The Fort Worth Press - Medicus Pharma Reports Full-Year 2025 Financial Results and Provides Corporate Update

PHILADELPHIA, PA / ACCESS Newswire / March 25, 2026 / 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, today reported audited financial results for the year ended December 31, 2025, and provided a corporate update highlighting significant progress across its SkinJect® and Teverelix development programs, as well as expansion into precision medicine and AI-enabled clinical development.

Management Commentary

"2025 marked a pivotal year for Medicus, highlighted by completion of our Phase 2 SkinJect study, efforts to expand into rare disease and women's health indications, and the integration of agentic AI-driven clinical development capabilities." stated Dr. Raza Bokhari. Executive Chairman & CEO of Medicus "The strength of our clinical dataset, combined with regulatory alignment and potential access to capital resources, positions the Company to advance toward registrational planning and strategic partnerships in 2026 and beyond."

SkinJect® Platform (Dermatology / Oncology / Rare Disease)

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 an ~$2 billion market opportunity.

Skinject Phase 2 Positive Topline Dataset Highlights:

The company completed a 90 patient Phase 2 clinical study, titled, "A randomized, double-blind, three-arm Phase 2 study evaluating two dose levels of microneedle-mediated delivery of doxorubicin compared with a device-only control in patients with nodular basal cell carcinoma."

The randomized design of SKNJCT-003, including a device-only active control arm, provides a rigorous framework for evaluating the incremental therapeutic contribution of doxorubicin delivered through the SkinJect microneedle system.

The Study positive Topline data demonstrated:

• Up to 73% clinical clearance in the highest dose cohort (200ug dose)

• continued biological activity between Day 29 and Day 57, supporting durability of response

• 200 ug cohort at Day 57 suggest ~3 out of 4 treated patients may avoid immediate surgery

• Biological activity observed in the device-only arm reflects tumor disruption, also observed in March 2021 SKNJCT-001 Phase 1 study and SKNJCT-003 interim analysis in March 2025.

Pipeline Expansion and Strategic Innovation

• Gorlin Syndrome Expansion

  • Advancing SkinJect® for nevoid basal cell carcinoma syndrome, a rare genetic disorder characterized by multiple recurrent BCC lesions

  • Pursuing Expanded Access IND program for patients with multiple or inoperable lesions

  • Supports potential orphan disease positioning and broader clinical utility

• Platform Extension via HelixNano Collaboration

  • Entered into a non-binding collaboration with Helix Nanotechnologies, Inc.

  • Exploring integration of microneedle delivery with next-generation mRNA technologies, with potential applications in developing thermostable vaccines

Teverelix Platform (Prostate + Women's Health)

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 an ~$6 billion market opportunity.

• Long-acting GnRH antagonist designed to suppress testosterone without flare

• Potential cardiovascular safety advantage vs. GnRH agonists

• Core development programs:

  • Advanced prostate cancer (cardiovascular risk population)

  • Acute urinary retention (390-patient Phase 2b study)

• Women's Health Expansion

  • Evaluating Teverelix in symptomatic endometriosis, a high-prevalence condition with unmet need

  • Leveraging a genomics-enabled clinical strategy, including:

    • Hormonal pathway profiling

    • Biomarker-driven patient stratification

    • Precision trial design

• Future economic profile strengthened through royalty reduction (~4% → 2%) on worldwide net sales of Teverelix

AI-Enabled Clinical Development (Reliant AI Collaboration)

• Entered into a non-binding collaboration with Reliant AI Inc.

• Evolving toward development of an agentic AI-driven platform to optimize:

  • Clinical trial design and protocol simulation

  • Site selection and enrollment forecasting

  • Pharmacodynamic-informed patient stratification

  • Dose optimization and adaptive trial execution

• Proposed platform is intended to enable:

  • Capital-efficient development

  • Reduced clinical timelines

  • Data-driven decision-making across all current and future development programs

Financial Highlights (FY 2025)

During 2025, the Company strengthened its capital position through multiple financing initiatives securing ~$31.9 million in total financing proceeds.

The Company operates as a clinical-stage enterprise and expects to incur operating losses for the foreseeable future. As disclosed in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 (the "Annual Report"), substantial doubt exists regarding the Company's ability to continue as a going concern without additional financing.

• Cash and cash equivalents: $8.7 million (vs. $4.2 million in 2024)

• Operating expenses: $34.4 million

  • General & administrative: $17.9 million

  • Research & development: $7.7 million

  • In-process R&D (Teverelix acquisition): $8.7million

• Net loss: $35.4 million (vs. $11.2 million in 2024)

• Loss from operations: $34.4 million

• Net loss per share: $2.74

The Company's complete financial statements and results of operations for the year ended December 31, 2025, are included in its Annual Report, filed with the Securities and Exchange Commission on March 25, 2026.

Expected Upcoming Catalysts in 2026

The Company is entering a catalyst-rich period in 2026, including:

• End-of-Phase 2 FDA meeting (SkinJect®) to define registrational pathway

• Potential registrational trial design alignment under 505(b)(2) framework

• Advancement of Gorlin Syndrome Expanded Access program

• Continued evaluation of HelixNano-enabled platform expansion opportunities

• Initiation of Phase 2b Teverelix study in prostate cancer and AUR indications

• Expansion of Teverelix into women's health (endometriosis) using genomics-enabled clinical strategy

• Progression of agentic AI-driven clinical development platform with Reliant AI

• Ongoing strategic partnering discussions across both core programs, Skinject and Teverelix

Business update Conference Call

The Company will host a business update conference call on Thursday, March 26, 2026, beginning at 11:30 a.m. Eastern time. Babar K. Rao, MD, FAAD, an internationally recognized academic dermatologist and Principal Investigator of the SKNJCT-003 Phase 2 clinical study, will join the Company's leadership team during the call.

Participants are encouraged to pre-register for the conference call using this link to receive a dial-in number and PIN to bypass the live operator. Participants may pre-register at any time, including up to and after the call start time. Those unable to pre-register can participate by dialing 833-890-6070 (U.S./Canada) or 412-504-9736 (international). A webcast of the call can be accessed here.

For further information contact:

Carolyn Bonner, President and Chief Financial Officer
(610) 636-0184
[email protected]

Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
[email protected]

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.

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 an ~$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 an ~$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 compassionate access 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 Syndrome patients with multiple or inoperable BCCs access to SkinJect™, the Company's investigational D-MNAs, under physician supervision.

AI Enabled Clinical Development

In December 2025, the Company signed a non-binding letter of intent to collaborate with Reliant AI Inc., a decision-intelligence company specializing in generative AI for the life sciences, to develop an AI-driven clinical data analytics platform to support capital-efficient and time-efficient clinical development through data-driven dynamic clinical-site selection, pharmacodynamic (PD) informed patient stratification, and enrollment forecasting. The initial phase of the collaboration is expected to support the upcoming Teverelix clinical study planned for 2026. There can be no assurance that a definitive agreement will be executed or that the proposed collaboration will proceed as contemplated.

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 ability to continue as a going concern, 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 expectations regarding reported efficacy findings and whether there will be material changes to its reported SKNJCT-003 topline results 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, 2025, 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.

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SOURCE: Medicus Pharma Ltd

View the original press release on ACCESS Newswire

L.Rodriguez--TFWP