Verastem, Inc., (NASDAQ: VSTM) a clinical-stage biopharmaceutical
company focused on discovering and developing drugs to treat cancer by
the targeted killing of cancer stem cells, today reported financial
results for the quarter ended September 30, 2012, and also commented on
certain corporate accomplishments and plans.
“We have made key strategic moves in the third quarter to position
Verastem as a leader in therapeutic development targeting cancer stem
cells,” said Christoph Westphal, M.D., Ph.D., Chairman and Chief
Executive Officer of Verastem.
“We have appointed Joanna Horobin as Chief Medical Officer to lead our
clinical development across multiple programs and trials,” said Robert
Forrester, Verastem Chief Operating Officer. “Recent data presented at
the EORTC meeting provide a clinical proof-of-concept for the utility of
FAK inhibition in mesothelioma and indicate a particular sensitivity in
tumors lacking the tumor suppressor Merlin. We intend to quickly move
into a potential registration study with our lead FAK inhibitor,
VS-6063, in mesothelioma midyear 2013.”
Recent Accomplishments
Our significant recent
accomplishments include the following:
Focal Adhesion Kinase (FAK) Inhibition
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Accelerated the FAK program with the in-license of FAK inhibitor
VS-6063
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VS-6063 has completed a Phase 1 study in advanced solid tumors,
where it was well tolerated and demonstrated signs of clinical
activity
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VS-6063 is expected to enter into a potential registration study
in mesothelioma midyear 2013
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2012 International Mesothelioma Interest Group
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Presented data demonstrating that loss of the tumor suppressor
Merlin confers increased susceptibility to FAK inhibition.
Approximately 50% of patients with mesothelioma are Merlin-negative
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2012 EORTC Symposium on Molecular Targets and Cancer Therapeutics
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Presented data demonstrating strong single agent activity of FAK
inhibition in Merlin-negative triple negative breast cancer models
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GSK reported data from a Phase 1 trial where it saw positive
activity in mesothelioma in response to FAK inhibition and a
particular sensitivity in tumors lacking the tumor suppressor
Merlin. These findings corroborate Verastem’s research on FAK
inhibition’s importance for the treatment of mesothelioma
Dual PI3K/mTOR Inhibition
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2012 EORTC Symposium on Molecular Targets and Cancer Therapeutics
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Presented data on the targeted killing of cancer stem cells by
VS-5584 in models of triple negative breast cancer
Corporate
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Appointed Joanna Horobin, M.B., Ch.B., as Chief Medical Officer
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Appointed S. Louise Phanstiel to the Board of Directors
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Established a research collaboration with Eisai to discover
next-generation small molecule inhibitors of Wnt signaling
Third Quarter 2012 Financial Results
As of September 30,
2012, Verastem had cash, cash equivalents and investments of $97.4
million compared to $56.8 million on December 31, 2011.
Net loss for the three months ended September 30, 2012 (the “2012
Quarter”), was $10.4 million, or $0.51 per share applicable to common
shareholders, as compared to net loss of $4.0 million, or $2.98 per
share, for the three months ending September 30, 2011 (the “2011
Quarter”). Net loss for the 2012 Quarter includes license fees of $3.5
million, including the issuance of 192,012 shares of common stock, and
stock-based compensation expense of $1.6 million compared to stock-based
compensation expense of $652,000 for the 2011 Quarter.
Research and development expense for the 2012 Quarter was $8.1 million
compared to $3.1 million for the 2011 Quarter. The $5.0 million increase
from the 2011 Quarter to the 2012 Quarter principally resulted from an
increase of $3.4 million in license fees due to our agreement with
Pfizer, including the issuance of 192,012 shares of common stock, an
increase of $1.3 million in contract research organization expense and
an increase of $528,000 for personnel costs, including stock-based
compensation of $325,000, primarily due to increased headcount and a
higher fair value of our common stock. These expenses are partially
offset by decreases in consulting expense of $146,000 and lab supplies
of $114,000.
General and administrative expense for the 2012 Quarter was $2.3 million
compared to $965,000 for the 2011 Quarter. The $1.3 million increase
from the 2011 Quarter to the 2012 Quarter principally resulted from an
increase of $821,000 for personnel costs, including stock-based
compensation of $640,000, primarily due to a higher fair value of our
common stock, an increase of $385,000 in professional fees primarily
related to additional legal and accounting fees for being a publicly
traded company and an increase of $100,000 in insurance costs primarily
related to being a publicly traded company.
About Verastem, Inc.
Verastem, Inc. (NASDAQ: VSTM) is a
clinical-stage biopharmaceutical company focused on discovering and
developing drugs to treat cancer by the targeted killing of cancer stem
cells. Cancer stem cells are an underlying cause of tumor recurrence and
metastasis. Verastem is developing small molecule inhibitors of
signaling pathways that are critical to cancer stem cell survival and
proliferation: FAK, PI3K/mTOR and Wnt. For more information, please
visit www.verastem.com.
Forward-looking statements:
This press release includes
forward-looking statements about the Company’s strategy, future plans
and prospects, including statements regarding the development of the
Company’s compounds, including VS-6063, VS-4718 and VS-5584, and the
Company’s FAK PI3K/mTOR, Wnt and diagnostic programs generally, the
timeline for clinical development and regulatory approval of the
Company’s compounds, the structure of the Company’s planned clinical
trials and the ability of the Company to finance contemplated
development activities.. The words “anticipate,” “believe,” “estimate,”
“expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,”
“potential,” “will,” “would,” “could,” “should,” “continue,” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these identifying
words. Each forward-looking statement is subject to risks and
uncertainties that could cause actual results to differ materially from
those expressed or implied in such statement. Applicable risks and
uncertainties include the risks that the preclinical testing of the
Company’s compounds may not be predictive of the success of later
clinical trials, that the Company will be unable to successfully
complete the clinical development of its compounds, including VS-6063,
VS-4718 and VS-5584, that the development of the Company’s compounds
will take longer or cost more than planned, and that the Company’s
compounds will not receive regulatory approval or become commercially
successful products. Other risks and uncertainties include those
identified under the heading “Risk Factors” in the Company’s Annual
Report on Form 10-K for the year ended December 31, 2011 and in any
subsequent SEC filings. The forward-looking statements contained in this
presentation reflect the Company’s current views with respect to future
events, and the Company does not undertake and specifically disclaims
any obligation to update any forward-looking statements.
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Verastem, Inc.
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(A development-stage company)
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Unaudited Selected Balance Sheet Information
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(in thousands)
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September 30,
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December 31,
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2012
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2011
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Cash and cash equivalents
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$11,126
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$20,954
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Short-term investment
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35,726
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26,857
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Working capital
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44,132
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44,795
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Long-term investments
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50,579
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8,994
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Total assets
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98,830
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59,037
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Stockholders’ equity (deficit)
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95,612
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(12,766)
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Verastem, Inc.
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(A development-stage company)
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Unaudited Condensed Statements of Operations
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(in thousands, except per share amounts)
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Three months ended September 30,
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Nine months ended September 30,
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2012
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2011
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2012
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2011
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Operating expenses:
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Research and development
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$8,132
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$3,082
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$17,618
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$5,483
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General and administrative
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2,298
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965
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6,636
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2,195
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Total operating expenses
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10,430
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4,047
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24,254
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7,678
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Loss from operations
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(10,430)
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(4,047)
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(24,254)
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(7,678)
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Interest income
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63
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-
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191
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-
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Net loss
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(10,367)
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(4,047)
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(24,063)
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(7,678)
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Accretion of preferred stock
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-
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(10)
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(6)
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(18)
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Net loss applicable to common stockholders
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($10,367)
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($4,057)
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($24,069)
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($7,696)
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Net loss per share applicable to common stockholders–basic and
diluted
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($0.51)
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($2.98)
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($1.32)
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($6.27)
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Weighted-average number of common shares used in net loss per
share applicable to common stockholders-basic and diluted
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20,160
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1,361
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18,246
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1,226
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