MoonLake Immunotherapeutics reported a Q3 2025 net loss of $70.7 million, a widening from the $36.1 million loss posted in the same quarter last year. The company’s earnings per share fell to $-1.10, missing the consensus estimate of $-0.89 by $0.21, a miss of roughly 24%. Cash, cash equivalents and short‑term marketable securities stood at $380.5 million as of September 30, giving the company a runway that management expects to extend into the second half of 2027.
Research and development expenses climbed to $60.6 million, up $10.8 million from the $49.8 million reported in Q2 2025, reflecting intensified investment in sonelokimab’s Phase 3 programs. General and administrative costs were essentially flat at $10.8 million versus $10.9 million a quarter earlier, indicating disciplined overhead management. The broader loss expansion is therefore driven primarily by higher R&D outlays rather than a decline in operating efficiency.
Clinically, the Phase 2 LEDA trial in palmoplantar pustulosis achieved a mean PPPASI improvement of 64% at week 16, with 39% of patients reaching a ≥75% reduction, reinforcing the drug’s therapeutic promise. In the Phase 3 VELA program for hidradenitis suppurativa, interim analyses show continued improvement beyond the week‑16 primary endpoint; however, the VELA‑2 cohort narrowly missed its composite primary endpoint because of a higher‑than‑expected placebo response. A Type B meeting with the FDA is scheduled for December 15, 2025 to discuss the evidence package for a potential BLA submission.
Management reiterated that the current cash balance will support ongoing clinical development and potential regulatory submissions through H2 2027. While the company has yet to generate revenue, the guidance on cash runway signals confidence that the investment in sonelokimab’s pipeline will be sustained without immediate financing needs.
The earnings miss and widened loss underscore the cost intensity of late‑stage development, but the company’s strong cash position and positive clinical signals—particularly the LEDA data and the upcoming FDA meeting—provide a foundation for future progress. Investors will likely weigh the expanded loss against the strategic value of the pipeline and the potential for a successful BLA submission in the coming months.
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