美国
证券和交易委员会
华盛顿特区20549
表格
（标记一） | |
根据1934年证券交易法第13或15(d)条，本季度报告 | |
截至季度结束日期的财务报告 | |
或者 | |
根据1934年证券交易法第13或15（d)条的转型报告 | |
自 至过渡期结束 | |
委托文件编号：001-39866
(根据其章程规定的注册人准确名称)
（国家或其他管辖区的 | （IRS雇主 |
(主要行政办公室地址) | (邮政编码) |
(
(注册人电话号码，包括区号)
不适用
（如自上次报告以来发生更改，则包括更名、更改地址及更改财政年度）
根据证券法第12(b)条注册的证券： | ||||
每一类的名称 | 交易标志 | 在其上注册的交易所的名称 | ||
| ||||
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。
否☐
请勾选此项表示注册人是否在过去的12个月（或者注册人要求提交此类文件的更短期间）内已经提交了规定于S-t法规第405条（本章第232.405条）的互动式数据文件。
请在交易所法规则120.2规定的“大型加速申报人”、“加速申报人”、“小型报告公司”和“新兴成长公司”的定义中选中相应选项。
大型加速归档人☐ | 加速报告人☐ |
小型报告公司 | |
新兴成长公司 |
如果是新兴成长型企业，请勾选是否选择不使用按照《证券交易法》第13(a)条规定的新或修订财务会计准则的过渡期。
请在以下方框内打勾：公司是否是空壳公司(根据证券交易法第12b-2条规定定义）。是
截至2024年11月8日，注册人发行的A系列普通股，每股面值0.0001美元，已发行股份数量为
2
前瞻性声明
本季度报告表格10-Q（本季度报告） 根据《1933年证券法》第27A节及《1934年证券交易法》第21E节（交易所法），本报告包含前瞻性陈述。除历史事实外，本季度报告中包含的所有陈述，包括有关我们未来业务运营和财务状况、业务策略、药物候选者、计划的临床前研究和临床试验、临床前研究结果、临床试验、研发成本、监管审批、成功的时间和可能性及管理层未来运营的计划和目标的陈述，均为前瞻性陈述。这些陈述涉及已知和未知的风险、不确定性和其他重要因素，在某些情况下超出了我们的控制范围，可能导致我们的实际结果、表现或成就与任何前瞻性陈述所表达或暗示的未来结果、表现或成就存在重大差异。
在某些情况下，您可以通过“可能”、“将”、“应该”、“会”、“期待”、“计划”、“预测”、“能够”、“打算”、“目标”、“项目”、“相信”、“估计”、“预测”、“潜在”或“继续”等术语或这些术语的否定或其他类似表达来识别前瞻性陈述。本季度报告中的前瞻性陈述包括但不限于关于：
| • | 我们的财务业绩； |
| • | 我们获得额外现金的能力以及我们现有现金、现金等价物和可交易证券是否足以支持我们未来的营业费用和资本支出要求； |
| • | 我们所估计的关于费用、未来收入、资本需求和融资需要的准确性； |
| • | 开发denifanstat或我们可能开发的任何其他药物候选者的范围、进展、结果和成本，以及进行临床前研究和临床试验； |
| • | 我们能够在预计的时间内将药物候选者推进并成功完成临床试验，包括我们计划的denifanstat的第三阶段临床试验； |
| • | 获取和维持denifanstat或我们可能开发的任何其他药物候选者的监管批准所涉及的时间和成本，以及监管文件和批准的时间或可能性，包括我们期望为我们的药物候选者寻求特殊指定或加速批准用于各种适应症； |
| • | 与第三方有关denifanstat或任何其他未来药物候选者的开发和商业化的当前和未来协议； |
| • | 我们对美国中患有我们目标疾病的患者人数的估计，包括与代谢功能失调相关的脂肪性肝炎（MASH），以前称为非酒精性脂肪性肝炎（NASH），以及将在我们的临床试验中注册的受试者人数； |
| • | 我们与Ascletis BioScience Co. Ltd. (Ascletis)及其附属公司Gannex Pharma Co., Ltd. (Gannex)的关系，以及他们在denifanstat开发方面的成功； |
| • | 我们的临床试验能够证明denifanstat和我们可能开发的任何其他药物候选者的安全性和有效性，以及其他积极结果； |
| • | 我们关于商业化丹非那斯特和我们可能开发的其他药物候选者（如果获得批准）的计划，包括关注的地理区域以及我们组建销售团队的能力； |
| • | 竞争疗法的成功，这些疗法已经或可能会推出； |
| • | 与我们的竞争对手和行业相关的发展，包括竞争的药物候选者和治疗； |
3
| • | 我们关于迪尼凡斯他和我们可能开发的任何其他药物候选品进一步发展和制造的计划，包括我们可能为迪尼凡斯他或其他药物候选品寻求的额外适应症； |
| • | 美国和其他司法管辖区的现行规定和监管发展 |
| • | 我们有能力成功制造和供应迪尼凡斯他和我们可能为临床试验和商业用途开发的任何其他药物候选品，如果获批准； |
| • | 市场对迪尼凡斯他和我们可能开发的任何其他药物候选品的接受程度和速度，以及迪尼凡斯他和我们可能开发的任何其他药物候选品的价格和报销情况，如果获批准； |
| • | 我们关于能否获得、维护、保护和执行迪尼凡斯他以及任何未来药物候选品的知识产权保护的期望； |
| • | 实现任何战略交易所预期的收益的能力； |
| • | 我们有能力吸引和留住关键人员的持续服务，确定、聘用并留住更多合格的人员，并能够吸引具备开发、监管和商业化专业知识的额外合作伙伴； |
| • | 宏观经济条件和地缘政治动荡对我们的业务和运营造成的影响； |
| • | 我们对我们将在《作业机会与创新创业法案》下被视为新兴成长公司的期限的期望；及 |
| • | 我们对现有现金、现金等价物和有价证券的预期使用。 |
我们在很大程度上基于我们对我们的业务、我们所在行业以及我们认为可能影响我们的业务、财务状况、经营业绩和前景的金融趋势的当前期望和预测作出这些前瞻性声明，这些前瞻性声明并非未来业绩或发展的保证。这些前瞻性声明仅代表本季度报告日期的看法，并受到本季度报告第二部分第1A条“风险因素”和本季度报告其他地方描述的一系列风险、不确定性和假设的影响。由于前瞻性声明本质上受到风险和不确定性的影响，其中一些风险和不确定性无法预测或量化，您不应该将这些前瞻性声明视为未来事件的预测。我们前瞻性声明中反映的事件和情况可能无法实现或发生，实际结果可能会大幅偏离前瞻性声明中所展望的情况。除适用法律要求外，我们不打算在分发本季度报告之前公开更新或修改此处包含的任何前瞻性声明，无论是因任何新信息、未来事件还是其他原因。
此外，涉及“我们相信”等表述的声明反映了我们对相关主题的信念和观点。这些声明基于我们在本季度报告日期可获得的信息，虽然我们认为这些信息为这些声明提供了合理的基础，但这些信息可能存在局限或不完整，并不应将我们的声明解读为表示我们已对所有可能可获得的相关信息进行彻底调查或审查。这些声明本身具有不确定性，您应该注意不要过分依赖这些声明。
说明注释
反映了疾病命名从非酒精性脂肪性肝病（NAFLD）到代谢功能障碍相关脂肪肝病（MASLD），以及从非酒精性脂肪性肝炎（NASH）到代谢功能障碍相关脂肪性肝炎（MASH）的变化，在本文档中使用MASLD和MASH，而不是在提及使用术语NAFLD或NASH的出版物标题或其他活动时。
4
第一部分 财务信息
项目1。基本报表
SAGIMEt BIOSCIENCES INC.
简明资产负债表
(未经审计)
（以千为单位，股份和每股金额除外）
截至 | ||||||
2023年9月30日， | 十二月31日， | |||||
| 2024 |
| 2023 | |||
资产 | ||||||
流动资产： |
|
|
|
| ||
现金及现金等价物 | $ | | $ | | ||
短期市场证券 |
| |
| | ||
预付费用和其他流动资产 | | | ||||
总流动资产 | | | ||||
长期有价证券 | | — | ||||
经营租赁使用权资产 | | | ||||
总资产 | $ | | $ | | ||
负债和股东权益 |
|
|
|
| ||
流动负债: |
|
|
|
| ||
应付账款 | $ | | $ | | ||
应计费用和其他流动负债（包括截至2024年9月30日和2023年12月31日分别应付给关联方） |
| |
| | ||
经营租赁负债 |
| |
| | ||
流动负债合计 |
| |
| | ||
承担和可能承担的义务（注6） |
|
|
|
| ||
股东权益: |
|
|
|
| ||
未指定优先股，每股面值为美元 | ||||||
A 系列普通股 $ | | | ||||
B类普通股，$ | ||||||
其他资本公积 |
| |
| | ||
累积赤字 |
| ( |
| ( | ||
累计其他综合收益 |
| |
| | ||
股东权益总额 | |
| | |||
负债和股东权益总额 | $ | | $ | | ||
附注是这些未经审计的基本财务报表的一部分。
5
SAGIMEt BIOSCIENCES INC.
简明损益表和综合损失表
(未经审计)
（以千为单位，股份和每股金额除外）
| 三个月截至9月30日 | 九个月截至9月30日 | ||||||||||
2024 |
| 2023 |
| 2024 |
| 2023 | ||||||
$ | — | $ | | $ | — | $ | | |||||
营业费用： | ||||||||||||
研发 | | | | | ||||||||
一般管理费用 |
| |
| |
| |
| | ||||
总营业费用 |
| |
| |
| |
| | ||||
营业损失 |
| ( |
| ( |
| ( |
| ( | ||||
其他收入（费用）： | ||||||||||||
可赎回可转换优先股权证负债公允价值变动 | — | — | — | ( | ||||||||
A系列普通股权证负债公允价值的变动 | — | | — | | ||||||||
利息收入和其他净额 | | | | | ||||||||
总其他收入 |
| |
| |
| |
| | ||||
净损失 | $ | ( | $ | ( | $ | ( | $ | ( | ||||
A系列和B系列普通股每股净亏损，基础和稀释 | $ | ( | $ | ( | $ | ( | $ | ( | ||||
基本和稀释后A系列和B系列普通股的加权平均流通股数 |
| |
| | |
| | |||||
净亏损 | $ | ( | $ | ( | $ | ( | $ | ( | ||||
其他综合收益: |
|
|
|
|
|
|
|
| ||||
市场证券未实现收入净额 |
| |
| — |
| |
| | ||||
综合损失总额 | $ | ( | $ | ( | $ | ( | $ | ( | ||||
附注是这些未经审计的基本财务报表的一部分。
6
SAGIMEt BIOSCIENCES INC.
可赎回可转换优先股简明报表和
股东权益（赤字）
(未经审计)
（以千为单位，股数除外）
累积 | |||||||||||||||||||||||||
A轮融资 | B轮 | 额外的 | 其他 费用 | 总和 | |||||||||||||||||||||
普通股 |
|
| 普通股 | 已付资本 | 累计 | 综合 | 股东权益 | ||||||||||||||||||
| 股份 |
| 金额 |
|
| 股份 |
| 金额 |
| 资本 |
| 亏损 |
| 收入（损失） |
| 股权 | |||||||||
2024年1月1日的余额 | | $ | |
| | $ | — | $ | | $ | ( | $ | | $ | | ||||||||||
减去发行成本后的A系列普通股销售 | | | — | — | | — | — | | |||||||||||||||||
行使股票期权后发行A轮普通股 | | — | — | — | | — | — | | |||||||||||||||||
基于股票的薪酬费用 |
| — |
| — |
| — |
| — |
| |
| — |
| — |
| | |||||||||
证券投资的未实现损失 |
| — |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | |||||||||
净损失 |
| — |
| — |
| — |
| — |
| — |
| ( |
| — |
| ( | |||||||||
截至2023年6月30日的前六个月 |
| | $ | |
| | $ | — | $ | | $ | ( | $ | | $ | | |||||||||
与发行销售A类普通股相关的发行成本 | — | — | — | — | ( | — | — | ( | |||||||||||||||||
基于股票的薪酬费用 |
| — |
| — |
| — |
| — |
| |
| — |
| — |
| | |||||||||
未实现的投资损失来自可交易证券 |
| — |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | |||||||||
净损失 |
| — |
| — |
| — |
| — |
| — |
| ( |
| — |
| ( | |||||||||
2024年6月30日的余额 |
| | $ | |
| | $ | — | $ | | $ | ( | $ | ( | $ | | |||||||||
发行A轮普通股用于限制股票单位的解锁 |
| |
| — |
| — |
| — |
| — |
| — |
| — |
| — | |||||||||
股票期权基于的补偿费用 | — | — | — | — | | — | — | | |||||||||||||||||
可变现的交易性证券未实现收益 | — | — | — | — | — | — | | | |||||||||||||||||
净损失 | — | — | — | — | — | ( | — | ( | |||||||||||||||||
截至2024年9月30日的余额 | | $ | |
| | $ | — | $ | | $ | ( | $ | | $ | | ||||||||||
7
累积 | |||||||||||||||||||||||||||||||||||||
可赎回可转换 | A轮融资 | B轮 | 额外的 | 其他 费用 | 总和 | ||||||||||||||||||||||||||||||||
优先股票 | 普通股 | 普通股 | 普通股 | 实收资本 | 累计 | 综合 | 股东的 | ||||||||||||||||||||||||||||||
股份 |
| 金额 |
|
| 股份 |
| 金额 |
| 股份 |
| 金额 | 股份 |
| 金额 | 资本 |
| 亏损 |
| 损失 |
| 权益（亏损） | ||||||||||||||||
2023年1月1日的余额 |
| | $ | |
| | $ | | — | $ | — | — | $ | — | $ | | $ | ( | $ | ( | $ | ( | |||||||||||||||
基于股票的薪酬费用 |
| — |
| — |
| — |
| — | — | — | — | — |
| |
| — |
| — |
| | |||||||||||||||||
可变现的交易性证券未实现收益 |
| — |
| — |
| — |
| — | — | — | — | — |
| — |
| — |
| |
| | |||||||||||||||||
净损失 |
| |
| |
| — |
| — | — | — | — | — |
| — |
| ( |
| — | ( | ||||||||||||||||||
2023年3月31日余额 |
| | $ | |
| | $ | | — | $ | — | — | $ | — | $ | | $ | ( | $ | ( | $ | ( | |||||||||||||||
行使普通股权证 |
| — |
| — |
| |
| — | — | — | — | — |
| — |
| — |
| — |
| — | |||||||||||||||||
可变现的交易性证券未实现收益 | — | — | — | — | — | — | — | — | — | — | | | |||||||||||||||||||||||||
基于股票的薪酬费用 |
| — |
| — |
| — |
| — | — | — | — | — |
| |
| — |
| — |
| | |||||||||||||||||
净损失 |
| |
| |
| — |
| — | — | — | — | — |
| — |
| ( |
| — | ( | ||||||||||||||||||
2023年6月30日的余额 |
| | $ | |
| | $ | | — | $ | — | — | $ | — | $ | | $ | ( | $ | — | $ | ( | |||||||||||||||
可赎回可转换优先股转为A系列和B系列普通股 |
| ( | ( | — | — | | | | — | | — | — | | ||||||||||||||||||||||||
将普通股重分类为A系列普通股 | — | — | ( | ( | | | — | — | — | — | — | — | |||||||||||||||||||||||||
公开发行系列A普通股，扣除发行成本后收入为$ | — | — | — | — | | — | — | — | | — | — | | |||||||||||||||||||||||||
根据行使期权发行A系列普通股 | — | — | — | — | | — | — | — | | — | — | | |||||||||||||||||||||||||
行使普通股权证 | — | — | — | — | | — | — | — | — | — | — | — | |||||||||||||||||||||||||
基于股票的薪酬费用 |
| — | — | — | — | — | — | — | — | | — | — | | ||||||||||||||||||||||||
净损失 |
| — |
| |
| — |
| — | — |
| — | — |
| — |
| — |
| ( |
| — |
| ( | |||||||||||||||
2023年9月30日余额 |
| | $ | |
| — | $ | — | | $ | | | $ | — | $ | | $ | ( | $ | — | $ | | |||||||||||||||
附注是这些未经审计的基本财务报表的一部分。
8
SAGIMEt BIOSCIENCES INC.
精简现金流量表
(未经审计)
（单位：千）
九个月截至9月30日 | ||||||
2024 | 2023 | |||||
经营活动现金流量 |
|
|
|
| ||
净亏损 | $ | ( | $ | ( | ||
调整为净损失到经营活动现金流量净使用： |
|
|
|
| ||
按市价计量的证券贴现 |
| ( |
| ( | ||
非现金租赁费用 |
| |
| | ||
股票期权基于的补偿费用 |
| |
| | ||
可赎回可转换优先股权证负债公允价值变动 | — | | ||||
A系列普通股权证负债公允价值的变动 | — | ( | ||||
运营资产和负债的变化： |
|
|
| |||
预付费用和其他流动资产 |
| ( |
| ( | ||
应付账款、应计费用及其他流动负债 |
| ( |
| ( | ||
经营租赁负债 |
| ( |
| ( | ||
用于经营活动的净现金 |
| ( |
| ( | ||
投资活动现金流量 |
|
|
|
| ||
购买有市场流通的证券 | ( | — | ||||
市场证券的销售和到期 |
| |
| | ||
投资活动的净现金流量(使用)/提供的净现金流量 |
| ( |
| | ||
筹资活动现金流量 |
|
|
|
| ||
发行A系列普通股的收益，扣除发行成本 | | — | ||||
首次公开募股的收益，扣除承销商佣金和折扣 | — | | ||||
支付融资成本 |
| ( |
| — | ||
行使股票期权所得 | | | ||||
筹资活动产生的现金净额 |
| |
| | ||
现金及现金等价物净增加 |
| |
| | ||
期初现金及现金等价物余额 |
| |
| | ||
期末现金及现金等价物 | $ | | $ | | ||
补充非现金投融资活动: | ||||||
包括在应付账款和应计费用中的延期融资成本 | $ | | $ | — | ||
交易租赁义务获取的右 of use 资产 | $ | | $ | — | ||
附注是这些未经审计的基本财务报表的一部分。
9
SAGIMEt BIOSCIENCES INC.
简明基本报表附注（未经审计）
| 1. | 业务说明及基本准则 |
Sagimet Biosciences Inc.（公司）是一家注册于特拉华州、总部位于加利福尼亚州圣马特奥的临床阶段生物制药公司，正在开发称为脂肪酸合成酶（FASN）抑制剂的新型治疗药物，旨在针对因脂肪酸棕榈酸过量产生而导致的代谢和纤维化 通路。公司的主要 药物候选者denifanstat是一种口服每日服用一次的片剂，是一种选择性FASN抑制剂，用于治疗与代谢功能障碍相关的脂肪肝炎（MASH），之前称为非酒精性脂肪肝炎（NASH）。在2024年1月，公司宣布了Phase 20亿 FASCINATE-2临床试验中对比安慰剂、评估在活检确认的MASH患者中，Fibrosis阶段为F2或F3的denifanstat积极的顶线结果，观察为期52周。在2024年6月，公司呈现了来自Phase 20亿 FASCINATE-2临床试验的额外52周意向治疗（ITT）和F3亚组疗效数据。
在2024年10月，美国食品和药物管理局（FDA）授予denifanstat突破性疗法认证，用于治疗具有中度至重度肝纤维化的非肝硬化MASH（相当于F2到F3阶段的肝纤维化）。denifanstat的突破性疗法认证得到了来自Phase 20亿 FASCINATE-2临床试验中在活检确认的MASH患者中F2或F3阶段纤维化的积极数据的支持。
在2024年10月，公司与FDA成功完成了第2阶段结束的互动，支持denifanstat进入MASH的第3阶段。计划的项目将包括两项第3阶段试验：FASCINATE-3，评估F2/F3（非肝硬化）MASH患者，和FASCINIt，评估怀疑或确诊代谢功能障碍相关脂肪肝病（MASLD）/MASH患者。预计第3阶段项目将在2024年底启动。
除了MASH外，公司还在探索其FASN抑制剂在痤疮和某些癌症形式中的应用，这些疾病中脂肪酸代谢的失调也起着关键作用。denifanstat目前正在中国由公司授权合作伙伴Ascletis生物科学有限公司（Ascletis），这是一家Ascletis制药公司（Ascletis Pharma）的子公司，在一项中度至重度寻常痤疮的第3阶段临床试验和一项与贝伐单抗联合治疗的复发性多形性胶质母细胞瘤（GBM）的第3阶段试验中进行测试。2024年11月，Ascletis宣布已完成480名患者的痤疮第3阶段临床试验的入组。公司已为第二种FASN抑制剂TVb-3567完成了研究性新药（IND）启用研究。
随附的基本报表是按照美国普遍接受的会计原则（GAAP）编制的。这些注释中提到的任何适用指导均指GAAP，如会计标准分类（ASC）和由财务会计标准委员会（FASB）发布的会计标准更新（ASU）中所找到的。 为符合当年度报表展示，某些先前年度的金额已被重新分类。
这些未经审计的临时基本报表及其随附注释应与公司年度基本报表及其附注一并阅读，这些信息已包含在公司于2024年3月25日向证券交易委员会（SEC）提交的10-K表格中。附带的临时基本报表截至2024年9月30日及截至2024年和2023年9月30日的三个月和九个月的财务信息未经审计，但包括管理层认为对所呈现时期的公平陈述所必要的所有调整。临时业绩并不一定预示着全年业绩。2023年12月31日的资产负债表金额已源自该日期的经审计基本报表。
根据公认会计原则编制基本报表要求管理层进行估计和假设，这会影响在基本报表日期报告的资产和负债金额，以及在报告期间报告的收入和费用金额。这些估计包括对研发费用的应计、根据与第三方医药外包概念（CROs）协议提供的服务的应计成本、公司首次公开发行A系列普通股（IPO）之前的优先股和普通股估值，以及股票期权估值和基于股票的薪酬。公司持续评估其估计和判断，这些估计和判断基于历史和预期的结果和趋势，以及管理层认为在当时情况下合理的各种其他假设。实际结果可能与这些估计有所不同。
10
新兴成长企业地位
本公司是根据2012年《创业公司法案》(JOBS法案)的定义，属于新兴成长公司（EGC），并可能利用某些豁免，免于遵循适用于其他非EGC上市公司的各种报告要求。本公司可以利用这些豁免，直到根据JOBS法案第107条不再是EGC，并选择使用延长过渡期以遵守新的或修订的会计标准。因此，本公司的基本报表可能与根据上市公司FASB标准遵循有效日期的公司所发布的报表不可比拟。
流动性
附带的未经审计的基本报表是基于本公司将持续作为持续经营主体的假设编制的，这意味着业务的持续性、资产的实现以及在正常业务中满足负债和承诺。本公司将需要大量额外资金来为其研发和持续的营业费用提供资金。截至2024年9月30日，本公司依赖于公共和股权投资以及债务融资，以及来自许可安排的收益来资助其运营。自创立以来，本公司遭受了经常性的亏损和负现金流，截止到2024年9月30日，累计亏损为$
在2023年7月和8月，本公司完成了首次公开募股（IPO），并包括部分行使的 承销商超额配售的选项，公司出售了总计
T公司预计，截至2024年9月30日，其现金、现金等价物和可交易证券将足以支持公司在这些基本报表发布后至少12个月内的营业费用。未来，公司需要筹集额外资金，直到能够产生足够的收入来支持其开发活动（如果能够的话）。公司的未来营业活动，以及其筹集资本或发行债务融资的计划，可能会在未来提供额外的流动性，然而这些行动并不完全在公司控制之内，公司也无法预测这些行动产生所需流动性的结果。
在2024年8月，公司与Cantor Fitzgerald & Co.签署了一项受控股权发行销售协议，以建立市场发行（ATm发行），通过该发行，公司可能会在其自行决定的情况下不时出售高达$
| 2. | 除了下面的说明，公司的重要会计政策在我们的2023财年年度报告中已经描述，这些政策对这些简化合并财务报表和相关附注产生了重大影响。 |
公司的重要会计政策在审计财务报表及其附注中披露，这些报表包括在公司于2024年3月25日向SEC提交的截至2023年12月31日的10-k年报中。自那些审计财务报表之日起，公司的重要会计政策没有重大变化。
11
股票拆分
公司于2023年7月7日实施了一比一的股票拆分 作为股票拆分的结果，股东有权获得碎股，其碎股所得到的现金支付替代了碎股的分配。因此，所有列示在附表未经审计的简明财务报表及相关附注中的股份数和每股金额都已根据需要进行了追溯调整，以反映股票拆分的影响。未行使的普通股期权和普通股认股权证的普通股数量相应减少，如适用，行权价格按照管理这些证券的协议条款相应增加。为转换公司优先股而保留的普通股数量相应减少，转换价格相应增加。
每股净损失及普通股重新分类
基本和摊薄每股净损失是使用两类法计算的，适用于多类普通股和参与证券。公司的参与证券没有合同义务分享公司的亏损。因此，净损失完全归属于所有列示时段的普通股股东。基本每股净损失归属于普通股股东的计算方法是将净损失除以该时段内普通股加权平均流通股数，不考虑潜在稀释证券。摊薄每股净损失归属于普通股股东的计算方法是将净损失除以该时段内普通股和潜在稀释证券的加权平均流通股数。用于计算摊薄每股净损失归属于普通股股东的目的，普通股期权、限制性股份单位和普通股认股权证被视为潜在稀释证券。由于公司报告的时段内净亏损，基本和摊薄每股净损失归属于普通股股东的情况相同，因为所有潜在稀释证券都具有反稀释影响。
2023年7月18日，公司已发行和流通的每股普通股被重新分类为一股A系列普通股。2023年7月18日之前代表公司普通股的任何股票证书被视为代表A系列普通股，无需交出或交换。此外，在IPO过程中，公司未偿还的可转换优先股自动转换为一定数量的A系列普通股和一定数量的B系列普通股。A系列普通股和B系列普通股持有人的权利基本相同，仅就投票和转换而言有所不同。每股A系列普通股有一票的投票权，而B系列普通股没有投票权，除非法律另有规定。每股B系列普通股可以随时按其持有人的选择转换为一股A系列普通股，但受到一定的所有权限制。因此，归因于普通股股东的基本和稀释每股净损失是以未分配收益的综合方式呈现的，这些未分配收益在分配给每一系列普通股时，在所有呈现的期间都导致相同的每股净损失。
以下表格展示了截至2024年和2023年9月30日的三个月和九个月内每股基本和稀释净损失的计算（以千为单位，股票和每股数据除外）：
三个月截至9月30日 | 九个月截至9月30日 | |||||||||||
2024 | 2023 | 2024 |
| 2023 | ||||||||
分子： | ||||||||||||
净亏损 | $ | ( | $ | ( | $ | ( | $ | ( | ||||
分母： | ||||||||||||
基本和稀释后A系列和B系列普通股的加权平均流通股数 |
| |
| |
| |
| | ||||
A系列和B系列普通股每股净亏损，基础和稀释 | $ | ( | $ | ( | $ | ( | $ | ( | ||||
以下可能具有稀释效应的证券已被排除在计算淡水淡品种A和品种B普通股稀释加权平均份额之外，因为它们的影响将是抗稀释的:
12
三个月截至9月30日 | 九个月截至9月30日 | |||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |
期权购买A系列普通股 | | | | | ||||
warrants购买A系列普通股 | | | | | ||||
未获授限制性股票单位 | | — | | — | ||||
总计 |
| |
| |
| |
| |
最近颁布的会计声明
公司考虑了所有资产的适用性和影响。 未在下文讨论的资产予以评估，确定其不适用或对公司财务报表的影响预期很小。
2020年8月，FASB发布了ASU第2020-06号。、债务-债务与转换及其他期权（子课题470-20）和衍生工具与套期工具-公司内股权合同（子课题815-40）; 会计处理可转换工具和公司内股权合同，以解决适用GAAP的复杂性所导致的与某些具有债务和股本特征的金融工具的问题。 本修订案适用于2023年12月15日后开始的财政年度，包括其中的中期期间。 采用这一标准对公司的财务报表及相关披露没有影响。
尚未采用的新会计准则。
按照《公允价值清咨询机构的权威指南》要求披露公允价值清算的三级分类体系，如下： Segment Reporting (Topic 280)—Improvements to Reportable Segment Disclosures. ASU 2023-07 requires disclosure of incremental segment information on an interim and annual basis and provides new segment disclosure requirements for entities with a single reportable segment. ASU 2023-07 is effective for all public companies for fiscal years beginning after December 15, 2023, and interim periods within fiscal periods beginning after December 15, 2024, and requires retrospective application to all prior periods presented in the financial statements. The Company is assessing the impact of the adoption of this standard on its disclosures.
2023年12月，FASB发布了ASU 2023-09， Income Taxes (Topic 740)—所得税披露改进, a final standard on improvements to income tax disclosures. The standard requires disaggregated information about a reporting entity's effective tax rate reconciliation as well as information on income taxes paid. The standard is intended to benefit investors by providing more detailed income tax disclosures that would be useful in making capital allocation decisions and applies to all entities subject to income taxes. The new standard is effective for annual periods beginning after December 15, 2024. The Company is assessing the impact of the adoption of this standard on its disclosures.
3. | 公允价值计量和金融工具的公允价值 |
关于公允价值计量的权威指南建立了一个三层次的公允价值层次结构，用于披露公允价值计量，具体如下：
第1级 - 在活跃市场上针对相同资产或负债的报价价格。
第2级 - 除第1级价格之外的可观察输入，例如类似资产或负债的报价，非活跃市场的报价，或者通过可观察市场数据支持或可证实的其他输入，对于资产或负债的全部期限来说，这些输入是可观察的。
第3级 - 受到极少或没有市场活动支持且对资产或负债的公允价值具有重大影响的不可观察输入。
截至2024年9月30日和2023年12月31日，按照公允价值计量方式衡量的金融资产主要包括货币性资金和可交易证券。 现金等价物主要包括货币市场基金和其他可以迅速转换为现金且在购买时期限为三个月或更短的投资。现金等价物的公允价值为$
13
证券资产为$
公司评估有未实现亏损的证券（如有）以判断公允价值下降是否来自信用损失或其他因素，包括各种定性因素。截至2024年9月30日，公司未对公司的可供出售证券确认任何减值或信用损失。虽然公司将这些证券分类为可供出售，但公司并没有打算出售其投资，并基于其当前计划，公司目前相信自己有能力持有这些投资直至到期。
由于这些负债的短期性质，公司的应付账款、应计费用和其他流动负债的账面价值与其公允价值大致相当。
以公允价值计量的资产和负债根据对公允价值计量的重要性的最低输入水平进行整体分类。公司对某一特定输入对其整体公允价值计量的重要性的评估要求管理层进行判断，并考虑特定于资产或负债的因素。
公司的三级负债是根据其在重复计量基础上的公允价值进行测量，包括与购买权证有关的A系列普通股认股权负债。
以下表格列出了公司按照公允价值层次定期计量的金融资产（以千为单位）：
| 2024年9月30日 | ||||||||||||||
估值 |
| 摊销 |
| 未实现 |
| Unrealized |
| ||||||||
等级制度 | 成本 | 收益 | 损失 | 公允价值 | |||||||||||
资产 | |||||||||||||||
现金及现金等价物： | |||||||||||||||
货币市场基金 | 一级 | $ | | $ | — | $ | — | $ | | ||||||
现金等价物总计 | | — | — | | |||||||||||
短期市场性证券： | |||||||||||||||
商业本票 |
| 二级 | |
| |
| — |
| | ||||||
公司债务证券 | Level 2 | | | — | | ||||||||||
美国国债 | Level 2 | | | — | | ||||||||||
机构债券 | 二级 | | | — | | ||||||||||
资产支持证券 | 二级 | | | — | | ||||||||||
总的短期市场有价证券 | | | — | | |||||||||||
长期市场性证券： | |||||||||||||||
美国国债 | 二级 | | | — | | ||||||||||
资产支持证券 | Level 2 | | | — | | ||||||||||
总的长期市场有价证券 | | | — | | |||||||||||
所有基金类型和可交易证券 | $ | | $ | | $ | — | $ | | |||||||
14
December 31, 2023 | |||||||||||||||
Valuation |
| Amortized |
| Unrealized |
| Unrealized |
| ||||||||
Hierarchy | cost | Gains | Losses | Fair Value | |||||||||||
Assets | |||||||||||||||
Cash equivalents: | |||||||||||||||
Money market funds | Level 1 | $ | | $ | — | $ | — | $ | | ||||||
Corporate debt securities | Level 2 | | — | — | | ||||||||||
Total cash equivalents | | — | — | | |||||||||||
Short-term marketable securities: | |||||||||||||||
Commercial paper |
| Level 2 | |
| |
| — |
| | ||||||
Corporate debt securities | Level 2 | | | — | | ||||||||||
U.S. Treasury securities | Level 2 | | | — | | ||||||||||
Total short-term marketable securities | | | — | | |||||||||||
Total cash equivalents and marketable securities | $ | | $ | | $ | — | $ | | |||||||
4. | Prepaid Expenses and Other Current Assets |
Prepaid expenses and other current assets consisted of the following (in thousands):
| As of | |||||
September 30, | December 31, | |||||
2024 |
| 2023 | ||||
Prepaid clinical costs | $ | | $ | — | ||
Prepaid research and development costs | | | ||||
Prepaid insurance | | | ||||
Deferred financing costs (1) | | | ||||
Other |
| |
| | ||
Total prepaid expenses and other current assets | $ | | $ | | ||
____________
| (1) | Amount as of September 30, 2024 relates to deferred financing costs related to the ATM Offering entered into during August 2024. Amount as of December 31, 2023 relates to deferred financing costs related to the Company’s January 2024 follow-on offering. |
5. | Accrued Expenses and Other Current Liabilities |
Accrued expenses and other current liabilities consisted of the following (in thousands):
| As of | |||||
September 30, | December 31, | |||||
2024 |
| 2023 | ||||
Accrued payroll-related costs | $ | | $ | | ||
Accrued clinical costs | | | ||||
Accrued research and development costs | | | ||||
Accrued general and administrative costs | | | ||||
Accrued offering costs | — | | ||||
Other |
| |
| | ||
Total accrued expenses and other current liabilities | $ | | $ | | ||
15
6. | Commitments and Contingencies |
License and other agreements
Ascletis BioScience Co. Ltd
In January 2019, the Company entered into a license agreement that became effective in February 2019 with Ascletis BioScience Co. Ltd. (Ascletis), a subsidiary of Ascletis Pharma Inc. (Ascletis Pharma), a biotechnology company incorporated in the Cayman Islands and headquartered in Hangzhou, China. Ascletis Pharma, through a subsidiary, was the lead investor in the Company’s Series E redeemable convertible preferred stock financing in February 2019. The parties entered into this agreement with the intention to develop, manufacture, and commercialize the Company’s proprietary FASN inhibitor, denifanstat, which Ascletis refers to as ASC40. Under the terms of the license agreement, the Company granted Ascletis and its affiliates an exclusive, royalty-bearing sublicensable right and license under the Company’s intellectual property to develop, manufacture, commercialize and otherwise exploit denifanstat and other products containing denifanstat-related compounds in Greater China, consisting of the People’s Republic of China, Hong Kong, Macau and Taiwan.
The Company is eligible to receive development and commercial milestone payments from Ascletis in aggregate of up to $
In July 2023, the Company recognized $
In July 2023, the Company entered into an Assignment and Assumption Agreement with Ascletis and Ascletis’ affiliate Gannex Pharma Co., Ltd. (Gannex) under which Ascletis, while remaining responsible for performance under the license agreement, assigned all of its rights and obligations under the license agreement to Gannex and Gannex assumed such rights and obligations, effective as of October 2019.
Contract Research Organization
In June 2024, the Company entered into a contract with a global CRO to perform certain research and related services in connection with certain of the Company’s clinical trials and research studies (CRO Services Agreement). The terms of the CRO Services Agreement require the Company to pay to the CRO certain direct fees, investigator grants and other pass-through costs, generally on an upfront prepaid basis. These payments are capitalized at the time of payment and expensed in the period in which the research and development activity is performed. The Company may terminate the CRO Services Agreement or underlying statement of work at will with 60 days’ written notice.
Facility lease agreement
On March 12, 2019, the Company executed a non-cancelable operating lease agreement for
16
Operating lease costs were $
Guarantees and indemnifications
In the normal course of business, the Company enters into agreements that contain a variety of representations and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. As of September 30, 2024, the Company does not have any material indemnification claims that were probable or reasonably possible and consequently has not recorded related liabilities.
Legal Proceedings
From time to time, the Company may become involved in various legal proceedings that arise in the ordinary course of its business. The Company is not party to any material legal proceedings as of September 30, 2024.
7. | Stock-Based Compensation |
The 2023 Stock Option and Incentive Plan (2023 Plan) was adopted by the board of directors, approved by the Company’s stockholders on July 4, 2023, and became effective on July 13, 2023, replacing the 2017 Equity Incentive Plan. The number of shares initially reserved for issuance under the 2023 Plan was
In March 2024, the Company established a pool of
Total stock-based compensation recorded in the condensed statements of operations and comprehensive loss related to stock options and restricted stock units for employees and non-employees was as follows (in thousands):
| Three Months Ended September 30, |
| Nine Months Ended September 30, | |||||||||
2024 |
| 2023 | 2024 | 2023 | ||||||||
Stock options | $ | | $ | | $ | | $ | | ||||
Restricted stock units |
| |
| — |
| |
| — | ||||
Total stock-based compensation expense | $ | | $ | | $ | | $ | | ||||
Included in: | ||||||||||||
General and administrative expense | $ | | $ | | $ | | $ | | ||||
Research and development expense |
| |
| |
| |
| | ||||
Total stock-based compensation expense | $ | | $ | | $ | | $ | | ||||
Stock options
The Company grants stock options which consist of (i) time-based options, which vest and become exercisable, subject to the participant’s continued employment or service through the applicable vesting date and (ii) performance-based options, which vest based on performance measures against predetermined objectives that include successful completion of qualified equity offerings or announced
17
topline results for clinical trials and positive clinical results over a specified performance period. The Company’s time-based options have various vesting schedules that range from vesting immediately to vesting over a
The following table summarizes stock option activity for the nine months ended September 30, 2024 (in thousands, except share and per share data):
|
|
| Weighted- |
| ||||||
Number of | Average | |||||||||
Shares | Weighted- | Remaining | ||||||||
Underlying | Average | Contractual | Aggregate | |||||||
Outstanding | Exercise | Term | Intrinsic | |||||||
Options | Price | (in Years) | Value | |||||||
Outstanding, January 1, 2024 |
| | $ | |
| $ | | |||
Options granted |
| | |
|
| |||||
Options exercised | ( | | ||||||||
Options forfeited/expired |
| ( | |
|
| |||||
Outstanding, September 30, 2024 (1) |
| | $ | |
| $ | — | |||
Vested and exercisable as of September 30, 2024 |
| | $ | |
| $ | — | |||
____________
| (1) | Includes |
During the nine months ended September 30, 2024 and 2023, the weighted average grant-date fair value per share of stock options granted was $
As of September 30, 2024, there was $
Restricted stock units
The Company’s restricted stock units generally vest over a
The following table summarizes restricted stock unit activity:
Weighted-Average | |||||
| Restricted |
| Grant Date | ||
| Stock Units |
| Fair Value | ||
Outstanding, January 1, 2024 |
| | $ | | |
Granted |
| | | ||
Vested/released |
| ( | | ||
Forfeited/expired |
| ( | | ||
Outstanding, September 30, 2024 | | $ | | ||
As of September 30, 2024, the total unrecognized compensation expense related to unvested restricted stock units was $
18
Valuation assumptions
The fair value of each stock option granted was estimated on the date of grant using the Black-Scholes option pricing model using the following assumptions:
| Nine Months Ended September 30, | |||||
2024 | 2023 | |||||
Expected volatility |
| % | % | |||
Risk-free interest rate |
| % | % | |||
Dividend yield |
| |
| |
| |
Expected term (in years) |
| |||||
The expected term of the stock options represents the average of the contractual term of the options and the weighted-average expected vesting period. The risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant. The expected volatility rate was based on the historical volatilities of comparable companies in the Company’s industry. The Company has never declared or paid any cash dividends and does not presently plan to pay cash dividends in the foreseeable future. Consequently, the Company used an expected dividend yield of
Employee stock purchase plan
The 2023 Employee Stock Purchase Plan (the ESPP) was adopted by the board of directors in July 2023 with an initial total of
8. | Related Party Transactions |
Jinzi J. Wu, Ph.D., a member of the Company’s board of directors until June 2024, founded and serves as the chief executive officer of Ascletis, Gannex, and Ascletis Pharma.
During the nine months ended September 30, 2024 and 2023, the Company recognized $
19
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed financial statements and related notes included elsewhere in this Report on Form 10-Q for the quarter ended September 30, 2024 (Quarterly Report). This discussion and analysis and other parts of this Quarterly Report contain forward-looking statements based upon our current plans and expectations that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and beliefs. Our actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Risk Factors” and elsewhere in this Quarterly Report. You should carefully read the “Risk Factors” section of this Quarterly Report to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements.
Overview
We are a clinical-stage biopharmaceutical company developing novel therapeutics called fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Our lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH). Denifanstat has been studied in over 740 people to date in our clinical trials, including our Phase 2 FASCINATE-1 and Phase 2b FASINATE-2 clinical trials.
In January 2024, we announced positive topline results from the Phase 2b FASCINATE-2 clinical trial evaluating denifanstat in 168 biopsy-confirmed MASH patients with stage F2 or F3 fibrosis compared to placebo at week 52. The Phase 2b FASCINATE-2 clinical trial achieved statistically significant results on primary and multiple secondary endpoints at week 52 in MASH patients in the modified intention to treat (mITT) population, including:
| ● | The primary endpoints of ≥2-point reduction in NAS (NAFLD Activity Score) without worsening of fibrosis (denifanstat 52% vs. placebo 20%, p=0.0003), and MASH resolution without worsening of fibrosis with ≥2-point reduction in NAS (denifanstat 36% vs. placebo 13%, p=0.0044). |
| ● | Multiple secondary endpoints of fibrosis improvement by ≥ 1 stage with no worsening of MASH (denifanstat 41% vs. placebo 18%, p=0.0102), MASH resolution with no worsening of fibrosis (denifanstat 38% vs. placebo 16%, p=0.0043), and a greater proportion of MRI-derived proton density fat fraction (MRI-PDFF) ≥30% responders relative to placebo (denifanstat 65% vs. placebo 21%, p<0.0001). MRI-PDFF responders are patients with ≥8% liver fat content at baseline who achieve a ≥30% relative reduction of liver fat at the end of treatment. |
Denifanstat showed also statistical significance in fibrosis improvement as measured by an artificial intelligence (AI) digital pathology-based qFibrosis assessment. Additionally, our precision medicine approach is core to our development strategy in MASH and includes the identification of pharmacodynamic and predictive biomarkers to confirm target engagement and clinical response in patients treated with denifanstat.
In June 2024, we presented positive data from the Phase 2b FASCINATE-2 clinical trial of denifanstat versus placebo in biopsy-confirmed MASH patients at the European Association for the Study of the Liver (EASL) Congress. Our EASL presentation included the following 52-week data from the intention to treat (ITT), mITT, and F3 mITT patient populations:
| • | The primary endpoint of ≥2-point reduction in NAS (NAFLD Activity Score) without worsening of fibrosis (denifanstat 38% vs. placebo 16%, p=0.0035) or MASH resolution with ≥2-point reduction in NAS without worsening of fibrosis (denifanstat 26% vs. placebo 11%, p=0.0173) in the ITT population. |
| • | Secondary endpoints of fibrosis improvement by ≥ 1 stage with no worsening of MASH in the ITT (denifanstat 30% vs. placebo 14%, p=0.040) and F3 mITT (denifanstat 49% vs. placebo 13%, p=0.0032) populations. |
| • | Fibrosis improvement by ≥ 2 stages with no worsening of MASH in the mITT (denifanstat 20% vs. placebo 2%, p=0.0065) and F3 mITT (denifanstat 34% vs. placebo 4%, p=0.0065) populations. |
20
| • | A statistically significant difference in progression to cirrhosis (F4) in mITT population (denifanstat 5% vs. placebo 11%, p=0.0386). |
| • | A statistically significant difference in fibrosis improvement by ≥ 1 stage with no worsening of MASH for patients on a stable background dose of a GLP-1RA (denifanstat 42% vs. placebo 0%, p=0.034) in the mITT population. |
| • | A statistically significant increase in beneficial polyunsaturated triglycerides at the end of 52 week of treatment (+42% denifanstat vs. -4% placebo, p<0.001) in the mITT population. |
| • | A biomarker of denifanstat activity (tripalmitin) showed an early and sustained reduction in de novo lipogenesis at 4-weeks (-2.4ug/ml with denifanstat vs. -0.4ug/mL placebo, p=0.001) and 13-weeks (-2.2ug/mL with denifanstat vs. -0.1ug/mL placebo, p=0.005) in the ITT population. |
In October 2024, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to denifanstat for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Treatments that receive Breakthrough Therapy designation must target a serious or life-threatening disease and preliminary clinical evidence must indicate that the drug may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints. Breakthrough Therapy designation of denifanstat was supported by positive data from the Phase 2b FASCINATE-2 clinical trial in biopsy-confirmed MASH patients with stage 2 or stage 3 fibrosis.
In October 2024, we completed successful end-of-Phase 2 interactions with the FDA, supporting the advancement of denifanstat into Phase 3 in MASH. Based on our ongoing discussions with the FDA, the phase 3 program will consist of two double-blind, placebo-controlled multicenter registrational trials:
| • | FASCINATE-3 in patients with F2/F3 (non-cirrhotic) MASH: The trial is expected to evaluate the efficacy and safety of denifanstat in this population, with primary endpoints being liver biopsy assessments at 52 weeks, at which time Sagimet plans to seek accelerated approval in the U.S. and Europe. The trial will continue until such point in time that the required number of clinical outcomes is reached, which we estimate at 3.5 years. |
| • | FASCINIT in patients with suspected or confirmed diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD)/MASH: The trial is expected to evaluate the efficacy and safety of denifanstat in this population, with primary endpoints being safety and tolerability at 52 weeks. Non-invasive biomarkers will be assessed as part of the secondary endpoints, with no liver biopsy endpoint. |
The Phase 3 program is designed to comprise a minimum of 1,800 patients exposed to denifanstat and is expected to initiate by the end of 2024.
We are also evaluating the promise of FASN inhibition, beyond MASH, in additional disease areas in which dysregulation of fatty acid metabolism also plays a key role, including in acne and certain forms of cancer. Denifanstat is currently being tested in China by our license partner, Ascletis BioScience Co. Ltd. (Ascletis), a subsidiary of Ascletis Pharma Inc. (Ascletis Pharma), in a Phase 3 clinical trial for moderate to severe acne vulgaris and a Phase 3 clinical trial in recurrent glioblastoma multiforme (GBM) in combination with bevacizumab. In November 2024, Ascletis announced completion of enrollment of 480 patients in the acne Phase 3 clinical trial and that it expects to announce topline results in the second quarter of 2025. We expect these results to inform our development strategy in these indications. We have completed Investigational New Drug (IND)-enabling studies for a second FASN inhibitor, TVB-3567.
21
Components of results of operations
License revenue
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from product sales for the foreseeable future. Our revenues to date have been generated solely from the license agreement with Ascletis. We expect that our revenue for the next several years will be derived primarily from this agreement and any additional collaboration into which we may enter.
Research and development expenses
Research and development expenses represent costs incurred in performing research, development and manufacturing activities in support of our own product development efforts and include personnel-related costs (such as salaries, employee benefits and stock-based compensation) for our personnel in research and development functions; costs related to acquiring, developing and manufacturing supplies for preclinical studies, clinical trials and other studies, including fees paid to contract manufacturing organizations (CMOs); costs and expenses related to agreements with contract research organizations (CROs), investigative sites and consultants to conduct non-clinical and preclinical studies and clinical trials; professional and consulting services costs; and facility and other allocated costs.
All research and development expenses are charged to operations as incurred in accordance with Accounting Standards Codification 730, Research and Development. We account for non-refundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received, rather than when the payment is made.
We expect our research and development expenses to increase substantially for the foreseeable future as we advance our drug candidates into and through preclinical studies and clinical trials, pursue regulatory approval and expand our pipeline.
General and administrative expenses
Our general and administrative expenses consist primarily of costs and expenses related to: personnel (including salaries, employee benefits and stock-based compensation) in our executive, finance and accounting and other administrative functions; legal services, including relating to intellectual property and corporate matters; accounting, auditing, consulting and tax services; insurance; information technology; and facility and other allocated costs not otherwise included in research and development expenses.
We expect our general and administrative expenses to increase substantially for the foreseeable future as we increase our headcount and continue to grow our corporate infrastructure. We also anticipate that we will incur increased expenses as a result of operating as a public company, including expenses related to audit, legal and tax-related services associated with maintaining compliance with Securities and Exchange Commission (SEC) rules and regulations and those of any national securities exchange on which our securities are traded, additional insurance expenses, investor relations activities and other administrative and professional services.
Other income
Other income consists primarily of interest income earned on our cash, cash equivalents and marketable securities offset by accretion of discounts to maturity on our marketable securities.
22
Results of operations
Comparison of the three months ended September 30, 2024 and 2023
The following table summarizes our results of operations for the periods indicated (in thousands):
Three Months Ended |
| |||||||||||
September 30, |
| |||||||||||
| 2024 |
| 2023 |
| $ Change |
| % Change |
| ||||
License revenue | $ | — | $ | 2,000 | $ | (2,000) | (100) | % | ||||
Operating expenses: | ||||||||||||
Research and development | 12,653 | 4,958 | 7,695 |
| 155 | % | ||||||
General and administrative |
| 4,249 |
| 4,494 |
| (245) |
| (5) | % | |||
Total operating expenses |
| 16,902 |
| 9,452 |
| 7,450 |
| 79 | % | |||
Loss from operations |
| (16,902) |
| (7,452) |
| (9,450) |
| 127 | % | |||
Total other income |
| 2,283 |
| 1,099 |
| 1,184 |
| nm | ||||
Net loss | $ | (14,619) | $ | (6,353) | $ | (8,266) |
| 130 | % | |||
nm—not meaningful
License revenue – License revenue for the three months ended September 30, 2023 was $2.0 million, recognized from the license agreement with Ascletis. We did not recognize any license revenue during the three months ended September 30, 2024.
Research and development – Research and development expense increased by $7.7 million, or 155%, for the three months ended September 30, 2024, compared to the three months ended September 30, 2023. This increase was primarily due to (i) a $5.5 million net increase in clinical trial expenses related primarily to start-up costs incurred for our Phase 3 program of denifanstat in MASH, which was partially offset by lower clinical trial expenses for the Phase 2b FASCINATE-2 trial as the trial was substantially complete in the first quarter of 2024 and topline results for the trial were announced in January 2024, (ii) a $1.3 million increase in manufacturing costs for clinical batches of denifanstat in preparation for the Phase 3 clinical development program, and (iii) a $0.9 million increase in other non-clinical study costs for denifanstat.
General and administrative – General and administrative expenses decreased by $0.2 million, or 5%, for the three months ended September 30, 2024, compared to the three months ended September 30, 2023 primarily due to (i) a $0.3 million decrease in stock-based compensation expense and (ii) a $0.2 million decrease in tax expense recognized in conjunction with the development milestone received from Ascletis under the Ascletis license agreement in July 2023. This decrease in general and administrative expenses was partially offset by a $0.3 million increase in professional fees largely due to public company compliance activities.
Other income – Other income increased by $1.2 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023, primarily due to an increase of interest income earned on the cash proceeds received from our initial public offering (IPO) and the January 2024 follow-on offering.
23
Comparison of the nine months ended September 30, 2024 and 2023
The following table summarizes our results of operations for the periods indicated (in thousands):
Nine Months Ended |
| |||||||||||
September 30, |
| |||||||||||
| 2024 |
| 2023 |
| $ Change |
| % Change |
| ||||
License revenue | $ | — | $ | 2,000 | $ | (2,000) | (100) | % | ||||
Operating expenses: | ||||||||||||
Research and development | 24,228 | 14,121 | 10,107 |
| 72 | % | ||||||
General and administrative |
| 12,031 |
| 9,153 |
| 2,878 |
| 31 | % | |||
Total operating expenses |
| 36,259 |
| 23,274 |
| 12,985 |
| 56 | % | |||
Loss from operations |
| (36,259) |
| (21,274) |
| (14,985) |
| 70 | % | |||
Total other income |
| 6,893 |
| 1,549 |
| 5,344 |
| nm | ||||
Net loss | $ | (29,366) | $ | (19,725) | $ | (9,641) |
| 49 | % | |||
nm—not meaningful
License revenue – License revenue for the nine months ended September 30, 2023 was $2.0 million, recognized from the license agreement with Ascletis. We did not recognize any license revenue during the nine months ended September 30, 2024.
Research and development – Research and development expense increased by $10.1 million, or 72%, for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023. This increase was primarily due to (i) a $4.5 million increase in manufacturing costs for clinical batches of denifanstat in preparation for the Phase 3 clinical development program, (ii) a $3.8 million net increase in clinical trial expenses primarily related to start-up costs incurred for our Phase 3 program of denifanstat in MASH, which was partially offset by lower clinical trial expenses for the Phase 2b FASCINATE-2 trial as the trial was substantially complete in the first quarter of 2024 and topline results for the trial were announced in January 2024, and (iii) a $1.5 million increase in other non-clinical study costs for denifanstat.
General and administrative – General and administrative expenses increased by $2.9 million, or 31%, for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023 primarily due to (i) a $1.7 million increase in professional fees, largely due to public company compliance, (ii) a $0.4 million increase in personnel related expenses, largely driven by an increase in headcount, and (iii) a $0.5 million increase in insurance expenses due to our transition to a public company in 2023.
Other income – Other income increased by $5.3 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023, primarily due to an increase of interest income earned on the cash proceeds received from our IPO and the January 2024 follow-on offering.
Liquidity and capital resources
Sources and uses of cash
Since our inception, we have devoted substantially all of our resources to researching, discovering and developing our pipeline of proprietary FASN inhibitors and other drug targets, organizing and staffing our company, performing business planning, establishing our intellectual property portfolio, raising capital and general and administration activities to support and expand such activities. We do not have any products approved for sale and have not generated any revenue from product sales. Our revenues to date have been generated solely from the license agreement with Ascletis.
To date, we have financed our operations primarily through public and private equity and debt financings, including our IPO of Series A common stock in July 2023 and our follow-on offering in January 2024, from which we received aggregate net proceeds of $190.9 million. Prior to these public offerings, we raised $233.3 million in gross proceeds from the sale of our redeemable convertible preferred stock and convertible notes.
24
In August 2024, we entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. to establish an at-the-market offering (ATM Offering) through which we may sell, from time to time at our sole discretion up to $75.0 million of shares of our Series A common stock. There were no sales under the ATM Offering during the three and nine months ended September 30, 2024.
As of September 30, 2024, we had cash, cash equivalents and marketable securities of $170.0 million. We do not expect to generate any revenue from commercial product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our drug candidates, which we expect will take a number of years, if ever. We anticipate that we will continue to incur significant expenses for the foreseeable future as we continue to advance our drug candidates through preclinical and clinical trials; manufacture supplies for our preclinical studies and clinical trials; expand our corporate infrastructure, including the costs associated with being a public company; pursue regulatory approval of our drug candidates; hire additional personnel; acquire, discover, validate and develop additional drug candidates; and obtain maintain, expand and protect our intellectual property portfolio.
Until we can generate a sufficient amount of revenue from the commercialization of our drug candidates or additional revenue from collaboration agreements with third parties, if ever, we expect to finance our future cash needs through public or private equity or debt financings, third-party funding and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches. The sale of equity or convertible debt securities may result in dilution to our stockholders and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. Debt financings may subject us to covenant limitations or restrictions on our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Our ability to raise additional funds may be adversely impacted by macroeconomic conditions, disruptions to and volatility in the credit and financial markets and geopolitical turmoil. There can be no assurance that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable or acceptable to us. If we are unable to obtain adequate financing when needed or on terms favorable or acceptable to us, we may be forced to delay, reduce the scope of or eliminate one or more of our research and development programs.
Our future capital requirements will depend on many factors, including:
| ● | difficulties obtaining regulatory approval to commence a clinical trial or complying with conditions imposed by a regulatory authority regarding the scope or term of a clinical trial; |
| ● | conditions imposed on us by the FDA or other regulatory authorities regarding the scope or design of our clinical trials; |
| ● | delays in reaching or failing to reach agreement on acceptable terms with prospective CROs, CMOs, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly; |
| ● | insufficient supply of our drug candidates or other materials necessary to conduct and complete our clinical trials; |
| ● | difficulties obtaining institutional review board (IRB) or ethics committee approval to conduct a clinical trial at a prospective site; |
| ● | slow enrollment and retention rate of subjects in our clinical trials; |
| ● | the FDA or other regulatory authority requiring alterations to any of our study designs, our preclinical strategy or our manufacturing plans; |
| ● | governmental or regulatory delays and changes in regulatory requirements, policy and guidelines; serious and unexpected drug-related side effects related to the drug candidate being tested; |
| ● | lack of adequate funding to continue clinical trials; |
| ● | subjects experiencing severe or unexpected drug-related adverse effects; |
25
| ● | occurrence of severe adverse effects in clinical trials of the same class of agents conducted by other companies; |
| ● | any changes to our manufacturing process, suppliers or formulation that may be necessary or desired; |
| ● | third-party vendors not performing manufacturing and distribution services in a timely manner or to sufficient quality standards; |
| ● | third-party clinical investigators losing the licenses or permits necessary to perform our clinical trials, not performing our clinical trials on our anticipated schedule or consistent with the clinical trial protocol, good clinical practice (GCP), or other regulatory requirements; |
| ● | third-party contractors not performing data collection or analysis in a timely or accurate manner; |
| ● | third-party contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all of the data produced by such contractors in support of our marketing applications; and |
| ● | failure of our third-party contractors, such as CROs and CMOs, or our investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner. |
A change in the outcome of any of these or other variables could significantly change our costs and timing associated with the development of our drug candidates. Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such change.
We rely and will continue to rely on third parties in the conduct of our preclinical studies and clinical trials and for manufacturing and supply of our drug candidates. We have no internal manufacturing capabilities, and we will continue to rely on third parties for our preclinical study and clinical trial materials. Given our stage of development, we do not yet have a marketing or sales organization or commercial infrastructure. Accordingly, if we obtain regulatory approval for any of our drug candidates, we also expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.
We enter into contracts in the normal course of business for products and services, including contract research and contract manufacturing services, which include provisions allowing for termination under certain conditions and timelines. These contracts generally do not include payments for early termination and are considered cancellable contracts.
Based on our current business plans, we believe that our existing cash, cash equivalents, and marketable securities as of September 30, 2024, will be sufficient for us to fund our operating expenses for at least the next 12 months from the issuance of this Quarterly Report.
Cash flows
The following table shows a summary of our cash flows for each of the periods presented below (in thousands):
Nine Months Ended September 30, | ||||||
| 2024 |
| 2023 | |||
Net cash (used in) provided by: |
|
|
|
| ||
Operating activities | $ | (31,411) | $ | (16,683) | ||
Investing activities |
| (71,533) |
| 32,200 | ||
Financing activities |
| 104,819 |
| 86,167 | ||
Net increase in cash and cash equivalents | $ | 1,875 | $ | 101,684 | ||
Cash flows from operating activities. Net cash used in operating activities was $31.4 million for the nine months ended September 30, 2024, and primarily related to cash used to fund clinical development, manufacturing and other non-clinical activities for denifanstat, inclusive of clinical-batch manufacturing and other trial start-up costs for our Phase 3 program of denifanstat in MASH, as well as costs to build out our corporate infrastructure and costs associated with being a public company.
26
Net cash used in operating activities was $16.7 million for the nine months ended September 30, 2023 and primarily related to cash used to fund clinical development and other pre-clinical activities for denifanstat, primarily relating to the Phase 2b FASCINATE-2 trial for which topline results were announced in January 2024, as well as other costs to support our corporate infrastructure. Cash expenses were offset by the net $1.7 million development milestone received from Ascletis in connection with the Ascletis license agreement during the nine months ended September 30, 2023.
Cash flows from investing activities - Net cash used in investing activities was $71.5 million for the nine months ended September 30, 2024 and related to purchases of marketable securities of $94.3 million, partially offset by proceeds received from the sale and maturity of marketable securities of $22.8 million.
Net cash provided by investing activities was $32.2 million for the nine months ended September 30, 2023, which related solely to proceeds received from sales of marketable securities.
Cash flows from financing activities - Net cash provided by financing activities was $104.8 million for the nine months ended September 30, 2024, which primarily related to net cash proceeds of $105.7 million received from the sale of Series A common stock in our January 2024 follow-on offering and $0.1 million in proceeds from stock option exercises during the period, offset by the payment of financing costs related to the January 2024 follow-on offering of $1.0 million.
Net cash provided by financing activities was $86.2 million for the nine months ended September 30, 2023, which related primarily to the proceeds received from our IPO, net of underwriters' commissions and discounts.
Critical accounting policies and estimates
We prepare our financial statements in accordance with accounting principles generally accepted in the United States of America. The preparation of financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, costs and expenses and related disclosures. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ significantly from the estimates made and changes in estimates may occur.
During the nine months ended September 30, 2024, there were no material changes to our critical accounting estimates or in the methodology used for estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2023.
Emerging growth company and smaller reporting status
We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act (the JOBS Act). Under the JOBS Act, emerging growth companies can delay the adoption of new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. Other exemptions and reduced reporting requirements under the JOBS Act for emerging growth companies include an exemption from the requirement to provide an auditor’s report on internal controls over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, as amended, an exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation and less extensive disclosure about our executive compensation arrangements. We have elected to use the extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that (i) we are no longer an emerging growth company or (ii) we affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.
We will remain an emerging growth company until the earliest of (i) the last day of our first fiscal year in which we have total annual gross revenues of $1.235 billion or more, (ii) December 31, 2028, (iii) the date on which we are deemed to be a large accelerated filer, under the rules of the SEC, which means the market value of equity securities that is held by non-affiliates exceeds $700.0 million as of the prior June 30th and (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.
27
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Recently adopted accounting pronouncements
See Note 2. Significant Accounting Policies, included in our unaudited interim financial statements in Item 1 of this Quarterly Report for more information.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information under this item.
Item 4. Controls and Procedures
Disclosure controls and procedures
We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, (Exchange Act), that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of the end of the period covered by this Quarterly Report. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that as of September 30, 2024, our disclosure controls and procedures were effective to provide reasonable assurance that the information required to be disclosed by us in this Quarterly Report was (a) reported within the time periods specified by the SEC rules and regulations, and (b) communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding any required disclosure.
Changes in internal control over financial reporting
During the quarter ended September 30, 2024, there have been no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15(d)-15(f) promulgated under the Exchange Act, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Our management believes that there are currently no claims or actions pending against us, the ultimate disposition of which would have a material adverse effect on our results of operations, financial condition or cash flows, nor are we aware of any governmental proceedings involving potential monetary sanctions.
28
Item 1A. Risk Factors
Our business is subject to substantial risks and uncertainties. You should carefully consider the information contained in this Quarterly Report on Form 10-Q, the risks and uncertainties described below, and the risk factors and other information contained in our other public filings in evaluating our business, including our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 25, 2024.
Although we have received Breakthrough Therapy designation for denifanstat, this may not lead to a faster development, regulatory review or approval process, and it does not increase the likelihood of receiving marketing approval in the United States.
In October 2024, the FDA granted Breakthrough Therapy designation to denifanstat for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). A Breakthrough Therapy is defined as a therapy that is intended, alone or in combination with one or more other therapies, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For therapies that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Therapies designated as breakthrough therapies by the FDA may also be eligible for priority review and accelerated approval.
The Breakthrough Therapy designation we have obtained for denifanstat may not result in faster development processes, reviews or approvals compared to therapies considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, the FDA may later decide that our denifanstat development program no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. In addition, the FDA may later decide that denifanstat no longer meets the conditions for qualification.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Recent sales of unregistered equity securities
There were no unregistered sales of equity securities during the period covered by this quarterly report on Form 10-Q.
Use of proceeds from initial public offering of common stock
On July 18, 2023, we completed our IPO. Our registration statement on Form S-1 (File No. 333-256648) relating to the IPO was declared effective by the SEC on July 13, 2023. We issued an aggregate of 5,312,500 shares of our Series A common stock at a price of $16.00 per share. The aggregate gross proceeds of the IPO were $96.4 million, inclusive of an additional 714,272 shares of Series A common stock sold upon the partial exercise of the underwriters' purchase option. We received approximately $86.2 million in net proceeds after deducting approximately $6.7 million in underwriting discounts and commissions and approximately $3.5 million in other offering costs. None of the expenses associated with the IPO were paid to directors, officers, persons owning 10% or more of any class of equity securities, or to their associates, or to our affiliates. Goldman Sachs & Co., Cowen and Company and Piper Sandler & Co. acted as joint book-running managers for the IPO, and JMP Securities acted as lead manager.
There has been no material change in our planned use of the net proceeds from the IPO as described in our final prospectus filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on July 17, 2023.
Issuer purchases of equity securities
None.
Item 3. Defaults Upon Senior Securities
Not applicable.
29
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Rule 10b5-1 trading plans
During the quarter ended September 30, 2024, none of our directors or officers (as defined in Rule 16a-1 under the Exchange Act)
30
Item 6. Exhibits
Exhibit |
| Description |
| Method of Filing |
10.1 |
| Incorporated by reference to Exhibit 1.2 to the Company’s Registration Statement on Form S-3 filed on August 15, 2024 (File No. 001-281582) | ||
31.1 | Filed herewith | |||
31.2 | Filed herewith | |||
32.1 | Furnished herewith | |||
101.INS | Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document | Filed herewith | ||
101.SCH | Inline XBRL Taxonomy Extension Schema Document | Filed herewith | ||
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | Filed herewith | ||
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | Filed herewith | ||
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | Filed herewith | ||
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | Filed herewith | ||
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | Filed herewith |
31
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Quarterly Report to be signed on its behalf by the undersigned, thereunto duly authorized.
SAGIMET BIOSCIENCES, INC. | ||
Date: November 14, 2024 | By: | /s/ David Happel |
David Happel | ||
President and Chief Executive Officer | ||
(Principal Executive Officer) | ||
Date: November 14, 2024 | By: | /s/ Thierry Chauche |
Thierry Chauche | ||
Chief Financial Officer | ||
(Principal Financial and Accounting Officer) | ||
32