Core Insights - Medicus Pharma Ltd. is set to present at the Biotech Showcase 2026, highlighting its focus on advancing clinical development programs for innovative therapeutics [1][2] Company Strategy - The company's strategy involves advancing select programs through Phase 2 proof-of-concept and pursuing licensing or strategic partnerships with established pharmaceutical companies for late-stage development and commercialization [5] - Medicus aims to assemble decision-grade clinical, regulatory, and operational data packages aligned with its out-licensing strategy as data matures across its programs [5] Clinical Development Updates - The SkinJect™ Phase 2 program, designed to non-invasively treat basal cell carcinoma (BCC), has achieved execution milestones, including the completion of enrollment of 90 patients in a randomized, double-blind, placebo-controlled study [6][7] - Topline decision-grade Phase 2 results are expected to be reported in the first quarter of 2026, with plans for an End-of-Phase 2 meeting with the FDA in the first half of 2026 [8][31] - Interim findings from the study indicated greater than 60% clinical clearance in an exploratory analysis [9] Regulatory and Geographic Expansion - Medicus has expanded the clinical and regulatory footprint of SkinJect™ to support development and partnering readiness, including approvals in the UK and the UAE for ongoing studies [10][30] - The FDA provided positive feedback regarding the potential use of the 505(b)(2) regulatory pathway for SkinJect™ [11] Collaboration and Partnerships - Medicus has entered a non-binding letter of intent with Reliant AI Inc. to develop an AI-driven clinical data analytics platform aimed at supporting capital-efficient clinical development [15][32] - The company is exploring co-development opportunities with Helix Nanotechnologies for thermostable infectious disease vaccines [17][23] Pipeline Expansion - The acquisition of Antev Limited has added Teverelix, a next-generation GnRH antagonist targeting advanced prostate cancer patients, to Medicus's pipeline [18][24] - Teverelix has shown promising results in previous clinical trials, including a Phase 2a study demonstrating a 97.5% probability of achieving castration levels of testosterone suppression [26] Patient Access Initiatives - Medicus is collaborating with the Gorlin Syndrome Alliance to pursue an Expanded Access IND program for SkinJect™, aiming to provide access to patients with multiple or inoperable BCCs [19][29]

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 - 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]