MoonLake Immunotherapeutics Stock Price, News & Analysis

MoonLake Immunotherapeutics (NASDAQ:MLTX) received positive final records from a Type B meeting with the U.S. FDA confirming that a BLA for sonelokimab (SLK) in hidradenitis suppurativa (HS) may establish substantial evidence of effectiveness (SEE) without new HS trials using data from VELA-1, VELA-2 and MIRA.

MIRA (n>1,000 combined with VELA) showed 43% HiSCR75 response with 120mg SLK (delta vs placebo 29 ppt, p<0.001). VELA-1 met primary and key secondary endpoints; VELA-2 reached significance under a treatment policy strategy but missed the primary composite (p=0.053). FDA advised including VELA-2 results for safety. MoonLake plans BLA submission in H2 2026 and will hold an Investor Day on February 23, 2026.

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.

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.