BIOAGE LABS, INC. STIFEL 2026 HEALTHCARE CONFERENCE - BIOAGE LABS INC

Financial Performance:

• Cash balance stands at just over $350 million, sufficient to fund current clinical activities including QUEL-CV, QUEL-DME, APJ programs, and potential new NLRP3 indications.
• No specific revenue, GAAP earnings, or debt figures provided as the company is pre-revenue and focused on R&D; funding is derived entirely from existing cash reserves.
• No mention of deferred revenue or cost of goods sold (COGS) as products are not yet commercialized.

Guidance and Future Outlook:

• QUEL-CV: Phase 2 dose-ranging data expected to read out by the end of the current year.
• QUEL-DME: Clinical data anticipated by the end of next year.
• APJ Programs: Investigational New Drug (IND) submission targeted by the end of the current year to enable debut of next-generation oral and parenteral candidates.
• New Indications: Plans to announce an additional NLRP3 indication once plans are solidified, following the DME trial's success.
• Long-term Goals: Establish BG-102 as a best-in-class NLRP3 inhibitor with a differentiated profile (CNS/retinal penetration) to address aging, inflammation, and ophthalmic diseases; expand into muscle preservation via APJ agonism.

Business Segments and Product Lines:

• Lead Program (BG-102): An oral NLRP3 inflammasome inhibitor with best-in-class potency (IC90 of 1.6 nM).
  • Cardiometabolic (QUEL-CV): Assessing 30mg, 60mg, and 90mg doses (pharmacokinetically equivalent to 120mg) to map exposure vs. inflammatory/metabolic biomarkers and liver MRI changes; CV indication currently not a priority.
  • Ophthalmology (QUEL-DME): Testing BG-102 as monotherapy and in combination with VEGF for Diabetic Macular Edema (DME) to improve visual acuity and reduce injection burden; primary indication for immediate focus.
  • Pipeline: Geographical Atrophy (GA), Mucosal Edema (MESI), and UME identified as high-priority ophthalmic indications.
• APJ Platform: Next-generation APJ agonists (oral and parenteral) designed to double weight loss when combined with incretins and preserve muscle mass/protein synthesis in older adults; first-in-class data shows full preservation of muscle size during bed rest.
• Patent Portfolio: IP secured until 2045 covering specific structures and broad ligands interacting with BG-102's unique binding site.

Market and Competitive Landscape:

• NLRP3 Differentiation: Unlike competitors targeting the ATPase pocket (e.g., Pfizer's MCC950 derivatives), BG-102 utilizes a novel binding site allowing inhibition of both active and inactive inflammasome forms, enabling near-complete (98%) target suppression and high CNS/retinal penetration.
• Cardiovascular Context: Analysis of the failed "ZEUS" trial suggests NLRP3 remains a valid target upstream of IL-6; however, the company has deprioritized acute MI/ASCVD indications in favor of ophthalmology and other areas.
• Ophthalmology Opportunity: Addresses a market dominated by frequent intravitreal injections; BG-102 offers an oral alternative to reduce treatment burden, targeting 40% of patients in the "watch and wait" phase or those refractory to VEGF therapy.
• Competitive Benchmarks: Early data from Flamazon Therapeutics (NLRP3 inhibitor) shows >50% lesion size slowing in GA, outperforming current complement inhibitors (~15% slowing).

Risks and Challenges:

• Clinical Trial Risks: Dependence on the success of the QUEL-DME trial to validate visual acuity benefits and establish the ophthalmology platform; potential for lack of separation in monotherapy arms in early disease stages.
• Strategic Pivot Risk: Shifting focus away from cardiometabolic CV indications based on "gray area" results from Artemis/ZEUS trials, though preparatory work remains for potential rapid redeployment if Artemis shows a decisive win.
• Regulatory/Hurdle: Need to demonstrate clear Pharmacodynamics (PD) and target engagement in the eye to support expansion into additional indications like GA.
• Market Adoption: Convincing the medical community to shift from standard-of-care injections to an oral therapy requires proven efficacy in disease control.

Management Commentary and Tone:

• Tone: Confident, optimistic, and strategically decisive. Management emphasizes the molecule's unique "best-in-class" biological profile and differentiated tissue distribution.
• Confidence: High confidence in BG-102's ability to achieve 24-hour complete target inhibition and placebo-like tolerability.
• Strategic Clarity: Clear pivot to ophthalmology as the primary beachhead while maintaining a "wait and see" stance on CV indications pending decisive data from Artemis.
• Cash Management: Reiterated that the current cash runway provides ample funding to reach proof-of-concept milestones without immediate need for dilutive financing.

Analyst Questions and Answers:

• Artemis/CV Indication: Management stated that a "decisive win" (statistically significant and large magnitude) in the Artemis trial would be required to re-prioritize the ASCVD indication, expressing skepticism that the ZEUS failure was due to patient selection given lack of subgroup signals.
• DME Patient Population: Clarified that the trial targets patients with compromised vision (not just "wet macula" with intact vision) to ensure measurable separation in visual acuity, focusing on the 40% "watch and wait" group and refractory patients.
• DME Biology: Confirmed DME is highly inflammatory (driven by hyperglycemia activating NLRP3) and that BG-102 addresses both the inflammatory cascade and pyroptotic cell death affecting microvasculature integrity.
• Systemic Biomarkers: Confirmed exploration of systemic cardiometabolic markers (glucose, kidney function) in DME trials to capture broader value beyond ocular metrics.
• Enrollment Status: QUEL-DME enrollment has begun; management reports a strong start, noting that the oral administration option may accelerate patient recruitment compared to injection-heavy trials.

Other Key Points:

• Mechanism Insight: The unique binding site of BG-102 allows inhibition of the NLRP3 inflammasome in its monomeric form, preventing the assembly of the decamer complex required for pyroptosis, explaining the superior depth of inhibition compared to ATPase-targeting competitors.
• Preclinical Validation: In preclinical models, BG-102 monotherapy fully rescued retinal vascular permeability and prevented lipofuscin accumulation in naturally aged mouse models.
• Dosing Paradigm: Phase 1 data supports a convenient once-daily dosing regimen with excellent dose proportionality.
• Target Validation: Human data linking NLRP3 activity to mortality reinforces the target's relevance for diseases of aging.