August 5, 2025 — MoonLake Immunotherapeutics (NASDAQ:MLTX) reported its Q2 2025 financial results, highlighting progress in its clinical programs and financial positioning. The Phase 3 VELA program in hidradenitis suppurativa (HS) is on track for a primary endpoint readout around September 2025, with a Biologic License Application (BLA) submission expected in mid-2026. Other clinical trials for sonelokimab in palmoplantar pustulosis (PPP), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), and adolescent HS are also advancing.
The company ended Q2 with $425.1 million in cash, cash equivalents, and short-term marketable debt securities, plus up to $425 million in additional non-dilutive funds. Key Q2 highlights include a non-dilutive financing agreement with Hercules Capital for up to $500 million, extending the cash runway into 2028 and supporting the potential launch of sonelokimab in 2027.
R&D expenses for the quarter were $49.8 million, up from $36.5 million in the previous quarter, due to increased spending on contract research organizations, contract manufacturing organizations, consulting, and personnel. General and administrative expenses remained steady at approximately $10.9 million.
Upcoming milestones include a R&D Day around September 2025 to present top-line results for the HS Phase 3 VELA program, and primary endpoint readouts for the Phase 2 LEDA trial in PPP (Q4 2025), the Phase 2 S-OLARIS trial in axSpA (Q1 2026), the Phase 3 VELA-TEEN trial in adolescent HS (H1 2026), and the Phase 2 IZAR trial in PsA (H1 2026).
Carla Bretes, Director IR & External Communications, ir@moonlaketx.com; ICR Healthcare, Mary-Jane Elliott, Namrata Taak, Ashley Tapp, Tel: +44 (0) 20 3709 5700, MoonLake@ICRHealthcare.com
Source: MoonLake Immunotherapeutics
