MoonLake Immunotherapeutics Stock Price, News & Analysis

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.

MoonLake Immunotherapeutics has signed a Master Development Services Agreement with Vetter Pharma International. This partnership will focus on the aseptic filling of syringes with sonelokimab, an investigational Nanobody^® targeting inflammatory diseases. The manufacturing studies are set to conclude, with clinical Good Manufacturing Practice batches expected by Q4 2022. This agreement strengthens the supply chain for sonelokimab, aimed at conditions like hidradenitis suppurativa and psoriatic arthritis, significantly impacting patients in need.