STIFEL 2026 HEALTHCARE CONFERENCE - BIOAGE LABS INC

Financial Performance:

• Cash balance stands at just over $350 million as of the last quarter.
• Cash reserves are sufficient to fund all current clinical activities, including the ongoing Quell-CV and Quell-DME trials.
• No specific revenue or profit metrics were reported as the company is in the clinical development stage with no commercial products on market.
• No debt information or detailed margins were disclosed in the call.

Guidance and Future Outlook:

• Quell-CV trial (dose-ranging in cardiometabolic patients) expected to read out at the end of the current year.
• Quell-DME trial (Diabetic Macular Edema) enrollment is underway with top-line data expected at the end of next year.
• IND submission for the APJ next-generation programs (oral and parenteral) targeted for the end of the current year.
• Clinical debut of APJ programs and development plans to be announced immediately following IND submission.
• An additional NLRP3 indication is planned to be announced once development plans are fully solidified; timing is near-term but unspecified.

Business Segments and Product Lines:

• BGE-102 (Lead Program): Oral NLRP3 inflammasome inhibitor demonstrating 98% trough inhibition of IL-1 beta and 86% reduction of hsCRP in Phase I.
• Cardiometabolic Segment: Quell-CV trial assesses three doses (30, 60, 90 mg) focusing on inflammatory/metabolic biomarkers and liver MRI; currently not a strategic priority pending surprise positive data from the Artemis trial.
• Ophthalmology Segment: Primary strategic focus; Quell-DME evaluates BGE-102 as monotherapy and in combination with VEGF for Diabetic Macular Edema, targeting visual acuity improvement.
• APJ Program: Next-generation APJ agonists (oral/parenteral) show preclinical potential to double weight loss and preserve muscle mass when combined with incretins; IND filing anticipated year-end.
• Indications: Priority indications include Diabetic Macular Edema (DME) and Geographic Atrophy (GA), with interest in Metastatic Eye Systemic Inflammation (MESI) and UME.

Market and Competitive Landscape:

• NLRP3 Target: Distinct from competitors (e.g., Pfizer's MCC950 derivatives) by utilizing a novel binding site allowing inhibition of both active and inactive inflammasome forms, enabling superior tissue distribution (CSF, retina).
• Cardiovascular: Cautiously interpreting the negative ZENITH trial results; believes NLRP3 is upstream of IL-1 beta/IL-6 pathways, suggesting a potential for benefit in specific populations, though not currently a priority.
• Ophthalmology: Aims to reduce treatment burden (oral vs. intravitreal injections) and address systemic drivers of disease (hyperglycemia/inflammation) beyond local VEGF inhibition.
• Competition: Compares favorably to Roche/Novartis IL-6 programs (e.g., Mickey Bar) regarding mechanism depth, noting NLRP3 captures broader biology including IL-1 beta, IL-18, and pyroptosis.

Risks and Challenges:

• Cardiovascular Strategy: Current shift away from ASCVD as a priority due to the Zeus trial results; reliance on a "surprise" positive signal from the Artemis trial to reconsider this path.
• Clinical Execution: Dependence on successful top-line results from Quell-DME to validate the ophthalmology beachhead strategy and support subsequent GA trials.
• Market Acceptance: Potential challenge in convincing patients and providers to switch from established intravitreal therapies to oral agents, though oral dosing is viewed as a significant value proposition for adherence.

Management Commentary and Tone:

• Confidence: Management expressed high confidence in BGE-102's best-in-class profile, specifically regarding potency (IC90 of 1.6 nM), tolerability (placebo-like), and tissue penetration.
• Strategic Focus: Clear pivot towards ophthalmology as the primary near-term commercial opportunity while maintaining financial runway for APJ and additional NLRP3 indications.
• Tone: Cautiously optimistic regarding the cardiometabolic pause, emphasizing readiness to pivot quickly if new data warrants, but firm on the current prioritization of eye diseases.

Analyst Questions and Answers:

• Artemis Trial Signal: Clarified that a "clear signal" or decisive magnitude of benefit in the Artemis trial (acute MI setting) would be required to reconsider the ASCVD indication, as current data suggests the failure in Zeus was likely due to biology/pathway depth rather than patient selection.
• DME Patient Population: Confirmed targeting the 40% "watch and wait" cohort (edema present but vision not yet compromised or patient unwilling to inject) as well as refractory patients on VEGF therapy.
• Biomarkers: Confirmed monitoring of systemic cardiometabolic markers (glucose, kidney function) in DME patients to capture systemic benefits alongside local ocular improvements.
• Enrollment Status: Quell-DME enrollment is proceeding well; oral dosing is expected to facilitate patient recruitment compared to needle-based therapies.
• Trial Endpoint: Visual acuity remains the primary endpoint for all DME trial arms, including monotherapy and combination groups.

Other Key Points:

• BioAge's platform leverages human aging biology for target discovery, focusing on inflammation pathways.
• BGE-102 demonstrates unique pharmacokinetic properties with high free levels in the CSF (0.7 CSF:PK ratio) and retina, supporting CNS and ophthalmic indications.
• Intellectual property for BGE-102 covers specific structures and broadly licenses ligands interacting with the novel binding site, extending through 2045.
• The company is capitalizing on the disconnect between clinical trial outcomes and real-world patient adherence by offering oral alternatives to frequent injections.