• Potential acquisition of VyGen-Bio would strengthen Coeptis' oncology pipeline by obtaining exclusive, worldwide ownership rights to GEAR™ Platform and companion diagnostic technologies

WEXFORD, Pa., March 29, 2023 /PRNewswire/ -- Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, announced it has obtained the exclusive right to negotiate towards the acquisition of VyGen-Bio, Inc. or its assets. Coeptis intends to immediately commence its due diligence review of VyGen-Bio's assets, including its IP and knowhow related to rights to GEAR™ cell therapy and companion diagnostic platforms, and, depending on the results of its due diligence analysis, turn to negotiation of definitive deal documents. VyGen-Bio's product candidates and platforms were discovered by scientists at the world-renowned Karolinska Institutet in Stockholm, Sweden, including Dr. Arnika Wagner, who is expected to play a key collaborative development role for Coeptis as the Company builds its capabilities to develop treatments for cancer and gains technologies to develop additional cell and gene therapies. 

This transaction, if finalized, would expand upon Coeptis' collaboration with VyGen-Bio, which is currently focused on CD38-GEAR-NK, a natural killer (NK) cell therapy for the treatment of CD38+ cancers with an initial focus on multiple myeloma, and CD38-Diagnostic, an in vitro diagnostic tool being developed to help identify cancer patients who may be appropriate candidates for anti-CD38 mAb therapy.

In the event a transaction is consummated, Coeptis would then be in a position to advance the development of various GEAR-engineered cells, including NK cells, T cells, and hematopoietic stem cells, and to pursue development of GEAR-engineered cells for use in combination with mAbs that target a potentially wide range of receptor targets. Additional development options that would be explored could include therapeutic modalities where the antigen-specificity of mAbs is used, such as CAR-T and bispecific antibodies for the treatment of a broad range of hematologic malignancies and solid tumors.

"We believe that the acquisition of VyGen-Bio's GEAR Platform would represent a significant inflection point in the growth of Coeptis and our strategy to be a leader in the development of 'next generation' cell therapy technologies for cancer and other diseases," said Dave Mehalick, President and CEO of Coeptis Therapeutics. "Our vision for GEAR is bold and ambitious, as we believe this novel cell engineering approach protects the integrity, fitness and function of the cell while importantly shielding it from destruction by co-administered mAbs. We believe the GEAR platform offers the potential to not only improve existing cancer therapies, but further expand the use of existing therapies in new indications."

"If we are able to successfully consummate an acquisition transaction, we plan to initially focus on advancing the first GEAR candidate, CD38-GEAR-NK, to the clinic for the treatment of multiple myeloma and to concurrently engage in business development activities to expand the GEAR Platform into new cell therapy products via potential co-development and/or licensing partnerships," Mehalick added.

GEAR was discovered by scientists at the Karolinska Institutet (KI), including Evren Alici M.D., Ph.D., Hans-Gustaf Ljunggren M.D., Ph.D., and Arnika Kathleen Wagner Ph.D. Drs. Alici, Ljunggren, and Wagner are founding members of VyGen-Bio and will continue to contribute in the development of the technology platforms as members of Coeptis' Scientific Advisory Board. Drs. Ljunggren and Alici are managing directors of NextGenNK, an international Competence Center for the development of next-generation NK cell-based cancer immunotherapies based at KI and funded by Sweden's innovations agency, Vinnova. KI is globally recognized for its Nobel Assembly, which awards the Nobel Prize in Physiology or Medicine.

"GEAR-NK cells, and ultimately all GEAR-engineered cells, are being designed to potentially decrease side-effects associated with certain mAb therapies and potentially reduce or eliminate the 'on-target-off-tumor' effect. As a Coeptis' SAB member, I look forward to collaborating in the development of these technologies, which may have widespread applicability in cancer and beyond," stated GEAR co-inventor, Dr. Wagner.

About Coeptis Therapeutics Holdings, Inc.

Coeptis Therapeutics Holdings, Inc., together with its subsidiaries including Coeptis Therapeutics, Inc. and Coeptis Pharmaceuticals, Inc., (collectively "Coeptis"), is a biopharmaceutical company developing innovative cell therapy platforms for cancer that have the potential to disrupt conventional treatment paradigms and improve patient outcomes. Coeptis' product portfolio and rights are highlighted by a universal, multi-antigen CAR T technology licensed from the University of Pittsburgh (SNAP-CAR), and a cell therapy technology (CD38-GEAR-NK) and an in vitro diagnostic (CD38-Diagnostic) targeting CD38-related cancers, which Coeptis is developing with VyGen-Bio and leading medical researchers at the Karolinska Institutet. Coeptis' business model is designed around maximizing the value of its current product portfolio and rights through in-license agreements, out-license agreements and co-development relationships, as well as entering into strategic partnerships to expand its product rights and offerings, specifically those targeting cancer. The Company is headquartered in Wexford, PA. For more information on Coeptis visit https://coeptistx.com/.

About VyGen-Bio™, Inc.

VyGen-Bio is a discovery-stage, cell-based immunotherapy company focused on the development of potentially transformational technology platforms. GEAR-NK is a modified NK cell-based therapeutic being designed to be co-administered with targeted antibodies. The Company is also developing companion diagnostics designed to potentially identify patient populations that may be most likely to benefit from targeted antibody therapies. Headquartered in Tampa, Florida on the campus of the H. Lee Moffitt Cancer Center, VyGen-Bio is a majority-owned subsidiary of Vycellix, Inc. (www.Vycellix.com). The Company's platforms were discovered by scientists at Karolinska Institutet (KI), Stockholm, Sweden that collaborate with VyGen-Bio. Additionally, VyGen-Bio is a Partner in "NextGenNK", an international Competence Center for the development of next-generation NK cell-based cancer immunotherapies based at KI and funded by Sweden's innovations agency, Vinnova. KI is globally recognized for its Nobel Assembly, which awards the Nobel Prize in Physiology or Medicine.

Cautionary Note Regarding Forward-Looking Statements 

This press release and statements of our management made in connection therewith contain or may contain "forward-looking statements" (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). Forward-looking statements include statements concerning our plans, objectives, goals, strategies, future events or performance, and underlying assumptions, and other statements that are other than statements of historical facts. When we use words such as "may," "will," "intend," "should," "believe," "expect," "anticipate," "project," "estimate" or similar expressions that do not relate solely to historical matters, we are making forward-looking statements. Forward-looking statements are not a guarantee of future performance and involve significant risks and uncertainties that may cause the actual results to differ materially and perhaps substantially from our expectations discussed in the forward-looking statements. Factors that may cause such differences include but are not limited to: (1) the inability to maintain the listing of the Company's securities on the Nasdaq Global Market following the business combination; (2) the risk that the business combination disrupts current plans and operations of Company as a result of the consummation of the business combination; (3) the inability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of the Company to grow and manage growth economically and hire and retain key employees; (4) the risks that the Company's products in development fail clinical trials or are not approved by the U.S. Food and Drug Administration or other applicable regulatory authorities; (5) costs related to the business combination; (6) changes in applicable laws or regulations; (7) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; and (8) the impact of the global COVID-19 pandemic on any of the foregoing risks and other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission (the "SEC"). The foregoing list of factors is not exclusive. All forward-looking statements are subject to significant uncertainties and risks including, but not limited, to those risks contained or to be contained in reports and other filings filed by the Company with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings made or to be made with the SEC, which are available for review at www.sec.gov. We undertake no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof unless required by applicable laws, regulations, or rules.

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