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Verastem Reports First Quarter 2013 Financial and Corporate Results
“During the first quarter we made key strides in advancing our
development programs targeting cancer stem cells,” said
“The combination trial of VS-6063 plus paclitaxel for ovarian cancer is
open and enrolling patients at all sites,” said
Q1 2013 and Recent Accomplishments
Our significant accomplishments include the following:
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Advanced the FAK inhibition program and defined a potential
registration pathway
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Met with the regulatory agencies in the US and
UK and, based on these discussions, we believe that positive results from our anticipated trial of VS-6063 in mesothelioma will enable us to seek regulatory approval - Advanced our diagnostic strategy through an agreement with LabCorp to develop a companion diagnostic for VS-6063 to stratify patients in the mesothelioma trial
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Filed for orphan drug designation for VS-6063 in mesothelioma
within the
European Union andUnited States - Initiated a Phase 1/1b study of VS-6063 in combination with paclitaxel for patients with ovarian cancer, which is open and enrolling at all sites
- Presented data at the 2013 AACR Annual Meeting showing that treatment with FAK inhibitor VS-4718 results in an approximate 200-fold reduction in the tumor-initiating capability of cells extracted from tumors as compared to paclitaxel in a xenograft model of triple negative breast cancer
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Received IND allowance from the
FDA for the VS-4718 Phase 1 trial to proceed in advanced solid tumors
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Met with the regulatory agencies in the US and
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Progressed the dual PI3K/mTOR inhibition program
- Conducted IND-enabling studies of VS-5584 with a goal of initiating Phase 1 clinical development in H2 2013
- Presented data at the 2013 AACR Annual Meeting demonstrating the ability of VS-5584 treatment to induce tumor regression in taxane-resistant patient-derived xenograft models
- Published data on PI3K/mTOR inhibitor VS-5584 in Molecular Cancer Therapeutics
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Increased the understanding of cancer stem cell biology
- Presented research results widely at scientific conferences including AACR, Keystone PI3 Kinase Symposium and the Molecular Medicine Tri-Conference Symposium on Targeting Cancer Stem Cells
2013 Milestones
Our planned upcoming clinical milestones include the following:
- Initiate the potentially pivotal trial in mesothelioma for VS-6063 midyear 2013
- Complete the dose finding portion of the Phase 1/1b trial of VS-6063 plus paclitaxel in ovarian cancer
- Begin enrollment of the expanded cohort of the Phase 1/1b trial of VS-6063 plus paclitaxel in ovarian cancer
- Initiate Phase 1 clinical development of VS-4718 H1 2013
- Initiate Phase 1 clinical development of VS-5584 H2 2013
Upcoming Events
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UBS Global Healthcare Conference -
Wednesday, May 22, 2013 , at8:30am ET at theSheraton New York Hotel ,New York, NY
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ASCO Breakfast
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Saturday, June 1, 2013 , at6:45am CT at theHyatt Regency McCormick Place ,Chicago, IL. Special guest Dr.Dean Fennel , Chair of Thoracic Medical Oncology,University of Leicester , will be presenting together with Chief Medical Officer, Dr.Joanna Horobin , and Head of Research,Jonathan Pachter , Ph.D. Topics will include mesothelioma etiology, the role of cancer stem cells in disease progression, current clinical treatments and the design ofVerastem's potentially pivotal trial of lead FAK inhibitor VS-6063. RSVP to bsullivan@verastem.com
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Research and Development Day
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Thursday, July 11, 2013 , at theHarvard Club inNew York, NY . Special guests include:Robert Weinberg , Ph.D., Founding Member,Whitehead Institute ; José Baselga, M.D., Ph.D., Physician in Chief,Memorial Sloan-Kettering Cancer Center ; andLee Krug , M.D., Thoracic Oncologist and Director of the Mesothelioma Program atMemorial Sloan-Kettering Cancer Center . Topics will include recent updates on the biology of cancer stem cells, clinical needs in the treatment of mesothelioma and strategies for the therapeutic targeting of PI3K/mTOR in cancer.Verastem will provide updates on the status of research and development and upcoming plans. RSVP to bsullivan@verastem.com
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As of
Net loss for the three months ended
Research and development expense for the 2013 Quarter was
General and administrative expense for the 2013 Quarter was
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,
VS-4718 and VS-5584, and the Company’s FAK, PI3K/mTOR and diagnostic
programs generally, the timeline for clinical development and regulatory
approval of the Company’s compounds, the structure of the Company’s
planned clinical trials and estimates of the Company’s ability to fund
operations. 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 may not be predictive of the success of later
clinical trials, that the Company will be unable to successfully
complete the clinical development of its compounds, including VS-6063,
VS-4718 and VS-5584, 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
Verastem, Inc. (A development-stage company) Unaudited Selected Consolidated Balance Sheet Information (in thousands) |
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March 31, |
December 31, |
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Cash, cash equivalents and investments | $84,414 | $91,520 | ||
Prepaid expenses and other current assets | 986 | 506 | ||
Property and equipment, net | 755 | 811 | ||
Other assets | 86 | 86 | ||
Total assets | $86,241 | $92,923 | ||
Accounts payable and accrued expenses | $3,040 | $2,399 | ||
Other liabilities | 370 | 58 | ||
Stockholders’ equity | 82,831 | 90,466 | ||
Total liabilities and stockholders’ equity | $86,241 | $92,923 | ||
Verastem, Inc. (A development-stage company) Unaudited Condensed Consolidated Statements of Operations (in thousands, except per share amounts) |
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Three Months Ended March 31, | ||||
2013 | 2012 | |||
Operating expenses: | ||||
Research and development | $5,296 | $4,803 | ||
General and administrative | 3,785 | 2,125 | ||
Total operating expenses | 9,081 | 6,928 | ||
Loss from operations | (9,081) | (6,928) | ||
Interest income | 44 | 57 | ||
Net loss | (9,037) | (6,871) | ||
Accretion of preferred stock | - | (6) | ||
Net loss applicable to common stockholders | ($9,037) | ($6,877) | ||
Net loss per share applicable to common stockholders–basic and diluted | ($0.44) | ($0.47) | ||
Weighted-average number of common shares used in net loss per share applicable to common stockholders-basic and diluted | 20,483 | 14,693 |
Source:
Verastem, Inc.
Brian Sullivan, 617-252-9314
bsullivan@verastem.com