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Verastem Reports First Quarter 2014 Financial and Corporate Results
“We continue to advance our development programs targeting cancer stem
cells,” said
“In March, we reported on a Phase 1 trial in Japanese patients where
VS-6063 was generally well tolerated and the safety and pharmacokinetic
profile was comparable to that seen in the US Phase 1 trial,” said Dr.
Q1 2014 and Recent Accomplishments
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COMMAND (Control Of Mesothelioma with MAinteNance Defactinib) |
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Registration-directed, randomized, double blind, placebo controlled study of VS-6063 immediately following frontline therapy in patients with malignant pleural mesothelioma |
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Open in 11 countries worldwide |
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Progressed the FAK inhibition program (VS-6063 and VS-4718) |
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Reported preliminary data from the Phase 1 study of VS-6063 in Japanese patients |
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VS-6063 was well tolerated at all dose levels; no SAEs or evidence of dose-limiting toxicity |
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Confirmed the recommended Phase 2 dose as 400mg BID, consistent with dosing in other countries |
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Safety and pharmacokinetic results support the advancement of the VS-6063 development program in Japanese patients |
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Acquired additional license rights to VS-4718 from Encarta, reducing future milestones and royalties associated with ongoing development |
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Strengthened the dual PI3K/mTOR inhibition program (VS-5584) |
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Granted new Japanese patent titled “Pyrimidine Substituted Purine Compounds As Kinase(s) Inhibitors” with claims covering the composition of matter for VS-5584 and VS-5584’s ability to inhibit and regulate cellular metabolism, growth, and proliferation |
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Increased the understanding of cancer stem cell biology |
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Presented research results at the 2014 American Academy of Cancer Research (AACR) Annual Meeting. The data presented at AACR expanded understanding of the mechanisms of VS-6063, VS-4718 and VS-5584 and their ability to target cancer stem cells. Of significant interest is that VS-6063 inhibits the focal adhesion kinase family members FAK and PYK2 which leads to the preferential targeting of cancer stem cells both directly and through inhibition of tumor-associated macrophages in the tumor microenvironment. Published evidence in both mesothelioma and breast cancer has demonstrated a correlation between an increase in tumor-associated macrophages and poor prognosis in these patients. The posters presented at AACR can be accessed here: http://bit.ly/R3M6wc |
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Published data in Cancer Research on NF2 and merlin biology in cancer stem cells found in mesothelioma. The paper is titled “Tumor Suppressor Alterations Cooperate to Drive Aggressive Mesotheliomas with Enriched Cancer Stem Cells via a p53–miR-34a–c-Met Axis.” The study results demonstrated that inactivation of specific tumor suppressors cooperate to drive the development of highly aggressive mesothelioma characterized by enhanced disease progression and an increase in cancer stem cells. The paper can be accessed here: http://bit.ly/1figRWX |
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Research was published in Nature Immunology highlighting the potential role of FAK inhibition in hematological malignancies. The paper can be accessed here: http://bit.ly/1bKYJ6M |
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Strengthened leadership team |
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Appointed Timothy J. Barberich to the Board of Directors. Mr. Barberich founded Sepracor in 1984 and served as CEO and Chairman for more than 20 years. Under his leadership at Sepracor, revenues grew to more than a billion dollars as the company partnered and commercialized a number of successful products, including Allegra®, Clarinex®, Lunesta® and Xopenex®. |
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2014 Clinical Milestones
Verastem’s planned upcoming clinical milestones include the following:
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Report interim data from the Phase 1/1b trial of VS-6063 in
combination with weekly paclitaxel in patients with ovarian cancer at
the 50th Annual
American Society of Clinical Oncologists (ASCO ) meeting
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Open COMMAND study sites in
Japan in H2 2014 - Report the interim analysis for the Phase 2 study of VS-6063 in patients with Kras-mutated NSCLC in H2 2014
- Report interim data on the Phase 1 trial of VS-4718 in H2 2014
- Report interim data on the Phase 1 trial of VS-5584 in H2 2014
Upcoming Events
ASCO Breakfast
Research and Development Day
First Quarter 2014 Financial Results
As of
Net loss for the 2014 Quarter was
Research and development expense for the 2014 Quarter was
General and administrative expense for the 2014 Quarter was
The number of outstanding common shares as of
Financial Guidance
Based on current operating plans, we expect to have sufficient cash, cash equivalents and investments to fund our research and development programs and operations into the first half of 2016.
About VS-6063
VS-6063 is an orally available 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). VS-4718 is currently being studied in a Phase 1 dose escalation study in patients with advanced cancers.
About VS-5584
VS-5584 is an orally available compound that has demonstrated potent and
highly selective activity against class 1 PI3K enzymes and dual
inhibitory actions against mTORC1 and mTORC2. In preclinical studies,
VS-5584 has been shown to reduce the percentage of cancer stem cells and
induce tumor regression in chemotherapy-resistant models.
About COMMAND
COMMAND is a registration-directed, double-blind, placebo-controlled trial of VS-6063 with Progression Free Survival (PFS) and Overall Survival (OS) as the primary endpoints. The design of COMMAND allows the opportunity to enrich for patients with tumors low in the biomarker, merlin. Preclinical and early clinical research has demonstrated that low merlin levels may be predictive of increased effectiveness of FAK inhibitors such as VS-6063. The COMMAND study stratifies patients to evaluate the effect of VS-6063 in both the overall patient population and the subgroup of patients whose tumors are low in merlin.
COMMAND is expected to enroll approximately 350-400 patients at clinical
sites in 12 countries, including the US,
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,
VS-4718 and VS-5584 and the Company’s FAK and mTOR/PI3K inhibition and
diagnostic programs generally, the timeline for clinical development and
regulatory approval of the Company’s compounds, including the potential
for opening COMMAND trial sites in
(A development-stage company) Unaudited Selected Consolidated Balance Sheet Information (in thousands) |
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March 31, | December 31, | |||||||
2014 | 2013 | |||||||
Cash, cash equivalents and investments | $ | 113,876 | $ | 123,656 | ||||
Prepaid expenses and other current assets | 943 | 643 | ||||||
Property and equipment, net | 577 | 631 | ||||||
Other assets | 330 | 331 | ||||||
Total assets | $ | 115,726 | $ | 125,261 | ||||
Accounts payable and accrued expenses | $ | 6,100 | $ | 7,087 | ||||
Other liabilities | 301 | 728 | ||||||
Stockholders’ equity | 109,325 | 117,446 | ||||||
Total liabilities and stockholders’ equity | $ | 115,726 | $ | 125,261 | ||||
Verastem, Inc. (A development-stage company) Unaudited Condensed Consolidated Statements of Operations (in thousands, except per share amounts) |
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Three months ended, March 31, | ||||||||||
2014 | 2013 | |||||||||
Operating expenses: | ||||||||||
Research and development | $ | 8,411 | $ | 5,296 | ||||||
General and administrative | 4,723 | 3,785 | ||||||||
Total operating expenses | 13,134 | 9,081 | ||||||||
Loss from operations | (13,134 | ) | (9,081 | ) | ||||||
Interest income | 72 | 44 | ||||||||
Net loss | ($13,062 | ) | ($9,037 | ) | ||||||
Net loss per share | ($0.51 | ) | ($0.44 | ) | ||||||
Weighted-average number of common shares used in net loss per share | 25,478 | 20,483 | ||||||||
Source:
Verastem, Inc.
Brian Sullivan, 617-252-9314
bsullivan@verastem.com