BioAge Labs (NasdaqGS:BIOA) FY Conference Summary Company Overview - **Company**: BioAge Labs - **Focus**: Developing therapies for metabolic diseases by harnessing the biology of human aging through the BioAge Discovery Platform, which includes over 150 million molecular data points [2][3] Key Points and Arguments Clinical Development - **Lead Program**: BGE-102, an oral brain-penetrant NLRP3 inhibitor, is being developed to target cardiovascular risk and other aging-related diseases [3][4] - **Clinical Data**: Initial phase I trial data showed that 93% of obese patients with elevated CRP normalized their CRP levels to below 2, indicating best-in-class performance with an 86% reduction in hs-CRP from baseline [4][20] - **Upcoming Trials**: Full phase I data set will be released in the first half of the year, with a three-month monotherapy study planned for the second half [6][41] Mechanism of Action - **NLRP3 Inhibition**: The mechanism targets inflammation linked to various diseases, with a focus on cardiovascular and ophthalmological conditions [5][24] - **Safety Profile**: The drug has shown a favorable safety profile with mild to moderate adverse effects and no dose-limiting toxicity observed [10][14] Market Potential - **Cardiovascular Indications**: The drug aims to reduce cardiovascular risk factors, with CRP being a significant biomarker for MACE outcomes [24][25] - **Ophthalmology Focus**: Plans to explore indications in diabetic macular edema (DME) and geographic atrophy, leveraging the drug's ability to penetrate the brain and eye [27][28] Competitive Landscape - **Oral vs. Injectable**: The oral formulation of BGE-102 presents a significant advantage over current injectable therapies, potentially improving patient compliance and treatment outcomes [28][29] - **Unmet Needs**: There is a substantial unmet need in both DME and geographic atrophy, with current therapies showing modest efficacy [34][35] Additional Important Content - **Intellectual Property**: BioAge holds a strong IP position with granted patents covering the composition of matter and novel binding sites for NLRP3 [11][12] - **Collaborations**: Ongoing partnerships with Novartis and Lilly to discover drugs and drug targets, with interest in expanding collaborations [8][42] - **Future Catalysts**: Anticipated milestones include the release of phase I data, initiation of DME trials, and IND submissions for additional programs [41][42] Conclusion BioAge Labs is positioned to make significant advancements in the treatment of metabolic diseases through its innovative approach to NLRP3 inhibition, with promising clinical data and a strong pipeline of upcoming trials and collaborations. The focus on oral therapies could address critical unmet needs in the market, particularly in cardiovascular and ophthalmological indications.

Core Insights - BioAge Labs, Inc. is a clinical-stage biotechnology company focused on developing therapeutic products for metabolic diseases by targeting human aging biology [1][3] - The company will present at the Jefferies Global Healthcare Conference in London from November 17-20, 2025 [1][2] Company Overview - BioAge's lead product candidate, BGE-102, is an orally available small-molecule NLRP3 inhibitor aimed at treating obesity and cardiovascular risk factors [3] - A Phase 1 SAD/MAD trial for BGE-102 is currently underway, with initial SAD data expected by the end of the year [3] - The company is also developing long-acting injectable and oral small molecule APJ agonists for obesity [3] - BioAge's preclinical programs utilize insights from its proprietary discovery platform based on human longevity data, targeting key pathways involved in metabolic aging [3]

Core Insights - BioAge Labs is advancing its clinical pipeline with the oral NLRP3 inhibitor BGE-102, set to initiate Phase 1 trials in the second half of 2025, with initial data expected by year-end [2][3] - The company has expanded its APJ agonist pipeline through a partnership for potent antibodies and has filed patents for novel oral small molecules [2][7] - BioAge is enhancing its discovery platform by profiling over 17,000 samples from the HUNT Biobank, which will generate millions of data points related to human longevity [5] Clinical Pipeline Development - The BGE-102 program has completed IND-enabling studies and has shown significant weight loss in preclinical models, both as a standalone treatment and in combination with semaglutide [3] - The Phase 1 SAD/MAD clinical trial for BGE-102 is planned for the second half of 2025, with initial SAD data anticipated by the end of the year [3][13] APJ Agonist Pipeline Expansion - BioAge entered an exclusive option agreement with JiKang Therapeutics to potentially in-license a novel APJ agonist nanobody, which is reported to have over 10-fold greater potency than apelin [7] - The company has filed a U.S. provisional patent for a new class of orally active APJ agonists with high solubility and metabolic stability [7] Discovery Platform Expansion - BioAge's collaboration with the HUNT Biobank aims to profile over 17,000 samples from more than 6,000 participants, generating extensive molecular measurements over decades [5] - The partnership provides BioAge exclusive access to the data for drug discovery purposes [5] Financial Performance - For Q2 2025, research and development expenses were $19.8 million, up from $10.5 million in Q2 2024, primarily due to increased costs related to licensing and development activities [9] - General and administrative expenses rose to $7.3 million from $4.8 million in the same period last year, driven by higher personnel-related expenses [10] - The net loss for Q2 2025 was $21.6 million, or $0.60 per share, compared to a net loss of $13.6 million, or $7.94 per share, in Q2 2024 [11] Cash Position - As of June 30, 2025, BioAge had approximately $313.4 million in cash, cash equivalents, and marketable securities, which is expected to fund operations through 2029 [12]

BioAge Platform & Collaborations - BioAge is harnessing the biology of human aging to develop new therapies for metabolic diseases[6], leveraging a validated platform with ongoing partnerships with Novartis & Lilly to discover drugs and drug targets[6, 11, 12] - The platform utilizes a large collection of longitudinal human aging data, comprising over 50 million molecular data points and over 10,000 profiles generated[6, 9] BGE-102 (NLRP3 Inhibitor) - BGE-102, an oral NLRP3 inflammasome inhibitor, shows potential as a best-in-class treatment with robust preclinical weight loss as a monotherapy and in combination with incretins[6] - Preclinical data indicates BGE-102 can achieve over 90% IL-1 suppression 24 hours after a single oral dose (10 mpk) in non-human primates, with an estimated equivalent human dose of less than 50 mg QD[40, 41] - In preclinical obesity models, BGE-102 monotherapy resulted in dose-dependent weight loss, and in combination with semaglutide, more than doubled weight loss[49, 52] - BioAge is planning a Phase 1 SAD / MAD with data anticipated by 2025 YE and an obesity POC trial with results expected in H2:2026[6, 33, 65] APJ Agonism - APJ agonism is being developed as an exercise mimetic for obesity, with the potential to double weight loss and fully restore body composition when combined with an incretin in preclinical models[7] - The company is advancing programs for both oral and parenteral administration of APJ agonists, with an IND submission targeted for 2026 YE[7] - Human genetic data from BioAge's platform shows that higher apelin protein levels are associated with preservation of grip strength and longevity[73, 74] Financial Status - BioAge reported a strong balance sheet with $335 million in cash as of March 31, 2025[93]