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 ( ...

IND submission planned for mid-2025 with Phase 1 SAD data anticipated by year end BGE-102 induced weight loss in preclinical obesity models, both as monotherapy and in combination with GLP-1 receptor agonistsInternally discovered compound has a novel binding site and potential best-in-class profile supporting once daily dosing EMERYVILLE, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", "the Company"), a clinical-stage biotechnology company developing therapeutic product candidates for ...

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against BioAge Labs, Inc. due to a class action complaint related to the company's IPO and alleged breaches of fiduciary duties by its board of directors [1] Group 1: Legal Investigation - A class action complaint was filed against BioAge on January 7, 2024, concerning its registration statement for the IPO held on September 26, 2024 [1] - The investigation focuses on whether BioAge's board of directors has breached their fiduciary duties to the company [1] Group 2: Product and Market Impact - On December 6, 2024, BioAge announced the discontinuation of the STRIDES Phase 2 trial for its lead product candidate, azelaprag, due to safety concerns related to elevated liver transaminase levels [2] - This announcement was unexpected, as BioAge had previously highlighted azelaprag's potential in patients undergoing obesity therapy with incretin drugs during its IPO [2] Group 3: Stock Price Reaction - Following the announcement regarding the discontinuation of the trial, BioAge's stock price fell significantly from $20.09 per share on December 6, 2024, to $4.65 per share on December 7, 2024 [3]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 Delaware 47-4721157 ( State or other jurisdiction of incorporation or organization) 5885 Hollis St, Suite 370 Emeryville, CA 94608 (I.R.S. Employer Identific ...

"The first quarter of 2025 was marked by strategic execution as we advanced our focused pipeline," said Kristen Fortney, Ph.D., CEO and co-founder of BioAge. "We've made significant progress with BGE-102, our brain-penetrant NLRP3 inhibitor, and are on track with IND-enabling studies to bring this potential best-in-class compound to the clinic this year, with initial Phase 1 data expected before year-end. Our new collaboration with Lilly expands our therapeutic capabilities into antibodies while validating ...

Advancement of lead candidate BGE-102, an oral, brain-penetrant NLRP3 inhibitor for obesity, with initial clinical data expected 2H25New strategic collaboration with Lilly ExploR&D expands therapeutic approach to novel metabolic aging targetsProgression of preclinical next-generation APJ agonists for obesity RICHMOND, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", “the Company”), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases, s ...

BioAge Labs, Inc. - BioAge Labs completed its IPO on September 27, 2024, selling 12.65 million shares at $18 per share, but the stock price fell significantly after the announcement of discontinuing the STRIDES Phase 2 study due to liver transaminitis observed in subjects [2][4] - Following the discontinuation of the clinical trial, BioAge's stock price dropped from $20.09 on December 6, 2024, to $4.65 on December 7, 2024 [2] - A federal securities fraud class action complaint was filed against BioAge and its officers, alleging that they made materially false and misleading statements regarding the STRIDES Phase 2 clinical trial and failed to disclose safety concerns [3][4] NAPCO Security Technologies, Inc. - A securities fraud class action complaint against NAPCO has survived a motion to dismiss, alleging that the company made materially false statements regarding internal controls and financial statements [7][9] - The complaint claims that NAPCO overstated inventory and net cost of goods sold, leading to inflated gross profit and necessitating a restatement of financial statements [8][9] - The court found that plaintiffs adequately pled claims of wrongdoing based on unusual stock sales by officers, which totaled over $108 million [9] Treace Medical Concepts, Inc. - A securities class action complaint alleges that Treace Medical made false statements regarding its primary product, the Lapiplasty 3D Bunion Correction System, and failed to disclose competition impacts on demand [11] - The complaint indicates that Treace's revenue declined and the company needed to accelerate plans for an alternative product due to competitive pressures [11] Virtu Financial Inc. - A securities fraud class action complaint against Virtu Financial has survived a motion to dismiss, alleging that the company failed to disclose deficiencies in its information access policies [14][15] - The court determined that employees had inappropriate access to sensitive non-public information, which could lead to regulatory scrutiny [16]

Core Viewpoint - The European Commission has referred the marketing authorization application for lecanemab to the Appeal Committee, following a positive opinion from the Committee for Medicinal Products for Human Use in February 2025 [1][6]. Company Overview - BioArctic AB is a Swedish biopharma company focused on innovative treatments for neurodegenerative diseases, including Alzheimer's disease [9]. - BioArctic developed lecanemab in collaboration with Eisai, which is responsible for clinical development and commercialization globally [3][9]. - BioArctic holds rights to commercialize lecanemab in the Nordic region and is preparing for joint commercialization with Eisai [3][8]. Product Information - Lecanemab (Leqembi) is a humanized IgG1 monoclonal antibody targeting amyloid-beta aggregates, approved in multiple markets including the U.S., Japan, and China for mild cognitive impairment and mild Alzheimer's dementia [5][6]. - The approval process in the EU will apply to all 27 member states, as well as Iceland, Liechtenstein, and Norway [2]. Clinical Development - The positive opinion for lecanemab's approval was based on Phase 3 data from the Clarity AD clinical trial, which met its primary and secondary endpoints with statistically significant results [6]. - Ongoing studies include the AHEAD 3-45 trial for individuals with preclinical Alzheimer's disease, fully recruited in October 2024, and the Tau NexGen study for Dominantly Inherited Alzheimer's Disease [7]. Collaboration Details - BioArctic and Eisai have collaborated since 2005, with key agreements for the development and commercialization of lecanemab signed in 2007 and 2015 [8]. - BioArctic incurs no development costs for lecanemab and is entitled to payments related to regulatory approvals and sales milestones [8].

Core Viewpoint - Eisai's simulation predicts Leqembi sales will reach JPY 250 to 280 billion for FY 2027, ending in March 2028 [1] Company Overview - BioArctic AB is a Swedish biopharma company focused on innovative treatments for neurodegenerative diseases, including Alzheimer's disease [8] - BioArctic developed Leqembi (lecanemab) in collaboration with Eisai, which is responsible for global commercialization and regulatory interactions [8] Product Information - Lecanemab is a humanized IgG1 monoclonal antibody targeting amyloid-beta aggregates, approved in multiple countries for mild cognitive impairment and mild Alzheimer's dementia [2][3] - A supplemental Biologics License Application for less frequent intravenous dosing was approved by the FDA in January 2025, with a new subcutaneous auto-injection formulation under review [4] Clinical Trials - Eisai's ongoing Phase 3 study (AHEAD 3-45) targets individuals with preclinical Alzheimer's disease and was fully recruited in October 2024 [5] - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease is also ongoing, utilizing lecanemab as a key therapy [5] Collaboration Details - BioArctic and Eisai have collaborated since 2005, with significant agreements for the development and commercialization of lecanemab [6][7] - BioArctic retains rights to commercialize lecanemab in the Nordic region and incurs no development costs, receiving milestone payments and royalties on global sales [7]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-42279 BIOAGE LABS, INC. (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of incorporation or organ ...