Company cash, cash equivalents, and investments
of $88.8 million as of December 31, 2024; pro forma cash position
of $128.6 million including debt refinancing and equity issuance
provides cash runway beyond FDA approval
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company
committed to advancing new medicines for patients with RAS/MAPK
pathway-driven cancers, today announced a new credit facility for
up to $150 million along with an equity investment of $7.5 million
with Oberland Capital Management LLC (Oberland Capital). In
addition, the Company announced a strategic collaboration with
IQVIA Inc. (IQVIA) to leverage IQVIA’s world-class infrastructure
and established commercialization solutions to complement its
launch strategy for the investigational combination of avutometinib
plus defactinib for the treatment of recurrent KRAS mutant
low-grade serous ovarian cancer (LGSOC) planned for mid-2025.
“The Oberland Capital transaction, coupled with our strategic
partnership with IQVIA, enables us to launch avutometinib plus
defactinib for recurrent LGSOC from a position of financial
strength and with commercialization solutions to accelerate our
launch. The additional capital will help us create a commercial
revenue stream to support our pipeline with new approaches for
patients needing treatments for complex and rare cancers,” said Dan
Paterson, president and chief executive officer of Verastem
Oncology.
Verastem’s commercialization efforts are in anticipation of
potential U.S. Food and Drug Administration (FDA) approval of
avutometinib plus defactinib in recurrent KRAS mutant LGSOC. The
Company announced on December 30, 2024, that the FDA set a
Prescription Drug User Fee Act (PDUFA) action date for its NDA
submission of June 30, 2025.
Under the terms of the note purchase agreement with Oberland
Capital, Verastem will issue an initial $75 million of notes at
closing, which is expected to occur on January 13, 2025. The
Company then has the ability to access up to an additional $75
million in notes upon achievement of certain pre-determined
milestones related to the potential regulatory approval and
commercialization of avutometinib plus defactinib for the treatment
of LGSOC. The notes carry an interest-only period of six years and
will bear interest at a floating rate, which is subject to both a
floor and a cap. The note purchase agreement also provides for
revenue participation pursuant to which Oberland Capital will
initially be entitled to 1.0% of the first $100 million of net
sales in each calendar year of certain of the Company’s products,
subject to pro-rata increase upon potential future draw downs.
In addition, the Company has entered into a stock purchase
agreement with affiliates of Oberland Capital for the private
placement of 1,416,939 shares of the Company’s common stock issued
at closing, representing $7.5 million of gross proceeds based on
the trailing 30-trading days volume-weighted average price or VWAP
of $5.2931 per share. Additionally, Oberland has the option to
participate in certain future equity offerings that may be
consummated by the Company within the three years from closing, for
up to $2.5 million at the same price per share in such offering.
Closing of the stock purchase agreement is expected to occur
concurrently with the closing of the note purchase agreement on
January 13, 2025. A portion of the proceeds from the notes and
equity investment will be used to fully repay amounts owed under
the Company’s existing loan with Oxford Finance ($42.7 million),
which has been terminated.
The Company had a preliminary unaudited cash, cash equivalents,
and short term investment balance of $88.8 million as of December
31, 2024. Taking into account the initial $75.0 million of notes
and $7.5 million of equity to be purchased by Oberland Capital at
closing, and the repayment of amounts owed under the Company’s
existing loan with Oxford Finance, the Company would have had
pro-forma cash, cash equivalents, and short-term investment balance
of $128.6 million as of December 31, 2024. Both the actual and pro
forma December 31, 2024 balances stated herein are preliminary,
unaudited estimates and subject to revision upon completion of the
Company's closing and audit processes and do not present all
information necessary for an understanding of the Company’s
financial condition as of, and its results of operations for the
fiscal year ended December 31, 2024. Additional details regarding
this financing will be available in a Current Report on Form 8-K to
be filed by the Company with the Securities and Exchange
Commission.
The agreement between Verastem and IQVIA allows Verastem to tap
into IQVIA’s industry-leading expertise and resources while
maintaining strategic oversight through the commercialization
process and launch. IQVIA will help accelerate key launch
capabilities resulting in significant savings while delivering a
world-class product launch.
About the Avutometinib and Defactinib Combination
Avutometinib is an oral RAF/MEK clamp that potentially inhibits
MEK1/2 kinase activities and induces inactive complexes of MEK with
ARAF, BRAF, and CRAF, potentially creating a more complete and
durable anti-tumor response through maximal RAS/MAPK pathway
inhibition. In contrast to currently available MEK-only inhibitors,
avutometinib blocks both MEK kinase activity and the ability of RAF
to phosphorylate MEK. This unique mechanism allows avutometinib to
block MEK signaling without the compensatory activation of MEK that
appears to limit the efficacy of the MEK-only inhibitors.
Defactinib is an oral, selective inhibitor of focal adhesion
kinase (FAK) and proline-rich tyrosine kinase-2 (Pyk2), the two
members of the focal adhesion kinase family of non-receptor protein
tyrosine kinases. FAK and Pyk2 integrate signals from integrin and
growth factor receptors to regulate cell proliferation, survival,
migration, and invasion. FAK activation has been shown to mediate
resistance to multiple anti-cancer agents, including RAF and MEK
inhibitors.
Verastem Oncology is currently conducting clinical trials with
avutometinib with and without defactinib in RAS/MAPK-driven tumors
as part of its Raf And Mek Program or
RAMP. Verastem is currently enrolling patients and activating sites
for RAMP 301 (GOG-3097/ENGOT-ov81/NCRI) (NCT06072781), an
international Phase 3 confirmatory trial evaluating the combination
of avutometinib and defactinib versus standard chemotherapy or
hormonal therapy for the treatment of recurrent low-grade serous
ovarian cancer (LGSOC).
Verastem was granted Priority Review and a Prescription Drug
User Fee Act (PDUFA) date of June 30, 2025, for its New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA),
for the investigational combination of avutometinib and defactinib
in adults with recurrent KRAS mutant LGSOC who received at least
one prior systemic therapy. Verastem initiated a rolling NDA in May
2024 to the FDA and completed its NDA submission in October 2024.
The FDA granted Breakthrough Therapy Designation for the treatment
of patients with recurrent LGSOC after one or more prior lines of
therapy, including platinum-based chemotherapy, in May 2021.
Avutometinib alone or in combination with defactinib was also
granted Orphan Drug Designation by the FDA for the treatment of
LGSOC.
Verastem Oncology has established a clinical collaboration with
Amgen to evaluate LUMAKRAS™ (sotorasib) in combination with
avutometinib and defactinib in both treatment-naïve patients and in
patients whose KRAS G12C mutant non-small cell lung cancer
progressed on a G12C inhibitor as part of the RAMP 203 trial
(NCT05074810). Verastem has received Fast Track Designation from
the FDA for the triplet combination in April 2024. RAMP 205
(NCT05669482), a Phase 1b/2 clinical trial evaluating avutometinib
and defactinib with gemcitabine/nab-paclitaxel in patients with
front-line metastatic pancreatic cancer, is supported by the PanCAN
Therapeutic Accelerator Award. FDA granted Orphan Drug Designation
to the avutometinib and defactinib combination for the treatment of
pancreatic cancer.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a late-stage development
biopharmaceutical company committed to the development and
commercialization of new medicines to improve the lives of patients
diagnosed with RAS/MAPK pathway-driven cancers. 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 FAK inhibition. For
more information, please visit www.verastem.com and follow us on
LinkedIn.
About Oberland Capital
Oberland Capital is a private investment firm formed in 2013
with assets under management in excess of $3.0 billion. The firm is
focused exclusively on investing in the global healthcare industry
and specializing in flexible investment structures customized to
meet the specific needs of its transaction partners. Oberland
Capital's broad suite of financing solutions includes monetization
of royalty streams, acquisition of future product revenues,
creation of project-based financing structures, and investments in
traditional debt and equity. With a combination of deep industry
knowledge and extensive structured finance experience, the Oberland
Capital team has a history of creating value for its transaction
partners. For more information, please visit
www.oberlandcapital.com or contact Johnna Schifilliti at (212)
257-5850.
Forward-Looking Statements
This press release includes forward-looking statements about,
among other things, Verastem Oncology’s programs and product
candidates, strategy, future plans and prospects, including
statements related to the anticipated timing of closing an funding
of the transactions with Oberland Capital, the expected outcome and
benefits of the collaboration and the agreement between Verastem
and IQVIA, the expected timing of further FDA action on the New
Drug Application (NDA) for the avutometinib and defactinib
combination product in KRAS-mutant and recurrent low-grade serous
ovarian cancer, the potential clinical value of various of the
Company’s clinical trials, interactions with regulators, the
potential for and timing of commercialization of product candidates
and potential for additional development programs involving
Verastem Oncology’s lead compound. 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.
Forward-looking statements are not guarantees of future
performance and are subject to risks and uncertainties that could
cause our 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 avutometinib in combination with
other compounds, including defactinib, LUMAKRAS™ and others; the
uncertainties inherent in research and development, such as
negative or unexpected results of clinical trials, the occurrence
or timing of applications for our product candidates that may be
filed with regulatory authorities in any jurisdictions; whether and
when regulatory authorities in any jurisdictions may approve or
reject any such applications that may be filed for our product
candidates, and, if approved, whether our product candidates will
be commercially successful in such jurisdictions; 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 trial design, labeling and other matters that
could affect the timing, 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; the uncertainty around the timing, scope and rate
of reimbursement for our product candidates; internal and
third-party estimates about the market opportunities of our drug
candidates may prove to be incorrect; third-party payors (including
government agencies) may not reimburse; there may be competitive
developments affecting our product candidates; data may not be
available when expected; that enrollment of clinical trials may
take longer than expected, which may delay our development
programs, including delays in review by the FDA of our NDA
submission in recurrent KRAS mutant LGSOC if enrollment in our
confirmatory trial is not well underway at the time of submission,
or that the FDA may require the Company to have completed
enrollment or to enroll additional patients in the Company’s
ongoing RAMP-301 confirmatory Phase 3 clinical trial prior to the
FDA taking action on our NDA seeking accelerated approval; risks
associated with preliminary and interim data, which may not be
representative of more mature data, including with respect to
interim duration of therapy data; our product candidates may cause
adverse safety events and/or unexpected concerns may arise from
additional data or analysis, or result in unmanageable safety
profiles as compared to their levels of efficacy; we may be unable
to successfully validate, develop and obtain regulatory approval
for companion diagnostic tests for our product candidates that
require or would commercially benefit from such tests, or
experience significant delays in doing so; the mature RAMP 201 data
and associated discussions with the FDA may not support the scope
of our NDA submission for the avutometinib and defactinib
combination in LGSOC, including with respect to both recurrent KRAS
mutant and recurrent KRAS wild type LGSOC; our product candidates
may experience manufacturing or supply interruptions or failures;
any of our third party contract research organizations, contract
manufacturing organizations, clinical sites, or contractors, among
others, who we rely on may fail to fully perform; we face
substantial competition, which may result in others developing or
commercializing products before or more successfully than we do
which could result in reduced market share or market potential for
our product candidates; we may be unable to successfully initiate
or complete the clinical development and eventual commercialization
of our product candidates; the development and commercialization of
our product candidates may take longer or cost more than planned,
including as a result of conducting additional studies or our
decisions regarding execution of such commercialization; we may not
have sufficient cash to fund our contemplated operations, including
certain of our product development programs; we may not attract and
retain high quality personnel; we or Chugai Pharmaceutical Co.,
Ltd. may fail to fully perform under the avutometinib license
agreement; the total addressable and target markets for our product
candidates might be smaller than we are presently estimating; we or
Secura Bio, Inc. (Secura) may fail to fully perform under the asset
purchase agreement with Secura, including in relation to milestone
payments; we may not see a return on investment on the payments we
have and may continue to make pursuant to the collaboration and
option agreement with GenFleet Therapeutics (Shanghai), Inc.
(GenFleet), or that GenFleet may fail to fully perform under the
agreement; we may not be able to establish new or expand on
existing collaborations or partnerships, including with respect to
in-licensing of our product candidates, on favorable terms, or at
all; 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; we may not pursue or
submit regulatory filings for our product candidates; our product
candidates may not receive regulatory approval, become commercially
successful products, or result in new treatment options being
offered to patients; and that our final audited cash, cash
equivalents, and short-term investments for the year ended December
31, 2024 may differ materially from the preliminary and unaudited
amount reported herein.
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, 2023, as filed with the Securities
and Exchange Commission (SEC) on March 14, 2024 and in any
subsequent filings with the SEC, which are available at
www.sec.gov. As a result of these and other factors, we may not
achieve the plans, intentions or expectations disclosed in our
forward-looking statements, and you should not place undue reliance
on our forward-looking statements. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250113992572/en/
For Investor and Media Inquiries: Julissa Viana Vice
President, Corporate Communications and Investor Relations
investors@verastem.com or media@verastem.com
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