Increases Borrowing Limit to $50 Million Over the Next 15 Months,
Through Potential Approval and Commercial Launch of Duvelisib
BOSTON--(BUSINESS WIRE)--Jan. 4, 2018--
Verastem, Inc. (Nasdaq:VSTM), focused on discovering and developing
drugs to improve the survival and quality of life of cancer patients,
today announced its entry into an amendment to its Loan and Security
Agreement with Hercules Capital, Inc., increasing its existing borrowing
limit under the loan facility from $25 million to up to $50 million in
financing. The increased loan facility proceeds will be available for
Verastem’s ongoing development programs, including regulatory and
commercialization activities for duvelisib, and for general corporate
purposes.
Verastem has received the first $15 million of financing under the
original Loan and Security Agreement. Additional tranches of up to $35
million in aggregate will be available to Verastem to drawdown subject
to certain conditions, including the U.S. Food and Drug Administration’s
(FDA) acceptance of Verastem’s New Drug Application (NDA) for duvelisib.
The additional funds available under the facility will only accrue
interest and principal repayments upon drawdown by Verastem.
“We are delighted to have the support and confidence of Hercules, a
premier partner known for its strategic investments in promising
healthcare companies and products,” said Julie Feder, Chief Financial
Officer of Verastem. “The availability of this increased credit facility
provides important flexibility in our long-term financing plan as
Verastem transitions into a commercial-stage business. We believe
duvelisib has the potential to offer an appealing new oral treatment
alternative to patients with relapsed or refractory chronic lymphocytic
leukemia (CLL)/small lymphocytic lymphoma (SLL) and relapsed or
refractory follicular lymphoma (FL). We remain on track to submit an NDA
to the FDA during the first quarter of 2018.”
About Duvelisib
Duvelisib is an investigational, dual inhibitor of phosphoinositide
3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support
the growth and survival of malignant B-cells and T-cells. PI3K signaling
may lead to the proliferation of malignant B-cells and is thought to
play a role in the formation and maintenance of the supportive tumor
microenvironment.1,2,3 Duvelisib is currently being evaluated
in late- and mid-stage clinical trials, including DUO™, a randomized,
Phase 3 monotherapy study in patients with relapsed or refractory
CLL/SLL,4 and DYNAMO™, a single-arm, Phase 2 monotherapy
study in patients with refractory iNHL that achieved its primary
endpoint of ORR.5 Duvelisib is also being evaluated for the
treatment of other hematologic malignancies, including T-cell lymphoma,
through investigator-sponsored studies.6 Information about
duvelisib clinical trials can be found on www.clinicaltrials.gov.
About Verastem, Inc.
Verastem, Inc. (Nasdaq:VSTM) is a biopharmaceutical company focused on
discovering and developing drugs to improve outcomes for patients with
cancer. Verastem is currently developing duvelisib, a dual inhibitor of
PI3K-delta and PI3K-gamma, which has successfully met the primary
endpoints in both a Phase 2 study in double-refractory iNHL and a Phase
3 clinical trial in patients with relapsed/refractory CLL/SLL. In
addition, Verastem is developing the FAK inhibitor, defactinib, which is
currently being evaluated in three separate clinical collaborations in
combination with immunotherapeutic agents for the treatment of several
different cancer types, including pancreatic, ovarian, non-small cell
lung cancer, and mesothelioma. Verastem’s product candidates seek to
treat cancer by modulating the local tumor microenvironment, enhancing
anti-tumor immunity and reducing cancer stem cells. For more
information, please visit www.verastem.com.
Verastem, Inc. 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 investigational product
candidates, including duvelisib and defactinib, and Verastem's PI3K and
FAK programs generally, the structure of our planned and pending
clinical trials and the timeline and indications for clinical
development and regulatory submissions. The words "anticipate,"
"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 the full data from
the DUO study will not be consistent with the previously presented
results of the study; that data may not be available when expected,
including for the Phase 3 DUO™ study; that even if data from clinical
trials is positive, regulatory authorities may require additional
studies for approval and the product may not prove to be safe and
effective; that the degree of market acceptance of product candidates,
if approved, may be lower than expected; that the timing, scope and rate
of reimbursement for our product candidates is uncertain; that there may
be competitive developments affecting our product candidates; that data
may not be available when expected; that enrollment of clinical trials
may take longer than expected; that our product candidates will cause
unexpected safety events or result in an unmanageable safety profile as
compared to their level of efficacy; that duvelisib will be ineffective
at treating patients with lymphoid malignancies; 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; that Verastem may
not have sufficient cash to fund its contemplated operations; that
Verastem or Infinity Pharmaceuticals, Inc. will fail to fully perform
under the duvelisib license agreement; that Verastem may be unable to
make additional draws under its debt facility or obtain adequate
financing in the future through product licensing, co-promotional
arrangements, public or private equity, debt financing or otherwise;
that Verastem will not pursue or submit regulatory filings for its
product candidates, including for duvelisib in patients with CLL or
iNHL; and that Verastem's product candidates will not receive regulatory
approval, become commercially successful products, or result in new
treatment options being offered to patients. 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,
2016 and in any subsequent filings with the U.S. Securities and Exchange
Commission. The forward-looking statements contained in this press
release reflect Verastem's views as of the date of this release, and
Verastem does not undertake and specifically disclaims any obligation to
update any forward-looking statements.
References
1Winkler et al. PI3K-delta and PI3K-gamma inhibition by
IPI-145 abrogates immune responses and suppresses activity in autoimmune
and inflammatory disease models. Chem Biol 2013; 20:1-11.
2Reif et al. Cutting Edge: Differential roles for
phosphoinositide 3 kinases, p110-gamma and p110-delta, in lymphocyte
chemotaxis and homing. J Immunol 2004:173:2236-2240.
3Schmid et al. Receptor tyrosine kinases and TLR/IL1Rs
unexpectedly activate myeloid cell PI3K, a single convergent point
promoting tumor inflammation and progression. Cancer Cell
2011;19:715-727.
4 www.clinicaltrials.gov,
NCT02004522
5 www.clinicaltrials.gov,
NCT01882803
6 www.clinicaltrials.gov,
NCT02783625, NCT02158091
View source version on businesswire.com: http://www.businesswire.com/news/home/20180104006342/en/
Source: Verastem, Inc.
Verastem, Inc.
Marianne Lambertson, 781-292-4273
Vice
President, Corporate Communications
mlambertson@verastem.com