附錄 99.1

Alpha Tau 公佈了來自 Alpha darT 多項臨牀試驗的可靠長期安全性和有效性數據

-在 四項頭頸癌或皮膚癌可行性試驗中,治療了81個病變,顯示完全緩解率為89%。

-兩年局部無復發 存活率為 77%。

-分析還顯示 沒有3級或更高的急性治療相關毒性,約有20%的患者出現急性2級毒性。

-治療 6 個月後,未觀察到 2 級或更高 晚期毒性。

耶路撒冷, 2023年8月17日(GLOBE NEWSWIRE)——創新的α放射癌症療法 Alpha Dart™ 的開發者 Alpha Tau Medical Ltd.(“Alpha Tau” 或 “公司”)(納斯達克股票代碼:DRTS,DRTSW)今天宣佈了無法切除、復發或局部晚期頭頸部或皮膚腫瘤患者的初步長期安全性和腫瘤 控制結果 在多家國際機構進行的四項前瞻性試驗中對Alpha darT進行了治療。

在 2017年2月至2022年12月期間,在四項前瞻性可行性試驗中,71名患者的81個病變接受了Alpha darT治療,其目標是 評估早期毒性和腫瘤反應結果。隨訪中位數為14個月(範圍:2-51個月)。在89%的治療病變(n=72)中觀察到完全的 反應(CR),10%(n=8)表現出部分反應,還有一名患者無法評估。 兩年精算局部無復發存活率 (LRFS) 為 77% [95% 置信區間:63—87]。包括複發性與非複發性 病變、基線腫瘤大小或組織學在內的變量並未影響長期結果。20% 的患者出現了與治療相關的 急性 2 級毒性(例如皮炎放射治療、治療部位局部疼痛或瘙癢),隨後 保守治療可以緩解;沒有 3 級或更高的相關急性毒性。該隊列中未觀察到2級或更高的晚期毒性 ,其定義為在Alpha darT治療六個月或之後發生的毒性。

Alpha Tau首席執行官Uzi Sofer指出:“我們 很高興能分享這些關於Alpha darT治療結果的長期數據。” “我們看到,接受Alpha darT治療的患者取得了持續令人鼓舞的結果,完全緩解率為89%,沒有3級或更高的毒性,這表明患者具有巨大的潛力。”Alpha Tau的首席營銷官羅伯特·登博士補充説:“這些 數據回答了Alpha Tau的一個重要問題,即我們所看到的強烈的短期局部反應是否會導致 的長期腫瘤控制。答案是肯定的,2年後的持久腫瘤控制率為77%。我們期待 繼續從我們的臨牀試驗中生成更多數據,包括我們的美國關鍵多中心重啟試驗(Alpha darT放射療法復發 SCC治療)、在加拿大蒙特利爾進行的胰腺癌試驗以及其他正在進行或計劃即將啟動的激動人心的試驗。”

耶路撒冷哈達薩醫學中心沙雷特腫瘤研究所所長、多項試驗的首席研究員阿倫·波波夫策教授評論説:“Alpha darT治療結果的持續和持續強度充分説明瞭Alpha darT對各種難以治療的實體瘤患者的變革潛力。”

關於 Alpha Dart™

Alpha darT(擴散 Alpha-emitters 放射療法)旨在通過腫瘤內輸送浸過鐳-224 的放射源,實現對實體瘤 的高效和保形α照射。當鐳衰變時,其短暫的女兒會從源頭中釋放出來 ,並在發射高能量α粒子的同時分散,目的是摧毀腫瘤。由於發出 alpha 的原子只能在很短的距離內擴散 ,因此 Alpha darT 的目標是主要影響腫瘤,並保護腫瘤周圍的健康組織。

關於 Alpha Tau Medical Ltd

Alpha Tau 成立於 2016 年 ,是一家以色列醫療器械公司,專注於用於治療實體瘤的 Alpha dart 的研究、開發和潛在商業化。該技術最初由 特拉維夫大學的 Itzhak Kelson 教授和 Yona Keisari 教授開發。

投資者 關係聯繫人

IR@alphatau.com

前瞻性 陳述

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.