UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39630 MOONLAKE IMMUNOTHERAPEUTICS (Exact Name of Registrant as Specified in Its Charter) Cayman Islands 98-1711963 (State or o ...

The Company today also released new data from multiple clinical trials of its Nanobody SLK: ® MoonLake Immunotherapeutics Reports Third Quarter 2025 Financial Results and Announces New Data from Clinical Trials of its Nanobody® Sonelokimab ZUG, Switzerland, November 5, 2025 – MoonLake Immunotherapeutics (NASDAQ: MLTX) ("MoonLake" or the "Company"), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced its financial results for the third qu ...

Core Insights - MoonLake Immunotherapeutics reported its financial results for Q3 2025, highlighting significant cash reserves and ongoing clinical trials for its investigational therapy sonelokimab [1][2]. Financial Performance - As of September 30, 2025, the company had cash, cash equivalents, and short-term marketable debt securities totaling $380.5 million, which is expected to fund operations into the second half of 2027 [2]. - Research and development expenses for Q3 2025 were $60.6 million, an increase from $49.8 million in the previous quarter, attributed to higher costs associated with clinical trials and consulting [2]. - General and administrative expenses remained stable at $10.8 million compared to $10.9 million in the previous quarter [2]. Clinical Trials and Data - New data from the Phase 2 LEDA trial indicated that sonelokimab (SLK) provided a 64% mean percent change in the Palmoplantar Psoriasis Area and Severity Index (PPPASI) at week 16, with 39% of patients achieving a ≥75% reduction [3]. - Interim analyses from the VELA-1 and VELA-2 Phase 3 trials in adult patients with Hidradenitis Suppurativa (HS) showed continuous clinical improvement beyond the primary endpoint at week 16 [4]. - The VELA-TEEN trial, focusing on adolescent HS patients, reported that 46% of participants achieved a HiSCR75 response at week 16 [5]. Regulatory and Future Milestones - A Type B meeting with the FDA is scheduled for December 15, 2025, to discuss the clinical evidence package for SLK in HS to support a Biologics License Application (BLA) [4][6]. - Upcoming milestones include the primary endpoint readout of the Phase 2 S-OLARIS trial in axial spondyloarthritis (axSpA) in Q1 2026 and the initiation of a Phase 3 trial in palmoplantar pustulosis (PPP) in Q3 2026 [6][8]. Market Context - Hidradenitis Suppurativa affects an estimated 2% of the population, with a projected market opportunity reaching $15 billion by 2035 due to the significant unmet need for effective treatments [24]. - The company is focused on inflammatory diseases with high unmet needs, including HS, psoriatic arthritis, and axial spondyloarthritis, which affect millions globally [10][14].

Core Viewpoint - The MoonLake class action lawsuit alleges that MoonLake Immunotherapeutics and its executives violated the Securities Exchange Act of 1934, impacting investors who purchased or acquired its common stock [1][3]. Company Overview - MoonLake Immunotherapeutics is a clinical stage biotechnology company focused on developing therapies for inflammatory skin and joint diseases, with its primary drug candidate being sonelokimab (SLK) for treating hidradenitis suppurativa (HS) [3]. Allegations - The lawsuit claims that MoonLake made false or misleading statements regarding SLK's efficacy compared to Union Chimique Belge's BIMZELX, which is an FDA-approved monoclonal antibody for HS [4]. - Specific allegations include that SLK and BIMZELX target the same inflammatory cytokines (IL-17A and IL-17F), and that SLK's unique Nanobody structure does not provide superior clinical benefits or increased tissue penetration as claimed [4]. Stock Impact - Following the announcement of disappointing Phase 3 VELA program results on September 28, 2025, which indicated SLK's failure to demonstrate competitive efficacy against BIMZELX, MoonLake's stock price plummeted nearly 90% [5]. Legal Process - The Private Securities Litigation Reform Act of 1995 allows any investor who purchased MoonLake common stock during the class period to seek lead plaintiff status in the lawsuit, representing the interests of the class [6]. Law Firm Background - Robbins Geller Rudman & Dowd LLP is a leading law firm in securities fraud and shareholder litigation, having recovered over $2.5 billion for investors in 2024 alone, and is recognized for securing significant monetary relief for investors [7].

Core Viewpoint - Investors in MoonLake Immunotherapeutics have the opportunity to lead a securities fraud class action lawsuit due to substantial losses incurred as a result of misleading statements made by the company regarding its products and clinical benefits [1][3]. Summary by Sections Lawsuit Details - The lawsuit alleges that from March 10, 2024, to September 29, 2025, the defendants failed to disclose critical information about the company's products, specifically that SLK and BIMZELX share the same molecular targets, and that SLK's unique Nanobody structure does not provide superior clinical benefits compared to BIMZELX [3]. Investor Participation - Investors who suffered losses in MoonLake Immunotherapeutics are encouraged to contact the Law Offices of Howard G. Smith before December 15, 2025, to participate in the ongoing securities fraud lawsuit [2][4]. Legal Rights - Investors have the option to retain counsel of their choice or remain absent members of the class action without taking any immediate action [5].

Core Viewpoint - Rosen Law Firm is reminding investors who purchased common stock of MoonLake Immunotherapeutics during the specified Class Period of the upcoming lead plaintiff deadline on December 15, 2025 [1]. Group 1: Class Action Details - Investors who bought MoonLake common stock between March 10, 2024, and September 29, 2025, may be eligible for compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties can join by submitting a form or contacting the law firm [3][6]. - The lawsuit claims that throughout the Class Period, defendants made false or misleading statements regarding the efficacy of their product SLK compared to traditional monoclonal antibodies [5]. Group 2: Legal Representation - Investors are encouraged to select qualified legal counsel with a proven track record in securities class actions, as many firms may not have the necessary experience or resources [4]. - The Rosen Law Firm has a history of successful settlements, including the largest securities class action settlement against a Chinese company at the time, and has recovered hundreds of millions for investors [4]. Group 3: Case Specifics - The complaint alleges that the defendants failed to disclose critical information about the differences between Nanobodies and monoclonal antibodies, leading to investor damages when the truth was revealed [5].

Core Viewpoint - A class action securities lawsuit has been filed against Lantheus Holdings, Inc. for alleged securities fraud affecting investors between February 26, 2025, and August 5, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that Lantheus made false statements and concealed information regarding its revenue outlook and growth potential, particularly related to the sales growth of its product Pylarify [2]. - It is alleged that Lantheus downplayed risks associated with competition, pricing dynamics, seasonality, and macroeconomic fluctuations, leading to an inaccurate portrayal of its market understanding [2]. Group 2: Investor Information - Investors who suffered losses during the specified timeframe have until November 10, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require this role [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees, indicating no financial obligation to participate in the lawsuit [3]. Group 3: Law Firm Background - Levi & Korsinsky, LLP has a history of securing hundreds of millions of dollars for shareholders and is recognized as one of the top securities litigation firms in the United States [4].

Core Viewpoint - A class action securities lawsuit has been filed against MoonLake Immunotherapeutics, alleging securities fraud that affected investors between March 10, 2024, and September 29, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that the defendants made false statements regarding MoonLake's drug candidate SLK, asserting that it shares molecular targets with BIMZELX and that SLK's unique Nanobody structure does not provide superior clinical benefits [2]. - It is alleged that the supposed increased tissue penetration of SLK would not lead to improved clinical efficacy, indicating that the defendants lacked a reasonable basis for their positive claims about SLK's superiority over traditional monoclonal antibodies [2]. Group 2: Investor Information - Investors who suffered losses during the specified period have until December 15, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require serving as a lead plaintiff [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees, emphasizing that there is no financial obligation to participate in the lawsuit [3]. Group 3: Legal Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years and consistently ranking among the top securities litigation firms in the United States [4].

Core Viewpoint - A class action securities lawsuit has been filed against MoonLake Immunotherapeutics, alleging securities fraud that affected investors between March 10, 2024, and September 29, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that the defendants made false statements regarding MoonLake's drug candidate SLK, asserting that it shares molecular targets with BIMZELX and that SLK's unique Nanobody structure does not provide superior clinical benefits [2]. - Allegations include that SLK's supposed increased tissue penetration does not translate to clinical efficacy, and thus the defendants lacked a reasonable basis for their positive claims about SLK's superiority over monoclonal antibodies [2]. Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until December 15, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require serving as lead plaintiff [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees, with no obligation to participate [3]. Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4].

Core Viewpoint - MoonLake Immunotherapeutics faces a securities class action lawsuit following the announcement of disappointing Phase 3 trial results for its product candidate sonelokimab (SLK), leading to a significant drop in share price by approximately 90% [1][2][6] Company Overview - MoonLake Immunotherapeutics is a clinical-stage biotechnology company focused on treating skin inflammatory diseases driven by cytokines IL-17A and IL-17F [3][4] Trial Results and Market Reaction - The Phase 3 trials for SLK revealed that only one of the two trials achieved statistical significance, with results showing substantially lower efficacy compared to the competitor's FDA-approved product, BIMZELX [6] - Following the announcement, MoonLake's share price plummeted by $55.75, or about 90%, on September 29, 2025 [2][6] Allegations of Misleading Information - The lawsuit claims that MoonLake misled investors regarding SLK's trial design and efficacy, asserting that the company made false statements about the advantages of SLK's Nanobody structure over traditional monoclonal antibodies [5][6] - Specific allegations include misleading claims about the clinical benefits of SLK compared to BIMZELX, including the assertion that SLK's structure would provide superior clinical efficacy [5] Legal Proceedings - The class action lawsuit is focused on the propriety of MoonLake's statements about SLK's trial design and data, with a class period defined from March 10, 2024, to September 29, 2025 [3][5] - The lead plaintiff deadline for the lawsuit is set for December 15, 2025 [3]