MoonLake Immunotherapeutics Announces Positive Outcome from its Final Pre-BLA Meeting with the U.S. FDA and Reports First Quarter 2026 Financial Results

About this update from Moonlake Immunotherapeutics

MoonLake conducted a positive final pre-BLA (Biologics License Application) meeting with the U.S. Food and Drug Administration (FDA), where MoonLake and the FDA aligned on submission plans and the label strategy for sonelokimab (SLK) in hidradenitis suppurativa (HS) This included the acceptability of MIRA trial data to establish substantial evidence of effectiveness (SEE), full inclusion of the VELA-TEEN trial data for a label including patients aged 12 years and above, and the strategy for inclusion of safety data across the MIRA and VELA trials – this aligns with the scenario presented at the Investor Day on February 23, 2026 The proposed label in HS is therefore expected to include the MIRA trial’s ~43% HiSCR75 response and the ~29 percentage point delta-to-placebo at week 12, which are the highest values observed across any adequate well-controlled clinical trial conducted in HS to date With no remaining gaps identified, the pre-BLA process for HS is complete, and the BLA submission to the FDA is planned for the end of September 2026 ; acceptance, including a decision on Priority Review designation associated with the inclusion of VELA-TEEN adolescent data, is expected by end of November 2026 Other clinical trials of SLK are progressing well and are expected to support a catalyst-rich roadmap over the next 12 months, including the release of 52 weeks data from the Phase 3 VELA clinical trials and week 16 read-outs from the Phase 3 IZAR clinical trials in Psoriatic Arthritis (PsA) MoonLake ended the first quarter with $357.9 million in cash, cash equivalents and short-term marketable debt securities and expects to have a cash runway to the end of 2027; additionally, up to $400 million in non-dilutive funds remain available through its debt facility with Hercules Capital ZUG, Switzerland , May 10, 2026 – MoonLake Immunotherapeutics (NASDAQ: MLTX) (“MoonLake” or the “Company”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced a positive outcome of its final pre-BLA meeting held on April 1, 2026 , with the FDA on the HS program of its Nanobody® SLK. During the meeting, MoonLake and the FDA aligned on the submission plans and the label strategy, the approach to include adolescent HS data in the BLA, and the safety data strategy. Specifically, the FDA re-confirmed the acceptability of including the data from the MIRA clinical trial as a key part to establish SEE and to analyze the data consistent with the approach used for the VELA clinical trials. The FDA also agreed to the inclusion of the VELA-TEEN trial data for adolescent HS patients with the trial considered final and pivotal at the time of final BLA submission. MoonLake therefore expects to include patients aged 12 years and above in its label proposal and has notified the FDA of its intent to apply for Priority Review. Furthermore, the FDA agreed to the proposed approach for the clinical safety section and that the safety data will be analyzed primarily based on the VELA-1 and VELA-2 data as per the previous discussion with the FDA. MoonLake thus expects to include the full safety data also for VELA-2 as planned. Finally, the FDA agreed that other key elements including non-clinical studies and the proposed safety pools and analyses appear complete and appropriate for BLA filing and review. No remaining gaps, including in the FDA’s Chemistry, Manufacturing, and Controls regulations, precluding the planned BLA submission were identified and no additional meetings are required as agreed between the FDA and MoonLake. With the overall structure of the label for HS aligned with the FDA, the Company is proceeding to build out the relevant sections of the label as planned, and as presented at the Investor Day on February 23, 2026 . The proposed label is expected to include the MIRA trial’s ~43% HiSCR 75 response rate and ~29 percentage point delta-to-placebo which are the highest observed values across any adequate and well-controlled clinical trial conducted in HS to date. Based on this feedback, MoonLake expects to submit the BLA for SLK in adult and adolescent HS to the FDA at the end of September 2026 . Following this, the acceptance of the BLA submission is expected to be received within 60 days at which point the FDA will also notify MoonLake whether Priority Review has been granted. Subject to FDA approval, the first commercial launch in the United States is expected in the second half of 2027. Today, MoonLake also reported its financial results for the first quarter of 2026. As of March 31, 2026 , MoonLake held cash, cash equivalents and short-term marketable debt securities of $357.9 million . The Company expects to have sufficient capital to fund its operating expenses and capital expenditure requirements to the end of 2027. MoonLake’s debt facility with Hercules Capital provides up to $400 million in additional non-dilutive funds to support future funding needs. Research and development expenses were $54.5 million for the three months ended March 31, 2026 , which was similar to the $56.0 million for the three months ended December 31, 2025 . General and administrative expenses were $15.5 million for the three months ended March 31, 2026 , compared to $9.2 million for the three months ended December 31, 2025 . The increase of $6.3 million was primarily related to $4.8 million in accelerated expense recognition due to a voluntary cancellation of unvested stock option awards for no consideration. Important upcoming anticipated milestones for MoonLake in 2026: Q2 2026: 52-week data of the VELA-1 and VELA-2 trials in HS Mid 2026: Primary endpoint readout of the Phase 3 IZAR-1 trial in PsA Mid 2026: Primary endpoint readout of Phase 3 VELA-TEEN trial in adolescent HS September 2026 : Submission of a BLA for HS Q4 2026: Primary endpoint readout of the Phase 3 IZAR-2 trial in PsA -Ends- MoonLake Immunotherapeutics MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The Company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and palmoplantar pustulosis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland . Further information is available at www.moonlaketx.com . About Nanobodies ® Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations. The terms Nanobody® and Nanobodies® are trademarks of Ablynx , a Sanofi company. About Sonelokimab Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHHs covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema. Sonelokimab is being assessed in two lead indications, hidradenitis suppurativa (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology, including adolescent HS, palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA). For adults with HS, sonelokimab is being assessed in two identical Phase 3 trials, the VELA-1 and VELA-2 trials, using the higher clinical response level of HS Clinical Response (HiSCR) 75 as the primary endpoint, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count. In September 2025 , the primary endpoint data from the VELA-1 and VELA-2 clinical trials were announced. In the combined VELA program, patients treated with SLK experienced a clinically meaningful and statistically significant improvement across all primary and key secondary endpoints using both pre-specified strategies (p

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