Spherocytosis, Hereditary

ZUG, Switzerland I April 3, 2025 I MoonLake Immunotherapeutics (MoonLake; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced that it has entered into an 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 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. The additional capital strengthens MoonLake’s balance sheet and provides financial support to rapidly advance sonelokimab and bring to market an investigational ~40 kDa humanized Nanobody® designed to directly target sites of inflammation by inhibiting all relevant IL-17 dimers (namely the IL-17A/A, IL-17A/F, and IL-17F/F dimers) and penetrating difficult-to-reach inflamed tissues. Matthias Bodenstedt, Chief Financial Officer at MoonLake Immunotherapeutics, said: “We are extremely excited to partner with Hercules Capital that recognizes the value and potential of sonelokimab. We were able to secure deal terms, including a very sizable commitment and a highly competitive cost of capital. This financing facility further bolsters our already robust cash position without diluting our shareholders’ stakes and effectively removes any perceived financing overhang as we approach our pivotal data readout for the HS VELA program this summer.” Bryan Jadot, Group Head and Senior Managing Director at Hercules Capital and John Miotti, Principal at Hercules Capital . added: “We are thrilled to partner with MoonLake Immunotherapeutics and support their mission of improving treatment outcomes for patients living with inflammatory diseases. This transaction highlights our commitment to empowering biotech companies as they navigate the critical path from clinical trials to market success” Capital Markets Update The Company plans to further discuss how the new facility provides financial and operational strength over the coming years and how it impacts its broader financing strategy, and plans to discuss important clinical updates, at an in-person and virtual Capital Markets Update on Tuesday, April 29, 2025 in New York. Further details will be announced closer to the date. Current Trials and Upcoming Data Readouts MoonLake is rapidly progressing a total of eight Phase 2 and Phase 3 clinical trials, plus other ancillary trials and expects to read out pivotal Phase 3 data for HS as of mid-2025. In the upcoming Capital Markets Update, the Company expects to share details on patient baseline characteristics for the VELA program and narrowed guidance with respect to the timing of the primary endpoint read-out, following screening of the last patients. MoonLake also anticipates sharing an interim read out from the Phase 2 LEDA trial of sonelokimab in palmoplantar pustulosis (PPP), the first clinical trial in PPP for an IL-17A and IL-17F inhibitor. Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said : “The new $500 million facility further strengthens our financial position. With this facility and existing cash balance, we are in control of our financing strategy, and we can drive the advancement of sonelokimab in multiple indications, while building our commercial readiness activities including in the United States. I am confident that narrowed guidance on the VELA primary endpoint readout and the presentation of baseline characteristics will continue to demonstrate our ability to execute and further validate the expectations on sonelokimab. I am very glad that the PPP Phase 2 LEDA trial recruited much faster than anticipated and that we will be able to share data with the market sooner than expected. This will further contribute to building the position of sonelokimab as a high-potential, multi-indication asset that can truly change the lives of patients.” Leerink Partners served as exclusive financial advisor to MoonLake on the term loan financing. Gibson, Dunn & Crutcher LLP and Kellerhals Carrard, served as legal counsel to the Company. DLA Piper LLP and Schellenberg Wittmer served as legal counsel to Hercules Capital. – 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 variable regions of heavy-chain-only antibodies domains (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, 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 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. SOURCE: MoonLake Immunotherapeutics

Over half of patients had no draining tunnels (DTs) at two years: In 425 hidradenitis suppurativa (HS) patients with ≥1 DTs at baseline, 55.7% (195/350) had no DTs at two years of treatment.≠ DTs are painful, pus-discharging tunnels under the skin resulting from long-term inflammation, frequently leading to scarring Clinically meaningful relief from skin pain: At two years of BIMZELX treatment, 63.6% (279/439) of patients reported no or mild skin pain, compared to 10.0% (55/551) at baseline≠ Sustained disease control across patient populations: Improvements in HiSCR50* and HiSCR75* sustained up to two years, regardless of age, sex, disease duration or severity, demonstrating efficacy regardless of patient demographics≠ Improved responses with earlier treatment: Patients demonstrated efficacy at high HiSCR90* and HiSCR100* thresholds, and those who had a shorter duration from diagnosis to treatment had better outcomes, emphasizing the importance of early diagnosis and early treatment≠ ATLANTA, March 7, 2025 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced two-year data from the BE HEARD^ trials for BIMZELX® (bimekizumab-bkzx) in moderate-to-severe hidradenitis suppurativa (HS). BIMZELX, the first and only medicine approved to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),1 continues to demonstrate sustained disease control and durable relief from key HS symptoms, including the potential to help prevent long-term structural damage caused by draining tunnels (DTs).2-7 "Draining tunnels cause debilitating symptoms such as pain and malodorous discharge, and can often result in irreversible scarring," said Christopher Sayed, MD, University of North Carolina, Chapel Hill. "These exciting results reveal that treatment with bimekizumab-bkzx reduces draining tunnels and the associated disease burden in patients with moderate-to-severe HS." Among patients with one or more DTs at baseline, the proportion who had 1–2, 3–5, or >5 DTs at two years were 26.6% (93/350), 11.1% (39/350), and 6.6% (23/350) respectively. In addition, 55.7% (195/350) had no DTs at two years.2 In a subgroup of patients with ≥5 DTs at baseline, 41.1% (62/151) had no DTs at two years.2 The majority of patients with HS experience disease-associated pain, a highly burdensome symptom that negatively impacts their quality of life.8-10 In addition to a reduction in clinical severity of skin pain with BIMZELX, measured by Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) skin pain scores, the proportion of patients reporting no impact on their Health Related Quality of Life (HRQoL) due to pain, based on HiSQOL pain item score increased from 2.7% (15/551) at baseline to 44.6% (196/439) at two years.3 BIMZELX was well tolerated over two years, with no new safety signals observed in the second year.5∞ "This new long-term data underscores UCB's dedication to improving outcomes for people with HS, by providing a treatment option that offers sustainable clinical improvements while helping to prevent the long-term structural damage associated with draining tunnels," said Fiona du Monceau, Executive Vice President, Head of Patient Evidence, UCB. "The substantial and sustained clinical improvements addressing a wide range of HS symptoms across broad patient populations highlights bimekizumab-bkzx's potential to address the unmet needs of people living with HS." UCB's data in HS will be presented as seven posters at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida, March 7-11.2-7,11 These abstracts complement other BIMZELX data presented at AAD in moderate-to-severe plaque psoriasis,12-17 psoriatic arthritis,18-20 ankylosing spondylitis, and non-radiographic axial spondyloarthritis,21,22 emphasizing UCB's leadership in addressing unmet health needs for people living with immune-mediated inflammatory diseases. The U.S. Food and Drug Administration (FDA) approved BIMZELX® (bimekizumab-bkzx) for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS) in November 2024. ^Further results from the BE HEARD trials evaluating the efficacy and safety profile of BIMZELX will be presented later this year. *HiSCR50/HiSCR75/HiSCR90/HiSCR100 is defined as at least a 50%/75%/90%/100% reduction in the total abscess and inflammatory nodule count, from baseline with no increase from baseline in abscess or draining tunnel count. ≠Data are reported as observed case (OC). Patients completing the 48-week BE HEARD I&II studies could enroll in BE HEARD EXT and receive open-label BIMZELX 320 mg every 2 weeks (Q2W) or Q4W based on HiSCR90 response averaged from Weeks 36, 40, and 44. Receiving BIMZELX Q2W to Week 16, then Q4W thereafter is the approved dosing regimen (Q2W/Q4W). Results included patients receiving both Q2W and Q4W after Week 48. ∞The data presented in this paragraph are post-hoc analyses. Results included patients receiving both Q2W and Q4W after Week 48. Notes to Editors: Further detail on selected BIMZELX two-year data in HS presented at AAD 2025: Data were pooled from the BE HEARD I and II studies and BE HEARD EXT. Week 48 completers could enroll in BE HEARD EXT and receive open-label BKZ 320 mg every 2 weeks (Q2W) or every 4 weeks (Q4W) based on ≥90% HS Clinical Response (HiSCR90; averaged from BE HEARD I and II Weeks 36, 40 and 44).2 The approved dosing regimen is 320 mg Q2W up to Week 16 and Q4W thereafter.1 Of the patients randomized to receive BIMZELX who completed Week 48 in the BE HEARD I and II studies, 556 patients entered BE HEARD EXT.23 Over half (55.7%) of patients had no draining tunnels (DTs) at two years : Most patients treated with BIMZELX demonstrated clinically meaningful reductions of DTs at one year, with >50% achieving elimination of DTs at two years.2 In patients with ≥5 DTs at baseline, 32.8% (58/177) had no DTs at Week 48, and 41.1% (62/151) had no DTs at Week 962¥ Clinically meaningful relief from skin pain : Patients treated with BIMZELX demonstrated clinically meaningful reductions in both HS skin pain severity and impact of pain through two years of treatment.3 The proportion of patients reporting severe or very severe pain decreased from 57.9% (319/551) at baseline to 11.4% (50/439) at Week 963¥ Sustained disease control across patient populations : Patients treated with BIMZELX demonstrated efficacy in all subgroups, regardless of age, sex, disease duration or severity, with improvements in HiSCR50 and HiSCR75 maintained over two years.4 Severity was assessed by International Hidradenitis Suppurativa Severity Score System (IHS4), and Hurley Stage.4 Hurley stage is one of the most widely used HS disease severity instruments, which stratifies patients into three stages based on the presence of clinical features such as extent of abscesses and severity of DTs24¥ Improved responses with earlier treatment : Patients treated with BIMZELX demonstrated efficacy at high HiSCR thresholds, in both the highest (≥10.74 years) and lowest (<2.38 years) disease duration quartiles, over two years.7 More patients in the lowest disease duration quartile achieved the stringent HiSCR90 and HiSCR100 thresholds, compared to those in the highest disease duration quartile, emphasizing the importance of early treatment7¥ At two years, HiSCR90 was achieved by 62.6% (72/115) in the lowest disease duration quartile, compared to 48.5% (49/101) in the highest disease duration quartile7 Similarly, at two years HiSCR100 was achieved by 56.5% (65/115) in the lowest disease duration quartile, compared to 30.7% (31/101) in the highest disease duration quartile7 Safety and tolerability: BIMZELX was generally well tolerated in patients with moderate-to-severe HS over two years, with no new safety signals observed in year two.5 Among 1,014 patients enrolled in BE HEARD I and II, 995 BKZ-treated patients, pooled across BE HEARD I and II studies and BE HEARD EXT, were included in this analysis (At year one: N=995; at year two: N=754).5 The most common treatment emergent adverse events (TEAEs) over 2 years were hidradenitis, coronavirus infection, and oral candidiasis5 ¥ Data are reported as observed case (OC). About hidradenitis suppurativa Hidradenitis suppurativa (HS) is a chronic, painful, and debilitating inflammatory skin disease that is associated with systemic manifestations.25,26 The main symptoms are nodules, abscesses, and pus-discharging draining tunnels (or sinus tracts leading out of the skin) which typically occur in the armpits, groin, and buttocks, but can occur anywhere on the body there are hair follicles.25,26 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.25,26 HS develops in early adulthood and affects approximately one percent of the population in most studied countries.25,26 ^ About BE HEARD trials The efficacy and safety profile of BIMZELX was evaluated in adult patients with moderate-to-severe hidradenitis suppurativa (HS) in two multicenter, randomized, double-blind, placebo-controlled Phase 3 studies (BE HEARD I and BE HEARD II).27 The two studies had a combined enrollment of 1,014 participants.27 In each study, patients were randomized 2:2:2:1 (initial [16 weeks]/maintenance [32 weeks]) to BIMZELX 320 mg every two weeks, four weeks or a combination (Q2W/Q2W, BKZQ2W/Q4W, BKZQ4W/Q4W or placebo/BKZQ2W).27 Patients who completed Week 48 could enroll in the open-label extension.23 Of 1,014 total patients, 556 patients randomized at baseline to BIMZELX in BE HEARD I and II completed Week 48 and entered the open-label extension study; 446 patients in the open-label extension study completed Week 96.23 For details about BE HEARD EXT: . About BIMZELX® (bimekizumab-bkzx) BIMZELX is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.1 IL-17A and IL-17F are key contributors of chronic inflammation and damage across multiple tissues, with IL-17F increasing over time.1, 28-30 IL-17F is over-expressed in skin and highly elevated in the serum of patients with psoriasis (PSO), psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), ankylosing spondylitis (AS), and hidradenitis suppurativa (HS).1, 28-31 The approved indications for BIMZELX in the U.S. are:1 Plaque psoriasis: BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy Psoriatic arthritis: BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis Non-radiographic axial spondyloarthritis: BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation Ankylosing spondylitis: BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis Hidradenitis suppurativa: BIMZELX is indicated for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa BIMZELX U.S. IMPORTANT SAFETY INFORMATION IMPORTANT SAFETY INFORMATION Suicidal Ideation and Behavior BIMZELX (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been definitively established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment. Infections BIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves. Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment. Liver Biochemical Abnormalities Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis. Inflammatory Bowel Disease Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs. Immunizations Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX. Most Common Adverse Reactions Most common (≥ 1%) adverse reactions in plaque psoriasis and hidradenitis suppurativa include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue. Most common (≥ 2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections. Most common (≥ 2%) adverse reactions in non-radiographic axial spondyloarthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections. Most common (≥ 2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash, and vulvovaginal mycotic infection. Please see Important Safety Information below and full U.S. Prescribing Information at . For further information, contact UCB: Investor Relations Antje Witte T +32.2.559.94.14 email [email protected] Brand Communications Nicole Herga T +1.773.960.5349 email [email protected] About UCB UCB, Brussels, Belgium () is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA. 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Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future. UCB is providing this information, including forward-looking statements, only as of the date of this press release. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. References 1 . BIMZELX® (bimekizumab-bkzx) U.S. Prescribing Information. . Accessed March 2025. 2 . Tzellos T, Sayed C, Gottlieb A, et al. Bimekizumab impact on draining tunnel reduction over 2 years in moderate to severe hidradenitis suppurativa: Results from BE HEARD EXT [poster]. AAD 2025. #64414. 3 . Orenstein L, Shi V, Gottlieb A, et al. Bimekizumab effect on pain severity and impact in moderate to severe hidradenitis suppurativa: 2-year results from BE HEARD EXT [abstract]. AAD 2025. #63286. 4 . Sayed C, Porter M, Kokolakis G, et al. Bimekizumab efficacy by patient subgroups in moderate to severe hidradenitis suppurativa: 2-year phase 3 results from BE HEARD EXT [abstract]. AAD 2025. #63285. 5 . Ingram J, Naik H, Zouboulis C, et al. Bimekizumab safety and tolerability in patients with moderate to severe hidradenitis suppurativa: 2-year results from BE HEARD EXT [abstract]. AAD 2025. #63331. 6 . Kimball A, Garg A, Lev-Tov H, et al. Bimekizumab clinical efficacy responses translate into improvements in patient outcomes to Week 48 in patients with moderate to severe hidradenitis suppurativa: Results from BE HEARD I&II [abstract]. AAD 2025. #63370. 7 . Chovatiya R, Forman S, Alavi A, et al. Bimekizumab efficacy by disease duration in moderate to severe hidradenitis suppurativa: 2-year phase 3 results from BE HEARD EXT [poster]. AAD 2025. #61888. 8 . Garg A, Neuren E, Cha D, et al. Evaluating patients' unmet needs in hidradenitis suppurativa: Results from the Global Survey Of Impact and Healthcare Needs (VOICE) Project. J Am Acad Dermatol. 2020;82(2):366–76. 9 . Matusiak L, Szczęch J, Kaaz K, et al. Clinical Characteristics of Pruritus and Pain in Patients with Hidradenitis Suppurativa. Acta Derm Venereol. 2018;98(2):191–94. doi: 10.2340/00015555-2815. 1 0. Krajewski P, Matusiak L, von Stebut E, et al. Quality-of-Life Impairment among Patients with Hidradenitis Suppurativa: A Cross-Sectional Study of 1795 Patient. Life (Basel). 2021;11(1):34. doi: 10.3390/life11010034. 1 1. Schneeweiss M, Anand P, Mostaghimi A, et al. Development and Validation of a Claims-Based Algorithm for Hidradenitis Suppurativa Severity [abstract]. AAD 2025. #63547. 1 2 . Blauvelt A, Khattri S, Rich P, et al. Bimekizumab efficacy and safety through 5 years in patients with moderate to severe plaque psoriasis in the US and Canada [abstract]. AAD 2025. #62275. 1 3. Gkini M-A, Lambert J, López-Ferrer A, et al. Bimekizumab efficacy in patients with plaque psoriasis: A post hoc stratification by weight over 4 years in BE BRIGHT [abstract]. AAD 2025. #62020. 1 4. Armstrong A, Feldman S, Gisondi P, et al. Bimekizumab efficacy in patients with psoriasis and concurrent hypertension, elevated body mass index, or hyperglycemia: Long-term results from BE BRIGHT [abstract]. AAD 2025. #63300. 1 5 . Langley R, Merola J, Thaçi D, et al. Bimekizumab 3-year efficacy in patients with psoriasis and risk factors for progression to psoriatic arthritis or screening positive for psoriatic arthritis: Long-term results from BE BRIGHT and BE RADIANT [abstract]. AAD 2025. #63312. 1 6 . Lebwohl M, Langley R, Strober B, et al. Bimekizumab achievement of 'super response' using a previously published definition in moderate to severe plaque psoriasis: Results from four phase 3/3b trials [abstract]. AAD 2025. 1 7 . Cutcutache I, MacLeod V, Valeo F, et al. Bimekizumab reduces systemic inflammation and cardiovascular risk gene signatures in psoriatic disease [abstract]. AAD 2025. #7925. 1 8. Gottlieb A, Asahina A, Thaçi D, et al. Bimekizumab treatment resulted in sustained improvements in pain and fatigue in patients with active psoriatic arthritis and baseline psoriasis: 2-year results from two phase 3 studies [poster]. AAD 2025. #62763. 1 9. Merola J, McInnes I, Mease P, et al. Head-to-head study of bimekizumab, an IL-17A/IL-17F inhibitor, and risankizumab, an IL-23 inhibitor, in patients with active psoriatic arthritis: Study design and rationale of BE BOLD, a phase 3b, randomized, parallel-group study. [poster]. AAD 2025. #62767. 2 0. Merola J, Tillett W, Warren R, et al. Achieving early skin clearance was associated with cumulative benefits on disease impact up to 2 years in patients with psoriatic arthritis and psoriasis treated with bimekizumab [oral presentation]. AAD 2025. 2 1. Gottlieb A, Proft F, van der Heijde D, et al. Maintenance of stringent clinical responses with bimekizumab in patients with axial spondyloarthritis: 2-year outcomes from two phase 3 studies [poster]. AAD 2025. #62156 2 2. Merola J, Mease P, Poddubnyy D, et al. Long-term safety and tolerability of bimekizumab in patients with axial spondyloarthritis and psoriatic arthritis: Updated results from phase 2b/3 studies and their open-label extensions [poster]. AAD 2025. #62152 2 3. Zouboulis CC, Garg A, Sayed CJ, et al. Bimekizumab efficacy and safety through 2 years in patients with hidradenitis suppurativa: Results from the phase 3 BE HEARD I&II trials and open-label extension BE HEARD EXT [abstract]. EADV 2024. 2 4. Ovadja Z, Schuit M, van der Horst C, and Lapid O. Inter‐ and intrarater reliability of Hurley staging for hidradenitis suppurativa. Br J Dermatol. 2019;181(2):344–9. 2 5. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1):18. 2 6. Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158–64. 2 7. Kimball AB, Jemec GBE, Sayed CJ, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48 week, randomised, double blind, placebo controlled, multicentre phase 3 trials. Lancet. 2024;403(10443):2504–19. 28. Glatt S, Baeten D, Baker T et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77:523–32. 29. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate-to-severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486. 30. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate-to-severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021;397(10273):487-498. 31. Rumberger BE, Boarder EL, Owens SL, et al. Transcriptomic analysis of hidradenitis suppurativa skin suggests roles for multiple inflammatory pathways in disease pathogenesis. Inflamm Res. 2020;69(10):967-973. US-BK-2500238 Date of preparation: March 2025 BIMZELX® is a registered trademark of the UCB Group of Companies. ©2025 UCB, Inc., Smyrna, GA 30080. All rights reserved. SOURCE UCB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Initiated the Phase 3 VELA program of the Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS) and the Phase 3 IZAR program in patients with active psoriatic arthritis (PsA) following positive FDA and EMA regulatory feedback, continuing to support a potential best-in-class profile across two key indications Initiated three new trials in the beginning of 2025 with the Nanobody® sonelokimab: Phase 3 VELA-TEEN trial in adolescent hidradenitis suppurativa (HS), Phase 2 LEDA trial in palmoplantar pustulosis (PPP) and Phase 2 S-OLARIS trial in axial spondyloarthritis (axSpA) Signed a three-year technology partnership with Komodo Health to advance research on inflammatory skin and joint conditions to tap into Komodo’s technology and real-world data Year-end cash, cash equivalents and short-term marketable debt securities of $448.0 million expected to support a roadmap rich in potential catalysts whilst providing a cash runway to at least the end of 2026 The Company will hold an in-person and virtual Capital Markets Update in Q2 of 2025 ZUG, Switzerland, February 26, 2025 – MoonLake Immunotherapeutics (NASDAQ: MLTX) (“MoonLake”), a clinical-stage biotechnology company advancing therapies to address significant unmet needs in inflammatory skin and joint diseases, today announced its financial results for the fourth quarter and year ended December 31, 2024. Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: "In 2024, we successfully advanced to Phase 3 clinical trials across several potential blockbuster indications with the launch of our Phase 3 VELA and Phase 3 IZAR programs, leaving us strongly positioned ahead of a data-rich 2025. With seven ongoing Phase 2 and Phase 3 trials, plus other ancillary trials running, this has been a time dedicated to execution, as we previously announced. With our pivotal HS data expected as of mid-2025, our focus is firmly on bringing this innovation to patients as we move towards commercialization.” Q4 highlights (including post-quarter end) Announced the initiation of two Phase 3 trials for active PsA with one focusing on biologic-naïve patients and including evaluation of radiographic progression (IZAR-1) and the other focusing on TNF-IR patients while being the first trial to include risankizumab as an active reference arm (IZAR-2) 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 Fourth quarter and year-end financial results As of December 31, 2024, MoonLake held cash, cash equivalents and short-term marketable debt securities of $448.0 million, compared to $493.9 million as of September 30, 2024. The decrease of $45.9 million was primarily attributable to an increase in clinical trial activities, partially offset by interest income on cash, cash equivalents and short-term marketable debt securities. Matthias Bodenstedt, Chief Financial Officer at MoonLake Immunotherapeutics, said: “In 2024, MoonLake transitioned into a late-stage clinical biotechnology company working in several growing multibillion-dollar dermatological and rheumatological indications. We have remained focused on careful cost control for shareholders, and continue to have a very healthy cash balance to support the growth of the business. We look forward to a data rich year ahead which could be transformational for the business.” Research and development expenses for the fourth quarter ended December 31, 2024 were $40.4 million, compared to $35.7 million in the previous quarter. Research and development expenses for the year ended December 31, 2024 were $112.8 million, compared to $31.8 million in the previous year. The increase of $81.0 million primarily related to an increase of $47.7 million in expenses pertaining to clinical development trials with contract research organizations, including the Phase 3 VELA program in HS and the Phase 3 IZAR program in PsA, as well as the additional trials in adolescent HS (the VELA-TEEN trial), PPP (the LEDA trial), axSpA (the S-OLARIS trial) and PsA (the P-OLARIS trial). An additional increase of $23.7 million related to supply and logistic services for such clinical development trials, including the purchase of a comparator drug for the IZAR-2 trial in PsA, and an increase of $5.4 million in personnel-related costs to support the Company’s research and development efforts. General and administrative expenses for the fourth quarter ended December 31, 2024 were $9.2 million, compared to $7.4 million in the previous quarter. General and administrative expenses for the year ended December 31, 2024 were $30.3 million, compared to $22.3 million in the previous year. The increase of $8.0 million primarily related to an increase of $3.3 million in personnel-related costs to support organizational growth, an increase of $2.4 million in expenses for advisory and professional services to support organizational growth, an increase of $1.6 million in office expenses driven by the new leases for additional office space, and an increase of $1.2 million in market research expenses. Other income, net for the year ended December 31, 2024 was $22.1 million, compared to $10.1 million for the previous year. The increase of $12.0 million primarily related to an increase of $12.3 million in realized interest on cash held in bank and cash investments in short-term marketable debt securities. Net loss for the year ended December 31, 2024 was $121.2 million, compared to $44.1 million for the previous year. Capital Markets Update in Q2 of 2025 The Company will hold an in-person and virtual Capital Markets Update in the second quarter of 2025 to provide an update on the Phase 3 HS VELA program, discuss additional clinical data and update the market on financials. Upcoming conferences TD Cowen 45th Annual Healthcare Conference: March 3-5 (Boston, US) American Association of Dermatology Annual Meeting (AAD): March 7-11 (Orlando, US) Leerink Partners Global Biopharma Conference: March 10-12 (Miami, US) Barclays 27th Global Healthcare Conference: March 11-13 (Miami, 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 variable regions of heavy-chain-only antibodies domains (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, 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; enrollment for clinical trials, including the Phase 3 VELA program, the VELA-TEEN trial and the IZAR program; 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 trials in adult HS, and 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 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, 2023 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. MoonLake Immunotherapeutics Media & Investors Relations Carla Bretes, Director IR & External Communications ir@moonlaketx.com ICR Healthcare Mary-Jane Elliott, Namrata Taak, Ashley Tapp Tel: +44 (0) 20 3709 5700 MoonLake@ICRHealthcare.com MOONLAKE IMMUNOTHERAPEUTICS CONSOLIDATED BALANCE SHEETS (Amounts in USD, except share data) MOONLAKE IMMUNOTHERAPEUTICS CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Amounts in USD, except share and per share data)