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Verastem Reports First Quarter 2016 Financial Results
“To date in 2016,
First Quarter 2016 and Recent Highlights:
Focal Adhesion Kinase Inhibition Program
Clinical Collaboration with Pfizer and
Merck KGaAto Evaluate Combination of VS-6063 and Avelumab in Ovarian Cancer – In March 2016, the companies announced a clinical trial collaboration agreement to evaluate the combination of Verastem’s focal adhesion kinase (FAK) inhibitor VS-6063 and Pfizer and Merck KGaA’s anti-PD-L1 immunotherapy avelumab. Verastemhas 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 Universityin St. Louis Initiated a Clinical Study of VS-6063 in Combination with Merck & Co.’s Pembrolizumab and Gemcitabine in Pancreatic Cancer – In January 2016, Verastemannounced the initiation of a Phase 1 dose-escalation study at Washington Universityto evaluate its FAK inhibitor VS-6063 in combination with Merck & Co.’s anti-PD-1 immunotherapy pembrolizumab and gemcitabine in patients with pancreatic cancer. The trial builds upon preclinical research conducted by Dr. David Denardo, presented at several conferences in late 2015 and early 2016, demonstrating the ability of FAK inhibition to increase the efficacy of checkpoint inhibition in the reduction of tumor volume and overall survival in models of pancreatic cancer. This Phase 1 clinical trial is currently enrolling and is anticipated to enroll approximately 50 patients with advanced pancreatic cancer.
Presented Scientific Data Supporting FAK Inhibition in
Combination with Immunotherapy at Key Medical Meetings –
During the first quarter of 2016,
Verastempresented data in support of its new development programs focused on advancing its FAK inhibitors in combination with immune-oncology agents and other current and emerging standard of care cancer treatments. Data were presented at several medical and scientific meetings, including the 2016 American Academy of Cancer Research(AACR), the Society for Gynecologic Oncology’s 2016 Annual Meeting on Women’s Cancer, the Keystone Symposium on Cancer Pathology, the Keystone Symposium on Stem Cells and Cancer, and Immunotherapy World 2016.
Presented Clinical Data from the Window of Opportunity Study at
iMig 2016 – In
May 2016, the Company announced results from the ongoing open-label, single-center, neoadjuvant Window of Opportunity study evaluating tolerability, along with biomarker and tumor volume response to VS-6063 (400mg BID) following either 12 days (Cohort 1) or 35 days (Cohort 2) of treatment in surgically-eligible patients with malignant pleural mesothelioma. Data analysis from Cohort 1 and Cohort 2 showed that VS-6063 was generally well tolerated with early signs of tumor reduction observed, with six of the twenty patients demonstrating an encouraging tumor reduction after brief treatment with VS-6063.
- Development of VS-4718 Continues in Solid Tumors – Dosing continues in a Phase 1 dose escalation trial evaluating single-agent VS-4718 and a Phase 1 clinical trial evaluating VS-4718 in combination with gemcitabine and Abraxane® is currently ongoing. Following results from the dose escalation trial, 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
- Confirmatory Recommended Phase 2 Dose and Expansion Cohorts – The maximum tolerated dose of single-agent VS-5584 has been reached in a Phase 1 study, and the recommended Phase 2 dose (RP2D) is being confirmed. Reductions in pharmacodynamic markers of PI3K and mTOR activity and clinical activity has been observed in some tumor types.
Gregory I. Berk, MD Named Chief Medical Officer – In April 2016, the Company announced the appointment of Gregory I. Berk, MD as Chief Medical Officer. Dr. Berk, a highly accomplished physician and a well-regarded oncology veteran with more than 25 years of both industry and academic experience, will be responsible for leading the Company's global clinical development strategy and clinical operations.
Announced Key Executive Management Appointments and Changes –
April 2016, the Company strengthened its management team through the appointment and promotion of several key individuals. Jonathan Pachter, PhD was promoted to Chief Scientific Officer, David Weaver, PhD was appointed Vice President, Translational Medicine, Joe Chiapponi, Vice President, Finance, was named Treasurer, Principal Accounting and Financial Officer and Oluwatoyin (Toyin) Shonukan, MD, has been appointed Vice President, Clinical Development. Dr. Shonukan most recently served as Senior Medical Director, Oncology Clinical Developmentat Vertex Pharmaceuticalsand has held previous senior appointments at Millennium: The Takeda Oncology Company, NovartisOncology and Eli Lilly.
First Quarter 2016 Financial Results
Net loss for the first quarter ended
Research and development expense for the 2016 Quarter was
General and administrative expense for the 2016 Quarter was
As of March 31, 2016, Verastem had cash, cash equivalents and investments of $99.5 million compared to $110.3 million as of December 31, 2015. Verastem used $10.8 million for operating activities during the 2016 Quarter settling one-time compensation payments, severance payments and paying down accounts payable and accruals.
The number of outstanding common shares as of March 31, 2016, was 36,992,418.
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.
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.
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 structure of our planned or pending clinical
trials, additional planned studies, the expected timing for the
reporting of data from ongoing trials 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
Unaudited Selected Consolidated Balance Sheet Information
|March 31,||December 31,|
|Cash, cash equivalents and investments||$||99,535||$||110,258|
|Prepaid expenses and other current assets||1,002||585|
|Property and equipment, net||1,865||2,048|
|Accounts payable and accrued expenses||$||6,124||$||10,040|
|Total liabilities and stockholders’ equity||$||102,564||$||113,094|
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
|Three months ended March 31,|
|Research and development||$||4,179||$||10,528|
|General and administrative||4,255||4,714|
|Total operating expenses||8,434||15,242|
|Loss from operations||(8,434)||(15,242)|
|Net loss per share—basic and diluted||$||(0.22)||$||(0.46)|
Weighted-average number of common shares
used in net loss per share-basic and diluted
Brian Sullivan, 781-292-4214