Company: MDCXW
Filing Date: 2025-09-11
Form Type: DRS
Source: 0001062993-25-015568
Chunk: 82

Company: Medicus Pharma Ltd.
Filing Date: 2025-09-11
Form: DRS
Chunk 82
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 the Company submitted a comprehensive package to the FDA seeking a Type C meeting during the week of October 6, 2025. On August 21, 2025 the Company announced that its Type C meeting request was accepted by the FDA, and the Company has submitted its queries in writing and expects to receive a response from the FDA before the end of Q3 2025.

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| CONFIDENTIAL TREATMENT REQUESTED BY MEDICUS PHARMA LTD. 
 PURSUANT TO 17 C.F.R. SECTION 200.83                    |

In May 2025, the Company received notice that a study may proceed with approval from United Arab Emirates (UAE) Department of Health (DOH) to commence clinical study (SKNJCT-004) to non-invasively treat BCC of the skin. The study is expected to randomize 36 patients in four clinical sites in the UAE. Cleveland Clinic Abu Dhabi is the principal investigator, along with Sheikh Shakbout Medical City, Burjeel Medical City, and American Hospital of Dubai. Insights Research Organization and Solutions (IROS), a UAE-based contract research organization that is an M42 portfolio company, is coordinating the clinical study for the Company. On September 8, 2025, the Company announced that the SKNJCT-004 phase 2 clinical study, to non-invasively treat BCC of the skin, commenced patient recruitment in Cleveland clinic Abu Dhabi.

In June 2025, the Company announced submission of a product development plan to the FDA to treat external Squamous Cell Carcinoma (SCC) in horses. The Company, in December 2024, received a minor use in major species designation (MUMS) for its dissolvable doxorubicin-containing microneedle array (D-MNA) to treat external squamous cell carcinoma (SCC) in horses. MUMS is a status similar to Orphan Drug status for human drugs. It entitles the Company to an extended 7-year period of exclusive marketing following approval, provided that the Company meets all the requirements for maintaining the designation.

In June 2025, the Company entered into a definitive agreement to acquire Antev Limited, a UK-based clinical biotech company developing Teverelix, a next-generation GnRH antagonist, as first in market product for cardiovascular high-risk prostate cancer patients and patients with first acute urinary retention episodes due to enlarged prostate.

The Share Consolidation

On June 25,