Medicus Pharma Ltd Clarifies Positive SkinJect Phase 2 Dataset
PHILADELPHIA, April 01, 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 issued a clarification regarding previously reported topline results from its Phase 2 clinical study of SKNJCT-003 in nodular basal cell carcinoma (BCC).
SkinJect, an investigational doxorubicin-containing microneedle array (D-MNA), is being developed as a potential non-surgical treatment option for patients with nodular BCC, a common form of skin cancer currently treated primarily with surgical intervention.
If confirmed in future studies, SkinJect may offer a meaningful alternative for patients seeking non-invasive therapies or with limited access to skin surgery.
The Company noted that certain aspects of the initial topline data presentation originally announced by the Company on March 5, 2026 -particularly relating to the device-only arm -may have led to confusion regarding their relevance to the future development of the program.
This release is intended to provide clear, direct guidance on how to interpret the dataset and how it informs the regulatory and clinical path forward.
1. Clarification on the Device-Only Arm (P-MNA / C-MNA)
The Phase 2 study included a microneedle device-only arm (referred to as P-MNA or C-MNA), which did not contain active drug and was incorporated to provide scientific and mechanistic context. The device-only arm provided useful mechanistic context; however, the Company's development focus is on the performance of the active treatment arms. in order to advance SkinJect to a registrational study.
The biological activity associated with microneedle-induced micro-injury is of academic and mechanistic interest and not part of the therapeutic positioning of SkinJect.
SkinJect is a drug-device combination therapy, and its clinical and regulatory value is derived from the intratumoral delivery of doxorubicin via the microneedle array (D-MNA).
2. Interpreting the Phase 2 Study
From a regulatory and development standpoint, the program is driven by the performance of the active treatment arms:
- 100µg D-MNA
- 200µg D-MNA
Topline phase 2 dataset (as previously reported) is tabulated below:
| Dose | # of patients(n) | Day 29 post-treatment | # of patients(n) | Day 57 post-treatment | ||||||
| 47 | CC | CR | 43 | CC | CR | |||||
| 100ug D-MNA | 17 | 47% | 24% | 12 | 42% | 33% | ||||
| 200ug D-MNA | 15 | 40% | 27% | 15 | 73% | 40% | ||||
CC: Clinical Clearance; CR: Histological Response
These cohorts demonstrated clinically meaningful activity and form the basis of all forward-looking development decisions. The 200µg cohort has emerged as the leading dose regimen, demonstrating the highest observed activity and continued improvement through Day 57.
These findings are based on topline analyses and will be further characterized and confirmed in the final Clinical Study Report. Further analyses will distinguish between protocol-defined endpoints and exploratory assessments.
It is also important to mention that this Phase 2 study is a "proof of concept" exploratory study and is primarily focused on achieving meaningful clinical (visual) clearance.
The Company believes the dataset represents decision-grade evidence supporting continued development of the SkinJect program and advancement toward regulatory discussions and potential strategic partnerships.
3. Clinical Study Report (CSR) Positioning
To ensure regulatory clarity and alignment, the Clinical Study Report (CSR) the Company expects to release will focus on:
- The 100µg and 200µg active treatment cohorts
- Clinical and histological outcomes relevant to therapeutic efficacy
- Dose-response characterization
The device-only arm will be treated as supportive, non-pivotal information and is not expected to form part of the core dataset used to advance the program.
4. Registrational Strategy: Focus on 200µg
Based on the totality of the data, the planned registrational development strategy will:
- Focus on the 200µg dose regimen
- Look into refined study design, endpoints, and biopsy timing
- Explore optimizing treatment schedule and patch duration
- Align with regulatory guidance at the planned upcoming End-of-Phase 2 (EOP2) meeting.
Management Commentary:
"We believe the positive topline results from 200 ug cohort at day 57, support the therapeutic value of SkinJect and establishes the best path forward towards registrational study," said Dr. Raza Bokhari, Executive Chairman and CEO of Medicus. "While the active device-only arm provided an important mechanistic context, its therapeutic effect is not pivotal to develop and commercialize doxorubicin containing microneedle arrays (D-MNA), relying on 505(b)2 pathway to registration. We are very pleased with the Phase 2 study dataset and look forward to participating in the planned EOP2 meeting with the FDA and accelerate partnering discussions".
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 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 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.
