MLTX

Results from the Phase 3 VELA clinical trials at Week 52 in adults with moderate-to-severe hidradenitis suppurativa (HS) demonstrate sonelokimab’s (SLK) potential best-in-class and best-in-disease profile, with consistent responses that are higher than those observed in trials of competing agents at the end of their respective parental trials Namely, ~67% of patients treated with SLK achieved HiSCR75 at the one-year mark, with more than one quarter of patients achieving inflammatory remission (IHS4-100), and around one third reaching HiSCR100 Patients treated with SLK likewise showed substantial improvement in HiSQOL at Week 52, with a mean score difference between end of trial and baseline of -15.0 points, indicating an average change from “severe” to “mild” impairment of the HS-related quality of life Almost half of the patients experienced a marked reduction in pain (at least a 3-point improvement from baseline in the worst skin pain Numerical Rating Scale (NRS)) No new safety signals were detected in the VELA trials to date, supporting a consistent safety profile through Week 52 Data from the VELA-TEEN trial in adolescent HS patients show strong therapeutic response and no new safety signals in adolescent patients, with nearly 70% of patients achieving HiSCR75 at Week 24 and almost half of patients reaching HiSCR100 Submission of the Biologics License Application (BLA) for SLK in HS, including data from adolescent patients, is expected at the end of September 2026, and will follow previous agency guidance on the label strategy An Investor Day webcast will be held on June 22, 2026, 8:00 – 9:30 a.m. EST (2:00 – 3:30 p.m. CET), to discuss these data and provide guidance on upcoming events ZUG, Switzerland, June 21, 2026 – MoonLake Immunotherapeutics (NASDAQ: MLTX) (MoonLake or the Company), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced the Week 52 results of the Phase 3 VELA-1 and VELA-2 clinical trials of its registrational global program in patients with moderate-to-severe HS. The Company also announced that it will host an Investor Day webcast on June 22, 2026, 8:00 – 9:30 a.m. EST (2:00 – 3:30 p.m. CET), including an open Q&A session. Results from the Phase 3 VELA clinical trials at Week 52Week 52 data for SLK showed consistent and further improvement in all clinical scores, compared to Week 16 data. Across both VELA-1 and VELA-2, 67.2% of patients treated with SLK achieved HiSCR75 and 33.1% of patients achieved HiSCR100 at Week 52 (n=396). The results were consistent across both trials (VELA-1: 68.3% HiSCR75, 31.2% HiSCR100; VELA-2: 66.0% HiSCR75, 35.1% HiSCR100). At Week 52, 26.0% of patients (n=396) achieved an IHS4-100 response (VELA-1: 24.4%, VELA-2: 27.7%), reflecting inflammatory remission, defined as a 100% reduction in abscesses (A100), nodules (N100) and draining tunnels (DT100). The long-term results of the VELA program are higher than in previous Phase 3 HS programs with competing agents (using the same pooled, as observed, end of parental trial data analysis). Relative to the competitor IL-17-A & F inhibitor monoclonal antibody, the SLK Nanobody®, for example, showed responses with over ~10% more responding patients for HiSCR75, HiSCR100 or IHS4-100. The strong long-term clinical responses observed with SLK were accompanied by sustained improvements in Patient-Reported Outcomes, which are considered to matter most to patients living with HS and their treating physicians. Patients treated with SLK consistently showed the largest reductions in the HS-specific Quality of Life score (HiSQOL) at Week 52, with a -15.3 mean score difference between end of trial and baseline in VELA-1, and -14.8 in VELA-2 (as observed, n=395). The broader skin DLQI score confirmed the HiSQOL results and showed clinically meaningful response (≥4-point improvement from baseline) in 75.0% (VELA-1) and 69.4% (VELA-2) of patients (as observed, in patients with baseline DLQI ≥4, n=363). Responses for both these quality of life metrics were higher than previously demonstrated in competitor pivotal HS studies. In line with these data, 46.5% of patients experienced a marked reduction in pain, measured as at least a 3-point reduction from baseline in the worst skin pain NRS (VELA-1: 48.4%, VELA-2: 44.3%; as observed, in patients with baseline worst skin pain score of ≥3, n=241). These findings demonstrate leading and durable improvements across outcomes of key relevance for patients, including quality of life, pain and long-term disease control. Responses seen in patients crossing over from placebo (switch to SLK at Week 16) confirm and validate these findings. After 4 Weeks of SLK treatment, HiSCR75 rates increased by ~20 percentage points across both studies. At the end of the VELA program (i.e., after 36 weeks of SLK treatment), cross-over patients (“Placebo-to-SLK”) showed HiSCR75 rates similar to those observed after 36 weeks of treatment in the “SLK-to-SLK” arms (~60%, as observed). The high acceptance rate and good tolerability of SLK across the VELA program was confirmed by the rate of patients rolling over into the VELA-OLE (two-year open-label extension) following the parental trials (~90% across all arms) further validating the convenience of the 120mg Q4W (once every four weeks) dosing regimen. Interim Week 24 data from the Phase 3 VELA-TEEN trialFurthermore, data from the VELA-TEEN clinical trial showed rapid onset and high response rates in adolescent patients with HS. Interim analysis of Week 24 data show that ~68% of patients treated with SLK achieved HiSCR75, alongside ~86% achieving HiSCR50 and ~45% achieving HiSCR100 (as observed, n=22). HiSCR75 rates in VELA‑TEEN were higher than those observed in the adult VELA program at comparable timepoints, indicating a pronounced clinical response in adolescent patients with earlier stage disease. SLK was generally well tolerated in this vulnerable patient population, and no new safety signals were observed. These promising results highlight the relevance and opportunity of an early treatment of HS with the goal to slow down the progression to irreversible tissue damage. The safety profile of SLK in the VELA clinical programs including VELA-TEEN remains consistent over time, with no new safety signals detected. Dr. Jorge Santos da Silva, Founder and Chief Executive Officer of MoonLake Immunotherapeutics, said: “The final Week 52 data from the VELA program confirm the strength of SLK across most, if not all, metrics that matter in HS: strong early efficacy, sustained and leading improvement over time, a consistent safety profile and great convenience in dosing. All this, not just for adult patients but also for adolescent patients. Together with the alignment we have reached with the FDA on our HS label strategy, these data support the potential for a highly differentiated label profile and reinforce our conviction that SLK has the potential to become a best-in-class and best-in-disease therapy for those living with HS.” Prof. Kristian Reich, Founder and Chief Scientific Officer of MoonLake Immunotherapeutics, added: “What is particularly compelling in the final Week 52 dataset is how consistently the strong clinical efficacy of SLK is reflected in Patient-Reported Outcomes. The sustained improvements we observed across HiSQOL, pain and broader quality of life measures are highly meaningful in HS, where the burden of disease extends far beyond lesion counts. In our view, these data highlight the potential of SLK to redefine long-term outcomes in HS by delivering durable disease control and meaningful improvements of the daily lives of patients combined with a favourable safety profile.” Next steps and anticipated BLA submissionMoonLake plans to submit the BLA for HS to the FDA at the end of September 2026. The pre-BLA process is concluded and no more regulatory meetings with the FDA will take place. Clarity on the Prescription Drug User Fee Act (PDUFA) date is currently expected by the end of November 2026, concurrent with the FDA’s acceptance of the BLA. The Company plans to submit a request for Priority Review for this BLA based on SLK’s potential best-in-class profile as well as its VELA-TEEN adolescent data; the FDA’s decision on the Priority Review request would be included in the application’s PDUFA date allocation/filing letter. Priority Review remains an upside scenario for MoonLake, subject to FDA resource and capacity considerations. If Priority Review is not granted, MoonLake expects a third or fourth quarter 2027 launch for SLK. Should Priority Review be granted, it is estimated that the time-to-market for SLK may be reduced by approximately one quarter. Investor Day, June 22, 2026The Company will hold an Investor Day for investors and analysts on June 22, 2026. The webcast will take place from 8:00 – 9:30 a.m. EST (2:00 – 3:30 p.m. CET), including an open Q&A session. A recording will be made available post-event. Webcast Access: https://edge.media-server.com/mmc/p/ke4wbinp In this session, MoonLake's CEO, Jorge Santos da Silva, CSO, Kristian Reich, and CFO, Matthias Bodenstedt, will present the final Week 52 data from the Phase 3 VELA program in HS and provide an update on the VELA‑TEEN clinical trial in adolescent HS, a recap of the proposed label, the Company’s view on its commercialization plan, as well as an outlook on H2 2026 events, including the readout of IZAR-1 Phase 3 trial in psoriatic arthritis (PsA). Important upcoming anticipated milestones for MoonLake: Mid 2026: Primary endpoint readout of the Phase 3 IZAR-1 trial in PsA Late Sep. 2026: Submission of a BLA for HS Late Nov. 2026: Expected PDUFA date allocation for HS BLA H2 2026: Primary endpoint readout of the Phase 3 IZAR-2 trial in PsA H2 2026: Interim readout of the Phase 2 P-OLARIS trial in PsA and axSpA -Ends- MoonLake ImmunotherapeuticsMoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The Company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and palmoplantar pustulosis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com. About Nanobodies®Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations. The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company. About SonelokimabSonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHHs covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema. Sonelokimab is being assessed in two lead indications, hidradenitis suppurativa (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology, including adolescent HS, palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA). For adults with HS, sonelokimab is being assessed in two identical Phase 3 trials, the VELA-1 and VELA-2 trials, using the higher clinical response level of HS Clinical Response (HiSCR) 75 as the primary endpoint, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count. In September 2025, the primary endpoint data from the VELA-1 and VELA-2 clinical trials were announced. In the combined VELA program, patients treated with SLK experienced a clinically meaningful and statistically significant improvement across all primary and key secondary endpoints using both pre-specified strategies (p<0.001). In VELA-1, SLK achieved statistical significance for all primary and key secondary endpoints using both pre-specified strategies (HiSCR75, delta to placebo of 17%, p<0.001). In VELA-2, intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in the Week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053). In June 2026, Week 52 Results of SLK from the VELA-1 and VELA-2 clinical trials were announced. Week 52 data for SLK showed consistent and further improvement in all clinical scores, compared to Week 16 data. Across both VELA-1 and VELA-2, 67.2% of patients treated with SLK achieved HiSCR75 and 33.1% of patients achieved HiSCR100 at Week 52 (as observed, n=396). The safety profile of sonelokimab in the VELA trials was consistent with previous trials with no new safety signals detected. Sonelokimab is currently undergoing evaluation in the VELA-TEEN Phase 3 trial, which is the first clinical study specifically focused on adolescent patients with moderate-to-severe HS. In June 2026, interim Week 24 data from the Phase 3 VELA-TEEN trial were announced. Interim analysis of Week 24 data show that ~68% of patients treated with SLK achieved HiSCR75, alongside ~86% achieving HiSCR50 and ~45% achieving HiSCR100 (as observed, n=22). HiSCR75 rates in VELA‑TEEN were higher than those observed in the adult VELA program at comparable timepoints, indicating a pronounced clinical response in adolescent patients with earlier stage disease. SLK was generally well tolerated in this vulnerable patient population, and no new safety signals were observed. For PsA, sonelokimab is being assessed in the Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201) evaluating the efficacy and safety of the Nanobody® sonelokimab over 24 weeks in patients with active PsA. Significant improvements were observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an American College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at Week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an ACR50 response compared to those on placebo at Week 12. All key secondary endpoints in the trial were met for the 60mg and 120mg doses with induction. The safety profile of sonelokimab in the ARGO trial was consistent with previous trials with no new safety signals detected. Sonelokimab is also being assessed in PPP, a debilitating inflammatory skin condition affecting a significant number of patients, including in the completed Phase 2 LEDA program. In the Phase 2 LEDA clinical trial in PPP, SLK demonstrated clinically meaningful and statistically significant benefit. Patients treated with SLK achieved a mean percent change from baseline in the Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) of 64% at Week 16, and 39% of patients achieved a ≥75% reduction in the PPPASI (PPPASI75), suggesting that SLK could provide clinically meaningful improvements in this disease for which there are currently no approved therapies. The safety profile of SLK in the LEDA trial was consistent with previous trials with no new safety signals detected. Additionally, sonelokimab is being assessed in the ongoing Phase 2 S-OLARIS and P-OLARIS trials for active axSpA and PsA, respectively. Both trials feature an innovative design complementing traditional clinical outcomes with cellular imaging techniques. Sonelokimab has also been assessed in a randomized, placebo-controlled third-party Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab generally presented a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575). In an earlier third-party Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab decreased (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019; 81:196–203). About the VELA programThe Phase 3 VELA program recruited a total of 838 patients across VELA-1 and VELA-2. Both global, randomized, double-blind, and placebo-controlled trials are identical in design evaluating the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe hidradenitis suppurativa. Similar to the design of the landmark Phase 2 MIRA trial, the primary endpoint is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75, defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trials also evaluate a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total reduction of ≥4, the proportion of patients achieving at least 50% reduction from baseline in Numerical Rating Scale (NRS50) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain) and complete resolution of Draining Tunnels (DT100). The VELA protocols and statistical analysis plans were prepared in accordance with regulatory agency advice and include two analysis strategies. The composite strategy for the VELA trials (also referred to as the primary estimand) is the primary statistical analysis. The protocol specifies the treatment policy strategy as the alternative method of handling intercurrent events to test the robustness of the VELA data. The trials compare a single 120mg dose of sonelokimab to placebo with HiSCR75 reading out at Week 16. Results of the Week 16 data were announced in September 2025. Results of the Week 52 data were announced in June 2026. Further details are available under NCT06411899 and NCT06411379 at www.clinicaltrials.gov. About the MIRA trialThe MIRA trial is a global, randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in the treatment of adult patients with active moderate-to-severe hidradenitis suppurativa. The trial recruited 234 patients, with the aim to evaluate two different doses of sonelokimab (120mg and 240mg) with placebo control and adalimumab as an active reference arm. The primary endpoint of the trial is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trial also evaluated a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total score of ≤5, and the proportion of patients achieving at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under NCT05322473 at www.clinicaltrials.gov. About the VELA-TEEN trialThe Phase 3 VELA-TEEN trial is an open-label, single-arm trial designed to evaluate sonelokimab 120mg administered subcutaneously once every two weeks (Q2W) until week six and once every four weeks (Q4W) from week eight onwards. The trial enrolled 35 adolescents, aged 12-17, with moderate-to-severe hidradenitis suppurativa, from U.S. sites experienced in clinical trials and pediatric dermatology. The primary trial phase will be 24 weeks with a primary endpoint evaluating the pharmacokinetics, safety, and tolerability of sonelokimab. VELA-TEEN will also evaluate several secondary endpoints, including the proportion of patients achieving the higher clinical response measure of the Hidradenitis Suppurativa Clinical Response (HiSCR) 75, in addition to HiSCR50. Other outcomes are the change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4), which includes the quantitative measure of draining tunnels, and the proportion of patients achieving a meaningful reduction of the Children’s Dermatology Life Quality Index (CDLQI) and the Patient’s Global Assessment of Skin Pain (PGA Skin Pain). Results of the interim Week 24 data were announced in June 2026. Further details are available under NCT06768671 at www.clinicaltrials.gov. About Hidradenitis SuppurativaHidradenitis suppurativa (HS) is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects an estimated 2% of the population, with three times more females affected than males. Real-world data in the United States indicate that at least 2 million unique patients have been diagnosed with and treated for HS between 2016 and 2023 alone, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity projected to reach $15bn by 2035. Onset typically occurs in early adulthood and HS has a profound negative impact on quality of life, with a higher morbidity than other dermatologic conditions. There is increasing scientific evidence to support IL-17A- and IL-17F-mediated inflammation as a key driver of the pathogenesis of HS, with other identified risk factors including genetics, cigarette smoking, and obesity. About the IZAR Program IZAR-1 and IZAR-2 are global, randomized, double-blind, placebo-controlled Phase 3 trials designed to evaluate the efficacy and safety of sonelokimab compared with placebo in a total of approximately 1,500 adults with active psoriatic arthritis (PsA), with a primary endpoint of superiority to placebo in American College of Rheumatology (ACR) 50 response at Week 16. IZAR-1 is expected to enroll biologic-naïve patients and include an evaluation of radiographic progression, while IZAR-2 is expected to enroll patients with an inadequate response to tumor necrosis factor-α inhibitors (TNF-IR) – reflecting patients commonly seen in clinical practice – and is the first PsA trial to include a risankizumab active reference arm. Both trials will also assess a range of secondary endpoints reflecting the multiple disease manifestations characteristic of PsA. These include skin and nail outcomes, multidomain outcomes, and Patient-Reported Outcome measures such as pain and quality of life assessments. Further details are available under NCT06641076 and NCT06641089 at http://www.clinicaltrials.gov. About the P-OLARIS trialThe P-OLARIS trial is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 60mg administered subcutaneously in adult patients with active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) with a focus on characterizing how sonelokimab affects markers of inflammation and tissue damage within joints. The trial aims to recruit approximately 20 patients with PsA and 10 patients with axSpA. The primary endpoint is the change in disease activity at Week 12, as measured by [68Ga]-fibroblast activation protein inhibitor (FAPI)-tracer uptake (SUVmax) on FAPI-positron emission tomography (PET)/low-dose computed tomography (CT) scans, a novel imaging modality able to detect inflammation and early tissue damage within joints. Throughout the trial, several other endpoints will be assessed including established clinical disease activity outcomes, as well as patient reported outcomes that assess the impact of disease signs and symptoms. The trial also features an innovative exploratory peripheral blood and tissue biomarker program.The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 ARGO trial in PsA as well as the Phase 2 S-OLARIS trial in axSpA which demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. Further details are available under EUCT number 2024-514504-13-00 at https://euclinicaltrials.eu. About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, progressive and complex inflammatory disease that manifests across multiple domains, leading to substantial functional impairment and decreased quality of life. The clinical features of PsA are diverse, comprising both musculoskeletal (peripheral arthritis, spondylitis, dactylitis, and enthesitis) and non-musculoskeletal (skin and nail disease) domains. PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology. About the S-OLARIS trialThe S-OLARIS trial is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 60mg administered subcutaneously in adult patients with active axial spondyloarthritis (axSpA). The trial recruited 26 patients. The primary endpoint is the change from baseline (CfB) in 18F-NaF SUVmax signals at Week 12 in the sacroiliac joints and spine as detected by PET. Throughout the trial, several other endpoints will be assessed including established clinical disease activity outcomes (e.g., ASAS), scores related to physical function, spinal mobility, and enthesitis as well as patient reported outcomes. The trial also features an innovative exploratory peripheral blood and tissue biomarker program. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 ARGO trial in psoriatic arthritis, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. Further details are available under EUCT number 2024-513498-36-00 at https://euclinicaltrials.eu. About Axial SpondyloarthritisAxial Spondyloarthritis (axSpA) typically impacts young people, with diagnosis based on chronic inflammatory back pain lasting more than three months with onset under 45 years of age. Advanced disease can lead to progressive and pathologic bone formation and joint fusion, severely limiting spinal mobility. Global reported prevalence of axSpA ranges from 0.5% to 1.5%. AxSpA can be categorized by disease progression into two subtypes: non-radiographic axSpA and ankylosing spondylitis (AS), also known as radiographic axSpA, which is diagnosed based on radiographic evidence of structural changes to the sacroiliac joints. Patients with axSpA experience fatigue, persistent morning stiffness, and pain that worsens at night and can disrupt sleep. Many patients also face the burden of comorbidities such as psoriatic arthritis and psoriasis. Studies have found elevated IL-17 levels in the blood and synovial fluid of patients with axSpA, and IL-17A and IL-17F are both thought to be key contributors to pathogenesis across the spondyloarthropathies. About the LEDA TrialThe LEDA trial is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 120mg administered subcutaneously in adult patients with palmoplantar pustulosis (PPP). The trial recruited 32 patients. The primary endpoint of the trial is percent change from baseline in Palmoplantar Psoriasis Area and Severity Index (ppPASI) with important secondary endpoints including ppPASI75 (at least 75% improvement in the ppPASI). The LEDA trial features an innovative translational research program using peripheral blood and tissue biomarkers as trial controls. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 MIRA trial in hidradenitis suppurativa, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. Further details are available under EUCT number 2024-513305-32-00 at https://euclinicaltrials.eu. About Palmoplantar PustulosisPalmoplantar Pustulosis (PPP) is characterized by the development of blister-like pustules within erythematous, scaly plaques on the palms and the soles of the feet. PPP typically develops in adulthood and more frequently impacts females. Patients frequently experience significant pain, burning, and itching sensations on the palms and soles of the feet which can be debilitating and impair their ability to work, sleep, or perform other activities of daily living. Currently, the treatment of PPP is challenging with a significant unmet need for novel therapies to reduce the symptom burden for patients. Evidence suggests that activation of the IL-17 pathway has an important role in disease pathophysiology. Cautionary Statement Regarding Forward Looking StatementsThis press release contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the efficacy and safety of sonelokimab for the treatment of moderate-to-severe HS; the anticipated interactions with regulatory authorities, including the FDA, and the anticipated BLA-submission, PDUFA date and request for Priority Review; the proposed label and labeling discussions with the FDA for sonelokimab in HS, including potential inclusion of clinical data from the MIRA trial; potential market opportunities for sonelokimab; upcoming anticipated clinical milestones, including the primary endpoint readouts of the Phase 3 IZAR-1 trial in PsA and Phase 3 IZAR-2 trial in PsA, interim endpoint readout of the Phase 2 P-OLARIS trial in PsA and axSPA and submission of a BLA for HS; the FDA’s decision on Priority Review designation; and timing of first commercial launch in the United States. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLake’s business in general and limited operating history; difficulty enrolling patients in clinical trials; state and federal healthcare reform measures that could result in reduced demand for MoonLake’s product candidates; reliance on third parties to conduct and support its preclinical studies and clinical trials; and the other risks described in or incorporated by reference into MoonLake’s Annual Report on Form 10-K for the year ended December 31, 2025, Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, and subsequent filings with the Securities and Exchange Commission. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based. Contacts: MoonLake Immunotherapeutics Media & Investors Relations [email protected] ICR Healthcare Mary-Jane Elliott, Sarah Elton-Farr, Ashley TappTel: +44 (0) 20 3709 [email protected]

MoonLake conducted a positive final pre-BLA (Biologics License Application) meeting with the U.S. Food and Drug Administration (FDA), where MoonLake and the FDA aligned on submission plans and the label strategy for sonelokimab (SLK) in hidradenitis suppurativa (HS) This included the acceptability of MIRA trial data to establish substantial evidence of effectiveness (SEE), full inclusion of the VELA-TEEN trial data for a label including patients aged 12 years and above, and the strategy for inclusion of safety data across the MIRA and VELA trials – this aligns with the scenario presented at the Investor Day on February 23, 2026 The proposed label in HS is therefore expected to include the MIRA trial’s ~43% HiSCR75 response and the ~29 percentage point delta-to-placebo at week 12, which are the highest values observed across any adequate well-controlled clinical trial conducted in HS to date With no remaining gaps identified, the pre-BLA process for HS is complete, and the BLA submission to the FDA is planned for the end of September 2026; acceptance, including a decision on Priority Review designation associated with the inclusion of VELA-TEEN adolescent data, is expected by end of November 2026 Other clinical trials of SLK are progressing well and are expected to support a catalyst-rich roadmap over the next 12 months, including the release of 52 weeks data from the Phase 3 VELA clinical trials and week 16 read-outs from the Phase 3 IZAR clinical trials in Psoriatic Arthritis (PsA) MoonLake ended the first quarter with $357.9 million in cash, cash equivalents and short-term marketable debt securities and expects to have a cash runway to the end of 2027; additionally, up to $400 million in non-dilutive funds remain available through its debt facility with Hercules Capital ZUG, Switzerland, May 10, 2026 – MoonLake Immunotherapeutics (NASDAQ: MLTX) (“MoonLake” or the “Company”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced a positive outcome of its final pre-BLA meeting held on April 1, 2026, with the FDA on the HS program of its Nanobody® SLK. During the meeting, MoonLake and the FDA aligned on the submission plans and the label strategy, the approach to include adolescent HS data in the BLA, and the safety data strategy. Specifically, the FDA re-confirmed the acceptability of including the data from the MIRA clinical trial as a key part to establish SEE and to analyze the data consistent with the approach used for the VELA clinical trials. The FDA also agreed to the inclusion of the VELA-TEEN trial data for adolescent HS patients with the trial considered final and pivotal at the time of final BLA submission. MoonLake therefore expects to include patients aged 12 years and above in its label proposal and has notified the FDA of its intent to apply for Priority Review. Furthermore, the FDA agreed to the proposed approach for the clinical safety section and that the safety data will be analyzed primarily based on the VELA-1 and VELA-2 data as per the previous discussion with the FDA. MoonLake thus expects to include the full safety data also for VELA-2 as planned. Finally, the FDA agreed that other key elements including non-clinical studies and the proposed safety pools and analyses appear complete and appropriate for BLA filing and review. No remaining gaps, including in the FDA’s Chemistry, Manufacturing, and Controls regulations, precluding the planned BLA submission were identified and no additional meetings are required as agreed between the FDA and MoonLake. With the overall structure of the label for HS aligned with the FDA, the Company is proceeding to build out the relevant sections of the label as planned, and as presented at the Investor Day on February 23, 2026. The proposed label is expected to include the MIRA trial’s ~43% HiSCR 75 response rate and ~29 percentage point delta-to-placebo which are the highest observed values across any adequate and well-controlled clinical trial conducted in HS to date. Based on this feedback, MoonLake expects to submit the BLA for SLK in adult and adolescent HS to the FDA at the end of September 2026. Following this, the acceptance of the BLA submission is expected to be received within 60 days at which point the FDA will also notify MoonLake whether Priority Review has been granted. Subject to FDA approval, the first commercial launch in the United States is expected in the second half of 2027. Today, MoonLake also reported its financial results for the first quarter of 2026. As of March 31, 2026, MoonLake held cash, cash equivalents and short-term marketable debt securities of $357.9 million. The Company expects to have sufficient capital to fund its operating expenses and capital expenditure requirements to the end of 2027. MoonLake’s debt facility with Hercules Capital provides up to $400 million in additional non-dilutive funds to support future funding needs. Research and development expenses were $54.5 million for the three months ended March 31, 2026, which was similar to the $56.0 million for the three months ended December 31, 2025. General and administrative expenses were $15.5 million for the three months ended March 31, 2026, compared to $9.2 million for the three months ended December 31, 2025. The increase of $6.3 million was primarily related to $4.8 million in accelerated expense recognition due to a voluntary cancellation of unvested stock option awards for no consideration. Important upcoming anticipated milestones for MoonLake in 2026: Q2 2026: 52-week data of the VELA-1 and VELA-2 trials in HS Mid 2026: Primary endpoint readout of the Phase 3 IZAR-1 trial in PsA Mid 2026: Primary endpoint readout of Phase 3 VELA-TEEN trial in adolescent HS September 2026: Submission of a BLA for HS Q4 2026: Primary endpoint readout of the Phase 3 IZAR-2 trial in PsA -Ends- MoonLake Immunotherapeutics MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The Company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and palmoplantar pustulosis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com. About Nanobodies® Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations. The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company. About Sonelokimab Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHHs covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema. Sonelokimab is being assessed in two lead indications, hidradenitis suppurativa (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology, including adolescent HS, palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA). For adults with HS, sonelokimab is being assessed in two identical Phase 3 trials, the VELA-1 and VELA-2 trials, using the higher clinical response level of HS Clinical Response (HiSCR) 75 as the primary endpoint, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count. In September 2025, the primary endpoint data from the VELA-1 and VELA-2 clinical trials were announced. In the combined VELA program, patients treated with SLK experienced a clinically meaningful and statistically significant improvement across all primary and key secondary endpoints using both pre-specified strategies (p<0.001). In VELA-1, SLK achieved statistical significance for all primary and key secondary endpoints using both pre-specified strategies (HiSCR75, delta to placebo of 17%, p<0.001). In VELA-2, intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in the week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053). From week 16, all patients are expected to continue to receive the 120mg dose of SLK through to 48 weeks, with a last assessment planned at week 52, followed by an open-label extension for up to two years. The safety profile of sonelokimab in the VELA trials was consistent with previous trials with no new safety signals detected. Sonelokimab is currently undergoing evaluation in the VELA-TEEN Phase 3 trial, which is the first clinical study specifically focused on adolescent patients with moderate-to-severe HS. For PsA, sonelokimab is being assessed in the Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201) evaluating the efficacy and safety of the Nanobody® sonelokimab over 24 weeks in patients with active PsA. Significant improvements were observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an American College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an ACR50 response compared to those on placebo at week 12. All key secondary endpoints in the trial were met for the 60mg and 120mg doses with induction. The safety profile of sonelokimab in the ARGO trial was consistent with previous trials with no new safety signals detected. Sonelokimab is also being assessed in PPP, a debilitating inflammatory skin condition affecting a significant number of patients, including in the completed Phase 2 LEDA program. In the Phase 2 LEDA clinical trial in PPP, SLK demonstrated clinically meaningful and statistically significant benefit. Patients treated with SLK achieved a mean percent change from baseline in the Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) of 64% at week 16, and 39% of patients achieved a ≥75% reduction in the PPPASI (PPPASI75), suggesting that SLK could provide clinically meaningful improvements in this disease for which there are currently no approved therapies. The safety profile of SLK in the LEDA trial was consistent with previous trials with no new safety signals detected. Additionally, Sonelokimab is being assessed in the ongoing Phase 2 S-OLARIS and P-OLARIS trials for active axSpA and PsA, respectively. Both trials feature an innovative design complementing traditional clinical outcomes with cellular imaging techniques. Sonelokimab has also been assessed in a randomized, placebo-controlled third-party Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab generally presented a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575). In an earlier third-party Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab decreased (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019; 81:196–203). About the VELA program The Phase 3 VELA program has enrolled over 800 patients across VELA-1 and VELA-2. Both global, randomized, double-blind, and placebo-controlled trials are identical in design evaluating the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe hidradenitis suppurativa. Similar to the design of the landmark Phase 2 MIRA trial, the primary endpoint is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75, defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trials also evaluate a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total reduction of ≥4, the proportion of patients achieving at least 50% reduction from baseline in Numerical Rating Scale (NRS50) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain) and complete resolution of Draining Tunnels (DT100). The VELA protocols and statistical analysis plans were prepared in accordance with regulatory agency advice and include two analysis strategies. The composite strategy for the VELA trials (also referred to as the primary estimand) is the primary statistical analysis. The protocol specifies the treatment policy strategy as the alternative method of handling intercurrent events to test the robustness of the VELA data. The trials compare a single 120mg dose of sonelokimab to placebo with HiSCR75 reading out at week 16. Results of the week 16 data were announced in September 2025. Further details are available under NCT06411899 and NCT06411379 at www.clinicaltrials.gov. About the MIRA trial The MIRA trial (M1095-HS-201) is a global, randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in the treatment of adult patients with active moderate-to-severe hidradenitis suppurativa. The trial recruited 234 patients, with the aim to evaluate two different doses of sonelokimab (120mg and 240mg) with placebo control and adalimumab as an active reference arm. The primary endpoint of the trial is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trial also evaluated a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total score of ≤5, and the proportion of patients achieving at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under NCT05322473 at www.clinicaltrials.gov. About the VELA-TEEN trial The Phase 3 VELA-TEEN trial is an open-label, single-arm trial designed to evaluate sonelokimab 120mg administered subcutaneously once every two weeks (Q2W) until week six and once every four weeks (Q4W) from week eight onwards. The trial aims to enroll 30-35 adolescents, aged 12-17, with moderate-to-severe hidradenitis suppurativa, from U.S. sites experienced in clinical trials and pediatric dermatology. The primary trial phase will be 24 weeks with a primary endpoint evaluating the pharmacokinetics, safety, and tolerability of sonelokimab. VELA-TEEN will also evaluate several secondary endpoints, including the proportion of patients achieving the higher clinical response measure of the Hidradenitis Suppurativa Clinical Response Score (HiSCR) 75, in addition to HiSCR50. Other outcomes are the change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4), which includes the quantitative measure of draining tunnels, and the proportion of patients achieving a meaningful reduction of the Children’s Dermatology Life Quality Index (CDLQI) and the Patients Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under NCT06768671 at www.clinicaltrials.gov. About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects an estimated 2% of the population, with three times more females affected than males. Real-world data in the United States indicates that at least 2 million unique patients have been diagnosed with and treated for HS between 2016 and 2023 alone, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity projected to reach $15bn by 2035. Onset typically occurs in early adulthood and HS has a profound negative impact on quality of life, with a higher morbidity than other dermatologic conditions. There is increasing scientific evidence to support IL-17A- and IL-17F-mediated inflammation as a key driver of the pathogenesis of HS, with other identified risk factors including genetics, cigarette smoking, and obesity. About the IZAR Program IZAR-1 (NCT06641076) and IZAR-2 (NCT06641089) are global, randomized, double-blind, placebo-controlled Phase 3 trials designed to evaluate the efficacy and safety of sonelokimab compared with placebo in a total of approximately 1,500 adults with active psoriatic arthritis (PsA), with a primary endpoint of superiority to placebo in American College of Rheumatology (ACR) 50 response at week 16. IZAR-1 is expected to enroll biologic-naïve patients and include an evaluation of radiographic progression, while IZAR-2 is expected to enroll patients with an inadequate response to tumor necrosis factor-α inhibitors (TNF-IR) — reflecting patients commonly seen in clinical practice — and is the first PsA trial to include a risankizumab active reference arm. Both trials will also assess a range of secondary endpoints reflecting the multiple disease manifestations characteristic of PsA. These include skin and nail outcomes, multidomain outcomes, and patient-reported outcome measures such as pain and quality of life assessments. Further details are available under NCT06641076 and NCT06641089 at www.clinicaltrials.gov. About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, progressive and complex inflammatory disease that manifests across multiple domains, leading to substantial functional impairment and decreased quality of life. The clinical features of PsA are diverse, comprising both musculoskeletal (peripheral arthritis, spondylitis, dactylitis, and enthesitis) and non-musculoskeletal (skin and nail disease) domains. PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology. About the S-OLARIS trial The S-OLARIS trial (M1095-axSpA-201) is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 60mg administered subcutaneously in adult patients with active axial spondyloarthritis (axSpA). The trial recruited 26 patients. The primary endpoint is the change from baseline (CfB) in 18F-NaF SUVmax signals at week 12 in the sacroiliac joints and spine as detected by PET. Throughout the trial, several other endpoints will be assessed including established clinical disease activity outcomes (e.g., ASAS), scores related to physical function, spinal mobility, and enthesitis as well as patient reported outcomes. The trial also features an innovative exploratory peripheral blood and tissue biomarker program. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 ARGO trial in psoriatic arthritis, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. Further details are available under EUCT number 2024-513498-36-00 at https://euclinicaltrials.eu. About Axial Spondyloarthritis Axial Spondyloarthritis (axSpA) typically impacts young people, with diagnosis based on chronic inflammatory back pain lasting more than three months with onset under 45 years of age. Advanced disease can lead to progressive and pathologic bone formation and joint fusion, severely limiting spinal mobility. Global reported prevalence of axSpA ranges from 0.5% to 1.5%. AxSpA can be categorized by disease progression into two subtypes: non-radiographic axSpA and ankylosing spondylitis (AS), also known as radiographic axSpA, which is diagnosed based on radiographic evidence of structural changes to the sacroiliac joints. Patients with axSpA experience fatigue, persistent morning stiffness, and pain that worsens at night and can disrupt sleep. Many patients also face the burden of comorbidities such as psoriatic arthritis and psoriasis. Studies have found elevated IL-17 levels in the blood and synovial fluid of patients with axSpA, and IL-17A and IL-17F are both thought to be key contributors to pathogenesis across the spondyloarthropathies. About the LEDA Trial The LEDA trial (M1095-PPP-201) is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 120mg administered subcutaneously in adult patients with palmoplantar pustulosis (PPP). The trial recruited 32 patients. The primary endpoint of the trial is percent change from baseline in Palmoplantar Psoriasis Area and Severity Index (ppPASI) with important secondary endpoints including ppPASI75 (at least 75% improvement in the ppPASI). The LEDA trial features an innovative translational research program using peripheral blood and tissue biomarkers as trial controls. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 MIRA trial in hidradenitis suppurativa, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. Further details are available under EUCT number 2024-513305-32-00 at https://euclinicaltrials.eu. About Palmoplantar Pustulosis Palmoplantar Pustulosis (PPP) is characterized by the development of blister-like pustules within erythematous, scaly plaques on the palms and the soles of the feet. PPP typically develops in adulthood, more frequently impacts females. Patients frequently experience significant pain, burning, and itching sensations on the palms and soles of the feet which can be debilitating and impair their ability to work, sleep, or perform other activities of daily living. Currently, the treatment of PPP is challenging with a significant unmet need for novel therapies to reduce the symptom burden for patients. Evidence suggests that activation of the IL-17 pathway has an important role in disease pathophysiology. Cautionary Statement Regarding Forward Looking Statements This press release contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the efficacy and safety of sonelokimab for the treatment of moderate-to-severe HS; the interactions and alignment with the FDA concerning the anticipated BLA submission; the proposed label and labeling discussions with the FDA for sonelokimab in HS, including potential inclusion of clinical data from the MIRA trial; potential market opportunities for sonelokimab; upcoming anticipated clinical milestones, including data of the VELA-1 and VELA-2 trials in HS, the primary endpoint readouts of the Phase 3 IZAR-trial in PsA, Phase 3 VELA-TEEN trial in adolescent HS and Phase 3 IZAR-2 trial in PsA and submission of a BLA for HS; the FDA’s decision on Priority Review designation; and timing of first commercial launch in the United States. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLake’s business in general and limited operating history; difficulty enrolling patients in clinical trials; state and federal healthcare reform measures that could result in reduced demand for MoonLake’s product candidates; reliance on third parties to conduct and support its preclinical studies and clinical trials; and the other risks described in or incorporated by reference into MoonLake’s Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent filings with the Securities and Exchange Commission. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based. Contacts: MoonLake Immunotherapeutics Media & Investors Relations [email protected] ICR Healthcare Mary-Jane Elliott, Sarah Elton-Farr, Ashley Tapp Tel: +44 (0) 20 3709 5700 [email protected] MOONLAKE IMMUNOTHERAPEUTICS CONDENSED CONSOLIDATED BALANCE SHEETS MOONLAKE IMMUNOTHERAPEUTICS CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited)

Results from the Phase 3 VELA clinical trials in adults with moderate-to-severe hidradenitis suppurativa (HS) show that clinical responses continue to improve to Week 40, with 62% of patients treated with sonelokimab (SLK) achieving HiSCR75 and up to 32% of patients achieving HiSCR100 An analysis of different hallmark lesions of HS shows that up to 25% of patients achieved inflammatory remission at Week 40, defined as a 100% reduction in abscesses (A100), nodules (N100) and draining tunnels (DT100) Patients treated with SLK also showed substantial improvements in HiSQOL items at week 40 versus baseline, ranging from 41% (pain), to 54% (walking, getting dressed) to 62% (down or depressed) Up to 43% of patients achieved an at least 3-point improvement from baseline in the worst skin pain NRS, while 65% of patients achieved an improvement of at least 4 points from baseline in DLQI No new safety signals were detected in the VELA trials to-date Detailed results will be presented at the S034 Late-Breaking Research: Session 2 by Prof. Alexa Kimball, Investigator at Beth Israel Deaconess Medical Center, and Professor of Dermatology at Harvard Medical School, at the 2026 AAD Annual Meeting on March 28, 2026 ZUG, Switzerland, March 28, 2026 – MoonLake Immunotherapeutics (NASDAQ: MLTX) (MoonLake or the Company), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announces long-term Week 40 results of the Phase 3 VELA-1 and VELA-2 clinical trials of its registrational global program in patients with moderate-to-severe HS and confirms the presentation of the data at the 2026 American Academy of Dermatology (AAD) Annual Meeting later today. The Phase 3 VELA program in adults with moderate-to-severe HS used the higher clinical response level of HS Clinical Response (HiSCR) 75 as the primary endpoint, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count. Key secondary endpoints included the change from baseline in the HS Quality of Life score (HiSQOL) as well as other scores that reflect the evolving needs of HS patients, treating physicians and regulators. These included the percentage of participants achieving at least a 55% reduction in the International HS Severity Scoring System (IHS4-55), the percentage of participants achieving at least a 3-point improvement from baseline in the worst skin pain Numerical Rating Scale (NRS) among participants with a baseline score of at least 3 points, and the percentage of patients achieving a Dermatology Quality of Life Index (DLQI) total score improvement of ≥4 (minimal clinically important difference), among participants with a baseline DLQI ≥4. A total of 838 patients were enrolled across both trials. Following the primary endpoint at Week 16, patients in the placebo arm were switched to receive SLK treatment for the remaining duration of the trial until Week 52. Patients originally randomized to the SLK arm continued to receive SLK at the monthly 120mg maintenance dose. All patients have completed Week 40 and discontinuation rates were at the low end to those observed in other pivotal HS trials. After Week 52, patients have the opportunity to switch into a two-year open-label extension trial. SLK demonstrated continued improvement of clinical scores and Patient Reported Outcomes (PROs) at Week 40. Across both VELA-1 and VELA-2, 62% of patients treated with SLK achieved HiSCR75 response and up to 32% of patients achieved HiSCR100 response at Week 40 (as observed). The results were consistent across both trials (VELA-1: 61.9% HiSCR75, 32.4% HiSCR100; VELA-2: 61.8% HiSCR75, 28.1% HiSCR100; as observed). Up to 77% of patients achieved an IHS-4 55 response (VELA-1: 74.3%, VELA-2: 77.4%; as observed) and up to 25% of patients achieved inflammatory remission at Week 40 (A100 + DT100 + N100; VELA-1: 25.2%, VELA-2: 21.1%; as observed). With 62% of SLK patients reaching a HiSCR75 response already at Week 40, SLK sets a new standard in long-term lesion control of HS. Approved IL-17A and IL17A & F inhibitors reported HiSCR75 response rates of approximately 40% and 60%, respectively, at the 1-year mark of their respective pivotal trials (approved doses, pooled analysis across pivotal trials). The strong long-term clinical responses were accompanied by continued improvement in PROs, which reflect critical quality of life outcomes for patients with HS. Patients treated with SLK showed a significant improvement of HiSQOL score at Week 40 with a -11.8 change from baseline in VELA-1, and -12.4 change from baseline in VELA-2 (mean HiSQOL at baseline of 26.5 (VELA-1) and 28.0 (VELA-2); as observed). While 59% of patients were within the “very severe” category on the HiSQOL severity score at baseline, 63% of patients were in the “mild / none” category at Week 40 (as observed, pooled). Improvements versus baseline in HiSQOL-Mini items ranged from 41% (pain), to 54% (walking, getting dressed) to 62% (down or depressed) at Week 40 (in patients with baseline >0, as observed, pooled). In addition, up to 43% of patients experienced a marked reduction of pain, as measured by an at least 3-point improvement from baseline in the worst skin pain NRS (VELA-1: 43.2%, VELA-2: 37.2%; as observed, baseline score of at least three points). 65% of patients achieved a meaningful (at least four points from baseline) improvement in DLQI (VELA-1: 64.6%, VELA-2: 65.3%; as observed, baseline DLQI of at least four points). The safety profile of SLK in the VELA clinical trials remains consistent over time, with no new safety signals detected. Prof. Alexa Kimball, President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Professor of Dermatology at Harvard Medical School said: “The Week 40 results from the VELA trials show an early and increasing clinical benefit over time for patients treated with sonelokimab, addressing a critical goal in HS treatment: long-term disease control. The consistency of the VELA data over time reinforces the opportunity for sonelokimab to address this important unmet need for patients living with HS.” Details of the Week 40 results from Phase 3 VELA clinical trials in HS will be presented by Prof. Alexa Kimball at the 2026 AAD Annual Meeting (S034 Late-Breaking Research: Session 2). The presentation titled Sonelokimab in Moderate-to-Severe HS: Long-term Results through Week 40 of Two Phase 3 Trials will be on March 28, 2026 at 4pm – 4.12pm ET (2pm – 2.12pm MT). Important upcoming anticipated milestones for MoonLake: Q2 2026: 52-week data of the VELA-1 and VELA-2 trials in HS Mid 2026: Primary endpoint readout of the Phase 3 IZAR-1 trial in PsA H2 2026: Submission of a BLA for HS H2 2026: Primary endpoint readout of the Phase 3 IZAR-2 trial in PsA -Ends- MoonLake Immunotherapeutics MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The Company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and palmoplantar pustulosis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com. About Nanobodies® Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations. The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company. About Sonelokimab Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHHs covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema. Sonelokimab is being assessed in two lead indications, hidradenitis suppurativa (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology, including adolescent HS, palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA). For adults with HS, sonelokimab is being assessed in two identical Phase 3 trials, the VELA-1 and VELA-2 trials, using the higher clinical response level of HS Clinical Response (HiSCR) 75 as the primary endpoint, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count. In September 2025, the primary endpoint data from the VELA-1 and VELA-2 clinical trials were announced. In the combined VELA program, patients treated with SLK experienced a clinically meaningful and statistically significant improvement across all primary and key secondary endpoints using both pre-specified strategies (p<0.001). In VELA-1, SLK achieved statistical significance for all primary and key secondary endpoints using both pre-specified strategies (HiSCR75, delta to placebo of 17%, p<0.001). In VELA-2, intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in the week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053). From week 16, all patients are expected to continue to receive the 120mg dose of SLK through to 48 weeks, with a last assessment planned at week 52, followed by an open-label extension for up to two years. The safety profile of sonelokimab in the VELA trials was consistent with previous trials with no new safety signals detected. Sonelokimab is currently undergoing evaluation in the VELA-TEEN Phase 3 trial, which is the first clinical study specifically focused on adolescent patients with moderate-to-severe HS. For PsA, sonelokimab is being assessed in the Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201) evaluating the efficacy and safety of the Nanobody® sonelokimab over 24 weeks in patients with active PsA. Significant improvements were observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an American College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an ACR50 response compared to those on placebo at week 12. All key secondary endpoints in the trial were met for the 60mg and 120mg doses with induction. The safety profile of sonelokimab in the ARGO trial was consistent with previous trials with no new safety signals detected. Sonelokimab is also being assessed in PPP, a debilitating inflammatory skin condition affecting a significant number of patients, including in the completed Phase 2 LEDA program. In the Phase 2 LEDA clinical trial in PPP, SLK demonstrated clinically meaningful and statistically significant benefit. Patients treated with SLK achieved a mean percent change from baseline in the Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) of 64% at week 16, and 39% of patients achieved a ≥75% reduction in the PPPASI (PPPASI75), suggesting that SLK could provide clinically meaningful improvements in this disease for which there are currently no approved therapies. The safety profile of SLK in the LEDA trial was consistent with previous trials with no new safety signals detected. Additionally, Sonelokimab is being assessed in the ongoing Phase 2 S-OLARIS and P-OLARIS trials for active axSpA and PsA, respectively. Both trials feature an innovative design complementing traditional clinical outcomes with cellular imaging techniques. Sonelokimab has also been assessed in a randomized, placebo-controlled third-party Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab generally presented a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575). In an earlier third-party Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab decreased (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019; 81:196–203). About the VELA program The Phase 3 VELA program has enrolled over 800 patients across VELA-1 and VELA-2. Both global, randomized, double-blind, and placebo-controlled trials are identical in design evaluating the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe hidradenitis suppurativa. Similar to the design of the landmark Phase 2 MIRA trial, the primary endpoint is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75, defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trials also evaluate a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total reduction of ≥4, the proportion of patients achieving at least 50% reduction from baseline in Numerical Rating Scale (NRS50) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain) and complete resolution of Draining Tunnels (DT100). The VELA protocols and statistical analysis plans were prepared in accordance with regulatory agency advice and include two analysis strategies. The composite strategy for the VELA trials (also referred to as the primary estimand) is the primary statistical analysis. The protocol specifies the treatment policy strategy as the alternative method of handling intercurrent events to test the robustness of the VELA data. The trials compare a single 120mg dose of sonelokimab to placebo with HiSCR75 reading out at week 16. Results of the week 16 data were announced in September 2025. Further details are available under NCT06411899 and NCT06411379 at www.clinicaltrials.gov. About the MIRA trial The MIRA trial (M1095-HS-201) is a global, randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in the treatment of adult patients with active moderate-to-severe hidradenitis suppurativa. The trial recruited 234 patients, with the aim to evaluate two different doses of sonelokimab (120mg and 240mg) with placebo control and adalimumab as an active reference arm. The primary endpoint of the trial is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trial also evaluated a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total score of ≤5, and the proportion of patients achieving at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under NCT05322473 at www.clinicaltrials.gov. About the VELA-TEEN trial The Phase 3 VELA-TEEN trial is an open-label, single-arm trial designed to evaluate sonelokimab 120mg administered subcutaneously once every two weeks (Q2W) until week six and once every four weeks (Q4W) from week eight onwards. The trial aims to enroll 30-35 adolescents, aged 12-17, with moderate-to-severe hidradenitis suppurativa, from U.S. sites experienced in clinical trials and pediatric dermatology. The primary trial phase will be 24 weeks with a primary endpoint evaluating the pharmacokinetics, safety, and tolerability of sonelokimab. VELA-TEEN will also evaluate several secondary endpoints, including the proportion of patients achieving the higher clinical response measure of the Hidradenitis Suppurativa Clinical Response Score (HiSCR) 75, in addition to HiSCR50. Other outcomes are the change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4), which includes the quantitative measure of draining tunnels, and the proportion of patients achieving a meaningful reduction of the Children’s Dermatology Life Quality Index (CDLQI) and the Patients Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under NCT06768671 at www.clinicaltrials.gov. About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects an estimated 2% of the population, with three times more females affected than males. Real-world data in the United States indicates that at least 2 million unique patients have been diagnosed with and treated for HS between 2016 and 2023 alone, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity projected to reach $15bn by 2035. Onset typically occurs in early adulthood and HS has a profound negative impact on quality of life, with a higher morbidity than other dermatologic conditions. There is increasing scientific evidence to support IL-17A- and IL-17F-mediated inflammation as a key driver of the pathogenesis of HS, with other identified risk factors including genetics, cigarette smoking, and obesity. About the IZAR Program IZAR-1 (NCT06641076) and IZAR-2 (NCT06641089) are global, randomized, double-blind, placebo-controlled Phase 3 trials designed to evaluate the efficacy and safety of sonelokimab compared with placebo in a total of approximately 1,500 adults with active psoriatic arthritis (PsA), with a primary endpoint of superiority to placebo in American College of Rheumatology (ACR) 50 response at Week 16. IZAR-1 is expected to enroll biologic-naïve patients and include an evaluation of radiographic progression, while IZAR-2 is expected to enroll patients with an inadequate response to tumor necrosis factor-α inhibitors (TNF-IR) — reflecting patients commonly seen in clinical practice — and is the first PsA trial to include a risankizumab active reference arm. Both trials will also assess a range of secondary endpoints reflecting the multiple disease manifestations characteristic of PsA. These include skin and nail outcomes, multidomain outcomes, and patient-reported outcome measures such as pain and quality of life assessments. Further details are available under NCT06641076 and NCT06641089 at www.clinicaltrials.gov. About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, progressive and complex inflammatory disease that manifests across multiple domains, leading to substantial functional impairment and decreased quality of life. The clinical features of PsA are diverse, comprising both musculoskeletal (peripheral arthritis, spondylitis, dactylitis, and enthesitis) and non-musculoskeletal (skin and nail disease) domains. PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology. About the S-OLARIS trial The S-OLARIS trial (M1095-axSpA-201) is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 60mg administered subcutaneously in adult patients with active axial spondyloarthritis (axSpA). The trial recruited 26 patients. The primary endpoint is the change from baseline (CfB) in 18F-NaF SUVmax signals at week 12 in the sacroiliac joints and spine as detected by PET. Throughout the trial, several other endpoints will be assessed including established clinical disease activity outcomes (e.g., ASAS), scores related to physical function, spinal mobility, and enthesitis as well as patient reported outcomes. The trial also features an innovative exploratory peripheral blood and tissue biomarker program. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 ARGO trial in psoriatic arthritis, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. Further details are available under EUCT number 2024-513498-36-00 at https://euclinicaltrials.eu. About Axial Spondyloarthritis Axial Spondyloarthritis (axSpA) typically impacts young people, with diagnosis based on chronic inflammatory back pain lasting more than three months with onset under 45 years of age. Advanced disease can lead to progressive and pathologic bone formation and joint fusion, severely limiting spinal mobility. Global reported prevalence of axSpA ranges from 0.5% to 1.5%. AxSpA can be categorized by disease progression into two subtypes: non-radiographic axSpA and ankylosing spondylitis (AS), also known as radiographic axSpA, which is diagnosed based on radiographic evidence of structural changes to the sacroiliac joints. Patients with axSpA experience fatigue, persistent morning stiffness, and pain that worsens at night and can disrupt sleep. Many patients also face the burden of comorbidities such as psoriatic arthritis and psoriasis. Studies have found elevated IL-17 levels in the blood and synovial fluid of patients with axSpA, and IL-17A and IL-17F are both thought to be key contributors to pathogenesis across the spondyloarthropathies. About the LEDA Trial The LEDA trial (M1095-PPP-201) is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 120mg administered subcutaneously in adult patients with palmoplantar pustulosis (PPP). The trial recruited 32 patients. The primary endpoint of the trial is percent change from baseline in Palmoplantar Psoriasis Area and Severity Index (ppPASI) with important secondary endpoints including ppPASI75 (at least 75% improvement in the ppPASI). The LEDA trial features an innovative translational research program using peripheral blood and tissue biomarkers as trial controls. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 MIRA trial in hidradenitis suppurativa, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. Further details are available under EUCT number 2024-513305-32-00 at https://euclinicaltrials.eu. About Palmoplantar Pustulosis Palmoplantar Pustulosis (PPP) is characterized by the development of blister-like pustules within erythematous, scaly plaques on the palms and the soles of the feet. PPP typically develops in adulthood, more frequently impacts females. Patients frequently experience significant pain, burning, and itching sensations on the palms and soles of the feet which can be debilitating and impair their ability to work, sleep, or perform other activities of daily living. Currently, the treatment of PPP is challenging with a significant unmet need for novel therapies to reduce the symptom burden for patients. Evidence suggests that activation of the IL-17 pathway has an important role in disease pathophysiology. Cautionary Statement Regarding Forward Looking Statements This press release contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the efficacy and safety of sonelokimab for the treatment of moderate-to-severe HS; potential market opportunities for sonelokimab; and upcoming anticipated clinical milestones, including data of the VELA-1 and VELA-2 trials in HS, the primary endpoint readouts of the Phase 3 IZAR-trial in PsA, Phase 3 VELA-TEEN trial in adolescent HS and Phase 3 IZAR-2 trial in PsA and submission of a BLA for HS. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLake’s business in general and limited operating history; difficulty enrolling patients in clinical trials; state and federal healthcare reform measures that could result in reduced demand for MoonLake’s product candidates; reliance on third parties to conduct and support its preclinical studies and clinical trials; and the other risks described in or incorporated by reference into MoonLake’s Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent filings with the Securities and Exchange Commission. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based. Dr. Kimball is a paid consultant for MoonLake Immunotherapeutics. Contacts: MoonLake Immunotherapeutics Media & Investors Relations [email protected] ICR Healthcare Mary-Jane Elliott, Sarah Elton-Farr, Ashley Tapp Tel: +44 (0) 20 3709 5700 [email protected]

Cormorant Asset Management disclosed a buy of 2,361,260 shares of MoonLake Immunotherapeutics (NASDAQ:MLTX) in its February 17, 2026 SEC filing, an estimated $27.86 million trade based on quarterly average pricing. According to a SEC filing dated February 17, 2026, Cormorant Asset Management increased its stake in MoonLake Immunotherapeutics (NASDAQ:MLTX) by 2,361,260 shares during the fourth quarter. The estimated transaction value, based on the period’s average closing price, was $27.86 million. The quarter-end value of the position increased by $43.11 million, a figure that includes both additional shares and changes in the share price. This was a buy, lifting MoonLake Immunotherapeutics to 2.65% of Cormorant Asset Management, LP’s reportable U.S. equities as of December 31, 2025. Top five holdings after the filing: NASDAQ:PRAX: $280.00 million (15.9% of AUM) NASDAQ:BBOT: $223.84 million (12.7% of AUM) NASDAQ:ABVX: $182.05 million (10.3% of AUM) NASDAQ:EYPT: $151.00 million (8.6% of AUM) NASDAQ:RAPP: $91.85 million (5.2% of AUM) As of February 17, 2026, shares of MoonLake Immunotherapeutics were priced at $17.52, down nearly 60% over the past year and well underperforming the S&P 500’s roughly 19% gain in the same period. MoonLake Immunotherapeutics develops clinical-stage therapies, with a primary focus on Sonelokimab, an investigational Nanobody therapy targeting inflammatory diseases. The firm operates a research-driven business model, generating value through the advancement of novel biologic drug candidates in trials for dermatological and rheumatological indications. It serves biopharmaceutical markets, targeting healthcare providers and patients affected by chronic inflammatory conditions such as hidradenitis suppurativa and psoriatic arthritis. MoonLake Immunotherapeutics is a clinical-stage biotechnology company specializing in the development of next-generation therapies for inflammatory diseases. The company leverages proprietary Nanobody technology to address significant unmet medical needs in dermatology and rheumatology. With a focused pipeline and ongoing clinical trials, MoonLake aims to establish a competitive position in the biopharmaceutical sector through innovative science and targeted indications. MoonLake Immunotherapeutics’ stock suffered a steep nearly 90% drop in a single day this past September after mixed Phase 3 results surfaced for its investigational nanobody, sonelokimab. That means Cormorant stepped in with that disappointment well priced in during the fourth quarter, and it might be because, under the hood, MoonLake’s lead drug candidate continues to advance through clinical development. Early clinical data have shown encouraging activity, and recent trial results in axial spondyloarthritis added another potential indication for the therapy. If later-stage studies confirm these findings, the drug could compete in large and rapidly expanding immunology markets. Financially, MoonLake remains a typical clinical-stage biotech. The company reported fourth-quarter R&D of $56 million and additional administrative expenses of $9.2 million as it continued funding research and clinical trials, ending the year with about $394 million in cash and equivalents, enough to fund operations into the second half of next year. Ultimately, it seems that the steep stock crash in September may have provided an attractive entry point, at least according to Cormorant’s move here. Before you buy stock in MoonLake Immunotherapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and MoonLake Immunotherapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $514,000!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,105,029!* Now, it’s worth noting Stock Advisor’s total average return is 930% — a market-crushing outperformance compared to 187% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of March 16, 2026. Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This Fund Bought $28 Million of a Beaten-Down Immunotherapy Stock Last Quarter. What Should Long-Term Investors Know? was originally published by The Motley Fool

MoonLake Immunotherapeutics recently reported full-year 2025 results showing a wider net loss of US$227.32 million and a basic loss per share of US$3.53, alongside announcing positive topline Phase 2 data for its lead drug candidate sonelokimab in axial spondyloarthritis with no new safety signals. The company also highlighted that more than 80% of patients in the axial spondyloarthritis trial achieved key response endpoints by week 12, while stating it has sufficient cash to fund operations into the second half of 2027. Against this backdrop, we will examine how the strong Phase 2 sonelokimab efficacy data shapes MoonLake Immunotherapeutics’ evolving investment narrative. Find 46 companies with promising cash flow potential yet trading below their fair value. To own MoonLake Immunotherapeutics, you need to believe sonelokimab can progress from encouraging trial data to a commercially viable franchise across multiple inflammatory diseases, despite ongoing losses and no current revenue. The latest axial spondyloarthritis Phase 2 readout, with over 80% of patients hitting key endpoints by week 12 and no new safety signals, reinforces the core drug thesis and adds a fresh catalyst alongside the planned H2 2026 BLA filing in hidradenitis suppurativa. That helps explain why most recent Wall Street calls remain positive, even as one high profile analyst stays cautious. At the same time, the wider 2025 net loss of US$227.32 million and reliance on external funding keep execution and financing risk very real, despite cash runway guidance into the second half of 2027. However, the growing cash burn against a zero-revenue model is something investors should note. Our valuation report unveils the possibility MoonLake Immunotherapeutics' shares may be trading at a premium. The Simply Wall St Community’s single fair value estimate of US$23.29 offers one reference point, while the latest sonelokimab data and ongoing cash burn highlight why many market participants may reach very different conclusions about MoonLake’s longer term potential. Explore another fair value estimate on MoonLake Immunotherapeutics - why the stock might be worth as much as 33% more than the current price! Disagree with this assessment? Extraordinary investment returns rarely come from following the herd, so go with your instincts. A great starting point for your MoonLake Immunotherapeutics research is our analysis highlighting 4 important warning signs that could impact your investment decision. Our free MoonLake Immunotherapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate MoonLake Immunotherapeutics' overall financial health at a glance. Opportunities like this don't last. These are today's most promising picks. Check them out now: Invest in the nuclear renaissance through our list of 84 elite nuclear energy infrastructure plays powering the global AI revolution. Uncover the next big thing with 30 elite penny stocks that balance risk and reward. Explore 22 top quantum computing companies leading the revolution in next-gen technology and shaping the future with breakthroughs in quantum algorithms, superconducting qubits, and cutting-edge research. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include MLTX. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

In the Phase 2 S-OLARIS clinical trial in axial spondyloarthritis (axSpA), sonelokimab (SLK) demonstrated clinically meaningful benefit with 80+% of patients achieving ASAS40 by Week 12 Consistently, other clinical and imaging scores also showed improvements of 80+% by week 12 for patients treated with SLK, including ASDAS-CRP and SPARCC MRI axSpA is a disease driven by inflammation leading to irreversible ossification (via osteoblast activity) and ultimately to irreversible restriction of mobility – objective PET/MRI imaging data further showed a significant reduction in inflammation and osteoblast activity deep in affected joints, already by week 12, suggesting potential for disease modification in axSpA for SLK As a biomarker-controlled trial, S-OLARIS data showed SLK reduced the levels of key inflammatory mediators in axSpA, in peripheral blood and biopsy samples from patients – the safety profile of SLK was similar to other trials and no new signals were detected MoonLake ended the fourth quarter with $394 million in cash, cash equivalents and short-term marketable debt securities which, together with funds from its latest equity raise (gross proceeds of $75 million), are expected to provide a cash runway into the second half of 2027 The Company also announced the amendment of its debt facility with Hercules Capital, with a concurrent drawdown of $25 million, and up to $400 million in non-dilutive funds remaining available to support future funding needs An Investor Day webcast has been confirmed for February 23, 2026, 8.00 – 9.30 am EST (2:00 – 3.30pm CET), including an open Q&A session ZUG, Switzerland, February 22, 2026 – MoonLake Immunotherapeutics (NASDAQ:MLTX) (“MoonLake” or the “Company”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announces topline results from the S-OLARIS Phase 2 trial of SLK in patients with radiographic and non-radiographic axSpA and announces its financial results for the fourth quarter and year ended December 31, 2025. An Investor Day webcast has been confirmed for February 23, 2026, 8.00 – 9.30 am EST (2:00 – 3.30pm CET), including an open Q&A session. Topline Phase 2 S-OLARIS clinical trial results of SLK in axSpA In the Phase 2 S-OLARIS trial in axSpA, SLK demonstrated clinically meaningful and statistically significant benefit. 81% of patients treated with SLK (n=26, mNRI), achieved an Assessment of Spondyloarthritis International Society 40 (ASAS40) response at Week 12. ASAS40 measures an improvement of at least 40% and an absolute improvement of ≥2 units on a 0-10 numerical rating scale from baseline in at least three of the four key domains (Patient Global Assessment of disease activity, total back pain, physical function, inflammation), with no worsening in the remaining domain and has been the primary endpoint for the latest approved therapies. More than 80% of patients also achieved a ‘clinically important improvement’ as per ASDAS-CRP score by Week 12 (mNRI). The clinical improvement, in patients treated with SLK, was confirmed by SPARCC MRI scores in the sacroiliac joint (SIJ), measuring inflammation and injury inside the bone, at week 12. This suggests rapid onset of action for SLK and IL-17A and F inhibitory activity in deep, difficult-to-access tissues. Importantly, PET imaging with an 18F-NaF tracer collected as part of the clinical trial showed significant reduction of inflammation and osteoblast activity in sacroiliac joints affected by axSpA, a key driver of irreversible ossification in the disease. Objective peripheral blood and tissue biomarker analyses conducted to control for the effect of SLK, showed rapid and sustained effects of the treatment with SLK in inhibiting key immune pathways known to drive inflammation and ossification in affected patients. The safety profile of SLK in the S-OLARIS trial was consistent with previous trials with no new safety signals detected. Data from this clinical trial further strengthens the potential of SLK in treating a wide array of inflammatory diseases and represents the fifth indication with positive data, in Phase 2 and Phase 3 clinical trials, for the IL-17A and F Nanobody®. Prof. Kristian Reich, Founder and Chief Scientific Officer at MoonLake Immunotherapeutics, said: “The data from our S-OLARIS trial marks a critical step in providing an effective treatment for patients with this devastating disease. The complementary data from clinical outcomes, MRI and PET imaging as well as peripheral blood and tissue biomarkers confirm our hypothesis of SLKs ability to access deeper tissue, which is essential to optimally control this chronic rheumatological condition and prevent irreversible mobility restriction. In our view, the impact of SLK on clinical parameters and key disease pathways observed in S-OLARIS already within the first 12 weeks of treatment highlight the potential of the drug to elevate clinical outcomes and to achieve disease modification in axSpA. With millions of patients affected by this devastating condition and limited impact of current therapies in improving relevant disease mechanisms, SLK has the potential to change the treatment paradigm in axSpA.” Prof. Xenofon Baraliakos, Head of Rheumatology at the Rheumazentrum Ruhrgebiet Herne & President of the European Alliance of Associations for Rheumatology (EULAR) said: “Completing the S-OLARIS trial has been a remarkable milestone for the axSpA and broader Rheumatology community. The combination of clinical, imaging, and biomarker data presents one of the clearest demonstrations to date of how targeting IL-17A and IL-17F with a Nanobody® can meaningfully reduce inflammation in the axial structures. The consistency and speed of response we observed in patients underline the significant potential of sonelokimab to address the unmet needs in this burdensome disease. It has been an honour for our team to contribute to advancing a therapy that could profoundly impact patient lives.” Financial results for the fourth quarter and year ended December 31, 2025 As of December 31, 2025, MoonLake held cash, cash equivalents and short-term marketable debt securities of $394.0 million. Research and development expenses for the quarter ended December 31, 2025, were $56.0 million, compared to $60.6 million in the previous quarter. General and administrative expenses for the quarter ended December 31, 2025 were $9.2 million, compared to the $10.8 million incurred in the previous quarter. The Company expects its cash, cash equivalents and short-term marketable debt securities to be sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2027. In addition, the Company announced the amendment of its debt facility with Hercules Capital, with a concurrent drawdown of $25 million, and up to $400 million in non-dilutive funds remaining available to support future funding needs. The Company expects to file its full annual report on Form 10-K with the U.S. Securities and Exchange Commission on February 25, 2026. Investor Day, February 23, 2026 The Company will hold an Investor Day for investors and analysts on February 23, 2026. The webcast will start at 8.00 – 9.30 am EST (2:00 – 3.30pm CET), including an open Q&A session. A recording will be made available post event. Webcast Access: https://edge.media-server.com/mmc/p/ke4wbinp In this session, MoonLake's CEO, Jorge Santos da Silva, CSO, Kristian Reich, and CFO, Matthias Bodenstedt, will present the axSpA S-OLARIS data. In addition, the team will discuss the outcomes of the recent Type B FDA Meeting for hidradenitis suppurativa (HS) and next steps regarding label strategy and BLA submission. An interim analysis of the continued response to SLK beyond week 16 from the HS VELA Phase 3 clinical trials in adult patients with HS will also be shared, as will interim data from the VELA‑TEEN clinical trial in adolescent HS. Finally, management will share an update on its financial position and outline key 2026 catalysts, including upcoming data releases from the Phase 3 IZAR trials in Psoriatic Arthritis (PsA), the market opportunity and planned Phase 3 program in palmo-plantar pustulosis (PPP), among other expected milestones. Important upcoming anticipated milestones for MoonLake: Q2 2026: 52-week data of the VELA-1 and VELA-2 trials in HS Mid 2026: Primary endpoint readout of the Phase 3 IZAR-1 trial in PsA Mid 2026: Primary endpoint readout of Phase 3 VELA-TEEN trial in adolescent HS H2 2026: Submission of a BLA for HS H2 2026: Primary endpoint readout of the Phase 3 IZAR-2 trial in PsA -Ends- MoonLake Immunotherapeutics MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The Company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and palmoplantar pustulosis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com. About Nanobodies® Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations. The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company. About Sonelokimab Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHHs covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema. Sonelokimab is being assessed in two lead indications, hidradenitis suppurativa (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology, including adolescent HS, palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA). For adults with HS, sonelokimab is being assessed in two identical Phase 3 trials, the VELA-1 and VELA-2 trials, using the higher clinical response level of HS Clinical Response (HiSCR) 75 as the primary endpoint, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count. In September 2025, the primary endpoint data from the VELA-1 and VELA-2 clinical trials were announced. In the combined VELA program, patients treated with SLK experienced a clinically meaningful and statistically significant improvement across all primary and key secondary endpoints using both pre-specified strategies (p<0.001). In VELA-1, SLK achieved statistical significance for all primary and key secondary endpoints using both pre-specified strategies (HiSCR75, delta to placebo of 17%, p<0.001). In VELA-2, intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in the week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053). From week 16, all patients are expected to continue to receive the 120mg dose of SLK through to 48 weeks, with a last assessment planned at week 52, followed by an open-label extension for up to two years. The safety profile of sonelokimab in the VELA trials was consistent with previous trials with no new safety signals detected. Sonelokimab is currently undergoing evaluation in the VELA-TEEN Phase 3 trial, which is the first clinical study specifically focused on adolescent patients with moderate-to-severe HS. For PsA, sonelokimab is being assessed in the Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201) evaluating the efficacy and safety of the Nanobody® sonelokimab over 24 weeks in patients with active PsA. Significant improvements were observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an American College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an ACR50 response compared to those on placebo at week 12. All key secondary endpoints in the trial were met for the 60mg and 120mg doses with induction. The safety profile of sonelokimab in the ARGO trial was consistent with previous trials with no new safety signals detected. Sonelokimab is also being assessed in PPP, a debilitating inflammatory skin condition affecting a significant number of patients, including in the completed Phase 2 LEDA program. In the Phase 2 LEDA clinical trial in PPP, SLK demonstrated clinically meaningful and statistically significant benefit. Patients treated with SLK achieved a mean percent change from baseline in the Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) of 64% at week 16, and 39% of patients achieved a ≥75% reduction in the PPPASI (PPPASI75), suggesting that SLK could provide clinically meaningful improvements in this disease for which there are currently no approved therapies. The safety profile of SLK in the LEDA trial was consistent with previous trials with no new safety signals detected. Additionally, Sonelokimab is being assessed in the ongoing Phase 2 S-OLARIS and P-OLARIS trials for active axSpA and PsA, respectively. Both trials feature an innovative design complementing traditional clinical outcomes with cellular imaging techniques. Sonelokimab has also been assessed in a randomized, placebo-controlled third-party Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab generally presented a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575). In an earlier third-party Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab decreased (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196–203). About the VELA program The Phase 3 VELA program has enrolled over 800 patients across VELA-1 and VELA-2. Both global, randomized, double-blind, and placebo-controlled trials are identical in design evaluating the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe hidradenitis suppurativa. Similar to the design of the landmark Phase 2 MIRA trial, the primary endpoint is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75, defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trials also evaluate a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total reduction of ≥4, the proportion of patients achieving at least 50% reduction from baseline in Numerical Rating Scale (NRS50) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain) and complete resolution of Draining Tunnels (DT100). The VELA protocols and statistical analysis plans were prepared in accordance with regulatory agency advice and include two analysis strategies. The composite strategy for the VELA trials (also referred to as the primary estimand) is the primary statistical analysis. The protocol specifies the treatment policy strategy as the alternative method of handling intercurrent events to test the robustness of the VELA data. The trials compare a single 120mg dose of sonelokimab to placebo with HiSCR75 reading out at week 16. Results of the week 16 data were announced in September 2025. Further details are available under NCT06411899 and NCT06411379 at www.clinicaltrials.gov. About the MIRA trial The MIRA trial (M1095-HS-201) is a global, randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in the treatment of adult patients with active moderate-to-severe hidradenitis suppurativa. The trial recruited 234 patients, with the aim to evaluate two different doses of sonelokimab (120mg and 240mg) with placebo control and adalimumab as an active reference arm. The primary endpoint of the trial is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trial also evaluated a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total score of ≤5, and the proportion of patients achieving at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under NCT05322473 at www.clinicaltrials.gov. About the VELA-TEEN trial The Phase 3 VELA-TEEN trial is an open-label, single-arm trial designed to evaluate sonelokimab 120mg administered subcutaneously once every two weeks (Q2W) until week six and once every four weeks (Q4W) from week eight onwards. The trial aims to enroll 30-35 adolescents, aged 12-17, with moderate-to-severe hidradenitis suppurativa, from U.S. sites experienced in clinical trials and pediatric dermatology. The primary trial phase will be 24 weeks with a primary endpoint evaluating the pharmacokinetics, safety, and tolerability of sonelokimab. VELA-TEEN will also evaluate several secondary endpoints, including the proportion of patients achieving the higher clinical response measure of the Hidradenitis Suppurativa Clinical Response Score (HiSCR) 75, in addition to HiSCR50. Other outcomes are the change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4), which includes the quantitative measure of draining tunnels, and the proportion of patients achieving a meaningful reduction of the Children’s Dermatology Life Quality Index (CDLQI) and the Patients Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under NCT06768671 at www.clinicaltrials.gov. About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects an estimated 2% of the population, with three times more females affected than males. Real-world data in the United States indicates that at least 2 million unique patients have been diagnosed with and treated for HS between 2016 and 2023 alone, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity projected to reach $15bn by 2035. Onset typically occurs in early adulthood and HS has a profound negative impact on quality of life, with a higher morbidity than other dermatologic conditions. There is increasing scientific evidence to support IL-17A- and IL-17F-mediated inflammation as a key driver of the pathogenesis of HS, with other identified risk factors including genetics, cigarette smoking, and obesity. About the IZAR Program IZAR-1 (NCT06641076) and IZAR-2 (NCT06641089) are global, randomized, double-blind, placebo-controlled Phase 3 trials designed to evaluate the efficacy and safety of sonelokimab compared with placebo in a total of approximately 1,500 adults with active psoriatic arthritis (PsA), with a primary endpoint of superiority to placebo in American College of Rheumatology (ACR) 50 response at Week 16. IZAR-1 is expected to enroll biologic-naïve patients and include an evaluation of radiographic progression, while IZAR-2 is expected to enroll patients with an inadequate response to tumor necrosis factor-α inhibitors (TNF-IR) — reflecting patients commonly seen in clinical practice — and is the first PsA trial to include a risankizumab active reference arm. Both trials will also assess a range of secondary endpoints reflecting the multiple disease manifestations characteristic of PsA. These include skin and nail outcomes, multidomain outcomes, and patient-reported outcome measures such as pain and quality of life assessments. Further details are available under NCT06641076 and NCT06641089 at www.clinicaltrials.gov. About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, progressive and complex inflammatory disease that manifests across multiple domains, leading to substantial functional impairment and decreased quality of life. The clinical features of PsA are diverse, comprising both musculoskeletal (peripheral arthritis, spondylitis, dactylitis, and enthesitis) and non-musculoskeletal (skin and nail disease) domains. PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology. About the S-OLARIS trial The S-OLARIS trial (M1095-axSpA-201) is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 60mg administered subcutaneously in adult patients with active axial spondyloarthritis (axSpA). The trial recruited 26 patients. The primary endpoint is the change from baseline (CfB) in 18F-NaF SUVmax signals at week 12 in the sacroiliac joints and spine as detected by PET. Throughout the trial, several other endpoints will be assessed including established clinical disease activity outcomes (e.g., ASAS), scores related to physical function, spinal mobility, and enthesitis as well as patient reported outcomes. The trial also features an innovative exploratory peripheral blood and tissue biomarker program. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 ARGO trial in psoriatic arthritis, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. Further details are available under EUCT number 2024-513498-36-00 at https://euclinicaltrials.eu. About Axial Spondyloarthritis Axial Spondyloarthritis (axSpA) typically impacts young people, with diagnosis based on chronic inflammatory back pain lasting more than three months with onset under 45 years of age. Advanced disease can lead to progressive and pathologic bone formation and joint fusion, severely limiting spinal mobility. Global reported prevalence of axSpA ranges from 0.5% to 1.5%. AxSpA can be categorized by disease progression into two subtypes: non-radiographic axSpA and ankylosing spondylitis (AS), also known as radiographic axSpA, which is diagnosed based on radiographic evidence of structural changes to the sacroiliac joints. Patients with axSpA experience fatigue, persistent morning stiffness, and pain that worsens at night and can disrupt sleep. Many patients also face the burden of comorbidities such as psoriatic arthritis and psoriasis. Studies have found elevated IL-17 levels in the blood and synovial fluid of patients with axSpA, and IL-17A and IL-17F are both thought to be key contributors to pathogenesis across the spondyloarthropathies. About the LEDA Trial The LEDA trial (M1095-PPP-201) is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 120mg administered subcutaneously in adult patients with palmoplantar pustulosis (PPP). The trial recruited 32 patients. The primary endpoint of the trial is percent change from baseline in Palmoplantar Psoriasis Area and Severity Index (ppPASI) with important secondary endpoints including ppPASI75 (at least 75% improvement in the ppPASI). The LEDA trial features an innovative translational research program using peripheral blood and tissue biomarkers as trial controls. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 MIRA trial in hidradenitis suppurativa, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. Further details are available under EUCT number 2024-513305-32-00 at https://euclinicaltrials.eu. About Palmoplantar Pustulosis Palmoplantar Pustulosis (PPP) is characterized by the development of blister-like pustules within erythematous, scaly plaques on the palms and the soles of the feet. PPP typically develops in adulthood, more frequently impacts females. Patients frequently experience significant pain, burning, and itching sensations on the palms and soles of the feet which can be debilitating and impair their ability to work, sleep, or perform other activities of daily living. Currently, the treatment of PPP is challenging with a significant unmet need for novel therapies to reduce the symptom burden for patients. Evidence suggests that activation of the IL-17 pathway has an important role in disease pathophysiology. Cautionary Statement Regarding Forward Looking Statements This press release contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the efficacy and safety of sonelokimab for the treatment of axSpA; potential market opportunities for sonelokimab; the anticipated usage of cash and the expected timing of when MoonLake’s operating cash would be fully spent; and upcoming anticipated corporate milestones. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLake’s business in general and limited operating history; difficulty enrolling patients in clinical trials; state and federal healthcare reform measures that could result in reduced demand for MoonLake’s product candidates; reliance on third parties to conduct and support its preclinical studies and clinical trials; and the other risks described in or incorporated by reference into MoonLake’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent filings with the Securities and Exchange Commission. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based. Contacts: MoonLake Immunotherapeutics Media & Investors Relations [email protected] ICR Healthcare Mary-Jane Elliott, Sarah Elton-Farr, Ashley Tapp Tel: +44 (0) 20 3709 5700 [email protected]

Ended the third quarter with $380.5 million in cash, cash equivalents and short-term marketable debt securities which, together with funds from a previously announced debt-facility, are expected to provide runway into the second half of 2027 Reported results of its Phase 2 LEDA clinical trial in Palmoplantar Pustulosis (PPP) where sonelokimab (SLK) demonstrated clinically meaningful and statistically significant benefit Reported an interim analysis of the long-term data from the VELA-1 and VELA-2 clinical trials in adults with Hidradenitis Suppurativa (HS), as well as an interim analysis of its VELA-TEEN clinical trial in adolescent HS, demonstrating the potential and competitive benefit of SLK in these patient populations Confirmed a Type B meeting with the U.S. Food and Drug Administration (FDA), scheduled to be held on December 15, 2025, to discuss adequacy of the current clinical evidence package of SLK in HS to support a Biologics License Application (BLA) Other clinical trials of SLK progressing well and expected to support a catalyst-rich roadmap over the next 12 months, including data releases from the Phase 2 S-OLARIS trial in Axial Spondyloarthritis (axSpA) and the Phase 3 IZAR trials in Psoriatic Arthritis (PsA) 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 quarter of 2025. As of September 30, 2025, MoonLake held cash, cash equivalents and short-term marketable debt securities of $380.5 million. The Company expects its cash, cash equivalents and short-term marketable securities, together with committed capital under a previously announced debt facility with Hercules Capital, to be sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2027. Research and development expenses for the quarter ended September 30, 2025, were $60.6 million, compared to $49.8 million in the previous quarter. The increase of $10.8 million was driven by increases in expenses with contract research organizations and contract manufacturing organizations, as well as consulting expenses and personnel-related costs, all to support the further ramp-up of MoonLake's clinical trials and preparations for the anticipated submission of the BLA for sonelokimab in the third quarter of 2026. General and administrative expenses for the quarter ended September 30, 2025 were $10.8 million, similar to the $10.9 million incurred in the previous quarter. The Company today also released new data from multiple clinical trials of its Nanobody® SLK: In the Phase 2 LEDA clinical trial in PPP, SLK demonstrated clinically meaningful and statistically significant benefit. Patients treated with SLK achieved a mean percent change from baseline in the Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) of 64% at week 16, and 39% of patients achieved a ≥75% reduction in the PPPASI (PPPASI75), suggesting that SLK could provide clinically meaningful improvements in this disease for which there are currently no approved therapies. The safety profile of SLK in the LEDA trial was consistent with previous trials with no new safety signals detected. The Company expects to commence a Phase 3 clinical trial in PPP in Q3 2026. In an interim analysis of long-term data from MoonLake's Phase 3 clinical trials in adult patients with HS, the VELA-1 and VELA-2 trials, SLK demonstrates continuous clinical improvement and potentially competitive advantages beyond the week 16 primary endpoint. The Company confirmed a Type B meeting with the FDA, which is scheduled to be held on December 15, 2025, to discuss adequacy of the current clinical evidence package of SLK in HS to support a Biologics License Application (BLA). An interim analysis of the VELA-TEEN clinical trial, a Phase 3 study of SLK in adolescent HS patients, showed that 46% of patients achieved a HiSCR75 response at week 16 (n=11). The trial is expected to enroll a total of 30-35 patients and topline results are expected to become available in 2026. The data is expected to be part of MoonLake's BLA submission. A presentation including the new clinical data for SLK is available at https://ir.moonlaketx.com. Important upcoming anticipated milestones for MoonLake: December 15, 2025: Type B meeting with the FDA (minutes expected within following 30 days) Q1 2026: Primary endpoint readout of the Phase 2 S-OLARIS trial in axSpA Q2 2026: 52 weeks data of the VELA-1 and VELA-2 trials in HS Q2 2026: Primary endpoint readout of the Phase 3 IZAR-1 trial in PsA Q2 2026: Primary endpoint readout of Phase 3 VELA-TEEN trial in adolescent HS Q3 2026: Initiate Phase 3 trial in PPP Q3/Q4 2026: Submission of a BLA H2 2026: Primary endpoint readout of the Phase 3 IZAR-2 trial in PsA -Ends- About MoonLake Immunotherapeutics MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The Company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and palmoplantar pustulosis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com. About Nanobodies® Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations. The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company. About Sonelokimab Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHHs covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema. Sonelokimab is being assessed in two lead indications, hidradenitis suppurativa (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology, including adolescent HS, palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA). For adults with HS, sonelokimab is being assessed in two identical Phase 3 trials, the VELA-1 and VELA-2 trials, using the higher clinical response level of HS Clinical Response (HiSCR) 75 as the primary endpoint, which defines a response as an at least 75% reduction in abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count. In September 2025, we announced primary endpoint data from the VELA-1 and VELA-2 clinical trials. In the combined VELA program, patients treated with SLK experienced a clinically meaningful and statistically significant improvement across all primary and key secondary endpoints using both pre-specified strategies (p<0.001). In VELA-1, SLK achieved statistical significance for all primary and key secondary endpoints using both pre-specified strategies (HiSCR75, delta to placebo of 17%, p<0.001). In VELA-2, intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in the week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053). From week 16, all patients are expected to continue to receive the 120mg dose of SLK through to 48 weeks, with a last assessment planned at week 52, followed by an open-label extension for up to two years. The safety profile of sonelokimab in the VELA trials was consistent with previous trials with no new safety signals detected. Sonelokimab is currently undergoing evaluation in the VELA-TEEN Phase 3 trial, which is the first clinical study specifically focused on adolescent patients with moderate-to-severe HS. For PsA, sonelokimab is being assessed in the Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201) evaluating the efficacy and safety of the Nanobody® sonelokimab over 24 weeks in patients with active PsA. Significant improvements were observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an American College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an ACR50 response compared to those on placebo at week 12. All key secondary endpoints in the trial were met for the 60mg and 120mg doses with induction. The safety profile of sonelokimab in the ARGO trial was consistent with previous trials with no new safety signals detected. Sonelokimab is also being assessed in the Phase 2 LEDA trial, which is ongoing for PPP, a debilitating inflammatory skin condition affecting a significant number of patients. Additionally, Sonelokimab is being assessed in the ongoing Phase 2 S-OLARIS and P-OLARIS trials for active axSpA and PsA, respectively. Both trials features an innovative design complementing traditional clinical outcomes with cellular imaging techniques. Sonelokimab has also been assessed in a randomized, placebo-controlled third-party Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575). In an earlier third-party Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196–203). About the VELA program The Phase 3 VELA program has enrolled over 800 patients across VELA-1 and VELA-2. Both global, randomized, double-blind, and placebo-controlled trials are identical in design evaluating the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe hidradenitis suppurativa. Similar to the design of the landmark Phase 2 MIRA trial, the primary endpoint is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75, defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trials also evaluate a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total reduction of ≥4, the proportion of patients achieving at least 50% reduction from baseline in Numerical Rating Scale (NRS50) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain) and complete resolution of Draining Tunnels (DT100). The VELA protocols and statistical analysis plans were prepared in accordance with regulatory agency advice and include two analysis strategies. The composite strategy for the VELA trials (also referred to as the primary estimand) is the primary statistical analysis. The protocol specifies the treatment policy strategy as the alternative method of handling intercurrent events to test the robustness of the VELA data. The trials compare a single 120mg dose of sonelokimab to placebo with HiSCR75 reading out at week 16. Results of the week 16 data were announced in September 2025. Further details are available under NCT06411899 and NCT06411379 at www.clinicaltrials.gov. About the VELA-TEEN trial The Phase 3 VELA-TEEN trial is an open-label, single-arm trial designed to evaluate sonelokimab 120mg administered subcutaneously once every two weeks (Q2W) until week six and once every four weeks (Q4W) from week eight onwards. The trial aims to enroll 30-35 adolescents, aged 12-17, with moderate-to-severe hidradenitis suppurativa, from U.S. sites experienced in clinical trials and pediatric dermatology. The primary trial phase will be 24 weeks with a primary endpoint evaluating the pharmacokinetics, safety, and tolerability of sonelokimab. VELA-TEEN will also evaluate several secondary endpoints, including the proportion of patients achieving the higher clinical response measure of the Hidradenitis Suppurativa Clinical Response Score (HiSCR) 75, in addition to HiSCR50. Other outcomes are the change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4), which includes the quantitative measure of draining tunnels, and the proportion of patients achieving a meaningful reduction of the Children’s Dermatology Life Quality Index (CDLQI) and the Patients Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under NCT06768671 at www.clinicaltrials.gov. About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects an estimated 2% of the population, with three times more females affected than males. Real-world data in the United States indicates that at least 2 million unique patients have been diagnosed with and treated for HS between 2016 and 2023 alone, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity projected to reach $15bn by 2035. Onset typically occurs in early adulthood and HS has a profound negative impact on quality of life, with a higher morbidity than other dermatologic conditions. There is increasing scientific evidence to support IL-17A- and IL-17F-mediated inflammation as a key driver of the pathogenesis of HS, with other identified risk factors including genetics, cigarette smoking, and obesity. About the IZAR Program IZAR-1 (NCT06641076) and IZAR-2 (NCT06641089) are global, randomized, double-blind, placebo-controlled Phase 3 trials designed to evaluate the efficacy and safety of sonelokimab compared with placebo in a total of approximately 1,500 adults with active psoriatic arthritis (PsA), with a primary endpoint of superiority to placebo in American College of Rheumatology (ACR) 50 response at Week 16. IZAR-1 is expected to enroll biologic-naïve patients and include an evaluation of radiographic progression, while IZAR-2 is expected to enroll patients with an inadequate response to tumor necrosis factor-α inhibitors (TNF-IR) — reflecting patients commonly seen in clinical practice — and is the first PsA trial to include a risankizumab active reference arm. Both trials will also assess a range of secondary endpoints reflecting the multiple disease manifestations characteristic of PsA. These include skin and nail outcomes, multidomain outcomes, and patient-reported outcome measures such as pain and quality of life assessments. Further details are available under NCT06641076 and NCT06641089 at www.clinicaltrials.gov. About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, progressive and complex inflammatory disease that manifests across multiple domains, leading to substantial functional impairment and decreased quality of life. The clinical features of PsA are diverse, comprising both musculoskeletal (peripheral arthritis, spondylitis, dactylitis, and enthesitis) and non-musculoskeletal (skin and nail disease) domains. PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology. About the S-OLARIS trial S-OLARIS is an open-label Phase 2 proof-of-concept trial aiming to investigate sonelokimab 60mg administered subcutaneously in approximately 25 patients with active axial spondyloarthritis (axSpA). The primary endpoint is the change from baseline (CfB) at week 12 in the uptake of 18F-NaF in the sacroiliac joints and spine using PET in combination with MRI imaging. Throughout the trial, several other endpoints will be assessed including established clinical disease activity outcomes (e.g., ASAS), scores related to physical function, spinal mobility, and enthesitis as well as patient reported outcomes. The trial also includes an exploratory peripheral blood and tissue biomarker program. About Axial Spondyloarthritis Axial Spondyloarthritis (axSpA) typically impacts young people, with diagnosis based on chronic inflammatory back pain lasting more than three months with onset under 45 years of age. Advanced disease can lead to progressive and pathologic bone formation and joint fusion, severely limiting spinal mobility. Global reported prevalence of axSpA ranges from 0.5% to 1.5%. AxSpA can be categorized by disease progression into two subtypes: non-radiographic axSpA and ankylosing spondylitis (AS), also known as radiographic axSpA, which is diagnosed based on radiographic evidence of structural changes to the sacroiliac joints. Patients with axSpA experience fatigue, persistent morning stiffness, and pain that worsens at night and can disrupt sleep. Many patients also face the burden of comorbidities such as psoriatic arthritis and psoriasis. Studies have found elevated IL-17 levels in the blood and synovial fluid of patients with axSpA, and IL-17A and IL-17F are both thought to be key contributors to pathogenesis across the spondyloarthropathies. About the LEDA Trial The LEDA trial is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 120mg administered subcutaneously in adult patients with palmoplantar pustulosis (PPP). The primary endpoint of the trial is percent change from baseline in Palmoplantar Psoriasis Area and Severity Index (ppPASI) with important secondary endpoints including ppPASI75 (at least 75% improvement in the ppPASI). The LEDA trial features an innovative translational research program using peripheral blood and tissue biomarkers as trial controls. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 MIRA trial in hidradenitis suppurativa, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. About Palmoplantar Pustulosis Palmoplantar Pustulosis (PPP) is characterized by the development of blister-like pustules within erythematous, scaly plaques on the palms and the soles of the feet. PPP typically develops in adulthood, more frequently impacts females. Patients frequently experience significant pain, burning, and itching sensations on the palms and soles of the feet which can be debilitating and impair their ability to work, sleep, or perform other activities of daily living. Currently, the treatment of PPP is challenging with a significant unmet need for novel therapies to reduce the symptom burden for patients. Evidence suggests that activation of the IL-17 pathway has an important role in disease pathophysiology. Cautionary Statement Regarding Forward Looking Statements This press release contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the anticipated timing of clinical trials and timing of the results from those trials, the anticipated timing of filing of a BLA in the United States; outcomes of discussions with regulatory authorities, the efficacy and safety of sonelokimab for the treatment of adult HS, adolescent HS, axSpA, PsA and PPP, including in comparison to existing standards or care or other competing therapies, clinical trials and research and development programs; potential market opportunities for sonelokimab; and MoonLake’s anticipated cash position. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that interim data analyses conducted prior to database lock and based on a limited number of patients having reached the relevant time point are not consistent with final data, risks and uncertainties associated with MoonLake’s business in general and limited operating history, difficulty enrolling patients in clinical trials, state and federal healthcare reform measures that could result in reduced demand for MoonLake’s product candidates and reliance on third parties to conduct and support its preclinical studies and clinical trials and the other risks described in or incorporated by reference into MoonLake’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent filings with the Securities and Exchange Commission. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based. Contacts: MoonLake Immunotherapeutics Media & Investors Relations [email protected] ICR Healthcare Mary-Jane Elliott, Namrata Taak, Ashley Tapp Tel: +44 (0) 20 3709 5700 [email protected] MOONLAKE IMMUNOTHERAPEUTICS CONDENSED CONSOLIDATED BALANCE SHEETS MOONLAKE IMMUNOTHERAPEUTICS CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited)

Phase 3 VELA program in hidradenitis suppurativa (HS) on track for an expected primary endpoint readout around September 2025 and an expected submission of a Biologic License Application (BLA) in the United States in mid-2026 Other clinical trials of sonelokimab in palmoplantar pustulosis (PPP), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA) and adolescent HS progressing well and expected to support a catalyst-rich roadmap over the next 12 months Ended the second quarter with $425.1 million in cash, cash equivalents and short-term marketable debt securities with up to an additional $425 million in non-dilutive funds remaining accessible through previously announced debt-facility ZUG, Switzerland, August 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 second quarter of 2025. Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “Q2 has been another strong quarter for MoonLake. We narrowed guidance for the timing of the primary endpoint readout for our pivotal Phase 3 VELA program in HS to around September and look forward to submitting the data for presentation at a key scientific congress in the fourth quarter of this year. Additionally, we delivered an earlier-than-expected interim readout of the Phase 2 LEDA trial in PPP, which provides further validation on the potential of sonelokimab, which we believe derisks the overall development of the asset. Our commitment to delivering real-world benefits to patients remains unwavering and we look forward to a critical quarter ahead with significant milestones expected.” Q2 highlights (including post-period end): Announced non-dilutive financing with Hercules Capital of up to $500 million in committed non-dilutive capital, extending the expected cash runway into 2028 and providing funding for the next steps of the Company’s growth, including the expected launch of sonelokimab in 2027, additional clinical trials and further investments for growth Conducted a Capital Markets Update both in-person in New York and virtually, which provided: Details on the up to $500 million non-dilutive financing agreement with Hercules Capital, which strengthens the Company’s financial position and supports the clinical and commercial objectives while preserving shareholder value Baseline characteristics of the Phase 3 VELA program and its comparability to the Phase 2 MIRA trial and other competitor trials, as well as narrowed guidance with respect to the timing of the primary endpoint readout An earlier-than-expected interim readout of the Phase 2 LEDA trial, the first clinical trial in PPP for an IL-17A and IL-17F inhibitor, which we believe further derisks the overall development of the asset and highlights the potential of sonelokimab in the evolving PPP market Views on market opportunities featuring insights from recent data analyses, competitor performance and strategic imperatives for the Company • Shared data from the Phase 2 ARGO trial in PsA with the rheumatology community at the European Congress of Rheumatology (EULAR) in Barcelona, Spain Second quarter 2025 financial results As of June 30, 2025, MoonLake held cash, cash equivalents and short-term marketable debt securities of $425.1 million. Research and development expenses for the quarter ended June 30, 2025, were $49.8 million, compared to $36.5 million in the previous quarter. The increase of $13.3 million was driven by increases in expenses with contract research organizations and contract manufacturing organizations, as well as consulting expenses and personnel-related costs, all to support the further ramp-up of MoonLake's clinical trials and preparations for the anticipated submission of the BLA for sonelokimab in mid-2026. General and administrative expenses for the quarter ended June 30, 2025 were $10.9 million, similar to the $11.0 million incurred in the previous quarter. Matthias Bodenstedt, Chief Financial Officer at MoonLake Immunotherapeutics, said: “MoonLake is in a robust financial position as we approach our first Phase 3 data readout for HS. The $500 million non-dilutive financing from Hercules Capital has significantly bolstered our cash position and enables us to confidently fund the launch of sonelokimab in 2027. This strengthened financial position also enables us to advance additional clinical trials and make further strategic investments to support our continued growth. With this solid backing, MoonLake is well positioned to deliver future value.” Important upcoming anticipated milestones for MoonLake: Around September 2025: R&D Day to present top-line results for the HS Phase 3 VELA program Q4 2025: Primary endpoint readout of the Phase 2 LEDA trial in PPP Q1 2026: Primary endpoint readout of the Phase 2 S-OLARIS trial in axSpA H1 2026: Primary endpoint readout of Phase 3 VELA-TEEN trial in adolescent HS H1 2026: Primary endpoint readout of Phase 2 IZAR trial in PsA Upcoming investor and medical conferences: European Academy of Dermatology and Venerology (EADV): 17-20 September, Paris, France Fall Clinical Dermatology Conference, 23-26 October, Las Vegas, US American Academy of Rheumatology (ACR): 24-29 October, Chicago, US Symposium on HS Advances (SHSA): 31 October - 2 November, Nashville, US Guggenheim 2nd Annual Healthcare Innovation Conference, 10-12 November, Boston, US Inflammatory Skin Disease Summit (ISDS): 12-15 November, New York, US Jefferies London Healthcare Conference, 17-20 November, London, UK Citi Annual Global Healthcare Conference, 2-4 December, Miami, US 8th Annual Evercore Healthcare Conference, 2-4 December, Coral Gables, Florida, US HS Academy, 5-7 December, Charlotte, US -Ends- About MoonLake Immunotherapeutics MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The Company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com. About Nanobodies® Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations. The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company. About Sonelokimab Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHHs covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema. Sonelokimab is being assessed in two lead indications, hidradenitis suppurativa (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology, including adolescent HS, palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA). For adults with HS, sonelokimab is being assessed in the Phase 3 trials, VELA-1 and VELA-2, following the successful outcome of MoonLake’s end-of-Phase 2 interactions with the FDA and as well as positive feedback from its interactions with the EMA announced in February 2024. In June 2023, topline results of the MIRA trial (NCT05322473) at 12 weeks showed that the trial met its primary endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR) 75, which is a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials, setting a landmark milestone. In October 2023, the full dataset from the MIRA trial at 24 weeks showed that maintenance treatment with sonelokimab led to further improvements in HiSCR75 response rates and other high threshold clinical and patient relevant outcomes. The safety profile of sonelokimab in the MIRA trial was consistent with previous trials with no new safety signals detected. Sonelokimab is currently undergoing evaluation in the VELA-TEEN Phase 3 trial, which is the first clinical study specifically focused on adolescent patients with moderate-to-severe HS. For PsA, sonelokimab is being assessed in the Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201) evaluating the efficacy and safety of the Nanobody® sonelokimab over 24 weeks in patients with active PsA. Significant improvements were observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an American College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an ACR50 response compared to those on placebo at week 12. All key secondary endpoints in the trial were met for the 60mg and 120mg doses with induction. The safety profile of sonelokimab in the ARGO trial was consistent with previous trials with no new safety signals detected. Sonelokimab is also being assessed in the Phase 2 LEDA trial, which is ongoing for PPP, a debilitating inflammatory skin condition affecting a significant number of patients. Additionally, Sonelokimab is being assessed in the ongoing Phase 2 S-OLARIS trial for active axSpA. The trial features an innovative design complementing traditional clinical outcomes with cellular imaging techniques. Sonelokimab has also been assessed in a randomized, placebo-controlled third-party Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575). In an earlier third-party Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196–203). About the VELA program The Phase 3 VELA program is expected to enroll 800 patients across VELA-1 (NCT0641189) and VELA-2 (NCT06411379). Both global, randomized, double-blind, and placebo-controlled trials are identical in design evaluating the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe hidradenitis suppurativa. Similar to the design of the landmark Phase 2 MIRA trial, the primary endpoint is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75, defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trials will also evaluate a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total reduction of ≥4, the proportion of patients achieving at least 50% reduction from baseline in Numerical Rating Scale (NRS50) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain) and complete resolution of Draining Tunnels (DT100). Further details are available under NCT06411899 and NCT06411379 at www.clinicaltrials.gov. About the VELA-TEEN trial The Phase 3 VELA-TEEN trial is an open-label, single-arm trial designed to evaluate sonelokimab 120mg administered subcutaneously once every two weeks (Q2W) until week six and once every four weeks (Q4W) from week eight onwards. The trial aims to enroll 30-40 adolescents, aged 12-17, with moderate-to-severe hidradenitis suppurativa, from U.S. sites experienced in clinical trials and pediatric dermatology. The primary trial phase will be 24 weeks with a primary endpoint evaluating the pharmacokinetics, safety, and tolerability of sonelokimab. VELA-TEEN will also evaluate several secondary endpoints, including the proportion of patients achieving the higher clinical response measure of the Hidradenitis Suppurativa Clinical Response Score (HiSCR) 75, in addition to HiSCR50. Other outcomes are the change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4), which includes the quantitative measure of draining tunnels, and the proportion of patients achieving a meaningful reduction of the Children’s Dermatology Life Quality Index (CDLQI) and the Patients Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under NCT06768671 at www.clinicaltrials.gov. About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects an estimated 2% of the population, with three times more females affected than males. Real-world data in the United States indicates that at least 2 million unique patients have been diagnosed with and treated for HS between 2016 and 2023 alone, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity projected to reach $15bn by 2035. Onset typically occurs in early adulthood and HS has a profound negative impact on quality of life, with a higher morbidity than other dermatologic conditions. There is increasing scientific evidence to support IL-17A- and IL-17F-mediated inflammation as a key driver of the pathogenesis of HS, with other identified risk factors including genetics, cigarette smoking, and obesity. About the IZAR Program IZAR-1 (NCT06641076) and IZAR-2 (NCT06641089) are global, randomized, double-blind, placebo-controlled Phase 3 trials designed to evaluate the efficacy and safety of sonelokimab compared with placebo in a total of approximately 1,500 adults with active psoriatic arthritis (PsA), with a primary endpoint of superiority to placebo in American College of Rheumatology (ACR) 50 response at Week 16. IZAR-1 is expected to enroll biologic-naïve patients and include an evaluation of radiographic progression, while IZAR-2 is expected to enroll patients with an inadequate response to tumor necrosis factor-α inhibitors (TNF-IR) — reflecting patients commonly seen in clinical practice — and is the first PsA trial to include a risankizumab active reference arm. Both trials will also assess a range of secondary endpoints reflecting the multiple disease manifestations characteristic of PsA. These include skin and nail outcomes, multidomain outcomes, and patient-reported outcome measures such as pain and quality of life assessments. Further details are available under NCT06641076 and NCT06641089 at www.clinicaltrials.gov. About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, progressive and complex inflammatory disease that manifests across multiple domains, leading to substantial functional impairment and decreased quality of life. The clinical features of PsA are diverse, comprising both musculoskeletal (peripheral arthritis, spondylitis, dactylitis, and enthesitis) and non-musculoskeletal (skin and nail disease) domains. PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology. About the S-OLARIS trial S-OLARIS is an open-label Phase 2 proof-of-concept trial aiming to investigate sonelokimab 60mg administered subcutaneously in approximately 25 patients with active axial spondyloarthritis (axSpA). The primary endpoint is the change from baseline (CfB) at week 12 in the uptake of 18F-NaF in the sacroiliac joints and spine using PET in combination with MRI imaging. Throughout the trial, several other endpoints will be assessed including established clinical disease activity outcomes (e.g., ASAS), scores related to physical function, spinal mobility, and enthesitis as well as patient reported outcomes. The trial also includes an exploratory peripheral blood and tissue biomarker program. About Axial Spondyloarthritis Axial Spondyloarthritis (axSpA) typically impacts young people, with diagnosis based on chronic inflammatory back pain lasting more than three months with onset under 45 years of age. Advanced disease can lead to progressive and pathologic bone formation and joint fusion, severely limiting spinal mobility. Global reported prevalence of axSpA ranges from 0.5% to 1.5%. AxSpA can be categorized by disease progression into two subtypes: non-radiographic axSpA and ankylosing spondylitis (AS), also known as radiographic axSpA, which is diagnosed based on radiographic evidence of structural changes to the sacroiliac joints. Patients with axSpA experience fatigue, persistent morning stiffness, and pain that worsens at night and can disrupt sleep. Many patients also face the burden of comorbidities such as psoriatic arthritis and psoriasis. Studies have found elevated IL-17 levels in the blood and synovial fluid of patients with axSpA, and IL-17A and IL-17F are both thought to be key contributors to pathogenesis across the spondyloarthropathies. About the LEDA Trial The LEDA trial is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 120mg administered subcutaneously in adult patients with palmoplantar pustulosis (PPP). The primary endpoint of the trial is percent change from baseline in Palmoplantar Psoriasis Area and Severity Index (ppPASI) with important secondary endpoints including ppPASI75 (at least 75% improvement in the ppPASI). The LEDA trial features an innovative translational research program using peripheral blood and tissue biomarkers as trial controls. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 MIRA trial in hidradenitis suppurativa, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. About Palmoplantar Pustulosis Palmoplantar Pustulosis (PPP) is characterized by the development of blister-like pustules within erythematous, scaly plaques on the palms and the soles of the feet. PPP typically develops in adulthood, more frequently impacts females. Patients frequently experience significant pain, burning, and itching sensations on the palms and soles of the feet which can be debilitating and impair their ability to work, sleep, or perform other activities of daily living. Currently, the treatment of PPP is challenging with a significant unmet need for novel therapies to reduce the symptom burden for patients. Evidence suggests that activation of the IL-17 pathway has an important role in disease pathophysiology. Cautionary Statement Regarding Forward Looking Statements This press release contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the anticipated timing of clinical trials and timing of the results from those trials, including the Phase 3 VELA trials in adult HS, the Phase 3 VELA-TEEN trial in adolescent HS, the Phase 3 IZAR trials in PsA, the Phase 2 LEDA trial in PPP and the Phase 2 S-OLARIS trial in axSpA; the anticipated timing of filing of a BLA in the United States; the efficacy and safety of sonelokimab for the treatment of adult HS, adolescent HS, axSpA, PsA and PPP, including in comparison to existing standards or care or other competing therapies, clinical trials and research and development programs; potential market opportunities for sonelokimab; and MoonLake’s anticipated cash position. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLake’s business in general and limited operating history, difficulty enrolling patients in clinical trials, state and federal healthcare reform measures that could result in reduced demand for MoonLake’s product candidates, reliance on third parties to conduct and support its preclinical studies and clinical trials, the impact of general economic, health, industrial or political conditions in the United States or internationally, including recently announced tariffs and potential additional tariffs, FDA and comparable foreign regulatory authorities changes in leadership or policies or issuing additional regulations or revising existing regulations, and the other risks described in or incorporated by reference into MoonLake’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent filings with the Securities and Exchange Commission, including MoonLake’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based. Contacts: MoonLake Immunotherapeutics Media & Investors Relations Carla Bretes, Director IR & External Communications [email protected] ICR Healthcare Mary-Jane Elliott, Namrata Taak, Ashley Tapp Tel: +44 (0) 20 3709 5700 [email protected] MOONLAKE IMMUNOTHERAPEUTICS CONDENSED CONSOLIDATED BALANCE SHEETS MOONLAKE IMMUNOTHERAPEUTICS CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited)

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 program) and disclosed baseline characteristics, replicating the Phase 2 MIRA trial Presented an interim readout of the Phase 2 LEDA study in PPP, highlighting the potential of sonelokimab in an indication with currently no approved therapeutics in the US and Europe, and further derisking the overall development of sonelokimab Ended the first quarter with $480.1 million in cash, cash equivalents and short-term marketable debt securities and announced closing of a debt facility, providing up to $500 million in non-dilutive funds and extending expected cash runway into 2028 ZUG, Switzerland, May 12, 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 first quarter of 2025. Matthias Bodenstedt, Chief Financial Officer of MoonLake Immunotherapeutics, said: “We continue executing across our portfolio of indications with quality, speed and efficiency. Having enrolled our Phase 3 VELA program with a patient population that mirrors our Phase 2 MIRA trial further increases our confidence in the primary endpoint data which we expect to present around September 2025. The interim readout in PPP opens up another potential blockbuster indication in dermatology with a significant unmet need, and also our trials in rheumatology are progressing well. The non-dilutive facility with Hercules Capital of up to $500 million in committed capital adds to our already strong balance sheet and extends our projected cash runway into 2028, which is expected to provide us with protection from a currently volatile market and retain value for existing shareholders." Q1 highlights (including post-period end): Initiated three new trials in the beginning of 2025 with the Nanobody® sonelokimab: Phase 3 VELA-TEEN trial in adolescent HS, Phase 2 LEDA trial in PPP and Phase 2 S-OLARIS trial in axSpA. Announced up to $500 million non-dilutive financing agreement with Hercules Capital Inc. (NYSE:HTGC), a leader in customized debt financing for companies in the life sciences and technology-related markets, for up to $500 million in non-dilutive capital, of which $75 million was drawn down at close and additional tranches will become available upon achievement of certain pre-specified milestones that are aligned with MoonLake’s strategy and funding needs. Held an in-person and virtual Capital Markets Update in New York on Tuesday, April 29, 2025 where we: Confirmed the baseline characteristics of the VELA program with the Nanobody® sonelokimab in HS and its comparability to Phase 2 MIRA and other competitor trials following the conclusion of patient recruitment and provided narrowed guidance with respect to the timing of the primary endpoint readout Announced an earlier-than-expected interim readout of the LEDA study, highlighting the potential of sonelokimab in the evolving PPP market and further derisking the overall development of the asset First quarter 2025 financial results As of March 31, 2025, MoonLake held cash, cash equivalents and short-term marketable debt securities of $480.1 million. Research and development expenses for the quarter ended March 31, 2025, were $36.5 million, similar to the $40.4 million in the previous quarter. General and administrative expenses for the quarter ended March 31, 2025 were $11.0 million, compared to the $9.2 million incurred in the previous quarter. The increase was primarily due to personnel-related costs to support organizational growth and legal and advisory fees incurred to negotiate the non-dilutive debt facility. Important upcoming anticipated milestones for MoonLake: Initiation of Phase 2 P-OLARIS trial of Nanobody® sonelokimab in PsA and axSpA (mid 2025) Top line results for Phase 3 VELA program for the Nanobody® sonelokimab in HS (around September 2025) Primary end point readout from the Phase 2 LEDA trial, the first clinical trial in PPP for an IL-17A and IL-17F inhibitor (2H 2025) Upcoming investor and medical conferences: Jefferies Global Healthcare Conference, June 3-5, New York Goldman Sachs Annual Global Healthcare Conference, June 10-13, Miami EULAR 2025 (European Congress of Rheumatology), June 11-14, Barcelona Leerink Partners Therapeutics Forum, July 8-9, Boston GRAPPA Annual Meeting, July, 10-12, Bogotá, Colombia -Ends- About MoonLake Immunotherapeutics MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The Company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com. About Nanobodies® Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations. The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company. About Sonelokimab Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHHs covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema. Sonelokimab is being assessed in two lead indications, hidradenitis suppurative (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology, including adolescent HS, palmo-plantar pustulosis (PPP) and axial spondyloarthritis (axSpA). For adults with HS, sonelokimab is being assessed in the Phase 3 trials, VELA-1 and VELA-2, following the successful outcome of MoonLake’s end-of-Phase 2 interactions with the FDA and as well as positive feedback from its interactions with the EMA announced in February 2024. In June 2023, topline results of the MIRA trial (NCT05322473) at 12 weeks showed that the trial met its primary endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR) 75, which is a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials, setting a landmark milestone. In October 2023, the full dataset from the MIRA trial at 24 weeks showed that maintenance treatment with sonelokimab led to further improvements in HiSCR75 response rates and other high threshold clinical and patient relevant outcomes. The safety profile of sonelokimab in the MIRA trial was consistent with previous trials with no new safety signals detected. Sonelokimab is currently undergoing evaluation in the VELA-TEEN Phase 3 trial, which is the first clinical study specifically focused on adolescent patients with moderate-to-severe HS. For PsA, sonelokimab is being assessed in the Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201) evaluating the efficacy and safety of the Nanobody® sonelokimab over 24 weeks in patients with active PsA. Significant improvements were observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an American College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an ACR50 response compared to those on placebo at week 12. All key secondary endpoints in the trial were met for the 60mg and 120mg doses with induction. The safety profile of sonelokimab in the ARGO trial was consistent with previous trials with no new safety signals detected. Sonelokimab is also being assessed in the Phase 2 LEDA trial, which is ongoing for PPP, a debilitating inflammatory skin condition affecting a significant number of patients. Additionally, Sonelokimab is being assessed in the ongoing Phase 2 S-OLARIS trial for active axSpA. The trial features an innovative design complementing traditional clinical outcomes with cellular imaging techniques. Sonelokimab has also been assessed in a randomized, placebo-controlled third-party Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575). In an earlier third-party Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196–203). About the VELA program The Phase 3 VELA program is expected to enroll 800 patients across VELA-1 and VELA-2. Both global, randomized, double-blind, and placebo-controlled trials are identical in design evaluating the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe hidradenitis suppurativa. Similar to the design of the landmark Phase 2 MIRA trial, the primary endpoint is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75, defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trials will also evaluate a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total reduction of ≥4, the proportion of patients achieving at least 50% reduction from baseline in Numerical Rating Scale (NRS50) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain) and complete resolution of Draining Tunnels (DT100). Further details are available under NCT06411379 and NCT06411899 at ClinicalTrials.gov. About the VELA-TEEN trial The Phase 3 VELA-TEEN trial is an open-label, single-arm trial designed to evaluate sonelokimab 120mg administered subcutaneously once every two weeks (Q2W) until week six and once every four weeks (Q4W) from week eight onwards. The trial aims to enroll 30-40 adolescents, aged 12-17, with moderate-to-severe hidradenitis suppurativa, from U.S. sites experienced in clinical trials and pediatric dermatology. The primary trial phase will be 24 weeks with a primary endpoint evaluating the pharmacokinetics, safety, and tolerability of sonelokimab. VELA-TEEN will also evaluate several secondary endpoints, including the proportion of patients achieving the higher clinical response measure of the Hidradenitis Suppurativa Clinical Response Score (HiSCR) 75, in addition to HiSCR50. Other outcomes are the change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4), which includes the quantitative measure of draining tunnels, and the proportion of patients achieving a meaningful reduction of the Children’s Dermatology Life Quality Index (CDLQI) and the Patients Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under NCT06768671 at ClinicalTrials.gov. About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects an estimated 2% of the population, with three times more females affected than males. Real-world data in the US indicates that at least 2 million unique patients have been diagnosed with and treated for HS between 2016 and 2023 alone, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity projected to reach $15bn by 2035. Onset typically occurs in early adulthood and HS has a profound negative impact on quality of life, with a higher morbidity than other dermatologic conditions. There is increasing scientific evidence to support IL-17A- and IL-17F-mediated inflammation as a key driver of the pathogenesis of HS, with other identified risk factors including genetics, cigarette smoking, and obesity. About the IZAR Program IZAR-1 (NCT06641076) and IZAR-2 (NCT06641089) are global, randomized, double-blind, placebo-controlled Phase 3 trials designed to evaluate the efficacy and safety of sonelokimab compared with placebo in a total of approximately 1,500 adults with active psoriatic arthritis (PsA), with a primary endpoint of superiority to placebo in American College of Rheumatology (ACR) 50 response at Week 16. IZAR-1 is expected to enroll biologic-naïve patients and include an evaluation of radiographic progression, while IZAR-2 is expected to enroll patients with an inadequate response to tumor necrosis factor-α inhibitors (TNF-IR) — reflecting patients commonly seen in clinical practice — and is the first PsA trial to include a risankizumab active reference arm. Both trials will also assess a range of secondary endpoints reflecting the multiple disease manifestations characteristic of PsA. These include skin and nail outcomes, multidomain outcomes, and patient-reported outcome measures such as pain and quality of life assessments. Further details are available under NCT06641076 and NCT06641089 at ClinicalTrials.gov. About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, progressive and complex inflammatory disease that manifests across multiple domains, leading to substantial functional impairment and decreased quality of life. The clinical features of PsA are diverse, comprising both musculoskeletal (peripheral arthritis, spondylitis, dactylitis, and enthesitis) and non-musculoskeletal (skin and nail disease) domains. PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology. About the S-OLARIS trial S-OLARIS is an open-label Phase 2 proof-of-concept trial aiming to investigate sonelokimab 60mg administered subcutaneously in approximately 25 patients with active axial spondylarthritis (axSpA). The primary endpoint is the change from baseline (CfB) at week 12 in the uptake of 18F-NaF in the sacroiliac joints and spine using PET in combination with MRI imaging. Throughout the trial, several other endpoints will be assessed including established clinical disease activity outcomes (e.g., ASAS), scores related to physical function, spinal mobility, and enthesitis as well as patient reported outcomes. The trial also includes an exploratory peripheral blood and tissue biomarker program. About Axial Spondyloarthritis Axial Spondyloarthritis (axSpA) typically impacts young people, with diagnosis based on chronic inflammatory back pain lasting more than three months with onset under 45 years of age. Advanced disease can lead to progressive and pathologic bone formation and joint fusion, severely limiting spinal mobility. Global reported prevalence of axSpA ranges from 0.5% to 1.5%. AxSpA can be categorized by disease progression into two subtypes: non-radiographic axSpA and ankylosing spondylitis (AS), also known as radiographic axSpA, which is diagnosed based on radiographic evidence of structural changes to the sacroiliac joints. Patients with axSpA experience fatigue, persistent morning stiffness, and pain that worsens at night and can disrupt sleep. Many patients also face the burden of comorbidities such as psoriatic arthritis and psoriasis. Studies have found elevated IL-17 levels in the blood and synovial fluid of patients with axSpA, and IL-17A and IL-17F are both thought to be key contributors to pathogenesis across the spondyloarthropathies. About the LEDA Trial The LEDA trial is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 120mg administered subcutaneously in adult patients with palmoplantar pustulosis (PPP). The primary endpoint of the trial is percent change from baseline in Palmoplantar Psoriasis Area and Severity Index (ppPASI) with important secondary endpoints including ppPASI75 (at least 75% improvement in the ppPASI). The LEDA trial features an innovative translational research program using peripheral blood and tissue biomarkers as trial controls. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 MIRA trial in hidradenitis suppurativa, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. About Palmoplantar Pustulosis Palmoplantar Pustulosis (PPP) is characterized by the development of blister-like pustules within erythematous, scaly plaques on the palms and the soles of the feet. PPP typically develops in adulthood, more frequently impacts females. Patients frequently experience significant pain, burning, and itching sensations on the palms and soles of the feet which can be debilitating and impair their ability to work, sleep, or perform other activities of daily living. Currently, the treatment of PPP is challenging with a significant unmet need for novel therapies to reduce the symptom burden for patients. Evidence suggests that activation of the IL-17 pathway has an important role in disease pathophysiology. Cautionary Statement Regarding Forward Looking Statements This press release contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: trial design, plans for and timing of clinical trials, including initiation of the Phase 2 P-OLARIS trial; the efficacy and safety of sonelokimab for the treatment of adult HS, adolescent HS, PPP, PsA and axSpA, including in comparison to existing standards or care or other competing therapies, clinical trials and research and development programs; the anticipated timing of the results from those studies and trials, including timing of topline results from the Phase 3 VELA program and primary endpoint readout from the Phase 2 LEDA trial; potential market opportunities for sonelokimab and MoonLake’s anticipated cash position. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLake’s business in general and limited operating history, difficulty enrolling patients in clinical trials, state and federal healthcare reform measures that could result in reduced demand for MoonLake’s product candidates, reliance on third parties to conduct and support its preclinical studies and clinical trials, the impact of general economic, health, industrial or political conditions in the United States or internationally, including recently announced tariffs and potential additional tariffs, FDA and comparable foreign regulatory authorities changes in leadership or policies or issuing additional regulations or revising existing regulations, and the other risks described in or incorporated by reference into MoonLake’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent filings with the Securities and Exchange Commission, including MoonLake’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based. Contacts: MoonLake Immunotherapeutics Media & Investors Relations Carla Bretes, Director IR & External Communications [email protected] ICR Healthcare Mary-Jane Elliott, Namrata Taak, Ashley Tapp Tel: +44 (0) 20 3709 5700 [email protected] MOONLAKE IMMUNOTHERAPEUTICS CONDENSED CONSOLIDATED BALANCE SHEETS MOONLAKE IMMUNOTHERAPEUTICS CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited)