UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended March 31,
2015
¨
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _________
to __________
Commission file number: 000-28347
ONCOVISTA INNOVATIVE THERAPIES, INC.
(Exact name of registrant as specified in its
charter)
Nevada |
33-0881303 |
(State or other jurisdiction of
incorporation or organization) |
(IRS Employer Identification
No.) |
14785 Omicron Drive
Suite 104
San Antonio, Texas 78245
(Address of principal executive offices)
(210) 677-6000
(Registrant's telephone number, including area
code)
Indicate
by check mark whether the issuer: (1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days. Yes x
No ¨
Indicate
by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive
Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post
such files). Yes x
No ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller
reporting company. See the definitions of “large accelerated
filer,” “accelerated
filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ¨
Accelerated filer ¨
Non-accelerated filer ¨
Smaller reporting company x
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨
No x
State the number of shares outstanding of each of the registrant's
classes of common equity, as of the latest practicable date: 22,012,896 shares of common stock with a par value of $.001 outstanding
as of May 14, 2015
ONCOVISTA INNOVATIVE THERAPIES, INC.
FORM 10-Q
FOR THE QUARTER ENDED MARCH 31, 2015
TABLE OF CONTENTS
PART I – FINANCIAL INFORMATION
ITEM
1 – FINANCIAL STATEMENTS
ONCOVISTA INNOVATIVE THERAPIES, INC. AND
SUBSIDIARIES
Consolidated Balance Sheets
| |
March 31, | | |
December 31, | |
| |
2015 | | |
2014 | |
| |
| (Unaudited) | | |
| | |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash
| |
$ | 56,030 | | |
$ | 12,514 | |
Total current assets | |
| 56,030 | | |
| 12,514 | |
| |
| | | |
| | |
Total assets | |
$ | 56,030 | | |
$ | 12,514 | |
| |
| | | |
| | |
LIABILITIES AND DEFICIT | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable (including related party accounts
payable of $1,390,293 and $1,304,293, respectively) | |
$ | 1,747,819 | | |
$ | 1,671,909 | |
Accrued expenses (including related party accrued
expenses of $785,000 and $760,000, respectively) | |
| 2,709,865 | | |
| 2,579,436 | |
Loan payable (including accrued interest of $12,995
and $8,329, respectively) | |
| 322,995 | | |
| 208,329 | |
Current portion of settlement payable | |
| 450,000 | | |
| 450,000 | |
Other liability – stock grant | |
| 66,000 | | |
| 66,000 | |
| |
| | | |
| | |
Total current liabilities | |
| 5,296,679 | | |
| 4,975,674 | |
| |
| | | |
| | |
Settlement payable – net of current portion | |
| 700,000 | | |
| 700,000 | |
Total liabilities | |
| 5,996,679 | | |
| 5,675,674 | |
| |
| | | |
| | |
Deficit | |
| | | |
| | |
Common stock, $.001 par value; 147,397,390 shares authorized, 22,
012,896 shares issued and outstanding | |
| 22,012 | | |
| 22,012 | |
Additional paid-in capital | |
| 20,217,341 | | |
| 20,217,341 | |
Accumulated deficit | |
| (26,180,002 | ) | |
| (25,902,513 | ) |
Total deficit | |
| (5,940,649 | ) | |
| (5,663,160 | ) |
Total liabilities and deficit | |
$ | 56,030 | | |
$ | 12,514 | |
See accompanying notes to the condensed consolidated
financial statements
ONCOVISTA INNOVATIVE THERAPIES, INC. AND
SUBSIDIARIES
Consolidated Statements of Operations
(Unaudited)
| |
Three Months Ended March 31, | |
| |
2015 | | |
2014 | |
Revenue | |
$ | – | | |
$ | – | |
| |
| | | |
| | |
Operating expenses: | |
| | | |
| | |
Research and development | |
| 160,909 | | |
| 150,273 | |
General and administrative | |
| 111,915 | | |
| 95,070 | |
Total operating expenses | |
| 272,824 | | |
| 245,343 | |
| |
| | | |
| | |
Other income (expense): | |
| | | |
| | |
Interest expense | |
| (4,665 | ) | |
| - | |
Interest income | |
| - | | |
| 5 | |
Loss on derivative liability | |
| - | | |
| (62,019 | ) |
Total other expense | |
| (4,665 | ) | |
| (62,014 | ) |
| |
| | | |
| | |
Net loss | |
$ | (277,489 | ) | |
$ | (307,357 | ) |
| |
| | | |
| | |
Net loss per share – basic and diluted | |
$ | (0.01 | ) | |
$ | (0.01 | ) |
| |
| | | |
| | |
Weighted average number of shares outstanding during the period - basic and diluted | |
| 22,012,896 | ` | |
| 21,627,868 | |
See accompanying notes to the condensed consolidated
financial statements
ONCOVISTA INNOVATIVE THERAPIES, INC. AND
SUBSIDIARIES
Consolidated Statements of Cash Flows
(Unaudited)
| |
Three Months Ended March 31, | |
| |
2015 | | |
2014 | |
Cash flows from operating activities | |
| | | |
| | |
Net loss | |
$ | (277,489 | ) | |
$ | (307,357 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Stock-based compensation | |
| - | | |
| 995 | |
Depreciation | |
| - | | |
| 477 | |
Loss on derivative liability | |
| - | | |
| 62,019 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid and other current assets | |
| - | | |
| 47,680 | |
Accounts payable | |
| 75,910 | | |
| 181,159 | |
Accrued expenses | |
| 130,429 | | |
| - | |
Accrued interest payable | |
| 4,666 | | |
| - | |
Net cash used in operating activities | |
| (66,484 | ) | |
| (15,027 | ) |
Cash flows from investing activities | |
| - | | |
| - | |
Cash flows from financing activities | |
| | | |
| | |
Proceeds from loans payable | |
| 110,000 | | |
| - | |
Net cash provided by financing activities | |
| 110,000 | | |
| - | |
Increase (decrease) in cash and cash equivalents | |
| 43,516 | | |
| (15,027 | ) |
Cash and cash equivalents at beginning of period | |
| 12,514 | | |
| 44,898 | |
Cash and cash equivalents at end of period | |
$ | 56,030 | | |
$ | 29,871 | |
See accompanying notes to the condensed consolidated
financial statements
| Note 1. | BASIS OF PRESENTATION, ORGANIZATION AND NATURE OF
OPERATIONS |
OncoVista Innovative Therapies, Inc. (“OVIT”) is a
biopharmaceutical company developing targeted anticancer therapies by utilizing tumor-associated biomarkers. OVIT’s
product pipeline is comprised of advanced (Phase II) and early (Phase I) clinical-stage compounds, late preclinical drug candidates
and early preclinical leads. OVIT is not committed to any single treatment modality or class of compound, but believes that successful
treatment of cancer requires a tailored approach based upon individual patient disease characteristics.
Through its former subsidiary, AdnaGen AG (“AdnaGen”),
OVIT previously developed diagnostic kits for several cancer indications, and marketed diagnostic kits in Europe for the detection
of circulating tumor cells (“CTCs”) in patients with cancer.
OVIT used the proceeds from the sale of its shares in AdnaGen to
fund development activities for its drug candidate portfolio. Additionally, OVIT is evaluating several opportunities
to license or acquire other compounds or diagnostic technologies that it believes will provide for treatments that are highly
targeted with low or no toxicity.
At March 31, 2015, OVIT had two full time employees. OncoVista,
Inc. (“OncoVista”), OVIT’s operating subsidiary, had no full-time employees.
| Note 2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
Basis of Presentation
The accompanying unaudited interim condensed consolidated financial
statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”)
and the rules and regulations of the United States Securities and Exchange Commission (the “Commission”) for interim
financial information. Accordingly, they do not include all the information and footnotes necessary for a comprehensive presentation
of financial position, results of operations, and changes in deficit or cash flows. It is management's opinion, however, that
all material adjustments (consisting of normal recurring adjustments) have been made which are necessary for a fair financial
statement presentation. The interim results for the period ended March 31, 2015 are not necessarily indicative of results for
the full fiscal year.
The unaudited interim consolidated financial statements should
be read in conjunction with the required financial information included as part of OVIT’s Form 10-K for the year ended December
31, 2014.
Principles of Consolidation
The consolidated financial statements include the accounts of OVIT
and OncoVista (collectively, the “Company”). All intercompany balances have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with GAAP
requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses
during the reporting period. Actual results could differ from those estimates.
Significant estimates include the valuation of warrants and stock
options granted for services or compensation, estimates of the probability and potential magnitude of contingent liabilities and
the valuation allowance for deferred tax assets.
Net Loss per Share
Basic earnings (loss) per share are computed by dividing the net
income (loss) by the weighted average number of common shares outstanding. Diluted earnings per share is computed by
dividing net income by the weighted average number of common shares outstanding including the effect of share equivalents. Common
stock equivalents consist of shares issuable upon the exercise of certain common stock purchase warrants and stock options.
As the Company had net losses from operations for the three
month periods ended March 31, 2015 and 2014, respectively, all unvested restricted stock, stock options and warrants are
considered to be anti-dilutive. At March 31, 2015 and 2014, the following shares have been excluded since their inclusion in
the computation of diluted EPS would be anti-dilutive:
| |
2015 | | |
2014 | |
Stock options outstanding under various stock option plans | |
| 1,231,500 | | |
| 1,381,500 | |
Warrants | |
| 350,000 | | |
| 1,625,000 | |
Restricted shares | |
| 336,847 | | |
| 300,000 | |
Total | |
| 1,918,347 | | |
| 3,306,500 | |
Share-Based Compensation
All share-based payments to employees are
recorded and expensed in the statements of operations under Accounting Standards Codification (“ASC”) 718 “Compensation
– Stock Compensation.” ASC 718 requires the measurement and recognition of compensation expense
for all share-based payment awards made to employees and directors including grants of employee stock options based on estimated
fair values. The Company has used the Black-Scholes option-pricing model to estimate grant date fair value for all
option grants.
Share-based compensation expense is based
on the value of the portion of share-based payment awards that is ultimately expected to vest during the year, less expected forfeitures. ASC
718 requires forfeitures to be estimated at the time of grant and revised, if necessary in subsequent periods if actual forfeitures
differ from those estimates.
Recent Accounting Pronouncements
The Company continually
assesses any new accounting pronouncements to determine their applicability. When it is determined that a new accounting pronouncement
affects the Company’s financial reporting, the Company undertakes a study to determine the consequences of the change to
its consolidated financial statements and assures that there are proper controls in place to ascertain that the Company’s
consolidated financial statements properly reflect the change.
In May 2014, FASB
issued ASU No. 2014-09 “Revenue from Contracts from Customers,” which supersedes the revenue recognition requirements
in “Revenue Recognition (Topic 605),” and requires entities to recognize revenue in a way that depicts the transfer
of potential goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled
to the exchange for those goods or services. ASU 2014-09 is effective for fiscal years, and interim periods within those years,
beginning after December 15, 2016, and is to be applied retrospectively, with early adoption not permitted. The Company is currently
evaluating the new standard and assessing the potential impact on its operations and financial statements.
| Note 3. | GOING CONCERN AND MANAGEMENT’S PLANS |
As reflected in the accompanying consolidated financial statements,
the Company reported a net loss of approximately $277,000, and net cash used in operations of approximately $66,000 for the three
months ended March 31, 2015, an accumulated deficit of approximately $26.2 million and total deficit of approximately $5.9 million
at March 31, 2015. These factors raise substantial 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, obtain additional capital, principally by obtaining additional debt and/or equity financing, and generate revenues from
collaborative agreements or sale of pharmaceutical products. There can be no assurance that these plans will be sufficient or
that additional financing will be available in amounts or terms acceptable to the Company, if at all.
Note 4. EQUIPMENT
Equipment balances at March 31, 2015 and December 31, 2014 are
summarized below:
| |
2015 | | |
2014 | |
Equipment | |
$ | 30,132 | | |
$ | 30,132 | |
Computer and office equipment | |
| 9,326 | | |
| 9,326 | |
| |
| 39,458 | | |
| 39,458 | |
Less: accumulated depreciation | |
| (39,458 | ) | |
| (39,458 | ) |
Equipment, net | |
$ | - | | |
$ | - | |
Accrued expenses at March 31, 2015 and December 31, 2014 are summarized
below:
| |
2015 | | |
2014 | |
Legal and professional | |
$ | 32,000 | | |
$ | 58,025 | |
Clinical and other studies | |
| 138,427 | | |
| 138,427 | |
Compensation | |
| 1,460,292 | | |
| 1,341,338 | |
Minimum royalty | |
| 1,047,500 | | |
| 1,010,000 | |
Other | |
| 31,646 | | |
| 31,646 | |
Total accrued expenses | |
$ | 2,709,865 | | |
$ | 2,579,436 | |
During the three months ended March 31, 2015, the Company borrowed $110,000 on various dates in exchange
for unsecured notes from a related party. The notes have an interest rate of 8%, and are due in one year from the date of issuance.
If the Company has not paid the notes in full by respective due dates, the interest rate increases to 10% per annum. Accrued interest
at March 31, 2015 is $12,995.
During the year ended December 31, 2014,
the Company borrowed $200,000 in exchange for unsecured notes totaling $200,000. The notes have an interest rate of 8%, and
are due on April 15, 2015. As the Company has not paid the notes in full and the holders have not converted the notes by
April 15, 2015, the interest has now rate increased to 10% per annum. The debt holders may convert the principal and any
interest into shares of common stock at a price of $0.75 per share, or 80% of the per share price of the Company’s next
equity offering.
The Company has evaluated the conversion and
contingent conversion features of the notes and determined that there is no bifurcation of the embedded conversion option required,
and that there was no beneficial conversion feature on the date of the borrowing or as of March 31, 2015.
Subsequent to the period ended March 31, 2015, the Company received additional bridge loans in the amount
of $30,000 from a related party. The loan was made prior to April 15, 2015 and on the same terms as the 2015 bridge loans. Subsequent
to April 15, 2015, no principal and interest were converted into shares of common stock.
| Note 7. | FAIR VALUE INFORMATION |
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 as of March 31, 2015 and December 31, 2014, respectively. The fair values
of accounts payable, notes payable and stock grant liability approximate the carrying amounts due to the short term nature of
these instruments. The fair value of related party accounts payable and accrued expenses are not practicable to estimate due to
the related party nature of the underlying transactions.
Note 8. LEASES, COMMITMENTS AND CONTINGENCIES
Lease Obligations
In January 2011, the Company entered a three-year lease with an affiliate of the CEO for laboratory space
which expired in December 2013. During 2014 and the three months ended March 31, 2015, the Company utilized the space even though
no terms have been negotiated and no payments have been made. The Company, however, continued to record rent expense on a month
to month basis. Total rent expense amounted to approximately $36,000 for each of the three month periods ended March 31, 2015 and
2014. These amounts are included in accrued expenses.
Legal Matters
On August 11, 2011, an action was filed against the Company in the United States District Court for the
Southern District of New York, entitled New Millennium PR Communications, Inc., against OncoVista Innovative Therapies, Inc., seeking
damages for the alleged breach of a public relations agreement. On January 31, 2013, a settlement was reached whereby the Company
agreed to pay New Millennium $7,000, in two payments of $3,500 each, and issue 25,000 warrants at an exercise price of $0.25 per
share.
On August 26, 2011, an action was filed against the Company in the Supreme Court of the State of New York,
New York County, entitled CAMOFI Master LDC and CAMHZN LDC against OncoVista Innovative Therapies, Inc. and OncoVista, Inc. The
action seeks damages for the alleged breach of a Subscription Agreement, a Warrant Agreement and an Anti-Dilution Agreement and
seeks an order directing the issuance of (i) an aggregate of 1,980,712,767 shares of the Company’s common stock, and (ii)
warrants to purchase an aggregate of 702,857,767 shares of the Company’s common stock at an exercise price of $0.001. On
October 20, 2011, the Company filed an answer to the complaint. On November 1, 2011, the plaintiffs made an extensive document
request to the Company for all documents related to the matter. The Company’s counsel has started taking depositions and
has requested access to CAMOFI Master LDC and CAMHZN Master LDC principals for further depositions. On June 29, 2012 CAMOFI Master
LDC and CAMHZN Master LDC filed for summary judgment. On August 9, 2012 the parties filed a stipulation with the court extending
the return date of motion for summary judgment until September 10, 2012. The court has not yet ruled on the motion to dismiss.
Oral arguments for the motion were conducted before the court on January 17, 2013. The judge asked the parties to reconvene and
to try to seek a settlement. While the judge indicated her belief that the Company was in breach of the anti-dilution agreement,
she also indicated that it may not be equitable to direct the issuance of hundreds of millions of additional shares, and reserved
her decision on the issue at that time. On March 5, 2015, the parties were able to reach a framework for settlement. The final
documents of the settlement are in preparation. Management estimated, based on the framework reached in March of 2015, that the
Company will pay approximately $1.2 million in settlement costs. This amount has been recorded as a settlement payable and is due
over a period of three years. If the Company does not meet the terms of the settlement framework, the framework would require the
Company to make additional payments of approximately $3.8 million.
On February 16, 2012, the Company filed an
action in the 225 Judicial District Court of the State of Texas, Bexar County, entitled OncoVista Innovative Therapies, Inc. against
J. Michael Edwards. The action seeks damages relating to the executive employment agreement of J. Michael Edwards, our former
Chief Financial Officer. Specifically we are seeking to have the Stock Option Agreement granted to Mr. Edwards on January 6, 2009
be declared void ab initio. The Company is also seeking damages and attorney fees. On March 30, 2012, the Company
received a copy of a counterclaim that may be filed in the same court and is seeking approximately $197,000, plus certain health
and life insurance benefits, in alleged compensation due. On December 12, 2012 Mr. Edwards filed a third party petition in the
court against third party defendant Alexander L. Weis, our Chairman, CEO & President. Depositions are ongoing and the Company
believes the counterclaimant’s allegations are without merit and intends to vigorously defend these claims.
| Note 9. | RELATED PARTY TRANSACTIONS |
Alexander L. Weis, Ph.D., Chairman of the Company’s Board
of Directors and its Chief Executive Officer, President, Chief Financial Officer and Secretary, and a significant shareholder,
is a beneficial owner of Lipitek International, Inc. and Lipitek Research, LLC. The Company leases its laboratory space from Lipitek,
Inc. During 2014 and three months ended March 31, 2015, the Company utilized the space even though no terms have been negotiated
and no payments have been made. The Company, however, continued to record rent expense on a month to month basis. Management believes
that rent is based on reasonable and customary rates as if the space were rented to a third party.
On November 17, 2005, the Company entered into a purchase agreement
with Lipitek and Dr. Weis, under which Lipitek granted the Company an option to purchase all membership interests in Lipitek Research,
LLC (Lipitek Research) for a purchase price of $5.0 million, which is payable quarterly based upon revenues of Lipitek Research
up to $50,000 per quarter. Through March 31, 2015, the Company had paid a total of $550,000 toward this agreement and has accrued
$1,100,000, representing one quarterly payment for 2009 and all of the 2010, 2011, 2012, 2013, 2014 and one quarter of 2015 amounts,
which are included in accounts payable in the consolidated balance sheets as of March 31, 2015 and December 31, 2014 and as a
component of research and development expense for the three months ended March 31, 2015 and 2014. The Company has not made any
payments toward the agreement in 2014 and 2015.
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 2015 and 2014, the Company did
not recognize any revenue from its share of Lipitek revenue.
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 would be 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.
In addition, the Company has a license agreement with Lipitek which requires the Company to pay minimum
royalties. The Company has accrued $25,000 and $100,000, which is included in accrued expenses in the consolidated balance sheet
of as of March 31, 2015 and December 31, 2014, respectively.
Common Stock
The Company is authorized to issue up to 147,397,390 shares of
common stock. At March 31, 2015, shares of common stock reserved for future issuance are as follows:
Stock options outstanding | |
| 1,231,500 | |
Warrants outstanding | |
| 350,000 | |
Stock options available for grant | |
| 2,309,250 | |
Restricted shares | |
| 336,847 | |
| |
| 4,227,597 | |
Stock Option Plans
All option grants are expensed in the appropriate period based
upon each award’s vesting terms, in each case with an offsetting credit to additional paid in capital. Under the authoritative
guidance for share based compensation, in the event of termination, the Company will cease to recognize compensation expense.
There is no deferred compensation recorded upon initial grant date, instead, the fair value of the share-based payment is recognized
ratably over the stated vesting period. No stock options were granted during the three months ended March 31, 2015 and 2014.
The stock-based compensation expense recorded by the Company for
the three months ended March 31, 2015 and 2014, with respect to awards under the Company’s stock plans are as follows:
| |
2015 | | |
2014 | |
Research and development | |
$ | - | | |
$ | 995 | |
Total employee stock-based compensation | |
$ | - | | |
$ | 995 | |
The following is a summary of the Company’s stock option
activity:
| |
Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Term | |
Aggregate Intrinsic Value | |
| |
| | |
| | |
| |
| |
Outstanding at January 1, 2015 | |
| 1,381,500 | | |
$ | 0.91 | | |
| |
| | |
Granted | |
| – | | |
| – | | |
| |
| | |
Exercised | |
| – | | |
| – | | |
| |
| | |
Forfeited | |
| (150,000 | ) | |
| 0.10 | | |
| |
| | |
Outstanding at March 31, 2015 | |
| 1,231,500 | | |
$ | 1.01 | | |
4.06 years | |
$ | 99,450
| |
Options Exercisable at March 31, 2015 | |
| 1,231,500 | | |
$ | 1.01 | | |
4.06 years | |
$ | 99,450
| |
Warrants
The following is a summary of the Company’s warrant activity:
| |
Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Term | | |
Aggregate Intrinsic Value | |
Outstanding at January 1, 2015 | |
| 350,000 | | |
$ | 0.37 | | |
| | | |
| | |
Granted | |
| - | | |
| | | |
| | | |
| | |
Forfeited | |
| - | | |
| | | |
| | | |
| | |
Outstanding at March 31, 2015 | |
| 350,000 | | |
$ | 0.37 | | |
| 0.51 | | |
$ | 13,875 | |
Exercisable at March 31, 2015 | |
| 350,000 | | |
$ | 0.37 | | |
| 0.51 | | |
$ | 13,875 | |
ITEM
2 – MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Our Management’s Discussion and Analysis
contains not only statements that are historical facts, but also statements that are forward-looking (within the meaning of Section
27A of the Securities Act and Section 21E of the Exchange Act). Forward-looking statements are, by their very nature,
uncertain and risky. These risks and uncertainties include international, national and local general economic and market
conditions; demographic changes; our ability to sustain, manage, or forecast growth; our ability to successfully make and integrate
acquisitions; raw material costs and availability; new product development and introduction; existing government regulations and
changes in, or the failure to comply with, government regulations; adverse publicity; competition; the loss of significant customers
or suppliers; fluctuations and difficulty in forecasting operating results; changes in business strategy or development plans;
business disruptions; the ability to attract and retain qualified personnel; the ability to protect technology; and other risks
that might be detailed from time to time in our filings with the SEC.
Although the forward-looking statements in
this report reflect the good faith judgment of our management, such statements can only be based on facts and factors currently
known by them. Consequently, and because forward-looking statements are inherently subject to risks and uncertainties,
the actual results and outcomes may differ materially from the results and outcomes discussed in the forward-looking statements.
You are urged to carefully review and consider the various disclosures made by us in this report and in our other reports as we
attempt to advise interested parties of the risks and factors that may affect our business, financial condition, and results of
operations and prospects.
The following discussion and analysis should
be read in conjunction with our financial statements, including the notes thereto, appearing elsewhere in this Report.
Overview
We are a biopharmaceutical company developing
targeted anticancer therapies by utilizing tumor-associated biomarkers. Our therapeutic strategy is based on targeting the patient’s
tumor(s) with treatments that will deliver drugs selectively based upon specific biochemical characteristics of the cancer cells
comprising the tumor. Through a combination of licensing agreements, as well as mergers and acquisitions, we have acquired the
rights to several technologies with the potential to more effectively treat cancers and significantly improve quality-of-life
for patients. We believe that the development of targeted approaches to the administration of anticancer agents should lead to
improved outcomes and reduced toxicity.
We previously developed diagnostic kits through
our former majority-owned German operating subsidiary, AdnaGen, for several cancer indications, and marketed diagnostic kits in
Europe for the detection of CTCs in patients with cancer. On October 28, 2010, we entered into a Stock Purchase Agreement
with Alere Holdings, whereby we, and the other AdnaGen shareholders, agreed to sell our respective shares of AdnaGen, and all
AdnaGen related business assets, to Alere Holdings for: (i) a $10 million up-front payment; (ii) $10 million in potential milestone
payments contingent upon the achievement of various balance sheet objectives within 24 months; and (iii) up to $63 million in
potential milestone payments contingent upon the achievement of various clinical, regulatory and sales objectives within next
36 months. We are entitled to receive our pro rata portion of approximately 78.01% of the up-front and potential milestone payments. In
November 2010, we received $6.0 million, net of expenses and certain fees, as our share of the $10 million up-front payment. No
milestone payments were received in 2015 or 2014.
Development Programs
Our most advanced product candidate is Cordycepin
(OVI-123) which is in Phase I/II clinical trials for refractory leukemia patients who express the enzyme terminal deoxynucleotidyl
transferase (TdT). We have received orphan drug designation from the FDA for Cordycepin which affords us seven years of market
exclusivity once the drug is approved for marketing. We initiated a Phase I/II trial based on the “original” ADA-sensitive
compound in the second quarter of 2008. The trial was initiated at two U.S. centers, The Dana Farber Cancer Institute in Boston,
Massachusetts and the Cancer Therapy Research Center at the University of Texas Health Sciences Center at San Antonio, Texas,
and is designed to enroll up to 24 patients in the first stage and up to 20 patients in the second stage. In October 2009, after
enrolling five patients in this clinical trial, we placed the clinical trial on administrative hold due to our limited capital
resources. We have engaged a clinical research organization (“CRO”) in France to do additional pre-clinical in-vitro
evaluations of Cordycepin and the ADA inhibitor Pentostatin with the intent of gaining a better understanding of the inhibition
effects of Pentostatin on Cordycepin. We are in the process of reinitiating the Phase I/II clinical trial to determine the maximum
tolerated dose, and expect to start enrolling patients in 2015 if additional financing is available.
We have completed Good Laboratory Practice
(“GLP”) animal drug safety studies in two species for our lead drug candidate from the L-nucleoside conjugate program
(OVI-117). We have accumulated in vitro and in vivo data indicating that several of the L-nucleoside
conjugates are effective against various types of cancer. To date, OVI-117 has undergone two proof-of-concept studies of human
cancers in animal models, as both a single agent and as a multi-agent combination therapy with oxaliplatin. The Investigational
New Drug application (IND) was submitted to the FDA on June 2, 2012 and approved by the FDA on July 5, 2012. We engaged a contract
manufacturer and a clinical batch of OVI-117 is available for use in our proposed Phase 1 trial. The clinical protocol has been
written and a principal investigator engaged. We believe that OVI-117 should be ready to enter Phase I clinical trials in 2015
if additional financing is available.
Research and development expenditures for
the above projects totaled approximately $161,000 and $150,000 for the three months ended March 31, 2015 and 2014, respectively. We
expect we will incur additional expenses of between $2.0 million to $3.0 million to complete the current phases of development
for the projects described above.
Other Research and Development Plans
In addition to conducting Phase I and Phase II clinical trials,
we plan to conduct pre-clinical research to accomplish the following:
| · | further deepen
and broaden our understanding of the mechanism of action (MoA) of our products in cancer; |
| · | develop alternative
delivery systems and determine the optimal dosage for different patient groups; |
| · | demonstrate
proof of concept in animal models of human cancers; and |
| · | develop successor
products to our current products. |
Other Strategic Plans
In addition to developing our existing anti-cancer
drug portfolio, we plan to obtain rights to additional drug candidates or diagnostic technologies through licensing, partnerships,
and mergers/acquisitions. Our efforts in this area will be guided by business considerations (cost of the opportunity, fit with
existing portfolio, etc.) as well as input from our clinical advisory board regarding likelihood of successful clinical development
and marketing approval. Our goal is to create a well-balanced product portfolio including lead molecules in different stages of
development and addressing different medical needs.
Critical Accounting Policies
We have identified the policies below as critical
to our business operations and the understanding of our results of operations. The impact and any associated risks related to
these policies on our business operations are disclosed throughout this section where such policies affect our reported and expected
financial results. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported
amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of our financial statements, and
the reported amounts of revenues and expenses during the reporting period. There can be no assurance that actual results will
not differ from those estimates.
OncoVista Innovative Therapies, Inc.
Revenue Recognition. While we have
not recognized revenues from continuing operations, we anticipate that future revenues will be generated from product sales. We
expect to recognize revenue from product sales in accordance with SEC, Staff Accounting Bulletin (“SAB”) No. 104,
“Revenue Recognition” that requires we recognize revenue when each of the following four criteria is met: 1) a contract
or sales arrangement exists; 2) products have been shipped or services have been rendered; 3) the price of the products or services
is fixed or determinable; and 4) collectability is reasonably assured. We anticipate that our customers will have no right of
return for products sold. Revenues will be considered to be earned upon shipment.
Share-Based Compensation. We follow
Accounting Standards Codification (“ASC”) 718 “Compensation – Stock Compensation” which
requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and directors
including grants of employee stock options based on estimated fair values. We have used the Black-Scholes option pricing model
to estimate grant date fair value for all option grants. The assumptions we use in calculating the fair value of share-based
payment awards represent management’s best estimates, but these estimates involve inherent uncertainties and the application
of management judgment. As such, as we use different assumptions based on a change in factors, our stock-based compensation expense
could be materially different in the future.
Results of Operations
Three Months Ended March 31, 201 and 2015
Research and development. Research
and development expenses increased by approximately $11,000, or 7%, to
approximately $161,000 for the three months ended March 31, 2015, as compared to approximately $150,000 for the three months ended
March 31, 2014. The increase was due to slightly higher costs in various research and development expenses.
General and administrative. General
and administrative expenses increased by approximately $17,000, or 18%, to approximately $112,000 for the three months ended March
31, 2015, as compared to approximately $95,000 for the three months ended March 31, 2014. The increase was due primarily to an
increase in legal fees.
Other Expense.
Other expense decreased $57,000, or 92% to expense of approximately $5,000 for the three months ended March 31, 2015, as compared
to expense of approximately $62,000 for the three months ended March 31, 2014. The decrease was primarily due to a loss on derivative
liability of approximately $62,000 that was recognized in 2014, partially offset by an increase in an interest expense related
to the bridge loans in 2015.
Going Concern and Recent Events
Our
consolidated financial statements for the three months ended March 31, 2015 have been prepared on a going concern basis, which
contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business.
We reported a net loss of approximately $277,000, and net cash used in continuing operations of approximately $66,000
for the three months ended March 31, 2015, an accumulated deficit of approximately $26.2 million and total deficit of approximately
$5.9 million as of March 31, 2015. The Report of the Independent Registered Public Accounting Firm on the Company’s financial
statements as of and for the year ended December 31, 2014 includes a “going concern” explanatory paragraph expressing
substantial doubt about the Company’s ability to continue as a going concern.
Our ability to continue as a
going concern depends on the success of management’s plans to achieve the following:
| · | Continue
to aggressively seek investment capital; |
| · | Develop
our product pipeline; |
| · | Advance
scientific progress in our research and development; and |
| · | Continue
to monitor and implement cost control initiatives to conserve cash. |
Liquidity and Capital Resources
At March 31, 2015, we had cash and cash equivalents
of approximately $56,000 compared to approximately $13,000 at December 31, 2014. In order to preserve principal and maintain liquidity,
our funds are primarily invested in checking and interest bearing saving accounts with the primary objective of capital preservation.
Based on our current projections, we believe that our available resources and cash flow are sufficient to meet our anticipated
operating cash needs for the next two to three months. Our ability to continue as a going concern is dependent on our ability
to further implement our strategic plan, continue to obtain additional debt and/or equity financing, and generate additional revenues
from collaborative agreements.
To date, we have financed our operations principally
through proceeds of offerings of securities exempt from the registration requirements of the Securities Act. We can provide no
assurance that additional funding will be available on terms acceptable to us, or at all. Accordingly, we may not be able to secure
the funding which is required to expand research and development programs beyond their current levels or at levels that may be
required in the future. If we cannot secure adequate financing, we may be required to delay, scale back or eliminate one or more
of our research and development programs or to enter into license or other arrangements with third parties to commercialize products
or technologies that we would otherwise seek to develop and commercialize ourselves. Our future capital requirements will depend
upon many factors, including:
| · | Continued scientific
progress in our research and development programs; |
| · | Costs and timing
of conducting clinical trials and seeking regulatory approvals and patent prosecutions; |
| · | Competing technological
and market developments; and |
| · | Our ability
to establish additional collaborative relationships. |
Accordingly, we may be required to issue equity
or debt securities or enter into other financial arrangements, including relationships with corporate and other partners, in order
to raise additional capital. Depending upon market conditions, we may not be successful in raising sufficient additional capital
for our short or long-term requirements. In such event, our business, prospects, financial condition, and results of operations
would be materially adversely affected.
Operating
Activities. For the three months ended March 31, 2015, net cash used in operations increased $51,000, or 342% to
approximately $66,000 compared to approximately $15,000 for the three months ended March 31, 2014. The increase was primarily
due to an increase in legal fees paid.
Investing
Activities. There was no cash provided by or used in investing activities for the three month periods ended March
31, 2015 and 2014.
Financing
Activities. For the three months ended March 31, 2015, net cash provided by financing activities increased by $110,000
compared to nil for the three months ended March 31, 2014. The increase is attributed to bridge loan of $110,000 raised during
the period.
Recent Accounting Pronouncements
The Company continually
assesses any new accounting pronouncements to determine their applicability. When it is determined that a new accounting pronouncement
affects the Company’s financial reporting, the Company undertakes a study to determine the consequences of the change to
its consolidated financial statements and assures that there are proper controls in place to ascertain that the Company’s
consolidated financial statements properly reflect the change.
In May 2014, FASB
issued ASU No. 2014-09 “Revenue from Contracts from Customers,” which supersedes the revenue recognition requirements
in “Revenue Recognition (Topic 605),” and requires entities to recognize revenue in a way that depicts the transfer
of potential goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled
to the exchange for those goods or services. ASU 2014-09 is effective for fiscal years, and interim periods within those years,
beginning after December 15, 2016, and is to be applied retrospectively, with early adoption not permitted. The Company is currently
evaluating the new standard and assessing the potential impact on its operations and financial statements.
ITEM 3 – Quantitative
and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined
by Rule 12b-2 of the Exchange Act and are not required to provide the information under this item.
ITEM 4 – CONTROLS
AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
As of March 31, 2015, the end of the period
covered by this report, we conducted, under the supervision and with the participation of our management, including our Chief
Executive Officer, an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as
defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act) in ensuring that information required to be disclosed by us in
our reports is recorded, processed, summarized and reported within the required time periods. Based on the foregoing, our Chief
Executive Officer concluded that because of the material weakness in internal control over financial reporting described below,
our disclosure controls and procedures were not effective as of March 31, 2015.
Management’s Quarterly Report on Internal Control over
Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Exchange
Act Rule 13a-15(f). Our internal control system is a process designed by, or under the supervision of, our principal executive
and principal financial officer, or persons performing similar functions, and effected by our Board of Directors, management and
other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with U.S. generally accepted accounting principles (“U.S.
GAAP”).
Our internal control over financial reporting
includes policies and procedures that pertain to the maintenance of records that, in reasonable detail, accurately and fairly
reflect transactions and dispositions of assets; provide reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with U.S. GAAP, and that receipts and expenditures are being made only in accordance
with the authorization of our management and directors; and provide reasonable assurance regarding prevention or timely detection
of unauthorized acquisition, use or disposition of our assets that could have a material effect on our consolidated financial
statements.
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 March 31, 2015. In making this assessment we
used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COS0) in Internal Control
– Integrated Framework. 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 March 31, 2015.
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 March 31, 2015:
| · | While
there were internal controls and procedures in place that relate to financial reporting
and the prevention and detection of material misstatements, these controls did not meet
the required documentation and effectiveness requirements under the Sarbanes-Oxley Act
(“SOX”)
and therefore, management could not certify that these controls were correctly implemented.
As a result, it was management’s
opinion that the lack of documentation warranted a material weakness in the financial
reporting process. |
| · | Our
disclosure controls and procedures were not effective to ensure that information required
to be disclosed by us in the reports that we file or submit under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified in the
SEC’s rules and
forms and to ensure that information required to be disclosed by us in the reports that
we file or submit under the Exchange Act is accumulated and communicated to our management,
including our CFO, as appropriate to allow timely decisions. Inadequate controls include
the lack of procedures used for identifying, determining, and calculating required disclosures
and other supplementary information requirements. |
| · | There
is lack of segregation of duties in financial reporting, as our financial reporting and
all accounting functions are performed by 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. |
Changes in Internal Control over Financial Reporting
There were no significant changes in our internal control over
financial reporting that occurred during the three months ended March 31, 2015 that have materially affected or are reasonably
likely to materially affect our internal control over financial reporting.
PART II – OTHER INFORMATION
ITEM
1 – LEGAL PROCEEDINGS
On August 11, 2011, an action was filed
against the Company in the United States District Court for the Southern District of New York, entitled New Millennium PR Communications,
Inc., against OncoVista Innovative Therapies, Inc., seeking damages for the alleged breach of a public relations agreement. On
January 31, 2013, a settlement was reached whereby the Company agreed to pay New Millennium $7,000, in two payments of $3,500 each,
and issue 25,000 warrants at an exercise price of $0.25 per share.
On August 26, 2011, an action was filed
against the Company in the Supreme Court of the State of New York, New York County, entitled CAMOFI Master LDC and CAMHZN LDC against
OncoVista Innovative Therapies, Inc. and OncoVista, Inc. The action seeks damages for the alleged breach of a Subscription Agreement,
a Warrant Agreement and an Anti-Dilution Agreement and seeks an order directing the issuance of (i) an aggregate of 1,980,712,767
shares of the Company’s common stock, and (ii) warrants to purchase an aggregate of 702,857,767 shares of the Company’s
common stock at an exercise price of $0.001. On October 20, 2011, the Company filed an answer to the complaint. On November 1,
2011, the plaintiffs made an extensive document request to the Company for all documents related to the matter. The Company’s
counsel has started taking depositions and has requested access to CAMOFI Master LDC and CAMHZN Master LDC principals for further
depositions. On June 29, 2012 CAMOFI Master LDC and CAMHZN Master LDC filed for summary judgment. On August 9, 2012 the parties
filed a stipulation with the court extending the return date of motion for summary judgment until September 10, 2012. The court
has not yet ruled on the motion to dismiss. Oral arguments for the motion were conducted before the court on January 17, 2013.
The judge asked the parties to reconvene and to try to seek a settlement. While the judge indicated her belief that the Company
was in breach of the anti-dilution agreement, she also indicated that it may not be equitable to direct the issuance of hundreds
of millions of additional shares, and reserved her decision on the issue at that time. On March 5, 2015, the parties were able
to reach a framework for settlement. The final documents of the settlement are in preparation. Management estimated, based on the
framework reached in March of 2015, that the Company will pay approximately $1.2 million in settlement costs. This amount has been
recorded as a settlement payable and is due over a period of three years. If the Company does not meet the terms of the settlement
framework, the framework would require the Company to make additional payments of approximately $3.8 million.
On February 16, 2012, the Company filed
an action in the 225 Judicial District Court of the State of Texas, Bexar County, entitled OncoVista Innovative Therapies, Inc.
against J. Michael Edwards. The action seeks damages relating to the executive employment agreement of J. Michael Edwards, our
former Chief Financial Officer. Specifically we are seeking to have the Stock Option Agreement granted to Mr. Edwards on January
6, 2009 be declared void ab initio. The Company is also seeking damages and attorney fees. On March 30, 2012, the Company
received a copy of a counterclaim that may be filed in the same court and is seeking approximately $197,000, plus certain health
and life insurance benefits, in alleged compensation due. On December 12, 2012 Mr. Edwards filed a third party petition in the
court against third party defendant Alexander L. Weis, our Chairman, CEO & President. Depositions are ongoing and the Company
believes the counterclaimant’s allegations are without merit and intends to vigorously defend these claims.
ITEM 1A – RISK
FACTORS
We are a smaller reporting company as defined by Rule 12b-2 of
the Exchange Act and are not required to provide the information under this item.
ITEM 2 – UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
There have been no events which are required
to be reported under this item.
ITEM 3 – DEFAULTS
UPON SENIOR SECURITIES
There have been no events which are required to be reported under
this item.
ITEM 4 – MINE
SAFETY DISCLOSURES
Not applicable.
ITEM 5 – OTHER
INFORMATION
Not applicable.
ITEM 6 – EXHIBITS
Exhibits:
Exhibit
No. |
|
Description |
31.1 |
|
Certification
of Chief Executive Officer Pursuant to the Securities Exchange Act of 1934, Rules 13a-14(a)
and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
31.2 |
|
Certification
of Chief Financial Officer Pursuant to the Securities Exchange Act of 1934, Rules 13a-14(a)
and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
32 |
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002 |
EX-101.INS |
|
XBRL Instance Document |
|
|
|
EX-101.SCH |
|
XBRL Taxonomy Extension Schema |
|
|
|
EX-101.CAL |
|
XBRL Taxonomy Extension Calculation Linkbase |
|
|
|
EX-101.DEF |
|
XBRL Taxonomy Extension Definition Linkbase |
|
|
|
EX-101.LAB |
|
XBRL Taxonomy Extension Label Linkbase |
|
|
|
EX-101.PRE |
|
XBRL Taxonomy Extension Presentation Linkbase |
SIGNATURES
Pursuant to the requirements of Section 13
or 15 (d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the
undersigned, thereunto duly authorized.
ONCOVISTA INNOVATIVE THERAPIES, INC.
/s/
Alexander L. Weis, Ph.D. |
|
Alexander L. Weis, Ph.D. |
|
Chief Executive Officer, and Chief Financial Officer |
|
(Principal Executive Officer, Principal Financial |
|
Officer and Principal Accounting Officer) |
|
|
|
Date: May 15, 2015 |
|
EXHIBIT 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND
PRESIDENT
PURSUANT TO THE SECURITIES EXCHANGE ACT OF 1934,
RULES 13a-14(a) AND 15d-14(a)
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Alexander L. Weis, certify that:
1. I have reviewed this Quarterly Report on
Form 10-Q for the period ended March 31, 2015 of OncoVista Innovative Therapies, Inc. (the "registrant");
2. Based on my knowledge, this report does
not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in
light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements,
and other financial information included in this report, fairly present in all material respects the financial condition, results
of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officer(s)
and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
(a) Designed such disclosure controls
and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared;
(b) Designed such internal control
over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of
the registrant's disclosure control and procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any
change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter
that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting;
and
5. The registrant's other certifying officer(s)
and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors
and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies
and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to
adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material,
that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: May 15, 2015 |
/s/ Alexander L. Weis, Ph.D. |
|
Alexander L. Weis, Ph.D., |
|
Chief Executive Officer and President |
EXHIBIT 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
PURSUANT TO THE SECURITIES EXCHANGE ACT OF 1934,
RULES 13a-14(a) AND 15d-14(a)
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Alexander L. Weis, certify that:
1. I have reviewed this Quarterly Report on
Form 10-Q for the period ended March 31, 2015 of OncoVista Innovative Therapies, Inc. (the "registrant");
2. Based on my knowledge, this report does
not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in
light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements,
and other financial information included in this report, fairly present in all material respects the financial condition, results
of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officer(s)
and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
(a) Designed such disclosure controls
and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared;
(b) Designed such internal control
over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of
the registrant's disclosure control and procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any
change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter
that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting;
and
5. The registrant's other certifying officer(s)
and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors
and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies
and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to
adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material,
that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: May 15, 2015 |
/s/ Alexander
L. Weis, Ph.D. |
|
Alexander L. Weis, Ph.D., |
|
Chief Financial Officer |
EXHIBIT 32
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the
Quarterly Report on Form 10-Q of OncoVista Innovative Therapies, Inc. (the "Company") for the period ended March 31,
2015 filed with the Securities and Exchange Commission (the "Report"), I, Alexander L. Weis, Chief Executive Officer,
President and Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements
of Section 13(a) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report
fairly presents, in all material respects, the consolidated financial condition of the Company as of the dates presented and consolidated
results of operations of the Company for the periods presented.
Dated: May 15, 2015
By: |
/s/
Alexander L. Weis, Ph.D. |
|
|
Alexander L. Weis, Ph.D. |
|
|
Chief Executive Officer, President and Chief Financial Officer |
|
|
|
|
This certification has been furnished solely
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
A signed original of this written statement
required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and
Exchange Commission or its staff upon request.
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