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Verastem Reports Third Quarter 2013 Financial and Corporate Results
“We continue to execute on our development plans and have made
significant and rapid progress in the third quarter,” said
“We recently initiated three additional clinical trials of lead
candidate VS-6063,” said Dr.
“It is our mission to develop novel therapies targeting cancer stem
cells to provide more durable responses for patients battling many types
of cancer,” said
Q3 2013 and Recent Accomplishments
Our significant accomplishments include the following:
Advanced the FAK inhibition program
- Initiated COMMAND: A randomized, placebo controlled study of VS-6063 as maintenance following frontline therapy in patients with mesothelioma being conducted at approximately 35 sites in 11 countries
-
Reported on the dose escalation portion of the Phase 1/1b study of
VS-6063 in combination with weekly paclitaxel in patients with ovarian
cancer
- The combination was well tolerated at both dose levels with no worsening of the well-known side effects of paclitaxel
- Initial activity observed including a Complete Response in one of the three patients in the first cohort
- Opened the expansion portion of the Phase 1/1b study of VS-6063 and weekly paclitaxel in ovarian cancer
- Initiated a Phase 2 study of VS-6063 in KRas-mutated non-small cell lung cancer
-
Initiated a Phase 1 study of VS-6063 in
Japan to evaluate the safety profile and pharmacokinetics of VS-6063 in Japanese patients - Opened all sites for the Phase 1 dose escalation trial of VS-4718 in patients with advanced cancers
- Presented 11 posters on the clinical and preclinical development of VS-6063 and the role of FAK in cancer stem cell-driven disease progression at the annual AACR-EORTC-NCI Molecular Targets, AACR Ovarian Cancer, Cancer Advance and World Lung conferences
Progressed the dual PI3K/mTOR inhibition program
- Received IND allowance to initiate a Phase 1 study of VS-5584. The study is anticipated to start by year end 2013 in patients with advanced solid tumors and lymphomas
-
Presented data at the 2013 AACR-EORTC-NCI Molecular Targets and the
American Chemical Society meetings demonstrating the ability of VS-5584 to reduce cancer stem cells across multiple preclinical tumor models
Strengthened balance sheet and clinical advisory team
-
Closed on a
$63.8 million public offering with net proceeds toVerastem totaling approximately$59.8 million inJuly 2013 -
Named
Jose Baselga , M.D., Ph.D., Physician in Chief atMemorial Sloan-Kettering Cancer Center , as Senior Medical Advisor
2013/14 Milestones
Our planned upcoming clinical milestones include the following:
- Initiate Phase 1 dose escalation study of VS-5584 in patients with advanced solid tumors and lymphomas by year end 2013
- Complete enrollment in the Phase 1b portion of the VS-6063 trial in combination with weekly paclitaxel in patients with ovarian cancer in H1 2014
-
Complete the Phase 1 dose escalation study of VS-6063 in patients with
advanced solid tumors in
Japan in H1 2014, with a goal of facilitating inclusion of Japanese sites into COMMAND in H2 2014 - Complete enrollment in the stage 1 portion of the VS-6063 Phase 2 trial in patients with non-small cell lung cancer midyear 2014
- Complete enrollment for the Phase 1 trial of VS-4718 in H2 2014
Upcoming Events
-
NY CEO Conference on
November 12 th and 13th at Apella inNew York City , NY -
Target TME Conference onNovember 18 th-20th at theRoyal Sonesta Hotel inBoston, MA -
Jefferies 2013 Global Healthcare Conference on
November 20 th and 21st atThe Waldorf Hilton inLondon, UK
Third Quarter 2013 Financial Results
As of
Net loss for the third quarter ended
Research and development expense for the 2013 Quarter was
General and administrative expense for the 2013 Quarter was
The number of outstanding common shares as of
About VS-6063
VS-6063 (defactinib) is an oral compound designed to target cancer stem
cells through the potent inhibition of focal adhesion kinase (FAK).
Cancer stem cells are an underlying cause of tumor resistance to
chemotherapy, recurrence and ultimate disease progression. Research by
About VS-4718
VS-4718 is an oral compound designed to target cancer stem cells through
the potent inhibition of focal adhesion kinase (FAK). Research by
About VS-5584
VS-5584 is an oral compound that potently and selectively inhibits the
class 1 PI3K isoforms, mTORC1 and mTORC2. In preclinical studies,
VS-5584 has been shown to reduce the percentage of cancer stem cells and
induce tumor regression in taxane-resistant models.
About
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,
or defactinib, VS-4718 and VS-5584 and the Company’s FAK, mTOR/PI3K and
diagnostic programs generally, the timeline for clinical development
including projected enrollment of trials, regulatory approval of the
Company’s compounds, the expected timing for the reporting of data from
ongoing trials, the structure of the Company’s planned or pending
clinical trials and the Company’s ability to fund operations. The words
“anticipate,” “appear,” “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 and
preliminary data from clinical trials may not be predictive of the
results or success of pending or later clinical trials, that data may
not be available when we expect it to be, that the Company will not be
able to enroll a sufficient number of patients in the expected
timeframe, 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
(A development-stage company) |
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Unaudited Selected Consolidated Balance Sheet Information |
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(in thousands) |
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September 30, | December 31, | |||||
2013 |
2012 |
|||||
Cash, cash equivalents and investments | $130,270 | $91,520 | ||||
Prepaid expenses and other current assets | 1,077 | 506 | ||||
Property and equipment, net | 674 | 811 | ||||
Other assets | 408 | 86 | ||||
Total assets | $132,429 | $92,923 | ||||
Accounts payable and accrued expenses | 5,293 | 2,399 | ||||
Other liabilities | 431 | 58 | ||||
Stockholders’ equity | 126,705 | 90,466 | ||||
Total liabilities and stockholders’ equity | $132,429 | $92,923 | ||||
Verastem, Inc. |
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(A development-stage company) |
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Unaudited Condensed Consolidated Statements of Operations |
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(in thousands, except per share amounts) |
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Three months ended, September 30, | Nine months ended, September 30, | |||||||||||
2013 |
2012 |
2013 |
2012 |
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Operating expenses: | ||||||||||||
Research and development | $6,789 | $8,132 | $18,130 | $17,618 | ||||||||
General and administrative | 3,855 | 2,298 | 11,879 | 6,636 | ||||||||
Total operating expenses | 10,644 | 10,430 | 30,009 | 24,254 | ||||||||
Loss from operations | (10,644) | (10,430) | (30,009) | (24,254) | ||||||||
Interest income | 53 | 63 | 131 | 191 | ||||||||
Net loss | ($10,591) | ($10,367) | ($29,878) | ($24,063) | ||||||||
Accretion of preferred stock | - | - | - | (6) | ||||||||
Net loss applicable to common |
($10,591) | ($10,367) | ($29,878) | ($24,069) | ||||||||
Net loss per share applicable to |
($0.47) | ($0.51) | ($1.37) | ($1.32) | ||||||||
Weighted-average number of |
22,437 | 20,160 | 21,797 | 18,246 | ||||||||
Source:
Verastem, Inc.
Brian Sullivan, 617-252-9314
bsullivan@verastem.com