MoonLake Immunotherapeutics - MLTX STOCK NEWS

ZUG, Switzerland, April 19, 2023 – MoonLake Immunotherapeutics AG (Nasdaq: MLTX) is hosting its Capital Markets Day in New York, featuring a live webcast for virtual attendees. The event runs from 10:30-12:30 EDT and includes presentations from the executive team discussing a financial update, near-term catalysts, and the company’s publication roadmap.

The focus will be on sonelokimab, a novel investigational Nanobody^® targeting inflammatory diseases, along with an update from Professor Kenneth B. Gordon on treatment landscapes following the AAD Annual Meeting. Top-line results for sonelokimab’s Phase 2 trial in hidradenitis suppurativa are anticipated by June 2023, with additional trials in psoriatic arthritis ongoing.

MoonLake Immunotherapeutics (NASDAQ:MLTX) reported its Q4 and year-end financial results for 2022, revealing a strong cash position of $72.1 million, providing operational runway into 2H 2024.

The company has completed patient enrollment ahead of schedule in its global Phase 2 trial of sonelokimab for Hidradenitis Suppurativa, with top-line results expected by June 2023. Additionally, enrollment for the Psoriatic Arthritis trial is ongoing and on schedule, with results anticipated by year-end. The net loss for the year was $64.5 million, an increase from $53.6 million in the prior period. The CEO highlighted the successful initiation of clinical trials and competitive positioning in the IL-17 inhibitor market.

MoonLake Immunotherapeutics announced the completion of patient enrollment and randomization ahead of schedule for its Phase 2 clinical trial of sonelokimab in treating moderate-to-severe hidradenitis suppurativa (HS). The trial, known as the MIRA trial, has reached its target of 210 patients and aims to evaluate the effectiveness of sonelokimab, a novel IL-17A and IL-17F inhibitor. Top-line results are expected by mid-2023, with a final readout planned for Q4 2023. The trial uses HiSCR75 as its primary endpoint, reflecting MoonLake's ambition to improve patient outcomes.

MoonLake Immunotherapeutics has initiated a Phase 2 study named ARGO for sonelokimab, targeting active psoriatic arthritis.

The randomized, double-blind trial involves approximately 200 patients to evaluate the drug's efficacy and safety against a placebo and adalimumab.

The primary endpoint is the ACR 50 response, measuring ≥50% improvement in disease symptoms. This follows successful results from a Phase 2b study in psoriasis, highlighting sonelokimab's potential in treating inflammatory conditions.

MoonLake Immunotherapeutics (NASDAQ:MLTX) reported its Q3 2022 financial results, highlighting a cash position of $83.5 million, providing a runway into 2H 2024. The global trial of sonelokimab for Hidradenitis Suppurativa continues to meet recruitment goals, with primary endpoint data expected mid-2023. Additionally, the Psoriatic Arthritis trial received FDA clearance and is on schedule. R&D expenses decreased to $9 million from $11.4 million, while the net loss narrowed to $14.7 million compared to the previous quarter.

MoonLake Immunotherapeutics has received FDA clearance to initiate a global Phase 2 clinical study for its investigational Nanobody® sonelokimab in patients with active psoriatic arthritis. The study aims to enroll around 200 patients to evaluate the drug's efficacy and safety against a placebo, with adalimumab as a reference. This milestone follows the completion of prior clinical trials and aims to assess significant outcomes related to this complex disease.