregate of $65,790 (4.6%) of the dollar amount invested. In addition, each
share of Series A Preferred Stock issued in connection with the Financings
accrues an annual dividend of 6.5%, or $65 per share payable annually in cash or
shares of Common Stock at the option of the Company, unless earlier converted or
redeemed.
Since
this registration statement of which this prospectus forms a part was not timely
filed or declared effective within 120 days following the January 27, 2010
Initial Filing Date for the 2009 Private Placement, we must pay to each selling
stockholder an amount equal to 2% of the dollar amount invested ($475,000), with
respect to shares being registered for resale herein (pro-rated for partial
months) for a maximum of eight months beyond the Scheduled Filing Date and/or
120 days from the Initial Filing Date. Such penalty may be paid in cash or
shares of Common Stock solely at the discretion of the Company. Thus, since the
registration statement was not filed by January 27, 2010, the total possible
payments we would have to make pursuant to these liquidated damages to selling
shareholders under this prospectus is eight (8) months or an aggregate of
$76,000 (16%) of the dollar amount invested. In addition, each share of
Series A Preferred Stock issued in connection with the Financings accrues
an annual dividend of 6.5%, or $65 per share payable annually in cash or shares
of Common Stock at the option of the Company, unless earlier converted or
redeemed.
The
amount of dividends payable in shares of Common Stock to each selling
stockholder listed in the Selling Stockholder table of this prospectus is
calculated by multiplying the principal amount of Series A Preferred Stock held
by such selling stockholder by 6.5% and divided by an assumed conversion price
of $.85 per share. Any amount of fractional shares of common stock to be
received by each selling stockholder upon payment of dividends has been rounded
up to the nearest whole number. This would determine the number of shares of
common stock issuable in full payment of dividends. Consequently, the dollar
value of the dividend payments that the Company may be required to make in the
first year in connection with the shares of Common Stock issuable in the 2008
Private Placement is $92,964 consisting of 109,369 shares of Common Stock and in
the 2009 Private Placement is $30,875 consisting of 36,324 shares of Common
Stock.
Except as
set forth in the immediately preceding paragraph, no payments have been made or
may be required to be made in the future in connection with the transaction to
any selling stockholder, any affiliate of a selling stockholder, or any person
with whom any selling stockholder has a contractual relationship regarding the
transaction (including any interest payments, liquidated damages, payments made
to "finders" or "placement agents," and any other payments or potential
payments).
54
The net
proceeds we received from the sale of preferred stock between November 2008 and
September 6, 2010 (the “Preferred Stock Offering”) solely from the stockholders
registered hereby were $1,673,697. From the gross proceeds of $2,030,859, Meyers
Associates LP, a FINRA member firm participating in the private placement,
received cash compensation of $203,086, plus reimbursement for expenses in the
amount of $67,076.
Total
possible payments to all selling stockholders and any of their affiliates in the
first year following the Preferred Stock Offering, are $265,629 consisting of
$123,839 of dividend payments and $141,790 of liquidated damages. Total possible
payments under agreements entered into in connection with the sale of the
preferred stock to all selling stockholders and any of their affiliates in the
year following November 30, 2008, consist of the following:
1. Since
the registration statement, of which this prospectus forms a part, was not
timely filed by January 27, 2009, we must pay to each selling stockholder an
amount equal to 2% per month of the dollar amount invested (pro-rated for
partial months) for 69 days if the registration statement is not declared
effective within 120 days following the April 7, 2009, Initial Filing Date)
for a maximum of eight months beyond the April 7, 2009 Initial Filing Date. Such
penalty may be paid in cash or shares of Common Stock solely at the discretion
of the Company. Thus, since the registration statement of which this prospectus
forms a part was not filed by January 27, 2009 or declared effective witin 120
days of January 27, 2010, the total possible payments we would have to make
pursuant to these liquidated damages to selling stockholders, unless waived,
would be an aggregate of $76,000.
2. We
have agreed to indemnify the selling stockholders for any losses they may incur
as a result of any breach of any of the representations, warranties, covenants
or agreements made by us in any of the transaction or disclosure documents with
respect to the Preferred Stock Offering, including this registration statement,
or as a result of any action instituted against a selling stockholder with
respect to the Preferred Stock Offering, unless such action is based upon a
breach of such selling stockholder's obligations or any violations by the
selling stockholder of state or federal securities laws or fraud, gross
negligence, willful misconduct or malfeasance. We do not anticipate having to
pay any amounts pursuant to this provision, but we are unable to estimate at
this time if any such payments will be payable, or, if payable, the amount of
such payments.
Total
Possible Profit to the Selling Stockholders from Other Securities Held by the
Selling Stockholders
None. The
Conversion Rate initially will be 1,177 shares of common stock ($.85 per share)
for each Share of Preferred Stock. However, if the Company issues or sells any
shares of its common stock (or options, warrants or convertible securities,
convertible or exchangeable into shares of common stock), then the Conversion
Rate will be adjusted to the price per share of common stock sold in such
subsequent common stock issuance.
Comparison
of Company Proceeds from the Preferred Stock Offering to Potential Investor
Profit
Gross
Proceeds from the Preferred Stock Offering:
|
$
|
4,933,136
|
(1)
|
|
Less
Payments Made (liquidated damages and dividends) or Required to be Made to
Selling Stockholders and Any of Their Affiliates:
|
$
|
265,629
|
||
Less
10% sales commissions (2)
|
$
|
197,789
|
||
Less
3% non-accountable expense allowance (2)
|
$
|
147,994
|
||
Less
10% warrant solicitation fee (2)
|
$
|
295,553
|
||
Resulting
Net Proceeds from the Financing:
|
$
|
4,026,171
|
||
Total
payments to Selling Stockholders from Sale of Shares
|
$
|
2,298,161
|
(3)
|
(1)
Reflects gross proceeds of $1,977,883 received by the Company from the Preferred
Stock Offering solely for those shareholders registered hereby, plus $2,955,253
of net proceeds to be received upon the exercise of warrants.
(2) These
amounts reflect payment to Meyers Associates, L.P., a FINRA member
firm.
55
(3)
Reflects net proceeds of $2,406,495 received by investors from the sale of
2,326,974 shares of Preferred Stock offered hereby at $1.00 per share after the
payment of assumed 8% sales commissions ($186,158); and receipt of $265,629 of
liquidated damages and dividends payable in the first year. There is no
potential investor profit from the sale of common stock underlying the Warrants
at $1.00 per share as their exercise price is $1.27 per share.
Prior
and Subsequent Transactions Between the Company and the Selling
Stockholders
None.
Relationship
Between Shares Issued and Outstanding and Shares Held by Selling
Stockholders
The
following table sets forth (a) the number of shares outstanding prior to
the Preferred Stock Offering held by persons other than the selling
stockholders, affiliates of the Company, and affiliates of the selling
stockholders, (b) the number of shares registered for resale by the selling
stockholders or their affiliates in this registration statement. These numbers
do not include securities underlying any outstanding convertible securities,
options or warrants.
Number
of shares outstanding prior to the Preferred Stock Offering held by
persons other than selling stockholders, affiliates of the Company and
affiliates of the selling stockholders
|
0 | |||
Number
of shares registered for resale by the selling stockholders or affiliates
of the selling stockholders in this registration statement
|
6,161,448 |
Payment
of Dividends
The
Company presently intends to pay the annual dividend of 6.5% per annum in shares
of Common Stock of the Company in order to conserve its cash.
Existing
Short Positions by Selling Stockholders
Based
upon information provided by the selling stockholders, we have a reasonable
belief that no selling stockholders currently have a short position in our
common stock as there is no public market for our securities.
Relationships
and Arrangements with Selling Stockholders, Affiliates and Parties with Whom Any
Selling Stockholders Have Contractual Relationships
Except as
set forth herein, we have no relationships or arrangements with the selling
stockholders, any affiliates of the selling stockholders, or any person with
whom any of the selling stockholders has a contractual relationship regarding
the transaction.
The
Company and Meyers Associates entered into a Placement Agency Agreement (the
“Agency”) as of May 28, 2008. Meyers was appointed the exclusive placement agent
in connection with the Preferred Stock Offering. In connection with the Shares
registered hereby, Meyers was paid selling commissions of $197,789 equal to 10%
of the gross proceeds received by the Company; a 3% non-accountable expense
allowance equal to $59,337; Placement Agent Warrants equal to 15% of the shares
sold in the Offering and reimbursement of certain out-of-pocket expenses. The
parties indemnified each other against claims made concerning the Offering. The
Agreement terminated upon completion of the Offering.
Meyers
Associates was granted a five-year right of first refusal for all future public
offerings or private financings under the Agency. Meyers will also receive a
warrant solicitation fee equal to 10% of total cash proceeds received from the
exercise of warrants for whom the Placement Agent was designated as the
soliciting broker. Under the Agency, Meyers Associates was employed as
Investment Banker and Financial Consultant for 24 months from the initial
Closing of the Offering at a monthly retainer of $5,000.
56
In
connection with the Preferred Stock Offering, the Company entered into an
Indemnification Agreement with Meyers Associates pursuant to which Meyers
Associates indemnified the Company and its affiliates against claims arising
from the issuance of securities to certain investors in exchange for accrued and
unpaid interest on bridge notes exchanged for securities in the Preferred Stock
Offering.
Each
investor in the Preferred Stock Offering entered into a Subscription Agreement
with the Company, a form of which has been filed as Exhibit 4.5 to the
Registration Statement. The terms of the securities are set forth herein under
the heading “Description of Securities.”
Method
for Determining the Number of Shares Being Registered Hereunder
We are
registering the number of: (i) shares of our common stock which are
issuable upon the conversion of Series A Preferred Stock, and (ii) the
shares of our common stock issuable on the exercise of warrants issued to the
selling stockholders, each purchased in the Preferred Stock Offering, as
described herein. The only shares being registered are those of retail
customers. No shares are being requested for any officer, director or affiliate
of the Company.
DESCRIPTION
OF SECURITIES
The
Company’s authorized capitalization consists of: (i) 45,000,000 authorized
shares of the Company’s common stock $.001 par value, of which 11,740,000 shares
are currently outstanding; (ii) 5,000,000 shares of Preferred Stock, $.10 par
value, of which 2,411.875 shares of Series A Convertible Preferred Stock are
currently issued and outstanding, and (iii) 500,000 shares have been
reserved for issuance upon exercise of options which may be granted to the
founders of the Company, certain officers, advisors and consultants of the
Company pursuant to the 2009 Option Plan, of which 100,000 options have been
granted.
Common
Stock
Each
share of common stock entitles its holder to one non-cumulative vote per share
and, subject to the preferential rights of the preferred stockholders, if any,
the holders of more than 50% of the shares voting for the election of directors
can elect all the directors if they choose to do so, and in such event the
holders of the remaining shares will not be able to elect a single director.
Holders of shares of common stock are entitled to receive such dividends as the
Board of Directors may, from time to time, declare out of Company funds legally
available for the payment of dividends. Upon any liquidation, dissolution or
winding up of the Company, holders of shares of common stock are entitled to
receive pro rata all of the assets of the Company available for distribution to
stockholders after the satisfaction of the liquidation preference of the
preferred stockholders, if any. None of the stockholders have any pre-emptive
rights to subscribe for or purchase any stock, warrants or other securities of
the Company. The common stock is not convertible or redeemable. Neither the
Company’s Certificate of Incorporation nor its By-Laws provide for pre-emptive
rights.
Series
A Convertible Preferred Stock
The
Series A Convertible Preferred Stock (“Preferred Stock”) has been authorized by
resolutions adopted by the Company’s Board of Directors and set forth in a
Certificate of Designation, Preferences and Rights (“Certificate of
Designation”), filed with the Secretary of State of Delaware on November 26,
2008, which contains the designations, rights, powers, preferences,
qualifications and limitations of the Preferred Stock. The Certificate of
Designation is filed as Exhibit 3.2 to this Registration Statement. The shares
of Preferred Stock are fully paid and non-assessable.
57
On
November 28, 2008, the Company completed the 2008 Private Placement of an
aggregate of approximately 1451.88 Units of the Company’s securities,
representing $1,451,876 principal amount of 6.5% Series A Convertible Preferred
Stock (“Preferred Stock”) at $1,000 per Unit. Between February 19, 2009 and
February 11, 2010, the Company completed the 2009 Private Placement of an
aggregate of 835 Units, representing $835,000 principal amount of Preferred
Stock. Between May 21, 2010 and September 6, 2010, the Company had the initial
closing of the 2010 Private Placement of 125 Units, representing $125,000
principal amount of Preferred Stock. This is the first series of preferred Stock
issued by the Company. Each Unit consisted of: $1,000 face value of
one share of Preferred Stock, convertible at $.85 per share into 1,177 shares of
common stock, with each share of Preferred Stock accruing an annual dividend of
6.5% or $65 per share payable annually in cash or shares of common stock at the
option of the Company, unless earlier converted or redeemed. Warrants included
in the Units are exercisable for five years from the effective date of the
registration statement at an exercise price of $1.27, payable in cash, unless
the Company fails to keep the registration statement effective to purchase 1,177
shares of common stock. A total of 2,411.875 shares of Preferred Stock were
purchased in the offerings, which are convertible into an aggregate of
approximately 2,838,924 shares of common stock. Of this amount, an aggregate of
2,326,974 shares have been registered for resale by 33 retail investors, which
amount excludes 511,950 shares of common Stock issuable upon converson of
Preferred Stock sold to the Placement Agent and its affiliates.
Rank. The Preferred
Stock ranks(i) senior to the common stock and any other class or series of the
Company’s capital stock either specifically ranking by its terms junior to the
Preferred Stock or not specifically ranking by its terms senior to or on parity
with the Preferred Stock, (ii) on parity with any class or series of the
Company’s capital stock specifically ranking by its terms on parity with the
Preferred Stock, and (iii) junior to any class or series of capital stock
specifically ranking by its terms senior to the Preferred Stock, in each case,
as to payment of dividends or as to distributions of assets upon liquidation,
dissolution or winding-up of the Company, whether voluntary or involuntary. The
approval of the holders of a majority of the Preferred Stock is required in
order for the Company to issue any capital stock with rights on parity with or
senior to the Preferred Stock.
Dividends. The
holders of the Preferred Stock are entitled to receive annual cumulative per
share dividends of 6.5% of the liquidation preference of the Preferred Stock,
out of funds legally available, prior to any payment of dividends on the
Company’s common stock or any other class of stock ranking junior to the
Preferred Stock. Such dividends are payable in cash or shares of common stock,
at the option of the Company, semiannually on the last business day of February
and August of each year (each a “Dividend Payment Date”), commencing in February
2009 with respect to the period from issuance through such date. The holders of
the Preferred Stock are entitled to share ratably with the holders of the common
stock in any dividend declared on the common stock.
Dividends
on the Preferred Stock will accrue whether or not the Company has earnings,
whether or not there are funds legally available for the payment of such
dividends and whether or not such dividends are declared. Dividends accumulate
to the extent they are not paid on the Dividend Payment Date to which they
relate. Accumulated unpaid dividends will not bear interest. According to
Delaware law, the Company may declare and pay dividends or make other
distributions on its capital stock only out of legally-available funds. In
addition, no dividends or distributions may be declared, paid or made if the
Company is or would be rendered insolvent by virtue of such dividend or
distribution.
The
Company may not (i) pay any dividends in respect of any shares of capital stock
ranking junior to the Preferred Stock (including the common stock), other than
dividends payable in the form of additional shares of the same junior stock as
that on which such dividend is declared, or (ii) redeem any shares of capital
stock ranking junior to the Preferred Stock (including the common stock), unless
and until all accumulated and unpaid dividends on the Preferred Stock have been,
or contemporaneously are, declared and paid in full.
Conversion. At the
election of the holder thereof, each share of Preferred Stock will be
convertible into common stock, at any time after issuance, at the Conversion
Rate, as it may be adjusted from time to time in accordance with the Certificate
of Designation. The Preferred Stock will not convert automatically into Common
Stock upon completion of this offering and only the underlying Common Stock
issuable upon conversion is registered for the resale under this prospectus. The
Conversion Rate initially will be 1,177 shares of common stock ($.85 per share)
for each Share of Preferred Stock. If the Company issues or sells any shares of
its common stock (or options, warrants or convertible securities, convertible or
exchangeable into shares of common stock) hereinafter, a “Subsequent common
stock Issuance”), then the Conversion Rate will be adjusted so that the number
of shares of common stock issuable upon conversion of each share of preferred
stock shall be equal to the quotient obtained by dividing $1,000 by the price
per share of common stock (or the conversion price per share in the case of a
sale of options, warrants or convertible securities) sold in such Subsequent
common stock Issuance.
The
Conversion Price is also subject to adjustment from time to time in the event of
(i) the issuance of common stock as a dividend or distribution on any class of
the Company’s capital stock; or (ii) the combination, subdivision or
reclassification of the common stock. No fractional shares will be issued upon
conversion. Payment of accumulated and unpaid dividends will be made upon
conversion to the extent of legally-available funds.
58
The
shares of Preferred Stock may also be converted into common stock at the
Conversion Rate at the Company’s option following the effectiveness of a
Registration Statement, if the Company’s common stock trades above 200% of the
Conversion Rate per share for a period of 20 consecutive trading
days.
Voting Rights. The
affirmative vote of the holders of at least two-thirds of the outstanding shares
of Preferred Stock, voting as a class, shall be required to authorize, effect or
validate (i) any change in the rights, privileges or preferences of the
Preferred Stock that would adversely affect the Preferred Stock, or (ii) the
authorization, creation, issuance or increase in the authorized or issued amount
of any class or series of stock ranking on parity with or superior to the
Preferred Stock with respect to the declaration and payment of dividends or
distribution of assets upon liquidation, dissolution or winding-up of our
Company. In addition, the holders of Preferred Stock shall have the right to
vote, together with holders of common stock as single class, on all matters upon
which the holders of common stock are entitled to vote pursuant to applicable
Delaware law or the Company’s Certificate of Incorporation. The Preferred Stock
shall vote on an “as converted basis” with each holder of Preferred Stock having
one vote for each Conversion Share underlying such holder’s shares of Preferred
Stock.
Liquidation. In the
event of any voluntary or involuntary liquidation, dissolution or winding-up of
the Company, before any payment or distribution of the assets of the Company
(whether capital or surplus), or the proceeds thereof, may be made or set apart
for the holders common stock or any stock ranking junior to Preferred Stock, the
holders of Preferred Stock will be entitled to receive, out of the assets of the
Company available for distribution to stockholders, a liquidating distribution
of $1,000 per share, plus any accrued and unpaid dividends, subject to
adjustment upon the occurrence of certain events. If, upon any voluntary or
involuntary liquidation, dissolution or winding up of the Company, the assets of
the Company are insufficient to make the full payment of $1,000 per share, plus
all accrued and unpaid dividends on the Preferred Stock and similar payments on
any other class of stock ranking on a parity with the Preferred Stock upon
liquidation, then the holders of Preferred Stock and such other shares will
share ratably in any such distribution of the Company’s assets in proportion to
the full respective distributable amounts to which they are entitled. Certain
events, including a consolidation or merger of the Company with or into another
corporation or sale or conveyance of all or substantially all the property and
assets of the Company will be deemed to be a liquidation, dissolution or
winding-up of the Company for purposes of the foregoing.
Derivative Liability.
On January 1, 2009, the Company adopted new guidance which determines whether an
instrument is indexed to an entity’s own stock. As a result, the Company’s
preferred stock and some of the Company’s outstanding warrants containing
exercise price reset provisions are classified as derivative liabilities. The
fair value of the derivative liability was calculated using a lattice model that
values the compound embedded derivatives based on a probability weighted
discounted cash flow model. This model is based on future projections of the
various potential outcomes. The embedded derivatives that were analyzed and
incorporated into the model included the conversion feature with the full
ratchet reset, and the redemption options. The Company determined the fair value
of the preferred stock to be $1,796,759 and $1,642,409 and the fair value of the
warrants to be $1,230,296 and $1,182,194 at June 30, 2010 and December 31, 2009,
respectively. The change in fair value during the six months ended June 30, 2010
and 2009 of $(137,560) and (115,580), respectively, is recorded as a derivative
loss in the Statements of Operations.
Miscellaneous. The
Company is not subject to any mandatory redemption or sinking fund provision
with respect to the Preferred Stock. The holders of the Preferred Stock are not
entitled to preemptive rights to subscribe for or to purchase any shares or
securities of any class which may at any time be issued, sold or offered for
sale by the Company. Shares of Preferred Stock redeemed or otherwise reacquired
by the Company shall be retired and shall be unavailable for subsequent issuance
as any class of the Company’s preferred stock.
59
Warrants
Each Unit
includes one detachable, transferable Warrant to purchase in aggregate 1,177
shares of the Company’s common stock (equivalent to 100% warrant coverage).
Warrants to purchase an aggregate of 2,838,924 shares of common stock were sold
in the Private Placement. Of this amount, an aggregate of 2,326,974 shares have
been registered for resale by 33 retail investors. The Warrants are exercisable
in whole or in part during the five-year period from the effective date of the
registration statement at a per share exercise price of $1.27 payable in cash,
except that cashless exercise shall apply if the Company fails to comply with
its registration obligation. In the event of any adjustment to the Conversion
Rate of the Preferred Stock as a result of a Subsequent common stock Issuance as
described above, the warrant exercise price will be adjusted to 150% of the
price paid for the shares of common stock (or equivalent thereof) in such
subsequent issuance respectively. The Warrants may be redeemed in whole or in
part by the Company, upon 30 days’ written notice, at price of $.01 share,
provided the average closing bid price of the common stock exceeds $1.70 per
share for the Warrants for a period of 20 consecutive trading days ending within
15 days prior to the date on which the notice of redemption is given and the
registration statement for underlying shares is effective. Additionally, the
Warrants contain provisions that protect holders against dilution by adjustment
of the exercise price in certain events, such as stock dividends, stock splits
and other similar events
Transfer
Agent and Warrant Agent
The
transfer agent for our common stock and warrant agent for our Warrants will be
Island Stock Transfer.
Certain
Market Information
We intend
to obtain a listing for our common stock on the OTCBB. There has been limited
trading, to date, of our common stock. An OTCBB listing does not guarantee that
an active trading market for our securities will develop. You will likely not be
able to sell your securities if an active trading market for our securities does
not develop. Further, we can give no assurance that such a market could be
sustained if a trading market for our securities were to develop, nor that our
securities offered hereby could be resold at their original offering price or at
any other price. Any market for our securities that may develop will very likely
be a limited one and, in all likelihood, be highly volatile. In any event, if
our securities traded at a low price, many brokerage firms may choose not to
engage in market making activities or effect transactions in our securities.
Accordingly, purchasers of our securities may have difficulties in reselling
them and many banks may not grant loans using our securities as
collateral.
Federal
regulations governing “penny stocks” could have a detrimental effect on holders
of our securities. Our securities are subject to the SEC rules that impose
special sales practice requirements upon broker-dealers that sell such
securities to parties other than established customers or accredited investors.
For transactions covered by these rules, the broker-dealer must make a special
suitability determination for the purchaser and receive the purchaser’s written
agreement to the transaction prior to the sale. Consequently, the rule may
affect the ability of purchasers of our securities to buy or sell in any market
that may develop. In addition, the SEC has adopted a number of rules to
regulate “penny stocks.” Because our securities currently constitute a “penny
stock” within the meaning of these rules, the rules would apply to us and
our securities. The rules may further affect the ability of owners of our
securities to sell their securities in any market that may develop for
them.
SHARES
ELIGIBLE FOR FUTURE SALE
Prior to
the offering made by this prospectus, there has been no market for our common
stock, and we cannot assure you that a trading market for our common stock will
develop or be sustained after this offering. Future sales of substantial numbers
of shares of our common stock, including shares issued upon exercise of options,
in the public market after this offering, or the anticipation of those sales,
could adversely affect market prices of our common stock prevailing from time to
time and could impair our ability to raise capital through sales of our equity
securities.
Upon
completion of this offering, we will have issued and outstanding 11,740,000
shares of common stock. Of this amount, 10,000,000 Founders Shares issued on May
12, 2008 and 1,365,000 Bridge Shares issued between August 2007 and April 2008
will all qualify for resale under Rule 144, commencing 90 days from the
effective date of this prospectus.
The
1,507,500 shares of common stock which are issued and outstanding and registered
on this registration statement, as well as the 2,326,974 shares of common stock
issuable upon conversion of preferred stock and 2,326,974 shares of common stock
issuable upon exercise of warrants will be freely tradable without restriction
under the Securities Act unless purchased by our “affiliates,” as that term is
defined in Rule 144 under the Securities Act.
Registered
securities may be sold in the public market only if they have been registered or
if they qualify for an exemption from registration under Rule 144 or Rule 701
under the Securities Act.
60
Rule
144
In
general, under Rule 144 under the Securities Act, a person (or persons whose
shares are aggregated) who is not deemed to have been an affiliate of ours at
any time during the three months preceding a sale, and who has beneficially
owned restricted securities within the meaning of Rule 144 for at least six
months (including any period of consecutive ownership of preceding
non-affiliated holders) would be entitled to sell those shares, subject only to
the availability of current public information about us which period will
commence 90 days from the date of the prospectus. A non-affiliated person who
has beneficially owned restricted securities within the meaning of Rule 144 for
at least one year would be entitled to sell those shares without regard to the
provisions of Rule 144.
A person
(or persons whose shares are aggregated) who is deemed to be an affiliate of
ours and who has beneficially owned restricted securities within the meaning of
Rule 144 for at least six months would be entitled to sell within any
three-month period a number of shares that does not exceed the greater of one
percent of the then outstanding shares of our common stock or the average weekly
trading volume of our common stock reported during the four calendar weeks
preceding such sale. Based on 11,740,000 shares currently outstanding,
approximately 117,400 shares may be sold every 90 days. Such sales are also
subject to certain manner of sale provisions, notice requirements and the
availability of current public information about us.
Rule
701
In
general, under Rule 701 of the Securities Act, most of our employees,
consultants or advisors who purchased shares from us in connection with a
qualified compensatory stock plan or other written agreement are eligible to
resell those shares 90 days after the date of this prospectus in reliance on
Rule 144, but without compliance with the holding period or certain other
restrictions contained in Rule 144.
Registration
Rights
The
Company has agreed to keep this Registration Statement current and effective to
permit the sale of the shares offered hereby until the earlier of (i) the date
that all of the shares have been sold pursuant to the Registration Statement, or
(ii) the date the holders of the shares receive an opinion of counsel that such
shares may be sold under the provisions of Rule 144(b)(i). The currently
outstanding shares of Common Stock, the Placement Agent’s Warrants and the
shares underlying the Placement Agent Warrants are not entitled to be included
in the Registration Statement.
If the
Registration Statement is not timely filed (which did not occur) or declared
effective within 120 days of the initial filing date, of if the Company does not
comply with certain of its obligations set forth in the Registration Rights
Agreement, the Company will pay investors liquidated damages of 2% of the
aggregate purchase price paid by such holder, pro rata for partial months,
for a maximum of eight months. Liquidated damages may be paid in cash or common
stock, at the Company’s option. See “Selling Stockholders-Additional
Disclosures” for a calculation of liquidated damages accrued by the Company for
the late filings of this registration statement. There can be no assurance that
the Registration Statement will become effective under the Securities Act or
that the Registration Statement will remain current and effective. The Company
shall bear all fees and expenses incurred in preparing, filing and maintaining
the effectiveness of this Registration Statement, except for brokerage
commissions, transfer taxes and the fees of counsel to the holders.
INDEMNIFICATION
Under the
General Corporation Law of the State of Delaware, the Company has the power to
indemnify any of its directors or executive officers who was or is a party, or
is threatened to be made a party, to any threatened, pending or completed
action, suit or proceeding, whether civil, criminal, administrative or
investigative as a result of such person being a director or executive officer
of the Company or any other corporation, partnership, joint venture or other
enterprise at the Company's request. The statutory indemnification covers
expenses, judgment, fines and amounts paid in settlement if the director or
executive officers acted in good faith and in a manner he reasonably believed to
be in, or not opposed to, the best interests of the Company, and, with respect
to any criminal action or proceeding if he had not reasonable cause to believe
his conduct was unlawful.
61
Insofar
as indemnification for liabilities under the Securities Act may be permitted to
officers, directors or persons controlling the Company pursuant to the foregoing
provisions, the Company has been informed that it is the opinion of the
Securities and Exchange Commission that such indemnification is against public
policy as expressed in such Securities Act and is, therefore,
unenforceable.
Equity
Compensation Plan Information
See
“Executive Compensation—2009 Employee Stock Incentive Plan” described
above.
PLAN
OF DISTRIBUTION
The
shares of our common stock being offered for sale pursuant to this prospectus
may be sold by the selling stockholders for their respective own accounts. The
selling stockholders include 32 retail accredited investors in our Bridge
Financing and Private Placement, and excludes our Placement Agent and its
President. We will receive none of the proceeds from this offering. The selling
stockholders will pay or assume brokerage commissions or other charges and
expenses incurred in the sale of the shares. The distribution of the shares by
the selling stockholders is not currently subject to any underwriting agreement.
Each selling stockholder must use a broker-dealer which is registered in the
state in which the selling stockholder seeks to sell their shares. The Company
has been advised that no selling stockbroker is a broker-dealer or an affiliate
of a broker-dealer.
The
selling stockholders will offer the Shares under this Prospectus on an immediate
and continuous basis at a fixed offering price of $1.00 per share. The initial
offering price is based, in part, on the last private sale of the Company’s
Common Stock at $1.00 per share and comparison by Management of similarly
situated companies.
The
shares may be sold or transferred for value by the selling stockholders, in one
or more transactions, in the over-the-counter market in privately negotiated
transactions or in a combination of such methods. The selling stockholders may
effect such transactions by selling or transferring the shares to or through
brokers and/or dealers, and such brokers or dealers may receive compensation in
the form of underwriting discounts, concessions or commissions from the selling
stockholders and/or the purchasers/transferees of the shares for whom such
brokers or dealers may act as agent. Such broker or dealer compensation may be
less than or in excess of customary commissions. However, the maximum
compensation to be received by any FINRA member or independent broker dealer
will not be greater than eight (8%) percent of the gross proceeds of any sale.
The selling stockholders and any broker or dealer that participate in the
distribution of the Shares are “underwriters” within the meaning of
Section 2(11) of the Securities Act, and any commissions received by them
and any profit on the resale of the shares sold by them may be deemed to be
underwriting discounts and commissions under the Securities Act and under the
FINRA Corporate Financing Rules.
The
selling stockholders may use any one or more of the following methods when
selling the shares:
·
|
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
·
|
block
trades in which the broker-dealer will attempt to sell the shares as agent
but may position and resell a portion of the block as principal to
facilitate the transaction;
|
·
|
purchases
by a broker-dealer as principal and resale by the broker-dealer for its
account;
|
·
|
privately
negotiated transactions;
|
·
|
settlement
of short sales entered into after the effective date of the registration
statement of which this prospectus is a
part;
|
·
|
broker-dealers
may agree with the selling stockholder to sell a specified number of such
shares at a stipulated price per
share;
|
·
|
a
combination of any such methods of
sale;
|
·
|
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise;
or
|
·
|
any
other method permitted pursuant to applicable
law.
|
62
Any of
the shares of our common stock being offered for sale pursuant to this
prospectus that qualify for sale pursuant to Rule 144 promulgated under the
Securities Act may be sold under Rule 144 commencing 90 days from the
effective date rather than pursuant to this prospectus.
There can
be no assurance that the selling stockholders will sell or transfer any of the
shares being offered pursuant to this prospectus.
EXPERTS
The
financial statements of SignPath Pharma at December 31, 2009 appearing in this
prospectus and in the registration statement have been audited by M&K CPAs,
PLLC, an independent registered public accounting firm, as set forth in their
report thereon appearing elsewhere herein, and are included in reliance upon
such report, given on the authority of such firm as experts in accounting and
auditing.
LEGAL
MATTERS
The
validity of the shares of our common stock being offered for sale pursuant to
this prospectus has been passed upon for us by Phillips Nizer LLP, 666 Fifth
Avenue, New York, NY 10103.
PROSPECTIVE
INVESTORS MAY RELY ONLY ON THE INFORMATION CONTAINED IN THIS PROSPECTUS. WE
HAVE NOT AUTHORIZED ANYONE TO PROVIDE PROSPECTIVE INVESTORS WITH DIFFERENT OR
ADDITIONAL INFORMATION. THIS PROSPECTUS IS NOT AN OFFER TO SELL NOR IS IT
SEEKING AN OFFER TO BUY IN ANY JURISDICTION WHERE SUCH OFFER, OR SALE IS NOT
PERMITTED. THE INFORMATION CONTAINED IN THIS PROSPECTUS IS CORRECT ONLY AS OF
THE DATE OF THIS PROSPECTUS, REGARDLESS OF THE TIME OF DELIVERY OF THIS
PROSPECTUS OR ANY SALE OF THESE SHARES.
63
INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
SIGNPATH
PHARMA INC.
Condensed
Consolidated Balance Sheets as of June 30, 2010 (Unaudited) and December
31, 2009 (restated)
|
F-1
|
|
Condensed
Consolidated Statements of Operations for the three and six months ended
June 30, 2010 and 2009 and from Inception on May 15, 2006 through June 30,
2010 (Unaudited) (restated)
|
F-2
|
|
Condensed
Consolidated Statements of Stockholders’ Equity (deficit) for the Period
from Inception on May 15, 2006 to June 30, 2010 (Unaudited)
(restated)
|
F-3-4
|
|
Condensed
Consolidated Statements of Cash Flows for the six months ended June 30,
2010 and 2009 and from Inception on May 15, 2006 through June 30, 2010
(Unaudited) (restated)
|
F-5
|
|
Notes
to Condensed Consolidated Financial Statements as of June 30, 2010
(Unaudited)
|
F-6-31
|
|
Report
of Independent Registered Public Accounting Firm
|
F-32
|
|
Consolidated
Balance Sheets as of December 31, 2009 (restated) and 2008
(restated)
|
F-33
|
|
Consolidated
Statements of Operations for the Years ended December 31, 2009
(restated)and 2008 (restated) and From Inception on May 15, 2006 to
December 31, 2009 (restated)
|
F-34
|
|
Consolidated
Statement of Stockholders’ Equity (Deficit) (Restated) for the Period from
Inception on May 15, 2006 (Inception) to December 31, 2009 (unaudited)
(restated)
|
F-35
|
|
Consolidated
Statements of Cash Flows for the Years ended December 31, 2009 (restated)
and 2008 (restated) and From Inception on May 15, 2006 to
December 31, 2009 (unaudited) (restated)
|
F-36
|
|
Notes
to Consolidated Financial Statements as of December 31,
2009
|
|
F-37-53
|
64
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Balance
Sheets
June
30,
|
December
31,
|
|||||||
2010
|
2009
|
|||||||
(Unaudited)
|
(Restated)
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS
|
||||||||
Cash
|
$ | 64,699 | $ | 295,418 | ||||
Total
Current Assets
|
64,699 | 295,418 | ||||||
EQUIPMENT,
net
|
3,306 | 2,400 | ||||||
TOTAL
ASSETS
|
$ | 68,005 | $ | 297,818 | ||||
LIABILITIES AND STOCKHOLDERS'
DEFICIT
|
||||||||
CURRENT
LIABILITIES
|
||||||||
Accounts
payable and accrued expenses
|
$ | 162,784 | $ | 117,967 | ||||
Derivative
liability
|
3,027,055 | 2,824,603 | ||||||
Total
Current Liabilities
|
3,189,839 | 2,942,570 | ||||||
STOCKHOLDERS'
DEFICIT
|
||||||||
Preferred
stock; $0.10 par value, 5,000,000 shares authorized 2,312 and 2,262 shares
issued and outstanding, respectively
|
231 | 226 | ||||||
Common
stock; $0.001 par value, 45,000,000 shares authorized; 11,740,000 and
11,340,000 shares issued and outstanding, respectively
|
11,741 | 11,341 | ||||||
Additional
paid-in capital
|
650,535 | 340,831 | ||||||
Deficit
accumulated during the development stage
|
(3,784,341 | ) | (2,997,150 | ) | ||||
Total
Stockholders' Deficit
|
(3,121,834 | ) | (2,644,752 | ) | ||||
TOTAL
LIABILITIES AND STOCKHOLDERS' DEFICIT
|
$ | 68,005 | $ | 297,818 |
The
accompanying notes are an integral part of these financial
statements.
F-1
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Operations
(Unaudited)
From
Inception
|
||||||||||||||||||||
For
the Three Months Ended
|
For
the Six Months Ended
|
Through
|
||||||||||||||||||
June
30,
|
June
30,
|
June
30,
|
||||||||||||||||||
2010
|
2009
|
2010
|
2009
|
2010
|
||||||||||||||||
(Restated)
|
(Restated)
|
(Restated)
|
||||||||||||||||||
REVENUES
|
$ | - | $ | - | $ | - | $ | - | $ | - | ||||||||||
OPERATING
EXPENSES
|
||||||||||||||||||||
General
and administrative
|
74,186 | 180,958 | 126,329 | 260,639 | 1,052,402 | |||||||||||||||
Consulting
expense
|
340,000 | - | 340,000 | - | 422,263 | |||||||||||||||
Financing
expense
|
- | - | - | - | 1,063,401 | |||||||||||||||
Research
and development, net
|
162,773 | 106,442 | 224,086 | 185,257 | 923,051 | |||||||||||||||
Total
Operating Expenses
|
576,959 | 287,400 | 690,415 | 445,896 | 3,461,117 | |||||||||||||||
OPERATING
LOSS
|
(576,959 | ) | (287,400 | ) | (690,415 | ) | (445,896 | ) | (3,461,117 | ) | ||||||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||||||||||
Gain
(loss) on derivative liability
|
(42,330 | ) | 17,692 | (137,560 | ) | (115,580 | ) | (340,786 | ) | |||||||||||
Grant
income
|
- | - | 40,784 | - | 81,557 | |||||||||||||||
Interest
expense
|
- | - | - | - | (63,995 | ) | ||||||||||||||
Total
Other Income (Expense)
|
(42,330 | ) | 17,692 | (96,776 | ) | (115,580 | ) | (323,224 | ) | |||||||||||
NET
LOSS BEFORE INCOME TAXES
|
(619,289 | ) | (269,708 | ) | (787,191 | ) | (561,476 | ) | (3,784,341 | ) | ||||||||||
PROVISION
FOR INCOME TAXES
|
- | - | - | - | - | |||||||||||||||
NET
LOSS
|
$ | (619,289 | ) | $ | (269,708 | ) | $ | (787,191 | ) | $ | (561,476 | ) | $ | (3,784,341 | ) | |||||
BASIC
AND DILUTED LOSS PER SHARE
|
$ | (0.05 | ) | $ | (0.02 | ) | $ | (0.07 | ) | $ | (0.05 | ) | ||||||||
WEIGHTED
AVERAGE NUMBER OF SHARES OUTSTANDING
|
11,405,934 | 11,340,000 | 11,373,149 | 11,340,000 |
The
accompanying notes are an integral part of these financial
statements.
F-2
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Stockholders' Equity (Deficit)
(Unaudited)
Deficit
|
||||||||||||||||||||||||||||
Accumulated
|
||||||||||||||||||||||||||||
Additional
|
During
the
|
Total
|
||||||||||||||||||||||||||
Preferred
Stock
|
Common
Stock
|
Paid-in
|
Development
|
Stockholders'
|
||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Stage
|
Equity
(Deficit)
|
||||||||||||||||||||||
Balance,
May 15, 2006
|
- | $ | - | - | $ | - | $ | - | $ | - | $ | - | ||||||||||||||||
Common
stock issued to founders for cash at $0.001 per
share
|
- | - | 10,000,000 | 10,000 | - | - | 10,000 | |||||||||||||||||||||
Net
loss for the year ended December 31, 2006
|
- | - | - | - | - | - | - | |||||||||||||||||||||
Balance,
December 31, 2006
|
- | - | 10,000,000 | 10,000 | - | - | 10,000 | |||||||||||||||||||||
Common
stock issued for bridge debt at $0.85 per
share
|
- | - | 257,500 | 258 | 218,617 | - | 218,875 | |||||||||||||||||||||
Net
loss for the year ended December 31, 2007
|
- | - | - | - | - | (526,833 | ) | (526,833 | ) | |||||||||||||||||||
Balance,
December 31, 2007
|
- | - | 10,257,500 | 10,258 | 218,617 | (526,833 | ) | (297,958 | ) | |||||||||||||||||||
Preferred
stock issued for bridge debt at $1,000 per
share
|
890 | 89 | - | - | 889,786 | - | 889,875 | |||||||||||||||||||||
Preferred
stock issued for cash at $1,000 per share
|
562 | 56 | - | - | 561,944 | - | 562,000 | |||||||||||||||||||||
Common
stock issued for bridge debt at $0.85 per
share
|
- | - | 1,082,500 | 1,083 | 919,043 | - | 920,126 | |||||||||||||||||||||
Stock
offering costs
|
- | - | - | - | (270,948 | ) | - | (270,948 | ) | |||||||||||||||||||
Net
loss for the year ended December 31, 2008
|
- | - | - | - | - | (1,695,766 | ) | (1,695,766 | ) | |||||||||||||||||||
Balance,
December 31, 2008
|
1,452 | 145 | 11,340,000 | 11,341 | 2,318,442 | (2,222,599 | ) | 107,329 |
The
accompanying notes are an integral part of these financial
statements.
F-3
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Stockholders' Equity (Deficit)
(Unaudited)
Deficit
|
||||||||||||||||||||||||||||
Accumulated
|
||||||||||||||||||||||||||||
Additional
|
During
the
|
Total
|
||||||||||||||||||||||||||
Preferred Stock
|
Common Stock
|
Paid-in
|
Development
|
Stockholders'
|
||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Stage
|
Equity (Deficit)
|
||||||||||||||||||||||
Balance,
December 31, 2008
|
1,452 | 145 | 11,340,000 | 11,341 | 2,318,442 | (2,222,599 | ) | 107,329 | ||||||||||||||||||||
Cumulative
effect of adoption of ASC 815
|
- | - | - | - | (1,632,825 | ) | (43,808 | ) | (1,676,633 | ) | ||||||||||||||||||
Preferred
stock issued for cash at $1,000 per share
|
810 | 81 | - | - | (178,632 | ) | - | (178,551 | ) | |||||||||||||||||||
Stock
offering costs
|
- | - | - | - | (166,154 | ) | - | (166,154 | ) | |||||||||||||||||||
Net
loss for the year ended December 31, 2009
|
- | - | - | - | - | (730,743 | ) | (730,743 | ) | |||||||||||||||||||
Balance,
December 31, 2009 (restated)
|
2,262 | 226 | 11,340,000 | 11,341 | 340,831 | (2,997,150 | ) | (2,644,752 | ) | |||||||||||||||||||
Preferred
stock issued for cash at $1,000 per share
|
50 | 5 | - | - | (14,896 | ) | - | (14,891 | ) | |||||||||||||||||||
Stock
offering costs
|
- | - | - | - | (15,000 | ) | - | (15,000 | ) | |||||||||||||||||||
Common
stock issued for services
|
- | - | 400,000 | 400 | 339,600 | - | 340,000 | |||||||||||||||||||||
Net
loss for the six months ended June 30, 2010
|
- | - | - | - | - | (787,191 | ) | (787,191 | ) | |||||||||||||||||||
Balance,
June 30, 2010 (unaudited)
|
2,312 | $ | 231 | 11,740,000 | $ | 11,741 | $ | 650,535 | $ | (3,784,341 | ) | $ | (3,121,834 | ) |
The
accompanying notes are an integral part of these financial
statements.
F-4
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
From
Inception
|
||||||||||||
on
May 15, 2006
|
||||||||||||
For
the Six Months Ended
|
Through
|
|||||||||||
June
30,
|
June
30,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
(Restated)
|
(Restated)
|
|||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (787,191 | ) | $ | (561,476 | ) | $ | (3,784,341 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Common
stock issued for services
|
340,000 | - | 340,000 | |||||||||
Common
stock issued with bridge financing
|
- | - | 1,139,001 | |||||||||
Depreciation
expense
|
484 | 400 | 2,084 | |||||||||
Change
in derivative liability
|
137,560 | 115,580 | 340,786 | |||||||||
Changes
in operating assets and liabilities
|
||||||||||||
Accounts
payable and accrued expenses
|
44,818 | 90,273 | 162,786 | |||||||||
Net
Cash Used in Operating Activities
|
(264,329 | ) | (355,223 | ) | (1,799,684 | ) | ||||||
INVESTING
ACTIVITIES
|
||||||||||||
Purchase
of equipment
|
(1,390 | ) | - | (5,390 | ) | |||||||
Net
Cash Used in Investing Activities
|
(1,390 | ) | - | (5,390 | ) | |||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from notes payable
|
- | - | 889,875 | |||||||||
Stock
offering costs paid
|
(15,000 | ) | (127,554 | ) | (452,102 | ) | ||||||
Preferred
stock issued for cash
|
50,000 | 560,000 | 1,422,000 | |||||||||
Common
stock issued for cash
|
- | - | 10,000 | |||||||||
Net
Cash Provided by Financing Activities
|
35,000 | 432,446 | 1,869,773 | |||||||||
NET
INCREASE (DECREASE) IN CASH
|
(230,719 | ) | 77,223 | 64,699 | ||||||||
CASH
AT BEGINNING OF PERIOD
|
295,418 | 181,128 | - | |||||||||
CASH
AT END OF PERIOD
|
$ | 64,699 | $ | 258,351 | $ | 64,699 | ||||||
SUPPLEMENTAL
DISCLOSURES OF CASH FLOW INFORMATION
|
||||||||||||
CASH
PAID FOR:
|
||||||||||||
Interest
|
$ | - | $ | - | $ | - | ||||||
Income
taxes
|
$ | - | $ | - | $ | - | ||||||
NON
CASH FINANCING ACTIVITIES:
|
||||||||||||
Preferred
stock issued for bridge financing
|
$ | - | $ | - | $ | 1,676,633 |
The
accompanying notes are an integral part of these financial
statements.
F-5
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
1 - CONDENSED FINANCIAL STATEMENTS
The
accompanying financial statements have been prepared by the Company without
audit. In the opinion of management, all adjustments (which include only normal
recurring adjustments) necessary to present fairly the financial position,
results of operations, and cash flows at June 30, 2010, and for all periods
presented herein, have been made.
Certain
information and footnote disclosures normally included in financial statements
prepared in accordance with accounting principles generally accepted in the
United States of America have been condensed or omitted. It is suggested that
these condensed financial statements be read in conjunction with the financial
statements and notes thereto included in the Company's December 31, 2009 audited
financial statements. The results of operations for the period ended June 30,
2010 is not necessarily indicative of the operating results for the full
year.
NOTE
2 - GOING CONCERN
The
Company's financial statements are prepared using generally accepted accounting
principles in the United States of America applicable to a going concern which
contemplates the realization of assets and liquidation of liabilities in the
normal course of business. The Company has not yet established an ongoing source
of revenues sufficient to cover its operating costs and allow it to continue as
a going concern. The ability of the Company to continue as a going concern is
dependent on the Company obtaining adequate capital to fund operating losses
until it becomes profitable. If the Company is unable to obtain adequate
capital, it could be forced to cease operations.
In order
to continue as a going concern, the Company will need, among other things,
additional capital resources. Management's plan is to obtain such resources for
the Company by obtaining capital from management and significant shareholders
sufficient to meet its minimal operating expenses and seeking equity and/or debt
financing. However management cannot provide any assurances that the Company
will be successful in accomplishing any of its plans.
The
ability of the Company to continue as a going concern is dependent upon its
ability to successfully accomplish the plans described in the preceding
paragraph and eventually secure other sources of financing and attain profitable
operations. The accompanying financial statements do not include any adjustments
that might be necessary if the Company is unable to continue as a going
concern.
NOTE
3 – SIGNIFICANT ACCOUNTING POLICIES
Use of
Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities at the date of the financial statements and the reported amounts of
revenue and expenses during the reporting period. Actual results could differ
from those estimates.
Derivative Financial
Instruments
The
Company generally does not use derivative financial instruments to hedge
exposures to cash-flow risks or market-risks that may affect the fair values of
its financial instruments. The Company utilizes various types of financing to
fund our business needs, including preferred stock with warrants attached and
other instruments not indexed to our stock. The Company is required to record
its derivative instruments at their fair value. Changes in the fair value of
derivatives are recognized in earnings in accordance with ASC 815.
Recent Accounting
Pronouncements
The
Company has evaluated recent accounting pronouncements and their adoption has
not had or is not expected to have a material impact on the Company’s financial
position, or statements.
F-6
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
4 – ACCRUED LIABILITIES
Pursuant
to the applicable Codification literature, the Company has concluded it is
probable that it will pay $85,738 in liquidated damages pursuant to the
registration rights clause in certain of the securities sold in fiscal years
2008 and 2009. The Company was required to file a registration statement by
January 27, 2009. The Company failed to do so until April 7, 2009, resulting in
liquidated damages of 2% per month of the gross proceeds, which approximated
$1.8 million as of that date. During the year ended December 31, 2009, the
Company’s registration statement covering the securities was declared effective
by the SEC. Each holder is entitled to $47.32 per share owned. The Company has
resolved to pay the liquidated damages in shares of Common Stock valued at $1.00
per share, pursuant to the terms and provisions of the Certificate of
Designation, Preferences and Rights of Series A Convertible Preferred
Stock.
NOTE
5 – WARRANTS
A summary
of the status of the Company's warrants as of June 30, 2010 and changes
during the periods ended June 30, 2010 and December 31, 2009 and 2008 are
presented below:
Date of
|
Warrant
|
Exercise
|
Value if
|
Expiration
|
||||||||||||
Issuance
|
Shares
|
Price
|
Exercised
|
Date
|
||||||||||||
11/25/2008
|
1,259,639 | 1.27 | 1,599,742 |
11/25/2013
|
||||||||||||
11/25/2008
|
530,314 | 0.85 | 450,767 |
11/25/2013
|
||||||||||||
11/26/2008
|
449,220 | 1.27 | 570,509 |
11/25/2013
|
||||||||||||
Outstanding
at
12/31/2008
|
2,239,173 | 2,621,018 | ||||||||||||||
3/5/2009
|
347,215 | 1.27 | 440,963 |
3/5/2014
|
||||||||||||
3/5/2009
|
104,165 | 0.85 | 88,540 |
3/5/2014
|
||||||||||||
4/1/2009
|
17,655 | 1.27 | 22,422 |
4/1/2014
|
||||||||||||
4/1/2009
|
5,296 | 0.85 | 4,4502 |
4/1/2014
|
||||||||||||
6/17/2009
|
235,400 | 1.27 | 298,958 | * | ||||||||||||
6/17/2009
|
70,620 | 0.85 | 60,027 | * | ||||||||||||
7/23/2009
|
58,850 | 1.27 | 74,740 | * | ||||||||||||
7/23/2009
|
35,310 | 0.85 | 30,014 | * | ||||||||||||
8/20/2009
|
58,850 | 1.27 | 74,740 | * | ||||||||||||
9/9/2009
|
235,400 | 1.27 | 298,958 | * | ||||||||||||
9/9/2009
|
70,620 | 0.85 | 60,027 | * | ||||||||||||
Outstanding
at
12/31/2009
|
3,478,554 | 4,074,909 | ||||||||||||||
2/11/2010
|
29,425 | 1.27 | 37,370 | * | ||||||||||||
2/11/2010
|
17,655 | 0.85 | 15,007 | * | ||||||||||||
5/21/2010
|
29,425 | 1.27 | 37,370 | * | ||||||||||||
5/21/2010
|
17,655 | 0.85 | 15,007 | * | ||||||||||||
Outstanding
at
6/30/2010
|
3,572,714 | 4,179,663 |
* Fifth
anniversary date of the next registration statement to be filed.
The
warrants were issued in connection with the Preferred Stock Offering and were
valued using the Black-Scholes model using the following
assumptions: stock price at valuation, $0.85; strike price, $1.27 or
$0.85; risk free rate 0.90% to 2.16%, depending on date of issuance; 5 year
term; and volatility of 104% to 115%, depending on date of
issuance.
F-7
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
6 – DERIVATIVE LIABILITY AND FAIR VALUE MEASUREMENTS
The
Company’s only asset or liability measured at fair value on a recurring basis is
its derivative liability associated with its preferred stock and associated
warrants to purchase common stock. On January 1, 2009, the Company adopted new
guidance which determines whether an instrument is indexed to an entity’s own
stock. As a result, the Company’s preferred stock and some of the Company’s
outstanding warrants that were previously classified in equity were reclassified
to liabilities as these warrants contain exercise price reset features and are
no longer deemed to be indexed to the Company’s stock. Therefore, on January 1,
2009, 3,572,714 outstanding warrants of the Company containing exercise price
reset provisions, classified in equity, were reclassified to derivative
liability. These warrants had exercise prices ranging from $0.85 - $1.27 and
expire starting in December 2013. As of January 1, 2009, the fair value of these
derivative liabilities of $1,676,633 was recognized and resulted in a cumulative
effect adjustment to retained earnings of $43,808. The change in fair value
during the six months ended June 30, 2010 and 2009 of $(137,560) and $(115,580),
respectively, is recorded as a derivative loss in the accompanying Statements of
Operations.
The
Company classifies the fair value of these warrants under level three. The fair
value of the derivative liability was calculated using a lattice model that
values the compound embedded derivatives based on a probability weighted
discounted cash flow model. This model is based on future projections of the
various potential outcomes. The embedded derivatives that were analyzed and
incorporated into the model included the conversion feature with the full
ratchet reset, and the redemption options.
The
Series A Preferred Derivatives were valued using the following
assumptions:
|
·
|
The Company was 12 months from
being publicly traded and the Company/Holder would convert the Preferred
Stock based on 200% of the adjusted conversion
price;
|
|
·
|
The Preferred maturity date used
was 5 years following the Company being publicly traded (rolling 6 years
from the Valuation Date);
|
|
·
|
The stock price of $0.85 was used
as the fair value of the common stock based on the previous common stock
transaction;
|
|
·
|
The projected volatility curve
was based on the average of 17 comparable biotech companies historical
volatility:
|
|
·
|
The Holder would automatically
convert at a stock price of $1.70 if the Company was not in
default;
|
|
·
|
The Holder would convert on a
quarterly basis in equal amounts to maturity if in the money;
and
|
|
·
|
Capital raising events would
occur annually, generating reset events based on pricing not greater than
100% of market.
|
The
warrants were valued at issuance and marked to market quarterly for the period
2009 through June 2010. The five-year warrants are options to purchase shares of
common stock at an exercise price of $0.85 per share and $1.27, subject to
adjustments. The following assumptions were used for the valuation of the
derivative:
|
·
|
The stock price of $0.85 was used
as the fair value of the common stock based on the previous common stock
transaction;
|
|
·
|
The projected volatility curve
was based on the average of comparable companies as provided in the
Preferred assumptions above;
|
|
·
|
The Holder would exercise the
warrant at maturity if the stock price was above the exercise
price;
|
|
·
|
The Holder would exercise the
warrant at target prices starting at $1.58 for the Investor Warrants and
$1.40 for the Placement Agent Warrants, and lowering such target as the
warrants approached
maturity.
|
|
·
|
The Holder would automatically
convert all of the shares at a stock price of $1.58 for the Investor
Warrants and $1.40 for the Placement Agent
Warrants;
|
|
·
|
The Holder would convert on a
quarterly basis in amounts not to exceed the average quarters trading
volume based on historical performance, assuming the volume would increase
by 5% each quarter; and
|
|
·
|
Capital raising events would
occur annually, generating reset events based on pricing not greater than
100% of market for the Placement Agent Warrants and for the Investor
Warrants the reset would be 150% of the
Preferred.
|
F-8
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
6 – DERIVATIVE LIABILITY AND FAIR VALUE MEASUREMENTS (CONTINUED)
The
Company determined the fair value of the preferred stock to be $1,796,759 and
$1,642,409 and the fair value of the warrants to be $1,230,296 and
$1,182,194 at June 30, 2010 and December 31, 2009, respectively.
The
following shows the changes in the level three liability measured on a recurring
basis for the six months ended June 30, 2010:
Balance,
January 1, 2010
|
$ | 2,824,603 | ||
Derivative
loss
|
202,452 | |||
Balance,
June 30, 2010
|
$ | 3,027,055 |
NOTE
7 – CAPITAL STOCK
On
February 11, 2010, the Company issued 25 shares of its $0.10 par value
convertible preferred stock for cash at $1,000 per share.
Attached
to the 25 units of convertible preferred stock sold was a warrant, giving the
owners rights to purchase up to a total of 29,425 (or 1,177 common share per
warrant) shares of the Company’s common stock at strike price of
$1.27 per share for a five year period.
As part
of this issuance, the Company issued 17,655 warrants to the placement agent in
accordance with the placement agency agreements. These warrants give
the holder rights to purchase 17,655 shares of the Company’s common stock
at strike price of $0.85 per share for a five year period.
The
warrants were valued using the Black Scholes model using the following
assumptions: stock price at valuation, $0.85; strike price, $1.27 or
$0.85; risk free rate 0.91%; 5 year term; and volatility of 104%. The Company
attributed $10,384 of the total $24,997 of Additional Paid-in Capital associated
with the transaction to the warrants based on the relative fair value of the
warrants.
On May
21, 2010, the Company issued 25 shares of its $0.10 par value convertible
preferred stock for cash at $1,000 per share.
Attached
to the 25 units of convertible preferred stock sold was a warrant, giving the
owners rights to purchase up to a total of 29,425 (or 1,177 common share per
warrant) shares of the Company’s common stock at strike price of
$1.27 per share for a five year period.
As part
of this issuance, the Company issued 17,655 warrants to the placement agent in
accordance with the placement agency agreements. These warrants give
the holder rights to purchase 17,655 shares of the Company’s common stock
at strike price of $0.85 per share for a five year period.
The
warrants were valued using the Black Scholes model using the following
assumptions: stock price at valuation, $0.85; strike price, $1.27 or
$0.85; risk free rate 2.16%; 5 year term; and volatility of 106%. The Company
attributed $10,526 of the total $24,997 of Additional Paid-in Capital associated
with the transaction to the warrants based on the relative fair value of the
warrants.
On June
16, 2010 the Company issued 400,000 shares of common stock to officers and
consultants of the Company in exchange for services provided. The shares were
valued based on the market price of $0.85 per share and the Company recognized
$340,000 in consulting expense.
F-9
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
8 – SUBSEQUENT EVENTS
Pursuant
to the terms of a Letter Agreement dated July 12, 2010, Jack Levine was granted
options to purchase 100,000 shares of common stock at $0.85 per share upon his
joining the Board of Directors. The option vests in three equal installments on
each of the first three anniversary dates of the date of grant and is
exercisable for ten (10) years from the date of grant. He will be reimbursed for
reasonable expenses incurred, however will not receive any other cash
compensation.
In
accordance with ASC 855-10 Company management reviewed all material events
through the date of this report and there are no additional subsequent events to
report.
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS
On or
about August 2, 2010, the Company determined that it had improperly classified
its preferred stock and related warrants as permanent equity when, due to
certain provisions of the preferred stock and warrants, these instruments should
have been classified as derivative liabilities under ASC 815. The error resulted
in an overstatement of the Company’s additional paid-in capital account, an
understatement of its current liabilities, and an overstatement of the Company’s
net income. Under ASC 815, derivative instruments are to be revalued at each
reporting period with any change in the fair value of the instruments being
recorded in the Company’s income statement. The cumulative effect of the error
through June 30, 2010 is a $340,786 reduction to the Company’s net income, a
$3,027,055 increase in current liabilities, and a $2,686,269 decrease in
additional paid-in capital. Below are tables detailing the effect of the error
on the Company’s previously filed financial statements for the year end December
31, 2009 and for all reporting periods from March 31, 2009 through March 31,
2010.
MARCH 31,
2010
Balance
Sheet
March 31, 2010
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
ASSETS
|
||||||||||||
Cash
|
$ | 263,408 | $ | - | $ | 263,408 | ||||||
Equipment,
net
|
2,200 | - | 2,200 | |||||||||
TOTAL
ASSETS
|
$ | 265,608 | $ | - | $ | 265,608 | ||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||||||||||
Accounts
payable and accrued expenses
|
$ | 141,179 | $ | - | $ | 141,179 | ||||||
Derivative
liability - preferred stock
|
1,745,320 | (1,745,320 | ) | - | ||||||||
Derivative
liability - warrants
|
1,206,756 | (1,206,756 | ) | - | ||||||||
TOTAL
LIABILITIES
|
3,093,255 | (2,952,076 | ) | 141,179 | ||||||||
STOCKHOLDERS'
EQUITY (DEFICIT)
|
||||||||||||
Preferred
stock
|
229 | - | 229 | |||||||||
Common
stock
|
11,341 | - | 11,341 | |||||||||
Additional
paid-in capital
|
325,834 | 2,653,620 | 2,979,454 | |||||||||
Deficit
accumulated during the development stage
|
(3,165,051 | ) | 298,456 | (2,866,595 | ) | |||||||
TOTAL
STOCKHOLDERS' EQUITY (DEFICIT)
|
(2,827,647 | ) | 2,952,076 | 124,429 | ||||||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
|
$ | 265,608 | $ | - | $ | 265,608 |
F-10
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
MARCH 31,
2010
Statement
of Operations
For the Three Months Ended
|
||||||||||||
March 31, 2010
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
REVENUES
|
$ | - | $ | - | $ | - | ||||||
OPERATING
EXPENSES
|
113,456 | - | 113,456 | |||||||||
OPERATING
LOSS
|
(113,456 | ) | - | (113,456 | ) | |||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Loss
on derivative liability
|
(95,230 | ) | (95,230 | ) | - | |||||||
Grant
income
|
40,784 | - | 40,784 | |||||||||
Interest
expense
|
- | - | - | |||||||||
Total
Other Income (Expense)
|
(54,446 | ) | (95,230 | ) | 40,784 | |||||||
NET
LOSS BEFORE INCOME TAXES
|
(167,902 | ) | (95,230 | ) | (72,672 | ) | ||||||
PROVISION
FOR INCOME TAXES
|
- | - | - | |||||||||
NET
LOSS
|
$ | (167,902 | ) | $ | (95,230 | ) | $ | (72,672 | ) | |||
BASIC
AND DILUTED
|
||||||||||||
LOSS
PER SHARE
|
$ | (0.01 | ) | $ | (0.01 | ) | $ | (0.01 | ) | |||
BASIC
AND DILUTED
|
||||||||||||
WEIGHTED
AVERAGE NUMBER NUMBER OF SHARES OUTSTANDING
|
11,340,000 | - | 11,340,000 |
From Inception on May 15, 2006 through
|
||||||||||||
March 31, 2010
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
REVENUES
|
$ | - | $ | - | $ | - | ||||||
OPERATING
EXPENSES
|
2,884,157 | - | 2,884,157 | |||||||||
OPERATING
LOSS
|
(2,884,157 | ) | - | (2,884,157 | ) | |||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Loss
on derivative liability
|
(298,456 | ) | (298,456 | ) | - | |||||||
Grant
income
|
81,557 | - | 81,557 | |||||||||
Interest
expense
|
(63,995 | ) | - | (63,995 | ) | |||||||
Total
Other Income (Expense)
|
(280,894 | ) | (298,456 | ) | 17,562 | |||||||
NET
LOSS BEFORE INCOME TAXES
|
(3,165,051 | ) | (298,456 | ) | (2,866,595 | ) | ||||||
PROVISION
FOR INCOME TAXES
|
- | - | - | |||||||||
NET
LOSS
|
$ | (3,165,051 | ) | $ | (298,456 | ) | $ | (2,866,595 | ) |
F-11
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
MARCH 31,
2010
Statement
of Cash Flows
For the Three Months Ended
|
||||||||||||
March 31, 2010
|
||||||||||||
Restated
|
Adjustment
|
As Filed
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (167,902 | ) | $ | (95,230 | ) | $ | (72,672 | ) | |||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||||||
Common
stock issued with bridge financing
|
- | - | - | |||||||||
Depreciation
expense
|
200 | - | 200 | |||||||||
Change
in derivative liability
|
95,230 | 95,230 | - | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Accounts
payable and accrued expenses
|
23,212 | - | 23,212 | |||||||||
Net
Cash Used in Operating Activities
|
(49,260 | ) | - | (49,260 | ) | |||||||
INVESTING
ACTIVITIES
|
||||||||||||
Purchase
of equipment
|
- | - | - | |||||||||
Net
Cash Used in Investing Activities
|
- | - | - | |||||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from notes payable
|
- | - | - | |||||||||
Stock
offering costs paid
|
(7,750 | ) | - | (7,750 | ) | |||||||
Preferred
stock issued for cash
|
25,000 | - | 25,000 | |||||||||
Common
stock issued for cash
|
- | - | - | |||||||||
Net
Cash Provided by Financing Activities
|
17,250 | - | 17,250 | |||||||||
NET
INCREASE (DECREASE) IN CASH
|
(32,010 | ) | - | (32,010 | ) | |||||||
CASH
AT BEGINNING OF PERIOD
|
295,418 | - | 295,418 | |||||||||
CASH
AT END OF PERIOD
|
$ | 263,408 | $ | - | $ | 263,408 |
F-12
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
MARCH 31,
2010
Statement
of Cash Flows
From Inception on May 15, 2006 through
|
||||||||||||
March 31, 2010
|
||||||||||||
Restated
|
Adjustment
|
As Filed
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (3,165,051 | ) | $ | (298,456 | ) | $ | (2,866,595 | ) | |||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||||||
Common
stock issued with bridge financing
|
1,139,001 | - | 1,139,001 | |||||||||
Depreciation
expense
|
1,800 | - | 1,800 | |||||||||
Change
in derivative liability
|
298,456 | 298,456 | - | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Accounts
payable and accrued expenses
|
141,179 | - | 141,179 | |||||||||
Net
Cash Used in Operating Activities
|
(1,584,615 | ) | - | (1,584,615 | ) | |||||||
INVESTING
ACTIVITIES
|
||||||||||||
Purchase
of equipment
|
(4,000 | ) | - | (4,000 | ) | |||||||
Net
Cash Used in Investing Activities
|
(4,000 | ) | - | (4,000 | ) | |||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from notes payable
|
889,875 | - | 889,875 | |||||||||
Stock
offering costs paid
|
(444,852 | ) | - | (444,852 | ) | |||||||
Preferred
stock issued for cash
|
1,397,000 | - | 1,397,000 | |||||||||
Common
stock issued for cash
|
10,000 | - | 10,000 | |||||||||
Net
Cash Provided by Financing Activities
|
1,852,023 | - | 1,852,023 | |||||||||
NET
INCREASE (DECREASE) IN CASH
|
263,408 | - | 263,408 | |||||||||
CASH
AT BEGINNING OF PERIOD
|
- | - | - | |||||||||
CASH
AT END OF PERIOD
|
$ | 263,408 | $ | - | $ | 263,408 |
F-13
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31,
2009
Balance
Sheet
December 31, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
ASSETS
|
||||||||||||
Cash
|
$ | 295,418 | $ | - | $ | 295,418 | ||||||
Equipment,
net
|
2,400 | - | 2,400 | |||||||||
TOTAL
ASSETS
|
$ | 297,818 | $ | - | $ | 297,818 | ||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||||||||||
Accounts
payable and accrued expenses
|
$ | 117,967 | $ | - | $ | 117,967 | ||||||
Derivative
liability - preferred stock
|
1,642,409 | (1,642,409 | ) | - | ||||||||
Derivative
liability - warrants
|
1,182,194 | (1,182,194 | ) | - | ||||||||
TOTAL
LIABILITIES
|
2,942,570 | (2,824,603 | ) | 117,967 | ||||||||
STOCKHOLDERS'
EQUITY (DEFICIT)
|
||||||||||||
Preferred
stock
|
226 | - | 226 | |||||||||
Common
stock
|
11,341 | - | 11,341 | |||||||||
Additional
paid-in capital
|
340,831 | 2,621,376 | 2,962,207 | |||||||||
Deficit
accumulated during the development stage
|
(2,997,150 | ) | 203,227 | (2,793,923 | ) | |||||||
TOTAL
STOCKHOLDERS’ EQUITY(DEFICIT)
|
(2,644,752 | ) | 2,824,603 | 179,851 | ||||||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
$ | 297,818 | $ | - | $ | 297,818 |
F-14
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31,
2009
Statement
of Operations
For the Year ended
|
||||||||||||
December 31, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
REVENUES
|
$ | - | $ | - | $ | - | ||||||
OPERATING
EXPENSES
|
612,098 | - | 612,097 | |||||||||
OPERATING
LOSS
|
(612,098 | ) | - | (612,097 | ) | |||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Loss
on derivative liability
|
(159,418 | ) | (159,418 | ) | - | |||||||
Grant
income
|
40,773 | - | 40,773 | |||||||||
Interest
expense
|
- | - | - | |||||||||
Total
Other Income (Expense)
|
(118,645 | ) | (159,418 | ) | 40,773 | |||||||
NET
LOSS BEFORE INCOME TAXES
|
(730,743 | ) | (159,418 | ) | (571,324 | ) | ||||||
PROVISION
FOR INCOME TAXES
|
- | - | - | |||||||||
NET
LOSS
|
$ | (730,743 | ) | $ | (159,418 | ) | $ | (571,324 | ) | |||
BASIC
LOSS PER SHARE
|
$ | (0.06 | ) | $ | (0.01 | ) | $ | (0.05 | ) | |||
WEIGHTED
AVERAGE NUMBER NUMBER OF SHARES OUTSTANDING
|
11,340,000 | - | 11,340,000 |
From Inception on May 15, 2006 through
|
||||||||||||
December 31, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
REVENUES
|
$ | - | $ | - | $ | - | ||||||
OPERATING
EXPENSES
|
2,770,702 | - | 2,770,702 | |||||||||
OPERATING
LOSS
|
(2,770,702 | ) | - | (2,770,702 | ) | |||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Loss
on derivative liability
|
(203,226 | ) | (203,226 | ) | - | |||||||
Grant
income
|
40,773 | - | 40,773 | |||||||||
Interest
expense
|
(63,995 | ) | - | (63,995 | ) | |||||||
Total
Other Income (Expense)
|
(226,448 | ) | (203,226 | ) | (23,222 | ) | ||||||
NET
LOSS BEFORE INCOME TAXES
|
(2,997,150 | ) | (203,226 | ) | (2,793,924 | ) | ||||||
PROVISION
FOR INCOME TAXES
|
- | - | - | |||||||||
NET
LOSS
|
$ | (2,997,150 | ) | $ | (203,226 | ) | $ | (2,793,924 | ) |
F-15
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31,
2009
Statement
of Cash Flows
For the Year Ended
|
||||||||||||
December 31, 2009
|
||||||||||||
Restated
|
Adjustment
|
As Filed
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (730,743 | ) | $ | (159,418 | ) | $ | (571,324 | ) | |||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||||||
Common
stock issued with bridge financing
|
- | - | - | |||||||||
Depreciation
expense
|
800 | - | 800 | |||||||||
Change
in derivative liability
|
159,418 | 159,418 | - | |||||||||
Changes
in operating assets and liabilities
|
||||||||||||
Accounts
payable and accrued expenses
|
40,969 | - | 40,968 | |||||||||
Net
Cash Used in Operating Activities
|
(529,556 | ) | - | (529,556 | ) | |||||||
INVESTING
ACTIVITIES
|
||||||||||||
Purchase
of equipment
|
- | - | - | |||||||||
Net
Cash Used in Investing Activities
|
- | - | - | |||||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from notes payable
|
- | - | - | |||||||||
Stock
offering costs paid
|
(166,154 | ) | - | (166,154 | ) | |||||||
Preferred
stock issued for cash
|
810,000 | - | 810,000 | |||||||||
Common
stock issued for cash
|
- | - | - | |||||||||
Net
Cash Provided by Financing Activities
|
643,846 | - | 643,846 | |||||||||
NET
INCREASE (DECREASE) IN CASH
|
114,290 | - | 114,290 | |||||||||
CASH
AT BEGINNING OF PERIOD
|
181,128 | - | 181,128 | |||||||||
CASH
AT END OF PERIOD
|
$ | 295,418 | $ | - | $ | 295,418 |
F-16
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31,
2009
Statement
of Cash Flows
From Inception on May 15, 2006 through
|
||||||||||||
December 31, 2009
|
||||||||||||
Restated
|
Adjustment
|
As Filed
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (2,997,150 | ) | $ | (203,169 | ) | $ | (2,793,923 | ) | |||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||||||
Common
stock issued with bridge financing
|
1,139,001 | - | 1,139,001 | |||||||||
Depreciation
expense
|
1,600 | - | 1,600 | |||||||||
Change
in derivative liability
|
203,226 | 203,226 | - | |||||||||
Changes
in operating assets and liabilities
|
||||||||||||
Accounts
payable and accrued expenses
|
117,967 | - | 117,967 | |||||||||
Net
Cash Used in Operating Activities
|
(1,535,356 | ) | - | (1,535,356 | ) | |||||||
INVESTING
ACTIVITIES
|
||||||||||||
Purchase
of equipment
|
(4,000 | ) | - | (4,000 | ) | |||||||
Net
Cash Used in Investing Activities
|
(4,000 | ) | - | (4,000 | ) | |||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from notes payable
|
889,875 | - | 889,875 | |||||||||
Stock
offering costs paid
|
(437,101 | ) | - | (437,101 | ) | |||||||
Preferred
stock issued for cash
|
1,372,000 | - | 1,372,000 | |||||||||
Common
stock issued for cash
|
10,000 | - | 10,000 | |||||||||
Net
Cash Provided by Financing Activities
|
1,834,774 | - | 1,834,774 | |||||||||
NET
INCREASE (DECREASE) IN CASH
|
295,418 | - | 295,418 | |||||||||
CASH
AT BEGINNING OF PERIOD
|
- | - | - | |||||||||
CASH
AT END OF PERIOD
|
$ | 295,418 | $ | - | $ | 295,418 |
F-17
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
SEPTEMBER 30,
2009
Balance
Sheet
September 30, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
ASSETS
|
||||||||||||
Cash
|
$ | 402,983 | $ | - | $ | 402,983 | ||||||
Equipment,
net
|
2,600 | - | 2,600 | |||||||||
TOTAL
ASSETS
|
$ | 405,583 | $ | - | $ | 405,583 | ||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||||||||||
Accounts
payable and accrued expenses
|
$ | 165,272 | $ | - | $ | 165,272 | ||||||
Derivative
liability - preferred stock
|
1,693,941 | (1,693,941 | ) | - | ||||||||
Derivative
liability - warrants
|
1,173,998 | (1,173,998 | ) | - | ||||||||
TOTAL
LIABILITIES
|
3,033,211 | (2,867,939 | ) | 165,272 | ||||||||
STOCKHOLDERS'
EQUITY (DEFICIT)
|
||||||||||||
Preferred
stock
|
226 | - | 226 | |||||||||
Common
stock
|
11,341 | - | 11,341 | |||||||||
Additional
paid-in capital
|
340,830 | 2,402,719 | 2,743,549 | |||||||||
Deficit
accumulated during the development stage
|
(2,980,025 | ) | 465,220 | (2,514,805 | ) | |||||||
TOTAL
STOCKHOLDERS’ EQUITY (DEFICIT)
|
(2,627,628 | ) | 2,867,939 | 240,311 | ||||||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
$ | 405,583 | $ | - | $ | 405,583 |
F-18
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
SEPTEMBER 30,
2009
Statement
of Operations
For the Three Months Ended
|
||||||||||||
September 30, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
REVENUES
|
$ | - | $ | - | $ | - | ||||||
OPERATING
EXPENSES
|
64,968 | - | 64,968 | |||||||||
OPERATING
LOSS
|
(64,968 | ) | - | (64,968 | ) | |||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Loss
on derivative liability
|
(87,174 | ) | (87,174 | ) | - | |||||||
Grant
income
|
- | - | - | |||||||||
Interest
expense
|
- | - | - | |||||||||
Total
Other Income (Expense)
|
(87,174 | ) | (87,174 | ) | - | |||||||
NET
LOSS BEFORE INCOME TAXES
|
(152,142 | ) | (87,174 | ) | (64,968 | ) | ||||||
PROVISION
FOR INCOME TAXES
|
- | - | - | |||||||||
NET
LOSS
|
$ | (152,142 | ) | $ | (87,174 | ) | $ | (64,968 | ) | |||
BASIC
LOSS PER SHARE
|
$ | (0.01 | ) | $ | (0.01 | ) | $ | (0.01 | ) | |||
WEIGHTED
AVERAGE NUMBER NUMBER OF SHARES OUTSTANDING
|
11,340,000 | - | 11,340,000 |
For the Nine Months Ended
|
||||||||||||
September 30, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
REVENUES
|
$ | - | $ | - | $ | - | ||||||
OPERATING
EXPENSES
|
510,864 | - | 510,864 | |||||||||
OPERATING
LOSS
|
(510,864 | ) | - | (510,864 | ) | |||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Loss
on derivative liability
|
(202,754 | ) | (202,754 | ) | - | |||||||
Grant
income
|
- | - | - | |||||||||
Interest
expense
|
- | - | - | |||||||||
Total
Other Income (Expense)
|
(202,754 | ) | (202,754 | ) | - | |||||||
NET
LOSS BEFORE INCOME TAXES
|
(713,618 | ) | (202,754 | ) | (510,864 | ) | ||||||
PROVISION
FOR INCOME TAXES
|
- | - | - | |||||||||
NET
LOSS
|
$ | (713,618 | ) | $ | (202,754 | ) | $ | (510,864 | ) | |||
BASIC
LOSS PER SHARE
|
$ | (0.06 | ) | $ | (0.02 | ) | $ | (0.05 | ) | |||
WEIGHTED
AVERAGE NUMBER NUMBER OF SHARES OUTSTANDING
|
11,340,000 | - | 11,340,000 |
F-19
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
SEPTEMBER 30,
2009
Statement
of Operations
From Inception on May 15, 2006 through
|
||||||||||||
September 30, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
REVENUES
|
$ | - | $ | - | $ | - | ||||||
OPERATING
EXPENSES
|
2,369,336 | - | 2,369,336 | |||||||||
OPERATING
LOSS
|
(2,369,336 | ) | - | (2,369,336 | ) | |||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Loss
on derivative liability
|
(246,562 | ) | (246,562 | ) | - | |||||||
Grant
income
|
- | - | - | |||||||||
Interest
expense
|
(68,462 | ) | - | (68,462 | ) | |||||||
Total
Other Income (Expense)
|
(315,024 | ) | (246,562 | ) | (68,462 | ) | ||||||
NET
LOSS BEFORE INCOME TAXES
|
(2,684,360 | ) | (246,562 | ) | (2,437,798 | ) | ||||||
PROVISION
FOR INCOME TAXES
|
- | - | - | |||||||||
NET
LOSS
|
$ | (2,684,360 | ) | $ | (246,562 | ) | $ | (2,437,798 | ) |
F-20
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
SEPTEMBER 30,
2009
Statement
of Cash Flows
For the Nine Months Ended
|
||||||||||||
September 30, 2009
|
||||||||||||
Restated
|
Adjustment
|
As Filed
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (713,618 | ) | $ | (202,754 | ) | $ | (510,864 | ) | |||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||||||
Common
stock issued with bridge financing
|
- | - | - | |||||||||
Depreciation
expense
|
600 | - | 600 | |||||||||
Change
in derivative liability
|
202,754 | 202,754 | - | |||||||||
Changes
in operating assets and liabilities
|
||||||||||||
Accounts
payable and accrued expenses
|
88,273 | - | 88,273 | |||||||||
Net
Cash Used in Operating Activities
|
(421,991 | ) | - | (421,991 | ) | |||||||
INVESTING
ACTIVITIES
|
||||||||||||
Purchase
of equipment
|
- | - | - | |||||||||
Net
Cash Used in Investing Activities
|
- | - | - | |||||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from notes payable
|
- | - | - | |||||||||
Stock
offering costs paid
|
(166,154 | ) | - | (166,154 | ) | |||||||
Preferred
stock issued for cash
|
810,000 | - | 810,000 | |||||||||
Common
stock issued for cash
|
- | - | - | |||||||||
Net
Cash Provided by Financing Activities
|
643,846 | - | 643,846 | |||||||||
NET
INCREASE (DECREASE) IN CASH
|
221,855 | - | 221,855 | |||||||||
CASH
AT BEGINNING OF PERIOD
|
181,128 | - | 181,128 | |||||||||
CASH
AT END OF PERIOD
|
$ | 402,983 | $ | - | $ | 402,983 |
F-21
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
SEPTEMBER 30,
2009
Statement
of Cash Flows
From Inception on May 15, 2006 through
|
||||||||||||
September 30, 2009
|
||||||||||||
Restated
|
Adjustment
|
As Filed
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (2,684,360 | ) | $ | (246,562 | ) | $ | (2,437,798 | ) | |||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||||||
Common
stock issued with bridge financing
|
908,858 | - | 908,858 | |||||||||
Depreciation
expense
|
1,400 | - | 1,400 | |||||||||
Change
in derivative liability
|
246,562 | 246,562 | - | |||||||||
Changes
in operating assets and liabilities
|
||||||||||||
Accounts
payable and accrued expenses
|
130,649 | - | 130,649 | |||||||||
Net
Cash Used in Operating Activities
|
(1,396,891 | ) | - | (1,396,891 | ) | |||||||
INVESTING
ACTIVITIES
|
||||||||||||
Purchase
of equipment
|
(4,000 | ) | - | (4,000 | ) | |||||||
Net
Cash Used in Investing Activities
|
(4,000 | ) | - | (4,000 | ) | |||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from notes payable
|
847,500 | - | 847,500 | |||||||||
Stock
offering costs paid
|
(475,626 | ) | - | (475,626 | ) | |||||||
Preferred
stock issued for cash
|
1,422,000 | - | 1,422,000 | |||||||||
Common
stock issued for cash
|
10,000 | - | 10,000 | |||||||||
Net
Cash Provided by Financing Activities
|
1,803,874 | - | 1,803,874 | |||||||||
NET
INCREASE (DECREASE) IN CASH
|
402,983 | - | 402,983 | |||||||||
CASH
AT BEGINNING OF PERIOD
|
- | - | - | |||||||||
CASH
AT END OF PERIOD
|
$ | 402,983 | $ | - | $ | 402,983 |
F-22
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
JUNE 30,
2009
Balance
Sheet
June 30, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
ASSETS
|
||||||||||||
Cash
|
$ | 258,351 | $ | - | $ | 258,351 | ||||||
Equipment,
net
|
2,800 | - | 2,800 | |||||||||
TOTAL
ASSETS
|
$ | 261,151 | $ | - | $ | 261,151 | ||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||||||||||
Accounts
payable and accrued expenses
|
$ | 167,272 | $ | - | $ | 167,272 | ||||||
Derivative
liability - preferred stock
|
1,402,448 | (1,402,448 | ) | - | ||||||||
Derivative
liability – warrants
|
1,012,471 | (1,012,471 | ) | - | ||||||||
TOTAL
LIABILITIES
|
2,582,191 | (2,414,919 | ) | 167,272 | ||||||||
STOCKHOLDERS'
EQUITY (DEFICIT)
|
||||||||||||
Preferred
stock
|
196 | - | 196 | |||||||||
Common
stock
|
11,341 | - | 11,341 | |||||||||
Additional
paid-in capital
|
495,306 | 2,036,888 | 2,532,194 | |||||||||
Deficit
accumulated during the development stage
|
(2,827,883 | ) | 378,031 | (2,449,852 | ) | |||||||
TOTAL
STOCKHOLDERS’ EQUITY (DEFICIT)
|
(2,321,040 | ) | 2,414,919 | 93,879 | ||||||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
$ | 261,151 | $ | - | $ | 261,151 |
F-23
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
JUNE 30,
2009
Statement
of Operations
For the Three Months Ended
|
||||||||||||
June 30, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
REVENUES
|
$ | - | $ | - | $ | - | ||||||
OPERATING
EXPENSES
|
287,400 | - | 287,400 | |||||||||
OPERATING
LOSS
|
(287,400 | ) | - | (287,400 | ) | |||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Gain
on derivative liability
|
17,692 | 17,692 | - | |||||||||
Grant
income
|
- | - | - | |||||||||
Interest
expense
|
- | - | - | |||||||||
Total
Other Income (Expense)
|
17,692 | 17,692 | - | |||||||||
NET
LOSS BEFORE INCOME TAXES
|
(269,708 | ) | 17,692 | (287,400 | ) | |||||||
PROVISION
FOR INCOME TAXES
|
- | - | - | |||||||||
NET
LOSS
|
$ | (269,708 | ) | $ | 17,692 | $ | (287,400 | ) | ||||
BASIC
LOSS PER SHARE
|
$ | (0.02 | ) | $ | 0.00 | $ | (0.03 | ) | ||||
WEIGHTED
AVERAGE NUMBER OF SHARES OUTSTANDING
|
11,340,000 | - | 11,340,000 |
For the Six Months Ended
|
||||||||||||
June 30, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
REVENUES
|
$ | - | $ | - | $ | - | ||||||
OPERATING
EXPENSES
|
445,896 | - | 445,896 | |||||||||
OPERATING
LOSS
|
(445,896 | ) | - | (445,896 | ) | |||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Gain
(loss) on derivative liability
|
(115,580 | ) | (115,580 | ) | - | |||||||
Grant
income
|
- | - | - | |||||||||
Interest
expense
|
- | - | - | |||||||||
Total
Other Income (Expense)
|
(115,580 | ) | (115,580 | ) | - | |||||||
NET
LOSS BEFORE INCOME TAXES
|
(561,476 | ) | (115,580 | ) | (445,896 | ) | ||||||
PROVISION
FOR INCOME TAXES
|
- | - | - | |||||||||
NET
LOSS
|
$ | (561,476 | ) | $ | (115,580 | ) | $ | (445,896 | ) | |||
BASIC
LOSS PER SHARE
|
$ | (0.05 | ) | $ | (0.01 | ) | $ | (0.04 | ) | |||
WEIGHTED
AVERAGE NUMBER OF SHARES OUTSTANDING
|
11,340,000 | - | 11,340,000 |
F-24
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
JUNE 30,
2009
Statement of
Operations
From Inception on May 15, 2006 through
|
||||||||||||
June 30, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
REVENUES
|
$ | - | $ | - | $ | - | ||||||
OPERATING
EXPENSES
|
2,340,368 | - | 2,304,368 | |||||||||
OPERATING
LOSS
|
(2,340,368 | ) | - | (2,304,368 | ) | |||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Loss
on derivative liability
|
(159,388 | ) | (159,388 | ) | - | |||||||
Grant
income
|
- | - | - | |||||||||
Interest
expense
|
(68,462 | ) | - | (68,462 | ) | |||||||
Total
Other Income (Expense)
|
(227,850 | ) | (159,388 | ) | (68,462 | ) | ||||||
NET
LOSS BEFORE INCOME TAXES
|
(2,568,218 | ) | (159,388 | ) | (2,372,830 | ) | ||||||
PROVISION
FOR INCOME TAXES
|
- | - | - | |||||||||
NET
LOSS
|
$ | (2,568,218 | ) | $ | (159,388 | ) | $ | (2,372,830 | ) |
F-25
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
JUNE 30,
2009
Statement of Cash
Flows
For the Six Months Ended
|
||||||||||||
June 30, 2009
|
||||||||||||
Restated
|
Adjustment
|
As Filed
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (561,476 | ) | $ | (115,580 | ) | $ | (445,896 | ) | |||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||||||
Common
stock issued with bridge financing
|
- | - | - | |||||||||
Depreciation
expense
|
400 | - | 400 | |||||||||
Change
in derivative liability
|
115,580 | 115,580 | - | |||||||||
Changes
in operating assets and liabilities
|
||||||||||||
Accounts
payable and accrued expenses
|
90,273 | - | 90,273 | |||||||||
Net
Cash Used in Operating Activities
|
(355,223 | ) | - | (355,223 | ) | |||||||
INVESTING
ACTIVITIES
|
||||||||||||
Purchase
of equipment
|
- | - | - | |||||||||
Net
Cash Used in Investing Activities
|
- | - | - | |||||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from notes payable
|
- | - | - | |||||||||
Stock
offering costs paid
|
(127,554 | ) | - | (127,554 | ) | |||||||
Preferred
stock issued for cash
|
560,000 | - | 560,000 | |||||||||
Common
stock issued for cash
|
- | - | - | |||||||||
Net
Cash Provided by Financing Activities
|
432,446 | - | 432,446 | |||||||||
NET
INCREASE (DECREASE) IN CASH
|
77,223 | - | 77,223 | |||||||||
CASH
AT BEGINNING OF PERIOD
|
181,128 | - | 181,128 | |||||||||
CASH
AT END OF PERIOD
|
$ | 258,351 | $ | - | $ | 258,351 |
F-26
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
JUNE 30,
2009
Statement
of Cash Flows
From Inception on May 15, 2006 through
|
||||||||||||
June 30, 2009
|
||||||||||||
Restated
|
Adjustment
|
As Filed
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (2,568,218 | ) | $ | (159,388 | ) | $ | (2,372,830 | ) | |||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||||||
Common
stock issued with bridge financing
|
908,858 | - | 908,858 | |||||||||
Depreciation
expense
|
1,200 | - | 1,200 | |||||||||
Change
in derivative liability
|
159,388 | 159,388 | - | |||||||||
Changes
in operating assets and liabilities
|
||||||||||||
Accounts
payable and accrued expenses
|
132,649 | - | 132,649 | |||||||||
Net
Cash Used in Operating Activities
|
(1,330,123 | ) | - | (1,330,123 | ) | |||||||
INVESTING
ACTIVITIES
|
||||||||||||
Purchase
of equipment
|
(4,000 | ) | - | (4,000 | ) | |||||||
Net
Cash Used in Investing Activities
|
(4,000 | ) | - | (4,000 | ) | |||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from notes payable
|
847,500 | - | 847,500 | |||||||||
Stock
offering costs paid
|
(437,026 | ) | - | (437,026 | ) | |||||||
Preferred
stock issued for cash
|
1,172,000 | - | 1,172,000 | |||||||||
Common
stock issued for cash
|
10,000 | - | 10,000 | |||||||||
Net
Cash Provided by Financing Activities
|
1,592,474 | - | 1,592,474 | |||||||||
NET
INCREASE (DECREASE) IN CASH
|
258,351 | - | 258,351 | |||||||||
CASH
AT BEGINNING OF PERIOD
|
- | - | - | |||||||||
CASH
AT END OF PERIOD
|
$ | 258,351 | $ | - | $ | 258,351 |
F-27
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
MARCH 31,
2009
Balance
Sheet
March 31, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
ASSETS
|
||||||||||||
Cash
|
$ | 272,428 | $ | - | $ | 272,428 | ||||||
Equipment,
net
|
3,000 | - | 3,000 | |||||||||
TOTAL
ASSETS
|
$ | 275,428 | $ | - | $ | 275,428 | ||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||||||||||
Accounts
payable and accrued expenses
|
$ | 76,999 | $ | - | $ | 76,999 | ||||||
Derivative
liability - preferred stock
|
1,263,688 | (1,263,688 | ) | - | ||||||||
Derivative
liability - warrants
|
908,699 | (908,699 | ) | - | ||||||||
TOTAL
LIABILITIES
|
2,249,386 | (2,172,387 | ) | 76,999 | ||||||||
STOCKHOLDERS'
EQUITY (DEFICIT)
|
||||||||||||
Preferred
stock
|
175 | - | 175 | |||||||||
Common
stock
|
11,341 | - | 11,341 | |||||||||
Additional
paid-in capital
|
571,801 | 2,732,772 | 3,304,573 | |||||||||
Deficit
accumulated during the development stage
|
(2,557,275 | ) | (560,385 | ) | (3,117,660 | ) | ||||||
TOTAL
STOCKHOLDER’S EQUITY (DEFICIT)
|
(1,973,958 | ) | 2,172,387 | 198,429 | ||||||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
$ | 275,428 | $ | - | $ | 275,428 |
F-28
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
MARCH 31,
2009
Statement
of Operations
For the Three Months Ended
|
||||||||||||
March 31, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
REVENUES
|
$ | - | $ | - | $ | - | ||||||
OPERATING
EXPENSES
|
314,572 | - | 314,572 | |||||||||
OPERATING
LOSS
|
(314,572 | ) | - | (314,572 | ) | |||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Gain
(loss) on derivative liability
|
(133,272 | ) | (133,272 | ) | - | |||||||
Grant
income
|
- | - | - | |||||||||
Interest
expense
|
- | - | - | |||||||||
Total
Other Income (Expense)
|
(133,272 | ) | (133,272 | ) | - | |||||||
NET
LOSS BEFORE INCOME TAXES
|
(447,844 | ) | (133,272 | ) | (314,572 | ) | ||||||
PROVISION
FOR INCOME TAXES
|
- | - | - | |||||||||
NET
LOSS
|
$ | (447,844 | ) | $ | (133,272 | ) | $ | (314,572 | ) | |||
BASIC
LOSS PER SHARE
|
$ | (0.04 | ) | $ | (0.01 | ) | $ | (0.03 | ) | |||
WEIGHTED
AVERAGE NUMBER OF SHARES OUTSTANDING
|
11,340,000 | - | 11,340,000 |
From Inception on May 15, 2006 through
|
||||||||||||
March 31, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
REVENUES
|
$ | - | $ | - | $ | - | ||||||
OPERATING
EXPENSES
|
2,972,228 | - | 2,972,228 | |||||||||
OPERATING
LOSS
|
(2,972,228 | ) | - | (2,972,228 | ) | |||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Gain
(loss) on derivative liability
|
(177,080 | ) | (177,080 | ) | - | |||||||
Grant
income
|
- | - | - | |||||||||
Interest
expense
|
(68,462 | ) | - | (68,462 | ) | |||||||
Total
Other Income (Expense)
|
(245,542 | ) | (177,080 | ) | (68,462 | ) | ||||||
NET
LOSS BEFORE INCOME TAXES
|
(3,217,770 | ) | (177,080 | ) | (3,040,690 | ) | ||||||
PROVISION
FOR INCOME TAXES
|
- | - | - | |||||||||
NET
LOSS
|
$ | (3,217,770 | ) | $ | (177,080 | ) | $ | (3,040,690 | ) |
F-29
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
MARCH 31,
2009
Statement
of Cash Flows
For the Three Months Ended
|
||||||||||||
March 31, 2009
|
||||||||||||
Restated
|
Adjustment
|
As Filed
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (447,844 | ) | $ | (133,272 | ) | $ | (314,572 | ) | |||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||||||
Common
stock issued with bridge financing
|
156,976 | - | 156,976 | |||||||||
Depreciation
expense
|
200 | - | 200 | |||||||||
Change
in derivative liability
|
133,272 | 133,272 | - | |||||||||
Changes
in operating assets and liabilities
|
||||||||||||
Accounts
payable and accrued expenses
|
- | - | - | |||||||||
Net
Cash Used in Operating Activities
|
(157,396 | ) | - | (157,396 | ) | |||||||
INVESTING
ACTIVITIES
|
||||||||||||
Purchase
of equipment
|
- | - | - | |||||||||
Net
Cash Used in Investing Activities
|
- | - | - | |||||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from notes payable
|
- | - | - | |||||||||
Stock
offering costs paid
|
(46,304 | ) | - | (46,304 | ) | |||||||
Preferred
stock issued for cash
|
295,000 | - | 295,000 | |||||||||
Common
stock issued for cash
|
- | - | - | |||||||||
Net
Cash Provided by Financing Activities
|
248,696 | - | 248,696 | |||||||||
NET
INCREASE (DECREASE) IN CASH
|
91,300 | - | 91,300 | |||||||||
CASH
AT BEGINNING OF PERIOD
|
181,128 | - | 181,128 | |||||||||
CASH
AT END OF PERIOD
|
$ | 272,428 | $ | - | $ | 272,428 |
F-30
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
NOTE
9 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
MARCH 31,
2009
Statement
of Cash Flows
From Inception on May 15, 2006 through
|
||||||||||||
March 31, 2009
|
||||||||||||
Restated
|
Adjustment
|
As Filed
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (3,217,770 | ) | $ | (177,080 | ) | $ | (3,040,690 | ) | |||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||||||
Common
stock issued with bridge financing
|
1,865,018 | - | 1,865,018 | |||||||||
Depreciation
expense
|
1,000 | - | 1,000 | |||||||||
Change
in derivative liability
|
177,080 | 177,080 | - | |||||||||
Changes
in operating assets and liabilities
|
||||||||||||
Accounts
payable and accrued expenses
|
42,376 | - | 42,376 | |||||||||
Net
Cash Used in Operating Activities
|
(1,132,296 | ) | - | (1,132,296 | ) | |||||||
INVESTING
ACTIVITIES
|
||||||||||||
Purchase
of equipment
|
(4,000 | ) | - | (4,000 | ) | |||||||
Net
Cash Used in Investing Activities
|
(4,000 | ) | - | (4,000 | ) | |||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from notes payable
|
847,500 | - | 847,500 | |||||||||
Stock
offering costs paid
|
(355,776 | ) | - | (355,776 | ) | |||||||
Preferred
stock issued for cash
|
907,000 | - | 907,000 | |||||||||
Common
stock issued for cash
|
10,000 | - | 10,000 | |||||||||
Net
Cash Provided by Financing Activities
|
1,408,724 | - | 1,408,724 | |||||||||
NET
INCREASE (DECREASE) IN CASH
|
272,428 | - | 272,428 | |||||||||
CASH
AT BEGINNING OF PERIOD
|
- | - | - | |||||||||
CASH
AT END OF PERIOD
|
$ | 272,428 | $ | - | $ | 272,428 |
F-31
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Statements
of Cash Flows
(Unaudited)
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the
Board of Directors
SignPath
Pharma, Inc.
(A
Development Stage Enterprise)
Quakertown,
Pennsylvania
We have
audited the accompanying balance sheets of SignPath Pharma, Inc. (a development
stage enterprise) as of December 31, 2009 and 2008 and the related statements of
operations, stockholders’ equity (deficit) and cash flows for the twelve month
periods then ended. These financial statements are the responsibility of the
Company's management. Our responsibility is to express an opinion on these
financial statements based on our audit.
We
conducted our audit in accordance with standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. The Company is not required to
have, nor were we engaged to perform, an audit of its internal control over
financial reporting. Our audit included consideration of internal control over
financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company's internal control over financial
reporting. Accordingly, we express no such opinion. An audit includes examining,
on a test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also includes assessing the accounting principles
used and significant estimates made by management, as well as evaluating the
overall financial statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of SignPath Pharma, Inc. as of
December 31, 2009 and 2008 and the results of its operations and cash flows for
the periods described above in conformity with accounting principles generally
accepted in the United States of America.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 1 to the financial
statements, the Company has suffered recurring losses from operations, which
raises substantial doubt about its ability to continue as a going concern.
Management’s plans regarding those matters are described in Note 1. The
financial statements do not include any adjustments that might result from the
outcome of this uncertainty.
/s/
M&K CPAS, PLLC
www.mkacpas.com
Houston,
Texas
April 15,
2010, except for Note 11, as to which the date is August 23, 2010
F-32
SIGNPATH
PHARMA, INC
(A
Development Stage Company)
Balance
Sheets
(Restated)
December 31,
|
December 31,
|
|||||||
2009
|
2008
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS
|
||||||||
Cash
|
$ | 295,418 | $ | 181,128 | ||||
Total
Current Assets
|
295,418 | 181,128 | ||||||
EQUIPMENT,
net
|
2,400 | 3,200 | ||||||
TOTAL
ASSETS
|
$ | 297,818 | $ | 184,328 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT)
|
||||||||
CURRENT
LIABILITIES
|
||||||||
Accounts
payable and accrued expenses
|
$ | 117,967 | $ | 76,999 | ||||
Derivative
liability
|
2,824,603 | - | ||||||
Total
Current Liabilities
|
2,942,570 | 76,999 | ||||||
STOCKHOLDERS'
EQUITY
|
||||||||
Preferred
stock; $0.10 par value, 5,000,000 shares authorized 2,312 and 1,502 shares
issued and outstanding, respectively
|
226 | 145 | ||||||
Common
stock; $0.001 par value, 45,000,000 shares authorized; 11,340,000 and
11,340,500 shares issued and outstanding, respectively
|
11,341 | 11,341 | ||||||
Additional
paid-in capital
|
340,831 | 2,318,442 | ||||||
Deficit
accumulated during the development stage
|
(2,997,150 | ) | (2,222,599 | ) | ||||
Total
Stockholders' Equity (Deficit)
|
(2,644,752 | ) | 107,329 | |||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
|
$ | 297,818 | $ | 184,328 |
The
accompanying notes are an integral part of these financial
statements.
F-33
SIGNPATH
PHARMA, INC
(A
Development Stage Company)
Statements
of Operations
(Restated)
From Inception
|
||||||||||||
on May 15, 2006
|
||||||||||||
For the Year ended
|
Through
|
|||||||||||
December 31,
|
December 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
(unaudited)
|
||||||||||||
REVENUES
|
$ | - | $ | - | $ | - | ||||||
OPERATING
EXPENSES
|
||||||||||||
General
and administrative
|
243,492 | 101,406 | 461,411 | |||||||||
Consulting
expense
|
2,782 | 79,481 | 82,263 | |||||||||
Financing
expense
|
- | 891,949 | 1,063,401 | |||||||||
Legal
and professional expenses
|
74,794 | 143,527 | 238,047 | |||||||||
Licensing
expense
|
75,092 | 102,347 | 177,439 | |||||||||
Advertising
expense
|
- | 49,175 | 49,175 | |||||||||
Research
and development, net
|
215,938 | 263,886 | 698,966 | |||||||||
Total
Operating Expenses
|
612,098 | 1,631,771 | 2,770,702 | |||||||||
OPERATING
LOSS
|
(612,098 | ) | (1,631,771 | ) | (2,770,702 | ) | ||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Gain
(loss) on derivative liability
|
(159,418 | ) | - | (203,226 | ) | |||||||
Grant
income
|
40,773 | - | 40,773 | |||||||||
Interest
expense
|
- | (63,995 | ) | (63,995 | ) | |||||||
Total
Other Income (Expense)
|
(118,645 | ) | (63,995 | ) | (226,448 | ) | ||||||
NET
LOSS BEFORE INCOME TAXES
|
(730,743 | ) | (1,695,766 | ) | (2,997,150 | ) | ||||||
PROVISION
FOR INCOME TAXES
|
- | - | - | |||||||||
NET
LOSS
|
$ | (730,743 | ) | $ | (1,695,766 | ) | $ | (2,997,150 | ) | |||
BASIC
LOSS PER SHARE
|
$ | (0.06 | ) | $ | (0.15 | ) | ||||||
WEIGHTED
AVERAGE NUMBER NUMBER OF SHARES OUTSTANDING
|
11,340,000 | 11,174,651 |
The
accompanying notes are an integral part of these financial
statements.
F-34
SIGNPATH
PHARMA, INC
(A
Development Stage Company)
Statements
of Stockholders' Equity (Deficit)
(Restated)
Deficit
|
||||||||||||||||||||||||||||
Accumulated
|
||||||||||||||||||||||||||||
Additional
|
During the
|
Total
|
||||||||||||||||||||||||||
Preferred Stock
|
Common Stock
|
Paid-in
|
Development
|
Stockholders'
|
||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Stage
|
Equity
|
||||||||||||||||||||||
Balance,
May 15, 2006
|
- | $ | - | - | $ | - | $ | - | $ | - | $ | - | ||||||||||||||||
Common
stock issued to founders for cash at $0.001 per share
|
- | - | 10,000,000 | 10,000 | - | - | 10,000 | |||||||||||||||||||||
Net
loss for the year ended December 31, 2006
|
- | - | - | - | - | - | - | |||||||||||||||||||||
Balance,
December 31, 2006
|
- | - | 10,000,000 | 10,000 | - | - | 10,000 | |||||||||||||||||||||
Common
stock issued for bridge debt at $0.67 per share
|
- | - | 257,500 | 258 | 218,617 | - | 218,875 | |||||||||||||||||||||
Net
loss for the year ended December 31, 2007
|
- | - | - | - | - | (526,833 | ) | (526,833 | ) | |||||||||||||||||||
Balance,
December 31, 2007
|
- | - | 10,257,500 | 10,258 | 218,617 | (526,833 | ) | (297,958 | ) | |||||||||||||||||||
Preferred
stock issued for bridge debt at $1,000 per share
|
890 | 89 | - | - | 889,786 | - | 889,875 | |||||||||||||||||||||
Preferred
stock issued for cash at $1,000 per share
|
562 | 56 | - | - | 561,944 | - | 562,000 | |||||||||||||||||||||
Common
stock issued for bridge debt at $0.67 per share
|
- | - | 1,082,500 | 1,083 | 919,043 | - | 920,126 | |||||||||||||||||||||
Stock
offering costs
|
- | - | - | - | (270,948 | ) | - | (270,948 | ) | |||||||||||||||||||
Net
loss for the year ended December 31, 2008
|
- | - | - | - | - | (1,695,766 | ) | (1,695,766 | ) | |||||||||||||||||||
Balance,
December 31, 2008
|
1,452 | 145 | 11,340,000 | 11,341 | 2,318,442 | (2,222,599 | ) | 107,329 | ||||||||||||||||||||
Cumulative
effect of adoption of ASC 815
|
- | - | - | - | (1,632,825 | ) | (43,808 | ) | (1,632,825 | ) | ||||||||||||||||||
Preferred
stock issued for cash at $1,000 per share
|
810 | 81 | - | - | (178,632 | ) | - | (178,551 | ) | |||||||||||||||||||
Stock
offering cost
|
- | - | - | - | (166,154 | ) | - | (166,154 | ) | |||||||||||||||||||
Net
loss for the year ended December 31, 2009
|
- | - | - | - | - | (730,743 | ) | (730,743 | ) | |||||||||||||||||||
Balance,
December 31, 2009
|
2,262 | $ | 226 | 11,340,000 | $ | 11,341 | $ | 340,831 | $ | (2,997,150 | ) | $ | (2,600,944 | ) |
The
accompanying notes are an integral part of these financial statements.
F-35
SIGNPATH
PHARMA, INC
(A
Development Stage Company)
Statements
of Cash Flows
(Restated)
From Inception
|
||||||||||||
on May 15, 2006
|
||||||||||||
For the Year Ended
|
Through
|
|||||||||||
December 31,
|
December 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
|
(unaudited)
|
|||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (730,743 | ) | $ | (1,695,766 | ) | $ | (2,997,150 | ) | |||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||||||
Common
stock issued with bridge financing
|
- | 920,126 | 1,139,001 | |||||||||
Depreciation
expense
|
800 | 800 | 1,600 | |||||||||
Change
in derivative liability
|
159,418 | - | 203,226 | |||||||||
Changes
in operating assets and liabilities
|
||||||||||||
Accounts
payable and accrued expenses
|
40,969 | 29,187 | 117,967 | |||||||||
Net
Cash Used in Operating Activities
|
(529,556 | ) | (745,653 | ) | (1,535,356 | ) | ||||||
INVESTING
ACTIVITIES
|
||||||||||||
Purchase
of equipment
|
- | - | (4,000 | ) | ||||||||
Net
Cash Used in Investing Activities
|
- | - | (4,000 | ) | ||||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from notes payable
|
- | 632,875 | 889,875 | |||||||||
Stock
offering costs paid
|
(166,154 | ) | (270,948 | ) | (437,101 | ) | ||||||
Preferred
stock issued for cash
|
810,000 | 562,000 | 1,372,000 | |||||||||
Common
stock issued for cash
|
- | - | 10,000 | |||||||||
Net
Cash Provided by Financing Activities
|
643,846 | 923,927 | 1,834,773 | |||||||||
NET
INCREASE (DECREASE) IN CASH
|
114,290 | 178,274 | 295,418 | |||||||||
CASH
AT BEGINNING OF PERIOD
|
181,128 | 2,854 | - | |||||||||
CASH
AT END OF PERIOD
|
$ | 295,418 | $ | 181,128 | $ | 295,418 | ||||||
SUPPLEMENTAL
DISCLOSURES OF
|
||||||||||||
CASH
FLOW INFORMATION
|
||||||||||||
CASH
PAID FOR:
|
||||||||||||
Interest
|
$ | - | $ | - | $ | - | ||||||
Income
taxes
|
$ | - | $ | - | $ | - | ||||||
NON
CASH FINANCING ACTIVITIES:
|
||||||||||||
Preferred
stock issued for bridge financing
|
$ | $ | - | $ | 889,875 | |||||||
Derivative
liability
|
- | - | 1,676,633 |
The
accompanying notes are an integral part of these financial
statements.
F-36
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
1 – NATURE OF OPERATIONS
SignPath
Pharma, Inc, (the “Company”) was incorporated under the laws of the State of
Delaware on May 15, 2006. The Company was organized to develop proprietary
formulations of curcumin (diferuloylmethane), a naturally occurring compound
found in the root of the Curcuma longa (turmeric)
plant, for applications in malignant diseases. The Company’s product candidates
are currently in the pre-clinical testing phase.
Going
Concern
These
financial statements have been prepared on a going concern basis, which implies
that the Company will continue to realize its assets and discharge its
liabilities in the normal course of business. During the year ended December 31,
2009, the Company recognized sales revenue of $-0- and incurred a net loss of
$730,743. As of December 31, 2009, the Company had an accumulated deficit of
$2,997,150. During the year ended December 31, 2008, the Company recognized
sales revenue of $-0- and incurred a net loss of $1,695,766. The continuation of
the Company as a going concern is dependent upon the continued financial support
from its shareholders, the ability to raise equity or debt financing, and the
attainment of profitable operations from the Company's planned business. These
factors raise substantial doubt regarding the Company’s ability to continue as a
going concern. These consolidated financial statements do not include any
adjustments to the recoverability and classification of recorded asset amounts
and classification of liabilities that might be necessary should the Company be
unable to continue as a going concern.
The
Company’s plan of action over the next twelve months is to continue its
operations to develop proprietary formulations of curcumin and raise additional
capital financing to sustain operations.
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of
Presentation
These
financial statements and related notes are presented in accordance with
accounting principles generally accepted in the United States, and are expressed
in US dollars. The Company’s fiscal year-end is December 31.
The
preparation of these financial statements in conformity with generally accepted
accounting principles in the United States requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. The Company regularly evaluates estimates and assumptions
related to valuation allowances on accounts receivable, valuation and
amortization policies on property and equipment, and valuation allowances on
deferred income tax losses. The Company bases its estimates and assumptions on
current facts, historical experience and various other factors that it believes
to be reasonable under the circumstances, the results of which form the basis
for making judgments about the carrying values of assets and liabilities and the
accrual of costs and expenses that are not readily apparent from other sources.
The actual results experienced by the Company may differ materially and
adversely from the Company’s estimates. To the extent there are material
differences between the estimates and the actual results, future results of
operations will be affected.
Derivative Financial
Instruments
The
Company generally does not use derivative financial instruments to hedge
exposures to cash-flow risks or market-risks that may affect the fair values of
its financial instruments. The Company utilizes various types of financing to
fund our business needs, including preferred stock with warrants attached and
other instruments not indexed to our stock. The Company is required to record
its derivative instruments at their fair value. Changes in the fair value of
derivatives are recognized in earnings in accordance with ASC 815.
Cash and Cash
Equivalents
The
Company considers all highly liquid instruments with maturity of three months or
less at the time of issuance to be cash equivalents. As of December 31, 2009 and
2008 the Company had $295,418 and $181,128 of cash, respectively. The Company
had no cash equivalents.
F-37
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
Financial
Instruments
The fair
value of financial instruments, which include cash, accounts receivable, other
current assets, accounts payable, and accrued liabilities were estimated to
approximate their carrying value due to the immediate or relatively short
maturity of these instruments.
Fair Value of Financial
Instruments
The
Company adopted the standard issued by the FASB, which clarifies the definition
of fair value, prescribes methods for measuring fair value, and establishes a
fair value hierarchy to classify the inputs used in measuring fair value as
follows:
Level
1-Inputs are unadjusted quoted prices in active markets for identical assets or
liabilities available at the measurement date.
Level
2-Inputs are unadjusted quoted prices for similar assets and liabilities in
active markets, quoted prices for identical or similar assets and liabilities in
markets that are not active, inputs other then quoted prices that are
observable, and inputs derived from or corroborated by observable market
data.
Level
3-Inputs are unobservable inputs which reflect the reporting entity’s own
assumptions on what assumptions the market participants would use in pricing the
asset or liability based on the best available information.
The
carrying amounts reported in the balance sheets for cash, accounts receivable,
loans payable, and accounts payable and accrued expenses, approximate their fair
market value based on the short-term maturity of these instruments. The
following table presents assets and liabilities that are measured and recognized
at fair value as of December 31, 2009 and 2008, on a non-recurring
basis:
Total Gains
|
||||||||||||||||
Description
|
Level 1
|
Level 2
|
Level 3
|
(Losses)
|
||||||||||||
Accounts
payable and accrued expenses
|
$
|
-
|
$
|
-
|
$
|
117,967
|
$
|
-
|
||||||||
Derivative
liabilities
|
-
|
-
|
3,027,055
|
(340,786)
|
The
standard issued by the FASB concerning the fair value option for financial
assets and liabilities, became effective for the Company on January 1, 2008. The
standard establishes a fair value option that permits entities to choose to
measure eligible financial instruments and certain other items at fair value at
specified election dates. A business entity shall report unrealized gains and
losses on items for which the fair value options have been elected in earnings
at each subsequent reporting date. For the periods ended December 31, 2009 and
2008, there were no applicable items on which the fair value option was
elected.
Revenue
Recognition
The
Company will recognize revenue from the sale if their products in accordance
with ASC 605 “Revenue
Recognition in Financial Statements”. Revenue will be recognized only
when the price is fixed or determinable, persuasive evidence of an arrangement
exists, the service is provided, and collectability is assured.
Research and Development
Costs
The
Company expenses the costs of the development of its pharmaceutical products
during the period incurred. The Company incurred research and development
expenses of $215,937 and $263,886 during the years ended December 31, 2009 and
2008, respectively. The Company did receive grant income to help fund its
research and development efforts during the years ended December 31, 2009 and
2008 totaling $40,773 and $-0-, respectively.
Advertising
Costs
Advertising
costs are expensed as incurred and are recorded in the consolidated financial
statements as selling expense. For the years ended December 31, 2009 and 2008,
the Company recorded advertising and marketing costs of $-0- and $49,175
respectively.
F-38
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
Stock-Based
Compensation
The
Company records stock-based compensation in accordance with ASC 718 “Share Based
Payments”, using the fair value method. All transactions in which goods or
services are the consideration received for the issuance of equity instruments
are accounted for based on the fair value of the consideration received or the
fair value of the equity instrument issued, whichever is more reliably
measurable. Equity instruments issued to employees and the cost of the services
received as consideration are measured and recognized based on the fair value of
the equity instruments issued.
Basic and Diluted Net Income
(Loss) Per Share
The
Company computes net income (loss) per share in accordance with ASC 260, "Earnings per Share". ASC 260
requires presentation of both basic and diluted earnings per share (EPS) on the
face of the income statement. Basic EPS is computed by dividing net income
(loss) available to common shareholders (numerator) by the weighted average
number of shares outstanding (denominator) during the period. Diluted EPS gives
effect to all dilutive potential common shares outstanding during the period
using the treasury stock method and convertible preferred stock using the
if-converted method. In computing Diluted EPS, the average stock price for the
period is used in determining the number of shares assumed to be purchased from
the exercise of stock options or warrants. Diluted EPS excludes all dilutive
potential shares if their effect is anti dilutive.
For the Years Ended
|
||||||||
December 31,
|
||||||||
2009
|
2008
|
|||||||
Loss
(numerator)
|
$
|
(730,743)
|
$
|
(1,695,766
|
)
|
|||
Shares
(denominator)
|
11,340,000
|
11,174,651
|
||||||
Per
share amount
|
$
|
(0.06)
|
$
|
(0.15
|
)
|
Comprehensive
Loss
ASC 220,
“Reporting Comprehensive
Income,” establishes standards for the reporting and display of
comprehensive loss and its components in the consolidated financial statements.
As at December 31, 2009 and 2008, the Company did not record any comprehensive
income or loss.
Income
Taxes
Potential
benefits of income tax losses are not recognized in the accounts until
realization is more likely than not. The Company has adopted ASC 740 “Accounting for Income Taxes”
as of its inception. Pursuant to ASC 740 the Company is required to compute tax
asset benefits for net operating losses carried forward. The potential benefits
of net operating losses have not been recognized in these consolidated financial
statements because the Company cannot be assured it is more likely than not it
will utilize the net operating losses carried forward in future
years.
Recent Accounting
Pronouncements
In
January 2010, the FASB issued Accounting Standards Update 2010-02, Consolidation
(Topic 810): Accounting and Reporting for Decreases in Ownership of a
Subsidiary. This amendment to Topic 810 clarifies, but does not change, the
scope of current US GAAP. It clarifies the decrease in ownership provisions of
Subtopic 810-10 and removes the potential conflict between guidance in that
Subtopic and asset derecognition and gain or loss recognition guidance that may
exist in other US GAAP. An entity will be required to follow the amended
guidance beginning in the period that it first adopts ASC 810 (now included in
Subtopic 810-10). For those entities that have already adopted ASC 810-, the
amendments are effective at the beginning of the first interim or annual
reporting period ending on or after December 15, 2009. The amendments should be
applied retrospectively to the first period that an entity adopted ASC 810. The
Company does not expect the provisions of ASU 2010-02 to have a material effect
on the financial position, results of operations or cash flows of the
Company.
F-39
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
Recent Accounting
Pronouncements
(continued)
In
January 2010, the FASB issued Accounting Standards Update 2010-01, Equity (Topic
505): Accounting for Distributions to Shareholders with Components of Stock and
Cash (A Consensus of the FASB Emerging Issues Task Force). This amendment to
Topic 505 clarifies the stock portion of a distribution to shareholders that
allows them to elect to receive cash or stock with a limit on the amount of cash
that will be distributed is not a stock dividend for purposes of applying Topics
505 and 260. Effective for interim and annual periods ending on or after
December 15, 2009, and would be applied on a retrospective basis. The Company
does not expect the provisions of ASU 2010-01 to have a material effect on the
financial position, results of operations or cash flows of the
Company.
In
December 2009, the FASB issued Accounting Standards Update 2009-17,
Consolidations (Topic 810): Improvements to Financial Reporting by Enterprises
Involved with Variable Interest Entities. This Accounting Standards Update
amends the FASB Accounting Standards Codification for Statement
167.
In
December 2009, the FASB issued Accounting Standards Update 2009-16, Transfers
and Servicing (Topic 860): Accounting for Transfers of Financial Assets. This
Accounting Standards Update amends the FASB Accounting Standards Codification
for Statement 166.
In
October 2009, the FASB issued Accounting Standards Update 2009-15, Accounting
for Own-Share Lending Arrangements in Contemplation of Convertible Debt Issuance
or Other Financing. This Accounting Standards Update amends the FASB Accounting
Standard Codification for ASC 470.
In
October 2009, the FASB issued Accounting Standards Update 2009-14, Software
(Topic 985): Certain Revenue Arrangements That Include Software Elements. This
update changed the accounting model for revenue arrangements that include both
tangible products and software elements. Effective prospectively for revenue
arrangements entered into or materially modified in fiscal years beginning on or
after June 15, 2010. Early adoption is permitted. The Company does not expect
the provisions of ASU 2009-14 to have a material effect on the financial
position, results of operations or cash flows of the Company.
In
October 2009, the FASB issued Accounting Standards Update 2009-13, Revenue
Recognition (Topic 605): Multiple-Deliverable Revenue Arrangements. This update
addressed the accounting for multiple-deliverable arrangements to enable vendors
to account for products or services (deliverables) separately rather than a
combined unit and will be separated in more circumstances that under existing US
GAAP. This amendment has eliminated that residual method of allocation.
Effective prospectively for revenue arrangements entered into or materially
modified in fiscal years beginning on or after June 15, 2010. Early adoption is
permitted. The Company does not expect the provisions of ASU 2009-13 to have a
material effect on the financial position, results of operations or cash flows
of the Company.
In
September 2009, the FASB issued Accounting Standards Update 2009-12, Fair Value
Measurements and Disclosures (Topic 820): Investments in Certain Entities That
Calculate Net Asset Value per Share (or Its Equivalent). This update provides
amendments to Topic 820 for the fair value measurement of investments in certain
entities that calculate net asset value per share (or its equivalent). It is
effective for interim and annual periods ending after December 15, 2009. Early
application is permitted in financial statements for earlier interim and annual
periods that have not been issued. The Company does not expect the provisions of
ASU 2009-12 to have a material effect on the financial position, results of
operations or cash flows of the Company.
F-40
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
Recent Accounting
Pronouncements
In July
2009, the FASB ratified the consensus reached by EITF (Emerging Issues Task
Force) issued ASC Topic 470 "Accounting for Own-Share Lending Arrangements in
Contemplation of Convertible Debt Issuance". The provisions of ASC 470,
clarifies the accounting treatment and disclosure of share-lending arrangements
that are classified as equity in the financial statements of the share lender.
An example of a share-lending arrangement is an agreement between the Company
(share lender) and an investment bank (share borrower) which allows the
investment bank to use the loaned shares to enter into equity derivative
contracts with investors. ASC 470 is effective for fiscal years that beginning
on or after December 15, 2009 and requires retrospective application for all
arrangements outstanding as of the beginning of fiscal years beginning on or
after December 15, 2009. Share-lending arrangements that have been terminated as
a result of counterparty default prior to December 15, 2009, but for which the
entity has not reached a final settlement as of December 15, 2009 are within the
scope. Effective for share-lending arrangements entered into on or after the
beginning of the first reporting period that begins on or after June 15, 2009.
The Company does not expect the provisions of ASC 470 to have a material effect
on the financial position, results of operations or cash flows of the
Company.
NOTE
3 – EQUIPMENT
Property
and equipment are recorded at cost. Depreciation is calculated on the
straight-line method over the estimated useful life of the assets of 5 years.
Depreciation expense was $800 and $800 for the years ended December 31, 2009 and
2008, respectively.
Net Book Value
|
||||||||||||||||
Cost
|
Accumulated
Depreciation
|
December 31,
2009
|
December 31,
2008
|
|||||||||||||
Equipment
|
$
|
4,000
|
$
|
(1,600
|
)
|
$
|
2,400
|
$
|
3,200
|
|||||||
Totals
|
$
|
4,000
|
$
|
(1,600
|
)
|
$
|
2,400
|
$
|
3,200
|
NOTE
4 – ACCRUED LIABILITIES
Pursuant
to the applicable Codification literature, the Company has concluded it is
probable that it will pay $85,738 in liquidated damages pursuant to the
registration rights clause in certain of the securities sold in fiscal years
2008 and 2009. The Company was required to file a registration statement by
January 27, 2009. The Company failed to do so until April 7, 2009, resulting in
liquidated damages of 2% per month of the gross proceeds, which approximated
$1.8 million as of that date. During the year ended December 31, 2009, the
Company’s registration statement covering the securities was declared effective
by the SEC. Each holder is entitled to $47.32 per share owned. The Company has
resolved to pay the liquidated damages in shares of Common Stock valued at $1.00
per share, pursuant to the terms and provisions of the Certificate of
Designation, Preferences and Rights of Series A Convertible Preferred
Stock.
NOTE
5 – BRIDGE FINANCING NOTES PAYABLE
Beginning
in August 2007 the Company began a series of private financing transactions
(collectively known as “Bridge Financing”) with certain accredited investors of
units, each unit consisting of $1 in principal amount of 10% promissory notes
(“Bridge Stock”) and shares of Common Stock (“Bridge Stock”). The Company had
raised in fiscal year 2007 a total of $257,000 in Bridge Financing. In 2008, the
Company raised an additional $562,000 through the bridge financing arrangements.
As detailed in Note 4 below, during the year ended December 31, 2008, the Bridge
Notes with all accrued interest were converted to 890 shares of the Company’s
preferred stock.
F-41
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
6 – DERIVATIVE LIABILITY AND FAIR VALUE MEASUREMENTS
The
Company’s only asset or liability measured at fair value on a recurring basis is
its derivative liability associated with its preferred stock and associated
warrants to purchase common stock. On January 1, 2009, the Company adopted new
guidance which determines whether an instrument is indexed to an entity’s own
stock. As a result, the Company’s preferred stock and some of the Company’s
outstanding warrants that were previously classified in equity were reclassified
to liabilities as these warrants contain exercise price reset features and are
no longer deemed to be indexed to the Company’s stock. Therefore, on January 1,
2009, 3,572,714 outstanding warrants of the Company containing exercise price
reset provisions, classified in equity, were reclassified to derivative
liability. These warrants had exercise prices ranging from $0.85 - $1.27 and
expire starting in December 2013. As of January 1, 2009, the fair value of these
derivative liabilities of $1,676,633 was recognized and resulted in a cumulative
effect adjustment to retained earnings of $43,808. The change in fair value
during the year ended December 31, 2009 of $(159,418) is recorded as a
derivative loss in the accompanying Statements of Operations.
The
Company classifies the fair value of these warrants under level three. The fair
value of the derivative liability was calculated using a lattice model that
values the compound embedded derivatives based on a probability weighted
discounted cash flow model. This model is based on future projections of the
various potential outcomes. The embedded derivatives that were analyzed and
incorporated into the model included the conversion feature with the full
ratchet reset, and the redemption options.
The
Series A Preferred Derivatives were valued using the following
assumptions:
|
·
|
The Company was 12 months from
being publicly traded and the Company/Holder would convert the Preferred
Stock based on 200% of the adjusted conversion
price;
|
|
·
|
The Preferred maturity date used
was 5 years following the Company being publicly traded (rolling 6 years
from the Valuation Date);
|
|
·
|
The stock price of $0.85 was used
as the fair value of the common stock based on the previous common stock
transaction;
|
|
·
|
The projected volatility curve
was based on the average of 17 comparable biotech companies historical
volatility:
|
|
·
|
The Holder would automatically
convert at a stock price of $1.70 if the Company was not in
default;
|
|
·
|
The Holder would convert on a
quarterly basis in equal amounts to maturity if in the money;
and
|
|
·
|
Capital raising events would
occur annually, generating reset events based on pricing not greater than
100% of market.
|
The
warrants were valued at issuance and marked to market quarterly for the year
ended December 31, 2009. The five-year warrants are options to purchase shares
of common stock at an exercise price of $0.85 per share and $1.27, subject to
adjustments. The following assumptions were used for the valuation of the
derivative:
|
·
|
The stock price of $0.85 was used
as the fair value of the common stock based on the previous common stock
transaction;
|
|
·
|
The projected volatility curve
was based on the average of comparable companies as provided in the
Preferred assumptions above;
|
|
·
|
The Holder would exercise the
warrant at maturity if the stock price was above the exercise
price;
|
|
·
|
The Holder would exercise the
warrant at target prices starting at $1.58 for the Investor Warrants and
$1.40 for the Placement Agent Warrants, and lowering such target as the
warrants approached
maturity.
|
|
·
|
The Holder would automatically
convert all of the shares at a stock price of $1.58 for the Investor
Warrants and $1.40 for the Placement Agent
Warrants;
|
|
·
|
The Holder would convert on a
quarterly basis in amounts not to exceed the average quarters trading
volume based on historical performance, assuming the volume would increase
by 5% each quarter; and
|
|
·
|
Capital raising events would
occur annually, generating reset events based on pricing not greater than
100% of market for the Placement Agent Warrants and for the Investor
Warrants the reset would be 150% of the
Preferred.
|
F-42
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
6 – DERIVATIVE LIABILITY AND FAIR VALUE MEASUREMENTS (CONTINUED)
The
Company determined the fair value of the preferred stock to be $1,642,409 and
$-0- and the fair value of the warrants to be $1,182,194 and $-0- at December
31, 2009 and 2008, respectively.
The
following shows the changes in the level three liability measured on a recurring
basis for the year ended December 31, 2009:
Balance,
December 31, 2008
|
$
|
-
|
||
Derivative
loss
|
159,418
|
|||
Balance,
December 31, 2009
|
$
|
2,824,603
|
NOTE
7 – EQUITY
|
a)
|
On
March 5, 2009, the Company issued 295 shares of its par value $0.10
convertible preferred stock at $1,000 per
share.
|
|
b)
|
On
April 1, 2009, the Company issued 15 shares of its par value $0.10
convertible preferred stock at $1,000 per
share.
|
|
c)
|
On
June 17, 2009, the Company issued 200 shares of its par value $0.10
convertible preferred stock at $1,000 per
share.
|
|
d)
|
On
July 23, 2009, the Company issued 50 shares of its par value $0.10
convertible preferred stock at $1,000 per
share.
|
|
e)
|
On
August 20, 2009, the Company issued 50 shares of its par value $0.10
convertible preferred stock at $1,000 per
share.
|
|
f)
|
On
September 9, 2009, the Company issued 200 shares of its par value $0.10
convertible preferred stock at $1,000 per
share.
|
|
g)
|
On
January 24, 2008, the Company issued 632,500 common shares of the Company
at $0.85 per common share in accordance with the Bridge Note
agreements.
|
|
h)
|
On
February 26, 2008, the Company issued 25,000 common shares of the Company
at $0.85 per common share in accordance with the Bridge Note
agreements.
|
|
i)
|
On
February 27, 2008, the Company issued 175,000 common shares of the Company
at $0.85 per common share in accordance with the Bridge Note
agreements.
|
|
j)
|
On
March 4, 2008 the Company issued 25,000 common shares of the Company at
$0.85 per common share in accordance with the Bridge Note
agreements.
|
|
k)
|
On
March 11, 2008 the Company issued 50,000 common shares of the Company at
$0.85 per common share in accordance with the Bridge Note
agreements.
|
|
l)
|
On
March 17, 2008 the Company issued 50,000 common shares of the Company at
$0.85 per common share in accordance with the Bridge Note
agreements.
|
m)
|
On
April 11, 2008 the Company issued 50,000 common shares of the Company at
$0.85 per common share in accordance with the Bridge Note
agreements.
|
|
n)
|
On
April 14, 2008 the Company issued 25,000 common shares of the Company at
$0.85 per common share in accordance with the Bridge Note
agreements.
|
|
o)
|
On
April 15, 2008 the Company issued 75,000 common shares of the Company at
$0.85 per common share in accordance with the Bridge Note
agreements.
|
|
p)
|
On
November 25, 2008, the Company issued 890 shares of its par value $0.10
convertible preferred stock to extinguish bridge debt financing totaling
$889,875.
|
|
q)
|
On
November 25, 2008, the Company issued 562 shares of its par value $0.10
convertible preferred stock for cash at $1,000 per
share.
|
F-43
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
8 – SERIES A CONVERTIBLE PREFERRED STOCK
The
Series A Convertible Preferred Stock (“Preferred Stock”) has been authorized by
resolutions adopted by the Company’s Board of Directors and set forth in a
Certificate of Designation, Preferences and Rights (“Certificate of
Designation”), filed with the Secretary of State of Delaware on November 26,
2008, which contains the designations, rights, powers, preferences,
qualifications and limitations of the Preferred Stock. The shares of Preferred
Stock are fully paid and non-assessable.
As of
December 31, 2009 the Company has issued 2,262 share of Series A Convertible
Preferred stock as detailed in Note 4 above. Below is a discussion of the terms
of these securities.
Rank
The
Preferred Stock ranks(i) senior to the common stock and any other class or
series of the Company’s capital stock either specifically ranking by its terms
junior to the Preferred Stock or not specifically ranking by its terms senior to
or on parity with the Preferred Stock, (ii) on parity with any class or series
of the Company’s capital stock specifically ranking by its terms on parity with
the Preferred Stock, and (iii) junior to any class or series of capital stock
specifically ranking by its terms senior to the Preferred Stock, in each case,
as to payment of dividends or as to distributions of assets upon liquidation,
dissolution or winding-up of the Company, whether voluntary or involuntary. The
approval of the holders of a majority of the Preferred Stock is required in
order for the Company to issue any capital stock with rights on parity with or
senior to the Preferred Stock.
Dividends
The
holders of the Preferred Stock are entitled to receive annual cumulative per
share dividends of 6.5% of the liquidation preference of the Preferred Stock,
out of funds legally available, prior to any payment of dividends on the
Company’s common stock or any other class of stock ranking junior to the
Preferred Stock. Such dividends are payable in cash or shares of common stock,
at the option of the Company, semiannually on the last business day of February
and August of each year (each a “Dividend Payment Date”), commencing in February
2009 with respect to the period from issuance through such date. The holders of
the Preferred Stock are entitled to share ratably with the holders of the common
stock in any dividend declared on the common stock.
Dividends
on the Preferred Stock will accrue whether or not the Company has earnings,
whether or not there are funds legally available for the payment of such
dividends and whether or not such dividends are declared. Dividends accumulate
to the extent they are not paid on the Dividend Payment Date to which they
relate. Dividends that are due in cash and which are not paid within (5)
business days of the Dividend Payment date shall bear interest until paid at the
default rate. According to Delaware law, the Company may declare and pay
dividends or make other distributions on its capital stock only out of
legally-available funds. In addition, no dividends or distributions may be
declared, paid or made if the Company is or would be rendered insolvent by
virtue of such dividend or distribution.
The
Company may not (i) pay any dividends in respect of any shares of capital stock
ranking junior to the Preferred Stock (including the common stock), other than
dividends payable in the form of additional shares of the same junior stock as
that on which such dividend is declared, or (ii) redeem any shares of capital
stock ranking junior to the Preferred Stock (including the common stock), unless
and until all accumulated and unpaid dividends on the Preferred Stock have been,
or contemporaneously are, declared and paid in full.
Conversion
At the
election of the holder thereof, each share of Preferred Stock will be
convertible into common stock, at any time after issuance, at the Conversion
Rate, as it may be adjusted from time to time in accordance with the Certificate
of Designation. The Preferred Stock will not convert automatically into Common
Stock upon completion of this offering and only the underlying Common Stock
issuable upon conversion is registered for the resale under this
prospectus.
F-44
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
8 – SERIES A CONVERTIBLE PREFERRED STOCK (CONTINUED)
The
Conversion Rate initially will be 1,177 shares of common stock ($.85 per share)
for each Share of Preferred Stock. If the Company issues or sells any shares of
its common stock (or options, warrants or convertible securities, convertible or
exchangeable into shares of common stock) hereinafter, a “Subsequent common
stock Issuance”), then the Conversion Rate will be adjusted so that the number
of shares of common stock issuable upon conversion of each share of preferred
stock shall be equal to the quotient obtained by dividing $1,000 by the price
per share of common stock (or the conversion price per share in the case of a
sale of options, warrants or convertible securities) sold in such Subsequent
common stock Issuance.
The
Conversion Price is also subject to adjustment from time to time in the event of
(i) the issuance of common stock as a dividend or distribution on any class of
the Company’s capital stock; or (ii) the combination, subdivision or
reclassification of the common stock. No fractional shares will be issued upon
conversion. Payment of accumulated and unpaid dividends will be made upon
conversion to the extent of legally-available funds.
The
shares of Preferred Stock may also be converted into common stock at the
Conversion Rate at the Company’s option following the effectiveness of a
Registration Statement, if the Company’s common stock trades above 200% of the
Conversion Rate per share for a period of 20 consecutive trading
days.
Voting
Rights
The
affirmative vote of the holders of at least two-thirds of the outstanding shares
of Preferred Stock, voting as a class, shall be required to authorize, effect or
validate (i) any change in the rights, privileges or preferences of the
Preferred Stock that would adversely affect the Preferred Stock, or (ii) the
authorization, creation, issuance or increase in the authorized or issued amount
of any class or series of stock ranking on parity with or superior to the
Preferred Stock with respect to the declaration and payment of dividends or
distribution of assets upon liquidation, dissolution or winding-up of our
Company. In addition, the holders of Preferred Stock shall have the right to
vote, together with holders of common stock as single class, on all matters upon
which the holders of common stock are entitled to vote pursuant to applicable
Delaware law or the Company’s Certificate of Incorporation. The Preferred Stock
shall vote on an “as converted basis” with each holder of Preferred Stock having
one vote for each Conversion Share underlying such holder’s shares of Preferred
Stock.
Liquidation
In the
event of any voluntary or involuntary liquidation, dissolution or winding-up of
the Company, before any payment or distribution of the assets of the Company
(whether capital or surplus), or the proceeds thereof, may be made or set apart
for the holders common stock or any stock ranking junior to Preferred Stock, the
holders of Preferred Stock will be entitled to receive, out of the assets of the
Company available for distribution to stockholders, a liquidating distribution
of $1,000 per share, plus any accrued and unpaid dividends, subject to
adjustment upon the occurrence of certain events. If, upon any voluntary or
involuntary liquidation, dissolution or winding up of the Company, the assets of
the Company are insufficient to make the full payment of $1,000 per share, plus
all accrued and unpaid dividends on the Preferred Stock and similar payments on
any other class of stock ranking on a parity with the Preferred Stock upon
liquidation, then the holders of Preferred Stock and such other shares will
share ratably in any such distribution of the Company’s assets in proportion to
the full respective distributable amounts to which they are entitled. Certain
events, including a consolidation or merger of the Company with or into another
corporation or sale or conveyance of all or substantially all the property and
assets of the Company will be deemed to be a liquidation, dissolution or
winding-up of the Company for purposes of the foregoing.
F-45
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
9 – STOCK OPTIONS AND WARRANTS
The
Company’s 2009 Employee Stock Incentive Plan (the “2009 Option Plan”) was
adapted by the Company’s Board of Directors on February 9, 2009. The 2009 Plan,
which is administered by our Board of Directors, authorizes the issuance of a
maximum of 500,000 shares of our common stock, which may be authorized and
unissued shares or treasury shares. Employee options shall be deemed Incentive
Stock Options (as defined in the 2009 Option Plan) to the maximum extent
permitted by Section 422 of the Internal Revenue Code including a five-year
limit on exercise for 10% or greater stockholders with any excess grant to the
above individuals over the limits set by Section 422 being Non-Qualified Stock
Options as defined in the 2009 Option Plan. Both the Incentive Stock Options or
any Non-Qualified Stock Options must be granted at an exercise price of not less
than the fair market value of shares of common stock at the time the option is
granted and Incentive Stock Options granted to 10% or greater stockholders must
be granted at an exercise price of not less than 110% of the fair market value
of the shares on the date of grant. If any award under the 2009 Plan terminates,
expires unexercised, or is cancelled, the shares of common stock that would
otherwise have been issuable pursuant thereto will be available for issuance
pursuant to the grant of new awards. The 2009 Plan will terminate on February 9,
2019. As of December 31, 2009 no options had been granted under the
plan.
A summary
of the status of the Company's warrants as of December 31, 2009 and 2008 are
presented below:
Date of
|
Warrant
|
Exercise
|
Value if
|
Expiration
|
||||||
Issuance
|
Shares
|
Price
|
Exercised
|
Date
|
||||||
11/25/2008
|
1,259,639
|
1.27
|
1,599,742
|
11/25/2013
|
||||||
11/25/2008
|
530,314
|
0.85
|
450,767
|
11/25/2013
|
||||||
11/26/2008
|
449,220
|
1.27
|
570,509
|
11/25/2013
|
||||||
Outstanding
at
12/31/2008
|
2,239,173
|
2,621,018
|
||||||||
3/5/2009
|
347,215
|
1.27
|
440,963
|
3/5/2014
|
||||||
3/5/2009
|
104,165
|
0.85
|
88,540
|
3/5/2014
|
||||||
4/1/2009
|
17,655
|
1.27
|
22,422
|
4/1/2014
|
||||||
4/1/2009
|
5,296
|
0.85
|
4,502
|
4/1/2014
|
||||||
6/17/2009
|
235,400
|
1.27
|
298,958
|
*
|
||||||
6/17/2009
|
70,620
|
0.85
|
60,027
|
*
|
||||||
7/23/2009
|
58,850
|
1.27
|
74,740
|
*
|
||||||
7/23/2009
|
35,310
|
0.85
|
30,014
|
*
|
||||||
8/20/2009
|
58,850
|
1.27
|
74,740
|
*
|
||||||
9/9/2009
|
235,400
|
1.27
|
298,958
|
*
|
||||||
9/9/2009
|
70,620
|
0.85
|
60,027
|
*
|
||||||
Outstanding
at
12/31/2009
|
3,478,554
|
4,074,909
|
* Fifth
anniversary date of the next registration statement to be filed.
The
warrants were issued in connection with the Preferred Stock Offering and were
valued using the Black-Scholes model using the following assumptions: stock
price at valuation, $0.85; strike price, $1.27 or $0.85; risk free rate 0.90% to
2.16%, depending on date of issuance; 5 year term; and volatility of 104% to
115%, depending on date of issuance.
F-46
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
10 – INCOME TAXES
The
Company has adopted the provisions of ASC 740, “Accounting for Income
Taxes”. Pursuant to ASC 740, the Company is required to compute tax asset
benefits for net operating losses carried forward. The potential benefit of net
operating losses have not been recognized in the consolidated financial
statements because the Company cannot be assured that it is more likely than not
that it will utilize the net operating losses carried forward in future years.
The components of the net deferred tax asset at December 31, 2009 and 2008, the
statutory tax rate, the adjustments to reconcile to income tax expense and the
amount of the valuation allowance are indicated below:
December 31,
2009
|
December 31,
2008
|
|||||||
Loss
before taxes
|
$
|
(730,743
|
)
|
$
|
(1,695,766
|
)
|
||
Statutory
rate
|
39
|
)%
|
39
|
)%
|
||||
Computed
expected tax benefit
|
(284,990
|
)
|
(661,349
|
)
|
||||
Common
stock issued for services
|
-0-
|
-0-
|
||||||
Change
in valuation allowance
|
284,990
|
661,349
|
||||||
Reported
income taxes
|
$
|
-
|
$
|
-
|
December 31,
2009
|
December 31,
2008
|
|||||||
Deferred
tax asset
|
||||||||
-
Cumulative net operating losses
|
$
|
1,290,580
|
$
|
781,430
|
)
|
|||
-
Less valuation allowance
|
(1,290,580
|
)
|
(781,430
|
)
|
||||
Reported
income taxes
|
$
|
-
|
$
|
-
|
The
Company has incurred operating losses of $2,997,150 which, if unutilized, will
expire through to 2030. Future tax benefits, which may arise as a result of
these losses, have not been recognized in these consolidated financial
statements, and have been offset by a valuation allowance.
The
Company did not have any tax positions for which it is reasonably possible that
the total amount of unrecognized tax benefits will significantly increase or
decrease within the next 12 months.
The
Company includes interest and penalties arising from the underpayment of income
taxes in the consolidated statements of operations in the provision for income
taxes. As of December 31, 2009 and 2008, the Company had no accrued interest or
penalties related to uncertain tax positions.
The tax
years that remain subject to examination by major taxing jurisdictions are for
the years ended December 31, 2009, 2008 and 2007.
NOTE
11 – RESTATEMENT OF FINANCIAL STATEMENTS
On August
27, 2009 the Company was informed that the Public Company Accounting Oversight
Board ("PCAOB") revoked the registration of Moore & Associates who was
serving as the Company’s independent registered public accounting firm. The
revocation was a result of Moore’s violation of PCAOB rules and auditing
standards. This revocation of Moore’s registration required the Company to have
the financial statements previously issued reaudited for the fiscal year ended
December 31, 2008.
F-47
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
11 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
This
reaudit produced material differences from the previously filed versions. These
misstatements are the result of the following errors:
The
Company inappropriately recorded a warrant expense for the fair value of the
warrants issued in conjunction with the sale of its convertible preferred stock.
This resulted in an overstatement of Additional Paid-in Capital and General
& Administrative Expense of $799,184 (item A). Additionally, the Company
recorded the issuance of 57,500 shares in both the period ended December 31,
2007 and 2008. This resulted in an overstatement of Common Stock of $58,
Additional Paid-in Capital of $38,467 and Stock Offering Costs of $38,524 (item
B). The $38,524 overstatement of stock offering costs offsets the overstatement
of Additional Paid-in Capital thus only the $799,184 change due to item A is
reflected in the net change column below.
The
Company also discovered that there were various timing differences in accruing
accounts payable and the associated operating expense at period ends. The
aggregate of these difference are found in Items C. The Company also misstated
the number of preferred and common stock issued and outstanding which required
adjustments to be made to common stock, preferred stock and additional paid-in
capital (Items D). The difference between the net change in the statement of
operations and the net change in retained earnings on the balance sheet is due
to $90,768 of changes that affected the statement of operations for the year
ended December 31, 2007. This effect is also being realized as part of the
restatement of the 2008 financial statements.
On or
about August 2, 2010, the Company determined that it had improperly classified
its preferred stock and related warrants as permanent equity when, due to
certain provisions of the preferred stock and warrants, these instruments should
have been classified as derivative liabilities under ASC 815. The error resulted
in an overstatement of the Company’s additional paid-in capital account, an
understatement of its current liabilities, and an overstatement of the Company’s
net income. Under ASC 815, derivative instruments are to be revalued at each
reporting period with any change in the fair value of the instruments being
recorded in the Company’s income statement. The cumulative effect of the error
through June 30, 2010 is a $340,786 reduction to the Company’s net income, a
$3,027,055 increase in current liabilities, and a $2,686,269 decrease in
additional paid-in capital. Below are tables detailing the effect of the error
on the Company’s previously filed financial statements for the year end December
31, 2009 and for all reporting periods from March 31, 2009 through March 31,
2010.
Included
in this filing are the restated 2009 and 2008 fiscal year financial statements.
For comparative purposes, the table below presents the reaudited balance sheets
and income statements compared to the original filing.
F-48
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
11 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
Balance
Sheets
December 31,
|
December 31,
|
|||||||||||
2008
|
Net Change
|
2008
|
||||||||||
(Original)
|
(Restated)
|
|||||||||||
ASSETS
|
||||||||||||
CURRENT
ASSETS
|
181,128
|
-
|
181,128
|
|||||||||
EQUIPMENT,
net
|
3,200
|
-
|
3,200
|
|||||||||
TOTAL
ASSETS
|
$
|
184,328
|
-
|
$
|
184,328
|
|||||||
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
||||||||||||
CURRENT
LIABILITIES
|
||||||||||||
Accounts
payable and accrued expenses
|
$
|
-
|
76,999
|
(C)
|
$
|
76,999
|
||||||
Total
Current Liabilities
|
-
|
76,999
|
76,999
|
|||||||||
STOCKHOLDERS'
EQUITY
|
||||||||||||
Preferred
stock; $0.10 par value, 5,000,000 shares authorized 2,312
and 1,502 shares issued and outstanding,
respectively
|
150
|
(5
|
)
(D)
|
145
|
||||||||
Common
stock; $0.001 par value, 45,000,000 shares authorized; 11,307,500 and
11,307,500 shares issued and outstanding, respectively
|
11,365
|
(58
|
)
(B)
|
11,341
|
||||||||
34
|
(D)
|
|||||||||||
Additional
paid-in capital
|
2,898,931
|
(799,126
|
)
(A)
|
2,318,442
|
||||||||
218,637
|
(D)
|
|||||||||||
Deficit
accumulated during the development stage
|
(2,726,118
|
)
|
58
|
(B)
|
(2,222,599
|
)
|
||||||
799,126
|
(A)
|
|||||||||||
(295,665
|
)
|
|||||||||||
Total
Stockholders' Equity
|
184,328
|
(76,999
|
)
|
107,329
|
||||||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
184,328
|
-
|
$
|
184,328
|
F-49
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
11 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
Statements
of Operations
For the Year ended
|
||||||||||||
December 31,
|
||||||||||||
2008
|
Net Change
|
2008
|
||||||||||
(Original)
|
(Restated)
|
|||||||||||
REVENUES
|
$
|
-
|
-
|
$
|
-
|
|||||||
OPERATING
EXPENSES
|
||||||||||||
General
and administrative
|
902,858
|
(799,126
|
) (A)
|
101,406
|
||||||||
(2,326
|
) (C)
|
|||||||||||
Consulting
expense
|
79,481
|
-
|
79,481
|
|||||||||
Financing
expense
|
720,763
|
171,186
|
(D)
|
891,949
|
||||||||
Legal
and professional expenses
|
137,444
|
6,083
|
(C)
|
143,527
|
||||||||
Licensing
expense
|
102,347
|
-
|
102,347
|
|||||||||
Advertising
expense
|
49,175
|
-
|
49,175
|
|||||||||
Research
and development, net
|
233,990
|
29,896
|
(C)
|
263,886
|
||||||||
Total
Operating Expenses
|
2,226,058
|
(594,287
|
)
|
1,631,771
|
||||||||
OPERATING
LOSS
|
(2,226,058
|
)
|
594,287
|
(1,631,771
|
)
|
|||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Interest
expense
|
(63,995
|
)
|
-
|
(63,995
|
)
|
|||||||
Total
Other Income (Expense)
|
(63,995
|
)
|
-
|
(63,995
|
)
|
|||||||
NET
LOSS BEFORE INCOME TAXES
|
(2,290,053
|
)
|
594,287
|
(1,695,766
|
)
|
|||||||
PROVISION
FOR INCOME TAXES
|
-
|
-
|
-
|
|||||||||
NET
LOSS
|
$
|
(2,290,053
|
)
|
594,287
|
$
|
(1,695,766
|
)
|
|||||
BASIC
LOSS PER SHARE
|
$
|
(0.20
|
)
|
0.05
|
$
|
(0.15
|
)
|
|||||
WEIGHTED
AVERAGE NUMBER NUMBER OF SHARES OUTSTANDING
|
11,365,000
|
(190,349
|
)
|
11,174,651
|
F-50
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
11 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31,
2009
Balance
Sheet
December 31, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
ASSETS
|
||||||||||||
Cash
|
$
|
295,418
|
$
|
-
|
$
|
295,418
|
||||||
Equipment,
net
|
2,400
|
-
|
2,400
|
|||||||||
|
|
|
||||||||||
TOTAL
ASSETS
|
$
|
297,818
|
$
|
-
|
$
|
297,818
|
||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||||||||||
Accounts
payable and accrued expenses
|
$
|
117,967
|
$
|
-
|
$
|
117,967
|
||||||
Derivative
liability - preferred stock
|
1,642,409
|
(1,642,409
|
)
|
-
|
||||||||
Derivative
liability - warrants
|
1,182,194
|
(1,182,194
|
)
|
-
|
||||||||
|
|
|
||||||||||
TOTAL
LIABILITIES
|
2,942,570
|
(2,824,603
|
)
|
117,967
|
||||||||
STOCKHOLDERS'
EQUITY (DEFICIT)
|
||||||||||||
Preferred
stock
|
226
|
-
|
226
|
|||||||||
Common
stock
|
11,341
|
-
|
11,341
|
|||||||||
Additional
paid-in capital
|
340,831
|
2,621,376
|
2,962,207
|
|||||||||
Deficit
accumulated during the development stage
|
(2,997,150
|
)
|
203,227
|
(2,793,923
|
)
|
|||||||
|
|
|
||||||||||
TOTAL
STOCKHOLDERS’ EQUITY(DEFICIT)
|
(2,644,752
|
)
|
2,824,603
|
179,851
|
||||||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
$
|
297,818
|
$
|
-
|
$
|
297,818
|
F-51
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
11 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31,
2009
Statement
of Operations
For the Year ended
|
||||||||||||
December 31, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
REVENUES
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
OPERATING
EXPENSES
|
612,098
|
-
|
612,097
|
|||||||||
OPERATING
LOSS
|
(612,098
|
)
|
-
|
(612,097
|
)
|
|||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Loss
on derivative liability
|
(159,418
|
)
|
(159,418
|
)
|
-
|
|||||||
Grant
income
|
40,773
|
-
|
40,773
|
|||||||||
Interest
expense
|
-
|
-
|
-
|
|||||||||
Total
Other Income (Expense)
|
(118,645
|
)
|
(159,418
|
)
|
40,773
|
|||||||
NET
LOSS BEFORE INCOME TAXES
|
(730,742
|
)
|
(159,418
|
)
|
(571,324
|
)
|
||||||
PROVISION
FOR INCOME TAXES
|
-
|
-
|
-
|
|||||||||
NET
LOSS
|
$
|
(730,742
|
)
|
$
|
(159,418
|
)
|
$
|
(571,324
|
)
|
|||
BASIC
LOSS PER SHARE
|
$
|
(0.06
|
)
|
$
|
(0.01
|
)
|
$
|
(0.05
|
)
|
|||
WEIGHTED
AVERAGE NUMBER NUMBER OF SHARES OUTSTANDING
|
11,340,000
|
-
|
11,340,000
|
From Inception on May 15, 2006 through
|
||||||||||||
December 31, 2009
|
||||||||||||
Restated
|
Adjustments
|
As Filed
|
||||||||||
REVENUES
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
OPERATING
EXPENSES
|
2,770,701
|
|
(1)
|
2,770,701
|
||||||||
OPERATING
LOSS
|
(2,770,644
|
)
|
-
|
(2,770,644
|
)
|
|||||||
OTHER
INCOME (EXPENSE)
|
||||||||||||
Loss
on derivative liability
|
(203,226
|
)
|
(203,226
|
)
|
-
|
|||||||
Grant
income
|
40,773
|
-
|
40,773
|
|||||||||
Interest
expense
|
(63,995
|
)
|
-
|
(63,995
|
)
|
|||||||
Total
Other Income (Expense)
|
(226,448
|
)
|
(203,226
|
)
|
(23,222
|
)
|
||||||
NET
LOSS BEFORE INCOME TAXES
|
(2,997,150
|
)
|
(203,227
|
)
|
(2,793,923
|
)
|
||||||
PROVISION
FOR INCOME TAXES
|
-
|
-
|
-
|
|||||||||
NET
LOSS
|
$
|
(2,997,150
|
)
|
$
|
(203,227
|
)
|
$
|
(2,793,923
|
)
|
F-52
SIGNPATH
PHARMA, INC.
(A
Development Stage Company)
Notes to
the Financial Statements
June 30,
2010 and December 31, 2009
(Unaudited)
NOTE
11 – RESTATEMENT OF FINANCIAL STATEMENTS (CONTINUED)
DECEMBER 31,
2009
Statement
of Cash Flows
For the Year Ended
|
||||||||||||
December 31, 2009
|
||||||||||||
Restated
|
Adjustment
|
As Filed
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$
|
(730,742
|
)
|
$
|
(159,418
|
)
|
$
|
(571,324
|
)
|
|||
Adjustments
to reconcile net loss to net cash used by operating
activities:
|
||||||||||||
Common
stock issued with bridge financing
|
-
|
-
|
-
|
|||||||||
Depreciation
expense
|
800
|
-
|
800
|
|||||||||
Change
in derivative liability
|
159,418
|
159,418
|
-
|
|||||||||
Changes
in operating assets and liabilities
|
||||||||||||
Accounts
payable and accrued expenses
|
40,968
|
-
|
40,968
|
|||||||||
Net
Cash Used in Operating Activities
|
(529,556
|
)
|
-
|
(529,556
|
)
|
|||||||
INVESTING
ACTIVITIES
|
||||||||||||
Purchase
of equipment
|
-
|
-
|
-
|
|||||||||
Net
Cash Used in Investing Activities
|
-
|
-
|
-
|
|||||||||
FINANCING
ACTIVITIES
|
||||||||||||
Proceeds
from notes payable
|
-
|
-
|
-
|
|||||||||
Stock
offering costs paid
|
(166,154
|
)
|
-
|
(166,154
|
)
|
|||||||
Preferred
stock issued for cash
|
810,000
|
-
|
810,000
|
|||||||||
Common
stock issued for cash
|
-
|
-
|
-
|
|||||||||
Net
Cash Provided by Financing Activities
|
643,846
|
-
|
643,846
|
|||||||||
NET
INCREASE (DECREASE) IN CASH
|
114,290
|
-
|
114,290
|
|||||||||
CASH
AT BEGINNING OF PERIOD
|
181,128
|
-
|
181,128
|
|||||||||
CASH
AT END OF PERIOD
|
$
|
295,418
|
$
|
-
|
$
|
295,418
|
NOTE
12 – SUBSEQUENT EVENTS
In
accordance with ASC 855 Company management reviewed all material events through
the date of this report and there are no subsequent events to
report.
F-53
OUTSIDE
BACK COVER OF PROSPECTUS
We have
not authorized any dealer, salesperson or any other person to give any
information or to represent anything other than those contained in this
prospectus in connection with the offer contained herein, and, if given or made,
you should not rely upon such information or representations as having been
authorized by SignPath Pharma, Inc. This prospectus does not constitute an offer
of any securities other than those to which it relates or an offer to sell, or a
solicitation of an offer to buy, to those to which it relates in any state to
any person to whom it is not lawful to make such offer in such state. The
delivery of this prospectus at any time does not imply that the information
herein is correct as of any time after the date of this prospectus.
DEALER
PROSPECTUS DELIVERY REQUIREMENT
Until_________,
2011 [______ (90) days from the effective date of this prospectus], all dealers
that effect transactions in these securities, whether or not participating in
this offering, may be required to deliver a prospectus. This is in addition to
the dealers' obligation to deliver a prospectus when acting as underwriters and
with respect to their unsold allotments or subscriptions.
65
PART II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item 13.
Other
Expenses of Issuance and Distribution
SEC
Registration Fee
|
$
|
404.61
|
||
*Printing
and Photocopy Expenses
|
1,500.00
|
|||
*Legal
Fees and Expenses
|
16,000.00
|
|||
*State
Securities Qualification Fees and Expenses
|
3,000.00
|
|||
*Accounting
and Auditing Fees and Expenses
|
10,000.00
|
|||
*Miscellaneous,
including postage, courier, long distance telephone, etc.
|
95.39
|
|||
Total
|
$
|
31,000.00
|
*
Estimated
Item 14.
Indemnification of Directors
and Officers
The
following statutes, charter provisions and by-laws are the only statutes,
charter provisions, by-laws, contracts or other arrangements known to the
registrant which insure or indemnify a controlling person, director or officer
of the registrant in any manner against liability which he or she may incur in
his or her capacity as such.
The
Registrant’s Certificate of Incorporation provides:
SEVENTH:
The personal liability of the directors of the Corporation is hereby eliminated
to the fullest extent permitted by the provisions of paragraph (7) of subsection
(b) of § 102 of the General Corporation Law of the State of Delaware, as the
same may be amended and supplemented. Without limiting the generality of the
foregoing, a director of the Corporation shall not be liable to the Corporation
or its stockholders for monetary damages for breach of fiduciary duty as a
director, except to the extent such exemption from liability or limitation
thereof is not permitted under the General Corporation Law of the State of
Delaware as the same exists or may hereafter be amended. Any amendment,
modification or repeal of this Article SEVENTH shall not adversely affect any
right or protection of a director of the Corporation hereunder in respect of any
act or omission occurring prior to the time of such amendment, modification or
repeal.
EIGHTH:
The Corporation shall, to the fullest extent permitted by the provisions of §
145 of the General Corporation Law of the State of Delaware, as the same may be
amended and supplemented, indemnify any and all persons whom it shall have power
to indemnify under said section from and against any and all of the expenses,
liabilities, or other matters referred to in or covered by said section, and the
indemnification provided for herein shall not be deemed exclusive of any other
rights to which those indemnified may be entitled under any Bylaw, agreement,
vote of stockholders or disinterested directors or otherwise, both as to action
in such person's official capacity and as to action in another capacity while
holding such office, and shall continue as to a person who has ceased to be a
director, officer, employee, or agent and shall inure to the benefit of the
heirs, executors, and administrators of such person.
Item
15. Recent Sales of
Unregistered Securities
On May 12, 2008, the Registrant sold an
aggregate of 10,000,000 Founders Shares of Common Stock, $.001 par value, to the
following five (5) persons: Bruce Meyers, the Registrant’s founder (2,600,000
shares); Meyers Associates, L.P. (2,600,000 shares); Imtiaz Khan (2,500,000
shares); Dr. Arthur Bollon, a Director (800,000 shares) and Dr. Lawrence Helson,
Chief Executive Officer (1,500,000 shares). The shares were issued in
consideration of par value of $.001 per share and services rendered. There were
no underwriters in connection with the above transaction. The Registrant
believes that these securities were issued in transactions not involving any
public offering in reliance upon an exception from registration provided by
Section 4(2) of the Securities Act of 1933, as amended.
II-1
Between August 2007 and April 2008, the
Registrant completed five separate private financings (collectively, the “Bridge
Financing”) with certain accredited investors of units, each unit consisting of
$1 in principal amount of 10% promissory notes (referred to herein as the
“Bridge Notes”) and shares of Common Stock (the “Bridge Shares”). The Registrant
raised gross proceeds of approximately $847,500 in the Bridge Financing and the
holders of the Bridge Note also received an aggregate of 1,365,000 Bridge
Shares. The holders of $889,876 of Bridge Notes (including accrued and unpaid
interest) converted their Bridge Notes into Units in the Registrant’s November
28, 2008 financing described below. Mr. Meyers, the principal of the Placement
Agent and the Registrant’s founder was the holder of $57,500 in principal amount
of Bridge Notes which he exchanged for Units in the November 28, 2008 financing
and retained his 57,500 Bridge Shares.
On November 28, 2008, SignPath sold
1451.88 units (“Units”) of its securities at a price of $1,000 per Unit. Each
Unit consists of (i) one share of 6.5% Series A Convertible Preferred Stock
convertible into 1,177 shares of common stock (equivalent to $.85 per share of
common stock) following the effective date of this Registration Statement,
subject to adjustment, and (ii) one Warrant to purchase, 1,177 shares of common
stock at $1.27 per share for a five-year period following the effective date.
The Units were sold to 21 accredited investors, including Meyers Associates,
L.P., which purchased 117 Units as placement agent. Bruce Meyers, Founder of the
Registrant, President and CEO of the Placement Agent, purchased 264.67 units.
The Placement Agent received sales and commissions of 10% of the gross proceeds
of $1,451,875 from the sale of Units, as well as a non-accountable expense
allowance equal to 3% of the gross proceeds of the offering, and a Unit Purchase
Option to purchase 15% of the securities sold in the offering. The registrant
believes that these securities were issued in transactions not involving any
public offering in reliance upon an exception from registration provided by
Section 4(2) of the Securities Act of 1933, as amended and Regulation D
promulgated thereunder.
Between February 19, 2009 and April 3,
2009, the Registrant sold 310 Units (the same as described in the prior
paragraph) pursuant to a new offering dated December 12, 2008. The Units were
sold to seven accredited investors. Meyers Associates L.P., the Placement Agent,
received sales commissions of 10% ($31,000) of the gross proceeds of $310,000
from the sale of Units, as well as a non-accountable expense allowance equal to
3% of the gross proceeds of the offering, and a Unit Purchase Option to purchase
15% of the securities sold in the offering. The registrant believes that these
securities were issued in transactions not involving any public offering in
reliance upon an exception from registration provided by Section 4(2) of the
Securities Act of 1933, as amended and Regulation D promulgated
thereunder.
Between June 17, 2009 and August 30,
2010, the Registrant sold 550 Units (the same as described in the prior
paragraph). The Units were sold to seven accredited investors. Meyers Associates
L.P., the Placement Agent, received sales commissions of 10% ($55,000) of the
gross proceeds of $550,000 from the sale of Units, as well as a non-accountable
expense allowance equal to 3% of the gross proceeds of the offering, and a Unit
Purchase Option to purchase 15% of the securities sold in the offering. The
registrant believes that these securities were issued in transactions not
involving any public offering in reliance upon an exception from registration
provided by Section 4(2) of the Securities Act of 1933, as amended and
Regulation D promulgated thereunder.
Item 16.
Exhibits and Financial
Statement Schedules
(a)
Exhibits
3
|
.1
|
Certificate
of Incorporation of the registrant (1)
|
|
3
|
.2
|
Certificate
of Designation, Preferences and Rights of Series A Convertible Preferred
Stock (1)
|
|
3
|
.3
|
By-Laws
of the registrant (1)
|
|
3
|
.4
|
Amended
and Restated Certificate of Incorporation of the registrant dated August
2, 2006 (1)
|
|
3
|
.5
|
Certificate
of Amendment of the registrant dated May 27, 2008 (1)
|
|
4
|
.1
|
Form
of Common Stock Certificate (1)
|
|
4
|
.2
|
Form
of Common Stock Purchase Warrant (1)
|
|
4
|
.3
|
Form
of Bridge Note (1)
|
|
4
|
.4
|
Form
of Registration Rights Agreement (1)
|
|
4
|
.5
|
Form
of Subscription Agreement (1)
|
|
*5
|
.1
|
Opinion
of Phillips Nizer LLP.
|
|
10
|
.1
|
Employment
Agreement dated as of July 1, 2007 between the Registrant and Dr. Lawrence
Helson (1)
|
|
10
|
.2
|
2009
Employee Stock Incentive Plan (1)
|
|
10
|
.3
|
License
Agreement from University of Texas MD Anderson Career Center
(1)
|
|
10
|
.4
|
License
Agreement from The Johns Hopkins University
(1)
|
II-2
10
|
.5
|
September
6, 2007 Liposomal Formulation Manufacturing Agreement with Polymun
Scientific Immunbiologische Forschung (GmbH) (1)
|
|
10
|
.6
|
January
30, 2008 Service Agreement with Brookwood Pharmaceuticals
(1)
|
|
10
|
.7
|
Sponsored
Research Agreement dated as of September 18, 2007, by and between The
Johns Hopkins University, employer of Dr. Anirban Maitra and the
registrant. (1)
|
|
10
|
.8
|
Form
of Consulting Agreement for Scientific Advisory Board Members
(1)
|
|
10
|
.9
|
Patent
and Technology License Agreement dated August 18, 2008 between the
registrant and the University of North Texas Health Science Center.
(1)
|
|
10
|
.10
|
Sponsored
Research Agreement by and between the registrant and University of North
Texas Health Science Center at Fort Worth. (1)
|
|
10
|
.11
|
Agreement
dated June 30, 2007 by and between the Registrant and SAFC.
(1)
|
|
10
|
.12
|
Placement
Agency Agreement dated as of May 28, 2008 by and between SignPath Pharma
Inc. and Meyers Associates, L.P. (1)
|
|
10
|
.13
|
Indemnification
Agreement dated as of December, 2008 by and between SignPath Pharma Inc.
and Meyers Associates, L.P. (1)
|
|
10
|
.14
|
Extension
of Dr. Helson’s employment agreement. (1)
|
|
10
|
.15
|
Amendment
No. 1 to Sponsored Laboratory Research Agreement dated as of August 26,
2009 by and between the registrant and The University of Texas M.D.
Anderson Cancer Center. (2)
|
|
10
|
.16
|
Agreement
dated June 30, 2009 by and between the registrant and Topaz Technology,
Inc. (2)
|
|
*23
|
.1
|
Consent
of Philips Nizer LLP (included in Exhibit 5.1)
|
|
*23
|
.2
|
Consent
of M&K CPAS, PLLC.
|
* Filed
with this Registration Statement
(1)
Incorporated by reference to the Company’s Registration Statement on Form S-1
(Registration No. 333-158474), declared effective on August 10,
2009.
(2)
Incorporated by reference to the Company’s Annual Report on Form 10-K for the
year ended December 31, 2009.
Item
17. Undertakings
The
registrant hereby undertakes:
(1) To
file, during any period in which it offers or sells securities, a post-effective
amendment to this registration statement to:
(i)
Include any prospectus required by Section 10(a)(3) of the Securities Act of
1933, as amended (the “Act”);
(ii)
Reflect in the prospectus any facts or events arising after the effective date
of the Registration Statement which, individually or in the aggregate, represent
a fundamental change in the information in the registration statement.
Notwithstanding the foregoing, any increase or decrease in volume of securities
offered (if the total dollar value of securities offered would not exceed that
which was registered) and any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form of prospectus
filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the
changes in volume and price represent no more than a 20% change in the maximum
aggregate offering price set forth in the “Calculation of Registration Fee”
table in the effective registration statement; and
(iii) Include
any material information with respect to the plan of distribution not previously
disclosed in the registration statement on any material change to such
information in the Registration Statement.
(2) For
the purpose of determining any liability under the Act, each such post-effective
amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of the securities at that time
shall be deemed to be the initial bona fide offering thereof.
(3) To
file a post-effective amendment to remove from registration any of the
securities being registered which remain unsold at the termination of the
offering.
II-3
(4) For
determining liability under the Act, to any purchaser in the initial
distribution of securities, the undersigned registrant undertakes that in a
primary offering of securities of the undersigned registrant pursuant to this
registration statement, regardless of the underwriting method used to sell the
securities to the purchaser, if the securities are offered or sold to such
purchaser by means of any of the following communications, the undersigned
registrant will be a seller to the purchaser and will be considered to offer or
sell such securities to such purchaser: (i) Any preliminary prospectus or
prospectus of the undersigned registrant relating to the offering required to be
filed pursuant to Rule 424 (230.424 of this chapter); (ii) Any free
writing prospectus relating to the offering prepared by or on behalf of the
undersigned registrant or used or referred to by the undersigned registrant;
(iii) The portion of any other free writing prospectus relating to the
offering containing material information about the undersigned registrant or its
securities provided by or on behalf of the undersigned registrant; and
(iv) Any other communication that is an offer in the offering made by the
undersigned registrant to the purchaser.
(5) Insofar
as indemnification for liabilities arising under the Act may be permitted to
directors, officers and controlling persons of the registrant pursuant to the
foregoing provisions, or otherwise, the registrant has been advised that in the
opinion of the Securities and Exchange Commission such indemnification is
against public policy as expressed in the Act and is, therefore, unenforceable.
In the event that a claim for indemnification against such liabilities (other
than the payment by the registrant of expenses incurred or paid by a Director,
officer or controlling person of the registrant in the successful defense of any
action, suit or proceeding) is asserted by such director, officer or controlling
person in connection with the securities being registered, the registrant will,
unless in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the Act and
will be governed by the final adjudication of such issue.
(6) For
the purpose of determining liability under the Securities Act to any purchaser,
each prospectus filed pursuant to Rule 424(b) as a part of a registration
statement relating to an offering, other than registration statements relying on
Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be
deemed to be part of and included in the registration statement as of the date
it is first used after effectiveness. Provided, however, that no
statement made in the registration statement or prospectus that is part of the
registration statement or made in a document incorporated or deemed incorporated
by reference into the registration statement or prospectus that is part of the
registration statement will, as to a purchaser with a time of contract of sale
prior to such first use, supersede or modify any statement that was made in the
registration statement or prospectus that was part of the registration statement
or made in any such document immediately prior to such date of first
use.
II-4
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant has duly
caused this registration statement on Form S-1 to be signed on its behalf by the
undersigned, thereunto duly authorized, in the Town of Quakertown, Commonwealth
of Pennsylvania, on the 14 day of September, 2010.
SIGNPATH
PHARMA INC.
|
|
/s/ Dr.
Lawrence Helson
|
|
Dr.
Lawrence Helson
|
|
President
and Chief Executive Officer and
Director
|
In accordance with the requirements of
the Securities Act of 1933 as amended, this Registration Statement has been
signed by the following persons in the capacities and on the dates
stated:
Signature
|
Title
|
Date
|
||
/s/ Lawrence
Helson
|
President,
Chief Executive Officer and
|
September
14, 2010
|
||
Lawrence
Helson
|
Director
(Principal
Executive Officer and Principal
Financial
and Accounting Officer)
|
|||
/s/ Arthur
P. Bollon
|
Director
|
September
14, 2010
|
||
Arthur
P. Bollon
|
||||
/s/ Jack
Levine
|
Director
|
September
14, 2010
|
||
Jack
Levine
|
II-5
EXHIBIT INDEX
Exhibit
|
|||||||||
Number
|
Description
|
||||||||
5
|
.1
|
Opinion
of Phillips Nizer LLP
|
|||||||
23
|
.1
|
Consent
of Philips Nizer LLP (included in Exhibit 5.1)
|
|||||||
23
|
.2
|
Consent
of M&K CPAS, PLLC.
|
II-6