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Verastem Reports Year-End 2013 Financial Results
--A year of clinical execution: Three small molecule compounds in clinical development including the registration-directed COMMAND study—
--Multiple clinical data readouts anticipated starting in first half 2014--
"In 2013,
“The COMMAND study is accruing patients in many countries worldwide,”
said Dr.
In 2013,
“We ended 2013 on firm financial ground with a cash, cash equivalents
and investments balance of approximately
2013 and Recent Accomplishments
-
COMMAND (Control Of Mesothelioma with MAinteNance Defactinib)
- Initiation of a registration-directed, randomized, double blind, placebo controlled study of VS-6063 immediately following frontline therapy in patients with malignant pleural mesothelioma
-
Met with regulatory agencies in
the United States andUnited Kingdom and interacted with the regulatory agencies in an additional 10 countries - Accruing patients at 28 clinical sites
-
Received orphan drug designation for VS-6063 in mesothelioma in
both the U.S. and
Europe
-
Progressed the FAK inhibition program (VS-6063 and VS-4718)
- Reported the successful completion of the dose-escalation portion of VS-6063 in combination with weekly paclitaxel in patients with ovarian cancer.
- Completed accrual of the expansion phase of the study of VS-6063 in combination with weekly paclitaxel at the recommended Phase 2 dose
- Successfully accrued a Phase 1 study of VS-6063 in Japanese patients and confirmed the recommended Phase 2 dose as 400mg BID, consistent with dosing in other countries
- Initiated a Phase 2 study of VS-6063 in patients with Kras-mutated NSCLC with or without secondary alterations in either p16 or p53 genes
- Initiated a Phase 1 dose escalation study of VS-4718 in patients with advanced solid tumors
- Conducted research for the use of FAK inhibitors in Ikaros-loss of function B-cell Acute Lymphoblastic Leukemia
- Eliminated significant potential milestone and royalty payments for VS-4718 by acquiring product rights from previous licensor
-
Progressed the dual PI3K/mTOR inhibition program (VS-5584)
- Initiated a Phase 1 dose escalation study of VS-5584 in patients with advanced solid tumors and lymphomas
-
Expanded the research collaboration with
Eisai -
In response to encouraging results, the company extended the
research collaboration with
Eisai focused on generating novel inhibitors of Wnt/β-catenin signaling
-
In response to encouraging results, the company extended the
research collaboration with
-
Increased the understanding of cancer stem cell biology
-
Presented research results at major scientific conferences
including AACR,
ASCO , EORTC, World Lung, and SABCS -
Published data on NF2 and merlin biology in cancer stem cells
found in mesothelioma in
Cancer Research
-
Presented research results at major scientific conferences
including AACR,
-
Strengthened our development advisory team
-
Named
Jose Baselga , M.D., Ph.D., Physician in Chief atMemorial Sloan Kettering Cancer Center , as Senior Medical Advisor. Dr. Baselga is a world-renowned expert in breast cancer and PI3K-inhibitor translational research
-
Named
-
Enhanced corporate stability
-
Hired
Jack Green as Chief Financial Officer.Mr. Green was the Senior Vice President and Chief Financial Officer of GTC Biotherapeutics (formerlyGenzyme Transgenics Corporation ), and is a Certified Public Accountant (CPA) with over 30 years of financial experience, including 20 within the biotechnology industry -
Completed a secondary offering raising
$63.8 million in gross proceeds
-
Hired
2014 Clinical Milestones
Verastem’s planned upcoming clinical milestones include the following:
- Report interim data from the Phase 1/1b trial of VS-6063 in combination with weekly paclitaxel in patients with ovarian cancer during Q2 2014
-
Update of projected timing of COMMAND interim analyses at R&D Day
on
July 10 th at12:30pm ET inNew York, NY -
Assuming approval from regulatory authorities, initiate COMMAND
study centers in
Japan in H2 2014 - Report the interim analysis for the Phase 2 study of VS-6063 in patients with Kras-mutated NSCLC in H2 2014
- Report interim data on the Phase 1 trial of VS-4718 in H2 2014
- Report interim data on the Phase 1 trial of VS-5584 in H2 2014
Full Year 2013 Financial Results
As of
Net loss for the year ended
Research and development expense for the year ended
General and administrative expense for the 2013 Period was
Financial Guidance
Based on current operating plans, we expect to have sufficient cash, cash equivalents, short-term investments and long-term investments to fund our research and development programs and operations into the first half of 2016.
Conference Call Information
The
The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for 90 days following the call.
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
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 pathways. In preclinical
studies, VS-5584 has been shown to reduce the percentage of cancer stem
cells and induce tumor regression in taxane-resistant models.
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, VS-5584 and the Company’s FAK and mTOR/PI3K
inhibition and diagnostic programs generally, the timeline for clinical
development and regulatory approval of the Company’s compounds,
including the potential for opening COMMAND trial sites in
Verastem, Inc. (A development-stage company) Unaudited Condensed Consolidated Balance Sheets (in thousands) |
||||||
December 31, | ||||||
2012 | 2013 | |||||
Cash, cash equivalents and investments | $ | 91,520 | $ | 123,656 | ||
Prepaid expenses and other current assets | 506 | 643 | ||||
Property and equipment, net | 811 | 631 | ||||
Other assets | 86 | 331 | ||||
Total assets | $ | 92,923 | $ | 125,261 | ||
Accounts payable and accrued expenses | $ | 2,399 | $ | 7,087 | ||
Other liabilities | 58 | 728 | ||||
Stockholders’ equity | 90,466 | 117,446 | ||||
Total liabilities and stockholders’ equity | $ | 92,923 | $ | 125,261 |
Verastem, Inc. (A development-stage company) Unaudited Condensed Consolidated Statements of Operations (in thousands, except per share amounts) |
|||||||
Year ended December 31, | |||||||
2012 | 2013 | ||||||
Operating expenses: | |||||||
Research and development | $ | 21,712 | $ | 25,930 | |||
General and administrative | 10,518 | 15,472 | |||||
Total operating expenses | 32,230 | 41,402 | |||||
Loss from operations | (32,230 | ) | (41,402 | ) | |||
Interest income | 246 | 200 | |||||
Net loss | ($31,984 | ) | ($41,202 | ) | |||
Accretion of preferred stock | (6 | ) | ― | ||||
Net loss applicable to common stockholders | ($31,990 | ) | ($41,202 | ) | |||
Net loss per share applicable to common stockholders–basic and diluted | ($1.70 | ) | ($1.82 | ) | |||
Weighted-average number of common shares used in net loss per share applicable to common stockholders-basic and diluted | 18,765 | 22,680 |
Source:
Verastem, Inc.
Brian Sullivan, 617-252-9314
bsullivan@verastem.com