MoonLake Immunotherapeutics Q2 2024 Financial Results and Capital Markets Update for September 11

MoonLake Immunotherapeutics, a clinical-stage biotechnology firm, has disclosed its financial outcomes for the second quarter of 2024 and announced a Capital Markets Update scheduled for September 11. Specializing in developing advanced therapies for inflammatory diseases, the company has made substantial advancements with its Nanobody® sonelokimab across various dermatological and rheumatological conditions.

During the quarter, MoonLake began its Phase 3 VELA program aimed at evaluating sonelokimab's efficacy over 52 weeks in approximately 800 patients with moderate-to-severe hidradenitis suppurativa (HS). Topline results for the 16-week primary endpoint are expected by mid-2025. Additionally, a Phase 3 VELA TEEN trial targeting adolescents with HS is slated to enroll its first patients by the end of the year.

MoonLake also received favorable regulatory feedback from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for its Phase 3 IZAR program targeting psoriatic arthritis (PsA). The IZAR program will include two trials: IZAR-1 focusing on bio-naïve patients and radiographic progression, and IZAR-2 focusing on TNF-IR patients. The program aims to enroll approximately 1,500 patients, with enrollment starting in the fourth quarter of 2024.

Preparations are ongoing to initiate additional Phase 2 trials for sonelokimab in conditions like palmo-plantar pustulosis (PPP) and axial spondyloarthritis (axSpA). The first patients are expected to be enrolled before the year's end.

Dr. Jorge Santos da Silva, MoonLake's CEO, emphasized the company's strides toward clinical and regulatory milestones. "This quarter saw us take crucial steps towards registration as we enrolled the first patients into the HS Phase 3 trials for our Nanobody® sonelokimab. By the end of the year, we expect to have Phase 3 programs underway in both HS and PsA, two major inflammatory and immunology indications. We also plan to initiate a Phase 3 trial for adolescent HS, expected to be the first clinical trial focused on this population."

Financially, MoonLake ended the quarter with $519.8 million in cash, cash equivalents, and short-term marketable debt securities, offering a cash runway extending to the end of 2026. Research and development expenses for the quarter amounted to $23.7 million, up from $13.0 million in the previous quarter, primarily due to the costs associated with new clinical trials. General and administrative expenses were $6.9 million, similar to the previous quarter's $6.8 million.

Matthias Bodenstedt, MoonLake's Chief Financial Officer, stated, "MoonLake is in full execution mode and on track for numerous significant data reads in 2025, including the anticipated primary readout of the Phase 3 HS VELA program. With over $500 million in cash, we remain well-capitalized, and our runway guidance to the end of 2026 remains unchanged."

Upcoming significant events for MoonLake include the Capital Markets Update on September 11, the initiation of the Phase 3 IZAR program in PsA in Q4 2024, additional Phase 2 trials for dermatology and rheumatology indications in the second half of 2024, and the initiation of the Phase 3 VELA TEEN program around year-end 2024. The company also expects the topline primary endpoint readout for the Phase 3 VELA program in HS by mid-2025.

In summary, MoonLake Immunotherapeutics has made substantial progress in advancing its clinical programs, particularly in the areas of HS and PsA. With strong financial backing and a clear regulatory pathway, the company is poised for significant milestones in the coming years.