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BioAge Labs Announces Company Updates on APJ, NLRP3, and Platform Programs

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BioAge Labs announced significant updates to its clinical programs and platform development. The company has discontinued azelaprag development due to liver transaminitis observations in the STRIDES Phase 2 obesity trial, but is advancing next-generation APJ agonists with a development candidate expected by end of 2025.

The company nominated BGE-102, a brain-penetrant NLRP3 inhibitor, as a development candidate for neuroinflammation conditions, with Phase 1 SAD data expected by end of 2025. BioAge also expanded its discovery efforts through collaborations with Novartis (worth up to $550 million) and Lilly ExploR&D for antibody therapeutics development.

Financially, BioAge reported $334.5 million in cash and equivalents as of September 30, 2024, plus $27.6 million from IPO greenshoe exercise, extending runway beyond 2029.

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Positive

  • Strong cash position of $362.1M (including greenshoe proceeds) extending runway beyond 2029
  • Secured Novartis collaboration worth up to $550M in payments and milestones
  • Nominated BGE-102 as development candidate with potential best-in-class features
  • New strategic collaboration with Lilly ExploR&D for antibody therapeutics

Negative

  • Discontinuation of azelaprag due to liver safety concerns in Phase 2 trial
  • Delay in APJ program with new candidate nomination pushed to end of 2025

News Market Reaction

-1.12%
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-1.12% News Effect

On the day this news was published, BIOA declined 1.12%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Advancement of next-generation APJ agonists with discontinuation of azelaprag

Nomination of NLRP3 inhibitor BGE-102 as a development candidate, with initial Ph1 clinical data anticipated by end of 2025

Expansion of discovery efforts based on insights from BioAge’s platform, including a target identification collaboration with Novartis and a newly announced antibody therapeutics development collaboration with Lilly ExploR&D

RICHMOND, Calif., Jan. 28, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", “the Company”), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced company updates for its programs and platform.

• Advancement of next-generation APJ agonists with discontinuation of azelaprag

BioAge has terminated development of azelaprag, an orally available small molecule agonist of APJ, for obesity and other chronic diseases. The decision follows observations of liver transaminitis without clinically significant symptoms, and without clear dose dependence, in some patients in the azelaprag arms of the STRIDES Phase 2 clinical trial for obesity (link).

BioAge is developing structurally distinct APJ agonists in its pipeline, with the goal of nominating a development candidate by the end of 2025.

• Nomination of NLRP3 inhibitor BGE-102 as a development candidate, with initial Ph1 clinical data anticipated by end of 2025

BioAge is developing its novel, proprietary class of NLRP3 inhibitors, which have distinctive structural and biological properties and include molecules that penetrate the blood–brain barrier, for diseases associated with neuroinflammation. The Company has nominated a member of this class, the orally available, small-molecule brain-penetrant NLRP3 inhibitor BGE-102, as a development candidate. The structurally novel drug has potential best-in-class features, including high potency and high brain penetration, an important attribute for a compound that could be used for treatment of neuroinflammation linked to conditions such as obesity. IND-enabling experiments for BGE-102 are currently underway, and Phase 1 SAD data are anticipated by the end of 2025.

• Expansion of discovery efforts based on novel insights from BioAge’s platform, including collaborations with Novartis and Lilly

BioAge continues to leverage its discovery platform, which analyzes longitudinal human aging data to reveal the key molecular drivers of healthy aging to discover novel targets and molecules, via internal development programs and ongoing strategic collaborations.

In December, BioAge announced a multi-year research collaboration with Novartis to identify and validate novel therapeutic targets at the intersection of aging biology and exercise, combining BioAge's longitudinal human aging datasets with Novartis expertise in exercise biology. Under the terms of the agreement, BioAge will receive up to $20 million in upfront payments and research funding, plus up to $530 million in future long-term research, development, and commercial milestones (link).

BioAge has also entered a strategic collaboration with Lilly ExploR&D (part of Lilly Catalyze360) to discover two therapeutic antibodies that address novel metabolic aging targets identified by BioAge's discovery platform.

• Financial update

As of September 30, 2024, BioAge had approximately $334.5 million in cash and cash equivalents. This amount is not inclusive of the additional $27.6 million net fees from the exercise of the IPO’s greenshoe option on October 1, 2024. Existing cash and cash equivalents extend cash runway beyond 2029.

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 pipeline includes novel, orally available, brain-penetrant small-molecule NLRP3 inhibitors to treat metabolic diseases and conditions driven by neuroinflammation, as well as novel, structurally differentiated APJ agonists for metabolic disorders. 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.

Forward-looking statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." These statements include, but are not limited to, statements relating to anticipated preclinical and clinical development activities, timing of announcements of clinical results, trial initiation, and regulatory filings, potential benefits of the Company’s other product candidates and platform, the potential and timing of future milestone payments under the agreement with Novartis, and the current expected cash runway. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: BioAge’s ability to advance its product candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the Company’s ability to protect intellectual property, the Company’s commercial collaborations with third parties, the potential impact of global business or macroeconomic conditions, and the sufficiency of BioAge’s cash, cash equivalents and investments to fund its operations, and other factors discussed under the heading "Risk Factors" section of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and other documents BioAge files from time to time with the Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of BioAge's management team and speak only as of the date hereof, and BioAge specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts
PR: Chris Patil, media@bioagelabs.com 
IR: Dov Goldstein, ir@bioagelabs.com 
Partnering: partnering@bioagelabs.com 
Web: https://bioagelabs.com 


FAQ

Why did BioAge Labs discontinue azelaprag development in 2025?

BioAge Labs discontinued azelaprag development due to observations of liver transaminitis in some patients during the STRIDES Phase 2 clinical trial for obesity, although these symptoms were not clinically significant or clearly dose-dependent.

What is BioAge's BGE-102 and when will clinical data be available?

BGE-102 is a brain-penetrant NLRP3 inhibitor nominated as a development candidate for neuroinflammation conditions. Initial Phase 1 SAD clinical data is anticipated by the end of 2025.

How much is BioAge's collaboration with Novartis worth?

The Novartis collaboration is worth up to $550 million, including $20 million in upfront payments and research funding, plus up to $530 million in future milestones.

What is BioAge's current cash runway as of 2024?

BioAge has $362.1 million in cash and equivalents ($334.5M plus $27.6M from IPO greenshoe), extending their cash runway beyond 2029.
BioAge Labs Inc.

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