Philadelphia, Pennsylvania––April 29, 2025 – Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus“) and Antev Ltd. (“Antev“), a UK-based late clinical-stage drug development company, announced on 28 April that they have entered into a binding letter of intent dated April 26, 2025 (the “Letter Agreement“) pursuant to which Medicus has agreed to
Antev is a clinical stage 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 (AURr) episodes due to enlarged prostate.
Subject to the assumptions, qualifications, and conditions noted in the Letter Agreement, Medicus will negotiate and enter into a definitive agreement with Antev to acquire all issued and outstanding Antev Shares, on a fully diluted basis, in exchange for 2,666,600 (or approximately 19% in aggregate) of the issued and outstanding Medicus common shares (the “Consideration Shares“).
In addition to resale restrictions prescribed under applicable securities law, the Consideration Shares
Antev shareholders will be entitled to receive up to approximately US$65 million in additional contingent consideration tied to potential future FDA Phase 2 and New Drug Application approvals, as more particularly described in the Letter Agreement.
The Transaction is expected to close before the end of June 2025, subject to the completion of satisfactory due diligence by Medicus, negotiation of definitive agreements, obtaining applicable corporate, regulatory and other third-party approvals and the fulfillment of customary closing conditions. No assurances can be made that the parties will successfully negotiate and enter into a definitive agreement, or that the proposed transactions will be consummated on the terms or timeframe currently contemplated, or at all.
“The LOI to acquire Antev represents strategic depth in our drug development program” stated Dr. Raza Bokhari, Executive Chairman & CEO “Teverelex, a next generation GnRH antagonist, is relatively derisked and is well positioned to become first in class product to prevent acute urinary retention recurrence and treat advanced prostate cancer in patients with high cardiovascular risk profile, collectively representing ~$6Billion in potential market opportunity”
1. Antev Acute Urinary Retention (AUR) Indication:
Teverelix is aiming to be the first-in-class indication product for preventing recurrence of acute urinary retention (AURr) in males 45 years or older, who suffer from benign prostate hyperplasia (BPH). Antev has a US Food and Drug Administration (FDA) approved phase 2b study designed to randomize 390 men after a successful trial without catheterization (TWOC). 85% of nearly one million (1M) annual AUR episodes in the US occur in Men 60+ who suffer from enlarged prostate that manifests with age and frequently is followed by a recurrent episode within 6 months for approximately 30% of men, presenting a potential market opportunity of more than US $2B annually.
Antev planned Phase 2b Study Design in Acute Urinary Retention:
Randomized controlled double blinded study in 390 men after a successful TWOC in 60-70 sites in United States (US) and European Union (EU). The participants shall receive either single intramuscular (IM) or subcutaneous (SC) injection (90mg or 120mg) or placebo in addition to standard therapy. Primary endpoint is a composite of AURr, need for surgery or poor urinary flow metrics in the first 28 weeks plus 24 weeks follow up.
2. Antev High Cardiovascular (CV) Risk Advanced Prostate Cancer (APC) indication:
Teverelix is aiming to be the best-in-class indication product for hormone therapy for advanced prostate cancer (APC) patients with increased CV risk. Antev has a US Food and Drug Administration (FDA) approved phase 2b open label study designed to recruit 40 men with advanced prostate cancer. Antev is targeting a niche in patients with CV risk, aiming to provide an androgen deprivation therapy (ADT) option with potentially lower cardiac toxicity than conventional GnRH agonists. If approved, Teverelex could become the first hormone therapy labeled specifically for treating prostate cancer in patients with a history of cardiovascular disease. 300,000 to 500,000 men in the US are living with advanced stage prostate cancer presenting a potential market opportunity of more than US $4B annually.
Antev planned Phase 2b Study Design in Advanced Prostate Cancer
Open label study in 40 men with advanced prostate cancer suitable for ADT. The participants shall receive a loading dose of 180mg IM plus x2 180mg SC (total 540mg), followed by x2 180mg (360mg) SC day 29 and every 6 weeks. The total duration of the treatment is 22 weeks. Primary endpoint is to confirm castration rate by day 29, sustaining to day 155, probability greater than 90%.
