MoonLake Immunotherapeutics (MLTX) closed the last trading session at $36.99, gaining 0.1% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $76.43 indicates a 106.6% upside potential.The mean estimate comprises 14 short-term price targets with a standard deviation of $13.12. While the lowest estimate of $55 indicates a 48.7% increase from the current price level, the most optimistic ...

Commission file number: 001-39630 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 March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to MOONLAKE IMMUNOTHERAPEUTICS (Exact Name of Registrant as Specified in Its Charter) Cayman Islands 98-1711963 (State or other ...

MoonLake Immunotherapeutics Reports First Quarter 2025 Financial Results and Provides a Business Update Continued to make significant progress with the development of the Nanobody® sonelokimab across portfolio of indications, including Phase 3 studies in hidradenitis suppurativa (HS), psoriatic Arthritis (PsA) and adolescent HS, as well as Phase 2 studies in palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA)Announced completion of enrollment of patients in the Phase 3 program in HS (the VELA ...

MoonLake Immunotherapeutics Capital Markets Update New York April 29th 2025 © 2025 | Proprietary | MoonLake TX W: moonlaketx.com | E: info@moonlaketx.com Welcome to our Capital Markets Update Date: April 29th, 2025 Time: 8.30 am EST Location: New York | Topic | Sub-topics | | Speaker | Timing | | --- | --- | --- | --- | --- | | Introduction | - | Welcome | Jorge | 10 mins | | | - | MLTX & SLK summary | | | | | - | Key points for the session | | | | HS: Clinical & | - | VELA recruitment & baseline | Kristian ...

MoonLake Immunotherapeutics (MLTX) 2025 Capital Markets Day April 29, 2025 02:15 PM ET Speaker0 Good morning. Good afternoon. Welcome to the capital markets update of Moon Lake Immunotherapeutics. My name is Matthias Bodenstadt. I'm the chief financial officer of the company. With me here today are CEO and co founder, Georges Santos Dasilva and our CSO and co founder, Professor Christian Reich. It's a pleasure to have you here today for the capital markets update. We have a very exciting agenda. We will pro ...

MoonLake Immunotherapeutics to host a Capital Markets Day on Tuesday, April 29 Zug, Switzerland, April 25, 2025 – MoonLake Immunotherapeutics (Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, will host a virtual Capital Markets Day for investors and analysts on Tuesday, April 29, 2025. The event will highlight recent financial and clinical milestones and provide future strategic updates. The webcast, streamed live from New York, will s ...

Core Insights - MoonLake Immunotherapeutics (NASDAQ: MLTX) experienced a significant stock price increase of 600% within a six-month period in 2023, indicating strong market performance and investor interest [1]. Company Overview - MoonLake Immunotherapeutics was previously recognized as a multibagger stock, highlighting its potential for substantial returns on investment [1]. Investment Tools and Services - The Total Pharma Tracker offers a range of tools for DIY investors, including a software that allows users to input any ticker for extensive curated research material [2]. - For investors seeking personalized support, in-house experts at Total Pharma Tracker assist in identifying the best investable stocks, providing buy/sell strategies and alerts [2].

Clinical Development and Trials - SLK, a novel tri-specific IL-17A and IL-17F inhibiting Nanobody, is currently in clinical development for inflammatory diseases, with a focus on hidradenitis suppurativa (HS) and psoriatic arthritis (PsA) among others[21]. - The Phase 2b MIRA trial for HS showed positive top-line results, achieving the primary endpoint of HiSCR75 with a 29 percentage points delta to placebo at week 12[24][42]. - The Phase 2b ARGO trial for PsA also met its primary endpoint of ACR50, with significant improvements across all key outcomes reported[25]. - The ongoing clinical trials include the Phase 3 VELA program for HS and the Phase 3 IZAR program for PsA, with primary endpoint data expected in mid-2025 and the first half of 2026, respectively[31]. - SLK has been studied in over 700 patients across various trials, demonstrating significant improvements in primary endpoints compared to placebo[29]. - The VELA program aims to enroll 800 patients across two Phase 3 trials to evaluate the efficacy and safety of SLK in moderate-to-severe HS, with primary endpoint being the percentage of participants achieving HiSCR75[48]. - The IZAR program is expected to enroll approximately 1,500 adult patients across two Phase 3 trials, with a primary endpoint of superiority to placebo in ACR50 response at week 16[63]. - The P-OLARIS trial is set to explore the effects of SLK in patients with seronegative spondyloarthritis, with topline primary endpoint readout expected in the first half of 2026[65]. Market Potential and Strategy - The estimated worldwide prevalence for HS is approximately 2%, PsA and axSpA up to 1.0%, and PPP around 0.3%, indicating a significant market opportunity for SLK[35]. - The company plans to submit a Biologics License Application (BLA) for SLK in 2026, aiming for a commercial launch in the U.S. in 2027[30][31]. - The company is expanding its clinical development pipeline, with plans for additional trials in conditions such as palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA)[26][28]. - The company is investing in its manufacturing capabilities and plans to stockpile drug substance as pre-launch inventory in 2025[33]. Intellectual Property and Collaborations - The company aims to strengthen its intellectual property portfolio to support its Nanobody technology and may pursue in-licensing or acquisition of additional product candidates[37]. - The patent portfolio includes 24 issued patents related to IL-17 Nanobodies, with three U.S. patents providing protection until May 2032[80]. - The company entered into a collaboration agreement with SHL Medical in May 2023 to develop an autoinjector for SLK, with plans for pharmacokinetic studies in 2025[79]. - The company successfully transferred the drug product process to Vetter Pharma International GmbH in 2022 to ensure sufficient supply for potential commercialization[78]. Regulatory Considerations - The FDA's goal is to review standard BLA applications within ten months and priority review applications within six months after filing[107]. - A BLA must include all relevant data from preclinical studies and clinical trials, including negative results[105]. - The FDA may issue a Complete Response letter detailing deficiencies in a BLA, which must be addressed before resubmission[109]. - The FDA may require post-marketing studies to monitor the safety and efficacy of approved products[112]. - The FDA grants orphan drug exclusivity for seven years upon first approval for the designated disease, preventing other applications for the same indication under certain conditions[122]. - The FDA's interpretation of orphan drug exclusivity has evolved, potentially covering the full scope of the designated disease rather than just the specific indication[125]. Safety and Efficacy - The safety profile of SLK remains favorable, consistent with previous studies, and the discontinuation rate in the ARGO trial was low at 5%[62]. - 57% of patients treated with SLK 120mg achieved a HiSCR75 response at week 24, showing a 10 percentage point improvement from week 12[44]. - 31% and 49% of patients achieved complete resolution of inflammatory nodules and abscesses and draining tunnels, respectively, at week 24 with SLK 120mg, an increase of up to 15 percentage points[45]. - SLK demonstrated significant improvements in composite scores, with ACR50+PASI90 response rates up to 59%[60]. - In the highest dosage group of SLK, 57% of patients achieved total skin clearance (PASI 100 response) after 24 weeks[72]. Financial Aspects - The aggregate purchase price for the License Agreement with MHKDG was $29.9 million, including an upfront cash payment and equity issuance[86]. - Potential milestone cash payments of up to EUR 307.1 million ($319.3 million) are payable under the License Agreement, with EUR 7.5 million ($8.0 million) recognized as R&D expense to date[86]. Compliance and Regulatory Environment - The company is subject to various healthcare regulations, including the federal Anti-Kickback Statute and the False Claims Act, which can lead to significant penalties if violated[146][147][154]. - The company must comply with the U.S. federal Physician Payments Sunshine Act, requiring annual reporting of payments to healthcare professionals[150][152]. - Coverage and reimbursement from government programs like Medicare and Medicaid are critical for the acceptance of new products, with significant uncertainty regarding reimbursement levels[163][164]. - The company faces challenges in obtaining adequate reimbursement for products, particularly those administered under physician supervision, due to higher associated costs[166][167]. - Compliance with data privacy laws, including HIPAA and state-specific regulations, is essential, with potential penalties for violations[155][156][160]. Pricing and Market Access - The Inflation Reduction Act (IRA) allows CMS to negotiate drug prices and implement an inflation rebate for Medicare patients, impacting future pricing strategies[168]. - The introduction of cost-containment programs and price controls by governments may limit sales and affect product pricing strategies[168]. - The pharmaceutical industry is facing significant scrutiny regarding drug pricing practices, with ongoing legislative efforts aimed at increasing transparency and reducing costs, particularly under Medicare[178]. European Union Regulations - The European Union's pricing approval process for medicinal products can lead to significantly lower prices compared to the U.S., impacting the profitability of products launched in the EU[172]. - The new EU Clinical Trials Regulation (CTR) that came into force on January 31, 2022, overhauls the regulation of clinical trials for medicinal products in the EU[188]. - The approval process for clinical trials in the EU requires authorization from both the National Competent Authority and independent Ethics Committees[190]. - Innovative medicinal products approved in the EU qualify for eight years of data exclusivity and ten years of marketing exclusivity, with potential for an additional one-year exclusivity for new therapeutic indications[211][212].

Core Insights - MoonLake Immunotherapeutics is advancing its clinical-stage biotechnology efforts with a focus on therapies for inflammatory skin and joint diseases, having successfully moved to Phase 3 clinical trials for several potential blockbuster indications in 2024 [2][4]. Financial Performance - As of December 31, 2024, the company reported cash, cash equivalents, and short-term marketable debt securities totaling $448.0 million, a decrease from $493.9 million as of September 30, 2024, primarily due to increased clinical trial activities [3]. - Research and development expenses for Q4 2024 were $40.4 million, up from $35.7 million in Q3 2024, and for the full year, these expenses reached $112.8 million compared to $31.8 million in 2023, reflecting a significant increase in clinical development costs [4][8]. - General and administrative expenses for Q4 2024 were $9.2 million, compared to $7.4 million in the previous quarter, with total annual expenses rising to $30.3 million from $22.3 million in 2023 [7]. Clinical Development - The company initiated the Phase 3 VELA program for hidradenitis suppurativa (HS) and the Phase 3 IZAR program for psoriatic arthritis (PsA), following positive regulatory feedback from the FDA and EMA [5][6]. - In early 2025, three new trials were launched: the Phase 3 VELA-TEEN trial for adolescent HS, the Phase 2 LEDA trial for palmoplantar pustulosis (PPP), and the Phase 2 S-OLARIS trial for axial spondyloarthritis (axSpA) [5][6]. - The VELA program aims to enroll 800 patients and will evaluate the efficacy and safety of sonelokimab in adult patients with active moderate-to-severe HS [23]. Market Position and Future Outlook - MoonLake is positioned in a growing market with significant unmet needs in dermatological and rheumatological indications, with a cash runway expected to last until at least the end of 2026 [4][5]. - The company plans to hold a Capital Markets Update in Q2 2025 to discuss the Phase 3 HS VELA program and provide updates on clinical data and financials [9].

Company Analysis - MoonLake Immunotherapeutics (NASDAQ: MLTX) is preparing to report results from its two Phase 3 studies, VELA-1 and VELA-2, which evaluate the efficacy of its drug sonelokimab for treating adults with moderate-to-severe conditions [2] Industry Insights - The Biotech Analysis Central service provides deep-dive analysis of pharmaceutical companies, offering a library of 600+ biotech investing articles and a model portfolio of 10+ small and mid-cap stocks with detailed analysis for each [2] - The service is available for $49 per month, with a yearly subscription offering a 33.50% discount, reducing the cost to $399 per year [1]