Core Insights - Medicus Pharma Ltd. is advancing its Phase 2 clinical study (SKNJCT-003) for Doxorubicin Microneedle Array (D-MNA) targeting nodular basal cell carcinoma (BCC) and has completed enrollment of 90 patients in the U.S. [1][2][3] - The company anticipates releasing topline results for SKNJCT-003 by the end of Q1 2026 and plans to request an end-of-phase 2 meeting with the FDA in H1 2026 [1][2][3] Clinical Trial Details - The SKNJCT-003 study is a randomized, double-blind, placebo-controlled trial involving 90 subjects with BCC, comparing two dose levels of D-MNA against a placebo [4] - Participants are randomized into three groups: a placebo group, a low-dose group (100μg D-MNA), and a high-dose group (200μg D-MNA) [4] Previous Study Outcomes - The Phase 1 study (SKNJCT-001) demonstrated safety and tolerability, with no serious adverse events and six participants achieving complete responses [6] - An interim analysis in March 2025 showed over 60% clinical clearance among participants, indicating promising efficacy [7] Regulatory Developments - In November 2025, Medicus received full regulatory and ethical approvals in the UK to expand the SKNJCT-003 study [9][24][25] - The FDA provided positive feedback regarding the development of SkinJect, suggesting a potential 505(b)(2) regulatory pathway for D-MNA [7] Strategic Collaborations and Acquisitions - Medicus entered a non-binding MoU with Helix Nanotechnologies to explore co-development of mRNA vaccines [10][17] - The company acquired Antev Limited, which is developing Teverelix, a GnRH antagonist for advanced prostate cancer, enhancing its pipeline [11][18] Patient Advocacy Initiatives - A collaboration with the Gorlin Syndrome Alliance aims to provide expanded access to SkinJect for patients with Gorlin Syndrome, focusing on real-world data collection [13][14][22][23]

Core Viewpoint - Medicus Pharma Ltd. has appointed Carolyn Bonner as Chief Financial Officer in addition to her role as President, ensuring continuity and stability during the transition following the resignation of the previous CFO due to health reasons [1][2] Leadership Changes - Carolyn Bonner has been serving as Acting Chief Financial Officer since September 12, 2025, and her formal appointment aims to enhance operational and financial integration under a single leader [1][2] - Dr. Raza Bokhari, Executive Chairman & CEO, expressed gratitude to the departing CFO, Jim Quinlan, for his critical role in the company's founding and initial public offering [2] Experience and Background - Carolyn Bonner brings nearly 20 years of experience in healthcare and life sciences, previously serving as President & CEO of PCL, Inc., and holding roles in business development at Rosetta Genomics Ltd. and Inform Diagnostics, Inc. [3][4] Expanded Responsibilities - In her dual role, Bonner will oversee financial reporting, capital markets strategy, budgeting, forecasting, and lead strategic planning across clinical and corporate development initiatives [5] Clinical Development Programs - Medicus is conducting a Phase 2 clinical study (SKNJCT-003) for a novel treatment of basal cell carcinoma (BCC) using dissolvable doxorubicin-containing microneedle arrays, with positive interim results showing over 60% clinical clearance [6][7] - The company has received positive FDA feedback regarding its regulatory pathway for the development of SkinJect, indicating potential for further advancement [7] International Expansion - The company has initiated a clinical study (SKNJCT-004) in the UAE, with plans to randomize 36 patients across six sites, and has received regulatory approvals in the UK to expand its ongoing Phase 2 study [8][10][26] Strategic Collaborations - Medicus entered a non-binding memorandum of understanding with Helix Nanotechnologies to explore co-development of thermostable infectious disease vaccines [11][19] - A strategic collaboration with the Gorlin Syndrome Alliance aims to provide expanded access to SkinJect for patients with Gorlin Syndrome, focusing on real-world data collection for future regulatory filings [14][25] Pipeline Expansion - The acquisition of Antev Limited, a UK-based biotech company, enhances Medicus's pipeline with Teverelix, a next-generation GnRH antagonist for advanced prostate cancer patients [12][20] - Teverelix has shown promising results in clinical trials, with a Phase 2a study achieving a 97.5% probability of testosterone suppression [22][23]

Core Insights - November is recognized as Men's Health Awareness Month, highlighting advancements in cancer detection and treatment, particularly for prostate and skin cancer, which are prevalent among men [1][3] Prostate Cancer Treatment - Traditional hormone deprivation therapy for advanced prostate cancer is associated with increased cardiovascular risks, prompting the development of next-generation therapies that aim to mitigate these risks while effectively managing cancer [2][12] - Medicus Pharma has acquired Antev, a UK-based biotech company, which is developing Teverelix, a novel GnRH antagonist designed to reduce cardiovascular risks in patients with advanced prostate cancer [11][12] - Teverelix has shown promising results in clinical trials, achieving over 90% testosterone suppression in a Phase 2a study, although it did not maintain this level beyond 42 days [13][14] Skin Cancer Treatment - Basal cell carcinoma (BCC) is the most common skin cancer in the U.S., with 5 million new cases annually, and current treatments like Mohs surgery are costly and invasive [4][6] - Medicus Pharma's subsidiary, SkinJect Inc., is developing a dissolvable microneedle patch that delivers chemotherapy directly to skin lesions, providing a non-surgical and more patient-friendly treatment option [5][9] - The company is conducting multiple clinical studies to evaluate the safety and efficacy of this innovative treatment, with recent regulatory approvals in the UK to expand ongoing studies [17] Strategic Collaborations and Future Developments - Medicus Pharma has entered a non-binding memorandum of understanding with Helix Nanotechnologies to explore joint development opportunities, particularly in mRNA vaccine technology [10] - The company is also collaborating with the Gorlin Syndrome Alliance to facilitate access to its investigational SkinJect treatment for patients with Gorlin Syndrome, aiming to collect real-world data to support future regulatory submissions [16]

As filed with the Securities and Exchange Commission on November 19, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MEDICUS PHARMA LTD. (Exact name of Registrant as specified in its charter) ______________________________ (State or other jurisdiction of incorporation or organization) Ontario, Canada 2834 98-1778211 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Ide ...

Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 As filed with the Securities and Exchange Commission on September 29, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION MEDICUS PHARMA LTD. (Exact name of Registrant as specified in its charter) ______________________________ (State or other jurisdiction of incorporation or organization) Ontario, Canada 2834 98-1778211 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Id ...