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.
加利福尼亚州圣卡洛斯,2024年12月20日(全球新闻网络) -- Iovance Biotherapeutics, Inc. (纳斯达克: IOVA)("Iovance"或"公司")是一家专注于为癌症患者创新、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,今天宣布在2024年12月19日("授予日期"),公司批准向四十八名新的非执行员工授予总计203,980股Iovance普通股的诱导期权。
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.
该奖项是在Iovance的2021年修订和更新的诱导计划下授予的,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、2024年2月26日和2024年11月22日进行了修订和更新,提供了根据纳斯达克上市规则5635(c)(4),由公司的薪酬委员会向Iovance的新员工授予权益奖励。根据本新闻稿提到的每个授予的股票期权,行使价格为7.22美元,这是授予日期Iovance普通股的收盘价。每个股票期权在三年内逐步生效,其中三分之一的股票将在员工入职一年纪念日("第一次生效日期")时生效,其余股票将在接下来的两年内按八个季度分期生效,首个季度从第一次生效日期后的第一个季度开始,前提是员工在适用的生效日期保持继续就业。
About Iovance Biotherapeutics, Inc.
关于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.旨在成为全球创新、开发和提供肿瘤浸润淋巴细胞(TIL)疗法的领导者,致力于为癌症患者提供根治癌症的变革性方法,利用人类免疫系统识别和消灭每位患者不同类型癌细胞的能力。Iovance TIL平台在多个实体肿瘤中显示出有希望的临床数据。Iovance的Amtagvi是首个获得FDA批准用于实体肿瘤适应症的T细胞疗法。我们致力于持续创新细胞疗法,包括基因编辑细胞疗法,旨在延长和改善癌症患者的生命。如需更多信息,请访问。
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及其相关设计标志、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。
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," "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.
本新闻稿中讨论的某些事项是Iovance Biotherapeutics, Inc.(以下简称"公司"、"我们"或"我们的")根据1995年《私人证券诉讼改革法案》("PSLRA")的定义的"前瞻性声明"。在不限制前述内容的情况下,我们在某些情况下可能会使用诸如"预测"、"相信"、"潜在"、"继续"、"估计"、"预期"、"期待"、"计划"、"意图"、"预测"、"指导"、"展望"、"可能"、"可以"、"能够"、"应该"或其他表达未来事件或结果不确定性的词汇,旨在识别前瞻性声明。前瞻性声明基于假设和评估,这些假设和评估是依据管理层的经验以及对历史趋势、当前状况、预期的未来发展和其他被认为适当的因素的看法。本文新闻稿中的前瞻性声明是在本新闻稿日期提出的,我们不承担在新信息、未来事件或其他情况下更新或修订此类声明的责任。前瞻性声明并不是未来表现的保证,且受到风险、不确定性和其他因素的影响,其中许多因素超出我们的控制,这可能导致实际结果、活动水平、表现、成就和发展与这些前瞻性声明所表达或暗示的存在重大不同。可能导致实际结果、发展和业务决策与前瞻性声明存在重大差异的重要因素已在我们提交给美国证券交易委员会的文件中描述,包括我们最近的10-K表格年报和10-Q表格季度报告,并包括但不限于以下已知和未知风险及不确定性:与我们成功商业化我们的产品的能力相关的风险,包括Amtagvi,我们已获得美国食品药品监督管理局("FDA")的批准,以及Proleukin,我们已获得FDA和欧洲药品管理局("EMA")的批准;EMA或其他非美国监管机构可能未能批准或可能延迟批准我们提交的lifileucel在转移性黑色素瘤中的营销授权申请的风险;市场对我们产品的接受程度,包括Amtagvi和Proleukin,以及它们的定价和/或如果获批(在我们产品候选者的情况下)由支付方的报销,是否足以支持我们产品,包括Amtagvi和Proleukin,或产品候选者的持续商业化或开发;未来的竞争或其他市场因素可能对Amtagvi或Proleukin的商业潜力产生不利影响;与我们使用第三方制造商或在我们自己的设施制造我们的疗法的能力或无能为力相关的风险,包括我们在这些第三方制造商和我们自己设施中增加生产能力的能力,可能不利影响我们的商业推广;与合作者使用不同制造过程的临床试验的结果可能无法反映在我们赞助的试验中;最近Proleukin收购的成功整合的风险;我们产品,包括Amtagvi和Proleukin的成功开发或商业化可能无法从产品销售中产生足够的营业收入的风险,我们可能在短期内,或根本无法盈利;与我们成功开发、提交、获得或维持FDA、EMA或其他监管机构的批准、或其他有关我们产品候选者的行动的时机相关的风险;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议可能支持注册研究和随后获得FDA、EMA或其他监管机构的批准的风险,包括计划的单臂2期试验IOV-LUN-202可能无法支持注册的风险;进行中的临床试验或队列的初步和中期临床结果,包括疗效和安全性结果,可能未能反映在我们正在进行的临床试验的最终分析或这些试验中的子群中,或其他以往试验或队列中;可能需要根据FDA和其他监管机构的意见调整我们试验及其队列的入组风险;对宫颈癌患者护理环境的变化可能影响我们在该指示下的临床试验的风险;我们可能被要求根据FDA、EMA或其他监管机构的反馈开展额外的临床试验或修改正在进行或未来的临床试验的风险;我们对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这些监管机构对这些结果或沟通的解释不同的风险(包括我们与FDA关于我们非小细胞肺癌临床试验的先前会议的风险);Amtagvi正在进行的临床试验的临床数据可能在正在进行或计划的临床试验中未继续或重现,或可能不支持监管批准或授权更新的风险;可能意外支出减少我们的现金余额和预测,并增加我们的资本需求估计的风险;我们可能无法确认我们产品的营业收入的风险;Proleukin的收入可能不会继续作为Amtagvi收入的领先指标的风险;我们预期的运营和财务表现的风险,包括我们的财务指导和预测;全球大流行的影响;全球和国内地缘政治因素的影响;以及其他因素,包括我们无法控制的一般经济状况和监管发展。本新闻稿中提供的任何财务指导均假设以下情况:我们制造产品的能力没有重大变化;支付方覆盖没有重大变化;收入确认政策没有重大变化;在本新闻稿覆盖的期间内没有完成的新业务发展交易;以及汇率没有重大波动。
CONTACTS
联系方式
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,铁货
高级副总裁,投资者关系和企业通信
650-260-7120 分机264
Sara.Pellegrino@iovance.com
Jen Saunders
高级董事,投资者关系与企业传讯
267-485-3119
Jen.Saunders@iovance.com