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Medicus Pharma Reports Full-Year 2025 Financial Results and Provides Corporate Update

Key Takeaway: Medicus Pharma Ltd. reported its financial results for 2025, highlighting significant advancements in its clinical pipeline, particularly the completion of the Phase 2 SkinJect study. The company aims to expand into rare diseases and women's health, while also integrating AI-driven clinical development. Despite a strong capital position, concerns remain about ongoing operating losses and the company's future viability without additional financing.
Price reaction · baseline $0.4939 (2026-03-25 close) · hit pre-market · 2 other MDCX headline(s) in the window, move may be shared
day 0 close
-5.7%
day 1 · peak
-8.9%
day 3
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Market Sentiment Analysis

POSITIVE FACTORS

  • Completion of Phase 2 SkinJect study with promising results.
  • Strengthened capital position with $31.9 million in financing.
  • Expansion into rare diseases and women's health indications.

CONCERNS & RISKS

  • Substantial doubt regarding the Company's ability to continue as a going concern.
  • Operating losses expected for the foreseeable future.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~0 mo
High dilution risk
Lead asset
Teverelix DP
Phase 2 · Advanced Prostate Cancer

Full Press Release Details

Advances Clinical Pipeline Across Dermatology, Urology, Oncology and strengthens Capital Base to support Phase 2 Programs

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 productfocused 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 adevice-only active control arm,provides a rigorous framework for evaluating theincremental 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® fornevoid basal cell carcinoma syndrome, a rare genetic disorder characterized by multiple recurrent BCC lesions

PursuingExpanded Access IND programfor patients with multiple or inoperable lesions

Supports potentialorphan disease positioning and broader clinical utility

Platform Extension via HelixNano Collaboration

Entered into anon-binding collaboration with Helix Nanotechnologies, Inc.

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

Teverelix Platform (Prostate + Women's Health)

Teverelix®, a next generation GnRH antagonistis 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-actingGnRH antagonistdesigned to suppress testosterone without flare

Potentialcardiovascular safety advantagevs. 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 insymptomatic endometriosis, a high-prevalence condition with unmet need

Leveraging agenomics-enabled clinical strategy, including:

Hormonal pathway profiling
Biomarker-driven patient stratification
Precision trial design

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

AI-Enabled Clinical Development (Reliant AI Collaboration)

Entered into anon-binding collaboration with Reliant AI Inc.

Evolving toward development of anagentic AI-driven platformto 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 acatalyst-rich period in 2026, including:

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

Potentialregistrational trial design alignmentunder 505(b)(2) framework

Advancement ofGorlin Syndrome Expanded Access program

Continued evaluation ofHelixNano-enabled platform expansion opportunities

Initiation of Phase 2b Teverelix studyin prostate cancer and AUR indications

Expansion of Teverelix intowomen's health (endometriosis)using genomics-enabled clinical strategy

Progression ofagentic AI-driven clinical development platformwith Reliant AI

Ongoingstrategic partnering discussionsacross 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 thislinkto 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 accessedhere.

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 productfocused 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 antagonistis 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.

SOURCE:Medicus Pharma Ltd

Frequently Asked Questions

What were the key highlights of Medicus Pharma's 2025 results?

The key highlights include the completion of the Phase 2 SkinJect study and securing $31.9 million in financing.

What is the SkinJect platform focused on?

SkinJect is focused on treating non-melanoma skin diseases, particularly basal cell carcinoma and Gorlin Syndrome.

What are the future plans for Teverelix?

Future plans for Teverelix include initiating a Phase 2b study in prostate cancer and expanding into women's health.

What financial challenges does Medicus Pharma face?

The company faces substantial doubt about its ability to continue as a going concern without additional financing.

When is the business update conference call scheduled?

The business update conference call is scheduled for March 26, 2026, at 11:30 a.m. Eastern time.

Last updated: Mar 26, 2026