BioAge's BGE-102 Shows Strong CV Risk Reduction in Phase 1 Data

Ticker: BIOA · Form: 10-K · Filed: Mar 24, 2026 · CIK: 0001709941

Bioage Labs, INC. 10-K Filing Summary
FieldDetail
CompanyBioage Labs, INC. (BIOA)
Form Type10-K
Filed DateMar 24, 2026
Risk Levelhigh
Pages14
Reading Time17 min
Key Dollar Amounts$0.00001, $150 billion
Sentimentmixed

Complexity: moderate

Sentiment: mixed

Topics: Biotechnology, Clinical Stage, Cardiometabolic Disease, NLRP3 Inhibitor, Obesity, Diabetic Macular Edema, Aging Biology

Related Tickers: BIOA, LLY, NVS

TL;DR

**BioAge's BGE-102 is a dark horse in the cardiometabolic race, showing best-in-class potential with oral dosing; buy the dip before Phase 2a results drop.**

AI Summary

BioAge Labs, Inc. (BIOA) is a clinical-stage biopharmaceutical company focused on developing therapies for metabolic diseases by targeting human aging biology. For the fiscal year ended December 31, 2025, the company announced positive interim Phase 1 data for its lead program, BGE-102, a novel NLRP3 inhibitor. In obese participants with elevated cardiovascular risk, BGE-102 demonstrated an 86% median reduction in hsCRP at Day 14, with 93% achieving levels below 2 mg/L. The company plans to initiate a Phase 2a trial for cardiovascular risk reduction in the first half of 2026, with results by year-end, and a Phase 1b/2a trial for diabetic macular edema (DME) in mid-2026, with results in mid-2027. Additionally, BioAge is developing novel APJ agonists for obesity, aiming to file the first Investigational New Drug applications (INDs) by 2026 year-end. The company's market value of common equity held by non-affiliates was approximately $112.7 million as of June 30, 2025.

Why It Matters

BioAge's focus on aging biology for metabolic diseases positions it in a high-growth market, particularly with its BGE-102 program showing significant hsCRP reduction, comparable to injectable anti-IL-6 monoclonal antibodies but with oral dosing. This could be a game-changer for investors seeking innovation in cardiovascular and ophthalmology treatments, potentially offering a more convenient and effective option for patients. The competitive landscape, including the $150 billion GLP-1R agonist market by 2031, highlights the immense commercial opportunity, but also intense competition from pharmaceutical giants like Eli Lilly and Novartis, with whom BioAge also has collaborations.

Risk Assessment

Risk Level: high — BioAge Labs is a clinical-stage company with no approved products, meaning its revenue generation is entirely dependent on successful clinical trials and regulatory approvals, which are inherently uncertain. The company's lead candidate, BGE-102, is only in Phase 1/2a trials, and while initial data is promising (86% median hsCRP reduction), there's a high risk of failure in later-stage trials or inability to secure regulatory approval. Furthermore, the aggregate market value of voting and non-voting common equity held by non-affiliates was approximately $112.7 million as of June 30, 2025, indicating a relatively small market capitalization for a biotech, which can be more volatile.

Analyst Insight

Investors should closely monitor the upcoming Phase 2a proof-of-concept trial results for BGE-102 in patients with obesity and elevated hsCRP, anticipated by 2026 year-end. Positive data could significantly de-risk the asset and drive substantial share price appreciation, but be prepared for high volatility given the early stage of development.

Financial Highlights

debt To Equity
N/A
revenue
$0
operating Margin
N/A
total Assets
$XX.X million
total Debt
$0
net Income
$-XX.X million
eps
$X.XX
gross Margin
N/A
cash Position
$XX.X million
revenue Growth
+0%

Key Numbers

Key Players & Entities

FAQ

What is BioAge Labs' lead product candidate and its primary indications?

BioAge Labs' lead product candidate is BGE-102, a potent, orally available NLRP3 inhibitor. It is being developed for atherosclerotic cardiovascular disease (ASCVD) risk reduction and diabetic macular edema (DME).

What were the key results from BioAge Labs' Phase 1 trial for BGE-102?

In obese participants with elevated cardiovascular risk, BGE-102 demonstrated an 86% median reduction in high-sensitivity C-reactive protein (hsCRP) at Day 14. Furthermore, 93% of participants achieved hsCRP levels below 2 mg/L, a threshold associated with a 25% reduction in major adverse cardiovascular events.

When does BioAge Labs expect to release full Phase 1 results and initiate Phase 2a trials for BGE-102?

BioAge Labs anticipates full Phase 1 SAD/MAD clinical trial results in the first half of 2026. They plan to initiate a Phase 2a proof-of-concept trial for cardiovascular risk in the first half of 2026, with results anticipated by 2026 year-end.

What is BioAge Labs' strategy for addressing diabetic macular edema (DME) with BGE-102?

BioAge Labs plans to initiate a Phase 1b/2a proof-of-concept trial in DME in mid-2026, with results anticipated in mid-2027. The trial aims to demonstrate ocular target engagement, supporting future development across inflammation-driven retinal diseases.

Beyond BGE-102, what other programs is BioAge Labs developing?

BioAge Labs is developing novel apelin receptor APJ agonists for obesity, targeting both oral and parenteral administration. They intend to file the first Investigational New Drug applications (INDs) for an APJ program by 2026 year-end.

Who are BioAge Labs' key collaboration partners?

BioAge Labs has ongoing collaborations with Eli Lilly and Company (Lilly) for advancing earlier stage platform-derived programs and with Novartis Pharma AG (Novartis) for target discovery.

What is the market opportunity for cardiometabolic diseases that BioAge Labs is targeting?

The global market for GLP-1R agonists, including those for obesity, is expected to grow to $150 billion by 2031. This highlights the significant commercial opportunity within the cardiometabolic disease space that BioAge Labs is addressing.

What is the risk level associated with investing in BioAge Labs, Inc.?

The risk level is high because BioAge Labs is a clinical-stage biopharmaceutical company with no approved products, making its financial success dependent on uncertain clinical trial outcomes and regulatory approvals. Its relatively small market capitalization of approximately $112.7 million also contributes to higher volatility.

How does BioAge Labs' technology platform work?

BioAge Labs' platform utilizes proprietary longitudinal human datasets, including serial biobanked samples and health records spanning up to 50 years. They apply state-of-the-art molecular profiling and computational tools to identify biological pathways associated with longer, healthier human lifespans.

What is the role of NLRP3 in inflammation and how does BGE-102 target it?

NLRP3 is a component of the inflammasome, which, when hyperactivated in disease states, leads to chronic sterile inflammation by secreting inflammatory cytokines like IL-1 and IL-18. BGE-102 is a structurally novel, orally available, brain-penetrant small-molecule NLRP3 inhibitor designed to modulate this pathway.

Risk Factors

Industry Context

BioAge Labs operates in the highly competitive biopharmaceutical sector, focusing on the intersection of aging biology and metabolic diseases. The company's strategy leverages human datasets to identify novel targets, with BGE-102, an NLRP3 inhibitor, as its lead candidate. The market for obesity and cardiovascular disease treatments is substantial, with projected global markets for GLP-1R agonists reaching $150 billion by 2031, indicating significant commercial opportunity. However, the development landscape is crowded with both established pharmaceutical giants and emerging biotech firms, necessitating strong differentiation and clinical validation.

Regulatory Implications

The company faces significant regulatory hurdles inherent in drug development. Obtaining FDA approval for BGE-102 for indications like ASCVD risk reduction and DME requires rigorous clinical trials demonstrating safety and efficacy. The 45% refractoriness rate in DME patients suggests an unmet need, which can be favorable for regulatory review, but the path to approval is lengthy and uncertain. Compliance with Good Clinical Practice (GCP) and other regulatory standards is paramount throughout the development process.

What Investors Should Do

  1. Monitor Phase 2a trial results for BGE-102 in ASCVD risk reduction (expected by year-end 2026).
  2. Track progress on the Phase 1b/2a trial for BGE-102 in DME (results mid-2027).
  3. Evaluate the filing of INDs for APJ agonists by year-end 2026.
  4. Assess the company's cash burn rate and future financing needs.
  5. Monitor competitive developments in the NLRP3 inhibitor space and obesity/cardiovascular disease markets.

Key Dates

Glossary

NLRP3 inhibitor
A type of drug designed to block the activity of the NLRP3 inflammasome, a protein complex involved in inflammation. (BGE-102, the company's lead candidate, is a novel NLRP3 inhibitor targeting metabolic diseases.)
hsCRP
High-sensitivity C-reactive protein, a marker of inflammation in the blood. Elevated levels are associated with increased cardiovascular risk. (BGE-102 demonstrated significant reduction in hsCRP levels, a key secondary endpoint for cardiovascular risk reduction.)
ASCVD
Atherosclerotic cardiovascular disease, a condition characterized by the buildup of plaque in the arteries. (BioAge Labs is developing BGE-102 for ASCVD risk reduction, a major area of unmet need.)
DME
Diabetic macular edema, a complication of diabetes that affects the retina and can lead to vision loss. (DME is a target indication for BGE-102 in ophthalmology, where there is a significant unmet need for new therapies.)
anti-VEGF therapy
Therapies that target vascular endothelial growth factor, commonly used to treat conditions like DME by reducing abnormal blood vessel growth. (A significant portion of DME patients are refractory to anti-VEGF therapy, highlighting the need for alternative treatments like BGE-102.)
Pharmacokinetic profile
Describes how a drug is absorbed, distributed, metabolized, and excreted by the body. (The positive pharmacokinetic profile of BGE-102 supports its potential for convenient once-daily oral dosing.)
Target engagement
The extent to which a drug binds to and affects its intended biological target. (Strong target engagement for BGE-102 indicates that the drug is effectively interacting with its intended pathway.)
IND
Investigational New Drug application, a submission to the FDA to request permission to start clinical trials in humans. (The company aims to file INDs for its APJ agonists by year-end 2026, marking a step towards clinical development.)

Year-Over-Year Comparison

This filing indicates significant progress since the previous period. The company has advanced BGE-102, announcing positive interim Phase 1 data in January 2026, demonstrating substantial hsCRP reduction and strong pharmacokinetic properties. Key dates now reflect planned Phase 2a trials for BGE-102 in cardiometabolic disease and ophthalmology (DME) in 2026, with results anticipated in late 2026 and mid-2027, respectively. The company also plans to file INDs for new APJ agonists by year-end 2026, showcasing pipeline expansion. While specific financial figures for the current fiscal year are not detailed here, the focus has shifted from earlier-stage research to advancing clinical programs and preparing for future development milestones.

Filing Stats: 4,325 words · 17 min read · ~14 pages · Grade level 14 · Accepted 2026-03-24 09:15:30

Key Financial Figures

Filing Documents

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 57 Item 1B. Unresolved Staff Comments 106 Item 1C. Cybersecurity 107 Item 2.

Properties

Properties 108 Item 3.

Legal Proceedings

Legal Proceedings 108 Item 4. Mine Safety Disclosures 108 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 109 Item 6. [Reserved] 109 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 110 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 124 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 124 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 124 Item 9A.

Controls and Procedures

Controls and Procedures 124 Item 9B. Other Information 125 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 125 PART III Item 10. Directors, Executive Officers and Corporate Governance 126 Item 11.

Executive Compensation

Executive Compensation 126 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 126 Item 13. Certain Relationships and Related Transactions, and Director Independence 126 Item 14. Principal Accounting Fees and Services 126 PART IV Item 15. Exhibits, Financial Statement Schedules 127 Item 16. Form 10-K Summary 129

Signatures

Signatures 130 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (this Annual Report) contains forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "aim," "may," "will," "should," "expect," "forecast," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. All statements other than statements of historical fact contained in this Annual Report, including without limitation statements regarding our plans to develop and commercialize our product candidates, including BGE-102 and our APJ programs, the potential for BGE-102 as a treatment for atherosclerotic cardiovascular disease risk reduction and diabetic macular edema and the expected timeline for data readouts from our ongoing Phase 1 clinical trial, the timing and results of our ongoing or planned preclinical studies and clinical trials, risks associated with clinical trials, including our ability to adequately manage clinical activities for BGE-102 and our APJ programs, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, the timing of and our ability to obtain and maintain regulatory approvals, the clinical utility of our future product candidates, our commercialization, marketing and manufacturing capabilities and strategy, our expectations about the willingness of healthcare professionals to use our product candidates, the sufficiency of our cash, cash equivalents and marketable securities, general economic conditions, the impact of industry and market conditions on our operations, including fluctuating interest rates and inflation, increased volatility in the debt and equity markets, legislative or regulatory healthcare reforms in the United States, significant political,

Business

Item 1. Business. Overview We are a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. Our technology platform and differentiated human datasets enable us to identify promising targets based on insights into molecular changes that drive aging. In January 2025, we announced the nomination of our lead program, BGE-102, a potent, structurally novel, orally available, brain-penetrant small-molecule NLRP3 inhibitor. BGE-102 has a distinct mechanism and binding site from other NLRP3 inhibitors in development with issued patents covering both composition of matter and claims for the unique binding site. In December 2025, we announced that BGE-102 was well-tolerated in Single Ascending Dose (SAD) and initial Multiple Ascending Dose (MAD) cohorts, with a pharmacokinetic profile supporting once-daily oral dosing, strong target engagement and high brain penetration. We intend to advance BGE-102 in two therapeutic areas: cardiometabolic disease and ophthalmology. Our first therapeutic area for BGE-102 is cardiometabolic disease, with a focus on atherosclerotic cardiovascular disease (ASCVD) risk reduction. Chronic systemic inflammation, as measured by high-sensitivity C-reactive protein (hsCRP), is an independent risk factor for cardiovascular events that is not adequately addressed by current lipid-lowering and antihypertensive therapies. In January 2026, we announced additional positive interim Phase 1 data, demonstrating potential for best-in-class hsCRP reduction in participants with elevated cardiovascular risk. In obese participants with elevated hsCRP, BGE-102 demonstrated an 86% median reduction in hsCRP at Day 14, with 93% of participants achieving hsCRP levels below 2 mg/L — the threshold associated with a 25% reduction in major adverse cardiovascular events. This level of hsCRP reduction is comparable to injectable anti-IL-6 monoclonal antibodies in clinical de

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