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Verastem Reports Second Quarter 2016 Financial Results
“We continue to execute on the research and development of our two
clinical-stage oncology programs targeting several high unmet need tumor
types,” said Robert Forrester, President and Chief Executive Officer
of Verastem. “The scientific evidence of the importance of focal
adhesion kinase in maintaining the tumor microenvironment that leads to
immunosuppression and aggressive cancer continues to mount as described
in the recent Nature Medicine publication from our collaborators
Second Quarter 2016 and Recent Highlights:
Focal Adhesion Kinase (FAK) Inhibition Program
Published Preclinical Researchin Nature Medicine – In July 2016, the Company announced the publication of preclinical research conducted by our scientific collaborator, David G. DeNardo, PhD, Assistant Professor of Medicine, Division of Oncology, Department of Immunology, Washington University School of Medicinein St. Louis. In the published study, Dr. DeNardo demonstrates that FAK inhibition decreases fibrosis and immunosuppressive cell populations in pancreatic ductal adenocarcinoma, rendering previously unresponsive tumors sensitive to chemo- and immunotherapy. These findings provide important support and rationale for the ongoing Phase 1 dose-escalation clinical studies evaluating Verastem’s FAK inhibitors in combination with pembrolizumab and gemcitabine, and, gemcitabine and Abraxane® in patients with pancreatic cancer.
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-6063 in Combination with Immunotherapy
Continues in Pancreatic Cancer – Dosing continues in a
Washington University-sponsored Phase 1 dose-escalation study evaluating VS-6063 in combination with pembrolizumab and gemcitabine in patients with pancreatic cancer. This is the first clinical trial to evaluate FAK inhibition in combination with an immuno-oncology agent.
- Development of VS-4718 Continues in Solid Tumors – Clinical testing of VS-4718 continues in both a Phase 1 single agent dose escalation study in patients with solid tumors and in a Phase 1/1b combination study with gemcitabine and Abraxane® for the treatment of patients with newly diagnosed pancreatic cancer.
Dual PI3K and mTORC1/2 Inhibition Program
- Recommended Phase 2 Dose of VS-5584 – 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 have been observed in several tumor types.
New Appointments to the Board of Directors – In
June 2016, the Company announced that Michael Kauffman, MD, PhD, who has served as a director since November 2012, became Lead Director and Bruce J. Wendeljoined the Board as an independent director. Mr. Wendel is an industry veteran with a long history of building companies and bringing oncology drugs to market having served in executive roles at Abraxis, American Pharmaceutical Partners, IVAX Corporationand Bristol-Myers Squibb. He currently serves as Chief Strategic Officer at Hepalink USAand as a director at ProMetic Life Sciences Inc.
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 medical oncologist with 25 years of both industry and academic experience, will be responsible for leading the Company's global clinical development strategy and clinical operations.
Second Quarter 2016 Financial Results
Net loss for the second quarter ended
Research and development expense for the 2016 Quarter was
General and administrative expense for the 2016 Quarter was
As of June 30, 2016, Verastem had cash, cash equivalents and investments of $92.9 million compared to $110.3 million as of December 31, 2015. Verastem used $6.7 million for operating activities during 2016 Quarter.
The number of outstanding common shares as of June 30, 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 patients with cancer.
About PI3K and mTOR
PI3K and mTOR are components of a central proliferative signaling
pathway in multiple types of human cancer. 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 and pending clinical
trials and the timeline for clinical development, 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
Unaudited Selected Consolidated Balance Sheets Information
|June 30,||December 31,|
|Cash, cash equivalents and investments||$||92,866||$||110,258|
|Prepaid expenses and other current assets||667||585|
|Property and equipment, net||1,728||2,048|
|Accounts payable and accrued expenses||$||5,925||$||10,040|
|Total liabilities and stockholders’ equity||$||95,423||$||113,094|
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
|Three months ended June 30,||Six months ended June 30,|
|Research and development||$||4,492||$||11,045||$||8,671||$||21,573|
|General and administrative||4,217||4,417||8,472||9,131|
|Total operating expenses||8,709||15,462||17,143||30,704|
|Loss from operations||(8,709||)||(15,462||)||(17,143||)||(30,704||)|
|Net loss per share—basic and diluted||$||(0.23||)||$||(0.42||)||$||(0.46||)||$||(0.87||)|
Weighted-average number of common
Brian Sullivan, 781-292-4214