Core Viewpoint - Medicus Pharma Ltd. has submitted a request for a Type C meeting with the FDA to discuss the fast-tracking of its clinical development program for treating Basal Cell Carcinoma (BCC) using Dissolvable Doxorubicin-containing Microneedle Arrays (D-MNA) [1][2] Group 1: Clinical Development Program - The Type C meeting aims to align on the clinical pathway and seek FDA feedback on the D-MNA product development [2] - The clinical study SKNJCT-003 is a randomized, double-blind, placebo-controlled trial enrolling up to 60 subjects with BCC, evaluating two dose levels of D-MNA against a placebo [2][5] - The high-dose of 200μg D-MNA is the maximum dose used in the previous Phase 1 safety study, which was completed in March 2021 [3][5] Group 2: Study Design and Objectives - The company seeks FDA agreement on several key topics, including the appropriateness of selected doses, primary endpoints, patient population definitions, study design, and safety assessments for future studies [4] - The Phase 1 study (SKNJCT-001) met its primary objective of safety and tolerability, with no serious adverse events reported and six participants achieving complete responses [5][10] Group 3: Ongoing and Future Studies - The Phase 2 clinical study (SKNJCT-003) is currently underway at nine clinical sites in the U.S., with an interim analysis showing over 60% clinical clearance [6] - The number of participants in SKNJCT-003 has been increased to 90, and the company is expanding clinical trial sites to Europe [6] - A separate clinical study (SKNJCT-004) is being conducted in the UAE, aiming to randomize 36 patients across four sites [7] Group 4: Strategic Acquisitions - In June 2025, the company announced a definitive agreement to acquire Antev Limited, a UK-based biotech company developing Teverelix for advanced prostate cancer [8][11]

Core Viewpoint - Medicus Pharma Ltd has entered into a definitive agreement to acquire Antev Ltd, a UK-based clinical-stage drug development company, with Antev shareholders receiving approximately 17% equity stake in Medicus and up to US$65 million in contingent payments tied to future FDA approvals [1][4]. Group 1: Transaction Details - Medicus will acquire all issued and outstanding Antev Shares in exchange for 2,666,600 Medicus common shares, representing approximately 17% of the total shares [2]. - The transaction is expected to close by the end of August 2025, pending certain closing conditions including shareholder approval [5]. - Antev shareholders will be subject to a 9-month staggered lock-up and will grant voting rights to Medicus management for 36 months [3]. Group 2: Antev's Product Pipeline - Antev is developing Teverelix, a next-generation GnRH antagonist, targeting high-risk prostate cancer patients and those experiencing acute urinary retention due to enlarged prostate [6][14]. - Teverelix aims to prevent recurrence of acute urinary retention in men aged 45 and older, with a potential market opportunity exceeding US$2 billion annually [7]. - The FDA has approved a Phase 2b study for Teverelix in acute urinary retention, involving 390 participants [19]. Group 3: Market Potential - For advanced prostate cancer patients with increased cardiovascular risk, Teverelix presents a potential market opportunity of over US$4 billion annually, targeting 300,000 to 500,000 men in the US [10]. - Teverelix is designed to provide a hormone therapy option with potentially lower cardiac toxicity compared to conventional treatments [15]. Group 4: Clinical Development - Antev has completed a Phase 1 clinical trial for Teverelix, demonstrating good tolerance and rapid testosterone suppression [16]. - The company has also completed a Phase 2a study, achieving a primary endpoint of over 90% testosterone suppression but not maintaining this rate beyond 42 days [17]. - The FDA has provided guidance on Antev's proposed Phase 3 trial design for Teverelix, supporting its clinical development plans [18].

Core Insights - Medicus Pharma Ltd. has appointed Andrew Smith as Chief Operating Officer, bringing over three decades of experience in asset management and financial operations [2][3] - The company is actively engaged in clinical development, particularly with its SKNJCT-003 Phase 2 clinical study for treating Basal Cell Carcinoma (BCC) using novel Doxorubicin Microneedle Arrays (D-MNA) [4][8] Company Leadership - Andrew Smith's previous roles include Chief Executive of SR Asset Management and Co-Head of Americas at Aberdeen Asset Management, highlighting his extensive leadership experience [2][3] - Dr. Raza Bokhari, Executive Chairman and CEO, expressed confidence in Smith's expertise as the company expands its operations across three continents [3] Clinical Development Updates - The SKNJCT-003 Phase 2 clinical study has randomized over 50 of the 90 expected patients, with a positive interim analysis showing more than 60% clinical clearance [4][8] - The study is being conducted at nine clinical sites across the United States, having commenced patient randomization in August 2024 [4] - The investigational review board has increased the participant count for SKNJCT-003 from 60 to 90 subjects, and the company is also expanding clinical trial sites in Europe [4] Additional Clinical Studies - Medicus Pharma is conducting another clinical study, SKNJCT-004, in the United Arab Emirates, which aims to randomize 36 patients across four sites [5] - The principal investigator for the UAE study is Cleveland Clinic Abu Dhabi, with coordination by Insights Research Organization and Solutions [5] Acquisition Plans - The company has entered into a binding letter of intent to acquire Antev Ltd., a UK-based biotech company developing Teverelix for advanced prostate cancer patients [6][9] - The acquisition is subject to due diligence, negotiation of definitive agreements, and regulatory approvals [9]

Company Overview - Medicus Pharma Ltd. is a biotechnology company focused on developing novel therapeutics, particularly in the field of oncology [6][7] - The company's lead asset, SkinJect Inc., is developing a treatment for non-melanoma skin cancer using a patented dissolvable doxorubicin-containing microneedle array (D-MNA) [2][6] Clinical Trials - Medicus is conducting a Phase 2 clinical study (SKNJCT-003) across nine clinical sites in the United States, which began randomizing patients in August 2024 [3] - An interim analysis in March 2025 showed over 60% clinical clearance after more than 50% of the targeted 60 patients were randomized [3] - The investigational review board increased the number of participants in SKNJCT-003 to 90 subjects and expanded clinical trial sites to Europe [3] - A separate clinical study (SKNJCT-004) is underway in the UAE, aiming to randomize 36 patients across four sites [4] Acquisition Plans - In April 2025, Medicus entered into a binding letter of intent to acquire Antev Ltd., a UK-based biotech company developing Teverelix for advanced prostate cancer patients [5][8] - The acquisition is subject to due diligence, negotiation of definitive agreements, and regulatory approvals [8] Upcoming Events - Dr. Raza Bokhari, Executive Chairman and CEO of Medicus, will present corporate updates at the 2025 Bio International Convention on June 17, 2025 [1][2]

Philadelphia, Pennsylvania--(Newsfile Corp. - June 2, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) (the "Company") today announced the closing of its previously announced public offering of 2,260,000 units, on a "best-efforts" basis, at a price of $3.10 per unit. Each unit consisted of one common share of the Company and one warrant to purchase one common share. The warrants have an exercise price of $3.10 per share and will expire 5 years from the date of issuance. Maxim Group LLC acted as the lead placemen ...

Core Insights - Medicus Pharma Ltd. has received approval from the UAE Department of Health to commence a Phase 2 clinical study (SKNJCT-004) for the non-invasive treatment of Basal Cell Carcinoma (BCC) of the skin [1][2] - The study will involve 36 participants across four clinical sites in the UAE, including Cleveland Clinic Abu Dhabi [2][3] - The clinical trial is designed as a randomized, double-blind, placebo-controlled study to evaluate the efficacy of two dose levels of D-MNA compared to a placebo [3][4] Clinical Study Details - The SKNJCT-004 study will randomize participants into three groups: a placebo group, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA [3] - The high-dose of 200μg D-MNA is the maximum dose used in the previous Phase 1 study (SKNJCT-001), which met its primary objective of safety and tolerability [4][5] - In the Phase 1 study, D-MNA was well tolerated with no serious adverse events, and six participants achieved complete responses [5] Ongoing and Future Studies - The company is also conducting the SKNJCT-003 Phase 2 clinical study in the United States, which began randomizing patients in August 2024 and has shown a positive interim analysis with over 60% clinical clearance [6][7] - The number of participants in the SKNJCT-003 study has been increased to 90, and the company is expanding clinical trial sites in Europe [7] Strategic Developments - Medicus Pharma has entered into a binding letter of intent to acquire Antev Ltd., a UK-based biotech company developing a next-generation GnRH antagonist for prostate cancer patients [8][11] - The acquisition is subject to due diligence and regulatory approvals, with no guarantees on the completion of the transaction [11] Company Overview - Medicus Pharma Ltd. is focused on accelerating the clinical development of novel therapeutics and has a subsidiary, SkinJect Inc., dedicated to non-invasive treatments for basal cell skin cancer [9][10]

Core Viewpoint - Medicus Pharma Ltd. is acquiring Antev, a clinical-stage biotech company, to enhance its portfolio with Teverelix, a potential first-in-class therapy for cardiovascular high-risk prostate cancer patients and those experiencing acute urinary retention [1][3]. Group 1: Acquisition Details - Medicus will acquire all of Antev's issued shares in exchange for 2.67 million shares, representing approximately 19% of Medicus [2]. - Antev shareholders may receive up to $65 million in contingent consideration based on future FDA approvals [2]. - The transaction is expected to close before the end of June [2]. Group 2: Market Potential and Strategic Fit - Teverelix targets an estimated $2 billion addressable U.S. market for acute urinary retention, with no approved drugs currently available for recurrence [3]. - The acquisition aligns with Medicus' strategy, as it does not overlap with existing programs and could add significant value if Teverelix progresses smoothly into Phase 3 trials [4]. Group 3: Clinical Study Updates - Medicus announced a positive interim analysis for the SKNJCT-003 Phase 2 clinical study for treating basal cell carcinoma, showing over 60% complete clinical clearance among subjects [5]. - The investigational product D-MNA was well tolerated across both low and high-dose groups, with no dose-limiting toxicities or serious adverse events reported [5]. - The company plans to submit the interim analysis to the FDA as part of a package for a Type C meeting in Q2 2025 [6]. Group 4: Stock Performance - Following the news, MDCX stock increased by 15.8%, reaching $5.31 [6].