MoonLake Reports Third Quarter 2026 Financial Results and Provides a Business Update
Key Highlights
- ➤FDA BLA submitted for sonelokimab in moderate-to-severe hidradenitis suppurativa
- ➤IZAR-1 met all Week 16 clinical endpoints; 42.1% achieved ACR50
- ➤IZAR-2 psoriatic arthritis enrollment completed; topline results expected Q1 2027
- ➤$498.5 million cash and securities; runway expected through mid-2028
- ➤R&D expenses rose to $68.9 million, including accrued regulatory milestone fees
Expert Statements
Matthias Bodenstedt, Chief Financial Officer of MoonLake Immunotherapeutics
“This quarter reflects the strength of execution across MoonLake. With the BLA for sonelokimab in HS now submitted to the FDA, positive Week 16 results from the Phase 3 IZAR-1 trial and IZAR-2 fully enrolled, we are making important progress across both our regulatory and clinical priorities. At the same time, we believe our financial position and projected cash runway into mid-2028 position us well to prepare for the expected commercial launch of sonelokimab in the U.S. next year, and to continue advancing its broader potential across inflammatory diseases.”
* Biologics License Application for sonelokimab submitted to the U.S. Food and Drug Administration for the treatment of adults and adolescents with moderate-to-severe hidradenitis suppurativa, marking an important step towards potential U.S. approval and commercialization * Positive Week 16 results from the Phase 3 IZAR-1 trial in psoriatic arthritis reported, with all clinical endpoints met for sonelokimab 60 mg with induction * Enrollment completed in the Phase 3 IZAR-2 trial in psoriatic arthritis, with initial topline results expected in Q1 2027 following the predefined unblinding protocol * Phase 3 NOVA trial in palmoplantar pustulosis on track to start enrollment in November 2026 * MoonLake ended the third quarter with $498.5 million in cash, cash equivalents and short-term marketable debt securities and expects to have a cash runway to mid-2028; additionally, up to $400 million in non-dilutive funds remain available through its debt facility with Hercules Capital ZUG, Switzerland, November 4, 2026 – MoonLake Immunotherapeutics (NASDAQ: MLTX) ("MoonLake" or the "Company"), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today provided a business update and reported third quarter 2026 financial results.
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