MoonLake announces Week 40 Results from its Phase 3 Clinical Trials of Sonelokimab in Hidradenitis Suppurativa at the 2026 AAD Annual Meeting

Rhea-AI Summary

MoonLake (NASDAQ: MLTX) reported Week 40 Phase 3 VELA results for sonelokimab in moderate-to-severe hidradenitis suppurativa. Key highlights: 62% HiSCR75, up to 32% HiSCR100, up to 25% inflammatory remission, HiSQOL improvements of -11.8 and -12.4, and no new safety signals. Data presented at AAD on March 28, 2026.

Positive

• HiSCR75 62% of SLK patients achieved ≥75% lesion reduction at Week 40
• HiSCR100 up to 32% of patients achieved complete clearance at Week 40
• IHS4-55 up to 77% achieved ≥55% IHS4 reduction (VELA-1: 74.3%, VELA-2: 77.4%)
• HiSQOL improved mean change -11.8 (VELA-1) and -12.4 (VELA-2) at Week 40
• Pain and QoL gains: up to 43% ≥3-point pain NRS improvement; 65% ≥4-point DLQI improvement
• No new safety signals detected through Week 40

Negative

• Placebo crossover at Week 16 limits blinded placebo comparison beyond Week 16
• Week 40 vs 1-year comparators: SLK Week 40 data precede full 52-week pivotal comparisons to approved agents
• Regulatory milestones pending including BLA submission in H2 2026 and other Phase 3 readouts in 2026

Key Figures

HiSCR75 at Week 40: 62% of SLK patients HiSCR100 at Week 40: Up to 32% of SLK patients Inflammatory remission: Up to 25% of patients +5 more

8 metrics

HiSCR75 at Week 40 62% of SLK patients Phase 3 VELA-1 and VELA-2 HS trials, as observed

HiSCR100 at Week 40 Up to 32% of SLK patients Phase 3 VELA-1 and VELA-2 HS trials, as observed

Inflammatory remission Up to 25% of patients A100 + N100 + DT100 at Week 40, as observed

IHS4-55 response Up to 77% of patients International HS Severity Scoring System ≥55% reduction, Week 40

Trial enrollment 838 patients Total enrolled across VELA-1 and VELA-2

HiSQOL change -11.8 and -12.4 points Change from baseline at Week 40 (VELA-1, VELA-2)

Pain NRS improvement Up to 43% of patients ≥3‑point improvement in worst skin pain NRS at Week 40

DLQI improvement 65% of patients ≥4‑point DLQI improvement at Week 40, baseline DLQI ≥4

Market Reality Check

Price: $17.32 Vol: Volume 468,190 vs 20-day ...

low vol

$17.32 Last Close

Volume Volume 468,190 vs 20-day average 794,847, indicating subdued trading activity into this update. low

Technical Shares at $17.32, trading below the 200-day MA of $28.25 and 72.4% under the 52-week high.

Peers on Argus

MLTX fell 2.42% while key peers screened in momentum like KYMR showed gains of 4...

1 Up

MLTX fell 2.42% while key peers screened in momentum like KYMR showed gains of 4.25%, pointing to a stock-specific reaction rather than a broad biotech move.

Common Catalyst Multiple dermatology-focused peers (e.g., KYMR, PTGX) also reported AAD clinical data, suggesting a shared conference-driven clinical news cycle.

Previous Clinical trial Reports

4 past events · Latest: Sep 28 (Positive)

Same Type Pattern 4 events

Date	Event	Sentiment	Move	Catalyst
Sep 28	HS VELA wk16 data	Positive	-89.9%	Reported statistically significant Phase 3 VELA HS week 16 efficacy and safety.
Jan 08	New trials launched	Positive	-4.1%	Initiated three new trials in adolescent HS, PPP, and axSpA for sonelokimab.
Nov 13	PsA Phase 3 start	Positive	-1.6%	Started Phase 3 IZAR PsA program following positive Phase 2 ARGO results.
May 16	HS VELA start	Positive	+0.4%	Launched Phase 3 VELA HS program using HiSCR75 primary endpoint over 52 weeks.

Pattern Detected

Clinical trial announcements have often coincided with negative price moves, even when data were positive, suggesting a pattern of sell-the-news or high expectations around trial updates.

Recent Company History

Recent clinical trial news for MoonLake has centered on advancing sonelokimab through Phase 3 in HS and Phase 3 programs in PsA. Since May 16, 2024, the company launched the VELA HS program, then expanded sonelokimab into HS, PPP, and axSpA trials on Jan 8, 2025. The Sep 28, 2025 VELA week 16 readout showed statistically significant endpoints but a sharp negative price reaction. Today’s Week 40 HS data extend this same clinical narrative of sustained efficacy and safety.

Historical Comparison

-23.8% avg move · Across recent clinical trial headlines, the stock moved an average of -23.79%, showing that even pos...

clinical trial

-23.8%

Average Historical Move clinical trial

Across recent clinical trial headlines, the stock moved an average of -23.79%, showing that even positive sonelokimab data have often been met with selling pressure around such updates.

Clinical-trial news shows a clear progression: initiation of the VELA HS Phase 3 program in 2024, expansion into multiple indications in 2025, and detailed VELA week 16 HS efficacy. The new Week 40 HS data build on this path by demonstrating longer-term lesion control and quality-of-life benefits within the same registrational program.

Market Pulse Summary

This announcement delivers detailed Week 40 Phase 3 HS data, with 62% of patients achieving HiSCR75 ...

Analysis

This announcement delivers detailed Week 40 Phase 3 HS data, with 62% of patients achieving HiSCR75 and meaningful improvements across pain, quality-of-life, and inflammatory remission measures. These results extend earlier VELA readouts and reinforce sonelokimab’s role in MoonLake’s registrational HS program. Investors may track the planned 52‑week VELA data, upcoming PsA Phase 3 readouts, and the targeted H2 2026 BLA submission as key milestones for validating this long‑term efficacy profile.

Key Terms

hidradenitis suppurativa, nanobody, hs clinical response (hiscR), numerical rating scale, +2 more

6 terms

hidradenitis suppurativa medical

"Phase 3 VELA clinical trials in adults with moderate-to-severe hidradenitis suppurativa (HS)"

A chronic skin disease marked by recurring, painful lumps and tunnels under the skin that often leak and leave scars; it behaves like a slow-burning, recurring infection in areas with many sweat glands. For investors, it matters because the condition has few consistently effective treatments and causes long-term healthcare use, making successful new drugs, devices, or diagnostics potentially high-value opportunities while also carrying clinical-trial, regulatory and reimbursement risks.

nanobody medical

"sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease"

A nanobody is a very small, simplified version of an antibody that can bind to specific targets in the body much like a tiny, precision key fits into a lock. Because it is compact, stable and easier to produce than conventional antibodies, it can be developed into drugs, diagnostic tests or imaging agents more quickly and cheaply, which may speed development timelines and reduce manufacturing costs—factors investors watch closely.

hs clinical response (hiscR) medical

"used the higher clinical response level of HS Clinical Response (HiSCR) 75 as the primary endpoint"

HiSCR (Hidradenitis Suppurativa Clinical Response) is a standardized trial endpoint used to measure meaningful improvement in hidradenitis suppurativa, defined as at least a 50% reduction in the combined number of painful abscesses and inflammatory nodules without any increase in abscesses or draining fistulas. Investors care because HiSCR serves as a clear, quantifiable “pass/fail” yardstick for efficacy that regulators and doctors use to judge a drug’s benefit, directly affecting approval prospects, labeling, prescribing, and commercial potential.

numerical rating scale medical

"at least a 3-point improvement from baseline in the worst skin pain Numerical Rating Scale (NRS)"

A numerical rating scale is a simple system that assigns numbers to describe an asset, forecast, credit quality or clinical outcome so people can compare and track changes over time — like giving a movie one to five stars. For investors it turns complex information into an easy-to-read score that helps prioritize research, spot trends and make buy/sell decisions, while still requiring a look behind the number for details and assumptions.

biologics license application regulatory

"H2 2026: Submission of a BLA for HS"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

phase 3 medical

"long-term Week 40 results of the Phase 3 VELA-1 and VELA-2 clinical trials"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

AI-generated analysis. Not financial advice.

• 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
ir@moonlaketx.com

ICR Healthcare
Mary-Jane Elliott, Sarah Elton-Farr, Ashley Tapp
Tel: +44 (0) 20 3709 5700
MoonLake@ICRHealthcare.com

FAQ

What were the Week 40 HiSCR75 and HiSCR100 results for MoonLake (MLTX) sonelokimab?

At Week 40, 62% of patients treated with sonelokimab achieved HiSCR75 and up to 32% achieved HiSCR100. According to the company, results were consistent across VELA-1 and VELA-2 (VELA-1 HiSCR75 61.9%, HiSCR100 32.4%; VELA-2 HiSCR75 61.8%, HiSCR100 28.1%).

How did sonelokimab affect quality of life in the VELA trials (MLTX) at Week 40?

Sonelokimab produced meaningful HiSQOL improvements: -11.8 (VELA-1) and -12.4 (VELA-2) from baseline at Week 40. According to the company, HiSQOL-Mini items improved 41% for pain, 54% for mobility/dressing, and 62% for mood (pooled, as observed).

What pain and DLQI benefits did patients report with MLTX sonelokimab by Week 40?

Up to 43% of patients had ≥3-point improvement in worst skin pain NRS and 65% achieved ≥4-point DLQI improvement. According to the company, these figures were observed across VELA-1 and VELA-2 and reflect clinically meaningful patient-reported gains.

Did MoonLake report any new safety signals for sonelokimab in the Week 40 VELA data?

No new safety signals were detected through Week 40 in the VELA trials. According to the company, the safety profile of sonelokimab remained consistent over time across both VELA-1 and VELA-2 populations.

When and where were the Week 40 VELA trial results for MLTX presented?

The Week 40 results were presented at the 2026 AAD Annual Meeting on March 28, 2026 (S034 Late-Breaking Research: Session 2). According to the company, the presentation was delivered by Prof. Alexa Kimball at 4:00–4:12 PM ET.

What are MoonLake's next clinical and regulatory milestones for sonelokimab and MLTX in 2026?

Upcoming milestones include 52-week VELA data in Q2 2026, a BLA submission for HS in H2 2026, and Phase 3 IZAR readouts in mid-2026 and H2 2026. According to the company, these events are key to regulatory and commercial timelines.