MoonLake Immunotherapeutics - MLTX STOCK NEWS

MoonLake Immunotherapeutics (NASDAQ:MLTX) reported Q3 2024 financial results with $493.9 million in cash and equivalents, providing runway through 2026. R&D expenses increased to $35.7 million from $23.7 million in Q2, while G&A expenses rose to $7.4 million from $6.9 million. The company's Phase 3 clinical program in hidradenitis suppurativa is progressing with primary endpoint readout expected mid-2025. Multiple clinical trials are planned, including Phase 3 studies in psoriatic arthritis and adolescent HS, plus Phase 2 trials in palmoplantar pustulosis and axial spondyloarthritis, scheduled to commence around year-end.

MoonLake Immunotherapeutics (Nasdaq: MLTX), a clinical-stage biotech company, will host a Capital Markets Update on September 11, 2024, from 9:00 – 10:30 EST. The event will feature business updates from key executives and provide details on:

• Phase 3 programs for sonelokimab (SLK) in hidradenitis suppurativa and psoriatic arthritis
• Pipeline updates and catalysts for 2024-2026
• Phase 2 trials of SLK in palmo-plantar pustulosis
• Market opportunities and competitor analysis
• Financial presentation

The update will be followed by a Q&A session. Investors and analysts can register for the webcast online.

MoonLake Immunotherapeutics (NASDAQ:MLTX) reported its Q2 2024 financial results and announced a Capital Markets Update for September 11. Key highlights include:

1. Initiation of Phase 3 VELA program for sonelokimab in hidradenitis suppurativa (HS), with topline results expected mid-2025.

2. Positive feedback from FDA and EMA on the regulatory path for Phase 3 program in psoriatic arthritis (PsA).

3. $519.8 million in cash and equivalents, providing runway to end of 2026.

4. R&D expenses increased to $23.7 million, while G&A expenses remained stable at $6.9 million.

5. Upcoming events include initiation of Phase 3 IZAR program in PsA and additional Phase 2 trials in various indications.

MoonLake Immunotherapeutics has received positive regulatory feedback from both the FDA and EMA for its Phase 3 program of Nanobody® sonelokimab targeting psoriatic arthritis (PsA). The program, named IZAR, will enroll around 1,500 patients across two trials (IZAR-1 and IZAR-2). IZAR-1 will focus on bio-naïve patients and radiographic progression, while IZAR-2 will involve TNF-IR patients with risankizumab as a reference arm. The primary endpoint readout is anticipated by end-2026. This follows earlier positive feedback for their Phase 3 VELA program for hidradenitis suppurativa (HS). Recruitment for these trials is set to begin in Q4 2024.

MoonLake Immunotherapeutics has launched the Phase 3 VELA program, testing the Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS). The program aims to enroll 800 patients and is expected to report its topline primary endpoint at week 16 by mid-2025. Sonelokimab targets inflammation by inhibiting IL-17A/A, IL-17A/F, and IL-17F/F dimers. The Phase 3 program, following the successful Phase 2 MIRA trial, will use HiSCR75 as its primary endpoint. The trial will last 52 weeks, with an open-label extension up to two years.

MoonLake Immunotherapeutics reported positive feedback on the regulatory path for the Phase 3 program of Nanobody® sonelokimab, significant improvements in ARGO Phase 2 trial, and plans to commence four additional clinical trials across dermatology and rheumatology. The company ended Q1 2024 with $547.1 million in cash and expects a cash runway to the end of 2026.

MoonLake Immunotherapeutics partners with Komodo Health to enhance research on inflammatory skin and joint conditions, aiming to improve treatment for patients with hidradenitis suppurativa and active psoriatic arthritis. The collaboration will leverage Komodo's data and technology to accelerate the development of MoonLake's nanobody-based therapy, with a focus on market research, clinical trial site selection, and patient journey mapping.

MoonLake Immunotherapeutics announces positive 24-week data from the ARGO trial of sonelokimab in psoriatic arthritis, showcasing significant improvements and multi-domain responses. The Company also plans to commence Phase 3 trials in hidradenitis suppurativa, targeting a market opportunity exceeding $10bn by 2035. MoonLake further announces the initiation of four additional clinical trials across dermatology and rheumatology, highlighting the potential of sonelokimab in various inflammatory diseases.

MoonLake Immunotherapeutics to present MIRA trial data of Nanobody® sonelokimab in hidradenitis suppurativa as a late breaker at the AAD Annual Meeting 2024. MoonLake, a biotechnology company, will showcase 24-week data from its Phase 2 MIRA trial at the AAD Annual Meeting, highlighting the therapeutic effect of sonelokimab in treating moderate to severe hidradenitis suppurativa.