Key Highlights

  • The third quarter net loss was USD 0.93 per share against an estimate of USD 0.83, with no Revenue reported.
  • A Biologics License Application for sonelokimab in hidradenitis suppurativa was submitted to the FDA on September 30, 2026.
  • Cash, cash equivalents and short-term marketable Debt securities were USD 498.5 million, which management said funds operations to mid-2028.
  • Research and development expenses were USD 68.9 million, including USD 17.0 million of accrued regulatory milestone license fees.

MoonLake Immunotherapeutics (NASDAQ:MLTX) described a quarter built around regulatory and clinical steps for sonelokimab, its IL-17A and IL-17F inhibiting Nanobody. The company submitted a Biologics License Application to the FDA on September 30, 2026, seeking approval in moderate-to-severe hidradenitis suppurativa (HS) for adults and pediatric patients aged 12 and older. The third quarter net loss was USD 0.93 per share, against an estimate of USD 0.83, with revenue of USD 0.00.

Sonelokimab Programs and Regulatory Path

MoonLake describes itself as a single-asset company. In June 2026, week 52 data from the VELA-1 and VELA-2 trials showed 67.2% of treated patients (n=396) achieving HiSCR75 and 33.1% achieving HiSCR100. An interim VELA-TEEN analysis at week 24 showed about 68% of 22 adolescent patients achieving HiSCR75. Management stated that the VELA-TEEN trial is scheduled to complete in the fourth quarter of 2026 with topline results in the first quarter of 2027.

For the BLA, management stated it would be notified within about 60 days of submission whether the application is accepted for review, and would receive the review timeline within about 74 days. Subject to FDA approval, it named a U.S. commercial launch in the second half of 2027. Stockpiling of drug substance as pre-launch inventory began in the third quarter of 2025.

In psoriatic arthritis, the IZAR-1 trial reported at week 16 that 42.1% of biologic-naive patients on 60 mg with induction achieved an ACR50 response, the primary endpoint. IZAR-2 completed enrollment in September, with initial topline results named for the first quarter of 2027. Enrollment in the Phase 3 NOVA trial in palmoplantar pustulosis is scheduled to begin in November 2026, and P-OLARIS results are named for early 2027.

Quarterly Financial Results

The net loss was USD 79.55 million, against USD 70.69 million in the third quarter of 2025, and the loss per share was USD 0.93 compared with USD 1.10. Total operating expenses were USD 79.85 million, against USD 71.43 million. Research and Development expenses were USD 68.9 million, compared with USD 60.6 million, with the company citing USD 17.0 million of accrued regulatory milestone license fees owed to Merck Healthcare KGaA, Darmstadt, Germany, tied to acceptance of the BLA, USD 2.8 million of added Manufacturing and logistics costs for pre-launch inventory, and USD 1.3 million of other research costs.

General and administrative expenses were USD 10.98 million against USD 10.80 million. Other income, net was USD 3.59 million.

Cash, Financing and Spending Plans

The nine-month net loss was USD 211.1 million, including share-based compensation of USD 18.7 million, with cash outflow from operations of USD 185.2 million. Including restricted cash, the total was USD 501.4 million. In June 2026 the company sold 9,000,000 Class A shares at USD 20.00 plus pre-funded warrants for up to 1,000,000 shares, with net proceeds of USD 189.8 million. The underwriters' full over-allotment exercise on July 14 added net proceeds of USD 28.5 million.

An at-the-market program has USD 300.0 million available, and nine-month sales under it brought net proceeds of about USD 50.3 million. A new Lease for United Kingdom office space was signed on October 8, 2026, with minimum payments of about USD 8.9 million over a term of roughly 10 years.

Dated Items and Cash Runway

A net loss of USD 0.93 per share sits alongside USD 68.9 million of quarterly research and development expense, USD 498.5 million of liquid resources and a runway management placed at mid-2028. Management named dated items: a BLA acceptance notice about 60 days after submission, VELA-TEEN completion in the fourth quarter of 2026, NOVA enrollment in November 2026, and IZAR-2 topline results in the first quarter of 2027.