Company: MDCXW
Filing Date: 2025-09-29
Form Type: S-1
Source: 0001062993-25-015839
Chunk: 95

Company: Medicus Pharma Ltd.
Filing Date: 2025-09-29
Form: S-1
Chunk 95
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 delisted from the TSXV. The common shares continue to be listed on Nasdaq.

On August 29, 2025, we completed the acquisition of 98.6% of the issued and outstanding shares of Antev.

We are a clinical stage, multi-strategy life sciences, biotech company focused on investing in and accelerating clinical development programs of novel and disruptive therapeutic assets. Currently, we are developing two products, SkinJect, with an indication for basal cell carcinoma, and Teverelix, a next-generation GnRH antagonist that is a potentially first in market treatment of cardiovascular high-risk prostate cancer patients and patients with first AUR episodes due to an enlarged prostate.

Our principal purpose is to advance the clinical development program of the Products, while opportunistically identifying, evaluating, and acquiring accretive assets, properties or businesses. Through our wholly owned subsidiary, 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 D-MNA filed with the FDA under an Investigational New Drug Application and is regulated by the CDER, Oncology Division.

The business conducted by the Company prior to the Business Combination was undertaken by SkinJect. References to the Company in this section as of a date prior to the completion of the Business Combination relate to the business undertakings of SkinJect.

In 2016, SkinJect licensed certain intellectual property from the University of Pittsburgh. During 2016 and 2017, SkinJect developed validated manufacturing methods for the manufacture of the microneedle arrays covered by the licensed patents. In 2017 and 2018, SkinJect completed pre-clinical animal studies and related verification analyses.

In 2018, SkinJect prepared an IND application and submitted it to the FDA for the conduct of a dose escalation study in human subjects ("Phase 1 study"). The FDA issued a Study May Proceed letter in November 2018.The study was completed in March 2021 and the clinical study report showed that the study met its primary objective of safety and tolerability. The investigational product, D-MNA was found to be well-tolerated across all dose levels in all thirteen (13) participants enrolled in the study, with no dose-limiting toxicities (DLTs), serious adverse events (SAE), or study discontinuations. Furthermore, there were no