Company: MDCXW
Filing Date: 2025-09-29
Form Type: S-1
Source: 0001062993-25-015841
Chunk: 137

Company: Medicus Pharma Ltd.
Filing Date: 2025-09-29
Form: S-1
Chunk 137
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 Education/ Carnegie Mellon University |

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Teverelix

On August 29, 2025, we completed the acquisition of 98.6% of the issued and outstanding shares of Antev, a clinical stage biotech company developing Teverelix as a first-in-market product for cardiovascular high-risk prostate cancer patients and patients with first acute urinary retention episodes due to enlarged prostate.

Teverelix is a long-acting GnRH antagonist. Unlike GnRH agonists, which can cause a surge in testosterone levels, Teverelix directly suppresses sex hormone production without this surge, potentially reducing cardiovascular risks. This mechanism is particularly beneficial for patients with existing cardiovascular conditions.

Acute Urinary Retention Indication

An enlarged prostate can reduce the flow of urine and in some cases prevent urination, causing AUR. Teverelix operates by shrinking the prostate to allow urine flow. Currently there are no FDA-approved pharmacologic treatments to prevent AUR recurrence. The current standard of care for AUR involves catheterization, α-blockers and eventual surgical 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