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Medicus Pharma Ltd. Provides Update on Doxorubicin Containing Novel Microneedle Array (D-MNA) Clinical Development Program for the Treatment of Basal Cell Carcinoma (BCC) of the Skin and Reports Second Quarter 2025 Financial Highlights
Newsfile· 2025-08-21 11:30
Core Insights - Medicus Pharma Ltd. is advancing its clinical development program for a novel microneedle array (D-MNA) aimed at treating basal cell carcinoma (BCC) of the skin, with significant progress in its Phase 2 study [1][3][8] - The company has received FDA acceptance for a Type C meeting to discuss the D-MNA product development and seek fast-track approval for its clinical program [1][2] - Financial highlights for Q2 2025 indicate a net loss of $6.2 million, an increase in cash reserves to $9.7 million, and total operating expenses of $6.0 million, reflecting the company's investment in clinical development [12][13][15] Clinical Development - The SKNJCT-003 Phase 2 study has randomized over 75% of the 90 participants, focusing on the efficacy of D-MNA compared to a placebo [3][8] - The study is designed as a randomized, double-blind, placebo-controlled trial, evaluating two dose levels of D-MNA (100μg and 200μg) against a placebo [4][5] - An interim analysis in March 2025 showed over 60% clinical clearance among participants, with the study currently ongoing at nine clinical sites in the U.S. [8] Financial Performance - The company reported $11.5 million in net proceeds from financing and warrant exercises, enhancing its balance sheet [13] - Cash and cash equivalents increased from $4.0 million at the end of Q1 2025 to $9.7 million at the end of Q2 2025 [13] - Operating expenses rose to $6.0 million in Q2 2025 from $3.6 million in the same period in 2024, with R&D expenses slightly increasing to $1.4 million [13] Strategic Initiatives - Medicus Pharma is pursuing strategic transactions, including the acquisition of Antev Ltd., a UK-based biotech company focused on a GnRH antagonist for prostate cancer [10][18] - A non-binding memorandum of understanding has been established with Helix Nanotechnologies Inc. to explore the development of mRNA vaccines [11] - The company is also conducting a clinical study (SKNJCT-004) in the UAE, aiming to randomize 36 patients across four sites [9]