美国

证券和交易委员会

华盛顿特区20549

表格 10-Q

（在以下选项中加上一个）

☒根据1934年证券交易法第13或15(d)节的季度报告

截至季度结束日期的财务报告2024年9月30日

或者

☐根据1934年证券交易法第13或15(d)节的转型报告书

在从_________到_________的过渡期间

委员会档案号001-38128

CHECKPOINT THERAPEUTICS，INC.

(根据其章程规定的注册人准确名称)

特拉华州		47-2568632
（设立或组织的其他管辖区域）		（纳税人识别号码）

95 Sawyer路, 110号, Waltham, 万事达 02453

（总部地址及邮政编码）

(781) 652-4500

(注册人电话号码，包括区号)

根据证券法第12(b)条注册的证券：

每一类的名称		交易标的		Name of each exchange on which 注册的
普通股，每股面值0.0001美元		CKPT		纳斯达克资本市场

请在以下方框内打勾：(1) 在过去的12个月内(或者在注册公司需要提交此类报告的较短时期内)，公司已经提交了根据证券交易法1934年第13或15(d)条规定需要提交的所有报告；以及 (2) 在过去的90天内，公司一直受到了此类报告提交的要求。是 ☒NO☐

请在以下方框内打勾：公司是否已电子提交了在过去的12个月内（或者在公司需要提交此类文件的较短时期内）根据规则405 of Regulation S-T(232.405章节)所要求提交的每一个互动数据文件。YES ☒ NO ☐

请在复交法案第120亿.2 规则中查看说明“大型加速交流者”、“加速交流者”、“较小的报告公司”和“新兴成长型公司”，打勾表示

大型加速存取器	☐	30	☐
非加速申报人	☒	较小报告公司	☒
新兴成长公司	☐

如果是新兴增长型公司，请勾选，指示注册人是否选择不使用根据证券交易法第13(a)条规定提供的任何新的或修订的财务会计准则的延长过渡期进行遵守。☐

请用复选标志表示，公司是否是外壳公司（根据《交易所法》第120亿.2条规定）。是☐ NO ☒

请指示在最新可行日期每个申报人普通股类别的流通股数。

普通股类		Outstanding Shares as of November 8, 2024
A类普通股，面值0.0001美元		700,000
普通股，每股面值 $0.0001		48,132,500

CHECKPOINT THERAPEUTICS, INC.

表格10-Q

截至2024年9月30日季度结束

		页码。
第一部分财务信息

项目 1.	财务报表	3

	2024年9月30日和2023年12月31日的压缩资产负债表	3

	2024年9月30日和2023年经过三个和九个月的经营简明业绩表	4

	2024年9月30日和2023年经过三个和九个月的股东权益（赤字）简明报表	5

	截至2024年9月30日和2023年止的现金流量控件简表	7

	基本财务报表附注。	8

项目 2.	经营管理层讨论及经营成果分析	24

项目 3。	市场风险的定量和定性披露	30

项目 4。	控制和程序	30

第二部分.其他信息

项目 1。	法律诉讼	31

项目1A。	风险因素	31

事项2。	未登记证券的最近销售	62

项目6。	展示资料	63

签名		64

风险因素概要

我们的业务面临风险，您在做出投资决策之前应该了解这些风险。以下是与投资我们相关的主要风险的摘要，并非我们面临的唯一风险。您应仔细考虑这些风险因素，第1A款中描述的风险因素，以及我们向证券交易委员会（“SEC”）提交的其他报告和文件。

与我们的资金和资本需求相关的风险

●

自公司成立以来，我们已经遭受了巨额亏损，并预计在可预见的未来将继续亏损。我们的开发阶段产品尚未产生任何销售收入，我们不知道何时，或是否会从批准产品的销售中产生任何收入。

●

我们的持续经营存疑，这可能阻碍我们获得未来融资的能力。

●

我们的成功取决于为我们的开发项目和潜在商业化努力筹集额外资金，这可能会失败。即使成功，我们未来的筹资活动可能会 dilute 我们当前的股东，限制我们的业务，或要求我们放弃专有权利。

●

我们有限的资源可能导致我们未能利用商业机会或可能成功的产品候选人。

●

美国经济疲弱，包括在我们的地理范围内，过去对我们造成了不利影响，并可能在将来对我们造成不利影响。

有关我们的业务策略、结构和组织的风险

●

我们未来的增长和成功取决于我们成功开发和商业化产品候选药物的能力，可以通过建立内部商业基础设施或与商业合作伙伴交易来实现，而这些我们还没有做。

●

我们未来的增长取决于我们获取或对外授权产品或产品候选药物，并将这些产品整合到我们的业务中。

药物开发和商业化中固有的风险

●

因为临床前研究和早期临床试验的结果不一定能预测未来结果，我们推进的任何候选药物可能在后续临床试验中没有良好的结果。此外，我们宣布或发布的临床试验的中期、“最终”和初步数据可能会发生变化，或者感知的产品概况可能会受到影响，随着更多患者数据或额外终点的分析。

●

我们可能无法按计划时间获得任何产品候选药物所需的监管批准，甚至可能根本无法获得，这可能会导致成本增加，并延迟我们产生营业收入的能力。

●

如果候选产品显示出缺乏疗效或不良副作用，我们可能需要放弃或限制该候选产品的开发。

●

我们可能无法获得所需的标签声明或产品推广的预期用途，或者有利的排定分类，以成功推广我们的产品。

●

即使某个产品候选获得批准，它也可能要遵守各种后续的市场要求，包括研究或临床试验，以及增加的监管审查。

●

我们的竞争对手已经开发或可能为我们产品的目标适应症开发治疗方法，这可能会限制我们产品候选的商业机会和盈利能力。

●

如果我们的产品没有得到医疗社区的广泛认可，那么任何此类产品的收入可能会受到限制。

●

与我们当前或未来的任何产品候选相关的任何成功的产品责任索赔可能会导致我们承担重大责任并限制这些产品的商业化。

对依赖第三方的风险

●

我们依赖并将在未来依赖第三方医药外包概念和代工厂商来进行我们的临床前和临床研究及试验，完成商业和预商业制造，并最终实现商业化。如果这些第三方未能履行合同义务，未能通过监管检查或复查，未能按时完成，未能遵守适用的法规，或如果我们与这些第三方的关系受到影响，我们的产品候选者可能会被延迟，我们的营业收入潜力可能会受到限制。

●

我们依赖第三方获得的临床数据和结果，但这些数据和结果可能不准确或不可靠。

影响生物制药和其他行业的立法和法规相关风险

●

我们运营于一个高度监管的行业，无法预测未来任何立法或行政、执行行动对我们运营的影响。

●

我们可能会受到反回扣、欺诈和滥用、虚假索赔、透明度、健康信息隐私和安防-半导体以及其他医疗保健法律法规的约束，这可能使我们面临刑事制裁、民事罚款、合同损害、声誉损害、行政负担以及利润和未来收益的减少。

与知识产权及潜在许可方的争议相关的风险

●

如果我们无法为我们的科技和产品维持足够的专利保护，我们的竞争对手可能开发和商业化与我们的产品相似或完全相同的产品，这将损害我们成功商业化潜在产品的能力。

●

我们或我们的许可方可能会因侵犯第三方知识产权而面临昂贵且耗时的诉讼，或为了维护我们或我们的许可方的专利。

●

与我们的许可方之间的任何争议可能影响我们开发或商业化我们的产品候选者的能力。

与我们的平台和数据相关的风险

●

如果发生计算机系统故障、网络攻击或我们或第三方的网络安全缺陷，我们的业务和运营将受到影响。

与Fortress Biotech, Inc.（“Fortress”）的控制相关的风险

●

Fortress控制了我们普通股的投票多数，并有权每年获得大量股份奖励，这将导致我们其他股东的股权稀释，并可能减少我们普通股的价值。

●

我们已与Fortress签订了某些协议，并可能从无关联的第三方获得了更好的条款。

●

Fortress的利益可能并不总是与其他股东的利益一致，Fortress可能采取推进自身利益的行动，这与我们其他股东的意愿相悖。

与利益冲突有关的风险

●

我们与Fortress有某些共同的董事，这可能会在我们与Fortress之间产生利益冲突。

项目1. 基本报表。

Checkpoint Therapeutics，Inc.

简明资产负债表

(以千为单位，除每股数量和每股金额外)

（未经审计）


	2024年9月30日		2023年12月31日
资产
流动资产：
现金及现金等价物	$	4,703	$	4,928
预付费用和其他流动资产		476		450
总流动资产		5,179		5,378
总资产	$	5,179	$	5,378

负债和股东权益
流动负债:
应付账款和应计费用	$	15,635	$	15,485
应付账款和应计费用-关联方		2,009		2,815
普通股认股权负债		125		125
流动负债合计		17,769		18,425
总负债		17,769		18,425

委托和担保（注5）

股东权益（赤字）
普通股（$ 面值），授权股票数为0.0001（面值）。175,000,000 和 80,000,000 截至2024年9月30日和2023年12月31日，已授权发行股份。
A类普通股份， 700,000 截至2024年9月30日和2023年12月31日，已发行并流通的股份		—		—
普通股，45,095,500 和 27,042,035 股已发行和流通中截至2024年9月30日和2023年12月31日		5		3
可发行普通股 0 和 1,492,915 分别为2024年9月30日和2023年12月31日的股份		—		3,419
其他资本公积		329,078		297,864
累积赤字		(341,673)		(314,333)
基本报表中的总股东权益（赤字）		(12,590)		(13,047)
基本报表中的负债和股东权益（赤字）	$	5,179	$	5,378

附注是这份基本报表的一个组成部分。

Checkpoint Therapeutics，Inc.

经简化的损益表

(以千为单位，除每股数量和每股金额外)

（未经审计）


	截至9月30日的三个月				截至9月30日的九个月
	2024		2023		2024		2023
营业收入 - 关联方	$	—	$	31	$	41	$	97

营业费用:
研发费用		6,366		5,496		19,343		35,267
一般和管理费用		3,358		2,236		8,043		6,809
总营业费用		9,724		7,732		27,386		42,076
经营亏损		(9,724)		(7,701)		(27,345)		(41,979)

其他收入（费用）
利息收入		2		7		9		81
普通股权证债务的增益		—		1,970		—		9,179
外汇汇率损失		(3)		—		(4)		—
其他收入（支出）总额		(1)		1,977		5		9,260
净亏损	$	(9,725)	$	(5,724)	$	(27,340)	$	(32,719)

每股亏损：
普通股每股基本和稀释净损失	$	(0.23)	$	(0.29)	$	(0.73)	$	(2.07)
普通股的基本和稀释加权平均流通股数		43,151,861		19,988,079		37,556,863		15,842,693

附注是这份基本报表的一个组成部分。

Checkpoint Therapeutics，Inc.

股东权益（赤字）简明报表（以千美元为单位）

（以千为单位，股数除外）

（未经审计）

截至2024年9月30日三个月


							普通		附加				总计
	A类普通股			普通股			股票		实收资本		累计		股东权益
	分享	金额		分享	金额		可发行		资本		赤字		权益（亏损）
2024年6月30日的余额	700,000	$	—	41,631,500	$	4	$	—	$	316,195	$	(331,948)	$	(15,749)
普通股的发行，扣除发行成本 - 注册直接发行	—		—	1,230,000		1		—		10,954		—		10,955
发行普通股 - 创始人协议	—		—	146,341		—		—		318		—		318
基于股票的薪酬费用	—		—	—		—		—		1,611		—		1,611
行使预付资金和普通股票warrants	—		—	2,087,659		—		—		—		—		—
净亏损	—		—	—		—		—		—		(9,725)		(9,725)
2024年9月30日的余额	700,000	$	—	45,095,500	$	5	$	—	$	329,078	$	(341,673)	$	(12,590)

2024年9月30日结束的九个月


							常见		额外				总计
	A类普通股			普通股			股票		实缴		累计		股东权益
	分享	金额		分享	数量		可发行		资本		赤字		权益（亏损）
2023年12月31日的余额。	700,000	$	—	27,042,035	$	3	$	3,419	$	297,864	$	(314,333)	$	(13,047)
普通股的发行，扣除发行成本 - 注册直接发行	—		—	2,505,000		2		—		23,590		—		23,592
发行普通股 - 创始人协议	—		—	1,833,161		—		(3,419)		4,133		—		714
基于股票的薪酬费用	—		—	5,322,412		—		—		3,491		—		3,491
行使预资助的和普通股warrants，包括诱因	—		—	8,392,892		—		—		—		—		—
净亏损	—		—	—		—		—		—		(27,340)		(27,340)
2024年9月30日的余额	700,000	$	—	45,095,500	$	5	$	—	$	329,078	$	(341,673)	$	(12,590)

截至2023年9月30日三个月的时间


							普通		附加				总计
	A类普通股			普通股			股票		实收资本		累计		股东权益
	分享	金额		股	数量		可发行		资本		赤字		权益（亏损）
2023年6月30日的余额	700,000	$	—	17,238,393	$	2	$	—	$	266,209	$	(289,481)	$	(23,270)
发行普通股，扣除发行成本净额 - 注册直接发行	—		—	2,427,186		—		—		9,011		—		9,011
发行普通股 - 创始人协议	—		—	80,906		—		—		251		—		251
基于股票的薪酬费用	—		—	—		—		—		689		—		689
行使预购和普通股权证	—		—	1,956,062		—		—		—		—		—
净亏损	—		—	—		—		—		—		(5,724)		(5,724)
2023年9月30日的余额	700,000	$	—	21,702,547	$	2	$	—	$	276,160	$	(295,205)	$	(19,043)

截止2023年9月30日止九个月


							常见		额外				总计
	A类普通股			普通股份			股票		实收资本		累计		股东权益
	分享	金额		股份	金额		可发行		资本		赤字		权益（亏损）
2022年12月31日的余额	700,000	$	—	9,586,683	$	1	$	1,885	$	241,117	$	(262,486)	$	(19,483)
普通股发行数量净额，扣除发行费用 - 注册直接发售	—		—	6,957,186		1		—		30,124		—		30,125
发行普通股 - 创始人协议	—		—	609,433		—		(1,885)		2,694		—		809
基于股票的薪酬费用	—		—	1,101,098		—		—		2,225		—		2,225
行使预先融资和普通股认股权证	—		—	3,448,147		—		—		—		—		—
净亏损	—		—	—		—		—		—		(32,719)		(32,719)
2023年9月30日的余额	700,000	$	—	21,702,547	$	2	$	—	$	276,160	$	(295,205)	$	(19,043)

附注是这份基本报表的一个组成部分。

Checkpoint Therapeutics，Inc.

现金流量简明报表

（以千计）

（未经审计）


	截至9月30日的九个月
	2024		2023
经营活动产生的现金流量：
净亏损	$	(27,340)	$	(32,719)
调整为净损失到经营活动现金流量净使用：
基于股票的薪酬费用		3,491		2,225
普通股发行 - 创始人协议		714		809
普通股权证债务的增益		—		(9,179)
运营资产和负债的变化：
预付费用和其他流动资产		(26)		734
其他应收款 - 关联方		—		42
应付账款和应计费用		43		(4,243)
应付账款及其他应计费用-关联方		(806)		1,574
用于经营活动的净现金		(23,924)		(40,757)

筹资活动产生的现金流量：
普通股发行收益 - 注册直接发行		26,000		33,621
发行普通股的承销费用支付 - 注册直接发行		(2,301)		(3,160)
筹资活动产生的现金净额		23,699		30,461

现金及现金等价物净减少		(225)		(10,296)
期初现金及现金等价物余额		4,928		12,068
期末现金及现金等价物	$	4,703	$	1,772

非现金投资和筹资活动补充披露：
普通股发行 - 创始人协议	$	3,419	$	1,885
普通股发行的未支付发行成本 - 注册直接发行	$	107	$	336

附注是这份基本报表的一个组成部分。

附注1-业务运营的组织和描述

Checkpoint Therapeutics, Inc.（“公司” 或 “Checkpoint”）于2014年11月10日在特拉华州注册成立。Checkpoint是一家临床阶段的免疫疗法和靶向肿瘤学公司，专注于实体瘤患者新疗法的收购、开发和商业化。公司可以通过许可权利或以其他方式收购这些技术的所有权、为其研发提供资金并最终超越许可或将技术推向市场来获得这些技术的权利。

该公司是丰泽生物技术有限公司（“丰泽”）的多数控股子公司。

该公司的普通股在纳斯达克资本市场上市，交易代码为 “cKPT”。

流动性、资本资源和持续经营

该公司自成立以来已蒙受巨额营业亏损，预计在可预见的将来将继续蒙受巨额营业亏损，可能永远无法盈利。截至2024年9月30日，该公司的累计赤字为美元341.7百万。

2023年2月，公司完成了注册直接发行（“2023年2月注册直接发行”），发行和销售总额为 1,180,000 其普通股的收购价为美元5.25 注册直接发行中的每股。此外，该产品还包括 248,572 以预先注资的认股权证形式发行的普通股，价格为美元5.2499。在同时进行的私募中，公司发行并出售了A系列认股权证，最多可购买 1,428,572 普通股和b系列认股权证最多可购买 1,428,572 普通股。A系列和b系列认股权证是可行使发行后立即，行使价为美元5.00 每股。A系列认股权证将到期五年在发行日期之后，b系列认股权证将到期十八个月在发行日期之后。此次发行的总收益约为 $7.5 百万，净收益约为 $6.7 扣除大约 $ 后的百万0.8 百万美元的佣金和其他交易成本。

2023年4月，公司完成了注册直接发行（“2023年4月的注册直接发行”），发行和销售总额为 1,700,000 其普通股的收购价为美元3.60 注册直接发行中的每股普通股。在同时进行的私募中，公司发行并出售了A系列认股权证，最多可购买 1,700,000 普通股和b系列认股权证最多可购买 1,700,000 普通股。A系列和b系列认股权证是可行使发行后立即，行使价为美元3.35 每股。A系列认股权证将到期五年在发行日期之后，b系列认股权证将到期十八个月在发行日期之后。此次发行的总收益约为 $6.1 百万，净收益约为 $5.5 扣除大约 $ 后的百万0.6 百万美元的佣金和其他交易成本。

2023年5月，公司完成了注册直接发行（“2023年5月注册直接发行”），发行和销售总额为 1,650,000 其普通股的收购价为美元3.071 注册直接发行中的每股普通股。此外，该产品还包括 1,606,269 以预先注资的认股权证形式发行的普通股，价格为美元3.0709。普通股和预先注资的认股权证与A系列认股权证一起出售，最多可购买 3,256,269 普通股和b系列认股权证最多可购买 3,256,269 普通股。A系列和b系列认股权证是可行使发行后立即，行使价为美元2.821 每股。A系列认股权证将到期五年在发行日期之后，b系列认股权证将到期十八个月在发行日期之后。此次发行的总收益约为 $10.0 百万，净收益约为 $9.1 扣除大约 $ 后的百万0.9 百万美元的佣金和其他交易成本。

在2023年7月，公司完成了一项注册定向增发（“2023年7月注册定向增发”），发行和出售总计 2,427,186 股普通股，购买价格为$3.09 每股普通股的注册定向增发。此外，增发包含 809,062 股普通股，以预先出资的warrants形式，价格为$3.0899。普通股和预先出资的warrants与A系列warrants一起出售，以购买最多 3,236,248 普通股和B类认股权证的股份 3,236,248 股普通股。A系列和b warrants是可立即行使，行使价格为$每股。A系列warrants将在2.84 发行日期后的五年 B系列warrants将在十八个月发行日期后的。此次融资的总毛收益约为$10.0 除此之外，该发行还包括以股票预先定价认股权形式出售的4,623,659股普通股，并在并行的定向增发中出售可以购买多达5,853,659股普通股的普通认股权。9.1 普通认股权的行使将在股东批准发行股份行权后开始，行权价格为每股1.58美元，并将在普通认股权行权价期限届满后失效。0.9 百万的佣金和其他交易成本。

在2023年10月，公司与其现有warrants的一位持有者签订了一份诱导提案函协议（“2023年10月诱导提案”），以现金行使总计 6,325,354 股份的公司普通股，行使价格降低至$1.76 每股。warrants于2022年12月16日发给持有人，行使价格为$4.075 每股，并于2023年2月22日发放，行使价格为$5.00 每股，作为注册的直接发行的一部分。作为2023年10月诱导提案的一部分，公司同意发行新的未注册系列A warrants，以购买最多 6,325,354 股份的普通股，以及新的未注册系列B warrants，以购买最多 6,325,354 普通股的股份。系列A和B的warrants在发行时可以立即行使，附带行使价格万美元的1.51 每股。系列A的warrants将在五年之后到期，而系列B的warrants将在二十四个月之后到期。行使的总毛收入约为$11.1 百万，净收益约为$10.0 百万，扣除约$1.1 百万的佣金和其他交易费用。

在2024年1月，公司完成了注册直接发行（“2024年1月注册直接发行”），以发行和销售总计 1,275,000 的普通股，购买价格为$1.805 每股普通股。此外，该发行还包括 6,481,233 的普通股，形式为预先融资的warrants，价格为$1.8049。在同期的定向增发中，公司发行并出售了购买最多的普通warrants 7,756,233 普通股的分享。普通warrants在发行时即可行使，行使价格为$1.68 普通认股权行使价期限届满后将失效。五年自发行日期起。2024年1月的注册定向增发总毛收入约为$14.0 百万，扣除约$12.6 百万后的净收入约为$1.4 百万，作为佣金和其他交易费用的扣除。

在2024年7月，公司完成了注册定向增发（“2024年7月注册定向增发”），发行和销售总共 1,230,000 以每股$的价格购买其普通股2.05 每股普通股的价格为$。此外，发行包括 4,623,659 以预先资助的warrants形式的普通股2.0499价格为$。在同时进行的定向增发中，公司发行并出售了可购买最多的普通warrants 5,853,659 普通股。普通warrants将在股东批准发行股份的生效日期后2.05 以每股$的行权价格开始行使，并将在五年在发行日期后到期。2024年7月的注册直接发行的总毛收益约为$12.0 金额约为$百万。11.0 在扣除约$百万后。1.0 涉及约$百万的佣金和其他交易费用。

2024年11月12日，公司从行使现有系列b warrants中获得了约$百万。9.2 用于从2023年5月的注册定向增发中发行的普通股，数量为 3,256,269 行使价格为$。2.821 ，每股。

公司预计将继续使用先前融资交易的收益，主要用于一般企业目的，这可能包括公司的增长融资、开发新的或现有的产品候选者，以及资助资本支出、收购和投资。

根据《会计准则编纂》（“ASC”）205-40， 继续关注，该公司评估了总体上是否存在一些条件和事件，使人们对其在这些财务报表发布之日后的一年内继续作为持续经营企业的能力产生了重大怀疑。这项评估最初没有考虑到截至财务报表发布之日尚未充分实施的管理层计划的潜在缓解作用。当这种方法存在重大疑问时，管理层将评估其计划的缓解效果是否足以缓解人们对公司继续作为持续经营企业的能力的实质性怀疑。但是，只有在以下两个条件下才考虑管理层计划的缓解作用：（1）这些计划很可能在财务报表发布之日后的一年内得到有效实施；（2）这些计划实施后很可能会缓解相关条件或事件，这些条件或事件使人们对该实体能否在这些合并财务报表发布之日后的一年内继续作为持续经营企业产生重大怀疑。在进行分析时，管理层排除了其运营计划的某些不可能的内容。根据ASC 205-40，目前不认为未来可能从未来的股票或债务发行以及合伙企业等其他潜在来源获得潜在资金，因为这些计划并不完全在公司的控制范围内，截至本财务报表发布之日，这些计划也尚未得到董事会的批准。

该公司认为，假设没有行使未偿还的普通股认股权证，其现金和现金等价物仅足以为2025年第一季度的运营费用提供资金。该公司经常遭受运营亏损，存在净资本短缺，这使人们对公司自这些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严重怀疑。管理层缓解引发重大疑虑的情况的计划包括减少2024年的支出，包括通过推迟某些项目的开发时间表来实现预计的节省，以及通过公共或私募股权或债务融资和潜在合作伙伴关系寻求额外的现金资源。管理层得出的结论是，其计划成功地从其中一个或多个来源获得充足资金，或充分减少支出，尽管可能性较小。因此，公司得出结论，公司自这些财务报表发布之日起至少12个月内继续经营的能力存在重大疑问。该公司对预计其现有现金能够持续多长时间为其运营提供资金的估计是基于可能被证明是错误的假设，而且它可能比目前预期的更快地使用其可用资本资源。此外，不断变化的情况（其中一些可能超出其控制范围）可能导致公司的资本消耗速度超出其目前的预期，并且可能需要比计划更早地寻求额外资金。公司无法确定是否会以可接受的条件向其提供额外资金，或者根本无法确定是否能获得额外资金。

所附财务报表是在持续经营的基础上编制的，其中考虑在正常业务过程中变现资产和清偿负债。财务报表不包括因上述不确定性而可能产生的与所记录资产金额的可收回性和分类或负债金额和分类有关的任何调整。

附注2-重要会计政策

演示基础

随附的未经审计的中期简明财务报表是根据美利坚合众国公认的中期财务信息会计原则（“GAAP”）以及《交易法》第10-Q表和第S-X条例第10条的说明编制的。因此，它们不包括GAAP要求的完整财务报表的所有信息和附注。管理层认为，未经审计的中期简明财务报表反映了所有调整，其中仅包括公允列报所列期间余额和业绩所需的正常经常性调整。它们可能不包括GAAP要求的完整财务报表的所有信息和附注。因此，这些简明财务报表应与公司截至2023年12月31日止年度的经审计的财务报表及其附注一起阅读，后者包含在公司的10-k表中，并于2024年3月22日向美国证券交易委员会提交。任何过渡期的经营业绩不一定代表整个财年或任何其他过渡期的预期业绩。

估算值的使用

根据公认会计原则编制财务报表要求管理层做出估算和假设，这些估计和假设会影响财务报表日报告的资产负债金额和或有资产负债的披露以及报告期内报告的支出金额。实际结果可能与这些估计有所不同。

重要会计政策

公司的重大会计政策与2023年度10-K表格中之前披露的相同，暂无重大变化。

现金及现金等价物

公司认为，购买时具有三个月或更短原始到期日的高流动性投资是现金及现金等价物。

研究和开发成本

研发成本将在发生时支出。用于未来研发活动的货物和服务的预付款按实施活动或收到货物时支出，而不是付款时支出。公司代表执行研发服务的第三方支付的预付款和里程碑付款将随服务提供或达到里程碑时支出。

研发成本主要包括与人员相关的费用，包括工资、福利、差旅和其他相关费用，股权补偿，支付给许可和里程碑成本的第三方，以及支付给第三方医药外包机构进行临床前和临床研究，临床试验研究地点，顾问，获取和制造临床试验材料的成本，与监管申报相关的成本，实验室成本和其他物资的支出。

根据ASC 730-10-25-1的规定，研发如果被许可的技术尚未达到商业可行性并且没有其他未来用途，那么获得技术许可所产生的成本将计入研发费用。公司购买的此类许可需要完成大量的研发、监管和营销批准工作，以达到商业可行性并且没有其他未来用途。

年度股权费

根据与Checkpoint于2015年3月17日签订的创始人协议（以下简称“创始人协议”），并于2016年7月和2017年10月修订和重签，在每年1月1日，Fortress有权获得公司全摊薄流通股的 2.5%，以Checkpoint普通股支付（“年度股权费”）。年度股权费是公司组建、确认某些资产（包括由Fortress提供给Checkpoint的许可）时支付的考虑之一（见注4）。

公司将与Fortress签订的创始人协议中的年度股权费作为有条件给付款待记录。有条件给付款待在概率可行且合理可估计时记录。由于公司资产的性质和发展阶段，未来股价和流通股数在年度股权费发放前无法估计。由于这些不确定性，公司得出结论无法在实际于每年1月1日发行股份之前合理估计有条件给付款待。

根据创始人协议，公司发行了 1,492,915 2024年5月16日将普通股份分享给Fortress，作为年度股权费，代表 2.5%规模在2024年1月1日CheckPoint的全部摊薄权益中。公司在2024年1月1日的公司章程下没有足够的未保留授权股份来发行年度股权费的股份。因此，在2023年12月，Fortress和Checkpoint相互同意推迟发行，直到公司的公司章程已经修改以增加可以发行的授权数量为止。在2024年5月13日举行的公司2024年股东大会上，其股东批准了对公司公司章程的修正，以增加可用于发行的普通股授权数量。因为在发行2013年12月31日财务报表之前，2024年1月1日可以确定要发行给Fortress的已发行股份数量，因此公司在截至2013年12月31日的一年内记录了大约$3.4 百万美元的研发费用，并在截至2013年12月31日的一年内记录了的普通股可发行数量-创始人协议的贷项。

股票基于的补偿费用

公司在规定服务期内根据奖励的预估授予日公允价值和放弃率开销股票基于的补偿。公司根据发生的放弃予以核算。

公司使用Black-Scholes模型估算股票期权授予的公允价值。用于计算基于股票奖励的公允价值的假设代表管理团队的最佳估计，并涉及内在的不确定性和管理判断的应用。所有股票基于的补偿成本根据公司个体在公司所扮演的角色记录于综合利润表中的一般活动及研发成本。

此外，由于向雇员、董事及顾问发行的部分限制性股票、限制性股票单位及期权在实现特定里程碑时授予，因此总开销是不确定的。对于在实现里程碑时授予的奖励的补偿费用被确认为可能实现这些里程碑时。

普通股权证明责任

公司已发行独立权证，用于购买其普通股，以配合其融资活动，并根据适用的会计准则将其列为负债或权益工具，具体取决于权证协议的特定条款。被分类为负债的权证在每个有效期内重新计量。由于权证责任公允价值变动而产生的任何盈利或损失被认定为普通股权证明责任的损益，在综合利润表中作为其他收入（费用）的一部分。

公司使用Black-Scholes模型估算普通股权证明责任的公允价值。用于计算公允价值的假设代表管理团队的最佳估计，并涉及内在的不确定性和管理判断的应用。

公允价值计量

公司遵循ASC 820中的会计指导，对按公允价值计量的金融资产和负债进行公允价值测量。根据该会计指导，公允价值被定义为退出价格，代表在测量日期市场参与者之间进行有序交易时将收到的金额或转让负债时将支付的金额。因此，公允价值是基于市场的衡量，应基于市场参与者定价资产或负债时使用的假设来确定。

会计准则要求将公允价值衡量分类和披露为以下三个类别之一：

一级：	层次2- 除层次1外，还可以间接或直接观察到的其他输入，例如类似资产或负债的报价；在非活跃市场上的报价；或其他可以被观察到的或可通过观察到的市场数据证实，对于资产或负债的整个期限都具有重要作用的信息。

二级：	除了直接或间接可观察到的Level 1价格之外，还有可观察到的对于类似资产或负债的Observable inputs在市场上直接或间接可观察到。

三级计量：

无法观察到的输入很少或没有市场活动支持，它们是使用定价模型、折现现金流方法或类似技术确定价值的金融工具，以及对其公平价值的确定需要重大判断或估计的工具。

公允价值层次还要求实体在计量公允价值时最大程度地利用可观察的输入并最小化使用不可观察的输入。以公允价值计量的资产和负债根据对公允价值计量具有重要意义的最低输入水平进行分类。

公司的某些金融工具不以公平价值重复计量，而是以接近公平价值的金额记录，因为它们具有流动性或短期性质，例如应付账款和预提费用。

与客户签订合同的营业收入

The Company recognizes revenue under ASC 606, “Revenue from Contracts with Customers”. The core principle of the standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle:

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步骤1：识别与客户的合同。

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第二步：确定合同中的履约义务。

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第三步：确定交易价格。

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步骤4:将交易价格分配给合同中的履行义务。

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第5步：当公司满足绩效义务时，确认营业收入。

为了识别与客户签订合同中的绩效义务，公司必须评估合同中承诺的商品或服务，并确定每个被承诺的商品或服务是否是独立的。如果满足以下两个标准，绩效义务符合ASC 606对“独立”商品或服务（或商品或服务包）的定义：

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客户可以从商品或服务中受益，无论是独立使用还是与客户提供的其他资源一起使用（即，商品或服务能够被区分）；并

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实体向客户转让商品或服务的承诺在合同中能够单独识别，与合同中的其他承诺（即，向客户转让商品或服务的承诺在合同背景下是独立的）不同。

如果一个产品或服务不是独特的，则将该产品或服务与其他承诺的产品或服务结合，直到识别出一个独特的产品或服务捆绑包。

交易价格是实体预期为向客户转让承诺的商品或服务而有权获得的代价金额，不包括代表第三方收取的金额（例如，某些销售税）。与客户合同中承诺的代价可能包括固定金额、可变金额或两者。在确定交易价格时，实体必须考虑以下所有因素的影响：

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变量款项；

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限制对变量考虑的估计；

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合同中存在重大融资要素；

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非现金考虑；和

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支付给客户的考虑。

变量考虑仅在累计营业收入数量发生重大逆转的可能性不大时才包括在交易价格中，当与变量考虑相关的不确定性随后解决时。

交易价格根据相对独立销售价格基础分配给每项履约义务。每项履约义务分配的交易价格是在满足该履约义务时才确认，适时一次性或随着时间的推移。

仅当以下事件后发生时，即销售或使用后发生时，承诺以许可知识产权而获得的基于销售或使用的专利的营业收入才会确认：

后续的销售或使用发生；和

已分配部分或全部基于销售或使用的专利的销售或使用专利的履约义务已满足（或部分满足）时。

仅当资产的摊销期不超过1年时，一旦产生额外合同成本就会费用化；否则，额外合同成本会作为资产确认，并随着提供给客户的服务而摊销。

所得税

公司使用资产和负债法记录所得税。由于现有资产和负债的财务报表账面金额与其相应的所得税基础之间存在的暂时性差异，以及经营亏损和税收抵免结转，确认递延所得税资产和负债。如果管理层认为根据客观可验证证据的评估，递延税务资产无法得以回收的可能性较大，公司将建立估值准备金。对于在审计中更可能被维持的税务立场，公司确认最有可能实现的金额，该金额的实现可能性超过50%。对于在审计中不太可能被维持的税务立场，公司不予确认任何部分的收益。截至2024年9月30日和2023年12月31日，公司根据可用证据确定，净递延税务资产不太可能实现，因此已对此净递延税务资产提供全额估值准备金。

每股净亏损

每股净亏损通过将净亏损除以期间内流通的普通股加权平均数计算得出。稀释每股净亏损并不反映在行使期权和warrants后会发行的普通股的影响，因为其纳入会导致反稀释。以下表格总结了截至2024年9月30日和2023年潜在稀释证券的详细信息，这些证券在稀释每股净亏损的计算中被排除，因为它们会导致反稀释：


	九月三十日，
	2024	2023
warrants（注释6）	48,370,157	23,392,796
股票期权（注释6）	127,000	127,000
未归属的限制性股票奖励（注释6）	6,357,732	1,331,286
未归属的限制性股票单位（注释6）	2,798,246	619,884
总计	57,653,135	25,470,966

综合损失

当全部其他要求得到满足时，资产中的元件应该被完全识别和计量。

最近发布的会计声明

截至2024年9月30日的九个月期间，没有新的会计公告或最近发布的会计公告的更新，这些在公司截至2023年12月31日的10-k表格中披露，不会影响公司当前或未来的经营业绩、整体财务状况、流动性或披露。

注 3 – 许可协议

达纳-法伯癌症研究所

在2015年3月，公司与达纳－法伯癌症研究所（“达纳－法伯”）签署了独家许可协议，开发一系列针对PD-L1、糖皮质激素诱导的TNFR相关蛋白（“GITR”）和碳酸酐酶IX的全人源免疫肿瘤靶向抗体。达纳－法伯有资格在公司成功实现某些临床开发、监管和首次商业销售里程碑时，收到高达约$的付款，21.5 其中，$用于针对PD-L1的抗体里程碑的费用已被计入支出。此外，达纳－法伯还可以在公司成功实现某些基于总净销售额的销售里程碑时，收到高达$的总额，以及根据销售额的低到中单数百分比的分级特许权使用费。5.0 达纳－法伯还每年获得$的许可证维护费，此费用可抵扣未来的里程碑付款或特许权使用费。60.0 与达纳－法伯的许可协议相关，公司与TGTX签署了一份合作协议，开发和商业化抗PD-L1和抗GITR抗体的研究项目，专注于血液恶性肿瘤，而公司保留在实体肿瘤中开发和商业化这些抗体的权利。50,000Checkpoints的董事会主席兼Fortress的执行副主席、战略发展，Michael Weiss，同时也是TGTX的执行主席、总裁和首席执行官以及股东。

自2023年9月30日起，公司与TGTX同意互相

终止合作协议。在截至2024年9月30日和2023年9月30日的三个月中，公司承认零和 $10,000 与简明运营报表中的合作协议相关的收入。在截至2024年9月30日和2023年9月30日的九个月中，公司确认了约美元41,000 和 $51,000分别计入与简明运营报表中合作协议相关的收入。

阿迪马布有限责任公司

2015年10月，Fortress与Adimab, LLC（“Adimab”）签订了合作协议，使用其专有的核心技术平台发现和优化抗体。根据该协议，阿迪单抗对科西贝利单抗进行了优化，这是该公司最初从达纳-法伯获得许可的抗PD-L1抗体。2019年1月，Fortress将优化抗体的版权转让给了该公司，Checkpoint于当天直接与阿迪单抗签订了合作协议。根据协议条款，Adimab有资格从公司获得额外付款，总额不超过约美元2.5 百万美元，需多次申请监管部门批准，以实现该产品的商业化。此外，Adimab有资格根据净销售额的低个位数百分比获得特许权使用费。

2023 年 2 月，公司支付了不可退还的里程碑款项，即 $2.2 在美国食品药品监督管理局提交接受该公司用于转移性或局部晚期皮肤鳞状细胞癌的科西贝利单抗的生物制剂许可申请（“BLA”）后，百万美元用于研发费用。

NeuPharma, Inc.

2015年3月，Fortress与NeuPharma, Inc.（“NeuPharma”）签订了独家许可协议，在某些亚洲国家以外的全球范围内开发和商业化包括奥拉弗替尼在内的新型不可逆的第三代表皮生长因子抑制剂。同日，Fortress将其在表皮生长因子抑制剂中的所有权利和利益转让给了该公司。NeuPharma 有资格获得总额不超过约 $ 的额外付款39.0 百万美元是公司成功实现涵盖多达三种适应症的某些临床开发和监管里程碑，其中$22.5 一旦获得各种监管部门的批准，就需要100万美元才能将这些产品商业化。此外，NeuPharma有资格获得总额不超过$的付款40.0 根据所有指标的总净销售额，以及基于净销售额中到高个位数百分比的分级特许权使用费支付，公司成功实现了某些销售里程碑的百万美元。

Jubilant Biosys 有限公司

2016年5月，公司与Jubilant Biosys Limited（“Jubilant”）签订了许可协议，根据该协议，该公司获得了Jubilant一系列专利的全球独家许可，这些专利涵盖抑制BRD4等Bet蛋白（包括Ck-103）的化合物。Jubilant 有资格获得总额不超过约 $ 的付款88.4 公司成功实现某些临床开发和监管里程碑后获得百万美元，其中 $59.5 一旦获得各种监管部门的批准，就需要100万美元才能将这些产品商业化。此外，Jubilant有资格获得总额不超过$的付款89.3 百万美元，这是根据总净销售额成功实现某些销售里程碑的，此外还根据净销售额的低至中个位数百分比支付了特许权使用费。

关于与Jubilant签订的许可协议，公司与关联方TGTX签订了再许可协议，开发和商业化血液系统恶性肿瘤领域许可的化合物，而公司保留在实体瘤领域开发和商业化这些化合物的权利。自2023年9月30日起，公司和TGTX同意共同终止分许可协议。在截至2023年9月30日的三个月和九个月中，公司确认了约美元21,000 和 $45,000分别用于与简明运营报表中的分许可协议相关的收入。

与TGTX的合作均包含主题606下的单一材料履行义务，即授予功能性知识产权的许可。在TGTX有能力使用知识产权并从中受益时，该公司的履约义务已得到履行。在主题606通过之前，原始协议的履行义务已得到满足。合作协议修正案的履行义务已于2019年6月得到履行。

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Note 4 – Related Party Agreements

Founders Agreement and Management Services Agreement with Fortress

Effective March 17, 2015, the Company entered into a Founders Agreement with Fortress, which was amended in July 2016 and October 2017. The Founders Agreement provides, that in exchange for the time and capital expended in the formation of Checkpoint and the identification of specific assets the acquisition of which resulted in the formation of a viable emerging growth life science company, the Company shall: (i) issue annually to Fortress, on January 1 of each year, shares of common stock equal to two and one-half percent (2.5%) of the fully diluted outstanding equity of Checkpoint at the time of issuance; (ii) pay an equity fee in shares of common stock, payable within five (5) business days of the closing of any equity or debt financing for Checkpoint or any of its respective subsidiaries that occurs after the effective date of the Founders Agreement and ending on the date when Fortress no longer has majority voting control in Checkpoint’s voting equity, equal to two and one-half percent (2.5%) of the gross amount of any such equity or debt financing; and (iii) pay a cash fee equal to four and one half percent (4.5%) of Checkpoint’s annual net sales, payable on an annual basis, within ninety (90) days of the end of each calendar year. In the event of a change in control (as it is defined in the Founders Agreement), Checkpoint will pay a one-time change in control fee equal to five times (5x) the product of (i) monthly net sales for the twelve (12) months immediately preceding the change in control and (ii) four and one-half percent (4.5%). The Founders Agreement has a term of fifteen years, after which it automatically renews for one-year periods unless Fortress gives the Company notice of termination. The Founders Agreement will also automatically terminate upon a change of control.

Effective March 17, 2015, the Company entered into a Management Services Agreement (the “MSA”) with Fortress. Pursuant to the terms of the MSA, for a period of five (5) years, Fortress will render advisory and consulting services to the Company. Services provided under the MSA may include, without limitation, (i) advice and assistance concerning any and all aspects of Checkpoint’s operations, clinical trials, financial planning and strategic transactions and financings and (ii) conducting relations on behalf of the Company with accountants, attorneys, financial advisors and other professionals (collectively, the “Services”). The Company is obligated to utilize clinical research services, medical education, communication and marketing services and investor relations/public relation services of companies or individuals designated by Fortress, provided those services are offered at market prices. However, the Company is not obligated to take or act upon any advice rendered from Fortress and Fortress shall not be liable for any of the Company’s actions or inactions based upon their advice. Fortress and its affiliates, including all members of its Board of Directors, have been contractually exempt from fiduciary duties to the Company relating to corporate opportunities. In consideration for the Services, the Company will pay Fortress an annual consulting fee of $0.5 million (the “Annual Consulting Fee”), payable in advance in equal quarterly installments on the first business day of each calendar quarter in each year, provided, however, that such Annual Consulting Fee shall be increased to $1.0 million for each calendar year in which the Company has net assets in excess of $100 million at the beginning of the calendar year. The MSA shall be automatically extended for additional five-year periods unless Fortress or the Company provides notice to the other party of its desire not to automatically extend the term. For each of the three months ended September 30, 2024 and 2023, the Company recognized $125,000 in expense in the Condensed Statements of Operations related to the MSA. For each of the nine months ended September 30, 2024 and 2023, the Company recognized $375,000 in expense on its Condensed Statements of Operations related to the MSA.

Caribe BioAdvisors, LLC

In December 2016, the Company entered into an advisory agreement effective January 1, 2017 with Caribe BioAdvisors, LLC (“Caribe”), owned by Michael Weiss, to provide the advisory services of Mr. Weiss as Chairman of the Board. Pursuant to the agreement, Caribe will be paid an annual cash fee of $60,000, in addition to any and all annual equity incentive grants paid to members of the board. In June 2023, Mr. Weiss assigned the agreement to Hawkins BioVentures, LLC. For the three months ended September 30, 2024 and 2023, the Company recognized approximately $33,000 and $28,000, respectively, in expense in its Condensed Statements of Operations related to the advisory agreement, including approximately $18,000 and $13,000 in expense related to annual equity incentive grants. For the nine months ended September 30, 2024 and 2023, the Company recognized approximately $92,000 and $83,000, respectively, in expense in its Condensed Statements of Operations related to the advisory agreement, including approximately $47,000 and $37,000 in expense related to annual equity incentive grants.

Note 5 – Commitments and Contingencies

Leases

The Company is not a party to any leases for office space or equipment.

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License Agreements

The Company has undertaken to make contingent milestone payments to the licensors of its portfolio of product candidates. In addition, the Company would pay royalties to such licensors based on a percentage of net sales of each product candidate following regulatory marketing approval (See Note 3).

Litigation

The Company recognizes a liability for a contingency when it is probable that liability has been incurred and when the amount of loss can be reasonably estimated. When a range of probable loss can be estimated, the Company accrues the most likely amount of such loss, and if such amount is not determinable, then the Company accrues the minimum of the range of probable loss. The Company expenses legal costs as they are incurred.

The Company and James Oliviero have been named as defendants in a consolidated putative stockholder class action lawsuit pending in the United States District Court for the Southern District of New York (the “Court”), which was filed on April 5, 2024. The action is styled In re Checkpoint Therapeutics, Inc. Securities Litigation, No. 1:24-cv-02613-PAE (the “Securities Class Action”). On June 21, 2024, the Court appointed a lead plaintiff for the putative class and approved his choice of lead counsel. The lead plaintiff filed his amended complaint (the “Amended Complaint”) on August 23, 2024, which alleges that defendants violated the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and SEC Rule 10b-5 promulgated thereunder by making false and misleading statements and omissions, and that James Oliviero is named as a control person under Section 20(a) of the Exchange Act. The Amended Complaint was filed on behalf of stockholders who purchased shares of the Company’s common stock between March 10, 2021, and December 15, 2023, and seeks, among other things, monetary damages on behalf of the purported class. Defendants moved to dismiss the Amended Complaint on October 23, 2024.

The Company has been named as a nominal defendant and certain of its current and former directors and executive officers have been named as defendants in a derivative lawsuit pending in the United States District Court for the Southern District of New York. The action is styled Geary v. Oliviero, et al., No. 1:24-cv-03471 (the “Derivative Action”). The Complaint in the Derivative Action, which was filed on May 6, 2024, asserts claims against all defendants under Delaware law for, among other things, breach of fiduciary duty, claims against all defendants under Section 14(a) of the Exchange Act, and claims for contribution under the federal securities laws against certain of the defendants. On June 20, 2024, the Derivative Action was stayed pending final resolution of the anticipated motion to dismiss in the Securities Class Action, including any appeals therefrom.

The Company believes that the allegations in the Securities Class Action and the Derivative Action are without merit and intends to defend itself and its directors and executive officers vigorously. There is no assurance, however, that the Company or the other defendants will be successful in their defense of either of these allegations or that the Company’s insurance policy coverage will be available or adequate to fund any settlement or judgment or the litigation costs of these actions. Moreover, the Company is unable to predict the outcome or reasonably estimate a range of possible losses at this time.

Note 6 – Stockholders’ Equity

Common Stock

At the Company’s 2024 Annual Meeting of Stockholders held on May 13, 2024, its stockholders approved an amendment to its certificate of incorporation to increase the number of authorized shares of common stock available to issue by 95,000,000 to 175,000,000 with a par value of $0.0001 per share, of which 700,000 shares are designated as “Class A common stock.” The amendment was filed with the Secretary of State of the State of Delaware on May 13, 2024.

As of September 30, 2024 and December 31, 2023, there were 700,000 shares of Class A common stock issued and outstanding to Fortress. The holders of common stock are entitled to one vote per share of common stock held. The Class A common stockholders are entitled to a number of votes per share equal to 1.1 times a fraction, the numerator of which is the sum of the shares of outstanding common stock and the denominator of which is the number of shares of Class A common stock. Accordingly, the holder of shares of Class A common stock will be able to control or significantly influence all matters requiring approval by our stockholders, including the election of directors and the approval of mergers or other business combination transactions. Each share of Class A common stock is convertible, at the option of the holder thereof, into one (1) fully paid and non-assessable share of common stock subject to adjustment for stock splits and combinations.

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Registered Direct Offerings

In November 2020, the Company filed a shelf registration statement on Form S-3 (the “November 2020 Form S-3”), which was declared effective in December 2020 (File No. 333-251005). Under the November 2020 Form S-3, the Company may sell up to a total of $100 million of its securities.

In February 2023, the Company closed on the February 2023 Registered Direct Offering for the issuance and sale of an aggregate of 1,180,000 shares of its common stock at a purchase price of $5.25 per share of common stock. In addition, the offering includes 248,572 shares of common stock in the form of pre-funded warrants at a price of $5.2499. The pre-funded warrants were funded in full at closing except for a nominal exercise price of $0.0001, are exercisable commencing on the closing date and will terminate when such pre-funded warrants are exercised in full. In a concurrent private placement, the Company issued and sold Series A warrants to purchase up to 1,428,572 shares of common stock and Series B warrants to purchase up to 1,428,572 shares of common stock (collectively, the “February 2023 Common Stock Warrants”). The Series A and B warrants are exercisable immediately upon issuance with an exercise price of $5.00 per share. The Series A warrants will expire five years following the issuance date and the Series B warrants will expire eighteen months following the issuance date. The Company also issued the placement agent warrants to purchase up to 85,714 shares of common stock with an exercise price of $6.5625 per share. The total gross proceeds from the February 2023 Registered Direct Offering were approximately $7.5 million with net proceeds of approximately $6.7 million after deducting approximately $0.8 million in commissions and other transaction costs. The shares of common stock and the shares underlying the pre-funded warrants were registered for sale under the November 2020 Form S-3. In March 2023, the Company filed a registration statement on Form S-3 to register the February 2023 Common Stock Warrants and placement agent warrants, which was declared effective May 5, 2023 (File No. 333-270474). In February 2023, the pre-funded warrants from the February 2023 Registered Direct Offering were fully exercised. The February 2023 Common Stock Warrants and placement agent warrants met the criteria for equity classification.

In April 2023, the Company closed on the April 2023 Registered Direct Offering for the issuance and sale of an aggregate of 1,700,000 shares of its common stock at a purchase price of $3.60 per share of common stock. In a concurrent private placement, the Company issued and sold Series A warrants to purchase up to 1,700,000 shares of common stock and Series B warrants to purchase up to 1,700,000 shares of common stock (collectively, the “April 2023 Common Stock Warrants”). The Series A and B warrants are exercisable immediately upon issuance with an exercise price of $3.35 per share. The Series A warrants will expire five years following the issuance date and the Series B warrants will expire eighteen months following the issuance date. The Company also issued the placement agent warrants to purchase up to 102,000 shares of common stock with an exercise price of $4.50 per share. The total gross proceeds from the April 2023 Registered Direct Offering were approximately $6.1 million with net proceeds of approximately $5.5 million after deducting approximately $0.6 million in commissions and other transaction costs. The shares of common stock were registered for sale under the November 2020 Form S-3. In April 2023, the Company filed a registration statement on Form S-3 to register the April 2023 Common Stock Warrants and placement agent warrants, which was declared effective May 5, 2023 (File No. 333-271171). The April 2023 Common Stock Warrants and placement agent warrants met the criteria for equity classification.

The November 2020 Form S-3 expired in December 2023.

In March 2023, the Company filed a shelf registration statement on Form S-3 (the “March 2023 Form S-3”), which was declared effective May 5, 2023 (File No. 333-270843). Under the March 2023 Form S-3, the Company may sell up to a total of $150 million of its securities.

In May 2023, the Company closed on the May 2023 Registered Direct Offering for the issuance and sale of an aggregate of 1,650,000 shares of its common stock at a purchase price of $3.071 per share of common stock. In addition, the offering includes 1,606,269 shares of common stock in the form of pre-funded warrants at a price of $3.0709. The pre-funded warrants were funded in full at closing except for a nominal exercise price of $0.0001, are exercisable commencing on the closing date and will terminate when such pre-funded warrants are exercised in full. The common stock and the pre-funded warrants were sold together with Series A warrants to purchase up to 3,256,269 shares of common stock and Series B warrants to purchase up to 3,256,269 shares of common stock (collectively, the “May 2023 Common Stock Warrants”). The Series A and B warrants are exercisable immediately upon issuance with an exercise price of $2.821 per share. The Series A warrants will expire five years following the issuance date and the Series B warrants will expire eighteen months following the issuance date. The Company also issued the placement agent warrants to purchase up to 195,376 shares of common stock with an exercise price of $3.8388 per share. The total gross proceeds from the May 2023 Registered Direct Offering were approximately $10.0 million with net proceeds of approximately $9.1 million after deducting approximately $0.9 million in commissions and other transaction costs. The shares of common stock and the shares underlying the pre-funded warrants, May 2023 Common Stock Warrants, and placement agent warrants were registered for sale under the March 2023 Form S-3. In August 2023, the pre-funded

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warrants from the May 2023 Registered Direct Offering were fully exercised. The May 2023 Common Stock Warrants and placement agent warrants met the criteria for equity classification.

In July 2023, the Company closed on the July 2023 Registered Direct Offering for the issuance and sale of an aggregate of 2,427,186 shares of its common stock at a purchase price of $3.09 per share of common stock in a registered direct offering. In addition, the offering includes 809,062 shares of common stock in the form of pre-funded warrants at a price of $3.0899. The pre-funded warrants were funded in full at closing except for a nominal exercise price of $0.0001, are exercisable commencing on the closing date and will terminate when such pre-funded warrants are exercised in full. The common stock and the pre-funded warrants were sold together with Series A warrants to purchase up to 3,236,248 shares of common stock and Series B warrants to purchase up to 3,236,248 shares of common stock (collectively, the “July 2023 Common Stock Warrants”). The Series A and B warrants are exercisable immediately upon issuance with an exercise price of $2.84 per share. The Series A warrants will expire five years following the issuance date and the Series B warrants will expire eighteen months following the issuance date. The Company also issued the placement agent warrants to purchase up to 194,175 shares of common stock with an exercise price of $3.8625 per share. The total gross proceeds from the July 2023 Registered Direct Offering were approximately $10.0 million with net proceeds of approximately $9.1 million after deducting approximately $0.9 million in commissions and other transaction costs. The shares of common stock and the shares underlying the pre-funded warrants, July 2023 Common Stock Warrants, and placement agent warrants were registered for sale under the March 2023 Form S-3. In September 2023, the pre-funded warrants from the July 2023 Registered Direct Offering were fully exercised. The July 2023 Common Stock Warrants and placement agent warrants met the criteria for equity classification.

In January 2024, the Company closed on the January 2024 Registered Direct Offering for the issuance and sale of an aggregate of 1,275,000 shares of its common stock at a purchase price of $1.805 per share of common stock. In addition, the offering includes 6,481,233 shares of common stock in the form of pre-funded warrants at a price of $1.8049. The pre-funded warrants were funded in full at closing except for a nominal exercise price of $0.0001, are exercisable commencing on the closing date, and will terminate when such pre-funded warrants are exercised in full. In a concurrent private placement, the Company issued and sold common warrants to purchase up to 7,756,233 shares of common stock (the “January 2024 Common Stock Warrants”). The January 2024 Common Stock Warrants are exercisable immediately upon issuance with an exercise price of $1.68 per share and will expire five years following the issuance date. The Company also issued the placement agent warrants to purchase up to 465,374 shares of common stock with an exercise price of $2.2563 per share. The total gross proceeds from the January 2024 Registered Direct Offering were approximately $14.0 million with net proceeds of approximately $12.6 million after deducting approximately $1.4 million in commissions and other transaction costs. The shares of common stock and the shares underlying the pre-funded warrants were registered for sale under the March 2023 Form S-3. In March 2024, the Company filed a registration statement on Form S-3 to register the January 2024 Common Stock Warrants and placement agent warrants, which was declared effective April 5, 2024 (File No. 333-278397). In July 2024, the pre-funded warrants from the January 2024 Registered Direct Offering were fully exercised. The January 2024 Common Stock Warrants and placement agent warrants met the criteria for equity classification.

In July 2024, the Company closed on the July 2024 Registered Direct Offering for the issuance and sale of an aggregate of 1,230,000 shares of its common stock at a purchase price of $2.05 per share of common stock. In addition, the offering includes 4,623,659 shares of common stock in the form of pre-funded warrants at a price of $2.0499. The pre-funded warrants were funded in full at closing except for a nominal exercise price of $0.0001, are exercisable commencing on the closing date, and will terminate when such pre-funded warrants are exercised in full. In a concurrent private placement, the Company issued and sold common warrants to purchase up to 5,853,659 shares of common stock (the “July 2024 Common Stock Warrants”). The July 2024 Common Stock Warrants have an exercise price of $2.05 per share, will be exercisable after requisite approval of our stockholders is received, and have a term of exercise of five years from the issuance date. The Company also issued the placement agent warrants to purchase up to 351,220 shares of common stock with an exercise price of $2.5625 per share. The total gross proceeds from the July 2024 Registered Direct Offering were approximately $12.0 million with net proceeds of approximately $11.0 million after deducting approximately $1.0 million in commissions and other transaction costs. The shares of common stock and the shares underlying the pre-funded warrants were registered for sale under the March 2023 Form S-3. In August 2024, the Company filed a registration statement on Form S-3 to register the July 2024 Common Stock Warrants and placement agent warrants, which was declared effective August 30, 2024 (File No. 333-281650). As of November 8, 2024, 3,814,659 pre-funded warrants from the July 2024 Registered Direct Offering were fully exercised. The July 2024 Common Stock Warrants and placement agent warrants met the criteria for equity classification.

As of September 30, 2024, approximately $65.7 million of securities remain available for sale under the March 2023 Form S-3.

The Company may offer the securities under the Form S-3’s from time to time in response to market conditions or other circumstances if it believes such a plan of financing is in the best interests of its stockholders.

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Warrant Inducement

In October 2023, the Company entered into the October 2023 Inducement with a certain holder of its existing warrants to exercise for cash an aggregate of 6,325,354 shares of the Company’s common stock at a reduced exercise price of $1.76 per share. The exercised warrants included warrants issued in a December 2022 registered direct offering with an original exercise price of $4.075 per share and the February Common Stock Warrants issued in the February 2023 Registered Direct Offering with an original exercise price of $5.00 per share. As part of the October 2023 Inducement, the Company agreed to issue new unregistered Series A Warrants to purchase up to 6,325,354 shares of Common Stock and new unregistered Series B Warrants to purchase up to 6,325,354 shares of Common Stock (collectively, the “October 2023 Common Stock Warrants”). The Series A and B warrants are exercisable immediately upon issuance with an exercise price of $1.51 per share. The Series A warrants will expire five years following the issuance date and the Series B warrants will expire twenty-four months following the issuance date. The Company also issued the placement agent warrants to purchase up to 379,521 shares of common stock with an exercise price of $2.20 per share. The total gross proceeds from the October 2023 Inducement were approximately $11.1 million with net proceeds of approximately $10.0 million after deducting approximately $1.1 million in commissions and other transaction costs. In November 2023, the Company filed a registration statement on Form S-3 to register the October 2023 Common Stock Warrants and placement agent warrants, which was declared effective November 24, 2023 (File No. 333-275644). The October 2023 Common Stock Warrants and placement agent warrants met the criteria for equity classification.

Upon the close of the transaction, the Company issued the holder 110,000 of the 6,325,354 shares of common stock that were issuable upon exercise of the existing warrants. Due to the beneficial ownership limitation provisions in the inducement offer letter agreement, the remaining 6,215,354 shares were initially unissued, and held in abeyance for the benefit of the holder until notice from the holder that the shares may be issued in compliance with the agreement. In January 2024, the final shares held in abeyance were issued to the holder.

Shares Issued Under the Founders Agreement

Pursuant to the Founders Agreement, the Company issued 368,907 shares of common stock to Fortress for the Annual Equity Fee, representing 2.5% of the fully diluted outstanding equity of Checkpoint on January 1, 2023 (see Notes 2 and 4).

Pursuant to the Founders Agreement, the Company issued to Fortress 2.5% of the aggregate number of shares of common stock issued in the February, April, and May 2023 registered direct offerings noted above. Accordingly, the Company issued 159,620 shares of common stock to Fortress and recorded expense of approximately $0.6 million related to these issuances, which is included in general and administrative expenses in the Company’s Condensed Statements of Operations for the nine months ended September 30, 2023.

Pursuant to the Founders Agreement, the Company issued 1,492,915 shares of common stock to Fortress on May 16, 2024 for the Annual Equity Fee, representing 2.5% of the fully diluted outstanding equity of Checkpoint on January 1, 2024. The Company did not have enough unreserved authorized shares under its certificate of incorporation on January 1, 2024 to issue the shares for the Annual Equity Fee. Therefore, in December 2023, Fortress and Checkpoint mutually agreed to defer the issuance until such time as certificate of incorporation has been amended in order to increase the number of authorized that may be issued thereunder. At the Company’s 2024 Annual Meeting of Stockholders held on May 13, 2024, its stockholders approved an amendment to its certificate of incorporation to increase the number of authorized shares of common stock available to issue. Because the number of outstanding shares issuable to Fortress was determinable on January 1, 2024 prior to the issuance of the December 31, 2023 financial statements, the Company recorded approximately $3.4 million in research and development expense and a credit to Common shares issuable-Founders Agreement during the year ended December 31, 2023.

Pursuant to the Founders Agreement, the Company issued to Fortress 2.5% of the aggregate number of shares of common stock issued in the January and July 2024 registered direct offerings noted above. Accordingly, the Company issued 340,246 shares of common stock to Fortress and recorded expense of approximately $714,000 related to these issuances, which is included in general and administrative expenses in the Company’s Condensed Statements of Operations for the nine months ended September 30, 2024.

Equity Incentive Plan

The Company has in effect the Amended and Restated 2015 Incentive Plan (“2015 Incentive Plan”). The 2015 Incentive Plan was adopted in March 2015 by our stockholders. Under the 2015 Incentive Plan, the compensation committee of the Company’s board of directors is authorized to grant stock-based awards to directors, officers, employees and consultants. At the Company’s 2024 Annual

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Meeting of Stockholders held on May 13, 2024, its stockholders approved an amendment to the 2015 Incentive Plan to increase the shares available for issuance to 18,000,000 shares. The plan expires 10 years from the effective date of the amendment and limits the term of each option to no more than 10 years from the date of grant.

On May 24, 2024, the Company filed a registration statement on Form S-8 under the Securities Act registering the common stock issued, issuable or reserved for issuance under our 2015 Incentive Plan. The registration statement became effective immediately upon filing, and shares covered by the registration statement are eligible for sale in the public markets, subject to grant of the underlying awards, vesting provisions and Rule 144 imitations applicable to our affiliates.

As of September 30, 2024, 8,010,406 shares are available for issuance under the 2015 Incentive Plan.

Restricted Stock Awards

Certain employees, directors and consultants have been awarded restricted stock. The restricted stock vesting consists of milestone and time-based vesting. The following table summarizes restricted stock award activity for the nine months ended September 30, 2024:


		Weighted Average
	Number of	Grant Date Fair
	Shares	Value
Non-vested at December 31, 2023	1,316,120	$	6.88
Granted	5,346,306		1.89
Forfeited	(23,894)		6.28
Vested	(280,800)		8.40
Non-vested at September 30, 2024	6,357,732	$	2.62

As of September 30, 2024, there was $6.4 million of total unrecognized compensation cost related to non-vested restricted stock, which is expected to be recognized over a weighted-average period of 1.7 years. This amount does not include, as of September 30, 2024, 1,466,733 shares of restricted stock outstanding which are performance-based and vest upon achievement of certain corporate milestones. The expense is recognized over the vesting period of the award. Stock-based compensation for milestone awards will be measured and recorded if and when it is probable that the milestone will be achieved.

Restricted Stock Units

The following table summarizes restricted stock units activity for the nine months ended September 30, 2024:


		Weighted Average
	Number of	Grant Date Fair
	Shares	Value
Non-vested at December 31, 2023	615,884	$	2.77
Granted	2,200,000		1.84
Forfeited	(17,638)		2.25
Non-vested at September 30, 2024	2,798,246	$	2.04

As of September 30, 2024, all restricted stock units outstanding are performance-based and vest upon achievement of certain corporate milestones. The expense for milestone awards will be measured and recorded if and when it is probable that the milestone will be achieved.

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Stock Options

The following table summarizes stock option award activity for the nine months ended September 30, 2024:


				Weighted Average
				Remaining
		Weighted Average		Contractual Life
	Stock Options	Exercise Price		(in years)
Outstanding as of December 31, 2023	127,000	$	8.88	8.60
Outstanding as of September 30, 2024	127,000	$	8.88	7.85
Vested and exercisable as of September 30, 2024	120,250	$	6.50	8.13

Upon the exercise of stock options, the Company will issue new shares of its common stock. The Company used the Black-Scholes Model for determining the estimated fair value of stock-based compensation related to stock options.

Warrants

A summary of warrant activities for the nine months ended September 30, 2024 is presented below:


				Weighted Average
				Remaining
		Weighted Average		Contractual Life
	Warrants	Exercise Price		(in years)
Outstanding as of December 31, 2023	30,097,671	$	2.36	3.00
Granted	25,531,378		1.87
Exercised	(7,258,892)		—
Outstanding as of September 30, 2024	48,370,157	$	2.20	2.98

Upon the exercise of warrants, the Company will issue new shares of its common stock. The weighted average exercise price and weighted average remaining contractual life amounts presented in the table above exclude the effect of the 11,104,892 pre-funded warrants granted by the Company during the nine-months ended September 30, 2024, with an average exercise price of $0.0001. During the nine months ended September 30, 2024, 7,258,892 of those pre-funded warrants were exercised.

Stock-Based Compensation

The following table summarizes stock-based compensation expense for the three and nine months ended September 30, 2024 and 2023 ($ in thousands):


	For the three months ended September 30,				For the nine months ended September 30,
	2024		2023		2024		2023
Research and development	$	543	$	304	$	1,629	$	881
General and administrative		1,068		385		1,862		1,344
Total stock-based compensation expense	$	1,611	$	689	$	3,491	$	2,225

Note 7 – Common Stock Warrant Liabilities

On December 16, 2022, the Company closed on an offering for the sale of shares of its common stock and pre-funded warrants as part of a registered direct offering. The common stock and the pre-funded warrants were sold together with Series A and Series B common stock warrants. The Company also issued the placement agent warrants to purchase shares of common stock as part of the offering. After the October 2023 Inducement, only the placement agent warrants remained outstanding from this offering.

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The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity and ASC 815-40, Derivatives and Hedging - Contracts in Entity’s Own Equity. For warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance, and each balance sheet date thereafter.

The Company deemed the placement agent warrants issued in December 2022 to be classified as liabilities on the balance sheet as they contain terms for redemption of the underlying security that are outside its control. The warrants were recorded at the time of closing at a fair value, determined by using the Black-Scholes Model, and will be revalued at each reporting period thereafter for as long as they remain outstanding. The Company revalued the warrants at September 30, 2024 and December 31, 2023, resulting in a fair value of approximately $125,000 for each period.


	Common Stock
	Warrant
	Liabilities
Common Stock Warrant liabilities at December 31, 2023	$	125
Change in fair value of Common Stock Warrant liabilities		—
Common Stock Warrant liabilities at September 30, 2024	$	125

The Company used the Black-Scholes Model for determining the estimated fair value of the common stock warrant liabilities. A summary of the weighted average (in aggregate) significant unobservable inputs used in measuring the warrant liability is determined using Level 3 inputs as follows:


	September 30,			December 31,
	2024			2023
Exercise price	$	5.41		$	5.41
Volatility		108.0	%		96.4	%
Expected life		3.2			4.0
Risk-free rate		3.6	%		3.8	%
Dividend yield		—			—

Note 8 - Accounts Payable and Accrued Expenses

At September 30, 2024 and December 31, 2023, accounts payable and accrued expenses consisted of the following ($ in thousands):


	September 30,		December 31,
	2024		2023
Accounts payable	$	7,891	$	6,570
Accrued compensation		1,102		1,206
Accrued Research and development		6,419		7,123
Other		223		586
Total accounts payable and accrued expenses	$	15,635	$	15,485

Note 9 – Subsequent Events

On November 12, 2024, the Company received approximately $9.2 million from the exercise of existing Series B warrants for the issuance of 3,256,269 shares of common stock from the May 2023 Registered Direct Offering with an exercise price of $2.821 per share. The shares of common stock issuable upon the exercise of the warrants were registered under the March 2023 Form S-3.

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Item 2. Financial Information.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Forward-Looking Statements

Statements in the following discussion and throughout this report that are not historical in nature are “forward-looking statements.” You can identify forward-looking statements by the use of words such as “expect,” “anticipate,” “estimate,” “may,” “will,” “should,” “intend,” “believe,” and similar expressions, although not all forward-looking statements contain these identifying words. Although we believe the expectations reflected in these forward-looking statements are reasonable, such statements are inherently subject to significant risks and uncertainties and we can give no assurances that our expectations will prove to be correct. Actual results could differ materially from those described in this report because of numerous factors, many of which are beyond our control. These factors include, without limitation, those described under Item 1A “Risk Factors.” We undertake no obligation to update these forward-looking statements to reflect events or circumstances after the date of this report or to reflect actual outcomes.

Overview

We are a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. We are evaluating our lead antibody product candidate, cosibelimab, an anti-programmed death-ligand 1 (“PD-L1”) antibody licensed from the Dana-Farber Cancer Institute, in an ongoing global, open-label, multicohort Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including ongoing cohorts in locally advanced and metastatic cutaneous squamous cell carcinoma (“CSCC”) intended to support one or more applications for marketing approval. Based on top-line and interim results in metastatic and locally advanced CSCC, respectively, we submitted a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for these indications in January 2023. On December 15, 2023, the FDA issued a complete response letter (“CRL”) for the cosibelimab BLA for the treatment of patients with metastatic or locally advanced CSCC who are not candidates or curative surgery or radiation. The CRL only cited findings that arose during a multi-sponsor inspection of our third-party contract manufacturing organization as approvability issues to address in a resubmission. In July 2024, we announced that we had completed a resubmission of the BLA to the FDA for cosibelimab to potentially address the approvability issues cited in the CRL. The resubmission was accepted by the FDA as a complete response, and the FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date of December 28, 2024. In addition, we are evaluating our lead small-molecule, targeted anti-cancer agent, olafertinib, a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer.

In January 2022, we announced top-line results from a registration-enabling cohort of our multi-regional, Phase 1 clinical trial of cosibelimab in patients with metastatic CSCC. The cohort met its primary endpoint, with cosibelimab demonstrating a confirmed objective response rate (“ORR”) of 47.4% (95% CI: 36.0, 59.1) based on independent central review of 78 patients enrolled in the metastatic CSCC cohort using Response Evaluation Criteria in Solid Tumors version 1.1 (“RECIST 1.1”).

In June 2022, we announced interim results from a registration-enabling cohort of our multi-regional, Phase 1 clinical trial of cosibelimab in patients with locally advanced CSCC that are not candidates for curative surgery or radiation. Cosibelimab demonstrated a confirmed ORR of 54.8% (95% CI: 36.0, 72.7) based on independent central review of 31 patients enrolled in the cohort.

In July 2023, we announced longer-term results for cosibelimab from its pivotal studies in locally advanced and metastatic CSCC. These results demonstrated a deepening of response over time, resulting in complete response rates of 26% and 13% in locally advanced and metastatic CSCC, respectively. Additionally, the confirmed ORR in metastatic CSCC increased to 50.0% based on independent central review using RECIST 1.1. Furthermore, responses continue to remain durable over time with the median duration of response not yet reached in either group. Updated safety data across 247 patients enrolled and treated with cosibelimab in all cohorts of the ongoing study remain consistent with those previously reported.

We have also entered into various collaboration agreements with TG Therapeutics, Inc. (“TGTX”), a related party, to develop and commercialize certain assets in connection with our licenses in the field of hematological malignancies, while we retain the right to develop and commercialize these assets in solid tumors. Effective September 30, 2023, the Company and TGTX agreed to mutually terminate these collaborations, with full rights reverting back to us.

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To date, we have not received approval for the sale of any product candidate in any market and, therefore, have not generated any product sales from any product candidates. In addition, we have incurred substantial operating losses since our inception, and expect to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of September 30, 2024, we have an accumulated deficit of $341.7 million.

We are a majority-controlled subsidiary of Fortress.

Checkpoint Therapeutics, Inc. was incorporated in Delaware on November 10, 2014 and commenced principal operations in March 2015. Our executive offices are located at 95 Sawyer Road, Suite 110, Waltham, MA 02453. Our telephone number is (781) 652-4500 and our email address is ir@checkpointtx.com.

Critical Accounting Policies and Use of Estimates

Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements. We evaluate our estimates and judgments on an ongoing basis, including, but not limited to, those related to research and development expenses, accrued research and development expenses and stock-based compensation. We base our estimates on historical experience, known trends and events and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

For a discussion of our critical accounting estimates, see the MD&A in the 2023 Form 10-K. There were no material changes in our critical accounting estimates or accounting policies from December 31, 2023.

Accounting Pronouncements

During the three-month period ended September 30, 2024, there were no new accounting pronouncements or updates to recently issued accounting pronouncements disclosed in the 2023 Form 10-K that are expected to materially affect the Company’s present or future financial statements.

Results of Operations

Comparison of the Three Months Ended September 30, 2024 and 2023

Revenue

For the three months ended September 30, 2024, revenue was nil compared to approximately $31,000 for the three months ended September 20, 2023. The prior period revenue consisted of patent fees related to our collaborations with TGTX.

Research and Development Expenses

Research and development expenses primarily consist of personnel related expenses, including salaries, benefits, travel, and other related expenses, stock-based compensation, payments made to third parties for license and milestone costs related to in-licensed products and technology, payments made to third party CROs for preclinical and clinical studies, investigative sites for clinical trials, consultants, the cost of acquiring and manufacturing clinical trial materials, costs associated with regulatory filings and patents, laboratory costs and other supplies.

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For the three months ended September 30, 2024, research and development expenses were approximately $6.4 million, compared to $5.5 million for the three months ended September 30, 2023, an increase of $0.9 million. The current period research and development expenses primarily consisted of $3.1 million related to commercial manufacturing costs and additional inventory build, which is expensed prior to approval, to support a potential launch of cosibelimab, $1.1 million related to clinical costs for cosibelimab, $1.4 million related to salary expenses, and $0.5 million related to stock compensation expense. The prior period research and development expenses primarily consisted of $2.0 million related to commercial manufacturing costs for cosibelimab, $1.6 million related to clinical costs for the CK-301-101 study, $1.3 million related to salary expenses, and $0.3 million related to stock compensation expense.

We anticipate our research and development expenses will remain relatively consistent for the remainder of 2024.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related expenses, including stock-based compensation, for executives and other administrative personnel, recruitment expenses, professional fees and other corporate expenses, including investor relations, legal activities, marketing and facilities-related expenses.

For the three months ended September 30, 2024, general and administrative expenses were approximately $3.4 million, compared to $2.2 million for the three months ended September 30, 2023, an increase of $1.2 million. The current period general and administrative expenses primarily consisted of stock compensation expense of $1.1 million, $0.4 million related to salary expenses, $0.9 million related to legal and accounting fees, $0.3 million related to our issuance of shares to Fortress pursuant to the Founders Agreement in connection with the sale of shares of our common stock, $0.1 million related to investor relation fees, and $0.1 million related to marketing costs. The prior period general and administrative expenses primarily consisted of stock compensation expense of $0.4 million, $0.4 million related to salary expenses, $0.5 million related to legal and accounting fees, $0.1 million related to investor relation fees, $0.1 million related to marketing costs, and $0.2 million related to our issuance of shares to Fortress pursuant to the Founders Agreement in connection with the sale of shares of our common stock.

We anticipate our general and administrative expenses will increase modestly for the remainder of 2024.

Other Income (Expense)

For the three months ended September 30, 2024, interest income was approximately $2,000 compared to approximately $7,000 for the three months ended September 30, 2023, a decrease of approximately $5,000. The decrease was primarily due to our cash balances and interest rates between the periods.

For the three months ended September 30, 2024, there was no change in the value of common stock warrant liabilities compared to June 30, 2024. For the three months ended September 30, 2023, the gain on common stock warrant liabilities was approximately $2.0 million. The gain on common stock warrant liabilities is comprised of the fair value remeasurement of the common stock warrant liabilities on September 30, 2023 associated with the registered direct offering we completed in December 2022. We account for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480 and ASC 815. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.

For the three months ended September 30, 2024, foreign currency exchange loss was approximately $3,000, which is comprised of the currency fluctuation when purchasing goods and services in another currency relative to the United States dollar.

Comparison of the Nine Months Ended September 30, 2024 and 2023

Revenue

For the nine months ended September 30, 2024, revenue was approximately $41,000 compared to approximately $97,000 for the nine months ended September 30, 2023. The current and prior period revenue consisted of patent fees related to our collaborations with TGTX.

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Research and Development Expenses

For the nine months ended September 30, 2024, research and development expenses were approximately $19.3 million, compared to $35.3 million for the nine months ended September 30, 2023, a decrease of $16.0 million. The current period research and development expenses primarily consisted of $8.2 million related to commercial manufacturing costs and additional inventory build, which is expensed prior to approval, to support a potential launch of cosibelimab, $3.4 million related to clinical costs for the CK-301-101 study, $4.2 million related to salary expenses, and $1.6 million related to stock compensation expense. The prior period research and development expenses primarily consisted of $17.7 million related to commercial manufacturing costs and inventory build, $5.5 million related to clinical costs for our product candidates, $3.5 million related to regulatory expenses, including $3.2 million for the PDUFA fee to the FDA for the BLA filing for cosibelimab in the first quarter of 2023, $3.9 million related to salary expenses, and $0.9 million related to stock compensation expense.

General and Administrative Expenses

For the nine months ended September 30, 2024, general and administrative expenses were approximately $8.0 million, compared to $6.8 million for the nine months ended September 30, 2023, an increase of $1.2 million. The current period general and administrative expenses primarily consisted of stock compensation expense of $1.9 million, $1.3 million related to salary expenses, $2.2 million related to legal and accounting fees, $0.3 million related to investor relation fees, $0.2 million related to marketing costs, and $0.7 million related to our issuance of shares to Fortress pursuant to the Founders Agreement in connection with the sale of shares of our common stock. The prior period general and administrative expenses primarily consisted of stock compensation expense of $1.3 million, $1.2 million related to salary expenses, $1.4 million related to legal and accounting fees, $0.3 million related to investor relation fees, $0.1 million related to marketing costs, and $0.8 million related to our issuance of shares to Fortress pursuant to the Founders Agreement in connection with the sale of shares of our common stock.

Other Income (Expense)

For the nine months ended September 30, 2024, interest income was approximately $9,000 compared to approximately $81,000 for the nine months ended September 30, 2023, a decrease of approximately $72,000. The decrease was primarily due to our cash balances and interest rates between the periods.

For the nine months ended September 30, 2024, there was no change in the value of common stock warrant liabilities compared to December 31, 2023. For the nine months ended September 30, 2023, the gain on common stock warrant liabilities was approximately $9.2 million. The gain on common stock warrant liabilities is comprised of the fair value remeasurement of the common stock warrant liabilities on September 30, 2023 associated with the registered direct offering we completed in December 2022. We account for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480 and ASC 815. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.

For the nine months ended September 30, 2024, foreign currency exchange loss was approximately $4,000, which is comprised of the currency fluctuation when purchasing goods and services in another currency relative to the United States dollar.

Liquidity and Capital Resources

We have incurred substantial operating losses since our inception and expect to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of September 30, 2024, we had an accumulated deficit of $341.7 million.

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In February 2023, we closed on a registered direct offering (the “February 2023 Registered Direct Offering”) for the issuance and sale of an aggregate of 1,428,572 shares of our common stock at a purchase price of $5.25 per share. In addition, the offering included 248,572 shares of common stock in the form of pre-funded warrants at a price of $5.2499. In a concurrent private placement, we issued and sold Series A warrants to purchase up to 1,428,572 shares of common stock and Series B warrants to purchase up to 1,428,572 shares of common stock. The Series A and B warrants are exercisable immediately upon issuance with an exercise price of $5.00 per share. The Series A warrants will expire five years following the issuance date and the Series B warrants will expire eighteen months following the issuance date. The total gross proceeds from the offering were approximately $7.5 million with net proceeds of approximately $6.7 million after deducting approximately $0.8 million in commissions and other transaction costs. In February 2023, the pre-funded warrants from the February 2023 Registered Direct Offering were fully exercised. In October 2023, the Series A and Series B warrants from the February 2023 Registered Direct Offering were fully exercised at a reduced exercise price of $1.76 per share as part of the October 2023 inducement offer letter agreement (see below).

In April 2023, we closed on a registered direct offering (the “April 2023 Registered Direct Offering”) for the issuance and sale of an aggregate of 1,700,000 shares of our common stock at a purchase price of $3.60 per share. In a concurrent private placement, we issued and sold Series A warrants to purchase up to 1,700,000 shares of common stock and Series B warrants to purchase up to 1,700,000 shares of common stock. The Series A and B warrants are exercisable immediately upon issuance with an exercise price of $3.35 per share. The Series A warrants will expire five years following the issuance date and the Series B warrants will expire eighteen months following the issuance date. The total gross proceeds from the offering were approximately $6.1 million with net proceeds of approximately $5.5 million after deducting approximately $0.6 million in commissions and other transaction costs.

In May 2023, we closed on a registered direct offering (the “May 2023 Registered Direct Offering”) for the issuance and sale of an aggregate of 1,650,000 shares of our common stock at a purchase price of $3.071 per share. In addition, the offering included 1,606,269 shares of common stock in the form of pre-funded warrants at a price of $3.0709. The common stock and the pre-funded warrants were sold together with Series A warrants to purchase up to 3,256,269 shares of common stock and Series B warrants to purchase up to 3,256,269 shares of common stock. The Series A and B warrants are exercisable immediately upon issuance with an exercise price of $2.821 per share. The Series A warrants will expire five years following the issuance date and the Series B warrants will expire eighteen months following the issuance date. The total gross proceeds from the offering were approximately $10.0 million with net proceeds of approximately $9.1 million after deducting approximately $0.9 million in commissions and other transaction costs. In August 2023, the pre-funded warrants from the May 2023 Registered Direct Offering were fully exercised.

In July 2023, we closed on a registered direct offering (the “July 2023 Registered Direct Offering”) for the issuance and sale of an aggregate of 2,427,186 shares of our common stock at a purchase price of $3.09 per share. In addition, the offering included 809,062 shares of common stock in the form of pre-funded warrants at a price of $3.0899. The common stock and the pre-funded warrants were sold together with Series A warrants to purchase up to 3,236,248 shares of common stock and Series B warrants to purchase up to 3,236,248 shares of common stock. The Series A and B warrants are exercisable immediately upon issuance with an exercise price of $2.84 per share. The Series A warrants will expire five years following the issuance date and the Series B warrants will expire eighteen months following the issuance date. The total gross proceeds from the offering were approximately $10.0 million with net proceeds of approximately $9.1 million after deducting approximately $0.9 million in commissions and other transaction costs. In September 2023, the pre-funded warrants from the July 2023 Registered Direct Offering were fully exercised.

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In October 2023, we entered into an inducement offer letter agreement (the “October 2023 Inducement”) with a certain holder of our existing warrants to exercise for cash an aggregate of 6,325,354 shares of our common stock at a reduced exercise price of $1.76 per share. The warrants were issued to the holder on December 16, 2022 with an exercise price of $4.075 per share and on February 22, 2023 with an exercise price of $5.00 per share as part of registered direct offerings. As part of the inducement, we agreed to issue new unregistered Series A warrants to purchase up to 6,325,354 shares of Common Stock and new unregistered Series B warrants to purchase up to 6,325,354 shares of Common Stock (collectively, the “October 2023 Common Stock Warrants”). The Series A and B warrants are exercisable immediately upon issuance with an exercise price of $1.51 per share. The Series A warrants will expire five years following the issuance date and the Series B warrants will expire twenty-four months following the issuance date. The total gross proceeds from the exercise were approximately $11.1 million with net proceeds of approximately $10.0 million after deducting approximately $1.1 million in commissions and other transaction costs. Upon the close of the transaction, we issued the holder 110,000 of the 6,325,354 shares of common stock that were issuable upon exercise of the existing warrants. Due to the beneficial ownership limitation provisions in the inducement offer letter agreement, the remaining 6,215,354 shares were initially unissued, and held in abeyance for the benefit of the holder until notice from the holder that the shares may be issued in compliance with the agreement. In January 2024, the final shares held in abeyance were issued to the holder.

In January 2024, we closed on a registered direct offering (the “January 2024 Registered Direct Offering”) for the issuance and sale of an aggregate of 1,275,000 shares of our common stock at a purchase price of $1.805 per share of common stock. In addition, the offering included 6,481,233 shares of common stock in the form of pre-funded warrants at a price of $1.8049. The common stock and the pre-funded warrants were sold together with common warrants (the “January 2024 Common Stock Warrants”) to purchase up to 7,756,233 shares of common stock. The January 2024 Common Stock Warrants are exercisable immediately upon issuance with an exercise price of $1.68 per share and will expire five years following the issuance date. The total gross proceeds from the January 2024 Registered Direct Offering were approximately $14.0 million with net proceeds of approximately $12.6 million after deducting approximately $1.4 million in commissions and other transaction costs. In July 2024, the pre-funded warrants from the January 2024 Registered Direct Offering were fully exercised.

In July 2024, we closed on a registered direct offering (the “July 2024 Registered Direct Offering”) for the issuance and sale of an aggregate of 1,230,000 shares of its common stock at a purchase price of $2.05 per share of common stock. In addition, the offering includes 4,623,659 shares of common stock in the form of pre-funded warrants at a price of $2.0499. The common stock and the pre-funded warrants were sold together with common warrants (the “July 2024 Common Stock Warrants”) to purchase up to 5,853,659 shares of common stock. The July 2024 Common Warrants have an exercise price of $2.05 per share, will be exercisable after requisite approval of our stockholders is received, and have a term of exercise of five years from the issuance date. The total gross proceeds from the July 2024 Registered Direct Offering were approximately $12.0 million with net proceeds of approximately $11.0 million after deducting approximately $1.0 million in commissions and other transaction costs. As of November 8, 2024, 3,814,659 pre-funded warrants from the July 2024 Registered Direct Offering were fully exercised.

On November 12, 2024, we received approximately $9.2 million from the exercise of existing Series B warrants for the issuance of 3,256,269 shares of common stock from the May 2023 Registered Direct Offering with an exercise price of $2.821 per share.

Our major sources of cash have been proceeds from the sale of equity securities. We expect to use these proceeds primarily for general corporate purposes, which may include financing our growth, developing new or existing product candidates, and funding capital expenditures, acquisitions and investments.

We believe that our cash and cash equivalents are only sufficient to fund our operating expenses into the first quarter of 2025, assuming no exercises of outstanding common stock warrants. We will need to secure additional funds through equity or debt offerings, or other potential sources such as partnerships to fully develop and commercialize, if approved, our product candidates. Our estimate as to how long we expect our existing cash to be able to continue to fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Further, changing circumstances, some of which may be beyond our control, could cause us to consume capital faster than we currently anticipate, and we may need to seek additional funds sooner than planned. We cannot be certain that additional funding will be available on acceptable terms, or at all. These factors individually and collectively raise substantial doubt about our ability to continue as a going concern.

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Cash Flows for the Nine Months Ended September 30, 2024 and 2023

Operating Activities

Net cash used in operating activities was approximately $23.9 million for the nine months ended September 30, 2024, compared to approximately $40.8 million for the nine months ended September 30, 2023. The decrease in net cash used in operating activities was primarily related to a reduction in commercial manufacturing and regulatory fees for cosibelimab in the current period.

Investing Activities

There were no investing activities for the nine months ended September 30, 2024 and 2023.

Financing Activities

Net cash provided by financing activities was $23.7 million for the nine months ended September 30, 2024, compared to $30.5 million for the nine months ended September 30, 2023. Cash provided by financing activities in the current period was related to the net proceeds from the issuance of common shares as part of our January and July 2024 registered direct offerings. The prior period amount was related to the net proceeds from the issuance of common shares as part of four registered direct offerings.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this item.

Item 4. Controls and Procedures

Disclosure Controls and Procedures

We maintain “disclosure controls and procedures,” as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, to allow timely decisions regarding required disclosure.

The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

With respect to the quarter ended September 30, 2024, under the supervision and with the participation of our management, we conducted an evaluation of the effectiveness of the design and operations of our disclosure controls and procedures. Based upon this evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures are effective. Management does not expect that our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control systems are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in a cost-effective control system, no evaluation of internal control over financial reporting can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been or will be detected.

Changes in Internal Control over Financial Reporting:

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended September 30, 2024 which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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Part II. Other Information

Item 1. Legal Proceedings.

We and James Oliviero have been named as defendants in a consolidated putative stockholder class action lawsuit pending in the United States District Court for the Southern District of New York (the “Court”), which was filed on April 5, 2024. The action is styled In re Checkpoint Therapeutics, Inc. Securities Litigation, No. 1:24-cv-02613-PAE (the “Securities Class Action”). On June 21, 2024, the Court appointed a lead plaintiff for the putative class and approved his choice of lead counsel. The lead plaintiff filed his amended complaint (the “Amended Complaint”) on August 23, 2024, which alleges that defendants violated the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and SEC Rule 10b-5 promulgated thereunder by making false and misleading statements and omissions, and that James Oliviero is named as a control person under Section 20(a) of the Exchange Act. The Amended Complaint was filed on behalf of stockholders who purchased shares of our common stock between March 10, 2021, and December 15, 2023, and seeks, among other things, monetary damages on behalf of the purported class. Defendants moved to dismiss the Amended Complaint on October 23, 2024.

We have been named as a nominal defendant and certain of our current and former directors and executive officers have been named as defendants in a derivative lawsuit pending in the United States District Court for the Southern District of New York. The action is styled Geary v. Oliviero, et al., No. 1:24-cv-03471 (the “Derivative Action”). The Complaint in the Derivative Action, which was filed on May 6, 2024, asserts claims against all defendants under Delaware law for, among other things, breach of fiduciary duty, claims against all defendants under Section 14(a) of the Exchange Act, and claims for contribution under the federal securities laws against certain of the defendants. On June 20, 2024, the Derivative Action was stayed pending final resolution of the anticipated motion to dismiss in the Securities Class Action, including any appeals therefrom.

We intend to defend ourselves and our directors and executive officers vigorously.

Item 1A. Risk Factors

The following information sets forth risk factors that could cause our actual results to differ materially from those contained in forward-looking statements we have made in this report and those we may make from time to time. You should carefully consider the risks described below, in addition to the other information contained in this report and our other public filings, before making an investment decision. Our business, financial condition or results of operations could be harmed by any of these risks. The risks and uncertainties described below are not the only ones we face. Additional risks not presently known to us or other factors not perceived by us to present significant risks to our business at this time also may impair our business operations.

Risks Related to Our Finances and Capital Requirements

We have incurred significant losses since our inception and anticipate that we will incur continued losses for the foreseeable future. We may never achieve or maintain profitability.

We have a limited operating history, and we have focused primarily on in-licensing and developing our product candidates, with the goal of supporting regulatory approval for these product candidates. We have incurred losses since our inception in November 2014 and have an accumulated deficit of $341.7 million as of September 30, 2024. We expect to continue to incur significant operating losses for the foreseeable future. We also do not anticipate that we will achieve profitability for a period of time after generating material revenues, if ever. If we are unable to generate revenues, we will not become profitable and may be unable to continue operations without continued funding. Because of the numerous risks and uncertainties associated with developing pharmaceutical products, we are unable to predict the timing or amount of increased expenses or when or if, we will be able to achieve profitability. Our net losses may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially if:

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one or more of our product candidates are submitted for marketing approval, as is the case with cosibelimab, or are approved for commercial sale, due to our need to establish the necessary commercial infrastructure to launch this product candidate without substantial delays, including manufacturing to build pre-commercial inventory, hiring sales and marketing personnel and contracting with third parties for warehousing, distribution, cash collection and related commercial activities;

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we are required by the FDA or foreign regulatory authorities, to perform studies in addition to those currently expected;

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we initiate one or more clinical trials to pursue additional indications for our product candidates, or if there are any delays in completing our clinical trials or the development of any of our product candidates;

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we execute other collaborative, licensing or similar arrangements and the timing of payments we may make or receive under these arrangements;

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there are variations in the level of expenses related to our current and future development programs;

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there are any product liability or intellectual property infringement lawsuits in which we may become involved;

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there are any regulatory developments affecting product candidates of our competitors; and

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one or more of our product candidates receives regulatory approval.

Our ability to become profitable depends upon our ability to generate revenue. To date, we have not generated any revenue from the sale of our development stage products, and we do not know when, or if, we will generate any revenue. To obtain revenues from sales of our product candidates, we must succeed, either alone or with third parties, in developing, obtaining regulatory approval for, manufacturing and marketing products with commercial potential. Our ability to generate revenue depends on a number of factors, including, but not limited to, our ability to:

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obtain regulatory approval for one or more of our product candidates, or any future product candidate that we may license or acquire;

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manufacture commercial quantities of one or more of our product candidates or any future product candidate, if approved, at acceptable cost levels; and

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develop a commercial organization and the supporting infrastructure required to successfully market and sell one or more of our product candidates or any future product candidate, if approved.

Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or even continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.

We will require substantial additional funding which may not be available to us on acceptable terms, or at all. If we fail to raise the necessary additional capital, we may be unable to complete the development and potential commercialization of our product candidates, or continue our development programs.

Our operations have consumed substantial amounts of cash since inception. We expect to significantly increase our spending to advance the preclinical and clinical development, and resulting regulatory approval request submissions, of our product candidates and launch and commercialize any product candidates for which we may receive regulatory approval, including building a commercial organization to address certain markets. We will require additional capital for the further development and, if approved, commercialization of our product candidates, as well as to fund our other operating expenses and capital expenditures. We believe, assuming no business or corporate development transactions are consummated, and that no outstanding common stock warrants are exercised, that our cash and cash equivalents are only sufficient to fund our operating expenses into the first quarter of 2025. Accordingly, we intend to continue our active discussions with third party pharmaceutical and biotechnology companies to evaluate potential partnerships or other types of corporate development transactions, including strategic mergers.

We cannot be certain that additional funding will be available on acceptable terms, or at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or, if approved, commercialization of one or more of our product candidates. We may also seek collaborators for one or more of our current or future product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available. Any of these events could significantly harm our business, financial condition and prospects.

Our future funding requirements will depend on many factors, including, but not limited to:

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the timing, design and conduct of, and results from, preclinical studies and clinical trials for our product candidates;

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the timing and process of regulatory approval reviews and potential delays in our efforts to seek regulatory approval for our product candidates, and any costs associated with such delays;

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the costs of establishing a commercial organization to sell, market and distribute our product candidates;

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the rate of progress and costs of our efforts to prepare for the submission or resubmission of an NDA or BLA for any of our product candidates or any product candidates that we may in-license or acquire in the future, and the potential that we may need to conduct additional clinical trials to support applications for regulatory approval;

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the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights associated with our product candidates, including any such costs we may be required to expend if our licensors are unwilling or unable to do so;

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the cost and timing of securing sufficient supplies of our product candidates from our third-party manufacturers for clinical trials and in preparation for commercialization;

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the effect of competing technological and market developments;

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the terms and timing of any collaborative, licensing, co-promotion or other arrangements that we may establish;

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the costs associated with litigation, adverse remedy judgments and/or settlements, including with respect to the Securities Class Action, the Derivative Action and any future actions that may be brought against the Company;

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if one or more of our product candidates are approved, the potential that we may be required to file a lawsuit to defend our patent rights or regulatory exclusivities from challenges by companies seeking to market generic versions of one or more of our product candidates; and

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the success of the commercialization of one or more of our product candidates, if approved.

Future capital requirements will also depend on the extent to which we acquire or invest in additional complementary businesses, products and technologies, but we currently have no commitments or agreements relating to any of these types of transactions.

In order to carry out our business plan and implement our strategy, we anticipate that we will need to obtain additional financing from time to time and may choose to raise additional funds through strategic collaborations, licensing arrangements, public or private equity or debt financing, bank lines of credit, asset sales, government grants, or other arrangements. We are also engaging in discussions with third party pharmaceutical and biotechnology companies to evaluate potential partnerships or other types of corporate development transactions, including a strategic merger. We cannot be sure that any additional funding, if needed, partnership or any other type of corporate development transaction, will be available on terms favorable to us or at all. Furthermore, any additional equity or equity-related financing, or equity that may be issued or sold in a corporate development transaction, may be dilutive to our stockholders, and debt or equity financing, if available, may subject us to restrictive covenants and significant interest costs. If we obtain funding through a strategic collaboration, merger, or licensing arrangement, we may be required to relinquish our rights to certain of our product candidates or marketing territories.

Our inability to raise capital when needed would harm our business, financial condition and results of operations, and could cause our stock price to decline or require that we wind down our operations altogether.

There is substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing.

Our unaudited condensed financial statements as of September 30, 2024 have been prepared under the assumption that we will continue as a going concern for the next twelve months. We do not believe that our cash and cash equivalents are sufficient for the next twelve months after the date that our financial statements are issued. As a result of our financial condition and other factors described herein, there is substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern will depend on our ability to obtain additional funding, as to which no assurances can be given. We continue to analyze various alternatives, including potentially obtaining debt or equity financings or other arrangements. Our future success depends on our ability to raise capital. We cannot be certain that raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to us or, if available, will be on terms acceptable to us. If we issue additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of our common stock, and our current shareholders may experience dilution. If we are unable to obtain funds when needed or on acceptable terms, we may be required to curtail our current development programs, cut operating costs, forego future development and other opportunities or even terminate our operations. Additionally, we intend to continue our active discussions with third party pharmaceutical and biotechnology companies to evaluate potential partnerships or other types of corporate development transactions, including strategic mergers.

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Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, grants and license and development agreements in connection with any collaborations. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

If we raise additional funds through collaborations, mergers, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

We are a “smaller reporting company,” which means that the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.

We will remain a smaller reporting company until the fiscal year following the determination that our voting and non-voting common shares held by non-affiliates is more than $250 million measured on the last business day of our second fiscal quarter, or our annual revenues are more than $100 million during the most recently completed fiscal year and our voting and non-voting common shares held by non-affiliates is more than $700 million measured on the last business day of our second fiscal quarter. Smaller reporting companies are able to provide simplified executive compensation disclosure, are exempt from the auditor attestation requirements of Section 404, and have certain other reduced disclosure obligations, including, among other things, being required to provide only two years of audited financial statements and not being required to provide selected financial data, supplemental financial information or risk factors.

We have elected to take advantage of certain of the reduced reporting obligations. We cannot predict whether investors will find our common stock less attractive if we 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 our stock price may be reduced or more volatile.

We no longer qualify as an “emerging growth company,” and as a result, we have to comply with increased disclosure and compliance requirements.

We no longer qualify as an emerging growth company (“EGC”) as defined in the Jumpstart Our Business Startups Act (the “JOBS Act”) because in 2023, we reached the five-year anniversary of the first sale of our common stock pursuant to an effective registration statement under the Securities Act of 1933. As such, we are no longer exempt from certain disclosure and compliance requirements that apply to other public companies but did not previously apply to us due to our status as an EGC. These requirements include, but are not limited to:

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compliance with any requirement that may be adopted by the PCAOB regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, including critical audit matters;

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the requirement that we provide more detailed disclosures regarding executive compensation, although we are still able to take advantage of exemptions provided to smaller reporting companies; and

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the requirement that we obtain stockholder approval of any golden parachute payments not previously approved.

We anticipate increased expenses, including exchange listing and SEC requirements, director and officer insurance premiums, legal, audit and tax fees, regulatory compliance programs, and investor relations costs associated with being a public company and ceasing to be an emerging growth company.

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We may expend our limited resources to pursue certain product candidates or indications and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Because we have limited financial and managerial resources, we focus on research programs and product candidates that we identify for specific indications. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable products. If we do not accurately and/or effectively evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.

Weakness in the U.S. economy, including within our geographic footprint, has adversely affected us in the past and may adversely affect us in the future.

We have been, and will continue to be, impacted by general business and economic conditions in the United States. These conditions include short-term and long-term interest rates, inflation, money supply, political issues, war, legislative and regulatory changes, fluctuations in both debt and equity capital markets, broad trends in industry and finance, unemployment and the strength of the U.S. economy and the local economies in which we operate, all of which are beyond our control.

Worldwide financial markets have recently experienced periods of extraordinary disruption and volatility, which have been exacerbated by the COVID-19 pandemic, the Russia/Ukraine conflict and the evolving conflict in Israel and Gaza, resulting in heightened credit risk, reduced valuation of investments, decreased economic activity, heightened risk of cyberattacks, and inflation. Moreover, many companies have experienced reduced liquidity and uncertainty as to their ability to raise capital during such periods of market disruption and volatility. In the event that these conditions recur or result in a prolonged economic downturn, our results of operations, financial position and/or liquidity could be materially and adversely affected. In addition, as a result of recent financial and political events, we may face increased regulation.

Risks Related to our Business Strategy, Structure, and Organization

We currently have no drug products for sale and are dependent on the future success of our product candidates. We can give no assurances that any of our product candidates will receive regulatory approval or be successfully commercialized.

To date, we have invested a significant portion of our efforts and financial resources in the acquisition and development of our product candidates. As a development-stage company, we have limited experience and have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biopharmaceutical area. Our future success is substantially dependent on our ability to successfully develop, obtain regulatory approval for, and then successfully commercialize such product candidates, either by building an in-house commercial infrastructure or through a transaction with a commercial partner, which we have yet to do. Our product candidates are currently in preclinical development or in clinical trials. Our business depends entirely on the successful development and commercialization of our product candidates, which may never occur. We currently have no drug products for sale, currently generate no revenues from sales of any drug products and may never be able to develop or commercialize a marketable drug.

The successful development, and any commercialization of our technologies and any product candidates that may occur, would require us to successfully perform a variety of functions, including:

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developing our technology platform;

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identifying, developing, formulating, manufacturing and commercializing product candidates;

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entering into and maintaining successful licensing and other arrangements with product development partners;

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achieving clinical endpoints to support preparation of approval applications;

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participating in regulatory approval processes, including ultimately gaining approval to market a drug product, which may not occur;

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obtaining sufficient quantities of our product candidates from our third-party manufacturers to meet clinical trial needs and, if approved, to meet commercial demand at launch and thereafter;

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establishing and maintaining agreements with wholesalers, distributors and group purchasing organizations on commercially reasonable terms;

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conducting sales and marketing activities including hiring, training, deploying and supporting a sales force and creating market demand for our product candidates through our own marketing and sales activities, and any other arrangements to promote our product candidates that we may establish;

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maintaining patent protection and regulatory exclusivity for our product candidates; and

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obtaining market acceptance for our product candidates.

Each of these requirements will require substantial time, effort and financial resources.

We intend to use data from our ongoing Phase 1 clinical trial of cosibelimab, conducted outside the United States, in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including CSCC, to potentially support one or more U.S. BLAs and comparable applications for marketing approval outside the U.S. In January 2020, we announced that we had initial discussions with the FDA to execute this strategy in CSCC. Based on top-line and interim results in metastatic and locally advanced CSCC, respectively, we submitted a BLA to the U.S. FDA for these indications in January 2023. In December 2023, the FDA issued a CRL for the cosibelimab BLA due to inspection issues at the third-party contract manufacturing organization. In July 2024, we announced that we had completed a resubmission of the BLA to the FDA for cosibelimab to potentially address the approvability issues cited in the CRL. The resubmission was accepted by the FDA as a complete response, and the FDA has set a PDUFA goal date of December 28, 2024. Although no approvability issues regarding use of data from the Phase 1 clinical trial were noted in the CRL, the FDA reserves the right to review the BLA again in its entirety. We believe, based on published FDA guidance documents, public statements of companies with comparable product candidates, and past interactions with the FDA, that exclusively foreign clinical data from a single study may be acceptable to support marketing approval(s) under FDA regulations. If we prove to be incorrect, running additional studies in the U.S. will require substantial time, effort and financial resources or may not be possible at all.

Our operations have been limited to organizing our company, acquiring, developing and securing our proprietary technologies and obtaining preclinical data or clinical data for various product candidates. These operations provide a limited basis for you to assess our ability to continue to identify product candidates, develop and commercialize product candidates in our portfolio and any product candidates we are able to identify and enter into successful collaborative arrangements with other companies in the future, as well as for you to assess the advisability of investing in our securities.

Each of our product candidates will require additional preclinical or clinical development, management of preclinical, clinical and manufacturing activities, regulatory approval in the jurisdictions in which we plan to market the product, obtaining manufacturing supply, building of a commercial organization, and significant marketing efforts before we generate any revenues from product sales, which may not occur. We are not permitted to market or promote any of our product candidates in the U.S. or any other jurisdiction before we receive regulatory approval from the FDA or comparable foreign regulatory authority, respectively, and we may never receive such regulatory approval for any of our product candidates.

We cannot guarantee that the resubmission of the BLA for cosibelimab will address all issues identified in the CRL to support approval.

On July 2, 2024, we announced that we had completed the resubmission of the cosibelimab BLA potentially addressing the approvability issues cited in the CRL. The resubmission was accepted by the FDA as a complete response, and the FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date of December 28, 2024. While we believe the BLA resubmission addresses all the approvability issues identified in the CRL, there is no guarantee that the FDA will ultimately agree that such issues have been successfully addressed and resolved or that new approvability issues will not be raised during the BLA resubmission review. Any inability to successfully work with the FDA to find a satisfactory solution to address any issues or concerns in a timely manner or at all during the review process for the BLA, including any inability to provide the FDA with data, analysis or other information sufficient to support an approval of the BLA, may adversely impact the prospects for FDA approval. In addition, an FDA inspection or re-inspection of any facility, including those of our third-party contract manufacturing organization (“CMO”) or otherwise, may further delay, or adversely impact, potential approval. We cannot guarantee that any of our facilities, including our third-party CMO’s facility, will pass any such inspection or reinspection. If we and our CMO are unable to adequately respond to and address any approvability issues or observations raised by FDA during the resubmission review, the approval of cosibelimab could be delayed or a second CRL could be issued. Therefore, it remains unclear when the FDA will approve our BLA, if at all. The previously received CRL, any additional CRLs, and any subsequent

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resulting delay in the development and approval of cosibelimab may prevent, decrease and/or delay expected revenue. Any of these risks could have a material impact on our business, operating results, and financial condition.

Our future growth depends on our ability to identify and acquire or in-license products and successfully integrating such acquired or in-licensed products into our existing operations.

An important part of our business strategy is to continue to develop a pipeline of product candidates by acquiring or in-licensing products, businesses or technologies that we believe are a strategic fit with our focus on novel combinations of immuno-oncology antibodies and small molecule targeted anti-cancer agents. Future in-licenses or acquisitions, however, may entail numerous operational and financial risks, including:

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exposure to unknown liabilities;

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disruption of our business and diversion of our management’s time and attention to develop acquired products or technologies;

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difficulty or inability to secure financing to fund development activities for such acquired or in-licensed technologies in the current economic environment;

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incurrence of substantial debt or dilutive issuances of securities to pay for acquisitions;

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higher than expected acquisition and integration costs;

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increased amortization expenses;

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difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;

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impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and

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inability to retain key employees of any acquired businesses.

We have limited resources to identify and execute the acquisition or in-licensing of third-party products, businesses and technologies and integrate them into our current infrastructure. In particular, we may compete with larger pharmaceutical companies and other competitors in our efforts to establish new collaborations and in-licensing opportunities. These competitors likely will have access to greater financial resources than us and may have greater expertise in identifying and evaluating new opportunities. Moreover, we may devote resources to potential acquisitions or in-licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts.

Risks Inherent in Drug Development and Commercialization

Because results of preclinical studies and early clinical trials are not necessarily predictive of future results, any product candidate we advance may not have favorable results in later clinical trials or receive regulatory approval. Moreover, interim, “top-line,” and preliminary data from our clinical trials that we announce or publish may change, or the perceived product profile may be negatively impacted, as more patient data or additional endpoints (including efficacy and safety) are analyzed.

Pharmaceutical development has inherent risks. The outcome of preclinical development testing and early clinical trials may not be predictive of the outcome of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their product candidates. Once a product candidate has displayed sufficient preclinical data to warrant clinical investigation, we will be required to demonstrate through adequate and well-controlled clinical trials that our product candidates are effective with a favorable benefit-risk profile for use in populations for their target indications before we can seek regulatory approvals for their commercial sale. Many drug candidates fail in the early stages of clinical development for safety and tolerability issues or for insufficient clinical activity, despite promising preclinical results. Accordingly, no assurance can be made that a safe and effective dose can be found for these compounds or that they will ever enter into advanced clinical trials alone or in combination with other product candidates. Moreover, success in early clinical trials does not mean that later clinical trials will be successful because product candidates in later-stage clinical trials may fail to demonstrate sufficient safety or efficacy despite having progressed through initial clinical testing. Companies frequently experience significant setbacks in advanced clinical trials, even after earlier clinical trials have shown promising results. There is an extremely high rate of failure of pharmaceutical candidates proceeding through clinical trials.

Individually reported outcomes of patients treated in clinical trials may not be representative of the entire population of treated patients in such studies. In addition, registration trials or larger scale Phase 3 studies, which are often conducted internationally, are inherently

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subject to increased operational risks compared to earlier stage studies, including the risk that the results could vary on a region to region or country to country basis, which could materially adversely affect the outcome of the study or the opinion of the validity of the study results by applicable regulatory agencies.

From time to time, we may publicly disclose top-line or preliminary data from our clinical trials, which is based on a preliminary analysis of then available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of such data, and we may not have received or had the opportunity to fully and carefully evaluate all data from the particular study or trial, including all endpoints and safety data. As a result, top-line or preliminary results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Top-line or preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the top-line, interim, or preliminary data we previously published. When providing top-line results, we may disclose the primary endpoint of a study before all secondary endpoints have been fully analyzed. A positive primary endpoint does not translate to all, or any, secondary endpoints being met. As a result, top-line and preliminary data should be viewed with caution until the final data are available, including data from the full safety analysis and the final analysis of all endpoints.

Further, from time to time, we may also disclose interim data from our preclinical studies and clinical trials. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. For example, many of the results reported in our early clinical trials rely on local investigator-assessed efficacy outcomes which may be subject to greater variability or subjectivity than results assessed in a blinded, independent, centrally reviewed manner, often required of final or later phase, adequate and well-controlled registration-directed clinical trials. If the results from our registration-directed trials are different from the results found in the earlier studies, we may need to terminate or revise our clinical development plan, which could extend the time for conducting our development program and could have a material adverse effect on our business. Also, time-to-event based endpoints such as duration of response and progression-free survival have the potential to change, sometimes drastically, with longer follow-up. In addition, as patients continue on therapy, there can be no assurance given that the final safety data from studies, once fully analyzed, will be consistent with prior safety data presented, will be differentiated from other similar agents in the same class, will support continued development, or will be favorable enough to support regulatory approvals for the indications studied. Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our company in general. The information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and regulators or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure. If the interim, top-line or preliminary data that we report differ from final results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, or successfully commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

Delays in clinical testing could result in increased costs to us and delay our ability to generate revenue.

Although we are conducting and planning for certain clinical trials relating to our product candidates, there can be no assurance that the FDA, or any comparable foreign regulatory authority, will accept our proposed trial designs. We may experience delays in our clinical trials and we do not know whether current or planned clinical trials will begin on time, need to be redesigned, enroll patients on time or be completed on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including delays related to:

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obtaining regulatory approval to commence a trial;

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reaching agreement on acceptable terms with prospective contract research organizations (“CROs”), and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

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obtaining institutional review board (“IRB”), or ethics committee, as applicable, approval at each site;

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recruiting a sufficient number of suitable patients to participate in a trial;

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clinical sites deviating from trial protocol or dropping out of a trial;

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having patients complete a trial or return for post-treatment follow-up;

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developing and validating companion diagnostics on a timely basis, if required;

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obtaining resolution for any clinical holds that arise from the FDA or any comparable foreign regulatory authority;

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adding new clinical trial sites; or

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availability of raw materials or manufacturing sufficient quantities of product candidate for use in clinical trials.

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We could encounter delays if a clinical trial is suspended or terminated by us, by the IRBs or ethics committees of the institutions in which such trials are being conducted, by the Data Safety Monitoring Board monitoring such trial or by the FDA or other regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug candidate, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

If we experience delays in the completion of, or termination of, any clinical trial of our product candidates, the commercial prospects of our product candidates will be harmed, and our ability to generate product revenues from any of these product candidates will be delayed, or such revenues may not be generated at all. In addition, any delays in completing our clinical trials will increase our costs, slow down our product candidate development and approval process and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may harm our business, financial condition and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

Difficulties in the enrollment of patients in clinical trials may prevent or delay receipt of necessary regulatory approvals.

Patient enrollment, a significant factor in the timing of clinical trials, is affected by many factors including the size and nature of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the design of the clinical trial, competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating. Furthermore, we intend to rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials and we intend to have agreements governing their committed activities, however, we will have limited influence over their actual performance.

We may not be able to initiate or continue clinical trials for one or more of our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory authorities outside the United States. Some of our competitors have ongoing clinical trials for product candidates that treat the same indications that we are targeting for our product candidates, and patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ product candidates. Available therapies for the indications we are pursuing can also affect enrollment in our clinical trials. Patient enrollment is affected by other factors including:

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the severity of the disease under investigation;

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the eligibility criteria for the study in question;

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the perceived risks and benefits of the product candidate under study;

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the efforts to facilitate timely enrollment in clinical trials;

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the patient referral practices of physicians;

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the number of clinical trials sponsored by other companies for the same patient population;

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the ability to monitor patients adequately during and after treatment; and

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the proximity and availability of clinical trial sites for prospective patients.

Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in increased development costs for our product candidates or future product candidates, which would cause the value of our company to decline and limit our ability to obtain additional financing.

Russian military action in Europe may impact foreign countries in which we enrolled patients in our clinical trials.

In February 2022, Russia commenced a military invasion of Ukraine. Russia’s invasion and the ensuing response by Ukraine may prevent the FDA from auditing our five clinical sites that enrolled a total of 17 patients in these countries during its review of our BLA for cosibelimab. If we are delayed or not able to obtain regulatory approval, our business may be adversely affected.

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We may not receive regulatory approval for our product candidates, or their approval may be delayed, which would have a material adverse effect on our business and financial condition.

Our product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA, by other regulatory agencies in the United States, by the European Medicines Agency and by comparable foreign regulatory authorities outside the United States. Failure to obtain marketing approval for one or more of our product candidates or any future product candidate will prevent us from commercializing the product candidate. We have not received approval to market any of our product candidates from regulatory authorities in any jurisdiction. We have only limited experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely on third-party CROs and other third-party vendors to assist us in this process. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, regulatory authorities. One or more of our product candidates or any future product candidate may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use. If any of our product candidates or any future product candidate receives marketing approval, the accompanying label may limit the approved use of our drug by severity of disease, patient group, or include contraindications, interactions, or warnings, which could limit sales of the product.

The process of obtaining marketing approval, both in the United States and abroad, is expensive, may take many years if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Changes in marketing approval policies during the development period, changes in available therapies and standards of care, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our study design, including the control arm used in our study, or data are insufficient for approval and require additional preclinical studies or clinical trials. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of a product candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

Under the FDA’s accelerated approval regulations, which only apply to certain drug products, the FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. While we may undertake development programs for one or more of our product candidates that we believe, if successful, could support a submission for marketing approval under the accelerated approval regulations, we may ultimately fail to meet the criteria to do so, which may cause delays in the approval or rejection of an application.

If we experience delays in obtaining approval or if we fail to obtain approval of one or more of our product candidates or any future product candidate, the commercial prospects for our product candidates may be harmed and our ability to generate revenue will be materially impaired.

In addition, even if we were to obtain approval, regulatory authorities may approve any of our product candidates or any future product candidate for fewer or more limited indications than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketing studies, including clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. The regulatory authority may also require the label to contain warnings, contraindications, or precautions that limit the commercialization of that product. Any of these scenarios could compromise the commercial prospects for one or more of our product candidates or any future product candidate.

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If serious adverse or unacceptable side effects are identified during the development of one or more of our product candidates or any future product candidate, we may need to abandon or limit our development of some of our product candidates.

If one or more of our product candidates or any future product candidate are associated with undesirable side effects or adverse events in clinical trials or have characteristics that are unexpected, we may need to abandon their development or limit development to more narrow uses or subpopulations in which the adverse events, undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. In our industry, many compounds that initially showed promise in early-stage testing have later been found to cause serious adverse events that prevented further development of the compound. In the event that our clinical trials reveal a high or unacceptable severity and prevalence of adverse events, our trials could be suspended or terminated and the FDA or comparable foreign regulatory authorities could order us to cease further development or deny approval of one or more of our product candidates or any future product candidate for any or all targeted indications. The FDA could also issue a letter requesting additional data or information prior to making a final decision regarding whether to approve a product candidate. The number of requests for additional data or information issued by the FDA in recent years has increased and resulted in substantial delays in the approval of several new drugs. Adverse events or undesirable side effects caused by one or more of our product candidates or any future product candidate could also result in the inclusion of unfavorable information in our product labeling, denial of regulatory approval by the FDA or other regulatory authorities for any or all targeted indications, and in turn prevent us from commercializing and generating revenues from the sale of that product candidate. Adverse events or drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial and could result in potential product liability claims.

Additionally, if one or more of our product candidates or any future product candidate receives marketing approval and we or others later identify undesirable side effects caused by this product, a number of potentially significant negative consequences could result, including:

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regulatory authorities may require the addition of unfavorable labeling statements, including specific warnings, black box warnings, adverse reactions, precautions, and/or contraindications;

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regulatory authorities may suspend or withdraw their approval of the product, and/or require it to be removed from the market;

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we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product; or

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our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of any of our product candidates or any future product candidate or could substantially increase our commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues, or any revenues, from its sale.

Public concern regarding the safety of drug products could delay or limit our ability to obtain regulatory approval, result in the inclusion of unfavorable information in our labeling, or require us to undertake other activities that may entail additional costs.

In light of widely publicized events concerning the safety risk of certain drug products, the FDA, members of Congress, the Government Accountability Office, medical professionals and the general public have raised concerns about potential drug safety issues. These events have resulted in the withdrawal of drug products, revisions to drug labeling that further limit use of the drug products and the establishment of risk management programs. The Food and Drug Administration Amendments Act of 2007 (“FDAAA”), grants significant expanded authority to the FDA, much of which is aimed at improving the safety of drug products before and after approval. In particular, the new law authorizes the FDA to, among other things, require post-approval studies and clinical trials, mandate changes to drug labeling to reflect new safety information and require risk evaluation and mitigation strategies for certain drugs, including certain currently approved drugs. It also significantly expands the federal government’s clinical trial registry and results databank, which we expect will result in significantly increased government oversight of clinical trials. Under the FDAAA, companies that violate these and other provisions of the new law are subject to substantial civil monetary penalties, among other regulatory, civil and criminal penalties. The increased attention to drug safety issues may result in a more cautious approach by the FDA in its review of data from our clinical trials. Data from clinical trials may receive greater scrutiny, particularly with respect to safety, which may make the FDA or other regulatory authorities more likely to require additional preclinical studies or clinical trials. If the FDA requires us to conduct additional preclinical studies or clinical trials prior to approving any of our product candidates, our ability to obtain approval of this product candidate will be delayed. If the FDA requires us to provide additional clinical or preclinical data following the approval of any of our product candidates, the indications for which this product candidate is approved may be limited or there may be specific warnings or limitations on dosing, and our efforts to commercialize our product candidates may be otherwise adversely impacted.

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Even if one or more of our product candidates receives regulatory approval, it and any other products we may market will remain subject to substantial regulatory scrutiny.

If one or more of our product candidates that we may license or acquire is approved, the approved product candidate will be subject to ongoing requirements and review by the FDA and other regulatory authorities. These requirements include labeling, packaging, storage, advertising, promotion, record-keeping and submission of safety and other post-market information and reports, registration and listing requirements, cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping of the drug, and requirements regarding company presentations and interactions with health care professionals.

The FDA, or other regulatory authorities, may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of the product. The FDA and other applicable regulatory authorities closely regulate the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA and other applicable regulatory authorities impose stringent restrictions on manufacturers’ communications regarding off-label use and if we do not market our products for only their approved indications, we may be subject to enforcement action for off-label marketing. Violations of the Federal Food, Drug and Cosmetic Act relating to the promotion of prescription drugs may lead to investigations, civil claims, and/or criminal charges alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws.

In addition, later discovery of previously unknown adverse events or other problems with our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

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restrictions on such products, operations, manufacturers or manufacturing processes;

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restrictions on the labeling or marketing of a product;

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restrictions on product distribution or use;

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requirements to conduct post-marketing studies or clinical trials;

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warning letters, untitled letters, import alerts, and/or inspection observations;

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withdrawal of the products from the market;

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refusal to approve pending applications or supplements to approved applications that we submit;

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recall of products;

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fines, restitution or disgorgement of profits;

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suspension or withdrawal of marketing or regulatory approvals;

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suspension of any ongoing clinical trials;

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refusal to permit the import or export of our products;

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product seizure; or

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injunctions, consent decrees, and/or the imposition of civil or criminal penalties.

The FDA’s policies, or the policies of other applicable regulatory authorities, may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates, or negatively affect those products for which we may have already received regulatory approval, if any. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may be subject to the various actions listed above, including losing any marketing approval that we may have obtained.

Regulatory approval by the FDA, or any similar regulatory authorities outside the United States, is limited to those specific indications and conditions for which clinical safety and efficacy have been demonstrated.

Any regulatory approval is limited to those indications for use for which a product is deemed to be safe and effective by the FDA, or other similar regulatory authorities outside the United States. In addition to the regulatory approval required for new drug products, new formulations or new or additional indications for use for an already approved product also require regulatory approval. If we are not able to obtain regulatory approval for any desired future indications for our products, our ability to effectively market and sell our products may be prevented or reduced, and our business may be adversely affected.

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While physicians may choose to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical studies and approved by the regulatory authorities, our ability to promote products is limited to those indications that are specifically approved by the FDA, or similar regulatory authorities outside the United States. These “off-label” uses are common across medical specialties and may constitute an appropriate treatment for some patients in certain circumstances. Regulatory authorities in the U.S. generally do not regulate the practice of medicine or behavior of physicians in their choice of treatments. Regulatory authorities do, however, restrict promotion by pharmaceutical companies on the subject of off-label use. If our promotional activities fail to comply with these regulations or guidelines, we may be subject to warnings from, or enforcement action by, these authorities. In addition, our failure to follow FDA, or any applicable foreign regulatory authority, rules and guidelines relating to promotion and advertising may cause the FDA, or such applicable foreign regulatory authority, to suspend or withdraw an approved product from the market, require a recall or institute fines or penalties, or could result in disgorgement of money, operating restrictions, injunctions or criminal prosecution, any of which could harm our business.

We will need to obtain FDA approval of any proposed product brand names, and any failure or delay associated with such approval may adversely impact our business.

A pharmaceutical product cannot be marketed in the U.S. or other countries until we have completed a rigorous and extensive regulatory review process, including approval of a brand name. Any brand names we intend to use for our product candidates will require approval from the FDA regardless of whether we have secured a formal trademark registration from the United States Patent and Trademark Office (“USPTO”). The FDA typically conducts a review of proposed product brand names, including an evaluation of the potential for confusion with other product names. The FDA may also object to a product brand name if it believes the name inappropriately implies medical claims. If the FDA objects to any of our proposed product brand names, we may be required to adopt an alternative brand name for our product candidates. If we adopt an alternative brand name, we would lose the benefit of our existing trademark applications for such product candidate and may be required to expend significant additional resources in an effort to identify a suitable product brand name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA. We may be unable to build a successful brand identity for a new trademark in a timely manner or at all, which would limit our ability to commercialize our product candidates.

If our competitors develop treatments for any of our product candidates’ target indications and those competitor products are approved more quickly, marketed more successfully or demonstrated to be more effective, the commercial opportunity for our product candidate will be reduced or eliminated.

The biotechnology and pharmaceutical industries are subject to rapid and intense technological change. We face, and will continue to face, competition in the development and marketing of our product candidates from academic institutions, government agencies, research institutions and biotechnology and pharmaceutical companies. There can be no assurance that developments by others will not render one or more of our product candidates obsolete or noncompetitive. Furthermore, new developments, including the development of other drug technologies and methods of preventing the incidence of disease, occur in the pharmaceutical industry at a rapid pace. These developments may render one or more of our product candidates obsolete or noncompetitive.

Competitors may seek to develop alternative formulations that do not directly infringe on our in-licensed patent rights. The commercial opportunity for one or more of our product candidates could be significantly harmed if competitors are able to develop alternative formulations outside the scope of our in-licensed patents. Compared to us, many of our potential competitors have substantially greater:

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capital resources;

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development resources, including personnel and technology;

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clinical trial experience;

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regulatory experience;

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expertise in prosecution of intellectual property rights; and

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manufacturing, distributing and sales and marketing experience.

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As a result of these factors, our competitors may obtain regulatory approval of their products more rapidly than we are able to or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize one or more of our product candidates. Our competitors may also develop drugs that are more effective, safe, useful and less costly than ours and may be more successful than us in manufacturing and marketing their products. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. We will also face competition from these third parties in establishing clinical trial sites, in patient registration for clinical trials, and in identifying and in-licensing new product candidates.

Further, generic therapies are typically sold at lower prices than branded therapies and are generally preferred by hospital formularies and managed care providers of health services. We anticipate that, if approved, our product candidates will face increasing competition in the form of generic versions of branded products of competitors, including those that have lost or will lose their patent exclusivity. In the future, we may face additional competition from a generic form of our own candidates when the patents covering them begin to expire, or earlier if the patents are successfully challenged. If we are unable to demonstrate to physicians and payers that the key differentiating features of our product candidates translate to overall clinical benefit or lower cost of care, we may not be able to compete with generic alternatives.

If any of our product candidates are successfully developed but do not achieve broad market acceptance among physicians, patients, healthcare payors and the medical community, the revenues that any such product candidates generate from sales will be limited.

Even if our product candidates receive regulatory approval, they may not gain market acceptance among physicians, patients, healthcare payors and the medical community. Coverage and reimbursement of our product candidates by third-party payors, including government payors, generally would also be necessary for commercial success. The degree of market acceptance of any approved products would depend on a number of factors, including, but not necessarily limited to:

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the efficacy and safety as demonstrated in clinical trials;

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the timing of market introduction of such product candidates as well as competitive products;

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the clinical indications for which the drug is approved;

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acceptance by physicians, major operators of hospitals and clinics and patients of the product as a safe and effective treatment;

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the potential and perceived advantages of product candidates over alternative treatments;

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the safety of product candidates in a broader patient group (i.e. based on actual use);

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the cost of treatment in relation to alternative treatments;

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the availability of adequate reimbursement and pricing by third parties and government authorities;

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changes in regulatory requirements by government authorities for our product candidates

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relative convenience and ease of administration;

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the prevalence and severity of side effects and adverse events;

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the effectiveness of our sales and marketing efforts; and

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unfavorable publicity relating to the product.

If any product candidate is approved but does not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors and patients, we may not generate sufficient revenue from these products and in turn we may not become or remain profitable.

Reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our products profitably.

There is significant uncertainty related to the third-party coverage and reimbursement of newly approved drugs. Such third-party payors include government health programs such as Medicare, managed care providers, private health insurers and other organizations. We intend to seek approval to market our product candidates in the U.S., Europe and other selected foreign jurisdictions. Market acceptance and sales of our product candidates in both domestic and international markets will depend significantly on the availability of adequate coverage and reimbursement from third-party payors for any of our product candidates and may be affected by existing and future health care reform measures.

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Government and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement for new drugs and, as a result, they may not cover or provide adequate payment for our product candidates. These payors may conclude that our product candidates are less safe, less effective or less cost-effective than existing or future introduced products, and third-party payors may not approve our product candidates for coverage and reimbursement or may cease providing coverage and reimbursement for these product candidates.

Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time consuming and costly process that could require us to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our products. We may not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement. If reimbursement of our future products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, it may impact the market acceptance of our products and we may be unable to achieve or sustain profitability.

In some foreign countries, particularly in the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product candidate. To obtain reimbursement or pricing approval in some countries, we may be required to conduct additional clinical trials that compare the cost-effectiveness of our product candidates to other available therapies. If reimbursement of our product candidates is unavailable or limited in scope or amount in a particular country, or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability of our products in such country.

If we are unable to establish sales, marketing, and distribution capabilities or to enter into agreements with third parties to market and sell our product candidates, we may be unsuccessful in commercializing our product candidates, if they are approved.

We currently do not have a marketing or sales organization for the marketing, sales and distribution of pharmaceutical products. In order to commercialize any approved product candidate, we would need to build marketing, sales, distribution, managerial and other non-technical capabilities, or arrange for third parties to perform these services, and we may be unsuccessful in doing so. In the event of successful development and regulatory approval of any of our current or future product candidates, we expect to build a targeted specialist sales force to market or co-promote the product. There are risks involved with establishing our own sales, marketing and distribution capabilities. For example, recruiting and training a sales force is expensive and time consuming and could delay any product launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

Factors that may inhibit our efforts to commercialize our products on our own include:

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our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;

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the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future products;

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the lack of complementary or other products to be offered by sales personnel, which may put us at a competitive disadvantage from the perspective of sales efficiency relative to companies with more extensive product lines; and

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unforeseen costs and expenses associated with creating our own sales and marketing organization.

We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for one or more of our product candidates or a future product candidate we may license or acquire and may have to limit their commercialization.

The use of one or more of our product candidates and any future product candidate we may license or acquire in clinical trials and the sale of any products for which we obtain marketing approval expose us to the risk of product liability claims. For example, we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Product liability claims might be brought against us by consumers, health care providers or others using, administering or selling our products. If we cannot successfully defend ourselves against these claims, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

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withdrawal of clinical trial participants;

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suspension or termination of clinical trial sites or entire trial programs;

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decreased demand for any product candidates or products that we may develop;

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initiation of investigations by regulators;

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impairment of our business reputation;

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costs of related litigation;

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substantial monetary awards to patients or other claimants;

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loss of revenues;

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reduced resources of our management to pursue our business strategy; and

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the inability to commercialize our product candidate or future product candidates.

We have obtained, and will continue to obtain, limited product liability insurance coverage for any and all of our current and future clinical trials. However, our insurance coverage may not reimburse us or may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive, and, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. If we obtain marketing approval for one or more of our product candidates in development, we intend to expand our insurance coverage to include the sale of commercial products, but we may be unable to obtain commercially reasonable product liability insurance for any products approved for marketing. On occasion, large judgments have been awarded in class action lawsuits based on drugs that had unanticipated side effects. A successful product liability claim or series of claims brought against us could cause our stock price to fall and, if judgments exceed our insurance coverage, could decrease our cash and adversely affect our business.

Risks Related to Reliance on Third Parties

We have contracted with third parties for the manufacture of our approved products, if any. If such contract manufacturer fails to timely produce sufficient product volume, to pass regulatory inspections or re-inspections, or to comply with applicable regulations, the commercialization of our product candidates may be delayed, we may be unable to meet market demand, and we may lose potential revenues.

The manufacture of pharmaceutical products requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls, and the use of specialized processing equipment. We have entered into development and supply agreements with one or more contract manufacturers for the completion of pre-commercialization manufacturing development activities and the manufacture of commercial supplies for each of our product candidates. Any termination or disruption of our relationships with our contract manufacturers may materially harm our business and financial condition and frustrate any commercialization efforts for each respective product candidate.

All of our contract manufacturers must comply with strictly enforced federal, state and foreign regulations, including cGMP requirements enforced by the FDA through its establishment inspection program. We are required by law to establish adequate oversight and control over raw materials, components and finished products furnished by our third-party suppliers and contract manufacturers, but we have little control over their compliance with these regulations.

Any failure to pass regulatory inspections or re-inspections, or comply with applicable regulations may result in fines and civil penalties, suspension of production, restrictions on imports and exports, suspension or delay in product approval, product seizure or recall, or withdrawal of product approval, and would limit the availability of our product and customer confidence in our product. Any manufacturing defect or error discovered after products have been produced and distributed could result in even more significant consequences, including costly recall procedures, re-stocking costs, potential for breach of contract claims, damage to our reputation and potential for product liability claims.

If the contract manufacturers upon whom we rely to manufacture one or more of our product candidates, and any future product candidate we may in-license, fails to deliver the required commercial quantities on a timely basis at commercially reasonable prices, we would likely be unable to meet demand for our products and we would lose potential revenues.

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We rely, and expect to continue to rely, on third parties to conduct our preclinical studies and clinical trials. Those third parties may perform unsatisfactorily, fail to meet deadlines for trial completion, or to comply with applicable regulatory requirements.

We rely on third-party CROs and site management organizations to conduct some of our preclinical studies and all our clinical trials for our product candidates, and plan to do the same for any future product candidate. We expect to continue to rely on third parties, such as CROs, site management organizations, image reading vendors, laboratories, clinical data management organizations, medical institutions and clinical investigators, to conduct some of our preclinical studies and all of our clinical trials. The agreements with these third parties might terminate for a variety of reasons, including a failure to perform by the third parties. If we need to enter into alternative arrangements, that could delay our product development activities.

Our reliance on these third parties for research and development activities reduces our control over these activities but does not relieve us of our responsibilities. For example, we remain responsible for ensuring that each of our preclinical studies and clinical trials are conducted in accordance with the general investigational plan and protocols for the trial and for ensuring that our preclinical studies are conducted in accordance with good laboratory practices (“GLPs”) as appropriate. Moreover, the FDA requires us to comply with standards, commonly referred to as good clinical practices (“GCPs”), for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Regulatory authorities enforce these requirements through periodic inspections of trial sponsors, clinical investigators and trial sites. If we or any of our clinical research organizations or other third-party vendors, institutions or investigators fail to pass regulatory inspections or fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a regulatory authority, such regulatory authority will determine that any of our clinical trials complies with GCP regulations. In addition, our clinical trials must be conducted with product produced under cGMP regulations. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process. We also are required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within specified timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

The third parties with whom we have contracted to help perform our preclinical studies and/or clinical trials may also have relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our preclinical studies or clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.

If any of our relationships with these third-party CROs or site management organizations terminate, we may not be able to enter into arrangements with alternative CROs or site management organizations or to do so on commercially reasonable terms. Switching or adding additional CROs or site management organizations involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO or site management organization commences work. As a result, delays could occur, which could compromise our ability to meet our desired development timelines. Though we carefully manage our relationships with our CROs or site management organizations, there can be no assurance that we will not encounter similar challenges or delays in the future. Forces beyond our control could disrupt the ability of our third-party CROs, site management organizations, image reading vendors, laboratories, clinical data management organizations, medical institutions and clinical investigators to conduct our preclinical studies and our clinical trials for our product candidates and for any future product candidate.

We rely, and expect to continue to rely, on third parties for the manufacture of our product candidates for preclinical and clinical testing, and for the future commercialization of our approved products, if any. Reliance on third parties increases the risk that we will not have sufficient quantities of our products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

We do not have any manufacturing facilities. We rely, and expect to continue to rely, on third parties for the manufacture of our product candidates for preclinical and clinical testing, and plan to do so for commercial manufacture of any of our product candidates that may receive marketing approval. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or any future product candidate or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.

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We also expect to rely on third-party manufacturers or third-party collaborators for the manufacture of commercial supply of any product candidates for which our collaborators or we may obtain marketing approval. We may be unable to establish or maintain any agreements with third-party manufacturers or to do so on acceptable terms. Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

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reliance on the third party for regulatory compliance and quality assurance, while still being required by law to establish adequate oversight and control over products furnished by that third party;

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the possible breach of the manufacturing agreement by the third party;

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manufacturing delays if our third-party manufacturers are unable to obtain raw materials due to supply chain disruptions, give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreement between us;

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the possible misappropriation of our proprietary information, including our trade secrets and know-how; and

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the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

We rely on our third-party manufacturers to produce or purchase from third-party suppliers the materials necessary to produce our product candidates for our preclinical and clinical trials. There are a limited number of suppliers for raw materials that we use to manufacture our drugs and there may be a need to assess alternate suppliers to prevent a possible disruption of the manufacture of the materials necessary to produce our product candidates for our preclinical and clinical trials, and if approved, ultimately for commercial sale. We do not have any control over the process or timing of the acquisition of these raw materials by our third-party manufacturers. Forces beyond our control could disrupt the global supply chain and impact our or our third-party manufacturers’ ability to obtain raw materials or other products necessary to manufacture our product candidates. Any significant delay in the supply of a product candidate, or the raw material components thereof, for an ongoing preclinical or clinical trial due to the need to replace a third-party manufacturer could considerably delay completion of our preclinical or clinical trials, product testing and potential regulatory approval of our product candidates. If our third-party manufacturers or we are unable to purchase these raw materials after regulatory approval has been obtained for a product candidate, the commercial launch of that product candidate would be delayed or there would be a shortage in supply, which would impair our ability to generate revenues from the sale of our product candidates.

The facilities used by our third-party manufacturers to manufacture our product candidates must be approved by the FDA pursuant to inspections that will be conducted after we submit or resubmit an NDA or BLA to the FDA. We are required by law to establish adequate oversight and control over raw materials, components and finished products furnished by our third-party manufacturers, but we do not control the day-to-day manufacturing operations of, and are dependent on, our third-party manufacturers for compliance with cGMP regulations for manufacture of our product candidates. Third-party manufacturers may not be able to comply with the cGMP regulations or similar regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations and pass regulatory inspections could result in sanctions being imposed on us, including clinical holds, fines, injunctions, restrictions on imports and exports, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products.

In 2023, our contract manufacturer for cosibelimab received certain observations from the FDA on Form 483 related to a multi-sponsor on-site inspection. In December 2023, the FDA issued a CRL for the cosibelimab BLA due to those inspection issues. In July 2024, we announced that we had completed a resubmission of the BLA to the FDA for cosibelimab to potentially address the approvability issues cited in the CRL. The resubmission was accepted by the FDA as a complete response, and the FDA has set a PDUFA goal date of December 28, 2024. The FDA’s review of our BLA resubmission requires a re-inspection of our third-party contract manufacturing organization. While we believe the BLA resubmission addresses all the issues identified in the CRL, there is no guarantee that the FDA will agree with the response and remediations in a timely manner or at all, that new issues will not be identified by FDA at our contract manufacturing organization, or that our third party-contract manufacturing organization will pass a regulatory inspection or re-inspection, which could negatively impact our ability to obtain regulatory approval for cosibelimab or obtain approval within reasonable timelines. If we and our CMO are unable to adequately respond to and address any approvability issues or observations raised by FDA during the resubmission review, the approval of cosibelimab could be delayed or a second CRL could be issued. Any further delays in approval will continue to increase our costs and could further delay or impede our ability to commence product sales and generate revenues.

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One or more of the product candidates that we may develop may compete with other product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us. Any performance failure on the part of our existing or future third-party manufacturers could delay clinical development or marketing approval. We do not currently have arrangements in place for redundant supply or a second source for bulk drug substance or the manufacture of drug product. If our current third-party manufacturers cannot perform as agreed, we may be required to replace such manufacturers. We may incur added costs and delays in identifying and qualifying any replacement manufacturers.

The U.S. DEA restricts the importation of a controlled substance finished drug product when the same substance is commercially available in the United States, which could reduce the number of potential alternative manufacturers for one or more of our product candidates.

Our current and anticipated future dependence upon others for the manufacture of our product candidates or products may adversely affect our future profit margins and our ability to commercialize any products that may receive marketing approval on a timely and competitive basis.

We also expect to rely on other third parties to store and distribute drug supplies for our clinical trials. Any performance failure on the part of our distributors could delay clinical development or marketing approval of our product candidates or commercialization of our products, if approved, producing additional losses and depriving us of potential product revenue.

We rely on clinical data and results obtained by third parties that could ultimately prove to be inaccurate or unreliable.

As part of our strategy to mitigate development risk, we seek to develop product candidates with well-studied mechanisms of action and may utilize biomarkers to assess potential clinical efficacy early in the development process. This strategy necessarily relies upon clinical data and other results obtained by third parties that may ultimately prove to be inaccurate or unreliable. Further, such clinical data and results may be based on products or product candidates that are significantly different from our product candidates or any future product candidate. If the third-party data and results we rely upon prove to be inaccurate, unreliable or not applicable to our product candidates or future product candidate, we could make inaccurate assumptions and conclusions about our product candidates and our research and development efforts could be compromised.

Risks Relating to Legislation and Regulation Affecting the Biopharmaceutical and Other Industries

We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad.

We cannot predict the likelihood, nature or extent of how government regulation that may arise from future legislation or administrative or executive action taken by the U.S. presidential administration may impact our business and industry. In particular, the U.S. President has taken several executive actions, specifically through rulemaking and guidance, that could impact the pharmaceutical business and industry. A few of the major administrative actions include:

On October 9, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule entitled, Modernizing and Clarifying the Physician Self-Referral Regulations and on the same day the HHS Office of Inspector General issued a similar rule, entitled Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary penalty Rules Regarding Beneficiary Inducements. The proposed rules are an effort to reform regulations dealing with anti-kickback and self-referral laws. The proposals are attempting to allow certain financial arrangements that would otherwise violate anti-kickback and self-referral laws for providers that are participating in value-based payment arrangements. The proposed rule could impact drug purchasing behavior to ensure providers are within their budget and/or restructure existing payment structures between providers and manufacturers.

On October 30, 2019, the Administration issued an advanced notice of proposed rulemaking (“ANPRM”) entitled, International Pricing Index Model for Medicare Part B Drugs. This ANPRM is soliciting feedback on a potential proposal to align United States drug prices in the Medicare Part B program with international prices. It also solicits public feedback on a policy that would allowing private-sector vendors to negotiate prices, take title to drugs, and improve competition for hospital and physician business. Although this is only a notice for a potential rule, it signals the Administration’s desire to regulatorily influence the United States drug pricing system that could adversely affect the industry.

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On November 15, 2019, CMS issued a proposed rule entitled, Transparency in Coverage and finalized the Calendar Year (“CY”) 2020 Outpatient Prospective Payment System (“OPPS”) & Ambulatory Surgical Center Price Transparency Requirements for Hospitals to Make Standard Charges Rule. Together the rules would increase price transparency through health plans and in hospitals. The affects may influence consumer purchasing habits in the health care sector as a whole. Although the transparency provisions are not yet in effect and the hospital price transparency requirements are subject to litigation, there could be implications for the industry related to drug pricing if or when it is enacted.

On November 18, 2019, CMS issued a proposed rule entitled, Medicaid Fiscal Accountability Regulation (“MFAR”). The proposed rule would significantly impact states’ ability to finance their Medicaid programs. If finalized, the MFAR could force states to restructure their Medicaid financing that could disincentivize or change state prescription drug purchasing behavior that would adversely impact the industry.

On December 18, 2019, the FDA issued a proposed rule entitled, Importation of Prescription Drugs. The proposed rule would allow the importation of certain prescription drugs from Canada. If finalized, states or other non-federal government entities would be able to submit importation program proposals to FDA for review and authorization. This proposed rule could also influence pricing practices in the United States.

On January 30, 2020, CMS issued a state waiver option entitled, Health Adult Opportunity (“HAO”). The HAO would allow states to restructure benefits and coverage policies for their Medicaid programs. The HAO will provide states administrative flexibilities in exchange for a capped federal share. The cap on the federal share is commonly referred to as a “block grant.” Importantly, the HAO allows states to set formularies that align with Essential Health Benefit requirements while still requiring manufacturers to participate in the Medicaid Rebate Program. Depending on utilization of the HAO by states, it could impact the industry – especially if states elect to use a formulary.

We are subject to new legislation, regulatory proposals and managed care initiatives that may increase our costs of compliance and adversely affect our ability to market our products, obtain collaborators and raise capital.

In the United States and certain foreign jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes to the healthcare system. In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively, the ACA, was signed into law, which substantially changed the way healthcare is financed by both governmental and private insurers in the United States. By way of example, the ACA increased the minimum level of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1%; it required collection of rebates for drugs paid by Medicaid managed care organizations; it imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell certain “branded prescription drugs” to specified federal government programs; it implemented a new methodology under which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected; it expanded the eligibility criteria for Medicaid programs; it created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and it established a Center for Medicare and Medicaid Innovation (“CMMI”) at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.

Since its enactment, there have been executive, judicial and Congressional challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future. President Trump signed several Executive Orders and other directives designed to delay the implementation of certain provisions of the ACA or otherwise circumvent some of the requirements for health insurance mandated by the ACA. Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive repeal legislation, several bills affecting the implementation of certain taxes under the ACA have been enacted. For example, in 2017, Congress enacted the Tax Cuts and Jobs Act, which eliminated the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year, a process that is commonly referred to as the “individual mandate.” In addition, the Further Consolidated Appropriations Act, 2020 permanently eliminated, effective January 1, 2020, the ACA-mandated “Cadillac” tax on high-cost employer-sponsored health coverage and medical device tax; and, effective January 1, 2021, it also eliminated the health insurance tax. On December 14, 2018, the U.S. District Court for the Northern District of Texas ruled that the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was repealed as part of the Tax Act, the remaining provisions of the ACA are invalid as well. On December 18, 2019, the U.S. Court of Appeals for the Fifth Circuit ruled that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the ACA are invalid as well. On June 17, 2021, the U.S. Supreme Court reversed the ruling of the Fifth Circuit, holding that the challengers lacked standing to sue and otherwise abstaining from reaching the merits of the case. Notwithstanding the resolution of this legal challenge, there may be other efforts to challenge, repeal, or replace the ACA. We are continuing to monitor any changes to the ACA that, in turn, may potentially impact our business in the future.

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President Joseph R. Biden, Jr. signed an Executive Order on Strengthening Medicaid and the Affordable Care Act, stating his administration’s intentions to reverse the actions of his predecessor and strengthen the ACA. As part of this Executive Order, the Department of Health and Human Services, United States Treasury, and the Department of Labor are directed to review all existing regulations, orders, guidance documents, policies, and agency actions and to consider if they are consistent with ensuring coverage under the ACA making high-quality healthcare affordable and accessible to Americans. We are unable to predict the likelihood of changes to the ACA or other healthcare laws which may negatively impact our profitability.

President Biden intends, as his predecessor did, to take action against drug prices which are considered “high.” Such measures could be addressed in a legislative package later in 2021 or with the reauthorization of the Prescription Drug User Fee Act (“PDUFA”) in 2022. Drug pricing continues to be a subject of debate at the executive and legislative levels of U.S. government and we expect to see legislation focusing on this in the coming year. The American Rescue Plan Act of 2021 signed into law by President Biden on March 14, 2021 includes a provision that will eliminate the statutory cap on rebates drug manufacturers pay to Medicaid beginning in January 2024. With the elimination of the rebate cap, manufacturers may be required to compensate states in an amount greater than what the state Medicaid programs pay for the drug.

Other legislative changes have been proposed and adopted since the ACA was enacted. These changes include aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, effective April 1, 2013, which, due to subsequent legislative amendments, will stay in effect through 2030 with the exception of a temporary suspension implemented under various COVID-19 relief legislation from May 1, 2020 through December 31, 2021. Moreover, there has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted legislation designed, among other things, to bring more transparency to product pricing, to review the relationship between pricing and manufacturer patient assistance programs, and to reform government program reimbursement methodologies for pharmaceutical products. The Prescription Drug Pricing Reduction Act, or PDPRA, which was introduced in Congress in 2019, and again in 2020, proposed to, among other things, penalize pharmaceutical manufacturers for raising prices on drugs covered by Medicare Parts B and D faster than the rate of inflation, cap out-of-pocket expenses for Medicare Part D beneficiaries, and several changes to how drugs are reimbursed in Medicare Part B. A similar drug pricing bill, the Elijah E. Cummings Lower Drug Costs Now Act, proposes to enable direct price negotiations by the federal government for certain drugs (with the maximum price paid by Medicare capped based on an international index), requires manufacturers to offer these negotiated prices to other payers, and restricts manufacturers from raising prices on drugs covered by Medicare Parts B and D. This Act passed in the House of Representatives when it was introduced in 2019, and it has been introduced again in the 2021 term. We cannot predict whether any proposed legislation will become law and the effect of these possible changes on our business cannot be predicted at this time.

Our current and future relationships with customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.

Healthcare providers, physicians and third-party payors in the United States and elsewhere will play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval. Our future arrangements with third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act, which may constrain the business or financial arrangements and relationships through which we sell, market and distribute any product candidates for which we obtain marketing approval. In addition, we may be subject to transparency laws and patient privacy regulation by U.S. federal and state governments and by governments in foreign jurisdictions in which we conduct our business. The applicable federal, state and foreign healthcare laws and regulations that may affect our ability to operate include:

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the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs, such as Medicare and Medicaid;

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federal civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), and their respective implementing regulations, which impose obligations on covered healthcare providers, health plans, and healthcare clearinghouses, as well as their business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

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the federal Open Payments program, which requires manufacturers of certain approved drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services (“CMS”), information related to “payments or other transfers of value” made to physicians, which is defined to include doctors, dentists, optometrists, podiatrists and chiropractors, and teaching hospitals and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by the physicians and their immediate family members. Data collection began on August 1, 2013 with requirements for manufacturers to submit reports to CMS by March 31, 2014 and 90 days after the end each subsequent calendar year. Disclosure of such information was made by CMS on a publicly available website beginning in September 2014; and

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analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations may involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, which could have a material adverse effect on our business. If any of the physicians or other healthcare providers or entities with whom we expect to do business, including our collaborators, is found not to be in compliance with applicable laws, it may be subject to criminal, civil or administrative sanctions, including exclusions from participation in government healthcare programs, which could also materially affect our business.

Risks Related to Intellectual Property and Potential Disputes with Licensors Thereof

If we are unable to obtain and maintain sufficient patent protection for our technology and products, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.

Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection in the United States and other countries with respect to our product candidates or any future product candidate that we may license or acquire and the methods we use to manufacture them, as well as successfully defending these patents and trade secrets against third-party challenges. We seek to protect our proprietary position by filing patent applications in the United States and abroad related to our novel technologies and product candidates, and by maintenance of our trade secrets through proper procedures. We will only be able to protect our technologies from unauthorized use by third parties to the extent that valid and enforceable patents or trade secrets cover them in the market they are being used or developed.

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The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify any patentable aspects of our research and development output and methodology, and, even if we do, an opportunity to obtain patent protection may have passed. Given the uncertain and time-consuming process of filing patent applications and prosecuting them, it is possible that our product(s) or process(es) originally covered by the scope of our patent applications may change or be modified throughout the patent prosecution process, leaving our product(s) or process(es) without patent protection. If our licensors or we fail to obtain or maintain patent protection or trade secret protection for one or more product candidates or any future product candidate we may license or acquire, third parties may be able to leverage our proprietary information and products without risk of infringement, which could impair our ability to compete in the market and adversely affect our ability to generate revenues and achieve profitability. Moreover, should we enter into other collaborations we may be required to consult with or cede control to collaborators regarding the prosecution, maintenance, defense and enforcement of patents licensed or developed under such collaborations. Therefore, these patents and applications may not be prosecuted, defended, and enforced in a manner consistent with the best interests of our business.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. In addition, no consistent policy regarding the breadth of claims allowed in pharmaceutical or biotechnology patents has emerged to date in the U.S. The patent situation outside the U.S. is even more uncertain. The patent laws of foreign countries may not protect our patent rights to the same extent as the laws of the United States, and we may fail to seek or obtain patent protection in all major markets. For example, European patent law restricts the patentability of methods of treatment of the human body more than United States patent law does. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after a first filing, or in some cases not at all. Therefore, we cannot know with certainty whether we or our licensors were the first to make the inventions claimed in patents or pending patent applications that we own or licensed, or that we or our licensors were the first to file for patent protection of such inventions. In the event that a third party has also filed a U.S. patent application relating to our product candidates or a similar invention, depending upon the priority dates claimed by the competing parties, we may have to participate in interference proceedings declared by the USPTO to determine priority of invention in the U.S. The costs of these proceedings could be substantial and it is possible that our efforts to establish priority of invention would be unsuccessful, resulting in a material adverse effect on our U.S. patent position. As a result, the issuance, scope, validity, enforceability and commercial value of our or any of our respective licensors’ patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection. For example, the federal courts of the United States have taken an increasingly dim view of the patent eligibility of certain subject matter, such as naturally occurring nucleic acid sequences, amino acid sequences and certain methods of utilizing the same, which include their detection in a biological sample and diagnostic conclusions arising from their detection. Such subject matter, which had long been a staple of the biotechnology and biopharmaceutical industry to protect their discoveries, is now considered, with few exceptions, ineligible in the first instance for protection under the patent laws of the United States. Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in our patents or in those licensed from a third-party.

In addition, U.S. patent laws may change, which could prevent or limit us from filing patent applications or patent claims to protect products and/or technologies or limit the exclusivity periods that are available to patent holders, as well as affect the validity, enforceability, or scope of issued patents.

Moreover, the patents or patent applications owned or filed by us, or by our licensors or other collaborators, may be subject to a third-party pre-issuance submission of prior art to the USPTO, or to opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or the patent rights of our licensors or collaborators. The costs of these proceedings could be substantial and it is possible that our efforts to establish priority of invention would be unsuccessful, resulting in a material adverse effect on our U.S. patent position. An adverse determination in any such submission, patent office trial, proceeding or litigation could reduce the scope of, render unenforceable, or invalidate, our patent rights, allow third parties to commercialize our technology or products 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. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

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Even if our patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner.

The issuance of a patent does not foreclose challenges to its inventorship, scope, validity or enforceability. Therefore, our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, 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 technology and products. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such product candidates might expire before or shortly after such product candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.

A third party may hold intellectual property, including patent rights that are important or necessary to the development and commercialization of our products. It may be necessary for us to use the patented or proprietary technology of third parties, whom may or may not be interested in granting such a license, to commercialize our products, in which case we would be required to obtain a license from these third parties on commercially reasonable terms, or our business could be harmed, possibly materially.

We depend on our licensors to maintain and enforce the intellectual property covering certain of our product candidates. We have limited, if any, control over the resources that our licensors can or will devote to securing, maintaining, and enforcing patents protecting our product candidates.

We depend on our licensors to protect the proprietary rights covering our antibody and certain of our small molecule product candidates and we have limited, if any, control over the amount or timing of resources that they devote on our behalf, or the priority they place on, maintaining patent rights and prosecuting patent applications to our advantage. Moreover, we have limited, if any, control over the strategies and arguments employed in the maintenance of patent rights and the prosecution of patent applications to our advantage.

Our licensors, depending on the patent or application, are responsible for maintaining issued patents and prosecuting patent applications for our antibody and certain of our small molecule product candidates. We cannot be sure that they will perform as required. Should they decide they no longer want to maintain any of the patents licensed to us, they are required to afford us the opportunity to do so at our expense. If our licensors do not perform, and if we do not assume the maintenance of the licensed patents in sufficient time to make required payments or filings with the appropriate governmental agencies, we risk losing the benefit of all or some of those patent rights. Moreover, and possibly unbeknownst to us, our licensors may experience serious difficulties related to their overall business or financial stability, and they may be unwilling or unable to continue to expend the financial resources required to maintain and prosecute these patents and patent applications. While we intend to take actions reasonably necessary to enforce our patent rights, we depend, in part, on our licensors to protect a substantial portion of our proprietary rights and to inform us of the status of those protections and efforts thereto.

Our licensors may also be notified of alleged infringement and be sued for infringement of third-party patents or other proprietary rights. We may have limited, if any, control or involvement over the defense of these claims, and our licensors could be subject to injunctions and temporary or permanent exclusionary orders in the U.S. or other countries. Our licensors are not obligated to defend or assist in our defense against third-party claims of infringement. We have limited, if any, control over the amount or timing of resources, if any, that our licensors devote on our behalf or the priority they place on defense of such third-party claims of infringement.

Because of the uncertainty inherent in any patent or other litigation involving proprietary rights, we or our licensors may not be successful in defending claims of intellectual property infringement alleged by third parties, which could have a material adverse effect on our results of operations. Regardless of the outcome of any litigation, defending the litigation may be expensive, time-consuming and distracting to management.

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Protecting our proprietary rights is difficult and costly, and we may be unable to ensure their protection.

The degree of future protection for our proprietary rights is uncertain, because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage, in addition to being costly and time consuming to undertake. For example:

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our licensors might not have been the first to make the inventions covered by each of our pending patent applications and issued patents;

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our licensors might not have been the first to file patent applications for these inventions;

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others may independently develop similar or alternative technologies or duplicate our product candidates or any future product candidate technologies;

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it is possible that none of the pending patent applications licensed to us will result in issued patents;

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the scope of our issued patents may not extend to competitive products developed or produced by others;

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the issued patents covering our product candidates or any future product candidate may not provide a basis for market exclusivity for active products, may not provide us with any competitive advantages, or may be challenged by third parties;

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we may not develop additional proprietary technologies that are patentable; or

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intellectual property rights of others may have an adverse effect on our business.

We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful, and an unfavorable outcome in any litigation would harm our business.

Competitors may infringe our issued patents or other intellectual property. To counter infringement or unauthorized use, we may be required to file one or more actions for patent infringement, which can be expensive and time consuming. Any claims we assert against accused infringers could provoke these parties to assert counterclaims against us alleging invalidity of our patents or that we infringe their patents; or provoke those parties to petition the USPTO to institute inter partes review against the asserted patents, which may lead to a finding that all or some of the claims of the asserted patents are invalid. In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of our pending patents at risk of being invalidated, rendered unenforceable, or interpreted narrowly. Because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. Furthermore, adverse results on U.S. patents may affect related patents in our global portfolio.

Our ability to develop, manufacture, market and sell one or more of our product candidates or any future product candidate that we may license or acquire depends upon our ability to avoid infringing the proprietary rights of third parties. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the general fields of fully human immuno-oncology targeted antibodies and targeted anti-cancer agents and cover the use of numerous compounds and formulations in our targeted markets. Because of the uncertainty inherent in any patent or other litigation involving proprietary rights, we and our licensors may not be successful in defending intellectual property claims asserted by third parties, which could have a material adverse effect on our results of operations. Regardless of the outcome of any litigation, defending the litigation may be expensive, time-consuming and distracting to management. In addition, because patent applications can take many years to issue, there may be currently pending applications that are unknown to us, which may later result in issued patents that one or more of our product candidates may infringe. There could also be existing patents of which we are not aware that one or more of our product candidates may infringe, even if only inadvertently.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities. In addition, 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. 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.

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There is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology and biopharmaceutical industries generally. If a third-party claims that we infringe their patents or misappropriated their technology, we could face a number of issues, including:

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infringement and other intellectual property claims which, with or without merit, can be expensive and time consuming to litigate and can divert management’s attention from our core business;

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substantial damages for past infringement which we may have to pay if a court decides that our product infringes a competitor’s patent;

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a court prohibiting us from selling or licensing our product unless the patent holder licenses the patent to us, which it would not be required to do;

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if a license is available from a patent holder, we may have to pay substantial royalties or grant cross licenses to our patents; and

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redesigning our processes so they do not infringe, which may not be possible or could require substantial funds, time, and may result in an inferior or less-desirable process or product.

If we fail to comply with our obligations under our intellectual property licenses and third-party funding arrangements, we could lose rights that are important to our business.

We have in-licensed the rights to all of our product candidates from third parties. Any disputes between us and any of our licensors regarding our rights under our license agreements may impact our ability to develop and commercialize these product candidates. Any uncured, material breach under any of our license agreements could result in our loss of exclusive rights to one or more of our product candidates and may lead to a complete termination of our related product development efforts.

We are currently a party to license agreements with Dana-Farber, Adimab, NeuPharma and Jubilant. In the future, we may become party to additional licenses that are important for product development and commercialization. If we fail to comply with our obligations under current or future license and funding agreements, our counterparties may have the right to terminate these agreements, in which event we might not be able to develop, manufacture or market any product or utilize any technology that is covered by these agreements or may face other penalties under the agreements. Such an occurrence could materially and adversely affect the value of a product candidate being developed under any such agreement or could restrict our drug discovery activities. Termination of these agreements or reduction or elimination of our rights under these agreements may result in our having to negotiate new or reinstated agreements with less favorable terms, or cause us to lose our rights under these agreements, including our rights to important intellectual property or technology.

We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

As is common in the biotechnology and pharmaceutical industry, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that we or these employees have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Even if frivolous or unsubstantiated in nature, litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management and the implicated employee(s).

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If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to seeking patent protection for our product candidates or any future product candidate, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position, particularly where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. We limit disclosure of such trade secrets where possible but we also seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who do have access to them, such as our employees, our licensors, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts, any of these parties may breach the agreements and may unintentionally or willfully disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. Moreover, if any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.

Risks Relating to Our Platform and Data

Our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or third parties’ cybersecurity.

We are increasingly dependent upon information technology systems, infrastructure, and data to operate our business. In the ordinary course of business, we collect, store, and transmit confidential information, including, but not limited to, information related to our intellectual property and proprietary business information, personal information, and other confidential information. It is critical that we maintain such confidential information in a manner that preserves its confidentiality and integrity. Furthermore, we have outsourced elements of our operations to third party vendors, who each have access to our confidential information, which increases our disclosure risk.

Although we have implemented internal security and business continuity measures and have developed an information technology infrastructure, our internal computer systems, as well as those of current and future third parties on which we rely, are vulnerable to damage from computer viruses and unauthorized access and may fail. Our information technology and other internal infrastructure systems, including corporate firewalls, servers, data center facilities, lab equipment, and internet connection, face the risk of breakdown or other damage or interruption from service interruptions, system malfunctions, natural disasters, terrorism, war, and telecommunication and electrical failures, as well as security breaches from inadvertent or intentional actions by our employees, contractors, consultants, business partners, and/or other third parties, or from cyber-attacks by malicious third parties (including the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other means to affect service reliability and threaten the confidentiality, integrity and availability of information), each of which could compromise our system infrastructure or lead to the loss, destruction, alteration, disclosure, or dissemination of, or damage or unauthorized access to, our data or data that is processed or maintained on our behalf, or other assets.

In addition, the loss or corruption of, or other damage to, clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and could significantly increase our costs to recover or reproduce the data. Likewise, we will rely on third parties for the manufacture of our current or future drug candidates and to conduct clinical trials, and similar events relating to their systems and operations could also have a material adverse effect on our business and lead to regulatory agency actions. The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity, and sophistication of attempted attacks and intrusions from around the world have increased.

Sophisticated cyber attackers (including foreign adversaries engaged in industrial espionage) are skilled at adapting to existing security technology and developing new methods of gaining access to organizations’ sensitive business data, which could result in the loss of proprietary information, including trade secrets. We may be unable to anticipate all types of security threats and to implement preventive measures effective against all such security threats. The techniques used by cyber criminals change frequently, may not be recognized until launched, and can originate from a wide variety of sources, including outside groups such as external service providers, organized crime affiliates, terrorist organizations, or hostile foreign governments or agencies.

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Any security breach or other event leading to the loss or damage to, or unauthorized access, use, alteration, disclosure, or dissemination of, personal information, including personal information regarding clinical trial subjects, contractors, directors, or employees, our intellectual property, proprietary business information, or other confidential or proprietary information, could directly harm our reputation, enable competitors to compete with us more effectively, compel us to comply with federal and/or state breach notification laws and foreign law equivalents, subject us to mandatory corrective action, or otherwise subject us to liability under laws and regulations that protect the privacy and security of personal information.

Each of the foregoing could result in significant legal and financial exposure and reputational damage that could adversely affect our business. Notifications and follow-up actions related to a security incident could impact our reputation or cause us to incur substantial costs, including legal and remediation costs, in connection with these measures and otherwise in connection with any actual or suspected security breach. Our efforts to detect and prevent security incidents and otherwise implement our internal security and business continuity measures, including those connected with any actual, potential, or anticipated attack, may cause us to incur significant cost, including those connected with the engagement of additional personnel (including third-party experts and consultants), employment protection technologies, and employee training.

The costs related to significant security breaches or disruptions could be material and our insurance policies may not be adequate to compensate us for the potential losses arising from any such disruption in, or failure or security breach of, our systems or third-party systems where information important to our business operations or commercial development is stored or processed. In addition, such insurance may not be available to us in the future on economically reasonable terms, or at all. Further, our insurance may not cover all claims made against us and could have high deductibles in any event, and defending a suit, regardless of its merit, could be costly and divert management attention. Furthermore, if the information technology systems of our third-party vendors and other contractors and consultants become subject to disruptions or security breaches, we may have insufficient recourse against such third parties and we may have to expend significant resources to mitigate the impact of such an event, and to develop and implement protections to prevent future events of this nature from occurring.

The occurrence of such a cybersecurity breach could result in interruptions in our operations, material disruption of our development programs or our business operations, and may cause us financial, legal, business, or reputational harm.

Risks Relating to Our Control by Fortress Biotech Inc.

Fortress controls a voting majority of our common stock.

Pursuant to the terms of the Class A common stock held by Fortress, Fortress is entitled to cast, for each share of Class A common stock held by Fortress, the number of votes that is equal to one and one-tenth (1.1) times a fraction, the numerator of which is the sum of the shares of outstanding common stock and the denominator of which is the number of shares of outstanding Class A common stock. Accordingly, as long as Fortress owns any shares of Class A common stock, they will be able to control or significantly influence all matters requiring approval by our stockholders, including the election of directors and the approval of mergers or other business combination transactions. The interests of Fortress may not always coincide with the interests of other stockholders, and Fortress may take actions that advance its own interests and are contrary to the desires of our other stockholders. Moreover, this concentration of voting power may delay, prevent or deter a change in control of us even when such a change may be in the best interests of all stockholders, could deprive our stockholders of an opportunity to receive a premium for their common stock as part of a sale of Checkpoint or our assets, and might affect the prevailing market price of our common stock.

Fortress has the right to receive a significant grant of shares of our common stock annually which will result in the dilution of your holdings of common stock upon each grant, which could reduce their value.

Under the terms of the Founders Agreement, which became effective as of March 17, 2015 and was amended and restated on July 11, 2016, Fortress has the right to receive an annual grant of shares of our common stock equal to 2.5% of the fully diluted outstanding equity at the time of issuance on January 1 of each year. This annual issuance of shares to Fortress will dilute your holdings in our common stock and, if the value of Checkpoint has not grown over the prior year, would result in a reduction in the value of your shares.

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We might have received better terms from unaffiliated third parties than the terms we receive in our agreements with Fortress.

The agreements we entered into with Fortress in connection with the separation include a Management Services Agreement and the Founders Agreement. While we believe the terms of these agreements are reasonable, they might not reflect terms that would have resulted from arm’s-length negotiations between unaffiliated third parties. The terms of the agreements relate to, among other things, payment of a royalty on product sales and the provision of employment and transition services. We might have received better terms from third parties because, among other things, third parties might have competed with each other to win our business.

Risks Related to Conflicts of Interest

The Chairman of our Board of Directors is also the Executive Chairman, President and Chief Executive Officer of TGTX, with whom we previously had a collaboration agreement and a sublicense agreement. As a result, during the terms of these agreements, certain conflicts of interest could have arisen which would have required the attention of our officers and independent directors who are unaffiliated with TGTX.

In connection with our license agreement with Dana-Farber and Adimab, we entered into a collaboration agreement with TGTX to develop and commercialize the anti-PD-L1 and anti-GITR antibody research programs, including cosibelimab in the field of hematological malignancies. In connection with our license agreement with Jubilant, we entered into a sublicense agreement with TGTX to develop and commercialize the Jubilant family of patents covering compounds that inhibit BET proteins such as BRD4, including CK-103, in the field of hematological malignancies. Michael S. Weiss, our Chairman of the Board of Directors, is also the Executive Chairman, President and Chief Executive Officer of TGTX.

Effective September 30, 2023, the Company and TGTX agreed to mutually terminate these collaborations.

The dual roles of our directors who also serve in similar roles with Fortress could create a conflict of interest and will require careful monitoring by our independent directors.

We share some directors with Fortress which could create conflicts of interest between the two companies in the future. While we believe that the Founders Agreement and the Management Services Agreement were negotiated by independent parties on both sides on arm’s length terms, and the fiduciary duties of both parties were thereby satisfied, in the future situations may arise under the operation of both agreements that may create a conflict of interest. We will have to be diligent to ensure that any such situation is resolved by independent parties. In particular, under the Management Services Agreement, Fortress and its affiliates are free to pursue opportunities which could potentially be of interest to Checkpoint, and they are not required to notify Checkpoint prior to pursuing the opportunity. Any such conflict of interest or pursuit by Fortress of a corporate opportunity independent of Checkpoint could expose us to claims by our investors and creditors and could harm our results of operations.

General Risks

Major public health issues, and specifically the pandemic caused by the spread of COVID-19, could have an adverse impact on our financial condition and results of operations and other aspects of our business.

On March 11, 2020, the World Health Organization declared that the rapidly spreading COVID-19 outbreak had evolved into a pandemic.

The COVID-19 pandemic negatively impacted the global economy, disrupted global supply chains, and created significant volatility and disruption of financial markets. Although COVID-19 has not had a material adverse effect on our business to date, if the coronavirus were to worsen, our business operations could be delayed or interrupted. For instance, our clinical trials may be affected by the pandemic. Site initiation, participant recruitment and enrollment, participant dosing, distribution of clinical trial materials, study monitoring and data analysis may be paused or delayed due to changes in hospital or university policies, federal, state or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related to the pandemic. If the coronavirus continues to spread, or if new variants emerge, some participants and clinical investigators may not be able to comply with clinical trial protocols.

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We currently rely on third parties, such as contract laboratories, contract research organizations, medical institutions and clinical investigators to conduct these studies and clinical trials. If these third parties themselves are adversely impacted by restrictions resulting from the coronavirus outbreak, we will likely experience delays and/or realize additional costs. We also rely on third parties for the manufacture of our product candidates for preclinical and clinical testing. Disruptions to the global supply chain could impact our or our third-party manufacturers’ ability to obtain raw materials or other products necessary to manufacture and distribute our product candidates. As a result, our efforts to obtain regulatory approvals for, and to commercialize, our product candidates may be delayed or disrupted.

We may not be able to manage our business effectively if we are unable to attract and retain key personnel.

We may not be able to attract and/or retain qualified management and commercial, scientific and clinical personnel in the future due to the intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses. If we are not able to attract and retain necessary personnel to accomplish our business objectives, we may experience constraints that will significantly impede the achievement of our development objectives, our ability to raise additional capital and our ability to implement our business strategy.

Our employees or third-party contractors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.

We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees or third-party contractors could include intentional failures to comply with FDA regulations, provide accurate information to the FDA, comply with manufacturing standards we have established, comply with federal and state health-care fraud and abuse laws and regulations, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, bribery, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Employee or third-party contractors misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation, as well as civil and criminal liability. 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 governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant fines and/or other civil and/or criminal sanctions.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. Although we believe that the safety procedures for handling and disposing of these materials comply with the standards prescribed by these laws and regulations, we cannot eliminate the risk of accidental contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.

Although we maintain workers’ compensation insurance to cover us for costs and expenses, we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials.

In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

如果系统出现故障，我们的业务和运营将会受到影响。

尽管已实施安全措施，但我们内部的计算机系统仍然容易受到计算机病毒、未经授权访问、自然灾害、恐怖主义、战争、以及电信和电力故障所造成的损害。任何系统故障、事故或安全漏洞导致我们业务中断的情况可能会严重干扰我们的药物开发项目。例如，从已完成的临床试验中丢失临床试验数据，可能会导致我们的监管批准努力延迟，并显著增加我们恢复或重新生成数据的成本。在任何中断或安全漏洞导致我们的数据或应用程序丢失或损坏，或者泄露机密或专有信息的情况下，我们可能会承担责任，一个或多个产品候选的进一步研发可能会延迟。

我们的普通股的市场价格和交易量一直波动较大。我们的股票可能会继续受到许多因素的影响，其中许多因素超出我们的控制范围，并可能阻止我们的股东以盈利出售我们的普通股。

生物技术和药品公司证券的市场价格历来变化很大，并且市场不时经历与特定公司的运营绩效无关的重大价格和成交量波动。

我们的普通股市场价格和交易量一直波动很大，可能会继续保持高度波动，并且可能会由于许多因素而大幅波动，包括：

●

与我们产品候选的临床开发相关的公告；

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关于我们努力获取药品候选产品或任何未来候选产品获得监管批准和商业化进展的公告，包括我们收到的FDA或美国以外的类似监管机构要求进行额外研究或数据，导致延迟或额外成本获得监管批准或推出这些候选产品（如果获得批准）；

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我们普通股市场的深度和流动性；

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投资者对我们和我们业务的看法；

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药品和生物技术行业或整体经济的市场条件可能受到经济或其他危机或外部因素的影响，包括COVID-19大流行对全球经济的影响；

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股市整体价格和成交量波动；

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我们的一个或多个产品候选品未能获得商业成功，或任何未来获批准的产品候选品失败；

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我们或竞争对手推出新产品的公告；

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产品开发结果或他人的知识产权相关的进展；

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有关我们潜在产品安全的诉讼或公众关注；

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实际季度运营结果的波动，以及投资者担心未来可能发生这种波动；

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我们运营结果偏离证券分析师或其他分析师评论的估计；

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医疗保健改革立法，包括旨在控制药品定价的措施，以及第三方覆盖和报销政策；

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与当前或未来战略合作相关的进展；和

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在金融和科学出版物以及在线投资者社区中讨论我们或我们的股价。

我们可能卷入证券集体诉讼事件，这可能转移管理层的注意力并损害我们的业务。

我们普通股的市场价格和交易量一直非常波动，并且可能继续保持高度波动。此外，股市不时经历显著的价格和交易量波动，这影响了生物技术和药品公司的普通股市场价格。广泛的市场波动可能导致我们股票市场价格下跌。过去，在公司证券市场价格波动后，经常发生证券集体诉讼。针对我们的证券集体诉讼可能导致潜在责任、大量费用以及转移我们管理倾向和资源，而不考虑结果。请参阅第二部分、项目1、法律诉讼。

事项2. 未经注册证券的最近销售。

我们在本项中未提供信息，以前在我们的10-k年度报告或8-k当前报告中已经包含了该信息。

项目 3。违反优先证券的行为。

None.

项目 4。矿山安全披露。

不适用。

项目5。其他信息。

None.

项目 6. 陈列品

附件编号		描述
31.1		根据《2002年萨班斯-豪利法》第302条的规定，认证Checkpoint Therapeutics, Inc.首席执行官所签署的文件，遵循规则13a-14(a)/15d-14(a)，日期为2024年11月12日。*

31.2		根据2002年萨班斯-豪利法案第302条款，于2024年11月12日签署的Checkpoint Therapeutics, Inc.首席金融官认证，依据第13a-14(a)/15d-14(a)条款。*

32.1		根据18 U.S.C. §1350的规定，由Checkpoint Therapeutics, Inc.的首席执行官出具的认证，依照2002年豪利法案第906节于2024年11月12日制定。**

32.2		根据18 U.S.C. §1350的规定，由Checkpoint Therapeutics, Inc.的信安金融官出具的认证，依照2002年豪利法案第906节于2024年11月12日制定。**

101		以下是截至2024年9月30日的公司的季度报告（表格10-Q）中的财务信息，采用可扩展商业报告语言（XBRL）格式： (i) 合并资产负债表， (ii) 合并运营报表， (iii) 合并股东权益报表， (iv) 合并现金流量表，以及 (v) 合并基本报表的附注（随此提交）。

104		封面交互式数据文件（格式为内联XBRL，包含展品101）。

*随此提交。

**随此呈交。

签名

根据1934年修订后的《交易法案》的要求，注册人已授权下面的授权代表代表其签署了该报告。

	Checkpoint Therapeutics，Inc.
	（注册人）
日期：2024年11月12日	作者：	/s/ James F. Oliviero
	詹姆斯·F·奥利维罗
	总裁兼首席执行官
	(首席执行官)