根据美国证券交易法第13或15(d)条规定提交的季度报告 |
根据美国证券交易法第13或15(d)条规定的过渡报告 |
（国家或其他管辖区的 公司成立或组织） |
（IRS雇主 唯一识别号码） | |
，（主要行政办公地址） |
(邮政编码) | |
每一类的名称 |
交易 符号: |
普通股，每股面值$0.001 ANNX | ||
| 大型快速提交者 | ☐ | 快速提交者 | ☐ | |||
非加速 归档人 |
☒ | 更小的报告公司 | ||||
| 成长型公司 | ||||||
目录
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i
前瞻性声明
本报告包含涉及风险和不确定性的前瞻性声明。这些声明涉及未来时期、未来事件或我们未来的经营或财务计划或绩效。在本报告中使用的“预期”、“相信”、“继续”、“可能”、“评估”、“期望”、“打算”、“预测”、“目标”、“可能”、“计划”、“可能”、“潜在”、“预测”、“项目”、“应该”、“寻找”、“建议”、“安排”、“目标”或“将”等类似表达旨在识别前瞻性声明，并包括但不限于：
| • | 我们未来的财务和业务绩效； |
| • | 我们业务和产品候选品的战略计划； |
| • | 我们产品候选品的特性，以及我们开发或商业化能力； |
| • | 我们的管线、产品候选品、VersAptx平台和管理团队的实力； |
| • | 临床试验和非临床研究的预期结果和时间； |
| • | 我们未来的资本需求和可用现金的充足性，包括我们预期的现金储备、这些需求的时间、现金的来源和用途； |
| • | 我们在融资方面的能力和继续作为持续经营的能力; |
| • | 我们调整运营计划支出水平的能力; |
| • | 我们遵守拜耳许可协议条款的能力; |
| • | 我们继续遵守纳斯达克资本市场的持续上市要求的能力; |
| • | 与我们的竞争对手和行业相关的发展和预测； |
| • | 我们期望能够获得、开发和保持知识产权保护，不侵犯他人权利的能力; |
| • | 我们保留关键科学或管理人员的能力; |
| • | 我们预期将在JOBS法案下成为新兴成长型企业的时间； |
| • | 任何已知或未知诉讼和监管程序的结果； |
| • | 我们的业务、扩张计划和机遇；以及 |
| • | 适用法律或法规的变更。 |
这些声明受已知和未知风险、不确定性和假设的影响，可能导致实际结果与前瞻性声明中暗示的或其他情况下暗示的结果有重大差异，包括以下内容：
| • | 与临床前期或临床开发和试验相关的风险； |
| • | 与预期业务和产品开发里程碑的时间相关的风险； |
| • | 我们对未来业务或业务模式的期望所基础的假设发生变化； |
| • | 我们开发、制造和商业化产品候选者的能力； |
| • | 我们对资本和资本需求的需求； |
| • | 我们筹集资本并继续作为一个持续经营公司的能力； |
| • | 一般经济、金融、法律、政治和业务条件以及国内外市场的变化； |
| • | 适用法律法规的变化，包括《2022年通胀减少法》的影响和潜在限制使用外国第三方服务提供商的立法； |
| • | 自然灾害的影响，包括气候变化，以及健康流行病对我们业务的影响； |
| • | 我们产品市场的规模和增长潜力，以及我们在这些市场竞争的能力； |
| • | 我们计划产品的市场接受度； |
1
| • | 其他经济、业务或竞争因素的影响，包括通货膨胀以及乌克兰和以色列的战争影响；和 |
| • | 本报告中“风险因素”部分所列的其他风险和不确定性。 |
鉴于这些风险和不确定性，您不应过分依赖这些前瞻性声明。
前瞻性声明受到一系列可能导致实际结果出现重大差异的风险和不确定性所影响。这些风险和不确定性包括但不限于本报告第二部分第1A项讨论的风险。我们在本报告中做出的这些前瞻性声明仅适用于本报告日期。除非在联邦证券法律规定和证券交易委员会（“SEC”）的规定下必须履行，否则我们明确否认就任何更新或修订本报告中包含的前瞻性声明作出任何公开发布的义务或承诺，以体现我们对相关预期的任何变化或基于该等声明的事件、条件或情况的任何变化。但您应当查阅我们在2024年股东年会的确认代理声明以及截至2023年12月31日的年度报告 10-K 以及形式为季度报告的年报 10-Q, 2023年的《年度报告》（2023年度报告），于2024年3月7日在SEC递交； 8-K 在与SEC提交的年度报告中进行的其他披露。
您应当完整阅读本报告，并理解我们实际未来的结果、活动水平和表现，以及其他事件和情况可能与我们的预期有重大不同。我们通过这些警示性声明对我们所有的前瞻性声明进行限定。
常用术语
除非上下文另有说明，本报告中提到的“公司”，“Vincerx”，“我们”，“我们”，“我们的”等类似术语指的是Vincerx Pharma，Inc. (前身为Vincera Pharma，Inc.之前为LifeSci Acquisition Corp.)及其合并子公司。“LSAC”指的是LifeSci投资公司，在业务组合（如下所定义）完成之前的前身公司。本报告中经常使用的其他术语包括以下内容：
| • | “ADC”指抗体药物复合物。 |
| • | “拜耳许可协议”指2020年10月7日签订的Legacy Vincera Pharma，拜耳股份公司和拜耳知识产权有限责任公司之间的某项许可协议。 |
| • | “BLA”指生物制品许可申请。 |
| • | “BPCIA”指2009年的生物制品定价竞争和创新法案。 |
| • | “业务组合”指合并和Merger协议中描述的其他交易。 |
| • | “章程”指我们的修订和重述章程。 |
| • | “CDK9”表示细胞周期依赖性激酶9。 |
| • | “证明书”指我们的第二份修订和重发证明书，经过修订。 |
| • | “cGMP”表示当前良好生产规范。 |
| • | “普通股”指我们的普通股，每股面值为0.0001美元。 |
| • | “CPT”表示喜树碱。 |
| • | “股份期权”指在业务组合结束后，根据合并协议，遗产持有者可能有资格获得的普通股权利。 |
| • | “交易所法”指的是1934年修订的证券交易法。 |
| • | “FDA”表示美国食品和药物管理局。 |
| • | “GAAP”代表美国通常会计准则。 |
| • | “IND”代表新药研究申请。 |
| • | “JOBS Act”代表2012年创业公司启动促进法案。 |
| • | “KSPi”代表肌动蛋白纺锤体蛋白抑制剂。 |
| • | “Legacy Holders”指的是业务合并前立信制药的股东。 |
2
| • | “Legacy Vincera Pharma”指的是业务组合之前的Vincera Pharma, Inc.，在业务组合之后更名为VNRX Corp。 |
| • | “合并”指的是Merger Sub与Legacy Vincera Pharma合并，Legacy Vincera Pharma作为存续公司并成为LSAC的全资子公司，该合并发生在2020年12月23日。 |
| • | “合并协议”指的是2020年9月25日签署的LSAC、Merger Sub、Legacy Vincera Pharma和Legacy Holders代表Raquel E. Izumi之间的某个合并协议。 |
| • | “Merger Sub”指的是LifeSci Acquisition Merger Sub, Inc.，一家特拉华州公司，也是业务组合时的LSAC全资子公司。 |
| • | “NDA”指的是新药申请。 |
| • | “P-TEFb” “P-TEFb”指的是正转录延伸因子beta。 |
| • | “证券法”指的是1933年修订的证券法。 |
| • | “SMDC”代表小分子药物偶联物。 |
| • | “USPTO”代表美国专利商标局。 |
Vincerx®，Vincerx Pharma®，Vincerx翼标志设计，CellTrapper®，以及VersAptx™ 是我们的商标或注册商标。本报告还可能包含属于其各自所有者的商标和商业名称。
风险因素摘要
我们的业务受到许多风险和不确定性的影响，这些风险和不确定性可能会影响我们成功实施业务策略的能力，并影响我们的财务状况。您应该仔细考虑本报告中的所有信息，尤其是本报告第II部分第1A项“风险因素”中描述的所有主要风险和所有其他特定因素，然后再决定是否投资于我们公司。
| • | 我们依赖于拜耳(adr)许可协议来为我们目前所有产品候选者的核心知识产权提供权利，该协议对我们施加了重大的支付和其他义务。如果我们未能履行拜耳(adr)许可协议下的义务，拜耳(adr)可能有权终止协议或寻求协议下的其他补救措施，而任何对拜耳(adr)许可协议的终止或失去重要权利都将严重影响我们开发和商业化VIP236、VIP943、VIP924、enitociclib、VersAptx平台以及其他融入这些知识产权的产品候选者和技术，筹集资本或继续业务经营。 |
| • | 我们在很大程度上依赖于VIP236、VIP943和enitociclib这些主要产品候选者的成功。如果我们无法及时完成这些主要产品候选者的开发、获得批准并进行商业化，我们的业务将受到损害。 |
| • | 我们在产品候选者开发工作的早期阶段，可能无法成功开发、制造、及时完成临床试验和将产品候选者进行商业化。 |
| • | 我们的长期前景部分取决于发现、开发、制造和商业化额外的产品候选者，这些候选者可能在开发过程中失败或遭遇延迟，从而对其商业可行性产生不利影响。 |
| • | 早期临床试验结果可能无法预测最后阶段或其他临床试验的结果。 |
| • | 我们不时公布或发布的临床试验的中期、"概要"和初步数据可能随着更多患者数据的出现而发生变化，并且必须经过审核和验证程序，这可能导致随后或最终数据发生重大变化。 |
| • | 自成立以来，我们一直出现净亏损，并预计在可预见的将来继续出现重大净亏损，不能保证我们能够筹集资金。 |
| • | 我们需要大量资本来资助我们的业务。如果我们无法在需要时或按可接受的条件筹集到这种资本，我们可能被迫延迟、减少或取消一项或多项研究和药物开发计划或未来的商业化努力，可能无法继续作为一个持续经营的实体。 |
3
| • | 即使获得批准，我们的产品候选者在医生、患者、健康保险支付者及其他医疗社区中的市场接受度未必足够，无法实现商业成功。 |
| • | 如果我们开发的任何产品候选者的市场机会比我们预期的要小，我们的营业收入可能会受到不利影响，我们的业务可能会遭受损失。 |
| • | 我们面临着激烈的竞争，如果我们的竞争对手比我们更快地开发和市场推广技术或产品，或者他们的产品比我们开发的产品更有效、更安全或成本更低，我们的商业机会将受到负面影响。 |
| • | 我们可能会花费有限的资源追求特定的产品候选者、目标或适应症，而未能抓住其他可能更有利可图或成功可能性更大的产品候选者、目标或适应症。 |
| • | 临床试验费用昂贵，耗时长，受到招募和其他延误的影响，并且可能需要持续到我们可用资金之外，我们不能确定是否能获得足够的资金，以成功完成目前处于前临床和临床开发阶段的任何产品候选者的开发、临床试验和商业化，如果它们成功的话。 |
| • | 我们的业务涉及显著的产品责任风险，如果我们无法获得足够的保险覆盖，这种能力的缺乏可能会对我们的业务和前景产生不利影响。 |
| • | 我们开发的任何产品候选者可能会受到不利的第三方覆盖和报销政策的影响，以及定价法规的限制，包括2022年通货膨胀减轻法案下的规定。 |
| • | 作为一家公司，我们处于早期发展阶段，有限的运营历史可能使我们难以评估成功的能力。 |
| • | 拜耳许可证协议要求我们支付重大里程碑和版税款项，其中一些将在我们任何产品候选者商业化之前触发，我们可能无法筹集到足够的资金或进入足够的战略联盟，以在到期时支付这些款项。 |
| • | 我们可能无法获得美国或外国的监管批准，因此可能无法实现我们产品候选者的商业化。 |
| • | 我们当前或未来的产品候选者在单独使用或与其他已批准的产品或正在研究的新药组合使用时，可能导致不良事件、毒性或其他不良副作用，从而影响安全性特征，可能会抑制监管批准，阻碍市场接受，限制其商业潜力，或导致严重的负面后果。 |
| • | 如果我们无法维持纳斯达克资本市场的持续上市要求，我们的普通股可能会被退市，这可能会对我们的普通股流动性和价格、我们进入资本市场的能力以及投资者及其他人的信心产生负面影响。 |
4
项目1。 |
基本报表。 |
9月30日， 2024 |
2023年12月31日， 2023 |
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(未经审计) |
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资产 |
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流动资产： |
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现金及现金等价物 |
$ | $ | ||||||
受限现金 |
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短期市场证券 |
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预付费用 |
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补助应收款 |
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其他流动资产 |
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总流动资产 |
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使用权 |
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物业、厂房和设备，净值 |
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授信应收款 |
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其他资产 |
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资产总额 |
$ |
$ |
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负债和股东权益 |
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流动负债 |
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应付账款 |
$ | $ | ||||||
应计费用 |
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租赁负债 |
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普通股认股权负债 |
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流动负债合计 |
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租赁负债，扣除流动部分后净值 |
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其他非流动负债 |
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总负债 |
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承诺和风险－注释6 |
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股东权益 |
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优先股，$0.0001 |
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普通股，每股面值为 $0.0001； |
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附加 实收资本 资本金 |
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累计其他综合收益 |
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累积赤字 |
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股东权益总额 |
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负债和股东权益总额 |
$ |
$ |
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三个月截至 9月30号, |
截至九个月结束 9月30日 |
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2023 |
2024 |
2023 |
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| 营业费用： |
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| 权证负债公允价值变动 |
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| 利息收入 |
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| 净损失 |
$ |
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$ |
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$ |
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| 其他综合收益: |
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| 净外汇翻译收益（损失） |
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| 未实现的市场证券净收益 |
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| 综合损失 |
$ |
( |
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$ |
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$ |
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| 普通股每股净亏损，基本和稀释 |
$ | ( |
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截至2024年9月30日止三个月 |
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普通股 |
额外 实收资本 |
已累积其它综合损益 综合 累多了的 |
累积赤字 赤字 |
股东权益总计 股东的 股本 |
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股份 |
金额 |
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| 截至2024年7月1日的结余 |
$ |
$ |
$ |
$ |
( |
) |
$ |
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| 股票发行与行使权证相关。 预先资助认股权证发行的所有证券（合共称为「证券」）所产出的美国联邦所得税影响摘要，但不构成所有潜在税务影响的完整分析。其他美国联邦税法（例如遗产和赠与税法）和任何适用的州、地方或其他税法都未被讨论。此讨论基于1986年修订版的美国内部税收法（「法典」）、据此制定的财政部税务法规、司法判决以及发布的美国国内税收局行政宣告，以上所有均有效至此处日期。这些法律可能会发生变化或被解释成不同的方式，任何此类变化或解释可能会以可能不利于持有证券的人的方式追溯适用。我们对以下事项未寻求任何美国国内税收局的裁决，也不会寻求：购买、持有和处分我们的证券的税务影响，且无法保证美国国内税收局或法院不会对所讨论的购买、持有和处分我们的证券的税务影响持有相反立场。 认股权证 |
— | — | — | — | — | |||||||||||||||||||
| 以股票形式发放的酬劳 |
— | — | — | — | ||||||||||||||||||||
| 累积翻译调整 |
— | — | — | — | ||||||||||||||||||||
| 持有有价证券未实现之利益 |
— | — | — | — | ||||||||||||||||||||
| 净亏损 |
— | — | — |
— | ( |
) | ( |
) | ||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| 2024年9月30日的结余 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
截至2024年9月30日止九个月 |
||||||||||||||||||||||||
普通股 |
其他 资本总额 资本 |
其他累计 综合 收入 |
累积 赤字 |
总计 股东 普通股 |
||||||||||||||||||||
股份 |
金额 |
|||||||||||||||||||||||
| 2024年1月1日的余额 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||
| 发行普通 预先资助的 来自公开发行的认股证和普通股，扣除$的佣金和费用 |
— |
— |
||||||||||||||||||||||
| 发行普通股以配合 市价配售股权业务 |
— | — |
— |
|||||||||||||||||||||
| 发行普通股，与行使其
相关的 预先资助 warrants |
— | — | — | — | — | |||||||||||||||||||
| 由员工股票计划发行普通股 |
— | — | — | |||||||||||||||||||||
| 以股份为基础的补偿 |
— | — | — | — | ||||||||||||||||||||
| 累积翻译调整 |
— | — | — | — | ||||||||||||||||||||
| 有价证券未实现收益 |
— | — | — | — | ||||||||||||||||||||
| 净亏损 |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| 截至2024年9月30日的结余 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
截至2023年9月30日三个月结束 |
||||||||||||||||||||||||
普通股 |
其他 Paid-in Capital |
Accumulated Other Comprehensive Income |
Accumulated Deficit |
Total 股东权益 股本 |
||||||||||||||||||||
股份 |
金额 |
|||||||||||||||||||||||
| 于2023年7月1日的结余 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||
| 股份报酬 |
— |
— |
— |
— |
||||||||||||||||||||
| 累计换算损益 |
— |
— |
— |
( |
) | — |
( |
) | ||||||||||||||||
| 有价证券未实现利益 |
— |
— |
— |
— |
||||||||||||||||||||
| 净亏损 |
— |
— |
— |
— |
( |
) | ( |
) | ||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| 2023年9月30日的余额 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
截至2023年9月30日止的九个月 |
||||||||||||||||||||||||
普通股 |
额外的 已实收资本 资本 |
累积其他 综合 收入（损失） |
累计 赤字 |
总计 股东权益 股本 |
||||||||||||||||||||
股份 |
金额 |
|||||||||||||||||||||||
| 2023年1月1日结余 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
|||||||||||||||
| 员工股票计划发行普通股 |
— | — | — | |||||||||||||||||||||
| 基于股票的酬劳 |
— | — | — | — | ||||||||||||||||||||
| 累积翻译调整 |
— | — | — | — | ||||||||||||||||||||
| 有价证券未实现利得 |
— | — | — | — | ||||||||||||||||||||
| 净亏损 |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| 截至2023年9月30日的结余 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
截至九个月结束 九月三十日 |
||||||||
2024 |
2023 |
|||||||
来自经营活动的现金流量 |
||||||||
净亏损 |
$ | ( |
) | $ | ( |
) | ||
调整为使净亏损转化为经营活动所使用现金： |
||||||||
折旧 |
||||||||
以股份为基础的补偿 |
||||||||
Amortization of摊销金额： 使用权利 |
||||||||
认股权证负债公平价值变动 |
( |
) | ||||||
市场证券折让的净摊销 |
( |
) | ( |
) | ||||
营运资产和负债的变化： |
||||||||
预付及其他流动资产 |
||||||||
应收补助款 |
||||||||
其他资产 |
( |
) | ( |
) | ||||
应付帐款 |
( |
) | ( |
) | ||||
应计费用 |
( |
) | ||||||
租赁负债 |
( |
) | ( |
) | ||||
经营活动所用的净现金 |
( |
) | ( |
) | ||||
投资活动之现金流量: |
||||||||
可销售证券的购入 |
( |
) | ( |
) | ||||
有价证券的销售和到期 |
||||||||
投资活动所提供（使用）的净现金 |
( |
) | ||||||
来自筹资活动的现金流量: |
||||||||
来自员工股票计划发行普通股的收益 |
||||||||
来自公开发售的收益，扣除交易成本 |
||||||||
来自 市价配售股权业务 |
||||||||
筹资活动提供的净现金 |
||||||||
汇率变动对现金、现金等价物和受限现金的影响 |
||||||||
现金、现金等价物和受限制现金的总体减少 |
( |
) | ||||||
期初的现金、现金等价物和受限现金 |
||||||||
期末现金、现金等价物和受限现金 |
$ |
$ |
||||||
现金及现金等价物 |
$ |
|||
受限制的现金 |
||||
总计 |
$ |
|||
截至2024年9月30日的公平价值测量 |
||||||||||||||||
级别 1 |
级别 2 |
第3级 |
总计 |
|||||||||||||
资产： |
||||||||||||||||
现金等价物： |
||||||||||||||||
货币市场基金 |
$ | $ | $ | $ | ||||||||||||
短期可市场证券： |
||||||||||||||||
美国政府债务券 |
||||||||||||||||
美国政府机构证券 |
||||||||||||||||
现金及可供出售金融资产总额 |
$ | $ | $ | $ | ||||||||||||
截至2023年12月31日的公允价值测量 |
||||||||||||||||
级别 1 |
级别 2 |
第3级 |
总计 |
|||||||||||||
资产： |
||||||||||||||||
现金等价物： |
||||||||||||||||
货币市场基金 |
$ | $ | $ | $ | ||||||||||||
美国政府债务券 |
||||||||||||||||
美国政府机构证券 |
||||||||||||||||
现金等价物总额 |
$ | $ | $ | $ | ||||||||||||
截至2024年9月30日的公允价值测量 |
||||||||||||||||
级别 1 |
级别 2 |
第3级 |
总计 |
|||||||||||||
负债： |
||||||||||||||||
传承私募 warrants 负债 |
$ | $ | $ | $ | ||||||||||||
总公平价值 |
$ | $ | $ | $ | ||||||||||||
截至2023年12月31日的公允价值测量 |
||||||||||||||||
级别 1 |
级别 2 |
第3级 |
总计 |
|||||||||||||
负债： |
||||||||||||||||
传承私募 warrants 负债 |
$ | $ | $ | $ | ||||||||||||
总公平价值 |
$ | $ | $ | $ | ||||||||||||
权证 负债 |
||||
账目余额－2024年1月1日 |
$ |
|||
在公允价值内 |
||||
余额 – 2024年9月30日 |
$ |
|||
截至 2024年9月30日 |
截至 2023年12月31日 |
|||||||
| 股票价格 |
$ | $ | ||||||
| 行使价格 |
$ | $ | ||||||
| 期限（年） |
||||||||
| 波动性 (年度) |
% | % | ||||||
| 无风险利率 |
% | % | ||||||
| 股息收益率 (每股) |
% | % | ||||||
2024年9月30日 |
||||||||||||||||
摊销成本 |
未能体现的总额 收益 |
毛 未实现亏损 |
公平价值 |
|||||||||||||
| 资产： |
||||||||||||||||
| 短期可市场证券： |
||||||||||||||||
| 美国政府债务券 |
$ | $ | $ | $ | ||||||||||||
| 美国政府机构证券 |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 所有有价证券总值 |
$ | $ | $ | $ | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 截至三个月的期间 | 截至九个月结束 | |||||||||||||||
| 2024年9月30日 | 2023年9月30日 | 2024年9月30日 | 2023年9月30日 | |||||||||||||
| 租赁成本 |
||||||||||||||||
| 营运租赁成本 |
$ | $ | $ | $ | ||||||||||||
| 变量租赁成本 |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 总营运租赁费用 |
$ | $ | $ | $ | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 其他资讯 |
||||||||||||||||
| 来自经营租赁的营运现金流量 |
$ | $ | $ | $ | ||||||||||||
| 租赁权 |
$ | $ | $ | $ | ||||||||||||
| 加权平均剩余租期-营运租赁 |
||||||||||||||||
| 营运租赁的加权平均折扣率 |
% | % | % | % | ||||||||||||
| 剩余期至2024年12月31日 |
$ | |||
| 截至2025年12月31日的年度 |
||||
| 2026年12月31日结束的年度 |
||||
| |
|
|||
| 总计 |
||||
| 现值折现较少 |
( |
) | ||
| |
|
|||
| 2024年9月30日的简明综合账册中包括的运营租赁负债 |
$ | |||
| |
|
股份数量 |
加权平均 授予日期公允 每股价值 |
|||||||
| 截至2024年1月1日的非归属 |
$ |
|||||||
| 已生效 |
( |
) | ||||||
| |
|
|
|
|||||
| 截至2024年3月31日的非归属 |
$ |
|||||||
| 已归属 |
( |
) | ||||||
| |
|
|
|
|||||
| 截至2024年6月30日和9月30日未归属 |
$ |
|||||||
| |
|
|
|
|||||
股份数量 |
加权平均 授予日期公平 每股价值 |
|||||||
| 截至2023年1月1日未归属 |
$ |
|||||||
| 已归属 |
( |
) | ||||||
| |
|
|
|
|||||
| 截至2023年3月31日未完全授予 |
||||||||
| 已授予 |
( |
) | ||||||
| |
|
|
|
|||||
| 截至2023年6月30日未完全授予 |
$ |
|||||||
| 已授予 |
( |
) | ||||||
| |
|
|
|
|||||
| 截至2023年9月30日未完全授予 |
$ |
|||||||
| |
|
|
|
|||||
期权股票 |
加权平均 行使价 |
加权 平均 剩余 合约期限 （以年计） |
总计 内在的 价值 |
|||||||||||||
| 2024年1月1日未对外发行的股份数量 |
$ | $ | ||||||||||||||
| 期权授予 |
— | — | ||||||||||||||
| 行使期权 |
( |
) | — | — | ||||||||||||
| 期权取消 |
( |
) | — | — | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 至2024年9月30日止，杰出款项 |
$ | $ | ||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 期权于2024年9月30日生效并可行使 |
$ | $ | ||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
截至9个月 截至9月30日 |
||||||||
2024 |
2023 |
|||||||
行使价格 |
$ | $ | ||||||
预期期限（年） |
||||||||
波动性（年度） |
% | % | ||||||
无风险利率 |
% | % | ||||||
股息率（每股） |
% | % | ||||||
受限股 单位 |
加权平均 购买价格 |
加权 平均 剩余 合约人寿 （以年计） |
总计 内在的 价值 |
|||||||||||||
2024年1月1日未对外发行的股份数量 |
$ | — | $ | — | ||||||||||||
授予 |
— | — | ||||||||||||||
已发行股票 |
— | — | ||||||||||||||
已取消 |
— | — | ||||||||||||||
至2024年9月30日止，杰出款项 |
$ | $ | ||||||||||||||
| 截至2024年9月30日的三个月 | 截至九个月结束时 | |||||||||||||||
| 2024年9月30日 | 2023年9月30日 | 2024年9月30日 | 2023年9月30日 | |||||||||||||
研究与开发 |
$ | $ | $ | $ | ||||||||||||
一般及行政 |
||||||||||||||||
总股份补偿费用 |
$ |
$ |
$ |
$ |
||||||||||||
| 截至三个月的期间 九月三十日 |
截至九个月结束 九月30日， |
|||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
分子: |
||||||||||||||||
净亏损 |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
分母: |
||||||||||||||||
基本和稀释后每股平均股份 |
||||||||||||||||
每股普通股基本和稀释净亏损 |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
For the three and nine months ended September 30, |
||||||||
2024 |
2023 |
|||||||
期权持有量 |
||||||||
限制性股票单位 |
||||||||
认股权证 |
||||||||
限制性股票 |
||||||||
总计 |
||||||||
| 项目二。 | 管理层对财务状况和营运结果的讨论和分析。 |
以下讨论，应与管理层对财务状况及经营业绩的讨论及分析，以及截至 2023 年 12 月 31 日止年度之经审核合并财务报表及附注，并连同阅读本公司表格年报 10-K 截至二零二三年十二月三十一日止年度，并附于本报告其他地方的未经审核简结合并财务报表及其附注。以下讨论和分析中包含的某些信息包括涉及风险和不确定性的前瞻性声明。
概述
我们是一家临床阶段生物制药公司，专注于利用我们广泛的开发和肿瘤科专业知识，以推进旨在满足癌症治疗未满足的医疗需求的新疗法。我们目前的管道完全源于拜耳许可协议，根据该协议，我们已根据某些拜耳专利获得独家、具有特许版权的全球授权和 专业知识 开发、使用、制造、商业化、转授权和分发 (i) 一个生物结合平台，其中包括下一代抗体-药物联合物和小分子药物联合物，以及 (ii) 一个小分子药物计划，包括 P-TEFB 抑制剂化合物。我们打算使用这些候选产品以针对患者特定的针对性方法治疗各种癌症。我们相信，这些候选产品与目前针对类似癌症生物学的目的计划有所区别，如果获得批准，可能会改善癌症患者的临床结果。
尽管针对性治疗方面取得了几十年的进展，但根据国家卫生统计中心，癌症仍然是美国人口中第二大死亡原因。癌症不是一种单一疾病，而是一种疾病星座，每种疾病都需要一种独特的方法来击败它。我们的愿景是通过多种针对性药物管道来解决癌症患者未满足的医疗需求。我们的生物结合平台包括 VIP943 和 VIP924，这些化合物是新一代 ADC 化合物，解决已知和新型肿瘤学目标，我们相信可以提供比目前 ADC 化合物更高的安全性和有效性。我们的生物结合计划还包括用于固体肿瘤的 SMDC VIP236。我们的小分子药物计划包括 enitociclib，这是一种高度选择性的临床阶段 P-TEFB/CDK9 抑制剂。除了我们的主要产品之外，我们还获得其他仍处于临床前阶段的产品候选产品的权利。
与拜耳的授权合约
在业务合并完成后，我们根据拜尔授权协议支付了 5,000 万美元的预先授权费。此外，我们将负责向拜耳进行重大开发和商业里程碑付款，以及持续商业销售的版权费用。请参阅下面的「流动性和资本资源」下的讨论。
演示基础
我们目前通过一个营运部门进行业务。作为 前收入 公司没有任何商业营运，我们迄今为止的活动为有限，主要在美国进行。我们的历史结果按 GAAP 和美元报告。
营运结果的组成部分
我们是一家研究和开发阶段的公司，因为可能难以预测的原因，我们的历史结果可能不代表我们未来的结果。因此，我们未来财务业绩的驱动因素，以及该等业绩的组成部分，可能无法与我们的历史营运业绩相比。
收入
到目前为止，我们尚未记录任何来源（包括产品销售）的任何收入，并且我们不预期在可预见的将来从产品销售中产生任何收入。如果我们针对我们的产品候选人的开发工作成功，并且导致监管机构批准，或与第三方签订授权协议，我们将来可能会从产品销售中获得收入。但是，我们无法确保我们何时会产生这样的收入（如果有）。
研发费用
研究和开发费用包括或将包括我们的产品候选产品的临床开发和发现工作（包括进行临床前研究）、制造开发工作、准备和进行临床试验，以及与我们产品候选人的监管申报有关的活动。研究开发费用被记录为已发生的费用，而在收到用于研究和开发的商品或服务之前所支付的款项，将资本化直到收到商品或服务为止。透过资产购买获得技术许可证所产生的费用，须支付研究和
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如果授权的科技尚未达到技术可行性且没有其他未来用途，则开发费用会计入。研究和开发费用包括或可能包括：
| • | 与员工相关的费用，包括工资、奖金、福利、股票基础补偿以及参与研究和开发工作的员工的其他相关成本； |
| • | 根据与临床研究机构、调查地点和顾问签订的协议所产生的外部研究和开发费用，以进行我们的临床前研究； |
| • | 与临床前研究和临床试验的材料制造相关的成本，包括支付给合同制造组织的费用； |
| • | 实验室用品和研究材料； |
| • | 与遵循法规要求相关的成本；以及 |
| • | 设施、折旧和其他分配费用，包括租金、设施维护、保险和设备的直接和分配费用。 |
研究和开发活动是我们业务模型的核心。产品候选者在临床开发的后期阶段通常比早期阶段的开发成本更高，主要是因为后期临床试验的规模和持续时间增加。根据我们获取额外资本的能力，我们预计未来我们的研究和开发费用将会增加，因为我们继续开发产品候选者和制造过程，并进行临床前和临床项目的探索和研究活动。由于临床前和临床开发的本质不可预测，我们无法确定我们的产品候选者的当前或未来临床前研究和临床试验的启动时间、持续时间或完成成本。临床和临床前开发时间表、成功的概率和开发成本可能与预期有实质性的差异。我们预计，将根据持续和未来临床前研究和临床试验的结果、法规发展以及我们对每个产品候选者商业潜力的持续评估，不断判断哪些产品候选者应该追求以及要对每个产品候选者投入多少资金。我们的临床开发成本预计将在我们启动、继续和扩展临床试验时大幅增加。我们的未来费用可能因为以下因素而在每个时期有显著变化：
| • | 为了将我们的产品候选者推进临床试验而进行的前期研究所产生的费用，包括通胀、乌克兰和以色列的战争、供应链中断以及健康疫情和流行病等因素的影响； |
| • | 每位患者的临床试验成本，包括根据患者接受的剂量数以及组合疗法的药物产品成本； |
| • | 每个临床试验中注册的患者人数； |
| • | 批准所需的临床试验数量； |
| • | 临床试验中包含的场地数量； |
| • | 进行临床试验的国家； |
| • | 招募符合资格患者所需的时间长度； |
| • | 该 脱落 或患者中断率； |
| • | 监管机构要求进行潜在的额外安全监控； |
| • | 患者参与临床试验的时间及 后续跟进； |
| • | 产品候选品的开发阶段； |
| • | 第三方承包商未能符合监管要求或按时履行其对我们的合约义务，或者根本未履行； |
| • | 与临床试验有关的保险成本，包括产品责任保险； |
| • | 监管机构或机构审查委员会要求我们或我们的研究者因各种原因暂停或终止临床开发，包括不符合监管要求或发现参与者面临不可接受的健康风险；以及 |
| • | 我们产品候选的疗效和安全性概况。 |
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一般及行政费用
一般及行政费用主要由高层和行政人员的薪资及相关成本组成，包括基于股票的补偿、差旅费用及招聘费用。其他一般及行政费用包括法律、会计及专业服务的费用与保险成本。 与税务有关 保险成本。
根据我们获取额外资本的能力，我们预期未来一般及行政费用将随著扩展我们的营运及制造行业以支持我们产品候选者的临床前研究和临床试验的启动、持续和扩展而增加。我们也预期由于会计、审计、法律及咨询服务的支付，以及维持遵守纳斯达克上市规则和美国证券交易委员会要求、董事及高级职员责任保险、投资者和公众关系活动及作为一家上市公司运营的其他费用，我们的一般及行政费用将增加。
拆改权证负债的公平价值变动
我们的某些私人warrants根据ASC的规定被分类为负债。 815-40, 衍生品及对冲 – 在实体自身股权中的合约。warrant负债的公允价值变动包括这些私人warrant的公允价值变动。
营运成果结果
2024年和2023年截至9月30日的三个月比较
以下表格列出了我们在指定期间的历史营业结果（金额以千计）：
| 截至三个月的期间 九月三十日， |
截至九个月结束 9月30日， |
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| 2024 | 2023 | 金额变动 | 2024 | 2023 | 金额变动 | |||||||||||||||||||
| 营业费用： |
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| 一般及行政 |
$ | 3,885 | $ | 3,508 | $ | 377 | $ | 10,419 | $ | 11,816 | $ | (1,397 | ) | |||||||||||
| 研究与开发 |
3,908 | 6,101 | (2,193 | ) | 12,218 | 25,260 | (13,042 | ) | ||||||||||||||||
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| 营业费用总额 |
7,793 | 9,609 | (1,816 | ) | 22,637 | 37,076 | (14,439 | ) | ||||||||||||||||
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| 营业损失 |
(7,793 | ) | (9,609 | ) | 1,816 | (22,637 | ) | (37,076 | ) | 14,439 | ||||||||||||||
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| 其他收益（费用） |
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| 认股权证负债公平价值变动 |
(331 | ) | 112 | (443 | ) | (272 | ) | 12 | (284 | ) | ||||||||||||||
| 利息收入 |
154 | 260 | (106 | ) | 410 | 1,053 | (643 | ) | ||||||||||||||||
| 其他收入（费用） |
127 | 230 | (103 | ) | 419 | 804 | (385 | ) | ||||||||||||||||
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| 其他收入（支出）总计 |
(50 | ) | 602 | (652 | ) | 557 | 1,869 | (1,312 | ) | |||||||||||||||
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| 净亏损 |
$ | (7,843 | ) | $ | (9,007 | ) | $ | 1,164 | $ | (22,080 | ) | $ | (35,207 | ) | $ | 13,127 | ||||||||
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研究与开发
截至2024年9月30日的三个月和九个月内，研究与开发费用分别减少约220万美元和1300万美元，与截至2023年9月30日的三个月和九个月相比。2024年9月30日的三个月与2023年相同期间相比的减少主要是因为研究服务减少约240万美元和人员相关费用减少约80万美元，部分被临床相关费用约90万美元的增加所抵销。2024年9月30日的九个月与2023年相同期间相比的减少主要是由于研究服务减少约680万美元、与我们的ADC计划相关的制造服务减少约440万美元，以及人员相关费用减少约210万美元，部分被临床相关费用约130万美元的增加所抵销。
一般行政
一般及行政费用在截至2024年9月30日的三个月和九个月，分别增加约30万美元和减少约140万美元，相较于截至2023年9月30日的三个月和九个月。2024年9月30日的三个月相比于2023年同时期的增加主要是由于专业服务增加了50万美元，部分抵消了个人相关费用减少10万美元。2024年9月30日的九个月相比于2023年同时期的减少主要是由于个人相关费用减少约70万美元及设施和其他公司间接费用减少约50万美元。
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拆改权证负债的公平价值变动
截至2024年9月30日的三个月内，warrants负债的公允价值变动主要是由于我们普通股的波动性增加。对于截至2023年9月30日的三个月和九个月，股价变动微不足道。
利息收入
利息收入主要由现金、现金等价物及可交易证券的利息收入和实现的收益或损失组成。2024年9月30日的三个月内利息收入从2023年9月30日的30万美元减少到20万美元，九个月内的利息收入从110万美元减少到40万美元，这是由于我们的现金等价物和可交易证券投资组合的减少。
其他收入（费用）
其他收入（支出）主要包括截至2024年9月30日的三个月和九个月的估计补助收入，分别约为10万美元和40万美元，这些收入与我们在德国子公司进行的研究活动有关，部分被与某些与欧洲第三方厂商之间的外币交易收益和损失抵消。
流动性和资本资源
到目前为止，我们尚未从任何来源产生任何营业收入，包括已批准药品的商业销售，我们也不期望在可预见的未来中产生营业收入。如果我们未能及时完成产品候选的开发或未能获得其监管批准，我们产生未来营业收入的能力将受到不利影响。我们不知道何时，或是否，我们将从我们的产品候选中产生任何营业收入，并且我们不期望在获得我们的产品候选的监管批准并实现商业化之前产生营业收入。
我们预期2024年的营业费用将与2023年相当，但需依赖额外资本的筹集。我们打算优先配置资源，以推进VIP943的第一阶段研究，并在其他领域控制支出，包括可裁减支出。我们相信可以根据未来临床试验的时间安排来调整我们的营运计划支出水平，这取决于完成这些试验所需的充足资金。我们定期评估我们临床开发计划的状态以及潜在的策略选项。
我们还将负责根据Bayer许可协议向Bayer支付大量款项。我们在业务合并完成后，向Bayer支付了500万美元的预付许可费。此外，根据Bayer许可协议，我们还需要向Bayer支付在某些开发和商业销售里程碑达成后的重大未来或有性付款，以及基于净商业销售的持续特许权使用费。这些里程碑付款的大小和时间将因特定许可产品、是否涉及许可的产品或生物结合许可产品（以及哪个生物结合计划）、特定病症指标的数量、与达成里程碑相关的不同国家数量、净商业销售等因素而有很大的变化，因此难以估算未来需要向Bayer支付的总款项及其到期时间。 P-TEFb 如果我们为每个国家和疾病指标达成所有里程碑，我们将有义务支付的开发和商业里程碑付款将在每个授权产品范围内从1.1亿美元到高达3.18亿美元，并且在至少五个授权产品成功商业化后，我们可能需要支付的总里程碑付款将超过10亿美元。在我们能够从任何产品候选者的商业销售中产生足够的营业收入之前，我们需要向Bayer支付其中某些里程碑付款。除了里程碑付款之外，我们还需要根据Bayer许可协议向Bayer支付基于净商业销售的授权产品的一位数到低双位数百分比范围的持续特许权使用费。
因此，我们预计在持续营运方面将需要相当可观的额外资金。截至2024年9月30日，我们拥有约1010万美元的现金、现金等价物和可供出售证券。2024年4月，我们透过出售普通股筹集了1690万美元，扣除约90万美元的佣金、承销折扣和发行费用， 预先资助的 warrants及相关的warrants。我们打算将资本资源投入到我们的产品候选者的临床前和临床开发、公开公司的合规成本以及根据拜耳许可协议的某些里程碑付款。根据我们当前的业务计划和假设，我们相信我们现有的现金及现金等价物将使我们能够在2025年初资助我们的营业费用和资本需求。我们对于我们的资本能够资助营业费用和资本需求的预期时间估算，是基于可能会被证明错误的计划和假设，我们可能会比目前预期的更早使用可用的资本资源。变化的情况，其中一些可能超出我们的控制，可能导致可用的现金减少或使我们比目前预计的更快消耗资本，我们可能需要或选择更早寻求额外的基金。
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由于与我们的产品候选者的研究、开发、制造、临床试验和商业化相关的诸多风险和不确定性，我们无法估计我们的运营资本需求的确切金额。我们未来的资金需求将取决于许多因素，包括但不限于：
| • | 我们开发的程度， 收购、 或获取其他产品候选者和技术， |
| • | 与我们的产品候选者和其他项目相关的研究活动、临床试验、工艺开发和制造的成本和时间 扩大规模 活动，随着我们将它们推进到临床前和临床开发阶段； |
| • | 我们可能追求的产品候选者的数量和开发要求； |
| • | 我们产品候选者的监管审查的成本、时间和结果； |
| • | 根据拜耳许可协议，我们对拜耳的里程碑付款的时间和金额； |
| • | 我们能够进入的合作或其他协议的程度，以提供额外的资本资源； |
| • | 在我们扩大研究和开发能力以及建立和扩展我们的商业基础设施和运营方面的人员和相关成本； |
| • | 对于我们获得市场批准的任何产品候选品，包括产品制造、营销、销售和分销等未来商业化活动的成本和时间安排； |
| • | 根据拜耳许可协议向拜耳支付的特许权使用费； |
| • | 准备、提交和起诉专利申请的成本和时间，维护和执行我们的知识产权，以及捍卫任何与知识产权相关的索赔； |
| • | 从我们获得市场批准的产品候选者的商业销售中获得的营业收入（如有）； |
| • | 作为一家上市公司的运营成本。 |
识别潜在的产品候选者并进行前临床研究和临床试验是一个耗时、昂贵且不确定的过程，完成这一过程需要许多年，而我们可能永远无法生成获得市场批准和实现产品销售所需的数据或结果。此外，如果我们的产品候选者获得批准，可能也不会取得商业成功。如果有的话，我们的商业收入将来自于我们不期待在近期内（如果能够的话）上市的产品候选者的销售。
因此，我们需要继续依赖额外融资来实现我们的业务目标。在我们通过出售股权或可转换债务证券筹集额外资本的情况下，我们的股东的所有权权益将或可能被稀释，而且这些证券的条款可能包括清算或其他优先权，这将对我们股东的权利产生不利影响。任何未来的债务融资和股权融资（如果可用）可能涉及限制和约束我们采取特定行动的契约，比如承担额外债务、进行资本支出、签订利润分享或其他安排，或宣布分红。如果我们通过与第三方的合作、战略联盟或市场营销、分销或许可安排筹集额外资金，我们可能需要放弃对我们的技术、未来收入来源、研究项目或产品候选者的有价值权益，或根据可能对我们不利的条款授予许可，尤其是在当前经济或市场环境下。我们没有任何承诺的外部资金来源。由疫情或其他流行病、通货膨胀及其他经济和市场条件、乌克兰和以色列的战争、无法维持我们在纳斯达克资本市场的上市地位以及其他因素引起的市场波动，也可能对我们在需要时获取资本的能力产生不利影响。我们未能在需要时以可接受的条款筹集资本，将对我们的财务状况和追求业务策略的能力产生负面影响，我们可能必须减少我们的员工人数或推迟、缩小范围、暂停或消除一个或多个前临床项目、临床试验或未来商业化努力，或缩减我们的运营。
根据ASU 2014-15,实体持续经营能力不确定性的披露 (子主题 205-40), 我们已评估在综合考虑的情况下，是否存在令我们对未来一年能够持续经营产生实质性怀疑的条件和事件，这些事件是在我们未经审计的合并财务报表发布之日后的一年内。在现有现金资源及目前与预期的营业损失的背景下，
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由于现金流为负，我们预计在发布我们未经审计的简明合并基本报表的周年之前需要额外的资本，而这些额外资本可能无法在需要的时候按照可接受的条款或根本不能获得。 一年 因此，我们得出结论，这些情况及获取额外资本的不确定性对我们在未经审计的简明合并基本报表发布之日起的一年内继续作为一个持续经营体的能力产生了实质性的疑虑。
我们的业务运营，以及我们与之开展业务的第三方，已经受到并可能继续受到健康大流行和流行病，以及经济、商业和政治事件的负面影响，包括通货膨胀以及乌克兰和以色列的战争。这些因素在多大程度上可能继续对我们的业务和运营产生影响，将取决于未来高度不确定且无法自信预测的发展。管理层继续评估这些因素对我们当前运营和未来计划的影响，并打算采取适当措施帮助缓解其影响，但无法保证这些努力会成功，以及这些因素不会对我们的财务状况和经营业绩产生负面影响。
现金流
下表提供了我们在所指期间的现金流数据摘要（金额以千为单位）：
| 截至九个月结束 9月30日, |
||||||||
| 2024 | 2023 | |||||||
| 用于经营活动的净现金 |
$ | (19,946 | ) | $ | (32,434 | ) | ||
| 投资活动提供的净现金流量 |
$ | (6,963 | ) | $ | 35,750 | |||
| 融资活动提供的净现金 |
$ | 17,007 | $ | 96 | ||||
经营活动现金流
截至目前，我们在经营活动中使用的现金流主要包括与研发、临床试验以及一般和行政活动相关的薪资和专业服务费用。尽管我们继续扩大我们的产品候选者的临床试验，并寻求市场批准，但考虑到我们当前的资本限制，我们预计近期经营活动中使用的现金将减少。如果获得额外资金，我们的开发活动和时间表可能会加速，且在我们开始从我们的业务中产生任何实质性现金流之前，经营活动中使用的现金可能会再次开始增加。
截至2024年9月30日的九个月，经营活动中使用的净现金约为1990万美元，主要由临床服务提供商的付款、内部薪资成本和第三方专业服务组成，因为我们作为一家上市公司运营，并为进行我们的临床试验做准备。我们截至2024年9月30日的九个月的净损失约为2210万美元，其中包括约290万美元与股票期权补偿相关的费用。
投资活动现金流
截至2024年9月30日的九个月，投资活动中使用的现金流由1150万美元的可交易证券购买组成，部分被约450万美元的可交易证券销售和到期抵消。截止2023年9月30日的九个月，投资活动提供的净现金则由约4760万美元的可交易证券销售和到期组成，部分被约1180万美元的可交易证券购买抵消。
融资活动现金流
在2024年3月29日，我们签署了ATm协议，该协议规定我们将发行和出售总计最高5000万美元的普通股股票股份。截至2024年9月30日，我们以每股平均1.167美元的价格出售了总计2,120,849股普通股股票，扣除约20万美元的佣金和发行费用后，净收益约为220万美元。截至2024年9月30日，ATm协议下仍可使用约4750万美元。在2024年第三季度，我们没有通过ATm协议出售普通股股票。
在2024年4月30日，我们完成了一项承销的公开发行，包括(i) 600万股我们的普通股和相应的warrants，允许购买最多600万股普通股，以及(ii) 向某些投资者， 预先资金 warrants，允许购买最多1600万股普通股和相应的warrants，允许购买最多1600万股普通股。每一股普通股与相应的普通股warrant一起以0.75美元的组合发行价格出售，每个 预先资金 warrants与相应的普通股warrant一起以每个0.7499美元的组合发行价格出售，该价格等于普通股和相应普通股warrant的组合发行价格减去每个0.0001美元的行使价格。 预先资金 warrants。我们从此次发行中获得的净收益约为1480万美元，扣除约70万美元的承销折扣、佣金和发行费用后。
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或资产负债表调整的安排。 资产组合安排
我们不是任何 表外贷款 表格安排，如SEC规则所定义。
关键会计估计
我们对财务状况和经营成果的讨论和分析是基于我们的合并基本报表，这些报表是根据GAAP编制的。编制这些合并基本报表需要我们做出影响我们报告的资产、负债、收入和费用金额的估计和判断。
我们持续评估我们的估计和判断，包括与衍生负债、应计费用和基于股票的补偿相关的估计。我们根据历史经验和我们认为在该情况下一般合理的各种其他假设来基于我们的估计，结果构成了对资产和负债的账面价值及并不明显的收入和费用报告金额进行判断的基础。实际结果可能与这些估计不同，基于本报告第二部分第1A项中的风险和不确定性，“风险因素”。
我们的关键会计估计在我们2023年12月31日结束的年度报告中详细说明。 10-K 除非在本报告的未经审计的简明合并基本报表的注释2中描述的内容外，我们的关键会计政策和重要估计没有实质性变化。 10-K 该表格中列出了截至2023年12月31日的年度报告以来进入第2或第3临床试验阶段、已提交监管审查或近期在美国、欧盟或日本获得监管批准的以下新分子实体（NME）和新适应症线性扩展（NILEX）产品。
| 项目 3。 | 关于市场风险的定量和定性披露。 |
在我们业务的日常过程中，我们面临市场风险，包括利率变动和外汇汇率波动的影响。关于这些市场风险的定量和定性披露信息如下所示。
利率风险
现金和受限现金仅包括存放在存款账户中的现金，因此不受利率上升或下降的影响。此外，我们将所有高流动性投资视为现金等价物。截止2024年9月30日，我们持有现金等价物和可交易证券。这些投资的短期性质不会受到利率变化的显著影响。任何利息-bearing工具都带有一定的风险；然而，我们未曾遭受，且不预期会遭受因利率变动而造成的重大风险。假设在所呈现的任何期间内利率变化10%，将不会对我们未经审计的简明合并基本报表产生重大影响。
外汇风险
我们的业务主要以美元为计价单位，我们预计未来的经营业绩不会受到外汇交易风险的显著影响。在任何所呈现期间，假设外汇汇率变化10%，对我们未经审计的合并基本报表不会产生重大影响。
| 项目 4。 | 管制和程序 |
披露控制和程序的评估。
我们保持“披露控制和程序”，该术语在交易法规则中有定义 为确保来自公司以及其合并子公司的重要信息在编制本报告期间被其他实体及时通报给我们，我们设计了这样的信息披露控制和程序，或在我们的监督下引起了这样的信息披露控制和程序的设计； 根据交易法，我们设计了“披露控制和程序”，旨在确保我们在交易法下提交或发布的报告中所要求披露的信息在美国证券交易委员会规则和表格规定的时间内被记录、处理、汇总和报告，并确保这些信息被汇总并传达给我们的管理层，包括首席执行官和信安金融负责人，以便及时做出关于必要披露的决策。在设计和评估我们的披露控制和程序时，管理层认识到，无论披露控制和程序设想得多么完善和顺利运行，都只能提供合理的，而不是绝对的保证，确保披露控制和程序的目标得以实现。我们的披露控制和程序已经被设计以满足合理保证标准。此外，在设计披露控制和程序时，我们的管理层必然要在评估可能的披露控制和程序的成本效益关系时运用自己的判断。任何披露控制和程序的设计也部分基于对未来事件发生可能性的某些假设，不能保证任何设计在所有潜在未来条件下都有助于实现其既定目标。
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根据截至本报告涵盖周期末的评估，我们的首席执行官（我们的主要执行官）和首席财务官（我们的主要财务官）得出的结论是，截至该日期，我们的披露控制和程序在合理保证水平上是有效的。
有关财务报告内部控制变更
在截至2024年9月30日的三个月内，我们的财务报告内部控制（根据交易所法案的规定）没有发生变化，这些变化对我们财务报告的内部控制没有实质性影响，或者合理地可能对我们的财务报告的内部控制产生实质性影响。 13a-15(f) 和 15d-15(f) 截至2024年9月30日的三个月内，我们的财务报告内部控制（根据交易所法案的规定）没有发生变化，这些变化对我们财务报告的内部控制没有实质性影响，或者合理地可能对我们的财务报告的内部控制产生实质性影响。
第二部分
| 项目1。 | 法律诉讼。 |
我们目前并不是任何法律程序的当事方，也不知道是否有任何针对我们的待决或威胁的法律程序，这些程序可能对我们的业务、经营结果或财务状况产生重大不利影响。我们可能会不时参与因日常业务而产生的法律程序。
| 项目 1A。 | 风险因素。 |
与我们产品候选者的发现、开发和商业化相关的风险
我们依赖于拜耳许可协议，提供与我们所有当前产品候选者相关的核心知识产权的权利，该协议对我们施加了重大的付款和其他义务。我们未能履行拜耳许可协议下义务的任何情况，可能会赋予拜耳终止或寻求该协议下其他救济的权利，拜耳许可协议下任何重要权利的终止或丧失都会显著且不利地影响我们开发和商业化VIP236、VIP943、VIP924、enitociclib、VersAptx平台及其他包含此类知识产权的产品候选者和技术的能力，以及筹集资金或继续我们的运营。
我们已根据拜耳许可协议以独占、全球的方式许可了与VIP236、VIP943、VIP924、enitociclib、VersAptx平台及我们其他当前产品候选者相关的核心专利和其他知识产权。拜耳许可协议继续生效， Lilly也可以在CoLucid控制权发生变更时终止许可协议，除非新的所有者同意受许可协议的条款和条件约束。 及授权的 按产品逐个许可 在相关国家，产品基础在没有剩余专利付款义务之前可以终止，若我们严重违反我们的物质义务、被对我们提起破产或其他破产程序，或我们寻求撤销或挑战任何许可专利的有效性，拜耳可提前终止。如果出于任何原因，拜耳许可协议被终止，或者我们以其他方式失去重要权利，将对我们的业务和开发、商业化当前产品候选者、筹集资金或继续运营的能力造成重大不利影响。
拜耳许可协议对我们施加了与开发、商业化、资金、付款、尽职调查、知识产权保护和其他事项相关的义务。我们在业务结合结束后支付给拜耳500万美元的前期许可费。此外，我们还需在达到特定开发和商业销售里程碑时向拜耳支付重要的未来款项，这些里程碑涉及授权产品。里程碑付款的大小和时间将会根据特定授权产品、是否涉及到P-TEFb授权产品或生物偶联授权产品（以及哪个生物偶联项目）、不同疾病指示的数量、与里程碑实现相关的不同国家的数量以及净商业销售的水平等因素而大大不同，因此很难估计可能需要向拜耳支付的总款项以及这些款项的到期日。 P-TEFb 如果我们为每个国家和疾病指示达成所有里程碑，我们将有义务为每个授权产品支付从1.1亿到3.18亿美元的开发和商业里程碑付款，并且在至少五个授权产品成功商业化后，我们可能需要支付超过10亿美元的总里程碑付款。除了里程碑付款外，我们还需根据拜耳许可协议向拜耳支付在单个数字到低双位百分比区间的持续专利使用费，基于授权产品的净商业销售。
在我们能够实现任何这些里程碑的情况下，其中许多将在我们能够产生足够的收入（或在开发里程碑的情况下根本没有收入）之前实现，以及相关的里程碑付款将到期。因此，我们将需要获得大量额外资金，或者达成战略合作关系，以便支付这些里程碑，但无法保证我们能够以可接受的条件或根本不获得必要的资金，或者我们能够达成足够的战略合作关系以支付这些里程碑，或根本支付。如果我们无法筹集必要的额外资金，达成必要的战略合作关系，或以其他方式支付这些里程碑，我们将违反拜耳许可协议，如果不解决，拜耳将有权终止协议或寻求其他救济，这将对我们的业务和前景以及我们开发和商业化当前产品候选者、筹集资本或继续运营的能力产生重大和不利的影响。
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我们在很大程度上依赖于VIP236、VIP943和enitociclib这三款主要产品候选的成功。如果我们无法及时完成这些主要产品候选的开发、获得批准并进行商业化，我们的业务将受到损害。
我们未来的成功在很大程度上依赖于我们能够及时启动和完成临床试验，获得市场批准，并成功商业化VIP236、VIP943和enitociclib这三款主要产品候选。我们正在为这些主要产品候选的开发投入大量精力和财务资源，这将需要额外的临床开发、临床、前临床和制造活动的评估、政府监管机构的市场批准、大量投资，以及显著的市场推广工作，才可能从产品销售中产生收入。我们在获得FDA及其他国家相关监管机构的市场批准之前，不能市场或推广这些或任何其他产品候选，并且我们可能永远无法获得此类市场批准。
我们主要产品候选的成功将取决于多个因素，包括：
| • | 临床试验的启动、成功的患者招募和及时的完成； |
| • | 与美国及国际临床开发的合同研究组织和临床现场建立和维护关系； |
| • | 临床试验中的不良事件及其他药物相关不良事件的频率和严重性； |
| • | 达到FDA或任何相应外国监管机构对市场批准的剂量选择、疗效、安全性和耐受性概况的满意； |
| • | 与第三方药品供应商、制造商和分销商建立和维护供应协议； |
| • | 获得和维持专利保护、商业秘密保护和监管独占权，既包括美国也包括国际市场； |
| • | 在任何市场批准后继续保持可接受的安全性概况；以及 |
| • | 我们与其他疗法的竞争能力。 |
我们无权控制许多这些因素，包括临床开发和监管提交过程的某些方面、对我们知识产权的潜在威胁，以及未来合作伙伴的制造、营销、分销和销售努力。如果我们在及时或根本没有成功的情况下，在一个或多个这些因素上出现问题，我们可能会遭遇重大延迟或无法成功商业化这些主要产品候选者，这将对我们的业务和前景造成实质性的伤害。
我们在我们的产品候选者的开发努力中处于早期阶段，我们可能无法在及时的基础上成功开发、制造、完成临床试验并商业化我们的产品候选者。
VIP236、VIP943和VIP924是我们VersAptx平台下的首批产品候选者，其潜在的治疗益处尚未得到证明，我们可能永远无法成功开展、完成临床试验，获得市场批准，并商业化这些或我们VersAptx平台下的其他任何产品候选者。虽然其他公司正在开发多个生物偶联和ADC候选者，但目前尚无使用我们专有细胞毒素（从SN38这一著名细胞毒药物及其活性代谢物伊立替康优化得到的CPt载体）或使用KSPi和CellTrapper的ADC的批准生物偶联疗法。我们可能会发现与KSPi或我们优化的CPt载体相关的新风险，我们的CellTrapper技术的渗透性可能没有初步测试所暗示的那么高，我们的连接技术可能没有初步测试所暗示的那么有效，或者可能存在其他问题，这些问题可能比我们当前认为的更具挑战性，这可能会延长获得监管批准所需的观察期，或者导致未能获得批准，或可能需要额外的临床前和临床测试。虽然VIP236、VIP943和VIP924的临床前试验结果显示 概念验证 对于每个产品候选者，我们可能无法在患者身上展示我们认为他们可能具备的任何或所有药理学益处。如果我们使用的KSPi战斗头或优化的CPt载荷在某些产品候选者中不安全，我们将不得不放弃或重新设计我们目前所有的主导ADC或SMDC产品候选者。我们尚未成功，也可能永远无法成功证明VIP236、VIP943和VIP924在关键临床试验中的有效性和安全性，也无法获得随后的市场批准。
Enitociclib是一种新型 P-TEFb/CDK9 抑制剂，其潜在的治疗益处尚未得到验证。虽然其他公司正在开发几种CDK9抑制剂候选者，但目前没有批准的抑制CDK9用于癌症治疗的疗法，因此，Enitociclib的监管路径可能会出现新的问题，这可能导致开发延迟或
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批准。此外，enitociclib可能不会在患者身上展示我们相信它可能具备的任何或所有药理学效益。来自临床前研究或早期临床试验的积极结果不一定能预测计划中的enitociclib临床试验的结果。我们尚未成功，并且可能永远无法成功地在关键临床试验中证明enitociclib的疗效和安全性，或在此后获得市场批准。
如果我们无法成功开发、进行或完成临床试验，获得市场批准，并商业化我们的产品候选，我们的业务和前景将受到重大影响。
我们的长期前景部分依赖于发现、开发、制造和商业化更多的产品候选，这些产品候选可能在开发中失败或遭受延迟，从而对其商业可行性产生不利影响。
我们未来的经营结果取决于我们成功发现、开发、获得监管批准、制造和商业化当前处于临床前和临床开发中的产品候选的能力。产品候选在制造以及临床前和临床开发的任何阶段都可能意外失败。由于与安全性、疗效、临床执行、医疗标准变化和其他不可预测变量相关的风险，产品候选的历史失败率很高。来自产品候选的临床前测试或早期临床试验的结果可能无法预测在该产品候选的后期临床试验中将获得的结果。
我们可能开发的其他产品候选的成功将取决于许多因素，包括以下几点：
| • | 生成足够的数据以支持临床试验的启动或继续； |
| • | 获得监管许可以启动临床试验； |
| • | 与进行临床试验所需的各方签订合同； |
| • | 及时完成患者的成功入组以及临床试验的完成； |
| • | 及时制造出足够数量的产品候选物用于临床试验；以及 |
| • | 临床试验中的不良事件。 |
早期临床试验的结果可能无法预测晚期或其他临床试验的结果。
来自临床前研究和早期临床试验的积极和有前途的结果可能无法预测晚期临床试验的结果，或者相同产品候选物用于治疗其他适应症的临床试验的结果。尽管在经过临床前研究和初步临床试验后，晚期临床试验中的产品候选物可能未能显示出所期望的安全性和有效性特征。晚期临床试验可能在显著方面与早期临床试验有所不同，包括纳入和排除标准、有效性终点、给药方案和统计设计的变化。此外，在特定适应症的临床试验中取得成功并不能保证该产品候选物在治疗其他适应症时也会成功。许多生物技术行业的公司在早期开发阶段取得鼓励或积极的结果后，曾在晚期临床试验中遭遇重大挫折。我们无法保证在我们正在进行或计划的晚期临床试验以及任何后续或上市后确认的临床试验中不会遭遇类似的挫折。因此，尽管在早期临床试验中观察到积极结果，我们的产品候选物可能在关键或上市后确认的临床试验中未能显示出足够的有效性。
我们不时宣布或发布的来自我们的临床试验的初步、“顶线”和初步数据可能会随着更多患者数据的获得而变化，并且这些数据可能会受到审计和验证程序的影响，这可能导致最终数据发生重大变化。
不时我们可能会发布临时或“顶线”来自临床试验的初步数据。积极的初步数据可能无法预测该试验后续或总体结果。初步数据面临风险，随着数据的更多可用，可能会发生一个或多个结果的重大变化。此外，初步数据还面临风险，随着患者入组的持续和更多患者数据的可用，可能会有一个或多个临床结果发生重大变化。因此，任何正在进行的临床试验中的积极初步结果可能无法预测在已完成试验中的这样的结果。我们还在分析数据时做出假设、估计、计算和结论，并且我们可能没有收到或有机会完全评估所有数据。因此，我们报告的初步数据可能与同一临床试验的未来结果存在差异，或者在收到并完全评估额外数据后，可能会有不同的结论或考虑从而影响这些结果。初步数据仍然需要审计和验证程序，这可能导致最终数据与我们之前发布的初步数据存在重大差异。因此，在最终数据可用之前，初步数据应谨慎对待。最终数据与初步数据相比发生重大不利变化可能会对我们的业务和前景造成实质性损害。 “顶线” 数据来自临床试验。积极的初步数据可能无法预测该试验后续或总体结果。初步数据面临风险，随着数据的更多可用，可能会发生一个或多个结果的重大变化。此外，初步数据还面临风险，随着患者入组的持续和更多患者数据的可用，可能会有一个或多个临床结果发生重大变化。因此，任何正在进行的临床试验中的积极初步结果可能无法预测在已完成试验中的这样的结果。我们还在分析数据时做出假设、估计、计算和结论，并且我们可能没有收到或有机会完全评估所有数据。因此，我们报告的初步数据可能与同一临床试验的未来结果存在差异，或者在收到并完全评估额外数据后，可能会有不同的结论或考虑从而影响这些结果。初步数据仍然需要审计和验证程序，这可能导致最终数据与我们之前发布的初步数据存在重大差异。因此，在最终数据可用之前，初步数据应谨慎对待。最终数据与初步数据相比发生重大不利变化可能会对我们的业务和前景造成实质性损害。
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即使获得批准，我们的产品候选者也可能无法在医疗社区的医生、患者、医疗保险支付者和其他人员中获得足够的市场认可，从而实现商业成功。
即使我们的产品候选者获得监管批准，它们也可能无法在医生、患者、医疗保险支付者和医疗社区的其他人员中获得足够的市场认可。我们任何已批准产品候选者的市场认可程度将取决于多个因素，包括：
| • | 市场推出的时间、竞争药物的数量、临床特征和潜在优势； |
| • | 我们提供安全性和有效性可接受证据的能力； |
| • | 医疗保健标准的变化； |
| • | 相对便捷和易于使用； |
| • | 对我们产品候选者的使用限制，例如标签中带有的警告或禁忌，或者风险评估与缓解策略（如果有的话），这些可能不适用于替代治疗和竞争产品； |
| • | 定价和成本效益，可能受到监管控制。 |
| • | 健康维护组织和其他第三方支付者的覆盖范围、报销和足够支付的可用性；和 |
| • | 不良副作用的流行程度和严重性。 |
如果我们的任何产品候选者获得批准但未能获得医生、医院、医疗支付者和患者的足够接受，我们可能无法从该产品候选者生成或获得足够的营业收入，并且我们的财务结果可能会受到负面影响。
如果我们开发的任何产品候选者的市场机会比我们认为的要小，那么我们的营业收入可能会受到不利影响，我们的业务也可能受到损害。
我们打算将产品候选者的开发重点放在各种肿瘤指征的治疗上。我们对可能从我们的产品候选者治疗中受益的可治疗患者群体的预测是基于我们的估计。这些估计是根据多种来源得出的，可能是错误的。此外，新的研究可能会改变这些癌症的预估发病率或流行率。此外，我们的产品候选者可能不最终适合可治疗的患者群体。我们的市场机会也可能受到未来进入市场的竞争对手治疗的限制。如果我们的任何估计证明不准确，我们开发的任何产品候选者的市场机会可能会大幅减少，并对我们的业务和前景产生不利实质影响。
我们面临着激烈的竞争，如果我们的竞争对手比我们更快地开发和营销技术或产品，或者开发的产品比我们开发的产品候选者更有效、更安全或成本更低，我们的商业机会将受到不利影响。
我们的竞争对手正在开发大量药物候选者和新疗法，以治疗我们可能尝试开发的产品候选者的疾病。几家药品和生物技术公司在临床试验或开发中拥有CDK9抑制剂、ADC、免疫疗法或其他与我们在肿瘤指征上竞争的产品。我们的竞争对手，单独或与合作伙伴一起，可能在财务、制造、营销、药物研发、技术和人力资源以及商业专业知识方面拥有明显更大的优势，并且可能比我们更早开始开发他们的药物候选者。我们的竞争对手可能还有更多的经验：
| • | 开发药物候选物； |
| • | 进行临床前和临床试验； |
| • | 获得监管批准；以及 |
| • | 商业化产品候选物。 |
如果我们的竞争对手开发和商业化的产品比我们可能开发的产品更安全、更有效，副作用更少或更轻微，使用更方便，覆盖范围更广，营销更有效，能够获得报销，或比我们可能开发的任何产品价格更低，我们的商业机会可能会减少或消失。我们的竞争对手也可能比我们更快获得FDA或其他相应的外国监管机构对其产品的营销批准。
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我们的批准可能会导致我们的竞争对手在我们能够进入市场之前建立强大的市场地位。竞争对手开发的技术进步或产品可能使我们的技术或产品候选者过时、失去竞争力或不具经济性。我们预计，随着新公司进入市场和科学发展的进步，我们将面临更激烈的竞争。如果我们无法有效竞争，我们从开发的产品（如果获得批准）中产生营业收入的机会可能会受到不利影响。
我们可能会将有限的资源用于追求特定的产品候选者、目标或适应症，却未能利用可能更有利可图或成功几率更大的其他产品候选者、目标或适应症。
由于我们有限的财务和管理资源，我们专注于为特定适应症识别的开发程序、治疗平台和产品候选者。因此，我们可能会放弃或推迟追求其他治疗平台或产品候选者，或者其他目标或适应症的机会，而这些机会后来证明具有更大的商业潜力或更高的成功几率。我们的资源分配决策可能导致我们未能利用可行的商业产品或有利可图的市场机会。我们对当前和未来研究与开发程序、治疗平台和特定适应症产品候选者的支出可能无法产生任何具有商业可行性的产品。如果我们未能准确评估特定产品候选者的商业潜力或目标市场，我们可能会通过合作、许可或其他特许权安排放弃对该产品候选者的有价值的权利，而在那种情况下保留独占开发和商业化权利对我们来说更为有利。
临床试验费用高昂、耗时，受到招募和其他延误的影响，可能需要在我们可用资金之外继续进行，我们不能确定自己是否能筹集到足够的资金，成功完成目前在临床前和临床开发中的任何产品候选者的开发、临床试验和商业化，前提是它们获得成功。
临床试验的结果不确定，可能需要继续进行超出我们可用资金的范围。失败可能在临床试验的任何阶段发生，我们可能会经历许多不可预见的事件，这可能会延迟或阻止我们当前或未来产品候选者的商业化，包括但不限于：
| • | 在确保临床研究者和试验场所方面的延迟； |
| • | 在获得机构审查委员会和监管批准以开始临床试验的延迟； |
| • | 患者招募和入组速度慢于预期，或因竞争患者来自其他试验、识别具有我们提议适应症的患者的困难、健康大流行或流行病的影响、健康维护组织和其他第三方支付者提供的覆盖、报销或充足支付的有限或无可用性等因素而未达到目标患者数量； |
| • | 不可预见的安全问题； |
| • | 由于未完全探讨的药代动力学和药效学行为或诸如FDA的Optim项目等倡议引发的不确定给药问题； |
| • | 新疗法的批准和引入，或实践标准或监管指导的变化，使我们的临床试验终点或我们提议的适应症的目标吸引力降低； |
| • | 在治疗期间或之后无法充分监测患者，或研究者或患者对试验方案的遵从性存在问题； |
| • | 无法在大规模的受控研究中复制从少量患者的无对照试验中获得的安全性和有效性数据； |
| • | 医疗研究人员无法或不愿意遵循我们的临床协议；并且 |
| • | 临床试验物资不可用。 |
此外，在我们的产品候选药物从拜耳的收购之前，我们没有参与或控制其前临床或临床开发。 许可 因此，我们依赖于拜耳按照适用的协议和法律、监管及科学标准开展开发，准确报告在我们获得产品候选药物权利之前进行的所有前临床研究和临床试验及其他研究的结果，正确收集和解释这些研究、试验和其他研究的数据，并向我们提供完整的信息、数据集和报告，以充分证明在我们获得这些产品候选药物权利时报告的结果。这些领域的任何问题都可能导致我们产品候选药物开发中的成本增加和延误，这可能会对我们从未来销售产品候选药物中获取任何营业收入的能力产生不利影响，如果获得批准的话。
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如果我们在临床试验中遭受重大延迟、挫折或负面结果或终止，我们可能无法继续开发候选产品或创造收入，我们的开发成本可能会显著增加。我们的临床试验得出的不良或不确定的结果可能会大大延迟或完全停止我们候选产品的进一步开发。
我们的临床试验得出的不良或不确定的结果可能会大大延迟或完全停止我们候选产品的进一步开发。尽管早期临床试验取得了良好的结果，但许多公司未能在后期临床试验中证明候选产品的安全性或有效性。以前不可预见和不可接受的副作用可能会中断、延迟或中断我们的候选产品的临床试验，并可能导致 FDA 拒绝批准我们的候选产品。在整个开发过程中，我们将需要证明特定使用适应症的安全性和有效性，并监测临床试验方案和其他良好临床实践要求的安全性和遵守情况。迄今为止，我们的任何候选产品的临床试验均未证明其长期安全性和有效性。
在涉及我们某些候选产品的临床前和临床试验中，已注意到某些毒性和不良事件。此外，我们已经或可能对多个适应症进行临床试验，并且存在一种风险，即在一个适应症的试验中观察到的不可接受的毒性或不良事件可能导致涉及同一候选产品的所有试验延迟或暂停。即使我们认为从候选产品的临床试验中收集的数据在安全性和有效性方面令人鼓舞，但监管机构可能认为这些数据不足以保证产品获得批准。监管官员可能以与我们不同的方式解释此类数据，这可能会延迟、限制或阻碍监管部门的批准。美国食品和药物管理局或我们可能随时暂停或终止临床试验。在完成候选产品的临床试验，或获得监管部门批准将我们的候选产品商业化方面出现任何失败或重大延迟，都可能对我们的业务和前景造成重大损害。
我们的临床前开发、临床试验、制造、供应链和其他运营和业务活动，以及与我们开展业务的第三方（包括我们的合同制造商、合同研究机构、托运人、临床试验场所等）的运营和业务活动，已经并将来可能受到健康流行病和流行病的不利影响。
无论我们在哪里有临床试验场所或其他业务运营，我们的业务都受到健康流行病和流行病的不利影响，并且将来可能会受到不利影响。此外，健康大流行和流行病可能会对第三方制造商、合同研究机构、托运人、临床试验场所以及我们所依赖的其他第三方的运营造成重大干扰。我们依赖全球供应链来将产品用于临床试验，如果获得监管机构的批准，则用于商业化。运营中断，无论是否与 新冠肺炎 或其他健康流行病或流行病，已经影响并将来可能会影响美国和其他国家的第三方制造设施的人员或材料的供应或成本，这已经影响并可能继续影响我们的供应链。如果我们与供应商或其他供应商的关系因疫情或流行病而延迟、缩减或终止，我们可能无法与替代供应商或供应商达成协议，也无法按照商业上合理的条件或及时这样做。
此外，我们的临床试验已经而且将来可能会受到健康流行病或流行病的影响。由于人员短缺、将医院资源优先用于治疗和管理受疫情或流行病影响的患者、患者对在疫情或流行病期间参与临床试验的担忧，或者临床场所所在国家和地区的政府当局采取的公共卫生措施，临床场所的启动和患者入组已经延迟，将来也可能会延迟。如果隔离或其他限制性措施阻碍患者行动或中断医疗服务，则某些患者可能难以遵守临床试验方案的某些方面。同样，我们无法成功招募和留住作为医疗保健提供者可能面临更多暴露或受到机构、城市或州政府额外限制的患者、主要研究人员和现场工作人员，这可能会对我们的临床试验业务产生不利影响。
我们的业务存在巨大的产品责任风险，如果我们无法获得足够的保险，这种无能为力可能会对我们的业务和前景产生不利影响。
我们的业务使我们面临治疗疗法的开发、测试、制造和营销所固有的重大产品责任风险。产品责任索赔可能会延迟或阻碍我们的开发计划的完成。如果我们成功推销产品，此类说法可能会导致美国食品和药物管理局或其他监管机构对我们的产品、制造工艺和设施或营销计划的安全性和有效性进行调查。美国食品和药物管理局或其他监管机构的调查可能会导致召回我们的产品或采取更严厉的执法行动，限制其可能使用的批准适应症，或者暂停或撤回批准。无论案情或最终结果如何，责任索赔还可能导致对我们产品的需求减少，我们的声誉受损，相关诉讼的辩护费用，转移
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管理层的时间和我们的资源，以及对临床试验参与者或患者的重大货币奖励。我们拥有或可能获得的任何保险可能无法提供足够的覆盖，以应对潜在的责任。此外，临床试验和产品责任保险变得越来越昂贵，且获取难度加大。因此，我们可能无法以合理的成本获得足够的保险，以保护我们免受产品责任索赔造成的损失，这可能会对我们进行临床试验的能力产生负面影响，并对我们的业务和财务状况产生不利影响。
我们开发的任何产品候选者可能会受到不利的第三方覆盖和报销实践以及价格监管的影响，包括2022年通货膨胀减缓法案下的规定。
在国内和国际市场上，在获得批准的情况下，我们任何产品候选者的销售将在一定程度上取决于我们的产品费用在多大程度上将受到第三方支付者的覆盖，如政府医疗计划、商业保险和管理医疗组织。这些第三方支付者决定哪些药物将被覆盖，并为这些药物设定报销水平。控制医疗费用已成为政府和私人第三方支付者的优先事项，药品价格在这一努力中受到关注，包括2022年通货膨胀减缓法案下的药品定价条款。政府和私人第三方支付者试图通过对某些药物进行强制价格谈判以及限制某些药物的覆盖和报销金额来控制成本，这可能影响我们盈利性销售产品候选者的能力。成本控制措施可能导致我们降低为产品设定的价格，这可能导致产品收入低于预期。不利的价格限制可能会阻碍我们收回对当前或未来产品候选者的投资，即使这些产品候选者获得了市场批准。
第三方支付方的报销可能取决于几个因素，包括第三方支付方对产品使用的判断：
| • | 其健康计划下的覆盖利益； |
| • | 安全、有效且医学上必要； |
| • | 适合特定患者； |
| • | 具有成本效益；以及 |
| • | 既不是实验性也不是调查性。 |
从政府或其他第三方支付方获得产品的覆盖和报销批准是一个耗时且成本高昂的过程，可能需要我们向支付方提供支持我们产品使用的科学、临床和成本效益数据。此外，关于新批准药物的第三方支付方覆盖和报销存在显著的不确定性。我们可能无法提供足够的数据以获得对覆盖和报销的接受。我们不能确定我们的任何产品候选药物将获得覆盖或充分的报销。同时，我们不能确定报销金额不会减少我们产品的需求或价格。如果报销不可用或仅在有限程度上可用，我们可能无法商业化我们某些产品。此外，在美国，第三方支付方正日益试图通过限制新药的覆盖和报销水平来控制医疗成本。因此，关于第三方支付方将如何以及在多大程度上报销患者使用新批准药物的费用存在显著不确定性，这反过来又会对药物的定价施加压力。
我们在某些情况下使用生物标志物，这些标志物尚未经过科学验证，而我们对生物标志物数据的依赖可能导致我们低效地配置资源。
我们在某些情况下利用生物标志物来促进我们的药物开发并优化我们的临床试验。生物标志物是指血液或肿瘤细胞中存在的蛋白质或其他物质，可以作为特定细胞过程的指标。我们相信，这些生物标志物在帮助我们评估我们的产品候选者是否通过其假定机制产生预期效果方面发挥着有用的作用，从而在早期阶段识别出更有前景的产品候选者，并高效地分配我们的资源。我们还相信，生物标志物最终可能使我们能够改善与临床试验相关的患者选择，监测患者遵循试验协议的情况。
然而，在大多数情况下，生物标志物尚未经过科学验证。如果我们对生物标志物的理解和使用不准确或存在缺陷，或者我们对它们的依赖存在其他错误，我们不仅无法从使用生物标志物中获得任何好处，还可能在试图开发潜力较小的产品候选者时低效地投入时间和财务资源。此外，生物标志物数据目前并未被FDA或美国、欧盟或其他地方的其他监管机构在产品候选者的监管批准申请中接受，且没有保证这些数据将来会被相关当局接受。我们的生物标志物数据不应被解读为有效性的证据。
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我们的创始人在其他公司成功开发癌症疗法并不能保证我们能够成功开发或商业化我们当前或未来的任何候选产品。
Ahmed m. Hamdy 博士和 Raquel E. Izumi 博士是校长 联合创始人 来自开发 CALQUENCE 的公司 Acerta Pharma BV® 并最终被阿斯利康公司收购。Hamdy和Izumi博士先前成功地许可了临床前阶段的分子，并通过临床试验开发了该分子并获得了全面的上市许可，但这并不能保证我们将成功开发或商业化我们当前或未来的任何候选产品。
未能吸引和留住熟练人员可能会损害我们的药物开发和商业化努力。
我们的业务高度依赖于我们吸引和留住管理、临床开发、科学、研究、技术和其他熟练人员的能力。目前，对于拥有这些技能和专业知识的高管和员工，竞争非常激烈，而且这种竞争可能会持续下去。无法吸引和留住我们的管理、临床开发、科学、研究、技术和其他熟练人员可能会延迟或阻碍我们的药物开发和其他业务目标的实现，并可能对我们的业务和前景产生重大不利影响。我们还依靠顾问和顾问来协助我们制定和实施业务目标。我们的顾问和顾问要么是自雇人士，要么受雇于其他组织，他们可能存在利益冲突或其他承诺，例如与其他组织的咨询或咨询合同，这可能会影响他们为我们的业务和运营做出贡献的能力。
我们或我们所依赖的第三方可能会受到自然灾害、健康流行病和其他自然灾害的不利影响 人造的 事故或事件，包括气候变化的影响，以及我们的业务连续性和灾难恢复计划，可能无法充分保护我们免受严重灾难的影响。
任何计划外事件，例如洪水、火灾、爆炸、地震、极端天气状况、健康大流行或流行病、电力短缺、电信故障、战争（例如乌克兰和以色列战争）或其他自然或 人造的 导致我们无法充分利用我们的设施、我们所依赖的第三方设施或进行临床前研究或临床试验的事故或事件，包括气候变化的影响，可能会对我们的业务产生重大不利影响。此外，我们制定的灾难恢复和业务连续性计划可能不足以应对严重灾难或类似事件。作为风险管理政策的一部分，我们将保险承保范围维持在我们认为适合我们业务的水平。但是，如果这些设施发生事故或事故，则无法保证保险金额足以弥补任何损害和损失。如果我们的设施或我们所依赖的第三方的设施由于事故或事故或任何其他原因而无法运营，即使在很短的时间内，我们的业务也可能会受到损害。
如果我们的计算机系统或我们的合作伙伴、合同研究机构、承包商、顾问或其他与我们合作的第三方的计算机系统发生系统故障、网络攻击、数据丢失或其他安全事件，或者我们未能遵守适用的数据安全和隐私法律、法规和标准，我们的业务和运营将受到不利影响。
尽管实施了安全措施，但我们的计算机系统以及我们的合作伙伴、合同研究机构、信息技术服务提供商、承包商、顾问、律师事务所和会计师事务所以及与我们合作的其他第三方的计算机系统可能会遭受计算机病毒、未经授权的访问、数据泄露、网络钓鱼攻击、勒索软件攻击的损害， 拒绝服务 攻击、网络犯罪、自然灾害、恐怖主义、战争以及电信和电力故障。我们依靠我们的合作伙伴和第三方提供商来实施有效的安全措施，并识别和纠正任何此类故障、缺陷或漏洞。安全漏洞或中断的风险，特别是通过网络攻击或网络入侵，包括计算机黑客、外国政府和网络恐怖分子发动的网络攻击或网络入侵，已显著增加，越来越难以发现。如果发生故障、事故或安全漏洞，并导致我们的运营或合作伙伴或第三方提供商的运营中断，则可能导致机密信息被盗用，包括我们的知识产权或财务信息或临床试验参与者的个人数据，我们的药物开发计划出现重大中断或延迟，或重大金钱损失。例如，丢失已完成、正在进行或计划中的试验的临床前或临床试验数据，或候选产品的化学、制造和对照数据，可能会导致监管机构的批准工作延迟，并大大增加我们恢复或复制数据的成本。
此外，我们必须遵守为保护美国、欧洲和其他地方的业务和个人数据而颁布的越来越复杂、严格、有时甚至相互冲突的法律、法规和标准。这些法律为公司规定了处理个人数据的额外义务，并为存储数据的人员提供了某些个人隐私权。遵守现有、拟议和最近颁布的法律、法规和标准可能既昂贵又耗时，任何不遵守这些法律、法规和标准的行为都可能使我们面临法律和声誉风险。滥用或未能保护个人信息，包括临床试验参与者个人数据的任何泄露、丢失或泄露，也可能导致违反数据隐私法律、法规和标准，政府机构或其他机构对我们提起诉讼，政府当局处以罚款，损害我们的声誉和信誉，并可能对我们的业务产生负面影响。
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与我们的财务状况及对额外资本需求相关的风险
自成立以来我们已经产生了净亏损，预计在可预见的未来将继续产生显著的净亏损，并且没有保证我们能够筹集到资金。
自成立以来每个报告期我们都产生了净亏损，迄今为止未从产品销售中产生任何营业收入，并主要通过出售我们的股权证券来为我们的运营提供资金。我们的亏损主要是由于与从拜耳获取我们的产品候选者的许可相关的费用、筹集资金、建立我们的管理团队和业务基础设施、制造以及进行临床前研究和早期临床试验而产生的费用。因此，我们预计在可预见的未来将需要好几年，甚至更久，才能拥有商业化产品并能够从产品销售中产生营业收入。我们预计，随着我们继续进行研发工作并寻求获得产品候选者的监管批准和商业化，我们将继续产生显著的费用和不断增加的营业亏损。即使我们成功获得一项或多项产品候选者的市场批准并实现商业化，我们预计在发现、开发和营销额外潜在产品时，我们将继续产生可观的研发及其他费用。我们产生的净亏损可能会在每个季度之间显著波动，从而使我们的运营结果比较不一定很好地表明我们未来的表现。 期间之间 我们未来的净亏损规模在一定程度上将取决于我们未来费用的增长率和我们产生营业收入的能力。我们先前的亏损和预期的未来亏损对我们的营运资本、筹集额外资本的需求以及实现和维持盈利能力产生了不利影响，并将继续产生影响。
我们需要大量资本来融资我们的运营。如果我们无法在需要时筹集该资本，或不能以可接受的条款筹集到资金，我们可能被迫推迟、减少或取消一项或多项研究和药物开发计划或未来的商业化工作，并可能无法继续作为一个持续经营的企业。
开发药品产品，包括进行临床前研究和临床试验，是一个非常耗时、昂贵且不确定的过程，完成这一过程需要数年时间。我们预计与我们正在进行的活动相关的费用将大幅增加，特别是在我们启动和进行VIP236、VIP943、VIP924、enitociclib及其他产品候选药物的临床试验和寻求市场批准时。即使我们开发的一个或多个产品候选药物获得了商业销售批准，我们也预计会产生与任何已获批准的产品候选药物商业化相关的显著成本。这些支出将包括与拜耳许可协议及开发和商业里程碑相关的付款，在产生任何产品销售之前。此外，在我们许可的产品开始进行商业销售后，我们将负责在达到某些销售里程碑时支付进一步的重大款项，以及基于净商业销售的分层特许权使用费。
如果FDA或其他监管机构要求我们，或我们认为有必要，进行我们目前预计以外的临床试验或临床前研究，我们的费用可能会超出预期。其他意外费用也可能出现。此外，如果我们获得了任何产品候选药物的市场批准，我们预计会产生与药品销售、市场营销、制造和分销相关的重大商业化费用。由于我们计划和预期的临床试验的设计和结果高度不确定，我们无法合理地估计成功完成我们开发的任何产品候选药物的开发和商业化所需的实际金额。我们还预计将面临与作为上市公司运营相关的额外费用。因此，我们需要获得大量额外资金以维持我们的持续运营。
截至2024年9月30日，我们拥有约1010万美元的现金、现金等价物和可交易证券。我们打算利用现有的资本资源来推进和扩展我们的前临床和临床项目，为拜耳许可协议下的某些里程碑付款、我们的上市公司合规成本、以及用于营运资金和其他一般企业目的提供资金。根据我们目前的业务计划和假设，我们认为现有的现金及现金等价物足以支持我们的营业费用和资本支出要求，直到2025年初。我们预计现有的现金及现金等价物能够继续支持我们的营业费用和资本支出要求的时间取决于可能被证明错误的计划和假设，我们可能比目前预期的更早使用可用的资本资源。变化的情况，其中一些可能超出我们的控制范围，可能导致可用现金减少或使我们消耗资本的速度显著加快，我们可能需要或选择比计划更早寻求额外资金。
我们将需要通过公开或股权投资发行、债务融资、合作与许可安排或其他来源获得进一步资金，这可能会稀释我们的股东权益或限制我们的经营活动。通过发行股权或可转换债务证券筹集额外资金可能会导致我们的股东经历大幅稀释。通过债务融资筹集额外资金可能涉及限制我们业务活动和选择的条款。若我们通过合作和许可安排筹集额外资金，可能不得不放弃对我们的药物发现和其他技术、开发项目或产品候选者的宝贵权利，或以对我们不利的条件授予许可证。根据当前的经济和市场状况，额外资金可能并不会以有利的条件向我们提供，甚至根本无法获取。我们没有任何承诺的外部资金来源。由于通货膨胀和其他经济市场状况、乌克兰和以色列的战争、无法维持在纳斯达克资本市场的上市地位，或其他因素，市场波动性增加。
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还可能对我们在需要时获得资本的能力产生不利影响。我们未能在需要时或以可接受的条件筹集资金将对我们的财务状况和我们推行业务战略的能力产生负面影响，我们可能不得不推迟、缩小范围、暂停或取消一项或多项临床前项目、临床试验或未来的商业化工作，或削减我们的运营。
根据亚利桑那州立大学 2014-15,披露有关实体持续经营能力的不确定性（副主题 205-40), 我们已经评估了总体上是否存在一些条件和事件，使人们对我们在未经审计的简明合并财务报表发布之日起一年内继续作为持续经营企业的能力产生了重大怀疑。鉴于我们现有的现金资源以及当前和预期的营业亏损和负现金流，我们预计在此之前需要额外的资金 一年 我们未经审计的简明合并财务报表发布周年纪念日，此类额外资本可能无法按可接受的条件或根本无法在需要时提供。因此，我们得出的结论是，这些情况以及与我们获得额外资金的能力相关的不确定性使人们对我们在未经审计的简明合并财务报表发布之日起一年内继续作为持续经营企业的能力产生了重大怀疑。
作为一家公司，我们正处于发展的早期阶段，我们有限的运营历史可能使评估我们的成功能力变得困难。
我们于2018年12月成立，迄今为止，我们的业务主要集中在许可候选产品、筹集资金、建立管理团队和基础设施以及进行临床前研究和早期临床试验上。我们尚未表现出获得监管部门批准、以商业规模生产产品或与合同制造组织合作以代表我们这样做的能力，或开展成功商业化所需的销售和营销活动的能力。因此，对我们未来成功或可行性的任何预测都可能不像我们有更长的运营历史或成功开发和商业化产品的历史那样准确。此外，我们最终需要从一家以发展为重点的公司过渡到一家能够开展商业活动的公司。我们可能会遇到不可预见的开支、困难、并发症和延误，并且可能无法成功完成这样的过渡。
拜耳许可协议规定我们有义务支付重要的里程碑和特许权使用费，其中一些将在我们的任何其他候选产品商业化之前触发，我们可能无法筹集额外资本或建立足以在到期时支付这些金额的战略联盟。
在某些开发、监管和销售里程碑事件实现后，我们将负责根据拜耳许可协议支付未来的巨额或有付款和特许权使用费，其中一些事件可能发生在我们的任何候选产品商业化之前。在这种情况下，我们将需要在我们能够从任何候选产品的商业销售中获得足够的收入（如果有）之前支付这些款项。因此，我们将需要获得大量额外资金或建立战略联盟才能支付这些款项，而且无法保证我们将拥有支付此类款项所需的资金，也无法保证我们能够以可接受的条件或完全获得必要的资金，也无法保证在足以支付这些款项的水平上建立战略联盟。如果我们无法支付这些款项，我们将违反《拜耳许可协议》，该协议如果得不到解决，将赋予拜耳终止协议或寻求其他补救措施的权利，这将对我们的业务以及我们开发和商业化当前候选产品、筹集资金或继续运营的能力产生重大不利影响。
我们可能永远无法实现或维持盈利能力。
我们不知道何时或是否会盈利。迄今为止，我们尚未将任何产品商业化，也没有通过产品销售产生任何收入。我们预计短期内不会产生任何产品收入。为了实现并保持盈利，我们必须成功地开发、获得监管部门批准和商业化我们的一种或多种候选产品。这将要求我们在一系列具有挑战性的活动中取得成功，包括完成候选产品的临床前研究和临床试验，发现和开发其他候选产品，为成功完成临床试验的任何候选产品获得监管部门的批准，为任何批准的产品建立商业化能力，以及使任何批准的产品获得市场认可。我们可能永远无法在这些活动中取得成功。即使我们在这些活动中取得了成功，我们也可能永远无法创造足以实现或维持盈利能力的收入。
由于与生物技术产品开发和商业化相关的众多风险和不确定性，我们无法准确预测是否以及何时实现盈利。如果美国食品药品管理局或其他司法管辖区的任何类似监管机构要求我们在目前预计进行的研究或临床试验之外进行临床前研究或临床试验，或者如果临床前研究成功，向美国食品药品管理局提交IND申请、BLA或保密协议、生产临床试验用品和完成候选产品的临床试验时出现任何延迟或并发症，我们的费用可能会大幅增加以及我们的实现能力盈利能力可能会进一步延迟。即使我们实现盈利，我们也可能无法在后续时期维持盈利能力。
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与监管审批及其他法律合规事项相关的风险
我们可能无法获得美国或外国的监管批准，因此可能无法将我们的产品候选者商业化。
我们的产品候选者受到广泛的政府法规的监管，涉及研究、测试、开发、制造、安全、剂量选择与优化、有效性、批准、记录保存、报告、标签、存储、包装、广告与促销、定价、市场营销及分销等诸多方面。在美国及许多外国管辖区，必须成功完成严格的前临床测试和临床试验，以及广泛的监管审批流程，才能将新药上市。满足这些和其他监管要求既昂贵又耗时，还存在不确定性，并可能受到意外延误。我们无法保证我们可能开发的任何产品候选者将通过所有必要的测试，并获得我们开始销售所需的监管批准。
我们尚未进行、管理或完成大规模或关键临床试验，也没有管理与FDA或任何其他监管机构的监管审批流程，涉及我们的产品候选者。获得FDA和其他监管机构批准所需的时间不可预测，并且需要成功完成广泛的临床试验，这通常需要数年时间，具体取决于产品候选者的类型、复杂性和新颖性。FDA及其外国同行在评估临床试验数据时使用的标准在药物开发期间可能会变化，这使得预测它们将如何适用变得困难。我们还可能由于新的政府法规（包括未来的立法或行政措施）、政策变化或药物开发、临床试验和FDA监管审查期间的新举措而遇到意外的延误或增加成本。例如，在美国，FDA的Optimus计划已改变肿瘤学中的剂量寻找和剂量优化范式，强调选择最大化药物的有效性、安全性和耐受性的剂量，这可能会增加我们的临床试验的开发时间和成本。此外，欧盟于2022年1月全面实施欧盟临床试验条例，英国的药品和健康产品监管局将英国转变为完全独立的临床试验监管框架，这两者都可能导致重大不确定性和延误。
任何延迟或未能获取产品候选者所需的批准，将对我们从该产品候选者产生营业收入的能力产生重大和不利的影响。此外，任何批准将产品候选者投放市场的监管批准可能会对我们可以营销的产品候选者的批准用途或适应症，以及该产品候选者的标签或其他限制施加重大限制。此外，FDA有权要求作为批准新药申请(NDA)或生物制品许可申请(BLA)的一部分的风险评估和缓解策略，或在批准后，可能会对已批准的产品候选者的分销或使用施加进一步的要求或限制。这些限制和限制可能会显著限制产品候选者的市场规模，并影响第三方支付方的报销。
我们还受制于众多外国监管要求，涉及临床试验的进行、制造和营销授权、定价以及第三方报销等方面。外国监管批准过程在各国之间有所不同，并且通常包括与FDA批准相关的大多数如果不是所有的风险，以及由于满足外国管辖区的地方规定而产生的风险。此外，获得批准所需的时间可能与获得FDA批准所需的时间不同。任何在该外国管辖区内获得产品候选者的外国监管批准的延迟或失败，将对我们从该产品候选者产生营业收入的能力产生重大和不利的影响。
我们当前或未来的产品候选者可能会在单独使用或与其他批准产品或研究性新药联合使用时，导致不良事件、毒性或其他不良副作用，这可能导致安全性评估不足以抑制监管批准、防止市场接受、限制其商业潜力，或导致重大负面后果。
如果我们的产品候选者在临床前研究或临床试验中单独使用或与其他已批准的产品或新药联合使用时，出现较高且不可接受的副作用严重性和发生率或意外特征，我们可能需要中断、延迟或放弃其开发，或将开发限制到更狭窄的用途或子群体中，在这些子群体中，不良副作用或其他特征的发生率较低、严重性较轻，或从风险收益的角度看更加可接受。这些结果可能导致更严格的标签、实施风险评估和缓解策略，或者导致FDA或其相应的外国监管机构延迟或拒绝监管批准。与治疗相关的副作用也可能影响患者招募或已注册受试者完成试验的能力，或导致潜在的产品责任索赔。任何这些情况都可能导致更严格的标签，或导致FDA或相应的外国监管机构延迟或拒绝监管批准，并可能阻止我们实现或维持受影响产品候选者的市场接受度，这可能会损害我们的业务和前景。
我们正在进行中的和计划中的临床试验中的患者将来可能会遭受以前未观察到的重大不良事件或其他副作用。我们的一些产品候选者可能作为慢性疗法使用或在儿童人群中使用，针对这一人群，
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安全问题可能受到监管机构的特别审查。此外，如果这些产品候选者与其他治疗结合使用，可能会加重与其他治疗相关的不良事件。接受我们产品候选者治疗的患者可能也正在接受外科手术、放疗和化疗治疗，这些治疗可能会引起与我们产品候选者无关的副作用或不良事件，但仍可能影响我们的临床试验的成功。将危重病患者纳入我们的临床试验可能会导致由于这些患者可能正在使用的其他治疗或药物，或由于这些患者疾病的严重性而导致的死亡或其他不良医疗事件。
如果在我们当前或未来的临床试验中观察到显著的不良事件或其他副作用，我们可能在招募患者参加这些临床试验时遇到困难，患者可能会中途退出临床试验，或者我们可能被要求完全放弃该产品候选者的临床试验或开发工作。我们、FDA或其他类似的监管机构或机构审查委员会可能因各种原因在任何时间暂停某一产品候选者的临床试验，包括认为这些试验的受试者面临不可接受的健康风险或不良副作用。一些在生物技术行业开发的潜在疗法在早期试验中最初显示出治疗潜力，但后来发现它们会引起副作用，阻碍其进一步开发。即便这些副作用并不妨碍产品候选者获得或保持市场批准，不良副作用也可能由于其耐受性相较于其他疗法而抑制市场接受度。这些发展中的任何一项都可能严重损害我们的业务和前景。
另外，如果我们的任何产品候选者获得市场批准，与这些产品候选者相关的毒性在临床试验中未见的情况也可能在批准后出现，并导致需要进行额外的临床安全试验，药品标签上增加额外禁忌症、警告和注意事项，实施风险评估与缓解策略，对该产品的使用施加重大限制，或将该产品从市场撤回。我们无法预测我们的产品候选者是否会在人体中引起毒性，从而妨碍或导致监管批准的撤销，这基于临床前研究或早期临床试验。
在一个管辖区获得并维持对我们产品候选者的监管批准并不意味着我们将在其他管辖区成功获得这些产品候选者的监管批准。
在一个管辖区获得并维持对我们产品候选者的监管批准并不能保证我们能够在任何其他管辖区获得或维持监管批准。在一个管辖区获得监管批准的失败或延迟可能会对其他地方的批准流程产生负面影响。批准程序因管辖区而异，并可能涉及与美国不同的要求和行政审查期，包括额外的临床前研究或临床试验，因为在一个管辖区进行的临床试验可能不会被其他管辖区的监管机构接受。在美国以外的许多管辖区，一个产品候选者必须在可以在该管辖区销售之前获得报销批准。在某些情况下，我们打算对产品收取的价格也需获得批准。获得国外的监管批准以及建立和维持对外国监管要求的合规可能导致我们面临显著的延迟、困难和成本，并可能延迟或阻止我们产品在某些管辖区的推出。如果我们未能遵守国际市场的监管要求，或未能获得适用的市场批准，我们的目标市场将会缩小，我们实现产品候选者完全市场潜力的能力将受到损害。
即使我们的产品候选者获得监管批准，它们也将受到重要的上市后监管要求和监督。
我们可能会获得的针对我们产品候选者的任何监管批准将要求向监管机构提交报告，并进行监测以监控产品候选者的安全性和有效性，可能包含与特定年龄组的使用限制、警告、预防措施或禁忌症相关的重大限制，并可能包括繁重的上市后研究或风险管理要求。例如，FDA可能要求制定风险评估和缓解战略，以批准我们的产品候选者，这可能涉及对药物指南、医生培训和沟通计划的要求，或确保安全使用的其他要素，例如限制分销方法、患者登记和其他风险最小化工具。此外，如果FDA或外国监管机构批准我们的产品候选者，产品候选者的制造流程、标签、包装、分销、不良事件报告、储存、广告、推广、进口、出口和记录保存将需遵循广泛且持续的监管要求。这些要求包括安全性和其他上市后信息、报告和注册的提交，此外还有 正在进行中 遵循cGMP要求和良好临床实践，以进行任何我们在批准后进行的临床试验。此外，药品制造商及其设施需接受FDA和其他监管机构的持续审查和定期、不提前通知的检查，以确保遵守cGMP法规和标准。如果我们或监管机构发现产品存在以前未知的问题，例如不寻常严重程度或频率的不良事件，或制造该产品的设施存在问题，监管机构可能会对该产品、制造设施或我们施加限制，包括要求召回或撤回该产品。
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the market or suspension of manufacturing. In addition, failure to comply with FDA and other comparable foreign regulatory requirements may subject our company to administrative or judicially imposed sanctions, including:
| • | delays in or the rejection of product approvals; |
| • | restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials; |
| • | restrictions on the products, manufacturers, or manufacturing processes; |
| • | warning or untitled letters; |
| • | civil and criminal penalties; |
| • | injunctions; |
| • | suspension or withdrawal of regulatory approvals; |
| • | seizures, detentions, or import bans; |
| • | voluntary or mandatory recalls and publicity requirements; |
| • | total or partial suspension of production; and |
| • | imposition of restrictions on operations, including costly new manufacturing requirements. |
The occurrence of any event or penalty described above could inhibit our ability to commercialize our product candidates and generate revenue, require us to expend significant time and resources in response, generate negative publicity, and harm our business and prospects.
There can be no assurance that we will be able to pursue accelerated or other expedited approval of any of our product candidates, and the failure to obtain such accelerated or other expedited approval would result in a longer time period to commercialization of such product candidates, which could increase the cost of development and harm our competitive position in the marketplace.
We may choose to seek an accelerated approval for one or more of our product candidates. Under the accelerated approval program, the FDA may grant expedited approval to a product candidate designed to treat a serious or life-threatening condition that provides meaningful therapeutic benefit over available therapies upon a determination that such product candidate has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as irreversible morbidity or mortality. The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage but is a clinically important improvement from a patient and public health perspective. If granted, accelerated approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug’s clinical benefit. If such post-approval studies fail to confirm the drug’s clinical benefit, the FDA may withdraw its approval of the drug.
There can be no assurance that we will decide to pursue, or subsequent to FDA feedback continue to pursue, accelerated approval or any other form of expedited development, review, or approval. Furthermore, even if we decide to submit an application for accelerated approval or receive an expedited regulatory designation (e.g., breakthrough therapy designation) for our product candidates, there can be no assurance that such submission or application would be accepted or that any expedited development, review, or approval would be granted on a timely basis, or at all. The FDA or other comparable foreign regulatory authorities could also require us to conduct further studies prior to considering our application or granting approval of any type. A failure to obtain accelerated approval or any other form of expedited development, review, or approval for our product candidates would result in a longer time period to commercialization of such product candidates, could increase the cost of development of such product candidates, and could harm our competitive position in the marketplace.
We may be required to defend lawsuits or pay damages in connection with the alleged or actual violation of healthcare statutes such as fraud and abuse laws, and our corporate compliance programs cannot guarantee that we will always be in compliance with all relevant laws and regulations.
In addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal healthcare laws, commonly referred to as “fraud and abuse” laws, have been applied in recent years to restrict certain marketing practices in the pharmaceutical industry. Other jurisdictions, such as Europe, have similar laws. These laws include false claims and anti-kickback statutes. Anti-kickback laws make it illegal for a manufacturer to offer or pay any remuneration in exchange for, or to induce, the referral of business, including the purchase of a product. False claims laws prohibit anyone from knowingly and willingly presenting, or causing to be presented, for payment to third-party payors, including Medicare and Medicaid, claims for reimbursed products or services that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or services.
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Our activities relating to the sale and marketing of our products will be subject to scrutiny under these laws and regulations. It may be difficult to determine whether our activities comply with these complex legal requirements, and our corporate compliance programs cannot guarantee that we will always be in compliance with all relevant laws and regulations. Violations are punishable by significant criminal and civil fines and other penalties, as well as the possibility of exclusion of the affected product from coverage under governmental healthcare programs, including Medicare and Medicaid. If U.S. or foreign governments were to investigate or make allegations against us or any of our employees, or sanction or convict us or any of our employees, for violations of any of these legal requirements, this could have a material adverse effect on our business and prospects.
Our employees, agents, contractors, or collaborators may engage in misconduct or other improper activities.
We cannot ensure that our corporate compliance controls, policies, and procedures will in every instance protect us from acts committed by our employees, agents, contractors, or collaborators, including contract research organizations, electronic data capture companies, data management companies, contract clinical research associates, medical institutions, clinical investigators, contract laboratories, and other third parties, that would violate the laws or regulations of the jurisdictions in which we operate, including healthcare, employment, foreign corrupt practices, environmental, competition, and privacy laws and regulations. Such improper actions could subject us to civil or criminal investigations, and civil penalties, and could adversely impact our business and prospects.
For example, we are subject to the Foreign Corrupt Practices Act and similar anti-bribery or anti-corruption laws, regulations, and rules of other countries in which we operate. The Foreign Corrupt Practices Act generally prohibits offering, promising, giving, or authorizing others to give, anything of value, either directly or indirectly, to a non-U.S. government official in order to influence official action or otherwise obtain or retain business. The Foreign Corrupt Practices Act also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. Our business is heavily regulated and therefore involves significant interaction with public officials, including officials of non-U.S. governments. Additionally, in many other countries, the healthcare providers who prescribe pharmaceuticals are employed by their government, and the purchasers of pharmaceuticals are government entities, and our dealings with these prescribers and purchasers are therefore subject to regulation under the Foreign Corrupt Practices Act.
There is no certainty that our employees, agents, contractors, or collaborators, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. While we have implemented codes of conduct and other policies and controls to mitigate the risk of non-compliance with anti-corruption and anti-bribery laws, it is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from government investigations or other actions stemming from a failure to comply with these laws or regulations. Violations of such laws and regulations could result in, among other things, administrative, civil and criminal fines and sanctions against us, our directors, officers, or employees, the closing of our facilities, requirements to obtain export licenses, exclusion from participation in federal healthcare programs including Medicare and Medicaid, implementation of compliance programs, integrity oversight and reporting obligations, and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our products in one or more countries and could materially damage our business and prospects.
Risks Related to Our Dependence on Third Parties
Our manufacturing processes are complex, and we do not currently have our own manufacturing capabilities and will initially rely on third-party manufacturers for the development, clinical trials, and commercialization of any product candidate we may develop or sell.
The processes for manufacturing our product candidates, particularly our bioconjugation candidates, are very complex and take significant time and resources to develop and implement. In addition, our supply chain of raw materials, consumables, intermediates, drug substances, and drug products for use in our clinical trials and, if approved by regulatory authorities, commercialization rely on a worldwide supply chain. We do not currently operate our own manufacturing facilities or have our own manufacturing capabilities for clinical or commercial production of our product candidates under development and intend to initially rely on third-party manufacturers. Third-party manufacturers that have the capabilities, processes, and expertise that we need for our product candidates and that can meet our quality standards may be difficult to identify or retain, and even if retained, such third-party manufacturers may not be able to perform the manufacturing services we require within our planned timeframes. We anticipate relying on a limited number of third-party manufacturers until such time, if any, as we decide to expand our operations to include manufacturing capabilities. Certain of our key third-party manufacturers are located in China, and the United States and China are currently experiencing geopolitical tensions that could result in legislation or government intervention that adversely impacts our ability to
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manufacture in China, which could necessitate transitioning such manufacturing to other third-party manufacturers and increase costs, delay manufacturing, and lengthen timelines. In addition, the European Union, which is experiencing, and could continue to experience, the impact of the wars in Ukraine and Israel on supply chains, and other economic matters, including inflation. Such third-party manufacturers may implement, and certain of such manufacturers have implemented, price increases that could negatively impact our ability to afford their services.
If the FDA or comparable foreign regulatory authorities approve any of our product candidates for commercial sale, or if we significantly expand our clinical trials, we will need to manufacture them in larger quantities, and we may not be able to successfully increase the manufacturing capacity for any of our product candidates in a timely or economic manner or at all. Until such time, if any, that we directly control the manufacturing of our product candidates, we will have limited control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance, and qualified personnel, and we will be dependent on our third-party manufacturing partners for compliance with current cGMP requirements for the manufacture of our product candidates. If our third-party manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or comparable foreign regulatory authorities, we may not be able to secure or maintain regulatory approval for our product candidates. In addition, if any third-party manufacturer makes improvements in the manufacturing process for our product candidates, we may not own, or may have to share, the intellectual property rights to such improvements.
Any inability to identify and retain third-party manufacturers on a cost-effective basis, any performance failure on the part of such manufacturers, or any disruption in our supply chain as a result of economic uncertainty, political unrest, the wars in Ukraine and Israel, trade disputes, natural disasters, pandemics or epidemics, climate change, or otherwise, could delay the development, clinical trials, regulatory approval, or commercialization of our product candidates, which would harm our business and prospects.
If we fail to enter into and maintain successful collaborative arrangements or strategic alliances for our product candidates, we may have to reduce or delay our product candidate development or increase our expenditures.
An important element of our strategy for developing, manufacturing, and commercializing our product candidates is entering into collaborative arrangements or strategic alliances with pharmaceutical companies, research institutions, or other industry participants to advance our programs and enable us to maintain our financial and operational capacity. We face significant competition in seeking such collaborations and alliances. We may not be able to negotiate such collaborations or alliances on acceptable terms if at all. In addition, such collaborations or alliances may be unsuccessful. If we fail to create and maintain suitable collaborations or alliances, we may have to limit the size or scope of, or delay, one or more of our research or development programs. In addition, these kinds of collaborative arrangements and strategic alliances may place certain aspects of the development of our product candidates outside of our control, require us to relinquish important rights, limit our commercial opportunities, or otherwise be on terms unfavorable to us.
Dependence on collaborative arrangements or strategic alliances will subject us to several risks, including the risks that:
| • | we may not be able to control the amount and timing of resources that our collaborators may devote to our product candidates; |
| • | our collaborators may experience financial difficulties; |
| • | we may be required to relinquish important rights such as marketing and distribution rights; |
| • | business combinations or significant changes in a collaborator’s business strategy may adversely affect its willingness or ability to complete its obligations under any arrangement; |
| • | a collaborator could independently move forward with a competing product candidate developed either independently or in collaboration with others, including our competitors; and |
| • | collaborative arrangements are often terminated or allowed to expire, which would delay development and may increase the cost of developing our product candidates. |
Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
As product candidates proceed through preclinical and clinical trials towards potential approval and commercialization, various aspects of the development program, such as manufacturing methods and formulation, may be altered along the way to optimize processes and results or due to other factors. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause our current or future product candidates to perform differently and affect the costs, results, or timing of planned preclinical or clinical trials conducted with the altered materials. Such changes may also require additional testing, FDA notification, or FDA approval. This could delay completion of preclinical studies or clinical trials, require the conduct of bridging clinical trials, or repetition of one or more clinical trials, increase clinical trial costs, delay approval of product candidates, or jeopardize our ability to commence sales and generate revenue.
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Our applications for regulatory approval could be delayed or denied due to problems with studies conducted before we in-licensed the rights to some of our product candidates.
We currently license all of our product candidates from Bayer pursuant to the Bayer License Agreement. Our present development involving these product candidates relies to a certain extent upon previous development conducted by Bayer or other third parties over whom we had no control and before we in-licensed such product candidates. To receive regulatory approval of a product candidate, we must present all relevant data and information obtained during its development, including research conducted prior to our licensure of such product candidate. Although we are not currently aware of any such problems, any problems that emerge with preclinical or clinical development conducted prior to our in-licensing may affect future results or our ability to document prior development and conduct clinical trials, which could delay, limit, or prevent regulatory approval for our product candidates.
Due to our intention to rely in part on contract research organizations and other third parties to conduct clinical trials, we may be unable to directly control the timing, conduct, and expense of all aspects of our clinical trials.
We intend to rely in part on contract research organizations, electronic data capture companies, data management companies, contract clinical research associates, medical institutions, clinical investigators, contract laboratories, and other third parties to assist us in conducting clinical trials and obtaining regulatory approvals for our product candidates. In addition, we intend to rely in part on third parties to assist with our preclinical development of such product candidates. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, need to be replaced, or the quality or accuracy of the data they obtain is compromised due to their failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our preclinical development activities or clinical trials may be extended, delayed, suspended, or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates.
Risks Related to Our Intellectual Property
If we fail to comply with our obligations under any license, collaboration, or other agreement, including the Bayer License Agreement, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product candidates.
Pursuant to the Bayer License Agreement, we have been granted a license from Bayer to certain intellectual property rights covering VIP236, VIP943, VIP924, enitociclib, and our other product candidates. If, for any reason, our licenses under the Bayer License Agreement are terminated or we otherwise lose those rights, our business will be significantly and adversely affected. The Bayer License Agreement imposes, and any future collaboration agreements or license agreements we may choose to enter are likely to impose, various development, commercialization, funding, milestone payment, royalty, diligence, sublicensing, patent prosecution and enforcement, or other obligations on us. If we breach any material obligations, or use the intellectual property licensed to us in an unauthorized manner, we may be required to pay damages, and Bayer and any other licensor, may have the right to terminate the license, which could result in us being unable to develop, manufacture, and sell products that are covered by the licensed technology or having to negotiate new or reinstated licenses on less favorable terms, or enable a competitor to gain access to the licensed technology.
Moreover, disputes may arise regarding intellectual property subject to a licensing agreement, including:
| • | the scope of rights granted under the license agreement and other interpretation-related issues; |
| • | the extent to which our product candidates, technology, and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; |
| • | the sublicensing of patent and other rights under our third-party relationships; |
| • | our diligence obligations under the license agreement and what activities satisfy those diligence obligations; |
| • | the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by us, our licensors, and our partners; and |
| • | the priority of invention of patented technology. |
In addition, the Bayer License Agreement under which we license our core intellectual property and technology is complex, and certain provisions in the agreement may be susceptible to multiple interpretations. The resolution of any disagreement that may arise as a matter of contract interpretation could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under that agreement, either of which could have a
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material adverse effect on our business and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidate, which could have a material adverse effect on our business and prospects.
Our success depends on our ability to protect our intellectual property and our proprietary technologies.
Our commercial success depends in part on our ability to obtain and maintain intellectual property for VIP236, VIP943, VIP924, enitociclib, and our other product candidates, proprietary technologies, and their uses as well as our ability to operate without infringing upon the proprietary rights of others. We generally seek to protect our proprietary position by filing patent applications in the U.S. and abroad related to our product candidates, technologies, and their uses that are important to our business. We also seek to protect our proprietary position by acquiring or in-licensing relevant issued patents or pending applications from third parties.
Pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless, and until, patents issue from such applications, and then only to the extent the issued claims cover the technology. There can be no assurance that our patent applications or the patent applications of our licensors will result in additional patents being issued or that issued patents will afford sufficient protection against competitors with similar technology, nor can there be any assurance that the patents issued will not be infringed, designed around, or invalidated by third parties.
Even issued patents may later be found invalid or unenforceable or may be modified or revoked in proceedings instituted by third parties before various patent offices or in courts. The degree of future protection for our and our licensors’ proprietary rights is uncertain. Only limited protection may be available and may not adequately protect our rights or permit us to gain or keep any competitive advantage. These uncertainties and/or limitations in our ability to properly protect the intellectual property rights relating to our product candidates could have a material adverse effect on our business and prospects.
Although we have licensed issued patents that cover certain of our product candidates and technologies, we do not have issued patents covering all our product candidates and technologies, and we may need additional issued patents covering such product candidates and technologies. We cannot be certain that the claims in any of our U.S. pending patent applications, corresponding international patent applications, or those of our licensors, will be considered patentable by the USPTO, courts in the U.S., or the patent offices and courts in foreign countries, nor can we be certain that the claims in our issued patents or our licensor’s issued patents will not be found invalid or unenforceable if challenged.
The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or any of our potential future collaborators will be successful in protecting our product candidates by obtaining and defending patents. These risks and uncertainties include the following:
| • | the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment, and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; |
| • | patent applications may not result in any patents being issued; |
| • | patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable, or otherwise may not provide any competitive advantage; |
| • | our competitors, many of whom have substantially greater resources than we do and many of whom have made significant investments in competing technologies, may seek, or may have already obtained, patents that will limit, interfere with, or eliminate our ability to make, use, and sell our potential product candidates; |
| • | there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the U.S. for disease treatments that prove successful as a matter of public policy regarding worldwide health concerns; and |
| • | countries other than the U.S. may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop, and market competing product candidates. |
The patent prosecution process is also expensive and time-consuming, and we and our licensors may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner or in all jurisdictions where protection may be commercially advantageous. It is also possible that we or our licensors will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection.
In addition, although we enter into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of our research and development output, such as our employees, outside scientific collaborators, contract research organizations, third-party manufacturers, consultants, advisors, and other third parties, any of these parties may breach such agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to obtain patent protection.
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Given the amount of time required for the development, testing, and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected.
The patent position of biopharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. Our pending and future patent applications and those of our licensors may not result in patents being issued which protect our product candidates or which effectively prevent others from commercializing competitive product candidates.
In addition, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Even if patent applications we own or in-license currently or in the future issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage. Any patents that we own or in-license may be challenged or circumvented by third parties or may be narrowed or invalidated as a result of challenges by third parties. Consequently, we do not know whether our product candidates will be protectable or remain protected by valid and enforceable patents. Our competitors or other third parties may be able to circumvent our patents or the patents of our licensors by developing similar or alternative technologies or products in a non-infringing manner which could materially adversely affect our business and prospects.
Furthermore, our ability to obtain and maintain valid and enforceable patents also depends on whether the differences between our technology and relevant prior art allow our technology to be patentable over the prior art. Since patent applications in the United States and most other countries are confidential for a period after filing, we may not be certain that we or our licensors are the first to file any patent application related to our drug product candidates or technologies, potentially having a material adverse effect on our business and prospects. This will require us to be to be aware of the possibility of adverse determinations in any such submissions or proceedings, potentially reducing the scope or enforceability of, or invalidate, our patent rights, which would adversely affect our competitive position.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents or the patents of our licensors may be challenged in the courts or patent offices in the U.S. and abroad. We may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant review and inter partes review, or other similar proceedings challenging our owned patent rights. An adverse determination in any such submission, proceeding, or litigation could reduce the scope of, or invalidate or render unenforceable, our patent rights, allow third parties to commercialize our product candidates, and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights. Moreover, our patents or the patents of our licensors may become subject to post-grant challenge proceedings, such as oppositions in a foreign patent office, that challenge our priority of invention or other features of patentability with respect to our patents and patent applications and those of our licensors. Such challenges may result in loss of patent rights, loss of exclusivity, or in patent claims being narrowed, invalidated, or held unenforceable, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our product candidates. Such proceedings also may result in substantial cost and require significant time from our scientists and management, even if the eventual outcome is favorable to us. In addition, if the breadth or strength of protection provided by our patents and patent applications or the patents and patent applications of our licensors is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop, or commercialize current or future product candidates.
The validity, scope, and enforceability of any patents that cover a biologic subject to approval by the FDA via a BLA, such as VIP943 and VIP924, can be challenged by third parties.
For biologics subject to approval by the FDA via a BLA, such as VIP943 and VIP924, the BPCIA provides a mechanism for one or more third parties to seek FDA approval to manufacture or sell biosimilar or interchangeable versions of brand name biological products. If a biosimilar applicant successfully challenges our asserted patent claims, it could result in the invalidation of, or render unenforceable, some or all our relevant patent claims or result in a finding of non-infringement. Such litigation or other proceedings to enforce or defend our intellectual property rights are complex in nature, may be very expensive and time-consuming, may divert our management’s attention from our core business, and may result in unfavorable results that could limit our ability to prevent third parties from competing with VIP943 and VIP924 or any future biological product candidates.
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We may be involved in lawsuits to protect or enforce our patents or our licensors’ patents, which could be expensive, time consuming, and unsuccessful. Further, our issued patents or our licensors’ patents could be found invalid or unenforceable if challenged in court.
Competitors may infringe our intellectual property rights. To prevent infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition, in a patent infringement proceeding, a court may decide that a patent we own or in-license is not valid, is unenforceable, or is not infringed. If we or any of our potential future collaborators were to initiate legal proceedings against a third party to enforce a patent directed at one of our product candidates, the defendant could counterclaim that our patents or the patents of our licensors are invalid or unenforceable in whole or in part.
Third parties may also raise similar invalidity claims before the USPTO or patent offices abroad, even outside the context of litigation, and prior art could render our patents or our licensors’ patents invalid. Such mechanisms include re-examination, post-grant review, inter partes review, derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in the revocation of, cancellation of or amendment to our patents or our licensors’ patents in such a way that they no longer cover our current or future product candidates, technologies, or VersAptx Platform. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. There is also no assurance that there is not prior art of which we are aware, but which we do not believe affects the validity or enforceability of a claim in our patents and patent applications or the patents and patent applications of our licensors, which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim.
If a third party were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our current or future product candidates, technologies, or VersAptx Platform. In addition, if the breadth or strength of protection provided by our patents and patent applications or the patent and patent applications of our licensors is threatened, it could dissuade companies from collaborating with us to license, develop, or commercialize current or future product candidates. Such a loss of patent protection would have a material adverse impact on our business and prospects. Moreover, the issuance of a patent does not necessarily give us the right to practice the patented invention. Third parties may have blocking patents that could prevent us from marketing our own patented products and practicing our own patented technologies.
Even if resolved in our favor, litigation or other legal proceedings relating to our intellectual property rights may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities. In addition, such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or other legal proceedings relating to our intellectual property rights, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation or other proceedings.
Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common stock to decline.
During any intellectual property litigation, there could be public announcements of the initiation of the litigation as well as results of hearings, rulings on motions, and other interim proceedings in the litigation. If securities analysts or investors regard these announcements as negative, the perceived value of our existing products, programs, or intellectual property could be diminished. Accordingly, the market price of shares of our common stock may decline. Such announcements could also harm our reputation or the market for our future products, which could have a material adverse effect on our business and prospects.
Derivation proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to cease using the related technology or to attempt to license rights from the prevailing party.
Derivation proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority of inventions with respect to our patents or patent applications or those of our licensors. An unfavorable outcome could require us to cease using relevant inventions or to attempt to license rights from the prevailing party. Our business could be harmed if the prevailing party would not offer us a license on commercially reasonable terms. Our defense of derivation proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. In addition, the uncertainties associated with such proceedings could have a material adverse effect on our ability to raise the funds necessary to continue clinical trials or research programs, license necessary technology from third parties, or enter into development or manufacturing partnerships that would help us bring our product candidates to market.
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Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
Obtaining and enforcing patents in the pharmaceutical industry involve a high degree of technological and legal complexity. Changes in either the patent laws or in the interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property, increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents and weaken our ability to obtain new patents or to enforce our existing patents and the patents we might obtain or license in the future.
We may be subject to claims challenging the inventorship or ownership of our licensor’s patents, our patents and other intellectual property.
We may also be subject to claims that former employees or other third parties have an ownership interest in our licensor’s patents, our patents, or other intellectual property. Litigation or other proceedings may be necessary to defend against these and other claims challenging inventorship or ownership. For example, because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights. Such an outcome could have a material adverse effect on our business and prospects. Even if we are successful in defending against such claims, litigation could result in substantial costs and distraction to management and other employees.
Patent terms may not protect our competitive position on our product candidates for an adequate amount of time.
Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open to competition from products of third parties. Given the amount of time required for the development, testing, and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
If we do not obtain patent term extension for our product candidates, our business may be materially harmed.
Depending upon the timing, duration and specifics of FDA marketing approval of our product candidates, one or more of our patents or in-licensed patents may be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984. This Act permits a patent restoration term of up to five years as compensation for patent term lost during product development and FDA regulatory review. A maximum of one patent may be extended per FDA approved product as compensation for the patent term lost during FDA regulatory review. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, and only those claims covering such approved drug product, a method for using it, or a method for manufacturing it may be extended. Patent term extension may also be available in certain foreign countries upon regulatory approval of our product candidates. However, we may not be granted an extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents, or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. If we are unable to obtain patent term extension or restoration or the term of any such extension is less than we request, our competitors may obtain approval of competing products following our patent expiration, and our revenue could be reduced, possibly materially. Further, if this occurs, our competitors may take advantage of our investment in development and trials by referencing our clinical and preclinical data to launch their product earlier than might otherwise be the case.
We may not be able to protect our intellectual property rights throughout the world.
Filing, prosecuting and defending patents in all countries throughout the world can be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as in the United States. These products may compete with our product candidates, and our patents, the patents of our licensors, or other intellectual property rights may not be effective or sufficient to prevent them from competing.
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The requirements for patentability differ regionally. Some countries limit the enforceability of patents against government agencies or government contractors, while others have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. If we are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business and prospects may be adversely affected.
The standards applied by the USPTO and foreign patent offices in granting patents are not always applied uniformly or predictably. As such, we do not know the degree of future protection that we will have on our technologies and product candidates. While we will endeavor to protect our technologies and product candidates with intellectual property rights such as patents, the process of obtaining patents is time consuming, expensive, and unpredictable. Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of some countries do not favor patent enforcement and other intellectual property protection, which could make it difficult for us to stop infringement of our patents or our licensors’ patents or marketing of competing products in violation of our proprietary rights.
Beginning in March 2023, European patent applicants have the option of participating in the Unitary Patent System (“UPS”), subject to the jurisdiction of the Unitary Patent Court (“UPC”), on an issued patent-by-issued patent, or patent application-by-patent application basis. This new system is a significant change in European patent practice, and the UPC is a new court system, with no established legal precedent, resulting in uncertainty for patent holders and applicants. We will consider, case-by-case, with each individual patent or application, the risks and benefits of participating in the UPS. We will continue to monitor the evolution of the UPS and UPC, especially over the course of its seven-years’ transitional period as the new system and the new court gains footing.
Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents or the patents of our licensors at risk of not issuing or being invalidated or interpreted narrowly and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
Geopolitical actions in the United States and in foreign countries could increase the uncertainties and costs surrounding the prosecution, maintenance, or enforcement of our patent applications or issued patents or those of any current or future licensors. For example, United States and foreign government actions related to Russia’s invasion of Ukraine have limited and prevented the filing, prosecution, and maintenance of patent applications and issued patents in Russia, and actions by the Russian government allow Russian companies and individuals to exploit inventions owned by patentees from the United States without consent or compensation. These actions could adversely affect our business.
Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance fees, renewal fees, annuity fees, and various other governmental fees on patents and applications will be due to the USPTO and various foreign patent offices at many points over the lifetime of our licensor’s patents and applications and those that we own. We rely on our outside patent annuity service to pay these fees when due. Additionally, the USPTO and various foreign patent offices require compliance with many procedural, documentary, fee payment, and other similar provisions during the patent application process. We employ reputable law firms and other professionals to help us comply, and in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with rules applicable to the relevant jurisdiction. However, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If such an event were to occur, it could have a material adverse effect on our business and prospects.
If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest, and our business may be adversely affected.
We intend to use registered and unregistered trademarks or trade names to brand and market ourselves and our products and technologies. Our trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential business partners or customers in our markets of interest. At times, competitors may adopt trade names or trademarks like ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Our efforts to enforce or protect our proprietary rights related to trademarks and trade names may be ineffective and could result in substantial costs and diversion of resources. If we are unable to enforce and protect our trademarks and tradenames and establish name recognition based on our trademarks and trade names, we may not be able to compete effectively, and our business and prospects could be adversely affected.
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If we are unable to protect the confidentiality of our proprietary information, our business and competitive position would be harmed.
We rely on the protection of our proprietary information, including our technologies and know-how, to maintain our competitive position. Although we have taken steps to protect such information, including entering confidentiality agreements with third parties and confidential information and inventions agreements with employees, consultants, and advisors, we cannot provide any assurances that these parties would not breach such agreements and disclose our proprietary information, and we may not be able to obtain adequate remedies in the event of such breaches. Enforcing claims that a party illegally used or disclosed such information is difficult, expensive, and time-consuming, and the outcome is unpredictable.
Moreover, third parties may obtain or come upon this or similar information independently, and we would have no right to prevent them from using that technology or information to compete with us. If any of these events occurs or if we otherwise lose such protection the value of our proprietary information may be greatly reduced, and our competitive position would be harmed.
We may be subject to claims that we or our employees, agents, or consultants have wrongfully used or disclosed alleged confidential information or trade secrets of third parties.
We have entered and may enter in the future into non-disclosure and confidentiality agreements to protect the proprietary positions of third parties, such as outside scientific collaborators, contract research organizations, third-party manufacturers, consultants, advisors, potential partners, and other third parties. In addition, we may engage employees, agents, and consultants to assist us in the development of our product candidates who were previously employed at, or have previously provided or are currently providing services to, other pharmaceutical companies, including our competitors or potential competitors. We may become subject to claims or litigation where a third party asserts that we or our employees, agents, or consultants used or disclosed trade secrets or other information proprietary to such third parties. Defense of such matters, regardless of their merit, could involve substantial litigation expense and be a diversion from our business, and we cannot predict whether we would prevail in any such actions. In addition, third parties making claims against us may be able to sustain the costs of complex intellectual property litigation more effectively than we can because they have substantially greater resources. Moreover, intellectual property litigation, regardless of its outcome, may cause negative publicity, result in the disclosure of our confidential information in discovery, and adversely impact our ability to market or otherwise commercialize our product candidates and technologies. Failure to defend against any such claim could subject us to significant liability for monetary damages or prevent or delay our developmental and commercialization efforts, which could adversely affect our business and prospects. Even if we are successful in defending against such claims, such litigation could result in substantial costs and be a distraction to our management team and other employees.
We may need to license intellectual property from third parties, and such licenses may not be available on commercially reasonable terms or at all.
Third parties may hold intellectual property, including patent rights, that are important or necessary to the development or commercialization of our product candidates. in which case we would be required to obtain a license from such third parties on commercially reasonable terms. Such a license may not be available, or it may not be available on commercially reasonable terms. Our business would be harmed if we are not able to obtain such a license on commercially reasonable terms or at all or if a non-exclusive license is offered and our competitors gain access to the same intellectual property rights. In addition, even if we are able to obtain such a license, we may not have control over, nor the ability to provide input with respect to, the prosecution, maintenance, or enforcement of the patents that we license, and our licensors may fail to take the steps that we believe are necessary or desirable in order to obtain, maintain, defend and enforce the licensed patents.
Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
Our commercial success depends in part on avoiding infringement of the patents and proprietary rights of third parties. However, our research, development, and commercialization activities may be subject to claims that we infringe or otherwise violate patents or other intellectual property rights owned or controlled by third parties. Other entities may have or obtain patents or proprietary rights that could limit our ability to make, use, sell, offer for sale, or import our current or future product candidates, which could impair our competitive position. There is a substantial amount of litigation, and administrative proceedings, both within and outside the United States, involving patent and other intellectual property rights in the biopharmaceutical industry, including patent infringement lawsuits, oppositions, reexaminations, inter partes review proceedings, and post-grant review proceedings. Numerous third-party U.S. and foreign issued patents and pending patent applications exist in the fields in which we are developing product candidates. There may be third party patents or patent applications with claims to materials, formulations, methods of manufacture, or methods for treatment related to the use or manufacture of our product candidates.
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As the pharmaceutical industry expands and more patents are issued, the risk increases that our product candidates may be subject to claims of infringement of the patent rights of third parties. Because patent applications are maintained as confidential, until the relevant application is published, we may be unaware of third-party patents that may be infringed by commercialization of any of our product candidates, and we cannot be certain that we were the first to file a patent application related to a product candidate or technology. Moreover, because patent applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents that our product candidates may infringe. In addition, identification of third-party patent rights that may be relevant to our technology is difficult because patent searching is imperfect due to differences in terminology among patents, incomplete databases, and the difficulty in assessing the meaning of patent claims. There is also no assurance that prior art that we do not believe is relevant to our business may, ultimately be found to limit our ability to make, use, sell, offer for sale, or import our current or future products and impair our competitive position. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. Any claims of patent infringement asserted by third parties would be time consuming and could:
| • | result in costly litigation that may cause negative publicity or, if we were found to be infringing willfully, result in treble damages; |
| • | require us to enter into royalty or licensing agreements, which may not be available on commercially reasonable terms, or at all, or which might be non-exclusive, which could result in our competitors gaining access to the same technology; |
| • | require us to develop non-infringing technology, which may not be possible on a cost-effective basis; |
| • | cause development delays; |
| • | prevent us from commercializing any of our product candidates until the asserted patent expires or is held finally invalid or not infringed in a court of law; |
| • | subject us to significant liability to third parties; or |
| • | divert the time and attention of our technical personnel and management. |
Although no third party has asserted a claim of patent infringement against us as of the date of this report, others may hold proprietary rights that could prevent our product candidates from being marketed. For example, we are aware of issued patents that claim a method of treatment based upon a general mode of action. These claims could be alleged to cover enitociclib in certain treatment indications. While we believe that these patents are difficult to enforce and that we would have valid defenses to these claims of patent infringement, we cannot be certain that we would prevail in any dispute and we cannot be certain how an adverse determination would affect our business.
Parties making claims against us may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. Furthermore, because of the large amount of discovery required in connection with intellectual property litigation or administrative proceedings, there is a risk that some of our confidential information could be compromised by disclosure. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have material adverse effect on our ability to raise additional funds or otherwise have a material adverse effect on our business and prospects.
We may in the future pursue invalidity proceedings with respect to third-party patents. The outcome following legal assertions of invalidity is unpredictable. Even if resolved in our favor, these legal proceedings could distract our technical and management personnel from their normal responsibilities and may cause us to incur significant expenses, which could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing, or distribution activities. In addition, we may not have sufficient financial or other resources to conduct such proceedings adequately. Some of these third parties may be able to sustain the costs of such proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent proceedings could compromise our ability to compete in the marketplace. There could be public announcements of the results of hearings, motions, or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. If we do not prevail in the patent proceedings, such third parties may assert a claim of patent infringement directed at our technologies or product candidates, which could have a material adverse effect on our business and prospects.
We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
Because our development programs may in the future require the use of proprietary rights held by third parties, the growth of our business may depend in part on our ability to acquire, in-license, or use third-party proprietary rights. We may be unable to acquire or in-license any compositions of matter, methods of use, processes, or other third-party intellectual property rights that we
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identify as necessary for our product candidates. The licensing and acquisition of third-party intellectual property rights is competitive, and more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, capital resources, and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. If we are unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have, we may have to abandon development of the relevant program or product candidate, which could have a material adverse effect on our business and prospects.
Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:
| • | others may be able to develop products that are similar to our product candidates but that are not covered by the claims of the patents that we own or license; |
| • | we or our licensors or collaborators might not have been the first to file patent applications covering certain of our inventions; |
| • | others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; |
| • | it is possible that the pending patent applications we own or license will not lead to issued patents; |
| • | issued patents that we own or license may be held invalid or unenforceable, as a result of legal challenges by our competitors; |
| • | our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; |
| • | we may not develop additional proprietary technologies that are patentable; |
| • | the patents of others may have an adverse effect on our business; and |
| • | we may choose not to file a patent to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property. |
Should any of these events occur, it could significantly harm our business and prospects.
Risks Related to Operating as a Public Company
If we are not able to maintain compliance with the continued listing requirements of The Nasdaq Capital Market, our common stock may be delisted, which could negatively impact the liquidity and price of our common stock, our ability to access the capital markets, and the confidence of investors and others.
On May 22, 2024, we received written notice from The Nasdaq Stock Market LLC (“Nasdaq”) that the closing bid price of our common stock for the prior 30 consecutive business days was lower than the minimum bid price requirement of $1.00 per share. To regain compliance, within 180 calendar days of the date of such notice, or by November 18, 2024, the closing bid price of our common stock must be at least $1.00 per share for a minimum of 10 consecutive business days. If we do not regain compliance with the minimum bid price requirement within the initial 180 day compliance period, we may be eligible for an additional 180-calendar day compliance period if at that time we meet the continued listing standard for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market with the exception of the minimum bid price requirement. If we fail to maintain compliance with the continued listing requirements and Nasdaq delists our common stock, we could face material adverse consequences, including:
| • | limited availability of market quotations and decreased liquidity for our common stock, resulting in a decline in the trading price of our common stock; |
| • | adverse impact on the ability of stockholders to sell our common stock; |
| • | limited news and analyst coverage and negative publicity; and |
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| • | decreased ability to raise capital and potential loss of confidence by investors, suppliers, customers, collaborators, and employees. |
As a public company, we face increased expenses and administrative burdens, which could have an adverse effect on our business, financial condition, and results of operations.
As a public company, we face increased legal, accounting, administrative, and other costs and expenses. The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform, the Consumer Protection Act of 2010, the Public Company Accounting Oversight Board, the securities exchanges, and the rules and regulations thereunder impose additional reporting and other obligations on public companies. Compliance with public company requirements results in increased costs and makes certain activities more time-consuming, including expenses associated with SEC reporting requirements. In addition, if any issues in complying with those requirements are identified (for example, if the auditors identify a material weakness or significant deficiency in our internal control over financial reporting), we could incur additional costs in rectifying those issues, and the existence of those issues could adversely affect our reputation or investor perceptions of us and also increase our costs of obtaining director and officer liability insurance. Risks associated with our status as a public company may make it more difficult to attract and retain qualified persons to serve on our board of directors or as executive officers. The additional reporting and other obligations imposed by these rules and regulations increase our legal and financial compliance costs and the costs of related legal, accounting, and administrative activities. These increased costs require us to divert a significant amount of money that could otherwise be used to expand our business and achieve our strategic objectives. Advocacy efforts by stockholders and third parties may also prompt additional changes in governance and reporting requirements, which could further increase costs.
We are an “emerging growth company” within the meaning of the Securities Act, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our stock less attractive to investors.
We are an emerging growth company, as defined in the JOBS Act. For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,” including exemption from compliance with the auditor attestation requirements of Section 404, reduced disclosure obligations regarding executive compensation, exemptions from the requirements of holding a nonbinding advisory vote on executive compensation, and stockholder approval of any golden parachute payments not previously approved. We will cease to be an emerging growth company on the date that is the earliest of (a) the last day of the fiscal year in which we have total annual gross revenue of $1.235 billion or more, (b) December 31, 2025, the last day of our fiscal year following the fifth anniversary of the date of the completion of our initial public offering, (c) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years, or (d) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
In addition, under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. Even after we no longer qualify as an emerging growth company, we may still qualify as a “smaller reporting company,” which would allow us to take advantage of many of the same exemptions from disclosure requirements, including exemption from compliance with the auditor attestation requirements of Section 404 and reduced disclosure obligations regarding executive compensation in this report and our periodic reports and proxy statements.
We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock, and the market price of our common stock may be more volatile.
Our failure to timely and effectively implement controls and procedures required by Section 404(a) of the Sarbanes-Oxley Act could have a material adverse effect on our business.
As a public company, we will be required to provide management’s attestation on internal controls in the future under Section 404(a) of the Sarbanes-Oxley Act. Management may not be able to effectively and timely implement controls and procedures that adequately respond to these increased regulatory compliance and reporting requirements. If we are not able to implement the additional requirements of Section 404(a) in a timely manner or with adequate compliance, we may not be able to assess whether our internal controls over financial reporting are effective, which may subject us to adverse regulatory consequences and could harm investor confidence and the market price of our common stock.
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Our management has limited experience in operating a public company.
Our executive officers have limited experience in the management of a publicly traded company and may not be able to effectively manage a public company that is subject to significant regulatory oversight and reporting obligations under federal securities laws. Their limited experience in dealing with the increasingly complex laws pertaining to public companies could be a significant disadvantage in that it is likely that an increasing amount of their time may be devoted to these activities, which will result in less time being devoted to our management and growth. We may not have adequate personnel with the appropriate level of knowledge, experience, and training in the accounting policies, practices, or internal controls over financial reporting required of public companies in the United States. The development and implementation of the standards and controls necessary for us to achieve the level of accounting standards required of a public company in the United States may require costs greater than expected. It is possible that we will be required to expand our employee base and hire additional employees to support our operations as a public company, which will increase our operating costs.
Any material weaknesses in or other inability to maintain effective internal control over financial reporting could adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner.
Our management is responsible for establishing and maintaining adequate internal control over financial reporting designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with GAAP. Our management is likewise required, on a quarterly basis, to evaluate the effectiveness of our internal controls and to disclose any changes and material weaknesses identified through such evaluation in those internal controls. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. We have in the past and may in the future determine that there are material weaknesses in our internal control over financial reporting. Any material weaknesses or other inability to maintain effective internal control over financial reporting could adversely impact our ability to report our financial position and results of operations on a timely and accurate basis. If our consolidated financial statements are not accurate, investors may not have a complete understanding of our operations and may lose confidence in our financial reporting and our business, reputation, results of operations, liquidity, financial condition, stock price, and ability to access the capital markets could be adversely affected. In addition, we may be unable to maintain or regain compliance with applicable securities laws, stock market listing requirements, and covenants regarding the timely filing of periodic reports, we may be subject to regulatory investigations and penalties, and we may face claims invoking the federal and state securities laws. Any such litigation or dispute, whether successful or not, could have a material adverse effect on our business and prospects.
General Risk Factors
Our stock price has been volatile and our stock has been thinly traded, and you may not be able to sell shares of our common stock at or above the price you paid.
The trading price of our common stock has been volatile and is subject to wide fluctuations. Since the completion of the Business Combination, our common stock has been thinly traded. As a result of the low trading volume of our common stock, the trading of relatively small quantities of shares by our stockholders could disproportionately influence the market price of our common stock in either direction. The price for our shares could, for example, decline significantly in the event that a large number of shares of our common stock are sold on the market without commensurate demand, as compared to an issuer with a higher trading volume that could better absorb those sales without an adverse impact on its stock price.
There are numerous factors that can influence our stock price volatility and trading volume, some of which are beyond our control. These factors could include:
| • | our ability to develop or commercialize products; |
| • | results of our clinical trials and nonclinical studies; |
| • | our capital levels and cash runway, capital requirements, and capital raising activities, including issuances of securities or the incurrence of debt; |
| • | our ability to enter into and maintain collaboration arrangements; |
| • | actual or anticipated fluctuations in our financial results or the financial results of companies perceived to be similar; |
| • | changes in the market’s expectations about our operating results; |
| • | success of competitors; |
| • | our operating results failing to meet the expectation of securities analysts or investors in a particular period; |
| • | changes in financial estimates and recommendations by securities analysts concerning us or the oncology industry in general; |
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| • | operating and share price performance of other companies that investors deem comparable to us; |
| • | changes in laws and regulations affecting our business; |
| • | our ability to meet compliance requirements and obtain regulatory approvals; |
| • | our ability to obtain and maintain proprietary protection for our current and future product candidates; |
| • | commencement of, or involvement in, litigation involving us; |
| • | the volume of shares of our common stock available for public sale; |
| • | any major change in our board of directors or management; |
| • | sales of shares of common stock by our directors, executive officers, or significant stockholders, or the perception that such sales could occur; and |
| • | general economic and political conditions such as recessions, interest rates, inflation, fuel prices, international currency fluctuations and acts of war or terrorism. |
In addition, the stock markets have experienced extreme price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many companies, particularly those in the biotechnology industry. These fluctuations have often been unrelated or disproportionate to the operating performance of those companies. Broad market and industry factors, as well as general economic, political, regulatory, and market conditions, may negatively affect the market price of our common stock, regardless of our actual operating performance.
Volatility in our stock price could subject us to securities class action litigation.
In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because biotechnology companies have experienced significant stock price declines and volatility in recent years. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business and prospects.
If securities or industry analysts do not publish research or reports about us, or publish negative reports, our stock price and trading volume could decline.
The trading market for our common stock will depend, in part, on the research and reports that securities or industry analysts publish about us. We do not have any control over these analysts. If our operating results fail to meet analyst estimates or one or more of the analysts who cover us downgrade our common stock or change their opinion, our stock price would likely decline. If one or more of these analysts cease coverage of us or fail to regularly publish reports on us, we could lose visibility in the financial markets, which could cause our stock price or trading volume to decline.
Future sales of shares of our common stock may depress the market price of our common stock.
Sales of a substantial number of shares of our common stock in the public market, or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. As of October 31, 2024, we had outstanding warrants to purchase an aggregate of 37,411,000 shares of common stock. Additionally, up to 6,000,000 Earnout Shares may be issued in connection with the Merger Agreement, provided that certain conditions are met. Pursuant to our Offer to Exchange Eligible Options for New Restricted Stock Units dated August 13, 2024, 1,470,314 restricted stock units were issued in exchange for eligible stock options, which restricted stock units are subject upon vesting to automatic “sell-to-cover” requirements to satisfy tax withholding requirements. To the extent that any of the warrants are exercised or otherwise converted into shares of our common stock, conditions to receive Earnout Shares are met, or shares are sold pursuant to “sell-to-cover” requirements, additional shares of our common stock will be issued, which will result in dilution to the holders of our common stock and increase the number of shares eligible for sale in the public market. Such shares are eligible for sale in the public market, subject to volume limitations under Rule 144 under the Securities Act with respect to shares held by directors, executive officers, and other affiliates, and certain of such shares are eligible for sale in the public market under our currently effective Registration Statement on Form S-3. Sales, or potential sales, of substantial numbers of shares in the public market could increase the volatility of, or adversely affect, the market price of our common stock.
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Our Certificate of Incorporation provides, subject to limited exceptions, that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for certain stockholder litigation matters, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees, or stockholders.
Our Certificate of Incorporation requires, to the fullest extent permitted by law, that derivative actions brought in our name, actions against directors, officers, and employees for breach of fiduciary duty, and other similar actions may be brought solely and exclusively in the Court of Chancery in the State of Delaware or, if that court lacks subject matter jurisdiction, another federal or state court situated in the State of Delaware. Any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock shall be deemed to have notice of and consented to the forum provisions in our Certificate of Incorporation. In addition, our Certificate of Incorporation and our Bylaws provide that the federal district courts of the United States shall be the exclusive forum for the resolution of any complaint asserting a cause of action under the Securities Act and the Exchange Act. In March 2020, the Delaware Supreme Court found that an exclusive forum provision providing for claims under the Securities Act to be brought in federal court is facially valid under Delaware law. We intend to enforce this provision, but we do not know whether courts in other jurisdictions will agree with this decision or enforce it.
This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees, or stockholders, which may discourage lawsuits with respect to such claims. Alternatively, if a court were to find the choice of forum provision contained in our Certificate of Incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business and prospects.
Concentration of ownership among our existing executive officers, directors, and their affiliates may prevent stockholders from influencing significant corporate decisions.
As of October 31, 2024, Dr. Ahmed M. Hamdy, our Chief Executive Officer, and Dr. Raquel E. Izumi, our President and Chief Operations Officer, together beneficially owned, directly or indirectly, approximately 11.8% of our outstanding common stock, and our directors and executive officers as a group beneficially owned approximately 15.6% of our outstanding common stock. As a result, these stockholders will be able to exercise significant influence on all matters requiring stockholder approval, including the election of directors, any amendment of our Certificate of Incorporation, and approval of significant corporate transactions.
We have never paid dividends on our capital stock and we do not anticipate paying dividends in the foreseeable future.
We have never paid dividends on any of our capital stock and currently intend to retain any future earnings to fund the growth of our business. In addition, we may enter into credit agreements or other borrowing arrangements in the future that will restrict our ability to declare or pay cash dividends on our common stock. Any determination to pay dividends in the future will be at the discretion of our board of directors and will depend on our financial condition, operating results, capital requirements, general business conditions, and other factors that our board of directors may deem relevant. As a result, capital appreciation, if any, of our common stock will be the sole source of gain for the foreseeable future.
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ITEM 5. |
Other Information. |
| ITEM 6. | Exhibits. |
| † | In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release No. 34-47986, the certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this report and will not be deemed “filed” for purposes of Section 18 of the Exchange Act, or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act, except to the extent that the registrant specifically incorporates it by reference. |
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| VINCERX PHARMA, INC. | ||||||
| Date: November 12, 2024 | /s/ Dr. Ahmed M. Hamdy | |||||
| Dr. Ahmed M. Hamdy | ||||||
| Chief Executive Officer | ||||||
| Date: November 12, 2024 | /s/ Alexander A. Seelenberger | |||||
| Alexander A. Seelenberger | ||||||
| Chief Financial Officer | ||||||
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