MoonLake Immunotherapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported a net loss of $79.5 million for the three months ended September 30, 2026, compared to a net loss of $61.8 million for the three months ended June 30, 2026.
• Basic and diluted net loss per share was $0.93 for the quarter ended September 30, 2026, compared to $0.84 for the quarter ended June 30, 2026.
• Total operating expenses were $79.9 million for the quarter ended September 30, 2026, an increase from $61.7 million in the prior quarter.
• Research and development expenses were $68.9 million for the quarter ended September 30, 2026, up from $50.2 million in the prior quarter, primarily due to accrued milestone license fees associated with the expected acceptance of the BLA submission.
• General and administrative expenses were $11.0 million for the quarter ended September 30, 2026, down from $11.4 million in the prior quarter.
• Ended the quarter with $498.5 million in cash, cash equivalents, and short-term marketable debt securities (specifically $379.7 million in cash and cash equivalents and $118.8 million in short-term marketable debt securities).
• Long-term debt stood at $100.0 million as of September 30, 2026, compared to $99.5 million as of June 30, 2026.
• Total shareholders' equity was $381.6 million as of September 30, 2026, down from $428.2 million as of June 30, 2026.

Guidance and Future Outlook:

• Expects sufficient capital to fund operating expenses and capital expenditure requirements to mid-2028.
• Anticipates up to $400 million in non-dilutive funds remain available through its debt facility with Hercules Capital.
• Plans for a commercial launch of sonelokimab in the U.S. in the second half of 2027.
• Expects to receive FDA notification on BLA acceptance within approximately 60 days of submission (by end of November 2026) and the planned review timeline within approximately 74 days (by mid-December 2026).
• Forecasts a mid-cycle review in the first half of 2027.
• Expects to announce initial topline results for the Phase 3 IZAR-2 trial in psoriatic arthritis in the first quarter of 2027.
• Expects to announce Week 52 topline results for the Phase 3 IZAR-1 trial in psoriatic arthritis in the second quarter of 2027.
• Expects results from the P-OLARIS trial to become available in early 2027.
• Expects to present final topline results for the VELA-TEEN trial at a scientific meeting in the first quarter of 2027.

Business Segments and Product Lines:

• Hidradenitis Suppurativa (HS): Submitted a Biologics License Application (BLA) to the FDA on September 30, 2026, for sonelokimab in adults and adolescents (12 years and older) with moderate-to-severe HS. The BLA is supported by data from the MIRA and VELA (including VELA-TEEN) clinical programs.
• Psoriatic Arthritis (PsA): Reported positive Week 16 results from the Phase 3 IZAR-1 trial, where all clinical endpoints were met for sonelokimab 60 mg with induction. 42.1% of biologic-naïve patients treated with sonelokimab 60 mg achieved an ACR50 response at Week 16. Enrollment for the Phase 3 IZAR-2 trial was completed in September 2026.
• Palmoplantar Pustulosis (PPP): The Phase 3 NOVA trial is on track to commence enrollment in November 2026.
• Adolescent HS: The VELA-TEEN trial is expected to complete in the fourth quarter of 2026.
• Axial Spondyloarthritis (axSpA): The P-OLARIS trial results are expected in early 2027.

Market and Competitive Landscape:

• The HS market opportunity is projected to reach $15 billion by 2035, with an estimated 2 million unique patients diagnosed and treated in the U.S. between 2016 and 2023.
• Sonelokimab is a novel investigational Nanobody® that inhibits IL-17A and IL-17F dimers, targeting inflammatory diseases with major unmet needs.
• The IZAR-2 trial in PsA is the first to include a risankizumab active reference arm.
• The P-OLARIS and S-OLARIS trials utilize innovative cellular imaging techniques (FAPI-PET/CT and 18F-NaF PET) to assess inflammation and tissue damage.

Risks and Challenges:

• Forward-looking statements regarding efficacy, safety, regulatory interactions, and commercial launch timing are subject to risks and uncertainties, including potential differences between actual and anticipated results.
• Risks include difficulty enrolling patients in clinical trials, reliance on third parties for preclinical and clinical studies, and potential impacts from state and federal healthcare reform measures.
• Specific trial risks include intercurrent events, such as the higher-than-expected placebo arm in the VELA-2 trial which precluded statistical significance in the primary endpoint using the composite strategy.

Management Commentary and Tone:

• Matthias Bodenstedt, Chief Financial Officer, stated that the quarter reflects the strength of execution across MoonLake, highlighting progress in regulatory and clinical priorities.
• Management expressed confidence that the financial position and projected cash runway into mid-2028 position the company well to prepare for the expected commercial launch of sonelokimab in the U.S. next year.

Other Key Points:

• The BLA submission for HS marks an important step towards potential U.S. approval and commercialization.
• The company is advancing preparations for market access, medical affairs, patient engagement, and commercial infrastructure for the potential U.S. launch.
• Sonelokimab demonstrated strong efficacy across multiple disease domains in the IZAR-1 trial, including patient-reported and physical outcomes.
• In the Phase 2 LEDA trial for PPP, sonelokimab achieved a mean percent change from baseline in PPPASI of 64% at Week 16, with 39% of patients achieving a PPPASI75 response.
• In the Phase 2 ARGO trial for PsA, approximately 60% of patients treated with sonelokimab achieved an ACR50 response and Minimal Disease Activity at Week 24.
• The VELA-TEEN trial interim data showed ~68% of adolescent patients achieved HiSCR75, with higher response rates compared to the adult VELA program at comparable timepoints.
• No new safety signals were detected across the VELA, IZAR-1, LEDA, or ARGO trials.