Citius Oncology Engages Jefferies as Exclusive Financial Advisor to Explore Strategic Alternatives
Citius Oncology (Nasdaq: CTOR), a majority-owned subsidiary of Citius Pharmaceuticals (Nasdaq: CTXR), has engaged Jefferies as its exclusive financial advisor to explore strategic alternatives for maximizing shareholder value. The company is considering various options including partnerships, joint ventures, mergers, acquisitions, and licensing transactions.
The announcement comes as Citius Oncology prepares to launch LYMPHIR™, their recently FDA-approved therapy for treating patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) who have undergone at least one prior systemic therapy.
The company has not established a specific timeline for this strategic review process and will only disclose developments if the Board of Directors approves a specific transaction or deems disclosure necessary. There is no guarantee that this process will result in any strategic transaction.
Citius Oncology (Nasdaq: CTOR), una filiale a maggioranza di Citius Pharmaceuticals (Nasdaq: CTXR), ha incaricato Jefferies come consulente finanziario esclusivo per esplorare alternative strategiche al fine di massimizzare il valore per gli azionisti. L'azienda sta valutando diverse opzioni, tra cui partnership, joint venture, fusioni, acquisizioni e transazioni di licenza.
L'annuncio arriva mentre Citius Oncology si prepara a lanciare LYMPHIR™, la loro recente terapia approvata dalla FDA per il trattamento di pazienti con linfoma cutaneo T-cellulare (CTCL) in stadio I-III recidivante o refrattario, che hanno già ricevuto almeno una terapia sistemica precedente.
L'azienda non ha stabilito un cronoprogramma specifico per questo processo di revisione strategica e divulgherà sviluppi solo se il Consiglio di Amministrazione approverà una transazione specifica o riterrà necessaria la divulgazione. Non c'è garanzia che questo processo porti a una transazione strategica.
Citius Oncology (Nasdaq: CTOR), una subsidiaria de mayoría de Citius Pharmaceuticals (Nasdaq: CTXR), ha contratado a Jefferies como su asesor financiero exclusivo para explorar alternativas estratégicas para maximizar el valor para los accionistas. La compañía está considerando diversas opciones que incluyen asociaciones, empresas conjuntas, fusiones, adquisiciones y transacciones de licencia.
El anuncio llega mientras Citius Oncology se prepara para lanzar LYMPHIR™, su terapia recientemente aprobada por la FDA para tratar a pacientes con linfoma cutáneo de células T (CTCL) en estadios I-III que han recibido al menos una terapia sistémica previa.
La empresa no ha establecido un cronograma específico para este proceso de revisión estratégica y solo revelará desarrollos si la Junta Directiva aprueba una transacción específica o considera necesaria la divulgación. No hay garantía de que este proceso resulte en una transacción estratégica.
Citius Oncology (Nasdaq: CTOR)은 Citius Pharmaceuticals (Nasdaq: CTXR)의 대다수 소유 자회사로, 주주 가치를 극대화하기 위한 전략적 대안을 탐색하기 위해 Jefferies를 독점 재무 자문사로 선정했습니다. 이 회사는 파트너십, 합작 투자, 인수합병, 인수 및 라이센스 거래 등 다양한 옵션을 고려하고 있습니다.
이번 발표는 Citius Oncology가 재발성 또는 난치성 1-3기 피부 T세포 림프종(CTCL) 환자 치료를 위한 최근 FDA 승인 요법인 LYMPHIR™를 출시할 준비를 하고 있는 시점에 나왔습니다.
회사는 이 전략적 검토 과정에 대한 구체적인 일정은 정하지 않았으며, 이사회가 특정 거래를 승인하거나 공개가 필요하다고 판단하지 않는 한 발전 상황을 공개하지 않을 것입니다. 이 과정이 전략적 거래로 이어질 것이라는 보장은 없습니다.
Citius Oncology (Nasdaq: CTOR), une filiale majoritairement détenue de Citius Pharmaceuticals (Nasdaq: CTXR), a choisi Jefferies comme conseiller financier exclusif pour explorer des alternatives stratégiques visant à maximiser la valeur pour les actionnaires. L'entreprise envisage diverses options, notamment des partenariats, des coentreprises, des fusions, des acquisitions et des transactions de licences.
Cette annonce intervient alors que Citius Oncology se prépare à lancer LYMPHIR™, sa thérapie récemment approuvée par la FDA pour traiter des patients atteints de lymphome cutané à cellules T (CTCL) de stade I-III, qui ont déjà reçu au moins une thérapie systémique précédente.
L'entreprise n'a pas établi de calendrier spécifique pour ce processus de révision stratégique et ne divulguera les développements que si le Conseil d'administration approuve une transaction spécifique ou juge nécessaire la divulgation. Il n'y a aucune garantie que ce processus aboutisse à une transaction stratégique.
Citius Oncology (Nasdaq: CTOR), eine mehrheitlich im Besitz von Citius Pharmaceuticals (Nasdaq: CTXR) befindliche Tochtergesellschaft, hat Jefferies als exklusiven Finanzberater beauftragt, um strategische Alternativen zur Maximierung des Aktionärswertes zu prüfen. Das Unternehmen erwägt verschiedene Optionen, einschließlich Partnerschaften, Joint Ventures, Fusionen, Akquisitionen und Lizenztransaktionen.
Die Ankündigung erfolgt, während Citius Oncology sich auf die Einführung von LYMPHIR™ vorbereitet, ihrer kürzlich von der FDA genehmigten Therapie zur Behandlung von Patienten mit rezidiviertem oder refraktärem kutanem T-Zell-Lymphom (CTCL) im Stadium I-III, die bereits mindestens eine vorherige systemische Therapie erhalten haben.
Das Unternehmen hat keinen spezifischen Zeitrahmen für diesen strategischen Prüfungsprozess festgelegt und wird Entwicklungen nur bekannt geben, wenn der Vorstand eine bestimmte Transaktion genehmigt oder die Bekanntgabe für notwendig erachtet. Es gibt keine Garantie dafür, dass dieser Prozess zu einer strategischen Transaktion führen wird.
- Recently received FDA approval for LYMPHIR™ for CTCL treatment
- Strategic review could lead to value-enhancing transactions
- Engagement of prominent investment bank Jefferies indicates serious pursuit of strategic options
- Uncertainty regarding the outcome of the strategic review process
- No guaranteed timeline for potential transactions
Insights
The engagement of Jefferies as a financial advisor is a strategically significant move that could reshape Citius Oncology's future. Jefferies' strong track record in healthcare M&A and their expertise in orchestrating deals averaging
The micro-cap status of Citius Oncology (
The most probable outcomes include: 1) A strategic partnership with revenue-sharing agreements, 2) An outright acquisition by a larger pharmaceutical company, or 3) A merger with a complementary oncology-focused company. The lack of a specified timeline suggests flexibility in negotiations, which could benefit shareholders by allowing for optimal deal terms rather than rushing to meet artificial deadlines.
The strategic review announcement, coming immediately after LYMPHIR™'s FDA approval, represents a calculated move to maximize the asset's value. CTCL treatment landscapes have historically attracted premium valuations due to their orphan drug status and specialized market position. Recent comparable transactions in the rare disease space have commanded multiples of 4-6x peak sales potential.
LYMPHIR™'s positioning in the relapsed/refractory setting, coupled with its recent FDA approval, significantly de-risks the asset for potential acquirers. The therapy addresses a clear unmet need in Stage I-III CTCL patients who have failed prior systemic therapy, a market segment with effective treatment options. This strategic review could potentially unlock substantial value, particularly given the current undervaluation relative to the commercial potential of an FDA-approved oncology asset.
For retail investors, this development suggests a potential near-term catalyst, though the outcome remains uncertain. Historical patterns in similar situations indicate that successful strategic reviews in oncology often result in deal premiums ranging from
The engagement of Jefferies underscores Citius Oncology's commitment to exploring all avenues for enhancing its strategic positioning and advancing its mission to improve patient outcomes in oncology. Strategic alternatives under consideration may include, but are not limited to, partnerships, joint ventures, mergers, acquisitions, licensing or other strategic transactions.
"We are excited to partner with Jefferies, a leading global investment bank with deep expertise in the life sciences sector, to help us explore opportunities that align with our long-term vision. As we prepare to launch our first cancer therapy, now is an opportune time to review options that would be in the best interests of patients and shareholders," said Leonard Mazur, Chief Executive Officer of Citius Oncology. "Our goal is to deliver value to shareholders by making a meaningful impact in the oncology space."
Citius Oncology is committed to commercializing LYMPHIR™, recently approved by the
The Company has not set a specific timeline for the strategic engagement and does not intend to disclose developments unless and until its Board of Directors has approved a specific transaction or course of action, or the company otherwise determines that disclosure is appropriate or necessary. There can be no assurance, however, that this process will result in a strategic transaction or other alternative.
About LYMPHIR™ (denileukin diftitox-cxdl)
LYMPHIR is a targeted immune therapy for relapsed or refractory CTCL indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.
In 2021, denileukin diftitox received regulatory approval in
About Citius Oncology, Inc.
Citius Oncology, Inc. (Nasdaq: CTOR) is 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 Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) 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. 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. Citius Pharmaceuticals owns
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, unless noted otherwise, that apply to Citius Pharma and Citius Oncology, are: whether the objectives of the strategic alternative review process will be achieved; the timing, terms, structure, benefits and costs of a strategic transaction, if any; the risk that the strategic alternatives review and its announcement could have an adverse effect on the ability of the Company to retain and hire key personnel and maintain business relationships and on its operating results and business generally; our ability to commercialize LYMPHIR and any of our other product candidates that may be approved by the FDA; our need for substantial additional funds; 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; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; 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 risks have been and may be further impacted by any future public health risks. 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 Citius Oncology's and Citius Pharma's Annual Report on Form 10-K for the year ended September 30, 2024, filed with the SEC on December 27, 2024, as 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
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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SOURCE Citius Oncology, Inc.
FAQ
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