Northstrive sets FDA pre-IND meeting for obesity treatment

NEWPORT BEACH, Calif. - Northstrive Biosciences Inc., a subsidiary of PMGC Holdings Inc. (NASDAQ:ELAB), a micro-cap biotech company with a market capitalization of $2.91 million and impressive revenue growth of 112% in the last twelve months, has announced a scheduled pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) set for April 23, 2025. The meeting will focus on the development of EL-22, a novel treatment designed to preserve muscle mass during weight loss therapies, particularly in combination with GLP-1 receptor agonists.

EL-22 utilizes a myostatin-engineered probiotic approach, aiming to target a key pathway in muscle health. Preclinical studies, including a 2022 publication on mdx mice, have shown promising physiological and functional improvements. Additionally, EL-22 has completed a Phase 1 clinical trial in South Korea, demonstrating general safety and tolerability in healthy volunteers.

Deniel Mero, Co-founder of Northstrive Biosciences, expressed optimism about the upcoming FDA meeting, stating that it marks a significant step in advancing EL-22 as a potential breakthrough therapy for obesity. The company anticipates clear guidance from the FDA to proceed with human trials.

Post-meeting, Northstrive plans to file an IND application within 2025 and subsequently begin clinical trials to evaluate EL-22’s effectiveness in conjunction with GLP-1 receptor agonists for the treatment of obesity. According to InvestingPro analysis, while PMGC maintains strong gross profit margins of 71%, the company’s financial health score indicates challenges ahead as it rapidly burns through cash reserves.

Northstrive Biosciences focuses on developing advanced aesthetic medicines, with EL-22 being their lead asset. PMGC Holdings, Northstrive’s parent company, operates as a diversified holding company with interests across various industries, including biopharmaceuticals.

The press release includes forward-looking statements subject to risks and uncertainties. PMGC Holdings has outlined these risks in its filings with the Securities and Exchange Commission, cautioning that actual results may differ from those projected. While the company maintains a healthy current ratio of 3.86, InvestingPro data reveals 16 additional key insights about PMGC’s financial position and market performance, available to subscribers along with detailed Fair Value analysis and growth projections.

This article is based on a press release statement from PMGC Holdings Inc.

In other recent news, PMGC Holdings Inc. has announced a 1-for-7 reverse stock split to maintain compliance with Nasdaq’s minimum bid price requirement. This strategic move ensures the company retains its listing on The Nasdaq Capital Market. Additionally, PMGC Holdings has ended its License Agreement with INmune Bio, which involved the development and commercialization of INmune Bio’s EMx technology. The mutual termination means PMGC Holdings will no longer owe fees to INmune Bio, and the company is exploring other in-licensing opportunities.

Moreover, PMGC Holdings has raised $1.94 million through a warrant inducement agreement, as detailed in a recent SEC filing. Univest Securities, LLC acted as the financial advisor for this transaction, receiving a fee of 7% of the total proceeds. The company also announced an agreement with institutional investors to exercise Series A warrants, expected to generate an additional $1.9 million in gross proceeds. This transaction involves issuing new warrants, pending shareholder approval.

PMGC Holdings has also achieved full compliance with Nasdaq’s minimum bid price requirement, following a previous warning of non-compliance. As part of its rebranding strategy, the company has renamed two of its subsidiaries: Elevai Research Inc. is now PMGC Research Inc., and Elevai Biosciences, Inc. is now Northstrive Biosciences Inc. These developments reflect PMGC Holdings’ ongoing efforts to align its operations and maintain its market position.

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