Core Insights - The company is developing Teverelix® as a leading product for advanced prostate cancer patients with high cardiovascular risk and as a first-in-class treatment for Acute Urinary Retention Relapse prevention, representing a combined market opportunity of approximately US$6 billion [1][20]. Clinical Development - The Phase 2b study is an open-label trial enrolling 40 men with advanced prostate cancer, with a total treatment duration of approximately 22 weeks [2]. - The primary endpoint is to confirm medical castration by Day 29 with sustained suppression through Day 155, targeting a probability exceeding 90% [2][9]. Mechanism of Action - Teverelix is a long-acting injectable GnRH antagonist that provides immediate receptor antagonism, allowing for rapid suppression of luteinizing hormone (LH), follicle-stimulating hormone (FSH), and downstream sex hormones without an initial testosterone surge [4][21]. - This mechanism is particularly relevant for patients with advanced prostate cancer and elevated cardiovascular risk, as GnRH agonists may contribute to adverse cardiovascular outcomes [5][6]. Target Patient Population - Teverelix is specifically developed for advanced prostate cancer patients with objectively defined cardiovascular risk, including those with recent major adverse cardiovascular events (MACE) or severe subclinical atherosclerosis [7]. - Approximately 300,000 to 500,000 men in the U.S. are living with advanced prostate cancer, representing an estimated annual market opportunity exceeding US$4 billion [7]. Regulatory Strategy - The company has received FDA clearance to initiate the Phase 2b study and has aligned on a development indication focused on hormone therapy for advanced prostate cancer patients with increased cardiovascular risk [10][23]. - A clear Phase 3 framework is defined to evaluate sustained castration efficacy alongside cardiovascular outcomes, which may establish Teverelix as a new therapeutic backbone for patients where cardiovascular safety is critical [11][10]. Strategic Partnerships - The company is well-positioned for strategic partnership discussions, particularly with organizations seeking differentiated late-stage oncology assets supported by a clear regulatory and labeling strategy [12]. - The development strategy includes advancing select programs through Phase 2 proof-of-concept and pursuing licensing or strategic partnerships for late-stage development and commercialization [13]. Additional Programs - Medicus is also advancing SkinJect™, a proprietary dissolvable microneedle array platform for the non-invasive treatment of basal cell carcinoma, with topline decision-grade data expected in Q1 2026 [14][27].

Core Insights - The amendment to the license agreement reduces the royalty rate on Teverelix® from approximately 4% to 2%, while maintaining global rights and intellectual property control [1][2] - Teverelix® is being developed as a first-in-class product for Acute Urinary Retention relapse prevention and as a best-in-class treatment for prostate cancer patients with high cardiovascular risk, representing a potential market opportunity of around US$6 billion [1][3] License Agreement Details - The amended agreement clarifies the royalty term on a country-by-country basis and does not change the scope of the license or the underlying intellectual property [2] - Medicus retains exclusive worldwide rights to develop, manufacture, and commercialize Teverelix, including the ability to grant sublicenses, which supports flexible global partnering strategies [3][4] Economic Impact - The reduced royalty burden is expected to enhance Teverelix's attractiveness for future partnerships, particularly for late-stage development and commercialization [3] - The amendment reflects scientific progress and intellectual property expansion achieved by the Antev team, aligning the parties under a simplified economic framework [5] Development Strategy - Medicus aims to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships for late-stage development and commercialization [10] - The company is focused on assembling decision-grade clinical and regulatory data packages to support its partnering-focused model [10] Clinical Development of Teverelix - Teverelix is a long-acting injectable GnRH antagonist that suppresses sex hormone production without an initial surge, potentially reducing cardiovascular risks for patients with existing conditions [7][18] - Previous studies have shown Teverelix to be well tolerated, with significant testosterone suppression achieved in clinical trials [19][20] SkinJect™ Program - Medicus is advancing its SkinJect™ program, a proprietary dissolvable microneedle array platform for treating basal cell carcinoma, with Phase 2 data expected in early 2026 [11][24] - The company has received regulatory approvals in the UK to expand its ongoing Phase 2 clinical study for SkinJect™ [23]

Core Insights - Medicus Pharma Ltd. has announced that its abstract on Teverelix has been accepted for presentation at the AACE Annual Meeting 2026, highlighting the company's focus on advancing clinical development programs for innovative therapeutics [1][2] Group 1: Teverelix Clinical Data - The accepted abstract titled "Evaluation of Teverelix, a Long-Acting GnRH Antagonist" presents results from two Phase 1 studies involving 48 healthy premenopausal women, assessing pharmacokinetics, pharmacodynamics, bone turnover, and safety [2] - Key findings indicate rapid and reversible hormone suppression with stable bone markers, demonstrating the potential of Teverelix in women's health, particularly for conditions like endometriosis affecting approximately 10% of women of reproductive age [3][7] - The studies showed that Teverelix achieved dose-dependent estradiol suppression, with levels reaching the clinically relevant Barbieri window (30–50 pg/mL), and sustained hormone suppression lasting up to two to three weeks post-injection [7] Group 2: Mechanism and Safety Profile - Teverelix operates as a long-acting injectable GnRH antagonist, providing immediate receptor antagonism and rapid suppression of LH, FSH, and downstream sex hormones without an initial surge [4][16] - The drug has not shown significant cardiovascular safety signals in prior studies, which is particularly relevant for advanced prostate cancer patients with elevated cardiovascular risk [5] Group 3: Development Strategy - Medicus aims to advance select programs through Phase 2 proof-of-concept studies and pursue strategic partnerships for late-stage development and commercialization [8] - The company is also advancing its SkinJect™ program for non-invasive treatment of basal cell carcinoma, with topline data expected in Q1 2026 [9][22] Group 4: Regulatory and Strategic Collaborations - Medicus has received regulatory approvals in the UK for expanding its Phase 2 study evaluating Doxorubicin Microneedle Array for basal cell carcinoma [21] - The company has entered a non-binding memorandum of understanding with Helix Nanotechnologies to explore collaboration on mRNA platform development [13]

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]