MoonLake Immunotherapeutics Stock Price, News & Analysis

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MoonLake Immunotherapeutics (Nasdaq: MLTX) priced an underwritten offering of 7,142,857 Class A ordinary shares at $10.50 per share, producing gross proceeds of approximately $75 million. The offering is expected to close on or about November 6, 2025, subject to customary closing conditions.

All securities are being sold by MoonLake. Net proceeds, together with existing cash and marketable securities, are intended to fund research and development of sonelokimab and for general corporate purposes. Leerink Partners is sole bookrunning manager. A shelf registration became effective on September 11, 2023.

MoonLake Immunotherapeutics (NASDAQ: MLTX) reported Q3 2025 results and clinical updates. As of September 30, 2025, the company held $380.5 million in cash, cash equivalents and short-term marketable securities, and expects committed debt capacity to provide runway into the second half of 2027. R&D spend for the quarter was $60.6 million vs. $49.8 million in the prior quarter, driven by CRO/CMO, consulting and personnel costs to support trial ramp-up and BLA preparations.

Clinical highlights: Phase 2 LEDA in palmoplantar pustulosis showed a mean PPPASI change −64% at week 16 and PPPASI75 in 39%; safety consistent with prior trials. Interim Phase 3 VELA and VELA-TEEN data showed ongoing benefit in hidradenitis suppurativa, with VELA-TEEN HiSCR75 = 46% (n=11). A Type B meeting with FDA is scheduled for Dec 15, 2025, and a BLA submission is targeted in Q3/Q4 2026.

MoonLake Immunotherapeutics (NASDAQ: MLTX) reported week 16 results from its Phase 3 VELA program testing sonelokimab in moderate to severe hidradenitis suppurativa (HS). The combined trials showed statistically significant improvements across all primary and key secondary endpoints (p<0.001).

In VELA-1, sonelokimab achieved statistical significance with a 17% delta to placebo (p<0.001). VELA-2 showed a 9% delta but missed statistical significance (p=0.053) due to higher-than-expected placebo response. Using the treatment policy strategy, both trials achieved significant HiSCR75 at week 16, with sonelokimab showing 35% and 36% response rates versus placebo rates of 18% and 26% respectively.

The drug demonstrated a favorable safety profile with no new safety signals, including absence of suicidal ideation and behavior. The company will seek regulatory guidance for the path to registration while continuing other clinical studies in multiple indications.

MoonLake Immunotherapeutics (NASDAQ:MLTX), a biotechnology company, reported Q2 2025 financial results and significant clinical progress. The company ended Q2 with $425.1 million in cash and secured up to $500 million in non-dilutive financing from Hercules Capital, extending cash runway into 2028.

Key financial metrics include R&D expenses of $49.8 million (up $13.3 million from previous quarter) and G&A expenses of $10.9 million. The company's Phase 3 VELA program in hidradenitis suppurativa (HS) is progressing toward primary endpoint readout around September 2025, with BLA submission expected mid-2026.

Multiple clinical trials for sonelokimab are advancing in various indications including PPP, axSpA, PsA, and adolescent HS, with significant readouts expected through 2026. The company anticipates product launch in 2027.

MoonLake Immunotherapeutics (NASDAQ: MLTX) reported its Q1 2025 financial results, highlighting significant progress in its clinical programs. The company ended Q1 with $480.1 million in cash and secured a $500 million non-dilutive debt facility with Hercules Capital, extending cash runway into 2028. R&D expenses were $36.5 million, while G&A expenses increased to $11.0 million. Key developments include completed enrollment for Phase 3 VELA program in hidradenitis suppurativa (HS), with results expected around September 2025, and positive interim readout of Phase 2 LEDA study in palmoplantar pustulosis. The company initiated three new trials with sonelokimab: Phase 3 VELA-TEEN in adolescent HS, Phase 2 LEDA in PPP, and Phase 2 S-OLARIS in axial spondyloarthritis.

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.