We are a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. (Incorporated in Delaware) 

Our technology platform and differentiated human datasets enable us to identify promising targets based on insights into molecular changes that drive aging. Our primary focus is metabolic disease, one of the greatest global healthcare challenges.

Azelaprag, our lead product candidate, is an orally available small molecule that has been well-tolerated in 265 individuals across eight Phase 1 clinical trials. In preclinical obesity models, azelaprag demonstrated the ability to more than double the weight loss induced by a glucagon-like-peptide-1 receptor (GLP-1R) agonist while also restoring healthy body composition and improving muscle function. These preclinical results are supported by our Phase 1b clinical trial in older adults on bed rest where we observed decreased muscle atrophy, preservation of muscle quality and improved metabolism in subjects treated with azelaprag over a 10-day period.

We plan to assess azelaprag’s potential to drive significant improvements in weight loss when combined with a GLP-1R agonist in two Phase 2 clinical trials. While the results of these preclinical studies and early clinical trials have demonstrated the potential use of azelaprag for the treatment of metabolic disease, they may not be predictive of the results of later-stage clinical trials. The ongoing STRIDES clinical trial will assess azelaprag in combination with tirzepatide, marketed as Zepbound^® by Eli Lilly and Company (Lilly), with topline results anticipated in the third quarter of 2025. The second Phase 2 clinical trial will assess azelaprag in combination with semaglutide, marketed as Wegovy^® by Novo Nordisk, with initiation expected in the first half of 2025. We believe these trials will directly support our ultimate therapeutic goal of developing an all-oral combination product for obesity. We also intend to initiate an insulin sensitivity proof-of-concept trial of azelaprag monotherapy in the first half of 2025 to support potential indication expansion.

We are also developing orally available small molecule brain-penetrant NLRP3 inhibitors for the treatment of diseases driven by neuroinflammation. We anticipate submitting an Investigational New Drug application (IND) for an NLRP3 inhibitor in the second half of 2025 and, if cleared, initiating a Phase 1 clinical trial in the first half of 2026.

Note: Net loss on no product revenue is for the 12 months that ended June 30, 2024.

(Note: BioAge Labs,  Inc., upsized its IPO at pricing – to 11.0 million shares – up from 10.5 million shares in the prospectus – and priced the IPO at $18.00 – the mid-point of its $17.00-to-$19.00 range – to raise $198 million on Wednesday night, Sept. 25, 2024. Background: BioAge Labs, Inc. upsized its IPO by 40 percent – increasing the number of shares to 10.5 million – up from 7.5 million initially – and keeping the price range at $17.00 to $19.00 – to raise $189.0 million, if the IPO is priced at the $18.00 mid-point of its range, according to an S-1/A filing dated Sept. 25, 2024.)

(Background: BioAge Labs, Inc. disclosed the terms for its IPO in an S-1/A filing dated Sept. 18, 2024: The company is offering 7.5 million shares at a price range of $17.00 to $19.00 to raise $135.0 million. Background: BioAge Labs, Inc. filed its S-1 on Sept. 3, 2024, without disclosing the terms. Estimated IPO proceeds are $100.0 million.)