Medicus Pharma Ltd. recently announced it has entered into non-binding letter of intent (LOI) with Reliant AI Inc., 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.

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.