Medicus Pharma Receives FDA “Study May Proceed” Letter for NDA-Enabling Registrational SkinJect® Study in Patients with Gorlin Syndrome

Medicus Pharma Ltd. (NASDAQ:MDCX) (“Medicus” or the “Company”), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, today announced that the U.S. Food and Drug Administration (“FDA”) has completed its safety review of the Company's Investigational New Drug ("IND") application for SKNJCT-005 and issued a "Study May Proceed" letter authorizing the initiation of the Company's NDA-enabling registrational Phase 2b clinical study evaluating SkinJect® (D-MNA) 200 mcg in patients with Gorlin Syndrome presenting with multiple basal cell carcinomas ("BCCs"). The FDA authorization follows Medicus' submission of the SKNJCT-005 protocol and the Company's comprehensive response to the Agency's June 18, 2026, information requests.

“Receiving FDA clearance to initiate our registrational Gorlin Syndrome study represents a significant regulatory milestone for the SkinJect ® program,” stated Dr. Raza Bokhari, Medicus Executive Chairman and CEO. "Importantly, the FDA's recommendations strengthen the registrational study by enhancing the scientific rigor of the efficacy assessments while further supporting the long-term evaluation of treatment durability. We believe these refinements position SkinJect® to generate an even more robust data package as we advance toward a potential NDA submission for patients with Gorlin Syndrome, a population with substantial unmet medical need, who frequently face repeated surgeries throughout their lifetimes. The ability to treat multiple lesions using a localized precision therapy represents an important advancement and what we believe could become a new standard of care for this patient population."

SKNJCT-005 is designed as a Phase 2b, open-label, multicenter, NDA-enabling registrational study evaluating SkinJect® 200 mcg in patients with Gorlin Syndrome (Nevoid Basal Cell Carcinoma Syndrome) who develop multiple basal cell carcinomas requiring repeated surgical treatment. The study is intended to generate robust efficacy and safety data to support registration of SkinJect® in this rare disease population and is expected to enroll up to 50 patients. SkinJect® is a proprietary dissolvable microneedle-array patch that delivers doxorubicin directly into basal cell carcinoma lesions, enabling localized treatment while minimizing systemic drug exposure. Previous Phase 1 and Phase 2 studies have demonstrated a favorable safety profile together with encouraging clinical and histological clearance rates in patients with basal cell carcinoma. The submitted protocol cites data from the completed 90-patient SKNJCT-003 study demonstrating 64% clinical clearance and 55% histological clearance following three treatments with the 200-mcg dose at Day 57.

As part of the FDA review process, the Agency provided constructive recommendations designed to enhance the scientific and regulatory utility of the study. Medicus agreed to incorporate these recommendations through a protocol amendment, including: requiring baseline biopsy confirmation of nodular basal cell carcinoma for all enrolled patients; revising the primary efficacy endpoint to require both clinical and histological clearance at a prespecified time point; requiring in-person investigator assessment of clinical clearance in conjunction with...