Denileukin Diftitox

Avenue Capital Group to provide up to $25 Million via Senior Credit Facility with an initial $10 million tranche funded at closing; additional tranches subject to certain conditions Avenue Capital Group将通过高级信贷安排提供高达2500万美元的资金，初始1000万美元部分在交割时提供；额外部分资金需满足特定条件。Gross proceeds of approximately $11.5 million secured by a concurrent exercise of certain outstanding warrants held by single healthcare-focused institutional investor 通过同时行使某家专注于医疗保健的机构投资者持有的某些未偿认股权证，获得了约1150万美元的总收益。Financings to support ongoing commercial execution while preserving flexibility for future growth initiatives 为支持持续的商业执行提供资金，同时为未来的增长计划保留灵活性CRANFORD, N.J. 新泽西州克兰福德, ，May 5, 2026 2026年5月5日/PRNewswire/ -- Citius Oncology, Inc. ('Citius Oncology' or the 'Company') (Nasdaq: /PRNewswire/ -- Citius Oncology, Inc.（“Citius Oncology”或“公司”）（纳斯达克：CTOR 构造函数), a specialty biopharmaceutical company focused on the development and commercialization of novel targeted oncology therapies, today announced that it has entered into a senior secured term loan credit facility (the 'Credit Facility') with Avenue Venture Opportunities Fund II, L.P., a fund of Avenue Capital Group ('Avenue'), providing for up to $25 million in capital to support the ongoing commercialization of LYMPHIR. ），一家专注于开发和商业化新型靶向肿瘤疗法的特色生物制药公司，今天宣布已与Avenue Capital Group（“Avenue”）旗下的基金Avenue Venture Opportunities Fund II, L.P.达成一项高级担保定期贷款信贷协议（“信贷协议”），提供高达2500万美元的资金，以支持LYMPHIR的持续商业化。® ®(denileukin diftitox-cxdl), approved by the Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy, and has also entered into a definitive agreement for the immediate exercise of certain outstanding warrants, with expected gross proceeds to the Company of approximately $11.5 million. （地尼白介素-右丙亚胺），获美国食品药品监督管理局（FDA）批准用于治疗至少经过一次先前全身治疗后复发或难治性I-III期皮肤T细胞淋巴瘤（CTCL）的成年患者，并且已达成一项最终协议，立即行使某些尚未行使的认股权证，预计将为公司带来约1150万美元的毛收入。The combined financings are expected to provide enhanced financial flexibility to support commercial execution, working capital, and general corporate purposes.. 合并后的融资预计将提供增强的财务灵活性，以支持商业执行、营运资本和一般公司用途。'This Credit Facility strengthens our ability to continue to execute on the LYMPHIR launch, aligning capital access with commercial performance, and underscoring the confidence that a global investment firm like Avenue Capital has in our commercial trajectory and the long-term potential of LYMPHIR. In parallel, the warrant exercise financing provides additional near-term capital to further support our commercial efforts Collectively, this provides the company with meaningful financial flexibility as we continue to scale our commercial infrastructure, drive adoption of LYMPHIR among treating physicians, and expand patient access to this important therapy for relapsed or refractory cutaneous T-cell lymphoma. “这项信贷安排加强了我们继续执行LYMPHIR发布的能力，将资本获取与商业表现相结合，并凸显了像Avenue Capital这样的全球投资公司对我们商业轨迹及LYMPHIR长期潜力的信心。同时，认股权证行使融资为我们提供了额外的短期资本，以进一步支持我们的商业努力。总体而言，这为公司在扩大商业基础设施、推动治疗医生对LYMPHIR的采用以及扩大复发或难治性皮肤T细胞淋巴瘤患者获得这一重要疗法的机会的过程中，提供了有意义的财务灵活性。We are pleased to have Avenue as a capital partner as we advance our mission to improve outcomes for patients with limited treatment options,' said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharmaceuticals.. “我们很高兴有Avenue作为我们的资本合作伙伴，因为我们正在推进改善有限治疗选择患者的使命，”Citius Oncology和Citius Pharmaceuticals董事长兼首席执行官Leonard Mazur表示。'Citius Oncology has a differentiated, FDA-approved therapy with a targeted commercial opportunity. We are excited to support the Citius team as they execute on their commercialization strategy and work to realize the full value of their first FDA-approved asset,' said Chad Norman, Senior Portfolio Manager of Avenue Capital Group.. “Citius Oncology拥有一个差异化且经FDA批准的疗法，具有针对性的商业机会。我们很高兴支持Citius团队执行其商业化战略，并努力实现其首个FDA批准资产的全部价值，”Avenue Capital Group高级投资组合经理Chad Norman表示。H.C. Wainwright & Co. is acting as the exclusive origination, structuring and placement agent to Citius Oncology for the financings. H.C. Wainwright & Co. 担任Citius Oncology融资的独家发起、结构设计和配售代理。Financings Summary 融资摘要The Credit Facility has a term of 3.5 years and includes an initial tranche of $10 million, to be fully funded at closing, plus two additional tranches of up to an aggregate of $15 million, subject to achievement of predefined revenue milestones and liquidity conditions. The Company has agreed to issue to Avenue warrants to purchase up to 11,111,111 shares of the Company's common stock, at an exercise price of $0.90 per share, exercisable for a period of five years following the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the warrants. 该信贷融资期限为3.5年，包括初始的1000万美元额度，将在结算时全额提供，另外还有两笔总计不超过1500万美元的额度，需在达成预定义的收入里程碑和流动性条件后提供。公司已同意向Avenue发行认股权证，可购买多达11,111,111股公司普通股，行权价为每股0.90美元，自股东批准发行因行使认股权证而可发行的股份之日起五年内可行权。The Company will also issue to Avenue warrants to purchase shares of common stock equal to 10% of the amount funded in each future tranche, divided by the exercise price of $0.90 per share. Additionally, Avenue will have the right, at any time while any loan is outstanding, to convert up to $4.0 million of the outstanding principal under the credit facility into shares of the Company's common stock at a price per share equal to 120% of the exercise price of the warrant, subject to certain terms and conditions, including beneficial ownership limitations.. 公司还将向Avenue发行认股权证，以每股0.90美元的行权价计算，可购买相当于每个未来分期资金额度10%的普通股股份。此外，在任何贷款未偿还期间，Avenue有权随时将信贷额度下最多400万美元的未偿还本金转换为公司的普通股股票，转换价格为认股权证行权价的120%，但需符合特定条款和条件，包括对受益所有权的限制。Concurrently, the Company entered into definitive agreements with a single healthcare-focused institutional investor for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 12,777,778 shares of common stock, originally issued in July 2025, September 2025, and December 2025, at a reduced exercise price of $0.90 per share, with expected gross proceeds to the Company of approximately $11.5 million prior to deduction of placement agent fees and other offering expenses. 同时，公司与一家专注于医疗保健的机构投资者签订了最终协议，该投资者将立即行使某些尚未行使的认股权证，以每股0.90美元的降低行权价购买总计高达12,777,778股普通股，这些认股权证最初分别于2025年7月、2025年9月和2025年12月发行。预计公司在扣除配售代理费用和其他发行开支前的总收益约为1,150万美元。In consideration for the immediate exercise of these warrants for cash, the Company will issue new unregistered warrants to purchase up to 25,555,556 shares of common stock. The new warrants will have an exercise price of $0.90 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the new warrants and will expire five years after the later of (i) the date of stockholder approval and (ii) the effective date of the Resale Registration Statement (as defined below). 鉴于这些认股权证立即以现金行使，公司将发行新的未注册认股权证，可购买最多 25,555,556 股普通股。新认股权证的行权价为每股 0.90 美元，将于股东批准发行因行使新认股权证而可发行的股份的生效日起开始可行权，并在以下两者较晚日期的五年后到期：(i) 股东批准之日，及 (ii) 转售登记声明（定义见下文）的生效日。The new warrant offering is expected to close on or about May 6, 2026, subject to satisfaction of customary closing conditions.. 新股认股权证发行预计将在2026年5月6日或左右完成，但需满足惯例的交割条件。The Company intends to use the net proceeds from the financings primarily to fund ongoing LYMPHIR commercialization efforts such as sales force expansion, market access initiatives, medical affairs activities, and manufacturing supply chain support, with the remainder to be used for working capital and general corporate purposes.. 公司拟将融资所得净额主要用于推动LYMPHIR的商业化进程，例如扩充销售队伍、市场准入计划、医学事务活动及生产供应链支持，剩余部分将用作营运资金和一般企业用途。Warrant Offering Disclosure 证券发行披露The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the '1933 Act') and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ('SEC') or an applicable exemption from such registration requirements. 上述新认股权证是根据《1933年证券法》（经修订，简称“1933法案”）的适用豁免条款，在私募中发行的，且这些认股权证以及可依其行使而发行的普通股均未根据1933法案进行注册，因此在没有向美国证券交易委员会（“SEC”）注册或适用注册要求的豁免情况下，不得在美国境内发售或出售。The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants (the 'Resale Registration Statement').. 公司已同意向美国证券交易委员会提交一份注册声明，涵盖因行使新认股权证而可发行的普通股股票的转售（“转售注册声明”）。The Company also has agreed to amend certain existing warrants to purchase up to an aggregate of 15,697,024 shares of the Company's common stock that were previously issued to the investor in December 2025, with an exercise price of $1.09 per share, effective upon the closing of the offering, such that the amended warrants will have a reduced exercise price of $0.90 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the warrants and will expire five years after the date of stockholder approval.. 公司还同意修改先前在2025年12月向投资者发行的、可购买总计15,697,024股公司普通股的某些现有认股权证，其行权价格为每股1.09美元。修改后的认股权证将在本次发行完成时生效，行权价格将降至每股0.90美元，自股东批准行使认股权证所发行股份的生效日期起可行权，并在股东批准之日起五年后到期。This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.. 本新闻稿不构成出售或购买这些证券的要约或要约邀请，也不得在任何州或司法管辖区进行此类证券的销售，因为在该等州或司法管辖区，未根据其证券法进行注册或资格认证前，此类要约、邀请或销售将属违法。About LYMPHIR 关于LYMPHIR® ®(denileukin diftitox （地尼白介素 diftitox）‑ ‑cxdl) cxdl)LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (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 (DT) fragments. LYMPHIR 是一种用于治疗复发或难治性皮肤T细胞淋巴瘤（CTCL）的靶向免疫疗法，适用于在至少一种先前系统治疗后的I-III期疾病。它是一种重组融合蛋白，结合了IL-2受体结合域和白喉毒素（DT）片段。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.. 该药剂特异性结合到细胞表面的IL-2受体上，使进入细胞的白喉毒素片段抑制蛋白质合成。被细胞摄取后，DT片段被切割，游离的DT片段抑制蛋白质合成，导致细胞死亡。Denileukin diftitox-cxdl展示了通过直接杀伤作用清除免疫抑制性调节T淋巴细胞（Tregs）和针对表达IL-2R的肿瘤的抗肿瘤活性。In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia. 2021年，Denileukin diftitox在日本获得监管批准，用于治疗复发或难治性CTCL和外周T细胞淋巴瘤（PTCL）。随后，在2021年，Citius获得了独家许可，拥有除印度、日本及亚洲某些地区以外所有市场开发和商业化Denileukin diftitox的权利。LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.. LYMPHIR（地尼白介素 diftitox-cxdl）于2025年12月获得FDA批准，并随后在美国上市。About Citius Oncology, Inc. 关于Citius Oncology公司Citius Oncology, Inc. (Nasdaq: Citius Oncology, Inc.（纳斯达克：CTOR 构造函数) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. The Company believes the addressable U.S. ）是一个开发和商业化新型靶向肿瘤学疗法的平台。2025年12月，Citius Oncology推出了LYMPHIR，该药物获FDA批准用于治疗曾接受过至少一种先前系统治疗的复发或难治性I–III期CTCL成年患者。公司认为其在美国的可覆盖市场。market 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. 市场超过4亿美元，正在增长，且现有疗法未能充分满足需求。强大的知识产权保护涵盖了孤儿药资格、复杂技术、商业秘密以及用于免疫肿瘤学与检查点抑制剂联合治疗的待批专利，这将进一步支持Citius Oncology的竞争地位。For more information, please visit . 有关更多信息，请访问 。www.citiusonc.com www.citiusonc.com. 。About Avenue Capital Group 关于大道资本集团Avenue Capital Group is a global investment firm founded in 1995 and headquartered in New York, with offices across the United States, Europe, Asia, and Abu Dhabi. The firm manages assets estimated at approximately $9.8 billion and is primarily focused on specialty lending, opportunistic credit, and other special situations investments. Avenue Capital Group是一家全球投资公司，成立于1995年，总部位于纽约，在美国、欧洲、亚洲和阿布扎比设有办事处。该公司管理的资产估计约为98亿美元，主要专注于特殊贷款、机会信贷及其他特殊情况投资。The Avenue Growth Lending strategy seeks to provide creative financing solutions to high-growth, publicly traded and venture capital-backed technology and life science companies, focusing generally on companies within the underserved segment of the market created by the widening financing gap between commercial banks and larger debt funds. 大道成长借贷策略旨在为高增长、公开上市和风险资本支持的技术和生命科学公司提供创造性的融资解决方案，通常专注于因商业银行与大型债务基金之间融资缺口扩大而形成的市场服务不足的细分领域中的公司。For more information, please visit . 有关更多信息，请访问 。www.avenuecapital.com www.avenuecapital.com. 。Forward-Looking Statements 前瞻性声明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 Oncology. 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. 本新闻稿可能包含1933年《证券法》第27A条和1934年《证券交易法》第21E条所指的“前瞻性陈述”。这些陈述是基于我们对未来事件影响Citius Oncology的预期和信念而作出的。您可以通过它们使用诸如“将”、“预期”、“估计”、“预计”、“计划”、“应该”、“可能”以及具有类似含义的其他词语或术语或使用未来日期来识别这些陈述。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, and include all statements related to the closing and intended use of net proceeds from the offerings. 前瞻性声明基于管理层的当前预期，并受可能对我们业务、经营结果、财务状况和股价产生负面影响的风险和不确定性约束，包括与发行相关的所有声明以及净收益的预期用途。Factors that could cause actual results to differ materially from those currently anticipated are: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; the availability of future tranches under the Credit Facility and our ability to conduct future financings; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our ability to regain compliance with Nasdaq's continued listing standards; early-stage clinical data may not be predictive of results from larger or later-stage studies; our ability to . 可能导致实际结果与当前预期有重大差异的因素包括：我们需要大量额外资金，以及我们是否有能力筹集更多资金以支持公司未来至少12个月的运营；信贷额度下未来分期款项的可用性及我们进行未来融资的能力；我们成功将LYMPHIR商业化并建立可持续收入流的能力；对LYMPHIR及我们的候选产品市场规模的估计及其在任何市场的接受度；我们能否确保战略合作伙伴关系并扩大LYMPHIR的国际准入；与研发活动结果相关的风险，包括来自我们现有及任何新管线资产的风险；我们能否重新符合纳斯达克持续上市标准的能力；早期临床数据可能无法预测更大规模或后期研究的结果；我们的能力。www.sec.gov www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. 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.. ，包括Citius Oncology截至2025年9月30日的年度报告Form 10-K，该报告已于2025年12月23日提交给美国证券交易委员会（SEC）。这些前瞻性声明仅截至本文发布之日有效，我们明确声明不承担任何义务或承诺公开发布对本文所含任何前瞻性声明的更新或修订，以反映我们预期的任何变化或任何相关事件、条件或情况的变化，除非法律另有要求。Investor Contact: 投资者联系方式： Ilanit Allen 伊兰尼特·艾伦[email protected] 电子邮件地址908-967-6677 x113 908-967-6677 转113Media Contact: 媒体联系人：STiR-communications STiR通讯Greg Salsburg 格雷格·萨尔斯堡[email protected] 电子邮件地址SOURCE Citius Oncology, Inc. 来源：Citius Oncology, Inc.21 21% %more press release views with 更多新闻稿浏览量与 Request a Demo 请求演示