Medicus Pharma Business Update Call to Highlight 80% Overall Response Rate (ORR) in Phase 2 SkinJect Study and Agentic AI-enabled Drug Development Plan
PHILADELPHIA, March 26, 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 announced it will host a business update conference call at 11:30 a.m. Eastern Time.
The call will highlight new analysis from its Phase 2 SkinJect® study, including an overall response rate (ORR) of 80% in the 200µg cohort at Day 57, and outline the Company’s planning toward an agentic AI–enabled clinical development platform.
The Company believes these results position the 200µg cohort as the leading dose regimen in the study, demonstrating the highest activity observed to date with continued improvement through Day 57.
Conference Call Details
- Time: 11:30 a.m. ET
- Pre-registration: https://dpregister.com/sreg/10207261/10379bd1029
- Dial-in. (US/Canada): 833-890-6070
- Dial-in. (International): 412-504-9736
- Q&A Web Link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=DeCGoBHR
The Key Highlights to be presented at the conference call are:
Independent Clinical Perspective — Dr. Babar Rao (Principal Investigator)
The call will feature Dr. Babar Rao, an internationally acclaimed dermatology key opinion leader and Principal Investigator of the SKNJCT-003 study, who will provide an independent clinical interpretation of the dataset.
Dr. Rao is a board-certified dermatologist and dermatopathologist, and currently serves as:
- Professor of Dermatology and Pathology, Rutgers Robert Wood Johnson Medical School
- Clinical Associate Professor of Dermatology, Weill Cornell Medical College
He has authored over 200 peer-reviewed publications and has served as principal investigator in multiple dermatology clinical trials.
Dr. Rao is expected to highlight:
- The clinical significance of 73% clearance at Day 57 in the 200µg cohort
- A clear separation versus device-only active control, supporting incremental drug effect
- The role of:
- Microneedle-mediated tumor disruption
- Local immune activation and wound-healing pathways
Importantly, Dr. Rao is expected to place these findings in the context of the broader basal cell carcinoma (BCC) treatment landscape:
- BCC is the most common cancer worldwide, with millions of new cases diagnosed annually in the United States alone
- Standard treatments such as Mohs surgery, while effective, are capacity constrained.
As a result, there is a significant treatment backlog, where patients may face delays or undergo procedures that may not be immediately necessary.
Dr. Rao is expected to emphasize:
The observed ~73% clinical clearance suggests that approximately three out of four treated lesions may achieve visual resolution, which in clinical practice could allow many patients to defer or avoid immediate surgical intervention.
If confirmed in future studies, this approach may:
- Reduce procedural burden on healthcare systems
- Improve patient access to care
- Allow prioritization of surgical resources for higher-risk or refractory cases
He is also expected to reinforce that:
- The dataset is clinically meaningful
- Supports continued development and regulatory engagement
- May be impactful in Gorlin Syndrome and other high-burden populations
Phase 2 Data Deep Dive — 200µg Cohort (Day 57)
Medicus will present expanded analysis of the 15-patient 200µg cohort, which demonstrated the highest activity in the study:
- 73% Clinical (visual) clearance
- 40% Histological complete response (CR)
80% Overall Response Rate (CR + partial response) with potential to exceed this level pending final Clinical Study Report (CSR)
Previously reported Topline results of the study, along with additional preliminary dataset representing partial response (PR) and over-all response rate (ORR) for each cohort, are tabulated which demonstrates that clearance rates increased between Day 29 and Day 57, consistent with continued biological activity over time.
Table 1. SKNJCT-003 Phase 2 topline Data by Treatment Arm
| Treatment Arm | (n) | Day 29 post-treatment | (n) | Day 57 post-treatment | ||||||
| 47 | CC | CR | PR* | ORR* | 43 | CC | CR | PR* | ORR* | |
| 200 μg D-MNA | 15 | 40% | 27% | 20% | 47% | 15 | 73% | 40% | 40% | 80% |
| C-MNA | 15 | 33% | 20% | 20% | 40% | 16 | 38% | 38% | 6% | 44% |
| 100 μg D-MNA | 17 | 47% | 24% | 29% | 53% | 12 | 42% | 33% | 42% | 75% |
*Preliminary -pending final CSR (Clinical Study Report)
C-MNA: Microneedle device-only control arm, D-MNA: Doxorubicin-loaded microneedle array n:number of patients, CC: Clinical Clearance, CR: Histological Clearance, PR: Partial Response, ORR: Overall Response Rate
The Company will also highlight:
- Continued improvement from Day 29 to Day 57, supporting a durable and evolving treatment effect
- Evidence of biological activity across responders and partial responders
CEO Strategic and Clinical Positioning — Dr. Raza Bokhari
Dr. Raza Bokhari, Chairman and Chief Executive Officer, is expected to outline:
- That the Phase 2 study was a proof-of-concept study “exploratory” study primarily designed to evaluate clinical (visual) clearance, with the objective of addressing a large unmet need and helping relieve the treatment backlog in basal cell carcinoma.
- That refinement of histological clearance endpoints is expected to be a focus of registrational study design discussions at the planned End-of-Phase 2 (EOP2) meeting with the FDA
- The Company’s view that the dataset is decision-grade and supports regulatory and business partnership engagement
He is also expected to discuss:
- Optimization strategies focused on the 200µg dose
- Treatment duration and repeat dosing strategies
And position the broader opportunity:
- Addressing a large and underserved BCC patient population
- Positioning SkinJect as a minimally invasive alternative to surgery
- Expansion into Gorlin Syndrome and additional indications
Advancing Toward Agentic AI–Enabled Drug Development
The Company is expected to highlight its planning toward an Agentic AI–driven clinical development platform
Designed to:
- Optimize clinical trial design and protocol simulation
- Enable dynamic site selection and enrollment forecasting
- Improve patient stratification and dose optimization
- Increase capital efficiency and probability of success
Financial Position and Capital Strategy — Carolyn Bonner, CFO
Carolyn Bonner, President and Chief Financial Officer, is expected to provide an update on:
- Approximately $31.9 million raised during 2025
- $8.7 million in cash and cash equivalents at year-end 2025
- Continued disciplined investment in clinical development
She is expected to emphasize alignment of capital strategy with key upcoming value inflection points, including:
- Regulatory engagement
- Clinical data maturation
- Strategic partnering opportunities
Position Entering a Catalyst-Rich 2026
The Company believes it is entering a catalyst-rich period, including:
- End-of-Phase 2 FDA meeting (SkinJect)
- Potential registrational pathway alignment
- Initiation of Phase 2b Teverelix study
- Expansion into women’s health (endometriosis)
- Advancement of AI-enabled development platform
- Ongoing strategic partnering discussions
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 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.
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