The Clinical Study is Expected to Randomize 36 Participants in Cleveland Clinic Abu Dhabi (CCAD) and Three Other Clinical Sites in UAE

Philadelphia, Pennsylvania - Newsfile Corp. - February 27, 2025 - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce that it has submitted a clinical design (SKNJCT-004) to UAE DOH to non-invasively treat BCC of the skin. The study is expected to randomize thirty-six (36) patients in four sites in UAE, which are Cleveland Clinic Abu Dhabi (CCAD), Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), and American Hospital of Dubai (AHD). Insights Research Organization and Solutions (IROS), a UAE-based contract research organization, is coordinating the clinical study for the Company. IROS is a M42 portfolio company. Clinical Trial Design (SKNJCT-004) The clinical study, SKNJCT-004, is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 36 subjects presenting with BCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared to a placebo control. The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA. The high-dose, 200μg D-MNA, proposed in the study is the maximum dose that was used in the Company's Phase 1 safety and tolerability study (SKNJCT-001) completed in March 2021. SKNJCT-001 met its primary objective of safety and tolerability. The investigational product, D-MNA, was well tolerated across all dose levels in all 13 participants enrolled in the study, with no dose-limiting toxicities (DLTs), or serious adverse events (SAEs). Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examinations. The study also describes the efficacy of the investigational product, D-MNA, with 6 participants experiencing complete responses. The complete response is defined as the disappearance of BCC histologically in the final excision at the end of study visit. The participants profile demonstrating complete responses was diverse, and all participants (6/6) had nodular subtype of BCC. The Company also has SKNJCT-003 Phase 2 clinical study currently underway in 9 clinical sites in the United States, which is expected to randomize 60 patients. The patient recruitment in this study, which began in August 2024, has now randomized more than 50% of the 60 patients expected to be enrolled in the study. The Company is on track to complete an interim data analysis of SKNJCT-003 before the end of Q1 2025 and to submit its findings to the United States Food and Drug Administration (FDA) as part of a package seeking a Type C meeting with the FDA in Q2 2025. The purpose of the Type C meeting is to formally discuss the product development and gain further alignment on the clinical pathway. The Company's aim is to gain FDA's consent to fast-track the clinical development program. "We are making substantial progress in expanding the clinical development program of our novel non-invasive treatment to cure the most common cancer in the world, beyond the shores of United States, stated Dr. Raza Bokhari, Executive Chairman & CEO. "UAE is rapidly emerging as a significant hub for Pharmaceutical R&D, driven by strategic investments, public-private partnerships and a commitment to innovation. A clinical study in the middle east will help us gather useful efficacy and safety data. It will also help us strengthen our clinical development program, as we aspire to bring to market not only the first-in-class, but also the best-in-class, novel non-invasive treatment regimen for BCC". For further information contact: Carolyn Bonner, President (610) 636-0184 cbonner@medicuspharma.com Jeremy Feffer LifeSci Advisors (212) 915-2568 jfeffer@lifesciadvisors.comAbout Medicus Pharma Ltd:Medicus Pharma Ltd. (Nasdaq: MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutics assets. SkinJect Inc. a wholly owned subsidiary of Medicus Pharma Ltd, is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using patented dissolvable microneedle patch to deliver chemotherapeutic agent to eradicate tumors cells. The Company has completed a phase 1 safety & tolerability study (SKNJCT-001) in March of 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of the investigational product D-MNA, with six (6) participants experiencing complete response on histological examination of the resected lesion. The Company submitted a Phase 2 IND clinical protocol to the FDA in January 2024 for a randomized, controlled, double-blind, multicenter clinical study...