Medicus Pharma Ltd. Announces Submission of Type C Meeting Request to the Food and Drug Administration (FDA)

Rhea-AI Summary

Medicus Pharma (NASDAQ: MDCX) has submitted a Type C meeting request to the FDA for October 2025 to discuss their D-MNA (Dissolvable Doxorubicin-containing Microneedle Arrays) development program for treating Basal Cell Carcinoma (BCC).

The company's Phase 2 clinical trial SKNJCT-003 is currently ongoing at 9 U.S. sites, with an expanded enrollment to 90 subjects. A March 2025 interim analysis showed promising results with over 60% clinical clearance. The trial evaluates two dose levels (100μg and 200μg) against a placebo control.

Additionally, Medicus is conducting the SKNJCT-004 trial in the UAE across four sites, targeting 36 patients. In June 2025, the company announced a definitive agreement to acquire Antev Limited, a UK biotech developing Teverelix for prostate cancer treatment.

Positive

• Positive interim analysis showing >60% clinical clearance in Phase 2 trial
• Previous Phase 1 trial (SKNJCT-001) demonstrated safety with no serious adverse events
• Expansion of clinical trial sites to Europe and UAE
• Strategic acquisition of Antev Limited to expand product pipeline

Negative

• Pending FDA approval for fast-track designation
• Final trial results still pending for both SKNJCT-003 and SKNJCT-004 studies

Insights

Biotech Clinical Development Expert

Medicus seeks FDA fast-track for promising skin cancer treatment with positive early data; regulatory momentum builds alongside pipeline expansion.

Medicus Pharma's FDA Type C meeting request represents a strategic regulatory milestone in their D-MNA program for basal cell carcinoma (BCC). The company is seeking FDA alignment to potentially accelerate their clinical pathway based on encouraging safety and early efficacy signals.

The submission package includes sophisticated regulatory questions focused on dose selection, endpoint validation, patient population parameters, and study design - all critical elements for successful drug development. Notably, the company is proposing complete histological clearance at 6 weeks as the primary endpoint, a rigorous efficacy measure that would demonstrate definitive tumor elimination.

Their ongoing Phase 2 trial (SKNJCT-003) employs a robust randomized, double-blind, placebo-controlled design across 9 U.S. sites, testing two active dose levels (100μg and 200μg) against placebo. The interim analysis showing >60% clinical clearance is particularly significant, as it suggests meaningful therapeutic activity, prompting expansion to 90 subjects from the initial 60.

This builds upon their completed Phase 1 study (SKNJCT-001) which established safety across all dose levels with no dose-limiting toxicities or serious adverse events. Importantly, 6 participants with nodular BCC achieved complete histological responses, providing proof-of-concept for their technology.

The parallel UAE study (SKNJCT-004) demonstrates global development expansion with prestigious institution participation. This multi-pronged approach accelerates data collection and potentially strengthens their regulatory position. The recent Antev acquisition further diversifies their pipeline beyond dermatological oncology into prostate disease management, indicating strategic portfolio expansion.

The Company's aim is to seek FDA consent to fast track the Clinical Development Program to treat Basal Cell Carcinoma (BCC) of the skin using Dissolvable Doxorubicin-containing Microneedle Arrays (D-MNA)

Philadelphia, Pennsylvania--(Newsfile Corp. - July 8, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce submission of a comprehensive package to the United States Food and Drug Administration (the "FDA") seeking a Type C meeting with the FDA during the week of October 6^th, 2025.

The purpose of the Type C meeting is to formally discuss the D-MNA product development and gain further alignment on the clinical pathway. The Company's aim is to gain the FDA's consent to fast-track the clinical development program and seek feedback on future clinical plans for the D-MNA development program. More specifically, a list of draft questions and key topics seeking the FDA's feedback are:

1. Based on the robust systemic safety margin (when considering the relative bioavailability of the topical patch as compared to traditional parenteral routes), the Company has chosen to explore doses that provide the greatest possibility of efficacy. Does the FDA agree with the doses selected for future study?

2. Does the FDA agree that complete histological clearance at 6 weeks post-treatment is an appropriate primary endpoint for the next study?

3. Does the FDA agree with the proposed patient population definition, including tumor size limits, location restrictions, and histological confirmation requirements?

4. Does the FDA agree that a randomized, double-blind, vehicle-controlled study design is appropriate for future studies that are intended to demonstrate the effectiveness of D-MNA in treating BCC?

5. Does the FDA agree that the current safety assessments are adequate for the proposed future study(ies)?

Clinical Trial Design

The clinical study (SKNJCT-003) is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 60 subjects presenting with BCC of the skin. The study will evaluate 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, proposed 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.

SKNJCT-003 Phase 2 clinical study is currently underway in nine (9) clinical sites across United States which commenced randomizing patients in August 2024. In March 2025, the Company also announced a positively trending interim analysis for SKNJCT-003 demonstrating more the 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 increased the number of participants in SKNJCT-003 to Ninety (90) subjects. The Company also announced expanding clinical trial sites in Europe.

The Company also has a clinical design (SKNJCT-004) currently underway in United Arab Emirates (UAE). The study is expected to randomize 36 patients in four sites in UAE. Cleveland Clinic Abu Dhabi (CCAD) is the principal investigator, along with Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), 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 June 2025, the Company announced its entry into a definitive agreement to acquire Antev Limited. ("Antev"), a UK-based clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as 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.

For further information, contact:

Carolyn Bonner, President
(610) 636-0184
cbonner@medicuspharma.com

Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.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 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 patented dissolvable microneedle patch to deliver chemotherapeutic agent to eradicate tumors cells. The Company has 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 United States and Europe. The Company has also commenced a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-004) in UAE.

In June 2025, the Company also announced its entry into a definitive agreement to acquire Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as 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. The transaction with Antev is subject to the fulfillment of certain closing conditions, including obtaining Antev shareholder approval and other applicable corporate, regulatory and third-party approvals. No assurances can be given that the parties will successfully close the proposed transaction on the terms or timeframe currently contemplated or at all.

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 intention to hold a Type C meeting with the FDA and the timing thereof, the Company's aim to fast 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, the commencement of the SKNJCT-004 study and the potential results of and benefits of such study, the Antev transaction, including the closing of the transaction or the timing thereof, the potential benefits of the Antev transaction, if consummated, including plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix, and the potential market opportunities related thereto, the results of the interim analysis, which may or may not correlate with the findings of the clinical study report that will be compiled following completion of the phase 2 study, the Company's plans and expectations concerning, and future outcomes relating to, the submission and advancement of the phase 2 clinical protocol, the randomization of patients and size of the 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", "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target" 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 public filings on EDGAR and on 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 cautioned that the foregoing list is not exhaustive, and readers are encouraged to review the Company's long form prospectus accessible on the Company's profile on EDGAR at www.sec.gov and on SEDAR+ at www.sedarplus.ca. 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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/258042

FAQ

What are the Phase 2 clinical trial results for Medicus Pharma's (MDCX) BCC treatment?

The interim analysis of SKNJCT-003 Phase 2 trial showed over 60% clinical clearance, with the study expanded to include 90 subjects across 9 U.S. clinical sites.

What is the purpose of Medicus Pharma's Type C meeting with the FDA?

The meeting aims to discuss D-MNA product development, seek fast-track designation for the clinical development program, and gain FDA feedback on future clinical plans.

What were the safety results from Medicus Pharma's Phase 1 trial for D-MNA?

The Phase 1 trial (SKNJCT-001) demonstrated that D-MNA was well-tolerated with no dose-limiting toxicities or serious adverse events across all dose levels in 13 participants.

What is the significance of Medicus Pharma's Antev Limited acquisition?

The acquisition adds Teverelix to Medicus's pipeline, a next-generation GnRH antagonist for treating high-risk advanced prostate cancer and acute urinary retention relapse patients.

How many clinical trial sites does Medicus Pharma (MDCX) have for its BCC treatment?

Medicus has 9 clinical sites across the United States for SKNJCT-003 and 4 sites in the UAE for SKNJCT-004, with additional expansion planned in Europe.