STIFEL 2026 HEALTHCARE CONFERENCE - BIOAGE LABS INC

Financial Performance:

• Reported a cash balance of just over $350 million as of the last quarter.
• Cash reserves are sufficient to fund all current clinical activities, including QUEL-CV, QUEL-DME, APJ programs through proof-of-concept, and an additional BG-102 indication.
• No specific revenue, earnings, or debt figures were disclosed in the transcript; the company remains in the clinical development stage.

Guidance and Future Outlook:

• QUEL-CV (Cardiometabolic): Expected to report top-line data by the end of the current year.
• QUEL-DME (Ophthalmology): Enrolling patients with top-line data anticipated by the end of next year.
• APJ Programs: Targeting Investigational New Drug (IND) submission by the end of the current year to debut oral and parenteral next-generation programs.
• Additional Indication: Plans to announce a new BG-102 indication once development plans are fully solidified (timeline unspecified).
• Long-term Goal: Establish a beachhead in ophthalmology to leverage oral delivery for reducing treatment burden in retinal diseases.

Business Segments and Product Lines:

• BG-102 (NLRP3 Inhibitor): Lead oral candidate demonstrating best-in-class potency (IC90 of 1.6 nM) and deep target inhibition (98% trough suppression of IL-1β, 86% CRP reduction in obese/inflamed cohorts).
  • QueL-CV Trial: Dose-ranging study (30, 60, 90 mg) assessing metabolic/inflammatory biomarkers and liver MRI; currently ongoing.
  • QueL-DME Trial: Investigating BG-102 as monotherapy and combination therapy with VEGF for Diabetic Macular Edema (DME); aims to improve visual acuity and reduce injection burden.
  • Ophthalmology Pipeline: High priority indications include Geographic Atrophy (GA) and Macular Edema with Subretinal Fluid (MESI), supported by preclinical data showing prevention of retinal tissue deterioration.
• APJ Agonism: Targeting longevity and physical function; combines with incretins to double weight loss and preserve muscle mass. First-generation compound showed preservation of muscle size in older adults at bed rest.
• Platform Differentiation: BG-102 utilizes a novel binding site on NLRP3 (distinct from Pfizer's MCC950), allowing inhibition of both active and inactive inflammasome forms, with exceptional tissue distribution into the CSF and retina.
• IP Portfolio: Patents filed covering specific structures and broad claims for ligands interacting with the novel binding site, extending to 2045.

Market and Competitive Landscape:

• Cardiovascular Context: Management views the recent Zeus trial results as reinforcing NLRP3 as a valid upstream target rather than refuting it, despite the trial's negative primary endpoint; however, atherosclerotic cardiovascular disease (ASCVD) is no longer a near-term priority.
• Ophthalmology Opportunity: Significant market demand exists for oral therapies to replace intravitreal injections, addressing a patient segment of "watch and wait" patients (40% of DME patients) and those with incomplete disease control on VEGF therapy.
• Competitive Differentiation: BG-102 offers a distinct mechanism from IL-6 inhibitors (e.g., Roche/Regeneron), targeting upstream cytokines (IL-1β, IL-18) and pyroptosis, potentially addressing the root inflammatory drivers of DME and GA.
• Market Trends: Growing focus on "healthy aging" and inflammation as a driver of chronic disease (MASH, kidney disease, AMD).

Risks and Challenges:

• Cardiovascular Uncertainty: ASCVD program is on pause; management requires a "very decisive win" from the upcoming Artemis trial (Novo acute MI study) to reconsider this indication.
• Trial Success Dependency: Commercial viability for ophthalmology hinges on demonstrating visual acuity benefits in the QUEL-DME trial and subsequent trials for GA.
• Patient Enrollment: While oral dosing may facilitate enrollment compared to injections, competition for DME patients remains high.
• Biomarker Correlation: Reliance on CRP as a proxy for anti-inflammatory activity, though acknowledged that CRP reduction does not guarantee cardiovascular benefit (citing Zeus).

Management Commentary and Tone:

• Tone: Confident, optimistic, and strategic. Management emphasizes the "best-in-class" pharmacodynamic profile of BG-102 and the unique value proposition of oral administration in ophthalmology.
• Strategy: Clear pivot toward ophthalmology and aging-related metabolic health, deprioritizing immediate large-scale cardiovascular development pending new data.
• Communication: Transparent about the status of the ASCVD program (on pause) and the rationale behind the strategic shift based on the Zeus data analysis.

Analyst Questions and Answers:

• Artemis/ASCVD Strategy: Analyst asked what data would trigger a restart of the ASCVD program. Management stated they need a "very decisive win" (statistical significance or clear magnitude) from the Artemis trial, as they remain skeptical that the Zeus patients were simply "too far gone" given the lack of subgroup signals.
• DME Patient Population: Analyst questioned the target segment. Management highlighted the "watch and wait" group (40% of patients) and VEGF-incompliant patients as key targets, noting that oral therapy would significantly reduce the treatment burden of intravitreal injections.
• Mechanism in DME: Management affirmed DME is highly inflammatory, driven by hyperglycemia activating NLRP3, leading to VEGF induction and pyroptosis-mediated endothelial damage.
• Systemic Impact: Confirmed that the trial will monitor systemic metabolic markers (glucose control, kidney function) to capture benefits beyond the eye.
• Trial Progress: Reported enrollment is "going well" and on track for top-line data at the end of next year.

Other Key Points:

• Unique Binding Site: The company utilized a de novo approach (Dell screen) to identify a novel binding site on NLRP3, characterizing it via collaboration with the University of Bonn.
• Preclinical Models: Utilization of an outbred mouse strain to study natural aging, showing BG-102 analogs prevent lipofuscin accumulation and retinal degradation.
• Combination Potential: BG-102 is being tested in combination with VEGF inhibitors to enhance disease control in DME.
• Funding Adequacy: Management explicitly stated current cash reserves cover the full scope of the roadmap through proof-of-concept for all major programs.