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SAN DIEGO, July 1, 2024 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ('Kintara'), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, and TuHURA Biosciences, Inc. ('TuHURA'), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today provided an overview of Kintara's and TuHURA's recent corporate and clinical advancements and outlined upcoming expected near term milestones..
圣地亚哥,2024年7月1日/PRNewswire/--Kintara Therapeutics,Inc.(纳斯达克:KTRA)(“Kintara”)是一家专注于开发新型实体瘤癌症疗法的生物制药公司,TuHURA Biosciences,Inc.(“TuHURA”)是一家三期注册阶段的免疫肿瘤学公司,开发新技术以克服对癌症免疫疗法的耐药性,今天概述了Kintara和TuHURA最近的公司和临床进展,并概述了即将到来的预期近期里程碑。。
Recent Corporate Achievements
近期公司业绩
In April 2024, Kintara and TuHURA entered into definitive merger agreement (the 'Merger Agreement'), pursuant to which Kayak Mergeco, Inc., Kintara's wholly-owned subsidiary, will merge with and into TuHURA, with TuHURA surviving the merger and becoming Kintara's direct, wholly-owned subsidiary (the 'Merger')..
2024年4月,Kintara和TuHURA签订了最终合并协议(“合并协议”),根据该协议,Kayak Mergeco,Inc.,Kintara的全资子公司,将与TuHURA合并并并入TuHURA,TuHURA在合并中幸存下来,成为Kintara的直接全资子公司(“合并”)。。
The Merger is expected to close in the third quarter of 2024.
合并预计将于2024年第三季度结束。
Kintara's existing stockholders will own approximately 5.5% of combined company's common stock at the closing of the Merger, inclusive of the contingent value right ('CVR') linked to the achievement of enrollment of a minimum of 10 patients in the REM-001 study, with such patients each completing 8 weeks of follow-up on or before December 31, 2025..
Kintara的现有股东将在合并结束时拥有合并公司普通股的约5.5%,其中包括与REM-001研究中至少10名患者入选相关的或有价值权(“CVR”),这些患者在2025年12月31日或之前完成8周的随访。。
TuHURA to advance a single Phase 3 trial for IFx-2.0 personalized cancer vaccine as adjunctive therapy with Keytruda® in first-line treatment for advanced Merkel cell carcinoma in the second half of 2024 under FDA's accelerated approval pathway.
根据FDA的加速批准途径,TuHURA将于2024年下半年推进IFx-2.0个性化癌症疫苗的单阶段3试验,作为Keytruda®在晚期默克尔细胞癌一线治疗中的辅助治疗。
TuHURA's first-in-class bifunctional Antibody Drug Conjugates (ADCs) represent potential upside partnering opportunities.
TuHURA的一流双功能抗体-药物偶联物(ADC)代表了潜在的优势合作机会。
$31 million subscribed financing by TuHURA in connection with the Merger Agreement expected to provide cash runway into late 2025.
TuHURA就合并协议认购了3100万美元的融资,预计将在2025年末提供现金跑道。
On June 12, 2024, Kintara received a 180-day extension until December 9, 2024 from The Nasdaq Stock Market LLC to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market, in accordance with Nasdaq Listing Rule 5810(c)(3)(A).
2024年6月12日,根据纳斯达克上市规则5810(c)(3)(a),金塔拉收到纳斯达克股票市场有限责任公司(Nasdaq Stock Market LLC)的180天延期至2024年12月9日,以重新遵守继续在纳斯达克资本市场上市的最低出价要求。
Recent Clinical Advancements
近期临床进展
Advanced enrollment, dosing and clinical site expansion in Kintara's open label 15-patient REM-001 study in cutaneous metastatic breast cancer (CMBC).
Kintara的皮肤转移性乳腺癌(CMBC)开放标签15例患者REM-001研究中的高级登记,剂量和临床部位扩展。
As of June 26, 2024, four patients have been dosed in the open label 15-patient REM-001 study in CMBC.
。
In addition to Memorial Sloan Kettering Cancer Center, Montefiore Medical Center, the University Hospital for Albert Einstein College of Medicine, will soon begin screening patients.
除了纪念斯隆·凯特琳癌症中心外,阿尔伯特·爱因斯坦医学院的大学医院蒙特菲奥医学中心也将很快开始筛查患者。
The majority of the costs to run this study will be covered by the $2.0 million Small Business Innovation Research (SBIR) grant Kintara was awarded from the National Institutes of Health (NIH).
这项研究的大部分费用将由美国国立卫生研究院(NIH)授予的200万美元小企业创新研究(SBIR)资助金支付。
In March 2024, Kintara expanded inclusion criteria in the open label 15-patient REM-001 study in CMBC to include patients receiving pembrolizumab (KEYTRUDA®) for at least three months at screening. This is expected to significantly increase the pace of enrollment.
。预计这将大大提高入学速度。
Expected Near-term Milestones
预期近期里程碑
Q3 2024: Close Merger with TuHURA.
2024年第3季度:与TuHURA的紧密合并。
Q4 2024: Complete enrollment and 8 week follow-up of 10 patients in the REM-001 study.
2024年第4季度:在REM-001研究中完成10名患者的登记和8周随访。
2H 2024: Commence TuHURA's Phase 3 trial for IFx-2.0 personalized cancer vaccine for advanced Merkel cell carcinoma under FDA's accelerated approval pathway.
2024年下半年:根据FDA的加速批准途径,开始TuHURA针对晚期默克尔细胞癌的IFx-2.0个性化癌症疫苗的3期临床试验。
About Kintara
关于Kintara
Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs. Kintara is developing therapeutics for clear unmet medical needs with reduced risk development programs. The Company's lead program is REM-001 Therapy for cutaneous metastatic breast cancer (CMBC)..
Kintara位于加利福尼亚州圣地亚哥,致力于为未满足医疗需求的患者开发新型癌症疗法。Kintara正在开发治疗方法,以减少风险开发计划,满足明确未满足的医疗需求。该公司的主导项目是REM-001治疗皮肤转移性乳腺癌(CMBC)。。
Kintara has a proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 Therapy, which consists of the laser light source, the light delivery device, and the REM-001 drug product, has been previously studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy.
Kintara拥有专有的晚期光动力治疗平台,有望作为局部皮肤或内脏肿瘤治疗以及其他潜在适应症。REM-001疗法由激光光源,光传递装置和REM-001药物产品组成,先前已在先前接受过化疗和/或失败的CMBC患者的四项2/3期临床试验中进行了研究。放射治疗。
In CMBC, REM-001 has a clinical efficacy to date of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications..
在CMBC中,REM-001迄今为止具有80%的CMBC可评估病变完全缓解的临床疗效,并且现有的强大安全数据库涵盖了大约1100名患者的多种适应症。。
For more information, please visit www.kintara.com or follow us on X at @Kintara_Thera, Facebook and LinkedIn.
欲了解更多信息,请访问www.kintara.com或通过X关注我们@kintara\u Thera、Facebook和LinkedIn。
About TuHURA Biosciences, Inc.
关于TuHURA Biosciences,Inc。
TuHURA Biosciences, Inc. is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. TuHURA's lead personalized cancer vaccine candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) in first line treatment for advanced or metastatic Merkel Cell Carcinoma..
TuHURA Biosciences,Inc.是一家三期注册阶段的免疫肿瘤学公司,开发新技术以克服对癌症免疫疗法的耐药性。TuHURA的主要个性化癌症疫苗候选物IFx-2.0旨在克服对检查点抑制剂的主要耐药性。TuHURA正在准备启动IFx-2.0的单一随机安慰剂对照3期注册试验,作为Keytruda®(pembrolizumab)的辅助治疗,用于晚期或转移性默克尔细胞癌的一线治疗。。
In addition to its cancer vaccine product candidates, TuHURA is leveraging its Delta receptor technology to develop first-in-class bi-functional ADCs, targeting Myeloid Derived Suppressor Cells to inhibit their immune suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies..
除了候选的癌症疫苗产品外,TuHURA正在利用其Delta受体技术开发一流的双功能ADC,靶向骨髓来源的抑制细胞,以抑制其对肿瘤微环境的免疫抑制作用,以防止T细胞衰竭和获得对检查点抑制剂和细胞疗法的耐药性。。
For more information, please visit tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.
有关更多信息,请访问tuhurabio.com,并在Facebook、X和LinkedIn上与TuHURA联系。
No Offer or Solicitation
无要约或招揽
This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any proxy, consent, authorization, vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
本通信不旨在也不构成买卖要约或买卖任何证券的邀约,或任何代理、同意、授权、投票或批准的邀约,也不构成任何司法管辖区的证券销售,在任何司法管辖区的证券法律规定的登记或资格之前,此类要约、邀约或销售将是非法的。
No offering of securities shall be made, except by means of a prospectus meeting the requirements of the U.S. Securities Act of 1933, as amended..
除通过符合经修订的《1933年美国证券法》要求的招股说明书外,不得发行证券。。
Additional Information About the Proposed Transaction for Investors and Shareholders
投资者和股东关于拟议交易的其他信息
In connection with the proposed transaction between Kintara and TuHURA (the 'Proposed Transaction'), Kintara has filed relevant materials with the U.S. Securities and Exchange Commission (the 'SEC'), including a registration statement on Form S-4 that contains a preliminary proxy statement and preliminary prospectus of Kintara (the 'proxy statement/prospectus').
关于Kintara和TuHURA之间的拟议交易(“拟议交易”),Kintara已向美国证券交易委员会(“SEC”)提交了相关材料,包括表S-4中的登记声明,其中包含Kintara的初步委托书和初步招股说明书(“委托书/招股说明书”)。
This registration statement has not yet been declared effective and Kintara has filed or may file other documents regarding the Proposed Transaction with the SEC. This press release is not a substitute for the registration statement or for any other document that Kintara has filed or may file with the SEC in connection with the Proposed Transaction.
本登记声明尚未宣布生效,Kintara已向或可能向SEC提交了与拟议交易有关的其他文件。本新闻稿不能替代登记声明或Kintara已向或可能向SEC提交的与拟议交易有关的任何其他文件。
KINTARA URGES INVESTORS AND STOCKHOLDERS TO READ THE REGISTRATION STATEMENT, THE PRELIMINARY PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN AND THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT KINTARA, TUHURA, THE PROPOSED TRANSACTION AND RELATED MATTERS.
金塔拉敦促投资者和股东在获得注册声明、初步委托书/招股说明书和向SEC提交的任何其他相关文件以及对这些文件的任何修订或补充时,仔细阅读其全部内容,因为它们包含并且将包含有关金塔拉、图胡拉、拟议交易和相关事项的重要信息。
A definitive proxy statement/prospectus will be sent to Kintara's stockholders once available. Investors and stockholders will be able to obtain free copies of the proxy statement/prospectus and other documents filed by Kintara with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov.
一旦可用,将向金塔拉的股东发送最终的委托书/招股说明书。。
In addition, investors and stockholders should note that Kintara communicates with investors and the public using its website (www.kintara.com), the investor relations website (https://www.kintara.com/investors) where anyone will be able to obtain free copies of the preliminary proxy statement/prospectus and other documents fi.
(https://www.kintara.com/investors)任何人都可以免费获得初步委托书/招股说明书和其他文件的副本。
Participants in the Solicitation
征集参与者
Kintara, TuHURA and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from stockholders in connection with the Proposed Transaction. Information about Kintara's directors and executive officers including a description of their interests in Kintara is included in Kintara's most recent Annual Report on Form 10-K, including any information incorporated therein by reference, as filed with the SEC.
Kintara、TuHURA及其各自的董事和执行官可被视为与拟议交易有关的股东代理人征集活动的参与者。有关Kintara董事和执行官的信息,包括他们在Kintara的权益描述,包含在Kintara最新的年度报告中,格式为10-K,包括通过引用纳入其中的任何信息,并提交给SEC。
Additional information regarding these persons and their interests in the transaction has been and will be included in the preliminary proxy statement/prospectus and other relevant materials filed with the SEC when they become available relating to the Proposed Transaction. These documents can be obtained free of charge from the sources indicated above..
有关这些人及其在交易中的利益的其他信息已经并将在初步委托书/招股说明书和其他与拟议交易相关的材料可用时,包含在提交给SEC的相关材料中。这些文件可以从上述来源免费获得。。
Safe Harbor Statement
安全港声明
This news release contains forward-looking statements that are not historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions.
本新闻稿包含前瞻性陈述,这些陈述并非1995年《私人证券诉讼改革法案》所指的历史事实。前瞻性陈述仅基于我们目前对业务未来、未来计划和战略、预测、预期事件和其他未来状况的信念、期望和假设。
In some cases you can identify these statements by forward-looking words such as 'believe,' 'may,' 'will,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'could,' 'should,' 'would,' 'project,' 'plan,' 'expect,' 'goal,' 'seek,' 'future,' 'likely' or the negative or plural of these words or similar expressions.
在某些情况下,您可以通过前瞻性词语识别这些陈述,例如“相信”、“可能”、“意志”、“估计”、“继续”、“预期”、“打算”、“可能”、“应该”、“会”、“项目”、“计划”、“期望”、“目标”、“寻求”、“未来”、“可能”或这些词语的否定或复数或类似表达。
Examples of such forward-looking statements include but are not limited to express or implied statements regarding Kintara's or TuHURA's management team's expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the Proposed Transaction and the expected effects, perceived benefits or opportunities and related timing with respect thereto, expectations regarding clinical trials and research and development programs, in particular with respect to TuHURA's IFx-Hu2.0 product candidate and its TME modulators development program, and any developments or results in connection therewith; the anticipated timing of the results from those studies and trials; expectations regarding the use of capital resources, including the net proceeds from the financing that closed in connection with the signing of the definitive agreement, and the time period over which the combined company's capital resources will be sufficient to fund its anticipated operations; and the expected trading of the combined company's stock on The Nasdaq Capital M.
此类前瞻性陈述的例子包括但不限于关于Kintara或TuHURA管理团队对未来的期望、希望、信念、意图或策略的明示或暗示陈述,包括但不限于以下陈述:拟议交易和预期效果、感知利益或机会以及相关时间安排、临床试验和研发计划的期望,特别是TuHURA的IFx-Hu2.0候选产品及其TME调节剂开发计划,以及与之相关的任何发展或结果;这些研究和试验结果的预期时间;关于资本资源使用的预期,包括因签署最终协议而结束的融资净收益,以及合并公司的资本资源足以为其预期运营提供资金的时间段;以及合并后公司股票在Nasdaq Capital M的预期交易。
You are cautioned that such statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. The forward-looking statements and other information contained in this news release are made as of the date hereof and Kintara does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.
您需要注意的是,这些声明并不能保证未来的业绩,我们的实际结果可能与前瞻性声明中规定的结果有很大差异。本新闻稿中包含的前瞻性声明和其他信息是在本新闻稿发布之日做出的,Kintara不承担任何义务公开更新或修改任何前瞻性声明或信息,无论是由于新信息、未来事件或其他原因,除非适用证券法有此要求。
Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities..
本协议中的任何内容均不构成出售任何证券的要约或购买任何证券的要约。。
Investor Contacts
投资者联系人
Kintara Therapeutics, Inc.Robert E. HoffmanKintara Therapeuticsrhoffman@kintara.com
金塔拉治疗公司Robert E.HoffmanKintaraTherapeuticsrhoffman@kintara.com
TuHURA Biosciences, Inc.Jenene ThomasJTC Team, LLCtuhura@jtcir.com
TuHURA Biosciences,股份有限公司Jenene ThomasJTC团队,LLCtuhura@jtcir.com
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