Medicus Pharma Provides Update on SKNJCT-003 Phase 2 Clinical Study for the Treatment of Nodular Basal Cell Carcinoma

The Institutional Review Board Has Approved the Increase in Number of Patients from Sixty (60) to Ninety (90). The Company to Expand the Study into Additional Trial Sites in Europe.

Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”) is pleased to announce that Institutional Review Board (IRB) has approved the increase in number of patients from sixty (60) to Ninety (90 The phase 2 clinical study (SKNJCT-003) which is currently underway in nine (9) clinical sites in United States will expand into additional sites in United States, as well as two clinical trial sites in Europe.

The Company also announced that it has randomized more the forty-five (45) participants in the study and is on track to submit the package seeking a Type C meeting with the United States Food and Drug Administration (FDA) before the end of Q2 2025.

“Increasing the number of participants in the study and expanding the clinical trial sites in Europe is very time appropriate,” stated Dr. Raza Bokhari, Executive Chairman & CEO. “With our study design awaiting approval by the Department of Health in Abu Dhabi, and exploring collaboration in the Asia-pacific region, we are makingpromising progress in securing global validation of our novel, non-invasive treatment for BCC.”

Earlier in March 2025, the Company’s interim analysis showed that clinical study SKNJCT-003 is trending positively with a proportion of subjects with complete clinical clearance of more than 60%. The analysis also showed 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.

Clinical Trial Design

The clinical study is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 90 subjects presenting with BCC of the skin. The study evaluates 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: aplacebo-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, 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).