MDCX News & Events

Medicus Pharma announced that Babar Rao, MD, FAAD, an internationally recognized academic dermatologist and Principal Investigator of the SKNJCT-003 Phase 2 clinical study, will join the Company's leadership team during a business update webcast on March 26, 2026 at 11:30 a.m. Eastern time. The SKNJCT-003 study represents a randomized, double-blind Phase 2 clinical trial designed to rigorously evaluate the therapeutic contribution of doxorubicin delivered through the SkinJect microneedle platform in patients with nodular basal cell carcinoma. The update call will follow the filing of the Company's Form 10-K for fiscal year 2025, expected after market close on March 25, 2026. During the call, Dr. Rao will provide clinical interpretation and independent investigator perspective on the recently reported positive dataset from SKNJCT-003. The randomized design of SKNJCT-003, including a device-only control arm, provides a rigorous framework for evaluating the incremental therapeutic contribution of doxorubicin delivered through the SkinJect microneedle system. The study results demonstrate clear separation in clinical response between the D-MNA treatment arm and P-MNA treatment arm in the 200-microgram cohort at Day 57, supporting the continued development of SkinJect as a potential non-surgical treatment option for patients with basal cell carcinoma. The biological activity observed in the device-only arm likely reflects tumor disruption and localized immune activation resulting from microneedle insertion, a phenomenon previously described in intratumoral and microneedle-mediated device studies evaluating solid tumors. The 200-microgram treatment cohort demonstrated the strongest efficacy signal, achieving 73% clinical clearance and 40% histological clearance at Day 57. Importantly, the magnitude of response observed in the active treatment cohort relative to the device-only control arm provides clinically meaningful evidence of drug-mediated therapeutic effect within a biologically active microneedle delivery platform. The Company believes the dataset represents decision-grade evidence supporting continued development of the SkinJect program and advancement toward regulatory discussions and potential strategic partnerships.

Medicus Pharma provided additional context regarding the recently reported topline dataset from the Phase 2 SKNJCT-003 study evaluating SkinJect microneedle delivery of D-MNA and P-MNA for basal cell carcinoma, BCC. The dataset demonstrated 73% clinical clearance and 40% histological clearance in the 200-microgram treatment cohort at Day 57, representing the strongest treatment response observed in the study. "We believe that these findings are particularly notable given the device-based mechanism of SkinJect, where microneedle delivery itself may produce biological activity that can contribute to responses observed even in placebo active arm, that was not tip-loaded with the chemotherapeutic agent," the company said.

Medicus Pharma announces topline results from its Phase 2 clinical study evaluating safety and efficacy of Doxorubicin Microneedle Array, D-MNA, to non-invasively treat basal cell carcinoma of the skin. The Company believes the topline results are not only positive but decision-grade that should support an end of phase 2 meeting with the FDA in the first half of 2026 as well as accelerate partnering readiness. "We are extremely encouraged by these topline results, which not only validate management's scientific and investment thesis, but also provide what we consider to be decision-grade evidence of clinical activity, particularly at the 200-microgram dose level," said Dr. Raza Bokhari, Executive Chairman & CEO of Medicus.