ME Therapeutics Scientific and Corporate Update

VANCOUVER, British Columbia--(BUSINESS WIRE)--ME Therapeutics Holdings Inc. (“ME Therapeutics” or the “Company”) (CSE: METX) (FSE: Q9T), a publicly listed biotechnology company working on novel cancer fighting drugs that reprogram and redirect immune cells to fight cancer, is pleased to provide a corporate update and an outline of its strategic positioning within the rapidly emerging in vivo immune cell engineering and chimeric antigen receptor (CAR) space.

ME Therapeutics continues to focus its attention to scientifically validated cancer targets to develop a diverse pipeline of drug candidates to move into clinical testing. Our pipeline candidates include therapeutic mRNAs designed to promote an anti-cancer immune response in cancers such as microsatellite stable (MSS) metastatic colorectal cancer that is currently untreatable with immunotherapy. Our lead therapeutic mRNA activates an important, scientifically validated target called STING (Stimulator of Interferon Genes), specifically in the tumor microenvironment. In a preclinical colorectal cancer model, our STING activator leads to the specific recruitment of immune cells into the tumor and significantly reduces tumor growth. Importantly, our data suggests that a single dose of our STING activator can synergize with a PD-1 checkpoint inhibitor where the PD-1 inhibitor is ineffective on its own. This could mean that providing our STING activator may unlock the efficacy of checkpoint inhibitors in otherwise unresponsive tumors. In addition, we believe this candidate may solve some of the past roadblocks observed with drugs targeting STING through the targeted delivery into myeloid cells in the tumor microenvironment which could reduce systemic side effects.

The Company is also continuing to make significant progress advancing its in vivo CAR pipeline. Traditional CAR-T therapies (currently approved for blood cancers) rely on an ex vivo process. This requires harvesting a patient’s T-cells, shipping them to a lab, genetically modifying them, and shipping them back for re-infusion. While highly effective, this process is costly, slow, and complex. In vivo CAR therapy bypasses these logistical hurdles by delivering the genetic instructions directly into the patient. The patient’s body becomes the factory, engineering its own immune cells to fight cancer. This approach offers the potential for "off-the-shelf" availability, reduced costs, and broader accessibility. Recently, the investment community has recognized in vivo delivery as the next frontier in biotech and ME Therapeutics believes that targeting both myeloid cells and T cells with a single in vivo CAR may enhance efficacy of CAR therapy in solid tumors making it even more broadly applicable. Our pipeline includes an in vivo CAR using our recently licensed CD22 nanobody asset, a CAR targeting a validated protein expressed in the tumor microenvironment in most solid tumors, and a potentially universal CAR that may be used to target any cancer protein with existing antibodies. The Company has made progress optimizing its CAR constructs to be functional in both myeloid cells and T cells to potentially enhance efficacy in solid tumors by reprogramming both cell types. Testing has shown that our CARs function effectively for myeloid cell based killing of tumor cells and that the same CARs can lead to T cell activation. Our plan is to initiate in vivo testing of our optimized CARs using validated lipid nanoparticle (LNP) delivery systems in mouse cancer models in the coming weeks.

Finally, the Company has been exploring the possible use of its lead antibody candidate targeting G-CSF to overcome resistance to current VEGF-inhibitors as there has been renewed interest in VEGF as a target in immunotherapy due to the recent success of bi-specific antibodies targeting PD-1 and VEGF.

To unlock additional value for existing shareholders, ME Therapeutics is continuing to work with Luckosky Brookman LLP in pursuit of a potential listing on either the Nasdaq Capital Market or New York Stock Exchange American (NYSE) and has met with several specialized investment banks to potentially assist in the process. The Company continues to assess the necessary steps for uplisting and will work to meet the financial and regulatory requirements for approval. However, there is no guarantee that the Company will satisfy the criteria, that an application will be accepted or as to the timing for completion of any of these steps.

"The excitement we are starting to see in the market for immune reprograming in vivo is not just a trend—it is the necessary evolution of cancer care. By combining our deep expertise in the immune system with advanced LNP delivery from worldclass partners and validated targets such as CD22, ME Therapeutics is building a platform capable of reshaping the tumor microenvironment and democratizing cell therapy.” – Salim Dhanji, PhD, CEO.

About ME Therapeutics

Myeloid Enhancement (ME) Therapeutics is a publicly listed biotechnology company based in Vancouver focused on developing novel therapeutics designed to reprogramme immune cells in vivo to reshape the tumor microenvironment and to directly recognize and kill cancer cells. For more information, visit metherapeutics.com.

Neither the Canadian Securities Exchange nor any Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Statement Regarding Forward-Looking Statements

This news release includes certain “forward-looking statements” under applicable Canadian securities legislation. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements in this news release include, but are not limited to, statements regarding the Company’s patent protection, research plans, the intended outcomes of the research, the intended benefits and applications of the Company’s technology, the Company’s plans for development of its business, plans for potential first-in-human clinical trials, opportunities to explore earlier stage drug discovery and to enhance the Company’s drug pipeline, its reliance on third-party collaborators, regarding potential in-licensing and partnership opportunities, the Company’s plan for pursuing a U.S. listing and the projected benefits to shareholders, and as to the timing for the various plans set out in this news release. Such statements are subject to risks and uncertainties that may cause actual results, performance or developments to differ materially from those contained in the statements, including risks related to factors beyond the control of the Company, that the results of the testing are not favorable or consistent with results to date, G-CSF proves to be an unsuitable target to treat cancer, that the Company’s mRNA or in vivo CAR candidates prove ineffective during testing, that the Company’s business may not develop as set out in this news release, that the Company does not proceed with human clinical trials or that the results of such trials, if any, are not favorable, that the Company does not acquire the necessary regulatory approvals, that the Company does not complete any licensing or partnership agreements or that if such agreements are completed that the terms may not be favorable to the Company, that the Company does not have sufficient funds to advance its business plan, that the research is not completed within the projected timelines, that a U.S. listing is not obtained, and such other risks described in the Company’s public disclosure and risks which are inherent to businesses of this nature. No assurance can be given that any of the events anticipated by the forward-looking statements will occur or, if they do occur, what benefits the Company will obtain from them. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ from forward-looking statements. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.