Company: MDCXW
Filing Date: 2025-09-19
Form Type: DRS
Source: 0001062993-25-015719
Chunk: 146

Company: Medicus Pharma Ltd.
Filing Date: 2025-09-19
Form: DRS
Chunk 146
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REATMENT REQUESTED BY MEDICUS PHARMA LTD.PURSUANT TO 17 C.F.R. SECTION 200.83</div>

In January 2023, the FDA reviewed the Phase 1 and Phase 2a data and provided written guidance on Antev's proposed Phase 3 trial design for Teverelix. This supports the Company's clinical plans to develop Teverelix as a treatment for advanced prostate cancer patients with increased cardiovascular risk.

In December 2023, the FDA approved a Phase 2b open label study designed to recruit 40 men with advanced prostate cancer suitable for ADT. The participants will receive a loading dose of 180mg via intramuscular injection plus two 180mg doses via subcutaneous injection (total dosage of 540mg), followed by two 180mg doses (total dosage of 360mg) via subcutaneous injection on day 29 and every 6 weeks. The total duration of the treatment is 22 weeks. The primary endpoint is to confirm castration rate by day 29, sustaining to day 155, with a probability greater than 90%.

In November 2024, the FDA approved a Phase 2b study of Teverelix to treat AUR. The planned Phase 2b study is a randomized controlled double-blind study involving 390 men after a successful trial without catheterization in 60 to 70 sites in the United States and European Union. The patients will receive either a single intramuscular or a single subcutaneous injection (90 mg or 120 mg) or placebo in addition to standard therapy. The primary endpoint for the Phase 2b study is a composite of AUR, need for surgery or poor urinary flow metrics in the first 28 weeks plus 24 weeks follow up.

Patent Protection

Composition of matter patents for Teverelix have a natural expiration in 2039 and pending method of use patent applications, if issued, will have a natural expiration between 2044 and 2045, subject to any patent term adjustment that may be awarded. The table below summarizes the patents we hold for Teverelix, each of which is a utility patent.

| Country       
 Name          | Title                                                          | Application 
         No. | Priority  
 Date      | Filed      
 Date       |     Patent 
        No. | Issue     
 Date      | Projected  
 Expiration 
 Date       | Status  | Assignee  
 (s)       |
| United States | Composition for treating one or more estrogen related