Author: Medicus Pharma Ltd

PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / January 23, 2026 / Medicus Pharma Ltd. (NASDAQ:MDCX) (“Medicus” or the “Company”), a precision guided biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, CEO Dr Raza Bokhari joined Steve Darling from Proactive https://youtu.be/8EErx6aQEXs to announce that the company was honored with the opportunity to ring the Nasdaq Opening Bell at the Nasdaq MarketSite in New York’s Times Square, marking the one-year anniversary of Medicus’ listing on the Nasdaq exchange.

Dr. Bokhari said the milestone reflects the company’s progress since going public and highlights its continued focus on disciplined execution across a streamlined and strategically selected clinical portfolio. Since its Nasdaq debut, Medicus has concentrated on advancing key therapeutic assets through Phase 2 proof-of-concept studies while actively pursuing licensing opportunities and strategic partnerships with established pharmaceutical companies that are well positioned to manage late-stage development and global commercialization.

Medicus’ current development pipeline is anchored by two lead programs. SkinJect is a localized, immunogenic precision therapy being developed for the treatment of basal cell carcinoma, the most common form of skin cancer. The company estimates SkinJect addresses a market opportunity of approximately $2 billion.

The pipeline also includes Teverelix, a next-generation gonadotropin-releasing hormone (GnRH) antagonist designed for patients with advanced prostate cancer who are at high cardiovascular risk and susceptible to acute urinary retention relapse. Medicus estimates the combined market opportunity for its pipeline assets at approximately $6 billion. The company announced today that the royalty rate payable on worldwide net sales of Teverelix has been reduced from ~4% to 2%, with the royalty term clarified on a country-by-country basis in line with standard industry practice. The company says this makes Teverelix more attractiveness for future partnering.

The video of the proactive interview is available by clicking on this link https://youtu.be/8EErx6aQEXs

For further information contact:

Carolyn Bonner, President and Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.com

Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.com

About Medicus Pharma Ltd.
Medicus Pharma Ltd. (Nasdaq:MDCX) is a precision-guided 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 across three continents.

SkinJect Inc., a wholly owned subsidiary of Medicus Pharma Ltd., is a development-stage life sciences company focused on commercializing a novel, non-invasive treatment for basal cell skin cancer using a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumor cells. The Company completed a Phase 1 study (SKNJCT-001) in March of 2021, which met its primary objective of demonstrating safety and tolerability; the study also describes the efficacy of the investigational product doxorubicin-containing microneedle arrays (D-MNA), with six 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 (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 gonadotrophin-releasing hormone (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.

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 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 U.S. Food and Drug Administration (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, the FDA approved the Phase 2b study design in advanced prostate cancer covering 40 patients.

In November 2024, the FDA approved the Phase 2b study design in AURr covering 390 patients.

In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome.

Under the collaboration, Medicus and the GSA will jointly pursue the Expanded Access IND Program with the FDA to allow patients with multiple, recurrent, or inoperable basal cell carcinomas (BCCs) to access SkinJect under physician-supervised treatment protocols. The initiative aims to establish a framework for expanded access while collecting valuable real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SkinJect in this rare disease population.

In November 2025, the Company received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. The approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA approval followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA granted study-wide governance approval, confirming compliance with UK Good Clinical Practice and National Health Service capacity and capability standards.

In December 2025, the Company announced that it has successfully completed enrolment of 90 patients in the United States for Phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. The Company expects to release topline results for SKNJCT-003 in the first quarter of 2026 and secure an end-of-Phase 2 meeting with the FDA in the first half of 2026.

In December 2025, Medicus announced a non-binding letter of intent with Reliant AI Inc., a decision-intelligence company specializing in generative AI for the life sciences industry, to collaborate on the development of an AI-driven clinical data analytics platform. Subject to execution of definitive agreements, the platform is expected to support capital-efficient clinical development through data-driven dynamic clinical-site selection, patient stratification and enrollment forecasting. The initial phase of the collaboration is expected to support an upcoming Teverelix clinical study planned for 2026, with potential expansion into later-stage development programs in collaboration with a strategic partner.

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, statements regarding the Company’s leadership and prospects, the collaboration with GSA including the potential benefits thereof for GSA, those suffering with Gorlin Syndrome and Medicus (including as it relates to the development of SkinJect™), ability to be approved for the Expanded Access IND Program to enable those suffering with Gorlin Syndrome to access SkinJect™ under physician-supervised treatment protocols, the development of Teverelix and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix for AURr, high CV risk prostate cancer, women’s health indications like endometriosis, 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, including with respect to the Company’s submission for approval in the FDA Commissioner’s National Priority Voucher program, 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 Company’s expectation to release topline results for SKNJCT-003 in the first quarter of 2026 and to secure an EOP2 meeting with the FDA in the first half of 2026, entry into definitive documents with Reliant and the expected terms thereof, engaging in proposed Medicus-sponsored studies currently contemplated in the Reliant non-binding letter of intent and the expected benefits thereof, the expansion of SKNJCT-003 into the United Kingdom and the potential benefits therefrom, the advancement 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

View the original press release on ACCESS Newswire

The engagement establishes a multi-phase framework to support AI enabled capital efficient 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 collectively representing ~$6 billion in potential market opportunity

PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / December 22, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) (“Medicus” or the “Company”), a precision guided biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce that it has entered into non-binding letter of intent (LOI) with Reliant AI Inc. (“Reliant”), a decision-intelligence company for the life sciences, specializing in generative AI, to collaborate on the development of an artificial-intelligence-powered data analytics platform designed to support clinical trial execution through data-driven insights.

Reliant AI Inc. is a privately held decision-intelligence company powering the next generation of life sciences research with generative AI. Founded by former DeepMind and Google Brain researchers Karl Moritz Hermann and Marc Bellemare, and life sciences expert Richard Schlegel, Reliant AI combines cutting-edge machine learning with deep biomedical expertise The company’s platform automates data-intensive workflows-from systematic literature reviews to commercial success prediction-enabling biopharma teams to make faster, evidence-based decisions.

The proposed platform is intended to enhance data-driven decision-making across Medicus’ clinical pipeline by integrating Reliant’s proprietary AI technology with Medicus’ clinical, operational, and proprietary datasets. The platform is expected to support more efficient trial execution, including dynamic clinical-site selection, patient stratification, and enrollment forecasting. The initial phase of the collaboration will focus on dynamic site selection, supported by targeted patient-stratification analyses, for an upcoming Teverelix clinical study planned to commence in 2026.

“This proposed collaboration reflects an important strategic step of selectively deploying advanced analytics and AI tools to improve the efficiency, quality, and predictability of clinical development,” stated Dr. Raza Bokhari, Medicus Exec. Chairman & CEO “by integrating AI-enabled modeling with our clinical and pharmacodynamic data, we aim to support more precise trial execution while maintaining capital discipline We see this as the foundation for a broader, data-driven clinical execution capability. Starting with Teverelix, our goal is to apply these insights to improve trial efficiency, inform patient selection, and support smarter decision-making as our programs move toward late-stage development.”

Planned Clinical Development Applications

Subject to execution of definitive agreements, the data analytics platform is expected to be initially deployed to support a Medicus-sponsored study planned for Q2-Q4 2026, with potential expansion to a larger, late-stage clinical study planned for 2028 in collaboration with a development or commercial partner.

Initial areas of focus under the LOI include:

• Dynamic site selection and re-selection during active patient recruitment

• Enrollment simulations and forecasting across geographies

• Comparative site-selection strategies to support study planning and partnering discussions

• Early pharmacodynamic (PD)-informed patient stratification to optimize inclusion criteria and analytical focus

The platform is expected to leverage public, commercial, and Medicus proprietary datasets to analyze disease burden, geographic distribution, and patient-subgroup characteristics, with the ability to scale into broader feasibility and stratification modules over time.

Proposed Commercial Structure

Subject to the execution of definitive agreements, Medicus and Reliant intend to structure the initial collaboration as a one-year, milestone-based services engagement with an aggregate financial commitment not to exceed $200,000, tied to defined delivery milestones over a 12-month period. The Company shall also make available all relevant clinical and operational resources to support this engagement.

Non-Binding Nature of the LOI

The letter of intent is non-binding, and does not create a partnership, joint venture, or agency relationship between the parties. Ownership, intellectual property rights, governance, and final commercial terms will be addressed, if at all, in definitive agreements. There can be no assurance that a definitive agreement will be executed or that the proposed collaboration will proceed as contemplated.

Skinject Clinical Development Program SKNJCT-003 & SKNJCT-004 Progress:

The Company is currently conducting a Phase 2 clinical study for SKNJCT-003 in nine (9) clinical sites across the United States. SKNJCT-003, which commenced randomizing patients in August 2024, is a double blinded, placebo controlled triple arm proof of concept Phase 2 clinical study, designed to non-invasively treat basal cell carcinoma (BCC) of the skin using novel, patent protected, dissolvable doxorubicin-containing microneedle arrays (D-MNA). In December 2025, the Company announced that it has successfully completed enrolment of ninety (90) patients in the United States for phase 2 clinical study (SKNJCT-003). The Company expects to release topline results for SKNJCT-003 in the first quarter of 2026 and secure an end of phase 2 (EOP2) meeting with the FDA in the first half of 2026.

In March 2025, the Company 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 September 2025, the Company received positive feedback from the Food and Drug Administration (FDA) regarding its Type C meeting supporting the development of SkinJect, indicating that the Company may follow the FDA’s 505(b)(2) regulatory pathway to non-invasively treat BCC of the skin using dissolvable D-MNA.

In October 2025, the Company treated its first patient in the 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 with Cleveland Clinic Abu Dhabi (CCAD) as the principal investigator. 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 November 2025, the Company received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. The approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA approval followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA granted study wide governance approval, confirming compliance with U.K. Good Clinical Practice and National Health Service capacity and capability standards.

Skinject Platform Expansion:

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, to explore co-development of thermostable infectious disease vaccines.

Pipeline Expansion-Acquisition of Antev

In August 2025, the Company completed the acquisition of Antev Limited (“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, 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.

Patient Access & Advocacy-Gorlin Syndrome Alliance Collaboration

In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect™, the Company’s investigational doxorubicin containing microneedle arrays (D-MNA) for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome.

Under the collaboration, Medicus and the GSA will jointly pursue the Expanded Access IND Program with the FDA to allow patients with multiple, recurrent, or inoperable BCCs of the skin to access SkinJect™ under physician-supervised treatment protocols. The initiative aims to establish a framework for expanded access while collecting valuable real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SkinJect™ in this rare disease population.

For further information contact:

Carolyn Bonner, President and Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.com

Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.com

About Reliant AI Inc.

Reliant AI Inc. is a privately held decision-intelligence company powering the next generation of life sciences research with generative AI. The company’s platform automates data-intensive workflows-from systematic literature reviews to commercial success prediction-enabling biopharma teams to make faster, evidence-based decisions.

Founded by former DeepMind and Google Brain researchers Karl Moritz Hermann and Marc Bellemare, and life sciences expert Richard Schlegel, Reliant AI combines cutting-edge machine learning with deep biomedical expertise. The company has offices in Montreal, Canada, and Berlin, Germany, and is backed by Tola Capital and Inovio Capital. For more information, visit www.reliant.ai.

About Medicus Pharma Ltd.

Medicus Pharma Ltd. (Nasdaq:MDCX) is a precision guided 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, 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

In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect™, the Company’s investigational doxorubicin containing microneedle arrays (D-MNA) for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome.

Under the collaboration, Medicus and the GSA will jointly pursue the Expanded Access IND Program with the Food and Drug Administration (FDA) to allow patients with multiple, recurrent, or inoperable basal cell carcinomas (BCCs) to access SkinJect™ under physician-supervised treatment protocols. The initiative aims to establish a framework for expanded access while collecting valuable real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SkinJect™ in this rare disease population.

In November 2025, the Company received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin. The approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA approval followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA granted study wide governance approval, confirming compliance with U.K. Good Clinical Practice and National Health Service capacity and capability standards.

In December 2025, the Company announced that it has successfully completed enrolment of ninety (90) patients in the United States for phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. The Company expects to release topline results for SKNJCT-003 in the first quarter of 2026 and secure an end of phase 2 (EOP2) meeting with the FDA in the first half of 2026.

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, statements regarding the Company’s leadership and prospects, the collaboration with GSA including the potential benefits thereof for GSA, those suffering with Gorlin Syndrome and Medicus (including as it relates to the development of SkinJect™), ability to be approved for the Expanded Access IND Program to enable those suffering with Gorlin Syndrome to access SkinJect™ under physician-supervised treatment protocols, 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, including with respect to the Company’s submission for approval in the FDA Commissioner’s National Priority Voucher program, 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 Company’s expectation to release topline results for SKNJCT-003 in the first quarter of 2026 and to secure an EOP2 meeting with the FDA in the first half of 2026, entry into definitive documents with Reliant and the expected terms thereof, engaging in proposed Medicus-sponsored studies currently contemplated in the Reliant non-binding letter of intent and the expected benefits thereof, the expansion of SKNJCT-003 into the United Kingdom and the potential benefits therefrom, the advancement 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

View the original press release on ACCESS Newswire

Maxim Group LLC is acting as the exclusive Financial Advisor for the transaction

PHILADELPHIA, PA / ACCESS Newswire / December 5, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) (“Medicus” or the “Company”), a precision guided biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, today announced that it has entered into a warrant inducement agreement for the immediate exercise of the total outstanding Series A Warrants and Series B Warrants that the Company issued on July 14, 2025 (the “Warrants”). Pursuant to the warrant inducement agreement, the investor has agreed to reduce the exercise price of the outstanding Warrants to an amended price of $1.92, and to exercise all outstanding Warrants to purchase an aggregate of 2,680,000 shares of the Company’s common shares at the amended exercise price of $1.92. The gross proceeds from the exercise of the Warrants are expected to be approximately $5.1 million, prior to deducting placement agent fees and estimated offering expenses. The common shares issuable upon exercise of the Series A and Series B Warrants are registered pursuant to an effective registration statement on Form S-1 (No. 333-291651).

Maxim Group LLC is acting as the exclusive Financial Advisor for the transaction.

In consideration for the immediate exercise of the existing Warrants, the Company also agreed to issue to the investor unregistered Series C and Series D Warrants to purchase an aggregate of 4,020,000 of the Company’s common shares, each with an exercise price of $2.00 per share (the “New Warrants”). The New Warrants will feature substantially the same terms, will be exercisable in accordance with their terms and will expire five- and one-half years from the date of issuance. The Company has agreed to timely file a registration statement with the Securities and Exchange Commission (“SEC”) covering the resale of the common shares issuable upon exercise of the New Warrants.

The closing of the warrant exercise transactions is expected to occur on or about December 5, 2025, subject to satisfaction of customary closing conditions.

The New Warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the “1933 Act”) and, along with the common shares issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (“SEC”) or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

For further information contact:

Carolyn Bonner, President and Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.com

Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.com

About Medicus Pharma Ltd.

Medicus Pharma Ltd. (Nasdaq:MDCX) is a precision guided 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, 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

In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect^™, the Company’s investigational doxorubicin containing microneedle arrays (D-MNA) for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome.

Under the collaboration, Medicus and the GSA will jointly pursue the Expanded Access IND Program with the Food and Drug Administration (FDA) to allow patients with multiple, recurrent, or inoperable basal cell carcinomas (BCCs) to access SkinJect^™ under physician-supervised treatment protocols. The initiative aims to establish a framework for expanded access while collecting valuable real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SkinJect^™ in this rare disease population.

In November 2025, the Company received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin. The approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA approval followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA granted study wide governance approval, confirming compliance with U.K. Good Clinical Practice and National Health Service capacity and capability standards

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, statements regarding the Company’s leadership and prospects, the collaboration with GSA including the potential benefits thereof for GSA, those suffering with Gorlin Syndrome and Medicus (including as it relates to the development of SkinJect^™), ability to be approved for the Expanded Access IND Program to enable those suffering with Gorlin Syndrome to access SkinJect^™ under physician-supervised treatment protocols, 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, including with respect to the Company’s submission for approval in the FDA Commissioner’s National Priority Voucher program, 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 expansion of SKNJCT-003 into the United Kingdom and the potential benefits therefrom, the advancement 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.

View the original press release on ACCESS Newswire

THE SKNJCT-003 CLINICAL STUDY EXPANSION INTO THE UNITED KINGDOM TO FURTHER ENABLE GLOBAL PATIENT RECRUITMENT AND CLINICAL DATASET TOWARD A PIVOTAL STUDY PROGRAM

PHILADELPHIA, PA / ACCESS Newswire / November 13, 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 it has received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin.

The phase 2 clinical study (SKNJCT-003) which is currently underway in nine (9) clinical sites in United States can now expand into additional sites in United Kingdom.

The approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA approval followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA granted study wide governance approval, confirming compliance with U.K. Good Clinical Practice and National Health Service (NHS) capacity and capability standards.

“The United Kingdom regulatory and ethical approval is another major step forward in establishing a global footprint of our novel, non-invasive treatment for BCC of the skin, which we believe represents more than $2 billion in potential market opportunity,” stated Dr. Raza Bokhari, Medicus’s Executive Chairman & CEO. “With clinical development programs now active across United States, Europe, and the Middle East, we are enhancing global patient recruitment and clinical dataset which, among other things, would assist us in designing a robust pivotal program”.

SKNJCT-003 Clinical Trial Design
The SKNJCT-003 clinical study is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 90 subjects presenting with BCC of the skin. The study evaluates the efficacy of two dose levels of D-MNA compared to a placebo control. The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA.

The high-dose, 200μg D-MNA, in the study is the maximum dose that was used in the Company’s Phase 1 safety and tolerability study (SKNJCT-001) completed in March 2021.

SKNJCT-001 met its primary objective of safety and tolerability. The investigational product, D-MNA, was well tolerated across all dose levels in all 13 participants enrolled in the study, with no dose-limiting toxicities (DLTs), or serious adverse events (SAEs). Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examinations. The study also describes the efficacy of the investigational product, D-MNA, with 6 participants experiencing complete responses. The complete response is defined as the disappearance of BCC histologically in the final excision at the end of study visit. The participants profile demonstrating complete responses was diverse, and all participants (6/6) had nodular subtype of BCC.

In March 2025, the Company 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 approved to increase 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. In September 2025, the Company received positive feedback from the Food and Drug Administration (FDA) regarding its Type C meeting supporting the development of Skinject, indicating that the Company may follow 505(b)(2) regulatory pathway to non-invasively treat BCC using dissolvable D-MNA.

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.

In October 2025, the company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SKINJECT™, the Company’s investigational doxorubicin containing microneedle arrays (D-MNA) for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome.

Under the collaboration, Medicus and the GSA will jointly pursue the Expanded Access IND Program with the Food and Drug Administration (FDA) to allow patients with multiple, recurrent, or inoperable basal cell carcinomas (BCCs) to access SKINJECT™ under physician-supervised treatment protocols. The initiative aims to establish a framework for expanded access while collecting valuable real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SKINJECT™ in this rare disease population.

For further information contact:
Carolyn Bonner, President and Acting Chief Financial Officer
(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

In October 2025, the company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SKINJECT™, the Company’s investigational doxorubicin containing microneedle arrays (D-MNA) for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome.

Under the collaboration, Medicus and the GSA will jointly pursue the Expanded Access IND Program with the Food and Drug Administration (FDA) to allow patients with multiple, recurrent, or inoperable basal cell carcinomas (BCCs) to access SKINJECT™ under physician-supervised treatment protocols. The initiative aims to establish a framework for expanded access while collecting valuable real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SKINJECT™ in this rare disease population.

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 collaboration with GSA including the potential benefits thereof for GSA, those suffering with Gorlin Syndrome and Medicus (including as it relates to the development of SkinJect), ability to be approved for the Expanded Access IND Program to enable those suffering with Gorlin Syndrome to access SKINJECT™ under physician-supervised treatment protocols, 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 expansion of SKNJCT-003 into the United Kingdom and the potential benefits therefrom, the advancement 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

View the original press release on ACCESS Newswire

Clinical development programs for doxorubicin-containing microneedle array (D-MNA) and Teverelix, a next generation GnRH antagonist, are steadily advancing

PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / November 14, 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 therapeutic assets, announced today its financial and operating results for the quarter ending September 30, 2025, and highlighted important corporate updates.

Third Quarter Corporate Highlights:

• Skinject Clinical Development Program SKNJCT-003 & SKNJCT-004 Progress:

The Company is currently conducting a Phase 2 clinical study for SKNJCT-003 in nine (9) clinical sites across the United States. SKNJCT-003, which commenced randomizing patients in August 2024, is a double blinded, placebo controlled triple arm proof of concept Phase 2 clinical study, designed to non-invasively treat basal cell carcinoma (BCC) of the skin using novel, patent protected, dissolvable doxorubicin-containing microneedle arrays (D-MNA).

In August 2025, the Company announced that SKNJCT-003 has randomized more than seventy-five percent (75%) of the ninety (90) participants expected to be randomized in the study.

In September 2025, the Company received positive feedback from the Food and Drug Administration (FDA) regarding its Type C meeting supporting the development of SkinJect, indicating that the Company may follow the FDA’s 505(b)(2) regulatory pathway to non-invasively treat BCC of the skin using dissolvable D-MNA.

In October 2025, the Company treated its first patient in the 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 is the principal investigator.

In November 2025, the company received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. The approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA approval followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA granted study wide governance approval, confirming compliance with U.K. Good Clinical Practice and National Health Service capacity and capability standards.

• Skinject Platform Expansion:

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, to explore co-development of thermostable infectious disease vaccines.

• Pipeline Expansion-Acquisition of Antev

In August 2025, the Company completed the acquisition of Antev Limited (“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, 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.

• Patient Access & Advocacy-Gorlin Syndrome Alliance Collaboration

In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect^™, the Company’s investigational doxorubicin containing microneedle arrays (D-MNA) for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome.

Under the collaboration, Medicus and the GSA will jointly pursue the Expanded Access IND Program with the FDA to allow patients with multiple, recurrent, or inoperable BCCs of the skin to access SkinJect^™ under physician-supervised treatment protocols. The initiative aims to establish a framework for expanded access while collecting valuable real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SkinJect^™ in this rare disease population.

Today the Company also announced its financial and operating results for the quarter ended September 30, 2025, highlights of which are provided below.

Third Quarter Financial Highlights

The addition of $10.4 million of aggregate net proceeds from financing transactions and the exercise of warrants has bolstered the Company’s already strong balance sheet as it continues to progress its clinical development program while pursuing strategic acquisition, building out its core management team and strengthening its board of directors.

Cash and cash equivalents were $8.7 million at the end of the third quarter compared to $5.3 million at the end of the same period in 2024.

• Total operating expenses were $15.4 million for the third quarter compared to $2.3 million for the same period in 2024.

• Research and development expenses were $1.7 million for the third quarter compared to $0.6 million for the same period in 2024.

• General and administrative expenses were $5.0 million for the third quarter compared to $1.8 million for the same period in 2024.

• Net loss for the third quarter was $16.0 million compared to $2.3 million for the same period in 2024. This reflects increased expenses as the Company accelerates its clinical development program in United States, Europe and the Middle East, raises additional capital, completed the acquisition of Antev in the United Kingdom and continues to integrate Antev into its business and operations, as well as continues to pursue strategic growth.

The Company’s complete financial statements for the quarter are included in its quarterly report on Form 10-Q, which was filed with the Securities and Exchange Commission on November 14, 2025, and are also available on SEDAR+.

Management Commentary

“The fundamentals of the Company continue to remain strong,” stated Dr. Raza Bokhari, Medicus’s Executive Chairman and CEO. “The clinical development program of SkinJect, which we believe represents more the $2 billion in potential market opportunity, is now active across the United States, Europe, and the Middle East. This expansion is enhancing global patient recruitment and our clinical dataset, which, among other things, is expected to assist us in designing a robust pivotal program. Completing the acquisition of Antev has been the highlight of the third quarter, which not only adds strategic depth to our drug development pipeline but also strengthens our team, both at the board and management levels. We believe, Teverelix, a next generation GnRH antagonist, is well positioned to become a first in class product to prevent acute urinary retention relapse due to enlarged prostate, and to treat advanced prostate cancer in patients with high cardiovascular risk profile, collectively representing approximately US$6 billion in potential market opportunity. The Company’s balance sheet is stable, and management’s confidence level is high.”

For further information contact:

Carolyn Bonner, President and Acting Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.com

Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.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, 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

In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect^™, the Company’s investigational doxorubicin containing microneedle arrays (D-MNA) for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome.

Under the collaboration, Medicus and the GSA will jointly pursue the Expanded Access IND Program with the Food and Drug Administration (FDA) to allow patients with multiple, recurrent, or inoperable basal cell carcinomas (BCCs) to access SkinJect^™ under physician-supervised treatment protocols. The initiative aims to establish a framework for expanded access while collecting valuable real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SkinJect^™in this rare disease population.

In November 2025, the Company received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin. The approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA approval followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA granted study wide governance approval, confirming compliance with U.K. Good Clinical Practice and National Health Service capacity and capability standards

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 collaboration with GSA including the potential benefits thereof for GSA, those suffering with Gorlin Syndrome and Medicus (including as it relates to the development of SkinJect^™), ability to be approved for the Expanded Access IND Program to enable those suffering with Gorlin Syndrome to access SkinJect^™ under physician-supervised treatment protocols, 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 expansion of SKNJCT-003 into the United Kingdom and the potential benefits therefrom, the advancement 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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