The Company will provide an update on its novel Doxorubicin containing Microneedle Array (D-MNA) treatment to non-invasively treat basal cell carcinoma of the skin (BCC) and development of Teverelix, a next generation GnRH Antagonist as a first in class market product for Acute Urinary Retention (AURr) and high CV risk Prostate Cancer
D-MNA and Teverelix collectively represent ~$8 billion in potential market opportunity
PHILADELPHIA, PA / ACCESS Newswire / September 24, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) (“Medicus” or the “Company”), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce that members of its executive management team will participate in a live fireside chat on Monday, September 29, 2025, hosted by Kumaraguru (Kumar) Raja, Ph.D., Senior Biotechnology Analyst at Brookline Capital Markets.
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Event: |
Fireside Chat with Kumar Raja, Ph.D, Brookline Capital Markets Senior Biotech Analyst |
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Date: |
Monday, September 29, 2025 |
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Time: |
11:00 a.m. to 12:00 p.m. Eastern Time |
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Registration: |
https://us02web.zoom.us/meeting/register/mhqmY5t1TrqAoxSRCyVXFg |
Following a company overview from Dr. Raza Bokhari Executive Chairman and CEO of Medicus Pharma, there will be two featured presentations providing updates on the Company’s key development programs:
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Ed Brennan, MD, FACS Chief Scientific Officer & Head of R&D Program, will discuss SkinJect™ D-MNA novel treatment to non-invasively treat basal cell carcinoma (BCC) of the skin and provide an update on the progress of phase 2 clinical studies.
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Faisal Mehmud, MD, MRCP, Chief Medical Officer, will provide an update on Teverelix, a next generation GnRH antagonist as a first in class market product to prevent relapse of acute urinary retention (AURr) and high CV risk prostate cancer.
The fireside chat will conclude with a Q&A session during which participants can ask questions live or submit them during the webcast. Please note this event will be live only; there will be no publicly available recording or archived webcast.
The Company’s lead asset, SkinJect Inc., is a development stage biotechnology company focused on commercializing a novel treatment for non-melanoma skin cancer, especially BCC, using a patented dissolvable doxorubicin-containing microneedle array (D-MNA). D-MNA delivers the chemotherapeutic agent transdermally at the site of the lesion to eradicate tumor cells.
The Company is currently conducting a Phase 2 clinical study for SKNJCT-003 in nine (9) clinical sites across the United States which commenced randomizing patients in August 2024. In March 2025, the Company also announced a positively trending interim analysis for SKNJCT-003 demonstrating more than 60% clinical clearance. The interim analysis was conducted after more than 50% of the then-targeted 60 patients in the study were randomized. The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed. In April 2025, the investigational review board increased the number of participants in SKNJCT-003 to ninety (90) subjects. The Company is expanding its trial sites in Europe and has randomized more than 75% of the ninety (90) participants expected to be randomized in the study.
The Company also has a clinical study (SKNJCT-004) currently underway in the United Arab Emirates (UAE). The study is expected to randomize thirty-six (36) patients in six (6) sites in the UAE. Cleveland Clinic Abu Dhabi (CCAD) is the principal investigator, along with Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), Rashid Hospital (RH), Clemenceau Medical Center (CMC) and American Hospital of Dubai (AHD). Insights Research Organization and Solutions (IROS), a UAE-based contract research organization, is coordinating the clinical study for the Company. IROS is a M42 portfolio company.
In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as a first in market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate.
Antev’s flagship drug candidate is Teverelix trifluoroacetate (Teverelix TFA), a long-acting gonadotrophin-releasing hormone (GnRH) antagonist. Unlike GnRH agonists, which can cause an initial surge in testosterone levels, Teverelix directly suppresses sex hormone production without this surge, potentially reducing cardiovascular risks. This mechanism is particularly beneficial for patients with existing cardiovascular conditions. Teverelix is formulated as a microcrystalline suspension, allowing for sustained release and a six-week dosing interval, which may improve patient compliance and outcomes.
For further information contact:
Carolyn Bonner, President
(610) 636-0184
cbonner@medicuspharma.com
Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicspharma.com
About Medicus Pharma Ltd.
Medicus Pharma Ltd. (NASDAQ:MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and potentially disruptive therapeutics assets. The Company is actively engaged in multiple countries, spread over three continents.
SkinJect Inc. a wholly owned subsidiary of Medicus Pharma Ltd., is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumors cells. The Company completed a phase 1 safety & tolerability study (SKNJCT-001) in March of 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of the investigational product D-MNA, with six (6) participants experiencing complete response on histological examination of the resected lesion. The Company is currently conducting a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) in the United States and Europe. The Company has also commenced a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-004) in the United Arab Emirates.
In August 2025, the Company announced its entry into a non-binding memorandum of understanding (the “MoU”) with Helix Nanotechnologies, Inc. (“HelixNano”), a Boston Based biotech company focused on developing a proprietary advanced mRNA platform, in respect of their shared mutual interest in the development or commercial arrangement contemplated by the MoU. The MoU is non-binding and shall not be construed to obligate either party to proceed with a joint venture or any further development or commercial arrangement, unless and until definitive agreements are executed.
In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as a first in market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate.
Antev’s flagship drug candidate is Teverelix trifluoroacetate (Teverelix TFA), a long-acting gonadotrophin-releasing hormone (GnRH) antagonist. Unlike GnRH agonists, which can cause an initial surge in testosterone levels, Teverelix directly suppresses sex hormone production without this surge, potentially reducing cardiovascular risks. This mechanism is particularly beneficial for patients with existing cardiovascular conditions. Teverelix is formulated as a microcrystalline suspension, allowing for sustained release and a six-week dosing interval, which may improve patient compliance and outcomes.
In September 2020, Antev completed a Phase 1 clinical trial in which Teverelix was shown to be well tolerated with no dose-limiting toxicities and demonstrated rapid testosterone suppression. The study included 48 healthy male volunteers. In February 2023, Antev also completed a Phase 2a study in fifty (50) patients with advanced prostate cancer (APC), where Teverelix achieved the primary endpoint of greater than 90% probability of castration levels of testosterone suppression (97.5%) but the secondary endpoint of maintaining this rate above 90% was not met with the probability dropping to 82.5% by Day 42.
In January 2023, the FDA, reviewed the Phase 1 and Phase 2a data and provided written guidance on Antev’s proposed Phase 3 trial design for Teverelix. This milestone supports the Company’s clinical plans to develop Teverelix as a treatment for advanced prostate cancer patients with increased cardiovascular risk.
In December 2023, FDA approved the Phase 2b study design in advanced prostate cancer covering 40 patients.
In November 2024, FDA approved the Phase 2b study design in acute urinary retention covering 390 patients.
Cautionary Notice on Forward-Looking Statements
Certain information in this news release constitutes “forward-looking information” under applicable securities laws. “Forward-looking information” is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, the development of Teverelix and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix for AURr and high CV risk prostate cancer, and the potential market opportunities related thereto, the MOU, including the potential signing of definitive agreements between Medicus and HelixNano and the development of thermostable infectious diseases vaccines by combining HelixNano’s proprietary mRNA vaccine platform with Medicus’s proprietary microneedle array (MNA) delivery platform, the Company’s aim to fast-track the clinical development program and convert the SKNJCT-003 exploratory clinical trial into a pivotal clinical trial, and approval from the FDA and the timing thereof, plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of SkinJect through SKNJCT-003 and SKNJCT-004, and the potential market opportunities related thereto, the commencement of the SKNJCT-004 study and the potential results of and benefits of such study. Forward-looking statements are often but not always, identified by the use of such terms as “may”, “on track”, “aim”, “might”, “will”, “will likely result”, “could,” “designed,” “would”, “should”, “estimate”, “plan”, “project”, “forecast”, “intend”, “expect”, “anticipate”, “believe”, “seek”, “continue”, “target”, “potential” or the negative and/or inverse of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company’s annual report on form 10-K for the year ended December 31, 2024 (the “Annual Report”), and in the Company’s other public filings on EDGAR and SEDAR+, which may impact, among other things, the trading price and liquidity of the Company’s common shares. . Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
SOURCE: Medicus Pharma Ltd
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