Medicus Pharma (NASDAQ: MDCX), a biotech and life sciences company dedicated to advancing innovative therapeutic assets, has announced a strategic partnership with the Gorlin Syndrome Alliance (GSA) to expand compassionate access to SKINJECT(TM), its investigational doxorubicin-containing microneedle array (D-MNA). This collaboration aims to provide new treatment options for patients with Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome, a rare genetic condition that leads to the development of hundreds to thousands of basal cell carcinomas (BCCs) over a lifetime.

Under the partnership, Medicus and the GSA will work together to pursue the FDA's Expanded Access IND Program, enabling patients with multiple, recurrent, or inoperable BCCs to access SKINJECT(TM) under physician-supervised protocols. This initiative will not only provide immediate treatment options but also collect real-world safety and tolerability data to support future regulatory filings. Additionally, the collaboration will integrate patient-driven insights into the design and monitoring of SKINJECT(TM)'s long-term development, ensuring the therapy aligns with the needs of this underserved population.

SKINJECT(TM) is a localized, non-invasive investigational therapy designed to treat non-melanoma skin diseases, particularly basal cell carcinoma. The patented dissolvable microneedle array delivers doxorubicin directly to tumor cells, offering a precision approach to treatment. Interim results from the ongoing SKNJCT-003 Phase 2 trial in the U.S. have shown promising outcomes, with over 60% of patients achieving clinical clearance. The trial, which began in August 2024, has since expanded to include 90 participants across nine clinical sites, with more than 75% of patients already randomized. In September 2025, the FDA provided positive feedback during a Type C meeting, confirming that SKINJECT(TM) may follow the 505(b)(2) regulatory pathway, potentially accelerating its development timeline.

In addition to its U.S. trial, Medicus is conducting the SKNJCT-004 study in the United Arab Emirates (UAE), involving six hospital sites and 36 patients. The study is being coordinated by Insights Research Organization and Solutions (IROS), a UAE-based contract research organization, with Cleveland Clinic Abu Dhabi serving as the principal investigator.

Gorlin Syndrome affects approximately 1 in 31,000 people worldwide, often beginning in early childhood. Patients face a lifetime of recurring skin cancers, requiring frequent surgeries and treatments that can be physically and emotionally taxing. "Patients with Gorlin Syndrome endure a relentless cycle of skin cancers and disfiguring treatments," said Dr. Raza Bokhari, Executive Chairman and CEO of Medicus. "By collaborating with the Gorlin Syndrome Alliance, we aim to unite clinical science, regulatory expertise, and patient advocacy to deliver hope and innovation to this underserved community."

Meredith Weiss, Executive Director of the GSA, echoed this sentiment: "Our families live with a relentless disease, never free from the cycle of cancer. This collaboration bridges the gap between breakthroughs in skin cancer therapy and the real-world needs of Gorlin Syndrome patients. It gives our community a voice in designing ethical and responsible pathways to access novel therapies."

In August 2025, Medicus further diversified its pipeline with the acquisition of Antev, a UK-based biotech company developing Teverelix, a next-generation GnRH antagonist. Teverelix is designed for advanced prostate cancer patients with cardiovascular risks and those experiencing acute urinary retention due to an enlarged prostate. Unlike traditional GnRH agonists, Teverelix directly suppresses sex hormone production without causing an initial testosterone surge, potentially reducing cardiovascular complications. The drug's long-acting formulation allows for a six-week dosing interval, improving patient compliance and outcomes.

Medicus anticipates several key milestones in the coming months. Full data from the SKNJCT-003 trial is expected in 2026, which will be pivotal for regulatory positioning. Early patient experiences under the compassionate use program for Gorlin Syndrome are expected to strengthen regulatory filings and patient advocacy efforts. Additionally, progress in the UAE trial and updates on Teverelix's late-stage development will provide further momentum for the company.

About Medicus Pharma Ltd.
Medicus Pharma Ltd. (NASDAQ: MDCX) is a biotech and life sciences company focused on accelerating the clinical development of novel and potentially disruptive therapeutic assets. The company operates across multiple countries and continents, with a mission to address significant unmet medical needs through innovative solutions. Its wholly owned subsidiary, SkinJect Inc., specializes in non-invasive treatments for basal cell carcinoma using patented dissolvable microneedle technology.

For more information about Medicus Pharma please visit www.medicuspharma.com.