Medicus Pharma Highlights Three Years of Progress and Outlines Potential Path to Long Term Value
Advancing Precision Oncology and Partner-Ready Therapeutic Programs Through Capital-Efficient Development
PHILADELPHIA, Oct. 08, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”), a precision guided, biotech/life sciences company focused on advancing novel and potentially disruptive therapeutic assets, today provided a shareholder update celebrating its third anniversary, highlighting three years of progress, focused on execution and capital efficient drug development. The Company has advanced its transformation into a precision oncology-led biotechnology company, with a portfolio of select novel assets, anchored by CD228V, an investigational antibody-drug conjugate molecule utilizing Pfizer’s established vedotin linker-payload platform, SkinJect for basal cell carcinomas in patients with Gorlin syndrome and Teverelix for development opportunities in urology and women’s health.
This transformation, outlined in our recent strategic update, reflects progress in clinical advancement, strategic acquisitions, and investment in the people and capabilities needed to execute. From a company centered on SkinJect, we have built a portfolio with multiple potential paths to clinical and commercial value.
Our progress has occurred alongside stock-price volatility and pullback. We must make a concerted effort to explain more clearly, when we can, how the investments made to date position Medicus and support that explanation with measurable results.
Building the Foundation for Potential Long-Term Value
Our strategy is to identify promising therapeutic assets with existing scientific and clinical foundations and concentrate incremental investment on milestones that can strengthen their development prospects and partnering value.
Over these three years, we have assembled a board and management team and established the clinical, regulatory, financial, and governance capabilities needed to advance our programs. Commencing in October 2023, our progression from the TSX Venture Exchange to Nasdaq in November 2024, broadened our access to public capital markets. Approximately $90 million raised through equity and debt financing supported clinical development, strategic acquisitions, and organizational operations, while retaining resources for ongoing requirements.
That investment has given Medicus a broader portfolio and the capacity to pursue more complex development opportunities. Its ultimate return will depend on the clinical evidence we generate, the partnerships we secure, and the discipline with which we manage future spending.
CD228V and the Opportunity in Targeted Cancer Therapy
Antibody-drug conjugates, or ADCs, combine an antibody that recognizes a target on cancer cells with a potent cancer-killing payload. Their promise lies in directing treatment toward tumor cells, although the balance between antitumor activity and toxicity depends on the target, molecular design, and clinical setting.
CD228V brings together a less crowded solid-tumor target, second-generation molecular engineering, and an existing clinical and manufacturing foundation. It targets melanotransferrin, also known as CD228, a cell-surface protein associated with melanoma and expressed across several other solid tumors. Its expression and potential for internalization make it an attractive target for delivering an ADC payload.
Our initial priority is melanoma, particularly relapsed, refractory, or immunotherapy-resistant disease, where additional treatment options are needed. We intend to integrate biomarker work into development to better understand which patients may benefit.
We believe CD228V also has potential beyond melanoma, including in CD228-expressing lung, head and neck, and esophageal cancers. CD228V is early in development, and neither its efficacy nor an improved safety profile has been established; no approved therapy has yet validated CD228 as a treatment target.
We believe the combination of target biology, molecular design, and development readiness gives CD228V a compelling place in our portfolio. Our goal is to translate that foundation into evidence that can support further development and attract partners with complementary capabilities.
SkinJect and a Focused Gorlin Syndrome Strategy
We completed the SKNJCT-003 Phase 2 study, evaluated its findings, and identified the 200-microgram dose for further development. The FDA subsequently authorized initiation of SKNJCT-005, our planned registrational study in patients with Gorlin syndrome, an autosomal dominant rare disease.
Patients with Gorlin syndrome face a lifetime burden of recurrent basal cell carcinomas and repeated procedures. We believe this population provides a focused setting in which to evaluate SkinJect as a localized treatment option.
The completed work has informed dose selection and defined the next study, providing a clearer basis for allocating resources and evaluating potential partnerships. Additional clinical evidence and regulatory review remain necessary.
Teverelix and Partner Ready Development Opportunities
The acquisition of Antev in August 2025 expanded our portfolio into urology and women’s health through Teverelix, an investigational, next generation, GnRH antagonist. We subsequently strengthened its underlying economics by reducing the royalty rate and refined its priorities to acute urinary retention relapse prevention and symptomatic endometriosis, alongside a partnership-led strategy in advanced prostate cancer patients with high cardiovascular risk profile.
Our recent submission of an optimized registrational protocol for advanced prostate cancer is intended to incorporate previously FDA-cleared dose-optimization work into a proposed integrated development program. Subject to FDA review, this approach is designed to give potential partners a clearer plan for advancing the asset.
The Next Phase of Execution
Our priorities are to advance selected clinical and regulatory milestones, align organizational costs with those priorities, and pursue licensing, co-development, and other strategic opportunities. Partnerships could contribute non-dilutive development funding and expertise while reducing the capital Medicus would otherwise need to provide. Their timing, terms, and completion remain uncertain.
For our shareholders, we continue to strive to help make the connection between our portfolio and potential value more tangible. We are committed to explain the significance of each milestone, the resources required to reach it, and the decisions it enables. The measure of our progress should be stronger clinical evidence, clearer development pathways, and transactions that support continued advancement.
We remain confident in the purpose of our work and committed to responsible capital allocation. We have built a company with a broader scientific opportunity than when we began. Our mission is to demonstrate what that opportunity can deliver for patients and shareholders.
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 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.
Medicus’ strategy is to advance select programs through Phase 2 proof-of-concept and key clinical and regulatory inflection points that substantially reduce development risk and increase their attractiveness to potential pharmaceutical partners. By generating decision-grade clinical, regulatory and operational datasets, the Company seeks to create opportunities for strategic collaborations, regional licensing transactions and broader commercialization partnerships with established pharmaceutical companies. As data matures across its programs, Medicus intends to continue building differentiated development packages designed to maximize asset value while maintaining capital efficiency and development focus.
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 development of SkinJect® and the potential benefits thereof for those suffering with Gorlin Syndrome, the planned initiation, timing, design, conduct and results of the SKNJCT-005 registrational study in patients with Gorlin Syndrome, the development of Teverelix® and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix® for AURr, cardiovascular high-risk advanced prostate cancer, women’s health indications like endometriosis, the FDA’s feedback regarding the Company’s Phase 2b/3 registration-intent protocol for Teverelix® in APC, the proposed design of the Phase 2b/3 registration-intent program, the potential to reduce the overall planned APC clinical development program from approximately 1,500 patients to approximately 600 patients, the establishment of a defined, capital-efficient and partner-ready registrational pathway for Teverelix® without Medicus independently funding an additional APC clinical development study, Medicus’ intent and ability to out-license or otherwise strategically partner the Teverelix® APC program, the anticipated completion of GMP-grade manufacturing, quality-release and other clinical study readiness steps before the end of 2026, whether the proposed cardiovascular-focused registrational strategy, including the 12-month non-calcified coronary plaque endpoint assessed using non-invasive coronary CCTA and the evaluation of Teverelix® effects on APC patients at increased cardiovascular risk, could support registration, the Company’s capital-efficient portfolio strategy and the anticipated benefits thereof, 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, including 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, the timing, design, conduct and results of any future clinical study of CD228V, and the potential market opportunities related to CD228V, SkinJect® and Teverelix® and the Company’s other therapeutic assets. 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", “goal”, “strive”, “intended”, “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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