teverelix trifluoroacetate / Medicus Pharma - LARVOL DELTA

Medicus Pharma Ltd. To Present at Brookline Capital Markets (ACCESS Newswire) - "Following a company overview from Dr. Raza Bokhari Executive Chairman and CEO of Medicus Pharma, there will be two featured presentations providing updates on the Company's key development programs: Ed Brennan, MD, FACS Chief Scientific Officer & Head of R&D Program, will discuss SkinJect D-MNA novel treatment to non-invasively treat basal cell carcinoma (BCC) of the skin and provide an update on the progress of phase 2 clinical studies; Faisal Mehmud, MD, MRCP, Chief Medical Officer, will provide an update on Teverelix, a next generation GnRH antagonist as a first in class market product to prevent relapse of acute urinary retention (AURr) and high CV risk prostate cancer."

Clinical • Trial status • Basal Cell Carcinoma • Prostate Cancer

Medicus Pharma Ltd Announces a Definitive Agreement to Acquire Antev Ltd. UK (Medicus Pharma Press Release) - "Medicus Pharma...and Antev...announced today that they have entered into a definitive agreement dated June 29, 2025 (the 'Definitive Agreement') pursuant to which Medicus has agreed to acquire all of the issued and outstanding shares of Antev (the 'Antev Shares') on a share exchange basis (the 'Transaction'). Subject to the closing conditions noted in the Definitive Agreement, Medicus will acquire all issued and outstanding Antev Shares, on a fully diluted basis, in exchange for 2,666,600 (or approximately 17% in aggregate) of the issued and outstanding Medicus common shares (the 'Consideration Shares')....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."

M&A • Prostate Cancer

Teverelix is a potential treatment option for the prevention of acute urinary retention recurrence in men suffering from benign prostatic hyperplasia. (PubMed, Int Urol Nephrol) - "Teverelix shows potential as an effective, well-tolerated treatment for LUTS secondary to BPH, with rapid and sustained benefits. The significant prostate volume reduction suggests that teverelix may help prevent recurrent AUR, warranting further dedicated studies."

Clinical • Journal • Benign Prostatic Hyperplasia

A Model-Informed Drug Development Approach to Design a Phase 3 Trial of Teverelix Drug Product in Advanced Prostate Cancer Patients with Increased Cardiovascular Risk. (PubMed, Clin Pharmacol Drug Dev) - "Model simulation showed that a loading dose of 360 mg SC and 180 mg IM with a maintenance dose of 360 mg SC 6-weekly (Q6W) starting at day 28 can achieve a ≥95% castration rate up to 52 weeks. This dose regimen was selected for phase 3 clinical development, which includes cardiovascular safety assessment in comparison to a GnRH agonist."

Journal • Metastases • P3 data • Benign Prostatic Hyperplasia • Cardiovascular • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Efficacy, tolerability, and safety of teverelix DP in patients with advanced prostate cancer: A multicenter, open-label, phase 2 trial. (PubMed, Prostate) - "Overall, the teverelix DP doses were generally well-tolerated but did not adequately maintain castration levels."

Journal • Metastases • P2 data • Dermatology • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety, Pharmacokinetic and Pharmacodynamic Evaluation of Teverelix for the Treatment of Hormone-Sensitive Advanced Prostate Cancer: Phase 2 Loading-Dose-Finding Studies. (PubMed, Medicina (Kaunas)) - "Castrate levels of testosterone can be rapidly achieved following the subcutaneous injection of teverelix DP on 3 consecutive days. Streamlining of the administration of the loading dose and identifying a suitable maintenance dose will be investigated in future trials."

Clinical • Journal • Metastases • P2 data • PK/PD data • Cardiovascular • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Antev Receives US FDA Guidance on Teverelix Phase 3 Trial Design for Treating Advanced Prostate Cancer Patients with Increased Cardiovascular Risk (GlobeNewswire) - "Antev Ltd...announces that the US Food & Drug Administration (FDA) has provided written guidance on the company's proposed Phase 3 pivotal trial design....Antev's Scientific Adviser, Dr Neal Shore MD...said, 'There is an unmet medical need for a new specific 'cardio-oncology' indication for androgen deprivation therapy which will effectively treat the patient's cancer while not worsening cardiovascular safety. This proposed Phase 3 trial is designed to provide the level one evidence that this GnRH antagonist could be the treatment of choice for prostate cancer patients with cardiovascular risks.'"

Media quote • Regulatory

Antev Receives US FDA Guidance on Teverelix Phase 3 Trial Design for Treating Advanced Prostate Cancer Patients with Increased Cardiovascular Risk (GlobeNewswire) - "Antev Ltd...announces that the US Food & Drug Administration (FDA) has provided written guidance on the company’s proposed Phase 3 pivotal trial design....Antev’s proposed ANT-1111-04 is a global Phase 3 trial in up to 1,500 advanced prostate cancer patients with increased CV risk with a 1:1 randomization against standard of care (GnRH agonist) that aims to read out by 2027."

Clinical protocol • P3 data: top line • Genito-urinary Cancer • Oncology • Prostate Cancer

TEACh: Teverelix Evaluated in Advanced Prostate Cancer (clinicaltrials.gov) - P2 | N=50 | Completed | Sponsor: Antev Ltd. | Suspended ➔ Completed | Trial completion date: Sep 2023 ➔ Feb 2023

Metastases • Trial completion • Trial completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TEACh: Teverelix Evaluated in Advanced Prostate Cancer (clinicaltrials.gov) - P2 | N=69 | Suspended | Sponsor: Antev Ltd. | Recruiting ➔ Suspended | Trial primary completion date: Apr 2023 ➔ Dec 2022

Metastases • Trial primary completion date • Trial suspension • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TEACh: Teverelix Evaluated in Advanced Prostate Cancer (clinicaltrials.gov) - P2 | N=69 | Recruiting | Sponsor: Antev Ltd. | Trial completion date: Mar 2023 ➔ Sep 2023 | Trial primary completion date: Dec 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TEACh: Teverelix Evaluated in Advanced Prostate Cancer (clinicaltrials.gov) - P2; N=69; Recruiting; Sponsor: Antev Ltd.; Active, not recruiting ➔ Recruiting; N=20 ➔ 69; Trial completion date: Feb 2022 ➔ Mar 2023; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Pharmacokinetic, Safety, and Pharmacodynamic Properties of Teverelix Trifluoroacetate, a Novel Gonadotropin-Releasing Hormone Antagonist, in Healthy Adult Subjects. (PubMed, Clin Pharmacol Drug Dev) - "Teverelix maximum concentration and exposure increased in an approximately dose-proportional manner across the 60 to 120 mg SC doses. All 3 pharmacodynamic end points (luteinizing hormone, follicle-stimulating hormone, and total testosterone) showed reductions that were more prolonged following the 90 mg IM administration compared to 90 mg SC administration."

Clinical • Journal • PK/PD data • Endometriosis • Genito-urinary Cancer • Gynecology • Oncology • Prostate Cancer • Solid Tumor • Uterine Cancer • Uterine Leiomyoma

TEACh: Teverelix Evaluated in Advanced Prostate Cancer (clinicaltrials.gov) - P2; N=20; Active, not recruiting; Sponsor: Antev Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TEACh: Teverelix Evaluated in Advanced Prostate Cancer (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Antev Ltd.; Not yet recruiting ➔ Recruiting; Trial completion date: Nov 2021 ➔ Feb 2022; Trial primary completion date: May 2021 ➔ Dec 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TEACh: Teverelix Evaluated in Advanced Prostate Cancer (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: Antev Ltd.

Clinical • New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor