MoonLake Immunotherapeutics Reports Second Quarter 2025 Financial Results and Provides a Business Update
MoonLake Immunotherapeutics (NASDAQ:MLTX), a biotechnology company, reported Q2 2025 financial results and significant clinical progress. The company ended Q2 with $425.1 million in cash and secured up to $500 million in non-dilutive financing from Hercules Capital, extending cash runway into 2028.
Key financial metrics include R&D expenses of $49.8 million (up $13.3 million from previous quarter) and G&A expenses of $10.9 million. The company's Phase 3 VELA program in hidradenitis suppurativa (HS) is progressing toward primary endpoint readout around September 2025, with BLA submission expected mid-2026.
Multiple clinical trials for sonelokimab are advancing in various indications including PPP, axSpA, PsA, and adolescent HS, with significant readouts expected through 2026. The company anticipates product launch in 2027.
MoonLake Immunotherapeutics (NASDAQ:MLTX), un'azienda biotecnologica, ha comunicato i risultati finanziari del secondo trimestre 2025 e importanti progressi clinici. La società ha chiuso il secondo trimestre con 425,1 milioni di dollari in liquidità e ha ottenuto fino a 500 milioni di dollari di finanziamenti non diluitivi da Hercules Capital, estendendo la disponibilità di cassa fino al 2028.
I principali indicatori finanziari includono spese per R&S pari a 49,8 milioni di dollari (in aumento di 13,3 milioni rispetto al trimestre precedente) e spese generali e amministrative di 10,9 milioni di dollari. Il programma di Fase 3 VELA per l'idrosadenite suppurativa (HS) sta procedendo verso la lettura del criterio di valutazione primaria prevista per settembre 2025, con la presentazione della BLA attesa per metà 2026.
Numerosi studi clinici su sonelokimab stanno avanzando in diverse indicazioni, tra cui PPP, axSpA, PsA e HS adolescenziale, con importanti risultati attesi entro il 2026. L'azienda prevede il lancio del prodotto nel 2027.
MoonLake Immunotherapeutics (NASDAQ:MLTX), una empresa biotecnológica, reportó los resultados financieros del segundo trimestre de 2025 y avances clínicos significativos. La compañía cerró el segundo trimestre con 425.1 millones de dólares en efectivo y aseguró hasta 500 millones de dólares en financiamiento no dilutivo de Hercules Capital, extendiendo la liquidez hasta 2028.
Los principales indicadores financieros incluyen gastos en I+D de 49.8 millones de dólares (un aumento de 13.3 millones respecto al trimestre anterior) y gastos administrativos y generales de 10.9 millones de dólares. El programa de Fase 3 VELA en hidradenitis supurativa (HS) avanza hacia la lectura del endpoint primario alrededor de septiembre de 2025, con la presentación del BLA esperada para mediados de 2026.
Varios ensayos clínicos con sonelokimab están progresando en diversas indicaciones como PPP, axSpA, PsA y HS en adolescentes, con resultados importantes esperados hasta 2026. La compañía anticipa el lanzamiento del producto en 2027.
MoonLake Immunotherapeutics (NASDAQ:MLTX)는 생명공학 회사로서 2025년 2분기 재무 결과와 중요한 임상 진전을 발표했습니다. 회사는 2분기 말에 4억 2,510만 달러의 현금을 보유했으며, Hercules Capital로부터 5억 달러 규모의 비희석성 자금 조달을 확보하여 현금 운용 기간을 2028년까지 연장했습니다.
주요 재무 지표로는 연구개발비 4,980만 달러(전 분기 대비 1,330만 달러 증가)와 일반관리비 1,090만 달러가 포함됩니다. 회사의 3상 VELA 프로그램은 농포성한선염(HS) 치료를 목표로 2025년 9월경 1차 평가변수 결과 도출을 앞두고 있으며, BLA 제출은 2026년 중반으로 예상됩니다.
소넬로키맙에 대한 다수의 임상시험이 PPP, 축성 척추관절염(axSpA), 건선성 관절염(PsA), 청소년 HS 등 다양한 적응증에서 진행 중이며, 2026년까지 중요한 결과들이 기대됩니다. 회사는 2027년 제품 출시를 예상하고 있습니다.
MoonLake Immunotherapeutics (NASDAQ:MLTX), une société de biotechnologie, a annoncé ses résultats financiers du deuxième trimestre 2025 ainsi que des progrès cliniques significatifs. L'entreprise a clôturé le deuxième trimestre avec 425,1 millions de dollars en liquidités et a obtenu jusqu'à 500 millions de dollars de financement non dilutif auprès de Hercules Capital, prolongeant ainsi sa trésorerie jusqu'en 2028.
Les principaux indicateurs financiers comprennent des dépenses en R&D de 49,8 millions de dollars (en hausse de 13,3 millions par rapport au trimestre précédent) et des frais généraux et administratifs de 10,9 millions de dollars. Le programme de phase 3 VELA pour l'hidrosadénite suppurée (HS) progresse vers la lecture du critère d'évaluation principal prévue vers septembre 2025, avec une soumission du BLA attendue pour mi-2026.
Plusieurs essais cliniques sur le sonelokimab avancent dans différentes indications, notamment PPP, axSpA, PsA et HS chez les adolescents, avec des résultats importants attendus jusqu'en 2026. L'entreprise prévoit le lancement du produit en 2027.
MoonLake Immunotherapeutics (NASDAQ:MLTX), ein Biotechnologieunternehmen, berichtete über die Finanzergebnisse des zweiten Quartals 2025 sowie bedeutende klinische Fortschritte. Das Unternehmen schloss das zweite Quartal mit 425,1 Millionen US-Dollar in bar ab und sicherte sich bis zu 500 Millionen US-Dollar nicht verwässernde Finanzierung von Hercules Capital, wodurch die finanzielle Reichweite bis 2028 verlängert wurde.
Wichtige finanzielle Kennzahlen umfassen F&E-Ausgaben von 49,8 Millionen US-Dollar (ein Anstieg um 13,3 Millionen gegenüber dem Vorquartal) sowie Verwaltungs- und Gemeinkosten von 10,9 Millionen US-Dollar. Das Phase-3-VELO-Programm bei Hidradenitis suppurativa (HS) schreitet voran und strebt eine Auswertung des primären Endpunkts um September 2025 an, mit einer BLA-Einreichung Mitte 2026.
Mehrere klinische Studien zu Sonelokimab werden in verschiedenen Indikationen wie PPP, axSpA, PsA und jugendlicher HS vorangetrieben, mit bedeutenden Ergebnissen, die bis 2026 erwartet werden. Das Unternehmen plant die Produkteinführung für 2027.
- Secured up to $500 million non-dilutive financing from Hercules Capital
- Strong cash position of $425.1 million at quarter end
- Extended cash runway into 2028
- Multiple clinical trial readouts expected through 2026
- Phase 3 VELA program on track for September 2025 readout
- Earlier-than-expected interim readout of Phase 2 LEDA trial in PPP
- R&D expenses increased by $13.3 million quarter-over-quarter to $49.8 million
- Product launch not expected until 2027
- BLA submission timeline pushed to mid-2026
Insights
MoonLake reports solid Q2 with $425.1M cash, secured $500M non-dilutive financing, and awaits critical HS trial results in September.
MoonLake Immunotherapeutics (MLTX) delivered a strong second quarter with several significant developments that strengthen its position ahead of crucial clinical readouts. The company has successfully secured up to
The company's cash position remains robust at
The most immediate catalyst is the Phase 3 VELA program in hidradenitis suppurativa (HS), with primary endpoint results expected around September 2025. This represents a potential inflection point for MLTX as positive data would support their planned BLA submission in mid-2026. The company also reported an earlier-than-expected interim readout from their Phase 2 LEDA trial in palmoplantar pustulosis, which management believes further validates sonelokimab's potential and derisks the asset's development.
MoonLake has outlined a robust sequence of catalysts over the next 12 months, including multiple primary endpoint readouts across different indications. The management team has positioned the company to potentially transform from a clinical-stage biotech to a commercial entity by 2027, with sufficient capital to fund this transition. Their focus on inflammatory diseases with sonelokimab, a Nanobody® targeting IL-17A and IL-17F, could establish MLTX as a significant player in this therapeutic area if their clinical programs continue to yield positive results.
- Phase 3 VELA program in hidradenitis suppurativa (HS) on track for an expected primary endpoint readout around September 2025 and an expected submission of a Biologic License Application (BLA) in the United States in mid-2026
- Other clinical trials of sonelokimab in palmoplantar pustulosis (PPP), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA) and adolescent HS progressing well and expected to support a catalyst-rich roadmap over the next 12 months
- Ended the second quarter with
$425.1 million in cash, cash equivalents and short-term marketable debt securities with up to an additional$425 million in non-dilutive funds remaining accessible through previously announced debt-facility
ZUG, Switzerland, August 5, 2025 – MoonLake Immunotherapeutics (NASDAQ:MLTX) (“MoonLake” or the “Company”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced its financial results for the second quarter of 2025.
Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “Q2 has been another strong quarter for MoonLake. We narrowed guidance for the timing of the primary endpoint readout for our pivotal Phase 3 VELA program in HS to around September and look forward to submitting the data for presentation at a key scientific congress in the fourth quarter of this year. Additionally, we delivered an earlier-than-expected interim readout of the Phase 2 LEDA trial in PPP, which provides further validation on the potential of sonelokimab, which we believe derisks the overall development of the asset. Our commitment to delivering real-world benefits to patients remains unwavering and we look forward to a critical quarter ahead with significant milestones expected.”
Q2 highlights (including post-period end):
- Announced non-dilutive financing with Hercules Capital of up to
$500 million in committed non-dilutive capital, extending the expected cash runway into 2028 and providing funding for the next steps of the Company’s growth, including the expected launch of sonelokimab in 2027, additional clinical trials and further investments for growth - Conducted a Capital Markets Update both in-person in New York and virtually, which provided:
- Details on the up to
$500 million non-dilutive financing agreement with Hercules Capital, which strengthens the Company’s financial position and supports the clinical and commercial objectives while preserving shareholder value - Baseline characteristics of the Phase 3 VELA program and its comparability to the Phase 2 MIRA trial and other competitor trials, as well as narrowed guidance with respect to the timing of the primary endpoint readout
- An earlier-than-expected interim readout of the Phase 2 LEDA trial, the first clinical trial in PPP for an IL-17A and IL-17F inhibitor, which we believe further derisks the overall development of the asset and highlights the potential of sonelokimab in the evolving PPP market
- Views on market opportunities featuring insights from recent data analyses, competitor performance and strategic imperatives for the Company
- Details on the up to
• Shared data from the Phase 2 ARGO trial in PsA with the rheumatology community at the European Congress of Rheumatology (EULAR) in Barcelona, Spain
Second quarter 2025 financial results
As of June 30, 2025, MoonLake held cash, cash equivalents and short-term marketable debt securities of
Matthias Bodenstedt, Chief Financial Officer at MoonLake Immunotherapeutics, said: “MoonLake is in a robust financial position as we approach our first Phase 3 data readout for HS. The
Important upcoming anticipated milestones for MoonLake:
- Around September 2025: R&D Day to present top-line results for the HS Phase 3 VELA program
- Q4 2025: Primary endpoint readout of the Phase 2 LEDA trial in PPP
- Q1 2026: Primary endpoint readout of the Phase 2 S-OLARIS trial in axSpA
- H1 2026: Primary endpoint readout of Phase 3 VELA-TEEN trial in adolescent HS
- H1 2026: Primary endpoint readout of Phase 2 IZAR trial in PsA
Upcoming investor and medical conferences:
- European Academy of Dermatology and Venerology (EADV): 17-20 September, Paris, France
- Fall Clinical Dermatology Conference, 23-26 October, Las Vegas, US
- American Academy of Rheumatology (ACR): 24-29 October, Chicago, US
- Symposium on HS Advances (SHSA): 31 October - 2 November, Nashville, US
- Guggenheim 2nd Annual Healthcare Innovation Conference, 10-12 November, Boston, US
- Inflammatory Skin Disease Summit (ISDS): 12-15 November, New York, US
- Jefferies London Healthcare Conference, 17-20 November, London, UK
- Citi Annual Global Healthcare Conference, 2-4 December, Miami, US
- 8th Annual Evercore Healthcare Conference, 2-4 December, Coral Gables, Florida, US
- HS Academy, 5-7 December, Charlotte, US
-Ends-
About MoonLake Immunotherapeutics
MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The Company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com.
About Nanobodies®
Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations.
The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company.
About Sonelokimab
Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHHs covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema.
Sonelokimab is being assessed in two lead indications, hidradenitis suppurativa (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology, including adolescent HS, palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA).
For adults with HS, sonelokimab is being assessed in the Phase 3 trials, VELA-1 and VELA-2, following the successful outcome of MoonLake’s end-of-Phase 2 interactions with the FDA and as well as positive feedback from its interactions with the EMA announced in February 2024. In June 2023, topline results of the MIRA trial (NCT05322473) at 12 weeks showed that the trial met its primary endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR) 75, which is a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials, setting a landmark milestone. In October 2023, the full dataset from the MIRA trial at 24 weeks showed that maintenance treatment with sonelokimab led to further improvements in HiSCR75 response rates and other high threshold clinical and patient relevant outcomes. The safety profile of sonelokimab in the MIRA trial was consistent with previous trials with no new safety signals detected.
Sonelokimab is currently undergoing evaluation in the VELA-TEEN Phase 3 trial, which is the first clinical study specifically focused on adolescent patients with moderate-to-severe HS.
For PsA, sonelokimab is being assessed in the Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201) evaluating the efficacy and safety of the Nanobody® sonelokimab over 24 weeks in patients with active PsA. Significant improvements were observed across all key outcomes, including approximately
Sonelokimab is also being assessed in the Phase 2 LEDA trial, which is ongoing for PPP, a debilitating inflammatory skin condition affecting a significant number of patients.
Additionally, Sonelokimab is being assessed in the ongoing Phase 2 S-OLARIS trial for active axSpA. The trial features an innovative design complementing traditional clinical outcomes with cellular imaging techniques.
Sonelokimab has also been assessed in a randomized, placebo-controlled third-party Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575).
In an earlier third-party Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196–203).
About the VELA program
The Phase 3 VELA program is expected to enroll 800 patients across VELA-1 (NCT0641189) and VELA-2 (NCT06411379). Both global, randomized, double-blind, and placebo-controlled trials are identical in design evaluating the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe hidradenitis suppurativa. Similar to the design of the landmark Phase 2 MIRA trial, the primary endpoint is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75, defined as a ≥
About the VELA-TEEN trial
The Phase 3 VELA-TEEN trial is an open-label, single-arm trial designed to evaluate sonelokimab 120mg administered subcutaneously once every two weeks (Q2W) until week six and once every four weeks (Q4W) from week eight onwards. The trial aims to enroll 30-40 adolescents, aged 12-17, with moderate-to-severe hidradenitis suppurativa, from U.S. sites experienced in clinical trials and pediatric dermatology. The primary trial phase will be 24 weeks with a primary endpoint evaluating the pharmacokinetics, safety, and tolerability of sonelokimab. VELA-TEEN will also evaluate several secondary endpoints, including the proportion of patients achieving the higher clinical response measure of the Hidradenitis Suppurativa Clinical Response Score (HiSCR) 75, in addition to HiSCR50. Other outcomes are the change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4), which includes the quantitative measure of draining tunnels, and the proportion of patients achieving a meaningful reduction of the Children’s Dermatology Life Quality Index (CDLQI) and the Patients Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under NCT06768671 at www.clinicaltrials.gov.
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects an estimated
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
About the S-OLARIS trial
S-OLARIS is an open-label Phase 2 proof-of-concept trial aiming to investigate sonelokimab 60mg administered subcutaneously in approximately 25 patients with active axial spondyloarthritis (axSpA). The primary endpoint is the change from baseline (CfB) at week 12 in the uptake of 18F-NaF in the sacroiliac joints and spine using PET in combination with MRI imaging. Throughout the trial, several other endpoints will be assessed including established clinical disease activity outcomes (e.g., ASAS), scores related to physical function, spinal mobility, and enthesitis as well as patient reported outcomes. The trial also includes an exploratory peripheral blood and tissue biomarker program.
About Axial Spondyloarthritis
Axial Spondyloarthritis (axSpA) typically impacts young people, with diagnosis based on chronic inflammatory back pain lasting more than three months with onset under 45 years of age. Advanced disease can lead to progressive and pathologic bone formation and joint fusion, severely limiting spinal mobility. Global reported prevalence of axSpA ranges from
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
The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 MIRA trial in hidradenitis suppurativa, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively.
About Palmoplantar Pustulosis
Palmoplantar Pustulosis (PPP) is characterized by the development of blister-like pustules within erythematous, scaly plaques on the palms and the soles of the feet. PPP typically develops in adulthood, more frequently impacts females. Patients frequently experience significant pain, burning, and itching sensations on the palms and soles of the feet which can be debilitating and impair their ability to work, sleep, or perform other activities of daily living. Currently, the treatment of PPP is challenging with a significant unmet need for novel therapies to reduce the symptom burden for patients. Evidence suggests that activation of the IL-17 pathway has an important role in disease pathophysiology.
Cautionary Statement Regarding Forward Looking Statements
This press release contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the anticipated timing of clinical trials and timing of the results from those trials, including the Phase 3 VELA trials in adult HS, the Phase 3 VELA-TEEN trial in adolescent HS, the Phase 3 IZAR trials in PsA, the Phase 2 LEDA trial in PPP and the Phase 2 S-OLARIS trial in axSpA; the anticipated timing of filing of a BLA in the United States; the efficacy and safety of sonelokimab for the treatment of adult HS, adolescent HS, axSpA, PsA and PPP, including in comparison to existing standards or care or other competing therapies, clinical trials and research and development programs; potential market opportunities for sonelokimab; and MoonLake’s anticipated cash position. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking.
Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLake’s business in general and limited operating history, difficulty enrolling patients in clinical trials, state and federal healthcare reform measures that could result in reduced demand for MoonLake’s product candidates, reliance on third parties to conduct and support its preclinical studies and clinical trials, the impact of general economic, health, industrial or political conditions in the United States or internationally, including recently announced tariffs and potential additional tariffs, FDA and comparable foreign regulatory authorities changes in leadership or policies or issuing additional regulations or revising existing regulations, and the other risks described in or incorporated by reference into MoonLake’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent filings with the Securities and Exchange Commission, including MoonLake’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025.
Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based.
Contacts:
MoonLake Immunotherapeutics Media & Investors Relations
Carla Bretes, Director IR & External Communications
ir@moonlaketx.com
ICR Healthcare
Mary-Jane Elliott, Namrata Taak, Ashley Tapp
Tel: +44 (0) 20 3709 5700
MoonLake@ICRHealthcare.com
MOONLAKE IMMUNOTHERAPEUTICS
CONDENSED CONSOLIDATED BALANCE SHEETS
| (in thousands, except share and per share data) | June 30, 2025 (Unaudited) | March 31, 2025 (Unaudited) | ||
| Assets | ||||
| Current assets | ||||
| Cash and cash equivalents | $ 306,681 | $ 271,566 | ||
| Short-term marketable debt securities | 118,402 | 208,564 | ||
| Other receivables | 3,409 | 2,988 | ||
| Prepaid expenses | 26,989 | 23,146 | ||
| Total current assets | 455,481 | 506,264 | ||
| Non-current assets | ||||
| Operating lease right-of-use assets | 2,251 | 2,589 | ||
| Property and equipment, net | 667 | 711 | ||
| Other non-current assets | 1,697 | 1,698 | ||
| Total non-current assets | 4,615 | 4,998 | ||
| Total assets | $ 460,096 | $ 511,262 | ||
| Liabilities and Equity | ||||
| Current liabilities | ||||
| Trade and other payables | $ 17,079 | $ 12,006 | ||
| Accrued expenses and other current liabilities | 8,732 | 10,543 | ||
| Short-term portion of operating lease liabilities | 1,550 | 1,432 | ||
| Total current liabilities | 27,361 | 23,981 | ||
| Non-current liabilities | ||||
| Long-term debt | 73,381 | 73,022 | ||
| Long-term portion of operating lease liabilities | 836 | 1,142 | ||
| Pension liability | 574 | 536 | ||
| Total non-current liabilities | 74,791 | 74,700 | ||
| Total liabilities | 102,152 | 98,681 | ||
| Shareholders' equity | ||||
| Class A Ordinary Shares: | 6 | 6 | ||
| Class C Ordinary Shares: | — | — | ||
| Additional paid-in capital | 683,962 | 680,664 | ||
| Accumulated deficit | (330,757) | (275,537) | ||
| Accumulated other comprehensive income | 520 | 2,387 | ||
| Total shareholders’ equity | 353,731 | 407,520 | ||
| Noncontrolling interests | 4,213 | 5,061 | ||
| Total equity | 357,944 | 412,581 | ||
| Total liabilities and equity | $ 460,096 | $ 511,262 |
MOONLAKE IMMUNOTHERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
| (in thousands, except share and per share data) | Three Months Ended June 30, 2025 | Three Months Ended March 31, 2025 | ||
| Operating expenses | ||||
| Research and development | $ (49,762) | $ (36,459) | ||
| General and administrative | (10,936) | (11,026) | ||
| Total operating expenses | (60,698) | (47,485) | ||
| Operating loss | (60,698) | (47,485) | ||
| Interest expense | (2,037) | (18) | ||
| Other income, net | 6,779 | 7,097 | ||
| Loss before income tax | (55,956) | (40,406) | ||
| Income tax expense | (95) | (153) | ||
| Net loss | $ (56,051) | $ (40,559) | ||
| Of which: net loss attributable to controlling interests shareholders | (55,220) | (39,944) | ||
| Of which: net loss attributable to noncontrolling interests shareholders | (831) | (615) | ||
| Net unrealized loss on marketable securities and short-term investments | (1,908) | (2,756) | ||
| Actuarial gain on employee benefit plans | 13 | 95 | ||
| Other comprehensive loss | (1,895) | (2,661) | ||
| Comprehensive loss | $ (57,946) | $ (43,220) | ||
| Comprehensive loss attributable to controlling interests shareholders | (57,087) | (42,564) | ||
| Comprehensive loss attributable to noncontrolling interests | (859) | (656) | ||
| Weighted-average number of Class A Ordinary Shares, basic and diluted | 63,282,728 | 63,233,788 | ||
| Basic and diluted net loss per share attributable to controlling interests shareholders | $ (0.87) | $ (0.63) |
FAQ
What were MoonLake Immunotherapeutics (MLTX) Q2 2025 financial results?
When will MLTX announce Phase 3 VELA trial results for hidradenitis suppurativa?
How much funding did MoonLake secure from Hercules Capital?
What are the key upcoming milestones for MLTX in 2025-2026?
When does MoonLake expect to launch sonelokimab commercially?
