|
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 early (Phase I/II) 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. In August 2011, certain expenses related to legal fees were
paid to OncoVista, Inc., OVIT’s subsidiary, of approximately $204,000.
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 September 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 September 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 included as part of OVIT’s Form 10-K for the year ended December
31, 2011.
Principles of Consolidation
The consolidated financial statements include the accounts of
OVIT and OncoVista, Inc. (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 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 nine month
periods ended September 30, 2012 and 2011, all unvested restricted stock, stock options and warrants are considered to be anti-dilutive.
At September 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
|
|
|
|
1,381,500
|
|
Warrants
|
|
|
4,074,569
|
|
|
|
4,331,712
|
|
Total
|
|
|
5,456,069
|
|
|
|
5,713,212
|
|
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 believe 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 $1.3 million, and net cash used in operations of approximately $1.3 million for
the nine months ended September 30, 2012, an accumulated deficit of approximately $21.6 million and total deficit of approximately
$1.3 million at September 30, 2012. These factors raise substantial doubt about the Company’s ability to continue as a going
concern.
Management believes that the Company
has
sufficient capital to meet its anticipated operating cash requirements for the next 5 to 6 months.
The accompanying condensed 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.
As a result of the proceeds received pursuant to the Stock Purchase
Agreement with Alere Holdings, the Company has eliminated all of its outstanding debt. The Company is using the balance of the
proceeds from the sale of its shares in AdnaGen to fund on-going development activities for its drug candidate portfolio. Additionally,
the Company is evaluating several opportunities to license or acquire other compounds or diagnostic technologies that it believes
will provide for treatments that are highly targeted, efficacious and with low or no toxicity.
Equipment balances at September 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
|
|
|
(34,471
|
)
|
|
|
(29,236
|
)
|
Equipment, net
|
|
$
|
4,987
|
|
|
$
|
10,222
|
|
Accrued expenses at September 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
|
|
|
672,500
|
|
|
|
560,000
|
|
Other
|
|
|
75,240
|
|
|
|
1,239
|
|
Total accrued expenses
|
|
$
|
1,168,831
|
|
|
$
|
1,003,580
|
|
As of December 31, 2011, the Company had one outstanding
unsecured note in the principal amount of $100,000 and $67,711 in accrued interest. Interest accrued at a rate of 8%, payable
to a third party, and was due on demand. In July 2012, the Company entered into a settlement agreement to satisfy the
obligation in full with a one-time payment of $60,000, resulting in a gain on extinguishment of $114,495.
|
Note 7.
|
DERIVATIVE LIABILITY
|
The Company determined that warrants issued in connection with
the bridge round of debt financing entered into by the Company in January 2009 required liability classification due to certain
provisions (which were amended in 2010) that may result in an adjustment to the number shares issued upon settlement (see Note
10).
The estimated fair value of the derivative liability was $183,126
and $322,834 at September 30, 2012.
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
|
0.23% - 0.36%
|
Dividend yield
|
0%
|
Fair value measurements
Assets and liabilities measured at fair value as of September 30, 2012 are as follows:
|
|
|
|
|
Quoted prices in
active markets
|
|
|
Significant other
observable inputs
|
|
|
Significant
unobservable inputs
|
|
|
|
Value at
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
Derivative liability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2012
|
|
$
|
183,126
|
|
|
|
|
|
|
$
|
183,126
|
|
|
|
|
|
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 September 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 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. On January 20, 2012 the court denied the motion to dismiss the case due
to lack of subject matter jurisdiction. On July 10, 2012 the Company filed a motion for summary judgment. On September 11, 2012
New Millennium PR Communications, Inc. filed an opposition to the Company’s request for summary judgment. The court has not
yet ruled on the matter.
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.
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 our 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 for $12,000 per month. 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 September 30, 2012, the Company had paid a total of $550,000 toward this agreement and has accrued
$600,000 and $450,000, which is included in accounts payable in the condensed consolidated balance sheets as of September 30, 2012,
and December 31, 2011, respectively and recorded as research and development expense. During the nine month periods ended September
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 nine month periods ended
September 30, 2012 and 2011, the Company did not recognize any revenue from its share of Lipitek revenues.
|
Note 10.
|
CHANGES IN EQUITY
|
Common Stock
The Company is authorized to issue up to 147,397,390 shares
of common stock. At September 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
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 September
30, 2012 the shares have not been issued to Landmark Financial Corporation. The Company recorded $33,000 and $39,492 in consulting
expense for the restricted stock grant for the three and nine months ended September 30, 2012, respectively and $66,000 in accrued
expenses for the shares that were not issued as of September 30, 2012.
Stock Option Plans
All 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.
The Company granted stock options to employees, consultants
and directors to acquire 658,600 shares of common stock for future services having a fair market value of $135,354 during the nine
months ended September 30, 2011. Vesting periods for these options included the following: monthly over two years and monthly over
four years. No options were granted for the same period in 2012.
The stock-based compensation expense recorded by the Company
with respect to awards under the Company’s stock plans is as follows:
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2012
|
|
|
2011
|
|
|
2012
|
|
|
2011
|
|
Research and development
|
|
$
|
12,806
|
|
|
$
|
12,806
|
|
|
$
|
38,418
|
|
|
$
|
39,727
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
5,991
|
|
|
|
17,643
|
|
|
|
17,974
|
|
|
|
62,096
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total employee stock-based compensation
|
|
$
|
18,797
|
|
|
$
|
30,449
|
|
|
$
|
56,392
|
|
|
$
|
101,823
|
|
In addition to options granted to employees, the Company historically
granted options to consultants and for the nine months ended September 30, 2011, and recognized $6,077 as consulting expense. Such
amounts are included in general and administrative expense in the consolidated statements of operations for the nine months ended
September 30, 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 September 30, 2012
|
|
|
1,381,500
|
|
|
$
|
0.91
|
|
|
6.09 years
|
|
|
$
|
26,000
|
|
Options Exercisable at September 30, 2012
|
|
|
1,245,750
|
|
|
$
|
0.97
|
|
|
5.86 years
|
|
|
$
|
26,000
|
|
The following summarizes the activity of the Company’s
stock options that have not vested for the nine months ended September 30, 2012:
|
|
Shares
|
|
|
Weighted
Average Fair
Value
|
|
Nonvested at January 1, 2012
|
|
|
404,250
|
|
|
$
|
0.21
|
|
Granted
|
|
|
-
|
|
|
|
-
|
|
Vested
|
|
|
(268,500
|
)
|
|
|
0.21
|
|
Cancelled or forfeited
|
|
|
-
|
|
|
|
-
|
|
Outstanding at September 30, 2012
|
|
|
135,750
|
|
|
$
|
0.21
|
|
The total fair value of the stock options that vested during
the nine months ended September 30, 2012 and 2011 was $56,385 and $99,272 respectively. At September 30, 2012 there was $23,800
of additional unrecognized compensation cost related to stock options that will be recorded over a weighted average future period
of less than 1 year.
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.