Full Press Release Details
Carisma Therapeutics and OrthoCellix Enter into
Definitive Merger Agreement to Create Company Focused on Regenerative Cell Therapies for Orthopedic Diseases
- Proposed reverse merger with OrthoCellix, a wholly-owned subsidiary of Ocugen, to create Nasdaq-listed, late clinical-stage regenerative cell therapy company with a first-in-class technology platform, focused on orthopedic diseases
- OrthoCellix is developing the Phase 3-ready NeoCart as an autologous cartilage implant technology utilizing patient cells to repair articular cartilage defects of the knee
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 .
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 it."
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."
OrthoCellix's NeoCart Portfolio
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.
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
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
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
Capital Markets LLC 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.
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
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," "possible," "project,"
"should," "will," "would" and similar expressions (including the negatives of these terms or variations
of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.
These forward-looking statements are made based on current expectations, estimates, forecasts, and projections, as well as the beliefs