Attached files
file | filename |
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EX-31.1 - EX-31.1 - OMNI BIO PHARMACEUTICAL, INC. | c21308exv31w1.htm |
EX-10.5 - EX-10.5 - OMNI BIO PHARMACEUTICAL, INC. | c21308exv10w5.htm |
EX-10.2 - EX-10.2 - OMNI BIO PHARMACEUTICAL, INC. | c21308exv10w2.htm |
EX-10.4 - EX-10.4 - OMNI BIO PHARMACEUTICAL, INC. | c21308exv10w4.htm |
EX-31.2 - EX-31.2 - OMNI BIO PHARMACEUTICAL, INC. | c21308exv31w2.htm |
EX-10.6 - EX-10.6 - OMNI BIO PHARMACEUTICAL, INC. | c21308exv10w6.htm |
EX-32.1 - EX-32.1 - OMNI BIO PHARMACEUTICAL, INC. | c21308exv32w1.htm |
EX-10.1 - EX-10.1 - OMNI BIO PHARMACEUTICAL, INC. | c21308exv10w1.htm |
EX-10.3 - EX-10.3 - OMNI BIO PHARMACEUTICAL, INC. | c21308exv10w3.htm |
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarterly Period Ended June 30, 2011
or
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 000-52530
Omni
Bio Pharmaceutical, Inc.
(Exact Name of Registrant as Specified in its Charter)
Colorado | 20-8097969 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
5350 South Roslyn, Suite 430, Greenwood Village, CO 80111
(Address of principal executive offices, including zip code)
(Address of principal executive offices, including zip code)
(303) 867-3415
(Registrants telephone number, including area code)
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12
months (or for such shorter period that the registrant was required to submit and post such files).
Yes o No 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.
Large accelerated filer o | Accelerated filer þ | Non-accelerated filer o (Do not check if a smaller reporting company) | Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
The number of shares outstanding of the registrants common stock as of August 8, 2011 was
32,018,396.
OMNI BIO PHARMACEUTICAL, INC. & SUBSIDIARY
TABLE OF CONTENTS
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EX-10.3 | ||||||||
EX-10.4 | ||||||||
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EX-31.1 | ||||||||
EX-31.2 | ||||||||
EX-32.1 |
Table of Contents
Part I. FINANCIAL INFORMATION
Item 1. | Financial Statements. |
OMNI BIO PHARMACEUTICAL, INC. & SUBSIDIARY
(A Development Stage Company)
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
June 30, 2011 | March 31, 2011 | |||||||
(Unaudited) | (Unaudited) | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 3,189,128 | $ | 301,765 | ||||
Other current assets |
39,137 | 43,541 | ||||||
Total current assets |
3,228,265 | 345,306 | ||||||
Intangible assets, net |
60,610 | 61,931 | ||||||
TOTAL ASSETS |
3,288,875 | $ | 407,237 | |||||
LIABILITIES & STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 181,347 | $ | 41,763 | ||||
Amount due under sponsored research agreement |
140,223 | | ||||||
Accrued research and development costs |
96,646 | 44,736 | ||||||
Accrued liabilities |
76,158 | 116,500 | ||||||
Amounts due to related parties |
3,750 | 3,750 | ||||||
Total current liabilities |
498,124 | 206,749 | ||||||
Commitments and Contingencies (Notes 1, 3 and 6) |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $0.10 par value, 5,000,000 shares authorized, -0- shares
issued and outstanding |
| | ||||||
Common stock, $0.001 par value; 200,000,000 shares authorized;
31,782,396 and 28,980,496 shares issued and outstanding, respectively |
31,782 | 28,980 | ||||||
Additional paid-in capital |
35,431,460 | 31,336,345 | ||||||
Deficit accumulated during the development stage |
(32,672,491 | ) | (31,164,837 | ) | ||||
Total stockholders equity |
2,790,751 | 200,488 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY |
$ | 3,288,875 | $ | 407,237 | ||||
The accompanying notes are an integral part of these consolidated financial statements.
2
Table of Contents
OMNI BIO PHARMACEUTICAL, INC. & SUBSIDIARY
(A Development Stage Company)
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
For the Three Months Ended | February 28, 2006 | |||||||||||
June 30, | (Inception) through | |||||||||||
2011 | 2010 | June 30, 2011 | ||||||||||
Operating expenses: |
||||||||||||
General and administrative (including share-based
compensation of $919,803, $2,474,053 and
$15,247,354, respectively) |
$ | 1,316,200 | $ | 2,734,681 | $ | 19,300,016 | ||||||
Research and development |
192,132 | | 1,902,142 | |||||||||
License fee related party |
| | 5,615,980 | |||||||||
Charge for common stock issued pursuant to
license agreements |
| | 763,240 | |||||||||
Total operating expenses |
1,508,332 | 2,734,681 | 27,581,378 | |||||||||
Loss from operations |
(1,508,332 | ) | (2,734,681 | ) | (27,581,378 | ) | ||||||
Non-operating expenses: |
||||||||||||
Interest income (expense), net |
678 | 2,356 | (51,715 | ) | ||||||||
Accretion expense on notes payable
related party |
| (3,000 | ) | (56,125 | ) | |||||||
Charges for warrants issued in merger related
parties |
| | (1,948,237 | ) | ||||||||
Charge for
warrants issued in private placement related parties |
| | (403,350 | ) | ||||||||
Charges for modifications to warrants |
| | (2,631,686 | ) | ||||||||
Total non-operating expenses |
678 | (644 | ) | (5,091,113 | ) | |||||||
Net loss |
$ | (1,507,654 | ) | $ | (2,735,325 | ) | $ | 32,672,491 | ||||
Basic and diluted net loss per share |
$ | (0.05 | ) | $ | (0.10 | ) | ||||||
Weighted average shares outstanding basic and
diluted |
29,563,945 | 28,002,746 | ||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
3
Table of Contents
OMNI BIO PHARMACEUTICAL, INC. & SUBSIDIARY
(A Development Stage Company)
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
Deficit | ||||||||||||||||||||||||||||
Accumulated | ||||||||||||||||||||||||||||
Additional | During | Total | ||||||||||||||||||||||||||
Preferred Stock | Common Stock | Paid-in | Development | Stockholders | ||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Stage | Equity | ||||||||||||||||||||||
Balances at March 31, 2011 |
| $ | | 28,980,496 | $ | 28,980 | $ | 31,336,345 | $ | (31,164,837 | ) | $ | 200,488 | |||||||||||||||
Common stock and common stock purchase warrants sold in
private placement offering, net of offering costs of
$324,261 (June 2011 at $1.25 per unit) |
2,801,900 | 2,802 | 3,175,312 | 3,178,114 | ||||||||||||||||||||||||
Share-based compensation |
919,803 | 919,803 | ||||||||||||||||||||||||||
Net loss |
(1,507,654 | ) | (1,507,654 | ) | ||||||||||||||||||||||||
Balances at June 30, 2011 (unaudited) |
| $ | | 31,782,396 | $ | 31,782 | $ | 35,431,460 | $ | (32,672,491 | ) | $ | 2,790,751 | |||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
4
Table of Contents
OMNI BIO PHARMACEUTICAL, INC. & SUBSIDIARY
(A Development Stage Company)
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
February 28, 2006 | ||||||||||||
For the Three Months Ended | (Inception) | |||||||||||
June 30, | Through June 30, | |||||||||||
2011 | 2010 | 2011 | ||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
||||||||||||
Net loss |
$ | (1,507,654 | ) | $ | (2,735,325 | ) | $ | (32,672,491 | ) | |||
Adjustments used to reconcile net loss to net cash used in
operating activities: |
||||||||||||
Charge for warrant issued for purchase of license
related party |
| | 5,590,980 | |||||||||
Common stock issued pursuant to license agreements |
| | 763,240 | |||||||||
Share-based compensation |
919,803 | 2,474,053 | 15,247,354 | |||||||||
Charge for warrants issued in merger transaction
related parties |
| | 1,948,237 | |||||||||
Charge for warrants issued in private placement
transaction
related parties |
| | 403,350 | |||||||||
Charges for modifications to warrants |
| | 2,631,686 | |||||||||
Accretion expense related parties |
| 3,000 | 56,125 | |||||||||
Depreciation and amortization |
1,321 | 1,617 | 24,267 | |||||||||
Contributed rent |
| | 19,740 | |||||||||
Loss on disposal of equipment |
| 2,444 | ||||||||||
Changes in operating assets and liabilities: |
||||||||||||
Prepaid clinical trial fee |
| (365,000 | ) | | ||||||||
Other current assets |
4,404 | (17,873 | ) | (41,236 | ) | |||||||
Accounts payable |
139,584 | (11,842 | ) | 387,524 | ||||||||
Accrued liabilities |
(40,342 | ) | (12,818 | ) | (235,666 | ) | ||||||
Accrued research and development costs |
51,910 | | 96,646 | |||||||||
Amount due under sponsored research agreement |
140,223 | | 140,223 | |||||||||
Amounts due to related parties |
| 375 | 207,632 | |||||||||
Net cash used in operating activities |
(290,751 | ) | (663,813 | ) | (5,429,945 | ) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES: |
||||||||||||
Cash proceeds from reverse merger transactions |
| | 11,750 | |||||||||
Purchase of licenses |
| | (35,401 | ) | ||||||||
Purchase of property and equipment |
| | (7,423 | ) | ||||||||
Net cash used in investing activities |
| | (31,074 | ) | ||||||||
CASH FLOWS FROM FINANCING ACTIVITIES: |
||||||||||||
Net proceeds from the sale of common stock and warrants |
3,178,114 | | 7,464,059 | |||||||||
Proceeds from the issuance of notes payable to related
party |
| | 825,000 | |||||||||
Proceeds from the sale of common stock warrants |
| | 125,000 | |||||||||
Proceeds from the exercise of common stock warrants |
| | 236,088 | |||||||||
Net cash provided by financing activities |
3,178,114 | | 8,650,147 | |||||||||
Net increase (decrease) in cash and cash equivalents |
2,887,363 | (663,813 | ) | 3,189,128 | ||||||||
Cash and cash equivalents at beginning of period |
301,765 | 1,802,366 | | |||||||||
Cash and cash equivalents at end of period |
$ | 3,189,128 | $ | 1,138,553 | $ | 3,189,128 | ||||||
5
Table of Contents
OMNI BIO PHARMACEUTICAL, INC. & SUBSIDIARY
(A Development Stage Company)
(A Development Stage Company)
Notes to Consolidated Financial Statements (Unaudited)
NOTE 1 OVERVIEW AND BASIS OF PRESENTATION
Overview
Omni Bio Pharmaceutical, Inc. (Omni) is the licensee of patents and patent applications related
to novel compositions of matter and methods of use for an existing FDA approved drug, Alpha-1
antitrypsin (AAT). We currently hold three licenses with the Regents of the University of
Colorado (RUC) in the areas of cellular transplantation, bacterial disorders and viral disorders.
Our current licensed patent portfolio with RUC is comprised of 3 issued patents and 24 patent
applications. We also hold a fourth license to a patent application for the treatment of diabetes
with a privately-held company, Bio Holding, Inc. (Bio Holding).
We are currently focusing on three indications for treatment using AAT: diabetes, complications
due to graft rejections, also referred to as graft versus host disease (GVHD), and islet
transplantation. To date, our business efforts have been largely dedicated to pursuing additional
capital to fund Sponsored Research Agreements (SRAs) with the University of Colorado Denver
(UCD) in indications covered under the license agreements with RUC and Bio Holding and to fund a
human clinical trial in Type 1 diabetes. Since inception, we have not generated any revenues from
our operations.
Basis of Presentation
The accompanying unaudited consolidated financial statements are comprised of Omni and its
wholly-owned subsidiary, Omni Bio Operating, Inc., and have been prepared pursuant to the rules and
regulations of the Securities and Exchange Commission (SEC). Certain information and footnote
disclosures normally included in financial statements prepared in accordance with accounting
principles generally accepted in the United States of America (US GAAP) have been condensed or
omitted pursuant to such rules and regulations. In the opinion of management, the unaudited
consolidated financial statements have been prepared on the same basis as the annual audited
consolidated financial statements, and reflect all adjustments, consisting only of normal,
recurring adjustments, necessary for a fair presentation in accordance with US GAAP. The results of
operations for interim periods presented are not necessarily indicative of the operating results
for the full year. These unaudited consolidated financial statements should be read in connection
with the audited consolidated financial statements and notes thereto included in our Annual Report
on Form 10-K for the fiscal year ended March 31, 2011 (the 2011 Form 10-K). The balances as of
March 31, 2011 are derived from our audited consolidated financial statements.
Except as the context otherwise requires, the terms Company, we, our or us means Omni and
its wholly-owned subsidiary, Omni Bio Operating, Inc. (Omni Bio).
Going Concern
The accompanying financial statements have been prepared in conformity with US GAAP, which
contemplate our continuation as a going concern, whereby the realization of assets and liquidation
of liabilities are in the ordinary course of business. However, the report of our independent
registered public accounting firm on our consolidated financial statements, as of and for the year
ended March 31, 2011, contains an explanatory paragraph expressing substantial doubt as to our
ability to continue as a going concern. The going concern qualification resulted from, among
other things, our development-stage status, no revenue recognized since inception, our net losses
since inception and the outstanding and currently anticipated contractual commitments for research
and development efforts and clinical trials. As of June 30, 2011, we remain a development stage
company and our focus continues to be on raising capital to fund current operations and research
and development efforts on AAT indications. As of June 30, 2011, we had a deficit accumulated from
inception of $32.7 million, which included total non-cash charges from inception of approximately
$26.7 million. These conditions raise substantial doubt as to our ability to continue
as a going concern. These financial statements do not include any adjustments relating to the
recoverability and classification of recorded asset amounts, or amounts and classification of
liabilities that might be different should we be unable to continue as a going concern.
6
Table of Contents
OMNI BIO PHARMACEUTICAL, INC. & SUBSIDIARY
(A Development Stage Company)
Notes to Consolidated Financial Statements (Unaudited)
(A Development Stage Company)
Notes to Consolidated Financial Statements (Unaudited)
In June and August of 2011, we completed three closings of a private placement equity offering (the
2011 Private Placement) and raised approximately $3.45 million in net cash proceeds. See further
discussion and disclosures in Note 2. We expect that the cash raised in the 2011 Private Placement
will allow us to fund our operations through our fiscal year ended March 31, 2012 based on current
operating levels, however, we will need to engage in additional capital raising to operate beyond
that period. There is no assurance that we will be successful in raising additional capital on
acceptable terms or at all. Failure to obtain additional capital may have a material adverse
impact on our ability to continue our research and development efforts and fund our operating
expenses beyond March 31, 2012.
Supplemental Disclosures of Non-Cash Investing and Financing Activities
For the Three Months Ended | ||||||||
June 30, | ||||||||
2011 | 2010 | |||||||
Accounts payable converted to common stock |
$ | | $ | 49,982 | ||||
Notes payable related parties converted to common stock |
$ | | $ | 25,000 | ||||
Recently Issued Accounting Standard Updates
We have reviewed all of the FASBs Accounting Standard Updates through the filing date of this
report and have concluded that none will have a material impact on our future consolidated
financial statements.
NOTE 2 PRIVATE PLACEMENT TRANSACTION
On June 10, 2011, we accepted subscription agreements related to the sale of Units in a private
placement (the 2011 Private Placement). Each Unit is comprised of one share of our common
stock and one warrant to purchase one share of our common stock for a purchase price of $1.25 per
Unit. Each warrant in the Unit (the 2011 Private Placement Warrants) is exercisable at $2.00 per
share until five years from the initial closing of the 2011 Private Placement. The net proceeds of
the 2011 Private Placement will be used for general working capital purposes, research and
development projects and an initial equity investment of $2.0 million in a private biotech company
that is a related party. See further discussion in Note 6.
On June 10, 2011, we conducted the initial closing under the 2011 Private Placement, pursuant to
which we entered into subscription agreements for the purchase of 2,463,900 Units for an aggregate
subscription price of $3,079,875. After deducting offering expenses, including commissions and
expenses paid to the placement agent, net proceeds to us from such sales totaled $2,799,745.
Certain of our officers and directors purchased an aggregate of 50,000 Units in the initial closing
of the 2011 Private Placement.
On June 27, 2011, we conducted a second closing under the 2011 Private Placement, pursuant to which
we entered into subscription agreements for the purchase of 338,000 Units for an aggregate
subscription price of $422,500. After deducting offering expenses including commissions and
expenses paid to the placement agent, net proceeds to us from such sales totaled approximately
$384,000. Certain of our officers and directors purchased an aggregate of 50,000 Units in the
second closing of the 2011 Private Placement.
GVC Capital LLC (GVC Capital) served as the placement agent for the 2011 Private Placement and
earned a cash commission of 9% of the gross proceeds raised. In addition, we were obligated to
sell for a nominal fee to GVC
Capital, as the placement agent, warrants to purchase 9% of the total number of shares of our
common stock sold in the 2011 Private Placement, which are exercisable at a price of $1.50 per
share (the 2011 Private Placement PA Warrants). The 2011 Private Placement PA Warrants expire
five years from the date of the final closing of the 2011 Private Placement. We issued a total of
252,171 of 2011 Private Placement PA Warrants to GVC Capital in conjunction with the two closings
of the 2011 Private Placement. Two of our directors are senior managing partners in GVC Capital.
7
Table of Contents
OMNI BIO PHARMACEUTICAL, INC. & SUBSIDIARY
(A Development Stage Company)
Notes to Consolidated Financial Statements (Unaudited)
(A Development Stage Company)
Notes to Consolidated Financial Statements (Unaudited)
At our option, we may call the 2011 Private Placement Warrants through June 10, 2016 by giving the
holder notice of call upon 20 days written notice. Such notice may be given by us only within 10
days after our common stock has had a closing price of not less than $4.00 per share for 20 out of
30 consecutive trading days with trading volume in excess of 25,000 shares per day for that period
of days.
On August 8, 2011, we completed the final closing for the 2011 Private Placement, pursuant to which
we accepted subscription agreements for the purchase of 236,000 Units for an aggregate subscription
price of $295,000. After deducting offering expenses, including commissions and expenses paid to
the placement agent, net proceeds to us from such sales totaled approximately $267,000.
NOTE 3 CONTRACTUAL COMMITMENTS
Type 1 Diabetes Clinical Trial
On June 7, 2010, we executed an Investigational Site Agreement (the ISA), whereby we agreed to
fund a two-year clinical study to evaluate AAT in the treatment of patients with Type 1 diabetes
(the Diabetes Clinical Trial). The Diabetes Clinical Trial is initially to include 15 patients,
but may be expanded up to 50 patients. Base costs, which include the enrollment fee and other
incidental charges, for the 15 patients will be approximately $585,000, of which $365,000 had been
paid through June 30, 2011.
For the three months ended June 30, 2011, we recorded approximately $56,000 of research and
development expense related to the Diabetes Clinical Trial based on the number of patients infused
during the three months ended June 30, 2011 multiplied by the estimated Diabetes Clinical Trial
cost per patient. Two new patients were infused during the three months ended June 30, 2011.
Viral Disorders SRA
On August 18, 2010, we entered into an SRA with RUC whereby UCD will perform studies in
vitro and in vivo to determine the biological activity of AAT as an inhibitor of
influenza (the Viral SRA). We were required to make quarterly payments over a two-year
period to UCD, which totaled approximately $440,000, and as of June 30, 2011, we had paid
approximately $110,000.
On June 8, 2011, we gave written notice to RUC terminating the Viral SRA. Unless otherwise
negotiated with RUC, we must reimburse UCD for the total actual and reasonable costs
incurred by it under the Viral SRA through the date of termination, including those costs
necessary to implement the early termination of the Viral SRA and costs incurred by UCD as
a result of non-cancelable obligations, which may extend beyond the date of such
termination. In addition, certain indemnification obligations and intellectual property
rights will survive the termination of the Viral SRA. The termination of the Viral SRA
does not impact the continuance of the license agreement with RUC for viral disorders or
licensing of the intellectual property and patents (both issued and pending).
In July 2011, we received acknowledgment from UCD of our termination letter related to the Viral
SRA, and based on discussions related thereto, we have estimated and recorded a liability in the
amount of $140,000 for settlement of all obligations due under the Viral SRA. This liability is
represented as of June 30, 2011 under the caption Amount due under sponsored research agreement
on our unaudited Consolidated Balance Sheet included in this report.
8
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OMNI BIO PHARMACEUTICAL, INC. & SUBSIDIARY
(A Development Stage Company)
Notes to Consolidated Financial Statements (Unaudited)
(A Development Stage Company)
Notes to Consolidated Financial Statements (Unaudited)
Diabetes SRA
On September 3, 2010, we executed an SRA with UCD in the area of diabetes (the Diabetes SRA).
The Diabetes SRA was executed pursuant to a license agreement for the treatment of diabetes (the
Diabetes License) that we executed in 2009 with Bio Holding. The total amount due under the
Diabetes SRA is $88,000, of which $58,000 has been paid to date, and the final payment of $30,000
is due on or before September 3, 2011.
Future royalty payments under our license agreements are as follows:
Minimum | Milestone | Earned | Sublicense | |||||||||
License | Field of Use | Royalties | Royalties | Royalties (5) | Royalties (6) | |||||||
Bacterial License
|
Bacterial Disorders | $25,000 per year
starting May 15, 2011 |
(1 | ) | 4% of Net Sales | 20% to 30% | ||||||
Viral License
|
Viral Disorders (including HIV) |
$50,000 per year after first commercial sale |
(2 | ) | 4% of Net Sales | 20% to 30% | ||||||
Cellular Transplant License |
Cellular Transplant /Graft Rejection |
$50,000 per year after first commercial sale |
(3 | ) | 3% of Net Sales | 20% to 30% | ||||||
Diabetes License
|
Diabetes | None | None | 4% of Gross Revenues (4) | 30% (4) |
(1) | Payable to RUC as follows: $30,000 upon completion of preclinical trial; $50,000 upon completion of a phase I clinical trial; $100,000 upon completion of a phase II clinical trial; $200,000 upon completion of a phase III clinical trial; and $300,000 upon receipt of approval of FDA or foreign equivalent. | |
(2) | Payable to RUC as follows: $100,000 upon completion of any phase III clinical trial and $150,000 upon first commercial sale. No milestone royalties are required for the first indication. For the second indication, 100% of the milestone royalties shall be paid, and for subsequent indications 50% of the milestone royalties shall be paid. | |
(3) | Payable to RUC as follows: $25,000 upon initiation of a phase II clinical trial; $100,000 upon initiation of a phase III clinical trial; and $200,000 upon receipt of approval of FDA or foreign equivalent. | |
(4) | Payable to Bio Holding, Inc. | |
(5) | Earned Royalties are based on direct net sales of product by Omni. | |
(6) | Sublicense Royalties are based on royalties received by Omni on a sublicense arrangement with a third party. |
9
Table of Contents
OMNI BIO PHARMACEUTICAL, INC. & SUBSIDIARY
(A Development Stage Company)
Notes to Consolidated Financial Statements (Unaudited)
(A Development Stage Company)
Notes to Consolidated Financial Statements (Unaudited)
NOTE 4 NET LOSS PER SHARE
Basic loss per share is computed based on the weighted average number of common shares outstanding
during the period presented. Diluted earnings (loss) per share is computed using the weighted
average number of common shares outstanding plus the number of common shares that would be issued
assuming exercise or conversion of all potentially dilutive common shares. Potentially dilutive
securities are excluded from the calculation when their effect would be anti-dilutive. For all
periods presented in the consolidated financial statements, all potentially dilutive securities
have been excluded from the diluted share calculations as they were anti-dilutive as a result of
the net losses incurred for the respective periods. Accordingly, basic shares equal diluted shares
for all periods presented. For the three months ended June 30, 2011 and June 30, 2010, potentially
dilutive securities were comprised of approximately 13.7 million and 11.6 million common stock
purchase warrants, respectively.
NOTE 5 SHARE-BASED COMPENSATION
All equity-based awards to employees, directors and consultants are recognized in the consolidated
financial statements at the fair value of the award on the grant date. During the three months
ended June 30, 2011, we did not issue any equity-based awards.
Share-based compensation related to warrants and restricted stock units recorded for the three
months ended June 30, 2011 and 2010 was as follows:
2011 | 2010 | |||||||
Employees and directors |
$ | 919,803 | $ | 1,414,172 | ||||
Outside consultants |
| 1,059,881 | ||||||
$ | 919,803 | $ | 2,474,053 | |||||
As of June 30, 2011, there was approximately $5.7 million of total unrecognized compensation cost
related to non-vested share-based compensation arrangements that is expected to be recognized over
a weighted-average period of approximately 1.9 years.
A summary of activity related to warrants issued to employees, directors and consultants under
share-based compensation agreements for the three months ended June 30, 2011 is as follows:
Weighted | ||||||||||||||||
Weighted | Average | |||||||||||||||
Average | Remaining | |||||||||||||||
Exercise | Contractual | Aggregate | ||||||||||||||
Shares | Price | Term (in years) | Intrinsic Value | |||||||||||||
(As restated) | ||||||||||||||||
Outstanding at March 31, 2011 |
3,243,000 | $ | 1.97 | |||||||||||||
Granted |
| | ||||||||||||||
Exercised |
| | ||||||||||||||
Forfeited/expired/cancelled |
| | ||||||||||||||
Outstanding at June 30, 2011 |
3,243,000 | $ | 1.97 | 4.4 | $ | 1,712,000 | ||||||||||
Vested and exercisable at June 30, 2011 |
2,783,000 | $ | 1.80 | 4.2 | $ | 1,712,000 | ||||||||||
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OMNI BIO PHARMACEUTICAL, INC. & SUBSIDIARY
(A Development Stage Company)
Notes to Consolidated Financial Statements (Unaudited)
(A Development Stage Company)
Notes to Consolidated Financial Statements (Unaudited)
NOTE 6 SUBSEQUENT EVENT
Investment in BioMimetix Pharmaceutical, Inc.
On July 15, 2011, we acquired a 25% equity ownership of BioMimetix Pharmaceutical, Inc.
(BioMimetix) for cash consideration of $2,000,000 (the Investment). Concurrent with the
Investment, Duke University entered into an exclusive licensing arrangement with BioMimetix (the
Duke License). BioMimetix is a recently formed biopharmaceutical corporation and, as the
exclusive licensee of the Duke License, intends to develop a new class of patented compounds for
the treatment of various disease and health care treatment classifications including radiation
toxicity during the treatment of cancer using radiation therapy.
Dr. James Crapo, our Chief Executive Officer, is the founder and a significant shareholder of
BioMimetix and will also serve as its CEO and as a director.
Under the terms of the BioMimetix stockholders agreement, we have the right to appoint one
individual, reasonably acceptable to Dr. Crapo, to serve on BioMimetixs board of directors. In
addition, we received certain preemptive rights to purchase additional shares of BioMimetix and
other protective rights relating to the Investment.
In addition to our initial 25% equity ownership in BioMimetix, we were issued a common stock
purchase warrant (the Warrant) to acquire up to an aggregate 40% equity ownership interest in
BioMimetix for an additional $2,000,000. The Warrant may be exercised in whole or in part, and if
in part, our diluted equity ownership upon exercise will be calculated as follows: (Cash
Consideration Paid multiplied by 15% divided by $2,000,000) plus 25%. The Warrant is immediately
exercisable and expires on July 15, 2012.
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Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations. |
FORWARD LOOKING STATEMENTS
The following discussion contains forward-looking statements regarding us, our business, prospects
and results of operations that are subject to certain risks and uncertainties posed by many factors
and events that could cause our actual business, prospects and results of operations to differ
materially from those that may be anticipated by such forward-looking statements. Factors that may
affect such forward-looking statements include, without limitation: our ability and the ability of
BioMimetix to successfully develop new products and services for new markets; the impact of
competition on our revenues; changes in law or regulatory requirements that adversely affect our
ability to market our products; delays in the introduction of our products or services into the
market; our ability to secure adequate financing for our operations; and our failure to keep pace
with our competitors. For additional factors that may affect the validity of our forward-looking
statements, see the risk facts set forth in Part I. Item 1A Risk Factors of our 2011 Form 10-K
and Part II. Item 1A Risk Factors of this report.
When used in this report, words such as believes, anticipates, expects, intends and similar
expressions are intended to identify forward-looking statements, but are not the exclusive means of
identifying forward-looking statements. Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this report. We undertake no
obligation to revise any forward-looking statements in order to reflect events or circumstances
that may subsequently arise. Readers are urged to carefully review and consider the various
disclosures made by us in this report and other reports filed with the Securities and Exchange
Commission (SEC) that attempt to advise interested parties of the risks and factors that may
affect our business.
Overview
We are the licensee of applications and patents related to novel compositions of matter and methods
of use for an existing FDA approved drug, Alpha-1 antitrypsin (AAT). We currently hold three
licenses with the Regents of the University of Colorado (RUC) in the areas of cellular
transplantation, bacterial disorders and viral disorders. Our current licensed patent portfolio
with RUC is comprised of 3 issued patents and 24 patent applications. We also hold a fourth
license to a patent application for the treatment of diabetes with a privately-held company, Bio
Holding, Inc. (Bio Holding).
We are currently focusing on three indications for treatment using AAT: diabetes, complications
due to graft rejections, also referred to as graft versus host disease (GVHD), and islet
transplantation. To date, our business efforts have been largely dedicated to pursuing additional
capital to fund Sponsored Research Agreements (SRAs) with the University of Colorado Denver
(UCD) in indications covered under the license agreements with RUC and Bio Holding and to fund a
human clinical trial in Type 1 diabetes. Since inception, we have not generated any revenues from
our operations.
Current Scientific Developments
Clinical Trial on Type 1 Diabetes
On June 7, 2010, we entered into an Investigational Site Agreement (the Agreement) with
RUC and The Barbara Davis Center for Childhood Diabetes (collectively the Institution),
whereby the Institution, acting on behalf of Omni, agreed to arrange, administer and manage
a clinical study to evaluate Aralast NPTM (an Alpha-1 antitrypsin product
formulation made by Baxter Healthcare Corporation (Baxter)) in the treatment of patients
with Type 1 diabetes (the Diabetes Clinical Trial). The Diabetes Clinical Trial is
initially to include 15 patients, but may be expanded up to 50 patients. Base costs, which
include the enrollment fee and other incidental charges, for the 15 patients will be
approximately $585,000, of which $365,000 had been paid through June 30, 2011.
As of June 30, 2011, we had completed the infusions on the first eight patients, all of
whom were adolescents. In July 2011, we began infusions on two of the remaining seven
patients, all of whom are juveniles. Subject to review of the data on the first eight
patients, and review and approval from Baxter,
who is providing its formulation of AAT for the Diabetes Trial, we anticipate disclosing
clinical results of the first seven patients during the fourth quarter of calendar year
2011.
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Viral Disorders SRA
On August 18, 2010, we entered into an SRA with RUC whereby UCD will perform studies in
vitro and in vivo to determine the biological activity of AAT as an inhibitor of
influenza (the Viral SRA). We were required to make quarterly payments over a two-year
period to UCD, which totaled approximately $440,000, and as of June 30, 2011, we had paid
approximately $110,000.
On June 8, 2011, we gave written notice to RUC terminating the Viral SRA. Unless otherwise
negotiated with RUC, we must reimburse UCD for the total actual and reasonable costs
incurred by it under the Viral SRA through the date of termination, including those costs
necessary to implement the early termination of the Viral SRA and costs incurred by UCD as
a result of non-cancelable obligations, which may extend beyond the date of such
termination. In addition, certain indemnification obligations and intellectual property
rights will survive the termination of the Viral SRA. The termination of the Viral SRA
does not impact the continuance of the license agreement with RUC for viral disorders or
licensing of the intellectual property and patents (both issued and pending).
In July 2011, we received acknowledgment from UCD of our termination letter related to the Viral
SRA, and based on discussions related thereto, we have estimated and recorded a liability in the
amount of $140,000 for settlement of all obligations due under the Viral SRA. This liability is
represented as of June 30, 2011 under the caption Amount due under sponsored research agreement
on our unaudited Consolidated Balance Sheet included in this report.
Our decision to terminate the Viral SRA was made based our need to conserve cash and refocus our
research and development efforts on indications that we believe are the most commercially feasible
at this time. These indications include diabetes and cellular transplantation, which includes GVHD
and islet transplantation. Further, to pursue additional research and development and potential
future clinical trials in diabetes, GVHD and islet transplantation, we will most likely need to
form a strategic partnership with one or more of the current AAT manufacturers, which we expect
would include receiving financial support from them for AAT indications that they can most quickly
commercialize. However, there can be no assurance of forming a strategic partnership, and if so,
that we would receive financial funding.
Investment in BioMimetix
On July 15, 2011, we acquired a 25% equity ownership of BioMimetix Pharmaceutical, Inc.
(BioMimetix) for cash consideration of $2,000,000 (the Investment). Concurrent with the
Investment, Duke University entered into an exclusive licensing arrangement with BioMimetix (the
Duke License). BioMimetix is a recently formed biopharmaceutical corporation and, as the
exclusive licensee of the Duke License, intends to develop a new class of patented compounds for
the treatment of various disease and health care treatment classifications including radiation
toxicity during the treatment of cancer using radiation therapy.
Dr. James Crapo, our Chief Executive Officer, is the founder and a significant shareholder of
BioMimetix and will also serve as its CEO and as a director.
Under the terms of the BioMimetix stockholders agreement, we have the right to appoint one
individual, reasonably acceptable to Dr. Crapo, to serve on BioMimetixs board of directors. In
addition, we received certain preemptive rights to purchase additional shares of BioMimetix and
other protective rights relating to the Investment.
In addition to our initial 25% equity ownership in BioMimetix, we were issued a common stock
purchase warrant (the Warrant) to acquire up to an aggregate 40% equity ownership interest in
BioMimetix for an additional $2,000,000. The Warrant may be exercised in whole or in part, and if
in part, our diluted equity ownership upon exercise will be calculated as follows: (Cash
Consideration Paid multiplied by 15% divided by $2,000,000) plus 25%. The Warrant is immediately
exercisable and expires on July 15, 2012.
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Results of Operations For the Three Months Ended June 30, 2011 Compared to the Three Months
Ended June 30, 2010
The following discussion relates to our operations for the three months ended June 30, 2011 (the
June 2011 quarter) as compared to the three months ended June 30, 2010 (the June 2010 quarter).
Net loss For the June 2011 quarter, we reported a net loss of $1,507,654 as compared to a net
loss of $2,735,325 for the June 2010 quarter, a decrease of $1,227,671. This decrease was
primarily attributable to decreases in general and administrative expenses of approximately
$1,418,000, of which approximately $1,554,000 of this decrease was attributable to share-based
compensation. We have not reported any revenue since inception and it is highly likely that we
will not recognize any revenue in the near term.
General and administrative expenses General and administrative expenses for the June 2011 quarter
were $1,316,200, and included $919,503 of share-based compensation, as compared to $2,734,681 in
the June 2010 quarter, which included $2,474,053 of share-based compensation. As we have disclosed
in prior filings, management views general and administrative expenses exclusive of share-based
compensation as an important non-GAAP measure. Accordingly, excluding share-based compensation,
general and administrative expenses in the June 2011 quarter were $396,397 as compared to $260,628
for the June 2010 quarter, an increase of $135,769 or approximately 52%. This increase was
primarily due to higher expenses in certain expense categories, most notably officer salary and
consulting fees of approximately $68,0000; legal work for patent filings and related prosecution of
approximately $50,000; and a minimum royalty due under our license agreement with RUC for bacterial
disorders of $25,000. These expense increases were partially offset by a decrease of approximately
$29,000 related to an exploratory project for AAT biohazard indications that was incurred during
the June 2010 quarter. This project was halted in December 2010.
Research and development expenses For the June 2010 quarter, we did not incur any research and
development expenses as our current research and development projects commenced during the three
months ended September 30, 2010. For the June 2011 quarter, research and development expenses were
comprised of the costs of patient infusions for the Diabetes Clinical Trial and expenses associated
with the Viral and Diabetes SRAs.
Other non-operating expenses Non-operating expenses for the June 2011 quarter decreased
approximately $1,322 versus the June 2010 quarter primarily due to $678 of interest income earned
in the June 2011 quarter and accretion expense of $3,000 recognized in the June 2010 quarter
related to a note payable.
Liquidity and Capital Resources
Our unaudited consolidated financial statements as presented in Item 1 of this report have been
prepared in conformity with US GAAP, which contemplate our continuation as a going concern.
However, the report of our independent registered public accounting firm on our consolidated
financial statements, as of and for the year ended March 31, 2011, contains an explanatory
paragraph expressing substantial doubt as to our ability to continue as a going concern. The
going concern qualification resulted from, among other things, our development-stage status, no
revenue recognized since inception, our net losses since inception and the contractual commitments
due under our Diabetes Clinical Trial and SRAs. As of June 30, 2011, we remain a development stage
company and our focus continues to be on raising capital to fund current operations and research
development efforts, which could include future clinical trials on AAT indications. As of June 30,
2011, we had a deficit accumulated from inception of approximately $32.7 million, which included
total non-cash charges from inception of approximately $26.7 million. These conditions raise
substantial doubt as to our ability to continue as a going concern. Our unaudited consolidated
financial statements contained in this report do not include any adjustments relating to the
recoverability and classification of recorded asset amounts, or amounts and classification of
liabilities that might be different should we be unable to continue as a going concern.
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Private Placement
On June 10, 2011, we accepted subscription agreements related to the sale of Units in the 2011
Private Placement. Each Unit is comprised of one share of our common stock and one warrant to
purchase one share of our common stock for a purchase price of $1.25 per Unit. Each Private
Placement Warrant is exercisable at $2.00 per share until five years from the initial closing of
the 2011 Private Placement. The net proceeds of the 2011 Private Placement will be used for
general working capital purposes, research and development projects, and the initial equity
investment of $2.0 million in BioMimetix, a related party.
On June 10, 2011, we conducted the initial closing under the 2011 Private Placement, pursuant to
which we entered into subscription agreements for the purchase of 2,463,900 Units for an aggregate
subscription price of $3,079,875. After deducting offering expenses including commissions and
expenses paid to the placement agent, net proceeds to us from such sales totaled $2,799,745.
Certain of our officers and directors purchased an aggregate of 50,000 Units in the initial closing
of the 2011 Private Placement.
On June 27, 2011, we conducted a second closing under the 2011 Private Placement, pursuant to which
we entered into subscription agreements for the purchase of 338,000 Units for an aggregate
subscription price of $422,500. After deducting offering expenses including commissions and
expenses paid to the placement agent, net proceeds to us from such sales totaled approximately
$384,000. Certain of our officers and directors purchased an aggregate of 50,000 Units in the
second closing of the 2011 Private Placement.
GVC Capital served as the placement agent for the 2011 Private Placement and earned a commission of
9% of the gross proceeds raised. In addition, we were obligated to sell for a nominal fee to GVC
Capital, as the placement agent, warrants to purchase 9% of the total number of shares of our
common stock sold in the 2011 Private Placement, which are exercisable at a price of $1.50 per
share (the 2011 Private Placement PA Warrants). The 2011 Private Placement PA Warrants expire
five years from the date of the final closing of the 2011 Private Placement. We issued a total of
252,171 of 2011 Private Placement PA Warrants to GVC Capital in conjunction with the two closings
of the 2011 Private Placement. Two of our directors are Senior Managing Partners in GVC Capital.
At our option, we may call the 2011 Private Placement Warrants through June 10, 2016 by giving the
holder notice of call upon 20 days written notice. Such notice may be given by us only within 10
days after our common stock has had a closing price of not less than $4.00 per share for 20 out of
30 consecutive trading days with trading volume in excess of 25,000 shares per day for that period
of days.
On August 8, 2011, we completed the final closing for the 2011 Private Placement, pursuant to which
we accepted subscription agreements for the purchased of 236,000 Units for an aggregate
subscription price of $295,000. After deducting offering expenses including commissions and
expenses paid to the placement agent, net proceeds to us from such sales totaled approximately
$267,000. We raised total net proceeds of approximately $3.45 million from the 2011 Private
Placement.
Cash and Cash Equivalents
We consider all liquid investments purchased within 90 days of their original maturity to be cash
equivalents. Our cash and cash equivalents at June 30, 2011, March 31, 2011 and June 30, 2010 were
approximately $3.2 million, $0.3 million and $1.1 million, respectively.
Cash Flows from Operating Activities
For the June 2011 quarter, net cash used in operations was $290,751. The primary use of cash from
operations was general and administrative expenses excluding share-based compensation, which
totaled $396,397 and research and development expenses of $192,132. For this same period, the
primary sources of cash from operations was a net increase in accounts payable of $139,854, as a
result of our cash constraints during the June 2011 quarter and the accrual recorded as of June 30,
2011 in the amount of $140,223 related to the termination of the Viral SRA. For the
June 2010 quarter, net cash used in operations was $663,813. The primary uses of cash from
operations were general and administrative expenses excluding share-based compensation, which
totaled $260,628 and the initial prepayment of $365,000 related to the Diabetes Clinical Trial.
15
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Cash Flows from Investing Activities
For the June 2011 and June 2010 quarters, we did not generate or expend cash from investing
activities.
Cash Flows from Financing Activities
For the June 2011 quarter, we generated $3,178,114 of cash from financing activities from the 2011
Private Placement. This amount was net of offering costs of approximately $324,000. For the June
2010 quarter, we did not generate or expend cash from financing activities.
Anticipated Cash Commitments
As of June 30, 2011, we have obligations to complete the Diabetes Clinical Trial, which we estimate
to be approximately $215,000 and to pay off the amount due to UCD under the termination of the
Viral SRA, which we currently estimate to be approximately $140,000. Beginning in June 2011, we
began to reduce our cash expenditures through a plan to reduce employee headcount, curtail patent
prosecution in certain matters and terminate a research and development project that did not fit
with our AAT commercial opportunities in the near term. We may enter into additional research and
development projects and/or an additional clinical trial in AAT indication that we believe are the
most commercially viable in the near term, subject to raising additional capital from outside
investors or through a potential strategic partnership with a pharmaceutical company.
We expect that the cash raised in the 2011 Private Placement will allow us to operate through our
fiscal year ended March 31, 2012 based on current operating levels, however, we will likely need to
engage in additional capital funding to operate beyond that period. We will also need to raise an
additional $2 million by July 15, 2012 to allow us to purchase an aggregate 40% ownership in
BioMimetix, should we elect to exercise the Warrant.
We currently are pursuing various avenues to obtain additional capital including raising money in
the equity markets and strategic partnerships with pharmaceutical companies. There can be no
assurance that additional capital will be available to us on acceptable terms or at all. Failure to
obtain additional capital will have a material adverse impact on our ability to continue to
operate.
Critical Accounting Policies
We prepare our financial statements in accordance with US GAAP. Our significant accounting
policies are disclosed in Note 2 to our consolidated financial statements contained in our 2011
Form 10-K. The accounting policies most fundamental to the understanding our financial statements
are our use of estimates, including the accounting for clinical trials and other research and
development projects, the computation of share-based compensation and determination of fair value
of our stock price used in those computations; and the capitalization of license agreements and
impairment analysis of the capitalized license costs.
Item 3. | Quantitative and Qualitative Disclosures About Market Risk. |
There have been no material changes in qualitative and quantitative disclosures about market risk
since our 2011 Form 10-K.
16
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Item 4. | Controls and Procedures. |
Evaluation of Disclosure Controls and Procedures
We are responsible for establishing and maintaining disclosure controls and procedures that are
designed to ensure that information required to be disclosed in our Exchange Act reports is
recorded, processed, summarized and reported within the time periods specified in the SECs rules
and forms, and that such information is accumulated and communicated to our management, including
our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions
regarding required disclosure.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer,
evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e)
under the Exchange Act) as of June 30, 2011, and concluded that our disclosure controls and
procedures were effective as of that date.
Change in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting during the quarter ended June
30, 2011 that materially affected, or is reasonably likely to materially affect, our internal
control over financial reporting.
PART II OTHER INFORMATION.
Item 1. | Legal Proceedings. |
We are not a party to any material legal proceedings nor is our property the subject of any
material legal proceedings.
Item 1A. | Risk Factors. |
Other than as set for below, there have been no material changes or updates to the risk factors
previously disclosed in Item 1A. Risk Factors of our 2011 Form 10-K.
BioMimetix has no historical operations and will likely incur significant losses for the
foreseeable future.
We have provided the initial and only funding for BioMimetix. We will have no direct
management control over BioMimetix except to the effect that our Chief Executive Officer, Dr. James
Crapo, is also the Chief Executive Officer of BioMimetix. BioMimetixs success will depend in part
on its ability to obtain and maintain proprietary protection for the patents it licenses, or
alternatively, develops as newly filed patent applications. It is highly likely that BioMimetix
will require funding in excess of the resources that we may provide, even assuming the exercise of
our warrant to invest an additional $2.0 million to purchase additional ownership in BioMimetix.
There is no assurance that BioMimetix will secure additional funding sufficient to develop or
commercialize its intellectual property on acceptable terms to BioMimetix, or at all.
Our Chief Executive Officer is also the Chief Executive Officer and a significant shareholder of
BioMimetix.
Dr. Crapo is our Chief Executive Officer and a member of our Board. Dr. Crapo negotiated his
employment with us on the contingency that he be allowed to serve concurrently as a founder,
officer and director of BioMimetix, when and if it was formed and initially funded in the amount of
$2.0 million. Dr. Crapo is currently the second largest shareholder of BioMimetix next to us. Dr.
Crapo does not take any cash compensation from BioMimetix.
Because Dr. Crapos position and ownership in BioMimetix places him in a fiduciary position
related to both companies, he may be subject to potential conflicts of interest related to his
ownership, control and leadership
of both entities. There is a possibility that Dr. Crapo may be presented with corporate
opportunities that are pursued by BioMimetix rather than us and that may not be directly beneficial
to us.
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Because we will not own a majority voting interest in BioMimetix, we may be unable to control
BioMimetixs business operation or strategic direction.
Although we and Dr. Crapo may own in the aggregate more than 50% of the outstanding shares of
BioMimetix, we have no agreement with Dr. Crapo regarding the corporate strategy and management of
BioMimetix. As such, there is a risk that the corporate goals and strategy of BioMimetix may be
different from those that will directly benefit us and our stockholders.
Our investment in BioMimetix is speculative and risky, and we may not receive any return on such
investment.
BioMimetix is a private company and has no plans to go public in the foreseeable future. If
BioMimetix elects to stay private, or does not take an opportunity to sell out, our investment in
BioMimetix will be illiquid, and we may be unable to obtain a return on our investment in a
reasonable period of time, or at all.
BioMimetixs intellectual property may face competition from other Superoxide Dismutase (SOD)
mimetics companies.
The discovery of the SOD enzyme dates back to 1969 and significant research has been conducted
in the U.S. and internationally by institutions, companies and organizations in this field. The
Duke Patent that BioMimetix has licensed involves composition of matter claims. The beneficial
characteristics of the molecule contained in the Duke Patent may be exceeded by other existing
patents that BioMimetix is not familiar with, or patent applications that may have been recently
filed that BioMimetix has no knowledge of, all of which could interfere with the ability to
commercialize BioMimetixs intellectual property.
We anticipate that BioMimetix may face competition from various companies and institutions
with intellectual property in the field of SOD mimetics and radiation protection.
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds. |
None.
Item 3. | Defaults Upon Senior Securities. |
None.
Item 5. | Other Information. |
None.
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Item 6. | Exhibits. |
EXHIBIT # | DESCRIPTION | |||
3.1 | Articles of Incorporation (incorporated by reference to Exhibit 3.1 to the Registrants
Registration Statement on Form SB-2 filed on March 2, 2007) |
|||
3.2 | Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the Registrants
Current Report on Form 8-K filed on January 5, 2010) |
|||
3.3 | Articles of Amendment for Across America Financial Services, Inc. including Amendment to
Articles of Incorporation of Across America Financial Services, Inc. (incorporated by
reference to Exhibit 3.3 to the Registrants Current Report on Form 8-K filed on June 2, 2009) |
|||
10.1 | Subscription Agreement and Letter of Investment Intent for the 2011 Private Placement # |
|||
10.2 | Form of Investor Warrant for the 2011 Private Placement # |
|||
10.3 | Form of Placement Agent Warrant for the 2011 Private Placement # |
|||
10.4 | Employment Agreement with James D. Crapo dated July 15, 2011 # |
|||
10.5 | Restricted Stock Unit Agreement with James D. Crapo dated August 10, 2011 # |
|||
10.6 | Restricted Stock Unit Agreement with Charles A. Dinarello dated August 10, 2011 # |
|||
31.1 | Certification of Chief Executive Officer Pursuant to Rule 13a-14(a) under the Securities
Exchange Act of 1934 # |
|||
31.2 | Certification of Chief Financial Officer Pursuant to Rule 13a-14(a) under the Securities
Exchange Act of 1934 # |
|||
32.1 | Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Section 1350
of Chapter 63 of Title 18 of the United States Code # |
# | Filed herewith |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
OMNI BIO PHARMACEUTICAL, INC. | ||||||
August 15, 2011
|
By: | /s/ Robert C. Ogden
|
||||
Chief Financial Officer | ||||||
(Principal Financial and Accounting Officer) |
20