MoonLake Immunotherapeutics — Second Quarter 2026 Earnings Summary

Financial Performance

• Reported cash, cash equivalents, and short-term marketable debt securities of $537.0 million as of June 30, 2026.
• Research and development expenses were $50.2 million for the three months ended June 30, 2026, compared to $54.5 million for the three months ended March 31, 2026.
• General and administrative expenses were $11.4 million for the three months ended June 30, 2026, compared to $15.5 million for the three months ended March 31, 2026; the $4.1 million decrease was primarily due to $4.8 million in accelerated expense recognition in the prior quarter from voluntary cancellation of unvested stock options.
• Net loss was $61.8 million for the three months ended June 30, 2026, compared to $69.7 million for the three months ended March 31, 2026.
• Basic and diluted net loss per share was $0.84 for the three months ended June 30, 2026, compared to $0.98 for the three months ended March 31, 2026.
• Total operating expenses were $61.7 million for the three months ended June 30, 2026, compared to $70.0 million for the three months ended March 31, 2026.
• Interest expense was $2.6 million for the three months ended June 30, 2026, compared to $2.3 million for the three months ended March 31, 2026.
• Other income, net, was $2.6 million for the three months ended June 30, 2026, compared to $3.2 million for the three months ended March 31, 2026.
• Long-term debt was $99.5 million as of June 30, 2026, compared to $99.0 million as of March 31, 2026.
• Total shareholders' equity was $428.2 million as of June 30, 2026, compared to $254.0 million as of March 31, 2026.
• The company expects a cash runway to mid-2028.

Guidance and Future Outlook

• The IZAR-1 trial remains blinded and will continue until Week 52, with the full readout expected in the first half of 2027.
• The IZAR-2 trial in TNF-refractory patients is expected to complete enrollment in the third quarter of 2026.
• Enrollment for the Phase 3 trial in Palmoplantar Pustulosis (PPP) is expected to commence in the second half of 2026.
• Results from the P-OLARIS trial in PsA/axial spondyloarthritis are expected to be reported at the end of 2026 or early 2027.
• The Biologics License Application (BLA) submission for Hidradenitis Suppurativa (HS) is expected by the end of September 2026.
• A Prescription Drug User Fee Act (PDUFA) date allocation and decision on Priority Review for HS are expected by the end of November 2026.
• Up to $400 million in non-dilutive funds remain available through a debt facility with Hercules Capital.

Business Segments and Product Lines

• The Phase 3 IZAR-1 trial in biologic-naïve patients with active psoriatic arthritis (PsA) met all clinical endpoints at Week 16 for the 60 mg sonelokimab dose with induction.
• In IZAR-1, 42.1% of patients achieved an ACR50 response, 66.5% achieved an ACR20 response, 41.2% achieved Minimal Disease Activity (MDA), and 61% achieved PASI90.
• Patients treated with sonelokimab showed mean changes from baseline of -0.427 in HAQ-DI and 6.54 in SF-36 Physical Component Summary (PCS).
• Sonelokimab demonstrated a safety profile consistent with previous studies with no new safety signals identified in the blinded IZAR-1 analysis.
• The IZAR-2 trial will compare sonelokimab against an active reference arm of risankizumab in TNF-refractory patients.
• The company previously announced Week 52 data for the VELA program (HS), where 67.2% of patients achieved HiSCR75 and 33.1% achieved HiSCR100.
• Interim Week 24 data from the VELA-TEEN trial (adolescent HS) showed approximately 68% of patients achieved HiSCR75.
• Phase 2 LEDA trial data for Palmoplantar Pustulosis (PPP) showed a 64% mean percent change from baseline in PPPASI and 39% of patients achieving PPPASI75.
• Sonelokimab is being assessed in Phase 2 S-OLARIS and P-OLARIS trials for axial spondyloarthritis and PsA, respectively.

Market and Competitive Landscape

• Psoriatic arthritis is described as a complex disease affecting up to 30% of patients with psoriasis, with a significant unmet need for therapies addressing multiple domains.
• Hidradenitis suppurativa (HS) affects an estimated 2% of the population, with a market opportunity projected to reach $15 billion by 2035.
• The IZAR-1 trial does not include a Standard of Care arm, as data from the ARGO trial previously provided context for the bio-naïve population.
• The VELA-2 trial previously did not achieve statistical significance for its primary endpoint using the composite strategy due to a higher-than-expected placebo arm, though the treatment policy strategy was tested for robustness.

Risks and Challenges

• The press release includes standard forward-looking statement cautions regarding risks such as difficulty enrolling patients, regulatory outcomes, and reliance on third parties for clinical trials.
• The IZAR-1 trial remains blinded until the completion of the Phase 3 program, preventing comparative analysis versus placebo at this time.
• The VELA-2 trial previously faced challenges with intercurrent events in the placebo arm affecting statistical significance.

Management Commentary and Tone

• Dr. Jorge Santos da Silva, Founder and CEO, stated that the positive topline results represent an important milestone for patients and validate the broad potential of the Nanobody platform in inflammatory disease.
• Prof. Kristian Reich, Founder and Chief Scientific Officer, highlighted that the breadth of response across clinical, functional, and patient-reported outcomes is highly encouraging for a complex and heterogeneous disease like PsA.
• Management expressed conviction that sonelokimab has the potential to become a leading treatment option in PsA.

Other Key Points

• MoonLake Immunotherapeutics is a clinical-stage biotechnology company focused on sonelokimab, a novel investigational Nanobody that inhibits IL-17A and IL-17F.
• The company is headquartered in Zug, Switzerland, and was founded in 2021.
• Sonelokimab is being evaluated in multiple indications including HS, PsA, axSpA, and PPP.
• The IZAR-1 trial is the first PsA trial to include a risankizumab active reference arm in the IZAR-2 component.
• The VELA-TEEN trial is the first clinical study specifically focused on adolescent patients with moderate-to-severe HS.
• The company holds $537.0 million in cash and equivalents as of June 30, 2026, with a debt facility providing up to $400 million in additional non-dilutive funds.