Medicus Pharma Ltd Announces a Definitive Agreement to Acquire Antev Ltd. UK
Medicus Pharma (NASDAQ: MDCX) has announced a definitive agreement to acquire Antev Ltd., a UK-based clinical-stage drug development company. Under the agreement, Antev shareholders will receive a 17% equity stake in Medicus (2,666,600 shares) plus up to $65 million in contingent payments tied to FDA Phase 2 and New Drug Application approvals.
The acquisition centers on Antev's development of Teverelix, a next-generation GnRH antagonist, targeting two key indications: acute urinary retention (AUR) and advanced prostate cancer in cardiovascular high-risk patients. For AUR, Teverelix aims to be first-in-class with a $2B+ annual market opportunity, targeting nearly 1 million annual AUR episodes in the US. The FDA-approved Phase 2b study will involve 390 men across 60-70 US and EU sites.
For advanced prostate cancer, Teverelix targets a $4B+ annual market, specifically focusing on 300,000-500,000 US patients with increased cardiovascular risk. The FDA-approved Phase 2b open-label study will recruit 40 men to evaluate Teverelix as potentially the first hormone therapy specifically labeled for prostate cancer patients with cardiovascular disease history.
The transaction is expected to close by August 2025, subject to Antev shareholder approval and other regulatory requirements. The deal includes a 9-month staggered lock-up period and 36-month voting rights agreement favoring Medicus management.
Medicus Pharma (NASDAQ: MDCX) ha annunciato un accordo definitivo per acquisire Antev Ltd., una società britannica in fase clinica di sviluppo farmaceutico. Secondo l'accordo, gli azionisti di Antev riceveranno una quota azionaria del 17% in Medicus (2.666.600 azioni) oltre a un massimo di 65 milioni di dollari in pagamenti condizionati legati alle approvazioni FDA di Fase 2 e della Nuova Domanda di Farmaco.
L'acquisizione si concentra sullo sviluppo di Teverelix da parte di Antev, un antagonista GnRH di nuova generazione, che mira a due indicazioni chiave: ritenzione urinaria acuta (AUR) e cancro alla prostata avanzato in pazienti ad alto rischio cardiovascolare. Per l'AUR, Teverelix punta a essere il primo della sua classe con un mercato annuale superiore a 2 miliardi di dollari, rivolgendosi a quasi 1 milione di episodi annui di AUR negli Stati Uniti. Lo studio di Fase 2b approvato dalla FDA coinvolgerà 390 uomini in 60-70 siti tra USA e UE.
Per il cancro alla prostata avanzato, Teverelix mira a un mercato annuale superiore a 4 miliardi di dollari, concentrandosi specificamente su 300.000-500.000 pazienti statunitensi con rischio cardiovascolare aumentato. Lo studio di Fase 2b open-label approvato dalla FDA recluterà 40 uomini per valutare Teverelix come possibile prima terapia ormonale specificamente indicata per pazienti con cancro alla prostata con storia di malattia cardiovascolare.
La transazione dovrebbe concludersi entro agosto 2025, subordinatamente all'approvazione degli azionisti di Antev e ad altri requisiti normativi. L'accordo prevede un periodo di lock-up scaglionato di 9 mesi e un accordo sui diritti di voto di 36 mesi a favore della direzione di Medicus.
Medicus Pharma (NASDAQ: MDCX) ha anunciado un acuerdo definitivo para adquirir Antev Ltd., una compañía británica en etapa clínica de desarrollo de fármacos. Según el acuerdo, los accionistas de Antev recibirán una participación accionaria del 17% en Medicus (2.666.600 acciones) más hasta 65 millones de dólares en pagos contingentes vinculados a aprobaciones de la FDA de Fase 2 y de la Solicitud de Nuevo Fármaco.
La adquisición se centra en el desarrollo de Teverelix por parte de Antev, un antagonista GnRH de próxima generación, dirigido a dos indicaciones clave: retención urinaria aguda (AUR) y cáncer de próstata avanzado en pacientes con alto riesgo cardiovascular. Para AUR, Teverelix busca ser el primero en su clase con una oportunidad de mercado anual superior a 2 mil millones de dólares, apuntando a casi 1 millón de episodios anuales de AUR en EE. UU. El estudio de Fase 2b aprobado por la FDA involucrará a 390 hombres en 60-70 sitios en EE. UU. y la UE.
Para el cáncer de próstata avanzado, Teverelix apunta a un mercado anual superior a 4 mil millones de dólares, enfocándose específicamente en 300,000-500,000 pacientes en EE. UU. con riesgo cardiovascular elevado. El estudio abierto de Fase 2b aprobado por la FDA reclutará a 40 hombres para evaluar Teverelix como posiblemente la primera terapia hormonal etiquetada específicamente para pacientes con cáncer de próstata y antecedentes de enfermedad cardiovascular.
Se espera que la transacción se cierre para agosto de 2025, sujeto a la aprobación de los accionistas de Antev y otros requisitos regulatorios. El acuerdo incluye un periodo escalonado de bloqueo de 9 meses y un acuerdo de derechos de voto de 36 meses a favor de la dirección de Medicus.
Medicus Pharma (NASDAQ: MDCX)는 영국에 본사를 둔 임상 단계 신약 개발 회사인 Antev Ltd.를 인수하기 위한 최종 계약을 발표했습니다. 이 계약에 따라 Antev 주주들은 Medicus의 17% 지분(2,666,600주)과 FDA 2상 및 신약 신청 승인과 연계된 최대 6,500만 달러의 조건부 지급금을 받게 됩니다.
이번 인수는 Antev가 개발 중인 차세대 GnRH 길항제인 Teverelix에 중점을 두고 있으며, 두 가지 주요 적응증인 급성 요폐(AUR)와 심혈관 고위험 환자의 진행성 전립선암을 대상으로 합니다. AUR의 경우, Teverelix는 미국 내 연간 약 100만 건의 AUR 에피소드를 목표로 하며, 20억 달러 이상의 연간 시장 기회를 가진 최초의 치료제로 자리매김하는 것을 목표로 합니다. FDA 승인 2b상 연구는 미국과 유럽 60-70개 사이트에서 390명의 남성을 대상으로 진행됩니다.
진행성 전립선암의 경우, Teverelix는 심혈관 위험이 높은 미국 내 30만~50만 명의 환자를 대상으로 하여 40억 달러 이상의 연간 시장을 목표로 합니다. FDA 승인 2b상 공개 연구는 40명의 남성을 모집하여 심혈관 질환 병력이 있는 전립선암 환자에게 특별히 허가된 최초의 호르몬 치료제로서 Teverelix를 평가할 예정입니다.
이번 거래는 2025년 8월까지 완료될 예정이며, Antev 주주 승인 및 기타 규제 요건이 충족되어야 합니다. 계약에는 9개월간 단계적 락업 기간과 Medicus 경영진에게 유리한 36개월간의 의결권 계약이 포함되어 있습니다.
Medicus Pharma (NASDAQ : MDCX) a annoncé un accord définitif pour acquérir Antev Ltd., une société britannique en phase clinique de développement de médicaments. Dans le cadre de cet accord, les actionnaires d'Antev recevront une participation de 17 % dans Medicus (2 666 600 actions) ainsi que jusqu'à 65 millions de dollars de paiements conditionnels liés aux approbations de la FDA pour la phase 2 et la demande de nouveau médicament.
L'acquisition porte sur le développement par Antev de Teverelix, un antagoniste de la GnRH de nouvelle génération, ciblant deux indications clés : la rétention urinaire aiguë (AUR) et le cancer de la prostate avancé chez les patients à haut risque cardiovasculaire. Pour l'AUR, Teverelix vise à être le premier de sa classe avec une opportunité de marché annuelle de plus de 2 milliards de dollars, ciblant près d'un million d'épisodes annuels d'AUR aux États-Unis. L'étude de phase 2b approuvée par la FDA impliquera 390 hommes répartis sur 60 à 70 sites aux États-Unis et en Europe.
Pour le cancer de la prostate avancé, Teverelix cible un marché annuel de plus de 4 milliards de dollars, en se concentrant spécifiquement sur 300 000 à 500 000 patients américains à risque cardiovasculaire accru. L'étude ouverte de phase 2b approuvée par la FDA recrutera 40 hommes pour évaluer Teverelix comme potentiellement la première thérapie hormonale spécifiquement indiquée pour les patients atteints de cancer de la prostate avec antécédents de maladie cardiovasculaire.
La transaction devrait être finalisée d'ici août 2025, sous réserve de l'approbation des actionnaires d'Antev et d'autres exigences réglementaires. L'accord comprend une période de blocage échelonnée de 9 mois ainsi qu'un accord de droits de vote de 36 mois en faveur de la direction de Medicus.
Medicus Pharma (NASDAQ: MDCX) hat eine endgültige Vereinbarung zur Übernahme von Antev Ltd., einem klinisch fortgeschrittenen Arzneimittelentwicklungsunternehmen mit Sitz im Vereinigten Königreich, bekannt gegeben. Im Rahmen der Vereinbarung erhalten die Aktionäre von Antev einen 17%igen Anteil an Medicus (2.666.600 Aktien) sowie bis zu 65 Millionen US-Dollar an erfolgsabhängigen Zahlungen, die an FDA-Phase-2- und Zulassungen von Neuen Arzneimittelanträgen gebunden sind.
Die Übernahme konzentriert sich auf die Entwicklung von Teverelix durch Antev, einem GnRH-Antagonisten der nächsten Generation, der zwei Hauptindikationen adressiert: akuten Harnverhalt (AUR) und fortgeschrittenen Prostatakrebs bei Patienten mit hohem kardiovaskulärem Risiko. Für AUR strebt Teverelix an, als Erstes seiner Klasse einen jährlichen Markt von über 2 Milliarden US-Dollar zu erschließen und zielt auf fast 1 Million jährliche AUR-Episoden in den USA ab. Die von der FDA genehmigte Phase-2b-Studie wird 390 Männer an 60-70 Standorten in den USA und der EU umfassen.
Für fortgeschrittenen Prostatakrebs zielt Teverelix auf einen jährlichen Markt von über 4 Milliarden US-Dollar ab, wobei speziell 300.000 bis 500.000 US-Patienten mit erhöhtem kardiovaskulärem Risiko im Fokus stehen. Die von der FDA genehmigte offene Phase-2b-Studie wird 40 Männer rekrutieren, um Teverelix als möglicherweise erste Hormontherapie zu evaluieren, die speziell für Prostatakrebspatienten mit kardiovaskulärer Vorerkrankung zugelassen ist.
Die Transaktion soll bis August 2025 abgeschlossen sein, vorbehaltlich der Zustimmung der Antev-Aktionäre und weiterer behördlicher Anforderungen. Der Deal beinhaltet eine gestaffelte Sperrfrist von 9 Monaten sowie eine 36-monatige Stimmrechtsvereinbarung zugunsten des Managements von Medicus.
- Acquisition provides access to two significant market opportunities worth over $6B annually combined
- FDA-approved Phase 2b studies already in place for both drug indications
- Potential first-in-class drug for AUR indication with 1 million annual US cases
- Potential first hormone therapy specifically labeled for prostate cancer patients with cardiovascular disease
- Structured deal with contingent payments ($65M) tied to regulatory milestones reduces upfront risk
- Significant dilution for current Medicus shareholders with 17% equity stake going to Antev shareholders
- Transaction success dependent on pending clinical trial results and regulatory approvals
- Extended 9-month lock-up period may impact share liquidity
- No guarantee of closing as transaction remains subject to shareholder and regulatory approvals
Insights
Medicus's acquisition of Antev gives them access to Teverelix, targeting two lucrative markets with combined $6B annual potential.
This acquisition represents a strategic expansion of Medicus's pipeline through Antev's Teverelix, a next-generation GnRH antagonist targeting two distinct markets. The deal structure reflects a milestone-based approach with Medicus offering a 17% equity stake (2,666,600 shares) upfront plus
The commercial opportunity is substantial. Teverelix's first indication targets acute urinary retention recurrence (AURr) in men with enlarged prostates—a first-in-class opportunity addressing nearly 1 million annual AUR episodes in the US with a
Both indications have FDA-approved Phase 2b studies ready to proceed—the AURr study will enroll 390 patients across 60-70 sites in the US and EU, while the prostate cancer study will enroll 40 patients. The acquisition's risk mitigation features include a 9-month staggered lock-up period for Antev shareholders and voting rights granted to Medicus management for 36 months, allowing for operational control during the critical integration and clinical development phases.
This transaction follows the industry trend of larger pharma companies acquiring clinical-stage assets with differentiated mechanisms to expand therapeutic reach without bearing early research costs, while preserving capital through contingent, milestone-based payments.
Antev Shareholders to Receive Aggregate ~
Philadelphia, Pennsylvania--(Newsfile Corp. - June 30, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus") and Antev Ltd. ("Antev"), a UK-based clinical-stage drug development company, 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
In addition to resale restrictions prescribed under applicable securities law, the Consideration Shares issuable to Antev shareholders will be subject to a 9-month staggered lock-up and an agreement granting certain voting rights in favor of Medicus management for a period of 36 months.
Antev shareholders will be entitled to receive up to approximately US
The Transaction is expected to close before the end of August 2025, subject to the fulfillment of certain closing conditions, including obtaining Antev shareholder approval and other applicable corporate, regulatory and third-party approvals. No assurances can be given that the parties will successfully close the Transaction on the terms or timeframe currently contemplated or at all.
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.
- 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 prostate enlargement. 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).
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.
- 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 increased CV risk, aiming to provide 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. 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
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
For further information, contact:
Carolyn Bonner, President
(610) 636-0184
cbonner@medicuspharma.com
Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.com
About Medicus Pharma Ltd:
Medicus Pharma Ltd. (NASDAQ: MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutics assets. The company is actively engaged in multiple countries, spread over three continents.
SkinJect Inc. a wholly owned subsidiary of Medicus Pharma Ltd, is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using patented dissolvable microneedle patch to deliver chemotherapeutic agent to eradicate tumors cells. The Company has completed a phase 1 safety & tolerability study (SKNJCT-001) in March of 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of the investigational product D-MNA, with six (6) participants experiencing complete response on histological examination of the resected lesion. The Company submitted a Phase 2 IND clinical protocol to the FDA in January 2024 for a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003). In July 2024, an updated package was submitted to the FDA. The study design is to evaluate the efficacy of two dose of two dose levels (100 and 200 ug) of D-MNA compared to placebo (P-MNA) in sixty (60) subjects with nodular BCC. Patient recruitment is currently underway in nine sites across the United States. In April 2025. Investigational review board increased the number of participants to Ninety (90) subjects. In March 2025 the company also announced a positively trending interim analysis for SKNJCT-003 demonstrating more the
About Antev Ltd:
Antev is a clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as first in market product for high CV -risk prostate cancer patients and patients with first acute urinary retention (AUR) episodes due to enlarged prostate.
Antev's flagship drug candidate is Teverelix trifluoroacetate (Teverelix TFA), a long-acting gonadotrophin-releasing hormone (GnRH) antagonist. Unlike GnRH agonists, which can cause an initial 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. Teverelix is formulated as a microcrystalline suspension, allowing for sustained release and a six-week dosing interval, which may improve patient compliance and outcomes.
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 fifty (50) patients with advanced prostate cancer (APC), where Teverelix achieved the primary endpoint of greater than
In January 2023, the U.S. Food and Drug Administration (FDA), reviewed the Phase 1 and Phase 2a data and provided written guidance on Antev's proposed Phase 3 trial design for Teverelix. This milestone supports the company's clinical plans to develop Teverelix as a treatment for advanced prostate cancer patients with increased cardiovascular risk.
In December 2023, FDA approved the phase 2b study design in advanced prostate cancer covering 40 patients.
In November 2024, FDA approved the Phase 2b study design in acute urinary retention covering 390 patients.
Cautionary Notice on Forward-Looking Statements
Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the proposed Antev transaction and associated terms and timing, the potential benefits of the Antev transaction, if consummated, including plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix, and the potential market opportunities related thereto, the commencement of the SKNJCT-004 study and the potential results of and benefits of such study, the results of the interim analysis, which may or may not correlate with the findings of the clinical study report that will be compiled following completion of the phase 2 study, the Company's plans and expectations concerning, and future outcomes relating to, the submission and advancement of the phase 2 clinical protocol, the randomization of patients and size of the study, the Company's intention to complete and submit an interim data analysis to the FDA and to request a Type C meeting and the timing thereof, the Company's aim to fast fast-track the clinical development program and convert the SKNJCT-003 exploratory clinical trial into a pivotal clinical trial, and approval from the FDA and the timing thereof. Forward-looking statements are often but not always, identified by the use of such terms as "may", "on track", "aim", "might", "will", "will likely result", "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target" or the negative and/or inverse of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's public filings on EDGAR and on SEDAR+, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Readers are cautioned that the foregoing list is not exhaustive, and readers are encouraged to review the Company's long form prospectus accessible on the Company's profile on EDGAR at www.sec.gov and on SEDAR+ at www.sedarplus.ca. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
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FAQ
What are the terms of Medicus Pharma's acquisition of Antev Ltd?
What is the market potential for Antev's Teverelix drug?
What are the clinical trial plans for Teverelix in acute urinary retention (AUR)?
How many patients will be involved in Teverelix's prostate cancer trial?
When is the Medicus-Antev acquisition expected to close?
What makes Teverelix unique in the prostate cancer market?
