STIFEL 2026 HEALTHCARE CONFERENCE - BIOAGE LABS INC

Explicit Guidance:

• Q1 Artemis Trial Results: No specific data guidance; management anticipates a "very decisive win" to shift priority from ASCVD, though they remain skeptical of a positive signal given the lack of subgroup signals in the Zeus trial.
• Capital Allocation: Cash balance of >$350 million (reported) is expected to fund all ongoing clinical activities, including QUEL-CV, QUEL-DME, an additional BG-102 indication, and APJ programs.
• Share Count/Capital Management: No specific guidance on share count, buybacks, or dividends mentioned.

Business-Segment Outlook:

• BG-102 (NLRP3 Inhibitor):
  • QUEL-CV (Cardiometabolic): Aims to read out at the end of the current year; dose-ranging study (30, 60, 90 mg) to establish exposure-response relationships for CRP, liver fat, and inflammation. While data will be reviewed, ASCVD is currently "on pause" and "no longer a priority."
  • QUEL-DME (Diabetic Macular Edema): Currently enrolling; aiming for topline results at the end of the next year. Trials to assess monotherapy vs. baseline and VEGF combination therapy, powered for a 4-letter improvement in visual acuity.
  • Additional Indication: Planning to announce a new BG-102 indication once plans are solidified; this will be announced after proof-of-concept is established.
  • APJ Agonist Program: Two next-generation programs (oral and parenteral) targeting IND submission by the end of the current year. Clinical development plans to be debuted upon IND submission.
• Clinical Development Timeline:
  • End of Current Year: QUEL-CV topline data; APJ IND submission.
  • End of Next Year: QUEL-DME topline data; APJ clinical debut and development plan announcement.

Market and Competitive Outlook:

• Ophthalmology Market: Identifies a "huge disconnect" between trial outcomes and real-world outcomes driven by high treatment burden (injections). Anticipates significant value in streamlining care, allowing simultaneous treatment of bilateral retinal disease.
• Target Differentiation: Positions BG-102 as having "best-in-class" tissue distribution (CSF, retina) and deep target inhibition (98% trough IL-1β suppression), contrasting with competitors targeting downstream IL-6 or specific ATPase pockets.
• Competitive Landscape: Notes that existing NLRP3 programs (e.g., Pfizer's MCC950) target the ATPase pocket. BG-102 targets a distinct binding site, potentially allowing inhibition of both active and inactive inflammasome forms.
• Inflammation Market: Views NLRP3 as a critical upstream target compared to downstream IL-6 inhibition (Zeus trial), suggesting NLRP3 addresses the root cause of sterile inflammation in cardiometabolic and retinal diseases.

Macro / Industry Outlook:

• Patient Behavior: Anticipates improved enrollment in the QUEL-DME monotherapy arm due to patient preference for oral therapy over intravitreal injections.
• Regulatory Strategy: Focused on establishing clear pharmacodynamics and target engagement in the eye to support future indications (GA, MESI, UME) following the DME trial results.

Strategic Initiatives:

• Pipeline Expansion: Leveraging BG-102's retinal penetration to expand into Geographic Atrophy (GA), Macular Telangiectasia (MESI), and Uveitis (UME) as sequential priorities post-DME.
• APJ Program Launch: Preparing to debut the APJ program (a longevity and physical function target) via IND submission, with preclinical data showing weight loss doubling when combined with incretins and muscle preservation in bed-rest models.
• IP Portfolio: Extended IP claims filed through 2045 covering specific structures and broadly covering ligands for the distinct NLRP3 binding site.
• Strategic Pivot: Shifting focus away from ASCVD priority to prioritize Ophthalmology (DME/GA) and the new APJ asset, while maintaining preparatory CMC work for ASCVD readiness in case of a "surprise" in the Artemis trial.

Risks and Headwinds to Outlook:

• Cardiovascular Uncertainty: Reliance on the Artemis trial to potentially re-engage the ASCVD program; management remains skeptical of a positive outcome.
• Trial Execution Risk: QUEL-DME enrollment speed may vary, though oral dosing is expected to facilitate patient recruitment.
• Regulatory/Commercial: Need to demonstrate visual acuity benefits (4-letter improvement) to validate the mechanism in DME before expanding to GA or other ophthalmology indications.
• Data Interpretation: Potential for the Zeus trial negative result to be attributed to patient population ("too sick") rather than target failure, though management views the upstream biology as the more likely differentiator.

Management Tone on the Future:

• Confidence: High confidence in BG-102's pharmacodynamics ("complete target inhibition," "best-in-class profile") and tissue distribution.
• Cautious Optimism: Cautiously optimistic regarding APJ program success; highly excited to be "back in the clinic" with APJ soon.
• Strategic Clarity: Firm stance on pivoting resources to ophthalmology and APJ; no longer prioritizing ASCVD despite significant preparatory work, contingent on a "decisive win" in future data.

Miscellaneous:

• Biomarkers: Primary endpoints for QUEL-DME are visual acuity; QUEL-CV uses CRP. Exploratory markers include liver MRI, systemic metabolic labs, and retinal parameters.
• Mechanism: NLRP3 inhibition targets sterile inflammation (metabolic stress, nutrient excess) upstream of IL-6, addressing cytokine production and pyroptosis.
• Collaboration: Mention of collaboration with the University of Bonn for binding site characterization.