Company: MDCXW
Filing Date: 2025-09-29
Form Type: S-1
Source: 0001062993-25-015839
Chunk: 142

Company: Medicus Pharma Ltd.
Filing Date: 2025-09-29
Form: S-1
Chunk 142
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 interventions, all of which carry significant risks and complications.

We aim for Teverelix to be the first-in-class indication product for preventing recurrence of AUR in males 45 years or older who suffer from prostate enlargement. Eighty-five percent of nearly one million annual AUR episodes in the United States occur in men over 60 who suffer from enlarged prostate that manifests with age. An AUR episode is followed by a recurrent episode within 6 months for approximately 30% of men.

Data from Phase 2 clinical trials to date indicate that on average Teverelix reduces prostate volume by approximately 11% within four weeks of treatment while increasing urinary flow rate by 40%, with efficacy sustained for at least 16 weeks post-treatment.

High Cardiovascular (CV) Risk Advanced Prostate Cancer Indication

Prostate cancer patients with high cardiovascular risk face limited hormonal therapy options, as current GnRH agonists exacerbate cardiovascular risks. We aim for Teverelix to be the best-in-class indication product for hormone therapy for advanced prostate cancer patients with increased CV risk, providing an androgen deprivation therapy ("ADT") option with potentially lower cardiac toxicity than conventional GnRH agonists. If approved, Teverelix could become the first hormone therapy labeled specifically for treating prostate cancer in patients with a history of cardiovascular disease.

Data from Phase 2 clinical trials to date indicate that Teverelix provides testosterone suppression comparable to existing treatments, with better tolerability and lower incidence of CV-related adverse events.

Clinical Development

In September 2020, Antev completed a Phase 1 clinical trial in which Teverelix was shown to be well tolerated with no dose-limiting toxicities and demonstrated rapid testosterone suppression. The study included 48 healthy male volunteers. In February 2023, Antev also completed a Phase 2a study in 50 patients with advanced prostate cancer, where Teverelix achieved the primary endpoint of greater than 90% probability of castration levels of testosterone suppression (97.5%), but the secondary endpoint of maintaining this rate above 90% was not met with the probability dropping to 82.5% by day 42.

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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