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, is pleased to announce topline results from its Phase 2 clinical study (SKNJCT-003) evaluating safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin.
The Company believes the topline results are not only positive but decision-grade that should support an end of phase 2 (EOP2) meeting with the FDA in the first half of 2026 as well as accelerate partnering readiness.
SKNJCT-003 Clinical Trial Design and Topline Results:
The SKNJCT-003 clinical study was designed as a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling 90 patients presenting with nodular type BCC of the skin. The study evaluated the safety and efficacy of two dose levels of D-MNA compared to placebo control.
Participants were randomized 1:1:1 into three groups:
- Placebo-controlled group receiving P-MNA
- Low-dose group receiving 100μg of D-MNA
- High-dose group receiving 200μg of D-MNA
The primary endpoint for treatment of BCC is a binary, multi-component endpoint defined as achieving both clinical and histological clearance (i.e. the proportion of patients demonstrating both clinical (visual) clearance and histological clearance (CR) at a prespecified post-treatment timepoint.
The prespecified post-treatment timepoints at the end of the study were:
- Day 29 for 47 patients
- Day 57 for 43 patients
The Topline results are tabulated below:
| Dose | # of patients(n) | Day 29 post-treatment | # of patients(n) | Day 57 post-treatment | ||
| 47 | Clinical Clearance | Histological Clearance (CR) | 43 | Clinical Clearance | Histological Clearance (CR) | |
| Placebo | 15 | 33% | 20% | 16 | 38% | 38% |
| 100ug D-MNA | 17 | 47% | 24% | 12 | 42% | 33% |
| 200ug D-MNA | 15 | 40% | 27% | 15 | 73% | 40% |
The dataset demonstrates that clearance rates increased between Day 29 and Day 57, consistent with continued biological activity over time. The 200µg cohort demonstrated the highest observed activity at Day 57, achieving 73% Clinical Clearance and 40% Histological Clearance (CR).
“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 bedecision-grade evidence of clinical activity, particularly at the 200-microgram dose level,” said Dr. Raza Bokhari, Executive Chairman & CEO of Medicus.
“The observed increase in clearance rates at Day 57 in the higher-dose cohort reinforces the sustained biological activity of SkinJect and supports advancement into the next stage of development. Importantly, we believe this dataset strengthens our position in ongoing and prospective partnering discussions and may accelerate strategicengagement as we evaluate optimal pathways for value creation.”
Clinical Study Report and Regulatory Pathway:
These results reflect the analysis of the primary and key secondary efficacy endpoints. Final compilation of the Clinical Study Report (CSR), including full safety analyses and procedural observations such as post-excisional biopsy site assessments, remains ongoing and is expected to be completed in Q2 2026. The Company does not anticipatematerial changes to the reported efficacy findings.
The SKNJCT-003 study was not powered for registrational endpoints and no conclusions regarding regulatory approval or the outcome of the planned EOP2 meeting with the FDA can be drawn at this time, there can be no assurance that SKNJCT-003 will be granted regulatory approval from the FDA.
Strategic Focus on Phase 2 De-Risking and Partnering
Medicus’ development strategy is to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships with established pharmaceutical companies for late-stage development and commercialization.
The Company continues to assemble decision-grade clinical and regulatory data packages across its portfolio to support this partnering-focused model.
About Medicus Pharma Ltd.
Medicus Pharma Ltd. (Nasdaq: MDCX) is a precision-guided biotech/life sciences company focused on accelerating the clinical development programs of novel and potentially disruptive therapeutics assets. The Company is actively engaged in multiple countries across three continents.
SkinJect Inc., a wholly owned subsidiary of Medicus Pharma Ltd., is a development-stage life sciences company focused on commercializing a novel, non-invasive treatment for basal cell skin cancer using a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumor cells. The Company completed a Phase 1 study (SKNJCT-001) in March of 2021, which met its primary objective of demonstrating safety and tolerability; the study also describes the efficacy of the investigational product doxorubicin-containing microneedle arrays (D-MNA), with six participants experiencing complete response on histological examination of the resected lesion. The Company is currently concluding a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) in the United States and Europe. The Company has also commenced a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-004) in the United Arab Emirates.
In August 2025, the Company announced its entry into a non-binding memorandum of understanding (MoU) with Helix Nanotechnologies, Inc. (HelixNano), a Boston-based biotech company focused on developing a proprietary advanced mRNA platform, in respect of their shared mutual interest in the development or commercial arrangementcontemplated by the MoU. The MoU is non-binding and shall not be construed to obligate either party to proceed with a joint venture or any further development or commercial arrangement, unless and until definitive agreements are executed.
In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next-generation gonadotrophin-releasing hormone (GnRH) antagonist, as a first-in-market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate.
Unlike GnRH agonists, which can cause an initial surge in testosterone levels, Teverelix directly suppresses sex hormone production without this surge, potentially reducing cardiovascular risks. This mechanism is particularly beneficial for patients with existing cardiovascular conditions. Teverelix is formulated as a microcrystalline suspension, allowing for sustained release and a six-week dosing interval, which may improve patient compliance and outcomes.
In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome.
Under the collaboration, Medicus and the GSA will jointly pursue the Expanded Access IND Program with the FDA to allow patients with multiple, recurrent, or inoperable basal cell carcinomas (BCCs) to access SkinJect under physician-supervised treatment protocols. The initiative aims to establish a framework for expanded access while collecting valuable real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SkinJect in this rare disease population.
In November 2025, the Company received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. The approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA approval followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA granted study-wide governance approval, confirming compliance with UK Good Clinical Practice and National Health Service capacity and capability standards.
In December 2025, the Company announced that it has successfully completed enrolment of 90 patients in the United States for Phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. The Company expects to secure an end-of-Phase 2 meeting with the FDA in the first half of 2026.
In December 2025, Medicus announced a non-binding letter of intent with Reliant AI Inc., a decision-intelligence company specializing in generative AI for the life sciences industry, to collaborate on the development of an AI-driven clinical data analytics platform. Subject to execution of definitive agreements, the platform is expected to supportcapital-efficient clinical development through data-driven dynamic clinical-site selection, patient stratification and enrollment forecasting. The initial phase of the collaboration is expected to support an upcoming Teverelix clinical study planned for 2026, with potential expansion into later-stage development programs in collaboration with a strategic partner.
In February 2026, the Company announced that it has received “study may proceed” clearance from the U.S. Food and Drug Administration (FDA) to initiate its Phase 2b dose-optimization study of Teverelix®, an investigational next generation long-acting GnRH antagonist, in men with advanced prostate cancer (APC).