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BioAge Labs (BIOA) Earnings Call Presentation
2025-07-01 11:02
Corporate Presentation June 2025 2 Disclaimer BioAge Labs, Inc. (the "Company") does not (nor their respective affiliates, directors, members, officers, employees or agents) make any representation or warranty, express or implied, as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of the information and opinions contained in this Presentation or any other written or oral information made available to any interested party or its advisors and any liability therefor ...
BioAge Labs to Present Preclinical Data on APJ Agonism for Diabetic Obesity and Heart Failure at the American Diabetes Association (ADA) 85th Scientific Sessions
Globenewswire· 2025-06-21 22:00
Core Insights - BioAge Labs, Inc. is advancing apelin receptor (APJ) agonists for treating diabetic obesity and heart failure with preserved ejection fraction (HFpEF), showcasing enhanced glycemic control and cardioprotective effects in preclinical models [1][2][3] Company Developments - BioAge is presenting new preclinical data at the American Diabetes Association's 85th Scientific Sessions, highlighting the potential of APJ agonism in combination with incretin therapy [1][3] - The company is developing both oral small-molecule and long-acting injectable formulations of APJ agonists, with an Investigational New Drug (IND) filing targeted for 2026 [3][7] Research Findings - APJ agonism in preclinical models resulted in approximately double the weight loss compared to GLP-1 receptor agonists, while also restoring body composition and muscle function [2] - In mouse models of diabetic obesity, APJ agonist monotherapy reduced HbA1c to levels comparable to lean controls and improved glucose tolerance by 25% [5] - APJ agonist treatment in obesity-associated heart failure models reduced cardiac hypertrophy and markers of cardiac injury, with enhanced benefits observed when combined with incretin therapies [5] Presentation Details - BioAge's Chief Medical Officer, Dr. Paul Rubin, will present findings on the glycemic control effects of APJ agonists on June 21, 2025, while Dr. Shijun Yan will present data on cardioprotective effects on June 22, 2025 [4][5]
BioAge Labs Expands Drug Discovery Platform with Data from Leading European Biobank
GlobeNewswire News Room· 2025-06-17 13:00
Company to generate and analyze molecular profiles from over 17,000 samples from the HUNT Biobank in Norway to accelerate discovery of drug targets for aging-related diseases New data deepen platform insights into the biology of resilience across multiple therapeutic indications EMERYVILLE, Calif., June 17, 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 t ...
BioAge Labs (BIOA) FY Conference Transcript
2025-06-09 20:20
Summary of BioAge Conference Call Company Overview - **Company**: BioAge - **Focus**: Understanding mechanisms of aging to identify new targets for metabolic diseases [2][5] Key Points Pipeline and Strategy - BioAge is advancing several programs into the clinic, including: - **NLRP3 Inhibitor**: Targeting inflammation linked to obesity and other diseases, with an IND filing expected mid-year and SAD data by year-end [2][12] - **Next Generation Apelin Approach**: Aiming to file IND next year, with both oral and injectable forms [2][12] - Collaborations with **Lilly** and **Novartis** to leverage human data for target discovery [3][7] Collaborations - **Novartis Collaboration**: Focused on novel targets related to aging biology, particularly gene changes induced by exercise [7][10] - **Lilly Collaboration**: Building antibodies against new targets identified from BioAge's data platform [57] Mechanistic Insights - NLRP3 levels increase with age and are linked to obesity and cognitive decline [12][18] - The NLRP3 inhibitor shows potential for weight loss comparable to semaglutide, with additional benefits for cardiovascular health [14][18] Clinical Trials - Phase 1 trial for NLRP3 inhibitor will involve around 100 patients over three months, aiming for a single-digit percentage weight loss as a primary endpoint [20][22] - The trial design includes evaluating biomarkers alongside weight loss [21] Market Opportunity - Oral medications are seen as a potential game-changer due to cost-effectiveness compared to injectables [30][31] - A superior weight loss profile for oral drugs could significantly expand market access [31] Differentiation and Competitive Landscape - BioAge's NLRP3 inhibitor is differentiated by its brain penetration and potency, which are crucial for metabolic indications [33][50] - The company is monitoring competitors like **Ventix** and **Nothera**, focusing on weight loss efficacy as a key differentiator [32][48] Financial Outlook - BioAge has over $330 million in cash, providing a runway of more than three years to achieve upcoming milestones [46] Future Catalysts - Anticipated readouts include SAD data by year-end and obesity trial results in the first half of next year [53] Additional Insights - The aging process is a significant driver of chronic diseases, and BioAge aims to discover new therapeutic targets through its biobank resource [5][6] - The company is optimistic about the potential of NLRP3 inhibitors in treating multiple conditions beyond obesity, including neurodegenerative diseases [36][55] Conclusion BioAge is strategically positioned in the biotechnology sector with a focus on aging biology and metabolic diseases, backed by significant collaborations and a robust pipeline. The upcoming clinical data and market strategies will be critical in determining the company's future success.
BioAge Expands APJ Agonist Pipeline with Oral Small-Molecule and Long-Acting Biologic Candidates
Globenewswire· 2025-06-03 13:00
Core Insights - BioAge Labs has entered an option agreement with JiKang Therapeutics to potentially in-license a novel APJ agonist nanobody, enhancing its pipeline for obesity and other metabolic diseases [1][5] - The company has filed a provisional patent for new small molecule APJ agonists that are orally active and highly potent, indicating a strong focus on innovative therapeutic approaches [1][7] Group 1: APJ Agonist Program - Apelin, identified as a therapeutic target, has shown in preclinical studies to significantly enhance weight loss and improve muscle function, suggesting its potential as a pharmacological exercise mimetic [2][4] - BioAge aims to develop both oral and subcutaneous APJ agonists to cater to different segments of the obesity market, with plans to file an Investigational New Drug (IND) application in 2026 [3][4] Group 2: Collaboration with JiKang Therapeutics - The collaboration with JiKang allows BioAge to advance the APJ agonist nanobody into IND-enabling studies, with BioAge holding an exclusive option to license the program [6] - JiKang's nanobody is reported to be at least 10-fold more potent than apelin, indicating a significant advancement in pharmacological properties for treating metabolic diseases [5][6] Group 3: Intellectual Property Expansion - BioAge is rapidly advancing its internal small molecule APJ agonist program, having filed a U.S. provisional patent for a new class of agonists with picomolar potency and favorable drug-like attributes [7][8] - The design of these novel leads is supported by advanced computational modeling and AI initiatives, showcasing the company's commitment to innovative drug development [8] Group 4: Company Overview - BioAge Labs is a clinical-stage biopharmaceutical company focused on developing therapeutic candidates for metabolic diseases by targeting human aging biology [9] - The company's lead product candidate, BGE-102, is a small-molecule NLRP3 inhibitor for obesity, with significant weight loss demonstrated in preclinical models [9]
BioAge Labs completes IND-enabling studies for BGE-102, a potent, orally available, brain-penetrant NLRP3 inhibitor, and advances candidate toward the clinic
Globenewswire· 2025-05-29 13:00
Core Insights - BioAge Labs, Inc. is advancing its lead product candidate BGE-102, a small-molecule NLRP3 inhibitor, targeting obesity and related metabolic diseases with an IND submission planned for mid-2025 and initial Phase 1 data expected by the end of 2025 [1][9][10] Company Overview - BioAge Labs is a clinical-stage biotechnology company focused on developing therapeutic candidates for metabolic diseases by targeting the biology of human aging [10] - The company has identified NLRP3 as a therapeutic target based on its analysis of human aging cohorts, linking reduced NLRP3 activity to greater longevity [2] Product Development - BGE-102 has shown significant weight loss in preclinical obesity models, achieving approximately 15% weight reduction as monotherapy and over 20% when combined with GLP-1 receptor agonists like semaglutide [3][4] - The compound is characterized by a novel structure with a unique binding site, high potency (2 nM IC90 in human microglia), and favorable pharmacokinetics suggesting once-daily dosing [7][6] - Preclinical studies indicate a favorable safety profile for BGE-102, with a 35–75x safety margin for the predicted human dose and no adverse effects observed in toxicology studies [8] Clinical Milestones - The company plans to initiate a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial following IND clearance, with initial SAD data anticipated by the end of 2025 [9][12] - A Phase 1b proof-of-concept study in obesity is expected to commence in the second half of 2026, contingent on successful Phase 1 results [9]
BIOAGE ALERT: Bragar Eagel & Squire, P.C. is Investigating BioAge Labs, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm
GlobeNewswire News Room· 2025-05-22 01:00
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]
Bioage Labs, Inc.(BIOA) - 2025 Q1 - Quarterly Report
2025-05-06 20:40
Financial Performance - As of March 31, 2025, the total assets of BioAge Labs, Inc. were $343.8 million, a decrease from $358.2 million as of December 31, 2024[14]. - The company reported collaboration revenue of $1.45 million for the three months ended March 31, 2025, compared to no revenue in the same period of 2024[15]. - Total operating expenses increased to $17.9 million for the first quarter of 2025, up from $12.8 million in the same quarter of 2024, primarily driven by higher research and development costs[15]. - The net loss for the first quarter of 2025 was $12.93 million, slightly lower than the net loss of $12.99 million in the same period of 2024[15]. - Cash and cash equivalents at the end of the first quarter of 2025 were $257.5 million, down from $354.3 million at the end of 2024[20]. - The accumulated deficit increased to $265.7 million as of March 31, 2025, compared to $252.8 million at the end of 2024[25]. - The company incurred net cash used in operating activities of $17.36 million for the first quarter of 2025, compared to $15.67 million in the same period of 2024[20]. - The company reported a net loss of $12.9 million for the three months ended March 31, 2025, compared to a net loss of $13.0 million for the same period in 2024[115]. - The company has incurred significant operating losses since its inception, with net losses of $12.9 million and $13.0 million for the three months ended March 31, 2025 and 2024, respectively, resulting in an accumulated deficit of $265.7 million as of March 31, 2025[196]. Cash and Funding - The company had cash, cash equivalents, and marketable securities totaling $335.1 million as of March 31, 2025, sufficient to fund planned operations for at least one year[25]. - The company expects to finance its cash needs through equity offerings, debt financings, or other capital sources, which may dilute existing stockholders' ownership interests[27]. - The company has raised approximately $559.2 million in gross proceeds since its inception in 2015 through various securities[114]. - Existing cash, cash equivalents, and marketable securities are estimated to be sufficient to fund operations and capital expenses through 2029, although this is based on assumptions that may prove incorrect[159]. - The company has no committed sources of capital and may need to finance cash needs through equity offerings or debt financings, which could dilute existing stockholders' interests[162]. - The company has not yet demonstrated the ability to successfully complete clinical trials or obtain regulatory approvals, which poses significant risks to its business[194]. - Failure to raise adequate capital could significantly harm the company's business, financial condition, and prospects, potentially leading to delays or reductions in research programs[205]. Research and Development - Research and development expenses increased by $1.8 million, from $9.3 million in Q1 2024 to $11.1 million in Q1 2025, primarily due to a $2.7 million increase in direct costs related to other programs[146]. - The company expects to continue incurring net operating losses and anticipates significant increases in research and development expenses, general and administrative expenses, and capital expenditures[115]. - The company expects to incur substantial additional capital expenses as it advances its product candidates, particularly BGE-102, through preclinical and clinical development[201]. - The company plans to submit an IND for BGE-102 in mid-2025 and initiate a Phase 1 clinical trial in the second half of 2025[109]. - The company has terminated the development of azelaprag for obesity in January 2025 due to safety concerns but is advancing a new lead program, BGE-102, a small molecule NLRP3 inhibitor[108][109]. - Research and development expenses are expected to continue increasing substantially as the company progresses BGE-102 and other product candidates toward clinical trials[133]. Collaboration and Revenue Recognition - The company entered into a collaboration agreement with Novartis, which includes potential payments of up to $550 million in research and development milestones[124]. - The company recorded collaboration revenue of $1.5 million under the Novartis Agreement for the three months ended March 31, 2025, with no revenue recognized in the same period of 2024[95]. - Deferred revenue related to the Novartis Agreement was $11.4 million as of March 31, 2025[125]. - The Company evaluates collaboration agreements under ASC 606, which may include upfront license fees, research funding, and milestone payments[45]. - The Company recognizes revenue when performance obligations are satisfied, with deferred revenue classified within current liabilities if expected to be recognized within 12 months[41]. Risks and Challenges - The Company faces risks associated with the biotechnology industry, including regulatory approval uncertainties and dependence on third parties[36]. - The company has not generated any product revenue to date and anticipates incurring additional losses until significant sales can be generated from its products in development[24]. - The company is highly dependent on the successful development and commercialization of its lead product candidate, BGE-102, which is still in early development stages[207]. - Successful commercialization of BGE-102 will depend on various factors, including regulatory approvals and effective marketing strategies[208]. - The company must prioritize development of certain product candidates due to limited resources, which may impact its commercial success[210]. - The company anticipates continued significant losses for the foreseeable future and may never achieve or sustain profitability[196]. Internal Controls and Compliance - The company has identified material weaknesses in its internal control over financial reporting, although it has remediated these issues[197]. - The company does not expect the recent FASB updates on income tax disclosures and expense disaggregation to have a material impact on its consolidated financial statements[49][50]. - The company has no unrecognized tax benefits that would reduce its effective tax rate if recognized[101]. - The company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates less than $700.0 million and annual revenue below $100.0 million[181].
Bioage Labs, Inc.(BIOA) - 2025 Q1 - Quarterly Results
2025-05-06 20:35
Financial Performance - Net loss for Q1 2025 was $12.9 million, or $0.36 per share, compared to a net loss of $13.0 million, or $7.76 per share, in Q1 2024[11]. - The company reported a total comprehensive loss of $12.9 million for Q1 2025, slightly down from a comprehensive loss of $12.97 million in Q1 2024[16]. - Collaboration revenue for Q1 2025 was reported at $1.451 million, compared to no collaboration revenue in Q1 2024[16]. - Total operating expenses for Q1 2025 were $17.9 million, up from $12.8 million in Q1 2024[16]. Expenses - Research and development expenses increased to $11.1 million for Q1 2025, up from $9.3 million in Q1 2024, reflecting a $1.8 million rise primarily due to a $2.7 million increase in direct costs related to other programs[9]. - General and administrative expenses rose to $6.8 million in Q1 2025, compared to $3.5 million in Q1 2024, with a $3.3 million increase mainly due to a $2.0 million rise in personnel-related expenses[10]. Cash Position - As of March 31, 2025, the company had approximately $335.1 million in cash, cash equivalents, and marketable securities, sufficient to fund operations through 2029[12]. Development and Collaboration - BioAge nominated BGE-102 as its lead development candidate for obesity, with initial Phase 1 data expected in the second half of 2025[4]. - A new strategic collaboration with Lilly ExploR&D was announced to develop therapeutic antibodies targeting novel metabolic aging targets[7]. - The company continues to advance its portfolio of novel APJ agonists for obesity, aiming to nominate a development candidate by the end of 2025[8].
BioAge Labs Reports First Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire News Room· 2025-05-06 20:30
Core Insights - BioAge Labs, Inc. is advancing its clinical-stage pipeline focused on metabolic diseases by targeting human aging biology, with significant progress in its lead candidate BGE-102, a brain-penetrant NLRP3 inhibitor for obesity [2][3] Business Highlights - The nomination of BGE-102 as the lead development candidate for obesity was made in January 2025, showing potential best-in-class potency and targeting diseases driven by neuroinflammation [3] - A strategic collaboration with Lilly was announced to develop therapeutic antibodies targeting novel metabolic aging targets identified through BioAge's discovery platform [3] - The company is progressing its portfolio of novel APJ agonists for obesity, aiming to nominate a development candidate by the end of 2025 [3] Financial Results - Research and development expenses for Q1 2025 were $11.1 million, up from $9.3 million in Q1 2024, primarily due to increased costs related to IND-enabling activities for BGE-102 [4] - General and administrative expenses rose to $6.8 million in Q1 2025 from $3.5 million in Q1 2024, largely due to increased personnel-related expenses and stock-based compensation [5] - The net loss for Q1 2025 was $12.9 million, or $0.36 per share, compared to a net loss of $13.0 million, or $7.76 per share, in the same period of 2024 [7][12] Cash Position - As of March 31, 2025, BioAge had approximately $335.1 million in cash, cash equivalents, and marketable securities, which is expected to fund operations through 2029 [8]