Onconetix Signs Letter of Intent for Potential Business Combination with Ocuvex Therapeutics, Inc.
Onconetix (NASDAQ: ONCO) has signed a non-binding Letter of Intent for a potential business combination with Ocuvex Therapeutics, a private biopharmaceutical company specializing in ophthalmic therapeutics. The proposed transaction would result in Ocuvex shareholders owning approximately 90% of Onconetix's equity interests.
Ocuvex brings an FDA-approved product, Omlonti®, for ocular hypertension and open-angle glaucoma, along with late-stage clinical assets. Onconetix currently owns Proclarix®, an in vitro diagnostic test for prostate cancer approved in the EU, and ENTADFI, an FDA-approved treatment for benign prostatic hyperplasia.
The transaction completion is subject to due diligence, definitive agreement execution, adequate financing, and regulatory and stockholder approvals. There is no guarantee the transaction will be completed as proposed.
Onconetix (NASDAQ: ONCO) ha firmato una Lettera di Intenti non vincolante per una potenziale combinazione aziendale con Ocuvex Therapeutics, una società biopharmaceutica privata specializzata in terapie oftalmiche. La transazione proposta comporterebbe che gli azionisti di Ocuvex possiedano circa il 90% degli interessi patrimoniali di Onconetix.
Ocuvex porta un prodotto approvato dalla FDA, Omlonti®, per l'ipertensione oculare e il glaucoma ad angolo aperto, insieme a beni clinici in fase avanzata. Onconetix attualmente possiede Proclarix®, un test diagnostico in vitro per il cancro alla prostata approvato nell'UE, e ENTADFI, un trattamento approvato dalla FDA per l'iperplasia prostatica benigna.
Il completamento della transazione è soggetto a due diligence, esecuzione di un accordo definitivo, finanziamenti adeguati e approvazioni normative e degli azionisti. Non c'è alcuna garanzia che la transazione sarà completata come proposto.
Onconetix (NASDAQ: ONCO) ha firmado una Carta de Intención no vinculante para una posible combinación empresarial con Ocuvex Therapeutics, una empresa biofarmacéutica privada especializada en terapias oftálmicas. La transacción propuesta resultaría en que los accionistas de Ocuvex posean aproximadamente el 90% de los intereses patrimoniales de Onconetix.
Ocuvex aporta un producto aprobado por la FDA, Omlonti®, para la hipertensión ocular y el glaucoma de ángulo abierto, junto con activos clínicos en etapas avanzadas. Onconetix actualmente posee Proclarix®, una prueba diagnóstica in vitro para el cáncer de próstata aprobada en la UE, y ENTADFI, un tratamiento aprobado por la FDA para la hiperplasia prostática benigna.
La finalización de la transacción está sujeta a la debida diligencia, la ejecución de un acuerdo definitivo, financiación adecuada y aprobaciones regulatorias y de los accionistas. No hay garantía de que la transacción se complete como se propone.
Onconetix (NASDAQ: ONCO)는 Ocuvex Therapeutics와의 잠재적인 사업 결합을 위한 비구속적 의향서를 체결했습니다. Ocuvex는 안과 치료제를 전문으로 하는 개인 바이오 제약 회사입니다. 제안된 거래는 Ocuvex 주주가 Onconetix의 지분의 약 90%를 소유하게 될 것입니다.
Ocuvex는 안압 상승 및 개방각 녹내장에 대한 FDA 승인 제품인 Omlonti®와 후기 단계의 임상 자산을 보유하고 있습니다. Onconetix는 현재 EU에서 승인된 전립선암 진단 테스트인 Proclarix®와 양성 전립선 비대증에 대한 FDA 승인 치료제인 ENTADFI를 보유하고 있습니다.
거래 완료는 실사, 최종 계약 체결, 적절한 자금 조달 및 규제 및 주주 승인에 따라 달라집니다. 제안된 대로 거래가 완료될 것이라는 보장은 없습니다.
Onconetix (NASDAQ: ONCO) a signé une lettre d'intention non contraignante pour une éventuelle combinaison d'affaires avec Ocuvex Therapeutics, une société biopharmaceutique privée spécialisée dans les thérapies ophtalmiques. La transaction proposée entraînerait que les actionnaires d'Ocuvex détiennent environ 90 % des intérêts en capital d'Onconetix.
Ocuvex apporte un produit approuvé par la FDA, Omlonti®, pour l'hypertension oculaire et le glaucome à angle ouvert, ainsi que des actifs cliniques en phase avancée. Onconetix possède actuellement Proclarix®, un test de diagnostic in vitro pour le cancer de la prostate approuvé dans l'UE, et ENTADFI, un traitement approuvé par la FDA pour l'hyperplasie bénigne de la prostate.
La réalisation de la transaction est soumise à une diligence raisonnable, à l'exécution d'un accord définitif, à un financement adéquat et à des approbations réglementaires et des actionnaires. Il n'y a aucune garantie que la transaction sera finalisée comme proposé.
Onconetix (NASDAQ: ONCO) hat eine unverbindliche Absichtserklärung für eine mögliche Unternehmenszusammenschluss mit Ocuvex Therapeutics, einem privaten biopharmazeutischen Unternehmen, das sich auf ophthalmologische Therapeutika spezialisiert hat, unterzeichnet. Die vorgeschlagene Transaktion würde dazu führen, dass die Aktionäre von Ocuvex etwa 90% der Eigenkapitalanteile von Onconetix besitzen.
Ocuvex bringt ein von der FDA zugelassenes Produkt, Omlonti®, zur Behandlung von okulärer Hypertonie und Offenwinkelglaukom sowie klinische Vermögenswerte in der späten Phase mit. Onconetix besitzt derzeit Proclarix®, einen in-vitro-Diagnosetests für Prostatakrebs, der in der EU zugelassen ist, und ENTADFI, eine von der FDA zugelassene Behandlung für benigne Prostatahyperplasie.
Der Abschluss der Transaktion unterliegt der Due Diligence, der Ausführung eines endgültigen Vertrags, einer angemessenen Finanzierung sowie der Genehmigung durch Aufsichtsbehörden und Aktionäre. Es gibt keine Garantie, dass die Transaktion wie vorgeschlagen abgeschlossen wird.
- Acquisition brings FDA-approved product Omlonti® to portfolio
- Expands therapeutic reach beyond oncology into ophthalmology
- Adds late-stage clinical assets to pipeline
- Significant dilution with Ocuvex shareholders receiving 90% ownership
- Transaction subject to multiple contingencies and may not complete
- Requires additional financing to complete deal
Insights
This non-binding letter of intent between Onconetix and Ocuvex Therapeutics represents a potential reverse merger structure where Ocuvex shareholders would control 90% of the combined entity post-transaction. This structure indicates Ocuvex is effectively using Onconetix's Nasdaq listing as a vehicle to access public markets without traditional IPO processes.
The proposed combination would significantly transform Onconetix's therapeutic focus, expanding from men's health and oncology into ophthalmology through Ocuvex's portfolio. Most notably, Ocuvex brings Omlonti (omidenepag isopropyl), an FDA-approved glaucoma treatment that received regulatory clearance in September 2022, plus additional late-stage ophthalmic assets.
The extreme ownership dilution for current Onconetix shareholders (retaining just 10% post-merger) reflects either a substantial valuation gap between the companies or Onconetix's position of negotiating weakness. With Onconetix recently trading at a
Multiple contingencies remain before completion, including due diligence, definitive agreement negotiation, financing requirements, and regulatory approvals. The non-binding nature and numerous conditions create significant execution risk, with no guarantee of consummation under these terms or at all.
CINCINNATI, April 08, 2025 (GLOBE NEWSWIRE) -- Onconetix, Inc. (Nasdaq: ONCO) (“Onconetix” or the “Company”) (formerly Blue Water Biotech Inc.) and Ocuvex Therapeutics, Inc. (“Ocuvex”), a privately held biopharmaceutical company focused on the development and commercialization of ophthalmic therapeutic candidates to address highly prevalent diseases in need of new treatment options, today announced that they have signed a Non-Binding Letter of Intent contemplating a potential business combination transaction with Ocuvex.
Andrew J. Oakley, Chairman of the Board of Onconetix, stated, “We are excited about the opportunity to combine forces with Ocuvex, whose pipeline of commercial and late clinical stage ophthalmic assets will immediately expand our reach beyond oncology , enhancing shareholder value.”
Anthony W. Amato, President, CEO of Ocuvex, commented, “With an already FDA approved product, and late stage clinical assets, we believe that combining with Onconetix will allow us to broaden access to capital while continuing to focus on innovation and customer satisfaction. This is an exciting new chapter for our employees, customers, and stakeholders.”
Onconetix and Ocuvex will continue negotiations to enter into a definitive agreement. Upon closing of the proposed transaction, Onconetix will acquire all the issued and outstanding equity interests of Ocuvex in exchange for newly issued shares of common stock of Onconetix. Immediately following the closing of the proposed transaction, the pre-closing Ocuvex equity holders will own approximately
The Letter of Intent only represents a mutual indication of interest regarding the proposed transaction, and the terms of any such transaction are subject to a number of contingencies, including the completion of due diligence and the negotiation and execution of a definitive agreement. Completion of the proposed transaction will be subject to customary conditions, including (i) the completion of adequate financing, and (ii) the obtainment of applicable regulatory, stockholder and third-party approvals. There can be no assurance that a definitive agreement will be executed or that the proposed transaction will completed as proposed, or at all.
About Onconetix, Inc.
Onconetix (Nasdaq: ONCO) is a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men’s health and oncology. Through our recent acquisition of Proteomedix, we own Proclarix®, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union (“EU”) under the IVDR, which we anticipate will be marketed in the U.S. as a lab developed test (“LDT”) through our license agreement with Labcorp. We also own ENTADFI, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia (“BPH”), a disorder of the prostate.
For more information, visit www.onconetix.com.
About Ocuvex Therapeutics, Inc.
Ocuvex is a privately funded biopharmaceutical company focused on the development and commercialization of ophthalmic therapeutic candidates to address highly prevalent diseases in need of new treatment options and was formed through the merger of Ocuvex Inc. and Visiox Pharmaceuticals, Inc. in August 2024. Ocuvex’s lead asset, Omlonti® (omidenepag isopropyl ophthalmic solution)
Forward-Looking Statements
Certain statements in this press release are “forward-looking” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements (including, without limitation, the anticipated benefits and opportunities that may be generated by the proposed transaction described herein) are based on Onconetix’s current expectations, and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, whether a definitive agreement for the proposed transaction with Ocuvex and any related financing will be entered into; whether such transactions, or any other contemplated transaction, may be completed with different terms, in an untimely manner, or not at all; whether the Company will be able to realize the benefits of the proposed transaction described herein; Onconetix’s ability to integrate the assets and commercial operations contemplated to be acquired from Ocuvex into the Company’s business; market and other conditions; risks related to Onconetix’s ability to commercialize or monetize Proclarix; risks related to the Company’s present need for capital to commercially launch Proclarix and have adequate working capital; risks related to Onconetix’s ability to attract, hire and retain skilled personnel necessary to commercialize and operate the Company’s commercial products; the failure to obtain and maintain the necessary regulatory approvals to market and commercialize Onconetix’s products; risks related to the Company’s ability to obtain and maintain intellectual property protection for its current products; whether the Company will be able to maintain compliance with Nasdaq’s applicable listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; and the Company’s reliance on third parties, including manufacturers and logistics companies. As with any commercial-stage pharmaceutical product or any product candidate under clinical development, there are significant risks in the development, regulatory approval and commercialization of biotechnology products. Onconetix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Onconetix’s Annual Report on Form 10-K, filed with the SEC on April 11, 2024 and periodic reports filed with the SEC on or after the date thereof. All of Onconetix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof, and Onconetix assumes no obligation to update or revise these statements unless otherwise required by law.
No Offer or Solicitation
This press release does not and shall not constitute an offer to sell or a solicitation of an offer to buy any securities of Onconetix or Ocuvex, nor shall there be any offer, solicitation or sale of such securities, if any, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Investor and Media Contact Information:
Onconetix, Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, OH 45202
Phone: (513) 620-4101
Investor Contact Information:
Onconetix Investor Relations
Email: investors@onconetix.com
FAQ
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