Core Insights - MoonLake Immunotherapeutics has received positive regulatory feedback from both the FDA and EMA for its Phase 3 program of sonelokimab in psoriatic arthritis (PsA) [1][4][17] - The Phase 3 program, named IZAR, will enroll approximately 1,500 patients and includes two trials: IZAR-1 for biologic-naïve patients and IZAR-2 for TNF-IR patients [1][4][5] - The primary endpoint for both trials is the ACR 50 response at Week 16, with results expected by the end of 2026 [4][5][22] Company Overview - MoonLake Immunotherapeutics is a clinical-stage biotechnology company focused on developing therapies for inflammatory diseases, particularly hidradenitis suppurativa (HS) and psoriatic arthritis [32] - The company was founded in 2021 and is headquartered in Zug, Switzerland [32] - Sonelokimab is a novel investigational Nanobody® that inhibits IL-17A and IL-17F, which are key drivers of inflammation in these diseases [32] Psoriatic Arthritis (PsA) Insights - PsA is a chronic inflammatory arthritis that affects up to 30% of patients with psoriasis, primarily impacting individuals aged 30 to 60 [2][18] - The disease is characterized by joint pain, swelling, and stiffness, significantly affecting patients' quality of life [2][18] - The IL-17 pathway is believed to play a crucial role in the pathophysiology of PsA [2] Clinical Trial Details - The IZAR program will consist of two global, randomized, double-blind, placebo-controlled trials: IZAR-1 and IZAR-2 [4][5] - IZAR-1 will focus on biologic-naïve patients and assess radiographic progression, while IZAR-2 will include a risankizumab active reference arm for TNF-IR patients [4][5] - The primary endpoint for both trials is the ACR 50 response, with secondary endpoints reflecting various disease manifestations [5][20] Hidradenitis Suppurativa (HS) Insights - HS is a chronic skin condition affecting 0.05–4.1% of the global population, with a significant unmet need for effective treatments [12] - The condition leads to painful inflammatory lesions and can result in irreversible tissue destruction [12] - MoonLake is also conducting Phase 3 trials for sonelokimab in HS, following positive outcomes from earlier trials [7][21]

Core Insights - MoonLake Immunotherapeutics has initiated the Phase 3 VELA program for sonelokimab, targeting moderate-to-severe hidradenitis suppurativa (HS) with a primary endpoint of HiSCR75 [1][3][4] - The program aims to enroll 800 patients across two identical trials, VELA-1 and VELA-2, with topline results expected by mid-2025 [3][5][6] - Sonelokimab is designed to inhibit IL-17A and IL-17F, addressing a significant unmet need in HS treatment [2][18] Company Overview - MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company focused on developing sonelokimab, a novel investigational Nanobody® for inflammatory diseases [18] - The company was founded in 2021 and is headquartered in Zug, Switzerland [18] Product Details - Sonelokimab is a ~40 kDa humanized Nanobody® that selectively binds to IL-17A and IL-17F, facilitating targeted treatment of inflammation [7][18] - The drug is currently being evaluated for HS and psoriatic arthritis (PsA), with plans for additional indications in dermatology and rheumatology [8][10] Clinical Trial Information - The Phase 3 VELA program will assess the efficacy and safety of sonelokimab over 52 weeks, with a focus on achieving a ≥75% reduction in total abscess and inflammatory nodule count [3][6] - The trials will also evaluate secondary endpoints, including HiSCR50 and changes in quality of life metrics [6] Market Context - HS affects up to 4.1% of the global population, with significant morbidity and a market opportunity exceeding $10 billion by 2035 [2][17] - There is a critical need for new treatment options, as only two biologics are currently FDA approved for HS [4][17]

bymuratdenizMoonLake Rises, Competition Wanes: The Sonelokimab Saga Continues MoonLake Immunotherapeutics (NASDAQ:MLTX) is a clinical-stage biotech company developing treatments for autoimmune conditions. Their lead asset, sonelokimab, is an IL-17 inhibitor targeting psoriasis (Phase 3 ready), hidradenitis suppurativa [HS] (Phase 2), and psoriatic arthritis [PsA] (Phase 2). These are all large US markets. Psoriasis is estimated to eclipse $50 billion by 2030. HS is expected to be a $2.24 billion global ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39630 MOONLAKE IMMUNOTHERAPEUTICS (Exact Name of Registrant as Specified in Its Charter) Cayman Islands 98-1711963 (State or other ...

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 u ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (MARK ONE) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39630 MOONLAKE IMMUNOTHERAPEUTICS (Exact Name of Registrant as Specified in Its Charter) Cayman Islands 98-1711963 (IRS Employer Identi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39630 MOONLAKE IMMUNOTHERAPEUTICS (Exact Name of Registrant as Specified in Its Charter) Cayman Islands 98-1711963 (State or o ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39630 MOONLAKE IMMUNOTHERAPEUTICS (Exact Name of Registrant as Specified in Its Charter) Cayman Islands 98-1711963 (State or other ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39630 MOONLAKE IMMUNOTHERAPEUTICS (Exact Name of Registrant as Specified in Its Charter) Cayman Islands 98-1711963 (State or other ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (MARK ONE) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39630 MOONLAKE IMMUNOTHERAPEUTICS (Exact Name of Registrant as Specified in Its Charter) Cayman Islands 98-1711963 (IRS Employer Identi ...