MoonLake Immunotherapeutics Reports Q2 Results, $425.1mln in Cash

• MoonLake Immunotherapeutics reports Q2 2025 financial results • Phase 3 VELA program in HS on track for primary endpoint readout in September 2025 • Submission of BLA in the US expected in mid-2026 • Other clinical trials progressing well • Cash and marketable debt securities at $425.1 million • Non-dilutive funds of up to $425 million accessible • Catalyst-rich roadmap expected over the next 12 months

MoonLake Immunotherapeutics (NASDAQ: MLTX), a clinical-stage biotechnology company, has reported its financial results for the second quarter of 2025. The company ended the quarter with a robust cash position of $425.1 million, bolstered by securing up to $500 million in non-dilutive financing from Hercules Capital. This funding extends MoonLake's cash runway into 2028, providing a solid financial foundation for its expanding clinical pipeline.

Key financial highlights include Research and Development (R&D) expenses of $49.8 million, an increase of $13.3 million from the previous quarter. General and Administrative (G&A) expenses remained at $10.9 million. The company's Phase 3 VELA program in hidradenitis suppurativa (HS) is progressing towards its primary endpoint readout, expected around September 2025, with a potential Biologics License Application (BLA) submission in mid-2026. Multiple clinical trials for sonelokimab, MoonLake's investigational Nanobody® targeting IL-17A and IL-17F, are advancing across various indications, with significant readouts expected through 2026. The company anticipates a product launch in 2027.

MoonLake's Chief Executive Officer, Dr. Jorge Santos da Silva, commented, "Q2 has been another strong quarter for MoonLake. We narrowed guidance for the timing of the primary endpoint readout for our pivotal Phase 3 VELA program in HS to around September and look forward to submitting the data for presentation at a key scientific congress in the fourth quarter of this year. Additionally, we delivered an earlier-than-expected interim readout of the Phase 2 LEDA trial in PPP, which provides further validation on the potential of sonelokimab, which we believe derisks the overall development of the asset."

The company's Chief Financial Officer, Matthias Bodenstedt, noted, "MoonLake is in a robust financial position as we approach our first Phase 3 data readout for HS. The $500 million non-dilutive financing from Hercules Capital has significantly bolstered our cash position and enables us to confidently fund the launch of sonelokimab in 2027. This strengthened financial position also enables us to advance additional clinical trials and make further strategic investments to support our continued growth."

MoonLake's focus on inflammatory diseases with sonelokimab could establish the company as a significant player in this therapeutic area if its clinical programs continue to yield positive results. The company's commitment to delivering real-world benefits to patients remains unwavering, with a critical quarter ahead filled with significant milestones expected.

References:
[1] https://www.stocktitan.net/news/MLTX/moon-lake-immunotherapeutics-reports-second-quarter-2025-financial-oxqqfyssxfsh.html