On May 6, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, reported results from a pre-specified expanded dataset analysis demonstrating positive dose response from its Phase 2 SKNJCT-003 study evaluating safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to treat nodular basal cell carcinoma (BCC) of the skin, the most common type of skin cancer.

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These additional pre-specified analysis, build upon the previously reported positive topline results, provide expanded biological, histologic, and safety insights that further strengthen SkinJect’s therapeutic profile and future registrational discussions with the U.S. Food and Drug Administration (FDA). These additional findings are also consistent with prior Phase 1 clinical observations in the SKNJCT-001 study in March 2021, and interim analysis of SKNJCT-003 in March 2025, reinforcing reproducibility across studies.

SKNJCT-003 Study Design Overview (NCT06608238)::

The SKNJCT-003 (NCT06608238) clinical study was designed as a randomized, double-blind, three-arm Phase 2 study evaluating two dose levels of microneedle-mediated delivery of doxorubicin compared with a device-only control in patients with nodular basal cell carcinoma. It was a multi-center study designed to enroll 90 participants presenting with nodular type basal cell carcinoma. The participants were randomized 1:1:1 into three groups:

Device-controlled group receiving P-MNA
Low-dose group receiving 100µg of D-MNA
High-dose group receiving 200µg of D-MNA

Expanded central pathology reconciliation demonstrated that 69 participants met intended nodular BCC inclusion criteria, while 21 participants were identified as superficial or mixed subtype lesions.

The Results from Pre-specified Expanded Analysis of 69 participants are summarized below:

Dose # of patients(n) Day 29 post-treatment # of patients(n) Day 57 post-treatment
35 Clinical Clearance Histological Clearance (CR) 34 Clinical Clearance Histological Clearance (CR)
Device-only 12 42 % 25 % 14 29 % 29 %
100ug D-MNA 12 42 % 25 % 9 44 % 33 %
200ug D-MNA 11 46 % 27 % 11 64 % 55 %

The expanded analysis demonstrates a progressive and dose-dependent improvement, with the strongest separation emerging at Day 57.

"We are encouraged by these additional findings in the expanded analysis, which we believe meaningfully strengthens the clinical and regulatory foundation of the SKNJCT-003 Program" stated Dr. Raza Bokhari, Chairman and CEO of Medicus. "We are confident that this dataset moves us from Proof-of-concept to a clear registrational path, and we believe Skinject has the potential to fundamentally change the current approach of treating patients with BCC, addressing a major un-met medical need".

From Positive Topline Dataset to Positive Dose-Response:

The Company previously reported topline results from the population of 90 randomized patients, which demonstrated a positive topline and decision-grade dataset. The 69-patient refined efficacy analysis further strengthens the regulatory alignment of the study as the Company advances toward End-of-Phase 2 (EOP2) discussions with the FDA.

The topline dataset showed that:

The 200µg cohort achieved the highest observed activity at Day 57
Clearance rates improved from Day 29 to Day 57, consistent with continued biological activity over time

The pre-specified expanded dataset analysis builds on this foundation by:

Revealing a clear and consistent dose-response relationship across endpoints
Demonstrating stronger separation between the 200µg cohort and control, particularly at Day 57
Strengthens differentiation between drug-driven efficacy and device-only biological activity

Importantly, this expanded central pathology verified dataset provides a more precise and clinically interpretable view of treatment effect, with the 200µg cohort at Day 57 emerging as the leading dose with the most robust and consistent efficacy signal.

These findings suggest that many treated lesions may in the future be able to avoid immediate surgical intervention, representing a potentially meaningful shift in the treatment paradigm for BCC. Given the short treatment and excision timeline evaluated, these results are particularly encouraging and may suggest clinically meaningful anti-tumor activity within a highly practical therapeutic window.

Collectively, this dataset may support future registration-intent or NDA-enabling development discussions, including optimized patient population, lesion subtype, dose regimen, and treatment-to-excision interval.

D-MNA continued to demonstrate a highly favorable safety and tolerability profile, was generally well tolerated with no drug-related serious adverse events, no evidence of systemic doxorubicin toxicity, and predominantly mild localized treatment-site reactions, supporting repeatable lesion-directed administration consistent with prior Phase 1 observations.

Reinforcing Drug-Driven Therapeutic Effect:

The device-only arm also demonstrated early biological activity consistent with microneedle-induced local immune response, but it did not show sustained or deepening efficacy over time. In contrast, the 200µg D-MNA cohort demonstrated progressive improvement from Day 29 to Day 57, resulting in clear separation across both clinical and histological endpoints. This pattern is consistent with drug-driven therapeutic effect, rather than a device-only response.

Independent Investigator Validation Supports Clinical and Regulatory Read-Through

These findings are further supported by independent investigator validation from a leading academic dermatologist and clinical investigator.

Dr. Babar K. Rao, MD, FAAD, Principal Investigator of the SKNJCT-003 study, is an internationally recognized academic dermatologist, dermatopathologist, and clinical investigator in skin oncology. He serves as Professor of Dermatology and Pathology at Rutgers Robert Wood Johnson Medical School and holds academic appointments at Weill Cornell Medical College.

Dr. Rao has evaluated the dataset and noted that he believes it demonstrates a clinically meaningful rapid onset efficacy, clear differentiation between drug and device effect and a profile that supports continued development and regulatory progress. Dr. Rao noted the consistency between visual, histologic, and central pathology findings is highly encouraging and provides growing confidence that SkinJect is producing meaningful biologic anti-tumor effects. Notably, clinically meaningful anti-tumor responses were observed within weeks, potentially differentiating D-MNA from many existing non-surgical therapies that often require substantially longer treatment durations. This analysis also improves the understanding of the patient populations and treatment parameters most likely to optimize future clinical outcomes.

The Company believes these findings further de-risk advancement of the 200µg regimen and informs the design of subsequent development studies, including assessment timing, lesion selection, and endpoint strategy.

(Press release, Skinject, MAY 6, 2026, View Source [SID1234665233])