ELAB PMGC Holdings Inc

Northstrive Biosciences Inc. ("Northstrive"), a subsidiary of PMGC Holdings Inc. (NASDAQ: ELAB) ("PMGC," "we," or "our"), announced an update for its innovative obesity treatment candidates, EL-22 and EL-32, both aimed at optimizing fat loss while preserving muscle mass in patients undergoing weight loss therapies, including GLP-1 receptor agonists.

EL-22: Preparing for FDA Pre-IND Meeting Request

Northstrive is finalizing preparations for a pre-Investigational New Drug ("pre-IND") meeting request with the U.S. Food and Drug Administration ("FDA"). Northstrive anticipates having a Type B pre-IND meeting with the FDA in the second quarter of 2025. Northstrive has completed necessary translations and compiled preclinical and clinical inquiries from existing data from its South Korean licensing partner to support the meeting request. Concurrently, Northstrive is seeking a U.S.-based Current Good Manufacturing Practices (cGMP) manufacturing partner for EL-22.

EL-22 is a novel, patent-pending engineered probiotic designed to express myostatin on its surface, targeting the validated myostatin pathway to support muscle health. Preclinical studies, including a 2022 publication in mdx mice (a model of Duchenne muscular dystrophy), demonstrated significant physiological and functional improvements. 1 EL-22 has also completed a Phase 1 clinical trial in South Korea, where it was shown to be generally well-tolerated and safe in healthy volunteers.

Upon regulatory confirmation, Northstrive aims to file the Investigational New Drug application in 2025 and thereafter initiate clinical trials to evaluate the combination of EL-22 with GLP-1 receptor agonists for obesity treatment.

EL-32: Engaged CRO for Preclinical Study

Northstrive has entered into a research agreement with a leading preclinical contract research organization (CRO) specializing in metabolic disorders. The research agreement will support a planned study to evaluate EL-32, an engineered probiotic expressing dual myostatin and activin-A inhibitors, both as a monotherapy and in combination with the GLP-1 receptor agonist semaglutide. The focus of the study will be on glycemic control and body composition in diet-induced obese (DIO) mice.

"We are laying the groundwork to move both programs forward as potential treatments for obesity," said Deniel Mero, Co-founder of Northstrive Biosciences. "The FDA has cleared other myostatin-based therapies to start clinical trials in combination with GLP-1 receptor agonists, which gives us confidence and a precedent to follow a similar path by leveraging existing data from our Korean licensing partner to accelerate our pre-IND process."

Upcoming Presentation

Northstrive will present its novel obesity drug candidates at the exclusive UCLA Obesity Symposium, "Anti-Obesity Treatments: Challenges and Emerging Solutions," organized by the UCLA Metabolism Theme, an initiative of the UCLA David Geffen School of Medicine. The presentation, titled "Myostatin-Engineered L. Casei Bacteria As A Muscle Preserving Therapeutic," is scheduled for Friday, February 7, 2025.

About Northstrive Biosciences

Northstrive Biosciences Inc., a PMGC Holdings Inc. company, is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines. Northstrive's lead asset, EL-22, is leveraging an engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists. For more information, please visit www.northstrivebio.com

About PMGC Holdings Inc.

PMGC Holdings Inc. is a diversified holding company that manages and grows its portfolio through strategic acquisitions, investments, and development across various industries. Currently, our portfolio consists of three wholly owned subsidiaries: Northstrive Biosciences Inc., PMGC Research Inc., and PMGC Capital LLC. We are committed to exploring opportunities in multiple sectors to maximize growth and value. For more information, please visit https://www.pmgcholdings.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “believes,” “expects,” “plans,” “potential,” “would” and “future” or similar expressions such as “look forward” are intended to identify forward-looking statements. Forward-looking statements are made as of the date of this press release and are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results. Therefore, you should not rely on any of these forward-looking statements. These and other risks are described more fully in PMGC Holdings’ filings with the United States Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, and its other documents subsequently filed with or furnished to the SEC. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

IR Contact:IR@pmgcholdings.com

1 Reference: Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J. A New Method of Myostatin Inhibition in Mice via Oral Administration of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int. J. Mol. Sci. 2022, 23, 9059. https://doi.org/10.3390/ijms23169059.