OVIT OncoVista Innovative Therapies Inc (CE)

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-K

 

(Mark One)

x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF

THE SECURITIES EXCHANGE ACT OF 1934

 

For the Fiscal Year Ended December 31, 2011

 

¨ 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)

 

Securities registered pursuant to Section 12(b) of the Exchange Act:  None

 

Securities registered pursuant to Section 12(g) of the Exchange Act: Common Stock, $0.001 par value

 

Indicate by check mark whether the Company is a well-known seasoned issuer, as defined by Rule 405 of the Securities Act. Yes ¨   No x .

 

Indicate by check mark if the Company is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨   No x .

 

Indicate by check mark whether the Company (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 Company 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 if disclosure of delinquent filers in response to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of the Company’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ¨ .  

 

Indicate by check mark whether the Company is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated file and larger accelerated filer” 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 Act).

  Yes   ¨   No   x

 

The aggregate market value of the voting common equity held by non-affiliates of the registrant as of June 30, 2011 was approximately $7,654,578.00 (based upon 12,548,489 shares at $0.61per share).

 

As of March 26 2012, there were 21,370,725 shares of common stock outstanding.

 

 

 

ONCOVISTA INNOVATIVE THERAPIES, INC.

FORM 10-K

FOR THE YEAR ENDED DECEMBER 31, 2011

TABLE OF CONTENTS

 

PART I	1
ITEM 1 – BUSINESS	1
ITEM 1A – RISK FACTORS	13
ITEM 1B – UNRESOLVED STAFF COMMENTS	13
ITEM 2 – PROPERTIES	13
ITEM 3 – LEGAL PROCEEDINGS	13
ITEM 4 – MINE SAFETY DISCLOSURES	13
PART II	14
ITEM 5 – MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES	14
ITEM 6 – SELECTED FINANCIAL DATA	15
ITEM 7 – MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	15
ITEM 7A – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	22
ITEM 8 – FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA	22
ITEM 9 – CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE	22
ITEM 9A – CONTROLS AND PROCEDURES	22
ITEM 9B – OTHER INFORMATION	24
PART III	25
ITEM 10 – DIRECTORS, EXECUTIVE OFFICERS  AND CORPORATE GOVERNANCE	25
ITEM 11 – EXECUTIVE COMPENSATION	29
ITEM 12 – SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS	35
ITEM 13 – CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, DIRECTOR INDEPENDENCE	36
ITEM 14 – PRINCIPAL ACCOUNTANT FEES AND SERVICES	38
PART IV	39
ITEM 15 – EXHIBITS, FINANCIAL STATEMENT SCHEDULES	39

 

 

PART I

 

ITEM 1 – BUSINESS

 

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 expect to be a major participant in the oncology arena through the successful development and commercialization of innovative therapies which, as a result of their lower toxicity and greater efficacy, will increase patient survival rates and enhance patient quality of life. In targeting compounds for acquisition, we focus on candidates that have been previously tested in human clinical trials or animal models, as well as technologies that may improve the delivery or targeting of previously tested, and in some cases marketed, anticancer agents. Our senior management team and our panel of internationally-recognized clinical advisors have made significant contributions to the development of leading drugs currently used in cancer treatment. Management, in conjunction with our advisors, will evaluate in-licensing candidates based on several criteria, including development and registration strategies to be employed, commercialization opportunities and competitive technologies being developed elsewhere.

 

Ø

In the second quarter of 2008, we launched the Phase I/II clinical trial for Cordycepin (OVI-123) at two sites in the U.S. and, following completion of the Phase I portion of the trial, we planned to collect initial Phase II efficacy data in a small cohort of refractory leukemia patients who express the marker, TdT. In October 2009, after enrolling five patients in this clinical trial, we placed the clinical trial on administrative hold until such time that additional capital can be raised. 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 in 2012.

 

Ø

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) is currently being prepared. We have engaged a contract manufacturer and we are currently in the process of doing method transfer to ensure clinical batch availability by May 2012. The clinical protocol has been written and a principal investigator engaged. OncoVista believes that OVI-117 should be ready to enter Phase I clinical trials in 2012.

  

Based on our current capital position, the cost to further develop the drug compound, and the limited patent life remaining, we have elected to discontinue further development of our drug candidate, OVI-237, a liposomal formulation of a potent inhibitor of thymidylate synthase, and focus our efforts and resources on developing our other drug candidates.

 

We previously developed diagnostic kits through our former majority-owned German operating subsidiary, AdnaGen AG (“AdnaGen”), for several cancer indications, and marketed diagnostic kits in Europe for the detection of circulating tumor cells (“CTCs”) in patients with cancer.   In October 2010, we entered into a Stock Purchase Agreement with Alere Holdings Bermuda Limited Canon's Court (“Alere Holdings”), whereby we sold all of our shares, representing approximately 78% of the total issued and outstanding shares of AdnaGen.  Under the terms of the agreement, 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 the next 36 months.  We are entitled to receive our pro rata portion of the up-front and potential milestone payments. No milestone payments were received in 2011.

 

 

To date, we have financed our operations principally through offerings of securities exempt from the registration requirements of the Securities Act of 1933 (the “Securities Act”). We are using the proceeds from the sale of our shares in AdnaGen to fund on-going development activities for our drug candidate portfolio.  We estimate that our cash reserves will be sufficient to permit us to continue at our anticipated level of operations for at least nine to 12 months. However, we anticipate we will need to raise additional capital to support our current operations and fund in-licensing and research and development programs and will further require additional financing at various intervals in the future. We can provide no assurance that additional funding will be available on a timely basis, terms acceptable to us, or at all.

 

If we are unsuccessful raising additional funding, our business may not continue as a going concern and if sufficient capital is not available, we may be required to delay, further scale back or eliminate one or more of our research and development or acquisition and in-licensing 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. In such event, our business, prospects, financial condition, and results of operations may be adversely affected because we may be required to further scale back, eliminate, or delay development or acquisition efforts or product introductions or enter into royalty, sales, or other agreements with third parties in order to commercialize our products. Even if we do find additional funding sources, we may be required to issue securities with greater rights than those currently possessed by holders of our common stock. We may also be required to take other actions that may lessen the value of our common stock or dilute our common stockholders, including borrowing money on terms that are not favorable to us or issuing additional equity securities. If we experience difficulties raising money in the future, our business, prospects, financial condition, and results of operation will be materially adversely affected. See Note 3 of the consolidated financial statements.

 

During the last three fiscal years, we spent approximately $5.6 million on research and development, excluding discontinued operations.

 

Our Corporate Strategy

 

We have implemented a comprehensive, multi-faceted approach to candidate identification and product development in the oncology treatment. Our strategic plan consists of the following elements:

 

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A Practical, Rational Approach to Drug Development . Our management is well versed in the nuances associated with successful execution of the drug development and registration process. Registration strategies will be designed to address those issues which are critical to achieving success with respect to both the acceptability of a specific plan in the view of the FDA and the ability to achieve that plan with respect to the designated end points for that phase of the clinical trial. Furthermore, wherever possible these strategies will be designed to take advantage of the FDA’s accelerated approval paths for certain drugs and orphan drug designation.

 

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A Disciplined Internal Development Strategy for Therapeutics . Besides opportunistically evaluating candidates for potential in-licensing or acquisition, we possess two proprietary technologies which we believe will produce candidates for potential out-licensing. Both technologies target aspects of cell biology specific to most cancer cells, but not found in healthy cells and we expect these technologies to produce an array of candidates. We believe that, in many instances, the potential candidates can address opportunities with unmet needs, such as cancers which are very resistant to therapy or have high recurrence rates. In other instances, we believe that the candidates may address opportunities where the effectiveness of existing chemotherapeutics is hampered by the toxic side effects which the drugs produce. In these circumstances, we believe that the use of our product candidates in combination with existing drug therapies administered at lower dosage levels could produce comparable or improved effectiveness with diminished side effects versus the single agent therapy.

 

 

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In-licensing Candidate Selection and Acquisition Program . We believe that the relationships and reputation of the members of both our management and our clinical advisory board positions us to be exposed to many acquisition and in-licensing opportunities that would not normally be available to a company of our size. In many instances, the acquisition of biopharmaceutical companies by larger companies has resulted in drug programs being delayed or discontinued, due to such factors as loss of internal sponsorship (not created at the acquiring company), a perceived lack of market size (the desire for drugs with annual sales in excess of $1 billion) by the larger combined entity, or an overcrowded pipeline (too many product candidates to investigate, too many products to develop and a lack of sufficient resources). Indeed, the development of hundreds of potential oncology compounds that had been on the development track has been delayed or discontinued. We view many of these product candidates, together with some of the 400 plus compounds in the development pipeline, as potential candidates for in-licensing.

 

By leveraging the experience of our management team and clinical advisory board in selecting, developing and obtaining approval for many important chemotherapeutics, we believe that we will be able to discern those opportunities that truly possess the potential to become approved drugs within a targeted three-to-five year horizon. We involve our clinical advisory board in all major acquisition and in-licensing decisions. Given the experience and the active network of our management team and clinical advisory board, we expect to uncover many other promising candidates. Coupled with this, we generally attempt to structure our in-licensing deals so that if the in-licensed technology fails to perform as represented, we are able to recover any payments made by us in acquiring the technology.

 

Merger and Private Placement

 

On August 16, 2007, OncoVista-Sub, the private company conducting our cancer drug research and development, acquired an aggregate of 10,963,851 shares of our (formerly Aviation Upgrade Technologies, Inc.) common stock. On October 26, 2007, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with OncoVista Acquisition Corp. (“NewSub”), our then wholly owned subsidiary, and OncoVista-Sub. On November 13, 2007, NewSub merged with and into OncoVista-Sub with OncoVista-Sub remaining as the surviving corporation (the “Merger”). As a result of the Merger, OncoVista-Sub became our wholly-owned subsidiary and OncoVista-Sub’s existing business operations became our sole line of business. The Merger was accounted for as a reverse acquisition and recapitalization of OncoVista-Sub for financial accounting purposes.

 

Our Drug Candidate Pipeline

 

The following table summarizes the status of our various pre-clinical and clinical development programs underway:

 

Program		Indication		Status		Planned Activities		Commercial Rights
Cordycepin (OVI-123)		Refractory TdT Positive Leukemias		In Phase I/II Clinical Development; Open IND; Orphan Drug Designation Received		Phase I/II Trial Reinitiated in Third Quarter of 2012		OncoVista-Sub
L-Nucleoside Conjugates (OVI-117)		Colon Cancer		Pre-Clinical Development; Initiated GLP animal safety studies		Anticipated IND Filing in the Third Quarter of 2012 to Commence Phase I Trial		OncoVista-Sub

  

The following sections discuss various aspects of our portfolio of drug candidates and their respective therapeutic characteristics in more detail.

 

 

Cordycepin (OVI-123) (TdT-Positive Refractory Leukemias)

 

The American Cancer Society estimated that 43,050 new leukemia cases were diagnosed in 2010 in the U.S. While almost 250,000 individuals are living with, or are in remission from, leukemia in the U.S., the annual mortality rate is nearly 22,000. The four broad classifications of leukemia are:

 

	—	Acute lymphocytic leukemia (“ ALL ”);
	—	Chronic lymphocytic leukemia (“ CLL ”);
	—	Acute myelogenous leukemia (“ AML ”); and
	—	Chronic myelogenous leukemia (“ CML ”).

 

Cordycepin, which was obtained through OncoVista-Sub’s acquisition of Aengus Pharmaceuticals, Inc. in November 2005, was our first clinical-stage development compound. We are developing Cordycepin as a treatment option for certain leukemia patients that are either refractory to currently-used chemotherapeutics or have experienced a relapse. Cordycepin depends upon the presence of a DNA polymerase, known as terminal deoxynucleotidyl transferase (TdT), for our therapeutic activity. Approximately 95% of ALL patients express TdT, and approximately 10% of the AML cases express TdT. The range of CML cases that express TdT has been estimated at between 0% and 55% in scientific literature with an average of 21% among the cited articles. Generally, the TdT-positive patients that would either be refractory or have experienced a relapse are older adults.

 

Opportunity

 

Leukemia is a malignant cancer of the bone marrow and blood. Leukemia is characterized by the uncontrolled accumulation of blood cells and is categorized as either lymphocytic or myelogenous, either of which type can be acute or chronic. The terms lymphocytic and myelogenous denote the type of blood cell affected (lymphocytic involving lymphocyte cells in bone marrow and myelogenous implicating other blood cells). Acute leukemia is a rapidly progressing disease that results in the accumulation of immature, functionless cells in the marrow and blood, thereby resulting in a condition whereby the marrow often can no longer produce enough normal red blood cells, white blood cells and platelets. Anemia, a deficiency of red cells, develops in virtually all leukemia patients, and the lack of normal white cells impairs the body’s ability to fight infections. A shortage of platelets results in bruising and easy bleeding. Chronic leukemia, on the other hand, progresses more slowly and allows greater numbers of more mature, functional cells to be made.

 

Based on information obtained from the Surveillance, Epidemiology, and End Results (“SEER”) Program of the National Cancer Institute, while AML and CML have been cancers primarily of adults, with prevalence rates of 94% for AML in adults over the age of 20 and 97% for CML in adults over 20, ALL is more evenly distributed between adults and children. Approximately 65% of new cases diagnosed with ALL are in children under the age of 20, and while the treatment outcomes for ALL in children have generally been favorable with a five-year survival rate of 86% for children under the age of 15, the treatment response rates for adults have resulted in a lower overall five-year survival rate of 65%. Given the toxic profile of the treatment regimens for both adults and children, we believe that Cordycepin, as a TdT-dependent agent, could be used as part of a combination therapy regimen in order to minimize toxicities to both age groups while maintaining effectiveness.

  

Market

 

Currently, approximately 50 different drugs are being used to treat leukemia. In the past decade, several important new drugs and new uses for existing drugs have greatly improved cure rates or remission duration for some patients. Because of the likelihood of increased toxicity for standard- or lower-risk childhood ALL patients, most centers treat these patients with a less intense treatment regimen than the four- or five-dose treatment regimen used for higher risk patients. This regimen generally results in a complete remission rate of 95%. For adult ALL patients, the treatment regimen is similar to the childhood treatment regimen; however, for the 60% to 80% demonstrating remission during induction, the median remission duration is approximately 15 months. Unfortunately, those patients experiencing a relapse can succumb within one year.

 

 

AML treatment should be sufficiently aggressive to achieve complete remission since partial remission offers no substantial survival benefit. Initial therapy typically results in 60% to 70% of adults attaining complete remission during the induction phase. However, with an overall five year survival rate of 20%, the long-term prognosis in general is not good for adult AML patients. Unfortunately, while AML is a cancer of older adults, because of the therapy’s toxicity (from myelosuppression and increased risk of infection), induction chemotherapy is not generally offered to the very elderly.

 

Gleevec®, the standard primary course of treatment in CML, inhibits an enzyme (bcr-abl tyrosine kinase) resulting from the defective gene translocation. By selectively inhibiting the activity of this enzyme, Gleevec® offers dramatic advantages to patients, including decreased side effects, few adverse effects on normal tissues and a very high response rate. The effectiveness and tolerance of older patients and the projections from the first several years of clinical trials suggest that the drug will prolong the duration of hematological remission and extend the patient’s life, when compared to former therapies.

 

Similar to Gleevec®, our Cordycepin selectively targets cells expressing a specific enzyme involved in the disease’s pathway. In this case, Cordycepin is targeting cells expressing TdT. With an addressable patient population consisting primarily of 46,000 individuals with CML, Gleevec® /Glivec® full year sales for 2010 were $4.3 billion, according to Novartis. With an addressable patient population for Cordycepin in leukemia patients nearly half the addressable population of Gleevec®, we believe that our product possesses a significant market.

 

Clinical Development

 

Cordycepin has been studied in a National Cancer Institute-sponsored Phase I clinical trial for treating TdT-positive ALL leukemia patients. TdT is a polymerase expressed in immature, pre-B, pre-T lymphoid cells, and acute lymphoblastic leukemia/lymphoma cells. TdT, and similar enzymes found in fungi and parasites, recognize Cordycepin and its analogues and add them onto growing nucleic acid chains thereby terminating synthesis of the nucleic acid and replication of the cell. Importantly, TdT expression in normal human tissue is limited to primitive lymphoid cells in the bone marrow and thymus, so most normal cells in the body are unaffected by the drug. In addition to effectively treating TdT-positive ALL and CML, Cordycepin can also be used to treat diffuse high-grade lymphoblastic lymphoma, which also expresses TdT.

 

In a biological system, Cordycepin is converted to 3’-deoxyinosine by the enzyme adenosine deaminase (“ ADA ”), so Cordycepin must be administered with an ADA inhibitor, such as deoxycoformycin (Nipent ® or pentostatin) to protect Cordycepin and allow it to maintain its antileukemic activity. If the Phase I/II trial of Cordycepin demonstrates adequate safety and efficacy, we intend to develop an ADA-resistant analog of Cordycepin in order to eliminate the need for co-administration of deoxycoformycin.

 

The initial Phase I clinical trial data for the combination therapy was obtained in an ALL study of 14 patients between 1997 and 2000. No Cordycepin-related adverse events were noted. Biological activity in the last three patients of the escalating dosing study was noted by the transient clearing of peripheral blood blasts.  Since May 2007, we have had an open IND and in addition, in July 2007, our request for Orphan Drug designation for Cordycepin was granted by the FDA.

 

We initiated a Phase I/II trial based on the “original” ADA-sensitive compound in the second quarter of 2008. The trial was being conducted 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 was designed to enroll up to 24 patients in the first stage and up to 20 patients in the second stage. The primary objective of the 1 ^st phase of the study is to determine the maximally tolerated dose (“ MTD ”) and the recommended dose (RD) of Cordycepin, given one hour following a fixed dose of the ADA inhibitor Pentostatin, in patients with refractory TdT-positive leukemia. The primary objectives of the 2 ^nd phase of the study will be to determine the single and multiple dose pharmacokinetics of Cordycepin given one hour following a fixed dose of Pentostatin and to measure and quantify any clinical responses following administration of Cordycepin/Pentostatin at the recommended dose in 20 subjects Secondary objectives will include assessing the pharmacokinetics efficacy and safety at the MTD. We anticipate a total time period of 18 months for the trial during which patients will receive Cordycepin for three consecutive days repeated every 28 days. Patients will be eligible for re-treatment if all dose-related toxicities have been resolved by day 28 and there is no evidence of disease progression. Subjects may receive treatment until disease progression and will be followed for at least 30 days after the last administration of study drug.  In October 2009, after enrolling five patients in this clinical trial, we placed the clinical trial on administrative hold until such time that additional capital can be raised. 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 in 2012.

 

 

L-Nucleoside Conjugate (OVI-117)

 

Our L-nucleoside conjugate technology selectively targets certain cancer cell characteristics which make those cancer cells vulnerable to the actions of the drug, but leaves the healthy cells unaffected. In effect a new drug is created by conjugating an L-nucleoside to an existing chemotherapeutic agent that would be too toxic if delivered systemically. Several product candidates have been evaluated by us and one candidate (OVI-117) has been tested in animal models. We believe OVI-117 is a thymidylate synthase (TS) inhibitor with enhanced pharmacological properties which results in a retention of efficacy and a reduction of toxicity. OVI-117 has shown tumor growth inhibitory activity in human colon, breast, and prostate tumors growing in animal models.

 

Compounds evolving from our L-nucleoside conjugate technology may take advantage of cell membrane changes that differentiate cancerous cells from healthy cells. This anomalous characteristic of cancer cell membranes may present a unique opportunity for targeting these cells with new products which are uniquely designed cytotoxic nucleosides that selectively enter cancerous cells. After entering the cancer cells, these compounds may be enzymatically cleaved to release their cytotoxic agents causing the death of the cancer cell. The membranes of healthy cells may deny the L-nucleoside entry, so that cancerous cells are preferentially killed. As a result, we believe that there should be reduced side effects associated with this class of drug. Drug candidates using L-nucleoside conjugate technology have demonstrated efficacy in cell lines for colorectal, pancreas, melanoma, leukemia, and prostate cancers. OVI-117 has shown anti-tumor activity in animal models of several human cancers (including breast, prostate and colon), and our initial target indication is expected to be colorectal cancer.

 

The L-nucleoside conjugate technology was obtained through an exclusive, world-wide, royalty and milestone-bearing right and license to utilize the patents and technologies of Lipitek International, Inc. relating to L-nucleosides and their conjugates. Alexander L. Weis, Ph.D., Chairman of the Board of Directors, Chief Executive Officer, President, CFO and Secretary, is the ultimate beneficial owner of Lipitek International, Inc. and Lipitek Research LLC. Dr. Weis has agreed not to vote as a director in connection with any matter relating to Lipitek.

 

Opportunity

 

Colorectal cancer is the third most common form of cancer, and diagnosis of localized colon cancer is typically made by means of colonoscopy. Symptoms of colorectal cancer include:

 

	—	Change in bowel habits as seen by changes in frequency (due to either constipation or diarrhea), changes in stool caliber and changes in stool consistency;
	—	Blood in stools (melena, hematochezia);
	—	Bowel obstruction (rare) by the tumor;
	—	Anemia, with symptoms such as tiredness, malaise, pallor; and
	—	Unexplained weight loss.

 

The absence of discernible symptoms in the early stages of this disease is one reason why periodic screening with fecal occult blood testing and colonoscopy is so widely recommended.

 

 

For 2010, in the United States, the American Cancer Society estimated there would be 142,570 new colorectal cancer cases of which colon cancer accounted for 102,900 cases. Colon cancer is a highly treatable and often curable disease when diagnosed early and localized to the bowel. When detected at its earliest stage (Dukes’ A) as an in situ tumor, the curative rate for colon cancer approaches 90%, or five times the curative rate for colon cancers detected at a later stage. Unfortunately, 40% to 50% percent of patients have metastatic disease at the time of diagnosis after many of the above symptoms have been exhibited. Surgery is the primary form of treatment and is typically followed by a regimen of chemotherapy. Despite the fact that a majority of patients have the entire tumor removed by surgery, as many as 50% to 60% will ultimately die from either the metastatic colon cancer or from a recurrence. Deaths from colorectal cancer were estimated to be 51,370 in 2010 in the United States. 

 

Market

 

Standard treatment for patients with colon cancer has been open surgical resection of the primary and regional lymph nodes for localized disease. Surgery alone is curative in 25% to 40% of highly selected patients who develop resectable metastases in the liver and lung.

 

For 60% to 75% of the patients with colorectal cancer for whom surgery alone is insufficient to achieve a cure, adjuvant chemotherapy utilizing such extremely cytotoxic regimens as 5-FU based therapies, irinotecan or oxaliplatin are employed. However, due to the non-specific nature of these drugs (which attack both healthy and cancerous cells), the side effects profile includes severe diarrhea, neuropathy, nausea, neutropenia and fatigue. The median survival of these patients has improved from approximately 12 months in the mid-1990s to more than 20 months in 2003. The industry continues to research treatment methods that can improve upon both the length of survival and reduce the toxicity profiles.

 

Clinical Development

 

One of our L-nucleoside conjugate candidates, OVI-117, is a conjugate of an L-nucleoside  (L-uridine) and the highly toxic compound 5’-fluorodeoxyuridine monophosphate (FdUMP), a thymidylate synthase (TS) inhibitor. 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 in animals, as both a single agent and as a multi-agent combination therapy with oxaliplatin. We have completed Good Laboratory Practice (“GLP”) animal drug safety studies in two species for OVI-117. The Investigational New Drug application (IND) is currently being prepared. We have engaged a contract manufacturer and we are currently in the process of doing method transfer to ensure clinical batch availability by May 2012. 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 in 2012.

 

Liposomal Thymidylate Synthase (TS) Inhibitor (OVI-237) (solid tumors)

 

OVI-237 is a liposome encapsulated formulation of a potent thymidylate synthase inhibitor (TSI) with activity at picomolar concentrations. The drug was previously known as “OSI-7904L” and has been studied in a broad range of preclinical studies as well as several Phase I and Phase II human clinical trials. We were previously developing OVI-237 and had finalized a protocol and selected clinical sites to conduct a Phase II Study of OVI-237 monotherapy and combination therapy with cisplatin for the treatment of metastatic breast cancer.  Based on our current capital position, the cost to further develop the drug compound, and the limited patent life remaining, we have elected to discontinue further development and focus our efforts and resources on developing our other drug candidates.

 

 

Tubulin Isotype-Specific Anti-mitotics

 

We were previously evaluating several candidates as part of our research and development in this area. We expected to identify a lead compound in a family of novel chemotherapeutic compounds capable of distinguishing among the different forms (isotypes) of tubulin, a subunit protein of microtubules which play a critical role in the lives of cells. When a cell divides, microtubules constitute the mitotic spindle, and when a cell is not dividing, microtubules form a sub-cellular network that is responsible for various cellular activities such as respiration, protein synthesis, waste elimination, etc. Drugs that bind to tubulin are capable of interfering with microtubule dynamics and thereby preventing cells from dividing. In March 2010, we terminated our license agreements and returned the intellectual property related to these technologies, in return we are no longer obligated to pay $520,000 in liabilities for minimum royalties associated with these licenses.

  

Drug Development Expertise and Capabilities

 

Dr. Alexander L. Weis, Ph.D., our Chief Executive Officer, and our clinical advisory board have extensive experience in developing chemotherapeutics. Dr. Weis brings over 25 years of extensive experience in the biotechnology and pharmaceutical industries and is the founder of OncoVista-Sub and co-founder of ILEX Oncology.

 

Michael Moloney, our Chief Operating Officer who previously served as our Director of Program Management, brings more than 25 years experience as a seasoned pharmaceutical and biopharma executive with experience in clinical research, drug development, operations, and information technology.

 

Our clinical advisory board includes industry opinion leaders and oncologists with practical, relevant regulatory expertise, who can map out the very efficient registration strategies. Many individuals on the clinical advisory board have been instrumental in the development of such primary chemotherapeutics as Taxol®, Taxotere®, Oxaliplatin, Hycamtin®, Paraplatin®, Campath®, and Tarceva®.

 

Cancer drug development presents unique challenges in clinical development and registration. Obtaining marketing approval for a new drug depends upon the drug’s successful attainment of significant clinical endpoints such as increased overall survival and improvement in quality of life. According to the National Cancer Institute, less than 5% of cancer patients participate in clinical trials. This causes intense competition for trial participants, particularly in indications with the largest market potential (breast, lung, colon, and prostate cancer). The failure rate for drugs in clinical development is high. Fewer than one in 12 of all drugs entering clinical trials eventually gains approval according to the FDA. Not surprisingly, the attrition rate for anti-cancer drugs is even higher with roughly only one in 20 eventually getting to market from the clinic. Thus, successful clinical development and registration of a new drug depends, in large part, upon judicious selection of the lead compound, designation of demonstrable clinical end points and the availability of a sufficient pool of patients with appropriate characteristics. Our clinical advisory board gives us a critical advantage in these essential areas. Furthermore, in order to formulate a successful clinical development plan, it is imperative to know which drugs have already been approved and which drugs currently in clinical development are likely to be approved, since, ultimately, any newly approved drug will need to prove itself superior to, or at least equal to, previously-approved or about-to-be-approved therapies. Well constructed clinical development plans aimed at rapid marketing approval often take advantage of the FDA’s accelerated approval process which applies solely to diseases for which there is an unmet medical need. For cancers in which there are few treatment options and prognosis is poor, a new drug which shows even a small improvement in clinical endpoints may be approved based on Phase II clinical trial data. Taking advantage of this development path can save significant time and money in getting a drug to market. Our team is familiar with this path and plans to follow it as a part of our registration strategy when viable.

 

We believe that we will be able to monetize our product pipeline by efficiently identifying candidates, performing due diligence, negotiating in-license agreements and developing innovative clinical development and registration plans for strong product candidates. Before either acquiring or in-licensing any candidate, our Chief Executive Officer reviews the opportunity thoroughly with the clinical advisory board to determine the likelihood of successful product registration.

 

 

Collaborative Relationships and Partnerships

 

We anticipate that we will enter into strategic relationships with respect to the research and development, testing, manufacture, and commercialization of our product candidates. There are significant expenses, capital expenditures, and infrastructure involved in these activities. We believe that working together with strategic partners will expedite product formulation, production, and approval.

 

We have relationships with the University of Texas Health Science Center at San Antonio (UTHSCSA), the Cancer Therapy and Research Center (CTRC), the Dana-Farber Cancer Institute, and MD Anderson Cancer Center, one of the leading cancer research institutes in the nation.

 

Intellectual Property

 

As of March 30, 2012, we held eight issued US and worldwide patents and 2 patent applications. Our ability to protect and use our intellectual property in the continued development and commercialization of our technologies and products and to prevent others from infringing on our intellectual property is crucial to our success. Our basic patent strategy is to augment our current portfolio by continually applying for patents on new developments and obtaining licenses to promising product candidates and related technologies. We also maintain various trade secrets which we have chosen not to reveal by filing for patent protection. Our issued patents and patent applications provide protection for our core technologies. In addition to the foregoing patent activity, several continuations-in-part, and international patents have been filed.

 

We also rely on trade secrets and unpatentable know-how that we seek to protect, in part, by confidentiality agreements. Our policy is to require our employees, consultants, contractors, manufacturers, outside scientific collaborators and sponsored researchers, board of directors, technical review board and other advisors to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide that all confidential information developed or made known to the individual during the course of the individual’s relationship with us are to be kept confidential and not disclosed to third parties except in specific limited circumstances. We also require signed confidentiality or material transfer agreements from any company that is to receive our confidential information. In the case of employees, consultants and contractors, the agreements provide that all inventions conceived by the individual while rendering services to us shall be assigned to us as our exclusive property. There can be no assurance, however, that all persons who we desire to sign such agreements will sign, or if they do, that these agreements will not be breached, that we would have adequate remedies for any breach, or that our trade secrets or unpatentable know-how will not otherwise become known or be independently developed by competitors.

 

Our success will also depend in part on our ability to commercialize our technology without infringing the proprietary rights of others. Although we have conducted freedom of use patent searches, no assurance can be given that patents do not exist or could not be filed which would have an adverse affect on our ability to market our technology or maintain our competitive position with respect to our technology. If our technology components, products, processes or other subject matter are claimed under other existing U.S. or foreign patents or are otherwise protected by third party proprietary rights, we may be subject to infringement actions. In such event, we may challenge the validity of such patents or other proprietary rights or we may be required to obtain licenses from such companies in order to develop, manufacture or market our technology. There can be no assurances that we would be able to obtain such licenses or that such licenses, if available, could be obtained on commercially reasonable terms. Furthermore, the failure to either develop a commercially viable alternative or obtain such licenses could result in delays in marketing our proposed technology or the inability to proceed with the development, manufacture, or sale of products requiring such licenses, which could have a material adverse effect on our business, financial condition, and results of operations. If we are required to defend ourselves against charges of patent infringement or to protect our proprietary rights against third parties, substantial costs will be incurred regardless of whether or not we are successful. Such proceedings are typically protracted with no certainty of success. An adverse outcome could subject us to significant liabilities to third parties and force us to curtail or cease our development and commercialization of our technology.

 

 

We aggressively seek U.S. and international patent protection for the chemical compounds, processes, and other commercially important technologies which we develop. While we own specific intellectual property, we also in-license related technologies determined to be of strategic importance to the commercialization of our products or to have commercial potential of their own. For example, to continue developing and commercializing our current products, we may license intellectual property from commercial or academic entities to obtain technology rights that are required for our research and development or commercialization activities.

 

Government Regulation

 

The Drug and Therapeutic Product Development Process

 

The FDA requires that pharmaceutical and certain other therapeutic products undergo significant clinical experimentation and clinical testing prior to their marketing or introduction to the general public. Clinical testing, known as clinical trials or clinical studies , is either conducted internally by life science, pharmaceutical, or biotechnology companies or is conducted on behalf of these companies by contract research organizations.

 

The process of conducting clinical studies is highly regulated by the FDA, as well as by other governmental and professional bodies. Below is a description of the principal framework in which clinical studies are conducted, as well as a description of the number of the parties involved in these studies.

 

Protocols. Before commencing human clinical studies, the sponsor of a new drug or therapeutic product must submit an investigational new drug application, or IND, to the FDA. The application contains what is known in the industry as a protocol . A protocol is the blueprint for each drug study. The protocol sets forth, among other things, the following:

 

	—	who must be recruited as qualified participants;
	—	how often to administer the drug or product;
	—	what tests to perform on the participants; and
	—	what dosage of the drug or amount of the product to give to the participants.

 

Institutional Review Board . An institutional review board is an independent committee of professionals and lay persons which reviews clinical research studies involving human beings and is required to adhere to guidelines issued by the FDA. The institutional review board does not report to the FDA, but its records are audited by the FDA. Its members are not appointed by the FDA. All clinical studies must be approved by an institutional review board. The institutional review board’s role is to protect the rights of the participants in the clinical studies. It approves the protocols to be used, the advertisements which we or contract research organization conducting the study proposes to use to recruit participants, and the form of consent which the participants will be required to sign prior to their participation in the clinical studies.

 

Clinical Trials . Human clinical studies or testing of a potential product are generally done in three stages known as phase I through phase III testing. The names of the phases are derived from the regulations of the FDA. Generally, there are multiple studies conducted in each phase.

 

Phase I . Phase I studies involve testing a drug or product on a limited number of participants, typically 24 to 100 people at a time. Phase I studies determine a product’s basic safety and how the product is absorbed by, and eliminated from, the body. This phase lasts an average of six months to one year.

 

Phase II . Phase II trials involve testing up to 200 participants at a time who may suffer from the targeted disease or condition. Phase II testing typically lasts an average of one to two years. In Phase II, the drug is tested to determine its safety and effectiveness for treating a specific illness or condition. Phase II testing also involves determining acceptable dosage levels of the drug. If Phase II studies show that a new drug has an acceptable range of safety risks and probable effectiveness, a company will continue to review the substance in phase III studies.

 

 

Phase III . Phase III studies involve testing large numbers of participants, typically several hundred to several thousand persons. The purpose is to verify effectiveness and long-term safety on a large scale. These studies generally last two to three years. Phase III studies are conducted at multiple locations or sites. Like the other phases, phase III requires the site to keep detailed records of data collected and procedures performed.

 

New Drug Approval. The results of the clinical trials are submitted to the FDA as part of a new drug application (“ NDA ”).   Following the completion of phase III studies, assuming, the sponsor of a potential product in the United States believes it has sufficient information to support the safety and effectiveness of a product, it submits an NDA to the FDA requesting that the product be approved for marketing. The application is a comprehensive, multi-volume filing that includes the results of all clinical studies, information about the drug’s composition, and the sponsor’s plans for producing, packaging, and labeling the product. The FDA’s review of an application can take a few months to many years, with the average review lasting 18 months. Once approved, drugs and other products may be marketed in the United States, subject to any conditions imposed by the FDA.

 

Phase IV . The FDA may require that the sponsor conduct additional clinical trials following new drug approval. The purpose of these trials, known as phase IV studies, is to monitor long-term risks and benefits, study different dosage levels, or evaluate safety and effectiveness. In recent years, the FDA has increased its reliance on these trials. Phase IV studies usually involve thousands of participants. Phase IV studies also may be initiated by the company sponsoring the new drug to gain broader market value for an approved drug. For example, large-scale trials may also be used to prove effectiveness and safety of new forms of drug delivery for approved drugs. Examples may be using an inhalation spray versus taking tablets or a sustained-release form of medication versus capsules taken multiple times per day.

 

Biologics License Application. Once clinical trials are completed and the results tabulated and analyzed, a Biologics License Application (“ BLA ”) is submitted to the FDA. The application presents to FDA reviewers the entire history or the “whole story” of the drug product including animal studies/human studies, manufacturing, and labeling/medical claims. Before the FDA applies its scientific technical expertise to the review of the application, it will decide if the application gets a “priority review” or a “standard review.” This classification determines the review timeframe. A priority review is for a drug that appears to represent an advance over available therapy, whereas, a standard review is for a drug that appears to have therapeutic qualities similar to those of an already marketed product. Generally, an advisory committee (the Oncology Drug Advisory Committee, ODAC) will review the BLA and make a recommendation to the FDA. This outside advice is sought so that the FDA will have the benefit of wider expert input. The FDA usually agrees with the advisory committee decisions but they are not binding.

 

The FDA takes action on the BLA after their review is complete. There are three possible actions to be taken by the review team:

 

	—	Approved  – This indicates to a company that it may now market in the U.S.;
	—	Not Approved –This tells a company that the product may not be marketed in the U.S. and is accompanied by a detailed explanation as to why; and
	—	Approvable – This indicates that the FDA is prepared to approve the application upon the satisfaction of certain conditions. These drug products may not be legally marketed until the deficiencies have been satisfied, as well as any other requirements that may be imposed by the FDA.

 

The drug approval process is time-consuming, involves substantial expenditures of resources, and depends upon a number of factors, including the severity of the illness in question, the availability of alternative treatments, and the risks and benefits demonstrated in the clinical trials.

 

 

Orphan Drug Act. The Orphan Drug Act provides incentives to develop and market drugs (“ Orphan Drugs ”) for rare disease conditions in the United States. A drug that receives Orphan Drug designation and is the first product to receive FDA marketing approval for its product claim is entitled to a seven-year exclusive marketing period in the United States for that product claim. A drug which is considered by the FDA to be different than such FDA-approved Orphan Drug is not barred from sale in the United States during such exclusive marketing period even if it receives approval for the same claim. We can provide no assurance that the Orphan Drug Act’s provisions will be the same at the time of the approval, if any, of our products.

 

Other U.S. Regulations.

 

Various Federal and state laws, regulations, and recommendations relating to safe working conditions, laboratory practices, the experimental use of animals, and the purchase, storage, movements, import, export, use, and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research are applicable to our activities. They include, among others, the United States Atomic Energy Act, the Clean Air Act, the Clean Water Act, the Occupational Safety and Health Act, the National Environmental Policy Act, the Toxic Substances Control Act, and Resources Conservation and Recovery Act, national restrictions on technology transfer, import, export, and customs regulations, and other present and possible future local, state, or federal regulation. The extent of governmental regulation which might result from future legislation or administrative action cannot be accurately predicted.

 

Other Regulatory Matters.

 

Regulations imposed by authorities in other countries are a significant factor in the conduct of research, development, manufacturing, and eventual marketing of our products.

 

Competition

 

In addition to the specified therapies relative to each cancer discussed earlier, we generally face competition from pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and private research organizations in recruiting and retaining highly qualified scientific personnel and consultants and in the development and acquisition of technologies. The pharmaceutical and biotechnology industries are very competitive and are characterized by rapid and continuous technological innovation. We believe there are a significant number of potential drugs in preclinical studies and clinical trials to treat cancer that may result in effective, commercially successful treatments. In addition to most of the large pharmaceutical companies having small molecule programs, we are aware of large biotechnology companies, such as Amgen, Inc., Genentech, Inc., Biogen Idec Inc., and Eli Lilly & Co., which are developing small molecule therapeutics as treatments for cancer. Other, smaller companies in this field include: Allos, EntreMed, Threshold Pharmaceuticals, and Sunesis.

 

We recognize that most of our competitors have a broader range of capabilities and greater access to financial, technical, scientific, business development, recruiting, and other resources. Additionally, third party-controlled technology, which may be advantageous to our business, could be acquired or licensed by our competitors, thereby preventing us from obtaining technology on commercially reasonable terms, if at all. Because part of our strategy is to target markets outside of the United States through collaborations with third parties, we will compete for the services of third parties that may have already developed or acquired internal biotechnology capabilities or made commercial arrangements with other biopharmaceutical companies to target the diseases on which we have focused.

 

Employees

 

As of the date hereof, we have three full-time employees. Of our employees, two are executives and one is engaged in research and development.  We have engaged the services of experts in clinical/regulatory, quality assurance, and accounting as needed on an independent contractor basis to continue to advance our drug candidates through clinical studies.

 

 

Corporate Information

 

We were originally incorporated in Nevada on January 8, 1999 under the name, Aviation Upgrade Technologies, Inc. Our principal executive offices are located at 14785 Omicron Drive, Suite 104, San Antonio, Texas 78245 and our telephone number is (210) 677-6000.

 

ITEM 1A – RISK FACTORS

 

We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 ( “Exchange Act” ) and are not required to provide the information under this item.

 

ITEM 1B – UNRESOLVED STAFF COMMENTS

 

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

 

ITEM 2 – PROPERTIES

 

Our fully equipped office and research facilities are located in the Texas Research Park in San Antonio, Texas.  We have a total of 6,925 square feet of office and research space, of which the labs are fully equipped for organic chemistry, as well as analytical and biological activities. Pursuant to a Lease Agreement between Lipitek International and us, we lease the laboratory space for approximately $12,000 per month from Lipitek International under a three-year Lease Agreement that expires in December 2013.  Lipitek is an affiliate of Alexander L. Weis, Ph.D., our Chief Executive Officer, President, CFO, and Secretary.  Additionally, pursuant to a Lease Agreement between Texas Research and Technology Foundation and us, we lease office space located in San Antonio, Texas for approximately $1,200 per month on a month-to-month basis.

 

ITEM 3 – LEGAL PROCEEDINGS

 

 

On December 17, 2007, an action was filed against us in the Supreme Court of the State of New York, New York County, entitled Bridge Ventures, Inc. v. OncoVista, Inc. and Centrecourt Asset Management. The action seeks damages for the alleged breach of a consulting agreement and seeks an order directing the issuance of warrants to purchase our common stock. We filed a motion to dismiss the action, and on April 3, 2008 the motion was denied. We answered the complaint and asserted a counterclaim seeking compensation for the expenses that it incurred during the time that we worked with Bridge Ventures, Inc. The parties signed a settlement agreement, under which we paid $1,000 and issued 45,000 shares of our common stock. In March 2011, we issued the shares required by the settlement agreement, and recorded settlement expense of $9,000 related to the issuance of these shares.

 

On August 11, 2011, an action was filed against us in the United States District Court for the Southern District of New York, entitled New Millennium PR Communications, Inc., v. 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 our common stock. On October 5, 2011, we 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 our 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 us in the Supreme Court of the State of New York, New York County, entitled CAMOFI Master LDC and CAMHZN LDC v. 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 our common stock, and (ii) warrants to purchase an aggregate of 702,857,767 shares of our common stock at an exercise price of $0.001. On October 20, 2011, we filed an answer to the complaint. On November 1, 2011, the plaintiffs made an extensive document request to us for all documents related to the matter. Our counsel has started taking depositions and has requested access to CAMOFI Master LDC and CAMHZN Master LDC principals for further depositions.

 

ITEM 4 – MINE SAFETY DISCLOSURES

 

Not applicable.

 

 

PART II

 

ITEM 5 – MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

 

Market Information

 

From December 21, 2005 until January 13, 2008, our common stock was quoted on the OTC Bulletin Board under the symbol “AVUG.”  Our common stock currently trades under the symbol “OVIT” on the OTCQB™.  On October 22, 2007, we effected a 1.4739739-for-1 forward split of our outstanding common stock.  Until October 26, 2007, there was no trading of our common stock. The quarterly high and low reported sales prices for our common stock as quoted on the OTC QB™ for the periods indicated are as follows:

 

Year Ended December 31, 2011		High				Low
First Quarter		$	0.70			$	0.25
Second Quarter			0.65				0.47
Third Quarter			0.66				0.24
Fourth Quarter			0.43				0.06

 

Year Ended December 31, 2010		High				Low
First Quarter		$	0.40			$	0.15
Second Quarter			0.40				0.20
Third Quarter			0.47				0.25
Fourth Quarter			0.47				0.26

 

The foregoing quotations were provided by Yahoo! ® Finance and the quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not represent actual transactions.

 

The last reported sale price per share of common stock as quoted on the OTCQB was $0.50 on March 26, 2012. We have 21,370,725 shares of common stock issued and outstanding. Based on information available from our registrar and transfer agent, we estimate that we have approximately 267 stockholders of record.

 

Dividends

 

We have not declared nor paid any cash dividend on our common stock, and we currently intend to retain future earnings, if any, to finance the expansion of our business, and do not expect to pay any cash dividends in the foreseeable future. The decision whether to pay cash dividends on our common stock will be made by the Board of Directors, in their discretion, and will depend on our financial condition, operating results, capital requirements and other factors that the Board of Directors considers significant.

 

Recent Sales of Unregistered Securities

 

We did not sell any equity securities which were not registered under the Securities Act during the year ended December 31, 2011that were not otherwise disclosed on our Quarterly Reports on Form 10-Q or our Current Reports on Form 8-K filed during the year ended December 31, 2011.

 

Repurchases of Equity Securities by the Issuer and Affiliated Purchasers

 

None.

 

Use of Proceeds from Sales of Registered Securities

 

None.

 

 

ITEM 6 – SELECTED FINANCIAL DATA

 

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

 

ITEM 7 –  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 and Section 21E of 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 SEC.

 

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.

 

The following discussion and analysis should be read in conjunction with our financial statements, including the notes thereto, appearing elsewhere in this Report.

 

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 CTCs in patients with cancer. On October 28, 2010, we entered into a Stock Purchase Agreement with 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 78.01% 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. No milestone payments were received in 2011.

 

  

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 have only one convertible note payable outstanding in the amount of $168,000, including accrued interest of approximately $68,000, which is in default and is due on demand. 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.

 

Development Program

 

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 in 2012.

 

We have completed Good Laboratory Practice (“GLP”) animal drug safety studies in two species for OVI-117. The Investigational New Drug application (IND) is currently being prepared. We have engaged a contract manufacturer and we are currently in the process of doing method transfer to ensure clinical batch availability by May 2012. 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 in 2012.

 

Research and development expenditures for the above projects totaled approximately $1.2 million and $0.5million for the years ended 2011 and 2010, respectively. We expect we will incur additional expenses of between $2.0 million to $3.0 million to complete the current phases of development for the projects described above.

 

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, of course, 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.

 

 

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.

 

OncoVista Innovative Therapies, Inc.

 

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 our customers will have no right of return for products sold. Revenues are considered to be earned upon shipment.

 

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 clinical research organizations (“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.

  

AdnaGen AG (a discontinued operation)

 

Revenue Recognition . We recognize revenue in accordance with SEC, 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. Our customers have no right of return for products sold. Revenues are considered earned upon shipment.

 

Foreign Currency Translation. As previously described above, we previously sold all of our shares, representing approximately 78% of the total issued and outstanding shares, of AdnaGen.  The financial position and results of operations of AdnaGen were measured using the local currency (Euros “€”) as the functional currency.  Assets and liabilities of the subsidiary were translated at current exchange rates as of December 31, 2009, and related revenue and expenses have been translated at average exchange rates through October 31, 2010.  Equity transactions were translated at their historical rates.  Any resulting translation adjustments were included as a component of accumulated other comprehensive loss and as a component of deficit.  Transaction gains and losses related to operating assets and liabilities are included in other income (expense).

 

 

Results of Operations

 

Years Ended December 31, 2011 and 2010

 

Research and development.   Research and development expenses increased by approximately $0.7 million, or 140%, to approximately $1.2 million for the year ended December 31, 2011, as compared to $0.5 million for the year ended December 31, 2010.  The increase in 2011 is primarily due to the scaling up of our research and development operations for substantially the entire year as a result of the availability of sufficient capital resources resulting from the sale of AdnaGen.

  

General and administrative.   General and administrative expenses decreased by approximately $0.9 million, or 47%, to approximately $1.0 million for the year ended December 31, 2011, as compared to approximately $1.9 million for the year ended December 31, 2010.  In 2011, the decrease was due primarily to a decrease in stock-based compensation from the prior year, partially offset by an increase in consulting expense for professional services.

We expect general and administrative expense in 2012 to increase primarily due to an increase in salaries and benefits as we anticipate additional headcount in 2012 to support operations, and stock compensation expense for any restricted stock, options, or warrants granted during the year.  Additionally, we expect to continue to utilize external consultants to provide staff augmentation.

 

Other Income (Expense) . Other income (expense) decreased 126% to expense of approximately $28,500 for the year ended December 31, 2011 compared to income of approximately $0.1 million for the year ended December 31, 2010.  

 

Discontinued Operations . The results of operations for our former majority-owned German operating subsidiary, AdnaGen are classified as discontinued operations. On October 31, 2010, we ceased operations at AdnaGen upon the sale to Alere Holdings. Revenues, gain on sale of subsidiary and net income of $976,231, $12,665,488 and $12,300,054, respectively, are included in discontinued operations for the ten months ended October 31, 2010. There are no revenues, gain on sale of subsidiary or net income included in discontinued operations for the year ended December 31, 2011. There was a gain on sale of subsidiary of approximately $0.2 million for the year ended December 31, 2011, for the settlement related to the sale of AdnaGen.

 

 

Net Income (Loss). As a result of the foregoing, our net income decreased by approximately $12.0 million to a loss of approximately $2.0 million for the year ended December 31, 2011 compared to net income of approximately $10.0 million for the year ended December 31, 2010.

 

Going Concern and Recent Events

 

Our consolidated financial statements for the year ended December 31, 2011 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 $2.2 million from continuing operations, and net cash used in continuing operations of approximately $1.6 million for the year ended December 31, 2011, an accumulated deficit of approximately $20.3 million and a negative total equity of approximately $0.1 million at December 31, 2011. We are also in default on certain loans and related accrued interest aggregating $167,711 at December 31, 2011.

  

In November 2010, we received approximately $6.0 million as our pro rata portion of the up-front payment from the sale of our shares of AdnaGen as described above.  As a result of the stock purchase agreement with Alere Holdings, we believe we have sufficient capital to meet our anticipated operating cash requirements for the next nine to 12 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.

 

 

Liquidity and Capital Resources

 

At December 31, 2011, we had cash and cash equivalents of approximately $2.1 million compared to approximately $3.5 million at December 31, 2010. In order to preserve principal and maintain liquidity, our funds are primarily invested 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 nine to 12 months.  Our ability to continue as a going concern is dependent 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 year ended December 31, 2011, net cash used in continuing operations was approximately $1.6 million compared to approximately $1.6 million for the year ended December 31, 2010.

 

There were no discontinued operations for the year ended December 31, 2011.

 

Investing Activities. For the year ended December 31, 2011 net cash used by investing activities from continuing operations was $3,000, and net cash provided by discontinued operations was $204,000 for the settlement related to the sale of AdnaGen.

 

 

Financing Activities.   Cash provided by financing activities from continuing operations was $8,000 for the year ended December 31, 2011 as compared to approximately $0.9 million used in financing activities from continuing operations for the year ended December 31, 2010.  

 

Our outstanding material contractual obligations under lease and debt agreements as of December 31, 2011 are as follows:

 

		Payments Due by Period
						Two to
		Within				Three				Four to				After Five
		One Year				Years				Five Years				Years				Total
Loans and notes payable		$	100,000			$	—			$	—			$	—			$	100,000
Operating leases and other			144,000				144,000				—				—				288,000
		$	244,000			$	144,000			$	—			$	—			$	388,000

 

At March 25, 2012, we have only one convertible note payable outstanding in the amount of $100,000, with accrued interest of approximately $68,000, which is in default and is due on demand.

 

 

Recent Accounting Pronouncements

 

In January 2010, the Financial Accounting Standards Board (“FASB”) issued ASU 2010-06, Fair Value Measurements and Disclosures (Topic 820): Improving Disclosures about Fair Value Measurements (ASU 2010-06), which amends the existing fair value measurement and disclosure guidance currently included in Accounting Standards Codification (ASC) Topic 820, Fair Value Measurements and Disclosures , to require additional disclosures regarding fair value measurements. Specifically, ASU 2010-06 requires entities to disclose the amounts of significant transfers between Level 1 and Level 2 of the fair value hierarchy and the reasons for these transfers, the reasons for any transfer in or out of Level 3 and information in the reconciliation of recurring Level 3 measurements about purchases, sales, issuances and settlements on a gross basis. In addition, ASU 2010-06 also clarifies the requirement for entities to disclose information about both the valuation techniques and inputs used in estimating Level 2 and Level 3 fair value measurements. ASU 2010-06 was effective for interim and annual reporting periods beginning on January 1, 2010, except for additional disclosures related to Level 3 fair value measurements, which were effective for fiscal years beginning after December 15, 2010. The adoption of ASU 2010-06 did not impact our consolidated financial statements or results of operations.

 

In April 2010, the FASB issued ASU 2010-17, revenue recognition – milestone method (Topic 605), which provides guidance on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition to research or development arrangements. Under this guidance, we may recognize revenue contingent upon the achievement of a milestone in its entirety in the period in which the milestone is achieved, only if the milestone meets all the criteria within the guidance to be considered substantive. This amendment is effective on a prospective basis for research and development milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010. Early adoption is permitted. This amendment is effective for us beginning January 1, 2011.   The adoption of ASU 2010-17 did not have a material impact on our consolidated financial position or results of operations.

 

ASU 2011-04, “Fair Value Measurement (Topic 820) - Amendments to Achieve Common Fair Value Measurements and Disclosure Requirements in U.S. GAAP and IFRSs.” ASU 2011-04 amends Topic 820, “Fair Value Measurements and Disclosures,” to converge the fair value measurement guidance in U.S. generally accepted accounting principles and International Financial Reporting Standards. ASU 2011-04 clarifies the application of existing fair value measurement requirements, changes certain principles in Topic 820 and requires additional fair value disclosures. ASU 2011-04 is effective for annual periods beginning after December 15, 2011, and is not expected to have a significant impact on our consolidated financial statements.

 

ITEM 7A – 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 8 – FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

Our consolidated financial statements and notes thereto and the related independent public accounting firm report of OncoVista Innovative Therapies, Inc. and Subsidiaries are attached to this Annual Report beginning at Page F-1 and are incorporated herein by reference.

 

ITEM 9 – CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

 

None.

 

ITEM 9A – CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures.

 

As of December 31, 2011, the end of the period covered by this report, we conducted, under the supervision and with the participation of our management, including our Chief Executive Officer, an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act) in ensuring that information required to be disclosed by us in our reports is recorded, processed, summarized and reported within the required time periods. Based on the foregoing, our Chief Executive Officer concluded that because of the material weakness in internal control over financial reporting described below, our disclosure controls and procedures were not effective as of December 31, 2011.

 

 

 

Management’s Annual 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.

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 December 31, 2011. 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 December 31, 2011.

  

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 December 31, 2011:

 

—

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 Chief Financial Officer, 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 a consultant. 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.

 

 

Remediation of Material Weaknesses

 

Due to the increasing number and complexity of pronouncements, emerging issues and releases, and reporting requirements and regulations, we expect there will continue to be some risk related to financial disclosures. However, the process of identifying risk areas and implementing financial disclosure controls and internal controls over financial reporting required under the SOX continues to be complex and subject to significant judgment and may result in the identification in the future of areas where we may need additional resources. Additionally, due to the complexity and judgment involved in this process, we cannot guarantee that we will not find or have pointed out to us either by internal or external resources, additional areas needing improvement or resulting in a future assessment that our controls are or have become ineffective as a result of overlooked or newly created significant deficiencies or unmitigated risks.

  

Changes in Internal Controls over Financial Reporting

 

There have been no changes in our internal control over financial reporting that occurred during the year ended 2011 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

ITEM 9B – OTHER INFORMATION

 

None.

 

 

 

PART III

 

ITEM 10 – DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE

 

Directors and Executive Officers

 

Our directors and executive officers are as follows:

 

Name		Age		Position
Alexander L. Weis, Ph.D.		62		Chairman of the Board of Directors, Chief Executive Officer, President, Chief Financial Officer and Secretary
Alexander Ruckdaeschel		39		Director, Audit Committee Member, Compensation Committee Member
William J. Brock		62		Director, Audit Committee Chairman, Compensation Committee Chairman
Michael Moloney		53		Chief Operating Officer

 

Set forth below is biographical information with respect to each of the aforementioned individuals.

 

Alexander L. Weis, Ph.D. Dr. Weis has served as a member of our board, Chief Executive Officer, President and Secretary since August 2007, and our Chief Financial Officer since August 2009.  Dr. Weis is the principal founder of OncoVista-Sub and has been its Chairman, Chief Executive Officer, and President since its inception in September 2004.  Since February 2009, Dr. Weis also serves as AdnaGen’s Chief Executive Officer. Dr. Weis is a recognized leader and pioneer in the biotechnology and pharmaceutical industries and has led pharmaceutical companies through all stages from start-up through public offerings and as a manager of a substantial public company. Prior to forming our company, from 1989 to September 2004, Dr. Weis served as President of Lipitek International, Inc., a specialty pharmaceutical company that Dr. Weis founded. Dr. Weis was a co-founder of ILEX Oncology, which became a publicly traded company in 1997 (NASDAQ : ILXO ) and was later acquired by Genzyme Corporation in a stock transaction valued at over $1 billion. Dr. Weis served as ILEX’S Chief Scientific Officer and Executive Vice President from its founding in 1994 through 1998. Dr. Weis has worked for Vector Therapeutics, MykoBiologics, the Cancer Therapy and Research Center, Sterling Drugs, the Eastman Kodak Company and the Weizmann Institute of Science. Dr. Weis received his Ph.D. in Organic Chemistry from the Novosibirsk Institute of Organic Chemistry. Dr. Weis is a scientist and inventor, with over 60 publications and 30 patents. He is a Chartered Chemist and Fellow of the Royal Society of Chemistry, and was selected as the South Texas Entrepreneur of the Year in 1996.

 

Alexander Ruckdaeschel. Alexander Ruckdaeschel has served as a member of our board since December 2007, as a member of OncoVista-Sub's board since January 2005 and as a member of our Audit Committee and Compensation Committee since March 28, 2008. Mr. Ruckdaeschel is a venture capitalist and, since September, 2006, partner at Alphaplus-Advisors, a U.S. based hedge fund. From January 2003 to September 2006, he was a Fund Advisor at DAC-FONDS, a European Investment company specializing in small-cap Biotech equities worldwide. From December 2003 to July 2006, he was an investment advisor to Nanostart AG, one of Europe’s leading venture investment firms in the area of nanotechnology. Mr. Ruckdaeschel has extensive experience in the European solar industry. He also serves on the board of directors for several private companies. Prior to 2003, he was a research analyst with Dunmore Management, a global hedge fund, and Thieme Associates, an investment advisor. From 1992 to 2000 Mr. Ruckdaeschel served in the German military, participating in United Nations missions in Somalia, Croatia, and Bosnia.

  

William J. Brock. Mr. Brock has served on our board since December 2007, the board of OncoVista-Sub since September 2007, and as Chairman of our Audit Committee and Compensation Committee since March 28, 2008.  Currently, Mr. Brock is the CEO of Iron Rock LLC, a financial services firm that he founded that focuses on alternative investment products and their distribution, investment banking advisory and consulting services and asset management.  From August 2007 to December 2009, Mr. Brock served as the President of iPro One, a financial services firm. From July 2004 to August 2007, Mr. Brock was a vice president for private client services at Bear Stearns. From November 2002 to July 2004, Mr. Brock was a director of Houlihan, Lokey, Howard, and Zukin, an investment banking firm. From 2001 to 2002, Mr. Brock was Managing Director of Liberty Hampshire Corporation, New York, a diversified financial institution. Mr. Brock holds a Bachelor of Arts degree cum laude from Harvard College, and an M.B.A. from the Harvard University Graduate School of Business Administration.

 

 

Michael F. Moloney. Mr. Moloney has served as our Chief Operating Officer since January 2011. From November 2009 through December 2010, Mr. Moloney served as Director of Operations and Director of Information Systems for United Biologics.  Mr. Moloney previously served as our Director of Program Management from January 2008 through August 2009. From January 2007 through December 2007, Mr. Moloney was an independent consultant to the biopharmaceutical industry. From November 2001 through December 2006, Mr. Moloney served as Vice President, Information Systems and Technologies and a member of the Executive Management team for BioNumerik Pharmaceuticals, Inc. From June 2000 through November 2001, Mr. Moloney served as Director of Systems and Operations Technologies for BioNumerik Pharmaceuticals, Inc. From 1992 through June 2000, Mr. Moloney served as Director of Information Systems for the Cancer and Leukemia Group B (CALGB), a National Cancer Institute funded multi-center cooperative group engaged in cancer research. While at the CALGB, Mr. Moloney served as a member of the CALGB Statistical Center management team and the CALGB Operations Committee. Mr. Moloney held appointments on numerous CALGB scientific committees and served as Vice Chairman for the National Cancer Institute’s Intergroup Specimen Banking Committee. Prior to joining the CALGB, Mr. Moloney held various technical positions at Clinical Research International, Family Health International, and the North Carolina Hospital Association. Mr. Moloney received a B.S. in information systems from Alderson Broaddus College and an M.B.A. from The University of Texas at San Antonio.

  

Board of Directors and Officers

 

Each director is elected until our next annual meeting and until their successor is duly elected and qualified. The Board of Directors may also appoint additional directors up to the maximum number permitted under our by-laws. A director so chosen or appointed will hold office until the next annual meeting of stockholders. Each executive officer serves at the discretion of the Board of Directors and holds office until their successor is elected or until their resignation or removal in accordance with our articles of incorporation and by-laws.

 

Messrs. Ruckdaeschel and Brock are considered independent directors under Rule 4200(a)(15) of the Nasdaq Marketplace Rules, even though such definition does not currently apply to us as we are not listed on Nasdaq.

 

Meetings and Committees of the Board of Directors

 

During the year ended December 31, 2011, our Board of Directors held three meetings and took five actions by written consent.

 

Committees of the Board of Directors

 

On March 28, 2008, we established an Audit Committee and a Compensation Committee. Messrs. Brock and Ruckdaeschel serve on both committees with Mr. Brock serving as Chairman of both committees, as well as being deemed the “audit committee financial expert.”

 

The committees are responsible, respectively, for the matters described below.

 

Audit Committee

 

The Audit Committee is responsible for the following:

 

—

reviewing the results of the audit engagement with the independent auditors;

 

 

	—	identifying irregularities in the management of our business in consultation with our independent accountants, and suggesting an appropriate course of action;
	—	reviewing the adequacy, scope, and results of the internal accounting controls and procedures;
	—	reviewing the degree of independence of the auditors, as well as the nature and scope of our relationship with our independent auditors;
	—	reviewing the auditors’ fees; and
	—	recommending the engagement of auditors to the full Board of Directors.

 

A charter has been adopted to govern the Audit Committee. A copy of the charter can be found on our website at www.oncovista.com . The contents of our website, other than our Audit and Compensation Committee Charters, are not incorporated into this Report.

 

Compensation Committee

 

The Compensation Committee determines the salaries and incentive compensation of our officers and provides recommendations for the salaries and incentive compensation of our other employees and consultants.

 

Our compensation programs to date are intended to enable the attraction, motivation, reward, and retention of the management talent required to achieve corporate objectives and thereby increase shareholder value. It has been our policy to provide incentives to our senior management to achieve both short-term and long-term objectives and to reward exceptional performance and contributions to the development of our business. To attain these objectives, the executive compensation program may include a competitive base salary, cash incentive bonuses, and stock-based compensation.

 

The Compensation Committee will establish on an annual basis, subject to the approval of our Board of Directors and any applicable employment agreements, the salaries that will be paid to our executive officers during the coming year. In setting salaries, the compensation committee intends to take into account several factors, including the following:

 

	—	competitive compensation data;
	—	the extent to which an individual may participate in the stock plans which may be maintained by us; and
	—	qualitative factors bearing on an individual’s experience, responsibilities, management, and leadership abilities, and job performance.

 

A charter has been adopted to govern the Compensation Committee. A copy of the charter can be found on our website at www.oncovista.com .  The contents of our website, other than our Audit and Compensation Committee Charters, are not incorporated into this Report.

 

Clinical Advisory Board

 

We maintain a clinical advisory board consisting of internationally recognized physicians and scientists who advise us on scientific and technical aspects of our business.  The clinical advisory board meets periodically to review specific projects and to assess the value of new technologies and developments to us.  In addition, individual members of the scientific advisory board meet with us periodically to provide advice in particular areas of expertise.  The clinical advisory board consists of the following members:

  

Eric Rowinsky, M.D. – Chairman.  Dr. Rowinsky is a talented scientific executive with 20-plus years of experience in drug development in the oncology area.  He has authored approximately 300 scientific articles and 50 textbook chapters.  Dr. Rowinsky has led numerous clinical trials for oncology drugs and is a recognized leader in the field.  His prior affiliations include the Johns Hopkins University School of Medicine, the University of Texas Health Science Center at San Antonio and the Institute for Drug Development in San Antonio.  He played a key role in the development of Taxol®, Hycamtin®, Tarceva®, Erbitux®, and many other anticancer drugs.  Dr. Rowinsky is currently Executive Vice President and Chief Medical Officer at ImClone Systems, Inc., a wholly owned subsidiary of Eli Lilly & Co and an adjunct Professor of Medicine at New York University.

 

 

Esteban Cvitkovic, M.D. Dr. Cvitkovic is a board-certified, medical oncologist who practices medicine in Paris, France.  Dr. Cvitkovic has more than 30 years of international experience in oncology therapeutics including hands-on clinical research, clinical pharmacology, early single agent and combination regimens development, disease-oriented therapeutic impact assessment, evaluating new agents in pre-clinical development, and optimizing efficacy and combination development.  Dr. Cvitkovic is author of more than 160 peer-reviewed articles and 450 abstracts focusing on solid tumor oncology.  He led the clinical development of cisplatin and its combinations as well as oxaliplatin, vindesine, bleomycin, navelbine, and ET-743.  He played key consulting roles in registration strategy and post-registration development of recent products such as amifostine, docetaxel, CPT-11, and irofulven.  Dr. Cvitkovic’s career includes staff and academic appointments at Memorial Sloan-Kettering Cancer Center, Columbia Presbyterian Medical Center, Institut Gustave Rooury (Villejuif, France), Hôpital Paul Brooure (Villejuif, France) and Hôpital St. Louis (Paris).

 

Ronald P. McCaffrey, M.D. Dr. McCaffrey is a Lecturer in Medicine at the Harvard Medical School and a Clinical Associate in Medicine, Hematology-Oncology Division at The Brigham & Women's Hospital and Dana-Farber Cancer Institute.  Dr. McCaffrey has written over 90 publications and has co-edited two books.  In all, Dr. McCaffrey has 35-plus years of experience in his specialty.

  

Pedro Santabárbara, M.D., Ph.D. Dr. Santabárbara is currently Vice President of Strategic Development and Medical Affairs at PHARMA MAR S.A.  He received his M.D. and Ph.D. degrees from the University of Barcelona.  He has authored over 80 articles and abstracts in the field of oncology and has participated in a variety of hospital and academic activities as well.  He has worked for Bristol Myers Squibb (Taxol® team), Rhône–Poulenc Rorer (Taxotere® team), ILEX Oncology (Campath® team), Gilead Pharmaceuticals and, most recently, OSI Pharmaceuticals (Tarceva® team).  He is one of the most experienced developers of anticancer drugs.

  

Section 16(a) Beneficial Ownership Reporting Compliance

 

Section 16(a) of the Exchange Act requires our directors, officers and persons who own more than 10% of a registered class of our equity securities to file with the SEC initial reports of ownership and reports of changes in ownership of common stock and other equity securities.  Officers, directors and greater than 10% shareholders are required by SEC regulations to furnish us with copies of all Section 16(a) forms they file.

 

To the best of our knowledge, the following delinquencies occurred:

 

Name and Affiliation		No. of  Late Reports		No. of Transactions  Not Filed on  Timely Basis		Known Failures to File
Michael Moloney, Chief Operating Officer		–		1		Form 3

 

 

ITEM 11 – EXECUTIVE COMPENSATION

 

Executive Compensation

 

The following table sets forth the compensation earned during the years ended December 31, 2011 and 2010 by our current Chief Executive Officer and our only other officer. We refer to such individuals as “named executive officers”:

Name and Principal  Position		Year (1)				Salary ($)				Bonus ($)				Stock Awards ($)				Option  Awards ($)(2)				Non- Equity Incentive Plan Compen- sation ($)				Non- qualified Deferred Compen- sation ($)				All Other Compen- sation ($)				Total ($)
Alexander L. Weis, Ph.D. Chief Executive Officer,
President, Chief Financial Officer and Secretary			2011				310,000				—								—				—				—				12,000				322,000
			2010				51,667	(3)			375,667				875,000				—				—				—				2,000	(5)			1,304,334
Michael F. Moloney Chief Operating Officer			2011				180,000	(4)			—				—				86,741				—				—				3,600	(5)			270,341
			2010				—				—				—				—				—				—				—	(5)			—

 

 

(1)	The information is provided for each fiscal year which begins on January 1 and ends on December 31.
(2)	The amounts reflect the compensation expense in accordance with FAS 123(R) of these option awards. The assumptions used to determine the fair value of the option awards for fiscal years ended December 31, 2011 and 2010 are set forth in Note 11 of our audited consolidated financial statements included in this Annual Report on Form 10-K. Our named executive officers will not realize the value of these awards in cash unless and until these awards are exercised and the underlying shares subsequently sold.
(3)	Dr. Weis is entitled to a salary of $310,000 per annum. The amount referenced reflects the amount earned by Dr. Weis from November 1, 2010, through the end of the fiscal year 2010
(4)	Mr. Moloney rejoined us as Chief Operating Officer on January 3, 2011 and is entitled to a salary of $180,000 per annum.
(5)	See “All Other Compensation” table below.

 

All Other Compensation Table

 

All Other Compensation amounts in the Summary Compensation Table above consist of the following:

 

Name		Year				Automobile Allowance ($)				Medical Premiums ($)				Other ($)				Total ($)
Alexander L. Weis, Ph.D.
Chief Executive Officer, President, Chief			2011				12,000				—				—				12,000
Financial Officer, and Secretary			2010				2,000				—				—				2,000
Michael F. Moloney			2011				3,600				—				—				3,600
Chief Operating Officer			2010				—				—				—				—

 

 

The following table sets forth information concerning stock options and stock awards held by the named executive officers as of December 31, 2011.

 

		Option Awards																				Stock Awards
Name		Number of Securities Underlying Unexercised Options (#) Exercisable				Number of Securities Underlying Unexercised Options (#) Unexercisable				Equity Incentive Plan Awards Number of Securities Underlying Unexercised Unearned Options (#)				Option Exercise Price ($)				Option Expiration Date				Number of Shares or Units of Stock Held That Have Not Vested (#)				Market Value of Shares or Units of Stock Held That Have Not Vested ($)				Equity Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Vested (#)				Equity Incentive Plan Awards: Market or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested ($)
Alexander L. Weis, Ph.D. Director, CEO, President, CFO and Secretary			—				—				—								—				—				—				—				—
Michael F. Moloney
Chief Operating Officer			206,250	(1)			243,750	(1)			—			$	0.31				1/3/2021				—				—				—				—

 

  

(1)	These options were granted January 3, 2011 and have a two year vesting schedule

 

Employment Agreements

 

We are party to an employment agreement, dated October 1, 2004, with Alexander L. Weis, Ph.D., pursuant to which we have agreed to employ Dr. Weis as our Chief Executive Officer and Chairman of the Board for a four-year initial term, with one-year renewable terms, for base salary of $250,000 per year, subject to adjustment, plus a $1,000 per month car allowance.  Dr. Weis’ current base salary is $310,000 per annum. Dr. Weis is entitled to receive an annual cash bonus up to 40% of his base salary, provided that we meet certain performance objectives established by the Board of Directors. Dr. Weis is also entitled to a bonus upon our satisfaction of certain specified milestones. If Dr. Weis’ employment is terminated as a result of his death or disability, he (or in the case of his death, his estate) is entitled to severance of one year’s base salary, one year’s health insurance coverage for his wife and dependent children and, in the case of termination as a result of disability, one year’s health insurance coverage for Dr. Weis. If Dr. Weis’ employment is terminated without cause, he is entitled to one year’s base salary and one year’s health and life insurance that were in effect prior to his termination. No severance is payable if Dr. Weis’ employment is terminated for cause or if Dr. Weis’ resigns, retires or otherwise terminates his employment voluntarily.

 

We are party to an employment agreement, dated January 3, 2011, with Michael Moloney, pursuant to which we have agreed to employ Mr. Moloney as our Chief Operating Officer for a two-year initial term, with one-year renewable terms, for base salary of $180,000 per year, subject to adjustment, plus a $300 per month car allowance.  Mr. Moloney is also entitled to receive an annual cash bonus up to 30% of his base salary, provided that we meet certain performance objectives established by the Board of Directors. If Mr. Moloney’s employment is terminated without cause, he is entitled to three months base salary and one year’s health and life insurance that were in effect prior to his termination. No severance is payable if Mr. Moloney’s employment is terminated for cause or if Mr. Moloney resigns, retires or otherwise terminates his employment voluntarily.

 

 

To assist us in conserving our cash, from January 1, 2009, we paid one-half, but accrued the other half of the salaries of the former employees of our U.S. operating company, OncoVista-Sub, through May 15, 2009, which are included in accrued liabilities on our consolidated balance sheet at December 31, 2011.

 

Stock Option Plans

 

We have adopted the following stock option plans:

 

2007 Stock Option Plan

 

In June 2007, OncoVista-Sub’s Board of Directors adopted the 2007 Stock Option Plan (the “ 2007 Plan ”). The Plan authorizes the grant of incentive stock options, non-qualified stock options, and stock purchase rights (“ Right ”) with respect to up to an aggregate of 3,000,000 shares of our common stock to our employees and directors or our subsidiaries and individuals, including consultants, performing services for our benefit or for the benefit of a subsidiary. As a result of the Merger, the 2007 Plan was adopted by our Board of Directors and all options granted under the 2007 Plan were assumed by us. As of March 26, 2012, 869,000 non-qualified options under the 2007 Plan were issued.

 

Unless earlier terminated by the Board of Directors, the Plan (but not outstanding options or Rights) terminates in May 2017, after which no further awards may be granted under the 2007 Plan. The 2007 Plan will be administered by the full Board of Directors or, at the board’s discretion, by a committee of the board consisting of at least two persons who are “ disinterested person ” defined under Rule 16b-2(c)(ii) under the Exchange Act (the “ Committee ”).

 

Options and Rights. Recipients of options or Rights under the Plan (“ Optionees ”) are selected by the board or the Committee. The board or Committee determines the terms of each option or right granted including (1) the purchase price of shares subject to options or Rights, (2) the dates on which options or Rights become exercisable and (3) the expiration date of each option or Right (which may not exceed ten years from the date of grant). The minimum per share purchase price of options granted under the 2007 Plan for Incentive Stock Options is the fair market value (as defined in the 2007 Plan) of one share of our common stock on the date the option is granted.

 

The Administrator may grant alone, in addition to or in tandem with options granted under the 2007 Plan, to eligible persons Rights to purchase options for such number of shares of our common stock at the price, within the period and subject to the conditions set forth in the award. The purchase is to be effected by execution of a Restricted Stock Purchase Agreement in the form determined by the Administrator which may at the Administrator’s option grant us the right to repurchase the shares acquired at the original price paid in the event of the voluntary or involuntary termination of the purchaser’s service for any reason. The agreement may provide that the repurchase option lapses in whole or installments as to a service provider other than an officer, director, or consultant, at a rate of at least 20% per annum over five years from the date of purchase.

 

Option and Rights holders have no voting, dividend or other rights as stockholders with respect to shares of our Common Stock covered by options or Rights prior to becoming the holders of record of such shares. The purchase price upon the exercise of options or Rights may be paid as determined by the Administrator at the time of exercise in cash, by certified bank, cashier’s check or promissory note, by tendering stock held by the Option or Rights holders, as well as by cashless exercise either through the surrender of other shares subject to the option or through a broker. The total number of shares of our common stock available under the 2007 Plan and the number of shares and per share exercise price under outstanding options and Rights will be appropriately adjusted in the event of any stock dividend, reorganization, merger or recapitalization or a similar corporate event.

 

 

The Board of Directors may at any time terminate the 2007 Plan or from time to time make such modifications or amendments to the 2007 Plan as it may deem advisable and the board or Committee may adjust, reduce, cancel and re-grant an unexercised option if the fair market value declines below the exercise price except as may be required by any national stock exchange or national market association on which our common stock is then listed. In no event may the board, without the approval of stockholders, amend the 2007 Plan to increase the maximum number of shares of our common stock for which options or Rights may be granted under the 2007 Plan or change the class of persons eligible to receive options or Rights under the 2007 Plan.

  

Subject to limitations set forth in the 2007 Plan, the terms of option and Rights agreements will be determined by the board or Committee but may not be longer than ten years, and need not be uniform.

 

2007 Independent Directors’ Plan

 

In June 2007, OncoVista-Sub’s Board of Directors adopted the 2007 Stock Option Plan for Independent and Non-Employee Directors (the “ Directors Plan ”) for the purpose of promoting our interests and those of our stockholders by increasing the proprietary and vested interest of such Directors in our growth and performance.  As a result of the Merger, our Board of Directors assumed the Directors Plan and all options granted under the Directors Plan were assumed by us.

 

The Directors Plan relates to a maximum of 500,000 shares of our common stock for which options may be granted to Eligible Directors who are defined as Independent or Non-Employee Directors. An Independent Director is defined under the Directors Plan as a director meeting the requirements of Section 10A(m) under the Exchange Act and as defined by any exchange or market on which the common stock is traded or is listed. A Non-Employee Director is defined by reference to our definition in Rule 16b-3 under the Exchange Act. As of March 29, 2012, 37,500 options were issued under the Directors Plan. The Directors Plan is to be administered by the board of directors or the Compensation Committee of the board of directors, which is authorized to adopt, interpret, and amend regulations under the Directors Plan.

 

The Directors Plan specifies that each newly elected Independent or Non-Employee Director (“ Eligible Director ”) upon first election or appointment to the board will receive options to purchase 10,000 shares and immediately following each Annual Meeting of Stockholders each director who has been an Eligible Director for more than 12 months immediately preceding and including such meeting and the Chairman of the Board, if an Eligible Director, for the same period shall be granted an additional option to purchase 15,000 shares.

 

The exercise price of an option is to be the Fair Market Value, as defined in the Directors Plan. Payment shall be made in cash or unless otherwise determined by the board of directors, in shares of our common stock. The option may be exercised in whole or in part during the period commencing on the first anniversary of the grant date and ending on the date of termination of the option, which is the earlier of a date one year from the date the optionee is no longer a Director or ten years from the date of grant.

 

The Directors Plan provides for adjustment in the exercise price and shares subject to the Directors Plan and outstanding options in the event of a stock split, stock dividend, subdivision or combination of the common stock or change in corporate structure.

 

2004 Stock Option Plan

 

In October 2004, OncoVista-Sub’s Board of Directors adopted the 2004 Stock Option Plan (the “ 2004 Plan ”). As a result of the Merger, our Board of Directors assumed the 2004 Plan and all options granted under the 2004 Plan were assumed by us. The 2004 Plan authorized the grant of options with respect to up to an aggregate of 1,000,000 shares of our common stock to our employees, directors and consultants or to our affiliates. As of March 26, 2012 480,000 non-qualified options were issued under the 2004 Plan.

 

 

As the 2004 Plan was never approved by the shareholders, we have only granted non-qualified options under the 2004 Plan.  As such, the 2004 Plan permits us to grant only options which do not qualify as incentive stock options (“ Non-Qualified Options ”). Unless earlier terminated by the shareholders, the 2004 Plan will terminate in October 2014.

 

Financial Statement Treatment of Options. We expense the fair equity-based awards, such as stock options and warrants, granted in accordance with accounting principles generally accepted in the United States of America, in an amount equal to the fair value of the vested portion of the options as Rights using the Black-Scholes option pricing method on each grant date. Modifications such as lowering the exercise prices or extending the expiration dates could also result in material additions to our non-cash expenses.

 

To the extent outstanding options or Rights are repriced, such repricing will result in charges to our earnings equal to the difference between (i) the fair value of the vested portion of the options or Rights granted, utilizing the Black-Scholes option pricing model on each grant date and (ii) the charges to earnings previously made as a result of the initial grants of the options or Rights being repriced, which will have a dilutive effect on the earnings per share.

 

Federal Income Tax Consequences . The following is a brief discussion of the Federal income tax consequences of transactions under the 2004 Plan and 2007 Plan. This discussion is not intended to be exhaustive and does not describe state or local tax consequences.

 

Incentive Options . No taxable income is realized by the optionee upon the grant or exercise of an ISO, except as noted below with respect to the alternative minimum tax provided no reduction in the exercise price has been made since the date of grant except as a result of an anti-dilution event. If common stock is issued to an optionee pursuant to the exercise of an ISO, and if no disqualifying disposition of such shares is made by such optionee within two years after the date of grant or within one year after the transfer of such shares to such optionee, then (i) upon sale of such shares, any amount realized in excess of the option price will be taxed to such optionee as a long-term capital gain and any loss sustained will be a long-term capital loss, and (ii) no deduction will be allowed to the optionee’s employer for Federal income tax purposes.

 

Except as noted below for corporate “ insiders, ” if our common stock acquired upon the exercise of an ISO is disposed of prior to the expiration of either holding period described above, generally (i) the optionee will realize ordinary income in the year of disposition in an amount equal to the excess (if any) of the fair market value of such shares at exercise (or, if less, the amount realized on the disposition of such shares) over the option price paid for such shares and (ii) the optionee’s employer will be entitled to deduct such amount for Federal income tax purposes if the amount represents an ordinary and necessary business expense. Any further gain (or loss) by the optionee will be taxed as short-term or long-term capital gain (or loss), as the case may be, and will not result in any deduction by the employer.

 

Subject to certain exceptions for disability or death, if an ISO is exercised more than three months following termination of employment, the exercise of the option will generally be taxed as the exercise of a Non-Qualified Option.

  

For purposes of determining whether an optionee is subject to any alternative minimum tax liability, an optionee who exercises an ISO generally would be required to increase his or her alternative minimum taxable income, and compute the tax basis in the stock so acquired, in the same manner as if the optionee had exercised a Non-Qualified Option. Each optionee is potentially subject to the alternative minimum tax. In substance, a taxpayer is required to pay the higher of his/her alternative minimum tax liability or his/her “ regular ” income tax liability. As a result, a taxpayer has to determine his potential liability under the alternative minimum tax.

  

 

Non-Qualified Options . Except as noted below for corporate “ insiders, ” with respect to Non-Qualified Options: (i) no income is realized by the optionee at the time the option is granted; (ii) generally, at exercise, ordinary income is realized by the optionee in an amount equal to the difference between the option price paid for the shares and the fair market value of the shares, if unrestricted, on the date of exercise, and the optionee’s employer is generally entitled to a tax deduction in the same amount subject to applicable tax withholding requirements; and (iii) at sale, appreciation (or depreciation) after the date of exercise is treated as either short-term or long-term capital gain (or loss) depending on how long the shares have been held.

 

Special Rules Applicable To Corporate Insiders . As a result of the rules under Section 16(b) of the Exchange Act, “ insiders ” (as defined in the Exchange Act), depending upon the particular exemption from the provisions of Section 16(b) utilized, may not receive the same tax treatment as set forth above with respect to the grant and/or exercise of options. Generally, insiders will not be subject to taxation until the expiration of any period during which they are subject to the liability provisions of Section 16(b) with respect to any particular option. Insiders should check with their own tax advisers to ascertain the appropriate tax treatment for any particular option.

 

Benefits . Inasmuch as awards to all participants under the 2004 Plan and 2007 Plan will be granted at the sole discretion of the board or Committee, such benefits under the 2004 Plan and 2007 Plan, as applicable, are not determinable.

 

We believe that the 2004 Plan and 2007 Plan are important in attracting and retaining individuals with good ability to service us, motivating their efforts and serving our business interests, while reducing the cash payments which we would otherwise be required to make to accomplish such purposes.

 

Director Compensation

 

Effective December 6, 2010, independent members of our Board of Directors are entitled to $3,500 quarterly as remuneration for service as a member of the board plus reimbursement for travel expenses. The following table sets forth director compensation for the year ended December 31, 2011.

 

Name of Director		Fees Earned or Paid in Cash ($)				Stock Awards ($)				Option Awards ($)				Non-Equity Incentive Plan Compensation ($)				Nonqualified Deferred Compensation ($)				All Other Compensation ($)				Total ($)
Alexander L. Weis, Ph.D. (1)			—				—				—				—				—				—				—
Alexander Ruckdaeschel			14,000				—				—				—				—				—				14,000
William Brock			14,000				—				—				—				—				—				14,000

  

 

(1)

Please refer to the summary compensation table for executive compensation with respect to the named individual.

 

 

ITEM 12 – SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

 

The following table sets forth certain information regarding our shares of outstanding common stock beneficially owned as of the date hereof by (i) each of our directors and executive officers, (ii) all directors and executive officers as a group, and (iii) each other person who is known by us to own beneficially more than 5% of our common stock based upon 21,370,725 issued shares of common stock.

 

 

Name and Address of Beneficial Owners(1)		Amount and Nature of Beneficial Ownership				Percent Ownership 2
Alexander L. Weis, Ph.D., Director, Chief Executive Officer, President, Chief Financial Officer and Secretary			5,356,200	(3)			25.0	%
Alexander Ruckdaeschel, Director			140,000	(4)			*
William J. Brock, Director			120,000	(5)			*
Michael Moloney, Chief Operating Officer			427,050	(6)			2.0	%
All executive officers and directors as a group (four persons)			6,043,250				27.6	%
Wexford Spectrum Trading Ltd.   411 West Putnam Avenue Greenwich, CT 06830			2,592,855	(7)			11.7	%
CAMOFI Master LDC/CAMHZN Master LDC c/o Centrecourt Asset Management LLC 350 Madison Avenue, 8th Floor New York, New York 10017			2,272,759	(8)			10.4	%

 

* Less than 1.0%.

 

(1)	C/o our address, 14785 Omicron Drive, Suite 104, San Antonio, Texas 78245.
(2)	Except as otherwise indicated, we believe that the beneficial owners of common stock listed above, based on information furnished by such owners, have sole investment and voting power with respect to such shares, subject to community property laws where applicable.  Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities.  Shares of common stock subject to options or warrants currently exercisable or exercisable within 60 days, are deemed outstanding for purposes of computing the percentage of the person holding such options or warrants, but are not deemed outstanding for purposes of computing the percentage of any other person.
(3)	Includes 4,856,200 shares of common stock and 500,000 shares of common stock held in the name of Lipitek International, Inc.
(4)	Consists of 50,000 options to purchase shares of common stock at $0.10 per share until January 13, 2015; 40,000 options to purchase shares of common stock at $1.75 per share until September 8, 2017; and 50,000 options to purchase shares of common stock at $0.31 per share until December 3, 2020.
(5)	Consists of 45,000 options to purchase shares of common stock at $1.75 per share until August 28, 2017, and 75,000 options to purchase shares of common stock at $0.31 per share until December 3, 2020.
(6)	Includes 145,800 shares of common stock and 281,250 options to purchase shares of common stock at $0.31 per share until December 31, 2020.
(7)	Includes 1,714,284 shares of common stock; 428,571 warrants to purchase common stock at $2.50 per share until August 15, 2012; and 450,000 warrants to purchase shares of common stock at $0.10 per share until December 31, 2014.
(8)	Includes 1,463,741 shares of common stock; 257,143 warrants to purchase shares of common stock at $0.001 per share until July 1, 2012; 198,857 warrants to purchase shares of common stock at $2.50 per share until August 15, 2012 held by CAMOFI Master LDC; and 266,161 shares of common stock; and 86,857 warrants to purchase shares of common stock at $2.50 per share until August 15, 2012 held by CAMHZN Master LDC. Centrecourt Asset Management LLC is the investment manager of CAMOFI Master LDC and CAMHZN Master LDC.

 

  

 

 

Equity Compensation Plan Information

 

The following table sets forth information with respect to our 2004 Stock Option Plan (“ 2004 Plan ”),  our 2007 Stock Option Plan (the “ 2007 Plan ”) and 2007 Stock Option Plan for Independent and Non-Employee Directors (the “ Directors Plan ”) as of December 31, 2011:

 

Plan Category		Number of securities to be issued upon exercise of outstanding options, warrants and rights				Weighted-average exercise price of outstanding options, warrants and rights				Number of securities  remaining available for future issuance  under equity  compensation plans (excluding securities reflected in column (a))
		(a)				(b)				(c)
Equity compensation plans approved by security holders			—				—				—
Equity compensation plans not approved by security holders			2,857,500	(1)		$	1.70				1,956,700	(2)

  

 

	(1)	Represents 480,000 shares granted from the 2004 Plan, 869,000 shares granted from the 2007 Plan, 37,500 shares granted from the Director Plan and 1,476,000 warrants issued to nonemployees.
	(2)	Represents 170,000 shares available for issuance under the 2004 Plan, 1,319,200 shares available for issuance under the 2007 Plan and 467,500 shares available for issuance under the Director Plan.

 

ITEM 13 – CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, DIRECTOR INDEPENDENCE

 

Transactions with Related Persons

 

Our policy is to enter into transactions with related parties on terms that, on the whole, are no more favorable, or no less favorable, than those available from unaffiliated third parties. Based on our experience in the business sectors in which we operate and the terms of our transactions with unaffiliated third parties, we believe that all of the transactions described below met this policy standard at the time they occurred.

 

2009 Bridge Notes

 

On January 15, 2009, we and OncoVista-Sub completed an initial closing of a bridge round of debt financing, whereby we and OncoVista-Sub issued secured promissory notes (the “ Bridge Notes ”) in the aggregate principal amount of $750,000, in exchange for cash equal to the face amount of such Bridge Notes, to accredited investors as defined by Rule 501 under the Securities Act. Of the Bridge Notes issued, Bridge Notes in the principal amount of $350,000 were sold to affiliates of Dr. Weis and Bridge Notes in the principal amount of $300,000 were sold to Wexford Spectrum Trading Limited. Dr. Weis is Chairman of our board, Chief Executive Officer, President, and Secretary as well as one of our significant beneficial owners. Wexford Capital LLC is the investment sub-advisor of Wexford Spectrum Trading Limited which beneficially owns approximately 11% of our outstanding common stock. Dr. Paul Mieyal, a representative of Wexford Spectrum Trading Limited, was appointed to our Board of Directors commencing March 30, 2009.

 

The Bridge Notes bear interest at 10% per annum, increasing to 18% in the case of an event of default, and mature on the earlier of (i) January 15, 2010, (ii) the date upon we consummate a financing, the aggregate gross proceeds of which equal or exceed $5,000,000 (a “ Qualified Financing” ), and (iii) the acceleration of the maturity of the Bridge Notes as described therein.

 

 

In connection with the bridge financing, we issued to holders of the Bridge Notes detachable warrants (the “ Warrants ”), exercisable for a period of five years from the date of grant, of up to an amount or number of the securities offered in the first Qualified Financing, at an exercise price per security equal to the product of (x) and (y), where (x) equals the offering price per security in the first Qualified Financing and where (y) equals 0.90, subject to adjustment in certain instances.  In the event that no Qualified Financing shall be consummated by us prior to the expiration of the Warrants, the Warrants shall be exercisable for up to an aggregate of 750,000 shares of common stock, par value $0.001 per share, at an exercise price of $0.50 per share, subject to adjustment in certain instances.

 

One of the holders of the Bridge Notes has been granted the right to appoint its own nominee to our Board of Directors, which right shall expire upon such time that the Bridge Note is repaid in full.  

 

In January 2010, we obtained the consent of the holders of the Bridge Note financing to extend the maturity date from January 15, 2010 until the earlier of July 15, or such time that we obtain a “Qualified Financing.”  We revised the term “Qualified Financing” from aggregate gross proceeds of which equal or exceed $5,000,000 to $3,000,000, and increased the interest rate from 10% to 12%.  Additionally, we extended the expiration date for the Warrants to July 15, 2014, and reduced the exercise price to $0.10 per share. In July 2010, we again obtained the consent of the holders of the Bridge Note financing to extend the maturity date from July 15, 2010 until the earlier of December 31, 2010, or such time that we obtain a Qualified Financing, and we further increased the number of warrants to be issued by 50%, extending the expiration date to December 31, 2014.

 

In November 2010, we used the proceeds from the sale of our shares in AdnaGen to repay the outstanding principal and interest to the holders of the Bridge Notes.

 

Lipitek Agreements

 

In October 2004, we entered into a License Agreement with Lipitek International Inc. (“ Lipitek International ”), pursuant to which Lipitek International has granted to us an exclusive, world-wide, royalty and milestone-bearing right and license to utilize the patents and technologies of Lipitek International relating to L-Nucleosides and their conjugates.

 

On November 17, 2005, we entered into a Purchase Agreement with Lipitek International and Alexander L. Weis, Ph.D. pursuant to which Lipitek has granted us an option to purchase all membership interests in Lipitek Research LLC for a purchase price of $5,000,000, payable in installments. As of March 15, 2010, we have paid Lipitek International a total of $550,000 toward this agreement and we have accrued $450,000. On or before July 28, 2012, we are required to pay the balance of the purchase price. Prior to the full payment of the purchase price, we have the option, upon 30 day’s written notice, to abandon the purchase of Lipitek Research LLC upon forfeiture of all amounts already paid. In addition, Lipitek International and Dr. Weis agreed to use reasonable efforts to ensure that we have the right of first negotiation with respect to any Lipitek International intellectual property related to anti-cancer, anti-fungal, anti-parasitic and anti-malarial activities (except that derived from South American plants and vegetation) and to intellectual property arising out of any current research or research contract of Lipitek Research LLC.  Dr. Weis who is Chairman of our board and our Chief Executive Officer, President, Chief Financial Officer, and Secretary, has agreed not to vote as a director in connection with any matter relating to Lipitek.

 

Pursuant to a three-year Lease Agreement with Lipitek International which expires December 2013, we lease laboratory space for approximately $12,000 per month.

 

 

ITEM 14 – PRINCIPAL ACCOUNTANT FEES AND SERVICES

 

GHP Horwath P.C. (“GHP”)

 

GHP is our independent auditor and examined our financial statements for the years ended December 31, 2011 and,2010.  GHP performed the services listed below and was paid the fees listed below for the years ended December 31, 2011 and 2010.

 

Audit Fees

 

GHP was paid aggregate audit fees of approximately $48,000 and $46,500 for the years ended December 31, 2011 and December 31, 2010, respectively, for professional services rendered for the audit of our annual financial statements and for the reviews of the financial statements included in our quarterly reports on Form 10-Q during the first, second and third quarters of 2011 and 2010.

 

Audit Related Fees

 

GHP was paid no additional fees for the years ended December 31, 2011 and December 31, 2010, respectively, for assurance and related services reasonably related to the performance of the audit or review of our financial statements.

 

Tax Fees

 

GHP was paid fees of approximately $20,695 and $2,720 for the years ended December 31, 2011 and December 31, 2010, respectively, for professional services rendered for tax compliance, tax advice, and tax planning.

 

All Other Fees

 

GHP was not paid any other fees for professional services during the years ended December 31, 2011 and December 31, 2010.

 

Committee Approval

 

In accordance with the Charter of the Audit Committee, the committee must pre-approve all auditing services and permitted non-audit services (including the fees and terms thereof) to be performed by its independent auditor in order to safeguard the independence of the auditors.  With the exception of de minimis amounts for non-audit services, the committee approved all provided auditing services.

 

 

PART IV

 

ITEM 15 – EXHIBITS, FINANCIAL STATEMENT SCHEDULES

  

(a) Financial Statements:

 

Report of Independent Registered Public Accounting Firm (page F-3)

 

Consolidated Balance Sheets (page F-4)

 

Consolidated Statements of Operations (page F-5)

 

Consolidated Statements of Changes in Equity (page F-6)

 

Consolidated Statements of Cash Flows (F-7)

 

Notes to Financial Statements (pages F-8 through F-22)

 

 

(b) Exhibits:

 

Exhibit No.

Description

 

3.1	Certified Copy of the Articles of Incorporation of the Registrant. (1)

 

3.2	Bylaws. (2)

 

3.3	Certificate of Change of the Registrant. (3)

 

3.4	Certificate of Amendment to Articles of Incorporation of the Registrant. (9)

 

10.1	Executive Employment Agreement dated as of October 1, 2004, by and between OncoVista, Inc. and Alexander L. Weis, Ph.D. (2)

 

10.2	Agreement and Plan of Merger between Aengus Pharmaceuticals, Inc., OncoVista-Aengus, Inc. and OncoVista, Inc. dated as of November 7, 2005. (7)

 

10.3	License Agreement between Boston Medical Center Corporation and Aengus Pharmaceuticals, Inc., dated as of December 2, 2005. (8)

 

10.4	Assumption of Obligations of License Agreement and Consent to Transfer License Agreement between Boston Medical Center Corporation and OncoVista-Aengus, Inc.., dated December 2, 2005. (5)

 

10.5	License Agreement dated November 21, 2003 between Oxigene, Inc. and Aengus Pharmaceuticals, Inc. (5)

 

10.6	Consent and Agreement to Assign License Agreement between Oxigene Inc. and OncoVista Aengus Pharmaceuticals, Inc. dated December 2005. (5)

 

10.7	License Agreement effective as of October 13, 2004 between Lipitek International, Inc. and OncoVista, Inc. (5).

 

 

 

10.8	Purchase Agreement dated as of November 17, 2005 between Lipitek International, Inc. and OncoVista, Inc. (5)

 

10.9	Securities Purchase Agreement, between the Registrant, Törbjorn B. Lundqvist and OncoVista, Inc dated as of August 16, 2007. (4)

 

10.10

Form of Subscription Agreement between OncoVista, Inc. and purchasers of units in the OncoVista private placement that closed on August 15, 2007. (5)

 

10.11

Form of Registration Rights Letter between OncoVista, Inc. and purchasers of units in the OncoVista private placement that closed on August 15, 2007. (5)

 

10.12

Form of Warrant issued to purchasers of units in the OncoVista private placement that closed in August 15, 2007. (5)

 

10.13

Form of Lock-Up Agreement. (5)

  

10.14

Form of Subscription Agreement. (5)

 

10.15

2004 Stock Option Plan. (5)

 

10.16

2007 Stock Option Plan. (5)

 

10.17

2007 Stock Option Plan for Independent and Non-Employee Directors. (5)

 

10.18

License Agreement by and between OncoVista, Inc. and OSI Pharmaceuticals, Inc. dated October 4, 2007

  

10.19

Stock Purchase Warrant issued to OSI Pharmaceuticals, Inc., dated November 27, 2007. (6)

 

10.20

Stock Purchase Warrant issued to OSI Pharmaceuticals, Inc., dated November 27, 2007. (6)

  

10.21

Secured Promissory Note of OncoVista Innovative Therapies, Inc. and OncoVista, Inc. dated January 15, 2009. (8)

 

 

 

10.22

Registration Rights Agreement dated January 15, 2009 (8)

 

10.23

Form of Warrant dated January 15, 2009 (8)

 

10.24

Agreement with Gilford Securities Incorporated, dated April 1, 2010 (10)

 

10.25

Letter of Engagement with Motion Communications, Inc., effective May 1, 2010 (10)

 

10.26

Stock Purchase Agreement with Alere Holdings Bermuda Limited Canon’s Court, dated October 28, 2010 (11)

 

10.27

Executive Employment Agreement with Michael Moloney, dated January 3, 2011(12)

 

10.41

Consulting Agreement with FACT Consulting LLC, dated January 3, 2011(12)*

 

10.42

Media Advertising Agreement with MJD Media LLC, dated February 8, 2011(12)

 

10.43

Strategic Consulting Agreement with HealthPro BioVentures LLC, dated January 7, 2011(12)

 

10.44

Employment Agreement with Tamas Bakos, dated November 1, 2010(12)

 

10.45

Lease Agreement between OncoVista, Inc. and Lipitek International, Inc. dated January 3, 2011(12)

 

10.46

Consulting Agreement with New Millennium PR Communications, dated January 31, 2011(12)

 

14	Code of Ethics, dated March 28, 2008 (1)

 

21.1	List of Subsidiaries(14)

 

31.1	Certification of Principal Executive Officer pursuant to Rule 13a-14 and Rule 15d-14(a), promulgated under the Securities and Exchange Act of 1934, as amended*

 

31.2	Certification of Principal Financial Officer pursuant to Rule 13a-14 and Rule 15d 14(a), promulgated under the Securities and Exchange Act of 1934, as amended*

 

32	Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*

 

  

*	Filed herewith.

 

(1)	Filed as an exhibit to the Current Report on Form 8-K filed on October 29, 2007 with the Commission and incorporated by reference herein.

 

(2)	Filed as an exhibit to the Current Report on Form 8-K filed on November 13, 2007 with the Commission and incorporated by reference herein.

 

(3)	Filed as an exhibit to Form 10-SB filed on December 7, 1999 with the Commission and incorporated by reference herein.

 

(4)	Filed as an exhibit to the Current Report on Form 8-K filed on October 24, 2007 with the Commission and incorporated by reference herein.

 

 

 

 

(5)	Filed as an exhibit to the Current Report on Form 8-K filed August 22, 2007 with the Commission and incorporated by reference herein.

  

(6)	Filed as an exhibit to Current Report on Form 8-K/A filed on November 19, 2007 with the Commission and incorporated by reference herein.

 

(7)	Filed as an exhibit to Current Report on Form 8-K on December 3, 2007, with the Commission and incorporated by reference herein.

 

(8)	Filed as an exhibit to the Current Report on Form 8-K on November 19, 2007 with the Commission and incorporated by reference herein.

 

(9)	Filed as an exhibit to Annual Report of Form 10-K on March 30, 2009 with the Commission and incorporated by reference herein.

 

(10)	Filed as an exhibit to Current Report on Form 8-K filed on January 9, 2008 with the Commission and incorporated by reference herein.

 

(11)	Filed as an exhibit to Current Report on Form 8-K filed on January 17, 2008 with the Commission and incorporated by reference herein.

 

(12)	Filed as an exhibit to Quarterly Report of Form 10-Q on May 14, 2010 with the Commission and incorporated by reference herein.

 

(13)	Filed as an exhibit to Quarterly Report of Form 10-Q/A on December 23, 2010 with the Commission and incorporated by reference herein.
(14)	Filed as an exhibit to Annual Report on Form 10-KSB on April 14, 2008 with the Commission and incorporated by reference herein
(15)	Filed as an exhibit to Annual Report of Form 10-K on March 30, 2011 with the Commission and incorporated by reference herein.

 

 

 

 

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.

 

/s/ Alexander L. Weis
Alexander L. Weis, Ph.D.
Chief  Executive Officer, President, Secretary
and Chief Financial Officer
(Principal Executive Officer, Principal Financial
Officer and Principal Accounting Officer)

 

Date:  March 30, 2012 

 

           Pursuant to the requirements of the Securities and Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant in the capacities as on March 30, 2012. 

 

/s/ Alexander L. Weis
Alexander L. Weis, Ph.D.
Chairman of the Board of Directors
/s/ William J. Brock
William J. Brock
Director
/s/ Alexander Ruckdaeschel
Alexander Ruckdaeschel
Director

 

 

ONCOVISTA INNOVATIVE THERAPIES, INC. AND SUBSIDIARIES

Consolidated Financial Statements

Years Ended December 31, 2011 and 2010

 

 

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

 

		Page
Report of Independent Registered Public Accounting Firm		F-3
Consolidated Balance Sheets as of December 31, 2011 and 2010		F-4
Consolidated Statements of Operations for the Years Ended
December 31, 2011 and 2010		F-5
Consolidated Statements of Changes in Equity (Deficit)
for the Years Ended December 31, 2011 and 2010		F-6
Consolidated Statements of Cash Flows for the Years Ended
December 31, 2011 and 2010		F-7
Notes to Consolidated Financial Statements for the Years Ended
December 31, 2011 and 2010		F-8

 

 

  REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and Stockholders of

 

OncoVista Innovative Therapies, Inc.

 

We have audited the accompanying consolidated balance sheets of OncoVista Innovative Therapies, Inc. and Subsidiaries (the “Company”) as of December 31, 2011 and 2010, and the related consolidated statements of operations, changes in equity (deficit), and cash flows for each of the two years in the period ended December 31, 2011. These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits.

 

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall consolidated financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of OncoVista Innovative Therapies, Inc and Subsidiaries as of December 31, 2011 and 2010, and the results of their operations and their cash flows for each of the two years in the period ended December 31, 2011, in conformity with accounting principles generally accepted in the United States of America.

 

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 3 to the consolidated financial statements, the Company has suffered recurring losses and negative cash flows from operations that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 3. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

/s/GHP Horwath, P.C.

 

Denver, Colorado

 

March 30, 2012

 

 

 

ONCOVISTA INNOVATIVE THERAPIES, INC. AND SUBSIDIARIES

Consolidated Balance Sheets

 

		2011				2010
ASSETS
Current assets:
Cash and cash equivalents		$	2,125,229			$	3,524,496
Accounts receivable			429				7,379
Prepaid and other current assets			52,739				–
Total current assets			2,178,397				3,531,875
Equipment, net			10,222				16,232
Deposits and other assets			–				2,047
Total assets		$	2,188,619			$	3,550,154
LIABILITIES AND EQUITY (DEFICIT)
Current liabilities:
Accounts payable (including related party account payable of $452,000 and $250,000)		$	818,522			$	506,685
Accrued expenses (including related party accrued expense of $460,000 and $360,000)			1,003,580				942,102
Derivative liability			322,834				301,405
Notes payable and accrued interest			167,711				143,638
Total current liabilities			2,312,647				1,893,830
Commitments and contingencies
Equity (deficit):
Common stock, $.001 par value; 147,397,390 shares authorized, 21,370,725 and 21,149,675 shares issued and outstanding at December 31, 2011 and 2010, respectively			21,370				21,149
Additional paid-in capital			20,134,341				19,889,722
Accumulated deficit			(20,279,739	)			(18,254,547	)
Total equity (deficit)			(124,028	)			1,656,324
Total liabilities and equity (deficit)		$	2,188,619			$	3,550,154

 

See accompanying notes to consolidated financial statements

 

 

ONCOVISTA INNOVATIVE THERAPIES, INC. AND SUBSIDIARIES

Consolidated Statements of Operations

 

 

 

 

		2011				2010
Revenue		$	–			$	–
Operating expenses:
Research and development			1,157,448				450,910
General and administrative			1,043,727				1,947,571
Total operating expenses			2,201,175				2,398,481
Operating loss from continuing operations			(2,201,175	)			(2,398,481	)
Other income (expense):
Interest expense			(24,073	)			(147,012	)
Interest income			7,023				-
Loss on derivative liability			(21,429	)			(254,701	)
Extinguishment of royalty liability			-				520,000
Other			10,024				(9,709	)
Total other income (expense)			(28,455	)			108,578
Loss from continuing operations			(2,229,630	)			(2,289,903	)
Discontinued operations:
Loss from discontinued operations, net of income taxes			-				(365,434	)
Gain on sale of subsidiary			204,438				12,665,488
Income (loss) from discontinued operations			204,438				12,300,054
Net income (loss)			(2,025,192	)			10,010,151
Net income attributable to contingently redeemable noncontrolling interest (discontinued operations)			-				73,752
Net income attributable to noncontrolling interest (discontinued operations)			-				19,497
Net income (loss) attributable to OncoVista Innovative Therapies		$	(2,025,192	)		$	10,103,400
Net loss per share from continuing operations - basic and diluted		$	(.10	)		$	(0.11	)
Net income (loss) per share from discontinued operations - basic and diluted		$	-			$	0.61
Amounts attributable to OncoVista Innovative Therapies
Loss from continuing operations		$	(2,025,192	)		$	(2,289,903	)
Income (loss) from discontinued operations			-				12,393,303
Net income (loss)		$	(2,025,192	)		$	10,103,400
Weighted average number of shares outstanding during the period - basic and diluted			21,309,790				20,483,008

 

See accompanying notes to consolidated financial statements 

 

 

ONCOVISTA INNOVATIVE THERAPIES, INC. AND SUBSIDIARIES

Consolidated Statements of Changes in Equity (Deficit)

For the Years Ended December 31, 2011 and 2010

 

		Total				Comprehensive Loss				Common Stock				Additional paid-in capital				Accumulated deficit				Accumulated other comprehensive loss				Noncontrolling Interest
Balance at December 31, 2011		$	(11,248,505	)						$	21,149			$	18,560,394			$	(28,357,947	)		$	(1,430,618	)		$	(41,483	)
Comprehensive loss:
Net income			10,010,151			$	10,010,151				–				–				10,103,400				–				(93,249	)
Other comprehensive loss:
Foreign currency translation gain			26,427				26,427				–				–				–				26,427				–
Other comprehensive loss			26,427				26,427
Comprehensive loss			10,036,578			$	10,036,578
Disposition of AdnaGen			1,538,923																				1,404,191				134,732
Issuance of warrants for consulting services			63,710								–				63,710				–				–
Employee stock-based compensation			1,229,205								–				1,229,205				–				–
Non-employee stock-based consulting services			36,413								–				36,413				–				–
Balance at December 31, 2010			1,656,324								21,149				19,889,722				(18,254,547	)			-				-
Net loss			(2,025,192	)							–				–				(2,025,192	)			–				–
Issuance of warrants for consulting services			12,567								–				12,567				–				–
Employee stock-based compensation			120,621								–				120,621				–				–
Exercise of stock options			8,075								26				8,049				–				–
Issuance of stock for Legal settlement			9,000								45				8,955				–				–
Non-employee stock-based consulting services			6,077								–				6,077				–				–
Issuance of common stock for consulting services			88,500								150				88,350				–				–
Balance at December 31, 2011		$	(124,028	)						$	21,370			$	20,134,341			$	(20,279,739	)		$	-			$	-

 

See accompanying notes to consolidated financial statements  

 

 

ONCOVISTA INNOVATIVE THERAPIES, INC. AND SUBSIDIARIES

Consolidated Statements of Cash Flows

 

		Year ended December 31,
		2011				2010
Cash flows from operating activities
Net income (loss)		$	(2,025,192	)		$	10,010,151
Adjustments to reconcile net loss to net cash used in operating activities:
Loss from discontinued operations			-				365,434
Depreciation			6,741				9,292
Amortization of debt discount			-				25,635
Gain on sale of subsidiary			(204,438	)			(12,665,488	)
Loss on disposal of assets			2,129				-
Employee stock-based compensation			120,621				1,229,205
Common stock issued for consulting			88,500				-
Non-employee stock-based consulting expense			6,077				36,413
Non-employee stock-based consulting expense (warrants)			12,567				63,710
Loss (gain) on derivative liability			21,429				254,701
Gain on extinguishment of royalty liability			-				(520,000	)
Legal Settlement			9,000				-
Changes in operating assets and liabilities:
Accounts receivable			6,950				51,814
Prepaid and other assets			(50,692	)			–
Accounts payable			311,837				(414,834	)
Accrued expenses			61,478				3,049
Accrued interest payable			24,073				(63,713	)
Net cash used in continuing operations			(1,608,920	)			(1,614,631	)
Net cash provided by discontinued operations			-				1,059,676
Net cash used in operating activities			(1,608,920	)			(554,954	)
Cash flows from investing activities
Purchase of equipment			(2,860	)			–
Net cash (used in) provided by discontinued operations, including proceeds from sale of AdnaGen of $5,992,036			204,438				5,916,662
Net cash provided by (used in) investing activities			201,578				5,916,662
Cash flows from financing activities
Proceeds from exercise of stock options			8,075				–
Proceeds from loans and notes payable, related party			-				146,712
Repayments of loans and notes payable			-				(400,000	)
Repayments of loans and notes payable, related party			-				(606,212	)
Net cash provided by (used in) continuing operations			8,075				(859,500	)
Net cash provided (used in) by discontinued operations			-				(1,108,947	)
Net cash provided by (used in) financing activities			8,075				(1,968,447	)
Net cash used in continuing operations			(1,399,267	)			(2,474,131	)
Net cash provided by discontinued operations			-				5,867,391
Net increase in cash and cash equivalents			(1,399,267	)			3,393,260
Effect of exchange rates on cash			-				22,242
Cash and cash equivalents at beginning of year			3,524,496				108,994
Cash and cash equivalents at end of year		$	2,125,229			$	3,524,496
Supplemental disclosures of cash flow information:
Cash paid for interest		$	-			$	185,091

 

See accompanying notes to consolidated financial statements

 

 

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 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 December 31, 2011, 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

 

Principles of Consolidation

 

The consolidated financial statements include the accounts of OVIT, OncoVista and through October 31, 2010, the accounts of AdnaGen (collectively, the “Company”).  All intercompany balances have been eliminated in consolidation.

 

 

Use of Estimates

 

The preparation of financial statements in conformity with U.S. generally accepted accounting principles 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 during 2011 and 2010 include the valuation of warrants and stock options granted for services or compensation, estimates of the probability and potential magnitude of contingent liabilities, and the valuation allowance for deferred tax assets due to continuing operating losses.

 

Cash and Cash Equivalents

 

The Company considers all highly liquid investments with original maturities of three months or less at the time of purchase to be cash equivalents.

 

The Company minimizes its credit risk associated with cash by periodically evaluating the credit quality of its primary financial institution.  The balance at times may exceed federally insured limits. At December 31, 2011, the balance exceeded the federally insured limit by approximately $1.7million. The Company historically has not incurred any losses related to this credit risk.

 

Equipment

 

Equipment is stated at cost, less accumulated depreciation.  Costs greater than $1,000 are capitalized and depreciated on a straight-line basis over the estimated useful lives, which range from three to fourteen years.

 

Long-Lived Assets

 

Long-lived assets are reviewed for impairment periodically and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.  Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset.  If such assets are considered impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets.  As a result of these reviews, no impairment charge has been recorded during the years ended December 31, 2011 and 2010.

 

Revenue Recognition

 

While the Company has not recognized revenues from continuing operations, the Company anticipates that future revenues will be generated from product sales.  The Company expects to recognize revenue from product sales in accordance with SEC, Staff Accounting Bulletin (“SAB”) No. 104, “Revenue Recognition” that requires the Company 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. The Company anticipates that customers will have no right of return for products sold. Revenues are considered to be earned upon shipment.

 

Income Taxes

 

The Company accounts for income taxes under the asset and liability method, in which deferred tax assets and liabilities are recognized for the future tax consequences attributed to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases.  Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.  The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.  If it is more likely than not that some portion of a deferred tax asset will not be realized, a valuation allowance is recognized. 

 

 

The Company’s policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. The Company does not have any accrued interest or penalties associated with any unrecognized tax benefits, nor were any interest expense related to unrecognized tax benefits recognized for the years ended December 31, 2011 and 2010.

 

Significant management judgment is required in developing the provision for income taxes, including the determination of deferred tax assets and liabilities and any valuation allowances that might be required against the deferred tax assets.  Management evaluates its ability to realize its deferred tax assets on a quarterly basis and adjusts its valuation allowance when it believes that it is more likely than not that the asset will not be realized.

 

Research and Development Expenses

 

The Company’s research and development expense consists of costs associated with discovery research and product development.  Discovery research is comprised of employee costs, laboratory materials and supplies, and research-related overhead allocations.  Included in product development are clinical trial costs, including expenses associated with contract research organizations, contract manufacturing, employee costs, pharmacology studies, and costs to obtain, maintain and defend patents. These costs are expensed as incurred.

 

Regulatory Matters

 

Regulations imposed by federal, state and local authorities in the United States, as well as authorities in other countries, are a significant factor in the conduct of research, development, manufacturing and eventual marketing of the Company’s products.  In the United States, drugs, biological products, and medical devices are regulated by the United States Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration.

 

Net Loss per Share

 

Basic earnings (loss) per share are computed by dividing the 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 continuing operations for the last two years, all unvested restricted stock, stock options and warrants are considered to be anti-dilutive.  At December 31, 2011 and 2010, the following shares have been excluded since their inclusion in the computation of diluted EPS would be anti-dilutive:

 

		2011				2010
Stock options outstanding under our various stock option plans			1,381,500				949,000
Warrants			4,331,712				4,306,712
Total			5,713,212				5,255,712

 

 

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.

 

Reclassifications

 

Certain prior year balances have been reclassified to conform to the current year presentation.

 

Recent Accounting Pronouncements

 

In January 2010, the Financial Accounting Standards Board (“FASB”) issued ASU 2010-06, Fair Value Measurements and Disclosures (Topic 820): Improving Disclosures about Fair Value Measurements (ASU 2010-06), which amends the existing fair value measurement and disclosure guidance currently included in Accounting Standards Codification (ASC) Topic 820, Fair Value Measurements and Disclosures , to require additional disclosures regarding fair value measurements. Specifically, ASU 2010-06 requires entities to disclose the amounts of significant transfers between Level 1 and Level 2 of the fair value hierarchy and the reasons for these transfers, the reasons for any transfer in or out of Level 3 and information in the reconciliation of recurring Level 3 measurements about purchases, sales, issuances and settlements on a gross basis. In addition, ASU 2010-06 also clarifies the requirement for entities to disclose information about both the valuation techniques and inputs used in estimating Level 2 and Level 3 fair value measurements. ASU 2010-06 was effective for the Company beginning on January 1, 2010, except for additional disclosures related to Level 3 fair value measurements, which are effective for fiscal years beginning after December 15, 2010. The adoption of ASU 2010-06 did not have a material impact the Company’s consolidated financial statements or results of operations.

 

In April 2010, the FASB issued ASU 2010-17, Revenue Recognition – Milestone Method (Topic 605), which provides guidance on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition to research or development arrangements. Under this guidance, the Company may recognize revenue contingent upon the achievement of a milestone in its entirety in the period in which the milestone is achieved, only if the milestone meets all the criteria within the guidance to be considered substantive. This amendment is effective on a prospective basis for research and development milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010. Early adoption is permitted. This amendment is effective for the Company beginning January 1, 2011.   The adoption of ASU 2010-17 is not expected to have a material impact on the Company’s consolidated financial position or results of operations.

 

  ASU 2011-04, “Fair Value Measurement (Topic 820) - Amendments to Achieve Common Fair Value Measurements and Disclosure Requirements in U.S. GAAP and IFRSs.” ASU 2011-04 amends Topic 820, “Fair Value Measurements and Disclosures,” to converge the fair value measurement guidance in U.S. generally accepted accounting principles and International Financial Reporting Standards. ASU 2011-04 clarifies the application of existing fair value measurement requirements, changes certain principles in Topic 820 and requires additional fair value disclosures. ASU 2011-04 is effective for annual periods beginning after December 15, 2011, and is not expected to have a significant impact on our consolidated financial statements.

 

 

Note 3.       GOING CONCERN AND MANAGEMENT’S PLAN

 

As reflected in the accompanying consolidated financial statements, the Company reported a net loss from continuing operations of approximately $2.2 million, and net cash used in continuing operations of approximately $1.6 million for the year ended December 31, 2011, an accumulated deficit of approximately $20.3 million, and a negative total equity of approximately $0.1 million at December 31, 2011. The Company is also in default on a certain loan and related accrued interest aggregating of approximately $168,000 at December 31, 2011 (See Note 6).  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, the Company believes it has sufficient capital to meet its anticipated operating cash requirements for the next nine to 12 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 to continue as a going concern is dependent on management’s ability to further implement its strategic plan, obtain additional capital, principally by obtaining additional debt and/or equity financing, and generate additional revenues from collaborative agreements or sale of pharmaceutical products. 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.

 

Note 4.      EQUIPMENT

 

Equipment balances at December 31, 2011 and 2010 are summarized below:

 

		2011				2010
Equipment		$	30,132			$	30,132
Computer and office equipment			9,326				6,466
Furniture and fixtures			—				5,554
			39,458				42,152
Less: accumulated depreciation			(29,236	)			(25.920	)
Equipment, net		$	10,222			$	16,232

 

Note 5.      ACCRUED EXPENSES

 

Accrued expenses at December 31, 2011 and 2010 are summarized below:

 

		2011				2010
Legal and professional		$	21,250			$	55,000
Clinical and other studies			149,006				233,090
Compensation			272,085				239,469
Minimum royalty			560,000				410,000
Other			1,239				4,543
Total accrued expenses		$	1,003,580			$	942,102

 

In March 2010, the Company terminated its license agreements and returned the intellectual property related to technologies associated with tubulin isotype-specific anti-mitotics and a proprietary database of tubulin structures.  As a result, the Company is no longer obligated to pay $520,000 in liabilities for minimum royalties associated with these licenses as the licensor released the liability.  Accordingly, in March 2010, the Company reversed the accrued liability which had been included in current liabilities on the Company’s consolidated balance sheets and recorded a gain on extinguishment of royalty liability on its statement of operations.  

 

 

Note 6.     DEBT

 

As a result of the Stock Purchase Agreement with Alere Holdings, the Company has eliminated substantially all of its outstanding debt using a portion of the Company’s share of proceeds received from the initial milestone payment under the Stock Purchase Agreement.  In connection with the Stock Purchase Agreement, the Company’s contingently redeemable shares were issued and subsequently sold to Alere Holdings. The Company also repaid the principal and accrued interest to the holders of the 2009 Bridge Note, as well as the loans and advances from Alexander L. Weis, Ph.D., Chairman of the Company’s board of directors and its CEO, President, CFO and Secretary, and a significant shareholder (the “CEO”) and affiliates of the CEO.

 

The Company had the following outstanding loans and notes payable at December 31, 2011 and 2010:

 

		2011				2010
Unsecured convertible notes payable to a third party with interest at 8% and due on demand, matured in December 2005 (1)		$	100,000			$	100,000
Total notes payable			100,000				100,000
Less: current portion			(100,000	)			(100,000	)
Total long-term debt		$	–			$	–

 

(1)

The debt holder, at its option, may convert the principal and any accrued interest into shares of common stock at a price of $2.50 per share.  The Company is currently in default.

  

 

Note 7.     DERIVATIVE LIABILITY AND FAIR VALUE INFORMATION

 

The Company determined that warrants issued in connection with the bridge round of 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 of shares issued upon settlement (See Note 11).

 

In January 2010, the Company amended certain terms of the 2009 Bridge Note financing agreement, which did not affect the liability classification of the associated warrants.  In consideration for the modifications, the Company extended the expiration date for the warrants to July 15, 2014, and the exercise price of the warrants was reduced to $0.10 per share.  The modification of the terms of the warrants resulted in an additional expense of $67,172 at the amendment date.  In July 2010, certain terms for the warrants were further modified to increase by 50% the number of shares issuable upon exercise of the warrants, and extend the expiration date for the warrants to December 31, 2014.  The modification of the terms of the warrants resulted in an additional expense of $129,603 at the amendment date.  The estimated fair value of the derivative liability was $322,834 and $301,405 at December 31, 2011 and 2010, respectively.

 

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

 

Expected term			3-4 years
Volatility			86.5-100.5	%
Risk-free interest rate			0.36%-0.43	%
Dividend yield			0	%

 

Fair value measurements

 

Assets and liabilities measured at fair value as of December 31, 2011 and 2010 are as follows:

 

		Value				Quoted prices in active markets (Level 1)				Significant other observable inputs (Level 2)				Significant unobservable inputs (Level 3)
Derivative liability at December 31, 2011		$	322,834			$	–			$	322,834			$	–
Derivative liability at December 31, 2010		$	301,405			$	–			$	301,405			$	–

 

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 December 31, 2011 and 2010, respectively. The fair values of accounts receivable, accounts payable and notes payable approximate the carrying amounts due to the short-term nature of these instruments.  

 

 

Note 8.      COLLABORATION, LICENSE AND OTHER AGREEMENTS

 

OSI Pharmaceuticals

 

In November 2007, the Company entered into a license agreement with OSI Pharmaceuticals, Inc. (“OSI”) for a Phase II clinical drug candidate, OSI-7904L (the “License Agreement”).  OSI granted the Company an exclusive, royalty-bearing, worldwide license, with the right to grant sublicenses, with respect to OSI’s rights to OSI-7904L.

 

In consideration of the Company’s current capital position, the cost to further develop the drug compound, and the limited patent life remaining, management has elected to discontinue further development and focus their efforts and resources on developing the Company’s other drug candidates.  The management of the Company does not believe there will be any penalty under the current agreement or any future milestone payment obligations as a result of the termination.

 

Note 9.     LEASES, COMMITMENTS AND CONTINGENCIES

 

Lease Obligations

 

In January 2011, the Company entered a three-year lease with an affiliate of the CEO for office and laboratory space (see Note 10) which expires December 2013. As of December 31, 2011, our minimum lease payment requirements are as follows:

 

2012			$	144,000
2013				144,000
Thereafter				–
Total			$	288,000

 

Total rent expense amounted to approximately $160,500 and $98,000 for the years ended December 31, 2011 and 2010, respectively.

  

Employment Contracts

 

The Company has employment contracts with certain executive officers. The contracts have commitment periods of between one and two years, and are subject to automatic renewal for one year terms. Compensation provided under the contracts range from $183,600 to $322,000, as well as bonuses of up to 30% to 40% of base salary.  Bonuses are based on performance milestones, which have not yet been met; therefore, bonuses have not been paid or accrued for the years ended December 31, 2011 and 2010.  In the event of termination without cause, the contract provides for a severance of salary and benefits continuation for periods of between three months and one year.

  

Legal Matters

 

On December 17, 2007, an action was filed against the Company in the Supreme Court of the State of New York, New York County, entitled Bridge Ventures, Inc. v. OncoVista, Inc. and Centrecourt Asset Management. The action seeks damages for the alleged breach of a consulting agreement and seeks an order directing the issuance of warrants to purchase the Company’s common stock. The Company filed a motion to dismiss the action, and on April 3, 2008 the motion was denied.  The Company answered the complaint and asserted a counterclaim seeking compensation for the expenses that it incurred during the time that it worked with Bridge Ventures, Inc. The parties signed a settlement agreement, under which the Company paid $1,000 and is required to issue 45,000 shares of its common stock. In March 2011, the Company issued the shares required by the settlement agreement, and recorded settlement expense of $9,000 related to the issuance of these shares .

 

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. Based on a review of the current operative complaint, the Company believes that the plaintiff’s allegations are without merit, and intends to rigorously defend against the claim. The Company’s counsel has started taking depositions and has requested access to CAMOFI Master LDC and CAMHZN Master LDC principals for further depositions.

 

 

 

Note 10.    RELATED PARTY TRANSACTIONS

 

OncoVista

 

Alexander L. Weis, Ph.D., Chairman of the Company’s Board of Directors and its CEO, President, CFO 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 (see Note 9).  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 shall be payable quarterly based upon revenues of Lipitek Research up to $50,000 per quarter.  Through December 31, 2011, the Company has paid $550,000 toward this agreement and has accrued $450,000, representing one quarterly payment for 2009 and all of the 2010 and 2011 amounts, which are included in accounts payable in the consolidated balance sheets as of December 31, 2011 and 2010. The Company paid $0 and $250,000 toward the agreement which is included as a component of research and development expenses for the year ended December 31, 2011 and 2010, respectively.

 

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 2011 and 2010, the Company did not recognize any revenue from its share of Lipitek revenues.

 

For the potential acquisition of Lipitek, the Company determined that, under SEC Regulation S-X, Rule 11-01(d) (“ 11-01 ”), and ASC 805. Lipitek was classified as a development stage company and thus was not considered a business. As a result, purchase accounting rules did not apply.  The Company also cannot determine with any certainty at this time, if it will exercise the option to purchase Lipitek in the future.

 

AdnaGen (a discontinued operation)

 

Dr. Weis is also a beneficial owner of Biomarkers LLC (“Biomarkers”).  In September 2008, AdnaGen entered into an exclusive distribution and license agreement with Biomarkers. Pursuant to the terms of the license agreement, AdnaGen granted Biomarkers the right to distribute diagnostic kits in North America. In January 2009, AdnaGen also entered into an exclusive distribution and license agreement with Biomarkers granting Biomarkers the exclusive right to commercialize the AdnaGen diagnostic kits in South America and the Middle East. Pursuant to the terms of these license agreements, AdnaGen also granted Biomarkers the right to appoint sub-licensees at Biomarkers sole discretion. These agreements continued through December 2010. In 2010, the Company recorded revenue of approximately $15,000 (€11,000) from the sale of diagnostic kits to Biomarkers. The agreements were extended until December 2013.

 

Note 11.    CHANGES IN EQUITY (DEFICIT)

 

Common Stock Transactions of Accounting Acquirer Prior to Reverse Acquisition

 

In connection with the 2007 private placement, the Company issued warrants to the third parties to acquire 886,000 shares of common stock. The warrants are exercisable through August 15, 2012 at exercise prices of $0.001 and $2.50 per share, subject to adjustment for stock splits, stock dividends, distributions, reorganizations, reclassifications, consolidations, and mergers. These warrants are fully vested and non-forfeitable.  

 

 

Common Stock

 

The Company is authorized to issue up to 147,397,390 shares of common stock. At December 31, 2011, shares of common stock reserved for future issuance are as follows:

 

Stock options outstanding			1,381,500
Warrants outstanding			4,331,712
Stock options available for grant			2,159,250
			7,872,462

 

Restricted Stock

 

In October 2007, OncoVista 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 December 31, 2011, there was no unrecognized compensation cost related to unvested restricted stock.  For the year ended December 31, 2010, compensation expense of approximately $1.2 million was recognized for restricted stock grants. 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.

 

Stock Option Plans

 

In May 2007, the Company’s Board of Directors adopted the 2007 Stock Option Plan (“2007 Plan”).  The 2007 Plan provides for the grant of incentive stock options, non-statutory stock options, and restricted stock awards to employees, directors and consultants who provide services to OncoVista.  The Company has reserved 3,000,000 shares of common stock for issuance under the 2007 Plan.

 

In May 2007, the Board of Directors authorized the 2007 Stock Option Plan for Independent and Non-Employee Directors (the “Directors Plan”).  Options granted under the Directors Plan shall be nonstatutory options and may be granted to nonemployee directors at an exercise price equal to the fair market value at the date of grant. The maximum term of options granted under the Directors Plan is ten years. The term of the Directors Plan is ten years. The Company has reserved 500,000 shares of common stock for issuance under the Director Plan.

  

The Company granted options to its officers and employees under its 2004 Stock Incentive Plan (the “2004 Plan”).  The 2004 Plan is authorized to grant options for up to 1,000,000 shares of common stock to employees, directors, and consultants who provide service to the Company.  Options granted have a vesting schedule with a term ranging from grant date to four years and become fully exercisable based on specific terms imposed at the date of grant.  All awards pursuant to the 2004 Plan shall terminate upon the termination of the grantees employment for any reason.

 

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.  Vesting periods for the Company’s stock option awards during 2011 and 2010 included the following: monthly for twenty-four months, monthly for thirty-six months, and monthly for forty-eight months. The Company granted 658,600 and 299,000 options for services having fair values of $136,355 and $68,762 in 2011 and 2010, respectively.

 

The stock-based compensation expense recorded by the Company for the years ended December 31, 2011 and 2010, with respect to awards under the all option plans is as follows:

		2011				2010
Research and development		$	52,533			$	62,538
General and administrative			68,088				–
Total employee stock-based compensation		$	120,621			$	62,538

  

As of December 31, 2011, the unrecognized stock based compensation, of approximately $148,000, will be recognized over a weighted average period of less than two years.

 

 

The Company recognized $6,077 and $36,413 as consulting expense and such amounts are included in general and administrative expense in the consolidated statements of operations for the years ended December 31, 2011 and 2010, respectively.

 

The Company follows fair value accounting and the related provisions of ASC 718 for all share based payment awards. The fair value of each option or warrant granted is estimated on the date of grant using the Black-Scholes option-pricing model.

 

The assumptions used in the Black-Scholes for the years ended December 31, 2011 and 2010 are as follows:

 

		2011				2010
Risk-free interest rate			1.03-2.02	%			0.73	%
Expected dividend yield			0	%			0	%
Expected volatility			100.5	%			95.1	%
Expected life of option			3 - 10 years				10 years
Expected forfeitures			0	%			0	%

 

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, 2011			949,000			$	1.20
Granted			658,600			$	0.31
Exercised			(26,050	)			0.31
Forfeited			(200,050	)			0.39
Outstanding at December 31, 2011			1,381,500			$	0.91			6.84 years		$	68,000
Options Exercisable at December 31, 2011			977,250			$	1.14			5.96 years		$	58,250

   

The following summarizes the activity of the Company’s stock options that have not vested for the year ended December 31, 2010:

 

		2011								2010
		Shares				Weighted Average Grant  Date Fair  Value				Shares				Weighted Average Grant Date  Fair Value
Outstanding at January 1			336,000			$	0.40				140,000			$	1.92
Granted			658,600				0.21				299,000				0.23
Vested			(390,300	)			0.31				(103,000	)			1.99
Cancelled or forfeited			(200,050	)			0.32				–				–
Outstanding at December 31			404,250			$	0.21				336,000			$	0.40

 

The total intrinsic value of stock option exercises during the years ended December 31, 2011 and 2010 was approximately $7,555 and $0, respectively. 

 

 

Warrants

 

In January 2011, the Company engaged a firm to provide public relations and media services and issued a warrant to acquire 25,000 shares of its common stock at an exercise price of $0.35, with the shares vesting in equal monthly installments over three months. The Company recognized $12,567 as consulting expense which is included in general and administrative expense in the consolidated statements of operations. In addition, the agreement provides for a fee of $4,000 per month for three months.

 

In May 2010, the Company agreed to issue to a consulting firm warrants to acquire 250,000 shares of its common stock, with up to 150,000 vesting in equal monthly installments over six months at an exercise price of $0.38 for shares vesting in the first three months, and an exercise price equal to the last ten day average closing price at the end of the third month for the shares vesting the last three months.  Of the remaining warrants to acquire 100,000 shares of common stock, 50,000 vested immediately at an exercise price of $0.38, and 50,000 were issued and vested on the first day of the fourth month at an exercise price equal to the ten day average closing price through the last trading day of the third month.  The Company valued these warrants based on the Black-Scholes option pricing model and recorded approximately $70,800 as expense for the warrants.

 

In January 2009, in connection with the 2009 Bridge Note, the Company issued to holders of the notes detachable warrants to acquire 750,000 shares of common stock.  In July 2010, the Company amended the terms for the warrants, increasing the number of warrants to acquire shares by 375,000 for a total of 1,125,000 shares upon the exercise of the warrants.

 

The Black-Scholes assumptions used for warrants for the years ended December 31, 2011 and 2010 are as follows:

 

		2011				2010
Risk-free interest rate			0.98	%			0.25	%
Expected dividend yield			0	%			0	%
Expected volatility			100.5	%			100.4	%
Expected life			5 years				5 years
Expected forfeitures			0	%			0	%

 

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

 

		Shares				Weighted Average Exercise Price				Weighted Average Remaining Contractual Term		Aggregate Intrinsic Value
Outstanding at January 1, 2011			4,306,712			$	1.73
Granted			25,000			$	0.35
Exercised			-				-
Forfeited			-				-
Outstanding at December 31, 2011			4,331,712			$	1.72			1.42 years		$	370,993
Exercisable at December 31, 2011			4,331,712			$	1.72			1.42 years		$	370,993

 

 

As of December 31, 2011, there was no unrecognized compensation cost related to warrants.

 

 

 

Note 12.    INCOME TAXES

 

The Company has not incurred any U.S. Federal or state tax expense since its inception. Significant deferred tax assets at December 31, 2011 and 2010 are as follows:

 

		2011				2010
Deferred tax assets:
Net operating loss carryforwards, United States		$	4,894,000			$	1,245,000
Installment sale			305,000				607,000
Share-based compensation and consulting			2,152,000				2,081,000
Other			40,000				23,000
Total deferred tax assets			7,391,000				3,956,000
Less: valuation allowance			(7,391,000	)			(3,956,000	)
Net deferred tax assets		$	–			$	–

 

In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized.  The ultimate realization of deferred income tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible.  Management considers the scheduled reversal of deferred income tax liabilities, projected future taxable income, and tax planning strategies in making this assessment.  Based on consideration of these items, management has determined that enough uncertainty exists relative to the realization of the deferred income tax asset balances to warrant the application of a full valuation allowance as of December 31, 2011 and 2010.

 

At December 31, 2011, OncoVista, Inc. had U.S. tax net operating loss carryforwards of approximately $14.4 million available to offset future taxable income which will expire at various dates through 2031.  The utilization of tax net operating losses may be limited due to the change in ownership under Internal Revenue Code Section 382.  AdnaGen AG tax attributes from its separately filed tax return in Germany is subject to the rules and regulations of that country.

 

The actual tax benefit differs from the expected tax benefit for the years ended December 31, 2011 and 2010 (computed by applying the U.S. Federal Corporate tax rate of 34% to income before taxes) are as follows:

 

		2011				2010
Expected tax expense (benefit)			(34.0	)%			34.0	%
Permanent differences:			(135.4	)%
Adjustment for 2010 sale of subsidiary			—	%			1.2	%
Change in valuation allowance			169.4	%			(35.2	)%
Consolidated effective tax rate			–	%			–	%

 

The Company files income tax returns in the U.S. federal and Texas jurisdictions, and is no longer subject to tax examinations for years prior to 2004.

 

Note 13.    SEGMENT INFORMATION

 

The Company’s revenue is substantially derived from the operation in a single business segment, the development of innovative tumor diagnostics for detection, analysis, and treatment of rare (cancer) cells.  Sales to customers outside the United States (in Europe) were made by AdnaGen AG, the Company’s former German subsidiary. 

 

 

Through October 2010, the Company maintained a controlling interest in AdnaGen, a research and development company based in Langenhagen, Germany, which focused on the development of innovative tumor diagnostics by utilizing its proprietary technology for the detection and analysis of rare cells.  In November 2010, the Company sold all of its shares in AdnaGen. AdnaGen is reported as discontinued operations in the Company’s consolidated financial statements for the year ended December 31, 2010.

 

A summary of the Company’s operations for the year end December 31, 2010 is provided below:

 

		2010
		OncoVista				AdnaGen (1)				Total
Revenue		$	–			$	976,231			$	976,231
Operating expenses			2,398,481				1,177,793				3,576,274
Loss from operations			(2,398,481	)			(201,562	)			(2,600,043	)
Other income (expense), net			108,578				(163,872	)			(55,294	)
Gain on sale of subsidiary			–				12,665,488				12,665,488
Net loss		$	(2,289,903	)		$	12,300,054			$	10,010,151
Total assets		$	3,550,154			$	–			$	3,550,154

 

(1)

Presented as discontinued operations for the year ended December 31, 2010.

Note 14.    DISCONTINUED OPERATIONS

 

During 2010, the Company sold all of its shares in AdnaGen to provide liquidity for the Company and enable management to focus on the development of targeted anticancer therapies by utilizing tumor-associated biomarkers. The operating results from discontinued operations for the ten months ended October 31, 2010 were as follows:

 

Revenues		$	976,231
Loss from operations			(201,562	)

 

Note 15.    SUBSEQUENT EVENTS

 

On January 12, 2012 we entered into a consulting agreement with J. Kay Noel & Associates for services related to the development and implementation of regulatory strategies for OVI-117 and OVI-123 and to act as its U.S. Agent for interactions with the United States Food and Drug Administration (“FDA”).