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8-K - FORM 8-K - VION PHARMACEUTICALS INC | y02570e8vk.htm |
EX-99.2 - EX-99.2 - VION PHARMACEUTICALS INC | y02570exv99w2.htm |
Exhibit 99.1
COMPANY CONTACT: | Vion Pharmaceuticals, Inc. Alan Kessman, Chief Executive Officer Howard B. Johnson, President & CFO (203) 498-4210 |
VION PHARMACEUTICALS REPORTS
2009 THIRD QUARTER AND NINE-MONTH RESULTS
2009 THIRD QUARTER AND NINE-MONTH RESULTS
Company to hold Conference Call on November 12, 2009
NEW HAVEN, CT, November 10, 2009 VION PHARMACEUTICALS, INC. (OTC BULLETIN BOARD: VION) today
announced financial results for the three-month and nine-month periods ending September 30, 2009.
For the third quarter of 2009, the Company reported a net loss of $6.2 million, or $0.78 per share,
compared with a net loss of $6.8 million, or $0.92 per share, for the same 2008 period.
Weighted-average common shares outstanding for the three-month periods ended September 30, 2009 and
2008 were 8.0 million and 7.4 million, respectively.
For the nine-month period, the net loss was $17.1 million, or $2.15 per share, compared with a net
loss of $22.9 million, or $3.12 per share, for the same 2008 period. Weighted-average common
shares outstanding for the nine-month periods ended September 30, 2009 and 2008 were 8.0 million
and 7.4 million, respectively.
In the quarter, the Oncologic Drugs Advisory Committee (ODAC), which is the cancer drug advisory
panel of the U.S. Food and Drug Administration (FDA), voted in favor of requiring Vion to complete
a randomized study defining the efficacy and safety of the Companys lead oncology therapeutic
Onrigin (laromustine) Injection prior to receiving regulatory approval from the FDA. Vion
currently does not have the funds to conduct such a randomized trial.
On October 12, 2009, the Company announced it had hired the investment banking firm Merriman Curhan
Ford & Co. to assist in evaluating its strategic alternatives. These alternatives include any
combination of a restructuring of the Company and its debt and a sale of the Company or its assets.
The Company may also consider financing options. The Company expects its strategic review to be
completed in the fourth quarter of 2009. The outcome of the Companys strategic review will
determine whether the Company continues operations or whether it curtails or ceases operations,
liquidates its assets and/or files for bankruptcy.
The Company ended the third quarter of 2009 with cash and cash equivalents totaling $18.9 million.
The Companys review of its strategic alternatives will determine the Companys future operations,
if any, and levels of cash expenditures and employee staffing. It is likely that,
without additional financing, the cash and cash equivalents will not be adequate to fund operations
for the next twelve months.
About Vion Pharmaceuticals
Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of
cancer patients worldwide by developing and commercializing innovative oncology therapeutics. Vion
has two agents in clinical trials, OnriginÔ (laromustine) Injection and Triapine®.
The Company has submitted a New Drug Application to the FDA for OnriginÔ for remission
induction treatment for patients sixty years of age or older with de novo poor-risk AML. The FDAs
Oncologic Drug Advisory Committee has recommended to the FDA that a randomized trial for
OnriginÔ be completed prior to regulatory approval. Triapine®, a potent inhibitor
of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National
Cancer Institute. For additional information on Vion and its product development programs, visit
the Companys Internet web site at www.vionpharm.com.
This news release contains forward-looking statements. Such statements are subject to certain risk
factors which may cause Vions plans to differ or results to vary from those expected, including
Vion being unsuccessful in achieving its strategic alternatives, including any combination of a
restructuring of the Company and its debt, a sale of the Company or its assets, and raising new
capital, in which case it may have to consider curtailing or ceasing operations, liquidating its
assets and/or filing for bankruptcy, Vions potential inability to obtain regulatory approval for
its products, particularly OnriginÔ(laromustine) Injection, delays in the regulatory approval
process, particularly for OnriginÔ, delays or unfavorable results of drug trials, the
possibility that favorable results of earlier preclinical studies, clinical trials or interim
clinical trial data are not confirmed by safety and efficacy results in later or final clinical
trials, the need for additional research and testing, including the need for a randomized trial of
OnriginÔ prior to regulatory approval in accordance with the recommendation of the Oncologic
Drug Advisory Committee, the inability to manufacture product, the potential inability to secure
external sources of funding to continue operations, the inability to access capital and funding on
favorable terms, continued operating losses and the inability to continue operations as a result,
and a variety of other risks set forth from time to time in Vions filings with the Securities and
Exchange Commission, including but not limited to the risks attendant to the forward-looking
statements included under Item 1A, Risk Factors in Vions Form 10-K for the year ended December
31, 2008 and Vions Form 10-Q for the quarter ended September 30, 2009. Except in special
circumstances in which a duty to update arises under law when prior disclosure becomes materially
misleading in light of subsequent events, Vion does not intend to update any of these
forward-looking statements to reflect events or circumstances after the date hereof or to reflect
the occurrence of unanticipated events.
Conference Call
The Company will hold a conference call at 8:30 a.m. Eastern Time on November 12, 2009 to discuss
its operations and financial results.
To participate in the conference call, please dial (800) 591-6923 in the U.S. ((617) 614-4907 for
international callers) at least 15 minutes before the start of the call. When prompted for a pass
code, please enter 24266649.
An audio webcast of the call will be accessible at www.vionpharm.com. Those who wish to listen to
the conference call on the Web should visit the Investor Relations section of the Companys website
at least 15 minutes prior to the event broadcast, and follow the instructions provided to assure
that the necessary audio applications are downloaded and installed. These programs can be obtained
at no charge to the user.
A replay of the call will be available two hours after the completion of the call at (888) 286-8010 in the U.S., ((617) 801-6888 for international callers), pass code 62814687. The
replay will be available through November 26, 2009.
Financial Statements Follow
VION PHARMACEUTICALS, INC.
(A Development Stage Company)
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
(In thousands, except per share data) | 2009 | 2008 | 2009 | 2008 | ||||||||||||
(Unaudited) | (Unaudited) | |||||||||||||||
Technology license fee revenue |
$ | 5 | $ | 8 | $ | 15 | $ | 35 | ||||||||
Operating expenses: |
||||||||||||||||
Clinical trials |
1,532 | 2,060 | 4,143 | 7,867 | ||||||||||||
Other research and development |
1,904 | 1,620 | 5,420 | 5,892 | ||||||||||||
Total research and development |
3,436 | 3,680 | 9,563 | 13,759 | ||||||||||||
Marketing, general and administrative |
1,079 | 1,872 | 4,523 | 5,655 | ||||||||||||
Total operating expenses |
4,515 | 5,552 | 14,086 | 19,414 | ||||||||||||
Loss from operations |
(4,510 | ) | (5,544 | ) | (14,071 | ) | (19,379 | ) | ||||||||
Interest expense |
(1,671 | ) | (1,521 | ) | (5,675 | ) | (4,539 | ) | ||||||||
Interest income |
1 | 224 | 11 | 991 | ||||||||||||
Other income (expense), net |
(55 | ) | (3 | ) | 2,589 | (15 | ) | |||||||||
Loss before income taxes |
(6,235 | ) | (6,844 | ) | (17,146 | ) | (22,942 | ) | ||||||||
Income tax provision |
| | | | ||||||||||||
Net loss |
($6,235 | ) | ($6,844 | ) | ($17,146 | ) | ($22,942 | ) | ||||||||
Basic and diluted loss per share |
($0.78 | ) | ($0.92 | ) | ($2.15 | ) | ($3.12 | ) | ||||||||
Weighted-average number of shares
of common stock outstanding |
7,997 | 7,449 | 7,973 | 7,355 | ||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEET DATA
Sep 30, | Dec 31, | |||||||
(In thousands) | 2009 | 2008 | ||||||
(Unaudited) | ||||||||
Cash and cash equivalents |
$ | 18,928 | $ | 37,990 | ||||
Total assets |
19,830 | 39,474 | ||||||
Convertible senior notes |
55,037 | 55,443 | ||||||
Total liabilities |
60,363 | 62,858 | ||||||
Shareholders deficit |
(40,533 | ) | (23,384 | ) | ||||
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