Press release
MoonLake Immunotherapeutics Reports Third Quarter 2022 Financial Results and Provides Recent Business Update
MoonLake Immunotherapeutics Reports Third Quarter 2022 Financial Results and Provides Recent Business Update Global trial of sonelokimab in Hidradenitis
About this update from Moonlake Immunotherapeutics
[{"type":"text","content":"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 creating next-level therapies for inflammatory diseases, today announced its financial results for the quarter ended September 30, 2022, and provided a business update. MoonLake continues to develop its novel IL-17A and IL-17F inhibiting Nanobody® sonelokimab (“SLK” or “sonelokimab”) in multiple inflammatory diseases in dermatology and rheumatology where the pathophysiology is known to be driven by IL-17F and IL-17A. Sonelokimab is an investigational Nanobody® designed to treat inflammatory disease by inhibiting the IL-17A/A, IL-17A/F and IL-17F/F dimers that drive inflammation. In addition, being one third the size of a traditional monoclonal antibody and containing a human albumin-binding domain, SLK is designed to penetrate difficult-to-reach inflamed tissues and directly target sites of inflammation. In May 2022, MoonLake initiated its Phase 2 global trial of sonelokimab in HS (M1095-HS-201) (“MIRA”), which has continued to meet recruitment targets with an expected primary endpoint readout in mid-2023. HS is a severely debilitating chronic skin condition, with a prevalence of approximately 1% globally, that results in irreversible tissue destruction. MoonLake’s MIRA trial represents a landmark milestone in HS clinical development as it is the first known trial to use Hidradenitis Suppurativa Clinical Response (HiSCR) 75 as its primary endpoint. Using a ≥75% improvement of HiSCR as the primary endpoint reflects MoonLake’s goal to revolutionize patient outcomes by seeking a greater reduction in disease markers than is typically tested in clinical trials. MoonLake also remains on schedule with its global Phase 2 trial of sonelokimab in PsA (M1095-PSA...