BioAge Announces Indication Expansion for Oral NLRP3 Inhibitor BGE-102, with Plans to Initiate Phase 1b/2a Proof-of-Concept Clinical Trial in Patients with Diabetic Macular Edema in Mid-2026

Rhea-AI Summary

BioAge (Nasdaq: BIOA) is expanding development of oral NLRP3 inhibitor BGE-102 into ophthalmology, initiating a Phase 1b/2a proof-of-concept trial in diabetic macular edema (DME) in mid-2026 with results expected mid-2027. BGE-102 showed favorable tolerability in Phase 1 and robust reductions in inflammatory biomarkers (hsCRP, IL-6, IL-1β). Preclinical data report near-complete protection from retinal vascular leakage and up to 90% microvascular preservation. The DME POC will test intraocular IL-6 percent change and include BCVA and CST endpoints.

Positive

• Oral delivery potential could reduce intravitreal injection burden
• Phase 1 showed favorable tolerability and biomarker reductions (hsCRP, IL-6, IL-1β)
• Preclinical retinal model: near-complete protection from vascular leakage
• Up to 90% preservation of microvascular integrity in preclinical DME model
• Planned DME POC trial with primary endpoint of percent change in intraocular IL-6

Negative

• Clinical efficacy in retinal disease remains unproven in humans pending mid-2027 readout
• Key human data (full Phase 1 readout) expected in 1H 2026, leaving near-term uncertainty
• DME program is early-stage (Phase 1b/2a), so regulatory and commercialization outcomes are not established

News Market Reaction – BIOA

+5.75%

16 alerts

+5.75% News Effect

-5.9% Trough in 2 min

+$42M Valuation Impact

$764M Market Cap

1.1x Rel. Volume

On the day this news was published, BIOA gained 5.75%, reflecting a notable positive market reaction. Argus tracked a trough of -5.9% from its starting point during tracking. Our momentum scanner triggered 16 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $42M to the company's valuation, bringing the market cap to $764M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Retinal microvascular integrity: up to 90% preservation Lipofuscin reduction: approximately 80% DME POC start: mid-2026 +5 more

8 metrics

Retinal microvascular integrity up to 90% preservation Preclinical DME model with oral BGE-102

Lipofuscin reduction approximately 80% Preclinical aging model with NLRP3 inhibition

DME POC start mid-2026 Planned Phase 1b/2a DME trial initiation

DME data readout mid-2027 Planned Phase 1b/2a DME trial results

CV Phase 2a readout 2H 2026 BGE-102 cardiovascular risk proof-of-concept study

Phase 1 completion 1H 2026 Full BGE-102 Phase 1 data readout

1-day price change -6.28% Move ahead of DME indication expansion announcement

52-week range $2.88–$24.00 Current price <b>$20.16</b> vs 52-week low/high

Market Reality Check

Price: $20.51 Vol: Volume 1,052,971 is about...

normal vol

$20.51 Last Close

Volume Volume 1,052,971 is about 1.34x the 20-day average of 783,379, indicating elevated trading interest. normal

Technical Shares at $20.16 are trading above the 200-day MA of $6.50 and 16% below the 52-week high of $24.

Peers on Argus

BIOA fell 6.28% while several peers like DERM (-3.61%), CTOR (-5.41%) and SXTC (...

BIOA fell 6.28% while several peers like DERM (-3.61%), CTOR (-5.41%) and SXTC (-5%) also declined, but no names appeared in the momentum scanner, suggesting stock-specific drivers.

Historical Context

5 past events · Latest: Jan 12 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 12	Phase 1 data update	Positive	+27.2%	Additional positive Phase 1 MAD data for BGE-102 in high-risk patients.
Dec 08	Partner drug access	Positive	+1.9%	Leqembi added to China commercial insurance innovative drug list.
Dec 04	Phase 1 data update	Positive	+14.0%	Initial positive interim Phase 1 data showing high IL-1β suppression.
Dec 04	Clinical data presentation	Positive	+14.0%	New Leqembi CTAD data suggesting multi‑year delay in progression.
Nov 25	Conference participation	Neutral	+3.9%	Announcement of BIOA presentation at Piper Sandler healthcare conference.

Pattern Detected

Across recent news, positive clinical and corporate updates have consistently coincided with positive next‑day price reactions, with no recorded divergences.

Recent Company History

Over the last six months, BIOA has repeatedly highlighted progress for BGE-102, from first-in-human dosing on Aug 15, 2025 through Phase 1 initiation and successive positive interim data readouts in Dec 2025 and Jan 2026. These updates produced double‑digit gains of up to 27.23%. Alongside, conference participation and partner Alzheimer’s data also coincided with smaller but positive moves. Today’s indication expansion into DME builds on this steady clinical-development trajectory.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-11-05

An amended S-3/A filed on Nov 5, 2025 registers up to 2,227,124 common shares for resale by a selling stockholder. The company is not selling shares and will not receive proceeds, but the registration facilitates potential secondary sales while BIOA bears registration expenses. The shelf was not yet effective and shows no recorded usage.

Market Pulse Summary

The stock moved +5.8% in the session following this news. A strong positive reaction aligns with BIO...

Analysis

The stock moved +5.8% in the session following this news. A strong positive reaction aligns with BIOA’s history of sharp gains on BGE-102 clinical milestones, where prior trial updates produced moves up to 27.23%. The new DME indication and clearly laid-out timelines through mid-2027 extend the “pipeline in a pill” theme. However, the presence of an effective resale registration for up to 2,227,124 shares and recent insider selling could introduce supply overhang once enthusiasm moderates.

Key Terms

inflammasome, diabetic macular edema, geographic atrophy, intravitreal, +3 more

7 terms

inflammasome medical

"Growing preclinical and clinical evidence points to central role of the inflammasome in multiple retinal diseases"

A cellular protein assembly that senses danger or infection and turns on a rapid inflammatory response by activating enzymes that release signaling molecules and can trigger a controlled form of cell death. Think of it as a built‑in smoke detector and alarm system for immune cells: useful short-term to alert the body, but if it stays on it can cause chronic inflammation. Investors watch inflammasomes because they are drug targets and biomarkers that can affect a therapy’s effectiveness, safety profile, and regulatory path.

diabetic macular edema medical

"proof-of-concept (POC) study in patients with diabetic macular edema (DME)"

Diabetic macular edema is an eye condition in which fluid leaks into and swells the macula, the part of the retina used for sharp, central vision, often as a complication of diabetes. For investors it matters because it drives demand for medicines, medical devices and eye-care services, influences clinical trial and regulatory outcomes, and can affect healthcare costs and revenue forecasts—think of the macula as the camera’s central lens that becomes blurred when it soaks up excess fluid.

geographic atrophy medical

"potential for expansion into additional NLRP3-driven retinal diseases, including geographic atrophy"

Geographic atrophy is a progressive eye condition in which patches of light-sensing cells in the retina die, causing growing blind spots and ultimately significant central vision loss. For investors, it matters because the condition defines the market size and urgency for drugs, devices, and diagnostics — like a spreading hole in a photograph that companies aim to stop or repair — so clinical results, approvals, and reimbursement determine potential revenue and risk.

intravitreal medical

"patients ... who currently require frequent intravitreal injections"

An intravitreal treatment is one given by injecting medicine directly into the gel-like center of the eye, delivering drugs straight to the site of retinal disease rather than through pills or eye drops. Investors care because this delivery method affects development costs, regulatory review, clinical risk, manufacturing and distribution complexity, and reimbursement — all factors that influence a therapy’s commercial potential.

best-corrected visual acuity medical

"exploratory endpoints including best-corrected visual acuity (BCVA), central subfield thickness"

The sharpest level of sight a person can reach when using the best possible glasses or contact lenses; think of it as how well a camera can resolve detail once its lens is perfectly focused. It matters to investors because it is a common clinical measure and regulatory endpoint for eye drugs, procedures and devices, so changes in best-corrected visual acuity indicate whether a treatment works and can drive approval, market size and sales potential.

central subfield thickness medical

"exploratory endpoints including best-corrected visual acuity (BCVA), central subfield thickness (CST)"

Central subfield thickness is a measurement of the retina’s thickness at the very center of the macula, typically taken by an imaging scan of the eye; think of it like measuring the height of the ground at the center of a small target. It matters to investors because changes in this number are a common, objective medical endpoint used to judge whether eye drugs or devices relieve swelling and improve vision, which influences regulatory approval, market potential, and sales forecasts.

pharmacodynamics medical

"goal of the POC trial will be to demonstrate target engagement and pharmacodynamics (PD) for BGE-102"

Pharmacodynamics is how a drug actually affects the body — the strength, type and duration of its effects and the relationship between dose and response. Think of it like how turning a thermostat changes room temperature: it shows what the drug does and how much is needed to get the desired effect. Investors care because these properties drive clinical success, dosing convenience, safety profile and competitive advantage, all of which influence commercial potential and regulatory approval.

AI-generated analysis. Not financial advice.

BGE-102 has the potential for therapeutic retinal exposure with oral delivery, reducing treatment burden in ocular indications currently treated with intravitreal therapies

Growing preclinical and clinical evidence points to central role of the inflammasome in multiple retinal diseases where inflammation is a key feature, including diabetic macular edema (DME)

BGE-102 has demonstrated favorable tolerability to date in ongoing Phase 1 trial, with robust reductions in key inflammatory biomarkers including hsCRP, IL-6, and IL-1β

Proof-of-concept trial in DME is designed to demonstrate ocular target engagement, supporting future development across inflammation-driven retinal diseases

DME trial, with results anticipated mid-2027, to run in parallel with the BGE-102 Phase 2a cardiovascular risk trial, with results anticipated 2H26

EMERYVILLE, Calif., Jan. 20, 2026 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (Nasdaq: BIOA) ("BioAge", “the Company”), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced expansion of its BGE-102 development program into ophthalmology, with an initial proof-of-concept (POC) study in patients with diabetic macular edema (DME). BGE-102 is a potent, structurally novel, orally administered small molecule NLRP3 inhibitor with potential for therapeutic retinal exposure.

NLRP3 inflammasome activation is a central pathological feature in a range of retinal diseases. In DME, activation of NLRP3 by hyperglycemia leads to vascular leakage and compromised vision. DME represents the initial proof-of-concept indication for BGE-102 in ophthalmology, with potential for expansion into additional NLRP3-driven retinal diseases, including geographic atrophy.

“The efficacy observed with injectable IL-6 inhibitors in retinal disease validates targeting the inflammatory cascade in the eye,” said Kristen Fortney, PhD, CEO and co-founder of BioAge. “NLRP3 sits at the apex of this cascade, and BGE-102 offers the potential to deliver broader anti-inflammatory benefit in an oral formulation, which could meaningfully reduce treatment burden for patients with serious, sight-threatening conditions who currently require frequent intravitreal injections. In our ongoing Phase 1 trial, BGE-102 has already demonstrated the potential for best-in-class reductions in inflammatory markers of cardiovascular risk, our primary development focus, with a Phase 2a readout anticipated in 2H26. Together, these promising features position BGE-102 as a potential 'pipeline in a pill': a single oral therapy to address NLRP3-driven inflammation across cardiovascular, CNS, and ocular diseases.”

Preclinical evidence supporting development of BGE-102 for retinal disease

In a preclinical model of DME, oral BGE-102 demonstrated dose-dependent preservation of retinal vascular integrity, achieving near-complete protection from vascular leakage and up to 90% preservation of microvascular integrity. In retinal diseases more broadly, published studies [1, 2] have shown that deletion or inhibition of NLRP3 provides complete protection of the retinal pigment epithelium against pro-inflammatory challenges. And in preclinical studies performed by BioAge in a natural model of aging, NLRP3 inhibition reduced age-related accumulation of lipofuscin — a toxic aggregate linked to pathogenesis of retinal diseases including geographic atrophy — by approximately 80%.

Clinical evidence supporting anti-inflammatory approach in retinal disease

A growing body of clinical data supports the therapeutic rationale for targeting inflammation in inflammatory diseases of the retina. In macular edema patients (diabetic and/or uveitis), intravitreal IL-6 inhibitors have demonstrated sustained gains in visual acuity both as monotherapy and as incremental benefit when added to VEGF inhibitor therapy.

Planned proof-of-concept clinical trial in DME

BioAge plans to initiate a Phase 1b/2a POC trial in patients with DME in mid-2026. The randomized, controlled trial will evaluate patients across three arms to evaluate the efficacy of BGE-102 as a monotherapy and in combination with a VEGF inhibitor.

The goal of the POC trial will be to demonstrate target engagement and pharmacodynamics (PD) for BGE-102 in the eye to motivate future clinical development in retinal diseases driven by inflammation. The primary endpoint will be percent change in intraocular IL-6, with additional exploratory endpoints including best-corrected visual acuity (BCVA), central subfield thickness (CST) and intraocular and plasma biomarkers. Results are anticipated in mid-2027.

Additional details on preclinical data, clinical rationale, and trial design are available in the Company's corporate presentation at https://ir.bioagelabs.com.

Anticipated clinical milestones for BGE-102

• 1H 2026:
  • Completion of Phase 1 trial with full data readout, including two additional MAD cohorts in obese participants with elevated hsCRP
  • Initiation of Phase 2a POC trial in patients with obesity and cardiovascular (CV) risk factors.
• Mid-2026:
  • Initiation of Phase 1b/2a POC trial in patients with DME
• 2H 2026:
  • CV risk Phase 2a POC trial data readout
• Mid-2027:
  • DME Phase 1b/2a POC trial data readout
    

Background on BGE-102 and NLRP3

BGE-102 is a potent, orally available, brain-penetrant small molecule NLRP3 inhibitor being developed for diseases of inflammation including elevated cardiovascular risk. BGE-102 represents a structurally novel class of NLRP3 inhibitors developed by BioAge with a unique mechanism and binding site. NLRP3 is a key driver of age-related inflammation that has been implicated in a broad range of diseases, including cardiovascular disease, neurodegeneration, and metabolic disorders. In an ongoing Phase 1 clinical trial, the compound has demonstrated a favorable safety profile and robust reductions in key inflammatory biomarkers IL-6, hsCRP, and IL-1β in patients with obesity and elevated cardiovascular risk.

About BioAge Labs, Inc.

BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The Company's lead product candidate, BGE-102, is a potent, orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed for cardiovascular risk and retinal diseases. A Phase 1 SAD/MAD trial of BGE-102 is underway, with topline data including additional MAD cohorts anticipated in 1H26. The Company is also developing long-acting injectable and oral small molecule APJ agonists for obesity. BioAge’s additional preclinical programs, which leverage insights from the Company’s proprietary discovery platform built on human longevity data, address key pathways involved in metabolic aging.

Forward-looking statements

This press release contains "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our plans to develop and commercialize our product candidates, including BGE-102, the potential for BGE-102 as a treatment for cardiovascular and retinal diseases including DME, the expected timing of clinical trials, the timing and results of our clinical activities, risks associated with clinical trials, including our ability to adequately manage clinical activities, the timing of and our ability to obtain and maintain regulatory approvals and the clinical utility of our product candidates. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "potential," "possible," "will," "would," and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop, obtain regulatory approval for and commercialize our product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions, including due to the imposition of tariffs and other trade barriers; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; changes in or failure to comply with legal and regulatory requirements, including shifting priorities within the U.S. Food and Drug Administration; risks relating to access to capital and credit markets; and the other risks and uncertainties that are detailed under the heading "Risk Factors" included in BioAge's Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on November 6, 2025, and BioAge's other filings with the SEC filed from time to time. BioAge undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contacts
PR: Chris Patil, media@bioagelabs.com
IR: Dov Goldstein, ir@bioagelabs.com
Partnering: Peng Leong, partnering@bioagelabs.com
Web: https://bioagelabs.com

FAQ

What is BioAge (BIOA) announcing about BGE-102 and diabetic macular edema?

BioAge plans to initiate a Phase 1b/2a POC trial in DME in mid-2026 to assess ocular target engagement, with results anticipated mid-2027.

What primary endpoint will the BGE-102 DME trial (BIOA) use and when are results expected?

The primary endpoint is percent change in intraocular IL-6, and results are expected in mid-2027.

What human clinical evidence has BioAge reported for BGE-102 (BIOA) to date?

In an ongoing Phase 1, BGE-102 demonstrated favorable tolerability and reductions in inflammatory biomarkers including hsCRP, IL-6, and IL-1β.

What preclinical retinal results support BGE-102's use in DME for BIOA?

Preclinical DME models showed dose-dependent preservation of retinal vascular integrity with near-complete protection from leakage and up to 90% microvascular preservation.

How does the DME trial fit with BioAge's other BGE-102 programs (BIOA) and timelines?

The DME Phase 1b/2a POC (mid-2026 start, mid-2027 readout) will run in parallel with a Phase 2a cardiovascular risk POC that has a 2H26 data readout.