美國
證券交易委員會
華盛頓特區20549
表格
(標記一個)
根據1934年證券交易法第13或15(d)條款的季度報告。 |
截至2024年6月30日季度結束
或
根據1934年證券交易法第13或15(d)條款的過渡報告 |
過渡期間為從＿＿＿＿＿至＿＿＿＿＿
委員會檔案編號：
（依憑章程所載的完整登記名稱）
(依據所在地或其他管轄區) 的註冊地或組織地點) |
(國稅局雇主識別號碼) |
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(總部辦公地址) |
（郵政編碼） |
註冊人的電話號碼，包括區號：(
根據法案第12(b)條規定註冊的證券：
每種類別的名稱 |
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交易 標的 |
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每個註冊交易所的名稱 |
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請在核對標記上打勾，確認申報人（1）已在前12個月（或申報人被要求提交此類申報的縮短期間）內提交證券交易所法案第13條或第15(d)條要求申報的所有報告，以及（2）過去90天一直處於此類申報要求的範圍內。
請打勾表明申報人在過去的12個月（或申報人需在該較短期間內提交這些檔案）中已根據《對S-t法規（本章節第232.405條）的規定405條》提交了所有必須提交的交互式資料檔案。
勾選表示登記人是大型加速申報人、加速申報人、非加速申報人、較小型申報公司或新興成長公司。詳細定義請參閱《交易所法》第1202條中“大型加速申報人”、“加速申報人”、“較小型申報公司”和“新興成長公司”的定義。
大型加速歸檔人 |
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☐ |
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加速歸檔人 |
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☐ |
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☒ |
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小型報告公司 |
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新興成長型企業 |
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如果一家新興成長型公司，請用勾選標記表示該申報人已選擇不使用根據證交所法案13(a)條款提供的任何新的或修訂過的財務會計準則的延長過渡期。
請勾選是否為外殼公司 (依照交易所法規定定義的外殼公司條款120億2)。是 ☐ 否
截至2024年11月4日，登記人士持有 61,436,740股普通股，每股0.0001美元，已發行。
關於前瞻性陳述的特別注意事項
本季度報告10-Q表格，或稱本季度報告，包含根據1933年證券法第27A條修正條款，即證券法，和根據1934年證券交易法第21E條修正條款，即交易法，所作的前瞻性陳述。本季度報告中除了歷史事實陳述之外的所有陳述均為前瞻性陳述。在某些情況下，您可以通過“可能”、“將”、“應該”、“期望”、“打算”、“計劃”、“預期”、“相信”、“估計”、“預測”、“潛在”、“持續”或這些術語的否定形式或其他可比術語來識別前瞻性陳述。這些陳述不是對未來業績或績效的保證，涉及重大風險和不確定性。本季度報告中的前瞻性陳述包括但不限於關於：
i
本季度報告中的任何前瞻性聲明都反映了我們對未來事件和未來財務業績的當前看法，並涉及已知和未知風險、不確定性和其他因素，這些因素可能導致我們的實際結果、業績或成就與這些前瞻性聲明所暗示的任何未來結果、業績或成就存在實質性差異。可能導致實際結果與當前預期大相徑庭的因素包括，但不限於，本季度報告中在第二部分第1A項「風險因素」和其他地方所描述的內容。鑑於這些不確定性，您不應過分依賴這些前瞻性聲明。
所有聲明僅適用於本季度報告的日期。在每種情況下，實際結果可能會大不同於這些前瞻性信息。我們無法保證這些期望或前瞻性聲明會被證明是正確的。本季度報告中提到的風險因素或風險和不確定性之一發生或發生任何重大不利變化，或者包含在其他公開披露或我們的其他定期報告或其他文件或提交的文件中，這可能會對我們的業務、前景、財務狀況和經營成果造成重大不利影響。除法律要求外，我們不打算或計劃更新或修訂任何此類前瞻性聲明，以反映實際結果、計劃變更、假設、估計或投影或其他影響此類前瞻性聲明的情況，即使在本季度報告日期之後發生新信息或此類結果、變化或情況表明任何前瞻性信息將不會實現。我們在本季度報告之後公開的任何聲明或披露，修改或影響本季度報告中包含的任何前瞻性聲明，將被視爲修改或取代本季度報告中的這些聲明。
我們可能不時提供關於我們行業、一般業務環境以及某些疾病市場的估計、預測和其他信息，包括有關這些市場潛在規模、特定醫療狀況的患病率和流行率的估計。基於估計、預測、投影、市場調研或類似方法的信息固有地存在不確定性，實際事件、情況或數據，包括實際疾病流行率和市場規模，可能與季度報告中反映的信息有實質上差異。除非另有明確說明，我們獲取這些行業、業務信息、市場數據、流行信息和其他數據是從市場調研公司和其他第三方、行業、醫學和普通出版物、政府數據以及類似來源的報告、研究、調查和類似數據中獲得的，在某些情況下應用我們自身的假設和分析，這些假設和分析在未來可能不準確。
商標
出於方便起見，在本報告中，我們的商標和商業名稱有時會被稱爲沒有®和™符號，但這些提及不應被理解爲我們不會在適用法律下全力主張我們對其的權利的任何指示。
ii
目錄
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第I部分 |
1 |
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項目1。 |
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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事項二 |
16 |
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第3項。 |
26 |
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事項4。 |
26 |
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第二部分 |
27 |
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項目1。 |
27 |
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項目1A。 |
27 |
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事項二 |
29 |
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第3項。 |
29 |
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事項4。 |
29 |
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項目5 |
29 |
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項目6。 |
30 |
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31 |
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iii
Pa第一部分 ─ 財務信息
項目1 控件m 1. 基本報表
Monte Rosa Therapeutics, Inc.
簡明綜合資產負債表資產負債表（未經審計）
(以千爲單位，除每股數據外) |
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9月30日, |
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12月31日, |
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(未經審計) |
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2024 |
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2023 |
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資產 |
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流動資產： |
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現金及現金等價物 |
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$ |
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$ |
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有價證券 |
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其他應收款 |
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預付費用和其他流動資產 |
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總流動資產 |
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資產和設備，淨值 |
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經營租賃權使用資產 |
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受限現金 |
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其他長期資產 |
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資產總額 |
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$ |
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$ |
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負債和股東權益 |
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流動負債: |
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應付賬款 |
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$ |
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$ |
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應計費用及其他流動負債 |
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短期遞延收入 |
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經營租賃負債流動部分 |
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流動負債合計 |
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遞延收入，淨額 |
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責任計劃負債 |
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運營租賃負債淨值 |
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負債合計 |
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股東權益 |
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優先股，$0.0001 |
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普通股，每股面值爲 $0.0001； |
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額外實收資本 |
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累計其他綜合損失 |
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( |
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( |
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累積赤字 |
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( |
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( |
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股東權益總額 |
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負債和股東權益總額 |
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$ |
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$ |
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請參見簡明合併財務報表的附註。
1
Monte Rosa Therapeutics, Inc.
經調整的綜合經營狀況陳述經營狀況及全面虧損的簡明綜述（未經審計）
(以千爲單位，除每股數據外) |
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三個月結束 |
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截至九個月結束 |
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(未經審計) |
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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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營業費用： |
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研發 |
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一般行政 |
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營業費用總計 |
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經營虧損 |
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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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淨外匯收益（損失） |
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( |
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( |
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固定資產處置收益 |
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可交易證券出售虧損 |
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總其他收入 |
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稅前淨虧損 |
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( |
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( |
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( |
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( |
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所得稅費用 |
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( |
) |
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( |
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( |
) |
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( |
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淨損失 |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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每股基本和攤薄淨虧損 |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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用於計算的加權平均股本數 |
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綜合虧損： |
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淨損失 |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
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$ |
( |
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其他綜合收益: |
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養老金福利義務準備 |
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可供出售證券未實現收益 |
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綜合損失 |
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$ |
( |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
請參見簡明合併財務報表的附註。
2
Monte Rosa Therapeutics, Inc.
壓縮的綜合股東權益財務報表 股東權益(未經審計)
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（以千爲單位，除股份數量外） |
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股份 |
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金額 |
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額外的 |
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累積的 |
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累積的 |
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總計 |
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2024年1月1日餘額 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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受限普通股解鎖 |
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— |
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— |
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— |
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— |
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— |
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行使普通股期權 |
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— |
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— |
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— |
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養老金福利義務準備 |
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— |
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— |
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— |
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— |
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股票補償費用 |
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— |
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— |
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— |
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— |
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可供出售證券的未實現損失 |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
根據市場銷售協議發行普通股 |
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— |
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— |
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— |
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淨虧損 |
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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日的資產負債表 |
|
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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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行使普通股期權 |
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— |
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— |
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— |
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養老金福利義務準備 |
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— |
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— |
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— |
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— |
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股票補償費用 |
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— |
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— |
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— |
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— |
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可供出售證券的未實現損失 |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
員工股票購買計劃下的股票發行 |
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— |
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— |
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— |
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根據現行市場銷售協議發行普通股，扣除發行成本$89 |
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— |
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— |
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— |
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根據承銷公開發行協議發行普通股，扣除發行成本$3,290 |
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— |
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— |
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發行預先融資認股權證，減去發行成本$290 |
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— |
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— |
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— |
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— |
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淨虧損 |
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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日結餘 |
|
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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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|
行使普通股期權 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
養老金福利義務準備 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
股票補償費用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
可供出售證券未實現收益 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
淨虧損 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
餘額-2024年9月30日 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
請參見附註的精簡合併財務報表
3
Monte Rosa Therapeutics, Inc.
股東權益簡明綜合報表（未經審計）- 續
|
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|||||||||
（以千爲單位，除股份數量外） |
|
股份 |
|
|
金額 |
|
|
額外的 |
|
|
累積的 |
|
|
累積的 |
|
|
總計 |
|
||||||
餘額-2023年1月1日 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
受限普通股解禁 |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
行使普通股期權 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
養老金福利義務準備 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
股票補償費用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
可供出售證券未實現收益 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
淨虧損 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
截至2023年3月31日餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
限制性普通股份解禁 |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
行使普通股期權 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
養老金福利義務準備 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
股票補償費用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
可供出售證券的未實現損失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
員工股票購買計劃下的股票發行 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
淨虧損 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
餘額—2023年6月30日 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
受限普通股解禁 |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
行使普通股期權 |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
養老金福利義務準備 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
股票補償費用 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
可供出售證券的未實現損失 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
淨虧損 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
2023年9月30日餘額 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
請參見附註的精簡合併財務報表
4
Monte Rosa Therapeutics, Inc.
壓縮綜合現金流量表現金流量表（未經審計）
（以千爲單位） |
|
九個月結束 |
|
|||||
(未經審計) |
|
2024 |
|
|
2023 |
|
||
經營活動現金流量： |
|
|
|
|
|
|
||
淨損失 |
|
$ |
( |
) |
|
$ |
( |
) |
調整淨虧損爲經營活動使用的現金淨額 |
|
|
|
|
|
|
||
股票補償費用 |
|
|
|
|
|
|
||
折舊 |
|
|
|
|
|
|
||
可交易證券折現/溢價的淨增值 |
|
|
( |
) |
|
|
( |
) |
可交易證券出售虧損 |
|
|
|
|
|
|
||
處置固定資產收益 |
|
|
|
|
|
( |
) |
|
營運資產和負債的變化 |
|
|
|
|
|
|
||
其他應收款 |
|
|
( |
) |
|
|
|
|
預付費用和其他流動資產 |
|
|
( |
) |
|
|
|
|
應付賬款 |
|
|
( |
) |
|
|
( |
) |
應計費用及其他流動負債 |
|
|
|
|
|
|
||
責任計劃負債 |
|
|
|
|
|
( |
) |
|
租賃資產和租賃負債 |
|
|
( |
) |
|
|
|
|
遞延收入 |
|
|
( |
) |
|
|
|
|
經營活動使用的淨現金流量 |
|
$ |
( |
) |
|
$ |
( |
) |
投資活動現金流量： |
|
|
|
|
|
|
||
購買固定資產 |
|
|
( |
) |
|
|
( |
) |
固定資產出售的收益 |
|
|
|
|
|
|
||
購買有市場流通的證券 |
|
|
( |
) |
|
|
( |
) |
出售有市場流通的證券收益 |
|
|
|
|
|
|
||
可市場出售證券到期款 |
|
|
|
|
|
|
||
投資活動產生的淨現金流量 |
|
$ |
( |
) |
|
$ |
|
|
籌集資金的現金流量： |
|
|
|
|
|
|
||
根據市場銷售協議出售普通股所得款項，扣除承銷商折讓$ |
|
|
|
|
|
|
||
承銷的公開發行成本款項，扣除承銷商折讓$ |
|
|
|
|
|
|
||
發行預資助認股證所得款項 |
|
|
|
|
|
|
||
支付普通股和預購權證發行成本 |
|
|
( |
) |
|
|
|
|
行使員工期權收到的款項 |
|
|
|
|
|
|
||
員工股票購買計劃收入 |
|
|
|
|
|
|
||
籌資活動產生的現金淨額 |
|
$ |
|
|
$ |
|
||
現金，現金等價物和受限現金淨增加（減少） |
|
$ |
( |
) |
|
$ |
|
|
資金現金及受限現金期初餘額 |
|
|
|
|
|
|
||
資金現金及受限現金期末餘額 |
|
$ |
|
|
$ |
|
||
現金、現金等價物和受限制的現金的調節 |
|
|
|
|
|
|
||
現金及現金等價物 |
|
$ |
|
|
$ |
|
||
受限現金 |
|
|
|
|
|
|
||
現金、現金等價物和受限制的現金總額 |
|
$ |
|
|
$ |
|
||
非現金項目的補充披露 |
|
|
|
|
|
|
||
減少租賃激勵應收款項的使用權資產 |
|
$ |
|
|
$ |
|
||
應付賬款及應計費用中的軟件開發成本 |
|
$ |
|
|
$ |
|
||
請參見簡明合併財務報表的附註。
5
Monte Rosa Therapeutics, Inc.
No適用於壓縮綜合財務報表
(未經審計)
1. 業務和流動性描述
按照我們所處的風險和不確定性的假設，結果和在本招股書或在任何文檔中引用的前瞻性陳述中討論的事件可能不會發生。投資者應謹慎對待這些前瞻性陳述，它們僅在本招股書或在文檔中通過引用作爲參考，其僅在本招股書或在文檔中通過引用作爲參考的文件的日期發表時存在。我們沒有任何義務，並明確聲明不承擔任何義務，更新或更改任何前瞻性陳述，無論是基於新信息、未來事件或其他原因。我們或代表我們行事的任何人作出的所有後續前瞻性陳述，都受到本節中所包含或所提到的警示性聲明的明確限制。
Monte Rosa Therapeutics, Inc.是一家生物技術公司，開發一系列新型小分子精準藥物組合，利用人體的自然機制選擇性降解治療相關蛋白質。在這些簡明綜合財務報表中，除非上下文另有要求，否則對公司或Monte Rosa的引用均指Monte Rosa Therapeutics, Inc.及其全資子公司Monte Rosa Therapeutics AG，或Monte Rosa AG，以及Monte Rosa Therapeutics Securities Corp. Monte Rosa Therapeutics AG是一家瑞士製造業公司，於2018年4月根據瑞士法律成立。Monte Rosa Therapeutics, Inc.於2019年11月在特拉華州成立。公司總部位於馬薩諸塞州波士頓，研究業務分別位於波士頓和瑞士巴塞爾。
流動性考慮
自創立以來，公司將幾乎所有精力投入到業務規劃、研究和開發、招聘管理和技術人員、籌集資金，主要通過發行和銷售可轉讓票據、可轉換優先股、普通股的公開發行、註冊直接發行，並通過與羅氏合作等方式籌集資金，並通過與羅氏合作等方式籌集資金。
公司持續發現和開發其產品候選者將需要大量額外的研究和開發工作，包括廣泛的臨床前和臨床測試以及商業化前的監管批准。這些工作需要大量額外的資金、足夠的人員和製造行業設施以及廣泛的合規性報告能力。即使產品開發工作取得成功，公司何時能夠從產品銷售中獲得顯著收入，仍是不確定的。
截至2024年9月30日，公司累計虧損爲 $
2. 重要會計政策摘要
做法的基礎
附註綜合基本報表按照美國通用會計準則進行編制，並以美元表示。這些附註中對適用指南的任何參考均意味着參照財務會計準則委員會的會計準則編碼和會計準則更新，即FASB。所有集團公司之間的餘額和交易在合併中已被消除。
未經審計的財務信息
The 公司的簡明綜合基本報表按照美國通用會計準則和證券交易委員會的規定編制。公司認爲，所提供的信息反映了在報告期間內爲公平呈現財務狀況和業務運營結果所需的所有調整，這些調整均屬於正常和經常性質。公司考慮了在資產負債表日期之後但在基本報表發佈前發生的事項或交易。
6
發行了 爲了提供相對於某些估計的額外證據或確定需要額外披露的事項。中期期間的經營業績並不能必然反映出全年或任何其他中期期間可以預期的結果。
最近發佈的會計準則
公司選擇使用《啓動我們的商業創業法案》（JOBS法案）所提供的符合新或修訂的會計準則的延長過渡期。
2023年11月，FASB發佈了ASU 2023-07《分部報告（主題280）：改進可報告分部披露》，意在提供增強的分部披露。該標準將要求披露重要分部費用和其他分部項目以及確定最高經營決策者以及他們如何使用報告的分部盈利衡量指標來評估分部績效和分配資源。這些增強披露需要所有實體每年和中期都進行，即使它們只有一個可報告分部。該標準於2023年12月15日後開始的年度生效，以及2024年12月15日後開始的年度期間內的中期也都適用，允許提前採納。公司目前正在評估這項公告對我們相關披露的影響。
2023年12月，FASB發佈了ASU 2023-09《所得稅（主題740）：所得稅披露的改進》，意在提供年度所得稅披露的增強。該標準將要求在稅率協調錶中提供更詳細的信息，以及對已支付的所得稅等其他增強。該標準於2024年12月15日後開始的年度生效，允許提前採納。採納該標準的影響將對附帶的簡明合併財務報表沒有實質影響。
\\\
3. 公允價值計量
以下表格展示了公司按照重複基礎上公允價值衡量的財務資產和負債的信息，並指示了用於判斷此類公允價值的公允價值層次的水平（以千爲單位）：
|
|
截至2024年9月30日 |
|
|||||||||||||
|
|
一級 |
|
|
二級 |
|
|
三級 |
|
|
總計 |
|
||||
流動資產 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
貨幣市場基金 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
養老金計劃資產 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
企業債券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
美國國債證券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
所有基金類型估值的資產總額 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
截至2023年12月31日 |
|
|||||||||||||
|
|
一級 |
|
|
二級 |
|
|
三級 |
|
|
總計 |
|
||||
流動資產 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
貨幣市場基金 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
養老金計劃資產 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
企業債券 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
美國國債 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
所有基金類型估值的資產總額 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
貨幣市場基金是高流動性投資，並且交易活躍。公司貨幣市場基金的定價信息基於活躍市場上相同證券的報價價格。這種方法導致將這些證券分類爲公允價值層級的一級。
養老金計劃資產的公允價值已確定爲在Columna Collective Foundation Group投資基金內持有的活躍投保成員組合的贖回價值，並被分類爲公允價值層級的二級。
可交易證券包括公司債券和美國國債證券，根據ASC 320分類爲可供出售。 投資-債務和股權證券可交易證券被分類爲公允價值層級的二級，因爲定價輸入除了活躍市場上的報價價格之外。這些投資的公允價值是通過考慮從第三方定價服務獲取的估值來估算的。定價服務使用行業標準估值模型，包括基於收入和市場的方法，其中所有重大輸入都是可觀察的，無論是直接還是間接，以估算公允價值。這些輸入包括相同或類似證券的報告交易、經紀/經銷商的報價、發行人信用差價、基於歷史數據的基準證券以及其他可觀察到的輸入。
7
截至2023年7月31日，續借貸款協議下未償還的借款額爲
4. 有價證券
截至2024年9月30日的可交易證券包括如下（單位：千美元） 2024年9月30日的可交易證券如下（單位：千美元）:
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分期償還的 |
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未實現的 |
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未實現的 |
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公平 |
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||||
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成本 |
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收益 |
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損失 |
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數值 |
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Description |
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企業債券 |
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$ |
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$ |
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$ |
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美國國債證券 |
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總計 |
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$ |
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$ |
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$ |
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$ |
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||||
2023年12月31日的可交易證券如下（以千爲單位）：
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分期償還的 |
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未實現的 |
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未實現的 |
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公平 |
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||||
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成本 |
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收益 |
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損失 |
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數值 |
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Description |
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||||
企業債券 |
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$ |
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$ |
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$ |
( |
) |
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|||
美國財政部證券 |
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( |
) |
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總計 |
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$ |
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$ |
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$ |
( |
) |
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$ |
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|||
截至2024年9月30日，沒有個別證券處於未實現損失位置。公司持有高信用質量公司的債務證券，並確定其債務證券的信用風險沒有發生實質性變化。 公司還相信將能夠在到期時收回到期本金和利息金額。
5. 資產和設備淨額
固定資產及設備淨值包括以下內容（以千爲單位）：
|
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9月30日, |
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12月31日, |
|
||
實驗室設備 |
|
$ |
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$ |
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||
電腦硬件和軟件 |
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2,551 |
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租賃改良 |
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在建工程 |
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總資產和設備，成本 |
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$ |
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$ |
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||
減：累計折舊 |
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( |
) |
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( |
) |
資產和設備，淨值 |
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$ |
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$ |
|
||
以下表格總結了發生的折舊費用（以千元計）：
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三個月結束 |
|
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九個月結束 |
|
||||||||||
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2024 |
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2023 |
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2024 |
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2023 |
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||||
折舊費用 |
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$ |
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$ |
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$ |
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$ |
|
||||
6. 應計費用和其他流動負債
應計費用和其他流動負債包括以下項目（以千爲單位）：
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9月30日, |
|
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12月31日, |
|
||
|
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2024 |
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2023 |
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||
薪酬和福利 |
|
$ |
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$ |
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||
已發生的研究和開發 |
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||
其他 |
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其他流動負債總額 |
|
$ |
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|
$ |
|
||
8
7. 租賃
公司確定安排是否在初始階段爲租賃。 營業租賃包括在簡表合併資產負債表的營業租賃權益或ROU資產和營業租賃負債中。 公司有
ROU資產代表使用權益在租賃期內使用基礎資產的權利，租賃負債代表源自租賃的租金支付義務。 營業租賃ROU資產和負債根據租賃期內租金支付的現值於起始日期確認。 由於公司的租賃沒有提供隱含利率，管理層根據公司借入類似金額在類似期限內以抵押爲基礎支付的利率，估算增量借貸利率。 公司根據初始階段可用信息，使用其增量借貸利率確定租金支付的現值。
Klybeckstrasse租賃
2021年3月，公司與Wincasa AG簽訂了一份辦公室和實驗室空間的營業租賃協議，位於瑞士巴塞爾州巴塞爾市Klybeckstrasse 191號，佔地約
Harrison Avenue租約
2021年12月，公司簽訂了一份不可取消的辦公室和實驗室空間租賃協議，面積爲
根據哈里森大道租賃協議的條款，房東已經爲公司報銷了$元
截至2024年9月30日的三個和九個月的租賃費用包括以下幾項（以千元計）： 九個月的租賃費用包括以下幾項（以千元計）：
|
|
三個月結束 |
|
|
九個月結束 |
|
||||||||||
|
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2024 |
|
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2023 |
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2024 |
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2023 |
|
||||
營業租賃費用 |
|
$ |
|
|
$ |
|
|
$ |
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|
$ |
|
||||
變量租賃費用 |
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||||
租賃總費用 |
|
$ |
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|
$ |
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|
$ |
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|
$ |
|
||||
變量租賃費用通常包括公共區維護和物業稅。
以下表格總結了發生的租賃費用（以千爲單位）：
|
|
三個月結束 |
|
|
九個月結束 |
|
||||||||||
|
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2024 |
|
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2023 |
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2024 |
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2023 |
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||||
研發 |
|
$ |
|
|
$ |
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$ |
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$ |
|
||||
一般行政 |
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|
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|
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|
||||
租賃總費用 |
|
$ |
|
|
$ |
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|
$ |
|
|
$ |
|
||||
2024年9月30日止九個月的短期租賃成本和2023年均不重要。
與公司租賃相關的加權平均剩餘租賃期限和折現率如下：
9
|
|
截至2023年9月30日年
度報告 |
|
|
截至12月31日公允價值 |
|
||
加權平均剩餘租賃期限（年） |
|
|
|
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|
|
||
加權平均折扣率 |
|
|
% |
|
|
% |
||
有關本公司租約的補充現金流信息如下 2024年9月30日結束的九個月的信息如下（以千爲單位）：
|
|
九個月結束 |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
交易租賃義務獲取的右 of use 資產 |
|
$ |
|
|
$ |
|
||
用於計量租賃負債的現金支付 |
|
$ |
|
|
$ |
|
||
2024 年 9 月 30 日至 2023 年 9 月 30 日 ROU 資產的分期攤銷爲 $
截至 2024 年 9 月 30 日，截至每年 12 月 31 日的非可取消租約的未來最低租金支付額如下（以千爲單位）：
未折現租金支付額 |
|
|
|
|
2024 |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
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2027 |
|
|
|
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2028 |
|
|
|
|
此後 |
|
|
|
|
未折扣的最低租賃支付總額 |
|
|
|
|
少：推定利息 |
|
|
( |
) |
總經營租賃負債 |
|
$ |
|
|
8. 承諾和或有事項
法律訴訟
公司可能不時受到在業務日常運作中出現的法律訴訟，索賠和糾紛的影響。公司在未來支出可能性及支出可以合理估計時爲此類事項計提負債。截至2024年9月30日公司目前沒有參與訴訟，並且沒有爲任何訴訟責任設立或有準備金。
9. 合作與許可協議
羅氏合作與許可協議
Description
2023年10月，蒙特羅薩治療學AG，蒙特羅薩治療學公司全資子公司，與F·霍夫曼 - 萊洛仁公司或公司簽訂了一項合作與許可協議，即羅氏協議，與洛氏藥廠有限公司和洛氏藥廠股份公司，或羅氏。 根據協議，各方將尋求利用公司的專有藥物發現平台針對羅氏在腫瘤學和神經科學領域選擇的一組初始靶向癌症或神經疾病的分子膠水降解劑，或MGD，進行識別和開發，羅氏有權將合作擴展至包括其他選擇目標的合作選項，其中羅氏選擇的一定數量目標受羅氏擁有的替換權的限制。 公司將負責主導前臨床發現和研究活動，羅氏將領導後期前臨床和臨床開發活動。
根據羅氏協議，羅氏將在公司控制的專利和專有技術下擁有全球獨家許可權，用於開發和商業化針對適用目標的產品。 許可排他性受公司保留的權利的限制，僅用於履行協議下的義務。
羅氏協議規定的研究合作活動將由聯合研究委員會監督。
除非提前終止，羅氏協議將在協議下授權的每個產品的專利期限屆滿前保持有效。 合同中包含了終止條款，可按照整體、按國家或按目標的方式終止羅氏協議。
10
定價
2023 年 11 月，公司收到了 $
截至2024年9月30日，該公司已收到900萬美元，這與羅氏決定行使持續研發服務的期權有關。在隨附的簡明合併資產負債表中，相關付款最初被歸類爲遞延收入，並在提供相關研發服務時確認爲收入。
會計
本協議代表與客戶的交易，因此根據ASC 606進行覈算 與客戶簽訂合同的收入.
該公司確定，每個合作目標的開發和商業化許可證在背景下與承諾的初步研究服務既不能區分也不能區別。此外，公司已確定協議中的每個目標都與其他目標不同，因爲：（i）羅氏可以自行受益於給定目標的許可和研究服務，因爲可以對與之相關的結果進行離散評估；（ii）每個目標的研發結果不會影響公司的表現能力或羅氏評估任何其他目標結果的能力。因此，公司已在協議中確定了某些履約義務如下：
羅氏協議的總交易價格根據其相對獨立銷售價格分配給履約義務。該公司制定了羅氏協議中包含的履約義務的獨立銷售價格，確定了履行每項履約義務的估計總成本，目的是確定定期獨立出售此類物品的價格。 分配的交易價格通過以下兩種方式之一確認爲合作協議的收入：
截至 2024 年 9 月 30 日， $
10. 股本
未指定的優先股
公司
11
普通股
公司
此外，公司已向一位認可的投資者發行了預資助的權證，以購買
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
普通股持有人有權投票。每股普通股有一票，沒有累積投票權。
公司向創始人、員工和顧問發行了受限股票，對這些受限股票的費用按照直線法確認（見附註11）。這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，公司已爲受限股票解禁和期權行權而預留了以下普通股。
|
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9月30日, |
|
|
12月31日, |
|
||
期權購買普通股 |
|
|
|
|
|
|
||
未授予的受限普通股獎勵 |
|
|
|
|
|
|
||
未授予的受限普通股單位 |
|
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預融資認股權證 |
|
|
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|
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||
|
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||
按市場價格發行股票
2022年7月，公司與Jefferies LLC（以下簡稱"Jefferies"）簽訂了銷售協議，即銷售協議，根據該協議，公司可以通過Jefferies進行"市場價"的方式，不時地提供並出售其普通股，募集的總毛收益高達$
承銷公開發行
2024年5月，公司與TD證券（美國）有限責任公司（作爲若干承銷商的代表）簽訂了一份承銷協議，與承銷公開發行有關，或者稱爲本次發行，每股售價爲
註冊直接發行
2023年10月，公司根據證券購買協議進行的直接註冊發行中出售了預融資認股權，以購買價格爲$每份預融資認股權向一家合格投資者出售了
12
11。基於股票的薪酬
2020 年股票激勵計劃
公司的2020年股票期權和贈款計劃（即2020年計劃）規定，公司向員工、非僱員董事和顧問授予股票期權、限制性股票和其他股票獎勵。2021年計劃（定義見下文）生效後，沒有根據2020年計劃發佈進一步的通知。
2021 年股票激勵計劃
公司的 2021 年股票期權和激勵計劃（即 2021 年計劃）於 2021 年 5 月 28 日獲得公司董事會批准，並於 2021 年 6 月 17 日獲得公司股東的批准，並於公司首次公開募股註冊聲明宣佈生效之日前夕生效。2021年計劃規定向公司高管、員工、董事和顧問授予激勵性股票期權、非合格股票期權、股票增值權、限制性股票單位、限制性股票獎勵、非限制性股票獎勵、現金獎勵和股息等值權利。根據2021年計劃最初預留髮行的股票數量爲
2021 年員工股票購買計劃
公司的 2021 年員工股票購買計劃（即 2021 年 ESPP）於 2021 年 5 月 28 日獲得公司董事會批准，並於 2021 年 6 月 17 日獲得公司股東的批准，並於公司首次公開募股註冊聲明宣佈生效之日前夕生效。總共有
股票期權活動
以下總結了股票期權活動：
|
|
的數量 |
|
|
加權 |
|
|
加權 |
|
|
聚合 |
|
||||
傑出——2023 年 12 月 31 日 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
已授予 |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
已鍛鍊 |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
— |
|
|
被沒收 |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
— |
|
|
傑出——2024 年 9 月 30 日 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
已歸屬或預計將維斯特 — 2024 年 9 月 30 日 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
可鍛鍊——2024 年 9 月 30 日 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
授予期權的總內在價值按期權行使價與公司普通股估計公允價值之間的差額計算。
限制性股票獎勵活動
根據2020年計劃，向員工發放了未歸屬的限制性股票獎勵。限制性股票獎勵通常在四年內發放，前提是個人繼續在公司工作。
13
以下是限制性股票獎勵活動的總結：
|
|
數量 |
|
|
已授予和預期於2021年1月2日授予股份 |
|
||
截至2023年12月31日的未發行限制性股票獎勵 |
|
|
|
|
$ |
|
||
34,105 |
|
|
( |
) |
|
$ |
|
|
截至2024年9月30日的未發行限制性股票獎勵 |
|
|
|
|
$ |
|
||
在截至2024年9月30日的九個月內解限制的限制性股票獎勵的累計公允價值爲 $
限制性股票單位活動
公司從2022年開始根據2021年計劃向員工授予受限股票單位（RSUs）。每個RSU代表在解鎖時獲得一股公司普通股的權利。只要個人繼續在公司連續服務，RSUs將在兩年內解鎖。因此，每個RSU的股票補償費用按照解鎖期間的直線方式確認。每個RSU的公允價值基於授予日公司普通股的收盤價。
以下總結了受限制股票單位的活動：
|
|
數量 |
|
|
已授予和預期於2021年1月2日授予股份 |
|
||
2023年12月31日尚未歸屬的受限股票單位 |
|
|
|
|
$ |
|
||
已行權 |
|
|
|
|
$ |
|
||
34,105 |
|
|
( |
) |
|
$ |
|
|
被取消 |
|
|
( |
) |
|
$ |
|
|
2024年9月30日尚未歸屬的受限股票單位 |
|
|
|
|
$ |
|
||
截至2024年9月30日和2023年結束的九個月內已授予的受限股票單位的總公允價值爲 $
股票補償費用
股票期權補償費用按以下分類（單位：千）進行分類：
|
|
九個月結束 |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
研發 |
|
$ |
|
|
$ |
|
||
一般行政 |
|
|
|
|
|
|
||
共計股份獎勵支出 |
|
$ |
|
|
$ |
|
||
截至2024年9月30日，未實現的股票期權和限制性股票單位相關的總未確認股票報酬成本分別爲 $
12. 所得稅
在2024年和2023年截至9月30日的每個月，公司記錄了百萬美元的所得稅費用。所得稅費用主要與馬薩諸塞州可交易證券的利息收入以及資本化研究與開發費用產生的美國應稅收入有關。 $
公司繼續對其所有遞延稅資產保持完全減值準備。公司評估了涉及其能否實現遞延稅資產的積極和消極證據。公司考慮了自創立以來累積淨虧損的歷史和缺乏任何商業產品的情況。公司得出結論，很可能不會實現遞延稅資產的利益。公司在每個報告期重新評估積極和消極證據。
14
13. 每普通股淨虧損
基本和稀釋每股淨虧損是根據期間內普通股權重平均數計算的。公司普通股基礎和稀釋收益每股中包括預先擬定認股權證所代表的公司普通股。
|
|
三個月結束 |
|
|
九個月結束 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
淨損失 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
每股普通股淨虧損，基礎和稀釋後 |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
在計算淨虧損時使用的普通股加權平均數 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
以下未列入計算稀釋每股淨虧損的待發行潛在稀釋證券，因其效果不具稀釋性：
|
|
9月30日, |
|
|
9月30日, |
|
||
|
|
2024 |
|
|
2023 |
|
||
期權購買普通股 |
|
|
|
|
|
|
||
限制性普通股 |
|
|
|
|
|
|
||
限制性股票單位 |
|
|
|
|
|
|
||
14. 員工養老計劃
根據瑞士法律，公司與AXA Leben AG簽訂了定義利益計劃的養老金福利提供合同。所有福利組織在與AXA簽訂的合同框架內，由半自治的集體基金管理。 AXA直接支付到有資格的個人名下的保險福利。養老金計劃由員工和僱主的捐款資助。公司與集體基金之間的合同可以被任何一方終止。在終止的情況下，公司有義務爲員工找到替代的養老安排。由於無法保證員工養老安排將以相同條件繼續下去，公司可能會承擔養老金責任，儘管可能性很小。養老金資產被彙集到所有關聯公司中；資產的投資由集體基金的治理機構負責。
以下表格總結了發生的養老金費用（以千爲單位）：
|
|
三個月結束 |
|
|
九個月結束 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
養老金費用 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
公司於2021年2月實施了一項旨在符合《內部稅收法》第401（k）條的僱員定額捐款計劃，旨在涵蓋公司所有符合條件的美國僱員。所有員工都有資格立即成爲該計劃的參與者。每位在職員工可自願選擇每年向該計劃捐款一定比例的補償，但需遵守一定限制。公司保留權利但不被迫向該計劃額外捐款。公司進行安全港配對捐款，爲每位參與者的合格補償的（百分比）提供配對。
以下表格總結了發生的定額捐款費用（以千爲單位）：
|
|
三個月結束 |
|
|
九個月結束 |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
定義繳費支出 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
15
15。隨後發生的事件
2024年10月25日，Monte Rosa Therapeutics, Inc.（本公司）的全資子公司Monte Rosa Therapeutics AG與諾華製藥股份公司（Novartis）簽訂了許可協議或諾華協議。根據諾華協議，公司將向諾華授予獨家、特許使用費、可再許可和可轉讓的許可，用於開發、製造和商業化VAV1 MGD，包括mRT-6160，該藥物目前處於免疫介導疾病的1期臨床開發階段。公司負責完成正在進行的1期臨床研究，諾華負責從第二階段開始的所有後續開發和商業活動。受協議約束的開發和商業活動將由開發委員會和商業化委員會監督。
根據諾華協議，公司有權從諾華（1）獲得預付款 $
諾華協議受慣例成交條件的約束，包括1976年《哈特-斯科特-羅迪諾反壟斷改進法》下的監管許可。
雙方在協議中納入了習慣性終止條款，包括諾華完全終止諾華協議的能力。
項目1 控件管理層討論和分析財務狀況和經營業績
應該結合本季度報告中其他地方包含的未經審計的精簡綜合基本報表和相關附註閱讀以下討論和分析。本討論和分析以及本季度報告的其他部分包含基於當前信念、計劃和期望的前瞻性聲明，涉及風險、不確定性和假設，例如關於我們計劃、目標、期望、意圖和預期的聲明。由於多種因素，包括我們2023年年度報告中「第I部分，1A項目，風險因素」和本季度報告其他地方的「II部分，1A項目，風險因素」中所列明的因素，我們實際結果和選擇事件的時間可能與預期的前瞻性聲明有實質不同。您應仔細閱讀本季度報告的「風險因素」部分，以了解可能導致實際結果與我們前瞻性聲明實質不同的重要因素。也請參閱標題爲"關於前瞻性聲明的特別說明"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