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EX-31 - ARROGENE, INCf10q0712exh31.htm
EX-32 - ARROGENE, INCf10q0712exh32.htm


UNITED STATES SECURITIES

AND EXCHANGE COMMISSION



WASHINGTON, D.C. 20549



FORM 10-Q


QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934


For the Quarterly Period Ended July 31, 2012


Commission File Number: 000-52932




ARROGENE, INC.

(Exact name of registrant as Specified in its Charter)


Delaware

 

20-8057585

(State or Other Jurisdiction of
Incorporation or Organization)

 

(Internal Revenue Service
Employer Identification Number)

 

 

 

2500 Broadway, Bldg. F, Suite F-125
Santa Monica, CA

 

90404

(Address of Principal Executive Offices)

 

(Zip Code)


(310) 359-1680

(Issuer’s Telephone Number)


(Former name or former address, if changed since last report.)

Formerly Known As SRKP 16, Inc.



Securities registered under Section 12(b) of the Exchange Act:

None


Securities registered under Section 12(g) of the Exchange Act:

Common Stock, $.0001 par value per share


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 x   No o


Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (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 x   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 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)

 

 



1








Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act):  Yes o   No x


APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PRECEDING FIVE YEARS


Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court:  Yes o   No  o 


APPLICABLE ONLY TO CORPORATE USERS


As of September 12, 2012 the registrant had 21,090,860 shares of its common stock ($.0001 par value) outstanding.







2





TABLE OF CONTENTS


 

 

 

 

Page

 

 

PART I — FINANCIAL INFORMATION

 

 

 

 

 

 

 

Item 1.

 

Financial Statements

 

4

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets as of July 31, 2012 (unaudited) and October 31, 2011

 

4

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations for the three and nine months ended July 31, 2012 and July 31, 2011 (unaudited) and for the period from inception (August 7, 2007) through July 31, 2012

 

5

 

 

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the nine months ended July 31, 2012 and July 31, 2011 (unaudited) and for the period from inception (August 7, 2007) through July 31, 2012

 

6

 

 

 

 

 

 

 

Condensed Consolidated Statement of Stockholders’ Equity (Deficit) for the nine months ended July 31, 2012 (unaudited)

 

7

 

 

 

 

 

 

 

Notes to Unaudited Condensed Consolidated Financial Statements (unaudited)

 

8

 

 

 

 

 

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

16

 

 

 

 

 

 

 

Overview

 

17

 

 

 

 

 

 

 

Results of Operations

 

20

 

 

 

 

 

 

 

Liquidity and Capital Resources

 

21

 

 

 

 

 

Item 3.


Item 4.

 

Quantitative and Qualitative Disclosures About Market Risk


Controls and Procedures

 

23

 

 

 

 

 

 

 

PART II — OTHER INFORMATION

 

24

 

 

 

 

 

Item 1.


Item 1A.

    

Legal Proceedings


Risk Factors

 

24

 

 

 

 

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

24

 

 

 

 

 

Item 3.

 

Defaults Upon Senior Securities

 

24

 

 

 

 

 

Item 4.

 

[Removed and Reserved]

 

24

 

 

 

 

 

Item 5.

 

Other Information

 

24

 

 

 

 

 

Item 6.

 

Exhibits

 

24




3





PART 1.  FINANCIAL INFORMATION


Item 1.   Financial Statements

ARROGENE, INC.  

(A Development Stage Enterprise)


CONDENSED CONSOLIDATED BALANCE SHEETS

AS OF JULY 31, 2012 (UNAUDITED) AND OCTOBER 31, 2011


 

 

July 31,
2012

 

October 31,
2011

 

 

 

(Unaudited)

 

 

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

636,709

 

$

2,094

 

Prepaid expenses and deposit

 

17,250

 

10,024

 

Total current assets

 

653,959

 

12,118

 

 

 

 

 

 

 

Property and equipment, net

 

2,168

 

1,242

 

Total assets

 

$

656,127

 

$

13,360

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)

 

 

 

 

 

 

 

 

 

 

 

LIABILITIES:

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accrued compensation

 

$

10,460

 

$

79,453

 

Accrued legal fees

 

17,147

 

153,547

 

Related party payables                                                                                                            

 

11,300

 

66,350

 

Other payables and accrued expenses

 

36,438

 

9,747

 

Convertible notes

 

10,000

 

726,550

 

Total current liabilities

 

85,345

 

1,035,647

 

 

 

 

 

 

 

Total liabilities

 

85,345

 

1,035,647

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY (DEFICIT):

 

 

 

 

 

 

 

 

 

 

 

Preferred stock, $.0001 par value 10,000,000 shares authorized, none issued

 

 

 

Common stock, $.0001 par value; 100,000,000 shares authorized; 20,965,860 and 11,091,900 shares, respectively, issued and outstanding  

 

2,097

 

1,109

 

Additional paid-in capital

 

3,957,305

 

498,468

 

Deficit accumulated during the development stage

 

(3,388,620

)

(1,521,864

)

Total stockholders’ equity (deficit)

 

570,782

 

(1,022,287

)

Total liabilities and stockholders’ equity (deficit)

 

$

656,127

 

$

13,360

 


The accompanying notes are an integral part of these financial statements.



4






ARROGENE, INC.


(A Development Stage Enterprise)


  CONDENSED STATEMENTS OF OPERATIONS


FOR THE THREE AND NINE MONTHS ENDED JULY 31, 2012

AND 2011 AND THE PERIOD FROM AUGUST 7, 2007 (INCEPTION) THROUGH JULY 31, 2012

(Unaudited)


 

Three Months Ended
July 31,

 

Nine Months Ended
July 31,

 

Cumulative From Inception (August 7, 2007) through July 31, 2012

 

2012

 

2011

 

2012

 

2011

 

 

 

 

 

 

 

 

 

 

 

 

REVENUE

$             —

 

 

$              —

 

$

            —  

 

 

$                  —

 

$                 —

 

 

 

 

 

 

 

 

 

 

OPERATING EXPENSES:

 

 

 

 

 

 

 

 

 

Licensing fees

 

 

480,430

 

 

480,430

Research and development

32,250

 

 

61,182

 

 

61,182

General and administrative

190,386

 

170,782

 

567,895

 

693,755

 

1,967,997

 

222,636

 

170,782

 

1,109,507

 

693,755

 

2,509,609

 

 

 

 

 

 

 

 

 

 

Loss from operations

(222,636

)

(170,782

)

(1,109,507

)

(693,755

)

(2,509,609)

 

 

 

 

 

 

 

 

 

 

OTHER EXPENSE:

 

 

 

 

 

 

 

 

 

Interest

(84

)

(45,301

)

(757,249

)

(84,000

)

(879,011)

 

(84

)

(45,301)

 

(757,249

)

(84,000

)

(879,011)

 

 

 

 

 

 

 

 

 

 

NET LOSS

$    (222,720

)

$       (216,083

)

$    (1,866,756

)

$           (777,755

)

$   (3,388,620)

 

 

 

 

 

 

 

 

 

 

WEIGHTED AVERAGE SHARES OUTSTANDING:

 

 

 

 

 

 

 

 

 

Basic and diluted

20,743,686

 

10,991,900

 

16,496,425

 

10,991,900

 

N/A


LOSS PER SHARE:

Basic and diluted

$          (0.01)

 

$             (0.02)

 

$          (0.11)

 

$                (0.07)

 



N/A



The accompanying notes are an integral part of these financial statements.



5





ARROGENE, INC.

(A Development Stage Enterprise)


STATEMENTS OF CASH FLOWS


FOR THE NINE MONTHS ENDED JULY 31, 2012 AND 2011

AND THE PERIOD FROM AUGUST 7, 2007 (INCEPTION) THROUGH JULY 31, 2012


 

 

2012

 

2011

 


Cumulative From
Inception (August 7, 2007) Through July 31, 2012

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

Net loss

 

$

(1,866,756

)

$

(777,755

)

$

(3,388,620)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Non-cash charge for reduction in conversion price of Convertible Notes

 

726,550

 

 

726,550

Amortization of debt placement costs

 

 

83,826

 

121,517

Share-based payment expense

 

462,830

 

167,440

 

714,110

Depreciation expense

 

528

 

398

 

1,075

Increase in prepaid services and deposit

 

(7,226)

 

  (12,048)

 

(17,250)

Increase (decrease) in other payables and accrued expenses

 

(201,102) 

 

(34,648

268,394

Increase (decrease) in related party payables

 

(55,050)

 

(3,500

11,300

Net cash used in operating activities

 

(940,226

)

(576,287

)

(1,562,924)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

   Cash acquired in business acquisition

 

389,688

 

 

389,688

   Capital expenditures

 

(1,454

)

(1,789

)

(3,243)

        Net cash provided by (used in) investing activities

 

388,234

 

(1,789

)

386,445

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

Proceeds received from Promissory Notes

 

80,000

 

 

80,000

Repayments of Promissory Notes

 

(80,000

)

 

(80,000)

Net proceeds from sale of Units

 

1,186,607

 

 

1,186,607

Net proceeds from sale of Convertible Notes

 

 

472,399

 

624,351

Proceeds from sale of Series A Preferred Stock

 

 

 

930

    Advances from related parties

 

 

 

1,300

Net cash provided by financing activities

 

1,186,607

 

472,399

 

1,813,188

 

 

 

 

 

 

 

Net increase (decrease) in cash

 

634,615

 

(105,677

)

636,709

Cash and cash equivalents at the beginning of period

 

2,094

 

110,158

 

Cash and cash equivalents at the end of period

 

$

636,709

 

$

4,481

 

$

636,709




The accompanying notes are an integral part of these financial statements.





6





ARROGENE, INC.


CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY (DEFICIT)


FOR THE NINE MONTHS ENDED JULY 31, 2012

(UNAUDITED)


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preferred Stock

 

 

Common Stock

 

 

 

Deficit Accumulated in Development

 

 

 

 

 

Shares

 

Amount

 

 

Shares

 

Amount

 

APIC

 

Stage

 

Total

 

BALANCES,
October 31, 2011

…………………………………

 

 

$

 

 

11,091,900

 

$

1,109

 

$

498,468

 

$

(1,521,864

)

$

(1,022,287)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares issued for licensing agreement…………….

 

 

 

 

1,468,100

 

147

 

440,283

 

 

440,430

 

Business acquisition……………………………….

 

 

 

 

2,243,610

 

224

 

389,464

 

 

389,688

 

Sale of Units……………………………………….

 

 

 

 

1,385,250

 

139

 

1,186,468

 

 

1,186,607

 

Conversion of Convertible Notes into common stock…………………………………………….

 

 

 

 

4,777,000

 

478

 

1,442,622

 

 

1,443,100

 

Net loss

……………………………………………..

 

 

 

 

 

 

 

(1,866,756

)

(1,866,756)

 

BALANCES, July 31,
2012

 

 

$

 

 

20,965,860

 

$

2,097

 

$

3,957,305

 

$

(3,388,620

)

$

570,782

 


The accompanying notes are an integral part of these financial statements.



7






ARROGENE, INC.

(A Development Stage Enterprise)


NOTES TO CONDENSED CONSOLIDATED

FINANCIAL STATEMENTS

(UNAUDITED)


JULY 31, 2012 and 2011


(1)

BUSINESS AND OVERVIEW


Arrogene, Inc. (“Arrogene” f/k/a SRKP 16, Inc.), was incorporated under the laws of the State of Delaware on December 7, 2006.  On January 11, 2012, we consummated a reverse merger transaction (the “Reverse Merger”) with Arrogene Nanotechnology, Inc. (“ANI”), a company focused on oncology.  Hereafter, SRKP 16, Inc. and Arrogene are collectively referred to as the “Company.”  Effective September 4, 2012, SRKP 16, Inc. officially changed its name to Arrogene, Inc.


As a result of the Reverse Merger, the shareholders of ANI received 12,660,000 shares of Company common stock or approximately 86 % of the issued and outstanding common shares of the Company after the transaction.  Further, ANI warrant holders received identical common stock purchase warrants in the Company.  Additionally, immediately after the Reverse Merger, the officers of ANI became the officers of the Company and the Company’s Board of Directors consists solely of former ANI officers and directors. For accounting purposes, the Reverse Merger has been treated as an acquisition of the Company by ANI(the accounting acquirer) and a recapitalization of ANI.  As a result, the financial statements for all periods presented and discussed herein are those of ANI.  Concurrently with consummating the Reverse Merger, the Company sold 502,000 units (the “Units”), with each Unit consisting of  (i) one share of common stock, and (ii) two common stock purchase warrants (the “SRKP Warrants”) that are exercisable for five years from the date of issuance.  One of the SRKP Warrants is exercisable at $1.50 per share and the other is exercisable at $2.00 per share.  The Company received $404,688 in net proceeds from the sale of the Units after payment of commissions and other expenses associated with the offering, of which, $389,688 was acquired by ANI at the time of the Reverse Merger.  


The Company has an exclusive license (the License) to a family of related nano-biopolymers collectively referred to as Polycefin that are expected to be capable of acting as a drug delivery and targeting platform for cancer therapy and diagnositcs based on pre-clinical studies conducted at Cedars-Sinai Medical Center (“CSMC”).  Polycefin are designed to target cancer cells and deliver a variety of bound therapeutics to them.   In vivo pre-clinical studies have shown evidence that existing cancer drugs could have increased efficacy and reduced side effects when attached to the Polycefin platform.  We believe that Polycefin has the ability to harbor various drugs at the same time making it possibly a master delivery vehicle that can be customized for a particular tumor and potentially for an individual patient.  Additionally, in vivo testing has shown efficacy against more than one type of cancer (breast and brain) suggesting that Polycefin may have application to a wide range of cancer types, therapeutics and diagnostics.


We plan on commercializing our products using a licensing and cost sharing strategy, seeking to enter into arrangements with major pharmaceutical companies with existing cancer therapy drugs facing issues relating to patent expirations, market expansion or contraction.   It is our goal to only commence Phase I clinical trials with a commitment from a licensee to complete Phase II and III clinical trials, predicated on the successful outcome of each phase, and go to market, if approval is received.  Further, we are also exploring use of Polycefin as a potential medical diagnostic product(s) for oncology related applications.   We also have developed intellectual properties surrounding Laminin-411, a new bio-marker that the Company believes can be used as a diagnostic and prognostic test on biopsies for certain types of cancers. The Company has completed a clinical trial with over 400 human patients’ biopsies and is in the process of securing regulatory clearances to begin commercializing this new test as a Laboratory Developed Test (“LDT”).   The Company also expects Laminin-411 to be used as a targeting bio-marker for its Polycefin drugs



8





targeting certain cancers and it has published a paper on its in-vivo results for Glioblastoma that utilized Laminin-411. The Company is currently investigating applications of Laminin-411 in other cancers.


Pre-clinical investigation is also on-going on methods of inhibiting Laminin-411 as a therapeutic agent, which could be conjugated in various forms of Polycefin in the future.  The majority, of our planned products will require approval or marketing clearance from the United States Food and Drug Administration (the “FDA”).  To date we have not filed any applications with the FDA, but we have begun the process of validating our LDT with applicable regulators.


Since its inception in August 2007, ANI’s principal activities have involved developing a business strategy, raising capital, identifying and licensing the Polycefin technology, development of the technology, expanding intellectual property rights, and recruiting management, key staff, and board members.  For accounting purposes, the Company is considered a development stage company in accordance with Accounting Standards Codification (“ASC”) 915.  


(2) GOING CONCERN, MANAGEMENT’S PLANS AND BASIS OF PRESENTATION


Going Concern and Management’s Plans


The accompanying financial statements have been prepared assuming that the Company will continue as a going concern.  In connection with our audit as of and for the year ended October 31, 2011, our independent public accountants issued an opinion expressing substantial doubt about our ability to continue as a going concern.  Since our inception in August 2007, we have not generated revenue, incurred cash and operating losses, and as of July 31, 2012, had a deficit accumulated during the development stage of $3,388,620. We have relied primarily upon proceeds from the sale of convertible notes (the “Convertible Notes”) and Units to fund our operations.


As discussed above, in connection with the Reverse Merger, the Company sold 502,000 Units receiving net proceeds of $404,688 of which $389,688 remained at the time of the Reverse Merger.  Subsequent to the Reverse Merger, we have sold an additional 1,385,250 Units receiving net proceeds of $1,186,607 after payment of commissions and offering expenses. As of July 31, 2012, the Company’s cash balance was $636,709.  We are continuing to market the sale of Units and expect to have at least one additional closing before terminating the private placement. The Company is authorized to sell up to 4.0 million Units in the aggregate.  Management believes that existing cash on hand, combined with proceeds received from an additional sale of Units subsequent to July 31, 2012, described below in Note 5, will be sufficient to fund the Company’s planned activities and contractual obligations through at least the end of the Company’s first quarter of fiscal year 2013.   Accordingly, the Company will require additional funding, whether through the sale of Units or from alternative sources within the next six months.


In the event that we cannot raise sufficient capital within the required timeframe, it will have a material adverse effect on the Company’s liquidity, financial condition and business prospects or force the Company out of business.  The accompanying financial statements do not include adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from an inability of the Company to continue as a going concern.


Basis of Presentation


The accompanying condensed consolidated financial statements include the accounts of Arrogene and its wholly owned subsidiary ANI.  All intercompany transactions have been eliminated in consolidation.  The condensed consolidated financial statements have been prepared without audit pursuant to the rules and regulations of the Securities and Exchange Commission.  Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States have been condensed or omitted pursuant to such rules and regulations.  The condensed consolidated financial statements reflect all adjustments (consisting of only normal recurring entries), which in the opinion of management, are necessary to present fairly the financial position at July 31, 2012 and the results of operations and cash flows of the



9





Company for the three and nine months ended July 31, 2012 and 2011.  Operating results for the nine months ended July 31, 2012, are not necessarily indicative of the results that may be expected for the year ended October 31, 2012.



The unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and footnotes thereto for the year ended October 31, 2011 filed on Form 8-K on January 18, 2012.  


Use of Estimates and Assumptions


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 and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reported periods.  Actual results may differ from these estimates.


(3)

LICENSE AGREEMENT


On December 23, 2009, we entered into an agreement for the right to an exclusive license agreement with CSMC which provides us with the world-wide rights to U.S Patent No. 7,547,511 “Antisense Inhibition of Laminin-8 Expression to Inhibit Human Gliomas” along with related technical information to develop, market and sell human therapeutic and diagnostic products, including new pharmaceutical products and/or non-prescriptive products using the patented technology (the “CSMC Agreement”).  The CSMC Agreement has been amended four times; December 8, 2010, June 30, 2011, August 31, 2011 and October 28, 2011. The CSMC Agreement also provides us with the rights to several other related, filed, but yet unissued patents.  The CSMC Agreement requires royalty payments equal to 3.5% of the gross sales price and other forms of consideration (such as milestone and sublicense payments), as defined in the agreement, on all products using the licensed technology.  The CSMC Agreement expires on a country-by-country basis on the date that the last patent covered under the agreement expires (currently 2029).


In connection with effectuating the License, on November 2, 2011, we paid a non-refundable licensing fee of $40,000 as well as issued to CSMC 1,468,100 shares of common stock.  We valued the shares issued to CSMC at $.30 per share based on Convertible Notes most recently issued.  Accordingly, we recorded $440,430 as a licensing fee to reflect the issuance of these shares.  


The CSMC Agreement also requires us to achieve certain other milestones in order to maintain the agreement.  These include the following:


·

Begin development or enter into a joint venture, licensing or sub-licensing agreement, or other business arrangement with a third party not an affiliate of the Company to cause development of at least one product consistent with sound business practices by December 31, 2012;

·

Expend at least $500,000 in the aggregate toward the development or promotion of the sale of products based on the licensed patent rights or technical information commencing from the effective date of the agreement and continuing through and including December 31, 2012, and at least $1,000,000 annually thereafter, for further development or promotion of the sale of products through and including December 31, 2013;

·

Provide to CSMC at least $150,000 (in aggregate) within at least a four year period to fund research and development of the licensed patent rights and technical information;

·

On or before December 31, 2013, the Company shall have commenced a clinical trial or trials in connection with at least one intended commercial use;


We believe that we have, or we will, achieve the required milestones for the period ended December 31, 2012.  It is management’s belief that cash administrative expenses in support of the Company’s business activities meet the definition of “development and promotion” of the licensed technology. We can, however, provide no assurance that we will be able to meet any or all of these milestones in the future.




10





Further, in the event the Company issues or sells shares of common stock in addition to those sold in the private placement of Units previously discussed, the CSMC Agreement requires that the Company issue to CSMC additional shares of common stock for no additional consideration so as to assure CSMC will own 5% of the total issued and outstanding shares of the Company until December 31, 2015.  


(4)

CONVERTIBLE NOTES


Commencing October 2010 through April 2011, we sold in private transactions an aggregate of $726,550 of Convertible Notes.  The Convertible Notes were initially convertible into shares of our common stock at $.30 per share (the “Conversion Price”). The Convertible Notes do not bear interest and were originally payable on October 19, 2011. However, in October 2011, a majority of the note holders agreed to extend the maturity date of the notes to December 15, 2011.  The Convertible Notes are secured by a first lien security interest on all of our tangible and intangible assets.  The Convertible Notes automatically convert into shares of our common stock at the then current Conversion Price in the event that  (i) there is an effective registration statement registering the underlying common shares or the shares are eligible to be resold without restriction or limitation under Rule 144 of the Securities Act of 1934 and (ii) the closing bid price of our common stock as quoted on the OTC Bulletin Board or other principal trading market is at least 200% of the Conversion Price for 20 out of 30 consecutive trading days with an average daily trading volume of at least 1.0 million shares.  However, the Convertible Notes contain a provision that prohibits a holder from converting the note if such conversion would result in the holder owning more than 4.99% of our outstanding common stock at the time of such conversion.  Holders of the Convertible Notes have no voting, preemptive, or other rights of shareholders.


Events of default include failure to pay principal when due and payable; a failure to observe or perform any covenant, agreement or warranty, or otherwise breach, any term contained in the Convertible Notes or related borrowing documents that is not remedied within 30 days of notice; or if a proceeding commences under the United States Bankruptcy Code (whether voluntary or involuntary) and such proceeding is not controverted within 30 days or dismissed within 60 days after commencement.  An event of default can only be declared by a vote of the majority of the principal amount of the holders of the Convertible Notes upon not less than 30 days written notice to the Company.  If we fail to cure the default within the 30 day period, then the Conversion Price shall be reduced to $.15 per common share and the holders may declare all amounts due under the Convertible Notes immediately due and payable, apply to a court in California for the appointment of a receiver, convert the Convertible Notes to common stock or assert any other remedy available at law or in equity.


We did not repay the Convertible Notes by the December 15, 2011 extended maturity date and the notes were therefore technically in default.  As an inducement to obtain conversions, we agreed to reduce the conversion price of the Convertible Notes to $.15 per share.  During the nine months ended July 31, 2012, holders converted $716,550 of Convertible Notes into 4,777,000 shares of common stock.  $10,000 of Convertible Notes remains outstanding as of July 31, 2012.  As a result of the reduction in conversion price, we recorded a charge of $726,550, in accordance with ASC 470-50-40, which is included in interest expense on the accompanying condensed consolidated statements of operations.


In connection with the sale of the Convertible Notes, we paid the placement agent cash commissions equal to 10% of the gross proceeds received from the sale  (except for sales of Convertible Notes to Company identified purchasers including management and directors for which we paid cash commissions equal to 5%) and we issued to the placement agent common stock purchase warrants to acquire a number of common shares equal to 10% of the common shares issuable upon conversion of the Convertible Notes (the “Placement Agent Warrants”).  The Placement Agent Warrants have an exercise price of $0.30 per share and expire on October 19, 2015. We paid the placement agent cash commissions of $67,905 and issued warrants exercisable to purchase an aggregate of 242,183 shares of common stock.  We recorded the cash commissions and the fair value of the Placement Agent Warrants as debt placement costs which were amortized to interest expense over the original term of the Convertible Notes.  We used the Black-Scholes option pricing model to determine the fair value of the Placement Agent Warrants. For the nine months ended July 31, 2012 and 2011, we amortized $0 and $83,826, respectively, of debt placement costs which is included in interest expense on the accompanying condensed consolidated statements of operations.  For the three months ended July 31, 2012 and 2011, we amortized $0 and $45,214, respectively.




11





The assumptions used in valuing the Placement Agent Warrants issued during the nine months ended July 31, 2011 follows below.  The expected life used in the calculation was the life of the warrants at the date they became issuable.  The risk free interest rate was derived from U.S. government treasury securities for similar lived periods.  The volatility rate used was derived from a peer group of comparable public companies.


 

 

Nine Months ended July 31,

 

 

 

2012

 

2011

 

 

 

 

 

 

 

Risk free interest rate

 

 

N/A

 

 

1.47

 - 2.04%

Expected life

 

 

N/A

 

 

54.0-

58.5 mos.

Dividend yield

 

 

N/A

 

 

0

%

Volatility

 

 

N/A

 

 

83.28

%-84.5%


We evaluated the conversion feature of the Convertible Notes within the context of ASC 815 and concluded that it did not meet the definition of an embedded derivative due to the Company being privately held with no active market for its common stock.

 


(5)

STOCKHOLDERS’ EQUITY


Our articles of incorporation authorizes our board of directors (the “Board”) to issue up to 10,000,000 shares of preferred stock and allows the Board to determine preferences, conversion and other rights, voting powers, restrictions, limitations as to distributions, qualifications, and other terms and conditions.


 Preferred Stock


In connection with the Reverse Merger in January 2012, all outstanding shares of preferred stock, 1,030,000 shares in aggregate, were converted into 10,722,000 shares of common stock.


Common Stock


In connection with the formation of the Company, we issued 238,000 shares of common stock to founders.  We ascribed no value to these shares as management believes that the value of the common stock was $0 until after consummation of the CSMC Agreement in December 2009 and receipt of adequate funding.  


In December 2009, we issued to CSMC 31,900 shares of common stock in connection with entering into the CSMC Agreement.  We ascribed no value to the common shares issued to CSMC.  As described above in Note 3, in November 2011, we issued to CSMC 1,468,100 shares of common stock in order to effectuate the License. We valued the shares issued to CSMC at $.30 per share based on the stated conversion price of the Convertible Notes most recently issued.


In connection with accounting for the Reverse Merger, we are deemed to have issued to the shareholders of SRKP, 2,143,610 shares of common stock which we recorded at  $389,688 representing the net assets received in the acquisition.  As part of the same transaction, 100,000 shares of common stock were issued to legal counsel.



Units


As described above in Note 2, during the nine months ended July 31, 2012, we sold 1,385,250 Units for $1.00 per Unit, receiving net proceeds of $1,186,607 after payment of commissions and offering expenses. Each Unit consists of  (i) one share of common stock, and (ii) two SRKP Warrants.  




12





Subsequent to July 31, 2012, we sold an additional 125,000 Units receiving net proceeds of $102,377.


Warrants


On August 24, 2010, we entered into a financial advisory agreement with an investment banking firm to provide certain services over a six month period.  As compensation for the services, we issued common stock purchase warrants to acquire 840,000 shares of common stock at $.001 per share exercisable for five years from the date of issuance (the “Advisory Warrants”).  We recorded the Advisory Warrants at their fair value of $251,160 using the Black-Scholes option pricing model. We amortized the Advisory Warrants over the six month term of the agreement.  For the three months ended July 31, 2012 and 2011, we amortized $0 and $0, respectively, of Advisory Warrants.   For the nine months ended July 31, 2012 and 2011, we amortized $0 and $167,440, respectively, which is included in general and administrative expense on the accompanying condensed consolidated statements of operations.   


In connection with the sale of the Units, we are obligated to issue to the placement agents warrants to acquire 415,575 shares of common stock (the “Unit Placement Warrants”) with 138,525 warrants exercisable at $1.00 per share, 138,525 exercisable at $1.50 per share and 138,525 warrants exercisable at $2.00 per share.  Each warrant expires five years from the date of issuance.  As described above, in connection with the sale of the Units, we issued to the investors 1,385,250 warrants exercisable at $1.50 per share and 1,385,250 warrants exercisable at $2.00 per share.  These warrants expire on June 30, 2017.


In connection with the Reverse Merger, we assumed warrants from the sale of the Units to acquire 1,154,600 shares of common stock; 50,200 with an exercise price of $1.00 per share, 552,200 with an exercise price of $1.50 per share, and 552,200 with an exercise price of $2.00 per share.  Each warrant expires on January 11, 2017


(6)

PROMISSORY NOTES

In November 2011, the Company entered into two promissory note agreements each for $40,000 for an aggregate of $80,000 (the “Promissory Notes”).  The Promissory Notes did not bear interest but required repayment of $44,000 representing principal and an origination fee.  The Promissory Notes were to mature on January 30, 2012.  In addition to the required payment of principal and origination fee, upon repayment of each Promissory Note, the Company was obligated to issue 20,000 shares of common stock.  In the event the Promissory Notes were not repaid by January 30, 2012, the Company was to issue an additional 2,000 shares of common stock under each note for each thirty day period until the note is paid in full.  The Promissory Notes were unsecured.  

The Promissory Notes were repaid in full in January 2012.  Included in interest expense for the nine months ended July 31 2012 is $8,000 representing the origination fees.  Also included in interest expense for the nine months ended July 31, 2012 is $22,400 representing the value of the 40,000 shares of common stock issuable to the makers of the Promissory Notes.  As of July 31, 2012, these shares had not been issued, and accordingly, the associated liability is included in other payables and accrued expenses on the accompanying condensed consolidated balance sheet.

(7)

EARNINGS (LOSS) PER SHARE


Earnings (loss) per share are calculated in accordance with the provisions of ASC 260 “Earnings Per Share” (“ASC 260”). Under ASC 260, basic earnings (loss) per share are computed by dividing the Company’s income (loss) by the weighted average number of common shares outstanding. The impact of any potentially dilutive securities is excluded. Diluted earnings per share are computed by dividing the Company’s income (loss) attributable to common shareholders by the weighted average number of common shares and dilutive potential common shares outstanding during the period. In calculating diluted earnings per share, we utilize the “treasury stock method” for all stock options and warrants and the “if converted method” for all other convertible securities. For all periods presented, the basic and diluted loss per share is the same as the impact of potential dilutive common shares is anti-dilutive.



13






Warrants and convertible securities excluded from the calculation of diluted loss per share are as follows:


 

 

Three and Nine Months Ended
July 31
,

 

 

 

 

2012

 

2011

 

 

 

 

 

 

 

 

 

Warrants

 

5,422,858

 

1,082,183

 

 

Convertible debt

 

66,667

 

2,421,833

 

 



(8)  SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION


Cash paid during the period for:

 

 

Nine Months Ended July 31,

 

Cumulative from Inception

 

 

2012

 

2011

 

(August 7, 2007)

Interest

 

$

8,299

 

$

174

 

$           8,543

Income taxes

 

 

 


Supplemental disclosures of noncash investing and financing activities:

 

 

Nine Months Ended July 31,

 

 

 

2012

 

2011

 

 

 

 

 

 

 

Fair value of warrants issued under placement agent and advisory agreements

 

 

$                 —

 

 

$       34,233

 

Convertible Notes converted into common stock

 

 

716,550

 

 

 



(9)  COMMITMENTS, CONTINGENCIES, AND RELATED PARTY TRANSACTIONS


Related Party Transactions


Advances


During the year ended October 31, 2009, certain directors made nominal advances to the Company in order to fund operating expenses.  The advances were made on an informal basis and not pursuant to any documented agreement.  Accordingly, there is no stated repayment term or interest rate.  As of July 31, 2012 and October 31, 2011, the advances aggregated $1,300 and are included in related party payables on the accompanying condensed consolidated balance sheets.   The Company intends on repaying these advances during the year ended October 31, 2012.

 

Consulting Agreements


In December 2008, we entered into an agreement with an entity controlled by our chief executive officer for his services (the “Synthetica Agreement”).  The Synthetica Agreement was replaced by a second agreement for the personal services of our chief executive officer in July 2011.   Under the Synthetica Agreement, there was no monthly retainer or minimum billing amount but the maximum that could be charged to us in any given month could not exceed $15,000.  During the three months ended July 31, 2012 and 2011, we were billed $45,000 and $45,000, respectively, under these agreements.  During the nine months ended July 31, 2012 and 2011, we were billed $135,000 and



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$135,000, respectively, under these agreements. In October 2011, we issued 100,000 shares of common stock to Synthetica, Ltd (“Synthetica”) in satisfaction of $100,000 in accrued compensation that had been earned under the agreement.  At July 31, 2012 and October 31 2011, $0 and $60,000, respectively, is included in accrued compensation for amounts owed to Synthetica on the accompanying condensed consolidated balance sheets.  


In September 2010, we entered into a business and financial consulting agreement with an entity controlled by our Board chairman.   The agreement was for an initial term of 12 months with an automatic 12 month renewal period unless terminated by either party upon 30 days written notice.  There is no monthly retainer or minimum billing amount but the maximum that can be billed to us in a given month cannot exceed $10,000.  During the three months ended July 31, 2012 and 2011, we were charged $30,000 and $30,000, respectively, under this agreement which is included in general and administrative expense on the accompanying condensed consolidated statements of operations.  During the nine months ended July 31, 2012 and 2011, we were charged $90,000 and $90,000 under this agreement. At July 31, 2012 and October 31, 2011, $10,000 and $40,000, respectively, is included in related party payables on the accompanying balance sheets.


CSMC


Certain founders and directors of the Company are employees of CSMC.  These individuals are also the inventors of the Polycefin technology and are primarily responsible for its development.  Additionally, CSMC is a significant shareholder in the Company.  As described further in Note 3 above, we have an exclusive license agreement with CSMC for this technology.  


The CSMC Agreement requires royalty payments equal to 3.5% of the gross sales price and other forms of consideration (such as milestone and sublicense payments), as defined in the agreement, on all products using the licensed technology.  


Lease Agreement


For the period commencing November 2010 through March 2012, we had an agreement (the “Sublease”) with Compumed, Inc. (“Compumed”) for office space whereby we subleased space from Compumed.  Our chief executive officer also serves as the chief executive officer of Compumed.  The Sublease required monthly payments of $8,000 and was on a month-to-month basis.  The Sublease was approved by our Board.   For the three months ended July 31, 2012 and 2011 we recorded $0 and $24,000, respectively, of rent expense which is included in general and administrative expense on the accompanying condensed consolidated statements of operations.   For the nine months ended July 31, 2012 and 2011, we recorded $40,000 and $72,000, respectively, of rent expense under the Sublease. Additionally, at October 31, 2011, $24,000 of accrued but unpaid rent is included in related party payables on the accompanying condensed consolidated balance sheets.


Commitments and Contingencies


Litigation


From time to time, we may become party to litigation and other claims in the ordinary course of business.  To the extent that such claims and litigation arise, management would provide for them if upon the advice of counsel, losses are determined to be both probable and estimable.  We are currently not party to any litigation.


Office Lease


Effective March 1, 2012, we entered into a lease agreement for office space with a third party (the “Office Lease”).  The Office Lease requires eight monthly payments of $3,338 plus costs for incidental expenses.  We are recognizing



15





rent expense over the lease term using the straight-line method resulting in monthly expense of $2,226.  The Office Lease expires on February 29, 2013.



ITEM 2.

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION OR PLAN OF OPERATION


FORWARD LOOKING STATEMENTS


Our disclosure and analysis in this Quarterly Report on Form 10-Q (this “Form 10-Q”), in other reports that we file with the Securities and Exchange Commission, in our press releases and in public statements of our officers contain forward-looking statements.  Forward-looking statements are based on the current expectations of, or forecasts of future events made by, our management.  Forward-looking statements may turn out to be wrong.  They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties.  Many factors mentioned in this Form 10-Q, for example governmental regulation, general economic and capital market conditions in the United States, and competition in our industry, will be important in determining future results.  No forward-looking statement can be guaranteed, and actual results may vary materially from those anticipated in any forward-looking statement.


You can identify forward-looking statements by the fact that they do not relate strictly to historical or current events.  They use words such as “anticipate,” “estimate,” “expect” “will,” “may,” “intent,” “plan,” “believe,” and similar expressions in connection with discussion of future operating or financial performance.  These include statements relating to future actions, prospective products or product approvals, future performance or results of anticipated products, expenses, financial results or contingencies.


Although we believe that our plans, intentions and expectations reflected in these forward-looking statements are reasonable, we may not achieve these plans or expectations.  Forward-looking statements in this Form 10-Q will be affected by several factors, including the following: the ability of the Company to raise sufficient capital to finance its planned activities including completing development of its Polycefin technology; the ability of the Company to meet its obligations under the License including meeting the required milestones; receiving the necessary marketing clearance approvals from the United States Food and Drug Administration; successful clinical trials of the Company’s planned products including the ability to enroll the studies in a timely manner, patient compliance with the study protocol, and a sufficient number of patients completing the studies; the ability of the Company to commercialize its planned products; the ability of the Company to successfully manufacture its products in commercial quantities (through contract manufacturers); market acceptance of the Company’s planned products, the Company’s ability to successfully develop its licensed compounds, alone or in cooperation with others, into commercial products, the ability of the Company to successfully prosecute and protect its intellectual property, the Company’s limited operating history; the Company’s lack of profitability; and the Company’s ability to hire, manage and retain qualified personnel.  Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained in this Form 10-Q.  In particular, this Form 10-Q sets forth important factors that could cause actual results to differ materially from our forward-looking statements.  These and other factors, including general economic factors, business strategies, the state of capital markets, regulatory conditions, and other factors not currently known to us, may be significant, now or in the future, and the factors set forth in this Form 10-Q may affect us to a greater extent than indicated.  All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements set forth in this Form 10-Q and in other documents that we file from time to time with the Securities and Exchange Commission including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K to be filed in 2012.  Except as required by law, we do not undertake any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.




16





MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS


This management’s discussion and analysis of financial condition and results of operations should be read in conjunction with the Company’s financial statements and the related notes, and the other financial information included in this current report.


Overview


The Company was founded to commercialize both a new cancer treatment targeting technology and a proprietary molecular delivery platform that interferes with those targets in order to inhibit and finally eradicate tumor progression.  The Company is the exclusive licensee to certain intellectual property rights owned by CSMC in Los Angeles, one of the nation’s premiere research institutions.  CSMC has developed a family of related nano-biopolymers (collectively referred to here as Polycefin), believed capable of acting as a drug delivery and targeting platform for cancer therapy.  The founders of Arrogene were principally involved in all research and development behind all critical discoveries and science at CSMC related to Polycefin and authored all the patents underlying the technologies behind Polycefin (the “Technology”) and include internationally acclaimed brain surgeon and scientist Dr. Keith Black, Dr. Julia Ljubimova, Dr. Eggehard Holler, Dr. Alex Ljubimov.  Work on Polycefin involved seven years of development and over $6,000,000 of grants funded mainly from the NIH.  


We also have developed intellectual properties surrounding Laminin-411 a new bio-marker that we believe can be used as a diagnostic and prognostic test on biopsies for certain types of cancers. We have completed a clinical trial with over 400 human patients’ biopsies and are in the process of securing regulatory clearances to begin commercializing this new test as an LDT.   We also expect Laminin-411 to be used as a targeting bio-marker for Polycefin drugs targeting certain cancers and we have published our in-vivo results for Glioblastoma utilizing Laminin-4111. The Company is currently investigating applications of Laminin-411 in other cancers.


In vivo studies show evidence that when attached to the platform, drugs for cancer therapy could have increased treatment efficacy and reduced side effects.  In vivo and in vitro studies, many of which have been published, have shown that tumor size was reduced and animal survival increased using the targeting platform in conjunction with therapeutics as compared to using those same therapeutics in conventional therapies. 2 3


We believe that Polycefin has the ability to harbor various drugs at the same time making it a potential master delivery vehicle that can be customized for a particular tumor and even for an individual patient.4 Additionally, in vivo testing has shown effectiveness against more than one, widely different, type of cancer (HER2/neu Breast, EGFR Triple Negative Breast and Glioblastoma), suggesting that Polycefin’s application might be flexible and appropriate to a wide range of cancer types and therapeutics.


Arrogene’s product development plan focuses on delivering a diagnostic product line first, specifically around our Laminin-411 LDT. There is particular significance in bringing the Laminin-411 diagnostic test on the market, to increase human clinical experience with this novel bio-marker and as a precursor to possible therapeutic exploitation of Laminin-411 as a targeting anti-body in conjunction with Polycefin.


1 Ding H., Satoshi I., Ljubimov A., et al. (2011) Inhibition of brain tumor growth by intravenous poly (β-L-malic acid) nanobioconjucage with pH-dependent drug release. PNAS October 19, 2010 vol. 107 no. 42 18143-18148

2 Inoue  S., Ding H., Portilla-Arias J., et al  (2011) Polymalic Acid-Based Nanobiopolymer Provedes Efficient Systemic Breast Cancer Treatment by Inhibiting both Her2/neu Receptor Snthetsis and Activity. Cancer Res; 71(4) February 15, 2011

3 Inoue S, Patil R, Portilla-Arias J, Ding H, Konda B, et al. (2012) Nanobiopolymer for Direct Targeting and Inhibition of EGFR Expression in Triple Negative

Breast Cancer. PLoS ONE 7(2): e31070. doi:10.1371/journal.pone.0031070

4 Ding H., Portilla-Arias J., Patil R., et al. (2011). The optimization of polymalic acid peptide copolymers for endosomolytic drug delivery. Biomaterials 32 (2011) 5269-5278



17





We are also working to complete some of the pre-clinical work to support an Investigational New Drug (“IND”) application with the FDA for our first therapeutic compound, a process that we intend to follow as a second step.  Our expected initial indications for our therapeutic INDs and subsequent clinical trials center on primary breast  and lung cancers and their metastatic forms into the brain as well as Glioblastoma. However, a final decision on exactly which indication to target first, will be made in consultation with our potential licensing partners and will be based in part on their interest to target specific indications and active drugs.  


As survival rates for these primary cancers improve, increasingly significant percentiles of the patient population are developing metastatic forms of these cancers, which are often found late stage and have few or no treatment options.  Arrogene estimates that 30% of breast and 75% of lung primary cancers metastasize to the brain, based on published studies.  Polycefin’s ability to pass through the tumor’s Brain Blood Barrier could make it ideally suited for use as a diagnostic and/or therapeutic to treat such metastatic cancers, and these might present early market opportunities.  


It is estimated that approximately 207,000 new cases of breast cancer are diagnosed every year in the U.S. Approximately 204,000 cases of lung cancer are diagnosed annually. Additionally there are between 120,000 and 140,000 annual cases of cases of secondary brain cancers, according to various published sources. Based on these patient populations, and certain price and usage assumptions, we have estimated that the total market potential for Polycefin based therapeutics products could exceed $30 billion annually.


We plan to bring our products to market using a licensing and cost sharing strategy.  We will seek to joint venture with pharmaceutical companies with existing cancer therapy drugs or active diagnostic imaging agents.  


Over the following twelve months we have targeted a number of objectives and milestones that we plan to pursue utilizing the proceeds from the Private Placement including subsequent closings, if any.  Such objectives and milestones include having our recently retained regulatory consultant help us complete the definition of the appropriate approval pathway and devise a regulatory strategy and timelines; having scientific and laboratory staff working at CSMC on our behalf towards the completion of necessary clearances and validations to begin commercialization of our Laminin-411 LDT, as well as further pre-clinical development of our therapeutics; develop, design and conduct certain preclinical studies needed to apply to the FDA for IND clearance on our therapeutics; and begin clinical studies once such IND clearance can be obtained. There are various factors that can influence the timing of starting and completing these objectives and milestones as well as the total costs.  Such factors include, but are not limited to, the pace and success of scientific developments, the availability of financial and human resources, competing demands of our scientific team, and changes in regulatory requirements.  We have budgeted approximately $350,000, as revised, through December 2012 towards these efforts but given the inherent uncertainty and variability related to these activities, we cannot accurately predict start dates, completion dates and total costs.


In addition, we have begun to produce the key ingredients for the production of Polycefin, according to a proprietary production and purification process, in preparation to support both pre-clinical and clinical phases of upcoming clinical trials. We are also taking steps to negotiate outside supplies agreements to create industrial partnerships relating to the production under license of these compounds.


General Factors


Our profitability will be affected by costs associated with our efforts to develop Polycefin into a commercial product including regulatory approvals, the expansion of our general and administrative capabilities, and the expenses that we incur as a publicly-traded company.  These costs include costs associated with, among other things, financial reporting, information technology, complying with federal securities laws (including compliance with the Sarbanes-Oxley Act of 2002), tax administration and human resources related functions.  





18





Critical Accounting Policies and Estimates


The discussion and analysis of our financial condition and results of operations is based upon our financial statements which have been prepared in accordance with accounting principles generally accepted in the United States.  The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities.  On an on-going basis, we evaluate our estimates including those related to valuing our share-based compensation and contingencies.  We base our estimates on historical experience and on other assumptions that we believe to be reasonable under the circumstances, the results of which form our basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.  Actual results may differ from these estimates under different assumptions or conditions.


We cannot predict what future laws and regulations might be passed that could have a material effect on our results of operations.  We assess the impact of significant changes in laws and regulations on a regular basis and update the assumptions and estimates used to prepare our financial statements when we deem it necessary.


Revenue Recognition


While we have not generated revenue to date, we will recognize revenue when there is persuasive evidence that an arrangement exists, when title has passed, the price is fixed or determinable, and we are reasonably assured of collecting the resulting receivable.  Revenue arrangements that include multiple deliverables are divided into separate units of accounting if the deliverables meet certain criteria.  If applicable, we will record product revenues net of revenue reserves such as sales returns and allowances.   This accounting policy for revenue recognition may have a substantial impact on our reported results and relies on certain estimates that can require difficult, subjective and complex judgments on the part of management.


Share-Based Payments

We account for share-based payment costs at fair value on the date of grant and recognition of compensation over the service period for awards expected to vest. For stock options that may be granted in the future, the estimation of stock awards that will ultimately vest requires judgment, and to the extent actual results differ from our estimates, such amounts will be recorded as a cumulative adjustment in the period estimates are revised. We will consider various factors when estimating expected forfeitures, including historical experience. Actual results may differ substantially from these estimates.


We determine the fair value of warrants and stock options using the Black-Scholes valuation model, which considers the exercise price relative to the market value of the underlying stock, the expected stock price volatility, the risk-free interest rate and the dividend yield, and the estimated period of time option grants will be outstanding before they are ultimately exercised.  Significant management judgment is required in making certain of these assumptions.


Fair Value Measurements


We measure our financial assets and liabilities at fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., exit price) in an orderly transaction between market participants at the measurement date. Additionally, we are required to provide disclosure and categorize assets and liabilities measured at fair value into one of three different levels depending on the assumptions (i.e., inputs) used in the valuation. Level 1 provides the most reliable measure of fair value while Level 3 generally requires significant management judgment. Financial assets and liabilities are classified in their entirety based on the lowest level of input significant to the fair value measurement. The fair value hierarchy is defined as follows:


Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities.




19





Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.


Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.


Recently Issued Accounting Pronouncements

In May 2011, the FASB issued ASU 2011-04, Fair Value Measurement (“ASU 2011-04”), which amended ASC 820, Fair Value Measurements (“ASC 820”), providing a consistent definition and measurement of fair value, as well as similar disclosure requirements between U.S. GAAP and International Financial Reporting Standards. ASU 2011-04 changes certain fair value measurement principles, clarifies the application of existing fair value measurement and expands the disclosure requirements. ASU 2011-04 was effective for us beginning February 1, 2012. The adoption of ASU 2011-04 did not have a material effect on our consolidated financial statements or disclosures.


In December 2011, the FASB issued ASU No. 2011-11, "Disclosures about Offsetting Assets and Liabilities." The amendments in this update require enhanced disclosures around financial instruments and derivative instruments that are either (1) offset in accordance with either ASC 210-20-45 or ASC 815-10-45 or (2) subject to an enforceable master netting arrangement or similar agreement, irrespective of whether they are offset in accordance with either ASC 210-20-45 or ASC 815-10-45. An entity should provide the disclosures required by those amendments retrospectively for all comparative periods presented. The amendments are effective during interim and annual periods beginning after December 31, 2012. The Company does not expect this guidance to have any impact on its financial position, results of operations or cash flows.


RESULTS OF OPERATIONS


THREE MONTHS ENDED JULY 31, 2012 COMPARED TO THREE MONTHS ENDED JULY 31, 2011


Research and Development


During the three months ended July 31, 2012, we incurred $32,250 in research and development expense representing costs incurred for the management of our research and development activities.  We had no comparable expenses in the same period of the prior year.


General and Administrative


General and administrative expense increased by $19,604 or approximately 11% for the three months ended July 31, 2012 compared to the prior year period.  The increase in expense was primarily the result of costs associated with being a public reporting company in 2012 as well as increased legal fees associated with patent filings.


Loss from Operations


As a result of the factors described above, the loss from operations for the three months ended July 31, 2012, increased by $51,854 compared to the prior year period.


Other Expense


For the three months ended July 31, 2012, we recorded other expense of $84 compared to $45,301 for the prior year period. Expense for the three months ended July 31, 2011 consisted primarily of amortization of deferred offering costs related to the Convertible Notes.







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Net Loss


As a result of the factors described above, we recorded $222,720 of net loss for the three months ended July 31, 2012 compared to a net loss of $216,083 in the prior year period.


NINE MONTHS ENDED JULY 31, 2012 COMPARED TO NINE MONTHS ENDED JULY 31, 2011


Licensing Fees


We recorded $480,430 of licensing fees for the nine months ended July 31, 2012 representing the fair value of 1,468,100 shares of common stock issued to CSMC as well as a $40,000 cash payment to satisfy certain conditions precedent to effectuating the License.  There were no similar transactions during the prior year period.


Research and Development


During the nine months ended July 31, 2012, we incurred $61,182 in research and development expense representing costs incurred for the management of our research and development activities.  We had no comparable expenses in the same period of the prior year.


General and Administrative


General and administrative expense decreased by $125,860 or approximately 18% for the nine months ended July 31, 2012 compared to the prior year period.  The decrease in expense was the net result of expense recorded under a financial advisory agreement in 2011 that was not in existence during 2012 partially offset by expenses related to being a public reporting company during 2012.


Loss from Operations


As a result of the factors described above, the loss from operations for the nine months ended July 31, 2012, increased by $415,752 compared to the prior year period.


Other Expense


For the nine months ended July 31, 2012, we recorded other expense of $757,249 compared to $84,000 for the prior year period. Expense for the nine months ended July 31, 2012 includes a charge taken for reducing the conversion price of the Convertible Notes which resulted in the issuance of 2,388,500 additional shares of common stock.


Net Loss


As a result of the factors described above, we recorded $1,866,756 of net loss for the nine months ended July 31, 2012 compared to a net loss of $777,755 in the prior year period.


LIQUIDITY AND CAPITAL RESOURCES


Liquidity and Capital Resources


Operating Activities


As of July 31, 2012, we had $636,709 of cash and cash equivalents.  During the nine months ended July 31, 2012, $940,226 of cash was used in operating activities which primarily represents cash operating expenses and payment of certain accrued expenses.  








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Investing Activities


During the nine months ended July 31, 2012, $388,234 was provided by investing activities representing cash acquired in the Reverse Merger partially offset by capital expenditures.  As of July 31, 2012, we had no material commitments for capital expenditures.


Financing Activities


During the nine months ended July 31, 2012, we received $1,186,607 in net proceeds from the sale of 1,385,250 Units.  Additionally, during the nine months ended July 31, 2012, we received $80,000 in proceeds from the Promissory Notes which were repaid in full during the same nine month period.  


Sources of Capital


As of July 31, 2012, we had $636,709 of cash on hand.  As previously described, the Company has closed on the sale of Units pursuant to a private placement, generating $1,887,250 in gross proceeds inclusive of sales that took place prior to consummation of the Reverse Merger.  Under the terms of the private placement memorandum, as amended, we may sell up to an additional 2,112,750 Units until such time that we terminate the private placement.  In aggregate, if all of the Units are sold (excluding the overallotment option), gross proceeds of $4,000,000 may be raised.  In addition, based on the Units sold through the date of this Report, $7,528,132 in gross proceeds may be available to us upon the exercise of warrants, of which exercise cannot be assured, nor does management expect to receive in the near future.  Subsequent to July 31, 2012, we closed on the sale of 125,000 additional Units generating net proceeds of $102,377.


Requirements of Capital


In addition to the costs associated with operating our business in accordance with our plan, and complying with public company reporting requirements, the CSMC Agreement requires that we expend $500,000 and $1,000,000 during the calendar years ending December 31, 2012 and 2013, respectively, towards the development of one or more products using the licensed technology.  


Management’s Outlook


We believe that existing cash on hand, combined with the proceeds received from the sale of Units that took place subsequent to July 31, 2012 described above, will be sufficient to fund our planned operations and contractual commitments through at least the end of the Company’s first quarter of fiscal year 2013.  Accordingly, the Company will require additional funding, whether through the sale of Units or from alternative sources within the next six months.  We are continuing to market the sale of the Units and we believe that the Company will consummate at least one additional closing prior to terminating the offering. While management is hopeful that a sufficient number of Units will be sold to fund the Company’s planned activities and contractual operations for at least the next twelve months and beyond, there is no assurance that we will be successful in these efforts.


The success of our business will depend in great part on our ability to conduct research and development on the technology covered by the License.  Our plan forecasts the need for additional capital beyond the next twelve months even if we sell the maximum number of Units authorized.   Our ability to conduct research and development activities is greatly dependent upon our financial resources.  No assurance can be given that the necessary financing will be available on terms acceptable to us, if at all.  If adequate additional funds are not available when required, we may have to delay, scale-back, or eliminate certain aspects of our research, testing and/or development activities.  In the event that we cannot raise sufficient capital within the required timeframes, it will have a material adverse effect on the Company’s liquidity, financial condition and business prospects or force the Company out of business.





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Off-Balance Sheet Arrangements


The Company does not have any off-balance sheet arrangements.


Contractual Obligations


As a “smaller reporting company” as defined by Item 10 of Regulation S-K, the Company is not required to provide information required by this Item.


ITEM 3.  Quantitative and Qualitative Disclosures About Market Risk


As a “smaller reporting company” as defined by Item 10 of Regulation S-K, the Company is not required to provide information required by this Item.


ITEM 4.

CONTROLS AND PROCEDURES


Evaluation of Disclosure Controls and Procedures


We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed pursuant to the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC rules, regulations and related forms, and that such information is accumulated and communicated to our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.


As of July 31, 2012, we carried out an evaluation, under the supervision and with the participation of our principal executive officer and our principal financial officer of the effectiveness of the design and operation of our disclosure controls and procedures.  Based on this evaluation, our principal executive officer and our principal financial officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this report.


Changes in Internal Controls


There have been no changes in our internal controls over financial reporting during the quarter ended July 31, 2012 that have materially affected or are reasonably likely to materially affect our internal controls.




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PART II.

 

OTHER INFORMATION

 

 

 

 

 

 

 

Item 1.

 

Legal Proceedings

 

 

 

 

 

 

 

 

 

None.

 

 

Item 1A.

 

Risk Factors

 

 






Item 2.

 

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, the Company is not required to provide information required by this Item.




Unregistered Sales of Equity Securities and Use of Proceeds

 

 

 

 

 

 

 

 

 

The information required by paragraphs (a) and (c) through (e) of Item 701 of Regulation S-K with respect to the unregistered sales of equity securities by the Company in connection with the issuance of Units consisting of shares of common stock and warrants referenced in this Form 10-Q has been previously provided in a Current Report on Form 8-K filed with the Commission on July 19, 2012

 

 

 

 

 

 

 

Item 3.

 

Defaults Upon Senior Securities

 

 

 

 

 

 

 

 

 

None

 

 

 

 

 

 

 

 

 

 

 

 

Item 4.

 

Removed and Reserved

 

 

 

 

 

 

 

 

 

 

 

 

Item 5.

 

Other Information

 

 

 

 

 

 

 

 

 

None.

 

 

 

 

 

 

 

Item 6.

 

Exhibits and Reports on Form 8-K


 

 

 

 

Exhibits

 

 

 

 

 

 

31.1

 

Certification of Chief Executive Officer

 

 

 

 

31.2

 

Certification of Chief Financial Officer

 

 

 

 

32

 

Certification pursuant to USC Section 1350

 

 

 

 

101.INS

 

XBRL Instance**

 

 

 

 

101.SCH

 

XBRL Taxonomy Extension Schema**

 

 

 

 

101.CAL

 

XBRL Taxonomy Extension Calculation**

 

 

 

 

101.DEF

 

XBRL Taxonomy Extension Definition**

 

 

 

 

101.LAB

 

XBRL Taxonomy Extension Labels**

 

 

 

 

101.PRE

 

XBRL Taxonomy Extension Presentation**

 

 

 

 

 

 

 

 

 

 

 

 

 

** to be filed by amendment



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SIGNATURES


Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Quarterly Report to be signed on its behalf by the undersigned, thereunto duly authorized.


 

 

Arrogene, Inc.

 

 

 

 

 

Date:

September 13, 2012

 

 

By:

 /s/ Maurizio Vecchione

 

 

 

Maurizio Vecchione, Principal Executive Officer

 

 

 

 

Date:

September  13,  2012

 

 

By:

 /s/ Jeffrey S. Sperber

 

 

 

Jeffrey S. Sperber, Principal Financial and
Accounting Officer




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