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TenX Keane Acquisition Shareholders Approve Previously Announced Merger to Form Citius Oncology, Inc., a Publicly Listed Subsidiary of Citius Pharmaceuticals

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TenX Keane Acquisition shareholders have approved the merger with Citius Pharmaceuticals' oncology subsidiary to form Citius Oncology, Inc. The vote took place at an extraordinary general meeting on August 2, 2024. The newly combined company is expected to trade on Nasdaq under the Citius Oncology name. This merger aims to support the commercialization of LYMPHIR, pending approval, and explore additional oncology assets. The transaction is anticipated to provide Citius Oncology with improved access to public equity markets. Subject to closing conditions, the merger is expected to be completed in the coming weeks. This strategic move positions Citius Oncology to advance its oncology pipeline and potentially strengthen its market presence in the biopharmaceutical sector.

Gli azionisti di TenX Keane Acquisition hanno approvato la fusione con la sussidiaria oncologica di Citius Pharmaceuticals per formare Citius Oncology, Inc. Il voto si è svolto durante un'assemblea generale straordinaria il 2 agosto 2024. Si prevede che la nuova azienda combinata traderà su Nasdaq sotto il nome di Citius Oncology. Questa fusione mira a sostenere la commercializzazione di LYMPHIR, in attesa dell'approvazione, e a esplorare ulteriori asset oncologici. Si prevede che la transazione fornisca a Citius Oncology un accesso migliorato ai mercati azionari pubblici. Soggetta alle condizioni di chiusura, la fusione è prevista per essere completata nelle prossime settimane. Questa mossa strategica posiziona Citius Oncology per far avanzare il proprio pipeline oncologico e potenzialmente rafforzare la propria presenza sul mercato nel settore biofarmaceutico.

Los accionistas de TenX Keane Acquisition han aprobado la fusión con la subsidiaria de oncología de Citius Pharmaceuticals para formar Citius Oncology, Inc. La votación tuvo lugar en una junta general extraordinaria el 2 de agosto de 2024. Se espera que la nueva empresa combinada cotice en Nasdaq bajo el nombre de Citius Oncology. Esta fusión tiene como objetivo apoyar la comercialización de LYMPHIR, a la espera de aprobación, y explorar activos adicionales en oncología. Se anticipa que la transacción proporcione a Citius Oncology un mejor acceso a los mercados de capital público. Sujeta a las condiciones de cierre, se espera que la fusión se complete en las próximas semanas. Este movimiento estratégico posiciona a Citius Oncology para avanzar en su cartera oncológica y potencialmente fortalecer su presencia en el mercado del sector biofarmacéutico.

TenX Keane Acquisition의 주주들이 합병을 승인했습니다 Citius Pharmaceuticals의 종양학 자회사와 함께 Citius Oncology, Inc.로 구성하기 위해. 투표는 2024년 8월 2일 특별총회에서 진행되었습니다. 새로 결합된 회사는 Nasdaq에 상장될 것으로 예상됩니다 Citius Oncology라는 이름으로. 이 합병은 LYMPHIR의 상용화를 지원하는 것을 목표로 하며, 승인을 기다리고 있으며 추가 종양학 자산을 탐색합니다. 이 거래는 Citius Oncology에 공공 자본 시장에 대한 접근 개선을 제공할 것으로 예상됩니다. 마감 조건에 따라, 합병은 다음 주에 완료될 것으로 예상됩니다. 이 전략적 조치는 Citius Oncology가 종양학 파이프라인을 발전시키고 생명공학 분야에서의 시장 존재감을 강화할 수 있는 위치에 놓이게 합니다.

Les actionnaires de TenX Keane Acquisition ont approuvé la fusion avec la filiale oncologique de Citius Pharmaceuticals pour former Citius Oncology, Inc. Le vote a eu lieu lors d'une assemblée générale extraordinaire le 2 août 2024. La nouvelle entreprise combinée devrait être cotée sur le Nasdaq sous le nom de Citius Oncology. Cette fusion vise à soutenir la commercialisation de LYMPHIR, en attente d'approbation, et à explorer d'autres actifs en oncologie. La transaction devrait offrir à Citius Oncology un meilleur accès aux marchés des capitaux publics. Sous réserve des conditions de clôture, la fusion devrait être finalisée dans les prochaines semaines. Ce mouvement stratégique positionne Citius Oncology pour faire avancer son pipeline oncologique et potentiellement renforcer sa présence sur le marché dans le secteur des biopharmaceutiques.

Die Aktionäre von TenX Keane Acquisition haben die Fusion genehmigt mit der Onkologie-Tochtergesellschaft von Citius Pharmaceuticals zur Gründung von Citius Oncology, Inc. Die Abstimmung fand am 2. August 2024 auf einer außerordentlichen Hauptversammlung statt. Das neu kombinierte Unternehmen wird voraussichtlich unter dem Namen Citius Oncology an der Nasdaq gehandelt. Diese Fusion zielt darauf ab, die Kommerzialisierung von LYMPHIR zu unterstützen, während die Genehmigung aussteht, und zusätzliche Onkologie-Assets zu erkunden. Es wird erwartet, dass die Transaktion Citius Oncology einen verbesserten Zugang zu den öffentlichen Kapitalmärkten verschafft. Vorbehaltlich der Abschlussbedingungen wird die Fusion in den kommenden Wochen abgeschlossen. Dieser strategische Schritt positioniert Citius Oncology, um seine Onkologie-Pipeline voranzutreiben und möglicherweise seine Marktpräsenz im biopharmazeutischen Sektor zu stärken.

Positive
  • Shareholder approval for the merger, indicating investor confidence
  • Expected Nasdaq listing for the combined company, potentially increasing visibility and liquidity
  • Improved access to public equity markets for funding opportunities
  • Support for LYMPHIR commercialization, if approved, potentially leading to revenue generation
  • Opportunity to explore additional targeted oncology assets, potentially diversifying the product pipeline
Negative
  • Merger completion still subject to closing conditions, introducing uncertainty
  • Potential integration challenges and costs associated with the merger
  • LYMPHIR's approval still pending, presenting regulatory risk

Insights

The merger approval marks a significant milestone for Citius Pharmaceuticals and its oncology subsidiary. This strategic move creates Citius Oncology, Inc., a new publicly-traded entity focused on oncology assets. The transaction's primary benefits include:

  • Enhanced access to capital markets, potentially facilitating easier fundraising for future developments
  • Dedicated resources for LYMPHIR commercialization, if approved, which could accelerate market entry and revenue generation
  • Increased flexibility to explore additional oncology opportunities, potentially diversifying the product pipeline

However, investors should note that the success of this venture heavily depends on LYMPHIR's approval and market performance. The oncology market is highly competitive and the new entity will face challenges in establishing itself. Financial details are lacking, making it difficult to assess the immediate impact on valuation or potential dilution for existing shareholders.

The formation of Citius Oncology through this merger is a strategic move in the oncology space. LYMPHIR, their lead asset, targets cutaneous T-cell lymphoma (CTCL), a rare and challenging-to-treat cancer. If approved, it could address a significant unmet medical need. The dedicated oncology focus may accelerate:

  • Clinical development of LYMPHIR and potential label expansions
  • Exploration of synergistic oncology assets to build a robust pipeline
  • Collaborations with other biotech and pharma companies in the oncology field

However, the oncology market is highly competitive and rapidly evolving. Citius Oncology will need to demonstrate clear clinical benefits and differentiation for LYMPHIR to gain market share. The company's success will largely depend on LYMPHIR's efficacy, safety profile and ability to improve patient outcomes in CTCL.

The merger creating Citius Oncology represents a trend of oncology-focused spin-offs in the biotech sector. This strategy can potentially unlock value by:

  • Attracting specialized investors interested in pure-play oncology companies
  • Enabling more focused resource allocation and decision-making in oncology R&D
  • Potentially increasing the company's appeal as an acquisition target for larger pharmaceutical firms

However, as a standalone entity, Citius Oncology may face challenges such as:

  • Increased pressure to deliver results quickly
  • Potential loss of synergies with Citius Pharma's other assets
  • Higher operational costs as a separate public company

The success of this strategy will depend on LYMPHIR's performance and the company's ability to build a diverse oncology pipeline. Investors should closely monitor clinical trial results, regulatory milestones and any strategic partnerships or acquisitions post-merger.

TenX Keane shareholders voted to approve the previously announced merger with Citius Oncology at an extraordinary general meeting held on August 2, 2024

Post-merger company expected to trade on Nasdaq as Citius Oncology, Inc.

Transaction expected to support commercialization of LYMPHIR, if approved, and exploration of additional oncology assets

New York, NY, Aug. 05, 2024 (GLOBE NEWSWIRE) -- TenX Keane Acquisition (Nasdaq: TENKU, TENK, TENKR) (the “TenX”), a publicly traded special purpose acquisition company, today announced that on August 2, 2024, at the extraordinary general meeting, its shareholders voted to approve the previously announced business combination with the wholly owned oncology subsidiary of Citius Pharmaceuticals, Inc. (“Citius Pharma”) (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. The newly combined public company will continue to trade on the Nasdaq stock exchange and is to be renamed Citius Oncology, Inc. (“Citius Oncology”).

The transaction has been unanimously approved by the Board of Directors of TenX, Citius Pharma, and Citius Pharma’s oncology subsidiary. Subject to certain contractual as well as customary closing conditions, the merger is expected to be completed in the coming weeks.

The transaction is expected to provide Citius Oncology with improved access to the public equity markets, support the commercialization of LYMPHIR, if approved, and position the company to explore additional targeted oncology opportunities.

About the Merger

Pursuant to the business combination agreement, TenX will acquire Citius Pharma’s wholly owned subsidiary via a merger, with the newly combined publicly traded company to be named Citius Oncology, Inc. In the transaction, all shares of Citius Pharma’s wholly owned subsidiary will be converted into the right to receive common stock of the new public company, Citius Oncology. As a result, upon closing, Citius Pharma will hold approximately 65.6 million shares of common stock of Citius Oncology which will represent approximately 90% of the new public company. As part of the transaction, Citius Pharma will contribute up to $10 million in cash to Citius Oncology. An additional 12.75 million existing options will be assumed by Citius Oncology from Citius Pharma’s subsidiary.

The description of the transaction contained herein is only a summary and is qualified in its entirety by reference to the business combination agreement, a copy of which has been filed by TenX in a Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission on October 24, 2023.

Advisors

Newbridge Securities Corporation is acting as exclusive financial advisor to TenX and Maxim Group LLC is acting as exclusive financial advisor to Citius Pharma. The Crone Law Group, P.C., Han Kun Law Offices, Ogier are acting as U.S., PRC, and Cayman legal advisors to TenX, respectively. Wyrick Robbins Yates & Ponton LLP is acting as legal advisor to Citius Pharma and Citius Oncology.

About TenX Keane Acquisition

TenX Keane Acquisition is a blank check company, also commonly referred to as a special purpose acquisition company (SPAC) formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization, or similar business combination with one or more businesses or entities. TenX is led by Xiaofeng Yuan, Chairman and Chief Executive Officer, and Taylor Zhang, Chief Financial Officer, who are growth-oriented executives with a long track record of value creation across industries.

About Citius Oncology, Inc.

Citius Oncology will serve as a platform to develop and commercialize novel targeted oncology therapies. The company is seeking approval from the U.S. Food and Drug Administration (FDA) of LYMPHIR for an orphan indication in the treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin lymphoma. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology’s competitive positioning.

About LYMPHIR (denileukin diftitox-cxdl)

LYMPHIR is a specially engineered IL-2- diphtheria toxin fusion protein made using recombinant DNA technology. It works by targeting cells that have IL-2 receptors with a toxin derived from diphtheria bacteria. Once inside the cell, this toxin stops the cell from making proteins, which leads to cell death. LYMPHIR has two main effects. It directly kills tumor cells by binding to the IL-2 receptors and internalizing the diphtheria toxin directly into the tumor cells, causing them to die. Additionally, it boosts the body’s immune response by transiently reducing the number of regulatory T-cells (Tregs) that suppress the immune system, thereby enhancing the body’s ability to fight the tumor. If approved, LYMPHIR would be unique as the only IL-2 receptor targeted CTCL therapy, offering a novel option to patients cycling through multiple treatments.

In 2011 and 2013, the FDA granted orphan drug designation to LYMPHIR for the treatment of peripheral T-cell lymphoma (PTCL) and CTCL, respectively. In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of CTCL and PTCL. Subsequently in 2021, Citius Pharma acquired an exclusive license with rights to develop and commercialize LYMPHIR in all markets except for Japan and certain parts of Asia. The FDA is reviewing a Biologics License Application (BLA) for LYMPHIR and has set August 13, 2024, as the PDUFA target action date. Additional value-creating opportunities in larger markets include potential indications in peripheral T-cell lymphoma or as a combination therapy with CAR-T and PD-1 inhibitors, and in markets outside the U.S. Currently, two investigator-initiated trials are underway to explore LYMPHIR’s potential as an immuno-oncology combination therapy.

About Citius Pharmaceuticals, Inc.

Citius Pharma is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. The Company's diversified pipeline includes two late-stage product candidates. In May 2024, Citius Pharma announced positive topline data of Mino-Lok®, its antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections. Following the expected merger of Citius Oncology and TenX, Citius Pharma would hold approximately 90% of Citius Oncology, a standalone publicly traded company, with LYMPHIR as its primary asset. In addition, Citius Pharma completed enrollment in its Phase 2b trial of CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. For more information, please visit www.citiuspharma.com.

Forward-Looking Statements

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting TenX. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: the planned transaction between TenX Keane Acquisition and Citius Pharma to form Citius Oncology may not be completed for failure to meet closing conditions or other reasons; the anticipated benefits of the transaction may not be realized fully, if at all, or may take longer to realize than expected; the FDA may not approve LYMPHIR; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; the need for substantial additional funds; the ability to commercialize products if approved by the FDA; the dependence on third-party suppliers; the estimated markets for product candidates and the acceptance thereof by any market; the ability of product candidates to impact the quality of life of target patient populations; the ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; the early stage of products under development; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our SEC filings. These may be further impacted by any future public health risks or geopolitical events. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission (“SEC”) filings which are available on the SEC’s website at www.sec.gov, including in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on April 16, 2024, and updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Investor Contact:

Taylor Zhang
target@TenXkeane.com


FAQ

What is the new name of the company formed by the TenX Keane Acquisition merger?

The new company formed by the merger will be named Citius Oncology, Inc.

When did TenX Keane Acquisition (TENKU) shareholders approve the merger?

TenX Keane Acquisition shareholders approved the merger on August 2, 2024, at an extraordinary general meeting.

What is the main product that Citius Oncology aims to commercialize?

Citius Oncology aims to commercialize LYMPHIR, pending its approval.

Where is Citius Oncology expected to be listed after the merger?

Citius Oncology is expected to be listed and trade on the Nasdaq stock exchange after the merger.

What are the potential benefits of the merger for Citius Oncology?

The merger is expected to provide Citius Oncology with improved access to public equity markets, support for LYMPHIR commercialization, and opportunities to explore additional targeted oncology assets.

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