STIFEL 2026 HEALTHCARE CONFERENCE - IMMUNIC INC

Financial Performance:

• Generated $200 million in proceeds from a financing event in February.
• Current cash runway extends through the anticipated 2028 if warrants convert upon positive Phase 3 readouts, adding another potential $200 million tranche.
• No specific revenue, profit margin, or debt figures disclosed as the company is pre-revenue and in clinical development.
• No guidance provided on future financial metrics pending clinical outcomes.

Guidance and Future Outlook:

• Catalysts: Two Phase 3 pivotal trials (INSURE-1 and INSURE-2) for Relapsing MS (RMS) expected to read out in December; positive results would enable NDA filing.
• Pipeline Progress: Initiating Phase 3 PROTECT-MS study for Progressive MS with first patient expected in H1 of next year.
• Commercialization: Actively building commercial infrastructure to prepare for potential approval, targeting a targeted launch strategy rather than a broad rep force.
• Long-term Goal: Position Vitaflutamase calcium as the first potentially neuroprotective oral MS treatment addressing progression and safety/tolerability unmet needs.

Business Segments and Product Lines:

• Lead Asset: Vitaflutamase calcium (a NIR1 activator and DHO-DH inhibitor) targeting neuroinflammation and neurodegeneration.
• RMS Strategy: Two Phase 3 studies (INSURE-1/2) designed to power on relapse reduction and MRI outcomes, with pooled analysis for disability progression endpoints.
• Progressive MS Strategy: PROTECT-MS study (1,400 patients) utilizing time-to-worsening or 9-Hole Peg Test as primary endpoints to validate neuroprotection in non-active progressive MS.
• Target Patient Segments: (1) Patients preferring oral DMTs (~25-30% of market); (2) Patients discontinuing anti-CD20 therapies (~40,000 patients annually); (3) Older patients (55+) with comorbidities and polypharmacy risks.
• Phase 2 Data: Emphasis (RMS) showed 78% reduction in gadolinium-enhancing lesions and 42% relapse risk reduction; CALIPER (Progressive) showed significant sub-regional brain volume preservation and clinical benefit in non-active cohorts despite missing the primary whole brain atrophy endpoint.

Market and Competitive Landscape:

• Market Dynamics: MS market is dominated by anti-CD20s (50% share); high unmet need for therapies patients can stay on long-term.
• Competition: Competing against current oral DMTs (fumarates, S1P modulators) and emerging BTK inhibitors like Remibrutinib.
• Differentiation: Positioned to address safety gaps of anti-CD20s and oral DMTs (e.g., hepatotoxicity, infections, alopecia, acute adverse events like nausea/flushing).
• Pricing: Oral DMTs average $115,000 WAC with ~30% gross-to-net; expects strong payer acceptance due to unique mechanism (NIR1 activation) and distinct safety profile vs. Teriflunomide.
• Commercial Scale: Plans a lean, hyper-targeted sales force focused on the ~3,000 clinicians writing 80% of prescriptions, citing TG Therapeutics as a successful analog for small biotechs.

Risks and Challenges:

• Clinical Risk: Final efficacy and safety data for Phase 3 RMS trials are pending; progression endpoints may not achieve statistical significance in 18-month relapse studies.
• Safety Profile: Must maintain superior safety profile regarding liver signals, opportunistic infections, and acute tolerability issues (nausea, flushing) to avoid discontinuation.
• Regulatory: NDA filing is contingent entirely on positive Phase 3 readouts; failure to meet endpoints halts commercialization.
• Market Acceptance: Potential payer or prescriber requirements to fail older DMTs (e.g., Teriflunomide) before switching, though company argues distinct mechanism avoids direct generic competition.

Management Commentary and Tone:

• Tone: Highly confident and focused on near-term catalysts; expressed strong belief in the "neuroprotective" thesis and differentiation from current oral DMTs.
• Key Messaging: Emphasized the "totality of attributes" (efficacy + safety) over raw efficacy numbers; highlighted the unmet need in progression and the limitations of perpetual B-cell depletion.
• Strategy: Rejected cross-study comparisons with historical data, citing modern patient populations are healthier and have lower event rates.
• Resourcefulness: Expressed confidence that a small biotech can successfully compete in the MS space with a targeted approach.

Analyst Questions and Answers:

• Q: Expectations for RMS secondary endpoints (progression) and NIR1 impact?
  • A: Expect numerical advantage in progression but acknowledge statistical hurdles in 18-month RMS studies; progression data will be pooled from twin studies. Primary focus remains on relapse/MRI/safety; PROTECT-MS is the definitive progression study.
• Q: Safety profile expectations for a "home run" Phase 3?
  • A: Must show clean liver signal, no imbalance in serious/opportunistic infections, and manageable day-to-day tolerability (no nausea/diarrhea/flushing/alopecia).
• Q: Comparison to Remibrutinib (BTK inhibitor)?
  • A: Both can succeed; Remibrutinib has clean liver data but carries serious infection and bleeding risk imbalances. Vitaflutamase may be preferred for CD20 switchers, older patients with polypharmacy, or those fearing infection risks from BTK inhibition.
• Q: Step edits and generic competition (Teriflunomide)?
  • A: Unlikely to face step edits forcing failure of Teriflunomide due to distinct chemistry, mechanism (NIR1 vs. DHO-DH), and safety profile. Branded market share remains high even with generics present.

Other Key Points:

• NIR1 Mechanism: Unique dual mechanism targeting neuroinflammation and neurodegeneration; first approvable agent with potential neuroprotective properties in the oral class.
• Commercial Team: Plans to hire top talent with experience from major pharma (e.g., Genentech, Novartis, Roche analogs) to lead commercial launch.
• Warrant Structure: Warrants from the February financing have conversion opportunities tied to positive INSURE-1 and INSURE-2 data.