BioAge Expands APJ Agonist Pipeline with Oral Small-Molecule and Long-Acting Biologic Candidates

Company enters option agreement with JiKang Therapeutics to in-license novel APJ agonist antibody

New composition of matter IP filed for chemically distinct, orally active, and highly potent small molecule APJ agonists

EMERYVILLE, Calif., June 03, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", "the Company"), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced advances in its apelin receptor (APJ) agonist programs that strengthen the Company's pipeline of approaches for obesity and other indications. BioAge has entered into an option agreement with JiKang Therapeutics ("JiKang") to potentially in-license a novel APJ agonist nanobody. BioAge has also filed a provisional patent application covering internally developed, novel small molecule APJ agonists.

Apelin is an exercise-induced signaling molecule, known as an exerkine, which has been shown in preclinical studies to recapitulate many of the downstream benefits of exercise. BioAge identified apelin signaling as a therapeutic target based on analysis of human aging cohorts by the Company's platform, which revealed that higher levels of circulating apelin are predictive of both improved physical function and increased longevity. BioAge has shown that in preclinical obesity models, APJ agonism can approximately double the weight loss induced by GLP-1 receptor agonists while restoring healthy body composition and improving muscle function, suggesting that APJ agonists could serve as pharmacological exercise mimetics to enhance incretin therapy.

The Company plans to advance APJ agonists designed for both oral and subcutaneous administration in order to serve both segments of the obesity market, with the goal of filing an Investigational New Drug (IND) application for an asset from its APJ program in 2026.

"Apelin is a key target in metabolic aging, and we're happy to share significant updates on BioAge's next-generation approaches to APJ agonism," said Kristen Fortney, PhD, CEO and co-founder of BioAge. "Our preclinical data show that APJ agonism can amplify GLP-1–driven weight loss; by developing a long-acting injectable and an all-oral combination option in parallel, we aim to match diverse dosing preferences while driving greater efficacy and better body-composition outcomes."

Option Agreement with JiKang for Novel APJ Agonist Antibody

BioAge has secured an option to license JiKang Therapeutics' novel APJ-agonist nanobody, a single-domain antibody with potential applications in metabolic disease treatment. The nanobody developed by JiKang demonstrates exceptional pharmacological properties: at least 10-fold more potent than apelin, the natural ligand of APJ, with half maximal effective concentration (EC50) comparable to best-in-class small molecule APJ agonists.

JiKang is a biotechnology company specializing in targeting G protein–coupled receptors (GPCRs) for weight loss and metabolic diseases. JiKang was founded by Fei Xu, PhD, whose research group has pioneered foundational research on APJ structure and function at ShanghaiTech University for over a decade. "This collaboration with BioAge marks a critical step toward translating our APJ program from bench research to clinical applications," said Xu. "We are committed to advancing this innovative therapeutic candidate for patients worldwide."

Under the terms of the agreement, BioAge and JiKang will jointly advance the APJ agonist nanobody to the beginning of IND-enabling studies. BioAge holds an exclusive, pre-negotiated option to license the program; if exercised, BioAge will be solely responsible for worldwide development and commercialization across all indications. JiKang will receive an upfront option payment and research funding at signing, and is eligible for an option-exercise fee plus further development, regulatory, and sales-based milestones and tiered royalties, all subject to customary regulatory approvals.

Expansion of Intellectual Property for Novel Small Molecule APJ Agonists

BioAge is rapidly advancing its internal small molecule APJ agonist program. In May 2025 the Company filed a U.S. provisional patent for a new class of orally active, chemically distinct apelin receptor agonists that deliver picomolar potency together with drug-like attributes: excellent pharmacokinetics, high solubility, and metabolic stability. The design of these novel leads was supported by computational modeling based on cryo-EM–based structural insights, rapid analog synthesis, and AI design initiatives.

About BioAge Labs, Inc.

BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The Company's lead product candidate, BGE-102, is a potent, orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed for obesity. BGE-102 has demonstrated significant weight loss in preclinical models both as monotherapy and in combination with GLP-1 receptor agonists. IND submission and initiation of a Phase 1 SAD/MAD trial are planned for mid-2025, with initial SAD data anticipated by end of year. The Company is also developing long-acting injectable and oral small molecule APJ agonists. BioAge's additional preclinical programs, which leverage insights from the Company's proprietary discovery platform built on human longevity data, address key pathways involved in metabolic aging.

About JiKang

JiKang Therapeutics is committed to establishing itself as a global pioneer in GPCR innovative biologics discovery. By integrating a world-class GPCR science team with experienced antibody development industry experts, the company transforms cutting-edge GPCR structural insights into clinical advancements, leveraging AI power. Notably, JiKang is backed by prominent partners including XtalPi (Stock Code: HK2228), a leading company in AI+robotics–driven drug and material discovery technology.

Forward-looking statements

This press release contains "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our plans to develop and commercialize our product candidates, including BGE-102 and our APJ program, the timing and results of our planned clinical trials, including the APJ nanobody developed with JiKang, risks associated with clinical trials, including our ability to adequately manage clinical activities, the timing of our IND filing for BGE-102 or our APJ program and our ability to obtain and maintain regulatory approvals, the clinical utility of our product candidates, and general economic, industry and market conditions. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "potential," "possible," "will," "would," and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop, obtain regulatory approval for and commercialize our product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions, including due to the imposition of tariffs and other trade barriers; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; changes in or failure to comply with legal and regulatory requirements, including shifting priorities within the U.S. Food and Drug Administration; risks relating to access to capital and credit markets; and the other risks and uncertainties that are detailed under the heading "Risk Factors" included in BioAge's Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on May 6, 2025, and BioAge's other filings with the SEC filed from time to time. BioAge undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.



Contacts

PR: Chris Patil, [email protected]

IR: Dov Goldstein, [email protected]

Partnering: [email protected]

Web: https://bioagelabs.com