PHILADELPHIA, Sept. 08, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”), a precision-guided biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, today provided a strategic update highlighting its transformation into a precision oncology-led biotechnology company, anchored by the advancement of CD228V, a second-generation CD228-targeted antibody-drug conjugate (“ADC”), while pursuing capital-efficient strategic partnerships to advance clinical development opportunities across its SkinJect® and Teverelix® Programs.
CD228V now represents the principal strategic priority for Medicus, with initial development concentrated on establishing clinical proof-of-concept in a carefully selected tumor population, supported by an integrated clinical and translational strategy. Based on the existing biological, translational and clinical foundation, melanoma represents a compelling initial development opportunity, particularly in patients with relapsed or refractory disease.
The addition of CD228V represents a paradigm shift in Medicus’ clinical development portfolio and establishes precision oncology as a central component of the Company’s strategy.
CD228V is a second-generation ADC targeting melanotransferrin/CD228 in solid tumors. The program is supported by an active U.S. Investigational New Drug (IND), a first-in-human Phase 1 clinical study (NCT06799533), and substantial prior scientific, translational, and clinical development.
The Company believes successful demonstration of clinical proof-of-concept in melanoma, supported by an integrated translational and biomarker strategy, could provide an important foundation for subsequent development in other CD228-expressing solid tumors.
At the same time, Medicus is sharpening the development strategies for its two other therapeutic programs.
For SkinJect®, the Company believes the strongest risk-adjusted opportunity lies in Gorlin syndrome rather than broad sporadic/nodular Basal Cell Carcinoma (BCC) lesions. FDA has authorized initiation of SKNJCT-005, the Company’s NDA-enabling registrational Phase 2b study in patients with Gorlin syndrome presenting with multiple BCCs. Gorlin syndrome is a rare autosomal dominant disease in which patients can develop numerous BCC lesions throughout their lifetime, frequently requiring repeated surgical or other lesion-directed procedures.
The Company believes concentrating SkinJect® development on Gorlin syndrome could provide several potential strategic advantages beyond the more broadly competitive sporadic BCC market, which could include approvals for Orphan Drug Designation (“ODD”) and Rare Pediatric Disease (“RPD”) designation by the FDA as well as favorable rare-disease-anchored net pricing.
For Teverelix®, Medicus intends to prioritize the optimized approximately 126-patient Phase 2 acute urinary retention (“AUR”) program and PRECISION-E2, the Phase 2a study in women with symptomatic endometriosis, while continuing to advance the scientific and strategic positioning of Teverelix® in advanced prostate cancer (“APC”) through potential partnerships.
The Company believes this focused portfolio strategy provides multiple opportunities for meaningful clinical and shareholder value creation while enabling the Company to concentrate capital on programs with the most compelling near-term risk-adjusted potential.
Management Commentary:
“Medicus has undergone a significant transformation this year,” stated Dr. Raza Bokhari, Executive Chairman & CEO of Medicus. “Our objective is increasingly clear. We are concentrating our capital and organizational resources on programs where we believe focused clinical development and execution may create the greatest value and improve patient outcomes, while using strategic partnerships and other capital-efficient structures to preserve and unlock the potential value of other programs. We believe that our primary focus on precision oncology substantially enhances our long-term growth profile and positions the Company to participate in one of the most dynamic sectors of biotechnology.”
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 advancing the clinical development programs of novel and potentially disruptive therapeutic assets. The Company is actively engaged in multiple countries across three continents.
The Company’s current therapeutic assets are:
CD228V ADC, an investigational antibody-drug conjugate molecule utilizing Pfizer’s established vedotin linker-payload platform, directed against melanotransferrin (CD228), a cell-surface protein expressed across multiple solid tumor types, such as melanoma, squamous non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and esophageal cancer.
SkinJect®, an investigational novel localized immuno-oncology precision product focused on non-melanoma skin diseases, especially basal cell carcinoma (BCC) lesions in Gorlin Syndrome patients, a rare autosomal dominant disease also called nevoid BCC syndrome.
Teverelix®, an investigational next-generation GnRH antagonist, is being developed as a first-in-market product for cardiovascular high-risk advanced prostate cancer patients, patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate and symptomatic endometriosis.
Cautionary Notice on Forward-Looking Statements
Certain information in this news release constitutes "forward-looking statements" or “forward-looking information” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other applicable securities laws (collectively, “forward-looking statements”). "Forward-looking statements" are 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 co-development with Pfizer with respect to CD228V and the anticipated benefits thereof, the Company’s plans and expectations relating to the development, manufacture and commercialization of CD228V across human therapeutic indications, the timing, design, conduct and results of any future clinical study of CD228V, including the Company’s plans to initiate clinical development in melanoma, the Company’s intention to focus initial development on melanoma, with potential subsequent development in squamous non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and esophageal cancer, and to evaluate additional indications and lines of therapy; the potential market opportunities related to CD228V, SkinJect® and Teverelix® and the Company’s other therapeutic assets, and the development, advancement and commercialization thereof; the Company’s prioritization of CD228V and its related strategic and capital-allocation decisions, including its evaluation of strategic, partnership and other funding opportunities; the initiation, timing, design, conduct and results of the SKNJCT-005 registrational Phase 2b study and whether the results of that study will be sufficient to support the submission of a new drug application; the initiation, timing, design, conduct and results of the Company’s approximately 126-patient Phase 2 study in acute urinary retention and of PRECISION-E2, the Phase 2a study in women with symptomatic endometriosis; whether the FDA will grant Orphan Drug Designation or Rare Pediatric Disease designation for SkinJect® in Gorlin Syndrome and the benefits of any such designation, if granted; the potential pricing of, and reimbursement for, SkinJect®, if approved; the Company’s expectations regarding potential clinical and shareholder value creation and the sufficiency and allocation of its capital resources; and the Company’s ability to identify, negotiate and consummate strategic partnerships for SkinJect® and for Teverelix® in advanced prostate cancer on acceptable terms or at all. 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.
