Verastem, Inc. (NASDAQ: VSTM), focused on discovering and
developing drugs to treat cancer, today reported financial results
for the second quarter ended June 30, 2016, and also provided an
overview of certain corporate developments.
“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 at The Washington
University in Saint Louis. Enrollment and dosing continues in the
Phase 1 dose-escalation study evaluating our lead focal adhesion
kinase inhibitor VS-6063 in combination with Merck’s PD-1 inhibitor
pembrolizumab and gemcitabine in patients with pancreatic cancer.
We are looking forward to the commencement of a clinical
collaboration trial evaluating VS-6063 in combination with
Merck-KGaA and Pfizer’s PD-L1 inhibitor avelumab in ovarian cancer
during the second half of the year. We closed the quarter with a
strong balance sheet totaling $92.9 million in cash, cash
equivalents and short-term investments.”
Second Quarter 2016 and Recent Highlights:
Focal Adhesion Kinase (FAK) Inhibition Program
- Published Preclinical Research in
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 Medicine in 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.
Corporate
- 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. Wendel joined 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 Corporation and Bristol-Myers Squibb.
He currently serves as Chief Strategic Officer at Hepalink USA and
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 June 30, 2016 (2016
Quarter) was $8.6 million, or $0.23 per share, as
compared to a net loss of $15.4 million, or $0.42 per share,
for the second quarter ended June 30, 2015 (2015 Quarter). Net loss
includes non-cash stock-based compensation expense of $1.7
million and $2.6 million for the 2016 Quarter and 2015
Quarter, respectively.
Research and development expense for the 2016 Quarter was $4.5
million compared to $11.0 million for the 2015 Quarter. The
$6.5 million decrease from the 2015 Quarter to the 2016
Quarter was primarily related to a decrease of $4.9 million in
contract research organization expense for outsourced biology,
chemistry, development and clinical services, which includes our
clinical trial costs, a decrease in personnel related costs of $1.2
million, a decrease of approximately $584,000 in stock-based
compensation, and a net decrease of approximately $193,000 in
travel, facilities and other costs. These decreases were partially
offset by an increase of approximately $343,000 in consulting
fees.
General and administrative expense for the 2016 Quarter was $4.2
million compared to $4.4 million for the 2015 Quarter. The
decrease of approximately $200,000 from the 2015 Quarter to the
2016 Quarter primarily resulted from approximate decreases in
stock-based compensation expense of $330,000 and $230,000 in
consulting fees. These decreases were offset by a net increase of
approximately $360,000 in personnel costs, professional fees, and
other costs.
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.
Financial Guidance
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. Verastem
is currently conducting a dose escalation trial of VS-5584 in
patients with non-hodgkin’s lymphoma and chronic lymphocytic
leukemia.
About Verastem, Inc.
Verastem, Inc. (NASDAQ:VSTM) is a biopharmaceutical company
focused on discovering and developing drugs to improve outcomes for
patients with cancer. Our product candidates utilize a
multi-faceted approach to treat cancer by reducing cancer stem
cells, enhancing anti-tumor immunity, and modulating the local
tumor microenvironment. Our most advanced clinical product
candidates are the Focal Adhesion Kinase inhibitors, VS-6063 and
VS-4718, and the dual PI3K/mTOR inhibitor, VS-5584. For more
information, please visit www.verastem.com.
Verastem forward-looking statements notice:
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 events,
that Verastem will be unable to successfully initiate or complete
the clinical development of its product candidates, that the
development of Verastem’s product candidates will take longer or
cost more than planned, and that Verastem’s product candidates will
not receive regulatory approval or become commercially successful
products. Other risks and uncertainties include those identified
under the heading “Risk Factors” in Verastem’s Annual Report on
Form 10-K for the year ended December 31, 2015 and in any
subsequent SEC filings. The forward-looking statements contained in
this press release reflect Verastem’s current views with respect to
future events, and Verastem does not undertake and specifically
disclaims any obligation to update any forward-looking
statements.
Verastem, Inc.
Unaudited Selected Consolidated Balance
Sheets Information
(in thousands)
June 30, December 31,
2016 2015 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 Other assets 162
203
Total assets $ 95,423 $
113,094 Accounts payable and accrued expenses $ 5,925
$ 10,040 Other liabilities 430 585 Stockholders’ equity
89,068 102,469
Total liabilities and stockholders’
equity $ 95,423 $ 113,094
Verastem, Inc.
Unaudited Condensed Consolidated
Statements of Operations
(in thousands, except per share
amounts)
Three months ended June 30,
Six months ended June 30,
2016
2015 2016 2015 Operating expenses: 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 )
Interest income 140 85 280
147
Net loss $ (8,569
) $ (15,377 ) $ (16,863
) $ (30,557 ) Net loss per
share—basic and diluted $ (0.23 ) $
(0.42 ) $ (0.46 ) $
(0.87 )
Weighted-average number of
commonshares used in net loss per share-basic
anddiluted
36,992 36,522
36,983 34,931
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version on businesswire.com: http://www.businesswire.com/news/home/20160808005569/en/
Verastem, Inc.Brian Sullivan,
781-292-4214bsullivan@verastem.com
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