Company Secures up to $150 Million in
Non-Dilutive Funding from Oxford Finance LLC, Providing Additional
Financial Flexibility
Expected Cash Runway Through 2025; Supports
Continued Development and Potential Commercial Launches of VS-6766
and Defactinib
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company
committed to advancing new medicines for patients with cancer,
today announced it has entered into a credit facility with Oxford
Finance LLC for up to $150 million that is designed to primarily
support the continued development, commercial preparation and
potential launches of VS-6766 and defactinib.
“The term loan facility with Oxford is an ideal non-dilutive
opportunity for Verastem. Combined with our strong cash position
and expected future payments from Secura Bio related to the 2020
sale of COPIKTRA (duvelisib), we believe we have significant
financial optionality to advance our current development and
commercial objectives,” said Rob Gagnon, Chief Business and
Financial Officer of Verastem Oncology. “The strengthened balance
sheet will allow us to build on our breakthrough therapy
designation for VS-6766 and defactinib in low-grade serous ovarian
cancer and prepare for potential launches in both low-grade serous
ovarian cancer and KRAS-mutant non-small cell lung cancer.”
Under the terms of the loan agreement with Oxford Finance LLC,
Verastem drew an initial $25 million term loan at closing. The
Company has the ability to access up to an additional $125 million
in a series of tranches, $75 million of which are based on certain
pre-determined milestones and $50 million at the lender’s
discretion. The loans carry an interest-only period up to 48 months
and will bear interest at a floating rate which is subject to both
a floor and a cap.
The Company had cash, cash equivalents, and investment balance
of $100.3 million as of December 31, 2021. Taking into account the
initial drawdown of $25.0 million at closing, the Company would
have had pro-forma cash, cash equivalents, and investment balance
of $125.3 million as of December 31, 2021 and an expected cash
runway through 2025.
About VS-6766
VS-6766 (formerly known as CH5126766 and RO5126766) is a RAF/MEK
clamp that induces inactive complexes of MEK with ARAF, BRAF and
CRAF, potentially creating a more complete and durable anti-tumor
response through maximal RAS pathway inhibition. VS-6766 is
currently in late-stage development.
In contrast to currently available MEK inhibitors, VS-6766
blocks both MEK kinase activity and the ability of RAF to
phosphorylate MEK. This unique mechanism allows VS-6766 to block
MEK signaling without the compensatory activation of MEK that
appears to limit the efficacy of other inhibitors. The U.S. Food
and Drug Administration granted Breakthrough Therapy designation
for the combination of Verastem Oncology’s investigational RAF/MEK
inhibitor VS-6766, with defactinib, its FAK inhibitor, for the
treatment of all patients with recurrent low-grade serous ovarian
cancer (LGSOC) regardless of KRAS status after one or more prior
lines of therapy, including platinum-based chemotherapy.1
Verastem Oncology is conducting Phase 2 registration-directed
trials of VS-6766 alone and with defactinib in patients with
recurrent LGSOC and in patients with recurrent KRAS G12V-mutant
NSCLC as part of its RAMP (Raf And Mek
Program) clinical trials, RAMP 201 and RAMP 202,
respectively. Verastem Oncology has also established clinical
collaborations with Amgen and Mirati to evaluate LUMAKRAS™
(sotorasib) and adagrasib in combination with VS-6766 in KRAS
G12C-mutant NSCLC as part of the RAMP 203 and RAMP 204 trials,
respectively.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a development-stage
biopharmaceutical company committed to the development and
commercialization of new medicines to improve the lives of patients
diagnosed with cancer. Our pipeline is focused on novel small
molecule drugs that inhibit critical signaling pathways in cancer
that promote cancer cell survival and tumor growth, including
RAF/MEK inhibition and focal adhesion kinase (FAK) inhibition. For
more information, please visit www.verastem.com.
About Oxford Finance LLC
Oxford Finance is a specialty finance firm providing senior
secured loans to public and private life sciences and healthcare
services companies worldwide. For over 20 years, Oxford has
delivered flexible financing solutions to its clients, enabling
these companies to maximize their equity by leveraging their
assets. Since 2002, Oxford has originated approximately $8.8
billion in loans. Oxford is headquartered in Alexandria, Virginia,
with additional offices in California (San Diego, Palo Alto, and
Los Angeles), and the greater Boston and New York City metropolitan
areas. For more information, visit www.oxfordfinance.com.
Forward-Looking Statements Notice
This press release includes forward-looking statements about
Verastem Oncology’s strategy, future plans and prospects, including
statements related to the potential clinical value of various of
its clinical trials, the timing of commencing and completing
trials, including topline data reports, and potential for
additional development programs involving Verastem Oncology’s lead
compound as well as the potential commercialization of product
candidates. The words "anticipate," "believe," "estimate,"
"expect," "intend," "may," "plan," "predict," "project," "target,"
"potential," "will," "would," "could," "should," "continue," “can,”
“promising” 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 and
uncertainties, among other things, regarding: the success in the
development and potential commercialization of our product
candidates, including VS-6766 in combination with other compounds,
including defactinib, LUMAKRASTM and others; the occurrence of
adverse safety events and/or unexpected concerns that may arise
from additional data or analysis or result in unmanageable safety
profiles as compared to their levels of efficacy; our ability to
obtain, maintain and enforce patent and other intellectual property
protection for our product candidates; the scope, timing, and
outcome of any legal proceedings; decisions by regulatory
authorities regarding labeling and other matters that could affect
the availability or commercial potential of our product candidates;
whether preclinical testing of our product candidates and
preliminary or interim data from clinical trials will be predictive
of the results or success of ongoing or later clinical trials; that
the timing, scope and rate of reimbursement for our product
candidates is uncertain; that third-party payors (including
government agencies) may not reimburse; 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 experience manufacturing or supply interruptions or
failures; that we will be unable to successfully initiate or
complete the clinical development and eventual commercialization of
our product candidates; that the development and commercialization
of our product candidates will take longer or cost more than
planned; that we or Chugai Pharmaceutical Co., Ltd. will fail to
fully perform under the VS-6766 license agreement; that we or our
other collaboration partners may fail to perform under our
collaboration agreements; that we may not have sufficient cash to
fund our contemplated operations; that we may be unable to obtain
adequate financing in the future through product licensing,
co-promotional arrangements, public or private equity, debt
financing or otherwise; that we will be unable to execute on our
partnering strategies for VS-6766 in combination with other
compounds; that we will not pursue or submit regulatory filings for
our product candidates; and that our 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 the Company’s Annual Report on Form 10-K
for the year ended December 31, 2021 as filed with the Securities
and Exchange Commission (SEC) on March 28, 2022 and in any
subsequent filings with the SEC. The forward-looking statements
contained in this press release reflect Verastem Oncology’s views
as of the date hereof, and the Company does not assume and
specifically disclaims any obligation to update any forward-looking
statements whether as a result of new information, future events or
otherwise, except as required by law.
References
1 Verastem Oncology Press Release. Verastem Oncology Receives
Breakthrough Therapy Designation for VS-6766 with Defactinib in
Recurrent Low-Grade Serous Ovarian Cancer. May 24, 2021. Available
at:
https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-receives-breakthrough-therapy-designation-vs.
Accessed March 2022.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220328005165/en/
Investors:
Ajay Munshi Vice President, Corporate Development +1
781-469-1579 amunshi@verastem.com
Nate LiaBraaten +1 212-600-1902 nate@argotpartners.com
Media:
Lisa Buffington Corporate Communications +1 781-292-4205
lbuffington@verastem.com
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