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MoonLake Immunotherapeutics Reports First Quarter 2025 Financial Results and Provides a Business Update
GlobeNewswire News Room· 2025-05-12 20:00
Core Insights - MoonLake Immunotherapeutics reported its financial results for Q1 2025, highlighting progress in its clinical programs and financial stability [2][5][3] Financial Performance - As of March 31, 2025, the company held cash, cash equivalents, and short-term marketable debt securities totaling $480.1 million [5] - Research and development expenses for Q1 2025 were $36.5 million, a slight decrease from $40.4 million in the previous quarter [5] - General and administrative expenses increased to $11.0 million from $9.2 million in the previous quarter, primarily due to personnel-related costs and legal fees [5] - The net loss for Q1 2025 was $40.6 million, compared to a net loss of $14.0 million in Q1 2024 [42] Clinical Development Progress - The company has made significant advancements in its Phase 3 VELA program for hidradenitis suppurativa (HS), with enrollment completed and baseline characteristics mirroring the Phase 2 MIRA trial [7][3] - An interim readout from the Phase 2 LEDA study in palmoplantar pustulosis (PPP) was presented, indicating potential for sonelokimab in a market with no approved therapeutics [7][3] - Three new trials were initiated in early 2025, including the VELA-TEEN trial for adolescent HS and two Phase 2 trials for PPP and axial spondyloarthritis (axSpA) [8][7] Financing and Cash Runway - The company secured a non-dilutive financing agreement with Hercules Capital for up to $500 million, enhancing its financial position and extending its cash runway into 2028 [3][8] - As of the end of Q1 2025, the company’s total assets were $511.3 million, with total liabilities of $98.7 million [39][40] Market Opportunity - The market for hidradenitis suppurativa is projected to reach $15 billion by 2035, indicating a significant unmet need and opportunity for innovative therapies [26] - The company focuses on inflammatory diseases with high unmet needs, including HS and psoriatic arthritis (PsA), which affect millions globally [11][28]
MoonLake Immunotherapeutics to host a Capital Markets Day on Tuesday, April 29
Globenewswire· 2025-04-25 20:05
Core Viewpoint - MoonLake Immunotherapeutics is set to host a virtual Capital Markets Day on April 29, 2025, to discuss recent financial and clinical milestones, along with future strategic updates [1][2]. Financial Update - The company has secured a non-dilutive financing agreement of up to $500 million with Hercules Capital, enhancing its financial position and supporting clinical and commercial objectives while preserving shareholder value [3]. Clinical Updates - The Phase 3 VELA Program for Hidradenitis Suppurativa (HS) has completed patient recruitment, with management sharing baseline characteristics and comparability to other trials, along with narrowed guidance on the timing of primary endpoint read-out [4]. - An earlier-than-expected interim readout from the Phase 2 LEDA Study in Palmoplantar Pustulosis (PPP) indicates the potential of sonelokimab in the PPP market, further derisking the asset's overall development [5]. Future Strategic Outlook - Insights on market opportunities will be discussed, including recent data analyses, competitor performance, and strategic imperatives for the company [6]. A Q&A session will follow the presentation [6]. Company Overview - MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company focused on sonelokimab, a novel investigational Nanobody targeting inflammatory diseases, particularly HS and psoriatic arthritis, which affect millions globally [8][12]. - The company was founded in 2021 and is headquartered in Zug, Switzerland [8]. About Sonelokimab - Sonelokimab is a humanized Nanobody that selectively binds to IL-17A and IL-17F, inhibiting inflammation [12]. It is being evaluated for multiple indications, including HS and psoriatic arthritis, with ongoing trials demonstrating significant clinical responses [14][16]. Market Opportunity - Hidradenitis Suppurativa affects an estimated 2% of the population, with a projected market opportunity reaching $15 billion by 2035 due to significant unmet medical needs [22]. - Palmoplantar Pustulosis presents a similar challenge, with a high demand for novel therapies to alleviate symptoms [26].