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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根据纳斯达克上市规则5635(c)(4)报告诱因奖励。
Iovance Biotherapeutics ·  06/21 00:00

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日加拿大新闻社报导——Iovance生物制药公司(NASDAQ:IOVA)(以下简称“Iovance”或“公司”),一家专注于创新、开发和提供新型多克隆肿瘤浸润淋巴细胞(TIL)疗法的生物技术公司,宣布于2024年6月20日(“发放日期”)批准了激励性股票期权拨付,涵盖187,650股Iovance普通股,授予43名新员工(非高管员工)。

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.

该奖励是在Iovance的2021年诱因计划下授予的,该计划于2021年9月22日通过,并于2022年1月12日、2023年3月13日和2024年2月26日进行了修改,根据纳斯达克规则5635(c)(4),由公司的薪酬委员会向Iovance新员工授予股权奖励。本新闻稿中提到的每个股票期权的行使价格为$7.97,即股票授予日期上Iovance普通股的收盘价。每个股票期权在三年期内归属,其中三分之一的股票在员工开始日期(“首次归属日期”)的第一周年纪念日归属,其余股票在接下来的两年内的八个季度内分别归属,在首次归属日期之后的第一个季度开始,前提是员工通过适用的归属日期继续在公司工作。

About Iovance Biotherapeutics, Inc.

Amtagvi及其附带的设计标记,Proleukin,Iovance和IovanceCares是Iovance Biotherapeutics,Inc.或其子公司的商标和注册商标。所有其他商标和注册商标均为其各自所有者的财产。

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.旨在成为全球领先的肿瘤浸润淋巴细胞("TIL")疗法的创新者、开发者和提供者。我们正在通过利用人类免疫系统的能力,识别和摧毁每个患者身上的不同癌细胞,来开创治愈癌症的变革性方法。IovanceTIL平台已经在多个实体瘤方面显示出有希望的临床数据。Iovance的Amtagvi是第一种获得FDA批准用于实体瘤的T细胞疗法。我们致力于细胞疗法的持续创新,包括基因编辑细胞疗法,这些可能会延长和改善癌症患者的生命。欲了解更多信息,请访问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高级副总裁,投资者关系和企业传讯

Forward-Looking Statements

前瞻性声明

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.

本新闻通稿中讨论的某些事项是iovance biotherapeutics公司(以下简称“公司”、“我们”、“我们”或“我们的”)根据1995年《私人诉讼改革法》(PSLRA)解释的“前瞻性声明”。不限于前述,我们在某些情况下可能使用“预测”、“认为”、“潜在”、“继续”、“估计”、“预期”、“计划”、“打算”、“预测”、“指导”、“展望”、“可能”、“可能”、“将”、“应该”或其他表达不确定未来事件或结果的词语,旨在识别前瞻性声明。前瞻性声明基于管理层的经验和对历史趋势、当前情况、预期未来发展和其他认为合适的因素的感知进行假设和评估。本新闻稿中的前瞻性声明是自本新闻稿发布之日起作出的,我们无需承担更新或修订任何此类声明的义务,无论是基于新信息、未来事件还是其他原因。前瞻性声明并不是未来绩效的保证,而且可能面临风险、不确定性和其他因素,其中很多因素超出了我们的控制范围,这些因素可能会导致实际结果、活动水平、绩效、业绩和发展与这些前瞻性声明所表达或暗示的结果、活动水平、绩效、业绩和发展明显不同。可能导致实际结果、发展和业务决策与前瞻性声明明显不同的重要因素在我们提交给美国证券交易委员会的申报文件中的“风险因素”部分中进行了描述,包括我们最新的《年度报告》(表格10-K)和《季度报告》(表格10-Q)。这些重大已知和未知风险和不确定性包括我们的能力成功商业化我们的产品,包括已获得美国食品和药物管理局(“FDA”)批准的Amtagvi以及已获得美国FDA和欧洲药品管理局(“EMA”)批准的Proleukin,EMA或其他非美国监管机构可能不会批准或可能延迟批准我们提交给其的申请,以获得lifileucel在转移性黑色素瘤的营销批准;市场对我们的产品接受程度,包括获得在美国和其他国际市场上的定价和/或支付方报销批准的潜在产品(针对我们的产品候选者)以及这种接受程度是否足以支持我们的产品,包括Amtagvi和Proleukin及其潜在的产品候选人的持续商业化或开发,以及我们是否将在继续推广治疗程序之前获得足够的批准;这可能影响我们的营销策略;未来的竞争或其他市场因素可能会对Amtagvi或Proleukin的商业潜力产生负面影响;关于我们使用第三方制造商或我们自己的设施以制造我们的疗法的能力或无能力,包括我们的能力在这些第三方制造商和我们自己的设施中增加生产能力这可能对我们的商业推出产生负面影响;使用不同制造过程的合作伙伴的临床试验结果可能不会反映在我们赞助的试验中;最近的Proleukin收购成功整合的风险;我们的产品,包括已获得美国FDA批准的Amtagvi和已获得美国FDA和欧洲药品管理局(EMA)批准的Proleukin等,的成功开发或商业化可能不会在产品销售中产生足够的收入,并且我们可能不会在近期或根本不实现盈利;与我们的产品候选者相关的风险,包括已获得美国FDA批准的Amtagvi和已获得美国FDA和欧洲药品管理局(EMA)批准的Proleukin,我们可能需要在反馈FDA、EMA或其他监管机构的反馈下进行额外的临床试验或修改正在进行或计划进行的临床试验;我们的关键研究和队列的临床试验结果以及与FDA、EMA或其他监管机构的会见可能会支持FDA、EMA或其他监管机构的注册研究和随后的批准,包括计划中的单臂2期IOV-LUN-202试验可能无法支持注册;进行中的临床试验或亚组中的预备临床数据,包括正在进行的临床试验或亚组中的有效性和安全性结果,可能未反映在我们正在进行的临床试验或这些试验或先前的试验或亚组的最终分析中或其他先前的试验或亚组中;在FDA和其他监管机构的输入下,可能需要根据我们的试验和队列的审批对其进行调整;防治宫颈癌患者护理变革可能会影响我们在这种适应症中的临床试验;我们可能需要根据美国FDA、EMA或其他监管机构的反馈进行额外的临床试验或修改正在进行或将来的临床试验;我们对我们的临床试验结果的解释或与FDA、EMA或其他监管机构的沟通可能与监管机构的解释或沟通不同;对于正在进行的Amtagvi临床试验,临床数据将不会继续进行或重复进行,或不能为正在进行的或计划中的临床试验支持监管机构的批准或授权更新;未经预期的开支可能会影响我们估计的现金结余和预测,并增加我们的预计资金需求;新冠肺炎大流行的影响;以及其他因素,包括一般经济条件和监管发展,超出了我们的范围。

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
联系方式:Iovance生物制药公司:Sara Pellegrino,IRC高级副总裁,投资者关系和公司传播,650-260-7120 分机264;Jen Saunders,高级总监,投资者关系和公司传播,267-485-3119。Sara.Pellegrino@iovance.comJen Saunders高级董事,投资者关系和企业通信 267-485-3119 Jen.Saunders@iovance.com

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Source: Iovance Biotherapeutics, Inc.

来源:Iovance Biotherapeutics,Inc。

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