附录 99.1

Alpha Tau 公布了来自 Alpha darT 多项临床试验的可靠长期安全性和有效性数据

-在 四项头颈癌或皮肤癌可行性试验中,治疗了81个病变,显示完全缓解率为89%。

-两年局部无复发 存活率为 77%。

-分析还显示 没有3级或更高的急性治疗相关毒性,约有20%的患者出现急性2级毒性。

-治疗 6 个月后,未观察到 2 级或更高 晚期毒性。

耶路撒冷, 2023年8月17日(GLOBE NEWSWIRE)——创新的α放射癌症疗法 Alpha Dart™ 的开发者 Alpha Tau Medical Ltd.(“Alpha Tau” 或 “公司”)(纳斯达克股票代码:DRTS,DRTSW)今天宣布了无法切除、复发或局部晚期头颈部或皮肤肿瘤患者的初步长期安全性和肿瘤 控制结果 在多家国际机构进行的四项前瞻性试验中对Alpha darT进行了治疗。

在 2017年2月至2022年12月期间,在四项前瞻性可行性试验中,71名患者的81个病变接受了Alpha darT治疗,其目标是 评估早期毒性和肿瘤反应结果。随访中位数为14个月(范围:2-51个月)。在89%的治疗病变(n=72)中观察到完全的 反应(CR),10%(n=8)表现出部分反应,还有一名患者无法评估。 两年精算局部无复发存活率 (LRFS) 为 77% [95% 置信区间:63—87]。包括复发性与非复发性 病变、基线肿瘤大小或组织学在内的变量并未影响长期结果。20% 的患者出现了与治疗相关的 急性 2 级毒性(例如皮炎放射治疗、治疗部位局部疼痛或瘙痒),随后 保守治疗可以缓解;没有 3 级或更高的相关急性毒性。该队列中未观察到2级或更高的晚期毒性 ,其定义为在Alpha darT治疗六个月或之后发生的毒性。

Alpha Tau首席执行官Uzi Sofer指出:“我们 很高兴能分享这些关于Alpha darT治疗结果的长期数据。” “我们看到,接受Alpha darT治疗的患者取得了持续令人鼓舞的结果,完全缓解率为89%,没有3级或更高的毒性,这表明患者具有巨大的潜力。”Alpha Tau的首席营销官罗伯特·登博士补充说:“这些 数据回答了Alpha Tau的一个重要问题,即我们所看到的强烈的短期局部反应是否会导致 的长期肿瘤控制。答案是肯定的,2年后的持久肿瘤控制率为77%。我们期待 继续从我们的临床试验中生成更多数据,包括我们的美国关键多中心重启试验(Alpha darT放射疗法复发 SCC治疗)、在加拿大蒙特利尔进行的胰腺癌试验以及其他正在进行或计划即将启动的激动人心的试验。”

耶路撒冷哈达萨医学中心沙雷特肿瘤研究所所长、多项试验的首席研究员阿伦·波波夫策教授评论说:“Alpha darT治疗结果的持续和持续强度充分说明了Alpha darT对各种难以治疗的实体瘤患者的变革潜力。”

关于 Alpha Dart™

Alpha darT(扩散 Alpha-emitters 放射疗法)旨在通过肿瘤内输送浸过镭-224 的放射源,实现对实体瘤 的高效和保形α照射。当镭衰变时,其短暂的女儿会从源头中释放出来 ,并在发射高能量α粒子的同时分散,目的是摧毁肿瘤。由于发出 alpha 的原子只能在很短的距离内扩散 ,因此 Alpha darT 的目标是主要影响肿瘤,并保护肿瘤周围的健康组织。

关于 Alpha Tau Medical Ltd

Alpha Tau 成立于 2016 年 ,是一家以色列医疗器械公司,专注于用于治疗实体瘤的 Alpha dart 的研究、开发和潜在商业化。该技术最初由 特拉维夫大学的 Itzhak Kelson 教授和 Yona Keisari 教授开发。

投资者 关系联系人

IR@alphatau.com

前瞻性 陈述

This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Alpha Tau's current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau's ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau's limited operating history; (iii) Alpha Tau's incurrence of significant losses to date; (iv) Alpha Tau's need for additional funding and ability to raise capital when needed; (v) Alpha Tau's limited experience in medical device discovery and development; (vi) Alpha Tau's dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau's clinical studies to predict final study results; (viii) failure of Alpha Tau's early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau's ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau's Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau's exposure to patent infringement lawsuits; (xii) Alpha Tau's ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq's listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption "Risk Factors" in Alpha Tau's annual report filed on form 20-F with the SEC on March 9, 2023, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau's views as of any date subsequent to the date of this press release.