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]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited H1 2025 financial statements reveal a net loss of $34.5 million, increased operating expenses, and initial collaboration revenue [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets decreased to $322.1 million due to reduced cash, while liabilities also declined and the accumulated deficit grew to $287.3 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $220,330 | $354,349 | | Marketable securities (current & non-current) | $93,073 | $0 | | Total current assets | $301,697 | $357,103 | | **Total assets** | **$322,148** | **$358,234** | | **Liabilities & Equity** | | | | Total current liabilities | $22,837 | $27,775 | | Total liabilities | $27,367 | $35,107 | | Accumulated deficit | $(287,302) | $(252,811) | | **Total stockholders' equity** | **$294,781** | **$323,127** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported increased net losses of $21.6 million and $34.5 million for the three and six months ended June 30, 2025, primarily due to higher operating expenses Statement of Operations Summary (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $2,412 | $0 | $3,863 | $0 | | Research and development | $19,844 | $10,471 | $30,953 | $19,792 | | General and administrative | $7,339 | $4,798 | $14,127 | $8,290 | | Loss from operations | $(24,771) | $(15,269) | $(41,217) | $(28,082) | | **Net loss** | **$(21,563)** | **$(13,581)** | **$(34,491)** | **$(26,573)** | | Net loss per share | $(0.60) | $(7.94) | $(0.96) | $(15.70) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $37.3 million for H1 2025, with significant cash used in investing for marketable securities and financing for loan payments Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(37,332) | $(31,453) | | Net cash used in investing activities | $(93,629) | $(35) | | Net cash (used in) provided by financing activities | $(3,000) | $165,614 | | **Net (decrease) increase in cash** | **$(134,019)** | **$134,128** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business, liquidity, the Novartis collaboration, term loan, and a pending securities class action lawsuit - The company is a **biopharmaceutical firm** focused on developing therapies for **metabolic diseases** like obesity by targeting the biology of aging[22](index=22&type=chunk) - As of June 30, 2025, the company had an accumulated deficit of **$287.3 million** but believes its current cash, cash equivalents, and marketable securities of **$313.4 million are sufficient to fund operations for at least one year**[25](index=25&type=chunk)[26](index=26&type=chunk) - In December 2024, the company entered into a **collaboration agreement with Novartis**, recognizing **$3.9 million in revenue** for the six months ended June 30, 2025, with potential future milestones up to **$530.0 million**[90](index=90&type=chunk)[92](index=92&type=chunk)[94](index=94&type=chunk) - A **securities class action lawsuit** was filed against the company and its directors/officers on January 7, 2025, alleging false and misleading statements in connection with the IPO[81](index=81&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's metabolic disease focus, increased R&D expenses for H1 2025, and strong liquidity projected to fund operations through 2029 [Overview](index=30&type=section&id=Overview) The company is a biopharmaceutical firm focused on metabolic diseases, with lead programs BGE-102 and APJ agonists, and has accumulated a deficit of $287.3 million - The lead program is **BGE-102**, an oral NLRP3 inhibitor for obesity, with a **Phase 1 clinical trial** planned for H2 2025 and initial data expected by year-end 2025[109](index=109&type=chunk)[110](index=110&type=chunk) - The company is also developing novel oral and parenteral **APJ agonists** for obesity, with plans to **file INDs** for both programs by the end of 2026[111](index=111&type=chunk) - The company has incurred **significant operating losses** since inception, with an **accumulated deficit of $287.3 million** as of June 30, 2025[115](index=115&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20Operations) Net loss for H1 2025 increased to $34.5 million, driven by higher R&D and G&A expenses, partially offset by initial collaboration revenue Comparison of Results for the Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $3,863 | $0 | $3,863 | 100% | | Research and development | $30,953 | $19,792 | $11,161 | 56% | | General and administrative | $14,127 | $8,290 | $5,837 | 70% | | **Loss from operations** | **$(41,217)** | **$(28,082)** | **$(13,135)** | **47%** | R&D Expense Breakdown for the Six Months Ended June 30 (in thousands) | Program | 2025 | 2024 | $ Change | | :--- | :--- | :--- | :--- | | azelaprag | $2,800 | $7,215 | $(4,415) | | BGE-102 | $5,158 | $0 | $5,158 | | Other programs | $10,626 | $2,078 | $8,548 | | Indirect costs | $12,369 | $10,499 | $1,870 | | **Total R&D** | **$30,953** | **$19,792** | **$11,161** | - The increase in G&A expenses was primarily driven by a **$3.5 million increase in personnel-related costs** (largely stock-based compensation) and a **$1.4 million increase in legal fees**[154](index=154&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held $313.4 million in liquidity, projected to fund operations through 2029, with significant cash used in operations and investing activities - The company possessed **$313.4 million in cash, cash equivalents, and marketable securities** as of June 30, 2025[156](index=156&type=chunk) - Based on the current operating plan, existing cash is estimated to be **sufficient to fund operations and capital expenses through 2029**[166](index=166&type=chunk) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(37,332) | $(31,453) | | Net cash used in investing activities | $(93,629) | $(35) | | Net cash (used in) provided by financing activities | $(3,000) | $165,614 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=52&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing quantitative and qualitative market risk disclosures - As a smaller reporting company, **BioAge Labs is exempt from providing quantitative and qualitative disclosures about market risk**[191](index=191&type=chunk) [Item 4. Controls and Procedures](index=52&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting - Management concluded that the company's **disclosure controls and procedures were effective** as of the end of the period covered by the report (June 30, 2025)[192](index=192&type=chunk) - **No changes in internal control over financial reporting** occurred during the quarter that materially affected, or are reasonably likely to materially affect, these controls[193](index=193&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=53&type=section&id=Item%201.%20Legal%20Proceedings) The company is subject to a securities class action lawsuit filed January 7, 2025, alleging IPO-related violations, which it intends to vigorously defend - A **securities class action lawsuit** was filed against the company on January 7, 2025, alleging false and misleading statements in connection with its initial public offering[81](index=81&type=chunk) [Item 1A. Risk Factors](index=53&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including limited operating history, ongoing losses, capital needs, clinical development uncertainties, third-party reliance, and intense market competition - The company has a history of **significant operating losses** (**$287.3 million accumulated deficit** as of June 30, 2025) and will require substantial additional capital to finance operations[203](index=203&type=chunk)[208](index=208&type=chunk) - The business is highly dependent on the **successful development and commercialization of its lead product candidate, BGE-102**, which is in early development and faces an uncertain clinical and regulatory pathway[214](index=214&type=chunk) - The company relies on **third-party manufacturers in China and India**, exposing it to geopolitical risks, supply chain disruptions, and potential impacts from legislation like the BIOSECURE Act[308](index=308&type=chunk)[309](index=309&type=chunk) - The company is subject to a **securities class action lawsuit**, which could result in substantial costs and divert management's attention[428](index=428&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=130&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered equity sales and detailed the use of $217.2 million net proceeds from its September 2024 IPO and concurrent private placement Use of Proceeds from September 2024 Offerings | Offering | Gross Proceeds | Net Proceeds | | :--- | :--- | :--- | | Initial Public Offering | $227.7 million | $207.3 million | | Concurrent Private Placement | $10.6 million | $9.9 million | | **Total** | **$238.3 million** | **$217.2 million** | [Item 3. Defaults Upon Senior Securities](index=130&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities occurred during the reporting period [Item 4. Mine Safety Disclosures](index=130&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations [Item 5. Other Information](index=130&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted or terminated by directors or officers during the quarter [Item 6. Exhibits](index=131&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO/CFO certifications and Inline XBRL data files

[Business Highlights and Updates](index=1&type=section&id=Business%20Highlights%20and%20Updates) BioAge achieved significant Q2 2025 milestones, advancing its clinical pipeline, expanding APJ agonist programs, and enhancing discovery capabilities [NLRP3 Inhibitor Program (BGE-102)](index=1&type=section&id=NLRP3%20Inhibitor%20Program%20%28BGE-102%29) BioAge completed IND-enabling studies for BGE-102, an oral NLRP3 inhibitor for obesity, with Phase 1 trials starting H2 2025 - BGE-102, an oral NLRP3 inhibitor for obesity, completed IND-enabling studies and demonstrated significant preclinical weight loss, both as a monotherapy and in combination with semaglutide[3](index=3&type=chunk) - A Phase 1 SAD/MAD clinical trial is planned for the second half of 2025, with initial single ascending dose (SAD) data expected by year-end[2](index=2&type=chunk)[3](index=3&type=chunk) [APJ Agonist Pipeline Expansion](index=1&type=section&id=APJ%20Agonist%20Pipeline%20Expansion) BioAge expanded its APJ agonist pipeline through an exclusive option agreement and a new U.S provisional patent filing - Entered into an exclusive option agreement with JiKang Therapeutics for a novel APJ agonist nanobody that shows at least **10-fold greater potency** than apelin, the natural ligand[7](index=7&type=chunk) - Filed a U.S provisional patent application for a new class of orally active, chemically distinct APJ agonists with **picomolar potency** and favorable drug-like properties[7](index=7&type=chunk) [Discovery Platform Expansion](index=2&type=section&id=Discovery%20Platform%20Expansion) BioAge partnered with HUNT Biobank to profile **17,000+ samples**, securing exclusive access to molecular data for drug discovery - Launched an initiative with the HUNT Biobank to profile more than **17,000 samples** from over **6,000 participants**, generating **millions of molecular measurements**[4](index=4&type=chunk) - BioAge has **exclusive access** to the data generated from this partnership for drug discovery purposes[4](index=4&type=chunk) [Strategic Partnerships](index=2&type=section&id=Strategic%20Partnerships) BioAge advanced strategic collaborations with Novartis and Lilly ExploR&D for aging and metabolic disease targets - Continued the multi-year research collaboration with Novartis, announced in December 2024, to discover novel therapeutic targets at the intersection of aging biology and exercise physiology[8](index=8&type=chunk) - Progressed the strategic collaboration with Lilly ExploR&D, announced in January 2025, for the development of therapeutic antibodies targeting novel metabolic aging targets[8](index=8&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) BioAge reported a **net loss of $21.6 million** in Q2 2025 due to increased expenses, with **$313.4 million** cash, sufficient through 2029 [Key Financial Performance](index=2&type=section&id=Key%20Financial%20Performance) Q2 2025 saw R&D expenses rise to **$19.8 million** and G&A to **$7.3 million**, resulting in a **net loss of $21.6 million** Q2 2025 vs Q2 2024 Financial Highlights | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Research and Development | $19.8M | $10.5M | | General and Administrative | $7.3M | $4.8M | | Total Operating Expenses | $27.2M | $15.3M | | Net Loss | ($21.6M) | ($13.6M) | | Net Loss Per Share | ($0.60) | ($7.94) | - The **$9.3 million** increase in R&D expenses was primarily driven by an **$8.0 million** increase in costs for APJ agonist programs and a **$3.0 million** increase for the BGE-102 program, partially offset by a **$1.7 million** reduction in azelaprag costs[6](index=6&type=chunk) - The **$2.5 million** increase in G&A expenses was mainly due to a **$1.5 million** rise in personnel-related costs from stock-based compensation and a **$0.9 million** increase in legal fees[9](index=9&type=chunk) [Financial Position](index=3&type=section&id=Financial%20Position) As of June 30, 2025, BioAge maintained a strong financial position with **$313.4 million** in cash, sufficient to fund operations through 2029 - The company held approximately **$313.4 million** in cash, cash equivalents, and marketable securities as of June 30, 2025[11](index=11&type=chunk) - Management estimates that the current cash position is sufficient to fund operations and capital expenses through **2029**[11](index=11&type=chunk) Balance Sheet Summary | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total Current Assets | $301.7M | $357.1M | | Total Assets | $322.1M | $358.2M | | Total Liabilities | $27.4M | $35.1M | | Total Stockholders' Equity | $294.8M | $323.1M | [Corporate Information](index=3&type=section&id=Corporate%20Information) BioAge is a clinical-stage biopharmaceutical company focused on metabolic disease therapies, with standard forward-looking statements [About BioAge Labs, Inc.](index=3&type=section&id=About%20BioAge%20Labs%2C%20Inc.) BioAge is a clinical-stage biopharmaceutical company developing metabolic disease therapies by targeting human aging biology - BioAge is a clinical-stage biopharmaceutical company that targets the biology of human aging to develop therapies for metabolic diseases[12](index=12&type=chunk) - The lead product candidate is BGE-102, an oral NLRP3 inhibitor for obesity, with a Phase 1 trial planned for H2 2025. The company is also developing both injectable and oral APJ agonists for obesity[12](index=12&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section contains standard safe harbor statements, cautioning that projections are subject to significant risks and uncertainties - The press release contains forward-looking statements regarding plans to develop and commercialize product candidates, the timing and results of clinical trials, and the sufficiency of cash reserves[13](index=13&type=chunk) - These statements are subject to risks and uncertainties, including the ability to obtain regulatory approval, potential for adverse safety events, and dependence on collaborators, as detailed in the company's SEC filings[13](index=13&type=chunk)[14](index=14&type=chunk)

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]

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]