The Interim Analysis Showed Complete Clinical Clearance of More than Sixty (60%) Percent

Philadelphia, Pennsylvania - Newsfile Corp. - March 6, 2025 - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce a positively trending interim analysis for SKNJCT-003 Phase 2 clinical study to non-invasively treat basal cell carcinoma of the skin (BCC). The SKNJCT-003 clinical study is currently underway in nine (9) clinical sites in United States and is expected to randomize 60 patients. The interim analysis was conducted after more than 50% of the targeted 60 patients in the study were randomized. The interim analysis shows the clinical study SKNJCT-003 is trending positively with a proportion of subjects with complete clinical clearance of more than 60%. The analysis also shows the investigational product, D-MNA was well tolerated for both dose levels, a low-dose group receiving 100ug of D-MNA and a high-dose group receiving 200ug of D-MNA in all participants so far enrolled in the study, with no dose limiting toxicities (DLTs), or serious adverse events (SAEs). In addition, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examination. The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed. The Company plans to submit the interim analysis 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 immensely encouraged by the positively trending interim analysis," stated Dr. Raza Bokhari, Executive Chairman & CEO. "The interim analysis brings us one step closer to delivering a novel, non-invasive treatment for BCC." Clinical Trial Design The clinical study is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 60 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 submitted a clinical design (SKNJCT-004) to United Arab Emirates (UAE) Department of Health (DOH). The study is expected to randomize 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). 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,...