Company: MDCXW
Filing Date: 2025-09-29
Form Type: S-1
Source: 0001062993-25-015839
Chunk: 14

Company: Medicus Pharma Ltd.
Filing Date: 2025-09-29
Form: S-1
Chunk 14
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 approval from the United Arab Emirates Department of Health to commence Phase 2 clinical study (SKNJCT-004) to non-invasively treat basal cell carcinoma ("BCC") of the skin.

On June 23, 2025, the Company announced the appointment of Andrew Smith, age 57, to serve as the Company's Chief Operating Officer ("COO"). Mr. Smith first joined the Company as a consultant on May 27, 2025 and transitioned to his new role as COO on June 30, 2025.

On July 29, 2025, the Company and Deloitte LLP ("Deloitte") entered into an engagement letter whereby Deloitte was appointed as the exclusive lead financial adviser to the Company for the purpose of finding one or more partners for an out-licensing transaction for D-MNA for the treatment of BCC in adults, whether by license, option, or other agreed structure or mechanism.

On August 4, 2025, the Company announced that it entered into a non-binding memorandum of understanding with Helix Nanotechnologies Inc. ("HelixNano"), a Boston-based biotech company focused on developing an advanced mRNA platform to create vaccines and therapies to augment the immune system's power to fight disease, with the aim of forming a joint venture for the co-development and commercialization of thermostable mRNA-based vaccines utilizing each company's respective proprietary technologies. In parallel with such ongoing negotiations, Medicus and HelixNano have formalized their mutual intent to collaborate on the research, development and production of a batch of clinical-grade mRNA vaccine-loaded MNAs, which are intended for use in a Phase 1 clinical bridging study to compare the safety and preliminary efficacy of intramuscular injection vs. intradermal MNA delivery of HelixNano's vaccine candidate HN-0001, through the proposed joint venture.

On August 21, 2025, the Company announced that the FDA accepted the Company’s Type C Meeting request to formally discuss the D-MNA product development and gain further alignment on the clinical pathway. In September 2025, the FDA provided written responses to the Company’s queries, and agreed that the Company can rely on the 505(b)(2) regulatory pathway to treat BCC using D-MNA.

On September 8, 2025, the Company announced that its SKNJCT-004 phase 2 clinical study, to non-invasively treat BCC of the skin, has commenced patient recruitment in Cleveland clinic Abu Dhabi