UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
[X] QUARTERLY REPORT PURSUANT TO SECTION
13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended June 30,
2012
[ ] TRANSITION REPORT PURSUANT TO SECTION
13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _________
to __________
Commission file number: 000-28347
ONCOVISTA INNOVATIVE THERAPIES, INC.
(Exact name of registrant as specified in
its charter)
Nevada
|
33-0881303
|
(State or other jurisdiction of incorporation or organization)
|
(IRS Employer Identification No.)
|
14785 Omicron Drive
Suite 104
San Antonio, Texas 78245
(Address of principal executive offices)
(210) 677-6000
(Registrant's telephone number, including
area code)
Indicate by check mark whether the issuer:
(1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes
x
No
¨
Indicate by check mark whether the registrant
has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted
and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter
period that the registrant was required to submit and post such files). Yes
x
No
¨
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions
of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2
of the Exchange Act.
Large accelerated filer
¨
Accelerated
filer
¨
Non-accelerated filer
¨
Smaller reporting company
x
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the
Exchange
Act
). Yes
¨
No
x
State the number of shares outstanding of each of the registrant's
classes of common equity, as of the latest practicable date: 21,627,868 shares of common stock with a par value of $.001 outstanding
as of August 13, 2012.
PART I – FINANCIAL INFORMATION
|
2
|
|
|
ITEM 1 – FINANCIAL STATEMENTS
|
2
|
|
|
ITEM 2 – MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
13
|
|
|
ITEM 3 –
Quantitative and Qualitative Disclosures About Market Risk
|
17
|
|
|
ITEM 4 – CONTROLS AND PROCEDURES
|
17
|
|
|
PART II – OTHER INFORMATION
|
19
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|
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ITEM 1 – LEGAL PROCEEDINGS
|
19
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|
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ITEM 1A – RISK FACTORS
|
19
|
|
|
ITEM 2 – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
19
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|
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ITEM 3 – DEFAULTS UPON SENIOR SECURITIES
|
19
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|
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ITEM 4 – MINE SAFETY DISCLOSURES
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19
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|
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ITEM 5 – OTHER INFORMATION
|
19
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|
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ITEM 6 – EXHIBITS
|
20
|
PART I – FINANCIAL INFORMATION
ITEM 1 –
FINANCIAL STATEMENTS
ONCOVISTA INNOVATIVE THERAPIES, INC.
AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2012
|
|
|
2011
|
|
|
|
|
|
|
|
|
ASSETS
|
|
(Unaudited)
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
1,165,612
|
|
|
$
|
2,125,229
|
|
Accounts receivable, prepaid and other current assets
|
|
|
134,477
|
|
|
|
53,168
|
|
Total current assets
|
|
|
1,300,089
|
|
|
|
2,178,397
|
|
|
|
|
|
|
|
|
|
|
Equipment, net
|
|
|
6,732
|
|
|
|
10,222
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
1,306,821
|
|
|
$
|
2,188,619
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND DEFICIT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable (including related party account payable of $550,000 and $450,000, respectively)
|
|
$
|
825,005
|
|
|
$
|
818,522
|
|
Accrued expenses (including related party accrued expenses of $485,000 and $460,000, respectively)
|
|
|
1,127,331
|
|
|
|
1,003,580
|
|
Derivative liability
|
|
|
176,151
|
|
|
|
322,834
|
|
Notes payable
|
|
|
174,495
|
|
|
|
167,711
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
2,302,982
|
|
|
|
2,312,647
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity (deficit):
|
|
|
|
|
|
|
|
|
Common stock, $.001 par value; 147,397,390 shares authorized, 21,627,868
and 21,370,725 shares issued and outstanding at June 30, 2012 and December 31, 2011, respectively
|
|
|
21,627
|
|
|
|
21,370
|
|
Additional paid-in capital
|
|
|
20,171,936
|
|
|
|
20,134,341
|
|
Accumulated deficit
|
|
|
(21,189,724
|
)
|
|
|
(20,279,739
|
)
|
|
|
|
|
|
|
|
|
|
Total deficit
|
|
|
(996,161
|
)
|
|
|
(124,028
|
)
|
|
|
|
-
|
|
|
|
-
|
|
Total liabilities and deficit
|
|
$
|
1,306,821
|
|
|
$
|
2,188,619
|
|
See accompanying notes to the condensed
consolidated financial statements
ONCOVISTA INNOVATIVE THERAPIES, INC.
AND SUBSIDIARIES
Condensed Consolidated Statements of
Operations
(Unaudited)
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2012
|
|
|
2011
|
|
|
2012
|
|
|
2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
–
|
|
|
$
|
–
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
341,402
|
|
|
|
179,940
|
|
|
|
640,227
|
|
|
|
341,990
|
|
General and administrative
|
|
|
224,091
|
|
|
|
373,001
|
|
|
|
412,867
|
|
|
|
669,345
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
565,493
|
|
|
|
552,941
|
|
|
|
1,053,094
|
|
|
|
1,011,335
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(565,493
|
)
|
|
|
(552,941
|
)
|
|
|
(1,053,094
|
)
|
|
|
(1,011,335
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
1,033
|
|
|
|
–
|
|
|
|
2,388
|
|
|
|
–
|
|
Gain (loss) on derivative liability
|
|
|
316,496
|
|
|
|
(19,404
|
)
|
|
|
146,683
|
|
|
|
(297,549
|
)
|
Interest expense
|
|
|
(3,476
|
)
|
|
|
(12,636
|
)
|
|
|
(6,845
|
)
|
|
|
(13,473
|
)
|
Other
|
|
|
883
|
|
|
|
7,049
|
|
|
|
883
|
|
|
|
4,920
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense), net
|
|
|
314,936
|
|
|
|
(24,991
|
)
|
|
|
143,109
|
|
|
|
(306,102
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss
|
|
|
(250,557
|
)
|
|
|
(577,932
|
)
|
|
|
(909,985
|
)
|
|
|
(1,317,437
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted
|
|
$
|
(0.01
|
)
|
|
$
|
(0.03
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
(0.06
|
)
|
Weighted average number of shares outstanding during the period - basic and diluted
|
|
|
21,418,763
|
|
|
|
21,344,675
|
|
|
|
21,394,744
|
|
|
|
21,151,675
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Less than $0.01
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the condensed
consolidated financial statements
ONCOVISTA INNOVATIVE THERAPIES, INC.
AND SUBSIDIARIES
Condensed Consolidated Statements of
Cash Flows
(Unaudited)
|
|
Six months ended
June 30,
|
|
|
|
2012
|
|
|
2011
|
|
Cash flows from operating activities
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(909,985
|
)
|
|
$
|
(1,317,437
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
3,490
|
|
|
|
3,251
|
|
Employee stock-based compensation
|
|
|
37,595
|
|
|
|
71,373
|
|
Non-employee stock-based consulting expense
|
|
|
6,492
|
|
|
|
6,077
|
|
Common stock issued for consulting
|
|
|
–
|
|
|
|
88,500
|
|
Non-employee stock-based consulting expense (warrants)
|
|
|
–
|
|
|
|
15,416
|
|
(Gain) loss on derivative liability
|
|
|
(146,683
|
)
|
|
|
297,549
|
|
Loss on disposal of assets
|
|
|
–
|
|
|
|
2,129
|
|
Loss on legal settlement
|
|
|
–
|
|
|
|
9,000
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivables, prepaid and other current assets
|
|
|
(87,801
|
)
|
|
|
(18,949
|
)
|
Accounts payable
|
|
|
6,483
|
|
|
|
86,639
|
|
Accrued expenses
|
|
|
123,751
|
|
|
|
(34,136
|
)
|
Accrued interest payable
|
|
|
6,784
|
|
|
|
17,466
|
|
Net cash used in operating activities
|
|
|
(959,874
|
)
|
|
|
(773,122
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities
|
|
|
|
|
|
|
|
|
Purchase of equipment
|
|
|
–
|
|
|
|
(2,859
|
)
|
Net cash used in investing activities
|
|
|
–
|
|
|
|
(2,859
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows for financing activities
|
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options
|
|
|
257
|
|
|
|
-
|
|
Net cash provided by (used in) financing activities
|
|
|
257
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents
|
|
|
(959,617
|
)
|
|
|
(775,981
|
)
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period
|
|
|
2,125,229
|
|
|
|
3,524,496
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
1,165,612
|
|
|
$
|
2,748,515
|
|
See accompanying notes to the condensed
consolidated financial statements
|
Note 1.
|
BASIS OF PRESENTATION, ORGANIZATION AND NATURE OF
OPERATIONS
|
OncoVista Innovative Therapies, Inc. (“OVIT”) is
a biopharmaceutical company developing targeted anticancer therapies by utilizing tumor-associated biomarkers. OVIT’s
product pipeline is comprised of advanced (Phase I/II) and early (Phase I) clinical-stage compounds, late preclinical drug candidates
and early preclinical leads. OVIT is not committed to any single treatment modality or class of compound, but believes that successful
treatment of cancer requires a tailored approach based upon individual patient disease characteristics.
Through its former subsidiary, AdnaGen AG (“AdnaGen”),
OVIT previously developed diagnostic kits for several cancer indications, and marketed diagnostic kits in Europe for the detection
of circulating tumor cells (“CTCs”) in patients with cancer.
On October 28, 2010, OVIT entered into a Stock Purchase Agreement
with Alere Holdings Bermuda Limited Canon's Court (“Alere Holdings”), whereby OVIT sold all of its shares, representing
approximately 78% of the total issued and outstanding shares of AdnaGen to Alere Holdings. Under the terms of the agreement,
OVIT and the other AdnaGen shareholders agreed to sell their respective shares of AdnaGen, and all AdnaGen related business assets,
to Alere Holdings for: (i) a $10 million up-front payment; (ii) $10 million in potential milestone payments contingent upon the
achievement of various balance sheet objectives within 24 months; and (iii) up to $63 million in potential milestone payments contingent
upon the achievement of various clinical, regulatory and sales objectives within the next 36 months. OVIT is entitled
to receive its pro rata portion of the up-front and potential milestone payments. In November 2010, OVIT received $6.0
million, net of expenses and certain fees, as its share of the $10 million up-front payment. For the year ended December 31, 2011,
no milestone payments were received, however the Company recorded a gain on the sale of subsidiary of approximately $0.2 million,
for cash received for settlement related to the sale of AdnaGen.
OVIT is using the proceeds from the sale of its shares in AdnaGen
to fund on-going development activities for its drug candidate portfolio. Additionally, OVIT is evaluating several opportunities
to license or acquire other compounds or diagnostic technologies that it believes will provide for treatments that are highly targeted
with low or no toxicity.
At June 30, 2012, OVIT had three full time employees. OncoVista,
Inc. (“OncoVista”), OVIT’s operating subsidiary, had one full-time employee.
|
Note 2.
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
Basis of Presentation
The accompanying unaudited interim condensed consolidated financial
statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”)
and the rules and regulations of the United States Securities and Exchange Commission (the “Commission”) for interim
financial information. Accordingly, they do not include all the information and footnotes necessary for a comprehensive presentation
of financial position, results of operations, and changes in deficit or cash flows. It is management's opinion, however, that all
material adjustments (consisting of normal recurring adjustments) have been made which are necessary for a fair financial statement
presentation. The interim results for the period ended June 30, 2012 are not necessarily indicative of results for the full fiscal
year.
The unaudited interim consolidated financial statements should
be read in conjunction with the required financial information and financial statements included as part of OVIT’s Annual
Report on Form 10-K for the year ended December 31, 2011.
Principles of Consolidation
The consolidated financial statements include the accounts of
OVIT and OncoVista (collectively, the “Company”). All intercompany balances have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with GAAP
requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses
during the reporting period. Actual results could differ from those estimates.
Significant estimates include the valuation of warrants and
stock options granted for services or compensation, estimates of the probability and potential magnitude of contingent liabilities,
estimates relating to the fair value of derivative liabilities and the valuation allowance for deferred tax assets.
Net Loss per Share
Basic earnings (loss) per share are computed by dividing net
income (loss) by the weighted average number of common shares outstanding. Diluted earnings per share is computed by dividing net
income by the weighted average number of common shares outstanding including the effect of share equivalents. Common stock equivalents
consist of shares issuable upon the exercise of certain common stock purchase warrants and stock options.
As the Company has had losses from operations for
the six month periods ended June 30, 2012 and 2011, respectively, all unvested restricted stock, stock options and warrants are
considered to be anti-dilutive. At June 30, 2012 and 2011, the following shares have been excluded since their inclusion in the
computation of diluted EPS would be anti-dilutive:
|
|
2012
|
|
|
2011
|
|
|
|
|
|
|
|
|
|
|
Stock options outstanding under various stock option plans
|
|
|
1,381,500
|
|
|
|
1,407,575
|
|
Warrants
|
|
|
4,074,569
|
|
|
|
4,331,712
|
|
Total
|
|
|
5,456,069
|
|
|
|
5,739,287
|
|
Share-Based Compensation
All share-based payments to employees are recorded and expensed
in the statements of operations under Accounting Standards Codification (“ASC”) 718
“Compensation –
Stock Compensation.”
ASC 718 requires the measurement and recognition of compensation expense for all share-based payment
awards made to employees and directors, including grants of employee stock options, based on estimated fair values. The Company
has used the Black-Scholes option-pricing model to estimate grant date fair value for all option grants.
Share-based compensation expense is based on the value of the
portion of share-based payment awards that is ultimately expected to vest during the year, less expected forfeitures. ASC 718 requires
forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ
from those estimates.
Recent Accounting Pronouncements
The Company has evaluated all recently issued accounting pronouncements
and believes such pronouncements do not have a material effect on the Company’s financial statements
|
Note 3.
|
GOING CONCERN & MANAGEMENT’S PLANS
|
As reflected in the accompanying consolidated financial statements,
the Company reported a net loss of approximately $910,000, and net cash used in operations of $960,000 for the six months ended
June 30, 2012, an accumulated deficit of approximately $21.2 million and total deficit of approximately $996,000 at June 30, 2012.
The Company is also in default on a certain loan and related accrued interest aggregating $174,495 at June 30, 2012 (see Note 6).
Subsequent to June 30, 2012 the Company entered into a settlement agreement to satisfy the obligation in full for a one-time payment
of $60,000 (see Note 11). These factors raise substantial doubt about the Company’s ability to continue as a going concern.
As a result of the stock purchase agreement with
Alere Holdings, management believes that the Company has
sufficient capital to meet its anticipated operating cash
requirements for the next six to seven months.
The accompanying consolidated financial statements have been
prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal
course of business. These financial statements do not include any adjustments relating to the recovery of the recorded assets or
the classification of the liabilities that might be necessary should the Company be unable to continue as a going concern.
The ability of the Company
ability to continue as a going concern depends on the success of management’s plans to achieve the following:
|
·
|
Continue to aggressively seek investment capital;
|
|
·
|
Develop the Company’s product pipeline;
|
|
·
|
Advance scientific progress in our research and
development; and
|
Continue
to monitor and implement cost control initiatives to conserve cash.
There can be no assurance that these plans will be sufficient
or that additional financing will be available in amounts or terms acceptable to the Company, if at all.
Equipment balances at June 30, 2012 and December 31, 2011 are
summarized below:
|
|
2012
|
|
|
2011
|
|
|
|
|
|
|
|
|
Equipment
|
|
$
|
30,132
|
|
|
$
|
30,132
|
|
Computer and office equipment
|
|
|
9,326
|
|
|
|
9,326
|
|
|
|
|
39,458
|
|
|
|
39,458
|
|
Less: accumulated depreciation
|
|
|
(32,726
|
)
|
|
|
(29,236
|
)
|
Equipment, net
|
|
$
|
6,732
|
|
|
$
|
10,222
|
|
Accrued expenses at June 30, 2012 and December 31, 2011 are
summarized below:
|
|
2012
|
|
|
2011
|
|
|
|
|
|
|
|
|
Legal and professional
|
|
$
|
-
|
|
|
$
|
21,250
|
|
Clinical and other studies
|
|
|
149,006
|
|
|
|
149,006
|
|
Compensation
|
|
|
272,085
|
|
|
|
272,085
|
|
Minimum royalty
|
|
|
635,000
|
|
|
|
560,000
|
|
Other
|
|
|
71,240
|
|
|
|
1,239
|
|
Total accrued expenses
|
|
$
|
1,127,331
|
|
|
$
|
1,003,580
|
|
As of June 30, 2012 the Company had one outstanding unsecured note in the principal amount of $100,000
and $74,495 in accrued interest ($67,711 at December 31, 2011) at 8%, payable to a third party and due on demand. The Company has
since entered into a settlement agreement to satisfy the obligation in full with a one-time payment of $60,000 (see Note 11).
|
Note 7.
|
DERIVATIVE LIABILITY
|
The Company determined that warrants issued in connection with
a debt financing entered into by the Company in January 2009 required liability classification due to certain provisions that may
result in an adjustment to the number shares issued upon settlement.
The estimated fair value of the derivative liability was $176,151 and $322,834 at June 30, 2012 and December
31, 2011, respectively.
The Company uses the Black-Scholes pricing model to calculate
the fair value of its warrant liabilities. Key assumptions used to apply these models are as follows:
Expected term
|
|
|
2-3 years
|
|
Volatility
|
|
|
95%
|
|
Risk-free interest rate
|
|
|
0.41%
|
|
Dividend yield
|
|
|
0%
|
|
Fair value measurements
Assets and liabilities measured at fair value as of June 30,
2012, are as follows:
|
|
Value at
June 30, 2012
|
|
|
Quoted prices in active markets
(Level 1)
|
|
|
Significant other observable inputs
(Level 2)
|
|
|
Significant unobservable inputs
(Level 3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative liability
|
|
$
|
176,151
|
|
|
$
|
–
|
|
|
$
|
176,151
|
|
|
$
|
–
|
|
The fair value framework requires a categorization of assets
and liabilities into three levels based upon the assumptions (inputs) used to price the assets and liabilities. Level 1 provides
the most reliable measure of fair value, whereas Level 3 generally requires significant management judgment. The three levels are
defined as follows:
Level 1: Unadjusted quoted prices in active markets
for identical assets and liabilities.
Level 2: Observable inputs other than those included
in Level 1. For example, quoted prices for similar assets or liabilities in active markets or quoted prices for identical assets
or liabilities in inactive markets.
Level 3: Unobservable inputs reflecting management’s
own assumptions about the inputs used in pricing the asset or liability.
There were no financial assets or liabilities measured at fair value, with the exception of cash and cash
equivalents and the above mentioned derivative liability as of June 30, 2012 and December 31, 2011, respectively. The fair values
of accounts receivable, accounts payable and third-party debt approximate the carrying amounts due to the their interest rates
and / or short term nature of these instruments. The fair value of the related party accounts payable and accruals are not practicable
to estimate due to the related party nature of the underlying transaction.
|
Note 8.
|
LEASES, COMMITMENTS AND CONTINGENCIES
|
Legal Matters
On August 11, 2011, an action was filed against the Company
in the United States District Court for the Southern District of New York, entitled New Millennium PR Communications, Inc., against
OncoVista Innovative Therapies, Inc. The action seeks damages for the alleged breach of a public relations agreement and seeks
an order directing a cash payment of $75,750 and the issuance of warrants to purchase 25,000 shares of the Company’s common
stock. On October 5, 2011, the Company sent a notice of motion to the United States District Court for the Southern District of
New York seeking to dismiss the case due to lack of subject matter jurisdiction. New Millennium PR Communications, Inc. filed
an opposition to the Company’s request for dismissal. The court has not yet ruled on the motion to dismiss. The case has
been referred to the Magistrate Judge for settlement with a trial set for a date after July 30, 2012.
On August 26, 2011, an action was filed against the Company
in the Supreme Court of the State of New York, New York County, entitled CAMOFI Master LDC and CAMHZN LDC against OncoVista Innovative
Therapies, Inc. and OncoVista, Inc. The action seeks damages for the alleged breach of a Subscription Agreement, a Warrant Agreement
and an Anti-Dilution Agreement and seeks an order directing the issuance of (i) an aggregate of 1,980,712,767 shares of the Company’s
common stock, and (ii) warrants to purchase an aggregate of 702,857,767 shares of the Company’s common stock at an exercise
price of $0.001. On October 20, 2011, the Company filed an answer to the complaint. On November 1, 2011, the plaintiffs made an
extensive document request to the Company for all documents related to the matter. The Company’s counsel has started taking
depositions and has requested access to CAMOFI Master LDC and CAMHZN Master LDC principals for further depositions. On June 29,
2012 CAMOFI Master LDC and CAMHZN Master LDC filed for summary judgment. Discussions are currently ongoing between the parties
to seek a resolution to the mater. On August 9, 2012 the parties filed a stipulation with the court extending the return date of
motion for summary judgment until September 10, 2012.
On February 16, 2012, an action was filed by the Company in
the 225 Judicial District Court of the State of Texas, Bexar County, entitled OncoVista Innovative Therapies, Inc. against J. Michael
Edwards. The action seeks damages relating to the executive employment agreement of the Company’s former Chief Financial
Officer, J. Michael Edwards. Specifically the Company is seeking to have the Stock Option Agreement granted to Mr. Edwards on January
6, 2009 be declared
void ab initio
. The Company is also seeking damages and attorney fees. On March 30, 2012, the Company
received a copy of a counterclaim that may be filed in the same court and is seeking approximately $197,000 in alleged compensation
due.
|
Note 9.
|
RELATED PARTY TRANSACTIONS
|
Alexander L. Weis, Ph.D., Chairman of the Company’s Board
of Directors and its Chief Executive Officer, President, Chief Financial Officer and Secretary, and a significant shareholder,
is a beneficial owner of Lipitek International, Inc. and Lipitek Research, LLC. The Company leases its laboratory space from Lipitek,
Inc. under a three-year lease agreement. Management believes that rent is based on reasonable and customary rates as if the space
were rented to a third party.
On November 17, 2005, the Company entered into a purchase agreement
with Lipitek and Dr. Weis, under which Lipitek granted the Company an option to purchase all membership interests in Lipitek Research,
LLC (Lipitek Research) for a purchase price of $5.0 million, which is payable quarterly based upon revenues of Lipitek Research
up to $50,000 per quarter. Through June 30, 2012, the Company had paid a total of $550,000 toward this agreement and has accrued
$550,000 and $450,000, which is included in accounts payable in the consolidated balance sheets as of June 30, 2012, and December
31, 2011, respectively. During the six month period ended June 30, 2012 and 2011, the Company made no payments toward the agreement.
Prior to the full payment of the purchase price, the Company
has the option, upon 30 days written notice, to abandon the purchase of Lipitek Research and would forfeit the amounts already
paid. All intellectual property developments by Lipitek Research through the term of the agreement or 2012, whichever is later,
shall remain the Company’s property, irrespective of whether the option is exercised. In addition, the Company will receive
80% of the research and development revenue earned by Lipitek while the agreement is in place. In the six month periods ended June
30, 2012 and 2011, the Company did not recognize any revenue from its share of Lipitek revenues.
|
Note 10.
|
CHANGES IN DEFICIT
|
Common Stock
The Company is authorized to issue up to 147,397,390 shares
of common stock. At June 30, 2012, shares of common stock reserved for future issuance are as follows:
Stock options outstanding
|
|
|
1,381,500
|
|
Warrants outstanding
|
|
|
4,074,569
|
|
Stock options available for grant
|
|
|
2,159,250
|
|
|
|
|
|
|
|
|
|
7,615,319
|
|
Restricted Stock
In October 2007, the Company granted an aggregate of 2,000,000
shares of common stock to certain officers valued at $3.5 million based upon the quoted closing trading price on the date of issuance. These
shares vested, subject to future service requirements, two thirds on January 1, 2010 and one third on January 1, 2011. As of June
30, 2012, there was no unrecognized compensation cost related to unvested restricted stock. In April 2011, the Company granted
150,000 shares of restricted common stock to consultants, which were fully vested upon issuance. The Company recorded $88,500 in
consulting expense for the restricted stock grant.
On June 13, 2012, the Company entered into an agreement to grant
an aggregate of 300,000 shares of common stock to Landmark Financial Corporation which shares vest at the rate of 50,000 shares
per month for six months, the term of the agreement. These shares will be granted for services to be provided by Landmark Financial
Corporation related to identifying and evaluating alternative strategies for expanding the Company’s business. As of June
30, 2012 the shares have not been issued to Landmark Financial Corporation. The Company recorded $6,492 in consulting expense for
the restricted stock grant for the period of June 13 through June 30, 2012 and $66,000 in accrued expenses for the shares that
were not issued as of June 30, 2012.
Stock Option Plans
All option grants are expensed in the appropriate period based
upon each award’s vesting terms, in each case with an offsetting credit to additional paid in capital. Under the authoritative
guidance for share based compensation, in the event of termination, the Company will cease to recognize compensation expense. There
is no deferred compensation recorded upon initial grant date, instead, the fair value of the share-based payment is recognized
ratably over the stated vesting period. No stock options were granted during the six months ended June 30, 2012. The Company granted
stock options to employees, consultants and directors to acquire 658,600 shares of common stock for future services having a fair
value of $153,454 during the six months ended June 30, 2011. Vesting periods for the Company’s stock option awards during
2011 included the following: monthly over one year, monthly over two years, monthly over four years, and annually over four years.
The stock-based compensation expense recorded by the Company
for the six months ended June 30, 2012 and 2011, with respect to awards under the Company’s stock plans are as follows:
|
|
Six Months
|
|
|
Three Months
|
|
|
|
2012
|
|
|
2011
|
|
|
2012
|
|
|
2011
|
|
Research and development
|
|
$
|
25,612
|
|
|
$
|
26,921
|
|
|
$
|
12,806
|
|
|
$
|
12,806
|
|
General and administrative
|
|
$
|
11,983
|
|
|
$
|
44,452
|
|
|
$
|
5,991
|
|
|
$
|
21,284
|
|
Total employee stock-based compensation
|
|
$
|
37,595
|
|
|
$
|
71,373
|
|
|
$
|
18,797
|
|
|
$
|
34,090
|
|
In addition to options granted to employees, the Company historically granted options to consultants and
for the six months ended June 30, 2012 and 2011, recognized $0 and $6,077, respectively, as consulting expense. Such amounts are
included in general and administrative expense in the consolidated statements of operations for each of the six months ended June
30, 2012 and 2011.
The following is a summary of the Company’s stock option
activity:
|
|
Shares
|
|
|
Weighted Average Exercise Price
|
|
|
Weighted Average
Remaining Contractual Term
|
|
|
Aggregate
Intrinsic Value
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at January 1, 2012
|
|
|
1,381,500
|
|
|
$
|
0.91
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
–
|
|
|
|
–
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
–
|
|
|
|
–
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
–
|
|
|
|
–
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2012
|
|
|
1,381,500
|
|
|
$
|
0.91
|
|
|
|
6.34 years
|
|
|
$
|
24,000
|
|
Options Exercisable at June 30, 2012
|
|
|
1,156,250
|
|
|
$
|
1.02
|
|
|
|
5.93 years
|
|
|
$
|
24,000
|
|
The following summarizes the activity of the Company’s
stock options that have not vested for the six months ended June 30, 2012:
|
|
Shares
|
|
|
Weighted Average Fair Value
|
|
Nonvested at January 1, 2012
|
|
|
404,250
|
|
|
$
|
0.21
|
|
Granted
|
|
|
-
|
|
|
|
-
|
|
Vested
|
|
|
(179,000
|
)
|
|
|
0.21
|
|
Cancelled or forfeited
|
|
|
-
|
|
|
|
-
|
|
Outstanding at June 30, 2012
|
|
|
225,250
|
|
|
$
|
0.21
|
|
Warrants
On June 27, 2012 CAMOFI Master LDC and CAMHZN Master LDC exercised warrants for 216,000 and 41,143 shares
respectively of the Company’s common stock with an exercise price of $0.001 per share generating cash proceeds of $257.
|
Note 11.
|
SUBSEQUENT
EVENTS
|
On July 12, 2012 the Company consummated a settlement with a debt holder of one outstanding unsecured
note in the aggregate amount of $174,495 (as of June 30, 2012). The Company and the debt holder agreed to a one time payment of
$60,000 for complete and full payment of the debt which was paid in July 2012.
ITEM 2 –
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Our Management’s Discussion and Analysis contains not
only statements that are historical facts, but also statements that are forward-looking (within the meaning of Section 27A of the
Securities Act of 1933 (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934 (the “Exchange
Act”)). Forward-looking statements are, by their very nature, uncertain and risky. These risks and
uncertainties include international, national and local general economic and market conditions; demographic changes; our ability
to sustain, manage, or forecast growth; our ability to successfully make and integrate acquisitions; raw material costs and availability;
new product development and introduction; existing government regulations and changes in, or the failure to comply with, government
regulations; adverse publicity; competition; the loss of significant customers or suppliers; fluctuations and difficulty in forecasting
operating results; changes in business strategy or development plans; business disruptions; the ability to attract and retain qualified
personnel; the ability to protect technology; and other risks that might be detailed from time to time in our filings with the
Commission.
Although the forward-looking statements in this report reflect
the good faith judgment of our management, such statements can only be based on facts and factors currently known by them. Consequently,
and because forward-looking statements are inherently subject to risks and uncertainties, the actual results and outcomes may differ
materially from the results and outcomes discussed in the forward-looking statements. You are urged to carefully review and
consider the various disclosures made by us in this report and in our other reports as we attempt to advise interested parties
of the risks and factors that may affect our business, financial condition, and results of operations and prospects.
As used in this Quarterly Report, the terms “we,”
“us,” and “our,” mean OncoVista Innovative Therapies, Inc., our current subsidiary, OncoVista, Inc. (“OncoVista”)
and our former subsidiary, AdnaGen A.G. (“AdnaGen”), collectively, unless otherwise indicated.
Overview
We are a biopharmaceutical company developing targeted anticancer
therapies by utilizing tumor-associated biomarkers. Our therapeutic strategy is based on targeting the patient’s tumor(s)
with treatments that will deliver drugs selectively based upon specific biochemical characteristics of the cancer cells comprising
the tumor. Through a combination of licensing agreements, as well as mergers and acquisitions, we have acquired the rights to several
technologies with the potential to more effectively treat cancers and significantly improve quality-of-life for patients. We believe
that the development of targeted approaches to the administration of anticancer agents should lead to improved outcomes and reduced
toxicity.
We
previously developed diagnostic
kits through our former
majority-owned German operating
subsidiary, AdnaGen, for several cancer
indications, and marketed diagnostic kits in Europe for the detection of circulating tumor cells (“CTCs”) in patients
with cancer.
On October 28, 2010, we entered into a Stock Purchase Agreement with Alere Holdings Bermuda Limited Canon’s
Court (“Alere Holdings”), whereby we, and the other AdnaGen shareholders, agreed to sell our respective shares of AdnaGen,
and all AdnaGen related business assets, to Alere Holdings for: (i) a $10 million up-front payment; (ii) $10 million in potential
milestone payments contingent upon the achievement of various balance sheet objectives within 24 months; and (iii) up to $63 million
in potential milestone payments contingent upon the achievement of various clinical, regulatory and sales objectives within next
36 months. We are entitled to receive our pro rata portion of approximately 78% of the up-front and potential milestone payments.
In November 2010, we received $6.0 million, net of expenses and certain fees, as our share of the $10 million up-front payment.
As a result of the proceeds received pursuant to the Stock Purchase
Agreement with Alere Holdings, we have eliminated substantially all of our outstanding debt. We are using the balance of the proceeds
from the sale of our shares in AdnaGen to fund on-going development activities for our drug candidate portfolio. Additionally,
we are evaluating several opportunities to license or acquire other compounds or diagnostic technologies that we believe will provide
for treatments that are highly targeted, efficacious and with low or no toxicity.
Development Programs
Our most advanced product candidate is Cordycepin (OVI-123)
which is in Phase I/II clinical trials for refractory leukemia patients who express the enzyme terminal deoxynucleotidyl transferase
(TdT). We have received orphan drug designation from the FDA for Cordycepin which affords us seven years of market exclusivity
once the drug is approved for marketing. We initiated a Phase I/II trial based on the “original” ADA-sensitive compound
in the second quarter of 2008. The trial was initiated at two U.S. centers, The Dana Farber Cancer Institute in Boston, Massachusetts
and the Cancer Therapy Research Center at the University of Texas Health Sciences Center at San Antonio, Texas, and is designed
to enroll up to 24 patients in the first stage and up to 20 patients in the second stage. In October 2009, after enrolling five
patients in this clinical trial, we placed the clinical trial on administrative hold due to our limited capital resources. We have
engaged a clinical research organization (“CRO”) in France to do additional pre-clinical in-vitro evaluations of Cordycepin
and the ADA inhibitor Pentostatin with the intent of gaining a better understanding of the inhibition effects of Pentostatin on
Cordycepin. We are in the process of reinitiating the Phase I/II clinical trial to determine the maximum tolerated dose, and expect
to start enrolling patients later this year.
We have completed Good Laboratory Practice (“GLP”) animal drug safety studies in two species
for our lead drug candidate from the L-nucleoside conjugate program (OVI-117). We have accumulated
in vitro
and
in vivo
data indicating that several of the L-nucleoside conjugates are effective against various types of cancer. To date, OVI-117 has
undergone two proof-of-concept studies of human cancers in animal models, as both a single agent and as a multi-agent combination
therapy with oxaliplatin. The Investigational New Drug application (IND) was submitted to the FDA on June 2, 2012 and approved
by the FDA on July 5, 2012. We engaged a contract manufacturer and a clinical batch of OVI-117 is available for use in our proposed
Phase 1 trial. The clinical protocol has been written and a principal investigator engaged. We believe that OVI-117 should be ready
to enter Phase I clinical trials later in 2012.
Other Research and Development Plans
In addition to conducting Phase I and Phase II clinical trials,
we plan to conduct pre-clinical research to accomplish the following:
|
·
|
further deepen and broaden our understanding of the mechanism of action (MoA) of our products in cancer;
|
|
·
|
develop alternative delivery systems and determine the optimal dosage for different patient groups;
|
|
·
|
demonstrate proof of concept in animal models of human cancers; and
|
|
·
|
develop successor products to our current products.
|
Other Strategic Plans
In addition to developing our existing anti-cancer drug portfolio,
we plan to obtain rights to additional drug candidates or diagnostic technologies through licensing, partnerships, and mergers/acquisitions.
Our efforts in this area will be guided by business considerations (cost of the opportunity, fit with existing portfolio, etc.)
as well as input from our clinical advisory board regarding likelihood of successful clinical development and marketing approval.
Our goal is to create a well-balanced product portfolio including lead molecules in different stages of development and addressing
different medical needs.
Results of Operations
Three Months Ended June 30, 2012 and 2011
Research
and development.
Research and
development expenses increased by approximately $161,000, or 89%, to approximately $341,000 for the three months
ended June 30, 2012, as compared to approximately $180,000 for the three months ended June 30, 2011. The increase in 2012 is primarily
due to the finalizing our preclinical studies, developing our clinical protocol, manufacturing the drug product and the preparation
and submission of an IND to the FDA for OVI-117 to enter into Phase I trials.
General and administrative.
General and administrative
expenses decreased by approximately $149,000, or 40%, to approximately $224,000 for the three months ended June 30, 2012, as compared
to approximately $373,000 for the three months ended June 30, 2011. The decrease was due primarily to a decrease in stock-based
compensation from prior year, as well as a decrease in consulting expense for professional services.
Other Income (Expense)
.
The increase from other expense of approximately $25,000 to other income of approximately $315,000 is $340,000 or 1,360%, is due
primarily to a gain of approximately $316,000 on derivative liability in 2012 compared to a loss on derivative liability of approximately
$20,000 in 2011.
Net
Loss.
As a result of the foregoing, our net loss decreased by approximately $327,000, or 57%, to a net loss of approximately
$251,000 for the three months ended June 30, 2012, compared to a net loss of approximately $578,000 for the three months ended
June 30, 2011.
Six months ended June 30, 2012 and 2011
Research
and development.
Research and
development expenses increased by approximately $298,237, or 87%, to approximately $
640,227
for the six months ended June 30, 2012, as compared to $341,990 for the six months ended June 30, 2011. The increase in
2012 is primarily due to the continued development of our existing anti-cancer drug portfolio including reinitiating our patient
enrollment in our Phase I/II clinical trials for Cordycepin (OVI-123), as well as finalizing our preclinical studies, developing
our clinical protocol, manufacturing the drug product and the preparation and submission of an IND to the FDA for OVI-117 to enter
into Phase I trials.
General and administrative.
General and administrative
expenses decreased by approximately $256,478 or 38%, to approximately $412,867 for the six months ended June 30, 2012, as compared
to approximately $669,345 for the six months ended June 30, 2011. The decrease was due primarily a decrease in consulting expense
for professional services.
Other Income (Expense)
.
The increase from other expense of approximately $306,000 to other income of approximately $143,000 is $449,000 or 147%, is due
primarily to a gain of approximately $147,000 on derivative liability in 2012 compared to a loss on derivative liability of approximately
$298,000 in 2011.
Going Concern and Recent Events
Our
consolidated financial statements for the six months ended June 30, 2012 have been prepared on a going concern basis, which contemplates
the realization of assets and the settlement of liabilities and commitments in the normal course of business.
We
reported a net loss of approximately $0.9 million, and net cash used in continuing operations of approximately $960,000 for the
six months ended June 30, 2012, an accumulated deficit of approximately $21.2 million and total deficit of approximately $996,000
at June 30, 2012. The Company is also in default on certain loans and related accrued interest aggregating $174,495 at June 30,
2012. The Report of the Independent Registered Public Accounting Firm on the Company’s financial statements as of and for
the year ended December 31, 2011 includes a “going concern” explanatory paragraph expressing substantial doubt about
our ability to continue as a going concern.
In November 2010, we received approximately $6.0 million as
our pro rata portion of the up-front payment from the sale of its shares of AdnaGen as described above.
As
a result of the stock purchase agreement with Alere Holdings, we now have
sufficient capital to meet our anticipated
operating cash requirements for the next six to seven months.
Our ability to continue as
a going concern depends on the success of management’s plans to achieve the following:
|
·
|
Continue to aggressively seek investment capital;
|
|
·
|
Develop our product pipeline;
|
|
·
|
Advance scientific progress in our research and
development; and
|
|
·
|
Continue to monitor and implement cost control
initiatives to conserve cash.
|
Liquidity and Capital Resources
At June 30, 2012, we had cash and cash equivalents of approximately
$1.2 million compared to $2.1 million at December 31, 2011. In order to preserve principal and maintain liquidity, our funds are
primarily invested in checking and interest bearing saving accounts with the primary objective of capital preservation. Based on
our current projections, we believe that our available resources and cash flow are sufficient to meet our anticipated operating
cash needs for the next six to seven months. Our ability to continue as a going concern is dependent on our ability to further
implement our strategic plan, continue to obtain additional debt and/or equity financing, and generate additional revenues from
collaborative agreements.
To date, we have financed our operations principally through
proceeds of offerings of securities exempt from the registration requirements of the Securities Act. We can provide no assurance
that additional funding will be available on terms acceptable to us, or at all. Accordingly, we may not be able to secure the funding
which is required to expand research and development programs beyond their current levels or at levels that may be required in
the future. If we cannot secure adequate financing, we may be required to delay, scale back or eliminate one or more of our research
and development programs or to enter into license or other arrangements with third parties to commercialize products or technologies
that we would otherwise seek to develop and commercialize ourselves. Our future capital requirements will depend upon many factors,
including:
|
·
|
Continued scientific progress in our research and development programs;
|
|
·
|
Costs and timing of conducting clinical trials and seeking regulatory approvals and patent prosecutions;
|
|
·
|
Competing technological and market developments; and
|
|
·
|
Our ability to establish additional collaborative relationships.
|
Accordingly, we may be required to issue equity or debt securities
or enter into other financial arrangements, including relationships with corporate and other partners, in order to raise additional
capital. Depending upon market conditions, we may not be successful in raising sufficient additional capital for our short or long-term
requirements. In such event, our business, prospects, financial condition, and results of operations would be materially adversely
affected.
Operating
Activities.
For the six months ended June 30, 2012, net cash used in operations increased $187,000, or 24% to approximately
$960,000 compared to approximately $773,000 for the six months ended June 30, 2011. The increase was primarily due to cash used
in legal and research and development activities.
Investing
and Financing Activities.
There was no cash provided by investing and financing activities were not significant
for the six months ended June 30, 2012 or 2011.
Recent Accounting Pronouncements
We have evaluated all recently issued accounting pronouncements and we believe such pronouncements do
not have a material effect on our financial statements.
Critical Accounting Policies
We have identified the policies below as critical to our business
operations and the understanding of our results of operations. The impact and any associated risks related to these policies on
our business operations are disclosed throughout this section where such policies affect our reported and expected financial results.
The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets
and liabilities, disclosure of contingent assets and liabilities at the date of our financial statements, and the reported amounts
of revenues and expenses during the reporting period. There can be no assurance that actual results will not differ from those
estimates.
Revenue Recognition.
While we have not recognized
revenues from continuing operations, we anticipate that future revenues will be generated from product sales. We expect to recognize
revenue from product sales in accordance with SEC, Staff Accounting Bulletin (“SAB”) No. 104, “Revenue Recognition”
that requires we recognize revenue when each of the following four criteria is met: 1) a contract or sales arrangement exists;
2) products have been shipped or services have been rendered; 3) the price of the products or services is fixed or determinable;
and 4) collectability is reasonably assured. We anticipate that customers will have no right of return for products sold. Revenues
are considered to be earned upon shipment.
Share-Based Compensation.
We follow Accounting
Standards Codification (“ASC”) 718 “Compensation – Stock Compensation” which requires the measurement
and recognition of compensation expense for all share-based payment awards made to employees and directors including grants of
employee stock options based on estimated fair values. We have used the Black-Scholes option pricing model to estimate grant date
fair value for all option grants. The assumptions we use in calculating the fair value of share-based payment awards represent
management’s best estimates, but these estimates involve inherent uncertainties and the application of management judgment.
As such, as we use different assumptions based on a change in factors, our stock-based compensation expense could be materially
different in the future.
Preclinical Study and Clinical Trial Accruals.
Substantially all of our preclinical studies and clinical trials are being performed by third-party CROs and other outside vendors.
For preclinical studies, we use the percentage of work completed to date and contract milestones achieved to determine the accruals
recorded. For clinical trial accruals, we use the number of patients enrolled, period of patient enrollment and percentage of work
completed to date to estimate the accruals. We monitor patient enrollment levels and related activities to the extent possible
through internal reviews, correspondence and status meetings with CROs and review of contractual terms. Our estimates are dependent
on the timeliness and accuracy of data provided by our CROs and other vendors. If we have incomplete or inaccurate data, we may
under-or overestimate activity levels associated with various studies or clinical trials at a given point in time. In this event,
we could record adjustments to research and development expenses in future periods when the actual activity levels become known.
No material adjustments to preclinical study and clinical trial expenses have been recognized to date.
ITEM 3 –
Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined
by Rule 12b-2 of the Exchange Act and are not required to provide the information under this item.
ITEM 4 –
CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
As of June 30, 2012, under the supervision and with the participation
of our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), management has evaluated the
effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15 under the Exchange
Act. Based on that evaluation, the CEO and CFO concluded that, as of June 30, 2012, our disclosure controls and procedures were
ineffective at the reasonable assurance level in timely alerting him to material information required to be included in our periodic
SEC reports as a result of the material weakness in internal control over financial reporting discussed below,
our
disclosure controls and procedures were not effective as of
December 31, 2011. Management’s assessment of the effectiveness
of internal control over financial reporting is expressed at the level of reasonable assurance because a control system, no matter
how well designed and operated, can provide only reasonable, but not absolute, assurance that the control system’s objectives
will be met.
Management’s Quarterly Report on Internal Control over
Financial Reporting
Our management is responsible for establishing and maintaining
adequate internal control over financial reporting as defined in Exchange Act Rule 13a-15(f). Our internal control system is a
process designed by, or under the supervision of, our principal executive and principal financial officer, or persons performing
similar functions, and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S.
generally accepted accounting principles (
“U.S. GAAP”
).
Our internal control over financial reporting includes policies
and procedures that pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect transactions
and dispositions of assets; provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial
statements in accordance with U.S. GAAP, and that receipts and expenditures are being made only in accordance with the authorization
of our management and directors; and provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition,
use or disposition of our assets that could have a material effect on our consolidated financial statements.
Because of our inherent limitations, internal control over financial
reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject
to risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies
or procedures may deteriorate.
Management assessed the effectiveness of our internal control
over financial reporting as of June 30, 2012. As a result of its assessment, management identified a material weakness in our internal
control over financial reporting. Based on the weakness described below, management concluded that our internal control over financial
reporting was not effective as of June 30, 2012.
A material weakness is a deficiency, or combination of deficiencies,
in internal control over financial reporting, such that, there is a reasonable possibility that a material misstatement of our
annual or interim financial statements will not be prevented or detected on a timely basis. As a result of our assessment, management
identified the following material weaknesses in internal control over financial reporting as of June 30, 2012:
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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.
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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.
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There is lack of segregation of duties in financial reporting, as
our financial reporting and all accounting functions are performed by our Chief Financial Officer who also serves as our Chief
Executive Officer. This weakness is due to our lack of working capital to hire additional staff during the period covered by this
report. We intend to hire additional accounting personnel to assist with financial reporting as soon as our finances will allow.
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Changes in Internal Control Over Financial Reporting
There were no significant changes in our internal control over
financial reporting that occurred during the six months ended June 30, 2012 that have materially affected or are reasonably likely
to materially affect our internal control over financial reporting.
PART II – OTHER INFORMATION
ITEM 1 –
LEGAL PROCEEDINGS
There have been no events which are required
to be reported under this item.
ITEM 1A –
RISK FACTORS
We are a smaller reporting company as defined by Rule 12b-2
of the Exchange Act and are not required to provide the information under this item.
ITEM 2 –
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On June 27, 2012 CAMOFI Master LDC and
CAMHZN Master LDC exercised warrants for 216,000 and 41,143 shares respectively of our common stock with an exercise price of $0.001
per share.
The information set forth in Item 5 below
is incorporated herein by this reference.
ITEM 3 –
DEFAULTS UPON SENIOR SECURITIES
There have been no events which are required to be reported
under this item.
ITEM 4 –
MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5 –
OTHER INFORMATION
On January 11, 2012, we entered into an
Agreement
(the “Agreement”) with KP Pharmaceutical Technology, Inc., an Indiana corporation
(“KPPT”). The
Agreement provides that, in exchange for KPPT providing manufacturing and analytical testing of our lead drug candidate from the
L-nucleoside conjugate program, OVI-117, we shall pay KPPT a total fee of $158,000. There is no material relationship between us
and KPPT, other than with respect to the Agreement.
On June 13, 2012, we entered into an
Agreement
(the “Agreement”) with
Landmark Financial Corporation (“Landmark”). The Agreement provides that,
in exchange for Landmark identifying and evaluating alternative strategies for expanding our business, we shall pay Landmark (a)
a retainer fee consisting of 300,000 shares of the our common stock which vest at the rate of 50,000 shares per month for six months
(the term of the Agreement), and (b) a “success fee” for the consummation of each and any transaction closing during
the term of the Agreement and for 12 months thereafter, between the us and any party first introduced to us by Landmark. There
is no material relationship between us and Landmark, other than with respect to the Agreement.
On July 12, 2012 we consummated a settlement with a debt holder
of one outstanding unsecured note in the aggregate amount of $174,495 (as of June 30, 2012). We and the debt holder agreed to a
one time payment of $60,000 for complete and full payment of the debt.
ITEM 6 –
EXHIBITS
Exhibits:
Exhibit No.
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Description
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10.1
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Agreement with Landmark Financial Corporation dated June 13, 2012
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31.1
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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
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31.2
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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
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32
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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
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SIGNATURES
Pursuant to the requirements of Section 13 or 15 (d) of the
Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto
duly authorized.
ONCOVISTA INNOVATIVE THERAPIES, INC.
Alexander L. Weis, Ph.D.
Chief Executive Officer, and Chief Financial Officer
(Principal Executive Officer
,
Principal Financial
Officer and Principal Accounting Officer
)
Date: August 14, 2012
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