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 Insights - Medicus Pharma Ltd. has entered into a warrant inducement agreement for the immediate exercise of all outstanding Series A and Series B Warrants issued on July 14, 2025 [1] Company Summary - Medicus Pharma Ltd. is a precision guided biotech/life sciences company focused on advancing clinical development programs of novel and potentially disruptive therapeutic assets [1] Transaction Details - Maxim Group LLC is acting as the exclusive Financial Advisor for the transaction [1]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company operates with a team of experienced and qualified news journalists, ensuring independent content production [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors, including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

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 - Medicus Pharma Ltd (NASDAQ:MDCX) is highlighted as a promising investment opportunity due to its innovative pipeline and strategic initiatives, particularly the SkinJect product aimed at treating basal cell carcinoma [1][2] Company Developments - Maxim Group analyst Jason McCarthy has maintained a Buy rating on Medicus Pharma Ltd with a price target of $20, driven by the company's strong clinical results and acquisition strategies [1] - The FDA-supported 505(b)(2) pathway for SkinJect has demonstrated a 60% complete response rate in Phase 2 trials for non-invasive basal cell carcinoma, significantly exceeding typical benchmarks [1] - Medicus Pharma submitted an FDA Commissioner's national priority voucher application for SkinJect, emphasizing its potential as a non-invasive treatment for basal cell carcinoma [2] Product Highlights - SkinJect offers a non-surgical, locally administered therapy for basal carcinoma, which is the most common cancer in the US, utilizing a biodegradable microneedle patch that eliminates the need for Mohs surgery [3] - The CNPV submission for SkinJect underscores its public health value and potential impact on patients with Gorlin syndrome, who often face numerous surgeries throughout their lives [4] Company Focus - Medicus Pharma is a biotechnology company dedicated to accelerating the clinical development of new therapeutic assets, particularly focusing on improving patient safety and efficacy in areas with unmet medical needs [5]

Core Insights - Proactive provides fast, accessible, and actionable business and finance news content to a global investment audience [2] - The company focuses on medium and small-cap markets while also covering blue-chip companies and broader investment stories [3] - Proactive's news team delivers insights across various sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Technology Adoption - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

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 ...

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Insights - Medicus Pharma Ltd. has submitted an FDA Commissioner's National Priority Voucher application for its Doxorubicin Microneedle Array (D-MNA) to treat basal cell carcinoma (BCC), aligning with national health priorities [1][4][5] - The FDA's new approval pathway aims to expedite drug review times for products addressing significant public health needs, potentially reducing review times from 10-12 months to 1-2 months [2][3] Company Overview - Medicus Pharma Ltd. focuses on advancing clinical development programs for innovative therapeutics, with a particular emphasis on non-invasive treatments for skin cancer [1][24] - The company is actively engaged in clinical studies across multiple countries, including the United States and the United Arab Emirates [24] Clinical Development Program - The SKNJCT-003 program is a Phase 2 clinical study evaluating the efficacy of D-MNA in treating nodular BCC, with over 60% clinical clearance reported in interim analyses [11][12] - The study has expanded to include 90 participants, with over 75% already randomized [13] - A second clinical study, SKNJCT-004, has commenced in the UAE, with plans to randomize 36 patients [14][15] Public Health Impact - SkinJect addresses a significant public health issue by providing a non-surgical treatment option for BCC, which affects over five million new patients annually in the U.S. [6][17] - The treatment is particularly beneficial for patients with Gorlin syndrome, a rare genetic disorder leading to multiple BCCs, who often face repeated surgeries [10][21] Regulatory Developments - The FDA has indicated that products meeting specific criteria may receive accelerated approval, enhancing the potential for quicker market access for SkinJect [3][15] - Medicus has received regulatory approvals in the UK to expand its Phase 2 study, confirming compliance with local clinical standards [16][32] Strategic Collaborations - The company has entered a collaboration with the Gorlin Syndrome Alliance to facilitate expanded access to SkinJect for patients with recurrent or inoperable BCCs [21][22] - Medicus has also announced a memorandum of understanding with Helix Nanotechnologies to explore co-development of mRNA vaccines [18][25] Pipeline Expansion - Medicus completed the acquisition of Antev, a UK-based biotech company, to enhance its pipeline with Teverelix, a GnRH antagonist for advanced prostate cancer [19][20][26]