Iovance Biotherapeutics Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
Iovance Biotherapeutics Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
SAN CARLOS, Calif., Dec. 20, 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 December 19, 2024 (the "Date of Grant"), the Company approved the grant of inducement stock options covering an aggregate of 203,980 shares of Iovance's common stock to forty-eight new, non-executive employees.
加利福尼亞州聖卡洛斯,2024年12月20日(全球新聞網絡) -- Iovance Biotherapeutics, Inc. (納斯達克: IOVA)("Iovance"或"公司")是一家專注於爲癌症患者創新、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,今天宣佈在2024年12月19日("授予日期"),公司批准向四十八名新的非執行員工授予總計203,980股Iovance普通股的誘導期權。
The awards were granted under Iovance's Amended and Restated 2021 Inducement Plan, which was adopted on September 22, 2021 and amended and restated on January 12, 2022, March 13, 2023, February 26, 2024 and November 22, 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 $7.22, 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.
該獎項是在Iovance的2021年修訂和更新的誘導計劃下授予的,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、2024年2月26日和2024年11月22日進行了修訂和更新,提供了根據納斯達克上市規則5635(c)(4),由公司的薪酬委員會向Iovance的新員工授予權益獎勵。根據本新聞稿提到的每個授予的股票期權,行使價格爲7.22美元,這是授予日期Iovance普通股的收盤價。每個股票期權在三年內逐步生效,其中三分之一的股票將在員工入職一年紀念日("第一次生效日期")時生效,其餘股票將在接下來的兩年內按八個季度分期生效,首個季度從第一次生效日期後的第一個季度開始,前提是員工在適用的生效日期保持繼續就業。
About Iovance Biotherapeutics, Inc.
關於Iovance Biotherapeutics, Inc.
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 .
Iovance Biotherapeutics, Inc.旨在成爲全球創新、開發和提供腫瘤浸潤淋巴細胞(TIL)療法的領導者,致力於爲癌症患者提供根治癌症的變革性方法,利用人類免疫系統識別和消滅每位患者不同類型癌細胞的能力。Iovance TIL平台在多個實體腫瘤中顯示出有希望的臨牀數據。Iovance的Amtagvi是首個獲得FDA批准用於實體腫瘤適應症的T細胞療法。我們致力於持續創新細胞療法,包括基因編輯細胞療法,旨在延長和改善癌症患者的生命。如需更多信息,請訪問。
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.
Amtagvi及其相關設計標誌、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。
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," "can," "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; 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 risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues may not continue to serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global pandemic; the effects of global and domestic geopolitical factors; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates.
本新聞稿中討論的某些事項是Iovance Biotherapeutics, Inc.(以下簡稱"公司"、"我們"或"我們的")根據1995年《私人證券訴訟改革法案》("PSLRA")的定義的"前瞻性聲明"。在不限制前述內容的情況下,我們在某些情況下可能會使用諸如"預測"、"相信"、"潛在"、"繼續"、"估計"、"預期"、"期待"、"計劃"、"意圖"、"預測"、"指導"、"展望"、"可能"、"可以"、"能夠"、"應該"或其他表達未來事件或結果不確定性的詞彙,旨在識別前瞻性聲明。前瞻性聲明基於假設和評估,這些假設和評估是依據管理層的經驗以及對歷史趨勢、當前狀況、預期的未來發展和其他被認爲適當的因素的看法。本文新聞稿中的前瞻性聲明是在本新聞稿日期提出的,我們不承擔在新信息、未來事件或其他情況下更新或修訂此類聲明的責任。前瞻性聲明並不是未來表現的保證,且受到風險、不確定性和其他因素的影響,其中許多因素超出我們的控制,這可能導致實際結果、活動水平、表現、成就和發展與這些前瞻性聲明所表達或暗示的存在重大不同。可能導致實際結果、發展和業務決策與前瞻性聲明存在重大差異的重要因素已在我們提交給美國證券交易委員會的文件中描述,包括我們最近的10-K表格年報和10-Q表格季度報告,幷包括但不限於以下已知和未知風險及不確定性:與我們成功商業化我們的產品的能力相關的風險,包括Amtagvi,我們已獲得美國食品藥品監督管理局("FDA")的批准,以及Proleukin,我們已獲得FDA和歐洲藥品管理局("EMA")的批准;EMA或其他非美國監管機構可能未能批准或可能延遲批准我們提交的lifileucel在轉移性黑色素瘤中的營銷授權申請的風險;市場對我們產品的接受程度,包括Amtagvi和Proleukin,以及它們的定價和/或如果獲批(在我們產品候選者的情況下)由支付方的報銷,是否足以支持我們產品,包括Amtagvi和Proleukin,或產品候選者的持續商業化或開發;未來的競爭或其他市場因素可能對Amtagvi或Proleukin的商業潛力產生不利影響;與我們使用第三方製造商或在我們自己的設施製造我們的療法的能力或無能爲力相關的風險,包括我們在這些第三方製造商和我們自己設施中增加生產能力的能力,可能不利影響我們的商業推廣;與合作者使用不同製造過程的臨牀試驗的結果可能無法反映在我們贊助的試驗中;最近Proleukin收購的成功整合的風險;我們產品,包括Amtagvi和Proleukin的成功開發或商業化可能無法從產品銷售中產生足夠的營業收入的風險,我們可能在短期內,或根本無法盈利;與我們成功開發、提交、獲得或維持FDA、EMA或其他監管機構的批准、或其他有關我們產品候選者的行動的時機相關的風險;我們的關鍵研究和隊列的臨牀試驗結果,以及與FDA、EMA或其他監管機構的會議可能支持註冊研究和隨後獲得FDA、EMA或其他監管機構的批准的風險,包括計劃的單臂2期試驗IOV-LUN-202可能無法支持註冊的風險;進行中的臨牀試驗或隊列的初步和中期臨牀結果,包括療效和安全性結果,可能未能反映在我們正在進行的臨牀試驗的最終分析或這些試驗中的子群中,或其他以往試驗或隊列中;可能需要根據FDA和其他監管機構的意見調整我們試驗及其隊列的入組風險;對宮頸癌患者護理環境的變化可能影響我們在該指示下的臨牀試驗的風險;我們可能被要求根據FDA、EMA或其他監管機構的反饋開展額外的臨牀試驗或修改正在進行或未來的臨牀試驗的風險;我們對臨牀試驗結果的解釋或與FDA、EMA或其他監管機構的溝通可能與這些監管機構對這些結果或溝通的解釋不同的風險(包括我們與FDA關於我們非小細胞肺癌臨牀試驗的先前會議的風險);Amtagvi正在進行的臨牀試驗的臨牀數據可能在正在進行或計劃的臨牀試驗中未繼續或重現,或可能不支持監管批准或授權更新的風險;可能意外支出減少我們的現金餘額和預測,並增加我們的資本需求估計的風險;我們可能無法確認我們產品的營業收入的風險;Proleukin的收入可能不會繼續作爲Amtagvi收入的領先指標的風險;我們預期的運營和財務表現的風險,包括我們的財務指導和預測;全球大流行的影響;全球和國內地緣政治因素的影響;以及其他因素,包括我們無法控制的一般經濟狀況和監管發展。本新聞稿中提供的任何財務指導均假設以下情況:我們製造產品的能力沒有重大變化;支付方覆蓋沒有重大變化;收入確認政策沒有重大變化;在本新聞稿覆蓋的期間內沒有完成的新業務發展交易;以及匯率沒有重大波動。
CONTACTS
聯繫方式
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
Iovance Biotherapeutics公司:
Sara Pellegrino,鐵貨
高級副總裁,投資者關係和企業通信
650-260-7120 分機264
Sara.Pellegrino@iovance.com
Jen Saunders
高級董事,投資者關係與企業傳訊
267-485-3119
Jen.Saunders@iovance.com
譯文內容由第三人軟體翻譯。