MLTX - Earnings announcements

Ended the third quarter with $380.5 million in cash, cash equivalents and short-term marketable debt securities which, together with funds from a previously announced debt-facility, are expected to provide runway into the second half of 2027Reported results of its Phase 2 LEDA clinical trial in Palmoplantar Pustulosis (PPP) where sonelokimab (SLK) demonstrated clinically meaningful and statistically significant benefitReported an interim analysis of the long-term data from the VELA-1 and VELA-2 clinical trials in adults with Hidradenitis Suppurativa (HS), as well as an interim analysis of its VELA-TEEN clinical trial in adolescent HS, demonstrating the potential and competitive benefit of SL

Phase 3 VELA program in hidradenitis suppurativa (HS) on track for an expected primary endpoint readout around September 2025 and an expected submission of a Biologic License Application (BLA) in the United States in mid-2026Other clinical trials of sonelokimab in palmoplantar pustulosis (PPP), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA) and adolescent HS progressing well and expected to support a catalyst-rich roadmap over the next 12 monthsEnded the second quarter with $425.1 million in cash, cash equivalents and short-term marketable debt securities with up to an additional $425 million in non-dilutive funds remaining accessible through previously announced debt-facility Z

MoonLake Immunotherapeutics Reports First Quarter 2025 Financial Results and Provides a Business Update Continued to make significant progress with the development of the Nanobody® sonelokimab across portfolio of indications, including Phase 3 studies in hidradenitis suppurativa (HS), psoriatic Arthritis (PsA) and adolescent HS, as well as Phase 2 studies in palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA)Announced completion of enrollment of patients in the Phase 3 program in HS (the VELA program) and disclosed baseline characteristics, replicating the Phase 2 MIRA trialPresented an interim readout of the Phase 2 LEDA study in PPP, highlighting the potential of sonelokimab

Initiated the Phase 3 VELA program of the Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS) and the Phase 3 IZAR program in patients with active psoriatic arthritis (PsA) following positive FDA and EMA regulatory feedback, continuing to support a potential best-in-class profile across two key indicationsInitiated three new trials in the beginning of 2025 with the Nanobody® sonelokimab: Phase 3 VELA-TEEN trial in adolescent hidradenitis suppurativa (HS), Phase 2 LEDA trial in palmoplantar pustulosis (PPP) and Phase 2 S-OLARIS trial in axial spondyloarthritis (axSpA)Signed a three-year technology partnership with Komodo Health to advance research on inflam

MoonLake Immunotherapeutics Reports Third Quarter 2024 Financial Results and Provides a Business Update Ended the third quarter with $493.9 million in cash, cash equivalents and short-term marketable debt securities, expected to support a roadmap rich in potential catalysts and a cash runway to the end of 2026Strong market performance of other IL-17 inhibitors in hidradenitis suppurativa (HS) and other inflammatory indications validating large market opportunity for sonelokimabPhase 3 clinical program in HS is progressing as per plan with primary endpoint readout anticipated as of mid-2025Preparations for Phase 3 clinical program in psoriatic arthritis (PsA) completed with patient enrollmen

MoonLake Immunotherapeutics Reports Second Quarter 2024 Financial Results and Announces a Capital Markets Update for September 11 Initiated Phase 3 VELA program of the Nanobody® sonelokimab in hidradenitis suppurativa ("HS"), with topline results anticipated as of mid-2025Secured positive feedback from both U.S. Food and Drug Administration ("FDA") and the E.U. European Medicines Agency ("EMA") on the regulatory path for the Phase 3 program of the Nanobody® sonelokimab in psoriatic arthritis ("PsA") and outlined the clinical plan with topline results anticipated in end-2026Ended the quarter with $519.8 million in cash, cash equivalents and short-term marketable debt securities, expected to

MoonLake Immunotherapeutics Reports First Quarter 2024 Financial Results and Provides a Business Update Announced positive feedback from both FDA and EMA on the regulatory path for the Phase 3 program of the Nanobody® sonelokimab in hidradenitis suppurativa (HS) and outlined the development plan with topline results anticipated in mid-2025Reported significant improvements observed across all key outcomes with sonelokimab over 24 weeks in the ARGO Phase 2 trial in active psoriatic arthritis (PsA) including unprecedented multi-domain responses across joints, skin and other domains, supporting potential best-in-class profile of sonelokimabAnnounced the imminent commencement of four additional

MoonLake Immunotherapeutics Reports Full Year 2023 Financial Results, Recent Business Highlights and Announces an R&D Day on March 10 A successful year including the announcements of positive data from two Phase 2 trials of sonelokimab in hidradenitis suppurativa (HS), at 12 and 24 weeks, and active psoriatic arthritis (PsA), at 12 weeks, supporting a potential best-in-class profile across two key indications Phase 3 preparation for sonelokimab in HS nearing completion, following positive feedback from both FDA and EMAYear-end cash, cash equivalents and short-term marketable debt securities of $511.0 million, expected to support a roadmap rich in potential catalysts whilst providing a cash

MoonLake Immunotherapeutics Reports Third Quarter 2023 Financial Results and Provides a Business Update Announced positive full 24-week data from the global Phase 2 MIRA clinical trial, establishing the Nanobody® sonelokimab as a highly promising and differentiated therapeutic solution for hidradenitis suppurativa Presented positive 12-week data from the global Phase 2 MIRA clinical trial for sonelokimab in hidradenitis suppurativa at a late-breaking session during the European Academy of Dermatology and Venereology Congress Announced landmark top-line 12-week data from the global Phase 2 ARGO clinical trial evaluating the efficacy and safety of sonelokimab in patients with active psoriatic

MoonLake Immunotherapeutics Reports Fourth Quarter and Year-End 2022 Financial Results and Provides a Business Update Strong financial position: year-end cash, cash equivalents and short-term marketable debt securities of $72.1 million, expected to provide runway well into 2H 2024 and at least 12 months beyond expected key data readoutsRecent clinical data announced at the 81st Annual Meeting of the American Academy of Dermatology on the novel IL-17A and IL-17F inhibition further reinforces MoonLake's competitive position with sonelokimab in the Hidradenitis Suppurativa ("HS") landscapePatient enrollment and randomization completed ahead of schedule in a global Phase 2 trial of sonelokimab

MoonLake Immunotherapeutics Reports Third Quarter 2022 Financial Results and Provides Recent Business Update Global trial of sonelokimab in Hidradenitis Suppurativa (HS) has continued to meet recruitment targets with an expected primary endpoint readout in mid-2023Global Psoriatic Arthritis (PsA) trial received FDA clearance and US central IRB approvalQuarter-end position of $83.5 million in cash, cash equivalents and short-term marketable debt securities, providing cash runway into 2H2024 and at least 12 months beyond expected key readouts ZUG, Switzerland, November 14, 2022 – MoonLake Immunotherapeutics (NASDAQ:MLTX) ("MoonLake"), a clinical-stage biotechnology company focused on creatin