Medicus Pharma Reports KOL Validation of SkinJect Phase 2 Data of 80% Overall Response Rate

PHILADELPHIA, March 30, 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 independent clinical validation of its Phase 2 SkinJect® dataset from Dr. Babar Rao, principal investigator of the SKNJCT-003 study and a globally recognized dermatology key opinion leader. 

Dr. Rao's independent assessment reinforces the Company's view that the dataset is clinically meaningful, decision-grade, and supportive of continued development and regulatory engagement.

Dr. Rao, speaking in his capacity as principal investigator during the Company's business update call, stated: "In my view as principal investigator, the dataset is clinically meaningful, supports continued development, and justifies regulatory engagement and further trials."

Independent KOL Validation of Phase 2 Results

The SKNJCT-003 study is a randomized, double-blind, three-arm Phase 2 trial evaluating microneedle-mediated delivery of doxorubicin compared with a biologically active device-only control in patients with nodular basal cell carcinoma (BCC).

Dr. Rao described that the study design provides a rigorous clinical framework, enabling:

• Isolation of the incremental therapeutic contribution of doxorubicin
• Evaluation of both clinical (visual) and histological clearance endpoints
• Interpretation of outcomes in the context of a biologically active microneedle platform
  
  
  
  

"The clear separation between active drug and device-only control demonstrates a clinically meaningful therapeutic effect on top of a biologically active platform," Dr. Rao noted. 

The 200µg cohort at Day 57 demonstrated the highest observed activity in the study, including:

• ~80% overall response rate
• 73% clinical clearance
• 40% histological clearance
• Evidence of continued biological activity over time

These findings support the Company's selection of the 200µg dose as the lead regimen for further development.

Dr. Rao highlighted the real-world clinical implications of the dataset, particularly the importance of clinical (visual) clearance:

"Approximately three out of four treated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention."

In clinical practice, lesions achieving visual clearance may be monitored or treated with less invasive approaches, suggesting SkinJect® could serve as a non-surgical treatment alternative in appropriate patients.

This may be particularly impactful in:

• Patients with limited access to Mohs surgery
• Patients seeking less invasive treatment options
• Individuals with high lesion burden, including those with Gorlin Syndrome 
  
  
  
  

Dr. Babar Rao is a globally recognized dermatologist, dermatopathologist, Mohs surgeon, and clinical investigator with extensive experience in skin oncology and dermatologic research.

He currently serves as Professor of Dermatology and Pathology and Director of Clinical Research at Rutgers Robert Wood Johnson Medical School. He also holds academic appointments as Clinical Associate Professor of Dermatology at Weill Cornell Medical College and Adjunct Professor of Dermatology at California Health Sciences University.

Dr. Rao is board certified in dermatology and is a Fellow of the American Academy of Dermatology. He completed his dermatology residency and chief residency at Cornell University Medical Center, followed by advanced training at leading institutions including New York University Medical Center, Boston University School of Medicine, UT Southwestern Medical Center, and St. John's Institute of Dermatology at the University of London.

He has authored more than 200 peer-reviewed scientific publications and multiple academic book chapters and has served as principal investigator in numerous clinical trials evaluating novel therapies for skin cancer and other dermatologic conditions.

Dr. Rao has served as principal investigator across multiple dermatology clinical programs evaluating emerging therapeutic modalities in skin cancer.

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, 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. 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.