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Iovance Biotherapeutics Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Iovance Biotherapeutics Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

iovance biotherapeutics根據納斯達克上市規則5635(c)(4)報告誘因獎勵。
Iovance Biotherapeutics ·  06/21 12:00

SAN CARLOS, Calif., June 21, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the "Company"), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte ("TIL") therapies for patients with cancer, today announced that on June 20, 2024 (the "Date of Grant"), the Company approved the grant of inducement stock options covering an aggregate of 187,650 shares of Iovance's common stock to forty-three new, non-executive employees.

2024年6月21日加拿大新聞社報導——Iovance生物製藥公司(NASDAQ:IOVA)(以下簡稱“Iovance”或“公司”),一家專注於創新、開發和提供新型多克隆腫瘤浸潤淋巴細胞(TIL)療法的生物技術公司,宣佈於2024年6月20日(“發放日期”)批准了激勵性股票期權撥付,涵蓋187,650股Iovance普通股,授予43名新員工(非高管員工)。

The awards were granted under Iovance's 2021 Inducement Plan, which was adopted on September 22, 2021 and amended on January 12, 2022, March 13, 2023, and February 26, 2024 and provides for the granting of equity awards to new employees of Iovance by the Company's compensation committee in accordance with Nasdaq Listing Rule 5635(c)(4). Each of the stock options granted as referenced in this press release has an exercise price of $7.97, the closing price of Iovance's common stock on the Date of Grant. Each stock option vests over a three-year period, with one-third of the shares vesting on the first anniversary of the employee's start date (the "First Vesting Date"), and the remaining shares vesting in eight quarterly installments over the next two years, commencing with the first quarter following the First Vesting Date, subject to continued employment with the Company through the applicable vesting dates.

該獎勵是在Iovance的2021年誘因計劃下授予的,該計劃於2021年9月22日通過,並於2022年1月12日、2023年3月13日和2024年2月26日進行了修改,根據納斯達克規則5635(c)(4),由公司的薪酬委員會向Iovance新員工授予股權獎勵。本新聞稿中提到的每個股票期權的行使價格爲$7.97,即股票授予日期上Iovance普通股的收盤價。每個股票期權在三年期內歸屬,其中三分之一的股票在員工開始日期(“首次歸屬日期”)的第一週年紀念日歸屬,其餘股票在接下來的兩年內的八個季度內分別歸屬,在首次歸屬日期之後的第一個季度開始,前提是員工通過適用的歸屬日期繼續在公司工作。

About Iovance Biotherapeutics, Inc.

Amtagvi及其附帶的設計標記,Proleukin,Iovance和IovanceCares是Iovance Biotherapeutics,Inc.或其子公司的商標和註冊商標。所有其他商標和註冊商標均爲其各自所有者的財產。

Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte ("TIL") therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system's ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance's Amtagvi is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.

iovance biotherapeutics。Iovance Inc.旨在成爲全球領先的腫瘤浸潤淋巴細胞("TIL")療法的創新者、開發者和提供者。我們正在通過利用人類免疫系統的能力,識別和摧毀每個患者身上的不同癌細胞,來開創治癒癌症的變革性方法。IovanceTIL平台已經在多個實體瘤方面顯示出有希望的臨床數據。Iovance的Amtagvi是第一種獲得FDA批准用於實體瘤的T細胞療法。我們致力於細胞療法的持續創新,包括基因編輯細胞療法,這些可能會延長和改善癌症患者的生命。欲了解更多信息,請訪問www.iovance.com。.

Amtagvi and its accompanying design marks, Proleukin, Iovance, and IovanceCares are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

Iovance Biotherapeutics,Inc.:Sara Pellegrino,IRC高級副總裁,投資者關係和企業傳訊

Forward-Looking Statements

前瞻性聲明

Certain matters discussed in this press release are "forward-looking statements" of Iovance Biotherapeutics, Inc. (hereinafter referred to as the "Company," "we," "us," or "our") within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Without limiting the foregoing, we may, in some cases, use terms such as "predicts," "believes," "potential," "continue," "estimates," "anticipates," "expects," "plans," "intends," "forecast," "guidance," "outlook," "may," "could," "might," "will," "should," or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events, or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products, including Amtagvi, for which we have obtained U.S. Food and Drug Administration ("FDA") approval, and Proleukin, for which we have obtained FDA and European Medicines Agency ("EMA") approval; the risk that the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval for our marketing authorization application submission for lifileucel in metastatic melanoma; the acceptance by the market of our products, including Amtagvi and Proleukin, and their potential pricing and/or reimbursement by payors, if approved (in the case of our product candidates), in the U.S. and other international markets and whether such acceptance is sufficient to support continued commercialization or development of our products, including Amtagvi and Proleukin, or product candidates, respectively; the risk whether the number of patients treated and/or ATCs is an appropriate measure of commercial success and/or recognized revenue; future competitive or other market factors may adversely affect the commercial potential for Amtagvi or Proleukin; the risk regarding our ability or inability to manufacture our therapies using third party manufacturers or at our own facility, including our ability to increase manufacturing capacity at such third party manufacturers and our own facility, may adversely affect our commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk regarding the successful integration of the recent Proleukin acquisition; the risk that the successful development or commercialization of our products, including Amtagvi and Proleukin, may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain FDA, EMA, or other regulatory authority approval of, or other action with respect to, our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with the FDA, EMA, or other regulatory authorities may support registrational studies and subsequent approvals by the FDA, EMA, or other regulatory authorities, including the risk that the planned single arm Phase 2 IOV-LUN-202 trial may not support registration; preliminary and interim clinical results, which may include efficacy and safety results from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory agency input; the risk that the changing landscape of care for cervical cancer patients may impact our clinical trials in this indication; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from the FDA, EMA, or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA, EMA, or other regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities (including from our prior meetings with the FDA regarding our non-small cell lung cancer clinical trials); the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the effects of the COVID-19 pandemic; and other factors, including general economic conditions and regulatory developments, not within our control.

本新聞通稿中討論的某些事項是iovance biotherapeutics公司(以下簡稱“公司”、“我們”、“我們”或“我們的”)根據1995年《私人訴訟改革法》(PSLRA)解釋的“前瞻性聲明”。不限於前述,我們在某些情況下可能使用“預測”、“認爲”、“潛在”、“繼續”、“估計”、“預期”、“計劃”、“打算”、“預測”、“指導”、“展望”、“可能”、“可能”、“將”、“應該”或其他表達不確定未來事件或結果的詞語,旨在識別前瞻性聲明。前瞻性聲明基於管理層的經驗和對歷史趨勢、當前情況、預期未來發展和其他認爲合適的因素的感知進行假設和評估。本新聞稿中的前瞻性聲明是自本新聞稿發佈之日起作出的,我們無需承擔更新或修訂任何此類聲明的義務,無論是基於新信息、未來事件還是其他原因。前瞻性聲明並不是未來績效的保證,而且可能面臨風險、不確定性和其他因素,其中很多因素超出了我們的控制範圍,這些因素可能會導致實際結果、活動水平、績效、業績和發展與這些前瞻性聲明所表達或暗示的結果、活動水平、績效、業績和發展明顯不同。可能導致實際結果、發展和業務決策與前瞻性聲明明顯不同的重要因素在我們提交給美國證券交易委員會的申報文件中的“風險因素”部分中進行了描述,包括我們最新的《年度報告》(表格10-K)和《季度報告》(表格10-Q)。這些重大已知和未知風險和不確定性包括我們的能力成功商業化我們的產品,包括已獲得美國食品和藥物管理局(“FDA”)批准的Amtagvi以及已獲得美國FDA和歐洲藥品管理局(“EMA”)批准的Proleukin,EMA或其他非美國監管機構可能不會批准或可能延遲批准我們提交給其的申請,以獲得lifileucel在轉移性黑色素瘤的營銷批准;市場對我們的產品接受程度,包括獲得在美國和其他國際市場上的定價和/或支付方報銷批准的潛在產品(針對我們的產品候選者)以及這種接受程度是否足以支持我們的產品,包括Amtagvi和Proleukin及其潛在的產品候選人的持續商業化或開發,以及我們是否將在繼續推廣治療程序之前獲得足夠的批准;這可能影響我們的營銷策略;未來的競爭或其他市場因素可能會對Amtagvi或Proleukin的商業潛力產生負面影響;關於我們使用第三方製造商或我們自己的設施以製造我們的療法的能力或無能力,包括我們的能力在這些第三方製造商和我們自己的設施中增加生產能力這可能對我們的商業推出產生負面影響;使用不同製造過程的合作伙伴的臨床試驗結果可能不會反映在我們贊助的試驗中;最近的Proleukin收購成功整合的風險;我們的產品,包括已獲得美國FDA批准的Amtagvi和已獲得美國FDA和歐洲藥品管理局(EMA)批准的Proleukin等,的成功開發或商業化可能不會在產品銷售中產生足夠的收入,並且我們可能不會在近期或根本不實現盈利;與我們的產品候選者相關的風險,包括已獲得美國FDA批准的Amtagvi和已獲得美國FDA和歐洲藥品管理局(EMA)批准的Proleukin,我們可能需要在反饋FDA、EMA或其他監管機構的反饋下進行額外的臨床試驗或修改正在進行或計劃進行的臨床試驗;我們的關鍵研究和隊列的臨床試驗結果以及與FDA、EMA或其他監管機構的會見可能會支持FDA、EMA或其他監管機構的註冊研究和隨後的批准,包括計劃中的單臂2期IOV-LUN-202試驗可能無法支持註冊;進行中的臨床試驗或亞組中的預備臨床數據,包括正在進行的臨床試驗或亞組中的有效性和安全性結果,可能未反映在我們正在進行的臨床試驗或這些試驗或先前的試驗或亞組的最終分析中或其他先前的試驗或亞組中;在FDA和其他監管機構的輸入下,可能需要根據我們的試驗和隊列的審批對其進行調整;防治宮頸癌患者護理變革可能會影響我們在這種適應症中的臨床試驗;我們可能需要根據美國FDA、EMA或其他監管機構的反饋進行額外的臨床試驗或修改正在進行或將來的臨床試驗;我們對我們的臨床試驗結果的解釋或與FDA、EMA或其他監管機構的溝通可能與監管機構的解釋或溝通不同;對於正在進行的Amtagvi臨床試驗,臨床數據將不會繼續進行或重複進行,或不能爲正在進行的或計劃中的臨床試驗支持監管機構的批准或授權更新;未經預期的開支可能會影響我們估計的現金結餘和預測,並增加我們的預計資金需求;新冠肺炎大流行的影響;以及其他因素,包括一般經濟條件和監管發展,超出了我們的範圍。

CONTACTS  Iovance Biotherapeutics, Inc: Sara Pellegrino, IRC Senior Vice President, Investor Relations & Corporate Communications 650-260-7120 ext. 264 Sara.Pellegrino@iovance.com  Jen Saunders Senior Director, Investor Relations & Corporate Communications 267-485-3119 Jen.Saunders@iovance.com
聯繫方式:Iovance生物製藥公司:Sara Pellegrino,IRC高級副總裁,投資者關係和公司傳播,650-260-7120 分機264;Jen Saunders,高級總監,投資者關係和公司傳播,267-485-3119。Sara.Pellegrino@iovance.comJen Saunders高級董事,投資者關係和企業通信 267-485-3119 Jen.Saunders@iovance.com

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Source: Iovance Biotherapeutics, Inc.

來源:Iovance Biotherapeutics,Inc。

譯文內容由第三人軟體翻譯。


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