MoonLake Immunotherapeutics Q3 2024 Financial Results and Business Update

MoonLake Immunotherapeutics announced financial results for the third quarter of 2024 and provided a business update. The company, focusing on innovative therapies for inflammatory diseases, ended the quarter with $493.9 million in cash and equivalent assets, which is projected to support operations until the end of 2026. The promising market performance of IL-17 inhibitors in treating hidradenitis suppurativa (HS) and other inflammatory conditions has validated the potential for MoonLake's lead candidate, sonelokimab. This drug is currently in a Phase 3 clinical program for HS, with primary endpoint results expected by mid-2025. Additionally, preparations for the Phase 3 clinical trial in psoriatic arthritis (PsA) have been completed, and patient enrollment is set to begin soon.

MoonLake is also advancing other clinical programs, including Phase 2 trials for palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA), and a Phase 3 trial for adolescent HS, all scheduled to start around the end of the year. The company is making strides with sonelokimab, a Nanobody® that targets IL-17A and IL-17F dimers, which are implicated in various inflammatory conditions.

Dr. Jorge Santos da Silva, CEO of MoonLake, highlighted the clinical progress made with sonelokimab in the third quarter across multiple dermatology and rheumatology indications. He noted that the drug's ability to inhibit IL-17A and IL-17F dimers, coupled with the molecular benefits of the Nanobody® technology, has led to higher clinical responses in patients. This progress indicates significant differentiation of sonelokimab from its competitors, with multiple data catalysts expected in 2025, including the primary readout of the Phase 3 VELA program in HS.

In the third quarter, MoonLake’s Phase 3 HS program showed good progress with patient enrollment underway in North America and Europe for the VELA-1 and VELA-2 studies. Preparations for the Phase 3 PsA program were also completed, with the initial patient enrollments in the IZAR-1 and IZAR-2 studies imminent. These studies include bio-naïve patients and those who have had an inadequate response to TNF inhibitors. The company is also preparing for the first dedicated clinical trial in adolescent HS, set to begin at the end of the year. Additional Phase 2 trials in PPP and axSpA are also on track to start around year-end, with a Phase 2 trial for seronegative spondylarthritis scheduled to begin in early 2025.

The strong commercial performance of existing IL-17 inhibitors in HS and other inflammatory indications has surpassed market expectations, increasing awareness and diagnosis. This trend supports the significant commercial potential for sonelokimab, which, due to its unique molecular characteristics and promising clinical data, is positioned as a potentially best-in-class treatment.

Financially, MoonLake reported research and development expenses of $35.7 million for the quarter ending September 30, 2024, up from $23.7 million in the previous quarter. This increase was mainly due to the ramp-up of the Phase 3 VELA program and preparations for new clinical trials. General and administrative expenses were $7.4 million, up from $6.9 million in the previous quarter, primarily due to personnel-related costs to support the company’s growth.

Matthias Bodenstedt, Chief Financial Officer at MoonLake, emphasized the company's solid financial performance in Q3, maintaining a strong cash position projected to last through 2026. He reiterated the company’s focus on cost control while investing in large clinical development programs and preparation for regulatory filings and pre-commercial activities.

MoonLake will participate in several upcoming investor and medical conferences, which include the American College of Rheumatology Conference in Washington DC, the Jefferies London Healthcare Conference, and the JP Morgan Annual Healthcare Conference in San Francisco.

MoonLake Immunotherapeutics, founded in 2021 and based in Zug, Switzerland, is dedicated to transforming patient outcomes with sonelokimab, an investigational Nanobody® designed to treat inflammatory diseases by inhibiting IL-17A and IL-17F dimers that drive inflammation.