A class action lawsuit was filed against BioAge Labs, Inc. (BIOA) by Levi & Korsinsky on January 7, 2025. The plaintiffs (shareholders) alleged that they bought BIOA stock pursuant and/or traceable to a registration statement for its initial public offering (IPO) held on or about September 26, 2024, and are now seeking compensation for their financial losses. Investors who bought BioAge stock during that period can click here to learn about joining the lawsuit.
BioAge is a clinical-stage biopharmaceutical company is engaged in developing novel therapies for metabolic diseases and conditions driven by neuroinflammation.
The company’s tall claims about the potential efficacy and commercial prospects of its lead drug candidate Azelaprag, are at the heart of the current complaint. Azelaprag is an apelin receptor (APJ) agonist that increases weight loss and improves body composition in combination with incretin drugs. BioAge had mentioned in its IPO documents that it was conducting STRIDES clinical trials in collaboration with Eli Lilly and Co. (LLY).
BioAge Labs’ Misleading Claims
According to the lawsuit, BioAge, three of its senior officers and/or executives, and seven of its directors (Individual Defendants) repeatedly made false and misleading public statements in the registration statement. Particularly, they are accused that the registration statement was false and misleading at the time of the IPO because BioAge failed to disclose “the potential for liver transaminitis in any of its previous clinical Phase 1 trials and various preclinical tox studies.”
For instance, in the final prospectus, the company noted that Azelaprag had demonstrated good tolerance in 265 individuals across eight Phase 1 clinical trials. Additionally, in preclinical obesity models, the drug showed the ability to more than double the weight loss induced by a glucagon-like-peptide-1 receptor (GLP-1R) agonist. At the same time, the drug helped in restoring healthy body composition and improving muscle function.
Furthermore, the company stated that it planned to conduct two Phase 2 clinical trials to assess the potential impact from Azelaprag in significantly improving weight loss when combined with a GLP-1R agonist. It also added that the results from the preclinical trials must not be considered as predictive of the final results from late-stage trials.
The company added that the goal of the clinical trials was to access the weight loss potential. The primary endpoint was expected to be weight loss at 24 weeks. Plus, exploratory endpoints were changes in body composition and glucose control.
Notably, subsequent events (discussed below) revealed that the defendants wilfully misled investors about the potential efficacy of Azelaprag and expected results from the Phase 2 clinical trials.
Plaintiffs’ Arguments
The plaintiffs maintain that the Defendants deceived investors by preparing wrongful registration statement in connection to the IPO process. Accordingly, it contained untrue statements of critical facts but lacked corrective statements and legally required disclosures. Importantly, the company failed to disclose “the potential for liver transaminitis in any of its previous clinical Phase 1 trials and various preclinical tox studies.”
The information became clear on December 6, 2024, when BioAge announced that it was discontinuing the ongoing Phase 2 STRIDES studies of its lead product candidate Azelaprag. This was because the company observed liver transaminitis in some subjects receiving the drug. Following the news, BIOA stock collapsed over 76%, causing massive damage to shareholders’ returns.
