Item 8.01 - Other Events.
As previously announced, on September 20, 2022, Sesen Bio, Inc. ("Sesen Bio")
entered into a definitive merger agreement with CARISMA Therapeutics Inc., a
clinical-stage biopharmaceutical company focused on discovering and developing
innovative immunotherapies ("Carisma"), pursuant to which a wholly-owned
subsidiary of Sesen Bio will merge with and into Carisma (the "merger"), with
Carisma surviving as a wholly-owned subsidiary of Sesen Bio. Following extensive
engagement with Sesen Bio stockholders, the companies amended the merger
agreement on December 29, 2022 to deliver greater value in connection with
closing of the merger. The merger is currently expected to close in the first
quarter of 2023, subject to approval by Sesen Bio's stockholders and other
customary closing conditions.
On January 31, 2023, Carisma announced that it has appointed Padmanee Sharma,
MD, PhD to its Scientific Advisory Board, who brings valuable experience as
Carisma continues to advance its lead asset, CT-0508, and moves into the next
step of its clinical program with its anticipated combination trial with leading
immune-oncology treatment, KEYTRUDA® (pembrolizumab). A copy of the press
release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is
incorporated herein by reference.
Dr. Sharma is a prominent oncologist and immunologist whose research focuses on
investigating mechanisms and pathways within the immune system that facilitate
tumor rejection or elicit resistance to immune checkpoint therapy. Her expertise
in immuno-oncology reinforces Carisma's commitment to trialing its proprietary
targeted chimeric antigen receptor macrophages ("CAR-M") therapies in
combination with other therapies like checkpoint inhibitors which may have
synergistic effects in solid tumor cancers. Dr. Sharma has been awarded several
accolades over the course of her career as a result of her contributions to the
field of cancer immunotherapy, most recently receiving the 2021 Heath Memorial
Award and Randall Prize for Excellence in Cancer Research.
Dr. Sharma is a professor in the departments of Genitourinary Medical Oncology
and Immunology, Associate VP of Immunobiology and the T.C. and Jeanette D. Hsu
Endowed Chair in Cell Biology at The University of Texas MD Anderson Cancer
Center, which is one of the world's most respected centers devoted exclusively
to cancer care, research, education and prevention, and has been named one of
the top two hospitals in cancer care every year since US News & World Report
began its annual "America's Best Hospitals" ranking in 1990.
In December 2022, Carisma opened its first site to actively recruit patients for
its Phase 1 clinical trial that will test the safety of its lead candidate,
CT-0508, in combination with Merck's anti-PD1 therapy, KEYTRUDA, for the
treatment of HER2 overexpressing cancers. The combination trial will explore the
potential synergy for CAR-M to sensitize solid tumors to a checkpoint blockade.
The multi-site trial is actively recruiting at prominent cancer centers
including the University of North Carolina Lineberger Comprehensive Cancer
Center in Chapel Hill; City of Hope in Duarte, California; and Sarah Cannon
Research Institute at Tennessee Oncology - Nashville. Carisma intends to open
additional sites in the coming months.
Carisma anticipates the first patient in the Phase 1 combination trial will be
enrolled by the end of the first quarter of 2023.
Cautionary Note on Forward-Looking Statements
Any statements in this Current Report on Form 8-K about future expectations,
plans and prospects for Sesen Bio, Inc. ("Sesen Bio"), CARISMA Therapeutics Inc.
("Carisma Therapeutics") or the combined company, Sesen Bio's, Carisma
Therapeutics' or the combined company's strategy or future operations, and other
statements containing the words "anticipate," "believe," "contemplate,"
"expect," "intend," "may," "plan," "predict," "target," "potential," "possible,"
"will," "would," "could," "should," "continue," and similar expressions,
constitute forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. For example, statements concerning the
proposed transaction, the concurrent financing, the contingent value rights and
other matters, including without limitation: statements relating to the
satisfaction of the conditions to and consummation of the proposed transaction,
the expected timing of the consummation of the proposed transaction and the
expected ownership percentages of the combined company, Sesen Bio's and Carisma
Therapeutics' respective businesses, the strategy of the combined company,
future operations, advancement of the combined company's product candidates and
product pipeline, clinical development of the combined company's product
candidates, including expectations regarding timing of initiation and results of
clinical trials of the combined company, the ability of Sesen Bio to
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remain listed on the Nasdaq Stock Market, the completion of the concurrent
financing, and the receipt of any payments under the contingent value rights are
forward-looking statements. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various important
factors, including without limitation: (i) the risk that the conditions to the
closing of the proposed transaction are not satisfied, including the failure to
obtain stockholder approval of matters related to the proposed transaction in a
timely manner or at all; (ii) uncertainties as to the timing of the consummation
of the proposed transaction and the ability of each of Sesen Bio and Carisma
Therapeutics to consummate the proposed transaction, including completing the
concurrent financing; (iii) risks related to Sesen Bio's ability to correctly
estimate its expected net cash at closing and Sesen Bio's and Carisma
Therapeutics' ability to correctly estimate and manage their respective
operating expenses and expenses associated with the proposed transaction; (iv)
risks related to Sesen Bio's continued listing on the Nasdaq Stock Market until
closing of the proposed transaction; (v) the risk that as a result of
adjustments to the exchange ratio, Sesen Bio stockholders or Carisma
Therapeutics stockholders could own less of the combined company than is
currently anticipated; (vi) the risk that the conditions to payment under the
contingent value rights will not be met and that the contingent value rights may
otherwise never deliver any value to Sesen Bio stockholders; (vii) risks
associated with the possible failure to realize certain anticipated benefits of
the proposed transaction, including with respect to future financial and
operating results; (viii) uncertainties regarding the impact any delay in the
closing would have on the anticipated cash resources of the combined company
upon closing and other events and unanticipated spending and costs that could
reduce the combined company's cash resources; (ix) the effect of uncertainties
related to the actions of activist stockholders, which could make it more
difficult to obtain the approval of Sesen Bio stockholders with respect to the
transaction related proposals and result in Sesen Bio incurring significant fees
and other expenses, including for third-party advisors; (x) the occurrence of
any event, change or other circumstance or condition that could give rise to the
termination of the merger agreement; (xi) the effect of the announcement,
pendency or completion of the merger on Sesen Bio's or Carisma Therapeutics'
business relationships, operating results and business generally; (xii) costs
related to the merger; (xiii) the outcome of any legal proceedings that may be
instituted against Sesen Bio, Carisma Therapeutics or any of their respective
directors or officers related to the merger agreement or the transactions
contemplated thereby; (xiv) the ability of Sesen Bio or Carisma Therapeutics to
protect their respective intellectual property rights; (xv) competitive
responses to the proposed transaction and changes in expected or existing
competition; (xvi) the success and timing of regulatory submissions and
pre-clinical and clinical trials; (xvii) regulatory requirements or
developments; (xviii) changes to clinical trial designs and regulatory pathways;
(xix) changes in capital resource requirements; (xx) risks related to the
inability of the combined company to obtain sufficient additional capital to
continue to advance its product candidates and its preclinical programs; (xxi)
legislative, regulatory, political and economic developments; and (xxii) other
factors discussed in the "Risk Factors" section of Sesen Bio's Annual Report on
Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the
Securities Exchange Commission ("SEC"). In addition, the forward-looking
statements included in this communication represent Sesen Bio's and Carisma
Therapeutics' views as of the date hereof. Sesen Bio and Carisma Therapeutics
anticipate that subsequent events and developments will cause the respective
company's views to change. However, while Sesen Bio may elect to update these
forward-looking statements at some point in the future, Sesen Bio specifically
disclaims any obligation to do so, except as required under applicable law.
These forward-looking statements should not be relied upon as representing Sesen
Bio's views as of any date subsequent to the date hereof.
Important Additional Information
In connection with the proposed transaction between Carisma Therapeutics and
Sesen Bio, Sesen Bio filed with the SEC a registration statement on Form S-4 (as
amended, the "Registration Statement") that includes a proxy statement of Sesen
Bio and also constitutes a prospectus of Sesen Bio with respect to shares of
Sesen Bio common stock to be issued in the proposed transaction (the "Proxy
Statement/Prospectus"). The definitive Proxy Statement/Prospectus was first
mailed to Sesen Bio stockholders on or around January 24, 2023. Sesen Bio may
also file other relevant documents regarding the proposed transaction with the
SEC. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THESE MATERIALS, INCLUDING
THE REGISTRATION STATEMENT, THE DEFINITIVE PROXY STATEMENT/PROSPECTUS, AND ALL
OTHER RELEVANT DOCUMENTS THAT ARE OR WILL BE FILED WITH THE SEC IN CONNECTION
WITH THE PROPOSED TRANSACTION, INCLUDING ANY AMENDMENTS OR SUPPLEMENTS TO THESE
MATERIALS, BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE
PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. Investors and
security holders are able to obtain the definitive Proxy Statement/Prospectus
and other documents that are filed or will be filed by Sesen Bio with the SEC
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free of charge from the SEC's website at www.sec.gov or from Sesen Bio at the
SEC Filings section of www.sesenbio.com.
No Offer or Solicitation
This Current Report on Form 8-K shall not constitute an offer to sell or the
solicitation of an offer to buy any securities, nor shall there be any sale of
securities in any jurisdiction in which such offer, solicitation or sale would
be unlawful prior to registration or qualification under the securities laws of
any such jurisdiction. No offering of securities shall be made except by means
of a prospectus meeting the requirements of Section 10 of the Securities Act of
1933, as amended. Subject to certain exceptions to be approved by the relevant
regulators or certain facts to be ascertained, a public offer will not be made
directly or indirectly, in or into any jurisdiction where to do so would
constitute a violation of the laws of such jurisdiction, or by use of the mails
or by any means or instrumentality (including without limitation, facsimile
transmission, telephone or internet) of interstate or foreign commerce, or any
facility of a national securities exchange, of any such jurisdiction.
Participants in the Solicitation
Sesen Bio and Carisma Therapeutics and their respective directors, executive
officers and other members of management may be deemed to be participants in the
solicitation of proxies in respect of the proposed transaction. Information
about Sesen Bio's directors and executive officers is available in Sesen Bio's
Annual Report on Form 10-K for the fiscal year ended December 31, 2021, its
definitive proxy statement dated April 28, 2022 for its 2022 Annual Meeting of
Stockholders and its Current Report on Form 8-K filed with the SEC on August 31,
2022. Other information regarding the participants in the proxy solicitation and
a description of their interests in the proposed transaction, by security
holdings or otherwise, is included in the definitive Proxy Statement/Prospectus
and other relevant materials that are or will be filed with the SEC regarding
the proposed transaction. Investors should read the definitive Proxy
Statement/Prospectus carefully before making any voting or investment decisions.
You may obtain free copies of these documents from Sesen Bio or the SEC's
website as indicated above.
Item 9.01 - Financial Statements and Exhibits.
(d) Exhibits.
99.1 Carisma Press Release dated January 31, 2023
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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