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Verastem Reports Year-End 2015 Financial Results
“We are developing treatments that reduce cancer stem cells and modulate
the local tumor microenvironment to allow both cancer treatments and the
immune system to do their job more efficiently,” said Robert Forrester,
President and Chief Executive Officer of Verastem. “Our recently
announced collaborations with Pfizer and
Recent Highlights:
Focal Adhesion Kinase Inhibition Program
There is a growing body of preclinical research suggesting that focal
adhesion kinase (FAK) inhibition, when combined with PD-1 inhibitors,
may increase the anti-tumor activity of immunotherapeutic agents such as
programmed death receptor 1 (PD-1) and its corresponding ligand (PD-L1).
Research reports on this were published in the
The data presented provide an overview of preclinical research to date
demonstrating how FAK inhibition increases the influx of cytotoxic T
cells into tumors while reducing immuno-suppressive and stromal density
barriers to antitumor immune attack. This research suggests that FAK
inhibition creates a more favorable tumor microenvironment for the
antitumor effects of immune checkpoint inhibitors and potentially other
immunotherapies.
-
Clinical Collaboration with Pfizer and
Merck KGaA to Evaluate Combination of VS-6063 and Avelumab in Ovarian Cancer – InMarch 2016 , the companies announced their entry into a clinical trial collaboration agreement to evaluate the investigational combination of Verastem’s focal adhesion kinase (FAK) inhibitor VS-6063 and Pfizer/Merck KGaA’s anti-PD-L1 immunotherapy avelumab.Verastem has previously reported initial signs of clinical activity in patients with ovarian cancer when VS-6063 is used in combination with paclitaxel. Under the terms of the agreement, the parties will conduct a planned Phase 1/1b clinical trial evaluating escalating doses of the combination of VS-6063 and avelumab as a potential treatment option for patients with advanced ovarian cancer. -
Washington University in St. Louis Initiated a Clinical Study of VS-6063 in Combination with Merck & Co.’s Pembrolizumab and Gemcitabine in Pancreatic Cancer – InJanuary 2016 ,Verastem announced the initiation of a Phase 1 dose-escalation study atWashington University to evaluate Verastem’s FAK inhibitor VS-6063 in combination with Merck & Co.’s anti-PD-1 immunotherapy pembrolizumab and gemcitabine in patients with pancreatic cancer.
In addition, Verastem’s second FAK inhibitor, VS-4718, has demonstrated a generally well-tolerated safety profile in a single-agent ascending dose study and is suitable for progression into further clinical studies. Confirmatory cohorts to determine the recommended Phase 2 dose as well as expansion cohorts in biopsiable disease are planned for 2016. Additional studies for VS-4718 in 2016 include:
- Combination Trial of VS-4718 and Gemcitabine/Abraxane® – A clinical trial of VS-4718 in combination with gemcitabine and Abraxane® was recently initiated. Initial results of the dose escalation study are expected by year end 2016. Following results from the dose escalation, an expansion cohort of VS-4718 + Gemcitabine/Abraxane® vs Gemcitabine/Abraxane® alone in patients with pancreatic cancer is planned.
Dual PI3K/mTORC1/2 Inhibition Program
The maximum tolerated
dose of VS-5584 has been reached in the Phase 1, single-agent study of
VS-5584, and the recommended Phase 2 dose is being confirmed. Reductions
in pharmacodynamic markers of PI3K and mTOR activity and clinical
activity has been observed in some tumor types. Additional studies for
VS-5584 in 2016 include:
- Confirmatory Recommended Phase 2 Dose and Expansion Cohorts – A cohort of the single-agent VS-5584 trial is enrolling additional patients with solid tumors or lymphomas to confirm the recommended dose for Phase 2 trials. Expansion cohorts in ovarian and endometrial cancer, non-hodgkins lymphoma, and chronic lymphocytic leukemia are planned for 2016.
Full Year 2015 Financial Results
As of December 31, 2015, Verastem had cash, cash equivalents and
investments of $110.3 million compared to $92.7 million as of December
31, 2014. Verastem used $45.6 million for operating activities during
the year ended
Net loss for the 2015 Period was $57.9 million, or $1.61 per share, as
compared to a net loss of $53.4 million, or
Research and development expense for the 2015 Period was
General and administrative expense for the 2015 Period was
The number of outstanding common shares as of December 31, 2015, was 36,941,261.
Financial Guidance
Based on current operating plans, we expect to have sufficient cash, cash equivalents and short-term investments to fund our research and development programs and operations into 2018.
About Focal Adhesion Kinase
Focal Adhesion Kinase (FAK) is a non-receptor tyrosine kinase encoded by the PTK-2 gene that is involved in cellular adhesion and, in cancer, metastatic capability. VS-6063 (defactinib) and VS-4718 are orally available compounds that are potent inhibitors of FAK. VS-6063 and VS-4718 utilize a multi-faceted approach to treat cancer by reducing cancer stem cells, enhancing anti-tumor immunity, and modulating the local tumor microenvironment. VS-6063 and VS-4718 are currently being studied in multiple clinical trials for their ability to improve patient survival.
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
This press release includes forward-looking statements about Verastem’s
strategy, future plans and prospects, including statements regarding the
development and activity of Verastem’s product candidates, VS-6063,
VS-4718 and VS-5584, and Verastem’s FAK, PI3K/mTOR and diagnostics
programs generally, the utility of FAK inhibitors for the treatment of
cancer including in combination with other cancer treatments, the
timeline for clinical development and regulatory approval of our product
candidates, the structure of our planned or pending clinical trials, our
rights to develop or commercialize our product candidates and our
ability to finance contemplated development activities and fund
operations for a specified period. 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 Verastem’s product candidates 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 our product candidates will cause
unexpected safety events, that
Verastem, Inc. |
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Unaudited Selected Consolidated Balance Sheet Information |
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(in thousands) |
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December 31, | December 31, | |||||||||
2015 | 2014 | |||||||||
Cash, cash equivalents and investments | $ | 110,258 | $ | 92,675 | ||||||
Prepaid expenses and other current assets | 585 | 2,641 | ||||||||
Property and equipment, net | 2,048 | 2,825 | ||||||||
Other assets | 203 | 508 | ||||||||
Total assets | $ | 113,094 | $ | 98,649 | ||||||
Accounts payable and accrued expenses | $ | 10,040 | $ | 8,735 | ||||||
Other liabilities | 585 | 1,148 | ||||||||
Stockholders’ equity | 102,469 | 88,766 | ||||||||
Total liabilities and stockholders’ equity | $ | 113,094 | $ | 98,649 | ||||||
Verastem, Inc. |
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Unaudited Condensed Consolidated Statements of Operations |
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(in thousands, except per share amounts) |
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Year ended December 31, | ||||||||||||
2015 | 2014 | |||||||||||
Operating expenses: | ||||||||||||
Research and development | $ | 40,565 | $ | 35,448 | ||||||||
General and administrative | 17,634 | 18,159 | ||||||||||
Total operating expenses | 58,199 | 53,607 | ||||||||||
Loss from operations | (58,199 | ) | (53,607 | ) | ||||||||
Interest income | 334 | 242 | ||||||||||
Net loss | $ | (57,865 | ) | $ | (53,365 | ) | ||||||
Net loss per share–basic and diluted | $ | (1.61 | ) | $ | (2.07 | ) | ||||||
Weighted-average number of common shares |
35,932 | 25,804 | ||||||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20160303005326/en/
Source:
Verastem, Inc.
Brian Sullivan, 781-292-4214
bsullivan@verastem.com