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MoonLake Immunotherapeutics Reports Full Year 2023 Financial Results, Recent Business Highlights and Announces an R&D Day on March 10 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
By: GlobeNewswire - 29 Feb 2024 | Back to overview list |
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MoonLake Immunotherapeutics Reports Full Year 2023 Financial Results, Recent Business Highlights and Announces an R&D Day on March 10
ZUG, Switzerland, February 29, 2024 – MoonLake Immunotherapeutics (NASDAQ: MLTX) (“MoonLake”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced its financial results for the fourth quarter and year ended December 31, 2023, and provided recent business highlights. Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “2023 was another momentous year for MoonLake in the inflammation and immunology field. We reported positive results from two global Phase 2 trials of our Nanobody® sonelokimab in hidradenitis suppurativa (HS) and active psoriatic arthritis. We were highly selective in our choice of endpoints for these trials in a deliberate plan to raise the bar for patients suffering from these diseases characterized by profound patient burden and significant unmet medical need. Following highly encouraging interactions with both the FDA and EMA regarding our data and forthcoming Phase 3 trial designs for HS, we are completing plans to initiate our Phase 3 trials for both indications. On top of this, support from world-renowned experts, clinicians, and patient organizations for our data, science and methodologies continues to mount. We look forward to sharing more information with everyone at our upcoming R&D Day on 10 March.” Q4 highlights (including post-quarter end)
Fourth quarter and year-end financial results As of December 31, 2023, MoonLake held cash, cash equivalents and short-term marketable debt securities of $511.0 million, compared to $496.0 million as of September 30, 2023. The increase of $15.0 million was primarily attributable to the gross proceeds of at-the-market offerings, partially offset by cash used in the Company’s operations. Matthias Bodenstedt, Chief Financial Officer at MoonLake Immunotherapeutics, said: “MoonLake has added considerable shareholder value over the past year, and we are driven to continue building on this. In December of last year, and in early 2024, we pursued at-the-market offerings, bringing in gross proceeds of $85 million at minimal dilution. The new funds allow us to double down on the clinical development of sonelokimab across multiple indications, whilst securing an additional expected cash runway to the end of 2026. We are looking forward to sharing updates on our roadmap rich in potential catalysts, together with the highly anticipated 24 week data from our ARGO study in active psoriatic arthritis, at our upcoming R&D Day.” Research and development expenses for the fourth quarter ended December 31, 2023 were $8.1 million, compared to $7.6 million in the previous quarter. Research and development expenses for the year ended December 31, 2023 were $31.8 million, compared to $42.0 million in the previous year. The decrease was primarily driven by a decrease in milestone expense incurred under the in-licensing agreement of sonelokimab. General and administrative expenses for the fourth quarter ended December 31, 2023 were $6.9 million, compared to $5.4 million in the previous quarter. General and administrative expenses for the year ended December 31, 2023 were $22.3 million which was similar to the $23.0 million incurred in the prior year. Other non-operating income increased from $0.6 million in the prior year to $10.1 million for the year ended December 31, 2023. The increase was primarily attributable to interest income achieved from investments in short-term marketable debt securities. Net loss for the year ended December 31, 2023 was $44.1 million, compared to $64.5 million for the prior year ending December 31, 2022. R&D Day, on Sunday, March 10 MoonLake will be hosting an R&D Day for investors and analysts in San Diego, USA on Sunday, March 10 alongside the American Academy of Dermatology (AAD) annual meeting. The event will take place from 09:00 – 11:30 PST/ 12:00 – 14:30 EST/18:00 – 20:30 CET at the Hotel Westin Bayview, San Diego and will be webcast for virtual attendees. The R&D Day will provide important business updates from MoonLake’s executive team including:
The event will feature presentations from leading clinicians in dermatology and rheumatology. Professor Joseph F. Merola, Founding President of the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network Consortium (PPACMAN) and Vice President of GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis), and Professor Kenneth B. Gordon, Chair of Dermatology at the Medical College of Wisconsin, will share their perspectives on the potential of MoonLake’s investigational Nanobody® sonelokimab in IL-17A and IL-17F driven inflammatory diseases. A live Q&A session involving all presenters will follow the event. Register to attend either the in-person event or webcast here. A recording and additional details will be available on the Events & Presentations section of the Company’s website at www.ir.moonlaketx.com. Upcoming banking conferences
- 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. About Sonelokimab Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHH domains 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 human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema. Sonelokimab is being assessed in two trials, the Phase 2 ARGO trial in PsA and the Phase 2 MIRA trial in HS. 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 clinically relevant outcomes. In November 2023, MoonLake announced positive top-line results from its global Phase 2 ARGO trial evaluating the efficacy and safety of the Nanobody® sonelokimab in patients with active psoriatic arthritis (PsA). 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 American College of Rheumatology (ACR)50 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. Sonelokimab has also been assessed in a randomized, placebo-controlled 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 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). Sonelokimab is not yet approved for use in any indication. Sonelokimab is not yet approved for use in any indication. About the MIRA trial About the ARGO trial Cautionary Statement Regarding Forward Looking Statements 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; expectations regarding the timing of the Phase 3 programs in HS and PsA; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical studies; MoonLake’s substantial dependence on the success of its Nanobody® sonelokimab; 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 and clinical trials. 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. CONTACT: MoonLake Immunotherapeutics Investors Matthias Bodenstedt, CFO ir@moonlaketx.com MoonLake Immunotherapeutics Media Patricia Sousa, Director Corporate Affairs media@moonlaketx.com ICR Consilium Tel: +44 (0) 20 3709 5700 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)
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