美国
证券交易委员会
华盛顿特区20549
表格
(标记一个)
根据1934年证券交易法第13或15(d)条款的季度报告。 |
截至2024年6月30日季度结束
或
根据1934年证券交易法第13或15(d)条款的过渡报告 |
过渡期间为从＿＿＿＿＿至＿＿＿＿＿
委员会档案编号：
（依凭章程所载的完整登记名称）
(依据所在地或其他管辖区) 的注册地或组织地点) |
(国税局雇主识别号码) |
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(总部办公地址) |
（邮政编码） |
注册人的电话号码，包括区号：(
根据法案第12(b)条规定注册的证券：
每种类别的名称 |
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交易 标的 |
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每个注册交易所的名称 |
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请在核对标记上打勾，确认申报人（1）已在前12个月（或申报人被要求提交此类申报的缩短期间）内提交证券交易所法案第13条或第15(d)条要求申报的所有报告，以及（2）过去90天一直处于此类申报要求的范围内。
请打勾表明申报人在过去的12个月（或申报人需在该较短期间内提交这些档案）中已根据《对S-t法规（本章节第232.405条）的规定405条》提交了所有必须提交的交互式资料档案。
勾选表示登记人是大型加速申报人、加速申报人、非加速申报人、较小型申报公司或新兴成长公司。详细定义请参阅《交易所法》第1202条中“大型加速申报人”、“加速申报人”、“较小型申报公司”和“新兴成长公司”的定义。
大型加速归档人 |
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加速归档人 |
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小型报告公司 |
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新兴成长型企业 |
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如果一家新兴成长型公司，请用勾选标记表示该申报人已选择不使用根据证交所法案13(a)条款提供的任何新的或修订过的财务会计准则的延长过渡期。
请勾选是否为外壳公司 (依照交易所法规定定义的外壳公司条款120亿2)。是 ☐ 否
截至2024年11月4日，登记人士持有 61,436,740股普通股，每股0.0001美元，已发行。
关于前瞻性陈述的特别注意事项
本季度报告10-Q表格，或称本季度报告，包含根据1933年证券法第27A条修正条款，即证券法，和根据1934年证券交易法第21E条修正条款，即交易法，所作的前瞻性陈述。本季度报告中除了历史事实陈述之外的所有陈述均为前瞻性陈述。在某些情况下，您可以通过“可能”、“将”、“应该”、“期望”、“打算”、“计划”、“预期”、“相信”、“估计”、“预测”、“潜在”、“持续”或这些术语的否定形式或其他可比术语来识别前瞻性陈述。这些陈述不是对未来业绩或绩效的保证，涉及重大风险和不确定性。本季度报告中的前瞻性陈述包括但不限于关于：
i
本季度报告中的任何前瞻性声明都反映了我们对未来事件和未来财务业绩的当前看法，并涉及已知和未知风险、不确定性和其他因素，这些因素可能导致我们的实际结果、业绩或成就与这些前瞻性声明所暗示的任何未来结果、业绩或成就存在实质性差异。可能导致实际结果与当前预期大相径庭的因素包括，但不限于，本季度报告中在第二部分第1A项“风险因素”和其他地方所描述的内容。鉴于这些不确定性，您不应过分依赖这些前瞻性声明。
所有声明仅适用于本季度报告的日期。在每种情况下，实际结果可能会大不同于这些前瞻性信息。我们无法保证这些期望或前瞻性声明会被证明是正确的。本季度报告中提到的风险因素或风险和不确定性之一发生或发生任何重大不利变化，或者包含在其他公开披露或我们的其他定期报告或其他文件或提交的文件中，这可能会对我们的业务、前景、财务状况和经营成果造成重大不利影响。除法律要求外，我们不打算或计划更新或修订任何此类前瞻性声明，以反映实际结果、计划变更、假设、估计或投影或其他影响此类前瞻性声明的情况，即使在本季度报告日期之后发生新信息或此类结果、变化或情况表明任何前瞻性信息将不会实现。我们在本季度报告之后公开的任何声明或披露，修改或影响本季度报告中包含的任何前瞻性声明，将被视为修改或取代本季度报告中的这些声明。
我们可能不时提供关于我们行业、一般业务环境以及某些疾病市场的估计、预测和其他信息，包括有关这些市场潜在规模、特定医疗状况的患病率和流行率的估计。基于估计、预测、投影、市场调研或类似方法的信息固有地存在不确定性，实际事件、情况或数据，包括实际疾病流行率和市场规模，可能与季度报告中反映的信息有实质上差异。除非另有明确说明，我们获取这些行业、业务信息、市场数据、流行信息和其他数据是从市场调研公司和其他第三方、行业、医学和普通出版物、政府数据以及类似来源的报告、研究、调查和类似数据中获得的，在某些情况下应用我们自身的假设和分析，这些假设和分析在未来可能不准确。
商标
出于方便起见，在本报告中，我们的商标和商业名称有时会被称为没有®和™符号，但这些提及不应被理解为我们不会在适用法律下全力主张我们对其的权利的任何指示。
ii
目录
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页面 |
第一部分 |
1 |
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第 1 项。 |
1 |
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1 |
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2 |
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3 |
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5 |
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6 |
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第 2 项。 |
16 |
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第 3 项。 |
26 |
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第 4 项。 |
26 |
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第二部分。 |
27 |
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第 1 项。 |
27 |
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第 1A 项。 |
27 |
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第 2 项。 |
29 |
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第 3 项。 |
29 |
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第 4 项。 |
29 |
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第 5 项 |
29 |
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第 6 项。 |
30 |
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31 |
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iii
Pa第一部分 ─ 财务信息
项目1 控件m 1. 基本报表
Monte Rosa Therapeutics, Inc.
简明综合资产负债表资产负债表（未经审计）
(以千为单位，除每股数据外) |
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9月30日, |
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12月31日, |
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(未经审计) |
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2024 |
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2023 |
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资产 |
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流动资产： |
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现金及现金等价物 |
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$ |
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$ |
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有价证券 |
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其他应收款 |
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预付费用和其他流动资产 |
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总流动资产 |
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资产和设备，净值 |
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经营租赁权使用资产 |
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受限现金 |
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其他长期资产 |
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资产总额 |
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$ |
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$ |
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负债和股东权益 |
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流动负债: |
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应付账款 |
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$ |
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$ |
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应计费用及其他流动负债 |
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短期递延收入 |
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经营租赁负债流动部分 |
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流动负债合计 |
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递延收入，净额 |
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责任计划负债 |
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运营租赁负债净值 |
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负债合计 |
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股东权益 |
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优先股，$0.0001 |
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普通股，每股面值为 $0.0001； |
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额外实收资本 |
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累计其他综合损失 |
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( |
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( |
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累积赤字 |
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( |
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( |
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股东权益总额 |
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负债和股东权益总额 |
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$ |
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$ |
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请参见简明合并财务报表的附注。
1
Monte Rosa Therapeutics, Inc.
经调整的综合经营状况陈述经营状况及全面亏损的简明综述（未经审计）
(以千为单位，除每股数据外) |
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三个月结束 |
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截至九个月结束 |
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(未经审计) |
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2024 |
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2023 |
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2024 |
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2023 |
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合作收入 |
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$ |
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$ |
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$ |
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$ |
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营业费用： |
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研发 |
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一般行政 |
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营业费用总计 |
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经营亏损 |
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( |
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( |
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( |
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( |
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其他收入（支出）： |
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利息收入 |
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净外汇收益（损失） |
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( |
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( |
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固定资产处置收益 |
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可交易证券出售亏损 |
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总其他收入 |
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税前净亏损 |
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( |
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( |
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( |
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( |
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所得税费用 |
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( |
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( |
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( |
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( |
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净损失 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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每股基本和摊薄净亏损 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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用于计算的加权平均股本数 |
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综合亏损： |
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净损失 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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其他综合收益: |
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养老金福利义务准备 |
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可供出售证券未实现收益 |
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综合损失 |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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请参见简明合并财务报表的附注。
2
Monte Rosa Therapeutics, Inc.
压缩的综合股东权益财务报表 股东权益(未经审计)
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（以千为单位，除股份数量外） |
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股份 |
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金额 |
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额外的 |
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累积的 |
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累积的 |
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总计 |
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2024年1月1日余额 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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受限普通股解锁 |
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— |
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— |
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— |
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— |
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— |
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行使普通股期权 |
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— |
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— |
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— |
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养老金福利义务准备 |
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— |
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— |
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— |
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— |
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股票补偿费用 |
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— |
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— |
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— |
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— |
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可供出售证券的未实现损失 |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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根据市场销售协议发行普通股 |
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— |
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— |
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— |
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净亏损 |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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2024年3月31日的资产负债表 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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受限普通股解禁 |
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— |
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— |
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— |
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— |
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— |
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行使普通股期权 |
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— |
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— |
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— |
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养老金福利义务准备 |
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— |
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— |
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— |
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— |
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股票补偿费用 |
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— |
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— |
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— |
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— |
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可供出售证券的未实现损失 |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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员工股票购买计划下的股票发行 |
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— |
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— |
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— |
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根据现行市场销售协议发行普通股，扣除发行成本$89 |
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— |
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— |
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— |
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根据承销公开发行协议发行普通股，扣除发行成本$3,290 |
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— |
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— |
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发行预先融资认股权证，减去发行成本$290 |
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— |
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— |
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— |
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— |
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净亏损 |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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2024年6月30日结余 |
|
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
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受限制的普通股解除限制 |
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— |
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— |
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— |
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— |
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— |
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行使普通股期权 |
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— |
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— |
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— |
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养老金福利义务准备 |
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— |
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— |
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— |
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— |
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股票补偿费用 |
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— |
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— |
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— |
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— |
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可供出售证券未实现收益 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
净亏损 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
余额-2024年9月30日 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
请参见附注的精简合并财务报表
3
Monte Rosa Therapeutics, Inc.
股东权益简明综合报表（未经审计）- 续
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
（以千为单位，除股份数量外） |
|
股份 |
|
|
金额 |
|
|
额外的 |
|
|
累积的 |
|
|
累积的 |
|
|
总计 |
|
||||||
余额-2023年1月1日 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
受限普通股解禁 |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
行使普通股期权 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
养老金福利义务准备 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
股票补偿费用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
可供出售证券未实现收益 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
净亏损 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
截至2023年3月31日余额 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
限制性普通股份解禁 |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
行使普通股期权 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
养老金福利义务准备 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
股票补偿费用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
可供出售证券的未实现损失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
员工股票购买计划下的股票发行 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
净亏损 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
余额—2023年6月30日 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
受限普通股解禁 |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
行使普通股期权 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
养老金福利义务准备 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
股票补偿费用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
可供出售证券的未实现损失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
净亏损 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
2023年9月30日余额 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
请参见附注的精简合并财务报表
4
Monte Rosa Therapeutics, Inc.
压缩综合现金流量表现金流量表（未经审计）
（以千为单位） |
|
九个月结束 |
|
|||||
(未经审计) |
|
2024 |
|
|
2023 |
|
||
经营活动现金流量： |
|
|
|
|
|
|
||
净损失 |
|
$ |
( |
) |
|
$ |
( |
) |
调整净亏损为经营活动使用的现金净额 |
|
|
|
|
|
|
||
股票补偿费用 |
|
|
|
|
|
|
||
折旧 |
|
|
|
|
|
|
||
可交易证券折现/溢价的净增值 |
|
|
( |
) |
|
|
( |
) |
可交易证券出售亏损 |
|
|
|
|
|
|
||
处置固定资产收益 |
|
|
|
|
|
( |
) |
|
营运资产和负债的变化 |
|
|
|
|
|
|
||
其他应收款 |
|
|
( |
) |
|
|
|
|
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 |
|
|
|
|
|
|
||
责任计划负债 |
|
|
|
|
|
( |
) |
|
租赁资产和租赁负债 |
|
|
( |
) |
|
|
|
|
递延收入 |
|
|
( |
) |
|
|
|
|
经营活动使用的净现金流量 |
|
$ |
( |
) |
|
$ |
( |
) |
投资活动现金流量： |
|
|
|
|
|
|
||
购买固定资产 |
|
|
( |
) |
|
|
( |
) |
固定资产出售的收益 |
|
|
|
|
|
|
||
购买有市场流通的证券 |
|
|
( |
) |
|
|
( |
) |
出售有市场流通的证券收益 |
|
|
|
|
|
|
||
可市场出售证券到期款 |
|
|
|
|
|
|
||
投资活动产生的净现金流量 |
|
$ |
( |
) |
|
$ |
|
|
筹集资金的现金流量： |
|
|
|
|
|
|
||
根据市场销售协议出售普通股所得款项，扣除承销商折让$ |
|
|
|
|
|
|
||
承销的公开发行成本款项，扣除承销商折让$ |
|
|
|
|
|
|
||
发行预资助认股证所得款项 |
|
|
|
|
|
|
||
支付普通股和预购权证发行成本 |
|
|
( |
) |
|
|
|
|
行使员工期权收到的款项 |
|
|
|
|
|
|
||
员工股票购买计划收入 |
|
|
|
|
|
|
||
筹资活动产生的现金净额 |
|
$ |
|
|
$ |
|
||
现金，现金等价物和受限现金净增加（减少） |
|
$ |
( |
) |
|
$ |
|
|
资金现金及受限现金期初余额 |
|
|
|
|
|
|
||
资金现金及受限现金期末余额 |
|
$ |
|
|
$ |
|
||
现金、现金等价物和受限制的现金的调节 |
|
|
|
|
|
|
||
现金及现金等价物 |
|
$ |
|
|
$ |
|
||
受限现金 |
|
|
|
|
|
|
||
现金、现金等价物和受限制的现金总额 |
|
$ |
|
|
$ |
|
||
非现金项目的补充披露 |
|
|
|
|
|
|
||
减少租赁激励应收款项的使用权资产 |
|
$ |
|
|
$ |
|
||
应付账款及应计费用中的软件开发成本 |
|
$ |
|
|
$ |
|
||
请参见简明合并财务报表的附注。
5
Monte Rosa Therapeutics, Inc.
No适用于压缩综合财务报表
(未经审计)
1. 业务和流动性描述
按照我们所处的风险和不确定性的假设，结果和在本招股书或在任何文档中引用的前瞻性陈述中讨论的事件可能不会发生。投资者应谨慎对待这些前瞻性陈述，它们仅在本招股书或在文档中通过引用作为参考，其仅在本招股书或在文档中通过引用作为参考的文件的日期发表时存在。我们没有任何义务，并明确声明不承担任何义务，更新或更改任何前瞻性陈述，无论是基于新信息、未来事件或其他原因。我们或代表我们行事的任何人作出的所有后续前瞻性陈述，都受到本节中所包含或所提到的警示性声明的明确限制。
Monte Rosa Therapeutics, Inc.是一家生物技术公司，开发一系列新型小分子精准药物组合，利用人体的自然机制选择性降解治疗相关蛋白质。在这些简明综合财务报表中，除非上下文另有要求，否则对公司或Monte Rosa的引用均指Monte Rosa Therapeutics, Inc.及其全资子公司Monte Rosa Therapeutics AG，或Monte Rosa AG，以及Monte Rosa Therapeutics Securities Corp. Monte Rosa Therapeutics AG是一家瑞士制造业公司，于2018年4月根据瑞士法律成立。Monte Rosa Therapeutics, Inc.于2019年11月在特拉华州成立。公司总部位于马萨诸塞州波士顿，研究业务分别位于波士顿和瑞士巴塞尔。
流动性考虑
自创立以来，公司将几乎所有精力投入到业务规划、研究和开发、招聘管理和技术人员、筹集资金，主要通过发行和销售可转让票据、可转换优先股、普通股的公开发行、注册直接发行，并通过与罗氏合作等方式筹集资金，并通过与罗氏合作等方式筹集资金。
公司持续发现和开发其产品候选者将需要大量额外的研究和开发工作，包括广泛的临床前和临床测试以及商业化前的监管批准。这些工作需要大量额外的资金、足够的人员和制造行业设施以及广泛的合规性报告能力。即使产品开发工作取得成功，公司何时能够从产品销售中获得显著收入，仍是不确定的。
截至2024年9月30日，公司累计亏损为 $
2. 重要会计政策摘要
做法的基础
附注综合基本报表按照美国通用会计准则进行编制，并以美元表示。这些附注中对适用指南的任何参考均意味着参照财务会计准则委员会的会计准则编码和会计准则更新，即FASB。所有集团公司之间的余额和交易在合并中已被消除。
未经审计的财务信息
The 公司的简明综合基本报表按照美国通用会计准则和证券交易委员会的规定编制。公司认为，所提供的信息反映了在报告期间内为公平呈现财务状况和业务运营结果所需的所有调整，这些调整均属于正常和经常性质。公司考虑了在资产负债表日期之后但在基本报表发布前发生的事项或交易。
6
发行了 为了提供相对于某些估计的额外证据或确定需要额外披露的事项。中期期间的经营业绩并不能必然反映出全年或任何其他中期期间可以预期的结果。
最近发布的会计准则
公司选择使用《启动我们的商业创业法案》（JOBS法案）所提供的符合新或修订的会计准则的延长过渡期。
2023年11月，FASB发布了ASU 2023-07《分部报告（主题280）：改进可报告分部披露》，意在提供增强的分部披露。该标准将要求披露重要分部费用和其他分部项目以及确定最高经营决策者以及他们如何使用报告的分部盈利衡量指标来评估分部绩效和分配资源。这些增强披露需要所有实体每年和中期都进行，即使它们只有一个可报告分部。该标准于2023年12月15日后开始的年度生效，以及2024年12月15日后开始的年度期间内的中期也都适用，允许提前采纳。公司目前正在评估这项公告对我们相关披露的影响。
2023年12月，FASB发布了ASU 2023-09《所得税（主题740）：所得税披露的改进》，意在提供年度所得税披露的增强。该标准将要求在税率协调表中提供更详细的信息，以及对已支付的所得税等其他增强。该标准于2024年12月15日后开始的年度生效，允许提前采纳。采纳该标准的影响将对附带的简明合并财务报表没有实质影响。
\\\
3. 公允价值计量
以下表格展示了公司按照重复基础上公允价值衡量的财务资产和负债的信息，并指示了用于判断此类公允价值的公允价值层次的水平（以千为单位）：
|
|
截至2024年9月30日 |
|
|||||||||||||
|
|
一级 |
|
|
二级 |
|
|
三级 |
|
|
总计 |
|
||||
流动资产 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
货币市场基金 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
养老金计划资产 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
企业债券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
美国国债证券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
所有基金类型估值的资产总额 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
截至2023年12月31日 |
|
|||||||||||||
|
|
一级 |
|
|
二级 |
|
|
三级 |
|
|
总计 |
|
||||
流动资产 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
货币市场基金 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
养老金计划资产 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
企业债券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
美国国债 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
所有基金类型估值的资产总额 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
货币市场基金是高流动性投资，并且交易活跃。公司货币市场基金的定价信息基于活跃市场上相同证券的报价价格。这种方法导致将这些证券分类为公允价值层级的一级。
养老金计划资产的公允价值已确定为在Columna Collective Foundation Group投资基金内持有的活跃投保成员组合的赎回价值，并被分类为公允价值层级的二级。
可交易证券包括公司债券和美国国债证券，根据ASC 320分类为可供出售。 投资-债务和股权证券可交易证券被分类为公允价值层级的二级，因为定价输入除了活跃市场上的报价价格之外。这些投资的公允价值是通过考虑从第三方定价服务获取的估值来估算的。定价服务使用行业标准估值模型，包括基于收入和市场的方法，其中所有重大输入都是可观察的，无论是直接还是间接，以估算公允价值。这些输入包括相同或类似证券的报告交易、经纪/经销商的报价、发行人信用差价、基于历史数据的基准证券以及其他可观察到的输入。
7
截至2023年7月31日，续借贷款协议下未偿还的借款额为
4. 有价证券
截至2024年9月30日的可交易证券包括如下（单位：千美元） 2024年9月30日的可交易证券如下（单位：千美元）:
|
|
分期偿还的 |
|
|
未实现的 |
|
|
未实现的 |
|
|
公平 |
|
||||
|
|
成本 |
|
|
收益 |
|
|
损失 |
|
|
数值 |
|
||||
Description |
|
|
|
|
|
|
|
|
|
|
|
|
||||
企业债券 |
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
||||
美国国债证券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
总计 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
2023年12月31日的可交易证券如下（以千为单位）：
|
|
分期偿还的 |
|
|
未实现的 |
|
|
未实现的 |
|
|
公平 |
|
||||
|
|
成本 |
|
|
收益 |
|
|
损失 |
|
|
数值 |
|
||||
Description |
|
|
|
|
|
|
|
|
|
|
|
|
||||
企业债券 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
|
|
|||
美国财政部证券 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
总计 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
截至2024年9月30日，没有个别证券处于未实现损失位置。公司持有高信用质量公司的债务证券，并确定其债务证券的信用风险没有发生实质性变化。 公司还相信将能够在到期时收回到期本金和利息金额。
5. 资产和设备净额
固定资产及设备净值包括以下内容（以千为单位）：
|
|
9月30日, |
|
|
12月31日, |
|
||
实验室设备 |
|
$ |
|
|
$ |
|
||
电脑硬件和软件 |
|
|
|
|
|
|
||
2,551 |
|
|
|
|
|
|
||
租赁改良 |
|
|
|
|
|
|
||
在建工程 |
|
|
|
|
|
|
||
总资产和设备，成本 |
|
$ |
|
|
$ |
|
||
减：累计折旧 |
|
|
( |
) |
|
|
( |
) |
资产和设备，净值 |
|
$ |
|
|
$ |
|
||
以下表格总结了发生的折旧费用（以千元计）：
|
|
三个月结束 |
|
|
九个月结束 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
折旧费用 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
6. 应计费用和其他流动负债
应计费用和其他流动负债包括以下项目（以千为单位）：
|
|
9月30日, |
|
|
12月31日, |
|
||
|
|
2024 |
|
|
2023 |
|
||
薪酬和福利 |
|
$ |
|
|
$ |
|
||
已发生的研究和开发 |
|
|
|
|
|
|
||
其他 |
|
|
|
|
|
|
||
其他流动负债总额 |
|
$ |
|
|
$ |
|
||
8
7. 租赁
公司确定安排是否在初始阶段为租赁。 营业租赁包括在简表合并资产负债表的营业租赁权益或ROU资产和营业租赁负债中。 公司有
ROU资产代表使用权益在租赁期内使用基础资产的权利，租赁负债代表源自租赁的租金支付义务。 营业租赁ROU资产和负债根据租赁期内租金支付的现值于起始日期确认。 由于公司的租赁没有提供隐含利率，管理层根据公司借入类似金额在类似期限内以抵押为基础支付的利率，估算增量借贷利率。 公司根据初始阶段可用信息，使用其增量借贷利率确定租金支付的现值。
Klybeckstrasse租赁
2021年3月，公司与Wincasa AG签订了一份办公室和实验室空间的营业租赁协议，位于瑞士巴塞尔州巴塞尔市Klybeckstrasse 191号，占地约
Harrison Avenue租约
2021年12月，公司签订了一份不可取消的办公室和实验室空间租赁协议，面积为
根据哈里森大道租赁协议的条款，房东已经为公司报销了$元
截至2024年9月30日的三个和九个月的租赁费用包括以下几项（以千元计）： 九个月的租赁费用包括以下几项（以千元计）：
|
|
三个月结束 |
|
|
九个月结束 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
营业租赁费用 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
变量租赁费用 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
租赁总费用 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
变量租赁费用通常包括公共区维护和物业税。
以下表格总结了发生的租赁费用（以千为单位）：
|
|
三个月结束 |
|
|
九个月结束 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
研发 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
一般行政 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
租赁总费用 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
2024年9月30日止九个月的短期租赁成本和2023年均不重要。
与公司租赁相关的加权平均剩余租赁期限和折现率如下：
9
|
|
截至2023年9月30日年
度报告 |
|
|
截至12月31日公允价值 |
|
||
加权平均剩余租赁期限（年） |
|
|
|
|
|
|
||
加权平均折扣率 |
|
|
% |
|
|
% |
||
有关本公司租约的补充现金流信息如下 2024年9月30日结束的九个月的信息如下（以千为单位）：
|
|
九个月结束 |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
交易租赁义务获取的右 of use 资产 |
|
$ |
|
|
$ |
|
||
用于计量租赁负债的现金支付 |
|
$ |
|
|
$ |
|
||
2024 年 9 月 30 日至 2023 年 9 月 30 日 ROU 资产的分期摊销为 $
截至 2024 年 9 月 30 日，截至每年 12 月 31 日的非可取消租约的未来最低租金支付额如下（以千为单位）：
未折现租金支付额 |
|
|
|
|
2024 |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
此后 |
|
|
|
|
未折扣的最低租赁支付总额 |
|
|
|
|
少：推定利息 |
|
|
( |
) |
总经营租赁负债 |
|
$ |
|
|
8. 承诺和或有事项
法律诉讼
公司可能不时受到在业务日常运作中出现的法律诉讼，索赔和纠纷的影响。公司在未来支出可能性及支出可以合理估计时为此类事项计提负债。截至2024年9月30日公司目前没有参与诉讼，并且没有为任何诉讼责任设立或有准备金。
9. 合作与许可协议
罗氏合作与许可协议
Description
2023年10月，蒙特罗萨治疗学AG，蒙特罗萨治疗学公司全资子公司，与F·霍夫曼 - 莱洛仁公司或公司签订了一项合作与许可协议，即罗氏协议，与洛氏药厂有限公司和洛氏药厂股份公司，或罗氏。 根据协议，各方将寻求利用公司的专有药物发现平台针对罗氏在肿瘤学和神经科学领域选择的一组初始靶向癌症或神经疾病的分子胶水降解剂，或MGD，进行识别和开发，罗氏有权将合作扩展至包括其他选择目标的合作选项，其中罗氏选择的一定数量目标受罗氏拥有的替换权的限制。 公司将负责主导前临床发现和研究活动，罗氏将领导后期前临床和临床开发活动。
根据罗氏协议，罗氏将在公司控制的专利和专有技术下拥有全球独家许可权，用于开发和商业化针对适用目标的产品。 许可排他性受公司保留的权利的限制，仅用于履行协议下的义务。
罗氏协议规定的研究合作活动将由联合研究委员会监督。
除非提前终止，罗氏协议将在协议下授权的每个产品的专利期限届满前保持有效。 合同中包含了终止条款，可按照整体、按国家或按目标的方式终止罗氏协议。
10
定价
2023 年 11 月，公司收到了 $
截至2024年9月30日，该公司已收到900万美元，这与罗氏决定行使持续研发服务的期权有关。在随附的简明合并资产负债表中，相关付款最初被归类为递延收入，并在提供相关研发服务时确认为收入。
会计
本协议代表与客户的交易，因此根据ASC 606进行核算 与客户签订合同的收入.
该公司确定，每个合作目标的开发和商业化许可证在背景下与承诺的初步研究服务既不能区分也不能区别。此外，公司已确定协议中的每个目标都与其他目标不同，因为：（i）罗氏可以自行受益于给定目标的许可和研究服务，因为可以对与之相关的结果进行离散评估；（ii）每个目标的研发结果不会影响公司的表现能力或罗氏评估任何其他目标结果的能力。因此，公司已在协议中确定了某些履约义务如下：
罗氏协议的总交易价格根据其相对独立销售价格分配给履约义务。该公司制定了罗氏协议中包含的履约义务的独立销售价格，确定了履行每项履约义务的估计总成本，目的是确定定期独立出售此类物品的价格。 分配的交易价格通过以下两种方式之一确认为合作协议的收入：
截至 2024 年 9 月 30 日， $
10. 股本
未指定的优先股
公司
11
普通股
公司
此外，公司已向一位认可的投资者发行了预资助的权证，以购买
The holders of common stock are entitled to dividends when and if declared by the board of directors, subject to the preferences applicable to any outstanding shares of preferred stock. The board of directors has
普通股持有人有权投票。每股普通股有一票，没有累积投票权。
公司向创始人、员工和顾问发行了受限股票，对这些受限股票的费用按照直线法确认（见附注11）。这些受限股票通常每月解禁
截至 2024年9月30日和2023年12月31日，公司已为受限股票解禁和期权行权而预留了以下普通股。
|
|
9月30日, |
|
|
12月31日, |
|
||
期权购买普通股 |
|
|
|
|
|
|
||
未授予的受限普通股奖励 |
|
|
|
|
|
|
||
未授予的受限普通股单位 |
|
|
|
|
|
|
||
预融资认股权证 |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
按市场价格发行股票
2022年7月，公司与Jefferies LLC（以下简称"Jefferies"）签订了销售协议，即销售协议，根据该协议，公司可以通过Jefferies进行"市场价"的方式，不时地提供并出售其普通股，募集的总毛收益高达$
承销公开发行
2024年5月，公司与TD证券（美国）有限责任公司（作为若干承销商的代表）签订了一份承销协议，与承销公开发行有关，或者称为本次发行，每股售价为
注册直接发行
2023年10月，公司根据证券购买协议进行的直接注册发行中出售了预融资认股权，以购买价格为$每份预融资认股权向一家合格投资者出售了
12
11。基于股票的薪酬
2020 年股票激励计划
公司的2020年股票期权和赠款计划（即2020年计划）规定，公司向员工、非雇员董事和顾问授予股票期权、限制性股票和其他股票奖励。2021年计划（定义见下文）生效后，没有根据2020年计划发布进一步的通知。
2021 年股票激励计划
公司的 2021 年股票期权和激励计划（即 2021 年计划）于 2021 年 5 月 28 日获得公司董事会批准，并于 2021 年 6 月 17 日获得公司股东的批准，并于公司首次公开募股注册声明宣布生效之日前夕生效。2021年计划规定向公司高管、员工、董事和顾问授予激励性股票期权、非合格股票期权、股票增值权、限制性股票单位、限制性股票奖励、非限制性股票奖励、现金奖励和股息等值权利。根据2021年计划最初预留发行的股票数量为
2021 年员工股票购买计划
公司的 2021 年员工股票购买计划（即 2021 年 ESPP）于 2021 年 5 月 28 日获得公司董事会批准，并于 2021 年 6 月 17 日获得公司股东的批准，并于公司首次公开募股注册声明宣布生效之日前夕生效。总共有
股票期权活动
以下总结了股票期权活动：
|
|
的数量 |
|
|
加权 |
|
|
加权 |
|
|
聚合 |
|
||||
杰出——2023 年 12 月 31 日 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
已授予 |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
已锻炼 |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
— |
|
|
被没收 |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
— |
|
|
杰出——2024 年 9 月 30 日 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
已归属或预计将维斯特 — 2024 年 9 月 30 日 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
可锻炼——2024 年 9 月 30 日 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
授予期权的总内在价值按期权行使价与公司普通股估计公允价值之间的差额计算。
限制性股票奖励活动
根据2020年计划，向员工发放了未归属的限制性股票奖励。限制性股票奖励通常在四年内发放，前提是个人继续在公司工作。
13
以下是限制性股票奖励活动的总结：
|
|
数量 |
|
|
已授予和预期于2021年1月2日授予股份 |
|
||
截至2023年12月31日的未发行限制性股票奖励 |
|
|
|
|
$ |
|
||
34,105 |
|
|
( |
) |
|
$ |
|
|
截至2024年9月30日的未发行限制性股票奖励 |
|
|
|
|
$ |
|
||
在截至2024年9月30日的九个月内解限制的限制性股票奖励的累计公允价值为 $
限制性股票单位活动
公司从2022年开始根据2021年计划向员工授予受限股票单位（RSUs）。每个RSU代表在解锁时获得一股公司普通股的权利。只要个人继续在公司连续服务，RSUs将在两年内解锁。因此，每个RSU的股票补偿费用按照解锁期间的直线方式确认。每个RSU的公允价值基于授予日公司普通股的收盘价。
以下总结了受限制股票单位的活动：
|
|
数量 |
|
|
已授予和预期于2021年1月2日授予股份 |
|
||
2023年12月31日尚未归属的受限股票单位 |
|
|
|
|
$ |
|
||
已行权 |
|
|
|
|
$ |
|
||
34,105 |
|
|
( |
) |
|
$ |
|
|
被取消 |
|
|
( |
) |
|
$ |
|
|
2024年9月30日尚未归属的受限股票单位 |
|
|
|
|
$ |
|
||
截至2024年9月30日和2023年结束的九个月内已授予的受限股票单位的总公允价值为 $
股票补偿费用
股票期权补偿费用按以下分类（单位：千）进行分类：
|
|
九个月结束 |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
研发 |
|
$ |
|
|
$ |
|
||
一般行政 |
|
|
|
|
|
|
||
共计股份奖励支出 |
|
$ |
|
|
$ |
|
||
截至2024年9月30日，未实现的股票期权和限制性股票单位相关的总未确认股票报酬成本分别为 $
12. 所得税
在2024年和2023年截至9月30日的每个月，公司记录了百万美元的所得税费用。所得税费用主要与马萨诸塞州可交易证券的利息收入以及资本化研究与开发费用产生的美国应税收入有关。 $
公司继续对其所有递延税资产保持完全减值准备。公司评估了涉及其能否实现递延税资产的积极和消极证据。公司考虑了自创立以来累积净亏损的历史和缺乏任何商业产品的情况。公司得出结论，很可能不会实现递延税资产的利益。公司在每个报告期重新评估积极和消极证据。
14
13. 每普通股净亏损
基本和稀释每股净亏损是根据期间内普通股权重平均数计算的。公司普通股基础和稀释收益每股中包括预先拟定认股权证所代表的公司普通股。
|
|
三个月结束 |
|
|
九个月结束 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
净损失 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
每股普通股净亏损，基础和稀释后 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
在计算净亏损时使用的普通股加权平均数 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
以下未列入计算稀释每股净亏损的待发行潜在稀释证券，因其效果不具稀释性：
|
|
9月30日, |
|
|
9月30日, |
|
||
|
|
2024 |
|
|
2023 |
|
||
期权购买普通股 |
|
|
|
|
|
|
||
限制性普通股 |
|
|
|
|
|
|
||
限制性股票单位 |
|
|
|
|
|
|
||
14. 员工养老计划
根据瑞士法律，公司与AXA Leben AG签订了定义利益计划的养老金福利提供合同。所有福利组织在与AXA签订的合同框架内，由半自治的集体基金管理。 AXA直接支付到有资格的个人名下的保险福利。养老金计划由员工和雇主的捐款资助。公司与集体基金之间的合同可以被任何一方终止。在终止的情况下，公司有义务为员工找到替代的养老安排。由于无法保证员工养老安排将以相同条件继续下去，公司可能会承担养老金责任，尽管可能性很小。养老金资产被汇集到所有关联公司中；资产的投资由集体基金的治理机构负责。
以下表格总结了发生的养老金费用（以千为单位）：
|
|
三个月结束 |
|
|
九个月结束 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
养老金费用 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
公司于2021年2月实施了一项旨在符合《内部税收法》第401（k）条的雇员定额捐款计划，旨在涵盖公司所有符合条件的美国雇员。所有员工都有资格立即成为该计划的参与者。每位在职员工可自愿选择每年向该计划捐款一定比例的补偿，但需遵守一定限制。公司保留权利但不被迫向该计划额外捐款。公司进行安全港配对捐款，为每位参与者的合格补偿的（百分比）提供配对。
以下表格总结了发生的定额捐款费用（以千为单位）：
|
|
三个月结束 |
|
|
九个月结束 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
定义缴费支出 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
15
15。随后发生的事件
2024年10月25日，Monte Rosa Therapeutics, Inc.（本公司）的全资子公司Monte Rosa Therapeutics AG与诺华制药股份公司（Novartis）签订了许可协议或诺华协议。根据诺华协议，公司将向诺华授予独家、特许使用费、可再许可和可转让的许可，用于开发、制造和商业化VAV1 MGD，包括mRT-6160，该药物目前处于免疫介导疾病的1期临床开发阶段。公司负责完成正在进行的1期临床研究，诺华负责从第二阶段开始的所有后续开发和商业活动。受协议约束的开发和商业活动将由开发委员会和商业化委员会监督。
根据诺华协议，公司有权从诺华（1）获得预付款 $
诺华协议受惯例成交条件的约束，包括1976年《哈特-斯科特-罗迪诺反垄断改进法》下的监管许可。
双方在协议中纳入了习惯性终止条款，包括诺华完全终止诺华协议的能力。
项目1 控件管理层讨论和分析财务状况和经营业绩
应该结合本季度报告中其他地方包含的未经审计的精简综合基本报表和相关附注阅读以下讨论和分析。本讨论和分析以及本季度报告的其他部分包含基于当前信念、计划和期望的前瞻性声明，涉及风险、不确定性和假设，例如关于我们计划、目标、期望、意图和预期的声明。由于多种因素，包括我们2023年年度报告中“第I部分，1A项目，风险因素”和本季度报告其他地方的“II部分，1A项目，风险因素”中所列明的因素，我们实际结果和选择事件的时间可能与预期的前瞻性声明有实质不同。您应仔细阅读本季度报告的“风险因素”部分，以了解可能导致实际结果与我们前瞻性声明实质不同的重要因素。也请参阅标题为"关于前瞻性声明的特别说明"的部分。
Overview
We are a biotechnology company developing a portfolio of novel and proprietary MGDs. MGDs are small molecule drugs that employ the body’s natural protein destruction mechanisms to selectively degrade therapeutically-relevant proteins. MGDs work by inducing the engagement of defined surfaces identified on target proteins by an E3 ligase, such as cereblon. We have developed a proprietary and industry-leading protein degradation platform, called QuEENTM to enable our unique, target-centric, MGD discovery and development and our rational design of MGD products. We believe our small molecule MGDs may give us significant advantages over existing therapeutic modalities, including other protein degradation approaches. We prioritize our product development on therapeutic targets backed by strong biological and genetic rationale with the goal of discovering and developing novel medicines.
Monte Rosa Therapeutics AG, a Swiss operating company, was incorporated under the laws of Switzerland in April 2018. Monte Rosa Therapeutics, Inc was incorporated in Delaware in November 2019. We are headquartered in Boston, Massachusetts with research operations in both Boston and Basel, Switzerland.
16
Our most advanced product candidate, MRT-2359, is an orally bioavailable MGD targeting the translation termination factor protein GSPT1. The FDA cleared the IND for MRT-2359 in September 2022, and we initiated a phase 1/2 clinical trial for the treatment of MYC-driven solid and high-grade neuroendocrine tumors in October 2022. In October 2023, we presented interim data from the Phase 1 dose escalation part of our Phase 1/2 clinical trial of MRT-2359 demonstrating favorable pharmacokinetic (PK), pharmacodynamic (PD), and tolerability profiles and early, but we believe promising, signs of clinical activity, including tumor size reductions in patients with biomarker-positive cancers. In January 2023, MRT-2359 received Fast Track designation from the FDA for the treatment of patients with previously treated, metastatic NSCLC with L-MYC or N-MYC expression. In June 2023, MRT-2359 received Orphan Drug Designation from FDA for treatment of small cell lung cancer (SCLC). In December 2023, MRT-2359 received Fast Track Designation from the FDA for the treatment of patients with previously treated, metastatic SCLC with L-MYC or N-MYC expression. In June 2024, we announced initial safety and pharmacodynamic data from the 0.5 mg dose using the 21 days on, 7 days off regimen. We continue to evaluate a higher 0.75 mg, 21 days on, 7 days off dose cohort. We look forward to announcing updated clinical data before the end of 2024.
In October 2024, we announced a global exclusive development and commercialization license agreement with Novartis to advance VAV1 MGDs, including MRT-6160, currently in Phase 1 clinical development, for various immune-related conditions. In August 2024, we announced that the first participants had been dosed in an MRT-6160 Phase 1 single ascending dose/multiple ascending dose, or SAD/MAD, study. Initial clinical results, including safety, pharmacokinetics, VAV1 protein degradation, and key downstream pharmacodynamic markers, are anticipated by the first quarter of 2025.
In addition, MRT-8102, a NEK7-directed MGD for inflammatory diseases driven by IL-1β and the NLRP3 inflammasome, is now in IND-enabling studies, with an IND filing with the FDA planned for the first half of 2025.
Further, our CDK2 and Cyclin E1-directed MGD programs are progressing and continue to advance towards development candidate nominations. We expect to nominate a development candidate for the CDK2-directed MGD program by year-end 2024.
Liquidity
To date, we have financed our operations primarily through the issuance and sale of convertible promissory notes, convertible preferred stock, public offerings of our common stock, registered direct offerings, and through our collaboration with Roche. From our inception through the date hereof, there have been aggregate inflows of $684.8 million of gross proceeds from such transactions. Since inception, we have had significant operating losses. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures and, to a lesser extent, general and administrative expenditures. Our net loss was $135.4 million and $108.5 million for the years ended December 31, 2023 and 2022, respectively, and our net loss was $86.1 million and $102.1 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $452.0 million and $247.1 million in cash, cash equivalents, restricted cash and marketable securities.
Impact of global economic and political developments
The development of our product candidates could be disrupted and materially adversely affected in the future by global economic or political developments. In addition, economic uncertainty in global markets caused by political instability and conflict, and economic challenges caused by global pandemics or other public health events, may lead to market disruptions, including significant volatility in commodity prices, credit and capital market instability and supply chain interruptions. Our business, financial condition and results of operations could be materially and adversely affected by negative impacts on the global economy and capital markets resulting from these global economic conditions, particularly if such conditions are prolonged or worsen.
Components of operating results
Collaboration Revenue
Collaboration revenue represents amounts earned from our Collaboration and License Agreement with Roche.
Research and development expenses
Our research and development expenses include:
17
Most of our research and development expenses have been related to the development of our QuEENTM platform and advancement of our GSPT1 program, advancement of our disclosed and undisclosed programs including for CDK2, NEK7, VAV1, and CCNE1. With the exception of costs incurred for research and development on behalf of third parties, we have not reported program costs since our inception because we have not historically tracked or recorded our research and development expenses on a program-by-program basis. We use our personnel and infrastructure resources across the breadth of our research and development activities, which are directed toward identifying and developing product candidates.
We expense all research and development costs in the periods in which they are incurred. Costs for certain research and development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and third-party service providers.
We expect our research and development expenses to increase substantially for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, including investments in manufacturing, as we advance our programs and conduct clinical trials. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects, the costs of related clinical development costs or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.
General and administrative expenses
Our general and administrative expenses consist primarily of personnel costs and other expenses for outside professional services, including legal fees relating to patent and corporate matters, professional fees for accounting, auditing, tax and administrative consulting services, insurance costs and other operating costs. We expect our general and administrative expenses to increase over the next several years to support our continued research and development activities, manufacturing activities, and the potential commercialization of our product candidates and development of commercial infrastructure. We also anticipate our general and administrative costs will increase and with respect to the hiring of additional personnel, fees to outside consultants, lawyers and accountants, and costs associated with being a public company, such as expenses related to services associated with maintaining compliance with Nasdaq listing rules and SEC reporting requirements, insurance and investor relations costs.
Non-operating income and (expense)
Our non-operating income and (expense) includes (i) interest earned on our investments, including principally U.S. government-backed money-market funds and marketable securities; (ii) gains and losses on transactions of our Swiss subsidiary denominated in currencies other than the U.S. Dollar; (iii) proceeds from the sale of fixed assets; and (iv) realized losses on the sale of marketable securities.
Results of operations for the three months ended September 30, 2024 and 2023
The following sets forth our results of operations:
|
|
Three months ended |
|
|
|
|
||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Dollar change |
|
|||
Collaboration revenue |
|
$ |
9,216 |
|
|
$ |
— |
|
|
$ |
9,216 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
27,616 |
|
|
$ |
28,306 |
|
|
$ |
(690 |
) |
General and administrative |
|
|
8,127 |
|
|
|
8,662 |
|
|
|
(535 |
) |
Total operating expenses |
|
|
35,743 |
|
|
|
36,968 |
|
|
|
(1,225 |
) |
Loss from operations |
|
|
(26,527 |
) |
|
|
(36,968 |
) |
|
|
10,441 |
|
Other income |
|
|
2,739 |
|
|
|
2,254 |
|
|
|
485 |
|
Net loss before income taxes |
|
|
(23,788 |
) |
|
|
(34,714 |
) |
|
|
10,926 |
|
Provision for income taxes |
|
|
(71 |
) |
|
|
(170 |
) |
|
|
99 |
|
Net loss |
|
$ |
(23,859 |
) |
|
$ |
(34,884 |
) |
|
$ |
11,025 |
|
18
Collaboration revenue
Collaboration revenue of $9.2 million for the three months ended September 30, 2024 represents revenue recorded under the Roche License and Collaboration Agreement. As of September 30, 2024, $18.9 million was classified as current deferred revenue on the condensed consolidated balance sheet.
Research and development expenses
Research and development expenses were comprised of:
|
|
Three months ended |
|
|
|
|
||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Dollar change |
|
|||
External research and development services |
|
$ |
10,299 |
|
|
$ |
12,227 |
|
|
$ |
(1,928 |
) |
Personnel costs |
|
|
9,862 |
|
|
|
9,208 |
|
|
|
654 |
|
Laboratory and related expenses |
|
|
2,220 |
|
|
|
2,284 |
|
|
|
(64 |
) |
Facility costs and other expenses |
|
|
5,235 |
|
|
|
4,587 |
|
|
|
648 |
|
Research and development expenses |
|
$ |
27,616 |
|
|
$ |
28,306 |
|
|
$ |
(690 |
) |
As of September 30, 2024, we had 105 employees engaged in research and development activities in our facilities in the U.S. and Switzerland. As of September 30, 2023, we had 107 research and development employees in our facilities in the U.S. and Switzerland.
Most of our research and development expenses were driven by the successful achievement of key milestones in our research and development organization, including the continuation of the MRT-2359 clinical study, the advancement of MRT-6160 into the clinic, the progression of our preclinical pipeline, and the continued development of the Company’s QuEEN™ discovery engine. Research and development expenses for the three months ended September 30, 2024 and 2023 included non-cash stock-based compensation expense of $2.6 million and $2.3 million, respectively.
General and administrative expenses
General and administrative expenses to support our business activities were comprised of:
|
|
Three months ended |
|
|
|
|
||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Dollar change |
|
|||
Personnel costs |
|
$ |
5,702 |
|
|
$ |
5,440 |
|
|
$ |
262 |
|
Professional services |
|
|
572 |
|
|
|
1,277 |
|
|
|
(705 |
) |
Facility costs and other expenses |
|
|
1,853 |
|
|
|
1,944 |
|
|
|
(91 |
) |
General and administrative expenses |
|
$ |
8,127 |
|
|
$ |
8,661 |
|
|
$ |
(534 |
) |
As of September 30, 2024 and 2023 we had 28 and 26 employees engaged in general and administrative activities, respectively, principally in our U.S. facility. General and administrative expenses for the three months ended September 30, 2024 and 2023 included non-cash stock-based compensation expense of $1.6 million and $2.2 million, respectively.
Other income (expense)
Other income (expense), net was comprised of:
|
|
Three months ended |
|
|||||
(in thousands) |
|
2024 |
|
|
2023 |
|
||
Interest income, net |
|
$ |
2,892 |
|
|
$ |
2,227 |
|
Foreign currency exchange gain (loss), net |
|
|
(153 |
) |
|
|
27 |
|
Other income |
|
$ |
2,739 |
|
|
$ |
2,254 |
|
Other income and expense for the three months ended September 30, 2024 and 2023 is primarily attributable to interest earned on marketable securities.
19
Results of operations for the nine months ended September 30, 2024 and 2023
The following sets forth our results of operations:
|
|
Nine months ended |
|
|
|
|
||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Dollar change |
|
|||
Collaboration revenue |
|
$ |
14,975 |
|
|
$ |
— |
|
|
$ |
14,975 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
|
82,697 |
|
|
|
84,137 |
|
|
|
(1,440 |
) |
General and administrative |
|
|
26,394 |
|
|
|
24,311 |
|
|
|
2,083 |
|
Total operating expenses |
|
|
109,091 |
|
|
|
108,448 |
|
|
|
643 |
|
Loss from operations |
|
|
(94,116 |
) |
|
|
(108,448 |
) |
|
|
14,332 |
|
Other income |
|
|
8,385 |
|
|
|
6,708 |
|
|
|
1,677 |
|
Net loss before income taxes |
|
$ |
(85,731 |
) |
|
$ |
(101,740 |
) |
|
$ |
16,009 |
|
Provision for income taxes |
|
|
(406 |
) |
|
|
(360 |
) |
|
|
(46 |
) |
Net loss |
|
$ |
(86,137 |
) |
|
$ |
(102,100 |
) |
|
$ |
15,963 |
|
Collaboration revenue
Collaboration revenue of $15.0 million for the nine months ended September 30, 2024 represents revenue recorded under the Roche License and Collaboration Agreement. As of September 30, 2024, $18.9 million was classified as current deferred revenue on the condensed consolidated balance sheet.
Research and development expenses
Research and development expenses were comprised of:
|
|
Nine months ended |
|
|
|
|
||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Dollar change |
|
|||
External research and development services |
|
$ |
31,227 |
|
|
$ |
35,698 |
|
|
$ |
(4,471 |
) |
Personnel costs |
|
|
29,585 |
|
|
|
28,126 |
|
|
|
1,459 |
|
Laboratory and related expenses |
|
|
6,043 |
|
|
|
6,812 |
|
|
|
(769 |
) |
Facility costs and other expenses |
|
|
15,842 |
|
|
|
13,501 |
|
|
|
2,341 |
|
Research and development expenses |
|
$ |
82,697 |
|
|
$ |
84,137 |
|
|
$ |
(1,440 |
) |
As of September 30, 2024, we had 105 employees engaged in research and development activities in our facilities in the U.S. and Switzerland. As of September 30, 2023, we had 107 research and development employees in our facilities in the U.S. and Switzerland.
Most of our research and development expenses were driven by the successful achievement of key milestones in our research and development organization, including the continuation of the MRT-2359 clinical study, the advancement of MRT-6160 into the clinic, the progression of our preclinical pipeline, and the continued development of the Company’s QuEEN™ discovery engine. Research and development expenses for the nine months ended September 30, 2024 and 2023 included non-cash stock-based compensation expense of $7.9 million and $6.7 million, respectively.
General and administrative expenses
General and administrative expenses to support our business activities were comprised of:
|
|
Nine months ended |
|
|
|
|
||||||
(in thousands) |
|
2024 |
|
|
2023 |
|
|
Dollar change |
|
|||
Personnel costs |
|
$ |
16,443 |
|
|
$ |
14,770 |
|
|
$ |
1,673 |
|
Professional services |
|
|
3,850 |
|
|
|
3,451 |
|
|
|
399 |
|
Facility costs and other expenses |
|
|
6,101 |
|
|
|
6,090 |
|
|
|
11 |
|
General and administrative expenses |
|
$ |
26,394 |
|
|
$ |
24,311 |
|
|
$ |
2,083 |
|
As of September 30, 2024 and 2023 we had 28 and 26 employees engaged in general and administrative activities, respectively, principally in our U.S. facility. General and administrative expenses for the nine months ended September 30, 2024 and 2023 included non-cash stock-based compensation expense of $5.7 million and $5.9 million, respectively.
20
Other income (expense)
Other income (expense), net was comprised of:
|
|
Nine months ended |
|
|||||
(in thousands) |
|
2024 |
|
|
2023 |
|
||
Interest income, net |
|
$ |
7,971 |
|
|
$ |
6,966 |
|
Foreign currency exchange gain (loss), net |
|
|
414 |
|
|
|
(151 |
) |
Gain on disposal of fixed assets |
|
|
— |
|
|
|
24 |
|
Loss on sale of marketable securities |
|
|
— |
|
|
|
(131 |
) |
Other income |
|
$ |
8,385 |
|
|
$ |
6,708 |
|
The increase in interest and other income for the nine months ended September 30, 2024, is due to the strengthening of the U.S. Dollar with respect to, principally, the Swiss Franc.
Liquidity and capital resources
Overview
Due to our significant research and development expenditures, we have generated operating losses since our inception. We have funded our operations primarily through the sale of convertible promissory notes, convertible preferred stock, public offerings of our common stock and through our collaboration with Roche. As of September 30, 2024, we had $247.1 million in cash, cash equivalents, restricted cash and marketable securities. We have incurred losses since our inception and, as of September 30, 2024, we had an accumulated deficit of $452.0 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
At-the-Market Offering
On July 1, 2022, we filed a registration statement on Form S-3 (File No. 333-266003) with the SEC, which was declared effective on July 13, 2022, or the Shelf Registration Statement, in relation to the registration of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof for the purposes of selling, from time to time, our common stock, debt securities or other equity securities in one or more offerings. We also simultaneously entered into a Sales Agreement, or the Sales Agreement, with Jefferies LLC, or Jefferies, to provide for the offering, issuance and sale of up to an aggregate amount of $100.0 million of our common stock from time to time in “at-the-market” offerings, or the ATM Program, under the Shelf Registration Statement and subject to the limitations thereof. We will pay to the Jefferies cash commissions of up to 3.0 percent of the aggregate gross proceeds of sales of common stock under the Sales Agreement. As of the date of this Quarterly Report on Form 10-Q, 2,612,514 shares have been sold pursuant to the ATM Program.
Underwritten Public Offering
In May 2024, we entered into an underwriting agreement with TD Securities (USA) LLC, as representative of the several underwriters, related to an underwritten public offering, or the Offering, of 10,638,476 shares of common stock at a price of $4.70 per share, and, in lieu of Common Stock to certain investors, pre-funded warrants to purchase 10,638,524 shares of Common Stock at a price of $4.6999 per pre-funded warrant The purchase price per share of each pre-funded warrant represents the per share public offering price for the common stock, minus the $0.0001 per share exercise price of such pre-funded warrant.. The pre-funded warrants are immediately exercisable and may be exercised at any time until the pre-funded warrants are exercised in full. Aggregate gross proceeds from the Offering were $100 million, or aggregate net proceeds of $96.4 million after deducting the underwriter discounts, commissions, and other offering costs.
Registered Direct Offering
In October 2023, we sold in a registered direct offering pursuant to a securities purchase agreement pre-funded warrants to purchase 10,000,400 shares of the our common stock to an accredited investor at a purchase price of $2.4999 per pre-funded warrant for aggregate gross proceeds of $25.0 million. The pre-funded warrants are immediately exercisable at an exercise price of $0.0001 per share.
21
Cash flows
The following table summarizes our cash flows for the periods indicated:
|
|
Nine months ended |
|
|||||
(in thousands) |
|
2024 |
|
|
2023 |
|
||
Net cash provided by (used in): |
|
|
|
|
|
|
||
Operating activities |
|
$ |
(86,926 |
) |
|
$ |
(73,436 |
) |
Investing activities |
|
|
(13,556 |
) |
|
|
74,504 |
|
Financing activities |
|
|
98,284 |
|
|
|
2,319 |
|
Net increase (decrease) in cash, cash equivalents and restricted cash |
|
$ |
(2,198 |
) |
|
$ |
3,387 |
|
Operating activities
Net cash used in operating activities of $86.9 million during the nine months ended September 30, 2024, was attributable to our net loss of $86.1 million and decreases in our working capital of $18.3 million, partially off-set by non-cash charges of $17.5 million principally with respect to depreciation expense and stock-based compensation.
Net cash used in operating activities of $73.4 million during the nine months ended September 30, 2023, was attributable to our net loss of $102.1 million off-set by an increase in our working capital of $14.8 million and non-cash charges of $13.9 million principally with respect to depreciation expense and stock-based compensation.
Investing activities
Cash used in investing activities of $13.6 million during the nine months ended September 30, 2024 was primarily attributable to proceeds from the maturity of marketable securities of $152.6 million, offset by purchases of marketable securities of $162.4 million and purchases of property and equipment of $3.8 million.
Cash provided by investing activities of $74.5 million during the nine months ended September 30, 2023 was primarily attributable to proceeds from the maturity of marketable securities of $121.8 million and proceeds from the sale of marketable securities of $45.6 million, offset by purchases of marketable securities of $75.6 million and purchases of property and equipment of $17.4 million.
Financing activities
Net cash provided by financing activities of $98.3 million for nine months ended September 30, 2024 was primarily due the net proceeds from our Offering of $96.4 million.
Funding requirements
Any product candidates we may develop may never achieve commercialization and we anticipate that we will continue to incur losses for the foreseeable future. We expect that our research and development expenses, general and administrative expenses and capital expenditures will continue to increase. As a result, 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 or other capital sources, including potential collaborations, licenses and other similar arrangements. Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, third-party clinical research, manufacturing and development services, costs relating to the build-out of our headquarters, laboratories and manufacturing facility, license payments or milestone obligations that may arise, laboratory and related supplies, clinical costs, manufacturing costs, legal and other regulatory expenses and general overhead costs.
Based upon our current operating plan, and the anticipated $150 million upfront payment due from Novartis, we believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements for at least the next twelve months. We base this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.
We will continue to require additional financing to advance our current product candidates through clinical development, to develop, acquire or in-license other potential product candidates and to fund operations for the foreseeable future. We will continue to seek funds through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any failure to raise capital as and when needed could
22
have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs.
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:
Further, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development activities. We currently have no credit facility or committed sources of capital. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated product development programs.
Critical accounting policies and significant judgments and estimates
Our unaudited interim condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the U.S. The preparation of our unaudited interim condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our condensed financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are 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. We evaluate our estimates and assumptions on an ongoing basis. However, even though we believe we have used reasonable estimates and assumptions in preparing our interim condensed consolidated financial statements, the future effects of global economic and political developments and any future public health events on our results of operations, cash flows, and financial position are unclear. Our actual results may differ from these estimates under different assumptions or conditions.
Revenue Recognition
To date, our revenues have primarily consisted of consideration related to the License and Collaboration Agreement with Roche, which we are accounting for under ASC 606. In accordance with ASC 606, we recognize revenue when our customers obtain control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services.
To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of ASC 606, we perform the following five steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the assessment of the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when, or as we satisfy each performance obligation.
As part of the accounting for arrangements under ASC 606, we must use significant judgment to determine the performance obligations based on the determination under step (ii) above. We also use judgment to determine whether
23
milestones or other variable consideration, except for royalties and sales-based milestones, should be included in the transaction price as described below. We recognize revenue based on those amounts when, or as, the performance obligations under the contract are satisfied.
The transaction price is determined based on the consideration to which we will be entitled in exchange for transferring goods and services to the customer. To the extent the transaction price includes variable consideration, we estimate the amount of variable consideration that should be included in the transaction price utilizing either the expected value method or the most likely amount method, depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in management’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Any estimates, including the effect of the constraint on variable consideration, are evaluated at each reporting period for any changes.
If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price to each performance obligation on a relative standalone selling price basis unless the transaction price is variable and meets the criteria to be allocated entirely to a performance obligation or to a distinct service that forms part of a single performance obligation. The consideration to be received is allocated among the separate performance obligations based on relative standalone selling prices. Determining the standalone selling price of each performance obligation requires significant judgment and is discussed in further detail in Note 9.
We utilize judgment to assess the nature of the performance obligation to determine whether the performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. The measure of progress, and the resulting periods over which revenue should be recognized, are subject to estimates by management and may change over the course of the arrangement, which are subject to review by the joint research committee, or JRC. Such a change could have a material impact on the amount of revenue we record in future periods. We concluded that the transfer of control to the customer for the performance obligation occurs over the time period that the research and development services are provided by us. We recognize revenue for the performance obligation as those services are provided using an input method, based on the cumulative costs incurred compared to the total estimated costs expected to be incurred to satisfy the performance obligation. The percentage of completion method is, in management’s judgment, the best measure of progress towards satisfying the performance condition.
At the inception of each arrangement that includes research, development or regulatory milestone payments, we evaluate whether the milestones are considered likely to be met and estimate the amount to be considered for inclusion in the transaction price using the most-likely-amount method. If it is probable that a significant reversal in the amount of cumulative revenue recognized would not occur, the associated milestone value is included in the transaction price. For milestone payments due upon events that are not within our control, such as regulatory approvals, we are not able to assert that it is likely that the regulatory approval will be granted and that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur until those approvals are received. In making this assessment, we evaluate factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone. There is considerable judgment involved in determining whether it is probable that a significant reversal in the amount of cumulative revenue recognized would not occur.
We reevaluate the transaction price and our total estimated costs expected to be incurred at the end of each reporting period and as uncertain events, such as changes to the expected timing and cost of certain research, development and manufacturing activities that we are responsible for, are resolved or other changes in circumstances occur. If necessary, we will adjust our estimate of the transaction price or our estimates of the total costs expected to be incurred. To date, we have not had any significant changes in our estimates.
Other than the Company's revenue recognition policy described above, there have been no significant changes to our critical accounting policies from those described in “Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2023 Annual Report.
For a complete discussion of our significant accounting policies and recent accounting pronouncements, see Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report and Note 2 to our 2023 Annual Report.
Recently issued and adopted accounting pronouncements
Refer to Note 2, “Summary of Significant Accounting Policies,” in the accompanying notes to our and consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for a discussion of recent accounting pronouncements.
24
Contractual obligations and commitments
During the three months ended September 30, 2024, there have been no material changes to our contractual obligations and commitments from those described under “Part II, Item 7, 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, filed with the Securities and Exchange Commission on March 14, 2024.
Off-balance sheet arrangements
During the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as defined under SEC rules.
Emerging growth company status
In April 2012, the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” may take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Therefore, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this extended transition period and, as a result, we may adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-public companies instead of the dates required for other public companies. However, we may early adopt these standards.
We will cease to be an emerging growth company on the date that is the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more, (ii) the last day of our fiscal year following the fifth anniversary of the date of the closing of our initial public offering, or our IPO, (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years or (iv) the date on which we are deemed to be a large, accelerated filer under the rules of the SEC.
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates plus the aggregate amount of gross proceeds to us as a result of our IPO 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 after our IPO if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was 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 reports on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
25
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 required under this Item 3.
Item 4. Controls and procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and our principal financial officer have evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as of September 30, 2024. The term “disclosure controls and procedures,” as defined in the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Based on the evaluation of our disclosure controls and procedures as of September 30, 2024, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures as of such date are effective at the reasonable assurance level.
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) during three months ended September 30, 2024 that materially affected, or were reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations on Effectiveness of Controls
Our disclosure controls and procedures and internal control over financial reporting are designed to provide reasonable assurance of achieving the desired control objectives. Our management recognizes that any control system, no matter how well designed and operated, is based upon certain judgments and assumptions and cannot provide absolute assurance that its objectives will be met. Similarly, an evaluation of controls cannot 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 detected.
26
Part II ─ Other Information
Item 1. Legal proceedings
From time to time, we may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Although the results of litigation and claims cannot be predicted with certainty, as of September 30, 2024, we do not believe we are party to any claim or litigation the outcome of which, if determined adversely to us, would individually or in the aggregate be reasonably expected to have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk factors
Investing in our common stock involves a high degree of risk. You should carefully consider the following risks and uncertainties, those risks and uncertainties discussed in “Part I, Item 1A, Risk Factors” in our 2023 Annual Report, as amended and supplemented by the information in our subsequent Quarterly Reports on Form 10-Q, together with all of the other information contained in this Quarterly Report, including our unaudited condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report. The risk factor disclosure in our 2023 Annual Report and subsequent Quarterly Reports on Form 10-Q is qualified by the information that is described in this Quarterly Report. If any of the risks described below or in our 2023 Annual Report actually occur, our business, prospects, operating results and financial condition could suffer materially. In such event, the trading price of our common stock could decline and you might lose all or part of your investment.
Other than as set forth below, there have been no material changes to the risk factors set forth in our 2023 Annual Report.
Risks related to our financial position and capital needs
We have incurred significant operating losses since our inception and anticipate that we will incur continued losses for the foreseeable future.
Since our inception, we have focused substantially all of our efforts and financial resources on developing our proprietary QuEENTM platform, our proprietary MGD library and our initial pipeline of product candidates. To date, we have financed our operations primarily through the issuance and sale of convertible promissory notes, convertible preferred stock, public offerings of our common stock, registered direct offerings, and through our collaboration with Roche. From our inception through the date hereof, we raised an aggregate of $684.8 million of gross proceeds from such transactions. As of September 30, 2024, our cash, cash equivalents, restricted cash and marketable securities were $247.1 million. We have incurred net losses in each year since our inception, and we had an accumulated deficit of $452.0 million as of September 30, 2024. For the years ended December 31, 2023 and 2022, we reported net losses of $135.4 million and $108.5 million, respectively. For the nine months ended September 30, 2024 and 2023, we reported a net loss of $86.1 million and $102.1 million, respectively. Substantially all of our operating losses have resulted from costs incurred in connection with our research and initial pipeline programs and from general and administrative costs associated with our operations. We expect to continue to incur significant expenses and increasing operating losses over the next several years and for the foreseeable future. Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ deficit and working capital. We expect our expenses to significantly increase in connection with our ongoing activities, as we:
27
In addition, if we obtain marketing approval for our current or future product candidates, we will incur significant expenses relating to our commercialization of such product candidates via our sales, marketing, product manufacturing and distribution efforts. Because of the numerous risks and uncertainties associated with developing pharmaceutical drugs, including in light of economic fluctuations, we are unable to predict the extent of any future losses or when we will become profitable, if at all.
Even if we achieve profitability, we may not be able to sustain or increase our 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 development efforts, obtain product approvals, diversify our offerings or continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.
28
Item 2. Unregistered sales of equity securities, use of proceeds and issuer purchases of equity securities
Recent sales of unregistered equity securities
None.
Issuer purchases of equity securities
None.
Item 3. Defaults upon senior securities
None.
Item 4. Mine safety disclosures
Not Applicable.
Item 5. Other information
Rule 10b5-1 Trading Plans
During the fiscal quarter ended on September 30, 2024, none of our directors and officers (as defined in Rule 16a-1(f) under the Exchange Act)
29
Item 6. Exhibits
Exhibit Number |
|
Description |
|
|
|
3.1 |
|
|
3.2 |
|
|
3.3 |
|
|
31.1* |
|
|
32.1** |
|
|
|
|
|
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. |
101.SCH* |
|
Inline XBRL Taxonomy Extension Schema Document |
104* |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Filed herewith.
** Deemed to be furnished with this Quarterly Report on Form 10-Q and will not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the registrant specifically incorporates it by reference.
30
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
Monte Rosa Therapeutics, Inc. |
|
|
|
|
|
Date: November 7, 2024 |
|
By: |
/s/ Markus Warmuth |
|
|
|
Markus Warmuth |
|
|
|
Chief Executive Officer |
|
|
|
(Principal Executive Officer and Principal Financial Officer) |
31