Citius Pharmaceuticals Completes Merger of Subsidiary with TenX Keane to form Citius Oncology, Inc.
Citius Pharmaceuticals (CTXR) has completed the merger of its oncology subsidiary with TenX Keane Acquisition, forming Citius Oncology, Inc. The new entity is set to trade on Nasdaq under the ticker CTOR starting August 13, 2024. Citius Pharma retains approximately 90% ownership of Citius Oncology.
Key highlights include:
- FDA approval of LYMPHIR™ for treating cutaneous T-cell lymphoma
- Plans to distribute a portion of Citius Oncology shares to Citius Pharma shareholders
- Citius Pharma's Mino-Lok antibiotic lock solution achieved primary and secondary endpoints in Phase 3 Trial
The merger aims to provide greater financial and strategic flexibility, potentially unlocking value for both companies.
Citius Pharmaceuticals (CTXR) ha completato la fusione della sua sussidiaria oncologica con TenX Keane Acquisition, formando Citius Oncology, Inc. La nuova entità sarà quotata al Nasdaq con il ticker CTOR a partire dal 13 agosto 2024. Citius Pharma detiene circa il 90% delle azioni di Citius Oncology.
Punti salienti includono:
- Approvazione della FDA per LYMPHIR™ per il trattamento del linfoma cutaneo a cellule T
- Piani per distribuire una parte delle azioni di Citius Oncology agli azionisti di Citius Pharma
- La soluzione antibiotica a chiusura Mino-Lok di Citius Pharma ha raggiunto gli obiettivi primari e secondari nella Fase 3 della sperimentazione
La fusione mira a fornire maggiore flessibilità finanziaria e strategica, potenzialmente sbloccando valore per entrambe le aziende.
Citius Pharmaceuticals (CTXR) ha completado la fusión de su filial de oncología con TenX Keane Acquisition, formando Citius Oncology, Inc. La nueva entidad comenzará a cotizar en Nasdaq bajo el símbolo CTOR a partir del 13 de agosto de 2024. Citius Pharma retiene aproximadamente el 90% de la propiedad de Citius Oncology.
Aspectos destacados incluyen:
- aprobación de la FDA para LYMPHIR™ para el tratamiento del linfoma cutáneo de células T
- Planes para distribuir una parte de las acciones de Citius Oncology a los accionistas de Citius Pharma
- La solución de cierre antibiótico Mino-Lok de Citius Pharma logró los objetivos primarios y secundarios en el ensayo de Fase 3
La fusión tiene como objetivo proporcionar una mayor flexibilidad financiera y estratégica, desbloqueando potencialmente valor para ambas empresas.
Citius Pharmaceuticals (CTXR)는 자사의 종양학 자회사를 TenX Keane Acquisition과 합병하여 Citius Oncology, Inc.를 설립하였습니다. 새로운 기관은 2024년 8월 13일부터 Nasdaq에서 CTOR라는 티커로 거래될 예정입니다. Citius Pharma는 Citius Oncology의 약 90%의 지분을 보유하고 있습니다.
주요 내용은 다음과 같습니다:
- 피부 T세포 림프종 치료를 위한 LYMPHIR™의 FDA 승인
- Citius Oncology 주식의 일부를 Citius Pharma 주주에게 분배할 계획
- Citius Pharma의 Mino-Lok 항생제 잠금 솔루션이 3상 시험에서 주요 및 부차적 목표를 달성함
이 합병의 목적은 더 큰 재정적 및 전략적 유연성을 제공하여 두 회사 모두에게 가치를 창출하는 것입니다.
Citius Pharmaceuticals (CTXR) a finalisé la fusion de sa filiale en oncologie avec TenX Keane Acquisition, formant Citius Oncology, Inc. La nouvelle entité sera cotée au Nasdaq sous le symbole CTOR à partir du 13 août 2024. Citius Pharma conserve environ 90 % de la propriété de Citius Oncology.
Les points clés incluent :
- Approbation de la FDA pour LYMPHIR™ pour le traitement du lymphome cutané à cellules T
- Plans de distribution d'une partie des actions de Citius Oncology aux actionnaires de Citius Pharma
- La solution de verrouillage antibiotique Mino-Lok de Citius Pharma a atteint les objectifs primaires et secondaires dans l'essai de phase 3
La fusion vise à offrir une plus grande flexibilité financière et stratégique, libérant potentiellement de la valeur pour les deux entreprises.
Citius Pharmaceuticals (CTXR) hat die Fusion seiner Onkologie-Tochtergesellschaft mit TenX Keane Acquisition abgeschlossen und Citius Oncology, Inc. gegründet. Die neue Entität wird ab dem 13. August 2024 an der Nasdaq unter dem Ticker CTOR gehandelt. Citius Pharma besitzt etwa 90% der Anteile an Citius Oncology.
Wichtige Punkte sind:
- FDA-Zulassung für LYMPHIR™ zur Behandlung von kutanem T-Zell-Lymphom
- Pläne zur Verteilung eines Teils der Aktien von Citius Oncology an die Aktionäre von Citius Pharma
- Die Mino-Lok-Antibiotika-Verschlusstechnik von Citius Pharma hat die primären und sekundären Endpunkte in der Phase-3-Studie erreicht
Die Fusion zielt darauf ab, eine größere finanzielle und strategische Flexibilität zu bieten, die potenziell Wert für beide Unternehmen freisetzen könnte.
- FDA approval of LYMPHIR™ for cutaneous T-cell lymphoma treatment
- Citius Pharma retains approximately 90% ownership of Citius Oncology
- Mino-Lok antibiotic lock solution achieved primary and secondary endpoints in Phase 3 Trial
- Potential market opportunity of $1.8 billion for Mino-Lok
- Planned distribution of Citius Oncology shares to Citius Pharma shareholders
- Potential dilution of Citius Pharma's ownership in Citius Oncology due to future share distribution
Insights
The merger of Citius Pharmaceuticals' oncology subsidiary with TenX Keane to form Citius Oncology is a strategic move with significant financial implications. This transaction creates a pure-play oncology company with its own public listing, potentially unlocking value for shareholders. The recent FDA approval of LYMPHIR™ for cutaneous T-cell lymphoma adds immediate value to the new entity.
Citius Pharma retaining approximately 90% ownership in Citius Oncology allows them to benefit from future growth while maintaining control. The planned future distribution of Citius Oncology shares to Citius Pharma shareholders could provide additional value. Investors should monitor the performance of both entities separately, as this structure allows for more targeted investment strategies in either the oncology-focused or the broader pharmaceutical business.
The FDA approval of LYMPHIR™ for cutaneous T-cell lymphoma is a significant milestone in the oncology field. This therapy addresses an unmet need in a rare form of non-Hodgkin lymphoma, potentially improving treatment options for patients. The creation of Citius Oncology as a dedicated entity could accelerate the commercialization of LYMPHIR™ and the development of future oncology assets.
The shared services agreement ensures continuity in leadership and expertise, which is important for navigating the complex oncology market. Investors should watch for updates on LYMPHIR™'s market penetration and any pipeline expansions, as these will be key drivers for Citius Oncology's future growth and valuation.
The formation of Citius Oncology through this merger creates an intriguing investment opportunity in the oncology sector. The
The strategic flexibility gained from this transaction could lead to more targeted research and development efforts, potentially accelerating innovation in both companies. Market reaction to the new ticker CTOR will be important to watch, as it will indicate investor confidence in the standalone oncology business model. The future share distribution to Citius Pharma shareholders adds an interesting dynamic that could impact both stocks' valuations.
LYMPHIR™ for the treatment of cutaneous T-cell lymphoma approved by the FDA
Citius Pharmaceuticals, Inc. holds approximately
Shares of Citius Oncology, Inc. anticipated to begin trading on Nasdaq under the ticker "CTOR" on August 13, 2024
"This transaction is a significant milestone, providing us greater financial and strategic flexibility to advance our late-stage assets. We believe a publicly traded Citius Oncology offers a unique pure play investment opportunity and is better positioned to unlock the value of LYMPHIR, which was approved by the FDA last week. With this transaction, we look forward to launching LYMPHIR, facilitating future growth initiatives, and exploring additional potential oncology assets. It is our intention to distribute of a portion of our shares of Citius Oncology to Citius Pharma shareholders in the future," stated Leonard Mazur, Chairman and CEO of Citius Pharma and Citius Oncology.
"This transaction also enables Citius Pharma to focus on growing and unlocking the value of other assets in its portfolio, including our novel Mino-Lok antibiotic lock solution which recently achieved primary and secondary endpoints in a Phase 3 Trial and is now another step closer to entering a
As it has in the past, Citius Oncology will operate under a shared services agreement with Citius Pharma for the services of several key members of the Citius Pharma team, led by Leonard Mazur, Chief Executive Officer, Jaime Bartushak, Chief Financial Officer and Dr. Myron Czuczman, Chief Medical Officer. Myron Holubiak will serve as Executive Vice Chairman of the Citius Oncology Board of Directors.
About the Merger
Pursuant to the agreement, TenX acquired Citius Pharma's wholly owned subsidiary via a merger, with the newly combined publicly traded company renamed Citius Oncology, Inc. As part of the transaction, all shares of Citius Pharma's wholly owned subsidiary were converted into the right to receive common stock of Citius Oncology. Citius Pharma holds approximately
The description of the transaction contained herein is only a summary and is qualified in its entirety by reference to the merger agreement, a copy of which has been filed by Citius Pharma in a Current Report on Form 8-K, filed with the
Advisors
Maxim Group LLC is acting as exclusive financial advisor to Citius Pharma and Newbridge Securities Corporation is acting as exclusive financial advisor to TenX. Wyrick Robbins Yates & Ponton LLP is acting as legal advisor to Citius Pharma and Citius Oncology. The Crone Law Group P.C. is acting as legal advisor to TenX.
About Citius Oncology, Inc.
Citius Oncology will serve as a platform to develop and commercialize novel targeted oncology therapies. In August 2024, its primary asset, LYMPHIR, was approved by the FDA for the treatment of adults with relapsed or refractory CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds
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 reducing the number of regulatory T-cells (Tregs) that suppress the immune system, thereby enhancing the body's ability to fight the tumor. LYMPHIR is 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 PTCL and CTCL, respectively. In 2021, denileukin diftitox received regulatory approval in
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
Please read Important Safety Information and full Prescribing Information, including Boxed WARNING, for LYMPHIR at www.lymphirhcp.com.
About Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. In August 2024, the FDA approved LYMPHIR, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma that is now being developed by Citius Oncology. Citius Pharma's late-stage pipeline also includes Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 Trial. Citius is actively engaged with the FDA to outline next steps for both programs. 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 Citius. 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, and that apply to Citius Pharma and Citius Oncology as our majority owned subsidiary, are: the anticipated benefits of the transaction between TenX Keane Acquisition and Citius Pharma to form Citius Oncology may not be realized fully, if at all, or may take longer to realize than expected; Citius Oncology's ability to commercialize LYMPHIR; our need for substantial additional funds; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our ability to commercialize any of our other product candidates approved by the FDA; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; our 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 September 30, 2023, filed with the SEC on December 29, 2023, 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:
Ilanit Allen
ir@citiuspharma.com
ir@citiusonc.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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SOURCE Citius Pharmaceuticals, Inc.
FAQ
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