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, 2009
 
  ̈
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 March 29, 2010 was approximately $3,507,251 (based upon
9,352,776 shares at $0.375 per share).
 
 As of
March 24, 2010, there were 21,149,675 shares of common stock
outstanding.
 
 DOCUMENTS
INCORPORATED BY REFERENCE
 
 The
following documents are incorporated herein by reference in Part IV, Item 15:
(i) Registration Statement on Form 10-SB, filed December 7, 1999; (ii) Current
Report on Form 8-K, filed August 22, 2007; (iii) Current Report on Form 8-K,
filed October 24, 2007; (iv) Current Report on Form 8-K, filed October 29, 2007;
(v) Current Report on Form 8-K, filed November 13, 2007; (vi) Current Report on
Form 8-K, filed November 19, 2007; (vii) Current Report on Form 8-K/A, filed
November 19, 2007; (viii) Current Report on Form 8-K, filed December 3, 2007;
(ix) Current Report on Form 8-K, filed January 8, 2008; (x) Current Report on
Form 8-K, filed January 9, 2008; (xi) Current Report on Form 8-K, filed January
17, 2008; (xii) Annual Report on Form 10-K for the fiscal year December 31,
2008, filed March 30, 2009; and (xiii) Annual Report on Form 10-KSB for the
fiscal year December 31, 2007, filed April 14, 2008, are incorporated in Part
IV, Item 15.
  
  ONCOVISTA
INNOVATIVE THERAPIES, INC.
 FORM
10-K
 FOR
THE YEAR ENDED DECEMBER 31, 2009
 TABLE
OF CONTENTS
 
 PART
      I
                                                                      1ITEM
      1 – BUSINESS
                                                                      1ITEM
      1A – RISK FACTORS
                                                                      18ITEM
      2 – PROPERTIES
                                                                      18ITEM
      3 – LEGAL PROCEEDINGS
                                                                      18ITEM
      4 – REMOVED AND RESERVED
                                                                      18PART
      II
                                                                      19ITEM
      5 – MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND
      ISSUER PURCHASES OF EQUITY SECURITIES
                                                                      19ITEM
      6 – SELECTED FINANCIAL DATA
                                                                      20ITEM
      7 – MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
      RESULTS OF OPERATIONS
                                                                      20ITEM
      7A – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
      RISK
                                                                      28ITEM
      8 – FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
                                                                      28ITEM
      9 – CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
      FINANCIAL DISCLOSURE
                                                                      28ITEM
      9A – CONTROLS AND PROCEDURES
                                                                      28ITEM
      9A(T) – CONTROLS AND PROCEDURES
                                                                      30ITEM
      9B – OTHER INFORMATION
                                                                      30PART
      III
                                                                      31ITEM
      10 – DIRECTORS, EXECUTIVE OFFICERS  AND CORPORATE
      GOVERNANCE
                                                                      31ITEM
      11 – EXECUTIVE COMPENSATION
                                                                      35ITEM
      12 – SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
      RELATED STOCKHOLDER MATTERS
                                                                      42ITEM
      13 – CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, DIRECTOR
      INDEPENDENCE
                                                                      43ITEM
      14 – PRINCIPAL ACCOUNTANT FEES AND SERVICES
                                                                      45PART
      IV
                                                                      47ITEM
      15 – EXHIBITS, FINANCIAL STATEMENT SCHEDULES
                                                                      47
  
  PART
I
 
 ITEM
1 – BUSINESS
 
 Overview
 
 We are a
biopharmaceutical company commercializing diagnostic tests for metastatic
tumors, as well as developing targeted anticancer therapies by utilizing
tumor-associated biomarkers. We have developed diagnostic kits for breast,
colon, ovarian, and prostate cancers, and currently market diagnostic kits in
Europe for the detection of circulating tumor cells (“CTCs”) in patients with
breast and colon cancer. We believe we are positioned to leverage our
ownership in our subsidiary diagnostics company, AdnaGen, to realize short-term
revenues from sales of AdnaGen’s CE-marked diagnostic kits in Europe, while
utilizing the diagnostic technology to guide and expedite our anticancer drug
development efforts.
 
 Our
primary 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 use of methods to detect and analyze biomarkers in CTCs to determine
suitability of specific treatments as well as provide an early indication of
treatment success or failure will be key to bringing personalized targeted
medicines to market. We expect our proprietary diagnostic technology to
facilitate selection and stratification of clinical trial patients, as well as
monitor and predict the response of patients to treatment. 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.
 
 We are
currently marketing diagnostic kits in Europe for the detection of CTCs in
breast, colon, ovarian, and prostate cancer patients. The kits are manufactured
by AdnaGen and marketed through a combination of exclusive and non-exclusive
distribution agreements in Europe. We have also developed research products for
the detection of steroid receptors (ER/PR) and cancer stem cells.  We
have developed the protocol for a pivotal trial in metastatic breast cancer to
obtain approval to market the kit in the U.S. and will proceed with filing
subject to the availability of sufficient working capital. We plan to continue
to grow the market for AdnaGen diagnostic kits in the U.S. and Europe to provide
revenue and cash flow to help support our drug development efforts.
 
 We will
continue to use our proprietary diagnostic technology to progress our
anti-cancer drug portfolio providing better clinical outcomes by identifying and
treating only those patients who express certain
biomarkers.  Additionally, we anticipate establishing partnerships
with other drug companies to expedite their drug development efforts utilizing
our biomarker analysis technology.
 
 Our most
advanced drug candidate, OVI-237 is a liposomal formulation of a potent
inhibitor of thymidylate synthase (TS). Subject to the availability of
sufficient working capital, we plan on initiating the trial in 2010. 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 plan 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 completed the GLP animal drug safety studies for our
lead drug candidate from the L-nucleoside conjugate program (OVI-117). We have
begun to compile the Investigational New Drug (IND) Application for submission
to the U.S. Food and Drug Administration (“FDA”), which is a key step to
conducting human clinical trials. Submission of the IND for review has been
delayed until such time as we can raise additional capital.
  1
 
 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 have also loaned or advanced to AdnaGen approximately
€670,000 ($960,000) during the previous 24 months to support their
operations.  We believe the ability to execute our strategy relies on
the continued viability of AdnaGen. As such, we will likely continue to provide
advances to AdnaGen until they achieve positive cash flows adequate to support
their continued operations. We estimate that our cash reserves will be
sufficient to permit us to continue at our anticipated level of operations for
at least two to three months. Accordingly, 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 substantial 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.
As a result of the unavailability of sufficient capital resources and AdnaGen’s
cash needs, we were forced to scale back our research and development operations
during the previous twelve months.
 
 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 ourselves 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 $10.1 million on research and
development.
 
 Our
Corporate Strategy
 
 We have
implemented a comprehensive, multi-faceted approach to candidate identification
and product development in the oncology treatment and diagnostic market
segments. Our strategic plan consists of the following elements:
 
 ·
                An Integrated Diagnostics
      Strategy. AdnaGen’s proprietary diagnostics platform represents an
      opportunity to improve the probability of attaining FDA approval for our
      drugs. AdnaGen’s proprietary “combination-of-combinations” platform
      detects and analyzes circulating tumor cells for clinical diagnosis and
      staging. AdnaGen currently offers diagnostic products for colon and breast
      cancer diagnosis in the European market. AdnaGen’s platform is expandable
      to screen for the markers for virtually all cancer types. These assays are
      highly specific and sensitive, with the ability to detect as few as two
      circulating tumor cells per 5ml of blood (which contains approximately
      107
      normal nucleated cells) at a 95+% likelihood, thereby enabling the
      reproducible detection of low levels (better than 1 part per million) of
      circulating tumor cells in the blood. As part of our oncology drug
      development process, we expect to employ AdnaGen’s diagnostic technology
      to design clinical trial protocols which stratify the patient population
      to include patients most likely to respond based on the expression of
      specific tumor associated biomarkers. In addition, these tests may provide
      insight into the extent of the metastatic process thereby enabling the
      monitoring of disease progression as well as the effectiveness of
      treatment regimens.
  2
 
 ·
                In-licensing Candidate
      Selection and Acquisition Program. We believe that the
      relationships and reputation 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 have
      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.
 
 ·
                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 eyes of the FDA and the
      achievability of 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/or orphan drug
      designation.
 
 ·
                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. We expect these technologies to produce an array of candidates. We
      believe that, in many instances, the potential candidates will 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 will 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 by using our
      products in combination with existing drug therapies administered at lower
      dosage levels will produce comparable or improved effectiveness with
      diminished side effects versus the single agent
  therapy.
  3
  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. We have begun
to compile the Investigational New Drug (IND) application for submission to the
FDA, which is a key step to conducting human clinical trials. Submission of the
IND for review has been delayed until such time that we can raise additional
capital.
 Our other
platform technology related to a proprietary database of tubulin isotypes as
potential candidates for targeting by certain chemotherapeutics. Microtubules,
comprised of tubulin proteins, are instrumental in cell mitosis, and have been
proven as cancer targets by drugs such as the taxanes. We intended to screen our
proprietary database for candidates to be targeted either by drugs to be
developed by us, or by drugs already developed by other companies that are not
aware of the potential for selective tubulin targeting of their products. In
March 2010, we terminated our license agreements and returned the related
intellectual property to these technologies. In return we are no longer
obligated to pay $520,000 in liabilities related to minimum royalties associated
with these licenses.
 
 Merger
and Private Placement
 
 On August
16, 2007, OncoVista-Sub, the private company conducting our cancer drug research
and development, acquired from Torbjorn Lundqvist (“Lundqvist”) and a number of
minority stockholders an aggregate of 10,963,851 shares of our (formerly
Aviation Upgrade Technologies, Inc.) common stock (or 16,160,430 shares of our
common stock after giving effect to the forward split that went effective on
October 22, 2007) constituting approximately 95.7% of our then issued and
outstanding capital stock. In connection with OncoVista-Sub’s acquisition of our
shares, the license agreement with Lundqvist granting us worldwide marketing
rights for an electronic tire valve cap was terminated and all shares of
Automotive Upgrade Technologies, Inc., formerly a wholly owned subsidiary of
ours, were transferred to Lundqvist.
 
 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.
On the closing date of the Merger, each outstanding share of common stock of
OncoVista-Sub was exchanged for one share of our common stock such that
OncoVista-Sub's shareholders became holders of approximately 96.3% of our then
issued and outstanding capital stock. In addition, all our shares acquired by
OncoVista-Sub on August 16, 2007 were cancelled and returned to authorized but
unissued shares of our common stock.
 
 The
Merger was accounted for as a reverse acquisition and recapitalization of
OncoVista-Sub for financial accounting purposes. Consequently, the assets and
liabilities and the historical operations that are reflected in our financial
statements for periods prior to the Merger are those of OncoVista-Sub and have
been recorded at the historical cost basis of OncoVista-Sub, and our
consolidated financial statements for periods after completion of the Merger
include both our and OncoVista-Sub’s assets and liabilities, the historical
operations of OncoVista-Sub and our operations from the closing date of the
Merger.
 
 In
contemplation of the Merger, on August 15, 2007, OncoVista-Sub completed the
closing of a private placement (the “2007 Private Placement”)
whereby it sold to accredited investors a total of 970,712 units at $7.00 per
unit, each unit consisting of four shares of OncoVista-Sub common stock and a
warrant to acquire one share of OncoVista-Sub common stock. The net proceeds of
the private placement after payment of placement agent fees and other expenses
were approximately $6,223,000. In connection with the private placement,
OncoVista-Sub issued warrants to its placement agent, Maxim Group, LLC, to
acquire 278,857 shares of OncoVista-Sub common stock. The warrants and placement
agent warrants (collectively, the “Warrants”) are exercisable
through August 15, 2012 at the exercise price of $2.50 per share, subject to
adjustment for stock splits, stock dividends, distributions, reorganizations,
reclassifications, consolidations and mergers. The Warrants may also be
exercised on a cashless or net issuance basis if after August 15, 2008 there is
no effective registration statement covering the resale of the shares of common
stock and shares underlying the warrants. The offering was exempt from
registration under Section 4(2) of the Securities Act and Rule 506 of Regulation
D as promulgated by the Securities and Exchange Commission (“SEC”).
  4
  As a
result of the Merger, all shares issued in the 2007 Private Placement were
exchanged for our shares of common stock and the Warrants became exercisable for
shares of our common stock.
 
 Our
Current Product and Product Candidate Pipeline
 
 Our
current portfolio of compounds and technologies under development or planned
development include:
 
 ·
                AdnaGen
      Oncology Diagnostics;
 ·
                A
      Liposomal TS Inhibitor;
 ·
                Cordycepin;
 ·
                L-Nucleoside
      Conjugates; and
 ·
                Novel
      Tubulin Isotype-Specific
Anti-Mitotics.
 
 The
following table summarizes the status of our various pre-clinical and clinical
development programs underway, including both chemotherapeutic agents and
oncology diagnostic products:
  Program
                      
                      Indication
                      
                      Status
                      
                      Planned Activities
                      
                      Commercial RightsAdnaGen
      Diagnostic
                        Products
                      
                      Metastatic
      Solid Tumors; cancer stem cells
                      
                      Tests
                        Commercialized
      in
                        EU
      for Colon, Breast, Ovarian and Prostate Cancer
                      
                      Seeking
      Approval of Breast Test in the United States
                      
                      AdnaGenLiposomal
      TS Inhibitor
                        (OVI
      -237)
                      
                      Metastatic
      Solid Tumors
                      
                      Phase
      II Clinical Development
                      
                      Phase
      II Clinical Trial to be initiated in Second Half of 2010
                      
                      OncoVista-SubCordycepin
      (OVI-123)
                      
                      Refractory
      TdT Positive Leukemias
                      
                      In
      Phase I/II Clinical Development; Open IND; Orphan Drug Designation
      Received
                      
                      Phase
      I/II Trial initiated in Second Quarter of 2008
                      
                      OncoVista-SubL-Nucleoside
      Conjugates (OVI-117)
                      
                      Colon
      Cancer
                      
                      Pre-Clinical
                        Development;
      Initiated GLP animal safety studies
                      
                      Anticipated
      IND Filing in the Second Half of 2010 to Commence Phase I
      Trial
                      
                      OncoVista-SubTubulin
      Isotype-Specific
                        Anti-Mitotics
                      
                      Solid
      Tumors Expressing Specific Tubulin Isotypes
                      
                      Pre-Clinical
                        Development
                      
                      Design
      and Testing of Candidate Compounds
                      
                      OncoVista-Sub
 
 As a result of the unavailability of
sufficient capital resources and AdnaGen’s cash needs, we were forced to scale
back our research and development operations during the previous twelve months.
See Note 3 of the consolidated financial statements.
  5
 
 The
following sections discuss various aspects of our portfolio of drug candidates
and their respective therapeutic characteristics in more detail.
 
 AdnaGen
Diagnostic Products
 
 We
believe one of our key differentiators is our ability to detect and recognize
the expression of tumor-associated biomarkers in patients with metastatic
cancer. In order to prescribe an optimal chemotherapy regimen, the oncologist
must obtain pertinent diagnostic and staging information for the patient’s
cancer. In addition to analyzing the cancer cells under a microscope to diagnose
the cancer, the pathologist also determines the stage of the cancer by assessing
the aggressiveness of the cancer cells (i.e., staging) and by using a variety of
clinical measures such as size, how deeply the tumor has invaded tissues at the
site of origin, and the extent of any invasion into surrounding organs, lymph
nodes or distant sites. Patient history, physical signs, symptoms, and
information obtained from existing tests are also evaluated and
considered.
 
 The
administration of cytotoxic drugs (by means of chemotherapy) after surgery
and/or radiation therapy aims to kill remaining cancer cells and to reduce
recurrence risk. Since many more lives are claimed by metastatic cancers than by
primary cancers, the early detection of metastatic tumor cells can mean the
difference between life and death in certain instances. However, patients
experience a wide range of side effects due to the long-term exposure to
chemotherapy, including infection, pain in the mouth and throat, weight loss,
fatigue, hair loss, cognitive impairment, cardiac tissue damage and infertility.
The overall benefits of chemotherapy vary significantly across cancer
populations and the benefits of treatment do not always justify the cost of the
therapy or offset the physical and mental burden patients endure. In addition to
the above considerations in assessing the benefits versus the costs of
treatment, the oncologist needs specific grading and staging information to
assess the likelihood of recurrence.
 
 Balancing
the need to kill as many cancer cells as possible against the patient’s
tolerance of toxicities presents a major challenge. While the oncologist might
need specific diagnostic and staging information to optimally treat the patient,
many of the tools available to the radiologist or pathologist are constrained by
their ability to determine that needed information. A test to detect metastatic
tumor cells as early as possible could dramatically increase the probability of
long-term survival. Unfortunately, because tumor pathology and staging are
heavily dependent on visual assessment and human interpretation, many patients
are misclassified as high risk when they are truly low risk for recurrence or
low risk when they are high risk for recurrence, resulting in over-treatment for
some and under-treatment for others.
 
 An
ability to detect meaningful serum tumor-associated biomarkers in a quantitative
manner would significantly improve the treatment process on two fronts. First,
early detection of circulating tumor cells would enable a diagnosis of relapse
and enable the earlier commencement of treatment resulting in favorable
outcomes. Second, the detection of certain tumor-associated biomarkers would
facilitate stratification of patient populations into groups most likely to
respond to a dosing regimen. For those patients who possess a genetic
predisposition that precludes them from responding to cytotoxic drugs, initial
determination would eliminate the unnecessary side effects associated with a
treatment that will have no benefit to the patient.
 
 In late
2005, we obtained the rights to our diagnostic technology through the
acquisition of a majority interest in AdnaGen AG of Germany. OncoVista’s
ownership position in AdnaGen AG is currently approximately 95%. AdnaGen’s
proprietary assay technology has demonstrated the sensitivity and selectivity
required to detect a low number of cancer cells circulating among healthy cells
(at levels of roughly one part per million) early in the metastatic process,
thereby improving the patient’s chances of survival. AdnaGen’s proprietary
“combination-of-combinations” approach led to the first commercial product that
provided a complete solution for the detection and analysis of circulating tumor
cells (CTCs) for clinical diagnosis. The technology also provides quantitative
parameters for the prognosis of disease progression.
  6
 
 AdnaGen
currently markets AdnaGen kits for detection of CTCs in metastatic
colon,  metastatic breast cancer, and ovarian patients in Europe.
AdnaGen’s platform is expandable to encode the markers for virtually all cancer
types. These assays have a specificity of greater than 95% at a sensitivity of
two tumor cells per 5ml of blood, enabling the reproducible detection of low
levels of circulating tumor cells in the blood.
 
 The
advantages of this diagnostic technology include:
 
 ·
                Novel
      and highly sensitive detection of circulating tumor
  cells;
 ·
                Early
      detection of metastatic cancer;
 ·
                Monitoring
      of treatment efficacy; and
 ·
                Selection
      and stratification of clinical trial participants and
      patients.
 
 AdnaGen’s
technology could also be utilized in clinical trials to aid in determining the
optimal patient population and in assessing the effectiveness of a drug in
development. By utilizing tumor-associated biomarkers to determine patient
exclusion criteria in a trial’s protocol and thereby target the patients
expected to demonstrate optimal response, the probability of attaining FDA
approval could be enhanced. In addition, the detection of tumor markers could be
used to gauge the effectiveness of a patient’s treatment. This ability to
measure the effects of a chemotherapy regimen could be extended to the
oncologist’s office.
 
 We have
exclusive, worldwide rights for the use of the AdnaGen technology in oncology
drug development. Business development efforts have been initiated with several
major pharmaceutical companies with the goal of establishing partnerships which
apply our CTC technology to external drug development programs.  In
September 2008, AdnaGen entered into an exclusive distribution agreement with
TATAA Molecular Diagnostics s.r.o. (“TATAA”) for certain European
countries. The term of the agreement continues through December 31, 2013 and
requires TATAA to purchase certain minimum quantities. Additionally, in January
2009, AdnaGen entered into a non-exclusive distribution agreement with Sysmex
Europe GmbH (“Sysmex”)
for certain European countries, which was consequently terminated in August 2009
for non-performance. In August 2009, AdnaGen entered into a non-exclusive
distribution agreement with Lab 21 (Cambridge) for Great Britain and Ireland. In
November 2009 AdnaGen entered in an exclusive distribution agreement with TATAA
for Sweden. In March 2010 AdnaGen entered in an exclusive six-month distribution
agreement with GenoID for Hungary.
 
 Biomarkers
Partnership
 
 In
September 2008, AdnaGen entered into an exclusive distribution and license
agreement with Biomarkers LLC (“Biomarkers”) granting
Biomarkers the exclusive right to commercialize the AdnaGen diagnostic kits in
North America. Biomarkers will have the capability to run AdnaGen assays in a
CLIA laboratory based in New York in order to support on-going and planned
clinical trials.
 
 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 for research and development purposes
only in South America and the Middle East. In January 2010, AdnaGen expanded the
agreement to include the territories of Asia and Africa. Pursuant to the terms
of these license agreements, AdnaGen also granted Biomarkers the right to
appoint sub-licensees at Biomarkers sole discretion. These agreements continue
through December 2010, unless terminated by either party under the terms of the
agreement.  Alexander L. Weis, Ph.D., one of our directors and our
CEO, President, CFO and Secretary, and a significant shareholder, is also a
beneficial owner of Biomarkers.
 
 Gen-Probe
Partnership
 
 In
December, 2004, AdnaGen licensed their technology to Gen-Probe, Inc. (“Gen-Probe”) with respect to
quantitative detection of specific cells.
  7
 
 Under the
terms of the agreement, Gen-Probe is provided with the right to gain exclusive
access to AdnaGen technology for molecular diagnostic tests for prostate and
bladder cancers. Gen-Probe paid AdnaGen a license fee in 2005. The agreement
also includes additional milestone payments based on certain regulatory and
commercial events. In addition, the agreement provides that Gen-Probe will pay
AdnaGen royalties on sales of any products developed using AdnaGen’s
technology.  In 2008, after lengthy discussions, Gen-Probe chose not
to exercise their option to pursue the research and development
partnership.  In 2009, Gen-Probe agreed to non-exclusive marketing
rights for prostate cancer kits in the U.S. and Europe.
 
 Liposomal
Thymidylate Synthase (TS) Inhibitor (OVI-237) (solid tumors)
 
 OVI-237
is our most advanced clinical stage drug. It was obtained in November 2007 as a
result of an exclusive worldwide licensing agreement with OSI Pharmaceuticals
(Melville, New York).  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.
 
 OVI-237
is a liposome encapsulated formulation of a potent thymidylate synthase
inhibitor (TSI) with activity at picomolar concentrations. Salient features of
OVI-237 include:
 
 ·
                Most
      potent TSI in its class;
 ·
                Liposome
      formulation enhances pharmacokinetics: long half life in
      plasma;
 ·
                Unique
      biodistribution profile; enhanced accumulation and tumor residence
      time;
 ·
                No
      requirement for polyglutamation for anti-tumor
  activity;
 ·
                Independent
      of dihydropyrimidine dehydrogenase (DPD)
  activity;
 ·
                No
      requirement for folate
supplementation;
 ·
                No
      requirement for leukovorin;
 ·
                Manageable
      toxicity profile as a single agent and in combination with oxaliplatin and
      cisplatin; and
 ·
                More
      convenient dosing schedule with a 30 minute IV infusion compared to 24-48
      hour 5-FU dosing schedules.
 
 Approximately
150 patients have been treated with the drug in various Phase I and Phase II
trials and the results can be summarized as follows:
 
 ·
                In
      a Phase I trial (OVI-237 as a single agent), 11 out of 31 patients
      experienced stable disease (SD);
 ·
                In
      a Phase I trial (OVI-237 in combination with cisplatin), 3 patients (2
      breast and 1 gastric cancer; out of 27 patients total) experienced a
      partial response (PR) and 9 patients had
SD;
 ·
                In
      a Phase I study (OVI-237 in combination with oxaliplatin), 14 patients
      with colorectal cancer were treated, 2 patients experienced a PR and 11
      had SD;
 ·
                In
      a Phase II study (OVI-237 as a single agent) in patients with locally
      advanced or metastatic adenocarcinoma of the stomach or gastroesophageal
      junction, 46 patients were treated and evaluable; there was 1 complete
      response (CR), 7 PRs and 21 SDs;
 ·
                In
      a randomized, open label, Phase II study of OVI-237 vs. 5-FU/LV as
      first-line treatment in patients with unrespectable, locally advanced or
      metastatic adenocarcinoma of the biliary tract, 11 patients were treated
      in each arm and no responses were seen in the OVI-237 arm;
    and
 ·
                In
      a Phase II trial (single agent) of OVI-237 in patients with locally
      advanced or metastatic squamous cell carcinoma of the head and neck who
      have failed first line therapy, 10 patients were treated and 4 SDs were
      seen.
 
 From the
responses seen in previous trials, we believe that the drug has intrinsic
anti-tumor activity and that the key to successful clinical development leading
to registration will depend upon increasing response rates among the clinical
trial participants. To this end, we plan to utilize the AdnaGen technology for
characterizing biomarkers in circulating tumor cells to identify patients most
likely to respond to therapy and to monitor the effectiveness of
treatment.
  8
 
 With
OVI-237, we have finalized the 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. Subject to availability of sufficient
working capital, we plan on initiating the trial in 2010.
 
 Cordycepin
(OVI-123) (TdT-Positive Refractory Leukemias)
 
 The
American Cancer Society estimated that 44,270 new leukemia cases would be
diagnosed in 2008 in the U.S. While 200,000 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., 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.
 
 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.
  9
 
 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 2008 were $3.7 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 upside potential.
 
 Clinical
Development
 
 Cordycepin
has been studied in a National Cancer Institute-sponsored Phase I clinical trial
for treating TdT-positive ALL leukemia patients. The therapy depends upon the
presence of TdT for our activity. 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, OncoVista intends 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 fourteen 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.
  10
  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 is 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 1st phase
of the study will be 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 2nd 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, the Company placed the clinical trial on administrative hold until such
time that additional capital can be raised.
 
 L-Nucleoside
Conjugate (OVI-117)
 
 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., a member 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 discernable 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.
  11
 
 For 2008,
in the United States, the American Cancer Society estimated there would be
148,810 new colorectal cancer cases of which colon cancer accounted for 108,070
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 5 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 are
estimated to be 49,960 in 2008 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
 
 We have
accumulated in vitro
and in vivo data
indicating that several of the L-nucleoside conjugates are effective against
various types of cancer. 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. 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. OVI-117 has completed the GLP animal drug safety studies that are
necessary prior to submission of an IND. We have begun to compile the IND for
submission to the FDA, which is a key step to conducting human clinical trials.
Subject to availability of sufficient working capital, we plan to submit the
completed IND to the FDA for review during 2010.
 
 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. Some of the most commercially successful
anti-cancer drugs (the taxanes and Vinca alkaloids, for example) are members of
this class of compounds.
 
 One of
our goals was to use rational drug design to create better drugs than the
present ones. Using a proprietary database of 500 different tubulin structures,
we were identifying, synthesizing and screening newly created drugs designed to
be highly specific for isotypes that are prevalent in cancers and rare in normal
cells. The database contains proprietary information regarding tubulin
structures in human and other eukaryotic cells (i.e., cells with nuclei and
organelles) that we believe were previously unknown to medical science. This
combination of information regarding chemical structure and oncological activity
opens the door to dramatic changes in drug design, through
supercomputer-assisted screening procedures. We believed that access to this
proprietary in silico
technology would have helped us to develop new drugs more quickly, thereby
improving time to market and saving millions of dollars in unfocused laboratory
screening and optimization.
  12
 
 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 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.
 
 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 twelve 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-proven 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, MD Anderson Cancer Center and the San Antonio Cancer Institute
(SACI), one of the leading cancer research institutes in the
nation.
  13
  Intellectual
Property
 
 As of
March 29, 2010, we held rights to 41 issued US and worldwide patents and more
than 50 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. Patent
applications related to our proprietary tubulin database and anti-mitotic agents
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.
  14
 
 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.
  15
 
 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.
  16
 
 Other
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.
 
 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., Eli Lilly & Co., and OSI
Pharmaceuticals, Inc., which are developing small molecule therapeutics as
treatments for cancer. Other, smaller companies in this field include: Avalon,
Kosan, Allos, EntreMed, Threshold Pharmaceuticals, Vion Pharmaceuticals, Cougar
Biotechnology, and Sunesis. In the area of genomic-based diagnostic testing, we
are aware of several other companies that are offering or developing such tests
including Abbott Diagnostic Laboratories, Aureon Laboratories, Celera
Diagnostics, LLC, Correlogic Systems, Genomic Health, Monogram Biosciences,
Myriad Genetics, Roche Diagnostics and Veridex LLC.
 
 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
 
 In August
2009, as a result of limited operating capital, with the exception of Dr. Weis,
our CEO, President, CFO, and  Secretary, we terminated the employment
of all of our employees.  We have been able to engage the services of
experts in clinical/regulatory, quality assurance, finance, and accounting as
needed on an independent contractor basis to continue to advance our drug
candidates through clinical studies. Our German subsidiary, AdnaGen AG, has
eight full-time employees.
 
 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.
  17
 
 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 research facilities
are located in the Texas Research Park in San Antonio, Texas.  We have
a total of 10,000 square feet of office and research space.  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 laboratory space for approximately $17,000 per month from Lipitek
International under a five-year Lease Agreement that expired in December
2009. We continue to occupy this space on a month-to-month basis and have
been accruing approximately $17,000 per month for payments for this space.
Lipitek is an affiliate of Alexander L. Weis, Ph.D., our Chief Executive
Officer, President, CFO, and Secretary.
 
 Our
AdnaGen facility in Langenhagen, Germany occupies approximately 7,500 square
feet of laboratory and office space and houses eight full-time
employees.  The German facility is leased on an annual basis expiring
in December 2010 for approximately $12,000 per month. We believe that our
existing facilities are suitable and adequate to meet our current business
requirements.
 
 ITEM
3 – LEGAL PROCEEDINGS
 
 Except as set forth below, we are not
involved in any legal proceedings nor are we aware of any threatened
litigation.
 
 On
December 17, 2007, an action was filed against OncoVista Sub, 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
have answered the complaint and asserted a counterclaim seeking compensation for
the expenses that we incurred during the time that we worked with Bridge
Ventures, Inc. The parties signed a settlement agreement, under which we paid
$1,000 and are required to issue 45,000 shares of our common
stock.
 
 On July
8, 2008, AdnaGen commenced a lawsuit against Innogenetics N.V. (“Innogenetics”)
in the District Court of Hannover alleging that Innogenetics, a distributor of
certain AdnaGen diagnostic kits in Europe, breached the exclusive distribution
agreement that AdnaGen entered into with them. AdnaGen claimed that Innogenetics
did not order the contractual minimum quantities of diagnostic kits required to
maintain exclusivity.  AdnaGen terminated the exclusivity and sought
damages of approximately $550,000 (€369,000).  Following a bench
trial, on February 8, 2009, the District Court ruled in favor of Innogenetics
ordering AdnaGen to pay Innogenetics’ approximately €12,000 ($16,000) in court
costs and attorney fees.
 
 ITEM
4 – REMOVED AND RESERVED
  18
 
 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.”  From January 14, 2008, our common
stock is quoted on the OTC Bulletin Board under the symbol “OVIT.” 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 Bulletin Board for the periods indicated are as
follows:
  Year Ended December 31,
2009
                        
                        High
                        
                        
                        LowFirst
      Quarter
                        
                        $
                        1.05
                        
                        
                        $
                        0.13Second
      Quarter
                        
                        
                        0.70
                        
                        
                        
                        0.10Third
      Quarter
                        
                        
                        0.35
                        
                        
                        
                        0.09Fourth
      Quarter
                        
                        
                        0.25
                        
                        
                        
                        0.06Year Ended December 31,
2008
                        
                        High
                        
                        
                        LowFirst
      Quarter
                        
                        $
                        3.50
                        
                        
                        $
                        1.00Second
      Quarter
                        
                        
                        3.48
                        
                        
                        
                        0.70Third
      Quarter
                        
                        
                        2.00
                        
                        
                        
                        0.75Fourth
      Quarter
                        
                        
                        1.70
                        
                        
                        
                        0.20
 
 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 OTCBB was $0.375 on March 29, 2010. We have
21,149,675 shares of common stock issued and outstanding. Based on information
available from our registrar and transfer agent, we estimate that we have
approximately 250 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, 2009 that 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, 2009.
 
 Repurchases
of Equity Securities by the Issuer and Affiliated Purchasers
 
 None.
 
 Use
of Proceeds from Sales of Registered Securities
 
 None.
  19
 
 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 of 1933 and Section 21E of the
Securities 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 commercializing diagnostic tests for metastatic
tumors, as well as developing targeted anticancer therapies by utilizing
tumor-associated biomarkers. We have developed diagnostic kits for breast,
colon, ovarian, and prostate cancers, and currently market diagnostic kits in
Europe for the detection of CTC’s in patients with breast, colon and
prostate cancer. Subject to availability of sufficient working capital and
AdnaGen generating positive cash flow to support their operations within the
next twelve months, we believe we are positioned to leverage our ownership
in our diagnostics company, AdnaGen, to realize revenues from sales of AdnaGen’s
CE-marked diagnostic kits in Europe, while utilizing the diagnostic technology
to guide and expedite our anticancer drug development efforts.
 
 Our
product pipeline is comprised of advanced (Phase II) and early (Phase I)
clinical-stage compounds, late preclinical drug candidates and early preclinical
leads. We are not committed to any single treatment modality or class of
compound, but believe that successful treatment of cancer requires a tailored
approach based upon individual patient disease characteristics.
 
 As a
result of the unavailability of sufficient capital resources and AdnaGen’s cash
needs, we were forced to scale back our research and development operations
during the previous twelve months. In August 2009, with the exception of our
Chief Executive Officer, we terminated the employment of all employees of our
U.S. subsidiary, OncoVista, Inc., and instead engage independent contractors on
an as-needed basis. Our German subsidiary, AdnaGen AG, has eight full-time
employees. We are currently attempting to raise additional funds to provide
working capital. We have received and continue to receive cash advances from
companies affiliated with our Chief Executive Officer to support continuing
operations.  See Note 3 of the consolidated financial
statements.
  20
 
 Development
Program
 
 Our most
advanced drug candidate is OVI-237, a liposomal formulation of a thymidylate
synthase (TS) inhibitor which has been administered in over 150 patients so far
in various Phase I and Phase II trials. The drug was in-licensed in
November 2007 and we finalized the 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. Subject to the
availability of sufficient working capital, we plan on initiating the trial in
2010.
 
 Our next
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 until such
time that additional capital can be raised.
 
 We
completed the GLP animal drug safety studies for our lead drug candidate from
the L-nucleoside conjugate program (OVI-117). We have begun to compile the
Investigational New Drug (IND) application for submission to the FDA, which is a
key step to conducting human clinical trials. Subject to availability of
sufficient working capital, we plan to submit the completed IND for review
during 2010.
 
 Research
and development expenditures for the above projects totaled approximately $1.5
million and $2.5 million for the years ended 2009 and 2008, respectively. We
expect we will incur additional expenses of between $6.0 million to $8.0 million
to complete the current phases of development for the projects described
above.
 
 We are
also marketing kits in Europe for the detection of CTCs in breast, colon,
ovarian, and prostate cancer patients. The kits are manufactured by AdnaGen AG
(which is 95% owned by us) and marketed through non-exclusive distribution
agreements in Europe. We have also developed research products for the detection
of steroid receptors (ER/PR) and cancer stem cells.  We have developed
the protocol for a pivotal trial in metastatic breast cancer to obtain approval
to market the kit in the U.S.  Research and development expenditures
totaled approximately $982,000 and $927,000 for the years ended 2009 and 2008,
respectively.  We expect we will incur additional expenses of between
$2.0 million and $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;
 ·
                develop
      biomarker panels that complement our therapeutic products, based upon
      knowledge of the drugs MoA; and
 ·
                develop
      successor products to our current
products.
  21
 
 We also
plan to pursue our interest in the application of nanotechnologies in cancer
therapy through strategic alliances, partnerships, and licensing
agreements.
 
 Other
Strategic Plans
 
 We plan
to continue to grow the market for AdnaGen diagnostic kits in the U.S. and
Europe to provide revenue and cash flow to help support our drug development
efforts. In September 2008, AdnaGen entered into an exclusive distribution
agreement with TATAA for certain European countries. The term of the agreement
continues through December 31, 2013 and requires TATAA to purchase certain
minimum quantities. Additionally, in January 2009, AdnaGen entered into a
non-exclusive distribution agreement with Sysmex Europe GmbH (“Sysmex”) for
certain European countries, and consequently terminated in August 2009 for
non-performance. In August 2009, AdnaGen entered into a non-exclusive
distribution agreement with Lab 21 (Cambridge) for Great Britain and Ireland. In
November 2009 AdnaGen entered in an exclusive distribution agreement with TATAA
for Sweden. In March 2010 AdnaGen entered in an exclusive six-month distribution
agreement with GenoID for Hungary.
 
 In
September 2008, AdnaGen entered into an exclusive distribution and license
agreement with Biomarkers granting it the exclusive right to commercialize the
AdnaGen diagnostic kits in North America. Biomarkers will have the capability to
run AdnaGen assays in a CLIA laboratory based in New York in order to support
on-going and planned clinical trials.
 
 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 for research and development purposes
only in South America and the Middle East. In January 2010, AdnaGen expanded the
agreement to include the territories of Asia and Africa. These agreements
continue through December 2010, unless terminated by either party under the
terms of the agreement.
 
 We will
continue to use our proprietary diagnostic technology to progress our
anti-cancer drug portfolio providing better clinical outcomes by identifying and
treating only those patients who express certain
biomarkers.  Additionally, we anticipate establishing partnerships
with other drug companies to expedite their drug development efforts utilizing
our biomarker analysis technology.
 
 In
addition to developing our existing anti-cancer drug portfolio, we plan to
obtain rights to additional drug candidates 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.
 
 Revenue Recognition. We
recognize revenue 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. Our customers have no right of return for products sold.
Revenues are considered earned upon shipment.
  22
  Share-Based Compensation.We
follow Accounting Standards Codification (“ASC”) 718 “Compensation – Stock Compensation”which requires the measurement and recognition of compensation expense
for all share-based payment awards made to employees and directors including
grants of employee stock options based on estimated fair values. We have used
the Black-Scholes option pricing model to estimate grant date fair value for all
option grants.  The assumptions we use in calculating the fair value
of share-based payment awards represent management’s best estimates, but these
estimates involve inherent uncertainties and the application of management
judgment. As such, as we use different assumptions based on a change in factors,
our stock-based compensation expense could be materially different in the
future.
 
 Preclinical Study and Clinical Trial
Accruals.Substantially
all of our preclinical studies and clinical trials are being performed by
third-party CROs and other outside vendors. For preclinical studies, we use the
percentage of work completed to date and contract milestones achieved to
determine the accruals recorded.  For clinical trial accruals, we use
the number of patients enrolled, period of patient enrollment and percentage of
work completed to date to estimate the accruals.  We monitor patient
enrollment levels and related activities to the extent possible through internal
reviews, correspondence and status meetings with CROs and review of contractual
terms. Our estimates are dependent on the timeliness and accuracy of data
provided by our CROs and other vendors. If we have incomplete or inaccurate
data, we may under-or overestimate activity levels associated with various
studies or clinical trials at a given point in time. In this event, we could
record adjustments to research and development expenses in future periods when
the actual activity levels become known. No material adjustments to preclinical
study and clinical trial expenses have been recognized to
date.
 
 Foreign Currency Translation.The financial position and results of operations of our foreign
subsidiary are measured using the local currency (Euros) as the functional
currency. Assets and liabilities of the subsidiary have been translated at
current exchange rates as of December 31, 2009 and 2008, and related revenue and
expenses have been translated at an average exchange rate for the years ended
December 31, 2009 and 2008.  All equity transactions have been
translated at their historical rates when the transaction occurred. The
aggregate effect of translation adjustments is included as a component of
accumulated other comprehensive loss and as a component of stockholders’
deficit. Transaction gains and losses related to operating assets and
liabilities are included in other income (expense).
 
 Results
of Operations
 
 The following table sets forth, for the
period indicated, certain line items from our consolidated statements of
operations, expressed as a percentage of revenue:
 
 Year ended December 31,2009
                              
                              
                              2008Total
      revenues
                              
                              
                              100.0
                              %
                              
                              
                              100.0
                              %Operating
      expenses:Research
      and development
                              
                              
                              223.5
                              
                              
                              
                              672.8General
      and administrative
                              
                              
                              364.3
                              
                              
                              
                              1,018.9Total
      operating expenses
                              
                              
                              587.8
                              
                              
                              
                              1,691.7Loss
      from operations
                              
                              
                              (487.8
                              )
                              
                              
                              (1,591.7
                              )Other
      income (expense):Interest
      income
                              
                              
                              –
                              
                              
                              
                              10.9Interest
      expense
                              
                              
                              (75.6
                              )
                              
                              
                              (48.0
                              )Gain
      on debt settlement
                              
                              
                              –
                              
                              
                              
                              150.8Other
                              
                              
                              71.4
                              
                              
                              
                              (8.5
                              )Net
      loss
                              
                              
                              (491.8
                              )
                              
                              
                              (1,486.5
                              )
  23
  Years
Ended December 31, 2009 and 2008
 
 Revenue. Revenues were
approximately $982,000 for the year ended December 31, 2009, an increase of
$479,000 or 95% as compared to approximately $503,000 in 2008.  Our
revenues reflect royalties earned from the sale of diagnostic kits, licensing
and research and development revenue.  Revenues are summarized in the
following table:
 
 2009
                      
                      
                      2008Licensing
                      
                      $
                      196,724
                      
                      
                      $
                      52,447Diagnostic
      kits
                      
                      
                      762,642
                      
                      
                      
                      361,707Research
      and development, grant and other revenues
                      
                      
                      22,682
                      
                      
                      
                      89,171Total
      revenues
                      
                      $
                      982,048
                      
                      
                      $
                      503,325
 
 The
increase in revenue for the year ended December 31, 2009 is primarily
attributable to an increase in sales from diagnostic kits as a result of our
focus on executing new distribution agreements in the European
territory.  Additionally, the increase is due to payments from license
agreements, partially offset by a decrease in research and development revenue.
In 2008, AdnaGen terminated an exclusive distribution agreement in Europe with
Innogenetics to sell certain diagnostic kits.  Subsequently, we have
executed several non-exclusive distribution agreements to sell kits in the
European territory.  During the year ended December 31, 2009, we
recorded $105,000 (€75,000) in revenue from the sale of diagnostic kits to
Biomarkers.
 
 Research and
development.  Research and development expenses decreased by
approximately $1.2 million, or 35%, to approximately $2.2 million for the year
ended December 31, 2009, as compared to $3.4 million for the year ended December
31, 2008.  The decrease in 2009 is primarily due to the scaling back
of our research and development operations as a result of the unavailability of
sufficient capital resources and AdnaGen’s cash needs. Additionally, the
decrease was attributable to an increase in 2008 in expenses for preclinical and
clinical studies including the commencement of a Phase I/II study for OVI-123
(cordycepin), as well as to an increase in salaries and related costs with the
hiring of additional personnel to support our expanding clinical development
efforts.
 
 Based on
the availability of sufficient working capital, we expect
research and development expenses to increase in 2010 primarily due to increases
in expenditures related to the initiation of our Phase II clinical trial for
OVI-237, reopening our patient enrollment in our Phase I/II for OVI-123 and the
preparation and submission of an IND to the FDA for OVI-117.
 
 General and
administrative.General and administrative expenses decreased
by approximately $1.6 million, or 30%, to approximately $3.6 million for the
year ended December 31, 2009, as compared to approximately $5.1 million for the
year ended December 31, 2008.  In 2009, the decrease was due primarily
to reduced costs for legal and professional services, partially offset by an
increase in stock compensation expense attributable to options granted during
the current year. Additionally, the decrease is a related to terminating the
employment of all OncoVista, Inc. employees in August 2009 as a result of the
unavailability of sufficient capital resources.  In 2008, the increase
was due to professional services related to becoming a publicly traded company
subsequent to the completion of the reverse acquisition and
recapitalization.
 
 Based on the availability
of sufficient working capital, we expect general and administrative
expense in 2010 to increase primarily due to an increase in salaries and
benefits due to the addition of headcount in 2010, and stock compensation expense
for any restricted stock, options, or warrants granted during the
year.
 
 Other Income (Expense). Other
income (expense) decreased 108% to expense of approximately $43,000 for the year
ended December 31, 2009 compared to income of approximately $529,000 for the
year ended December 31, 2008.  The decrease was the result of a gain
of approximately $759,000 on a debt settlement recorded during the second
quarter of 2008, partially offset by foreign currency transaction losses.
Additionally, we recorded interest expense in the current year for debt discount
related to a bridge round of debt financing that we completed in January 2009,
offset by a gain on derivative liability.
  24
 
 Net Income (Loss).As a
result of the foregoing, our net loss decreased by approximately $2.7 million to
approximately $4.8 million for the year ended December 31, 2009 from a net loss
of approximately $7.5 million for the year ended December 31, 2008.
 
 Going
Concern
 
 The
Report of the Independent Registered Public Accounting Firm includes an
explanatory paragraph that describes substantial doubt about our ability to
continue as a going concern.  Our consolidated financial statements
for the year ended December 31, 2009 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 have
a net loss of approximately $4.8 million and net cash used in operations of
approximately $911,000 for the year ended December 31, 2009, a working capital
deficit of approximately $11.4 million, an accumulated deficit of approximately
$28.4 million and a total stockholders’ deficit of approximately $11.2 million
at December 31, 2009.
 
 These
conditions raise doubt about our ability to continue as a going
concern.  The accompanying consolidated financial statements do not
include any adjustments that might result from the outcome of this
uncertainty.  We expect AdnaGen to be profitable in 2010, however, we
expect OncoVista to continue to incur losses from operations in
2010.
 
 Our
ability to continue as a going concern depends on the success of management’s
plans to bridge such cash shortfalls in 2010 including the
following:
 
 ·
                Aggressively
      seeking investment capital;
 ·
                Furthering
      the development of our product
pipeline;
 ·
                Advancing
      scientific progress in our research and development;
  and
 ·
                Continuing
      to monitor and implement cost control initiatives to conserve
      cash.
 
 Liquidity
and Capital Resources
 
 At
December 31, 2009, we had cash and cash equivalents of approximately $109,000
compared to $91,000 at December 31, 2008. 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 insufficient to meet our anticipated
operating cash needs in the next two to three months.  As such, we
have received and continue to receive cash advances in the amount of
approximately $260,000 from our CEO or companies affiliated with our CEO to
support continuing operations.  Our ability to continue as a going
concern is dependent our ability to further implement our strategic plan,
resolve our liquidity problems, principally by obtaining additional debt and/or
equity financing, and generate additional revenues from collaborative agreements
or sale of pharmaceutical products.  These factors raise doubt about
our ability to continue as a going concern.
 
 To date,
we have financed our operations principally through proceeds of offerings of
securities exempt from the registration requirements of the Securities Act. In
January 2009, we completed a bridge round of debt financing, whereby we 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. In January 2010, we
obtained consent from the holders of the Bridge Note financing to extend the
maturity date from January 15, 2010 until the earlier of July 15, 2010 or such
time that we obtain a “Qualified Financing”.  We revised the term
“Qualified Financing” from aggregate gross proceeds of which equal or exceed
$5.0 million to $3.0 million, and increased the interest rate from 10 percent to
12 percent.  Additionally, we extended the expiration date for the
warrants granted in connection with the financing to July 15, 2014, and the
exercise price was reduced to $0.10 per share. We have also loaned or advanced
to AdnaGen approximately €670,000 ($960,000) during the previous 24 months to
support their operations.
  25
 
 We also
believe the ability to execute our strategy relies largely on the continued
viability of AdnaGen. As such, we will likely continue to provide advances to
AdnaGen until they attain revenue levels adequate to support their continued
operations and, based on current projections, we expect that they will require
at least at least €200,000 to €300,000 ($275,000 to $400,000) over the course of
the next three to six months.
 
 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:
 
 ·
                capital
      needs of AdnaGen;
 ·
                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;
 ·
                our
      ability to establish additional collaborative relationships;
      and
 ·
                the
      effect of commercialization activities and facility expansions if and as
      required.
 
 Accordingly,
we will 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, 2009, net cash
used in operating activities was approximately $911,000  compared to
approximately $3.9 million for the year ended December 31, 2008. Cash used in
operating activities decreased $3.0 million, or 76%, primarily due to a decrease
in our net loss of approximately $2.7 million for the year ended December 31,
2009, to $4.8 million as compared to approximately $7.5 million for the year
ended December 31, 2008.  The decrease in cash used in operations was
also attributable to a decrease of $675,000 in stock-based compensation for both
employees and non-employees related to option grants, restricted stock grants,
and warrants issued to a consultant.  In addition, operating
activities were impacted by an adjustment in the current year for the derivative
liability related to the bridge round of debt financing, partially offset by
amortization of the debt discount related to the debt financing, compared to an
adjustment for the recognition of a gain recorded in prior year related to the
extinguishment of debt.
 
 Investing
Activities.For the year ended December 31, 2009, net cash used in
investing activities was approximately $2,000 as compared to $104,000 for the
year ended December 31, 2008. Cash used in investing activities decreased
$102,000, or 98%, primarily as a result of approximately $70,000 paid to
increase our ownership interest in our subsidiary to over 95% in June
2008.
 
 Financing
Activities.Cash provided by financing activities was
approximately $1.0 million for the year ended December 31, 2009 as compared to
cash used in financing activities of approximately $193,000 for the year ended
December 31, 2008.  The increase was primarily due to the net proceeds
of approximately $1.0 million  from the bridge round of debt financing
completed in the current year, as well as loans from our CEO and affiliated
companies.  In 2008, we repaid certain notes payable resulting in a
gain on debt extinguishment.
  26
  Our
outstanding material contractual obligations under lease and debt agreements as
of December 31, 2009 are as follows:
 
 Payments Due by PeriodWithin
                        OneYear
                      
                      
                      Two to
                        Three
                        Years
                      
                      
                      Four to
                        FiveYears
                      
                      
                      After Five
                        Years
                      
                      
                      TotalLoans
      and notes payable
                      
                      $
                      6,750,517
                      
                      
                      $
                      −
                      
                      
                      $
                      −
                      
                      
                      $
                      −
                      
                      
                      $
                      6,750,517Operating
      leases and other
                      
                      
                      413,226
                      
                      
                      
                      −
                      
                      
                      
                      −
                      
                      
                      
                      −
                      
                      
                      
                      413,226$
                      7,163,743
                      
                      
                      $
                      −
                      
                      
                      $
                      −
                      
                      
                      $
                      −
                      
                      
                      $
                      7,163,743
 
 In April 2009, we negotiated a
contingent debt restructuring with three of its major creditors which if
completed would result in exchanging approximately €4.3 million ($6.2 million)
of debt and related accrued interest as of September 30, 2009, for an equity
share of approximately 18% of AdnaGen.  In addition, as part of the
contingent restructuring, we agreed to forgive approximately $887,000 in
receivables, advances, loans and related interest as of December 31, 2009, due
from AdnaGen if completed.  The debt restructuring is contingent on us
raising a minimum of €2.0 million ($2.9 million) that was originally to be due
no later than July 30, 2009.  In July 2009, we received an extension
until December 2009 to raise the additional capital required under the debt
restructuring agreement, which date was subsequently extended to May 31, 2010.
Upon completion of restructuring, we will own approximately 78% of
AdnaGen.
 
 Loans and
notes payable in the principal amount of $5,640,962 have a contingent repayment
plan. Under the plan, principal and accrued interest is payable at the maturity
date only if AdnaGen is profitable and achieves certain positive shareholder’s
equity, except with respect to debt in the principal amount of $716,650, for
which only the principal is subject to a contingent repayment plan. The debt
holders have signed subordination letters related to the principal and interest
providing that if AdnaGen is unable to repay, it would not lead to insolvency
under applicable German law. If not repaid at maturity, the debt will continue
to be outstanding until such time that AdnaGen has sufficient profits,
liquidation surplus, or net assets to repay the outstanding principal, the debt
is renegotiated, or AdnaGen becomes insolvent. Further, debt holders in the
principal amount of $4,299,900 have the right to receive a share of AdnaGen
profits under certain circumstances.
 
 In
October 2003, a third party loaned us a total of €515,000 accruing interest at
7.75% and due in June 2008. In February 2008, we placed approximately $200,000
(€128,750) in a separate escrow account in connection with a proposed settlement
for the outstanding loan balance and accrued interest which totaled
approximately $988,000 (€615,500).  In April 2008, the third party
accepted the debt settlement agreement.  We recorded the transaction
in April 2008, which resulted in a gain on settlement of debt in the amount of
$758,801 (€486,760).
 
 Recent
Accounting Pronouncements
 
 In
June 2009, FASB approved the FASB Accounting Standards Codification (“the
Codification”) as the single source of authoritative nongovernmental GAAP. All
existing accounting standard documents, such as FASB, American Institute of
Certified Public Accountants, Emerging Issues Task Force and other related
literature, excluding guidance from the Securities and Exchange Commission
(“SEC”), have been superseded by the Codification. All other non-grandfathered,
non-SEC accounting literature not included in the Codification has become
nonauthoritative. The Codification did not change GAAP, but instead introduced a
new structure that combines all authoritative standards into a comprehensive,
topically organized online database. The Codification is effective for interim
or annual periods ending after September 15, 2009, and impacts our
consolidated financial statements as all future references to authoritative
accounting literature will be referenced in accordance with the Codification.
There have been no changes to the content of our consolidated financial
statements or disclosures as a result of implementing the Codification during
the quarter ended September 30, 2009. As a result of our implementation of
the Codification during the quarter ended September 30, 2009, previous
references to new accounting standards and literature are no longer
applicable.
 
 27
  In
December 2007, the FASB issued ASC 805 “Business Combinations”
(formerly - SFAS No. 141 (R)), which became effective for fiscal periods
beginning after December 15, 2008. The standard changes the accounting for
business combinations, including the measurement of acquirer shares issued in
consideration for a business combination, the recognition of contingent
consideration, the accounting for pre-acquisition gain and loss contingencies,
the recognition of capitalized in-process research and development, the
accounting for acquisition-related restructuring cost accruals, the treatment of
acquisition related transaction costs, and the recognition of changes in the
acquirer’s income tax valuation allowance. The standard became effective for us
on January 1, 2009. We will apply the provisions of ASC 805 to any future
business combinations.
 
 On
January 1, 2009, we adopted ASC 810 “Consolidation” (formerly -
SFAS No. 160). The standard changes the accounting for non-controlling
(minority) interests in consolidated financial statements. In accordance with
the standard, we changed the reporting of non-controlling interest on the face
of the consolidated financial statements to separately classify non-controlling
interests within the equity section of the consolidated balance sheets and to
separately report the amounts attributable to controlling and non-controlling
interests in the consolidated statements of operations, and comprehensive loss
for all periods presented.  The standard also requires that the
noncontrolling interest continue to be attributed its share of losses even if
that attribution results in a deficit noncontrolling interest
balance.  Prior to adoption, we  had charged such excess
losses to the majority interest.
 
 On
January 1, 2009, we adopted ASC 815 “Derivatives and Hedging”
(formerly Emerging Issues Task Force “EITF” Issue No. 07-5), which requires the
application of a two-step approach in evaluating whether an equity-linked
financial instrument (or embedded feature) is indexed to our own stock,
including evaluation of the instrument’s contingent exercise and settlement
provisions. See Note 6 for the impact of the adoption of ASC 815 on our
consolidated results of operations, cash flows and financial
position.
 
 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, 2009, the end of the
period covered by this report, we conducted, under the supervision and with the
participation of our management, including its 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
Securities 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, 2009.
  28
  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, 2009. 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, 2009.
 
 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, 2009:
 
 ·
                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 Commission’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.
  29
  This Report does not include an
attestation report of our registered public accounting firm regarding internal
control over financial reporting. Management’s report was not subject to
attestation by our registered public accounting firm pursuant to temporary rules
of the SEC that permit us to provide only management’s report in this Annual
Report.
 
 Remediation
of Material Weaknesses
 
 During 2008, in order to materially
improve our internal control over financial reporting, we utilized external
consultants to assist in the implementation and design of policies and
procedures to  meet the required documentation and effectiveness
requirements under the SOX and help mitigate the lack of segregation of duties
within the financial reporting process.
 
 Even with this change, 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, or by our auditors following the implementation
of the external auditor requirement for their independent assessment of our
controls, 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
2009 that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
 
 ITEM
9A(T) – CONTROLS AND PROCEDURES
 
 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
9B – OTHER INFORMATION
 
 On August
31, 2009, our Board of Directors decreased its size from six to five with the
termination of Dr. Corey Levenson as an officer, effective
immediately.
 
 On July
31, 2009, J. Michael Edwards resigned as our Chief Financial Officer of the
Company, with such resignation becoming effective on August 14,
2009.  Alexander L. Weis, Ph.D. our Chief Executive Officer,
President, and Secretary, filled the vacancy of Chief Financial Officer created
by the resignation of Mr. Edwards.
  30
  PART
III
 
 ITEM
10 – DIRECTORS, EXECUTIVE OFFICERS  AND CORPORATE
GOVERNANCE
 
 Directors
and Executive Officers
 
 Our
directors and executive officers are as follows:
 
 Name
                              
                              Age
                              
                              PositionAlexander
      L. Weis, Ph.D.
                              
                              60
                              
                              Director,
      Chief Executive Officer, President, Chief Financial Officer and
      SecretaryAlexander
      Ruckdaeschel
                              
                              37
                              
                              Director,
      Audit Committee Member, Compensation Committee MemberJames
      Wemett
                              
                              61
                              
                              DirectorWilliam
      J. Brock
                              
                              60
                              
                              Director,
      Audit Committee Chairman, Compensation Committee
  ChairmanDr.
      Paul Mieyal
                              
                              40
                              
                              Director
 
 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.
 
 James Wemett.Mr. Wemett has
served on our board since December 2007 and the board of OncoVista-Sub
since May 2007. From May 2003 to June 2007, Mr. Wemett was an independent
consultant to Victorian Times, Inc., and from March 2004 to March 2007, was a
consultant to ROC Central, Inc., both of which are privately owned firms. In
1975 Mr. Wemett founded ROC Communications, a retail distributor of electronics
products which was sold in 2001. Mr. Wemett co-founded Technology Innovations
LLC in 1999, a private company and one of our stockholders, and serves on
Technology Innovations’ board. Mr. Wemett also serves on the board of directors
of Natural Nano, Inc (OTCBB:
NNAN). Mr. Wemett has also been an active fundraiser for Camp Good
Days, a non-profit summer camp for children with cancer.
  31
 
 William J. Brock.Mr. Brock
has served on our board since December 2007, the board of OncoVista-Sub since
September 2007, and Chairman of our Audit Committee and Compensation Committee
since March 28, 2008.  Since August 2007, Mr. Brock has 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 from Harvard College, and
an M.B.A. from the Harvard Graduate School of Business
Administration.
 
 Paul Mieyal, Ph.D. Dr. Mieyal
has served on our board since March 2009.  Since 2006, Dr. Mieyal has
served as a Vice President of Wexford Capital LLC, an SEC registered investment
advisor with over $5 billion under management located in Greenwich, CT. From
2000 to 2006, Dr. Mieyal was Vice President in charge of healthcare investments
for Wechsler & Co., Inc., a private investment firm and registered
broker-dealer. Dr. Mieyal also serves as a Director of Nephros, Inc. and Nile
Therapeutics, Inc. Dr. Mieyal received his Ph.D. in Pharmacology from New York
Medical College, a bachelor’s degree in chemistry and psychology from Case
Western Reserve University, and is a Chartered Financial Analyst.
 
 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, 2009, our Board of Directors held five meetings
and took actions by written consent on three occasions.
 
 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;
  32
 
 ·
                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.
  33
 
 Esteban
Cvitkovic, M.D. Dr. Cvitkovic is a board-certified, medical oncologist who
practices medicine in Paris, France.  Dr. Cvitkovic has more than
thirty 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).
 
 Allan M.
Green, M.D., Ph.D., J.D. Dr. Green is a senior advisor to industry in matters of
drug development and FDA Regulation.  He has authored over 50 articles
and abstracts and holds 6 patents.  Dr. Green is Adjunct Professor of
Law at the Boston College Law School, has 20-plus years of oncology experience,
holds a Ph.D. in Biochemistry and Metabolism from MIT, was formerly Medical
Director of New England Nuclear/Dupont Medical Products and, subsequently, was
founding CEO of Theseus Medical Imaging, Inc.  He is Board Certified
in Internal Medicine and Nuclear Medicine, and is an attorney in practice in
Cambridge, MA.
 
 Randall
K. Johnson, Ph.D.  Dr. Johnson’s experience includes work on novel
antimetabolites, DNA damaging agents,  mitotic spindle
poisons  and targeted therapeutics.  He has authored over
200 scientific papers and holds 14 patents.  His 30-plus years of
research experience have been focused on  discovery and development of
cancer therapeutics.  His work has encompassed both antineoplastic
targets and research to discover small molecule mimetics of hematopoietic growth
factors.  He has held senior positions in industry (GlaxoSmithKline)
as well as the U.S. National Cancer Institute.  He has been an
independent consultant for the past 7 years, during which time he has advised
more than 100 clients in the venture capital, biotech and pharmaceutical
industries.
 
 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 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 Securities Exchange Act of 1934 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.
  34
  To the
best of our knowledge, the following delinquencies have occurred:
 
 Name and Affiliation
                                                    
                                                    No. of Late
                                                      Reports
                                                    
                                                    
                                                    No. of Transactions
                                                      Not Filed on Timely
                                                      Basis
                                                    
                                                    Known Failures to
                                                      FileAlexander
      Ruckdaeschel, Director
                                                    
                                                    –
                                                    
                                                    
                                                    1
                                                    
                                                    Form
      4James
      Wemett, Director
                                                    
                                                    –
                                                    
                                                    
                                                    1
                                                    
                                                    Form
      4Paul
      Mieyal, Ph.D., Director
                                                    
                                                    –
                                                    
                                                    
                                                    1
                                                    
                                                    Form
      4Wexford
      Spectrum Trading Ltd.
                                                    
                                                    –
                                                    
                                                    
                                                    1
                                                    
                                                    Form
      4
 ITEM
11 – EXECUTIVE COMPENSATION
 
 Executive
Compensation
 
 The
following table sets forth the compensation earned during the years ended
December 31, 2009 and 2008 by our former Chief Executive Officer and Chief
Financial Officer, our current Chief Executive Officer, and Chief Technical
Officer and our two most highly compensated non-executive officers. 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
                    
                    2009
                    
                    
                    299,746
                    (3)
                    
                    
                    —
                    
                    
                    
                    875,000
                    
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    31,120
                    (5)
                    
                    
                    1,205,8662008
                    
                    
                    310,000
                    
                    
                    
                    —
                    
                    
                    
                    875,000
                    
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    17,496
                    (5)
                    
                    
                    1,202,496Corey
      Levenson, Ph.D.Chief
      Technical Officer
                    
                    2009
                    
                    
                    90,750
                    (4)
                    
                    
                    —
                    
                    
                    
                    291,667
                    
                    
                    
                    6,510
                    
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    4,500
                    (5)
                    
                    
                    392,0772008
                    
                    
                    198,000
                    
                    
                    
                    —
                    
                    
                    
                    291,667
                    
                    
                    
                    156,244
                    
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    8,555
                    (5)
                    
                    
                    654,466J.
      Michael EdwardsChief
      Financial Officer
                    
                    2009
                    
                    
                    64,167
                    (6)
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    340,003
                    
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    11,396
                    (5)
                    
                    
                    415,5662008
                    
                    
                    140,000
                    
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    54,537
                    
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    17,004
                    
                    
                    
                    211,541Tamas
      Bakos, Ph.D.,
                      Director
      of PreclinicalResearch
                    
                    2009
                    
                    
                    40,425
                    (4)
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    20,829
                    
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    6,965
                    (5)
                    
                    
                    68,2192008
                    
                    
                    88,200
                    
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    62,488
                    
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    10,368
                    (5)
                    
                    
                    161,056Michael
      F. Moloney
                      Director
      of Program Management
                    
                    2009
                    
                    
                    45,833
                    (4)
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    341,426
                    
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    11,396
                    (5)
                    
                    
                    398,6552008
                    
                    
                    93,205
                    (7)
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    48,824
                    
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    17,004
                    
                    
                    
                    159,033
 
 (1)
                The
      information is provided for each fiscal year which begins on January 1 and
      ends on December 31. The information provided for Corey Levenson, Tamas
      Bakos and Michael F. Moloney during 2009 relates to compensation from
      OncoVista Innovative Therapies, Inc. prior to their termination on August
      31, 2009.
  35
 
 (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, 2009 and 2008 are
      set forth in Note 10 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)
                Amount
      includes salary of $63,256 accrued through May 15, 2009 and unpaid As of
      March 29, 2010.
 (4)
                Amount
      represents salary of $40,541 accrued for Dr. Levenson, $17,357 accrued for
      Dr. Bakos and $19,679 accrued for Mr. Moloney but unpaid through August
      31, 2009, the employment termination
date.
 (5)
                See
      “All Other Compensation” table
below.
 (6)
                On
      August 14, 2009, Mr. Edwards resigned as our Chief Financial Officer,
      amount includes salary of $27,097 accrued but unpaid through August 14,
      2009.
 (7)
                Mr.
      Moloney is entitled to a salary of $100,000 per annum. The amount
      referenced reflects the amount earned by Mr. Moloney during fiscal year
      2008 since his commencement of employment on January 28,
    2008.
 
 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
                                              
                                              2009
                                              
                                              
                                              4,500
                                              
                                              
                                              
                                              3,682
                                              
                                              
                                              
                                              22,938
                                              
                                              
                                              
                                              31,120Financial
      Officer, and Secretary
                                              
                                              2008
                                              
                                              
                                              12,000
                                              
                                              
                                              
                                              5,496
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              17,496Corey
      Levenson, Ph.D.
                                              
                                              2009
                                              
                                              
                                              3,150
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              3,150Chief
      Technical Officer
                                              
                                              2008
                                              
                                              
                                              8,400
                                              
                                              
                                              
                                              155
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              8,555J.
      Michael Edwards
                                              
                                              2009
                                              
                                              
                                              —
                                              
                                              
                                              
                                              11,396
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              11,396Chief
      Financial Officer
                                              
                                              2008
                                              
                                              
                                              —
                                              
                                              
                                              
                                              17,004
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              17,004Tamas
      Bakos, Ph.D.
                                              
                                              2009
                                              
                                              
                                              —
                                              
                                              
                                              
                                              6,965
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              6,965Director
      of Preclinical Research
                                              
                                              2008
                                              
                                              
                                              —
                                              
                                              
                                              
                                              10,368
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              10,368Michael
      F. Moloney
                                              
                                              2009
                                              
                                              
                                              —
                                              
                                              
                                              
                                              11,396
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              11,396Director
      of Program Management
                                              
                                              2008
                                              
                                              
                                              —
                                              
                                              
                                              
                                              17,004
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              17,004
 
 The
following table sets forth information concerning stock options and stock awards
held by the named executive officers as of December 31, 2009.
  Option Awards
                                          
                                          
                                          Stock AwardsName
                                          
                                          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
                                            HeldThat
                                            HaveNot
                                            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
                                            OtherRights
                                            That
                                            Have Not
                                            Vested($)Alexander
      L. Weis, Ph.D. Director, CEO, President, CFOand
      Secretary
                                          
                                          
                                          —
                                          
                                          
                                          
                                          —
                                          
                                          
                                          
                                          —
                                          
                                          
                                          
                                          
                                          —
                                          
                                          
                                          
                                          500,000
                                          (1)
                                          
                                          
                                          80,000
                                          (2)
                                          
                                          
                                          —
                                          
                                          
                                          
                                          —
  
 (1)
                These
      options vest January 1, 2011.
 (2)
                Market
      value is based on the closing sales price of our common stock of $0.16 per
      share on December 31, 2009.
  36
 
 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 equal 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.
 
 Since
February 2009, Dr. Weis has been serving as AdnaGen’s Chief Executive Officer.
In such capacity he receives an additional salary of €10,000 ($13,500) per
month, and a daily per diem (€94). As a result of the extraordinary efforts
being expended by Dr. Weis in taking on this additional role and to further
incentivize him, on January 6, 2009, the Compensation Committee resolved to
compensate Dr. Weis as follows: (i) if AdnaGen’s indebtedness is restructured
into equity or long-term indebtedness, then we would pay Dr. Weis $50,000 for
restructuring into equity of AdnaGen or $100,000 for restructuring not involving
equity of AdnaGen in addition to the issuance of shares of capital stock of
AdnaGen representing 5% of the outstanding capital stock of AdnaGen as of the
restructuring, giving effect to such issuance (“Restructuring Shares”), (ii)
upon AdnaGen achieving revenues of $3,000,000 in calendar year 2009 and AdnaGen
achieving positive operational cash flow for the year 2009, we would pay Dr.
Weis a cash payment of $225,000 and 250,000 shares of our common stock (the
“Sales Milestone
Shares”), (iii) upon AdnaGen consummating additional financing through
entities introduced by Dr. Weis, we would pay Dr. Weis cash equal to 2% if in
the form of indebtedness or 4% if in a form other than indebtedness of the gross
proceeds of such additional financing plus shares of capital stock of AdnaGen
having an equal value to such cash bonus based on the valuation in such
financing (the “Financing
Shares”), (iv) upon AdnaGen consummating strategic transactions,
including mergers and acquisitions, through entities introduced by Dr. Weis, we
would pay Dr. Weis cash in an amount equal to 8% of the gross consideration of
such transactions if equal to or less than $300,000 or 5% if greater than
$300,000 or 3% if greater than $1,000,000, and (v) the Restructuring Shares,
Sales Milestone Shares and Financing Shares (collectively, the “Shares”) vest in 12 monthly
installments provided that if the employment of Dr. Weis by us terminates
without cause prior to the vesting in full of the Shares, any unvested Shares
shall be forfeited and if there is a change of control event, then the Shares
shall immediately vest in full.
 
 To assist
us in conserving our cash, since 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, through May 15, 2009, which are included
in accrued liabilities on our consolidated balance sheet.
 
 Stock
Option Plans
 
 We have
adopted the following stock option plans:
  37
  2007
Stock Option Plan
 
 In June
2007, OncoVista-Sub’s Board of Directors adopted the 2007 Stock Option Plan (the
“2007 Plan”) subject to
stockholder approval. The Plan authorizes the grant of ISOs, Non-Qualified Stock
Options, and stock purchase rights (“Rights”) 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 February 28,
2010, 150,000 non-qualified options under the 2007 Plan were
issued.
 
 The 2007
Plan permits us to grant (i) both Incentive Stock Options and Non-Qualified
Options and (ii) Stock Purchase Rights (“Rights”). 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 persons”
defined under Rule 16b-2(c)(ii) under the Securities Exchange Act, as amended
(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 5 years from the date of
purchase.
 
 Option
and Rights holders will 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.
  38
 
 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 Securities 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 Securities
Exchange Act. As of February 28, 2010, 20,000 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. At this time, we do
not have any standing committees and the Board of Directors will administer the
Directors Plan in lieu of a Compensation Committee.
 
 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”)
subject to stockholder approval. 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 February 28, 2010, 480,000
non-qualified options were issued under the 2004 Plan.
 
 The 2004
Plan permits us to grant both incentive stock options within the meaning of
Section 422 of the Internal Revenue Code of 1986, as amended (“Incentive Stock Options”or
“ISOs”)and 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 intend to 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 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.
  39
 
 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.
  40
  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
Securities 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
September 11, 2007, independent members of our Board of Directors are entitled
to $10,000 as annual 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,
2009.
  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(1)
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —Corey Levenson(1)
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —Alexander
      Ruckdaeschel
                      
                      
                      10,000
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      10,000James
      Wemett
                      
                      
                      10,000
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      10,000William
      Brock
                      
                      
                      10,000
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      10,000Paul
      Mieyal
                      
                      
                      10,000
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      —
                      
                      
                      
                      10,000
 
 (1)
              Please
      refer to the summary compensation table for executive compensation with
      respect to the named individual.
  41
  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
21,149,675 issued shares of common stock.
 
 Name and Address of Beneficial Owners1
                                                  
                                                  Amount and Nature of
                                                    Beneficial Ownership
                                                  
                                                  
                                                  Percent
                                                    Ownership2Alexander
      L. Weis, Ph.D., Director, Chief Executive Officer, President, Chief
      Financial Officer and Secretary
                                                  
                                                  
                                                  5,150,000
                                                  3
                                                  
                                                  
                                                  24.4
                                                  %Alexander
      Ruckdaeschel, Director
                                                  
                                                  
                                                  70,000
                                                  4
                                                  
                                                  
                                                  *James
      Wemett, Director
                                                  
                                                  
                                                  2,095,475
                                                  5
                                                  
                                                  
                                                  9.9
                                                  %William
      J. Brock, Director
                                                  
                                                  
                                                  30,000
                                                  6
                                                  
                                                  
                                                  *Paul
      Mieyal, Ph.D., Director
                                                  
                                                  
                                                  2,445,355
                                                  7
                                                  
                                                  
                                                  11.2
                                                  %All
      executive officers and directors as a group (five persons)
                                                  
                                                  
                                                  9,790,830
                                                  
                                                  
                                                  
                                                  44.5
                                                  %Technology
      Innovations8
                                                    15
      Schoen Place
                                                    Pittsford,
      NY 14534
                                                  
                                                  
                                                  1,050,475
                                                  
                                                  
                                                  
                                                  5.0
                                                  %Wexford
      Spectrum Trading Ltd.
                                                    411
      West Putnam Avenue
                                                    Greenwich,
      CT 06830
                                                  
                                                  
                                                  2,442,855
                                                  9
                                                  
                                                  
                                                  11.6
                                                  %CAMOFI
      Master LDC
                                                    CAMHZN
      Master LDC
                                                    c/o
      Centrecourt Asset Management LLC
                                                    350
      Madison Avenue, 8th Floor
                                                    New
      York, New York 10017
                                                  
                                                  
                                                  1,729,902
                                                  10
                                                  
                                                  
                                                  8.4
                                                  %
  *  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
500,000 shares held in the name of Lipitek International, Inc.; 1,000,000 shares
of restricted common stock vested on January 1, 2010; and 500,000 shares of
restricted common stock, which shall vest on January 1, 2011.
 4  Consists
of 50,000 options to purchase shares of common stock at $0.10 per share until
January 13, 2015, and 20,000 options to purchase shares of common stock at $1.75
per share until September 8, 2017.
 5  Includes
1,050,475 shares held in the name of Technology Innovations; 1,025,000 shares
held in the name of Biomed Solutions, LLC; and 20,000 options to purchase shares
of common stock at $1.75 per share until September 8, 2017.
 6  Consists
of 30,000 options to purchase shares of common stock at $1.75 per share until
August 28, 2017.
 7  Includes
1,714,284 shares held in the name of Wexford Trading Ltd.; 428,571 warrants to
purchase common stock at $2.50 per share until August 15, 2012; 300,000 warrants
to purchase common stock at $0.10 per share until July 15, 2014 and 2,500
options to purchase shares of common stock at $0.65 per share until March 28,
2019.
 8  Technology
Innovations, LLC is the beneficial owner of a majority of the outstanding
membership interests of Biomed Solutions, LLC which owns 1,025,000 shares; it
disclaims ownership of these shares except to the extent of its pecuniary
interest in Biomed Solutions, LLC. James Wemett and Michael Weiner, a former
director of OncoVista-Sub, are deemed to have voting and investment control over
these shares; they disclaim ownership of these shares except to the extent of
their pecuniary interest in Biomed Solutions LLC and Technology Innovations
LLC.
 9  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 300,000 warrants to purchase shares of
common stock at $0.10 per share until July 15, 2014.
 10  Includes
960,000 shares of common stock; 257,143 warrants to purchase shares of common
stock at $0.001 per share until July 1, 2012 and 203,000 warrants to purchase
shares of common stock at $2.50 per share until August 15, 2012 held by CAMOFI
Master LDC; 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.
  42
 
 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, 2009:
 
 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
                                  
                                  
                                  2,126,000
                                  (1)
                                  
                                  $
                                  2.17
                                  
                                  
                                  
                                  2,916,800
                                  (2)
 
 (1)
              Represents
      480,000 shares granted from the 2004 Plan, 150,000 shares granted from the
      2007 Plan,  20,000 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, 2,266,800
      shares available for issuance under the 2007 Plan and 480,000 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.
  43
 
 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 a member 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.
 
 We
entered into a Registration Rights Agreement with the holders of the Warrants
covering the shares of our common stock issuable upon exercise of the Warrants.
The Registration Rights Agreement requires us  to file a registration
statement with the SEC within 45 days of the final closing of the first
Qualified Financing (the “Filing Date”). We are
required to use our best efforts to cause the registration statement to become
effective as promptly as practicable after the filing thereof.  If we
do not file the registration statement with the SEC on or prior to the 45th day
following the Filing Date, or if the registration statement has not been
declared effective within 120 days following the Filing Date, we agreed to pay
to the holders liquidated damages in the amount of 0.5% of the offering price of
the Bridge Notes and the Warrants purchased thereby for each 30 days thereafter
until such registration statement shall be filed or effective, as applicable,
with the foregoing capped at 10%.
 
 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 (See Note 6) 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.
  44
  Biomarkers
Distribution Agreement
 
 In
September 2008, AdnaGen entered into an exclusive distribution and license
agreement with Biomarkers LLC, giving Biomarkers the exclusive right to
commercialize the AdnaGen kits in North America. Biomarkers will have the
capability to run AdnaGen assays in a CLIA laboratory based in New York in order
to support on-going and planned clinical trials.
 
 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 continue through December 2010 unless terminated by either
party under the terms of the agreement.  Alexander L. Weis, Ph.D., one
of our directors and our Chief Executive Officer, President, Secretary, Chief
Financial Officer, and a significant shareholder, is also a beneficial owner of
Biomarkers.
 
 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 February 28, 2009,
we have paid Lipitek International a total of $500,000. 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 a member 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 five-year Lease Agreement with Lipitek International which expired December
2009, we lease laboratory space for approximately $17,000 per month. We continue
to occupy this space on a month-to-month basis and have been accruing
approximately $17,000 per month for payments for this space.
 
 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, 2009 and December 31, 2008.  GHP performed the
services listed below and was paid the fees listed below for the years ended
December 31, 2009 and December 31, 2008.
 
 Audit
Fees
 
 GHP was
paid aggregate audit fees of approximately $59,000 and $81,000 for the years
ended December 31, 2009 and December 31, 2008, 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 2009 and
2008.
  45
  Audit
Related Fees
 
 GHP was
paid additional fees of approximately $0 and $1,000 for the years ended December
31, 2009 and December 31, 2008, 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 additional fees of approximately $660 and $8,000 for the years ended
December 31, 2009 and December 31, 2008, 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, 2009 and December 31, 2008.
 
 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.
  46
  PART
IV
 
 ITEM
15 – EXHIBITS, FINANCIAL STATEMENT SCHEDULES
 
 Exhibits:
 
 Exhibit No.
                                                  
                                                  Description2.1
                                                  
                                                  Agreement
      and Plan of Merger, dated as of October 26, 2007, by and between Aviation
      Upgrade Technologies, Inc., OncoVista, Inc. and OncoVista Acquisition
      Corp.(1)2.2
                                                  
                                                  Copy
      of Certificate of Merger dated November 13, 2007. (2)3.1
                                                  
                                                  Certified
      Copy of the Articles of Incorporation of the Registrant.(2)3.2
                                                  
                                                  Bylaws.(3)3.3
                                                  
                                                  Certificate
      of Change of the Registrant.(4)3.4
                                                  
                                                  Certificate
      of Amendment to Articles of Incorporation of the Registrant.(11)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
                                                  
                                                  Executive
      Employment Agreement dated as of January 15, 2005, by and between
      OncoVista, Inc. and Corey Levenson, Ph.D.(2)10.3
                                                  
                                                  Employment
      Agreement dated as of August 22, 2005, by and between OncoVista, Inc. and
      Robert Patterson.(2)10.4
                                                  
                                                  Employment
      Agreement dated as of January 1, 2005, by and between OncoVista, Inc. and
      Tamas Bakos, Ph.D.(2)10.5
                                                  
                                                  Employment
      Agreement dated as of July 3, 2006, by and between OncoVista, Inc. and
      Jeanne Kay Noel.(6)10.6
                                                  
                                                  Lease
      Agreement between OncoVista, Inc. and Lipitek International, Inc. dated
      January 1, 2005.(2)10.7
                                                  
                                                  Investment
      and Stock Purchase Agreement dated September 7, 2005 between AdnaGen AG,
      BioMed Venture GmbH, individual stockholders of AdnaGen AG and OncoVista,
      Inc.(
      8)10.8
                                                  
                                                  Stock
      Purchase Option Agreement dated as of September 7, 2005 between AdnaGen
      AG, BioMed Venture GmbH, individual stockholders of AdnaGen AG and
      OncoVista, Inc.(
      8)10.9
                                                  
                                                  Agreement
      and Plan of Merger between Aengus Pharmaceuticals, Inc., OncoVista-Aengus,
      Inc. and OncoVista, Inc. dated as of November 7, 2005.(8)10.10
                                                  
                                                  License
      Agreement dated as of December 30, 2004 between AdnaGen AG and Gen-Probe
      Inc.(6)10.11
                                                  
                                                  Amendment
      to License Agreement between AdnaGen AG and Gen-Probe, Inc. effective June
      30, 2006.(6)
  47
 
 10.12
                                                        
                                                        License
      Agreement between Boston Medical Center Corporation and Aengus
      Pharmaceuticals, Inc.(9)10.13
                                                        
                                                        Assumption
      of Obligations of License Agreement and Consent to Transfer License
      Agreement between Boston Medical Center Corporation and OncoVista-Aengus,
      Inc. (6)10.14
                                                        
                                                        License
      Agreement dated November 21, 2003 between Oxigene, Inc. and Aengus
      Pharmaceuticals, Inc.(6)10.15
                                                        
                                                        Consent
      and Agreement to Assign License Agreement between Oxigene Inc. and
      OncoVista Aengus Pharmaceuticals, Inc. dated December 2005.(6)10.16
                                                        
                                                        License
      Agreement effective as of October 13, 2004 between Lipitek International,
      Inc. and OncoVista, Inc.(6)10.17
                                                        
                                                        Patent
      License effective May 1, 2005 between Technology Innovations, LLC and
      OncoVista, Inc.(6)10.18
                                                        
                                                        License
      Agreement effective as of October 13, 2004 between Technology Innovations,
      LLC. and OncoVista, Inc.(6)10.19
                                                        
                                                        License
      Agreement between AdnaGen AG and Innogenetics N.V.(6)10.20
                                                        
                                                        Distribution
      Agreement dated January 29, 2007 between Innogenetics and AdnaGen AG.(6)10.21
                                                        
                                                        Purchase
      Agreement dated as of November 17, 2005 between Lipitek International,
      Inc. and OncoVista, Inc. (6)10.22
                                                        
                                                        Securities
      Purchase Agreement, dated as of August 16, 2007.(5)10.23
                                                        
                                                        Form
      of Subscription Agreement between OncoVista, Inc. and purchasers of units
      in the OncoVista private placement that closed on August 15, 2007.(6)10.24
                                                        
                                                        Form
      of Registration Rights Letter between OncoVista, Inc. and purchasers of
      units in the OncoVista private placement that closed on August 15,
      2007.(6)10.25
                                                        
                                                        Form
      of Warrant issued to purchasers of units in the OncoVista private
      placement that closed in August 15, 2007.(6)10.26
                                                        
                                                        Form
      of Lock-Up Agreement.(6)10.27
                                                        
                                                        Letter
      Agreement dated July 11, 2007 between OncoVista, Inc. and Maxim Group,
      LLC.(6)10.28
                                                        
                                                        Warrant
      dated August 15, 2007 issued to Maxim Group, LLC.(6)10.29
                                                        
                                                        Form
      of Subscription Agreement.(6)10.30
                                                        
                                                        2004
      Stock Option Plan.(6)10.31
                                                        
                                                        2007
      Stock Option Plan.(6)10.32
                                                        
                                                        2007
      Stock Option Plan for Independent and Non-Employee Directors.(6)
  48
 
 10.33
                                                            
                                                            License
      Agreement by and between OncoVista, Inc. and OSI Pharmaceuticals,
      Inc.(7)10.34
                                                            
                                                            Subscription
      Agreement, dated November 27, 2007, between OncoVista, Inc. and OSI
      Pharmaceuticals, Inc.(7)10.35
                                                            
                                                            Investors’
      Rights Agreement, dated November 27, 2007, between OncoVista, Inc. and OSI
      Pharmaceuticals, Inc.(7)10.36
                                                            
                                                            Stockholders
      Agreement, dated November 27, 2007, between OncoVista, Inc., OSI
      Pharmaceuticals, Inc., and Alexander L. Weis.(7)10.37
                                                            
                                                            Stock
      Purchase Warrant dated November 27, 2007.(7)10.38
                                                            
                                                            Stock
      Purchase Warrant dated November 27, 2007.(7)10.39
                                                            
                                                            Share
      Purchase Agreement between BioMed Venture GmbH and OncoVista, Inc.(12)10.40
                                                            
                                                            Executive
      Employment Agreement dated as of January 1, 2008 between Aviation Upgrade
      Technologies, Inc. and J. Michael Edwards. (10)10.41
                                                            
                                                            Secured
      Promissory Note of OncoVista Innovative Therapies, Inc. and OncoVista,
      Inc. dated January 15, 2009(9)10.42
                                                            
                                                            Registration
      Rights Agreement dated January 15, 2009(9)10.43
                                                            
                                                            Form
      of Warrant dated January 15, 2009(9)14
                                                            
                                                            Code
      of Ethics, dated March 28, 2008(1)21.1
                                                            
                                                            List
      of Subsidiaries(13)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.
  49
  (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 8, 2008 with
      the Commission and incorporated by reference
  herein.
 
 (11)
              Filed
      as an exhibit to Current Report on Form 8-K filed on January 9, 2008 with
      the Commission and incorporated by reference
  herein.
 
 (12)
              Filed
      as an exhibit to Current Report on Form 8-K filed on January 17, 2008 with
      the Commission and incorporated by reference
  herein.
 
 (13)
              Filed
      as an exhibit to Annual Report of Form 10-KSB on April 14, 2008 with the
      Commission and incorporated by reference
herein.
  50
  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. WeisAlexander
      L. Weis, Ph.D.Chief  Executive
      Officer, and Chief Financial Officer(Principal
      Executive Officer, Principal FinancialOfficer
      and Principal Accounting Officer)Date:  March
      31, 2010
   /s/
      Alexander L. WeisAlexander
      L. Weis, Ph.D.Chairman
      of the Board of Directors/s/
      William J. BrockWilliam
      J. BrockDirector/s/
      James WemettJames
      WemettDirector/s/
      Paul MievalPaul
      Mieval, Ph.D.Director
 51
 
 ONCOVISTA
INNOVATIVE THERAPIES, INC. AND SUBSIDIARIES
 Consolidated
Financial Statements
 Years
Ended December 31, 2009 and 2008
  
  INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
 
 PageReport
      of Independent Registered Public Accounting Firm
                    
                    F-3Consolidated
      Balance Sheets as of December 31, 2009 and 2008
                    
                    F-4Consolidated
      Statements of Operations for the Years Ended December 31, 2009 and
      2008
                    
                    F-5Consolidated
      Statements of Comprehensive Loss for the Years Ended December 31, 2009 and
      2008
                    
                    F-6Consolidated
      Statements of Changes in Deficit  for the Years Ended December
      31, 2009 and 2008
                    
                    F-7Consolidated
      Statements of Cash Flows for the Years Ended December 31, 2009 and
      2008
                    
                    F-8Notes
      to Consolidated Financial Statements for the Years
      Ended  December 31, 2009 and 2008
                    
                    F-9
  F-2
  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, 2009 and
2008, and the related consolidated statements of operations, comprehensive loss,
changes in deficit, and cash flows for each of the two years in the period ended
December 31, 2009.  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 standards of the Public Company
Accounting Oversight Board (United States).  Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement.  An audit
includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements.  An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall consolidated financial statement
presentation.  We believe that our audits provide a reasonable basis
for our opinion.
 
 In our
opinion, the financial statements referred to above present fairly, in all
material respects, the consolidated financial position of OncoVista Innovative
Therapies, Inc. and Subsidiaries as of December 31, 2009 and 2008, and the
consolidated results of their operations, and their cash flows for each of the
two years in the period ended December 31, 2009, 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 a net loss of
$4,800,000 and net cash used in operations of $900,000 for the year ended
December 31, 2009, a working capital deficit of $11,400,000, an accumulated
deficit of $28,300,00 and a total deficit of $11,200,000 at December 31,
2009.  These factors raise substantial doubt about the Company’s
ability to continue as a going concern.  Management’s plan in regards
to these matters is also described in Note 3.  The consolidated
financial statements do not include any adjustments that might result from the
outcome of this uncertainty.
 
 As
discussed in Note 2 to the consolidated financial statements, during 2009 the
provisions of new accounting standards relating to noncontrolling interests and
contracts in an entity’s own equity were adopted.
 
 /s/ GHP
Horwath P.C.
 
 Denver,
Colorado
 March 31,
2010
  F-3
  ONCOVISTA
INNOVATIVE THERAPIES, INC. AND SUBSIDIARIES
 Consolidated
Balance Sheets
 
 December 31,2009
                  
                  
                  2008ASSETSCurrent
      assets:Cash
      and cash equivalents
                  
                  $
                  108,994
                  
                  
                  $
                  91,482Accounts
      receivable
                  
                  
                  113,187
                  
                  
                  
                  171,775Inventory
                  
                  
                  26,962
                  
                  
                  
                  51,575Prepaid
      and other current assets
                  
                  
                  25,329
                  
                  
                  
                  33,851Total
      current assets
                  
                  
                  274,472
                  
                  
                  
                  348,683Equipment,
      net
                  
                  
                  91,341
                  
                  
                  
                  151,667Deposits
      and other assets
                  
                  
                  44,329
                  
                  
                  
                  53,783Total
      assets
                  
                  $
                  410,142
                  
                  
                  $
                  554,133LIABILITIES
      AND DEFICITCurrent
      liabilities:Accounts
      payable
                  
                  $
                  1,279,278
                  
                  
                  $
                  593,721Accrued
      expenses
                  
                  
                  2,042,504
                  
                  
                  
                  1,235,204Loans
      payable, related party
                  
                  
                  259,556
                  
                  
                  
                  –Loans
      payable
                  
                  
                  –
                  
                  
                  
                  1,318,980Notes
      payable
                  
                  
                  1,541,016
                  
                  
                  
                  804,850Contingently
      restructured debt
                  
                  
                  6,176,310
                  
                  
                  
                  –Accrued
      interest payable
                  
                  
                  359,983
                  
                  
                  
                  1,080,355Total
      current liabilities
                  
                  
                  11,658,647
                  
                  
                  
                  5,033,110Notes
      payable
                  
                  
                  –
                  
                  
                  
                  3,524,250Accrued
      interest payable
                  
                  
                  –
                  
                  
                  
                  338,328Other
                  
                  
                  –
                  
                  
                  
                  4,224Total
      liabilities
                  
                  
                  11,658,647
                  
                  
                  
                  8,899,912Commitments
      and contingenciesDeficit:OncoVista
      Innovative Therapies stockholders’ deficitCommon
      stock, $.001 par value; 147,397,390 shares authorized, 21,149,675 and
      20,316,475 shares issued and outstanding at December 31, 2009 and 2008,
      respectively
                  
                  
                  21,149
                  
                  
                  
                  20,316Additional
      paid-in capital
                  
                  
                  18,560,394
                  
                  
                  
                  16,389,878Accumulated
      deficit
                  
                  
                  (28,357,947
                  )
                  
                  
                  (23,574,947
                  )Accumulated
      other comprehensive loss
                  
                  
                  (1,430,618
                  )
                  
                  
                  (1,181,026
                  )Total
      OncoVista Innovative Therapies stockholders’ deficit
                  
                  
                  (11,207,022
                  )
                  
                  
                  (8,345,779
                  )Noncontrolling
      interest
                  
                  
                  (41,483
                  )
                  
                  
                  –Total
      deficit
                  
                  
                  (11,248,505
                  )
                  
                  
                  (8,345,779
                  )−
                  
                  
                  
                  −Total
      liabilities, and deficit
                  
                  $
                  410,142
                  
                  
                  $
                  554,133
 
 See
accompanying notes to consolidated financial statements
  F-4
  ONCOVISTA
INNOVATIVE THERAPIES, INC. AND SUBSIDIARIES
 Consolidated
Statements of Operations
 
 Year Ended December 31,2009
                  
                  
                  2008Revenues:Diagnostic
      kits
                  
                  $
                  762,642
                  
                  
                  $
                  361,707Licensing
                  
                  
                  196,724
                  
                  
                  
                  52,447Research
      and development revenue
                  
                  
                  22,682
                  
                  
                  
                  89,171Total
      revenues
                  
                  
                  982,048
                  
                  
                  
                  503,325Operating
      expenses:Research
      and development
                  
                  
                  2,193,143
                  
                  
                  
                  3,386,163General
      and administrative
                  
                  
                  3,570,046
                  
                  
                  
                  5,128,583Total
      operating expenses
                  
                  
                  5,763,189
                  
                  
                  
                  8,514,746Loss
      from operations
                  
                  
                  (4,781,141
                  )
                  
                  
                  (8,011,421
                  )Other
      income (expense):Interest
      expense
                  
                  
                  (741,325
                  )
                  
                  
                  (241,533
                  )Gain
      on debt settlement
                  
                  
                  −
                  
                  
                  
                  758,801Gain
      on derivative liability
                  
                  
                  568,512
                  
                  
                  
                  −Other
                  
                  
                  129,849
                  
                  
                  
                  12,129Total
      other (expense) income
                  
                  
                  (42,964
                  )
                  
                  
                  529,397Net
      loss
                  
                  
                  (4,824,105
                  )
                  
                  
                  (7,482,024
                  )Net
      loss attributable to noncontrolling interest
                  
                  
                  41,105
                  
                  
                  
                  −Net
      loss attributable to OncoVista Innovative Therapies
                  
                  $
                  (4,783,000
                  )
                  
                  $
                  (7,482,024
                  )Net
      loss per share - basic and diluted
                  
                  $
                  (0.26
                  )
                  
                  $
                  (0.41
                  )Weighted
      average number of shares outstanding during the period - basic and
      diluted
                  
                  
                  18,424,220
                  
                  
                  
                  18,235,055
 
 See
accompanying notes to consolidated financial statements
  F-5
 
 ONCOVISTA
INNOVATIVE THERAPIES, INC. AND SUBSIDIARIES
 Consolidated
Statements of Comprehensive Loss
 
 Year Ended December 31,2009
                  
                  
                  2008Net
      loss
                  
                  $
                  (4,824,105
                  )
                  
                  $
                  (7,482,024
                  )Other
      comprehensive income (loss):Foreign
      currency translation (loss) gain
                  
                  
                  (249,970
                  )
                  
                  
                  343,091Total
      other comprehensive (loss) income
                  
                  
                  (249,970
                  )
                  
                  
                  343,091Comprehensive
      loss
                  
                  
                  (5,074,075
                  )
                  
                  
                  (7,138,933
                  )Comprehensive
      loss attributable to noncontrolling interest
                  
                  
                  41,483
                  
                  
                  
                  −Comprehensive
      loss attributable to OncoVista Innovative Therapies
                  
                  $
                  (5,032,592
                  )
                  
                  $
                  (7,138,933
                  )
 
 See
accompanying notes to consolidated financial statements
  F-6
  ONCOVISTA
INNOVATIVE THERAPIES, INC. AND SUBSIDIARIES
 Consolidated
Statements of Changes in Deficit
 For
the Years Ended December 31, 2009 and 2008
 
 OncoVista Innovative Therapies, Inc. ShareholdersTotal
                      
                      
                      Comprehensive
                        Loss
                      
                      
                      Common
                        Stock
                      
                      
                      Additional
                        paid-in
                        capital
                      
                      
                      Accumulated
                        deficit
                      
                      
                      Accumulated
                        other
                        comprehensive
                        loss
                      
                      
                      Noncontrolling
                        InterestBalance
      at January 1, 2008
                      
                      $
                      (3,992,333
                      )
                      
                      
                      
                      
                      $
                      20,116
                      
                      
                      $
                      13,604,591
                      
                      
                      $
                      (16,092,923
                      )
                      
                      $
                      (1,524,117
                      )
                      
                      $
                      −Comprehensive
      loss:Net
      loss
                      
                      
                      (7,482,024
                      )
                      
                      $
                      (7,482,024
                      )
                      
                      
                      −
                      
                      
                      
                      −
                      
                      
                      
                      (7,482,024
                      )
                      
                      
                      −
                      
                      
                      
                      −Other
      comprehensive income:Foreign
      currency translation gain
                      
                      
                      343,091
                      
                      
                      
                      343,091
                      
                      
                      
                      −
                      
                      
                      
                      −
                      
                      
                      
                      −
                      
                      
                      
                      343,091
                      
                      
                      
                      −Other
      comprehensive income
                      
                      
                      343,091
                      
                      
                      
                      343,091Comprehensive
      loss
                      
                      
                      (7,138,933
                      )
                      
                      $
                      (7,138,933
                      )Purchase
      of additional equity interest in subsidiary
                      
                      
                      (70,374
                      )
                      
                      
                      
                      
                      
                      
                      −
                      
                      
                      
                      (70,374
                      )
                      
                      
                      −
                      
                      
                      
                      −Issuance
      of restricted common stock for consulting
                      
                      
                      110,000
                      
                      
                      
                      
                      
                      
                      
                      100
                      
                      
                      
                      109,900
                      
                      
                      
                      −
                      
                      
                      
                      −Issuance
      of warrants for consulting
                      
                      
                      1,012,292
                      
                      
                      
                      
                      
                      
                      
                      −
                      
                      
                      
                      1,012,292
                      
                      
                      
                      −
                      
                      
                      
                      −Exercise
      of common stock options
                      
                      
                      10,000
                      
                      
                      
                      
                      
                      
                      
                      100
                      
                      
                      
                      9,900
                      
                      
                      
                      −
                      
                      
                      
                      −Employee
      stock-based compensation
                      
                      
                      1,557,743
                      
                      
                      
                      
                      
                      
                      
                      −
                      
                      
                      
                      1,557,743
                      
                      
                      
                      −
                      
                      
                      
                      −Non-employee
      stock-based consulting
                      
                      
                      165,826
                      
                      
                      
                      
                      
                      
                      
                      −
                      
                      
                      
                      165,826
                      
                      
                      
                      −
                      
                      
                      
                      −
                      
                      
                      
                      −Balance
      at December 31, 2008
                      
                      
                      (8,345,779
                      )
                      
                      
                      
                      
                      
                      
                      20,316
                      
                      
                      
                      16,389,878
                      
                      
                      
                      (23,574,947
                      )
                      
                      
                      (1,181,026
                      )
                      
                      
                      −Comprehensive
      loss:Net
      loss
                      
                      
                      (4,824,105
                      )
                      
                      
                      (4,824,105
                      )
                      
                      
                      −
                      
                      
                      
                      −
                      
                      
                      
                      (4,783,000
                      )
                      
                      
                      −
                      
                      
                      
                      (41,105
                      )Other
      comprehensive loss:Foreign
      currency translation loss
                      
                      
                      (249,970
                      )
                      
                      
                      (249,970
                      )
                      
                      
                      −
                      
                      
                      
                      −
                      
                      
                      
                      −
                      
                      
                      
                      (249,592
                      )
                      
                      
                      (378
                      )Other
      comprehensive loss
                      
                      
                      (249,970
                      )
                      
                      
                      (249,970
                      )Comprehensive
      loss
                      
                      
                      (5,074,075
                      )
                      
                      $
                      (5,074,075
                      )Issuance
      of warrants for consulting
                      
                      
                      92,027
                      
                      
                      
                      
                      
                      
                      
                      −
                      
                      
                      
                      92,027
                      
                      
                      
                      −
                      
                      
                      
                      −Exercise
      of common stock options
                      
                      
                      833
                      
                      
                      
                      
                      
                      
                      
                      833
                      
                      
                      
                      −
                      
                      
                      
                      −
                      
                      
                      
                      −Employee
      stock-based compensation
                      
                      
                      1,937,633
                      
                      
                      
                      
                      
                      
                      
                      −
                      
                      
                      
                      1,937,633
                      
                      
                      
                      −
                      
                      
                      
                      −Non-employee
      stock-based consulting
                      
                      
                      140,856
                      
                      
                      
                      
                      
                      
                      
                      −
                      
                      
                      
                      140,856
                      
                      
                      
                      −
                      
                      
                      
                      −
                      
                      
                      
                      −Balance
      at December 31, 2009
                      
                      $
                      (11,248,505
                      )
                      
                      
                      
                      
                      
                      $
                      21,149
                      
                      
                      $
                      18,560,394
                      
                      
                      $
                      (28,357,947
                      )
                      
                      $
                      (1,430,618
                      )
                      
                      $
                      (41,483
                      )
 
 See
accompanying notes to consolidated financial statements
  F-7
  ONCOVISTA
INNOVATIVE THERAPIES, INC. AND SUBSIDIARIES
 Consolidated
Statements of Cash Flows
 
 Year ended December 31,2009
                  
                  
                  2008Cash
      flows from operating activitiesNet
      loss
                  
                  $
                  (4,824,105
                  )
                  
                  $
                  (7,482,024
                  )Adjustments
      to reconcile net loss to net cash used in operating
      activities:Depreciation
                  
                  
                  62,500
                  
                  
                  
                  75,829Amortization
      of debt discount
                  
                  
                  589,581
                  
                  
                  
                  −Gain
      on debt settlement
                  
                  
                  –
                  
                  
                  
                  (758,801
                  )Employee
      stock-based compensation
                  
                  
                  1,937,633
                  
                  
                  
                  1,557,743Non-employee
      stock-based consulting
                  
                  
                  140,856
                  
                  
                  
                  165,826Common
      stock issued for consulting
                  
                  
                  –
                  
                  
                  
                  110,000Non-employee
      stock-based consulting (warrants)
                  
                  
                  92,027
                  
                  
                  
                  1,012,292Gain
      on derivative liability
                  
                  
                  (568,512
                  )
                  
                  
                  −Changes
      in operating assets and liabilities:Accounts
      receivable
                  
                  
                  59,877
                  
                  
                  
                  16,106Inventory
                  
                  
                  24,790
                  
                  
                  
                  (17,377
                  )Prepaid
      and other assets
                  
                  
                  19,000
                  
                  
                  
                  63,449Accounts
      payable
                  
                  
                  664,830
                  
                  
                  
                  358,982Accrued
      expenses
                  
                  
                  720,849
                  
                  
                  
                  852,382Accrued
      interest payable
                  
                  
                  169,439
                  
                  
                  
                  184,137Net
      cash used in operating activities
                  
                  
                  (911,235
                  )
                  
                  
                  (3,861,456
                  )Cash
      flows from investing activitiesPurchase
      of equipment
                  
                  
                  (1,647
                  )
                  
                  
                  (33,180
                  )Cash
      paid to acquire equity interest in subsidiary
                  
                  
                  –
                  
                  
                  
                  (70,374
                  )Net
      cash used in investing activities
                  
                  
                  (1,647
                  )
                  
                  
                  (103,554
                  )Cash
      flows from financing activitiesProceeds
      from exercise of stock options
                  
                  
                  833
                  
                  
                  
                  10,000Proceeds
      from notes payable
                  
                  
                  1,005,508
                  
                  
                  
                  −Repayments
      of loans and notes payable
                  
                  
                  –
                  
                  
                  
                  (202,550
                  )Net
      cash provided by (used in) financing activities
                  
                  
                  1,006,341
                  
                  
                  
                  (192,550
                  )Net
      increase (decrease) in cash and cash equivalents
                  
                  
                  93,459
                  
                  
                  
                  (4,157,560
                  )Effect
      of exchange rates on cash
                  
                  
                  (75,947
                  )
                  
                  
                  (115,099
                  )Cash
      and cash equivalents at beginning of year
                  
                  
                  91,482
                  
                  
                  
                  4,364,141Cash
      and cash equivalents at end of year
                  
                  $
                  108,994
                  
                  
                  $
                  91,482Supplemental
      disclosures of cash flow information:Cash
      paid for interest
                  
                  $
                  229,418
                  
                  
                  $
                  103,329
 
 See
accompanying notes to consolidated financial statements
  F-8
  Note
      1.
              BASIS
      OF PRESENTATION, ORGANIZATION AND NATURE OF
  OPERATIONS
 
 OncoVista
Innovative Therapies, Inc. (“OVIT” or the “Company”) is a biopharmaceutical
company involved in the commercialization of diagnostic tests for metastatic
tumors, as well as the development of targeted anticancer therapies by utilizing
tumor-associated biomarkers. The Company has developed diagnostic kits for
breast, colon, ovarian and prostate cancers, and currently markets diagnostic
kits in Europe for the detection of circulating tumor cells (“CTCs”) in patients
with breast, colon, ovarian, and prostate cancer.  The Company has
also developed research products for the detection of steroid receptors (ER/PR)
and cancer stem cells.
 
 In August
2009, with the exception of the CEO, the Company terminated the employment of
all employees of OncoVista, Inc. (“OncoVista”), the Company’s U.S. operating
subsidiary.  AdnaGen AG, the Company’s German operating subsidiary,
has eight full-time employees. The Company is currently attempting to raise
additional funding to provide working capital. The Company has received and
continues to receive cash advances from companies affiliated with the CEO to
support continuing operations.
 
 In
December 2005, OncoVista acquired a controlling (51%) interest in AdnaGen AG
(“AdnaGen”), a research and development company based in Langenhagen,
Germany.  AdnaGen focuses on the development of innovative tumor
diagnostics by utilizing its proprietary technology for the detection and
analysis of rare cells.  In December 2007, OncoVista purchased from a
now former shareholder of AdnaGen an additional 34% equity interest in AdnaGen,
for consideration of $599,241. In June 2008, OncoVista purchased an additional
10% equity interest in AdnaGen, for consideration of $70,374 from now former
AdnaGen shareholders.  As a result of these purchases, OncoVista now
owns approximately 95% of AdnaGen subject to the contingent debt restructuring
described below and in Note 6.
 
 In April
2009, the Company negotiated a contingent debt restructuring with three of its
major creditors which, if completed, would result in exchanging approximately
€4.3 million ($6.2 million) of debt and related accrued interest as of December
31, 2009, for an equity share of approximately 18% of AdnaGen.  In
addition, as part of the contingent restructuring, OncoVista agreed to forgive
approximately $887,000 in receivables, advances, loans and related interest as
of December 31, 2009, due from AdnaGen if completed.  The debt
restructuring and the related share issuance is contingent on the Company
raising a minimum of €2.0 million ($2.9 million) that was originally to be due
no later than July 30, 2009.  In July 2009, the Company received an
extension until December 2009 to raise the additional capital required under the
debt restructuring agreement, which date was subsequently extended to May 31,
2010. Upon completion of restructuring, the Company will own approximately 78%
of AdnaGen.
 
 Note
      2.
              SUMMARY
      OF SIGNIFICANT ACCOUNTING POLICIES
 
 Principles
of Consolidation
 
 The
consolidated financial statements include the accounts of OVIT, OncoVista and
AdnaGen AG (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 2009 and 2008 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.
  F-9
 
 Comprehensive
Income (Loss)
 
 Comprehensive
income or loss is comprised of net earnings or loss and other comprehensive
income or loss, which includes certain changes in equity that are excluded from
net earnings, primarily foreign currency translation adjustments.
 
 Cash
and Cash Equivalents
 
 For the
purpose of the Statements of Cash Flows, 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. The balance did not exceed the federally insured limits at either
December 31, 2009 or 2008. The Company has not incurred any losses related this
credit risk in its history.
 
 Accounts
Receivable
 
 There has
been no identifiable bad debt expense during the years ended December 31, 2009
and 2008, respectively.  Additionally, the Company has not recorded
any allowance for doubtful accounts.  The allowance is generally
determined based on an account-by-account review.  Accounts are
charged off when collection efforts have failed and the account is deemed
uncollectible.  The Company does not charge interest on accounts
receivable.
 
 Inventory
 
 Inventory
is stated at the lower of cost or market, determined by the first-in, first-out
(FIFO) method.  Inventories consist of finished goods in the form of
select and detect breast cancer and colon cancer kits.  During the
years ended December 31, 2009 and 2008, respectively, there were no write-downs
to net realizable value due to obsolescence.
 
 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, 2009 and 2008.
 
 Noncontrolling
interest
 
 On
January 1, 2009, we adopted Financial Accounting Standards Board (“FASB”) issued
authoritative guidance related to Noncontrolling Interests in Consolidated
Financial Statements, the provisions of which, among others, require the
recognition of a noncontrolling interest (previously referred to as minority
interest), as a component of equity in the consolidated financial statements and
separate from the parent’s equity for all periods presented. In addition, the
amount of net income or loss attributable to the noncontrolling interest is
included in consolidated net income or loss on the face of the consolidated
statement of operations.
 
 F-10
  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 was any interest expense related to unrecognized tax benefits
recognized for the years ended December 31, 2009 and 2008.
 
 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.
 
 Revenue
Recognition
 
 The
Company recognizes revenue in accordance with SEC Staff Accounting Bulletin
(“SAB”) No. 101, “Revenue
Recognition in Financial Statements”(SAB No. 101), as amended by SAB No.
104, “Revenue
Recognition” (SAB No. 104). The Company recognizes 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’s current sources of revenue are as
follows:
 
 Licensing –The Company has
entered into various license agreements with third parties that generate
nonrefundable upfront and milestone license payments.  Upfront license
payments are reported as deferred revenue until they are recognizable as
revenue, generally on a straight line basis over the term of the respective
license period, beginning only after both the license period has begun and the
technology has been delivered. At December 31, 2009 and 2008, there was no
deferred revenue recognized from upfront license payments.  Milestone
payments from license agreements are recognized as revenue upon achievement of
the milestone provided the payment is nonrefundable.
 
 Diagnostic Kits –The Company
recognizes revenues from the sale of diagnostic test kits to third parties upon
shipment. The Company’s customers have no right of return for products
sold.
 
 Research and Development –The Company recognizes the revenue from contracts to perform research and
development services over the term of the applicable contract and as we complete
our obligations under that contract.
  F-11
  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.
 
 Customer
Concentration
 
 For the
year ended December 31, 2009 and 2008, the Company derived a substantial portion
of its revenues from four customers accounting for 63% of the Company’s revenue
(26%, 17%, 10% and 10%), and four customers accounting for 75% of the Company’s
revenue (31%, 18%, 16% and 10%), respectively.
 
 Two
customers accounted for approximately 75% of the accounts receivable balance
(44% and 31%) at December 31, 2009, and two customers accounted for
approximately 74% of the balance (50% and 24%) at December 31,
2008.
 
 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.  In
Europe, sales of diagnostic products are regulated by Directorate General III of
the European Commission, which allows the Company’s subsidiary to market its
products as clinical diagnostics under the CE label in the European
Community.
 
 Foreign
Country Risks
 
 The
Company may be exposed to certain risks as a portion of its operations are being
conducted in Germany.  These include risks associated with, among
others, the political, economic, and legal environment, as well as foreign
currency exchange risk.  The Company’s results may be adversely
affected by change in the political and social conditions in Germany due to
governmental policies with respect to laws and regulations, anti-inflationary
measures, currency conversions and remittances abroad, and rates and methods of
taxation, among other things.  The Company does not believe these
risks to be significant, and no such losses have occurred in the current or
prior years because of these factors.  However, there can be no
assurance that changes in political and other conditions will not result in any
adverse impact in future periods.
 
 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.
 
 At
December 31, 2009 and 2008, the following numbers of shares have been excluded
since their inclusion in the computation would be anti-dilutive:
 
 2009
                    
                    
                    2008Stock
      options outstanding under our various stock option plans
                    
                    
                    650,000
                    
                    
                    
                    1,180,000Warrants
                    
                    
                    3,681,712
                    
                    
                    
                    2,931,712Total
                    
                    
                    4,331,712
                    
                    
                    
                    4,111,712
  F-12
 
 For
purposes of the computation of net income per share, unvested restricted shares
(Note 11) are considered contingently returnable shares. These shares, although
classified as issued and outstanding, are not included in basic weighted average
number of shares until all necessary conditions are met that no longer cause the
shares to be contingently returnable. These contingently returnable shares are
to be included in diluted weighted average number of shares as of the beginning
of the period in which the conditions are satisfied.
 
 Share-Based
Compensation
  All
share-based payments to employees since inception have been recorded and
expensed in the statements of operations under Accounting Standards Codification
(“ASC”) 718 “Compensation –
Stock Compensation” (formerly FASB Statement of Financial Accounting
Standards “SFAS” No. 123R “Share-Based
Payment”).  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.
 
 Foreign
Currency Translation
 
 The
financial position and results of operations of the Company’s foreign subsidiary
are measured using the local currency (Euros “€”) as the functional
currency.  Assets and liabilities of the subsidiary have been
translated at current exchange rates as of December 31, 2009 and 2008, and
related revenue and expenses have been translated at average exchange rates for
the years ended December 31, 2009 and 2008.  All equity transactions
have been translated at their historical rates when the transaction
occurred.  Those translation adjustments are 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).
 
 Reclassifications
 
 Certain
prior year balances have been reclassified to conform to the current year
presentation.
 
 Recent
Accounting Pronouncements
 
 In
June 2009, FASB approved the FASB Accounting Standards Codification (“the
Codification”) as the single source of authoritative nongovernmental GAAP. All
existing accounting standard documents, such as FASB, American Institute of
Certified Public Accountants, Emerging Issues Task Force and other related
literature, excluding guidance from the Securities and Exchange Commission
(“SEC”), have been superseded by the Codification. All other non-grandfathered,
non-SEC accounting literature not included in the Codification has become
nonauthoritative. The Codification did not change GAAP, but instead introduced a
new structure that combines all authoritative standards into a comprehensive,
topically organized online database. The Codification is effective for interim
or annual periods ending after September 15, 2009, and impacts the
Company’s consolidated financial statements as all references to authoritative
accounting literature are now referenced in accordance with the Codification.
There have been no changes to the content of the Company’s consolidated
financial statements or disclosures as a result of implementing the
Codification.
 
 In
December 2007, the FASB issued ASC 805 “Business Combinations”
(formerly - SFAS No. 141 (R)), which became effective for fiscal periods
beginning after December 15, 2008. The standard changes the accounting for
business combinations, including the measurement of acquirer shares issued in
consideration for a business combination, the recognition of contingent
consideration, the accounting for pre-acquisition gain and loss contingencies,
the recognition of capitalized in-process research and development, the
accounting for acquisition-related restructuring cost accruals, the treatment of
acquisition related transaction costs, and the recognition of changes in the
acquirer’s income tax valuation allowance. The standard became effective for the
Company on January 1, 2009. The Company will apply the provisions of ASC 805 to
any future business combinations.
  F-13
 
 On
January 1, 2009, the Company adopted ASC 810 “Consolidation” (formerly -
SFAS No. 160). The standard changes the accounting for non-controlling
(minority) interests in consolidated financial statements. In accordance with
the standard, the Company has changed the reporting of non-controlling interests
on the face of the consolidated financial statements to separately classify
non-controlling interests within the equity section of the consolidated balance
sheets and to separately report the amounts attributable to controlling and
non-controlling interests in the consolidated statements of operations, and
comprehensive loss for all periods presented.  The standard also
requires that the noncontrolling interest continues to be attributed its share
of losses even if that attribution results in a deficit noncontrolling interest
balance.  Prior to adoption, the Company had charged such excess
losses to the majority interest.
 
 On
January 1, 2009, the Company adopted ASC 815 “Derivatives and Hedging”
(formerly Emerging Issues Task Force “EITF” Issue No. 07-5), which requires the
application of a two-step approach in evaluating whether an equity-linked
financial instrument (or embedded feature) is indexed to our own stock,
including evaluation of the instrument’s contingent exercise and settlement
provisions. See Note 6 for the impact of the adoption of ASC 815 on the
Company’s consolidated results of operations, cash flows, and financial
position.
 
 Note
      3.
              GOING
      CONCERN AND MANAGEMENT PLANS
 
 As
reflected in the accompanying consolidated financial statements, the Company has
a net loss of approximately $4.8 million and net cash used in operations of
approximately $911,000 for the year ended December 31, 2009, a working capital
deficit of approximately $11.4 million, an accumulated deficit of approximately
$28.4 million and a total deficit of approximately $11.2 million at December 31,
2009. The Company is also in default on certain loans, notes, and related
accrued interest aggregating $135,638 at December 31, 2009 (See Note 6). These
factors raise significant doubt about the Company’s ability to continue as a
going concern.
 
 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, resolve its
liquidity problems, principally by obtaining additional debt and/or equity
financing, and generate additional revenues from collaborative agreements or
sale of pharmaceutical products.
 
 In
January 2009, the Company secured $750,000 in bridge financing and has engaged
several investment banks to assist in raising funding to support ongoing
development activities. The Company also obtained additional funding of
approximately $260,000 during the year from related parties. As described in
Note 1, the Company also restructured approximately $6.2 million of debt and
related accrued interest subject to the Company raising a certain amount of
additional funding. There can be no assurance that these financings 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, 2009 and 2008 are summarized below:
 
 2009
                    
                    
                    2008Equipment
                    
                    $
                    528,795
                    
                    
                    $
                    520,584Computer
      and office equipment
                    
                    
                    108,747
                    
                    
                    
                    103,890Furniture
      and fixtures
                    
                    
                    5,554
                    
                    
                    
                    5,554643,096
                    
                    
                    
                    630,028Less:
      accumulated depreciation
                    
                    
                    (551,755
                    )
                    
                    
                    (478,361
                    )Equipment,
      net
                    
                    $
                    91,341
                    
                    
                    $
                    151,667
  F-14
 
 Note
      5.
              ACCRUED
      EXPENSES
 
 Accrued
expenses at December 31, 2009 and 2008 are summarized below:
 
 2009
                    
                    
                    2008Legal
      and professional
                    
                    $
                    988,584
                    
                    
                    $
                    693,397Clinical
      and other studies
                    
                    
                    279,197
                    
                    
                    
                    268,465Compensation
                    
                    
                    347,526
                    
                    
                    
                    129,549Other
                    
                    
                    427,197
                    
                    
                    
                    143,793Total
      accrued expenses
                    
                    $
                    2,042,504
                    
                    
                    $
                    1,235,204
 
 Note
      6.
              DEBT
 
 Including
the contingent debt restructuring described in Note 1, loans and notes payable
in the principal amount of $5,640,962 have a contingent repayment plan. Under
the plan, principal and accrued interest is payable at the maturity date only if
AdnaGen is profitable and achieves certain positive shareholder’s equity, except
with respect to debt in the principal amount of $716,650, for which only the
principal is subject to a contingent repayment plan. The debt holders have
signed subordination letters related to the principal and interest providing
that if AdnaGen is unable to repay, it would not lead to insolvency under
applicable German law. If not repaid at maturity, the debt will continue to be
outstanding until such time that AdnaGen has sufficient profits, liquidation
surplus, or net assets to repay the outstanding principal, the debt is
renegotiated, or AdnaGen becomes insolvent. Further, debt holders in the
principal amount of $4,299,900 have the right to receive a share of AdnaGen
profits under certain circumstances.
 
 The
Company had the following outstanding loans and notes payable at December 31,
2009 and 2008:
 
 2009
                        
                        
                        2008Unsecured
      loans payable to third parties with interest at 10% and due on demand
      (1)
                        
                        $
                        1,341,062
                        
                        
                        $
                        1,318,980Unsecured
      note payable to a third party with interest at 5%, maturing in December
      2010(1)
                        
                        
                        2,149,950
                        
                        
                        
                        2,114,550Unsecured
      note payable to a third party with interest at 9%, maturing in December
      2010(1)
                        
                        
                        1,433,300
                        
                        
                        
                        1,409,7004,924,312
                        
                        
                        
                        4,843,230Unsecured
      loans payable to related parties with interest at 10% and due on
      demand(2)
                        
                        
                        259,556
                        
                        
                        
                        –Unsecured
      notes payable to third parties with interest at 10%, maturing in January
      2010(3)
                        
                        
                        724,366
                        
                        
                        
                        –Unsecured
      convertible notes payable to a third party with interest at 8% and due on
      demand, matured in December 2005(4)
                        
                        
                        100,000
                        
                        
                        
                        100,000Unsecured
      note payable to a third party with interest at 5.5%, matured in June
      2008(5)
                        
                        
                        716,650
                        
                        
                        
                        704,850Total
      loans and notes payable
                        
                        
                        6,724,884
                        
                        
                        
                        5,648,080Less:
      current portion
                        
                        
                        (6,724,884
                        )
                        
                        
                        (2,123,830
                        )Total
      long-term debt
                        
                        $
                        –
                        
                        
                        $
                        3,524,250
  F-15
 
 (1)
              In
      April 2009, the Company negotiated a contingent debt restructuring with
      three of its major creditors (See Note
1).
 (2)
              Amount
      relates to loans and advances from the CEO and companies affiliated with
      the CEO.
 (3)
              In
      January 2009, the Company and OncoVista completed an initial closing of a
      bridge round of debt financing, whereby the Company 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 1933, as amended (the “Securities
      Act”).  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 a
      member of the Company’s Board, Chief Executive Officer, Chief Financial
      Officer, President, and Secretary, as well as one of the Company’s
      significant beneficial owners. Wexford Capital LLC is the investment
      sub-advisor of Wexford Spectrum Trading Limited which beneficially owns
      approximately 11% of the Company’s outstanding common stock and a
      representative of Wexford, Dr. Paul Mieyal, was appointed to the Board of
      Directors, such appointment 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 which the Company consummates 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.
 (4)
              The
      Company has $100,000 of convertible notes payable outstanding at December
      31, 2009.   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 market price at the date of each
      advance was either equal to or less than the conversion price;
      accordingly, there was no beneficial conversion
  feature.
 (5)
              Amount
      relates to an unsecured note payable in the amount of €500,000 with a
      contingent repayment plan for which principal is payable at the maturity
      date only if AdnaGen is profitable and achieves certain positive
      shareholder’s equity.
 
 In
October 2003, a third party loaned the Company a total of €515,000 accruing
interest at 7.75% and due in June 2008. In February 2008, the Company placed
approximately $200,000 (€128,750) in a separate escrow account in connection
with a proposed settlement for the outstanding loan balance and accrued interest
which totaled approximately $988,000 (€615,500).  In April 2008, the
third party accepted the debt settlement agreement which resulted in a gain on
settlement of debt in the amount of $758,801 (€486,760).
 
 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 shares issued upon settlement (See Note 6 and Note 11).
 
 The
Company recorded a derivative liability in the amount of $615,215 on the closing
date of the bridge round of debt financing. The liability was then adjusted to
fair value of $46,703 and included in other accrued liabilities in the
consolidated balance sheet as of December 31, 2009, resulting in a decrease in
the liability and an increase in other income of $568,512 for the year ended
December 31, 2009.
 
 The
Company uses the Black-Scholes pricing model to estimate the fair value of its
warrant liabilities. Key assumptions used to apply these models are as
follows:
 
 December 31,
                              2009
                            
                            
                            InceptionExpected
      term
                            
                            0
      years
                            
                            
                            5
      yearsVolatility
                            
                            86.5%
                            
                            
                            86.5%Risk-free
      interest rate
                            
                            0.43%
                            
                            
                            0.43%Dividend
      yield
                            
                            0%
                            
                            
                            0%
  F-16
 
 Fair
value measurements
 
 Assets
and liabilities measured at fair value as of December 31, 2009, are as
follows:
 
 Value
                        
                        
                        Quoted prices
                          in active
                          markets
                          (Level 1)
                        
                        
                        Significant
                          other observable
                          inputs
                          (Level 2)
                        
                        
                        Significant
                          unobservable
                          inputs
                          (Level 3)Derivative
      liability
                        
                        $
                        46,703
                        
                        
                        $
                        –
                        
                        
                        $
                        46,703
                        
                        
                        $
                        –
 
 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, 2009 and 2008, respectively. The fair values of
accounts receivable, accounts payable and third-party debt approximate the
carrying amounts due to the short term nature of these
instruments.  The fair value of debt due to related parties and the
contingently redeemable noncontrolling interest is not practicable to estimate
due to the related party nature of the underlying transactions.
 
 Note
      8.
              COLLABORATION,
      LICENSE AND OTHER AGREEMENTS
 
 OSI
Pharmaceuticals
 
 In
November 2007, OncoVista 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 2007,
pursuant to the License Agreement, OncoVista paid OSI an upfront license fee of
$500,000 and is required to make payments based upon the achievement of
specified milestones or product sales. In addition, if the drug candidate is
commercially sold, then OncoVista would be required to pay royalties based on
net sales of the drug. OncoVista would also be required to pay royalty and
milestone payments to OSI for certain third parties.  Also in 2007, as
additional consideration OncoVista issued 500,000 shares of common stock and two
warrants to OSI having a fair value of $1,743,580 (See Note 11). No royalties
were due or payable in 2009.
 
 Note
      9.
              LEASES,
      COMMITMENTS AND CONTINGENCIES
 
 Lease
Obligations
 
 In
January 2005, the Company entered a five-year non-cancelable lease with an
affiliate of Dr. Alexander Weis, one of the Company’s directors and the
Company’s CEO, President, CFO, and Secretary for office and laboratory space
(See Note 10).  AdnaGen maintains an annual operating lease for its
office and laboratory space which expired on December 31, 2009, as well as
operating leases for office equipment and vehicles. Remaining future minimum
lease payments are approximately $413,000 for the Company in 2010.
  F-17
  Total
rent expense amounted to approximately $411,000 and $405,000 for the years ended
December 31, 2009 and 2008, respectively.
  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 in its common stock.
 
 On July
8, 2008, AdnaGen commenced a lawsuit against Innogenetics N.V. (“Innogenetics”)
in the District Court of Hannover alleging that Innogenetics, a distributor of
certain AdnaGen diagnostic kits in Europe, breached the exclusive distribution
agreement that AdnaGen entered into with them. AdnaGen claimed that Innogenetics
did not order the contractual minimum quantities of diagnostic kits required to
maintain exclusivity.  AdnaGen terminated the exclusivity and sought
damages of approximately $550,000 (€369,000).  Following a bench
trial, on February 8, 2009, the District Court ruled in favor of Innogenetics
ordering AdnaGen to pay Innogenetics’ approximately €12,000 ($16,000) in court
costs and attorney fees.
 
 Note
      10.
              RELATED
      PARTY TRANSACTIONS
 
 Alexander
L. Weis, Ph.D., a member 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 five-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,
2009, the Company has paid $300,000 toward this agreement and has accrued
$300,000 representing one-half of the amounts for 2008 and all of the 2009
amounts, which are included in accounts payable in the consolidated balance
sheets as of December 31, 2009 and 2008. During 2009 and 2008, the Company paid
$0 and $200,000, respectively, toward the agreement which is included as a
component of research and development expenses.
 
 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
2009 and 2008, 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.
  F-18
  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. Biomarkers will have the capability to run AdnaGen assays in a Clinical
Laboratory Improvement Amendments (“CLIA”) laboratory based in New York in order
to support on-going and planned clinical trials.  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 continue through
December 2010, unless terminated by either party under the terms of the
agreement. In 2009 and 2008, the Company recorded revenue of approximately
$105,000 (€75,000) and $52,000 (€35,000) from the sale of diagnostic kits to
Biomarkers, respectively.
 
 Note
      11.
              CHANGES
      IN 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, 2009, shares of common stock reserved for future issuance are as
follows:
 
 Stock
      options outstanding
                    
                    
                    650,000Warrants
      outstanding
                    
                    
                    3,681,712Stock
      options available for grant
                    
                    
                    2,916,8007,248,512
 
 In June
2008, the Company granted 100,000 shares of its common stock to a consultant for
services valued at $110,000 based upon the quoted closing trading price on the
date of issuance.
 
 Restricted
Stock
 
 In
October 2007, OncoVista granted an aggregate of 2,000,000 shares of restricted
stock to certain officers for $3.5 million based upon the quoted closing trading
price on the date of issuance.  These shares vest, subject to future
service requirements, two thirds on January 1, 2010 and one third on January 1,
2011. As of December 31, 2009, there was approximately $1.2 million of total
unrecognized compensation cost related to unvested restricted
stock.  For the years ended December 31, 2009 and 2008, compensation
expense of approximately $1.2 million and $1.2 million, respectively, was
recognized for vested restricted stock grants.
 
 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.
  F-19
 
 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 2009 and 2008 included the following: one-half vesting on the first
anniversary and one-half on the second anniversary and annually over four
years.  The Company granted 1,010,000 and 240,000 options for future
services having fair values of $1,054,560 and $463,220 in 2009 and 2008,
respectively.
 
 The
stock-based compensation expense recorded by the Company for the years ended
December 31, 2009 and 2008, with respect to awards under the all option plans is
as follows:
 
 2009
                    
                    
                    2008Research
      and development
                    
                    $
                    362,256
                    
                    
                    $
                    119,122General
      and administrative
                    
                    
                    408,711
                    
                    
                    
                    271,953Total
      employee stock-based compensation
                    
                    $
                    770,967
                    
                    
                    $
                    391,075
 
 The
Company recognized $140,856 and $165,826 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, 2009 and 2008,
respectively.
 
 The
Company has followed 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
Black-Scholes assumptions used in the years ended December 31, 2009 and 2008 are
as follows:
 
 2009
                        
                        
                        2008Risk-free
      interest rate
                        
                        0.45-1.46%
                        
                        
                        2.54-3.09%Expected
      dividend yield
                        
                        0%
                        
                        
                        0%Expected
      volatility
                        
                        86.5%
                        
                        
                        80.5%Expected
      life of option
                        
                        10
      years
                        
                        
                        10
      yearsExpected
      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
                        ValueOutstanding
      at January 1, 2009
                      
                      
                      1,180,000
                      
                      
                      $
                      1.19Granted
                      
                      
                      1,010,000
                      
                      
                      $
                      0.01Exercised
                      
                      
                      (833,200
                      )
                      
                      $
                      0.001Forfeited
                      
                      
                      (706,800
                      )
                      
                      $
                      0.56Outstanding
      at December 31, 2009
                      
                      
                      650,000
                      
                      
                      $
                      1.57
                      
                      6.4
      years
                      
                      $
                      31,800Options
      Exercisable at December 31, 2009
                      
                      
                      510,000
                      
                      
                      $
                      1.46
                      
                      6.1
      years
                      
                      $
                      31,800
  F-20
 
 The
following summarizes the activity of the Company’s stock options that have not
vested for the year ended December 31, 2009:
 
 2009
                    
                    
                    2008Shares
                    
                    
                    Weighted
                      Average
                      Grant
                      Date Fair
                      Value
                    
                    
                    Shares
                    
                    
                    Weighted
                      Average
                      Grant Date
                      Fair ValueOutstanding
      at January 1
                    
                    
                    532,500
                    
                    
                    $
                    2.09
                    
                    
                    
                    550,000
                    
                    
                    $
                    2.31Granted
                    
                    
                    1,010,000
                    
                    
                    
                    1.04
                    
                    
                    
                    240,000
                    
                    
                    
                    1.93Vested
                    
                    
                    (820,700
                    )
                    
                    
                    1.39
                    
                    
                    
                    (207,500
                    )
                    
                    
                    2.37Cancelled
      or forfeited
                    
                    
                    (581,800
                    )
                    
                    
                    1.31
                    
                    
                    
                    (50,000
                    )
                    
                    
                    2.50Outstanding
      at December 31
                    
                    
                    140,000
                    
                    
                    $
                    1.92
                    
                    
                    
                    532,500
                    
                    
                    $
                    2.09
 
 The total
intrinsic value of stock option exercises during the years ended December 31,
2009 and 2008 was approximately $118,000 and $178,000,
respectively.
 
 Stock
and Warrants Issued for Licensing Rights of Intellectual Property
 
 During
2007, the Company issued 500,000 shares of common stock and 200,000 stock
warrants having a fair value of approximately $1.7 million to acquire the
licensing rights for intellectual property held by OSI (See Note
8).
 
 Warrants
 
 In
January 2009, in connection with the Bridge Note financing (See Note 6), the
Company 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.
 
 In
February 2008, the Company issued warrants to a consultant for services to
acquire 540,000 shares of common stock as follows: up to 180,000 shares at $2.50
per share; 180,000 shares at $3.50 per share; and 180,000 shares at $4.50 per
share, vesting in equal monthly installments over one year.
 
 In 2007,
the Company issued two warrants in connection with a license agreement with OSI
(See Note 8).  The first warrant is exercisable into the number of
shares of the Company’s common stock equal to $5.0 million divided by the
average closing price of the Company’s common stock on a national securities
exchange registered with the SEC for the 20 consecutive trading days immediately
following the listing of OncoVista’s common stock on such exchange; provided
that the warrant shall be exercisable for 19.99% of the Company’s outstanding
shares of common stock if the exercise of the warrant results in a number of
shares exceeding 20% of outstanding shares of common stock.  As the
Company’s stock is currently traded on the Over-the-Counter Bulletin Board, this
warrant has not been granted. The second warrant is exercisable, through
September 2013, for 200,000 shares of common stock at an exercise price of $2.50
per share. The warrants provide for an exercise on a “cashless” or “net
issuance” basis and are subject to adjustment for events such as stock splits,
stock dividends, distributions, reorganizations, consolidations, and mergers
affecting the Company’s common stock.
 
 In 2007,
the Company also issued 50,000 warrants to a third party at an exercise price of
$2.50 per share in return for professional and consulting services, exercisable
through November 2012. The Company valued these warrants based on the
Black-Scholes option pricing model and recorded $122,070 as a non-cash
charge.
  F-21
 
 The
Black-Scholes assumptions used for warrants for the years ended December 31,
2009 and 2008 are as follows:
 
 2009
                        
                        
                        2008Risk-free
      interest rate
                        
                        2.13%
                        
                        
                        2.13%Expected
      dividend yield
                        
                        0%
                        
                        
                        0%Expected
      volatility
                        
                        80.5%
                        
                        
                        80.5%Expected
      life of option
                        
                        5
      years
                        
                        
                        5
      yearsExpected
      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
                      ValueOutstanding
      at January 1, 2009
                    
                    
                    2,931,712
                    
                    
                    $
                    2.47Granted
                    
                    
                    750,000
                    
                    
                    $
                    0.50Exercised
                    
                    
                    -
                    
                    
                    
                    -Forfeited
                    
                    
                    -
                    
                    
                    
                    -Outstanding
      at December 31, 2009
                    
                    
                    3,681,712
                    
                    
                    $
                    2.06
                    
                    2.92
      years
                    
                    
                    *Warrants
      Exercisable at December 31, 2009
                    
                    
                    3,681,712
                    
                    
                    $
                    2.06
                    
                    2.92
      years
                    
                    
                    *
 
 *Intrinsic
value less than zero
 
 Note
      12.
              INCOME
      TAXES
 
 The
Company files separate tax returns for its parent and AdnaGen AG, the Company’s
German operating subsidiary.  The parent company does not benefit from
any losses or incur any tax liabilities with respect to its ownership of AdnaGen
AG.  Accordingly, the Company has not incurred any U.S. Federal or
State tax expense since its inception.
 
 Significant
deferred tax assets at December 31, 2009 and 2008 are as follows:
 
 2009
                      
                      
                      2008Deferred
      tax assets:Net
      operating loss carryforwards, United States
                      
                      $
                      5,206,000
                      
                      
                      $
                      4,912,000Impairment
      loss
                      
                      
                      607,000
                      
                      
                      
                      607,000Share-based
      compensation and consulting
                      
                      
                      1,650,000
                      
                      
                      
                      985,000Other
                      
                      
                      20,000
                      
                      
                      
                      27,000Total
      deferred tax assets
                      
                      
                      7,483,000
                      
                      
                      
                      6,531,000Less:
      valuation allowance
                      
                      
                      (7,483,000
                      )
                      
                      
                      (6,531,000
                      )Net
      deferred tax assets
                      
                      $
                      −
                      
                      
                      $
                      −
  F-22
 
 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, 2009 and 2008.
 
 At
December 31, 2008, OncoVista, Inc. had U.S. tax net operating loss carryforwards
of approximately $15.3 million available to offset future taxable income which
will expire at various dates through 2029.  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, 2009 and 2008 (computed by applying the U.S. Federal Corporate tax
rate of 34% to income before taxes) are as follows:
 
 2009
                    
                    
                    2008Expected
      tax expense (benefit)
                    
                    
                    (34.0
                    )%
                    
                    
                    (34.0
                    )%Permanent
      differences:Translation
      loss and other items
                    
                    
                    7.9
                    %
                    
                    
                    0.4
                    %Rate
      differential and impact of foreign subsidiary
                    
                    
                    6.3
                    %
                    
                    
                    4.2
                    %Change
      in valuation allowance
                    
                    
                    19.8
                    %
                    
                    
                    29.4
                    %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) are made by AdnaGen AG, the Company’s
German subsidiary.
 
 A summary
of the Company’s operations for the years end December 31, 2009 and 2008 is
provided below:
 
 2009OncoVista
                    
                    
                    AdnaGen
                    
                    
                    TotalRevenues
                    
                    $
                    –
                    
                    
                    $
                    982,048
                    
                    
                    $
                    982,048Operating
      expenses
                    
                    
                    3,927,905
                    
                    
                    
                    1,835,284
                    
                    
                    
                    5,763,189Loss
      from operations
                    
                    
                    (3,927,905
                    )
                    
                    
                    (853,236
                    )
                    
                    
                    (4,781,141
                    )Other
      income (expense), net
                    
                    
                    (2,601
                    )
                    
                    
                    (40,363
                    )
                    
                    
                    (42,964
                    )Net
      loss
                    
                    $
                    (3,930,506
                    )
                    
                    $
                    (893,599
                    )
                    
                    $
                    (4,824,105
                    )Total
      assets
                    
                    $
                    32,024
                    
                    
                    $
                    378,118
                    
                    
                    $
                    410,142
  F-23
 
 2008OncoVista
                    
                    
                    AdnaGen
                    
                    
                    TotalRevenues
                    
                    $
                    –
                    
                    
                    $
                    503,325
                    
                    
                    $
                    503,325Operating
      expenses
                    
                    
                    6,593,916
                    
                    
                    
                    1,920,830
                    
                    
                    
                    8,514,746Loss
      from operations
                    
                    
                    (6,593,916
                    )
                    
                    
                    (1,417,505
                    )
                    
                    
                    (8,011,421
                    )Other
      income (expense), net
                    
                    
                    9,760
                    
                    
                    
                    519,637
                    
                    
                    
                    529,397Net loss
                    
                    $
                    (6,584,156
                    )
                    
                    $
                    (897,868
                    )
                    
                    $
                    (7,482,024
                    )Total
      assets
                    
                    $
                    85,824
                    
                    
                    $
                    468,309
                    
                    
                    $
                    554,133
 
 Note
      14.
              SUBSEQUENT
      EVENTS
 
 In
January 2010, the Company obtained consent from the holders of the Bridge Note
financing (See Note 6) to extend the maturity date from January 15, 2010 until
the earlier of July 15, 2010 or such time that the Company obtains a “Qualified
Financing”.  The Company revised the term “Qualified Financing” from
aggregate gross proceeds of which equal or exceed $5.0 million to $3.0 million,
and increased the interest rate from 10 percent to 12
percent.  Additionally, the Company extended the expiration date for
the warrants granted in connection with the financing to July 15, 2014, and the
exercise price was reduced to $0.10 per share.
 
 F-24