Company: MDCXW
Filing Date: 2025-12-10
Form Type: DRS
Source: 0001062993-25-017281
Chunk: 29

Company: Medicus Pharma Ltd.
Filing Date: 2025-12-10
Form: DRS
Chunk 29
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 the other periodic reports incorporated herein by reference.

Our Company

We are a clinical-stage, multi-strategy, life science and biotech company focused on investing in and accelerating the clinical development programs of novel and disruptive therapeutic assets. Currently, we are developing two products, SkinJectTM ("SkinJectTM"), with an indication for basal cell carcinoma, and Teverelix trifluoroacetate ("Teverelix", and together with SkinJectTM, the "Products").

Through our wholly owned subsidiary, SkinJect, Inc. ("SkinJect"), we focus on the development of our in-licensed drug device combination product using novel dissolvable microneedle arrays for the treatment of non-melanoma skin cancers. Our combination product candidate is a doxorubicin tip-loaded microneedle arrays ("D-MNA") filed with the Food and Drug Administration (the "FDA") under an Investigational New Drug Application and is regulated by the Center for Drug Evaluation and Registration ("CDER"), Oncology Division.

Prior to the Company's acquisition of SkinJect, our business was undertaken by SkinJect as a stand-alone entity. References to our business as conducted at a date prior to the completion of the Business Combination (as defined below) relate to the business undertakings of SkinJect.

For information on the Business Combination, see "Corporate History and Information."

We are subject to significant risks and uncertainties, including those related to our limited operating history, our lack of historical earnings, and the fact that the Products are novel technologies for which regulatory approval might not be achieved. For more information, see "Risk Factors."

Our Strategy

Our principal purpose is to advance the clinical development program of the Products, which include SkinJectTM a novel, minimally invasive treatment for basal cell carcinoma and potentially other common forms of non-melanoma skin cancer and Teverelix, a next generation gonadotrophin-releasing hormone ("GnRH") antagonist that is a potentially first in market product for cardiovascular high-risk prostate cancer patients and patients with first acute urinary retention ("AUR") episodes due to enlarged prostate. We also seek to opportunistically identify, evaluate and acquire accretive assets, properties or businesses.

SkinJectTM is considered an Investigational New Drug ("IND") by the FDA. In January 2024, we submitted to the FDA a Phase 2 IND clinical protocol to non-invasively treat basal cell carcinoma of the skin using the Product. The clinical protocol was updated in July