MoonLake Immunotherapeutics Stock Price, News & Analysis

MoonLake Immunotherapeutics (Nasdaq: MLTX) has announced a virtual Capital Markets Day scheduled for Tuesday, April 29, 2025, at 8:30 AM EST. The event will be streamed live from New York and feature presentations from key executives including CEO Jorge Santos da Silva, CSO Kristian Reich, and CFO Matthias Bodenstedt.

Key agenda items include:

• Details of a $500 million non-dilutive financing agreement with Hercules Capital
• Updates on the Phase 3 VELA Program in Hidradenitis Suppurativa (HS), including patient recruitment completion and baseline characteristics
• Early interim readout of the Phase 2 LEDA Study in Palmoplantar Pustulosis (PPP)
• Strategic market outlook and competitor analysis

The one-hour presentation will be followed by a Q&A session, with a recording available after the event.

MoonLake Immunotherapeutics (MLTX) has secured up to $500 million in non-dilutive financing from Hercules Capital, with $75 million drawn at close. This agreement adds to their existing $448 million cash position and will support the company's growth, including the anticipated 2027 launch of sonelokimab.

The company is advancing eight Phase 2 and Phase 3 clinical trials for sonelokimab, a ~40 kDa humanized Nanobody® targeting IL-17 dimers. Key upcoming milestones include:

• Phase 3 VELA program in hidradenitis suppurativa (HS) with pivotal data expected mid-2025
• Earlier-than-expected interim readout of Phase 2 LEDA study in palmoplantar pustulosis (PPP)

MoonLake will host a Capital Markets Update on April 29, 2025, in New York to discuss the Hercules partnership and provide clinical updates, including VELA program baseline characteristics and primary endpoint readout timing.

MoonLake Immunotherapeutics (NASDAQ: MLTX) reported its full year 2024 financial results, highlighting significant clinical progress and strong financial position. The company initiated multiple Phase 3 trials including the VELA program for hidradenitis suppurativa and IZAR program for psoriatic arthritis. In early 2025, they launched three new trials with Nanobody® sonelokimab.

Financial highlights include $448.0 million in cash and equivalents as of December 31, 2024, providing runway until at least end of 2026. R&D expenses increased to $112.8 million in 2024 from $31.8 million in 2023, while G&A expenses rose to $30.3 million. The company reported a net loss of $121.2 million for 2024.

MoonLake signed a three-year technology partnership with Komodo Health and plans to hold a Capital Markets Update in Q2 2025 to discuss the Phase 3 HS VELA program and additional clinical data.

MoonLake Immunotherapeutics (Nasdaq: MLTX) has initiated three new clinical trials for its investigational Nanobody®, sonelokimab, targeting adolescent hidradenitis suppurativa (HS), palmoplantar pustulosis (PPP), and axial spondyloarthritis (axSpA).

The new trials include:

• Phase 3 VELA-TEEN trial in adolescent HS, evaluating safety and tolerability over 24 weeks in 30-40 adolescents.
• Phase 2 LEDA trial in PPP, assessing the efficacy of a 120mg subcutaneous dose in around 30 patients.
• Phase 2 S-OLARIS trial in axSpA, using PET/MRI imaging to measure inflammation reduction in 25 patients.

These trials expand MoonLake's portfolio to ten trials, encompassing major dermatology and rheumatology indications. Phase 2 and Phase 3 data readouts are expected in 2025 and 2026.

Dr. Jorge Santos da Silva, CEO, highlighted that 2025 will be a transformational year with key Phase 3 data for HS, a market projected to reach $15bn by 2035.

Prof. Kristian Reich, CSO, emphasized leveraging sonelokimab's molecular advantages in treating diseases characterized by IL-17 and IL-17F pathway activation. The new trials aim to address significant unmet medical needs in these conditions.

MoonLake Immunotherapeutics (Nasdaq: MLTX) has initiated its Phase 3 IZAR program evaluating sonelokimab in patients with active psoriatic arthritis (PsA). The program consists of two trials: IZAR-1 for biologic-naïve patients with radiographic progression evaluation, and IZAR-2 for TNF-IR patients, featuring risankizumab as an active reference arm. The trials will enroll approximately 1,500 adult patients across the US, Europe, and Latin America, evaluating 60mg and 120mg doses over 52 weeks. The program follows positive Phase 2 ARGO trial results, with primary endpoint readout expected in H1 2026.

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.