EMERYVILLE, Calif., Nov. 07, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (NASDAQ: BIOA) ("BioAge", "the Company"), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced that the Company will present at the Jefferies Global Healthcare Conference in London, November 17–20, 2025. Kristen Fortney, PhD, CEO and co-founder, and Dov Goldstein, MD, CFO, are scheduled to participate in a fireside chat on Monday, ...

Financial Performance - Total current assets decreased from $357,103,000 as of December 31, 2024, to $290,828,000 as of September 30, 2025, a decline of approximately 18.5%[14] - Collaboration revenue for the three months ended September 30, 2025, was $2,054,000, compared to $0 for the same period in 2024, indicating a significant increase[15] - Net loss for the three months ended September 30, 2025, was $20,171,000, compared to a net loss of $23,407,000 for the same period in 2024, showing an improvement of approximately 9.4%[15] - The company reported a total comprehensive loss of $54,632,000 for the nine months ended September 30, 2025, compared to $49,925,000 for the same period in 2024, indicating an increase in overall losses[15] - The company reported a net loss of $54.7 million for the nine months ended September 30, 2025, compared to a net loss of $50.0 million for the same period in 2024[22] - The net loss attributable to common stockholders for the three months ended September 30, 2025, was $20.2 million, compared to a net loss of $23.4 million for the same period in 2024, representing a decrease of approximately 13.5%[11] - For the nine months ended September 30, 2025, the net loss was $54.7 million, compared to $50.0 million for the same period in 2024, indicating an increase of approximately 9.4%[11] Expenses - Research and development expenses for the nine months ended September 30, 2025, rose to $49,466,000, up from $39,811,000 in 2024, reflecting a 24.5% increase[15] - Total operating expenses for the nine months ended September 30, 2025, were $70,274,000, compared to $52,832,000 in 2024, representing a 33.1% increase[15] - General and administrative expenses rose by $7.8 million, or 60%, from $13.0 million for the nine months ended September 30, 2024 to $20.8 million for the same period in 2025[162] - Research and development expenses increased by $9.7 million, or 24%, from $39.8 million for the nine months ended September 30, 2024 to $49.5 million for the same period in 2025[160] - Stock-based compensation expense increased to $8.97 million for the nine months ended September 30, 2025, from $4.26 million in the prior year[22] - Research and development expenses decreased by $1.5 million from $20.0 million for the three months ended September 30, 2024, to $18.5 million for the same period in 2025, primarily due to a $13.1 million reduction in azelaprag direct costs[154] - General and administrative expenses increased by $2.0 million from $4.7 million for the three months ended September 30, 2024, to $6.7 million for the same period in 2025, driven by increased legal fees and personnel-related expenses[155] Assets and Liabilities - Total liabilities decreased from $35,107,000 as of December 31, 2024, to $27,626,000 as of September 30, 2025, a reduction of about 21.1%[14] - Stockholders' equity decreased from $323,127,000 as of December 31, 2024, to $277,464,000 as of September 30, 2025, a decline of approximately 14.1%[14] - Cash and cash equivalents decreased from $354,349,000 as of December 31, 2024, to $215,573,000 as of September 30, 2025, a decline of approximately 39.2%[14] - The company had an accumulated deficit of $307.5 million as of September 30, 2025, up from $252.8 million as of December 31, 2024[28] - As of September 30, 2025, the company had $295.9 million in cash, cash equivalents, and marketable securities, with an accumulated deficit of $307.5 million[166] - The company has $4.1 million in non-cancellable lease obligations related to its Emeryville Lease, with $0.6 million due within the next 12 months[182] Revenue Recognition and Collaboration - The company has not generated any product revenue to date and anticipates incurring additional losses until it can generate significant sales[27] - The company recognized collaboration revenue of $5.9 million under the Novartis Agreement for the nine months ended September 30, 2025, with no revenue recognized in the same period of 2024[96] - The company entered into a collaboration agreement with Novartis, which includes potential payments of up to $550 million in future milestones[94] - The company evaluates collaboration agreements under ASC 606 and ASC 808 to determine the appropriate accounting treatment for multiple performance obligations[194] - The company recognizes revenue based on the satisfaction of performance obligations as outlined in ASC 606, impacting revenue recognition timing[186] Future Outlook and Plans - The company plans to finance its cash needs through equity offerings, debt financings, or other capital sources until it can generate substantial product revenues[30] - The company expects existing cash and marketable securities to fund operations through 2029, although this estimate is based on assumptions that may prove incorrect[177] - The company expects research and development expenses to continue to increase substantially as it progresses BGE-102 into additional clinical trials[137] - The company plans to file INDs for novel apelin receptor APJ agonists by the end of 2026[113] - The company expects to incur significant expenses related to developing commercialization capabilities for future product candidates if approved[120] Clinical Development - The lead product candidate, BGE-102, is being developed for obesity and cardiovascular risk factors, showing significant weight loss in preclinical models[24] - The first patient was dosed in the Phase 1 clinical trial for BGE-102 in August 2025, with initial data anticipated by year-end 2025[112] - The company discontinued its Phase 2 clinical trial for azelaprag in December 2024 due to liver transaminitis observed in some subjects[211] - The company has not completed any clinical trials beyond Phase 1b and has no products approved for commercial sale, making it difficult for investors to evaluate its business viability[208] - The transition from a research and development focus to supporting commercial activities has not been successfully demonstrated by the company[212] Capital and Funding - The company has raised approximately $559.2 million in gross proceeds since inception through various securities offerings[117] - The company has raised a total of $293.8 million from redeemable convertible preferred stock sales, $26.4 million from convertible notes, $238.3 million from common stock sales, and $0.7 million from stock option exercises as of September 30, 2025[210] - The company incurred net cash used in operating activities of $53.4 million for the nine months ended September 30, 2025, compared to $46.4 million for the same period in 2024[22] Risks and Challenges - The company has incurred significant operating losses since its inception and expects to continue incurring substantial losses for the foreseeable future[208] - The company requires substantial additional capital to finance operations and achieve its goals, with potential delays or reductions in research and development if capital is not raised[208] - The company faces unforeseen expenses and risks commonly experienced by biopharmaceutical companies[212] - The company is subject to risks related to securities litigation, which could divert management attention and incur significant costs[208]

Exhibit 99.1 BioAge Labs Reports Third Quarter 2025 Financial Results and Provides Business Updates First participant dosed in Phase 1 trial of BGE-102, oral CNS-penetrant NLRP3 inhibitor, with initial SAD data expected by year-end Continued advancement of oral and parenteral APJ agonist programs targeting 2026 IND submissions Research and development expenses were $18.5 million for the quarter ended September 30, 2025, compared to $20.0 million for the same period in 2024. The $1.5 million decrease in rese ...

First participant dosed in Phase 1 trial of BGE-102, oral CNS-penetrant NLRP3 inhibitor, with initial SAD data expected by year-end Continued advancement of oral and parenteral APJ agonist programs targeting 2026 IND submissions EMERYVILLE, Calif., Nov. 06, 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 provided business updates and ...

In other words, it's a different path to the same endpoint and with a similar outcome. A pre-clinical study suggested average weight loss of 15% when BGE-102 is used on its own, and up to 25% weight reduction when used in conjunction with semaglutide -- the generic name for the key component of Novo Nordisk's Wegovy.BGE-102 is distinctly different from Novo Nordisk's and Eli Lilly's top-selling weight-management drugs, however. All of their flagship weight-loss drugs are GLP-1 receptor agonists that make yo ...

Core Insights - BioAge Labs has seen a significant stock increase of 46.6% during the week ending October 25, 2025, following an upgrade from Citigroup analyst Samantha Semenkow, who raised the rating from neutral to buy and set a price target of $10 per share [1][2]. Company Developments - The new price target from Citigroup suggests a potential gain of approximately 32% from the stock's closing price on October 24, although these gains are not guaranteed [2]. - BioAge Labs is developing BGE-102, an experimental small-molecule drug that targets NLRP3 in the brain to manage weight, differing from existing GLP-1 receptor-targeting drugs like Wegovy and Zepbound [4][5]. - Positive trial results from a different NLRP3 inhibitor, VTX3232, were announced by Ventyx Biosciences, indicating potential for cardiovascular risk factor improvement, although it did not lead to weight loss [5][8]. Clinical Trial Progress - BioAge Labs began dosing patients in a phase 1 trial for BGE-102 in August, with preclinical studies showing obese animals treated with the drug lost up to 15% of their weight, and combined with Wegovy, weight loss increased to about 25% [6][9]. - The company expects to report top-line data from the single ascending dose portion of the phase 1 trial by the end of the year, but this data will not provide comprehensive insights into long-term safety or efficacy [9].

Core Viewpoint - HitGen Inc. celebrates the initiation of a Phase 1 clinical study of BGE-102, a novel NLRP3 inhibitor developed in collaboration with BioAge Labs, which triggers a milestone payment to HitGen under their partnership agreement [1][6]. Group 1: Product Development - BGE-102 is an orally available small molecule NLRP3 inhibitor designed for obesity treatment, targeting age-related inflammation linked to various diseases [2][7]. - The compound was developed from hit compounds identified through HitGen's DNA-encoded library (DEL) technology, showcasing the effectiveness of this platform in drug discovery [3][6]. Group 2: Collaboration and Milestones - The collaboration between HitGen and BioAge began with the identification of promising hit molecules in April 2021, leading to joint patent filings and further research publications [3][4]. - The advancement of BGE-102 into clinical studies validates HitGen's DEL platform and emphasizes the value of their partnership model [4][6]. Group 3: Company Overview - HitGen Inc. is a drug discovery research company based in Chengdu, China, with advanced technology platforms for small molecule and nucleic acid-based drug discovery [5]. - The company has established collaborations with numerous biopharmaceutical organizations globally, supporting various drug discovery projects from early stages to clinical trials [5].

Summary of BioAge Labs FY Conference Call Company Overview - **Company**: BioAge Labs (NasdaqGS:BIOA) - **Focus**: Development of therapeutics targeting metabolic aging and obesity Key Points Platform and Data - BioAge Labs has developed a unique platform with approximately **50 million molecular data points** collected over decades, making it one of the largest human aging data sets globally [5][6] - The platform focuses on identifying targets for metabolic aging, particularly in the context of obesity and related comorbidities [5][6] - Recently expanded its discovery capabilities by incorporating data from the **HUNT Biobank** in Norway, which includes over **30 years of health records** and a significant portion of individuals developing cardiometabolic diseases [12] Therapeutic Focus - The company is concentrating on the next generation of obesity therapies that address not only weight loss but also muscle loss and inflammation [6] - BioAge Labs is advancing its lead program, **BGE-102**, a brain-penetrant NLRP3 inhibitor, which has shown promising preclinical results in weight loss comparable to semaglutide [25][26] - The mechanism of BGE-102 targets neuroinflammation, which is linked to appetite dysregulation and obesity [25] Collaborations - BioAge Labs has established collaborations with major pharmaceutical companies, including **Novartis** and **Eli Lilly**. The Novartis partnership focuses on novel target discovery related to aging biology and exercise [18][21] - The collaboration with Eli Lilly involves developing molecules based on BioAge's human data, allowing for expanded capabilities in drug development [21] Clinical Development - BGE-102 has initiated a **Phase 1 study** with results expected by the end of the year, focusing on pharmacodynamics (PD) and safety [30][35] - The company plans to advance into a monotherapy obesity trial following the Phase 1 results, with a robust design aimed at weight loss [47] Financial Position - As of June, BioAge Labs reported over **$310 million** in cash, sufficient to fund operations for over three years, covering ongoing studies and development milestones [71] Future Catalysts - Upcoming catalysts include the **SAD data** by the end of the year, **MAD data** in the first half of 2026, and IND filings for APJ agonist programs by the end of 2026 [73] - External catalysts include data readouts from competitors, which may provide insights into the market landscape [74] Market Position and Strategy - BioAge Labs aims to leverage its unique platform to explore novel targets, differentiating itself from competitors who focus on validated targets [75] - The company is also exploring the integration of **artificial intelligence** in its operations, particularly in target discovery and molecule identification [77][81] Conclusion - BioAge Labs is positioned to capitalize on its extensive data platform and strategic collaborations to develop innovative therapies for metabolic aging and obesity, with a strong financial foundation to support its clinical and operational goals.

BioAge Labs (BIOA) Conference Summary Company Overview - BioAge Labs focuses on understanding mechanisms of aging and metabolic aging using longitudinal human data from biobanks [4][5] - The company has collaborations with Novartis and Lilly for target discovery and drug development [5] Key Programs and Developments NLRP3 Program (BGE 102) - BGE 102 is an oral, CNS-penetrant molecule targeting obesity, with potential best-in-class properties [6][7] - The molecule shows high potency in inhibiting IL-1 beta and has a novel binding site on NLRP3 [7][10] - Preclinical data indicates significant weight loss effects comparable to semaglutide, both as a monotherapy and in combination with incretin therapies [18][19][31] - The mechanism of action involves appetite suppression driven by neuroinflammation [15][16] - A Phase 1 study has commenced, with expected data on safety and IL-1 beta inhibition by the end of the year [23][25] APJ Program - The APJ program includes alternative oral small molecules and a nanobody, aiming to amplify weight loss and preserve muscle [51][52] - The goal is to file an IND for the oral small molecules next year, with potential for a monthly dosing regimen for the nanobody [52][66] - APJ has shown preclinical and clinical potential in preserving muscle, particularly in older populations [55][60] Market Position and Competitive Landscape - The oral obesity treatment market is considered wide open, with significant room for novel mechanisms [35] - BioAge aims to differentiate itself by combining mechanisms that enhance weight loss while maintaining tolerability [39] - The company is closely monitoring competitors' readouts, particularly from Ventex and Nodthera, to inform its strategy [34][41] Financial Outlook - As of June, BioAge had approximately $313 million in cash, providing a runway of over three years [89] - The company is focused on capitalizing on partnerships and collaborations to lower costs and enhance funding opportunities [90][91] Strategic Vision - BioAge envisions advancing a portfolio of differentiated mechanisms into clinical trials, targeting obesity and its comorbidities [80] - The company is exploring additional partnerships and collaborations to expand its pipeline and capabilities [78][79] Conclusion - BioAge Labs is positioned to be a leader in the obesity treatment space with its innovative approaches and strong pipeline, focusing on both NLRP3 and APJ mechanisms [100][101]

Core Insights - BioAge Labs, Inc. has initiated a Phase 1 clinical trial for BGE-102, a novel orally available small molecule NLRP3 inhibitor aimed at treating obesity, with initial data expected by the end of 2025 and top-line results from the obesity study anticipated by the end of 2026 [1][6] Group 1: Product Development - BGE-102 is a structurally novel class of NLRP3 inhibitors, targeting age-related inflammation linked to various diseases, including obesity [2][7] - The compound has shown a strong safety profile in GLP toxicology studies, with no adverse findings reported [3][4] - In preclinical models, BGE-102 demonstrated dose-dependent weight loss of up to 15% as monotherapy and approximately 25% when combined with semaglutide, indicating its potential for an all-oral obesity treatment regimen [4][6] Group 2: Clinical Trial Design - The Phase 1 study is randomized, double-blind, and placebo-controlled, assessing safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants [5] - The trial consists of two parts: single ascending doses and multiple ascending doses administered once daily for 14 days, with evaluations of pharmacokinetic profiles and CNS penetration [5][6] Group 3: Strategic Vision - The CEO of BioAge expressed optimism about BGE-102's potential to complement existing therapies like GLP-1 agonists, enhancing weight loss and addressing neuroinflammation associated with obesity [6] - Following the Phase 1 study, BioAge plans to advance BGE-102 into a proof-of-concept study in obesity in 2026, with top-line data expected by the end of that year [6][8]