MoonLake Immunotherapeutics (MLTX) is a clinical-stage biotechnology company focused on developing therapies for inflammatory skin and joint diseases. The company is primarily engaged in the development of Sonelokimab (SLK), a novel tri-specific IL-17A and IL-17F inhibiting Nanobody. MLTX aims to address significant unmet needs in dermatology and rheumatology through its innovative therapeutic approach.
- Sonelokimab (SLK) - Develops a tri-specific IL-17A and IL-17F inhibiting Nanobody for treating inflammatory diseases such as Hidradenitis Suppurativa, Psoriatic Arthritis, and Psoriasis. SLK offers advantages like high affinity, selective binding, and enhanced tissue penetration due to its small size and albumin-binding domain.
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Name | Position | External Roles | Short Bio | |
---|---|---|---|---|
Dr. Jorge Santos da Silva Executive | Chief Executive Officer | Professor and Board Advisor at the School of Medicine at Minho University (Portugal). | Co-founder of MoonLake AG; leads MLTX's development of Nanobody® sonelokimab for inflammatory diseases. | View Report → |
Dr. Kristian Reich Executive | Chief Scientific Officer | Guest-Professor at University Medical Center Hamburg-Eppendorf; Medical Advisor at TFS HealthScience; Board Member at Derma2go AG, Dermagnostix GmbH, and ProDerma Foundation. | Co-founder of MoonLake AG; global clinical leader in dermatology and immunology with over 25 years of experience and 300+ peer-reviewed publications. | |
Matthias Bodenstedt Executive | Chief Financial Officer | None | Former McKinsey Partner; oversees MLTX's financial strategy, including maintaining a strong cash position and supporting clinical development programs. | |
Catherine Moukheibir Board | Director | Chair of Audit Committees at Ironwood Pharmaceuticals, Biotalys, Oxford Biomedica, CMR Surgical, Asceneuron, and DNA Script. | Financial expert with extensive board experience in life sciences companies across the U.S. and Europe. | |
Dr. Andrew Phillips Board | Director | CEO and President of Aleksia Therapeutics, Nexo Therapeutics, and Blossom Bioscience; Director at Enliven Therapeutics and multiple private biotechnology companies. | Leader in life sciences-focused investment management and executive roles in biopharmaceutical companies. | |
Dr. Ramnik Xavier Board | Director | Core Institute Member at Broad Institute; Director of Klarman Cell Observatory and Broad's Immunology Program; Co-Director of Broad's Infectious Disease and Microbiome Program; Professor at Harvard Medical School. | Renowned biomedical researcher specializing in genetic variants, computational biology, and immunology; holds multiple leadership roles at prestigious institutions. | |
Simon Sturge Board | Independent Chairperson | Director at Galapagos NV; Director at two private biotechnology companies, a private consulting company, and a private investment company. | Former CEO of Kymab Ltd and COO of Merck Group Germany; extensive experience in biotechnology and pharmaceutical leadership. | |
Spike Loy Board | Director | Managing Director at BVF Partners L.P.; Director at multiple private biopharmaceutical companies. | Experienced in life sciences investment management and biopharmaceutical company leadership. |
Research analysts covering MoonLake Immunotherapeutics.
Notable M&A activity and strategic investments in the past 3 years.
Company | Year | Details |
---|---|---|
MoonLake Immunotherapeutics AG | 2022 | Deal value and structure: Completed on April 5, 2022, under a Business Combination Agreement dated October 4, 2021, with Helix Acquisition Corp. contributing $134,646,009 (including a $15,000,000 loan repayment), converting Series A preferred to common shares and issuing new classes of shares. Strategic rationale and capabilities: The acquisition advanced the development of Sonelokimab, a novel Nanobody® for treating inflammatory diseases, and repositioned the company with a new Nasdaq listing under MLTX. |
Merck Healthcare KGaA (SLK program) | 2021 | Strategic rationale and capabilities: The SLK program, focused on a tri-specific IL-17A/F nanobody that binds human albumin to extend its half-life, is positioned to be best-in-class for IL-17-driven inflammatory diseases, especially in a $44 billion market, with robust Phase II data in psoriasis supporting its development. Notable aspects: Although detailed deal value and structure were not provided, the acquisition strategically expands MoonLake's asset portfolio to target multiple inflammatory indications and compete against drugs like Bimekizumab. |
Recent press releases and 8-K filings for MLTX.
- Faruqi & Faruqi, LLP is investigating potential claims against MoonLake Immunotherapeutics (MLTX) following a significant stock drop.
- MLTX shares plummeted over 80% on Monday due to disappointing results from two late-stage trials of its experimental drug, sonelokimab, for hidradenitis suppurativa.
- One trial showed a statistically significant improvement over placebo but fell short of investor expectations, while the second trial failed to meet its primary endpoint entirely.
- Faruqi & Faruqi, LLP is investigating potential claims against MoonLake Immunotherapeutics (MLTX).
- The investigation follows a more than 80% drop in MoonLake's share price after disappointing results from two late-stage trials of its experimental drug, sonelokimab, for hidradenitis suppurativa.
- One study showed statistically significant improvement but fell short of investor expectations, while the second trial failed to meet its primary endpoint entirely.
- These outcomes have cast doubt on the drug's regulatory path and commercial potential, leading to analyst skepticism and a sharp market sell-off.
- The combined VELA program for sonelokimab in moderate-to-severe Hidradenitis suppurativa (HS) demonstrated clinically meaningful and statistically significant improvement across all primary and key secondary endpoints at week 16 (p<0.001).
- VELA-1 achieved statistical significance for all primary and key secondary endpoints, and VELA-2 also showed statistically significant HiSCR75 response rates at week 16 using the pre-specified treatment policy strategy.
- Sonelokimab exhibited a favorable safety profile with no new signals, including the absence of IBD, SI/B, and hepatic event signals.
- MoonLake Immunotherapeutics (MLTX) plans to seek regulatory guidance from the FDA in the coming weeks to confirm the registration path for sonelokimab in HS, believing the package should be approvable.
- MLTX continues to advance its pipeline, with near-term catalysts for PsA, PPP, and axSpA indications, with read-outs expected from Q2 2025 through H2 2026 for various trials.
- The combined VELA-1 and VELA-2 trials for sonelokimab in adults with moderate to severe hidradenitis suppurativa (HS) demonstrated clinically meaningful and significant improvements across all primary and secondary endpoints at week 16.
- VELA-1 met all primary and secondary endpoints, but VELA-2 experienced a higher-than-expected placebo arm, leading to a borderline P-value of 0.053 for the primary endpoint (HiSCR 75) at week 16 using the composite strategy.
- MoonLake Immunotherapeutics will seek regulatory advice on the VELA-2 results, expecting clarity within one to three months, and emphasizes the drug's strong responses in pain scores and quality of life with a favorable safety profile.
- The company cited a precedent where an approved HS drug (secukinumab) did not meet statistical significance in one of its Phase 3 trials and reported a cash position of $425 million from its last 10-Q.
- MoonLake Immunotherapeutics announced week 16 results from its Phase 3 VELA-1 and VELA-2 trials for sonelokimab in moderate-to-severe hidradenitis suppurativa (HS) on September 28, 2025.
- The combined VELA program demonstrated clinically meaningful and statistically significant improvement across all primary and key secondary endpoints (p<0.001) using both pre-specified analysis strategies.
- VELA-1 achieved statistical significance for all primary and key secondary endpoints (HiSCR75, delta to placebo of 17%, p<0.001), while VELA-2 did not reach statistical significance for the primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%, p=0.053) due to a higher-than-expected placebo response.
- Sonelokimab maintained a favorable safety profile with no new safety signals detected.
- The company plans to discuss the path to registration for sonelokimab in HS with regulatory authorities and has several other clinical trial readouts scheduled through H1 2026.
- VELA Phase 3 in HS achieved record recruitment with 800 patients across 17 countries in ~12 months, outperforming industry benchmarks.
- The company emphasized its strong financial footing with a up to $500m non-dilutive facility and a cash runway extended into 2028.
- Multiple clinical programs, including the PPP LEDA trial, are progressing, supporting a pipeline aimed for market launch in 2027.
- MoonLake Immunotherapeutics secured up to $500 million in non-dilutive financing from Hercules Capital, with an initial drawdown of $75 million, bolstering its balance sheet and strategic funding flexibility.
- The new facility complements an existing cash position of $448 million and is expected to fund advancements in clinical trials and further investments, including the anticipated 2027 launch of sonelokimab.
- A Capital Markets Update is scheduled for April 29, 2025 in New York to discuss clinical milestones, including updates on the Phase 3 HS (VELA) program and an interim readout from the Phase 2 LEDA trial.