Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”), a biotech/lifesciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, today announced the Company has submitted an optimized Phase 2 clinical study design to the U.S. Food and Drug Administration (“FDA”) for Teverelix, its investigational GnRH antagonist, for the prevention of recurrent acute urinary retention (“AURr”) in men with benign prostatic hyperplasia (“BPH”) as part of its existing open Investigational New Drug (“IND”) for Teverelix.

The Phase 2 study design has been refined under the leadership of Steven A. Kaplan, MD, FACS, a globally recognized leader in urology and men’s health, who will serve as Principal Investigator.

Dr. Kaplan is Professor of Urology at the Icahn School of Medicine at Mount Sinai and has held senior academic appointments at ColumbiaUniversity and Weill Cornell Medical College, where he served as Vice Chairman of Urology. He is internationally regarded as a leading authority in BPH, lower urinary tract symptoms (“LUTS”), and voiding dysfunction. He has also authored over 1,000 scientific publications, including more than 600 peer-reviewed articles, and is the recipient of the John K. Lattimer Award for Lifetime Achievement in Urology.

“This refined study design reflects a more capital-efficient development strategy intended to accelerate Teverelix’s path to commercialization,” said Dr. Raza Bokhari, Executive Chairman and CEO of Medicus. “By focusing on clear pharmacodynamic endpoints and incorporating an interim analysis designed to inform subsequent clinical development, we believe Teverelix can generate actionable clinical data more rapidly, enabling earlier strategic engagement and potential partnering opportunities.”

There are currently no approved pharmacologic therapies specifically indicated to prevent recurrence of AUR, primarily due to enlargedprostate. The Company’s proof-of-concept study design to evaluate Teverelix in AURr represents a novel approach addressing an underserved clinical need, representing an approximately $2 billion target market.

The updated Phase 2 study design (ANT-2111-02) incorporates:

• A targeted sample size of approximately 126 patients across the United States and Europe
• A design focused on detecting a clear pharmacodynamic signal (total prostate volume reduction)
• A structure optimized for dose and route differentiation

This design demonstrates a data-driven evolution toward generating decision-grade clinical evidence representing an approximately three-fold reduction in study size compared to the original design and a meaningful reduction in overall development cost, with correspondingimprovements in development efficiency and execution speed, supporting earlier strategic engagement and partnering discussions. The study is designed to generate an early pharmacodynamic signal within approximately 12 weeks.

AURr Study Design and Endpoints Overview

The optimized Phase 2 study is a randomized, double-blind, single-dose, four-arm design. Patients will be randomized to receive:

• Teverelix 90 mg (intramuscular)
• Teverelix 120 mg (subcutaneous)
• Matched placebo controls

All patients will receive a single injection on Day 1. The duration of the study is 52 weeks, which includes a 28-week treatment period and a 24-week follow-up. The patients will remain on standard-of-care alpha-blocker therapy.

The study is anchored by a mechanism-driven primary endpoint of percent change in total prostate volume (“TPV”) at Week 12. The secondary endpoints include maximum urine flow rate (“Qmax”), post void residual volume (“PVR”), AURr and need for intervention.

An interim analysis will be conducted after approximately 50 percent of patients have completed the Week 12 assessment to inform doseselection, route optimization and future Phase 3 study design. This interim analysis is expected to provide an early pharmacodynamic signal and support timely development decision.

Company’s key therapeutics assets are:

SkinJect™, a novel localized immuno-oncology precision product focused on non-melanoma skin diseases, especially basal cell carcinoma (BCC) and Gorlin Syndrome, a rare autosomal dominant disease also called nevoid BCC syndrome, collectively representing a ~$2 billion market opportunity.

Teverelix®, a next generation GnRH antagonist is a first-in-market product for cardiovascular high-risk advanced prostate cancer patients and patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate, collectively representing a ~$6 billion market opportunity.

The Company is actively engaged in following collaborations:

Skinject™ Platform Expansion

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, and there can be no assurance that such definitive agreements will be executed.

The Company is exploring co-development of thermostable infectious disease vaccines combining HelixNano’s proprietary mRNA technology with the Medicus microneedle array delivery platform.

Patient Access and Advocacy

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

In collaboration with the Gorlin Syndrome Alliance, Medicus is pursuing an Expanded Access IND program to provide Gorlin Syndromepatients with multiple or inoperable BCCs access to SkinJect™, the Company’s investigational D-MNAs, under physician supervision.