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Verastem Reports Third Quarter 2014 Financial and Corporate Results
“We ended the third quarter with
“We continue to see promising clinical signals from the VS-6063 program,
as evidenced by the recently announced data from the Window of
Opportunity study in surgically-eligible patients with mesothelioma, in
which we saw a reduction in a marker of cancer stem cells and
encouraging signs of clinical activity,” said Dr.
Q3 2014 AND RECENT HIGHLIGHTS:
VS-6063 (Focal Adhesion Kinase Inhibition)
-
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
-
Pursuing simultaneous development in the US, EU,
Japan ,Canada ,Australia andSouth Africa - 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
-
Presented preliminary data at the 12th
International Mesothelioma Interest Group (iMig) Conference inOctober 2014 -
VS-6063 treatment reduced FAK activity (pFAK-
Y397 ) by an average of 70% in patients evaluated to date - VS-6063 reduced a cancer stem cell marker in post-treatment biopsies in 5 out of 7 patients with evaluable paired biopsies
- Measurement of tumor size using RECIST modified for mesothelioma by CT/PET confirmed that there was no progression of disease while on the 12 day treatment with VS-6063 in any of the 10 patients. Moreover, 2 patients achieved tumor shrinkage consistent with a partial response (-30% and -49%)
- VS-6063 was well tolerated
- A protocol amendment has been submitted to expand the study to include an additional 10-15 patients and increase the treatment period from 12 to 35 days
- The presentation can be viewed here: http://bit.ly/ZSf3zC
-
VS-6063 treatment reduced FAK activity (pFAK-
VS-4718 (Focal Adhesion Kinase Inhibition)
-
VS-4718 is currently being evaluated in a Phase 1 clinical trial in
patients with advanced solid tumors
- Open-label, dose escalation study; designed to assess the safety, pharmacokinetics, pharmacodynamics, maximum tolerated dose and initial clinical activity of single agent VS-4718
-
VS-4718 is anticipated to start a Phase 1 dose escalation study in
hematological malignancies in Q1 2015
- Open-label, dose escalation study; designed to assess the safety, pharmacokinetics, pharmacodynamics, maximum tolerated dose and initial clinical activity of single agent VS-4718 in patients with either relapsed or refractory Acute Myeloid or B-Cell Acute Lymphoblastic Leukemia
-
Recently published article covering Verastem FAK inhibitors:
- “FAK in cancer: mechanistic findings and clinical applications.” Nat Rev Cancer. 2014 14: 598-610. http://1.usa.gov/1txeMxS. Comprehensive review of the important roles of FAK in cancer. FAK is critical for the survival and function of bulk tumor cells, cancer stem cells and tumor-associated stromal cells (endothelial cells, tumor-associated macrophages, cancer-associated fibroblasts). This publication reviewed the status of FAK inhibitors in clinical development, including VS-4718 and VS-6063.
VS-5584 (Dual mTORC 1/2 and PI3K Inhibition)
-
VS-5584, a dual mTORC1/2 and PI3K inhibitor, is currently being
evaluated in a Phase 1 clinical trial in patients with advanced solid
tumors
- Open-label, dose escalation, schedule finding study; designed to assess the safety, pharmacokinetics, pharmacodynamics, maximum tolerated dose and initial clinical activity of single agent VS-5584
- Presented data at iMig demonstrating the synergistic activities of VS-5584 and VS-6063 in cellular and animal models of mesothelioma.
- Expect to initiate a study evaluating the combination of VS-5584 and VS-6063 in patients with relapsed or progressive malignant pleural mesothelioma in Q1 2015
Corporate Events
-
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 VS-6063. The webcast of the presentation can be viewed here: http://bit.ly/1t5F34Z
-
Members of the
THIRD 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 (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, the
structure of the Company’s planned or pending clinical trials and the
Company’s estimates of how long its existing cash, cash equivalents and
investments will 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 or
interim 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) |
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September 30, | December 31, | |||||||
2014 |
2013 |
|||||||
Cash, cash equivalents and investments | $ | 93,366 | $ | 123,656 | ||||
Prepaid expenses and other current assets | 1,110 | 643 | ||||||
Property and equipment, net | 2,885 | 631 | ||||||
Other assets | 522 | 331 | ||||||
Total assets | $ | 97,883 | $ | 125,261 | ||||
Accounts payable and accrued expenses | $ | 8,160 | $ | 7,087 | ||||
Other liabilities | 912 | 728 | ||||||
Stockholders’ equity | 88,811 | 117,446 | ||||||
Total liabilities and stockholders’ equity | $ | 97,883 | $ | 125,261 | ||||
Verastem, Inc. Unaudited Condensed Consolidated Statements of Operations (in thousands, except per share amounts) |
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Three months ended |
Nine months ended |
|||||||||||||||||
2014 |
2013 |
2014 |
2013 |
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Operating expenses: | ||||||||||||||||||
Research and development | $ | 9,047 | $ | 6,789 | $ | 25,763 | $ | 18,130 | ||||||||||
General and administrative | 4,341 | 3,855 | 13,846 | 11,879 | ||||||||||||||
Total operating expenses | 13,388 | 10,644 | 39,609 | 30,009 | ||||||||||||||
Loss from operations | (13,388 | ) | (10,644 | ) | (39,609 | ) | (30,009 | ) | ||||||||||
Interest income | 56 | 53 | 193 | 131 | ||||||||||||||
Net loss | ($13,332 | ) | ($10,591 | ) | ($39,416 | ) | ($29,878 | ) | ||||||||||
Net loss per share applicable to |
($0.52 | ) | ($0.44 | ) | ($1.54 | ) | ($1.37 | ) | ||||||||||
Weighted-average number of |
25,811 | 24,127 | 25,654 | 21,797 | ||||||||||||||
Source:
Verastem, Inc.
Brian Sullivan, 781-292-4214
bsullivan@verastem.com