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-2026 Other clinical trials of sonelokimab in palmoplantar pustulosis (PPP), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA) and adolescent HS progressing well and expected to support a... Read More

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... Read More

MoonLake Immunotherapeutics to host a Capital Markets Day on Tuesday, April 29 Zug, Switzerland, April 25, 2025 – MoonLake Immunotherapeutics (Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, will host a virtual Capital Markets Day for investors and analysts on Tuesday, April 29, 2025. The event will highlight recent financial and clinical milestones... Read More

Agreement with Hercules Capital significantly increases financial and operational strength, provides up to $500 million in capital with no dilution to shareholders, an attractive cost of capital and low operational and strategic incumbrances, and sets a new standard for the quantum of a nondilutive facility for a development-stage therapeutics company. Facility adds to the $448 million cash position disclosed in previously... Read More

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 indications Initiated three new trials in the beginning of 2025 with the Nanobody ®... Read More

New trials in three new indications have been initiated 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) MoonLake now independently running seven trials in 2025 across large dermatology and rheumatology indications: adult HS, adolescent HS, psoriatic arthritis... Read More

Two trials for active psoriatic arthritis (PsA) with one focusing on biologic-naïve patients and including evaluation of radiographic progression (IZAR-1), and the other focusing on TNF-IR patients while being the first trial to include risankizumab as an active reference arm (IZAR-2) Program will evaluate sonelokimab for a total of 52 weeks, across IZAR-1 and IZAR-2, at sites in the United States, Europe and Latin America,... Read More

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 2026 Strong market performance of other IL-17 inhibitors in hidradenitis suppurativa (HS) and other inflammatory indications validating large market opportunity for sonelokimab Phase 3 clinical program in HS is progressing as... Read More

ZUG, Switzerland, September 9, 2024 – MoonLake Immunotherapeutics AG (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, will host a Capital Markets Update for investors and analysts live from New York on Wednesday, September 11 from 2024, from 9:00 – 10:30 EST/06:00 – 08:30 PST/14:00 – 16:30 CET The event will provide business updates from... Read More

Initiated Phase 3 VELA program of the Nanobody ® sonelokimab in hidradenitis suppurativa (“HS”), with topline results anticipated as of mid-2025 Secured 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... Read More

Builds upon the positive regulatory feedback received from FDA and EMA on Phase 3 VELA program for sonelokimab in hidradenitis suppurativa (HS), which has started recruitment Clarified path for PsA Phase 3 program with study design, patient population and endpoints agreed – program is called IZAR and two trials are planned with one focusing on bio-naïve patients and radiographic progression (IZAR-1) and another on TNF-IR... Read More

VELA is the first Phase 3 program in hidradenitis suppurativa to use the higher clinical response level of HiSCR75 as the primary endpoint The topline primary endpoint readout at week 16, together with data on other endpoints, is expected as of mid-2025 Program will evaluate sonelokimab for a total of 52 weeks, across VELA-1 and VELA-2, at sites in the United States and Europe, using a design informed by the landmark Phase 2... Read More

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-2025 Reported 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... Read More

MoonLake to tap into Komodo’s technology and real-world data to unlock the full potential of its next-gen Nanobody ® therapy San Francisco, US and Zug, Switzerland, April 10, 2024 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX) a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, and Komodo Health today announce a new technology partnership to help improve... Read More

Positive 24-week data from the ARGO trial of sonelokimab in PsA: Significant improvements observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an ACR50 response at week 24 Unprecedented multi-domain responses across joints, skin and other domains, including up to 52% of patients achieving ACR50+PASI100 and up to 61% of patients achieving Minimal Disease Activity (MDA),... Read More

MoonLake Immunotherapeutics to present MIRA trial data of Nanobody ® sonelokimab in hidradenitis suppurativa as a late breaker at the AAD Annual Meeting 2024 ZUG, Switzerland, March 4, 2024 – MoonLake Immunotherapeutics (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced that 24-week data from its Phase 2 MIRA trial with the... Read More

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 EMA Year-end cash, cash equivalents and... Read More

Clarified path for HS Phase 3 program with study design, patient population and endpoints agreed One dose of SLK (120mg) to be tested with a similar protocol as in Phase 2 Total Phase 3 population of 800 patients to be complemented by Phase 2 population for registration Phase 3 trial has similar design to validated Phase 2 trial and in line with the Company’s communications and expectations First patient expected to be... Read More

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... Read More

MoonLake Immunotherapeutics announces landmark Phase 2 results for Nanobody ® sonelokimab in active psoriatic arthritis First placebo-controlled randomized trial in active psoriatic arthritis (PsA) using a Nanobody ® to report positive topline results in support of potential best-in-class profile Primary endpoint ACR50 met with up to 47% (p<0.01 versus placebo) of patients on sonelokimab achieving ACR50 as early as week 12... Read More

MoonLake Immunotherapeutics announces the full dataset from its 24-week MIRA clinical trial, establishing the Nanobody ® sonelokimab as a highly promising and differentiated therapeutic solution for Hidradenitis Suppurativa (HS) Maintenance treatment with sonelokimab dosed every 4 weeks (Q4W), demonstrated that 57% of patients achieved HiSCR75 at week 24, increasing the landmark week 12 responses (primary endpoint) by over... Read More

Peer reviewed data presented during a late-breaking session at the European Academy of Dermatology and Venereology Congress (EADV) confirms the strong profile of sonelokimab in HS announced at MLTX’s R&D Day on June 26, 2023 HiSCR75 primary endpoint met with a significantly higher proportion of patients on sonelokimab 120mg (43.3%) compared to placebo (14.7%) achieving HiSCR75 at week 12; a 29 percentage points (ppt) delta... Read More

Phase 2 MIRA primary analysis trial results (12-week) for MoonLake’s Nanobody ® sonelokimab in hidradenitis suppurativa to be presented at a late-breaking session at the European Academy of Dermatology and Venereology Congress ZUG, Switzerland, October 4, 2023 – MoonLake Immunotherapeutics AG (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases,... Read More

MoonLake Immunotherapeutics to ho st a Capital Markets Day on Monday , September 11 ZUG, Switzerland, September 6, 2023 – MoonLake Immunotherapeutics AG (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, will host a Capital Markets Day for investors and analysts on Monday, September 11. The live webcast will be viewable from 11:30 am – 13:00... Read More

Achieved landmark milestone with positive results from Phase 2 MIRA trial in hidradenitis suppurativa (HS), suggesting that, as early as week 12, the Nanobody ® sonelokimab, relative to placebo, reaches the highest clinical activity among all other therapies tested in similarly stringent pivotal-like trials; top-line 24-week data readout is expected in mid-October 2023 Successfully completed randomization of the target 200... Read More

Randomization target of 200 patients completed ahead of schedule in the ARGO PsA trial Top-line 12-week results of the ARGO trial in PsA for the novel IL-17A and IL-17F inhibiting Nanobody ® sonelokimab, are now expected in the first half of November 2023, ahead of the American College of Rheumatology Conference, November 10-15 th A Capital Markets Day will be held on September 11 th 2023 to discuss the PsA market and share... Read More

MoonLake Immunotherapeutics Announces Pricin g of $ 40 0 Million Upsized Public Offering of Class A Ordinary Shares ZUG, Switzerland, June 28, 2023 – MoonLake Immunotherapeutics (Nasdaq:MLTX) (“MoonLake”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced the pricing on June 27, 2023 of its upsized underwritten public offering of 8,000,000 Class A... Read More

MoonLake Immunotherapeutics Announces Proposed Underwritten Public Offering ZUG, Switzerland, June 26, 2023 – MoonLake Immunotherapeutics (NASDAQ:MLTX) (“MoonLake”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced that it has commenced an underwritten public offering of $250 million of its Class A ordinary shares and, in lieu of Class A ordinary... Read More

MoonLake Immunotherapeutics achieves landmark milestone with positive Phase 2 results for Nanobody ® sonelokimab in hidradenitis suppurativa First placebo-controlled randomized trial in HS to report positive topline results using HiSCR75 as the primary endpoint Primary endpoint HiSCR75 met with 29 percentage points (ppt) delta vs placebo (p=0.0002) at week 12, setting a new bar in HS HiSCR50 met with 38 ppt delta vs placebo... Read More

Capital Markets Day held in April highlighted the differentiating features of sonelokimab and strong competitive position following competitor data in moderate-to-severe hidradenitis suppurativa (HS) Preparations are well underway for the announcement of top-line results from a Phase 2 trial of sonelokimab in moderate-to-severe HS around the end of June with final read-out of 24-week data by Q4 this year Patient enrollment... Read More

ZUG, Switzerland , May 3, 2023 – MoonLake Immunotherapeutics (NASDAQ: MLTX) (“MoonLake”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced that it has signed a collaboration agreement with SHL Medical, a world-leading provider of advanced drug delivery solutions, to develop an autoinjector for clinical and potential subsequent commercial supply of... Read More

ZUG, Switzerland, April 19, 2023 – MoonLake Immunotherapeutics AG (“MoonLake”; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, will host today its Capital Markets Day for investors and analysts in New York and virtually. The live event will be held in New York, US, with a webcast available for virtual attendees, from 10:30-12:30 EDT (15:30-17:30 BST /... Read More

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 readouts Recent clinical data announced at the 81 st 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... Read More

MoonLake Immunotherapeutics com pletes patient enrol l ment and randomization ahead of schedule in a Phase 2 trial of the Nanobody ® sonelokimab in moderate-to-severe hidradenitis suppurativa Enrollment target of 210 patients randomized completed ahead of schedule Top line results on the primary endpoint, for the novel IL-17A and IL-17F inhibitor Nanobody ® sonelokimab, expected mid-2023 First registered randomized trial in... Read More

MoonLake Immunotherapeutics screens first patient in Phase 2 study of the Nanobody ® sonelokimab in active psoriatic arthritis Phase 2 study represents an important step in psoriatic arthritis clinical development, assessing high threshold outcomes across joint and skin domains of this multi-faceted disease Global study to assess efficacy and safety of sonelokimab compared to placebo, with adalimumab as an active reference... Read More