PINX:OVIT Quarterly Report 10-Q Filing - 6/30/2012

Effective Date 6/30/2012

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 10-Q

 

(Mark One)

[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF

THE SECURITIES EXCHANGE ACT OF 1934

 

For the Quarterly Period Ended June 30, 2012

 

[ ] 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: 000-28347

 

ONCOVISTA INNOVATIVE THERAPIES, INC.

(Exact name of registrant as specified in its charter)

 

Nevada 33-0881303
(State or other jurisdiction of incorporation or organization) (IRS Employer Identification No.)

 

14785 Omicron Drive

Suite 104

San Antonio, Texas 78245

(Address of principal executive offices)

 

(210) 677-6000

(Registrant's telephone number, including area code)

 

Indicate by check mark whether the issuer: (1) 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 ¨

 

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 (§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 ¨

 

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 ¨        Accelerated filer ¨        Non-accelerated filer ¨      Smaller reporting company x

 

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

 

State the number of shares outstanding of each of the registrant's classes of common equity, as of the latest practicable date: 21,627,868 shares of common stock with a par value of $.001 outstanding as of August 13, 2012.

 

 
 

 

 

PART I – FINANCIAL INFORMATION 2
   
ITEM 1 – FINANCIAL STATEMENTS 2
   
ITEM 2 – MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 13
   
ITEM 3 – Quantitative and Qualitative Disclosures About Market Risk 17
   
ITEM 4 – CONTROLS AND PROCEDURES 17
   
PART II – OTHER INFORMATION 19
   
ITEM 1 – LEGAL PROCEEDINGS 19
   
ITEM 1A – RISK FACTORS 19
   
ITEM 2 – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS 19
   
ITEM 3 – DEFAULTS UPON SENIOR SECURITIES 19
   
ITEM 4 – MINE SAFETY DISCLOSURES 19
   
ITEM 5 – OTHER INFORMATION 19
   
ITEM 6 – EXHIBITS 20

 

 
 

 

PART I – FINANCIAL INFORMATION

 

ITEM 1 – FINANCIAL STATEMENTS

 

ONCOVISTA INNOVATIVE THERAPIES, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

 

   June 30,   December 31, 
   2012   2011 
         
ASSETS  (Unaudited)     
Current assets:          
Cash and cash equivalents  $1,165,612   $2,125,229 
Accounts receivable, prepaid and other current assets   134,477    53,168 
Total current assets   1,300,089    2,178,397 
           
Equipment, net   6,732    10,222 
           
Total assets  $1,306,821   $2,188,619 
           
LIABILITIES AND DEFICIT          
           
Current liabilities:          
Accounts payable (including related party account payable of $550,000 and $450,000, respectively)  $825,005   $818,522 
Accrued expenses (including related party accrued expenses of $485,000 and $460,000, respectively)   1,127,331    1,003,580 
Derivative liability   176,151    322,834 
Notes payable   174,495    167,711 
           
           
Total current liabilities   2,302,982    2,312,647 
           
Commitments and contingencies          
           
Equity (deficit):          
Common stock, $.001 par value; 147,397,390 shares authorized, 21,627,868 and 21,370,725 shares issued and outstanding at June 30, 2012 and December 31, 2011, respectively   21,627    21,370 
Additional paid-in capital   20,171,936    20,134,341 
Accumulated deficit   (21,189,724)   (20,279,739)
           
Total deficit   (996,161)   (124,028)
    -    - 
Total liabilities and deficit  $1,306,821   $2,188,619 

 

  

See accompanying notes to the condensed consolidated financial statements

 

2
 

 

 

ONCOVISTA INNOVATIVE THERAPIES, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

(Unaudited)

 

   Three Months Ended   Six Months Ended 
   June 30,   June 30, 
   2012   2011   2012   2011 
                 
Revenue  $   $   $   $ 
                     
Operating expenses:                    
Research and development   341,402    179,940    640,227    341,990 
General and administrative   224,091    373,001    412,867    669,345 
                     
Total operating expenses   565,493    552,941    1,053,094    1,011,335 
                     
Loss from operations   (565,493)   (552,941)   (1,053,094)   (1,011,335)
                     
Other income (expense):                    
Interest income   1,033        2,388     
Gain (loss) on derivative liability   316,496    (19,404)   146,683    (297,549)
Interest expense   (3,476)   (12,636)   (6,845)   (13,473)
Other   883    7,049    883    4,920 
                     
Total other income (expense), net   314,936    (24,991)   143,109    (306,102)
                     
Net Loss   (250,557)   (577,932)   (909,985)   (1,317,437)
                     
 
Net loss per share - basic and diluted
  $(0.01)  $(0.03)  $(0.04)  $(0.06)
Weighted average number of shares outstanding during the period - basic and diluted   21,418,763    21,344,675    21,394,744    21,151,675 
                     
*  Less than $0.01                    

   

See accompanying notes to the condensed consolidated financial statements

  

3
 

 

ONCOVISTA INNOVATIVE THERAPIES, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

   Six months ended
June 30,
 
   2012   2011 
Cash flows from operating activities          
Net loss  $(909,985)  $(1,317,437)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation   3,490    3,251 
Employee stock-based compensation   37,595    71,373 
Non-employee stock-based consulting expense   6,492    6,077 
Common stock issued for consulting       88,500 
Non-employee stock-based consulting expense (warrants)       15,416 
(Gain) loss on derivative liability   (146,683)   297,549 
Loss on disposal of assets       2,129 
Loss on legal settlement       9,000 
Changes in operating assets and liabilities:          
Accounts  receivables, prepaid and other current assets   (87,801)   (18,949)
Accounts payable   6,483    86,639 
Accrued expenses   123,751    (34,136)
Accrued interest payable   6,784    17,466 
Net cash used in operating activities   (959,874)   (773,122)
           
Cash flows from investing activities          
Purchase of equipment       (2,859)
Net cash used in investing activities       (2,859)
           
Cash flows for financing activities          
Proceeds from exercise of stock options
   257    - 
Net cash provided by (used in) financing activities   257    - 
           
Net decrease in cash and cash equivalents   (959,617)   (775,981)
           
Cash and cash equivalents at beginning of period   2,125,229    3,524,496 
           
Cash and cash equivalents at end of period  $1,165,612   $2,748,515 

 

 

See accompanying notes to the condensed consolidated financial statements

 

4
 

 

 

Note 1.BASIS OF PRESENTATION, ORGANIZATION AND NATURE OF OPERATIONS

 

OncoVista Innovative Therapies, Inc. (“OVIT”) is a biopharmaceutical company developing targeted anticancer therapies by utilizing tumor-associated biomarkers. OVIT’s product pipeline is comprised of advanced (Phase I/II) and early (Phase I) clinical-stage compounds, late preclinical drug candidates and early preclinical leads. OVIT is not committed to any single treatment modality or class of compound, but believes that successful treatment of cancer requires a tailored approach based upon individual patient disease characteristics.

 

Through its former subsidiary, AdnaGen AG (“AdnaGen”), OVIT previously developed diagnostic kits for several cancer indications, and marketed diagnostic kits in Europe for the detection of circulating tumor cells (“CTCs”) in patients with cancer.

 

On October 28, 2010, OVIT entered into a Stock Purchase Agreement with Alere Holdings Bermuda Limited Canon's Court (“Alere Holdings”), whereby OVIT sold all of its shares, representing approximately 78% of the total issued and outstanding shares of AdnaGen to Alere Holdings.  Under the terms of the agreement, OVIT and the other AdnaGen shareholders agreed to sell their respective shares of AdnaGen, and all AdnaGen related business assets, to Alere Holdings for: (i) a $10 million up-front payment; (ii) $10 million in potential milestone payments contingent upon the achievement of various balance sheet objectives within 24 months; and (iii) up to $63 million in potential milestone payments contingent upon the achievement of various clinical, regulatory and sales objectives within the next 36 months.  OVIT is entitled to receive its pro rata portion of the up-front and potential milestone payments.  In November 2010, OVIT received $6.0 million, net of expenses and certain fees, as its share of the $10 million up-front payment. For the year ended December 31, 2011, no milestone payments were received, however the Company recorded a gain on the sale of subsidiary of approximately $0.2 million, for cash received for settlement related to the sale of AdnaGen.

 

OVIT is using the proceeds from the sale of its shares in AdnaGen to fund on-going development activities for its drug candidate portfolio.  Additionally, OVIT is evaluating several opportunities to license or acquire other compounds or diagnostic technologies that it believes will provide for treatments that are highly targeted with low or no toxicity.

 

At June 30, 2012, OVIT had three full time employees. OncoVista, Inc. (“OncoVista”), OVIT’s operating subsidiary, had one full-time employee.

 

Note 2.SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Basis of Presentation

 

The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the United States Securities and Exchange Commission (the “Commission”) for interim financial information. Accordingly, they do not include all the information and footnotes necessary for a comprehensive presentation of financial position, results of operations, and changes in deficit or cash flows. It is management's opinion, however, that all material adjustments (consisting of normal recurring adjustments) have been made which are necessary for a fair financial statement presentation. The interim results for the period ended June 30, 2012 are not necessarily indicative of results for the full fiscal year.

 

The unaudited interim consolidated financial statements should be read in conjunction with the required financial information and financial statements included as part of OVIT’s Annual Report on Form 10-K for the year ended December 31, 2011.

 

5
 

 

Principles of Consolidation

 

The consolidated financial statements include the accounts of OVIT and OncoVista (collectively, the “Company”). All intercompany balances have been eliminated in consolidation.

 

Use of Estimates

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

Significant estimates include the valuation of warrants and stock options granted for services or compensation, estimates of the probability and potential magnitude of contingent liabilities, estimates relating to the fair value of derivative liabilities and the valuation allowance for deferred tax assets.

 

Net Loss per Share

 

Basic earnings (loss) per share are computed by dividing net income (loss) by the weighted average number of common shares outstanding. Diluted earnings per share is computed by dividing net income by the weighted average number of common shares outstanding including the effect of share equivalents. Common stock equivalents consist of shares issuable upon the exercise of certain common stock purchase warrants and stock options.

 

As the Company has had losses from operations for the six month periods ended June 30, 2012 and 2011, respectively, all unvested restricted stock, stock options and warrants are considered to be anti-dilutive. At June 30, 2012 and 2011, the following shares have been excluded since their inclusion in the computation of diluted EPS would be anti-dilutive:

 

   2012   2011 
           
Stock options outstanding under various stock option plans   1,381,500    1,407,575 
Warrants   4,074,569    4,331,712 
   Total   5,456,069    5,739,287 

 

Share-Based Compensation

All share-based payments to employees are recorded and expensed in the statements of operations under Accounting Standards Codification (“ASC”) 718 “Compensation – Stock Compensation.” ASC 718 requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and directors, including grants of employee stock options, based on estimated fair values. The Company has used the Black-Scholes option-pricing model to estimate grant date fair value for all option grants.

 

Share-based compensation expense is based on the value of the portion of share-based payment awards that is ultimately expected to vest during the year, less expected forfeitures. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

 

6
 

 

Recent Accounting Pronouncements

 

The Company has evaluated all recently issued accounting pronouncements and believes such pronouncements do not have a material effect on the Company’s financial statements

 

Note 3.GOING CONCERN & MANAGEMENT’S PLANS

 

As reflected in the accompanying consolidated financial statements, the Company reported a net loss of approximately $910,000, and net cash used in operations of $960,000 for the six months ended June 30, 2012, an accumulated deficit of approximately $21.2 million and total deficit of approximately $996,000 at June 30, 2012. The Company is also in default on a certain loan and related accrued interest aggregating $174,495 at June 30, 2012 (see Note 6). Subsequent to June 30, 2012 the Company entered into a settlement agreement to satisfy the obligation in full for a one-time payment of $60,000 (see Note 11). These factors raise substantial doubt about the Company’s ability to continue as a going concern. As a result of the stock purchase agreement with Alere Holdings, management believes that the Company has sufficient capital to meet its anticipated operating cash requirements for the next six to seven months.

 

The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. These financial statements do not include any adjustments relating to the recovery of the recorded assets or the classification of the liabilities that might be necessary should the Company be unable to continue as a going concern.

 

The ability of the Company ability to continue as a going concern depends on the success of management’s plans to achieve the following:

 

·Continue to aggressively seek investment capital;
·Develop the Company’s product pipeline;

·Advance scientific progress in our research and development; and

Continue to monitor and implement cost control initiatives to conserve cash.

 

There can be no assurance that these plans will be sufficient or that additional financing will be available in amounts or terms acceptable to the Company, if at all.

   

7
 

 

 

Note 4.EQUIPMENT

 

Equipment balances at June 30, 2012 and December 31, 2011 are summarized below:

 

   2012   2011 
         
Equipment  $30,132   $30,132 
Computer and office equipment   9,326    9,326 
    39,458    39,458 
Less: accumulated depreciation   (32,726)   (29,236)
Equipment, net  $6,732   $10,222 

 

Note 5.ACCRUED EXPENSES

 

Accrued expenses at June 30, 2012 and December 31, 2011 are summarized below:

 

   2012   2011 
         
Legal and professional  $-   $21,250 
Clinical and other studies   149,006    149,006 
Compensation   272,085    272,085 
Minimum royalty   635,000    560,000 
Other   71,240    1,239 
   Total accrued expenses  $1,127,331   $1,003,580 

 

Note 6.DEBT

 

As of June 30, 2012 the Company had one outstanding unsecured note in the principal amount of $100,000 and $74,495 in accrued interest ($67,711 at December 31, 2011) at 8%, payable to a third party and due on demand. The Company has since entered into a settlement agreement to satisfy the obligation in full with a one-time payment of $60,000 (see Note 11).

 

Note 7.DERIVATIVE LIABILITY

 

The Company determined that warrants issued in connection with a debt financing entered into by the Company in January 2009 required liability classification due to certain provisions that may result in an adjustment to the number shares issued upon settlement.

 

The estimated fair value of the derivative liability was $176,151 and $322,834 at June 30, 2012 and December 31, 2011, respectively.

 

The Company uses the Black-Scholes pricing model to calculate the fair value of its warrant liabilities. Key assumptions used to apply these models are as follows:

 

Expected term   2-3 years 
Volatility   95%
Risk-free interest rate   0.41%
Dividend yield   0%

 

 

8
 

 

Fair value measurements

 

Assets and liabilities measured at fair value as of June 30, 2012, are as follows:

 

   Value at
June 30, 2012
   Quoted prices in active markets
(Level 1)
   Significant other observable inputs
(Level 2)
   Significant unobservable inputs
(Level 3)
 
                     
Derivative liability  $176,151   $   $176,151   $ 

 

The fair value framework requires a categorization of assets and liabilities into three levels based upon the assumptions (inputs) used to price the assets and liabilities. Level 1 provides the most reliable measure of fair value, whereas Level 3 generally requires significant management judgment. The three levels are defined as follows:

 

Level 1: Unadjusted quoted prices in active markets for identical assets and liabilities.

Level 2: Observable inputs other than those included in Level 1. For example, quoted prices for similar assets or liabilities in active markets or quoted prices for identical assets or liabilities in inactive markets.

Level 3: Unobservable inputs reflecting management’s own assumptions about the inputs used in pricing the asset or liability.

 

There were no financial assets or liabilities measured at fair value, with the exception of cash and cash equivalents and the above mentioned derivative liability as of June 30, 2012 and December 31, 2011, respectively. The fair values of accounts receivable, accounts payable and third-party debt approximate the carrying amounts due to the their interest rates and / or short term nature of these instruments. The fair value of the related party accounts payable and accruals are not practicable to estimate due to the related party nature of the underlying transaction.

 

Note 8.LEASES, COMMITMENTS AND CONTINGENCIES

 

Legal Matters

 

On August 11, 2011, an action was filed against the Company in the United States District Court for the Southern District of New York, entitled New Millennium PR Communications, Inc., against OncoVista Innovative Therapies, Inc. The action seeks damages for the alleged breach of a public relations agreement and seeks an order directing a cash payment of $75,750 and the issuance of warrants to purchase 25,000 shares of the Company’s common stock. On October 5, 2011, the Company sent a notice of motion to the United States District Court for the Southern District of New York seeking to dismiss the case due to lack of subject matter jurisdiction. New Millennium PR Communications, Inc. filed an opposition to the Company’s request for dismissal. The court has not yet ruled on the motion to dismiss. The case has been referred to the Magistrate Judge for settlement with a trial set for a date after July 30, 2012.

 

On August 26, 2011, an action was filed against the Company in the Supreme Court of the State of New York, New York County, entitled CAMOFI Master LDC and CAMHZN LDC against OncoVista Innovative Therapies, Inc. and OncoVista, Inc. The action seeks damages for the alleged breach of a Subscription Agreement, a Warrant Agreement and an Anti-Dilution Agreement and seeks an order directing the issuance of (i) an aggregate of 1,980,712,767 shares of the Company’s common stock, and (ii) warrants to purchase an aggregate of 702,857,767 shares of the Company’s common stock at an exercise price of $0.001. On October 20, 2011, the Company filed an answer to the complaint. On November 1, 2011, the plaintiffs made an extensive document request to the Company for all documents related to the matter. The Company’s counsel has started taking depositions and has requested access to CAMOFI Master LDC and CAMHZN Master LDC principals for further depositions. On June 29, 2012 CAMOFI Master LDC and CAMHZN Master LDC filed for summary judgment. Discussions are currently ongoing between the parties to seek a resolution to the mater. On August 9, 2012 the parties filed a stipulation with the court extending the return date of motion for summary judgment until September 10, 2012.

 

9
 

 

On February 16, 2012, an action was filed by the Company in the 225 Judicial District Court of the State of Texas, Bexar County, entitled OncoVista Innovative Therapies, Inc. against J. Michael Edwards. The action seeks damages relating to the executive employment agreement of the Company’s former Chief Financial Officer, J. Michael Edwards. Specifically the Company is seeking to have the Stock Option Agreement granted to Mr. Edwards on January 6, 2009 be declared void ab initio. The Company is also seeking damages and attorney fees. On March 30, 2012, the Company received a copy of a counterclaim that may be filed in the same court and is seeking approximately $197,000 in alleged compensation due.

 

Note 9. RELATED PARTY TRANSACTIONS

 

Alexander L. Weis, Ph.D., Chairman of the Company’s Board of Directors and its Chief Executive Officer, President, Chief Financial Officer and Secretary, and a significant shareholder, is a beneficial owner of Lipitek International, Inc. and Lipitek Research, LLC. The Company leases its laboratory space from Lipitek, Inc. under a three-year lease agreement. Management believes that rent is based on reasonable and customary rates as if the space were rented to a third party.

 

On November 17, 2005, the Company entered into a purchase agreement with Lipitek and Dr. Weis, under which Lipitek granted the Company an option to purchase all membership interests in Lipitek Research, LLC (Lipitek Research) for a purchase price of $5.0 million, which is payable quarterly based upon revenues of Lipitek Research up to $50,000 per quarter. Through June 30, 2012, the Company had paid a total of $550,000 toward this agreement and has accrued $550,000 and $450,000, which is included in accounts payable in the consolidated balance sheets as of June 30, 2012, and December 31, 2011, respectively. During the six month period ended June 30, 2012 and 2011, the Company made no payments toward the agreement.

 

Prior to the full payment of the purchase price, the Company has the option, upon 30 days written notice, to abandon the purchase of Lipitek Research and would forfeit the amounts already paid. All intellectual property developments by Lipitek Research through the term of the agreement or 2012, whichever is later, shall remain the Company’s property, irrespective of whether the option is exercised. In addition, the Company will receive 80% of the research and development revenue earned by Lipitek while the agreement is in place. In the six month periods ended June 30, 2012 and 2011, the Company did not recognize any revenue from its share of Lipitek revenues.

  

Note 10. CHANGES IN DEFICIT

 

Common Stock

 

The Company is authorized to issue up to 147,397,390 shares of common stock. At June 30, 2012, shares of common stock reserved for future issuance are as follows:

 

Stock options outstanding   1,381,500 
Warrants outstanding   4,074,569 
Stock options available for grant   2,159,250 
      
    7,615,319 

 

Restricted Stock

 

In October 2007, the Company granted an aggregate of 2,000,000 shares of common stock to certain officers valued at $3.5 million based upon the quoted closing trading price on the date of issuance.  These shares vested, subject to future service requirements, two thirds on January 1, 2010 and one third on January 1, 2011. As of June 30, 2012, there was no unrecognized compensation cost related to unvested restricted stock. In April 2011, the Company granted 150,000 shares of restricted common stock to consultants, which were fully vested upon issuance. The Company recorded $88,500 in consulting expense for the restricted stock grant.

 

10
 

 

On June 13, 2012, the Company entered into an agreement to grant an aggregate of 300,000 shares of common stock to Landmark Financial Corporation which shares vest at the rate of 50,000 shares per month for six months, the term of the agreement. These shares will be granted for services to be provided by Landmark Financial Corporation related to identifying and evaluating alternative strategies for expanding the Company’s business. As of June 30, 2012 the shares have not been issued to Landmark Financial Corporation. The Company recorded $6,492 in consulting expense for the restricted stock grant for the period of June 13 through June 30, 2012 and $66,000 in accrued expenses for the shares that were not issued as of June 30, 2012.

 

Stock Option Plans

 

All option grants are expensed in the appropriate period based upon each award’s vesting terms, in each case with an offsetting credit to additional paid in capital. Under the authoritative guidance for share based compensation, in the event of termination, the Company will cease to recognize compensation expense. There is no deferred compensation recorded upon initial grant date, instead, the fair value of the share-based payment is recognized ratably over the stated vesting period. No stock options were granted during the six months ended June 30, 2012. The Company granted stock options to employees, consultants and directors to acquire 658,600 shares of common stock for future services having a fair value of $153,454 during the six months ended June 30, 2011. Vesting periods for the Company’s stock option awards during 2011 included the following: monthly over one year, monthly over two years, monthly over four years, and annually over four years.

 

The stock-based compensation expense recorded by the Company for the six months ended June 30, 2012 and 2011, with respect to awards under the Company’s stock plans are as follows:

 

   Six Months   Three Months 
   2012   2011   2012   2011 
Research and development  $25,612   $26,921   $12,806   $12,806 
General and administrative  $11,983   $44,452   $5,991   $21,284 
   Total employee stock-based compensation  $37,595   $71,373   $18,797   $34,090 

 

In addition to options granted to employees, the Company historically granted options to consultants and for the six months ended June 30, 2012 and 2011, recognized $0 and $6,077, respectively, as consulting expense. Such amounts are included in general and administrative expense in the consolidated statements of operations for each of the six months ended June 30, 2012 and 2011.

 

The following is a summary of the Company’s stock option activity:

 

   Shares   Weighted Average Exercise Price   Weighted Average
Remaining Contractual Term
   Aggregate
Intrinsic Value
 
                 
Outstanding at January 1, 2012   1,381,500   $0.91           
   Granted                  
   Exercised                  
   Forfeited                  
Outstanding at June 30, 2012   1,381,500   $0.91    6.34 years   $24,000 
Options Exercisable at June 30, 2012   1,156,250   $1.02    5.93 years   $24,000 

 

 

11
 

 

The following summarizes the activity of the Company’s stock options that have not vested for the six months ended June 30, 2012:

 

   Shares   Weighted Average Fair Value 
Nonvested at January 1, 2012   404,250   $0.21 
   Granted   -    - 
   Vested   (179,000)   0.21 
   Cancelled or forfeited   -    - 
Outstanding at June 30, 2012   225,250   $0.21 

 

Warrants

 

On June 27, 2012 CAMOFI Master LDC and CAMHZN Master LDC exercised warrants for 216,000 and 41,143 shares respectively of the Company’s common stock with an exercise price of $0.001 per share generating cash proceeds of $257.

 

Note 11. SUBSEQUENT EVENTS

 

On July 12, 2012 the Company consummated a settlement with a debt holder of one outstanding unsecured note in the aggregate amount of $174,495 (as of June 30, 2012). The Company and the debt holder agreed to a one time payment of $60,000 for complete and full payment of the debt which was paid in July 2012.

  

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ITEM 2 – MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Our Management’s Discussion and Analysis contains not only statements that are historical facts, but also statements that are forward-looking (within the meaning of Section 27A of the Securities Act of 1933 (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”)).  Forward-looking statements are, by their very nature, uncertain and risky.  These risks and uncertainties include international, national and local general economic and market conditions; demographic changes; our ability to sustain, manage, or forecast growth; our ability to successfully make and integrate acquisitions; raw material costs and availability; new product development and introduction; existing government regulations and changes in, or the failure to comply with, government regulations; adverse publicity; competition; the loss of significant customers or suppliers; fluctuations and difficulty in forecasting operating results; changes in business strategy or development plans; business disruptions; the ability to attract and retain qualified personnel; the ability to protect technology; and other risks that might be detailed from time to time in our filings with the Commission.

 

Although the forward-looking statements in this report reflect the good faith judgment of our management, such statements can only be based on facts and factors currently known by them.  Consequently, and because forward-looking statements are inherently subject to risks and uncertainties, the actual results and outcomes may differ materially from the results and outcomes discussed in the forward-looking statements.  You are urged to carefully review and consider the various disclosures made by us in this report and in our other reports as we attempt to advise interested parties of the risks and factors that may affect our business, financial condition, and results of operations and prospects.

 

As used in this Quarterly Report, the terms “we,” “us,” and “our,” mean OncoVista Innovative Therapies, Inc., our current subsidiary, OncoVista, Inc. (“OncoVista”) and our former subsidiary, AdnaGen A.G. (“AdnaGen”), collectively, unless otherwise indicated.

 

Overview

 

We are a biopharmaceutical company developing targeted anticancer therapies by utilizing tumor-associated biomarkers. Our therapeutic strategy is based on targeting the patient’s tumor(s) with treatments that will deliver drugs selectively based upon specific biochemical characteristics of the cancer cells comprising the tumor. Through a combination of licensing agreements, as well as mergers and acquisitions, we have acquired the rights to several technologies with the potential to more effectively treat cancers and significantly improve quality-of-life for patients. We believe that the development of targeted approaches to the administration of anticancer agents should lead to improved outcomes and reduced toxicity.

 

We previously developed diagnostic kits through our former majority-owned German operating subsidiary, AdnaGen, for several cancer indications, and marketed diagnostic kits in Europe for the detection of circulating tumor cells (“CTCs”) in patients with cancer. On October 28, 2010, we entered into a Stock Purchase Agreement with Alere Holdings Bermuda Limited Canon’s Court (“Alere Holdings”), whereby we, and the other AdnaGen shareholders, agreed to sell our respective shares of AdnaGen, and all AdnaGen related business assets, to Alere Holdings for: (i) a $10 million up-front payment; (ii) $10 million in potential milestone payments contingent upon the achievement of various balance sheet objectives within 24 months; and (iii) up to $63 million in potential milestone payments contingent upon the achievement of various clinical, regulatory and sales objectives within next 36 months. We are entitled to receive our pro rata portion of approximately 78% of the up-front and potential milestone payments. In November 2010, we received $6.0 million, net of expenses and certain fees, as our share of the $10 million up-front payment.

 

As a result of the proceeds received pursuant to the Stock Purchase Agreement with Alere Holdings, we have eliminated substantially all of our outstanding debt. We are using the balance of the proceeds from the sale of our shares in AdnaGen to fund on-going development activities for our drug candidate portfolio. Additionally, we are evaluating several opportunities to license or acquire other compounds or diagnostic technologies that we believe will provide for treatments that are highly targeted, efficacious and with low or no toxicity.

 

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Development Programs

 

Our most advanced product candidate is Cordycepin (OVI-123) which is in Phase I/II clinical trials for refractory leukemia patients who express the enzyme terminal deoxynucleotidyl transferase (TdT). We have received orphan drug designation from the FDA for Cordycepin which affords us seven years of market exclusivity once the drug is approved for marketing. We initiated a Phase I/II trial based on the “original” ADA-sensitive compound in the second quarter of 2008. The trial was initiated at two U.S. centers, The Dana Farber Cancer Institute in Boston, Massachusetts and the Cancer Therapy Research Center at the University of Texas Health Sciences Center at San Antonio, Texas, and is designed to enroll up to 24 patients in the first stage and up to 20 patients in the second stage. In October 2009, after enrolling five patients in this clinical trial, we placed the clinical trial on administrative hold due to our limited capital resources. We have engaged a clinical research organization (“CRO”) in France to do additional pre-clinical in-vitro evaluations of Cordycepin and the ADA inhibitor Pentostatin with the intent of gaining a better understanding of the inhibition effects of Pentostatin on Cordycepin. We are in the process of reinitiating the Phase I/II clinical trial to determine the maximum tolerated dose, and expect to start enrolling patients later this year.

 

We have completed Good Laboratory Practice (“GLP”) animal drug safety studies in two species for our lead drug candidate from the L-nucleoside conjugate program (OVI-117). We have accumulated in vitro and in vivo data indicating that several of the L-nucleoside conjugates are effective against various types of cancer. To date, OVI-117 has undergone two proof-of-concept studies of human cancers in animal models, as both a single agent and as a multi-agent combination therapy with oxaliplatin. The Investigational New Drug application (IND) was submitted to the FDA on June 2, 2012 and approved by the FDA on July 5, 2012. We engaged a contract manufacturer and a clinical batch of OVI-117 is available for use in our proposed Phase 1 trial. The clinical protocol has been written and a principal investigator engaged. We believe that OVI-117 should be ready to enter Phase I clinical trials later in 2012.

 

Other Research and Development Plans

 

In addition to conducting Phase I and Phase II clinical trials, we plan to conduct pre-clinical research to accomplish the following:

 

·further deepen and broaden our understanding of the mechanism of action (MoA) of our products in cancer;
·develop alternative delivery systems and determine the optimal dosage for different patient groups;
·demonstrate proof of concept in animal models of human cancers; and
·develop successor products to our current products.

 

Other Strategic Plans

 

In addition to developing our existing anti-cancer drug portfolio, we plan to obtain rights to additional drug candidates or diagnostic technologies through licensing, partnerships, and mergers/acquisitions. Our efforts in this area will be guided by business considerations (cost of the opportunity, fit with existing portfolio, etc.) as well as input from our clinical advisory board regarding likelihood of successful clinical development and marketing approval. Our goal is to create a well-balanced product portfolio including lead molecules in different stages of development and addressing different medical needs.

 

Results of Operations


Three Months Ended June 30, 2012 and 2011

 

Research and development. Research and development expenses increased by approximately $161,000, or 89%, to approximately $341,000 for the three months ended June 30, 2012, as compared to approximately $180,000 for the three months ended June 30, 2011. The increase in 2012 is primarily due to the finalizing our preclinical studies, developing our clinical protocol, manufacturing the drug product and the preparation and submission of an IND to the FDA for OVI-117 to enter into Phase I trials.

 

General and administrative. General and administrative expenses decreased by approximately $149,000, or 40%, to approximately $224,000 for the three months ended June 30, 2012, as compared to approximately $373,000 for the three months ended June 30, 2011. The decrease was due primarily to a decrease in stock-based compensation from prior year, as well as a decrease in consulting expense for professional services.

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Other Income (Expense). The increase from other expense of approximately $25,000 to other income of approximately $315,000 is $340,000 or 1,360%, is due primarily to a gain of approximately $316,000 on derivative liability in 2012 compared to a loss on derivative liability of approximately $20,000 in 2011.

 

Net Loss. As a result of the foregoing, our net loss decreased by approximately $327,000, or 57%, to a net loss of approximately $251,000 for the three months ended June 30, 2012, compared to a net loss of approximately $578,000 for the three months ended June 30, 2011.

 

Six months ended June 30, 2012 and 2011

 

Research and development. Research and development expenses increased by approximately $298,237, or 87%, to approximately $640,227 for the six months ended June 30, 2012, as compared to $341,990 for the six months ended June 30, 2011. The increase in 2012 is primarily due to the continued development of our existing anti-cancer drug portfolio including reinitiating our patient enrollment in our Phase I/II clinical trials for Cordycepin (OVI-123), as well as finalizing our preclinical studies, developing our clinical protocol, manufacturing the drug product and the preparation and submission of an IND to the FDA for OVI-117 to enter into Phase I trials.

 

General and administrative. General and administrative expenses decreased by approximately $256,478 or 38%, to approximately $412,867 for the six months ended June 30, 2012, as compared to approximately $669,345 for the six months ended June 30, 2011. The decrease was due primarily a decrease in consulting expense for professional services.

  

Other Income (Expense). The increase from other expense of approximately $306,000 to other income of approximately $143,000 is $449,000 or 147%, is due primarily to a gain of approximately $147,000 on derivative liability in 2012 compared to a loss on derivative liability of approximately $298,000 in 2011.

 

Going Concern and Recent Events

 

Our consolidated financial statements for the six months ended June 30, 2012 have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. We reported a net loss of approximately $0.9 million, and net cash used in continuing operations of approximately $960,000 for the six months ended June 30, 2012, an accumulated deficit of approximately $21.2 million and total deficit of approximately $996,000 at June 30, 2012. The Company is also in default on certain loans and related accrued interest aggregating $174,495 at June 30, 2012. The Report of the Independent Registered Public Accounting Firm on the Company’s financial statements as of and for the year ended December 31, 2011 includes a “going concern” explanatory paragraph expressing substantial doubt about our ability to continue as a going concern.

 

In November 2010, we received approximately $6.0 million as our pro rata portion of the up-front payment from the sale of its shares of AdnaGen as described above. As a result of the stock purchase agreement with Alere Holdings, we now have sufficient capital to meet our anticipated operating cash requirements for the next six to seven months.

 

Our ability to continue as a going concern depends on the success of management’s plans to achieve the following:

 

·Continue to aggressively seek investment capital;
·Develop our product pipeline;
·Advance scientific progress in our research and development; and
·Continue to monitor and implement cost control initiatives to conserve cash.

 

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Liquidity and Capital Resources

 

At June 30, 2012, we had cash and cash equivalents of approximately $1.2 million compared to $2.1 million at December 31, 2011. In order to preserve principal and maintain liquidity, our funds are primarily invested in checking and interest bearing saving accounts with the primary objective of capital preservation. Based on our current projections, we believe that our available resources and cash flow are sufficient to meet our anticipated operating cash needs for the next six to seven months. Our ability to continue as a going concern is dependent on our ability to further implement our strategic plan, continue to obtain additional debt and/or equity financing, and generate additional revenues from collaborative agreements.

 

To date, we have financed our operations principally through proceeds of offerings of securities exempt from the registration requirements of the Securities Act. We can provide no assurance that additional funding will be available on terms acceptable to us, or at all. Accordingly, we may not be able to secure the funding which is required to expand research and development programs beyond their current levels or at levels that may be required in the future. If we cannot secure adequate financing, we may be required to delay, scale back or eliminate one or more of our research and development programs or to enter into license or other arrangements with third parties to commercialize products or technologies that we would otherwise seek to develop and commercialize ourselves. Our future capital requirements will depend upon many factors, including:

 

·Continued scientific progress in our research and development programs;
·Costs and timing of conducting clinical trials and seeking regulatory approvals and patent prosecutions;
·Competing technological and market developments; and
·Our ability to establish additional collaborative relationships.

 

Accordingly, we may be required to issue equity or debt securities or enter into other financial arrangements, including relationships with corporate and other partners, in order to raise additional capital. Depending upon market conditions, we may not be successful in raising sufficient additional capital for our short or long-term requirements. In such event, our business, prospects, financial condition, and results of operations would be materially adversely affected.

 

Operating Activities. For the six months ended June 30, 2012, net cash used in operations increased $187,000, or 24% to approximately $960,000 compared to approximately $773,000 for the six months ended June 30, 2011. The increase was primarily due to cash used in legal and research and development activities.

 

Investing and Financing Activities. There was no cash provided by investing and financing activities were not significant for the six months ended June 30, 2012 or 2011.

 

Recent Accounting Pronouncements

 

We have evaluated all recently issued accounting pronouncements and we believe such pronouncements do not have a material effect on our financial statements.

 

Critical Accounting Policies

 

We have identified the policies below as critical to our business operations and the understanding of our results of operations. The impact and any associated risks related to these policies on our business operations are disclosed throughout this section where such policies affect our reported and expected financial results. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of our financial statements, and the reported amounts of revenues and expenses during the reporting period. There can be no assurance that actual results will not differ from those estimates.

 

Revenue Recognition. While we have not recognized revenues from continuing operations, we anticipate that future revenues will be generated from product sales. We expect to recognize revenue from product sales in accordance with SEC, Staff Accounting Bulletin (“SAB”) No. 104, “Revenue Recognition” that requires we recognize revenue when each of the following four criteria is met: 1) a contract or sales arrangement exists; 2) products have been shipped or services have been rendered; 3) the price of the products or services is fixed or determinable; and 4) collectability is reasonably assured. We anticipate that customers will have no right of return for products sold. Revenues are considered to be earned upon shipment.

 

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Share-Based Compensation. We follow Accounting Standards Codification (“ASC”) 718 “Compensation – Stock Compensation” which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and directors including grants of employee stock options based on estimated fair values. We have used the Black-Scholes option pricing model to estimate grant date fair value for all option grants. The assumptions we use in calculating the fair value of share-based payment awards represent management’s best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As such, as we use different assumptions based on a change in factors, our stock-based compensation expense could be materially different in the future.

 

Preclinical Study and Clinical Trial Accruals. Substantially all of our preclinical studies and clinical trials are being performed by third-party CROs and other outside vendors. For preclinical studies, we use the percentage of work completed to date and contract milestones achieved to determine the accruals recorded. For clinical trial accruals, we use the number of patients enrolled, period of patient enrollment and percentage of work completed to date to estimate the accruals. We monitor patient enrollment levels and related activities to the extent possible through internal reviews, correspondence and status meetings with CROs and review of contractual terms. Our estimates are dependent on the timeliness and accuracy of data provided by our CROs and other vendors. If we have incomplete or inaccurate data, we may under-or overestimate activity levels associated with various studies or clinical trials at a given point in time. In this event, we could record adjustments to research and development expenses in future periods when the actual activity levels become known. No material adjustments to preclinical study and clinical trial expenses have been recognized to date.

 

ITEM 3 – Quantitative and Qualitative Disclosures About Market Risk

 

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information under this item.

 

ITEM 4 – CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

As of June 30, 2012, under the supervision and with the participation of our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), management has evaluated the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15 under the Exchange Act. Based on that evaluation, the CEO and CFO concluded that, as of June 30, 2012, our disclosure controls and procedures were ineffective at the reasonable assurance level in timely alerting him to material information required to be included in our periodic SEC reports as a result of the material weakness in internal control over financial reporting discussed below, our disclosure controls and procedures were not effective as of December 31, 2011. Management’s assessment of the effectiveness of internal control over financial reporting is expressed at the level of reasonable assurance because a control system, no matter how well designed and operated, can provide only reasonable, but not absolute, assurance that the control system’s objectives will be met.

 

Management’s Quarterly Report on Internal Control over Financial Reporting

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Exchange Act Rule 13a-15(f). Our internal control system is a process designed by, or under the supervision of, our principal executive and principal financial officer, or persons performing similar functions, and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”).

 

Our internal control over financial reporting includes policies and procedures that pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect transactions and dispositions of assets; provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. GAAP, and that receipts and expenditures are being made only in accordance with the authorization of our management and directors; and provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on our consolidated financial statements.

 

17
 

 

 

Because of our inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

Management assessed the effectiveness of our internal control over financial reporting as of June 30, 2012. As a result of its assessment, management identified a material weakness in our internal control over financial reporting. Based on the weakness described below, management concluded that our internal control over financial reporting was not effective as of June 30, 2012.

 

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that, there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. As a result of our assessment, management identified the following material weaknesses in internal control over financial reporting as of June 30, 2012:

 

·While there were internal controls and procedures in place that relate to financial reporting and the prevention and detection of material misstatements, these controls did not meet the required documentation and effectiveness requirements under the Sarbanes-Oxley Act (“SOX”) and therefore, management could not certify that these controls were correctly implemented. As a result, it was management’s opinion that the lack of documentation warranted a material weakness in the financial reporting process.

 

·Our disclosure controls and procedures were not effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our CFO, as appropriate to allow timely decisions. Inadequate controls include the lack of procedures used for identifying, determining, and calculating required disclosures and other supplementary information requirements.

 

·There is lack of segregation of duties in financial reporting, as our financial reporting and all accounting functions are performed by our Chief Financial Officer who also serves as our Chief Executive Officer. This weakness is due to our lack of working capital to hire additional staff during the period covered by this report. We intend to hire additional accounting personnel to assist with financial reporting as soon as our finances will allow.

 

Changes in Internal Control Over Financial Reporting

 

There were no significant changes in our internal control over financial reporting that occurred during the six months ended June 30, 2012 that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.

 

18
 

PART II – OTHER INFORMATION

 

ITEM 1 – LEGAL PROCEEDINGS

 

There have been no events which are required to be reported under this item.

 

ITEM 1A – RISK FACTORS

 

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information under this item.

 

ITEM 2 – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

On June 27, 2012 CAMOFI Master LDC and CAMHZN Master LDC exercised warrants for 216,000 and 41,143 shares respectively of our common stock with an exercise price of $0.001 per share.

 

The information set forth in Item 5 below is incorporated herein by this reference.

 

ITEM 3 – DEFAULTS UPON SENIOR SECURITIES

 

There have been no events which are required to be reported under this item.

 

ITEM 4 – MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5 – OTHER INFORMATION

 

On January 11, 2012, we entered into an Agreement (the “Agreement”) with KP Pharmaceutical Technology, Inc., an Indiana corporation (“KPPT”). The Agreement provides that, in exchange for KPPT providing manufacturing and analytical testing of our lead drug candidate from the L-nucleoside conjugate program, OVI-117, we shall pay KPPT a total fee of $158,000. There is no material relationship between us and KPPT, other than with respect to the Agreement.

 

On June 13, 2012, we entered into an Agreement (the “Agreement”) with Landmark Financial Corporation (“Landmark”). The Agreement provides that, in exchange for Landmark identifying and evaluating alternative strategies for expanding our business, we shall pay Landmark (a) a retainer fee consisting of 300,000 shares of the our common stock which vest at the rate of 50,000 shares per month for six months (the term of the Agreement), and (b) a “success fee” for the consummation of each and any transaction closing during the term of the Agreement and for 12 months thereafter, between the us and any party first introduced to us by Landmark. There is no material relationship between us and Landmark, other than with respect to the Agreement.

 

On July 12, 2012 we consummated a settlement with a debt holder of one outstanding unsecured note in the aggregate amount of $174,495 (as of June 30, 2012). We and the debt holder agreed to a one time payment of $60,000 for complete and full payment of the debt.

 

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ITEM 6 – EXHIBITS

 

Exhibits:

 

Exhibit No.   Description
10.1   Agreement with Landmark Financial Corporation dated June 13, 2012
31.1  

Certification of Chief Executive Officer Pursuant to the Securities Exchange Act of 1934, Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

31.2  

Certification of Chief Financial Officer Pursuant to the Securities Exchange Act of 1934, Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

32   Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
20
 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15 (d) 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.

 

ONCOVISTA INNOVATIVE THERAPIES, INC.

 

 

 

Alexander L. Weis, Ph.D.

Chief Executive Officer, and Chief Financial Officer

(Principal Executive Officer, Principal Financial

Officer and Principal Accounting Officer)

 

 

Date: August 14, 2012

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PINX:OVIT OncoVista Innovative Therapies Inc Quarterly Report 10-Q Filling

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PINX:OVIT Quarterly Report 10-Q Filing - 6/30/2012
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