Medicus Pharma Ltd. Receives Full United Kingdom Regulatory and Ethical Approvals To Expand Phase 2 Clinical Study (SKNJCT-003) To Non-Invasively Treat Basal Cell Carcinoma (BCC) of the Skin

Rhea-AI Summary

Medicus Pharma (NASDAQ:MDCX) received full United Kingdom regulatory and ethical approvals (MHRA, HRA, WREC) to expand its Phase 2 study SKNJCT-003 evaluating Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC).

The randomized, double-blind, placebo-controlled study will enroll up to 90 subjects (1:1:1 placebo, 100μg, 200μg); the company reports >75% of the 90 participants have been randomized and an earlier interim analysis showed >60% clinical clearance. The 200μg dose matches the Phase 1 maximum; SKNJCT-001 (n=13) reported safety, tolerability and 6 complete responses. The company also completed the Antev acquisition (Aug 2025) and announced a collaboration with the Gorlin Syndrome Alliance for expanded access to SKINJECT™.

Positive

• UK approvals from MHRA, HRA, WREC to expand SKNJCT-003
• Trial size increased to 90 subjects with >75% randomized
• Interim analysis showed >60% clinical clearance (preliminary)
• FDA Type C feedback supports potential 505(b)(2) pathway
• Completed Antev acquisition in August 2025

Negative

• Interim analysis results are described as preliminary and may not hold in final data
• Phase 1 safety dataset was limited to 13 participants

Insights

Clinical Development Strategist

UK regulatory and ethics approvals let the Phase 2 SKNJCT-003 trial expand beyond the US, supporting broader enrollment and dataset growth toward a pivotal program.

The approvals from the MHRA, HRA, and WREC permit SKNJCT-003 to add U.K. sites to an otherwise U.S.-based, randomized, double-blind, placebo-controlled study enrolling up to 90 subjects with basal cell carcinoma. The trial tests two doses, 100μg and 200μg, versus placebo in a 1:1:1 randomization, and the company reports Phase 1 safety in 13 patients with no DLTs or SAEs and six complete responses; an interim Phase 2 analysis showed > 60% clinical clearance and the study has randomized > 75% of the planned 90 patients.

The positive regulatory clearances materially reduce operational barriers to recruit in the U.K. and strengthen the global dataset the company cites as necessary to design a pivotal program. Key dependencies remain factual and explicit: completion of enrollment, final randomized efficacy and safety readouts, and the Company’s engagement with regulators (the FDA gave feedback suggesting a 505(b)(2) pathway). The acquisition of Antev and the collaboration with the Gorlin Syndrome Alliance expand the company’s programmatic footprint but do not replace the need for conclusive Phase 2 outcomes.

Watch for concrete milestones over the next 6–18 months: completion of U.K. site activation and enrollment, full Phase 2 data readout timing, the FDA’s guidance following the Type C feedback, and any formal submission or decision dates for an Expanded Access IND under the Gorlin collaboration. These items will determine whether the expansion translates into clear regulatory or commercial advantage.

THE SKNJCT-003 CLINICAL STUDY EXPANSION INTO THE UNITED KINGDOM TO FURTHER ENABLE GLOBAL PATIENT RECRUITMENT AND CLINICAL DATASET TOWARD A PIVOTAL STUDY PROGRAM

PHILADELPHIA, PA / ACCESS Newswire / November 13, 2025 / 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 that it has received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin.

The phase 2 clinical study (SKNJCT-003) which is currently underway in nine (9) clinical sites in United States can now expand into additional sites in United Kingdom.

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 U.K. Good Clinical Practice and National Health Service (NHS) capacity and capability standards.

"The United Kingdom regulatory and ethical approval is another major step forward in establishing a global footprint of our novel, non-invasive treatment for BCC of the skin, which we believe represents more than $2 billion in potential market opportunity," stated Dr. Raza Bokhari, Medicus's Executive Chairman & CEO. "With clinical development programs now active across United States, Europe, and the Middle East, we are enhancing global patient recruitment and clinical dataset which, among other things, would assist us in designing a robust pivotal program".

SKNJCT-003 Clinical Trial Design
The SKNJCT-003 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: a placebo-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.

In March 2025, the Company announced a positively trending interim analysis for SKNJCT-003 demonstrating more than 60% clinical clearance. The interim analysis was conducted after more than 50% of the then-targeted 60 patients in the study were randomized. The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed. In April 2025, the investigational review board approved to increase the number of participants in SKNJCT-003 to ninety (90) subjects. The Company is expanding its trial sites in Europe and has randomized more than 75% of the ninety (90) participants expected to be randomized in the study. In September 2025, the Company received positive feedback from the Food and Drug Administration (FDA) regarding its Type C meeting supporting the development of Skinject, indicating that the Company may follow 505(b)(2) regulatory pathway to non-invasively treat BCC using dissolvable D-MNA.

The Company also has a clinical study (SKNJCT-004) currently underway in the United Arab Emirates (UAE). The study is expected to randomize thirty-six (36) patients in six (6) sites in the UAE. Cleveland Clinic Abu Dhabi (CCAD) is the principal investigator, along with Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), Rashid Hospital (RH), Clemenceau Medical Center (CMC) and American Hospital of Dubai (AHD). Insights Research Organization and Solutions (IROS), a UAE-based contract research organization, is coordinating the clinical study for the Company. IROS is a M42 portfolio company.

In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next generation 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.

Antev's flagship drug candidate is Teverelix trifluoroacetate (Teverelix TFA), a long-acting gonadotrophin-releasing hormone (GnRH) antagonist. 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™, the Company's investigational doxorubicin containing microneedle arrays (D-MNA) 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 Food and Drug Administration (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.

For further information contact:
Carolyn Bonner, President and Acting Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.com

Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicspharma.com

About Medicus Pharma Ltd.
Medicus Pharma Ltd. (NASDAQ:MDCX) is a 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, spread over three continents.

SkinJect Inc. a wholly owned subsidiary of Medicus Pharma Ltd., is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumors cells. The Company completed a phase 1 safety & tolerability study (SKNJCT-001) in March of 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of the investigational product D-MNA, with six (6) participants experiencing complete response on histological examination of the resected lesion. The Company is currently conducting 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 (the "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 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.

Antev's flagship drug candidate is Teverelix trifluoroacetate (Teverelix TFA), a long-acting gonadotrophin-releasing hormone (GnRH) antagonist. 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 September 2020, Antev completed a Phase 1 clinical trial in which Teverelix was shown to be well tolerated with no dose-limiting toxicities and demonstrated rapid testosterone suppression. The study included 48 healthy male volunteers. In February 2023, Antev also completed a Phase 2a study in fifty (50) patients with advanced prostate cancer (APC), where Teverelix achieved the primary endpoint of greater than 90% probability of castration levels of testosterone suppression (97.5%) but the secondary endpoint of maintaining this rate above 90% was not met with the probability dropping to 82.5% by Day 42.

In January 2023, the FDA, reviewed the Phase 1 and Phase 2a data and provided written guidance on Antev's proposed Phase 3 trial design for Teverelix. This milestone supports the Company's clinical plans to develop Teverelix as a treatment for advanced prostate cancer patients with increased cardiovascular risk.

In December 2023, FDA approved the Phase 2b study design in advanced prostate cancer covering 40 patients.

In November 2024, FDA approved the Phase 2b study design in acute urinary retention covering 390 patients

In October 2025, the company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SKINJECT™, the Company's investigational doxorubicin containing microneedle arrays (D-MNA) 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 Food and Drug Administration (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.

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, 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 and high CV risk prostate cancer, 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, 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 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.

SOURCE: Medicus Pharma Ltd

View the original press release on ACCESS Newswire

FAQ

What UK approvals did Medicus Pharma (MDCX) receive on November 13, 2025 for SKNJCT-003?

Medicus received regulatory approval from the MHRA, governance approval from the HRA, and a favorable ethical opinion from the WREC to expand SKNJCT-003 in the UK.

How many patients will MDCX enroll in the expanded SKNJCT-003 Phase 2 trial?

SKNJCT-003 is designed to enroll up to 90 subjects randomized 1:1:1 to placebo, 100μg D-MNA, or 200μg D-MNA.

What did the SKNJCT-003 interim analysis report and how reliable is it for MDCX (MDCX)?

An interim analysis reported >60% clinical clearance; the company notes these findings are preliminary and may not correlate with final study results.

Does the 200μg dose in SKNJCT-003 have prior clinical support for Medicus (MDCX)?

Yes; the 200μg dose equals the maximum dose used in SKNJCT-001, which met its primary safety and tolerability objective.

How does the UK expansion affect global recruitment for Medicus (MDCX)?

UK approvals allow expansion into additional sites, intended to enhance global patient recruitment and broaden the clinical dataset toward a pivotal program.

What other strategic moves did Medicus (MDCX) announce in 2025 related to SKINJECT™ and oncology assets?

In 2025 Medicus completed acquisition of Antev (Aug 2025) and announced a collaboration with the Gorlin Syndrome Alliance to pursue expanded access to SKINJECT™.