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Verastem Reports Second Quarter 2014 Financial and Corporate Results
“We ended the second quarter with a cash, cash equivalents and
investments balance of
“We continue to see encouraging clinical signals from the VS-6063
program, including reductions in markers of cancer stem cells, prolonged
disease stabilization and objective responses in the ongoing Phase 1/1b
combination study of VS-6063 and paclitaxel in patients with ovarian
cancer,” said Dr.
Q2 2014 AND RECENT HIGHLIGHTS:
Mesothelioma
-
COMMAND (Control Of
Mesothelioma with MAinteNance
Defactinib) Study
- Registration-directed, randomized, double-blind, placebo-controlled study of VS-6063 immediately following frontline therapy in patients with malignant pleural mesothelioma
-
With the addition of Japanese sites, we are pursuing simultaneous
development in the US, EU,
Japan ,Australia and other regions of mesothelioma incidence - COMMAND is now open in 12 countries worldwide
- An interim analysis is expected midyear 2015
-
“Window of Opportunity” study
- Single agent treatment with VS-6063 for 12 days in patients with malignant pleural mesothelioma prior to surgery
Ovarian Cancer
-
Phase 1/1b study of VS-6063 in combination with weekly paclitaxel
-
Presented interim data at the
American Society of Clinical Oncology (ASCO ) 2014 and a clinical update at the Company’s Research and Development Day- Interesting signs of early clinical activity; 64% best response of stable disease or better including two complete responses and three partial responses in the ongoing study
- Combination therapy was generally well-tolerated with no dose limiting toxicities
- Treatment with VS-6063 as a single agent for 10 days decreased both FAK activity and cancer stem cells in patient biopsies
-
Presented interim data at the
Third Annual Research and Development Day
-
Members of the
Verastem leadership team, along with a panel of experts, provided in-depth reviews of the Company’s development programs targeting cancer stem cells with a focus on lead candidate, VS-6063 -
A replay of the webcast can be accessed here
or by visiting the
Verastem website
Analyst Event at
- Provided a scientific update on the COMMAND study and discussed the rationale for targeting cancer stem cells in mesothelioma
-
A replay of the event webcast can be accessed here
or by visiting the
Verastem website
Increased the Understanding of Cancer Stem Cell Biology
-
Presented posters at the ASCO Annual Meeting. In addition to the
interim data that were presented for the ongoing trial of VS-6063 in
combination with paclitaxel in patients with ovarian cancer,
Verastem presented posters describing the trial designs for two of the Company’s other ongoing clinical trials: one for the registration-directed COMMAND study of VS-6063 for patients with malignant pleural mesothelioma, and the other for the study of VS-6063 for patients with non-small cell lung cancer. The posters presented atASCO can be accessed here. -
Presented research results at the 2014
American Academy of Cancer Research (AACR) Annual Meeting. The presented data expanded understanding of the mechanisms of VS-6063, VS-4718 and VS-5584 and their ability to target cancer stem cells. The data also highlighted VS-6063’s inhibitory effect on focal adhesion kinase family members FAK and PYK2 leading to the preferential targeting of cancer stem cells both directly and through inhibition of tumor-associated macrophages in the tumor microenvironment. Published research studies in both mesothelioma and breast cancer have 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.
Strengthened Leadership Team and Intellectual Property Portfolio
-
Appointed industry veteran
Paul A. Friedman , M.D. to theVerastem Board of Directors. Dr. Friedman previously served as Chief Executive Officer ofIncyte Corporation , where he oversaw the development and commercialization of Jakafi®. During his career, he also served in leadership positions atDuPont Pharmaceuticals andMerck Research Laboratories and was involved in the discovery and/or development of a number of successful pharmaceutical products, including Aggrastat®, Trusopt®, Crixivan®, Sustiva®, Pedvax®, Pneumovax®, Vaqta®, Varivax® Cozaar®/Hyzaar® and Fosamax®. Dr. Friedman earned his M.D. fromHarvard Medical School where he then became an Associate Professor of Medicine and Pharmacology and was a practicing physician atNew York-Presbyterian Hospital ,College of Physicians and Surgeons . - Granted US Patent No. 8,754,080 and European Patent No. 2,414,362 titled “Pyrimidine Substituted Purine Compounds As Kinase(s) Inhibitors” that cover the composition of matter for VS-5584 and its ability to inhibit and regulate cellular metabolism, growth, and proliferation.
SECOND QUARTER 2014 FINANCIAL RESULTS
As of
Net loss for the 2014 Quarter was
Research and development expense for the three months ended June 30,
2014 (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 (defactinib) 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 Robert Weinberg, Ph.D., scientific cofounder and chair of Verastem’s
About VS-4718
VS-4718 is an orally available 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 in patients with malignant pleural mesothelioma. The primary endpoints of COMMAND are progression free survival (PFS) and overall survival (OS). VS-6063 targets cancer stem cells which are an underlying cause of tumor progression and recurrence. 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,
or defactinib, VS-4718 and VS-5584 and the Company’s FAK inhibition
program, PI3K/mTOR and diagnostics programs generally, the timeline for
clinical development and regulatory approval of the Company’s compounds,
the expected timing for the reporting of data from ongoing trials, and
the structure of the Company’s planned or pending clinical trials. 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 ongoing or later clinical trials, that data may
not be available when we expect it to be, that enrollment of clinical
trials may take longer than expected, 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
Verastem, Inc. | ||||||||||||||||
Unaudited Selected Consolidated Balance Sheet Information | ||||||||||||||||
(in thousands) |
||||||||||||||||
June 30, | December 31, | |||||||||||||||
2014 | 2013 | |||||||||||||||
Cash, cash equivalents and investments | $104,352 | $123,656 | ||||||||||||||
Prepaid expenses and other current assets | 963 | 643 | ||||||||||||||
Property and equipment, net | 1,489 | 631 | ||||||||||||||
Other assets | 538 | 331 | ||||||||||||||
Total assets | $107,342 | $125,261 | ||||||||||||||
Accounts payable and accrued expenses | $7,324 | $7,087 | ||||||||||||||
Other liabilities | 839 | 728 | ||||||||||||||
Stockholders’ equity | 99,179 | 117,446 | ||||||||||||||
Total liabilities and stockholders’ equity | $107,342 |
$125,261 |
||||||||||||||
Verastem, Inc. | |||||||||||||||||||||||||||||||||||
Unaudited Condensed Consolidated Statements of Operations | |||||||||||||||||||||||||||||||||||
(in thousands, except per share amounts) |
|||||||||||||||||||||||||||||||||||
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||||||||||||||
Research and development |
|
$8,305 |
|
$6,045 |
|
$16,716 |
|
$11,341 |
|||||||||||||||||||||||||||
General and administrative | 4,782 | 4,239 | 9,505 | 8,024 | |||||||||||||||||||||||||||||||
Total operating expenses | 13,087 | 10,284 | 26,221 | 19,365 | |||||||||||||||||||||||||||||||
Loss from operations | (13,087 | ) | (10,284 | ) | (26,221 | ) | (19,365 | ) | |||||||||||||||||||||||||||
Interest income | 65 | 34 | 137 | 78 | |||||||||||||||||||||||||||||||
Net loss | ($13,022 | ) | ($10,250 | ) | ($26,084 | ) | ($19,287 | ) | |||||||||||||||||||||||||||
Net loss per share – basic and diluted | ($0.51 | ) | ($0.49 | ) | ($1.02 | ) | ($0.94 | ) | |||||||||||||||||||||||||||
Weighted-average number of |
25,669 | 20,729 | 25,574 | 20,607 | |||||||||||||||||||||||||||||||
Source:
Verastem, Inc.
Brian Sullivan, 617-252-9314
bsullivan@verastem.com