Press Release

May 20, 2014
Verastem to Present at the 2014 ASCO Annual Meeting

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 20, 2014-- Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, announced scheduled poster presentations at the American Society of Clinical Oncology Annual Meeting being held May 30June 3, 2014, at McCormick Place in Chicago, IL.

Interim data from the ongoing Phase 1/1b trial of lead candidate targeting cancer stem cells, VS-6063 (defactinib), a potent inhibitor of focal adhesion kinase (FAK), in combination with paclitaxel in patients with ovarian cancer will be presented. The study has completed enrollment of 22 patients at three sites in the US. In addition, investigators will present posters on the ongoing registration-directed COMMAND study of VS-6063 for patients with malignant pleural mesothelioma and the ongoing Phase 2 study of VS-6063 for patients with non-small cell lung cancer.

The company is also holding an analyst and investor event on the Sunday morning of ASCO, June 1st, at 6:30am CT at the Hyatt Regency McCormack Place.

The details for the poster presentations and events are as follows:

Date & Time: Saturday, May 31, 2014, from 1:15 to 5:00 p.m. CT
Poster Title: COMMAND: A Phase II Randomized, Double-blind, Placebo-Controlled, Multicenter Study of Defactinib as Maintenance Therapy in Subjects with Malignant Pleural Mesothelioma which has Not Progressed on at least 4 Cycles of Pemetrexed/Platinum therapy
Abstract Number: TPS7611
Session ID: General Poster Session: Lung Cancer - Non-small Cell Local-regional/Small Cell/Other Thoracic Cancers
Location: S Hall A2

Date & Time: Saturday, May 31, 2014, from 1:15 to 5:00 p.m. CT
Poster Title: A phase 2 study of defactinib (VS-6063), a cancer stem cell inhibitor that acts through inhibition of focal adhesion kinase (FAK), in patients (pts) with KRAS-mutant-non-small-cell lung cancer (NSCLC)
Abstract Number: TPS8126
Session ID: General Poster Session: Lung Cancer - Non-small Cell Metastatic
Location: S Hall A2

Date & Time: Monday, June 2, 2014, from 8:00 a.m. to 12:45 p.m. CT
Poster Title: Phase 1/1b Study of the FAK Inhibitor Defactinib (VS-6063) in Combination with Weekly Paclitaxel for Advanced Ovarian Cancer
Abstract Number: 5521
Session ID: Poster Highlights Session: Gynecologic Cancer
Location: E354b & E354a

Analyst Breakfast and Webcast

Verastem is also hosting an Analyst Breakfast during ASCO on Sunday, June 1, 2014 from 6:30 – 7:45 a.m. CT at the Hyatt Regency McCormick Place where a scientific update on the COMMAND study and the rationale for targeting cancer stem cells in mesothelioma will be discussed. Professor Dean Fennell, Ph.D., FRCP, Chair of Thoracic Oncology at the University of Leicester and Incoming President of the International Mesothelioma Interest Group will also speak. Breakfast will be served.

The full invitation can be accessed here. Please RSVP to Verastem@argotpartners.com.

A live, listen-only webcast of the event can be accessed here five minutes prior to the start of the event. A replay of the webcast will be archived on the Verastem website following the event.

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 Scientific Advisory Board, and Verastem has demonstrated that the FAK pathway is critical for the growth and survival of cancer stem cells. VS-6063 is currently being studied in the registration-directed COMMAND trial in mesothelioma (www.COMMANDmeso.com), a Phase 1/1b study in combination with paclitaxel for patients with ovarian cancer and a Phase 2 trial in patients with KRas-mutated non-small cell lung cancer. VS-6063 has been granted orphan drug designation in the U.S. and E.U. for use in mesothelioma.

About COMMAND

COMMAND is a registration-directed, double-blind, placebo-controlled trial of VS-6063 with Progression Free Survival (PFS) and Overall Survival (OS) as the primary endpoints. VS-6063 targets cancer stem cells. Cancer stem cells 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, UK, Japan, Australia, Canada, South Africa, New Zealand and countries in mainland Europe. Eligible patients who had a partial response or stable disease following standard first-line therapy with platinum/pemetrexed will be stratified to merlin low or high and then randomized to receive either placebo or 400 mg of defactinib. For more information visit www.COMMANDmeso.com

About Verastem, Inc.

Verastem, Inc. (NASDAQ:VSTM) is discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells. Cancer stem cells are an underlying cause of tumor recurrence and metastasis. Verastem is developing small molecule inhibitors of signaling pathways that are critical to cancer stem cell survival and proliferation: FAK, PI3K/mTOR and Wnt. For more information, please visit www.verastem.com.

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, and the Company’s FAK inhibition program, 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, and potential indications for clinical development. 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, 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 December 31, 2013 and in any subsequent SEC filings. The forward-looking statements contained in this presentation reflect the Company’s current views with respect to future events, and the Company does not undertake and specifically disclaims any obligation to update any forward-looking statements.

Source: Verastem, Inc.

Verastem, Inc.
Brian Sullivan, 617-252-9314
bsullivan@verastem.com