PHILADELPHIA, May 14, 2026 (GLOBE NEWSWIRE) -- 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 financial results for the three months ended March 31, 2026, and provided a corporate update highlighting continued execution across its SkinJect® and Teverelix® development programs.

During the first quarter of 2026, Medicus continued to advance its transition into a diversified clinical-stage biotechnology company with active development programs in dermatologic oncology and urology/oncology, while replenishing its balance sheet through multiple capital market initiatives.

The Company recently reported positive, decision grade, expanded dataset findings from its Phase 2 SKNJCT-003 study evaluating SkinJect® Doxorubicin Microneedle Array (D-MNA) for the treatment of nodular basal cell carcinoma (BCC), including evidence of positive dose response and registrational grade clearance rates in the 200-µg treatment cohort.

In parallel, Medicus advanced Teverelix®, its next-generation long-acting GnRH antagonist acquired through the acquisition of Antev Limited, with Food and Drug Administration (FDA) clearance to initiate a Phase 2b dose optimization study in advanced prostate cancer and submission of an optimized Phase 2 protocol in acute urinary retention recurrence prevention.

Management Commentary:

“During the first quarter of 2026, Medicus continued to execute on its transformation into a diversified clinical-stage biotechnology company, highlighted by expanded positive Phase 2 SkinJect® data, advancement of Teverelix® into additional clinical development pathways, and continued expansion of our regulatory and strategic initiatives,” stated Dr. Raza Bokhari, Medicus’ Executive Chairman & CEO. “We believe the growing strength of our clinical datasets, combined with expanded financing flexibility and continued development of AI-enabled clinical capabilities, positions the Company to pursue multiple value-driving milestones in dermatologic oncology, prostate cancer, acute urinary retention, and rare disease indications throughout 2026 and beyond.”

First Quarter 2026 and Recent Corporate Highlights

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 a ~$2 billion market opportunity.

In the first quarter 2026, the Company made the following noteworthy advances in the SkinJect® program:

• Reported positive topline and expanded dataset findings from the Phase 2 SKNJCT-003 clinical study evaluating D-MNA for nodular basal cell carcinoma.
• Expanded analysis demonstrated positive dose-response trends and clinically meaningful clearance activity in the 200-µg treatment cohort.
• Company believes the dataset supports continued FDA engagement regarding potential registrational development pathways.
• Completed enrollment of 90 patients in the U.S.-based Phase 2 SKNJCT-003 study.
• Continued expansion activities for the SKNJCT-004 UAE-based clinical study evaluating SkinJect® in additional geographic markets.
• Submitted an Orphan Drug Designation application to the FDA for SkinJect® in Gorlin Syndrome patients.
• Continued collaboration with the Gorlin Syndrome Alliance to support compassionate access and expanded access development initiatives.
  

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.

In the first quarter 2026, the Company made the following noteworthy advances in the Teverelix® program:

• FDA provided “study may proceed” clearance for the Company’s Phase 2b dose optimization study evaluating Teverelix® in advanced prostate cancer.
• Submitted optimized Phase 2 protocol to the FDA for prevention of recurrent acute urinary retention in men with benign prostatic hyperplasia.
• Presented additional clinical data relating to Teverelix® at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2026.
• Successfully amended the LifeArc licensing agreement, reducing the royalty rate payable on worldwide net sales from approximately 4% to 2%.

Other Strategic and Corporate Initiatives:

In the first quarter 2026, the Company continued to make progress in other relevant strategic and corporate initiatives, some of which are highlighted below:

• Continued development of the Company’s AI-enabled clinical development collaboration with Reliant AI.
• Expanded ATM financing capacity from up to approximately $15.3 million to up to $50 million subsequent to quarter end.
• Continued evaluation of additional strategic acquisition and partnering opportunities aligned with the Company’s multi-strategy development platform.
  

Financial Highlights (Q1 2026):

During the first quarter of 2026, the Company continued to replenish its capital position through utilization of its at-the-market (“ATM”) facility and Standby Equity Purchase Agreement (“SEPA”), securing approximately $10 million in aggregate gross financing proceeds during the quarter. Subsequent to quarter end, the Company also expanded its ATM facility from up to approximately $15.3 million to up to $50 million.

The Company operates as a clinical-stage enterprise and expects to incur operating losses for the foreseeable future. As disclosed in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, substantial doubt exists regarding the Company’s ability to continue as a going concern without additional financing. However, management believes the Company continues to have access to additional capital resources through public and private equity offerings, debt financings, strategic collaborations, licensing arrangements, and other financing initiatives. Financial results of the Company for the quarter ended March 31, 2026, include:

• Cash and cash equivalents: $6.4 million as of March 31, 2026 (vs. $4.0 million as of March 31, 2025) 
• Operating expenses: $8.6 million (vs. $5.1 million in Q1 2025) 
• General & administrative: $5.9 million (vs. $3.1 million in Q1 2025) 
• Research & development: $2.7 million (vs. $2.0 million in Q1 2025) 
• Net loss: $9.0 million (vs. $5.1 million in Q1 2025) 
• Loss from operations: $8.6 million (vs. $5.1 million in Q1 2025) 
• Net loss per share: $0.31 (vs. $0.42 in Q1 2025) 
  

The Company’s complete unaudited financial statements and results of operations for the quarter ended March 31, 2026 are included in its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 14, 2026. 

Expected Upcoming Catalysts in 2026

The Company expects 2026 to remain a catalyst-rich year with multiple anticipated milestones, 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 Orphan Drug designation, Registrational grade IND and Pediatrics Rare Disease Voucher Program
• Continued evaluation of HelixNano-enabled platform expansion opportunities
• 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
• Potential expansion of strategic collaborations and licensing discussions

The Company believes its current financing infrastructure, including the expanded ATM facility and existing capital market access, provides flexibility to support ongoing operations and advancement of its clinical development programs.

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.

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 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 Registrational IND Program to enable those suffering with Gorlin Syndrome to access SkinJect™ under physician-supervised treatment protocols, Orphan drug designation for Skinject 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, the overall response rate and potential changes thereto, 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, the Company’s ability to raise capital in future debt and equity offerings and the sufficiency of such financing infrastructure to support ongoing operations and advancement of its clinical development programs, and the potential expansion of strategic collaborations and licensing. 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.