Full Press Release Details
Carisma Therapeutics and OrthoCellix Enter into
Definitive Merger Agreement to Create Company Focused on Regenerative Cell Therapies for Orthopedic Diseases
PHILADELPHIA, PA and MALVERN, PA. June 23, 2025 (Globe Newswire) --
Carisma Therapeutics Inc. (Nasdaq: CARM) (Carisma) and OrthoCellix, Inc. (OrthoCellix), a wholly-owned subsidiary of Ocugen, Inc. (Nasdaq:
OCGN) (Ocugen), a clinical-stage company developing regenerative cell therapies for orthopedic diseases, today jointly announced that
they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus
on the development of OrthoCellix's NeoCart technology for the treatment of knee articular cartilage defects and plans to initiate
a U.S. Food and Drug Administration (FDA)-endorsed Phase 3 clinical trial for NeoCart .
"We believe merging OrthoCellix with Carisma will allow us to
create a publicly-traded company focused on the development of NeoCart and provide value for both Ocugen and Carisma stockholders
while unlocking true market potential of NeoCart ," said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-founder
of Ocugen. "We believe NeoCart has tremendous potential to deliver a truly transformative approach to cartilage repair, and
we've established OrthoCellix with dedicated resources to bring this revolutionary technology to the patients who desperately need
"Carisma evaluated a range of strategic alternatives, and we
believe this proposed transaction represents an opportunity to deliver significant value to our stockholders," said Steven Kelly,
President and Chief Executive Officer, of Carisma. "OrthoCellix is strongly positioned with its NeoCart platform, a dedication
to developing regenerative cell therapies, and a well-credentialed management team to lead the combined company."
About OrthoCellix's NeoCart Portfolio
OrthoCellix is developing NeoCart as an autologous cartilage implant
technology utilizing patient cells to repair articular cartilage defects of the knee. The novel platform merges a fortified 3D scaffold
and patented bioprocessing technology to grow chondrocytes-the cells responsible for maintaining cartilage health-to produce
adolescent-like cartilage at the time of implant. NeoCart has the potential to accelerate healing and reduce pain by creating a similar,
functional joint surface to help patients return to normal activities and prevent complications associated with articular cartilage damage.
OrthoCellix anticipates launching its Phase 3 clinical trial by the
end of 2025. Previously, NeoCart received Regenerative Medicine Advanced Therapy (RMAT) designation and concurrence from the FDA
on a single, confirmatory Phase 3 clinical trial to enable submission of a Biologics License Application.
About the Proposed Transactions
Under the terms of the merger agreement, OrthoCellix will merge
with and into a wholly-owned subsidiary of Carisma, with OrthoCellix continuing as a wholly-owned subsidiary of Carisma and the
surviving company of the Merger. Carisma will issue to the pre-merger OrthoCellix stockholder shares of Carisma common stock as
merger consideration in exchange for the cancellation of shares of capital stock of OrthoCellix. Carisma also expects to enter into
subscription agreements for a private financing with Ocugen and other select investors, which is expected to close concurrently with
the completion of the merger, to enable the combined company to complete the Phase 3 trial of NeoCart without any additional
cost or investment from Ocugen. In connection with the closing of the proposed transactions, Carisma stockholders will be issued
contingent value rights representing the right to receive certain payments from proceeds received by the combined company, if any,
related to Carisma's pre-transaction legacy assets.
Under the terms of the merger agreement, upon the closing of the proposed
transactions and after giving effect to the contemplated $25.0 million concurrent financing, OrthoCellix's stockholder and the other
participants in the concurrent financing are expected to own approximately 90% of the combined company, and existing Carisma stockholders
are expected to own approximately 10% of the combined company, each on a fully diluted basis. The percentage of the combined company that
each company's former stockholders will own after completion of the merger is subject to adjustment based on Carisma's net
cash at the closing and the proceeds from the concurrent financing, among other adjustments, in each case as described in the merger agreement.
Upon the closing of the proposed transactions, "Carisma Therapeutics
Inc." is expected to be renamed "OrthoCellix, Inc." and trade on the Nasdaq Capital Market under the ticker symbol OCLX.'
The transaction has been unanimously approved by the board of directors
of both companies and is expected to close in the second half of 2025, subject to customary closing conditions, including approvals by
the stockholders of each company and the effectiveness of a registration statement to be filed with the Securities and Exchange Commission
(the "SEC") to register the shares of Carisma common stock to be issued in connection with the merger. In connection with
the companies' entry into the merger agreement, directors and officers of Carisma and OrthoCellix's stockholder have executed
support agreements, pursuant to which they have agreed to vote all of their shares of capital stock in favor of the merger or the issuance
of Carisma equity in the merger, as applicable.
Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal counsel
to Carisma and Lucid Capital Markets, LLC is providing a fairness opinion to Carisma's board of directors. Chardan is serving as
M&A advisor and co-placement agent to OrthoCellix and Ocugen. Lake Street Capital Markets, LLC is co-placement agent to OrthoCellix,
as a subsidiary of Ocugen, Goodwin Procter LLP is serving as legal counsel to Ocugen and OrthoCellix, and Paul Hastings LLP is serving
as legal counsel to the placement agents.
OrthoCellix is a regenerative cell therapy company dedicated to
developing a first-in-class technology platform focused on cartilage defects and other orthopedic diseases to address considerable
unmet medical needs. The lead program within OrthoCellix is NeoCart with revolutionary 3D cell therapy technology designed to
repair and restore articular cartilage defects in the knee. The Company has a pipeline of additional treatments based on its
proprietary scaffold bioreactor and adhesive. OrthoCellix will utilize the Good Manufacturing Practice facility established by
Ocugen to support OrthoCellix's initial development of NeoCart .
About Carisma Therapeutics
Carisma Therapeutics is a biotechnology company pioneering macrophage
engineering to develop groundbreaking therapies for fibrosis and cancer. With a strong commitment to patient-centric innovation, Carisma
aims to deliver scalable, next-generation solutions that transform treatment paradigms. Carisma is headquartered in Philadelphia, PA.
For more information, please visit www.Carismatx.com.
Cautionary Note on Forward- Looking Statements
Certain statements in this communication, other than purely
historical information, may constitute "forward-looking statements" within the meaning of the federal securities laws,
including for purposes of the "safe harbor" provisions under the Private Securities Litigation Reform Act of 1995,
concerning Carisma, OrthoCellix, the proposed financing and the proposed merger between Carisma and OrthoCellix (collectively, the
"Proposed Transactions") and other matters. These forward-looking statements include, but are not limited to, express or
implied statements relating to Carisma's and OrthoCellix's management teams' expectations, hopes, beliefs,
intentions or strategies regarding the future including, without limitation, statements regarding: the structure, timing and
completion of the proposed merger by and between Carisma and OrthoCellix; the Proposed Transactions and the expected effects,
perceived benefits or opportunities of the Proposed Transactions; the combined company's listing on Nasdaq after the closing
of the Proposed Transactions; expectations regarding the structure, timing and completion of a concurrent financing, including
investment amounts from investors, timing of closing of the Proposed Transactions, expected proceeds, expectations regarding the use
of proceeds, and impact on ownership structure; the anticipated timing of the closing; the expected executive officers and directors
of the combined company; each company's and the combined company's expected cash position at the closing and cash runway
of the combined company following the proposed merger and any private financing; the future operations of the combined company,
including research and development activities; the nature, strategy and focus of the combined company; the development and
commercial potential and potential benefits of any product candidates of the combined company, including expectations around market
exclusivity and intellectual property protection; anticipated clinical drug development activities and related timelines, including
the expected timing for announcement of data and other clinical results; expectations regarding or plans for discovery, preclinical
studies, clinical trials and research and development programs, in particular with respect to NeoCart , and any developments or
results in connection therewith, including the target product profile of NeoCart ; the anticipated timing of the commencement of
and results from those studies and trials; the sufficiency of post-transaction resources to support the advancement of
OrthoCellix's pipeline through certain milestones and the time period over which OrthoCellix's post-transaction capital
resources will be sufficient to fund its anticipated operations; the cash balance of the combined entity at closing; expectations
related to the anticipated timing of the closing of the Proposed Transactions (the "Closing"); the expectations
regarding the ownership structure of the combined company; the expected trading of the combined company's stock on Nasdaq
under the ticker symbol "OCLX" after the Closing; and other statements that are not historical fact. All statements
other than statements of historical fact contained in this communication are forward-looking statements. In addition, any statements
that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying
assumptions, are forward-looking statements. The words "opportunity," "potential," "milestones,"
"pipeline," "can," "goal," "strategy," "target,"
"anticipate," "achieve," "believe," "contemplate," "continue,"
"could," "estimate," "expect," "intends," "may," "plan,"