Proposed ~$250 million all-cash
acquisition strengthens Regeneron's portfolio of diverse and
combinable immuno-oncology candidates
Lead investigational asset vidutolimod is a potential
best-in-class TLR9 agonist, with demonstrated clinical responses
observed in PD-1 refractory melanoma as monotherapy
Vidutolimod is currently being studied in combination with
other agents for melanoma, non-melanoma skin cancers, and head and
neck cancer
TARRYTOWN, N.Y. and CAMBRIDGE, Mass., April 19,
2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI),
a clinical stage biopharmaceutical company focused on proprietary
technology to harness the power of the immune system to combat
cancer, today announced a definitive agreement for the acquisition
of Checkmate by Regeneron at an all-cash price of $10.50 per share of Checkmate common stock. The
proposed acquisition values Checkmate at a total equity value of
approximately $250 million.
Checkmate's lead investigational candidate is vidutolimod, an
advanced generation CpG-A oligodeoxynucleotide Toll-like receptor 9
(TLR9) agonist delivered in a virus-like particle.
"As we continue to advance and expand our research efforts in
immuno-oncology, the acquisition of Checkmate will add a promising
new modality to Regeneron's toolkit of potential approaches for
difficult-to-treat cancers," said Leonard
S. Schleifer, M.D., Ph.D., President and Chief Executive
Officer of Regeneron. "The unique combination of a differentiated
Toll-like receptor 9 with other antibody-based oncology agents may
result in increased clinical benefit and provide new treatment
options for patients in need. We look forward to welcoming the
Checkmate team and their complementary scientific acumen to the
Regeneron family."
"We are thrilled that Checkmate will become part of Regeneron, a
biotechnology leader that shares our deep appreciation for science,
hunger for ground-breaking discoveries and commitment to helping
patients defeat cancer," said Alan
Bash, President and Chief Executive Officer of
Checkmate.
"We believe that the data we have generated with vidutolimod
positions Checkmate at the forefront of the innate immune activator
field. It is our hope that Regeneron's resources and expertise will
help accelerate the development of vidutolimod and realization of
the full potential of our virus-like particle (VLP) platform for
immunotherapy," said Art Krieg,
M.D., Checkmate's Founder and Chief Scientific Officer.
Vidutolimod is administered into the tumor and is believed to
induce and expand anti-tumor T cells and induce tumor regression as
a monotherapy in patients whose tumors previously progressed on
PD-1 checkpoint inhibition. In the Phase 1b program, documented abscopal responses were
seen in distant, un-injected lesions. Vidutolimod is an
investigational therapy and has not been approved by U.S. Food and
Drug Administration or any other regulatory agency.
The merger agreement provides for Regeneron, through a
subsidiary, to initiate a tender offer to acquire all outstanding
shares of Checkmate at an all-cash price of $10.50 per share of Checkmate common stock. The
closing of the tender offer will be subject to certain conditions,
including the tender of at least a majority of the outstanding
shares of Checkmate common stock, the expiration of the waiting
period under the Hart-Scott-Rodino Antitrust Improvements Act and
other customary closing conditions. Upon the successful completion
of the tender offer, Regeneron will acquire all shares not acquired
in the tender through a second-step merger. The transaction is
expected to close in mid-2022.
Regeneron's legal advisor for the transaction is Wachtell,
Lipton, Rosen & Katz. Centerview Partners is serving as
Checkmate's financial advisor and Goodwin Procter LLP is serving as
its legal advisor.
About Vidutolimod
Vidutolimod works by two
complementary mechanisms that together have a unique ability to
drive a strong systemic anti-tumor T cell response. First, the
virus-like particle (VLP) activates an immune response to the VLP,
leading to the production of antibodies that deliver the VLP
into plasmacytoid dendritic cells (pDC) and other immune
cells via specialized receptors called FcRs. This provides an
initial stimulatory signal to pDC and brings the CpG-A
to TLR9 (the receptor for CpG DNA) inside the pDC.
Second, CpG-A stimulates TLR9 in a manner that induces pDC to
release significantly higher levels of IFN-α and other type I
interferons than other innate immune activators, resulting in
a stronger anti-tumor T cell response.
Animal models and in vitro experiments suggest
that, when activated by vidutolimod by this combination of
signals, pDC recruit and coordinate a variety of other immune
cells, culminating in the generation of a strong anti-tumor T cell
response.
About Regeneron
Regeneron (NASDAQ: REGN) is a
leading biotechnology company that invents life-transforming
medicines for people with serious diseases. Founded and led for
nearly 35 years by physician-scientists, our unique ability to
repeatedly and consistently translate science into medicine has led
to nine FDA-approved treatments and numerous product candidates in
development, almost all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, pain, hematologic
conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our
proprietary VelociSuite® technologies,
such as VelocImmune®, which uses unique
genetically humanized mice to produce optimized fully human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please
visit www.regeneron.com or follow @Regeneron on
Twitter.
About Checkmate Pharmaceuticals
Checkmate Pharmaceuticals is a clinical stage biotechnology company
focused on developing its proprietary technology to harness the
power of the immune system to combat cancer. Checkmate
Pharmaceuticals' product candidate, vidutolimod (CMP-001), is an
advanced generation Toll-like receptor 9 (TLR9) agonist, delivered
as a biologic virus-like particle utilizing a CpG-A
oligodeoxynucleotide as a key component, designed to trigger the
body's innate immune system to attack tumors in combination with
other therapies. Information regarding Checkmate Pharmaceuticals is
available at www.checkmatepharma.com.
Forward-looking Statements
This communication
includes forward-looking statements that involve risks and
uncertainties relating to future events and the future performance
of Regeneron Pharmaceuticals, Inc. ("Regeneron") and
Checkmate Pharmaceuticals, Inc. ("Checkmate") and actual events or
results may differ materially from these forward-looking
statements. Words such as "anticipate," "expect," "intend," "plan,"
"believe," "seek," "estimate," variations of such words, and
similar expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. Risks that may cause these forward-looking
statements to be inaccurate include, without limitation:
uncertainties as to the timing of the tender offer and merger;
uncertainties as to how many of Checkmate's stockholders will
tender their stock in the offer; the possibility that competing
offers will be made; the possibility that various closing
conditions for the transaction may not be satisfied or waived,
including that a governmental entity may prohibit, delay, or refuse
to grant approval for the consummation of the transaction (or only
grant approval subject to adverse conditions or limitations); the
difficulty of predicting the timing or outcome of regulatory
approvals or actions, if any; the possibility that the transaction
does not close; risks related to Regeneron's ability to realize the
anticipated benefits of the proposed acquisition, including the
possibility that the expected benefits from the proposed
acquisition will not be realized or will not be realized within the
expected time period and that Regeneron and Checkmate will not be
integrated successfully; the effects of the transaction on
relationships with employees, other business partners or
governmental entities; negative effects of this announcement or the
consummation of the proposed acquisition on the market price of
Regeneron's or Checkmate's common stock and/or Regeneron's or
Checkmate's operating results; significant transaction costs;
unknown liabilities; the risk of litigation and/or regulatory
actions related to the proposed acquisition; the impact of
SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on
Regeneron's or Checkmate's business and its employees,
collaborators, and suppliers and other third parties on which
Regeneron and Checkmate rely; Regeneron's, Checkmate's, and their
collaborators' ability to continue to conduct research and clinical
programs; Regeneron's and Checkmate's ability to manage their
supply chains; Regeneron's ability to manage net product sales of
products marketed or otherwise commercialized by Regeneron and/or
its collaborators or licensees (collectively, "Regeneron's
Products"); the nature, timing, and possible success and
therapeutic applications of Regeneron's Products, product
candidates being developed by Regeneron and/or its collaborators or
licensees (collectively, "Regeneron's Product Candidates"), and
product candidates being developed by Checkmate, such as
vidutolimod; the extent to which the results from the research and
development programs conducted by Regeneron, Checkmate, and/or
their collaborators or licensees may be replicated in other studies
and/or lead to advancement of product candidates to clinical
trials, therapeutic applications, or regulatory approval; the
potential of the Toll-like receptor 9 (TLR9) agonist technology
discussed in this press release; uncertainty of the utilization,
market acceptance, and commercial success of Regeneron's Products,
Regeneron's Product Candidates, and vidutolimod and the impact of
studies (whether conducted by Regeneron, Checkmate or others and
whether mandated or voluntary) on any of the foregoing or any
potential regulatory approval of Regeneron's Products, Regeneron's
Product Candidates, and vidutolimod; the likelihood, timing, and
scope of possible regulatory approval and commercial launch of
Regeneron's Product Candidates and vidutolimod and new indications
for Regeneron's Products; the ability of Regeneron's and
Checkmate's collaborators, licensees, suppliers, or other third
parties (as applicable) to perform manufacturing, filling,
finishing, packaging, labeling, distribution, and other steps
related to Regeneron's Products, Regeneron's Product Candidates,
and vidutolimod; the ability of Regeneron and/or its collaborators
to manufacture and manage supply chains for multiple products and
product candidates; safety issues resulting from the administration
of Regeneron's Products, Regeneron's Product Candidates, and
vidutolimod in patients, including serious complications or side
effects in connection with the use of Regeneron's Products,
Regeneron's Product Candidates, and vidutolimod in clinical trials;
determinations by regulatory and administrative governmental
authorities which may delay or restrict Regeneron's ability to
continue to develop or commercialize Regeneron's Products,
Regeneron's Product Candidates, or Checkmate's ability to continue
to develop or commercialize vidutolimod; and competing drugs and
product candidates that may be superior to, or more cost effective
than, Regeneron's Products, Regeneron's Product Candidates, or
vidutolimod. A more complete description of these and other
material risks can be found in Regeneron's and Checkmate's filings
with the U.S. Securities and Exchange Commission, including
their Forms 10-K for the year ended December 31, 2021 as well
as the Schedule TO and related tender offer documents to be filed
by Regeneron and Scandinavian Acquisition Sub, Inc. and the
Schedule 14D-9 to be filed by Checkmate, and, if applicable, the
proxy statement referenced below. Any forward-looking statements
are made based on the current beliefs and judgments of Regeneron's
and Checkmate's management, and the reader is cautioned not to rely
on any forward-looking statements made by Regeneron or Checkmate.
Regeneron and Checkmate do not undertake any obligation to update
(publicly or otherwise) any forward-looking statement, including
without limitation any financial projection or guidance, whether as
a result of new information, future events, or otherwise.
Additional Information and Where to Find It
The tender
offer referenced in this communication has not yet commenced. This
communication is for informational purposes only and is neither an
offer to purchase nor a solicitation of an offer to sell securities
of Checkmate, nor is it a substitute for the tender offer materials
that Checkmate, Regeneron or its acquisition subsidiary,
Scandinavian Acquisition Sub, Inc. will file with the Securities
and Exchange Commission ("SEC"). The solicitation and offer to buy
Checkmate stock will only be made pursuant to an Offer to Purchase
and related tender offer materials that Regeneron intends to file
with the SEC. At the time the tender offer is commenced, Regeneron
and its acquisition subsidiary will file a Tender Offer Statement
on Schedule TO and thereafter Checkmate will file a
Solicitation/Recommendation Statement on Schedule 14D-9 with the
SEC with respect to the tender offer. Under certain circumstances
described in the definitive transaction documents, Regeneron may
determine to instead to terminate or withdraw the offer and effect
the transaction through a merger only, in which case the relevant
documents to be filed with the SEC will include a proxy statement
for the solicitation of votes of Checkmate stockholders to approve
the merger. CHECKMATE'S STOCKHOLDERS AND OTHER INVESTORS ARE URGED
TO READ CAREFULLY THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO
PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER
OFFER DOCUMENTS), THE SOLICITATION/RECOMMENDATION STATEMENT ON
SCHEDULE 14D-9, AND, IF APPLICABLE, THE PROXY STATEMENT BECAUSE
THEY WILL EACH CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF
CHECKMATE SECURITIES AND OTHER INVESTORS SHOULD CONSIDER BEFORE
MAKING ANY DECISION REGARDING WITH RESPECT TO THE TENDER OFFER, OR,
IF APPLICABLE, VOTING ON THE TRANSACTION. The Offer to Purchase,
the related Letter of Transmittal, certain other tender offer
documents, as well as the Solicitation/Recommendation Statement,
and if applicable, the proxy statement will be made available to
all stockholders of Checkmate at no expense to them and will also
be made available for free at the SEC's website at www.sec.gov.
Additional copies may be obtained for free by contacting either
Regeneron or Checkmate. Copies of the documents filed with the SEC
by Checkmate will be available free of charge on Checkmate's
website at https://ir.checkmatepharma.com or by contacting
Checkmate's Investor Relations Department at (617) 682-3625. Copies
of the documents filed with the SEC by Regeneron will be available
free of charge on Regeneron's website at
https://investor.regeneron.com or by contacting Regeneron's
Investor Relations Department at invest@regeneron.com or (914)
847-7741.
In addition to the Offer to Purchase, the related Letter of
Transmittal and certain other tender offer documents, as well as
the Solicitation/Recommendation Statement, and if applicable, the
proxy statement, Regeneron and Checkmate each file annual,
quarterly and current reports, proxy statements and other
information with the SEC. You may read and copy any reports or
other information filed by Regeneron or Checkmate at the SEC public
reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at
1-800-SEC-0330 for further information on the public reference
room. Regeneron's and Checkmate's filings with the SEC are also
available for free to the public from commercial document-retrieval
services and at the website maintained by the SEC at
http://www.sec.gov.
If the tender offer is terminated and the transaction is to be
effected by merger only, in which case, the approval of Checkmate
stockholders must be obtained, Regeneron, Checkmate and their
respective directors and executive officers may be deemed to be
participants in any such solicitation of proxies from Checkmate's
stockholders in connection with the proposed transaction.
Information regarding Regeneron's directors and executive officers
is available in its proxy statement that was filed with the SEC;
information regarding Checkmate's directors and executive officers
is available in its proxy statement that was filed with the SEC.
Other information regarding potential participants in any such
proxy solicitation will be contained in any proxy statement filed
in connection with the transaction.
Regeneron Media Relations
Alexandra Bowie
Tel: +1 914-847-3407
Alexandra.bowie@regeneron.com
Regeneron Investor Relations
Vesna Tosic
Tel: +1 914-847-5443
vesna.tosic@regeneron.com
Checkmate Media Contact
Karen
Sharma
MacDougall Advisors
Tel: +1 781-235-3060
ksharma@macdougall.bio
Checkmate Investor Contact
Rob Dolski
Chief Financial Officer
rdolski@checkmatepharma.com
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SOURCE Regeneron Pharmaceuticals, Inc.