Medicus Pharma Reports Positive Phase 2 SKNJCT-003 Topline Data Observing 73% Clinical Clearance and 40% Histological Clearance (CR) at Day 57 in 200μg Cohort
March 05 2026 - 7:30AM
PHILADELPHIA, March 05, 2026 (GLOBE NEWSWIRE) 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 | ||
|---|---|---|---|---|---|---|
| Clinical Clearance | Histological Clearance (CR) | Clinical Clearance | Histological Clearance (CR) | |||
| 47 | 43 | |||||
| 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 be decision-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 strategic engagement 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 anticipate material 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.
For further information contact:
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 arrangement contemplated 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 support capital-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).
Cautionary Notice on Forward-Looking Statements
Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the Company’s leadership and prospects, the collaboration with GSA including the potential benefits thereof for GSA, those suffering with Gorlin Syndrome and Medicus (including as it relates to the development of SkinJect™), ability to be approved for the Expanded Access IND Program to enable those suffering with Gorlin Syndrome to access SkinJect™ under physician-supervised treatment protocols, the development of Teverelix and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix for AURr, high CV risk prostate cancer, women’s health indications like endometriosis, and the potential market opportunities related thereto, the MOU, including the potential signing of definitive agreements between Medicus and HelixNano and the development of thermostable infectious diseases vaccines by combining HelixNano’s proprietary mRNA vaccine platform with Medicus’s proprietary microneedle array (MNA) delivery platform, the Company’s aim to fast-track the clinical development program and convert the SKNJCT-003 exploratory clinical trial into a pivotal clinical trial, and approval from the FDA and the timing thereof, including with respect to the Company’s submission for approval in the FDA Commissioner's National Priority Voucher program, plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of SkinJect through SKNJCT-003 and SKNJCT-004, and the potential market opportunities related thereto, the Company’s expectations regarding reported efficacy findings and whether there will be material changes to its reported SKNJCT-003 topline results and to secure an EOP2 meeting with the FDA in the first half of 2026, entry into definitive documents with Reliant and the expected terms thereof, engaging in proposed Medicus-sponsored studies currently contemplated in the Reliant non-binding letter of intent and the expected benefits thereof, the expansion of SKNJCT-003 into the United Kingdom and the potential benefits therefrom, the advancement of the SKNJCT-004 study and the potential results of and benefits of such study. Forward-looking statements are often but not always, identified by the use of such terms as "may", “on track”, “aim”, "might", "will", "will likely result", “could,” “designed,” "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target", “potential” or the negative and/or inverse of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's annual report on form 10-K for the year ended December 31, 2024 (the "Annual Report"), and in the Company's other public filings on EDGAR and SEDAR+, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
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