MoonLake Immunotherapeutics

MoonLake Immunotherapeutics announced that its shareholders approved an amendment and restatement of the 2022 Equity Incentive Plan at the Annual Meeting, increasing the shares available for stock-based awards by 5,000,000. The amendment also includes a one-year minimum vesting requirement and extends the plan's term to June 4, 2036. Additionally, shareholders elected Spike Loy as a Class I Director, ratified Baker Tilly US, LLP as the independent auditor, and approved the advisory vote on executive compensation.

MoonLake Immunotherapeutics entered into a Master Commercial Supply Agreement and a Capacity Agreement with Vetter Pharma International GmbH on May 22, 2026. The Master Commercial Supply Agreement outlines Vetter's manufacturing of pre-filled application systems for MoonLake's products, with product-specific schedules and adjustable pricing. The Capacity Agreement requires MoonLake to commit to annual demand forecasts, ensuring Vetter reserves filling capacity, with potential compensation obligations if minimum quantities are not met. These agreements build upon a previous development agreement for sonelokimab.

MoonLake Immunotherapeutics reported a significant increase in net loss for the first quarter of 2026, reaching $69.7 million, compared to $40.6 million in the same period last year. This was primarily driven by higher research and development expenses, which rose to $54.5 million. The company's cash and cash equivalents decreased to $298.5 million, but management believes it has sufficient capital to fund operations until the end of 2027, partly due to an amended $500.0 million credit facility.

MoonLake Immunotherapeutics announced a positive outcome from its final pre-BLA meeting with the FDA for sonelokimab (SLK) in hidradenitis suppurativa (HS), aligning on submission plans and label strategy, including data from MIRA and VELA-TEEN trials. The company plans to submit the BLA by the end of September 2026 and expects a decision on Priority Review by end of November 2026. Additionally, MoonLake reported $357.9 million in cash, cash equivalents, and short-term marketable debt securities for Q1 2026, with a cash runway expected until the end of 2027.

MoonLake Immunotherapeutics announced a positive final pre-BLA meeting with the FDA for sonelokimab (SLK) in hidradenitis suppurativa (HS), aligning on submission plans and label strategy, including data from MIRA and VELA-TEEN trials. The company plans to submit the BLA by end of September 2026, with a decision on Priority Review expected by end of November 2026, and a potential US launch in H2 2027. For Q1 2026, MoonLake reported a net loss of $(69.7) million and ended the quarter with $357.9 million in cash, expecting a cash runway until the end of 2027.