Core Insights - Medicus Pharma Ltd. is advancing its clinical development program for a novel microneedle array (D-MNA) aimed at treating basal cell carcinoma (BCC) of the skin, with significant progress in its Phase 2 study [1][3][8] - The company has received FDA acceptance for a Type C meeting to discuss the D-MNA product development and seek fast-track approval for its clinical program [1][2] - Financial highlights for Q2 2025 indicate a net loss of $6.2 million, an increase in cash reserves to $9.7 million, and total operating expenses of $6.0 million, reflecting the company's investment in clinical development [12][13][15] Clinical Development - The SKNJCT-003 Phase 2 study has randomized over 75% of the 90 participants, focusing on the efficacy of D-MNA compared to a placebo [3][8] - The study is designed as a randomized, double-blind, placebo-controlled trial, evaluating two dose levels of D-MNA (100μg and 200μg) against a placebo [4][5] - An interim analysis in March 2025 showed over 60% clinical clearance among participants, with the study currently ongoing at nine clinical sites in the U.S. [8] Financial Performance - The company reported $11.5 million in net proceeds from financing and warrant exercises, enhancing its balance sheet [13] - Cash and cash equivalents increased from $4.0 million at the end of Q1 2025 to $9.7 million at the end of Q2 2025 [13] - Operating expenses rose to $6.0 million in Q2 2025 from $3.6 million in the same period in 2024, with R&D expenses slightly increasing to $1.4 million [13] Strategic Initiatives - Medicus Pharma is pursuing strategic transactions, including the acquisition of Antev Ltd., a UK-based biotech company focused on a GnRH antagonist for prostate cancer [10][18] - A non-binding memorandum of understanding has been established with Helix Nanotechnologies Inc. to explore the development of mRNA vaccines [11] - The company is also conducting a clinical study (SKNJCT-004) in the UAE, aiming to randomize 36 patients across four sites [9]

Core Viewpoint - Medicus Pharma Ltd. and Helix Nanotechnologies Inc. have entered into a non-binding memorandum of understanding (MoU) to collaborate on the development of thermostable infectious disease vaccines by integrating their proprietary technologies [1][2]. Group 1: Collaboration Details - The MoU aims to combine HelixNano's mRNA vaccine platform with Medicus' microneedle array (MNA) delivery system for the co-development and commercialization of thermostable mRNA-based vaccines [1][2]. - Both companies are engaged in good faith negotiations to form a joint venture for this purpose [2]. - The collaboration includes a project to develop clinical-grade mRNA vaccine-loaded MNAs for a Phase 1 clinical bridging study comparing intramuscular injection and intradermal MNA delivery of HelixNano's vaccine candidate HN-0001 [3]. Group 2: Technological Innovations - The combination of HelixNano's mRNA platform and Medicus' MNA technology aims to create needle-free, thermostable vaccines that could eliminate cold-chain logistics, reduce distribution costs, and improve patient access [4]. - The project is expected to position the companies at the forefront of opportunities to prevent infectious diseases rather than just treating them [4]. Group 3: Research and Development Activities - Medicus and HelixNano will enter into a Sponsored Research Agreement with the University of Pittsburgh to conduct parts of the project under the direction of Dr. Lou Falo [6]. - HelixNano will supply the clinical drug product HN-0001 for the project, while the University will optimize the incorporation of this product into microneedle arrays [7][8]. Group 4: Non-Binding Nature of the MoU - The MoU is non-binding and does not obligate either party to proceed with the joint venture or any further development until definitive agreements are executed [9].

Core Points - Medicus Pharma Ltd. held its annual and special meeting of shareholders on July 22, 2025, where all resolutions were passed [1] - The company elected all eight nominees for the board of directors, including Congresswoman Cathy McMorris Rodgers and Ajay Raju [2][3] - The shareholders expressed pride in electing a diverse and experienced leadership team in drug development and governance [2] Board Members - Congresswoman Cathy McMorris Rodgers has a distinguished record in public service, serving as a U.S. Representative for Washington's 5th Congressional District from 2004 to 2025 [4][5] - Ajay Raju is an attorney and venture capitalist with extensive experience in structured finance, real estate, and life sciences [8] - Dr. Raza Bokhari serves as Executive Chairman and CEO, with a background in life sciences and healthcare services [9][10] - Other continuing board members include Dr. Larry Kaiser, Robert J. Ciaruffoli, William L. Ashton, Barry Fishman, and Dr. Sara R. May, each bringing significant experience in their respective fields [13][14][15][16][17] Shareholder Approvals - Shareholders approved the appointment of KPMG LLP as auditors and authorized the board to fix the auditors' remuneration [18] - An amendment to the company's by-laws was approved to increase the quorum requirement for shareholder meetings [18] - Approval was granted for the issuance of common shares under the Standby Equity Purchase Agreement, which may exceed 20% of the outstanding shares [18] - An amendment to increase the voting threshold required to remove the Chairman of the Board to 75% was also approved [18] Company Overview - Medicus Pharma Ltd. is a biotech/life sciences company focused on accelerating clinical development programs for novel therapeutics [20] - The company is engaged in multiple countries across three continents [20] - SkinJect Inc., a subsidiary of Medicus, is developing a non-invasive treatment for basal cell skin cancer using a dissolvable microneedle patch [21] - The company announced a definitive agreement to acquire Antev, a UK-based biotech company, which is subject to certain closing conditions [22]

Executive Chairman & CEO of the Company to Participate in a Fireside Chat Medicus Pharma Ltd. to Present at BTIG Virtual Biotech Conference 2025 Philadelphia, Pennsylvania--(Newsfile Corp. - July 21, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce the scheduling of the Fireside chat of Dr. Raza Bokhari, Executive Chairman and CEO, at the BTIG Virtual Biotech Conference 2025. Fireside Chat Event Details Date: Wednesday, July 30, 2025 Time: 9:20 a.m. ET The Fires ...

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]

Medicus Pharma Ltd. Announces Submission of Product Development Plan to the Food and Drug Administration (FDA) to Treat External Squamous Cell Carcinoma (SCC) in Horses Company Is Advancing Use of Novel Doxorubicin-containing Microneedle Array (D-MNA) Patch in Veterinary Oncology as an Orphan Drug June 09, 2025 7:30 AM EDT | Source: Medicus Pharma Ltd. Philadelphia, Pennsylvania--(Newsfile Corp. - June 9, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce submissi ...

Core Viewpoint - Medicus Pharma Ltd. has successfully closed a public offering of 2,260,000 units at a price of $3.10 per unit, which includes common shares and warrants for future purchases [1][2]. Group 1: Offering Details - The offering was conducted on a "best-efforts" basis, with each unit comprising one common share and one warrant to purchase an additional common share at the same price of $3.10, expiring in five years [1][2]. - Maxim Group LLC served as the lead placement agent, with Brookline Capital Markets and D. Boral Capital acting as co-placement agents [2]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily fund a Phase 2 proof of concept clinical trial for treating basal cell carcinoma using a doxorubicin-loaded dissolvable microarray needle skin patch [3]. - Additional proceeds may be allocated to expand the exploratory Phase 2 clinical trial to a pivotal trial and to cover other non-melanoma skin diseases, with any remaining funds directed towards general corporate purposes and working capital [3]. Group 3: Company Overview - Medicus Pharma Ltd. is a biotech/life sciences company focused on advancing clinical development programs for innovative therapeutics [6]. - SkinJect Inc., a wholly owned subsidiary, is developing a non-invasive treatment for basal cell skin cancer using a patented dissolvable microneedle patch [7]. - The company has completed a Phase 1 safety and tolerability study and is currently conducting multiple Phase 2 clinical studies in the United States, Europe, and the UAE [7]. Group 4: Acquisition Plans - In April 2025, the company announced a binding letter of intent to acquire Antev Ltd., a UK-based biotech company developing a next-generation GnRH antagonist for high-risk prostate cancer patients [8]. - The acquisition is subject to due diligence, negotiation of definitive agreements, and obtaining necessary approvals, with no guarantees of successful completion [8].