Azelaprag

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

Plus, news about Vigonvita Life Sciences and Lutris Pharma: For MASH developers, a race for cash: Akero Therapeutics aims to raise $300 million in an offering that was announced the same day it disclosed new mid-stage data for the drug it’s developing to treat severe forms of the liver disease. 89bio, which has a MASH candidate in Phase 3, also announced an offering on Monday, saying it plans to sell shares to raise $250 million. — Jaimy Lee BioAge officially drops Phase 2 obesity drug: The Richmond, CA-based biotech terminated development of azelaprag, the oral small molecule APJ agonist licensed from Amgen, after liver concerns forced it to stop a trial last month. The biotech has other APJ agonists in preclinical development, and it plans to soon send an NLRP3 inhibitor into the clinic. It anticipates having early Phase 1 single-ascending dose data by year’s end. The startup also disclosed a Lilly ExploR&D collaboration for two antibodies for “metabolic aging targets” found using BioAge’s discovery platform. Terms of the deal were not disclosed. — Kyle LaHucik Another HKEX IPO filing: A Chinese biopharma called Vigonvita Life Sciences has filed to go public on the Hong Kong Stock Exchange. The Suzhou-based drug developer has an approved Covid-19 treatment in China and Uzbekistan, plus a pipeline of candidates for RSV, depression, epilepsy, schizophrenia and other indications. — Kyle LaHucik Israeli biotech gets $30M: Lutris Pharma said the funding will help it test a topical gel that aims to reduce EGFRi-induced rashes caused by certain cancer drugs. Columbus Venture Partners, Pontifax Venture Capital, Peregrine Ventures and aMoon Fund backed the Tel Aviv-based startup, which expects to have topline Phase 2 results in the first half of this year. — Kyle LaHucik