MoonLake Immunotherapeutics (MLTX) investor relations material

Strategic and Regulatory Updates

• Preparing to submit BLA for sonelokimab (SLK) in HS in Q3, with potential US approval in H2 next year; regulatory feedback confirms no additional trials needed for efficacy or safety, with VELA-1 and MIRA supporting efficacy and VELA-2 supporting safety.

• Regulatory strategy leverages three well-controlled HS trials for BLA, aiming for leading efficacy and safety sections in the label compared to competitors.

• Label expected to be highly competitive, with potential inclusion of key efficacy metrics (HiSCR75, pain, IHS4) and differentiation in safety and dosing versus competitors.

• Commercial manufacturing capacity secured for up to five years post-launch; commercial team build-out and launch preparations to accelerate in H2 2024.

• Differentiation potential highlighted by lower injection volume, fewer induction injections, and absence of key adverse events seen in competitor products.

Clinical Data Highlights

• SLK demonstrates leading efficacy across multiple indications, with rapid onset and durable responses, outperforming competitors in axSpA and HS, and showing strong results in PPP and PsA.

• S-OLARIS Phase 2 in axSpA showed >80% ASAS40 and ASDAS-CRP response rates by week 12, with strong MRI and PET imaging evidence of reduced inflammation and ossification.

• Long-term VELA data in HS show sustained HiSCR75 responses and continuous quality of life improvements, with favorable safety profile and no new signals for liver, SIB, or dermatitis.

• VELA-TEEN interim data in adolescent HS patients demonstrate promising efficacy and safety, potentially supporting a broad label including adolescents.

• PPP Phase 2 data show >40% of patients achieving clear/almost clear disease, with biomarker validation and Fast Track status accelerating development.

Financial and Operational Outlook

• Cash position of $394M as of December 2025, with runway into H2 2027; raised ~$800m in equity and secured up to $500m in non-dilutive debt, with access to up to $400M in additional non-dilutive debt.

• Operating expenses stabilized at ~$65m per quarter, with R&D and G&A expenses declining as major studies conclude; PPP Phase 3 expected to be smaller than VELA.

• Commercial readiness supported by efficient cash burn and flexible debt facility, enabling transition to commercialization without additional equity dilution.

• Commercial strategy targets parity with bimekizumab on pricing and access, leveraging biosimilar entry to expand market and position SLK as a next-line, differentiated therapy.

• Multiple catalysts expected in 2024 and 2026, including regulatory meetings, data readouts, and BLA submission and acceptance.