0.010.010001814114--12-312024Q300Orchestra BioMed Holdings，Inc。P12MP24M0.020.030P6Mhttp://fasb.org/us-gaap/2024#優先利率會員P4YP2Yhttp://fasb.org/us-gaap/2024#PrimeRateMemberhttp://fasb.org/us-gaap/2024#PrimeRateMemberP4Y假0001814114srt : 最低成員obio : 贊助會員持有的私人認股權證2024-09-300001814114srt : 最大成員obio : 贊助會員持有的私人認股權證2024-09-300001814114us-gaap:限制性股票成員obio : 遺產管弦樂隊權證成員us-gaap:測量輸入無風險利率成員obio : 2023年股權激勵計劃成員2024-09-300001814114us-gaap:限制性股票成員obio : 遺產管弦樂隊權證成員us-gaap:測量輸入價格波動率成員obio : 2023年股權激勵計劃成員2024-09-300001814114us-gaap:限制性股票成員obio : 遺產樂團認股權證成員us-gaap:測量輸入預期期限成員obio : 股權激勵計劃2023成員2024-09-300001814114us-gaap:限制股票成員obio : 遺產樂團認股權證成員us-gaap:衡量輸入預期股息率成員obio : 股權激勵計劃2023成員2024-09-300001814114obio : 股權分類大道認股權證成員us-gaap:測量輸入價格波動成員2023-10-060001814114us-gaap:測量輸入無風險利率成員2023-10-060001814114srt : 最低成員obio : 普通認股權證成員us-gaap:測量輸入行使價格成員2023-01-260001814114srt : 最高成員obio : 普通認股權證成員us-gaap:測量輸入行使價格成員2023-01-260001814114srt : 最低成員us-gaap: 測量輸入無風險利率成員2023-01-260001814114srt : 最低成員us-gaap: 測量輸入價格波動性成員2023-01-260001814114srt : 最低成員us-gaap: 測量輸入預期期限成員2023-01-260001814114srt : 最高成員us-gaap: 測量輸入無風險利率成員2023-01-260001814114srt : 最大成員us-gaap:測量輸入價格波動性成員2023-01-260001814114srt : 最大成員us-gaap:測量輸入預期期限成員2023-01-260001814114us-gaap:測量輸入股價成員2023-01-260001814114us-gaap:測量輸入預期股息率成員2023-01-260001814114obio : 健康科學收購公司 2 成員obio : 美敦力公司 成員obio : 前向購買協議成員2023-01-302023-01-300001814114obio : 健康科學收購公司2成員obio : 美敦力公司成員obio : 前向購買協議成員2023-01-202023-01-200001814114us-gaap:普通股成員2024-01-012024-03-310001814114us-gaap:普通股成員2023-07-012023-09-300001814114obio : 架棚註冊聲明成員2024-01-012024-09-300001814114obio : 銷售協議成員2024-01-012024-09-300001814114obio : 健康科學收購公司 2 會員obio : Rtw 投資合夥公司 會員obio : 後盾協議 會員2023-01-252023-01-250001814114us-gaap:保留盈餘成員2024-09-300001814114us-gaap:額外繳入資本成員2024-09-300001814114us-gaap:累計其他綜合收益成員2024-09-300001814114us-gaap:保留盈餘 會員2024-06-300001814114us-gaap:額外支付的資本 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先前報告的情境成員us-gaap:累計其他綜合收益成員2022-12-310001814114us-gaap:保留盈餘成員2022-12-310001814114us-gaap:額外實收資本成員2022-12-310001814114us-gaap:累計其他綜合收益成員2022-12-310001814114us-gaap:普通股成員2024-09-300001814114us-gaap:CommonStockMember2024-06-300001814114us-gaap:CommonStockMember2024-03-310001814114us-gaap:CommonStockMember2023-12-310001814114us-gaap:CommonStockMember2023-09-300001814114us-gaap:CommonStockMember2023-06-300001814114us-gaap:CommonStockMember2023-03-310001814114us-gaap:CommonStockMember2022-12-310001814114us-gaap: 員工股票選擇權成員2024-09-300001814114us-gaap:員工股票期權成員2023-09-300001814114obio : Orchestra Biomed Inc 成員obio : 2023年股權激勵計劃成員2024-01-012024-09-300001814114obio : 2018年及2023年股權激勵計劃成員2023-01-012023-09-300001814114obio : 2018年及2023年股權激勵計劃成員2023-01-012023-12-310001814114obio : 2018年及2023年股權激勵計劃成員2023-12-310001814114obio : 2018年及2023年股權激勵計劃成員2024-01-012024-09-300001814114obio : 2018年及2023年股權激勵計劃成員2024-09-300001814114obio : Orchestra Biomed Inc 成員obio : 2018年股權激勵計劃 成員2024-09-300001814114obio : 2023年股權激勵計劃 成員2024-09-300001814114us-gaap:員工股票期權成員2024-01-012024-09-300001814114us-gaap:員工股票期權成員2023-01-012023-09-300001814114us-gaap:限制性股票成員2024-09-300001814114us-gaap:限制性股票成員2023-12-310001814114us-gaap:限制性股票成員2024-01-012024-09-300001814114obio : 基於績效的限制性股票獎勵 會員2024-01-012024-09-300001814114obio : Orchestra Biomed Inc 會員srt : 最高會員obio : 2018年股權激勵計劃 會員2024-01-012024-09-300001814114us-gaap：產品成員2024-07-012024-09-300001814114obio : 夥伴收入 會員2024-07-012024-09-300001814114us-gaap:產品會員2024-01-012024-09-300001814114obio : 夥伴收入 會員2024-01-012024-09-300001814114us-gaap:產品成員2023-07-012023-09-300001814114obio : 合作夥伴收入成員2023-07-012023-09-300001814114us-gaap:產品成員2023-01-012023-09-300001814114obio : 合作夥伴收入成員2023-01-012023-09-3000018141142025-10-012024-09-3000018141142024-10-012024-09-300001814114srt : 最小成員美元指數:辦公設備成員2024-09-300001814114srt : 最大成員us-gaap:辦公設備成員2024-09-300001814114obio : 研究與開發設備成員2024-09-300001814114obio : 製造設備成員2024-09-300001814114us-gaap:辦公設備成員2024-09-300001814114us-gaap：租賃權和租賃改良成員2024-09-300001814114美國通用會計原則：設備成員2024-09-300001814114us-gaap:辦公設備成員2023-12-310001814114us-gaap:租約及租約改善成員2023-12-310001814114us-gaap:設備成員2023-12-310001814114obio : 開放市場銷售協議成員2024-07-112024-07-110001814114obio : 策略性投資Motus GI成員2023-12-310001814114obio : Haemonetics Corporation成員obio : 策略性投資Vivasure成員2022-05-310001814114us-gaap:保留盈餘成員2024-07-012024-09-300001814114us-gaap:保留盈餘成員2024-04-012024-06-300001814114us-gaap:保留盈餘成員2024-01-012024-03-310001814114us-gaap:保留盈餘成員2023-07-012023-09-300001814114us-gaap:保留盈餘成員2023-04-012023-06-300001814114us-gaap:保留盈餘成員2023-01-012023-03-310001814114us-gaap:累計其他綜合收益成員2024-07-012024-09-300001814114us-gaap:累計其他綜合收益成員2024-04-012024-06-300001814114us-gaap:累計其他綜合收益成員2024-01-012024-03-310001814114us-gaap:累計其他綜合收益成員2023-07-012023-09-300001814114us-gaap:累計其他綜合收益成員2023-04-012023-06-300001814114us-gaap:累計其他綜合收益成員2023-01-012023-03-3100018141142023-04-122023-04-120001814114us-gaap:權證成員2023-09-300001814114us-gaap:權證成員2022-12-310001814114obio : Orchestra Biomed Inc 成員us-gaap:權證成員obio : 2023年度股權激勵計劃成員2024-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:限制性股票成員obio : 2023年度股權激勵計劃成員2024-09-300001814114obio : Orchestra Biomed Inc 會員us-gaap:職員股票期權會員obio : 2023 年股權激勵計劃會員2024-09-3000018141142023-01-012023-01-010001814114obio : 策略性投資 Motus GI 會員2023-07-012023-09-300001814114srt : 最大會員obio : 2024 年貸款及擔保協議會員us-gaap:後續事件成員2024-11-060001814114srt : 最大會員obio : 二零一九年貸款與擔保協議成員2022-06-300001814114obio : 二零二四年貸款與擔保協議第二和第三筆成員us-gaap:後續事件成員2024-11-060001814114obio : 二零二四年貸款與擔保協議第一筆成員us-gaap:後續事件成員2024-11-060001814114obio : 二零二四年貸款與擔保協議第四筆成員us-gaap:後續事件成員2024-11-060001814114obio : 二零二二年貸款與擔保協議第二筆成員2022-06-300001814114obio : 二零二二年度貸款和擔保協議第三批成員2022-06-300001814114obio : 二零二二年度貸款和擔保協議第一批成員2022-06-300001814114srt : 最大成員obio : 二零二四年度貸款和擔保協議成員us-gaap: 隨後事件成員2024-11-062024-11-060001814114srt : 最大成員obio : 二零一九年度貸款和擔保協議成員2022-06-012022-06-300001814114obio : Terumo 成員us-gaap：合作安排成員2024-09-300001814114obio : Terumo 成員us-gaap:合作安排成員2023-12-310001814114obio : Terumo 成員us-gaap:合作安排成員2023-09-300001814114obio : Terumo 成員us-gaap:合作安排成員2022-12-310001814114obio : Legacy Orchestra 成員2024-09-300001814114obio : 遺產管弦樂團成員2023-01-250001814114obio : 管弦樂生物醫學公司成員obio : 2023年股權激勵計劃成員2024-09-300001814114obio : 2018年股權激勵計劃成員2024-09-300001814114obio : 股權分類認股權證成員2024-09-300001814114obio : 股權分類遺產管弦樂團認股權證成員2024-09-300001814114us-gaap:限制性股票成員obio : 遺產管弦樂團認股權證成員obio : 2023年股權激勵計劃成員2023-12-310001814114obio : 贊助成員持有的私人認購權證2023-12-310001814114obio : 員工持有的私人認購權證成員2023-12-310001814114obio : 股票分類認購權證成員2023-12-310001814114obio : 股票分類傳統樂隊認購權證成員2023-12-310001814114obio : 股票分類大道認購權證成員2023-12-310001814114obio : Hsac 2 Holdings Llc 成員obio : 私人認購權證成員2023-01-260001814114obio : 健康科學收購公司2成員obio : 贊助商成員持有的私人認股權證2023-01-260001814114obio : 贊助商成員持有的私人認股權證2023-01-260001814114obio : 普通認股權證成員2022-12-310001814114us-gaap:受限股票成員obio : 傳承管弦樂團認股權證成員obio : 2023年股權激勵計畫成員2024-09-300001814114srt : 最低成員obio : 股權分類傳承管弦樂團權證成員2024-09-300001814114srt : 最大成員obio : 股權分類傳承管弦樂團權證成員2024-09-300001814114obio : 贊助商持有的私募權證成員2024-09-300001814114obio : 員工持有的私募權證成員2024-09-300001814114obio : 股權分類大道權證成員2024-09-300001814114obio : 基金一和二的權證成員obio : 兩千二十二年貸款及擔保協議成員2023-10-0600018141142023-09-300001814114obio : 傳承管弦樂團成員obio : 健康科學收購公司2成員2022-12-310001814114us-gaap:公司債務證券成員2023-12-310001814114USGovernmentDebtSecuritiesMember2023-12-310001814114us-gaap:公平價值輸入級別2成員us-gaap:企業債務證券成員2024-09-300001814114us-gaap:公平價值輸入層級1成員us-gaap:貨幣市場基金成員2024-09-300001814114us-gaap:貨幣市場基金成員2024-09-300001814114us-gaap:公平價值輸入級別2成員2024-09-300001814114us-gaap:公平價值輸入級別1成員2024-09-300001814114us-gaap:公司債券證券成員2024-09-300001814114us-gaap:公平價值輸入級別2成員obio : 公司及政府債券證券成員2023-12-310001814114us-gaap:公平價值輸入級別1成員us-gaap:由私人企業發行的抵押擔保證券成員2023-12-310001814114us-gaap:公允價值層級1成員us-gaap:貨幣市場基金成員2023-12-310001814114us-gaap:私人企業發行的抵押擔保證券成員2023-12-310001814114us-gaap:貨幣市場基金成員2023-12-310001814114us-gaap:公允價值層級2成員2023-12-310001814114us-gaap:公允價值層級1成員2023-12-310001814114obio : 公司與政府債務證券成員2023-12-310001814114obio : 策略性投資Motus GI成員2024-01-012024-09-300001814114obio : 策略性投資 Motus GI 成員2023-01-012023-09-300001814114obio : 策略性投資 Vivasure 成員2019-10-012019-12-3100018141142024-08-3100018141142022-11-3000018141142019-11-300001814114us-gaap:權證成員2024-01-012024-09-300001814114us-gaap:限制性股票成員2024-01-012024-09-300001814114us-gaap: 員工股票選擇權成員2024-01-012024-09-300001814114obio : 可沒收股份成員2024-01-012024-09-300001814114obio : 獲利考量成員2024-01-012024-09-300001814114us-gaap:權證成員2023-01-012023-09-300001814114us-gaap:限制性股票成員2023-01-012023-09-300001814114us-gaap:員工股票期權成員2023-01-012023-09-300001814114us-gaap：可轉換債務證券會員2023-01-012023-09-300001814114obio : 可沒收股份成員2023-01-012023-09-300001814114obio : 獲利考量成員2023-01-012023-09-300001814114obio : 股權分類途徑認股權證成員2023-01-012023-12-310001814114obio : Orchestra Biomed Inc成員us-gaap:認股權證成員us-gaap:銷售總務及管理費用會員obio : 2023年股權激勵計劃成員2024-07-012024-09-300001814114obio : Orchestra Biomed Inc成員us-gaap:權證成員us-gaap:研究與開發費用成員obio : 2023年股權激勵計劃成員2024-07-012024-09-300001814114obio : Orchestra Biomed Inc成員us-gaap:限制性股票成員us-gaap:銷售、一般與行政費用成員obio : 股權激勵計劃2023成員2024-07-012024-09-300001814114obio : Orchestra Biomed Inc成員us-gaap:限制性股票成員us-gaap:研究與開發費用成員obio : 股權激勵計劃2023成員2024-07-012024-09-300001814114obio : Orchestra Biomed Inc成員us-gaap:員工股票選擇權成員us-gaap:售銷、一般及管理費用成員obio : 股權激勵計劃2023成員2024-07-012024-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:員工股票選擇權成員us-gaap:研究與開發費用成員obio : 股權激勵計劃2023成員2024-07-012024-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:權證成員obio : 2023年股權激勵計劃成員2024-07-012024-09-300001814114obio : Orchestra Biomed Inc成員us-gaap:限制性股票成員obio : 2023年股權激勵計劃成員2024-07-012024-09-300001814114obio : Orchestra Biomed Inc成員us-gaap:員工股票期權成員obio : 2023年股權激勵計劃成員2024-07-012024-09-300001814114obio : Orchestra Biomed Inc成員us-gaap:權益認股權證成員us-gaap:銷售、一般及行政費用成員obio : 2023年股權激勵計畫成員2024-01-012024-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:權益認股權證成員us-gaap:研究與開發費用成員obio : 2023年股權激勵計畫成員2024-01-012024-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:受限制股票成員us-gaap:銷售、一般及管理費用成員obio : 2023年權益激勵計劃成員2024-01-012024-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:受限制股票成員us-gaap:研究與發展費用成員obio : 2023年權益激勵計劃成員2024-01-012024-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:員工股票選擇權成員us-gaap:銷售、一般及行政費用成員obio : 2023年股權激勵計劃成員2024-01-012024-09-300001814114obio : Orchestra Biomed Inc成員us-gaap:員工股票選擇權成員us-gaap:研究與發展費用成員obio : 2023年股權激勵計劃成員2024-01-012024-09-300001814114obio : Orchestra Biomed Inc成員us-gaap:權證成員obio : 2023年股權激勵計劃成員2024-01-012024-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:限制性股票成員obio : 2023年股權激勵計劃成員2024-01-012024-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:員工股票選擇權成員obio : 2023年股權激勵計劃成員2024-01-012024-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:Warrant成員us-gaap:銷售、總務及行政費用成員obio : 2023年股權激勵計畫成員2023-07-012023-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:Warrant成員us-gaap:研究與開發費用成員obio : 2023年股權激勵計畫成員2023-07-012023-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:限制性股票成員us-gaap:銷售、一般及行政費用成員obio : 2023 年度股權激勵計劃成員2023-07-012023-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:限制性股票成員us-gaap:研究與開發費用成員obio : 2023 年度股權激勵計劃成員2023-07-012023-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:僱員股票期權成員us-gaap:銷售一般及行政開支成員obio : 2023年股權激勵計劃成員2023-07-012023-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:僱員股票期權成員us-gaap:研究與開發開支成員obio : 2023年股權激勵計劃成員2023-07-012023-09-300001814114obio : Orchestra Biomed Inc 會員us-gaap:權證成員obio : 2023年股權激勵計劃成員2023-07-012023-09-300001814114obio : Orchestra Biomed Inc 會員us-gaap:受限股票成員obio : 2023年股權激勵計劃成員2023-07-012023-09-300001814114obio : Orchestra Biomed Inc 會員us-gaap:員工股票期權成員obio : 2023年股權激勵計劃成員2023-07-012023-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:權證成員us-gaap:銷售、一般及行政費用成員obio : 2023年股權激勵計劃成員2023-01-012023-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:權證成員us-gaap:研究與開發費用成員obio : 股權激勵計劃2023成員2023-01-012023-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:限制性股票成員us-gaap:銷售、一般及行政費用成員obio : 股權激勵計劃2023成員2023-01-012023-09-300001814114obio : Orchestra Biomed Inc 成員us-gaap:限制性股票成員us-gaap:研究與開發費用成員obio : 2023年股權激勵計畫成員2023-01-012023-09-300001814114obio : Orchestra Biomed Inc成員us-gaap:員工股票期權成員us-gaap:銷售、一般及行政費用成員obio : 2023年股權激勵計畫成員2023-01-012023-09-300001814114obio : Orchestra Biomed Inc成員us-gaap:員工股票期權成員us-gaap:研究與開發費用成員obio : 2023年股權激勵計劃成員2023-01-012023-09-300001814114obio : Orchestra Biomed Inc成員us-gaap:權證成員obio : 2023年股權激勵計劃成員2023-01-012023-09-300001814114obio : Orchestra Biomed Inc成員us-gaap:限制性股票成員obio : 2023年股權激勵計劃成員2023-01-012023-09-300001814114obio : Orchestra Biomed Inc成員us-gaap: 員工股票選擇權成員obio : 2023年股權激勵計劃成員2023-01-012023-09-300001814114us-gaap:額外繳入資本成員2024-07-012024-09-300001814114us-gaap: 其他已付資本成員2024-04-012024-06-3000018141142024-04-012024-06-300001814114us-gaap: 其他已付資本成員2024-01-012024-03-3100018141142024-01-012024-03-310001814114us-gaap: 其他已付資本成員2023-07-012023-09-3000018141142023-07-012023-09-300001814114us-gaap:限制性股票成員obio : 傳承管弦樂的權證成員obio : 2023年股權激勵計劃成員2024-01-012024-09-300001814114obio : 普通認股權證成員2023-01-012023-03-310001814114obio : 贊助商持有的私人認股權證成員2024-01-012024-09-300001814114us-gaap:限制性股票成員obio : 傳承管弦樂團認股權證成員us-gaap:測量輸入股價成員obio : 2023年股權激勵計劃成員2024-09-300001814114obio : 股權分類大道認股權證成員2023-10-0600018141142023-01-2600018141142022-12-310001814114obio : 健康科學收購公司2的成員obio : Rtw Investments Lp的成員obio : 保證金協議的成員2022-07-040001814114obio : Terumo協議的成員2024-01-012024-09-300001814114srt : 先前報告的情境成員美元指數：可轉換優先股類別2022-12-310001814114srt : 之前報告的情況的成員us-gaap:普通股成員2022-12-310001814114srt : 先前報告的成員us-gaap: 額外支付資本成員2022-12-310001814114srt : 先前報告的成員2022-12-310001814114us-gaap: 額外支付資本成員2023-04-012023-06-3000018141142023-04-012023-06-300001814114us-gaap: 普通股成員2023-04-012023-06-300001814114us-gaap: 普通股成員2024-07-012024-09-300001814114us-gaap: 普通股成員2024-04-012024-06-300001814114obio : Orchestra Biomed Inc 成員obio : 官員和董事權證成員2024-07-012024-09-300001814114obio : Orchestra Biomed Inc 成員obio : 官員和董事權證成員2024-01-012024-09-300001814114obio : 健康科學收購公司2 成員obio : 官員和董事權證成員2023-01-262023-01-260001814114obio : Orchestra Biomed Inc 成員obio : 官員和董事權證成員2023-01-012023-12-310001814114obio : Hsac 2 Holdings Llc 成員obio : 私人認股權證成員2023-01-262023-01-260001814114obio : 健康科學收購公司2成員obio : 由贊助商持有的私人認股權證成員2023-01-262023-01-260001814114obio : Hsac 2 Holdings Llc成員obio : 初始里程碑事件成員2023-01-262023-01-260001814114obio : Hsac 2 Holdings Llc成員obio : 最終里程碑事件成員2023-01-262023-01-260001814114obio : 健康科學收購公司2成員obio:RtwInvestmentsLp和Covidien集團S..r.l.成員obio:前向購買協議成員2022-07-042022-07-040001814114obio:健康科學收購公司2成員srt : 最低成員2023-01-262023-01-260001814114srt : 最大成員2023-01-262023-01-260001814114obio:健康科學收購公司2成員2023-01-260001814114obio:Motus GI Holdings Inc 投資成員2023-09-122023-09-120001814114obio:美敦力協議成員2024-09-300001814114obio : 美敦力協議成員2024-07-012024-09-300001814114obio : 美敦力協議成員us-gaap：應付帳款和應計負債成員2024-01-012024-09-300001814114obio : 美敦力協議成員2024-01-012024-09-300001814114obio : 美敦力協議成員2023-07-012023-09-300001814114obio : 美敦力協議成員2023-01-012023-09-300001814114obio : 閉幕後可行使36個月的成員us-gaap:限制性股票成員obio : 傳承管弦樂團認股權成員obio : 2023年股權激勵計劃成員2024-01-012024-09-300001814114obio : 自結算後24個月可行使成員us-gaap:限制性股票成員obio : 傳承管弦樂團認股權成員obio : 2023年股權激勵計劃成員2024-01-012024-09-300001814114obio : Hsac 2 Holdings Llc成員obio : 自結算後36個月可行使成員2023-01-262023-01-260001814114obio : Hsac 2 Holdings Llc 成員obio : 於成交後24個月可行使的成員2023-01-262023-01-260001814114obio : 健康科學收購公司2的成員obio : 於成交後36個月可行使的成員2023-01-262023-01-260001814114obio : 健康科學收購公司2的成員obio : 於成交後24個月可行使的成員2023-01-262023-01-260001814114srt : 最低成員2024-11-012024-11-300001814114srt : 最高成員2024-11-012024-11-300001814114srt : 最低成員2024-08-012024-08-310001814114srt : 最高成員2024-08-012024-08-310001814114srt : 最低成員2022-11-012022-11-300001814114srt : 最高成員2022-11-012022-11-300001814114srt : 最低成員2020-01-012020-01-310001814114srt : 最高成員2020-01-012020-01-310001814114obio : Vivasure成員的戰略投資2022-04-012022-06-300001814114us-gaap:權證成員2023-01-012023-09-300001814114obio : Medtronic 協議成員srt : 最低成員2024-01-012024-09-300001814114obio : Medtronic 協議成員srt : 最高成員2024-01-012024-09-300001814114obio : 兩千零十九年貸款及擔保協議成員2022-06-3000018141142023-01-012023-09-300001814114us-gaap:普通股成員2023-01-012023-03-310001814114us-gaap:額外實收資本成員2023-01-012023-03-310001814114srt : 最高成員2023-04-1200018141142023-04-120001814114obio : 基金一號及二號認股權證成員obio : 二零二二年貸款及擔保協議成員2023-10-062023-10-060001814114obio : 二零一九年貸款及擔保協議成員2022-06-012022-06-300001814114obio : 基金一號及二號認股權證成員2022-06-300001814114obio : 二零二四年貸款及擔保協議成員us-gaap:後續事件成員2024-11-062024-11-060001814114obio : 二零二二年貸款及擔保協議成員2022-06-300001814114obio : 二零二四年貸款及擔保協議成員us-gaap:後續事件成員2024-11-060001814114obio:二零二二年貸款及擔保協議成員2022-06-012022-06-300001814114obio:舊有管弦樂團成員2023-01-260001814114obio:銷售協議成員2024-08-120001814114obio:公開市場出售協議成員2024-08-120001814114obio:公開市場出售協議成員2024-05-150001814114obio:テルモ成員srt:最低成員us-gaap：合作安排成員2019-01-012019-12-310001814114obio : Terumo 成員srt : 最大成員us-gaap: 合作安排成員2019-01-012019-12-310001814114obio : Terumo 成員srt : 最小成員us-gaap: 合作安排成員2019-06-012019-06-300001814114obio : Terumo 成員us-gaap:合作安排成員2019-01-012019-12-310001814114obio : Terumo 成員us-gaap:合作安排成員2022-06-012022-06-300001814114obio : Terumo 成員srt : 最大成員us-gaap:合作安排成員2019-06-012019-06-300001814114obio : Terumo 成員us-gaap:合作安排成員2024-07-012024-09-300001814114obio : Terumo 成員us-gaap:合作安排成員2024-01-012024-09-300001814114obio : Terumo 成員us-gaap:合作安排成員2023-07-012023-09-300001814114obio : Terumo 成員us-gaap:合作安排成員2023-01-012023-09-300001814114obio : Terumo 成員us-gaap:合作安排成員2019-06-300001814114obio : Terumo成員srt : 最高成員us-gaap: 合作安排成員2019-06-3000018141142024-09-3000018141142023-12-310001814114obio : 股權分類大道認股權證成員2023-10-062023-10-060001814114obio : Hsac 2 Holdings Llc成員2023-01-262023-01-260001814114obio : 健康科學收購公司2成員2023-01-262023-01-260001814114obio : 健康科學收購公司2成員2023-01-012023-12-310001814114obio : 健康科學收購公司2成員srt : 最大成員obio : 初始里程碑事件成員2023-04-122023-04-120001814114obio : 健康科學收購公司2成員obio : 初始里程碑事件成員2023-04-122023-04-120001814114obio : 傳承樂團成員2023-04-122023-04-120001814114obio : Hsac 2 Holdings Llc成員2023-04-122023-04-120001814114obio : 健康科學收購公司2成員srt : 最大成員2023-01-262023-01-260001814114obio : 健康科學收購公司2的成員obio : 初始里程碑事件的成員2023-01-262023-01-260001814114obio : 健康科學收購公司2的成員obio : 最終里程碑事件的成員2023-01-262023-01-260001814114obio : 傳承樂團的成員2023-01-262023-01-2600018141142023-01-012023-12-310001814114obio : Terumo的成員us-gaap: 合作安排成員2019-06-012019-06-300001814114obio : 櫃檯註冊聲明成員2024-05-1500018141142023-01-012023-03-3100018141142024-07-012024-09-3000018141142024-11-0700018141142024-01-012024-09-30iso4217: eurobio:Yxbrli:股份iso4217:美元指數iso4217:美元指數xbrli:shares純種成員obio:trancheobio:Dobio:employee平方英尺obio:segment

目錄

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​

美國

證券交易委員會

華盛頓特區20549

​

表格10-Q

​

​

（選擇一個）

☒ 根據1934年證券交易法第13條或15(d)條的要求提交的季度報告

截至季度末 2024年9月30日

或

☐ 根據《1934年證券交易法》第13或15(d)條的過渡報告

過渡期限從 __________________ 到 __________________

委員會文件編號： 001-39421

Graphic

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交響樂生物醫藥控股公司

(註冊人名稱按章程所示)

特拉華州

   

92-2038755

(州或其他轄區的
成立或組織)

 

(IRS僱主
識別號.)

​

150 聯合廣場驅動

新希望, 賓夕法尼亞州 18938

(主要經營辦公室的地址，包括郵政編碼)

註冊人的電話號碼，包括區號：(215) 862-5797

根據《證券法》第12(b)條註冊的證券

每一類股票的名稱

    

交易代號

    

註冊的每個交易所名稱

普通股，每股面值爲$0.0001

 

OBIO

 

該 納斯達克 全球貨幣市場

​

請勾選是否註冊人（1）在過去12個月內（或在註冊人被要求提交此類報告的較短期間內）提交了根據1934年證券交易法第13條或15(d)條所要求的所有報告，以及（2）在過去90天內是否受到此類提交要求的約束。 是 ☒ 不 ☐

請勾選註冊人是否在過去的12個月內（或註冊人被要求提交此類文件的較短期限內）電子提交了根據規則405的《S-t規則》（本章第232.405節）要求提交的所有交互數據文件。 是 ☒ 不 ☐

請載明檢查標記，公司是否為大型加速披露人、加速披露人、非加速披露人、小型報告公司或新興成長公司。請於「交易所法案」第1202條中查閱「大型加速披露人」、「加速披露人」、「小型報告公司」和「新興成長公司」的定義。

大型加速報告公司

☐

加速報告公司

☐

非加速報告公司

☒

小型報告公司

☒

​

​

新興增長公司

☒

​

如果一家新興成長型企業，請勾選「是」表示註冊人選擇不使用根據證券交易所法第13(a)條所提供的任何新的或修改後的財務會計準則的延長過渡期來遵守。 ☐

請在覈準印章處打勾，表明公司是否為外殼公司（根據《交易所法》第120亿2條所定義）。是 ☐ 不 ☒

截至2024年11月7日，註冊人擁有 38,013,526 普通股股份，面值每股0.0001美元，已發行。

​

​

​

​

​

目錄

目錄

​

​

頁

第一部分 財務信息

1

​

​

​

項目 1。

基本報表

1

​

未經查覈的總體財務報表：

​

​

截至2024年9月30日（未經審計）和2023年12月31日的簡明合併資產負債表

1

​

截至2024年和2023年9月30日的三個月和九個月的合併運營和綜合損失的基本報表

2

​

截至2024年和2023年9月30日的三個月和九個月的股東權益（赤字）基本報表

3

​

現金流量基本報表 九 截至2024年和2023年9月30日的月份

4

​

基本報表未經審核簡明合併財務報表註腳

6

項目2。

管理層對 財務狀況 和 經營成果 的討論與分析

33

項目3。

關於市場風險的定量和定性披露

51

項目4。

控制項和程序

51

​

​

​

第二部分。其他信息

51

​

​

​

項目 1。

法律程序

51

項目 1A。

風險因素

52

項目2。

未註冊的股權證券銷售及資金用途

52

項目3。

高級證券的默認情況

52

項目4。

礦山安全披露

53

Item 5.

其他資訊

53

Item 6.

展品

56

簽名

57

​

​

​

​

i

目錄

關於前瞻性聲明的特別說明

本季度報告（本「季度報告」）包含前瞻性聲明。除本報告中包含的歷史事實外，所有其他聲明，包括關於我們未來運營和財務狀況、業務策略、產品候選者、計劃的臨床前研究和臨床試驗、臨床試驗結果、研發成本、監管審批、時機和成功的可能性，以及管理層未來運營的計劃和目標，均爲前瞻性聲明。這些聲明涉及已知和未知的風險、不確定性以及其他一些情況下超出我們控制範圍的重要因素，可能導致我們的實際結果、表現或成就與任何未來結果、表現或成就在實質上存在重大差異，而這些結果、表現或成就在前瞻性聲明中得到了表達或暗示。

在某些情況下，您可以通過諸如「可能」、「將」、「應該」、「會」、「期望」、「計劃」、「預期」、「可以」、「打算」、「目標」、「項目」、「考慮」、「相信」、「估計」、「預測」、「潛在」或「繼續」或這些術語的否定形式或其他相似表達來識別前瞻性聲明。本報告中包含的前瞻性聲明包括但不限於關於：

●我們在未來籌集融資的能力，包括我們在2024年11月與海格投資等其他方簽訂的貸款和安防-半導體協議下藉此外資金的能力；
●我們在保留或招募，或所需的變更方面的成功，在我們的高管、關鍵員工或董事中；
●我們以及第三方廠商和合作夥伴製造我們產品候選的能力；
●我們獲取用於製造我們產品候選的關鍵元件或材料的能力；
●我們實現並保持盈利的能力；
●我們實現預計的開發和商業化目標的能力；
●我們臨床研究和研發活動的進展、成本和結果；
●如果獲得批准，我們的產品候選的市場接受度；
●我們在競爭激烈的行業中與大型公司的競爭能力；
●我們經營結果的變化，使未來的經營結果難以預測；
●嚴重不良事件，可能阻礙我們產品候選者的臨床開發、監管批准或認證的不可取的副作用；
●我們管理增長或控制與增長相關的成本的能力；
●可能對我們的業務、財務狀況和股票價格產生不利影響的經濟條件；
●我們對第三方的依賴，以推動我們初始產品候選者（如果獲批准）的成功市場營銷和銷售；
●我們依賴第三方製造和提供重要的材料和元件給我們的產品和產品候選。
●我們及我們的合作伙伴能夠以簡單和經濟的方式獲得必要的監管批准和認證，適用於我們的產品候選。

ii

目錄

●我們保持符合監管和發帖要求的能力；
●與我們產品候選者相關的不良醫療事件、故障或失效，以及可能面臨的監管制裁；
●醫療成本控制壓力以及影響第三方支付方的覆蓋和報銷實踐的立法或行政改革；
●我們保護或執行我們的知識產權、未獲得專利的商業祕密、專有技術和其他科技的能力；
●我們從第三方獲取必要知識產權的能力；
●我們保護我們的商標、貿易名稱並建立我們的名稱識別度的能力；
●我們維持普通股在納斯達克證券市場有限公司（「納斯達克」）上市的能力；
●我們能夠在2026年下半年基於我們的現金、現金等價物、可交易證券，以及在本季度報告第2項（管理層對財務狀況和經營業績的討論與分析）標題爲「流動性和資本資源-融資要求」中討論的潛在未來支付或收入來資助我們的運營；

​

●我們的許可協議的成功；以及
●我們公開證券的流動性和交易。

我們主要基於對我們業務、我們所處的行業以及我們認爲可能影響我們業務、財務狀況、經營業績和前景的財務趨勢的當前預期和預測來作出這些前瞻性聲明，而這些前瞻性聲明並不保證未來的表現或發展。這些前瞻性聲明僅在本報告日期有效，並且受到在2023年12月31日結束的年度報告的「第1A項 風險因素」部分（「2023 10-K」）和本季度報告的「第1A項 風險因素」部分以及本季度報告其他地方所描述的若干風險、不確定性和假設的影響。由於前瞻性聲明本質上受到風險和不確定性的影響，其中一些是無法預測或量化的，因此您不應將這些前瞻性聲明視爲對未來事件的預測。我們前瞻性聲明中反映的事件和情況可能無法實現或發生，實際結果可能與前瞻性聲明中預測的結果有重大差異。我們不打算公開更新或修訂本報告中包含的任何前瞻性聲明，無論是由於任何新信息、未來事件或其他原因，法律要求的情況除外。

此外，聲明「我們相信」和類似的陳述反映了我們在相關主題上的信念和觀點。這些聲明是基於截至本報告日期可獲得的信息，而雖然我們相信這些信息爲此類聲明提供了合理基礎，但該信息可能是有限的或不完整的，我們的聲明不應解讀爲我們進行了對所有可能可用相關信息的詳盡調查或審查。這些聲明本質上是不確定的，請謹慎對待這些聲明。

​

​

iii

目錄

第一部分——財務信息

項目 1. 基本報表。

交響樂生物醫藥控股公司

簡明合併資產負債表

(以千為單位，除股數和每股資料外)

（未經審計）

​

​

​

​

​

​

​

​

    

截至9月30日，

    

十二月三十一日，

​

​

2024

​

2023

資產

 

​

  

 

​

  

流動資產：

 

​

  

 

​

  

現金及現金等價物

​

$

25,605

​

$

30,559

已售證券

​

 

41,321

​

 

56,968

戰略投資，流動部分

​

 

—

​

 

68

應收賬款，淨額

​

 

115

​

 

99

庫存

​

 

234

​

 

146

預付費用及其他流動資產

​

 

1,278

​

 

1,274

總流動資產

​

 

68,553

​

 

89,114

物業和設備，淨值

​

 

1,254

​

 

1,279

使用權資產

​

 

1,714

​

 

1,555

戰略投資，較少的當前部分

​

 

2,495

​

 

2,495

存款及其他資產

​

 

1,303

​

 

769

總資產

​

$

75,319

​

$

95,212

​

​

​

​

​

​

​

負債和股東權益

​

 

  

​

 

  

流動負債：

​

 

  

​

 

  

應付賬款

​

$

4,723

​

$

2,900

應計費用和其他負債

​

 

7,034

​

 

5,149

經營租賃負債，當前部分

​

 

395

​

 

649

流動部分遞延收入

​

 

4,066

​

 

2,510

總流動負債

​

 

16,218

​

 

11,208

遞延收益，減去當前部分

​

 

11,439

​

 

14,923

經營租賃負債，扣除流動部分

​

 

1,443

​

 

1,038

總負債

​

 

29,100

​

 

27,169

​

​

​

​

​

​

​

股東權益

​

 

  

​

 

  

優先股，$0.0001 每股面值； 10,000,000 授權股份; 無 截至2024年9月30日和2023年12月31日發行或流通。

​

 

—

​

 

—

普通股，$0.0001 每股面值； 340,000,000 授權股份; 37,942,905 和 35,777,412 截至2024年9月30日和2023年12月31日發行和流通的股份。

​

 

4

​

 

4

額外支付的資本

​

 

339,840

​

 

316,903

累計其他綜合收益（或損失）

​

 

98

​

 

(10)

累計負債

​

 

(293,723)

​

 

(248,854)

總股東權益

​

 

46,219

​

 

68,043

所有負債與股東權益

​

$

75,319

​

$

95,212

​

​

​

附帶的註釋是這些簡單合併基本報表的重要組成部分。

1

目錄

交響樂生物醫藥控股公司

合併損益和全面虧損的簡要合併報表

(以千為單位，除股數和每股資料外)

（未經審計）

​

​

​

​

​

​

​

​

​

​

​

​

​

​

    

截至九月三十日的三個月

    

截至九月三十日的九個月

​

​

2024

​

2023

​

2024

​

2023

營收:

 

​

  

 

​

  

 

​

  

 

​

  

合作伙伴營業收入

​

$

803

​

$

271

​

$

1,928

​

$

2,018

產品銷售額

​

 

184

​

 

148

​

 

457

​

 

480

總營業收入

​

 

987

​

 

419

​

 

2,385

​

 

2,498

費用:

​

 

  

​

 

  

​

 

  

​

 

  

產品營業收入成本

​

 

68

​

 

41

​

 

146

​

 

139

研究與開發

​

 

11,595

​

 

8,558

​

 

31,833

​

 

25,311

銷售、一般和行政

​

 

5,666

​

 

6,344

​

 

18,030

​

 

16,073

總支出

​

 

17,329

​

 

14,943

​

 

50,009

​

 

41,523

營業虧損

​

 

(16,342)

​

 

(14,524)

​

 

(47,624)

​

 

(39,025)

其他收益（支出）：

​

 

  

​

 

  

​

 

  

​

 

  

利息收入，淨額

​

 

916

​

 

915

​

 

2,834

​

 

2,741

對認股權證負債公允價值調整的損失

​

 

—

​

 

—

​

 

—

​

 

(294)

戰略投資公允價值的收益（損失）

​

 

—

​

 

293

​

 

(68)

​

 

276

其他費用

​

​

—

​

​

—

​

​

(11)

​

​

—

其他總收入

​

 

916

​

 

1,208

​

 

2,755

​

 

2,723

淨虧損

​

$

(15,426)

​

$

(13,316)

​

$

(44,869)

​

$

(36,302)

每股淨虧損

​

 

  

​

 

  

​

 

  

​

 

  

基本和攤薄

​

$

(0.41)

​

$

(0.38)

​

$

(1.23)

​

$

(1.11)

用於計算每股淨虧損的加權平均股份，基本和稀釋

​

 

37,621,495

​

 

35,243,598

​

 

36,406,635

​

 

32,586,431

綜合虧損

​

 

  

​

 

  

​

 

  

​

 

​

淨虧損

​

$

(15,426)

​

$

(13,316)

​

$

(44,869)

​

$

(36,302)

可供出售證券的未實現收益（損失）

​

 

121

​

 

19

​

 

108

​

 

(69)

綜合虧損

​

$

(15,305)

​

$

(13,297)

​

$

(44,761)

​

$

(36,371)

​

​

​

附帶的註釋是這些簡單合併基本報表的重要組成部分。

2

目錄

​

​

​

管絃樂生物控股公司

簡明合併股東權益（虧損）報表

(以千為單位，除股數和每股資料外)

（未經審計）

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

    

​

​

​

​

    

​

​

​

​

    

​

​

    

累計

    

​

​

    

總計

​

​

可轉換優先股

​

​

​

​

​

​

其他

​

其他

​

​

​

​

Stockholders’

​

​

股票

​

普通股

​

實收資本

​

綜合

​

累計

​

Equity

​

​

Shares

    

金額

​

Shares

    

金額

​

資本

​

(虧損) 收入

​

Deficit

​

(赤字)

2024年1月1日的餘額

 

—

​

$

—

 

35,777,412

​

$

4

​

$

316,903

​

$

(10)

​

$

(248,854)

​

$

68,043

可供出售證券的未實現收益

 

—

​

 

—

 

—

​

 

—

​

 

—

​

 

2

​

 

—

​

 

2

基於股票的薪酬

 

—

​

 

—

 

—

​

 

—

​

 

2,588

​

 

—

​

 

—

​

 

2,588

股票期權的行使

 

—

​

 

—

 

7,585

​

 

—

​

 

18

​

 

—

​

 

—

​

 

18

淨虧損

 

—

​

 

—

 

—

​

 

—

​

 

—

​

 

—

​

 

(13,463)

​

 

(13,463)

餘額，截至2024年3月31日

 

—

​

$

—

 

35,784,997

​

$

4

​

$

319,509

​

$

(8)

​

$

(262,317)

​

$

57,188

未實現的可交易證券損失

​

—

​

​

—

​

—

​

​

—

​

​

—

​

​

(15)

​

​

—

​

​

(15)

基於股票的薪酬

​

—

​

​

—

​

—

​

​

—

​

​

2,761

​

​

—

​

​

—

​

​

2,761

限制性股票單位歸屬

​

—

​

​

—

​

2,000

​

​

—

​

​

—

​

​

—

​

​

—

​

​

—

股票期權的行使

​

—

​

​

—

​

37,574

​

​

—

​

​

171

​

​

—

​

​

—

​

​

171

淨虧損

​

—

​

​

—

​

—

​

​

—

​

​

—

​

​

—

​

​

(15,980)

​

​

(15,980)

餘額，2024年6月30日

 

—

​

$

—

 

35,824,571

​

$

4

​

$

322,441

​

$

(23)

​

$

(278,297)

​

$

44,125

市場發行，扣除發行成本後 $465

​

—

​

​

—

​

2,000,000

​

​

—

​

​

15,035

​

​

—

​

​

—

​

​

15,035

可供出售證券的未實現收益

​

—

​

​

—

​

—

​

​

—

​

​

—

​

​

121

​

​

—

​

​

121

基於股票的薪酬

​

—

​

​

—

​

—

​

​

—

​

​

2,364

​

​

—

​

​

—

​

​

2,364

限制性股票單位歸屬

​

—

​

​

—

​

118,334

​

​

—

​

​

—

​

​

—

​

​

—

​

​

—

淨虧損

​

—

​

​

—

​

—

​

​

—

​

​

—

​

​

—

​

​

(15,426)

​

​

(15,426)

餘額，2024年9月30日

​

—

​

$

—

​

37,942,905

​

$

4

​

$

339,840

​

$

98

​

$

(293,723)

​

$

46,219

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

    

​

    

​

​

    

​

    

​

​

    

​

​

    

累計

    

​

​

    

總計

​

​

可轉換優先股

​

​

​

​

​

​

其他

​

其他

​

​

​

​

Stockholders’

​

​

股票

​

普通股

​

實收資本

​

綜合

​

累計

​

Equity

​

​

Shares

​

金額

​

Shares

​

金額

​

資本

​

(虧損) 收入

​

Deficit

​

(赤字)

2023年1月1日的餘額（之前報告的）

 

35,694,179

​

$

165,923

 

2,522,214

​

$

—

​

$

86,353

​

$

(8)

​

$

(199,734)

​

$

(113,389)

逆向資本化的追溯適用（注3）

 

(35,694,179)

​

 

(165,923)

 

17,665,636

​

 

2

​

 

165,921

​

 

—

​

 

—

​

​

165,923

2023年1月1日的合併影響餘額

 

—

​

 

—

 

20,187,850

​

 

2

​

 

252,274

​

 

(8)

​

 

(199,734)

​

 

52,534

合併和資本重組的影響（請參閱註釋3）

 

—

​

 

—

 

11,422,741

​

 

1

​

 

54,301

​

 

—

​

 

—

​

 

54,302

將遺留樂團的普通股Warrants重新分類到股東權益

 

—

​

 

—

 

—

​

 

—

​

 

2,373

​

 

—

​

 

—

​

 

2,373

未實現的可交易證券損失

 

—

​

 

—

 

—

​

 

—

​

 

—

​

 

(27)

​

 

—

​

 

(27)

基於股票的薪酬

 

—

​

 

—

 

—

​

 

—

​

 

1,489

​

 

—

​

 

—

​

 

1,489

股票期權的行使

 

—

​

 

—

 

2,325

​

 

—

​

 

10

​

 

—

​

 

—

​

 

10

行使Warrants

 

—

​

 

—

 

128,231

​

 

—

​

 

11

​

 

—

​

 

—

​

 

11

淨虧損

​

—

​

 

—

​

—

​

 

—

​

 

—

​

 

—

​

 

(10,940)

​

 

(10,940)

截至2023年3月31日的餘額

​

—

​

$

—

​

31,741,147

​

$

3

​

$

310,458

​

$

(35)

​

$

(210,674)

​

$

99,752

通過發行股份來結算收益

​

—

​

​

—

​

3,999,987

​

​

1

​

​

—

​

​

—

​

​

—

​

​

1

可流動證券的未實現損失

​

—

​

​

—

​

—

​

​

—

​

​

—

​

​

(61)

​

​

—

​

​

(61)

基於股票的薪酬

​

—

​

​

—

​

—

​

​

—

​

​

1,707

​

​

—

​

​

—

​

​

1,707

股票期權的行使

​

—

​

​

—

​

15,500

​

​

—

​

​

64

​

​

—

​

​

—

​

​

64

行使Warrants

​

—

​

​

—

​

32,279

​

​

—

​

​

22

​

​

—

​

​

—

​

​

22

限制性股票獎勵的沒收

​

—

​

​

—

​

(45,906)

​

​

—

​

​

—

​

​

—

​

​

—

​

​

—

淨虧損

​

—

​

​

—

​

—

​

​

—

​

​

—

​

​

—

​

​

(12,046)

​

​

(12,046)

截至2023年6月30日的餘額

​

—

​

$

—

​

35,743,007

​

$

4

​

$

312,251

​

$

(96)

​

$

(222,720)

​

$

89,439

可流通證券的未實現收益

​

—

​

​

—

​

—

​

​

—

​

​

—

​

​

19

​

​

—

​

​

19

基於股票的薪酬

​

—

​

​

—

​

—

​

​

—

​

​

3,510

​

​

—

​

​

—

​

​

3,510

股票期權的行使

​

—

​

​

—

​

965

​

​

—

​

​

4

​

​

—

​

​

—

​

​

4

淨虧損

​

—

​

​

—

​

—

​

​

—

​

​

—

​

​

—

​

​

(13,316)

​

​

(13,316)

截至2023年9月30日的餘額

​

—

​

$

—

​

35,743,972

​

$

4

​

$

315,765

​

$

(77)

​

$

(236,036)

​

$

79,656

​

​

​

​

​

​

​

​

​

​

​

​

​

附帶的註釋是這些簡單合併基本報表的重要組成部分。

3

目錄

交響樂生物醫藥控股公司

簡化合並現金流量表

(以千為單位，除股數和每股資料外)

（未經審計）

​

​

​

​

​

​

​

​

    

截至九月30日的九個月

​

​

2024

​

2023

經營活動產生的現金流量：

 

​

  

 

​

  

淨虧損

​

$

(44,869)

​

$

(36,302)

調整淨損失以對賬經營活動中使用的現金:

​

 

​

​

 

  

折舊和攤銷

​

 

224

​

 

215

基於股票的薪酬

​

 

7,713

​

 

6,706

Warrants負債公允價值調整損失

​

 

—

​

 

294

戰略投資公允價值損失（收益）

​

 

68

​

 

(276)

可交易證券相關的增值和利息

​

 

(1,270)

​

​

(3,181)

非現金租賃費用

​

 

505

​

 

473

遞延融資費用的攤銷

​

​

—

​

 

109

其他

​

​

11

​

​

—

經營資產與負債的變動：

​

 

​

​

​

​

應收賬款

​

 

(16)

​

 

10

庫存

​

 

(88)

​

 

139

預付費用和其他資產

​

 

(537)

​

 

(458)

應付賬款、應計費用及其他負債

​

 

3,681

​

 

(348)

經營租賃負債 – 流動及非流動

​

 

(514)

​

 

(516)

透過收入

​

 

(1,928)

​

 

(2,018)

用於經營活動的淨現金

​

 

(37,020)

​

 

(35,153)

投資活動產生的現金流：

​

 

​

​

 

  

購買物業和設備

​

 

(183)

​

 

(81)

可交易證券的銷售

​

​

69,401

​

​

115,690

購買可流通證券

​

 

(52,376)

​

 

(138,073)

投資活動提供的（使用的）淨現金

​

 

16,842

​

 

(22,464)

融資活動產生的現金流：

​

 

  

​

 

  

市場募集資金，扣除發行成本

​

​

15,035

​

​

—

Warrants行使所得

​

 

—

​

 

23

行使期權所得

​

 

189

​

 

78

合併的影響，扣除交易成本（注3）

​

 

—

​

 

56,810

融資活動提供的淨現金

​

 

15,224

​

 

56,911

現金及現金等價物淨減少額

​

 

(4,954)

​

 

(706)

現金及現金等價物，期初餘額

​

 

30,559

​

 

19,784

現金及現金等價物，期末餘額

​

$

25,605

​

$

19,078

​

​

​

​

​

​

​

現金流信息的補充披露

​

 

  

​

 

  

截至9月30日的九個月內支付的現金：

​

 

  

​

 

  

利息

​

$

—

​

$

1,098

非現金活動的補充披露

​

​

​

​

​

​

與新運營租賃負債相關的經營租賃使用權資產增加

​

$

665

​

$

—

與固定資產相關的應付賬款、應計費用及其他負債增加

​

$

27

​

$

—

​

​

​

​

​

​

​

​

​

附帶的註釋是這些簡單合併基本報表的重要組成部分。

4

目錄

​

​

​

​

交響樂生物醫藥控股公司

針對簡化合並基本報表的說明

(未經審計)

1. 組織和呈現基礎

Orchestra BioMed Holdings, Inc.（連同其子公司統稱爲「Orchestra」或「公司」，之前稱爲Health Sciences Acquisitions Corporation 2）是一家生物醫藥創新公司，通過與領先的醫療器械公司建立風險收益共享合作伙伴關係，加速將高影響力技術轉移給患者。公司的合作伙伴驅動業務模式專注於與領先的醫療器械公司建立戰略合作關係，以推動其開發的產品的成功全球商業化。公司的旗艦產品候選爲房室間隔調製（「AVIM」）治療（也稱爲BackBeat心臟神經調節治療（「BackBeat CNT」）），用於治療高血壓（「HTN」），這是全球死亡的一個重要風險因素，以及Virtue西羅莫司血管灌注氣球（「Virtue SAB」），用於治療動脈粥樣硬化性動脈疾病，這是全球首要的死亡原因。

在2023年1月26日之前，公司是一家特殊目的收購公司，成立的目的是與一個或多個業務或實體進行合併、聯合、股份交換、資產收購、股份購買、重組或類似的商業組合。在2023年1月26日（「交易結束日」），公司完成了根據2022年7月4日的合併協議和計劃（經2022年7月21日的合併協議修正案第1號和2022年11月21日的合併協議修正案第2號修訂的「合併協議」）所構想的商業組合，該協議涉及健康科學收購公司2，一家於2020年成立的開曼群島免稅公司的特殊目的收購公司（「HSAC2」），HSAC Olympus Merger Sub, Inc.，一家特拉華州公司及HSAC2的全資子公司（「合併子公司」），以及Orchestra BioMed, Inc.（「傳統Orchestra」）。根據合併協議，（i）HSAC2根據開曼群島公司法（2022年修正案）取消在開曼群島的註冊並根據特拉華州一般公司法第388節從而在特拉華州註冊（「國內化」）和（ii）合併子公司與傳統Orchestra合併，傳統Orchestra爲合併中的存續公司，合併生效後繼續作爲Orchestra的全資子公司（「合併」，連同國內化及合併協議所構想的其他交易一起，稱爲「商業組合」）。作爲國內化的一部分，公司名稱由「Health Sciences Acquisitions Corporation 2」更改爲「Orchestra BioMed Holdings, Inc.」詳見附註3了解更多信息。

Legacy Orchestra是公司的全資子公司，於2017年1月在德拉瓦州註冊成立，成立的目的是收購運營和其他資產，以及通過私募融資籌集資本。2018年5月，Legacy Orchestra與德拉瓦公司Caliber Therapeutics, Inc.、德拉瓦公司BackBeat Medical, Inc.和德拉瓦公司FreeHold Surgical, Inc.同時完成了合併（以下稱「合併」）。Legacy Orchestra在2019年完成了將BackBeat Medical, Inc.轉換爲德拉瓦有限責任公司BackBeat Medical, LLC（「BackBeat」）、將FreeHold Surgical, Inc.轉換爲FreeHold Surgical, LLC（「FreeHold」）以及將Caliber Therapeutics, Inc.轉換爲德拉瓦有限責任公司Caliber Therapeutics, LLC（「Caliber」）。

Caliber

Caliber Therapeutics, Inc.於2005年10月在德拉瓦州註冊成立，並於2008年開始開發其主打產品Virtue SAb。Virtue SAb是一個專利的藥物/器械組合產品，用於治療動脈疾病，能夠在球囊成形術過程中向血管壁提供名爲SirolimusEFR的西羅莫司延釋專利配方，而無需在球囊表面塗層或在動脈中留置如支架之類的永久植入物。2019年，Legacy Orchestra與Terumo Medical Corporation（「Terumo」）簽署了Virtue SAb的全球開發和商業化的分銷協議（「Terumo協議」）（見第4條）。

6

目錄

BackBeat

BackBeat Medical, Inc. 於2010年1月在特拉華州成立，並在同年開始開發其主要產品AVIm療法。AVIm療法是一種專利的可植入心臟刺激治療高血壓的方法，旨在立即、顯著且持續地降低血壓，同時調節通常驅動和維護血壓升高的自主神經系統反應。有關獨家許可和合作協議的詳細信息，請參閱第5條，日期爲2022年6月30日，由Legacy Orchestra、BackBeat和美敦力公司（美敦力plc的附屬公司）共同簽署（「美敦力協議」）。

FreeHold

FreeHold Surgical, Inc. 於2010年5月在特拉華州成立，並於2012年開始開發其用於微創手術的免持內窺器設備。FreeHold從事其內窺器產品的開發、銷售和營銷，在腹腔鏡和機器人手術中提供優化的視覺和總外科醫生控制。

呈報基礎及流動性

所附的未經審計的中期簡明合併基本報表是根據美國證券交易委員會（「SEC」）關於中期財務報告的規則和規定編制的。這些簡明報表未經審計，在管理層看來，包括所有必要的調整（包括正常的經常性調整和應計）以公正地展示中期的結果。2023年12月31日的簡明合併資產負債表是從該日期的經過審計的基本報表中提取而來的。截至2024年9月30日的九個月運營結果和現金流並不一定指示可能預期的2024財年截至12月31日的結果或任何其他未來期間。根據SEC針對中期報告的規則和規定，某些通常包含在符合一般公認會計原則的年度財務報表中的信息和腳註披露已被省略。這些未經審計的中期簡明合併基本報表應與包含在公司截至2023年12月31日的年度報告中的經過審計的合併財務報表一起閱讀，年度報告已於2024年3月27日向SEC提交，以及相關的附註。

公司運營歷史有限，其業務和市場的銷售及收入潛力尚未得到驗證。截至2024年9月30日，公司累計虧損達到$293.7百萬，並且自公司成立以來每年都經歷了淨虧損。公司預計未來將產生巨額運營虧損，並且在推進其產品商業化的過程中將需要額外的資金。公司面臨着諸多風險和不確定性，這些風險和不確定性與其他同規模公司在生物醫藥設備行業中的情況類似，例如臨床試驗結果的不確定性、額外融資的不確定性，以及運營虧損的歷史。

公司遵循財務會計準則委員會（「FASB」）會計標準分類（「ASC」）主題205-40的規定， 基本報表的展示——持續經營，要求管理層評估公司在財務報表發佈後一年內繼續作爲持續經營實體的能力。

根據截至2024年9月30日的現金及現金等價物和可流通證券的可用餘額，以及隨後收到的收益（見第16條註釋），管理層得出結論，認爲有足夠的資本來支持其運營並滿足發行這些財務報表日期後一年內的現金需求。管理層可能考慮在財務報表發行日期後的一年內通過發行股權證券、債務證券和/或其他產品的額外開發及商業化合作夥伴關係來籌集超出這一時間段的資本。任何未來融資的源頭、時機和可用性主要將取決於市場條件，尤其是公司研究和開發項目的進展。

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2。重要會計政策摘要

反向資本重組

根據美國公認會計原則（「反向資本重組」），業務合併被視爲反向資本重組。根據這種會計方法，HSAC2 被視爲 「被收購的」 公司，出於財務報告目的，Legacy Orchestra被視爲收購方。因此，出於會計目的，業務合併被視爲等同於Legacy Orchestra以 HSAC2 淨資產發行股票，同時進行資本重組。因此，反向資本重組前的合併資產、負債和經營業績是Legacy Orchestra的合併資產、負債和經營業績。此外，在業務合併之前，股份和相應的每股資本金額和虧損已根據合併協議中確定的匯率（「交換比率」）進行追溯重報。有關業務合併和匯率的更多信息，請參閱這些未經審計的簡明合併財務報表附註3。

新興成長型公司和小型申報公司地位

根據經2012年《Jumpstart我們的創業公司法》（「JOBS法」）修訂的1933年《證券法》（「《證券法》」）第2（a）條的定義，該公司是 「新興成長型公司」。因此，它有資格利用適用於非新興成長型公司的其他上市公司的各種報告要求的某些豁免，包括但不限於不要求遵守2002年《薩班斯-奧克斯利法案》第404條的核數師認證要求，減少其定期報告和委託書中有關高管薪酬的披露義務，以及豁免就高管薪酬和股東舉行不具約束力的諮詢投票的要求批准任何先前未批准的解僱協議款項。

此外，《喬布斯法》第102（b）（1）條免除了新興成長型公司遵守新的或修訂後的財務會計準則的要求，直到私營公司（即那些尚未宣佈生效的《證券法》註冊聲明或沒有根據經修訂的1934年《證券交易法》（「交易法」）註冊的證券）遵守新的或經修訂的財務會計準則之前，新興成長型公司無需遵守新的或修訂的財務會計準則。《喬布斯法案》規定，新興成長型公司可以選擇退出延長的過渡期並遵守適用於非新興成長型公司的要求，但任何此類選擇退出都是不可撤銷的。公司選擇不選擇退出這種延長的過渡期，這意味着當標準發佈或修訂且上市或私營公司的申請日期不同時，作爲新興成長型公司，公司可以在私營公司採用新的或修訂的標準時採用新的或修訂的標準。這可能會使公司的簡明合併財務報表與另一家既不是新興成長型公司也不是新興成長型公司的上市公司進行比較變得困難或不可能，後者由於所使用的會計準則可能存在差異而選擇不使用延長的過渡期。

最早在 (1) HSAC2 首次公開募股結束五週年之後的本財年的最後一天，(2) 公司年總收入至少爲12.35億美元的財年的最後一天，(3) 公司被視爲規則120.2定義的 「大型加速申報人」 的財年的最後一天，該公司將繼續是一家新興成長型公司根據《交易法》，如果公司普通股的市值爲面值美元，就會發生這種情況0.0001 截至同年第二財季的最後一個工作日，非關聯公司持有的每股（「公司普通股」）超過7億美元，或（4）公司在過去三年中發行超過10億美元的不可轉換債務證券之日。

根據《交易法》的定義，該公司也是 「小型申報公司」。即使在公司不再是新興成長型公司之後，該公司仍可能繼續是一家規模較小的申報公司。公司可以利用小型申報公司可獲得的某些按比例披露的優勢，並且能夠在以下時間內利用這些按比例披露的信息：(i) 非關聯公司持有的公司有表決權和無表決權普通股的市值低於公司第二財季最後一個工作日的2.5億美元，或 (ii) (a) 公司在此期間的年收入低於1億美元最近完成的財政年度

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並且（b）截至本公司第二財務季度最後一個工作日，非關聯方持有的公司投票和非投票普通股的市場價值少於70000万元。

估計的使用

根據美國公認會計原則（GAAP），編制簡明合併基本報表需要管理層進行估計和假設，這些估計和假設會影響報告的資產、負債、收入和費用的金額，以及相關的披露。管理層將其估計基於歷史經驗以及在此情況下認爲合理的假設。實際結果可能與這些估計有重大差異。存在重要估計的領域包括但不限於基於股票的補償公允價值、發生的研發成本、權證負債的公允價值以及根據Terumo協議完成合並業績義務的估計成本（見附註4）。

現金及現金等價物

現金及現金等價物存放在銀行或與銀行的保管帳戶中。現金等價物定義爲所有流動投資和從購買之日起到期爲90天或更短的貨幣市場基金，這些投資可以輕鬆轉換爲現金。

可交易證券

公司將剩餘到期少於一年的可市場證券，或其意圖使用這些投資來資助當前運營或將其用於當前運營的投資，視爲短期投資。這些投資代表對企業或政府證券的債務投資，這些證券被指定爲可供出售，並以公允價值計量，未實現的收益和損失報告在股東權益中作爲累計其他綜合收益（損失）。與公司投資相關的公允價值披露基於來自多種行業標準數據提供者的市場價格，通常代表在活躍市場中類似資產的報價，或者已通過可觀察的市場數據推導而來。

戰略投資

管理層已對關聯公司進行了投資，並評估公司是否對其戰略投資施加顯著影響。公司考慮其投資的性質和規模、持有的任何投票權和保護權、在其他公司治理中的參與情況，以及其他相關因素，例如是否存在合作或其他業務關係。迄今爲止，公司已得出結論，認爲其不能對戰略投資施加顯著影響。

公司的戰略投資包括Vivasure Medical Limited（「Vivasure」）的優先股，該公司爲一傢俬營公司及關聯方。對Vivasure的投資沒有可隨時確定的公允價值，按成本記錄，減去任何減值，加上或減去因相同或相似投資的可觀察價格變動而產生的變化。此外，因Vivasure的投資不具備便捷的市場流通性，公司將這些投資歸類爲非流動資產。截至2024年9月30日和2023年12月31日，對Vivasure的投資賬面價值爲$2.5百萬。公司的戰略投資以前包括持有的Motus GI Holdings, Inc.（「Motus GI」）的股份，該公司曾爲一家公開上市公司，於2024年第二季度宣佈清算和解散。公司已將這些對Motus GI的戰略投資在其資產負債表中分類爲流動資產。

金融工具的公允價值

公司應用ASC 820， 公允價值計量 （「ASC 820」），該標準建立了測量公允價值的框架，並澄清了該框架內公允價值的定義。ASC 820將公允價值定義爲退出價格，即在測量日期市場參與者之間的正常交易中，在公司主要或最有利的市場裏，爲資產所獲得的價格或爲轉移負債所支付的價格。公允價值

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ASC 820中建立的層級通常要求實體在測量公允價值時最大化可觀察輸入的使用，並最小化不可觀察輸入的使用。可觀察輸入反映市場參與者在爲資產或負債定價時使用的假設，並基於從獨立於報告實體的來源獲得的市場數據進行開發。不可觀察輸入反映實體基於市場數據的自身假設，以及實體對市場參與者在爲資產或負債定價時使用的假設的判斷，並應基於在特定情況下可用的最佳信息進行開發。

公司的現金及現金等價物、應收賬款、預付費用、應付賬款和應計費用的賬面價值接近公允價值，這是因爲這些金融工具的短期到期。此外，公司以公允價值記錄其在可交易證券和認股權證負債中的投資。有關公允價值測量的更多信息，請參見第6條註釋。

估值層級分爲三個等級。估值層級中的分類基於對公允價值測量而言重要的最低輸入等級。估值層級中的各個等級描述如下：

一級  —  具有未調整的、在活躍市場交易所上市的報價的資產和負債。公允價值測量的輸入是可觀察輸入，例如，活躍市場中相同資產或負債的報價。

二級  —  公允價值測量的輸入是使用最近交易的具有類似基礎條款的資產和負債的價格確定的，以及直接或間接的可觀察輸入，例如在常見報價區間可觀察到的利率和收益率曲線。

三級公允價值計量的輸入是不可觀察的輸入，例如估計、假設和評估技術，當資產或負債幾乎沒有或沒有市場數據時。

應收賬款和壞賬準備

應收賬款代表客戶應支付的金額。壞賬準備是通過評估各種因素，包括每個客戶的相對信用狀況、歷史收款經驗和應收賬款的賬齡，來記錄的預計損失。截止到2024年9月30日和2023年12月31日，已記錄壞賬準備爲 2024財年沒有記錄減值損失。認爲是必要的。

庫存

庫存按標準成本（大致相當於先進先出法的實際成本）和淨可實現價值的較低者列示。淨可實現價值代表在正常業務過程中估計的銷售價格，減去合理可預測的完工、處置和運輸成本。公司分析其庫存水平，並對已經過時或其成本超過預期淨可實現價值或庫存數量超過預期需求的庫存進行減值。超出需求的數量是通過將現有庫存與預測銷售進行比較來確定的，同時考慮庫存的保質期。過期庫存將被處置，其相關成本在營業成本中確認。截止到2024年9月30日和2023年12月31日，由於過時庫存所產生的減值費用爲 2024財年沒有記錄減值損失。被視爲必要。

研發預付款、應計費用及相關支出

公司在其第三方服務提供商進行的研發活動中產生費用，包括開展臨床前和臨床研究。公司需在每個報告日期估算其預付及應計的研發成本。這些估算依據與公司服務提供商建立的協議，以個別研究的工作完成進度爲準，在每個報告日期進行。公司通過與內部人員和外部服務提供商討論，以確定在每個報告期末的試驗或服務的進展或完成階段，從而確定在每個報告期末產生的研發活動的估算費用，並與第三方合同相應。

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agreed upon fee to be paid for such services. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are accepted by the Company or the services are performed. Accruals are recorded for the amounts of services provided that have not yet been invoiced.

Property and Equipment

Property and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation and amortization is computed using the straight-line method over the estimated useful lives of the respective assets. Leasehold improvements are amortized over the lesser of their useful life or the remaining life of the lease. When assets are retired or otherwise disposed of, the cost and related accumulated depreciation and amortization are removed from the balance sheet and any resulting gain or loss is reflected in operations in the period realized. Maintenance and repairs are charged to operations as incurred.

​

​

​

​

Asset category

    

Depreciable life

Manufacturing equipment

 

10 years

Office equipment

 

3 – 7 years

Research and development equipment

 

7 years

​

Leases

At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the terms of the arrangement. The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines the initial classification and measurement of its operating right-of-use (“ROU”) assets and operating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options that the Company is reasonably assured to exercise. The Company’s policy is to not record leases with a lease term of 12 months or less on its balance sheets.

The ROU asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. Lease expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the statements of operations.

Payments due under each lease agreement include fixed and variable payments. Variable payments relate to the Company’s share of the lessor’s operating costs associated with the underlying asset and are recognized when the event on which those payments are assessed occurs. Variable payments have been excluded from the lease liability and associated right-of-use asset.

The interest rate implicit in lease agreements is typically not readily determinable, and as such, the Company utilizes the incremental borrowing rate to calculate lease liabilities, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.

Debt Discount and Debt Issuance Costs

Debt discounts and debt issuance costs incurred in connection with the issuance of debt are capitalized and reflected as a reduction to the related debt liability. The costs are amortized to interest expense over the term of the debt using the effective-interest method.

Impairment of Long-Lived Assets

The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that

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the carrying amount of an asset may not be recoverable. Recoverability is measured by comparing the carrying amount to the future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the projected discounted future net cash flows arising from the asset. The Company has not identified any such impairment losses to date.

Warrants

The Company evaluates its warrants to determine if the contracts qualify as liabilities in accordance with ASC 480-10, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging (“ASC 815”). If the warrant is determined to meet the criteria to be liability classified, the warrant liability is marked-to-market each balance sheet date and recorded as a liability, with the change in fair value recorded in the Company’s condensed consolidated statements of operations and comprehensive loss as gain (loss) on fair value adjustment of warrant liability within other income or expense.

In bundled transactions, the proceeds received from any debt instruments and liability classified warrants are allocated to the warrant at fair value first, and the residual value is then allocated to the debt instrument. Upon conversion or exercise of a warrant that is subject to liability treatment, the instrument is marked to fair value at the conversion or exercise date and the fair value is reclassified to equity. Equity classified warrants are recorded within additional paid-in capital at the time of issuance at fair value as of the issuance date and are not subject to subsequent remeasurement.

Revenue Recognition

The Company recognizes revenue under the core principle according to ASC 606, Revenue from Contracts with Customers (“ASC 606”), to depict the transfer of control to the Company’s customers in an amount reflecting the consideration the Company expects to be entitled to. In order to achieve that core principle, the Company applies the following five step approach: (1) identify the contract with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when a performance obligation is satisfied.

The Company’s revenues are currently comprised of partnership revenues from the Terumo Agreement related to the development and commercialization of Virtue SAB, and product revenue from the sale of FreeHold’s intracorporeal organ retractors.

Partnership Revenues

To date, the Company’s partnership revenues have related to the Terumo Agreement as further described in Note 4. In future periods, partnership revenues may also include revenues related to the Medtronic Agreement as discussed in Note 5.

The Company assessed whether the Terumo Agreement fell within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) based on whether the arrangement involved joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. The Company determined that the Terumo Agreement did not fall within the scope of ASC 808. The Company then analyzed the arrangement pursuant to the provisions of ASC 606 and determined that the arrangement represents a contract with a customer and is therefore within the scope of ASC 606.

The promised goods or services in the Terumo Agreement include (i) license rights to the Company’s intellectual property, and (ii) research and development services. The Company also has optional additional items in the Terumo Agreement which are considered marketing offers and are accounted for as separate contracts with the customer if such option is elected by the customer, unless the option provides a material right which would not be provided without entering into the contract. Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer. Promised goods or services are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources or (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct in the Terumo

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Agreement, the Company considered factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own or whether the required expertise is readily available.

The Company estimates the transaction price for the Terumo Agreement performance obligations based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration includes both fixed consideration and variable consideration. At the inception of the Terumo Agreement, as well as at each reporting period, the Company evaluates the amount of potential payments and the likelihood that the payments will be received. The Company utilizes either the most likely amount method or expected amount method to estimate the amount expected to be received based on which method better predicts the amount expected to be received. If it is probable that a significant revenue reversal would not occur, the variable consideration is included in the transaction price.

The Terumo Agreement contains development and regulatory milestone payments. At contract inception and at each reporting period, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect partnership revenues and earnings in the period of adjustment.

The Terumo Agreement also includes sales-based royalties and the license is deemed to be the predominant item to which the royalties relate. Accordingly, the Company will recognize royalty revenue when the related sales occur. To date, the Company has not recognized any royalty revenue under the arrangement.

The Company has determined that intellectual property licensed to Terumo and the research and development services to be provided to support the premarket approval by the U.S. Food and Drug Administration (the “FDA”) for the in-stent restenosis (“ISR”) indication represent a combined performance obligation that is satisfied over time, and that the appropriate method of measuring progress for purposes of recognizing revenues relates to a proportional performance model that measures the proportional performance based on the costs incurred to date relative to the total costs expected to be incurred through the completion of the performance obligation. The Company evaluates the measure of progress at each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

The Company receives payments from Terumo based on billing schedules established in the contract. Such billings for milestone related events have 10-day terms from the date the milestone is achieved, royalty payments are 20-day terms after the close of each quarter, any optional services are 20 days after receipt of an invoice and any sales of the SirolimusEFR are within 30 days after receipt of the shipping invoices. Upfront payments are recorded as deferred revenue upon receipt or when due until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the right to consideration is unconditional.

Product Revenues

Product revenues related to sales of FreeHold’s intracorporeal organ retractors are recognized at a point-in-time upon the shipment of the product to the customer, and there are no significant estimates or judgments related to estimating the transaction price. The product revenues consist of a single performance obligation, and the payment terms are typically 30 days. Product revenues are recognized solely in the United States.

Stock-Based Compensation

The Company applies ASC 718-10, Compensation — Stock Compensation, which requires the measurement and recognition of compensation expenses for all stock-based payment awards made to employees and directors including employee stock options under the Company’s stock plans based on estimated fair values (see Note 11). Each award vests over the subsequent period during which the recipient is required to provide service in exchange for the award (the vesting period). The cost of each award is recognized as an expense in the financial statements over the respective vesting period on a straight-line basis.

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Under the requirements of ASU 2018-07, the Company accounts for stock-based compensation to nonemployees under the fair value method, which requires all such compensation to be calculated based on the fair value at the measurement date (generally the grant date) and recognized in the Company’s condensed consolidated statements of operations and comprehensive loss over the requisite service period. The Company accounts for forfeitures of stock-based awards as they occur.

Net Loss Per Share

Basic and diluted net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration of potential dilutive shares of common stock. Since the Company was in a loss position for the periods presented, basic net loss is the same as diluted net loss since the effects of potentially dilutive securities are antidilutive. Potentially dilutive securities include all outstanding warrants, stock options, Earnout Consideration (see Note 3), unvested restricted stock awards and restricted stock units. Shares of Company Common Stock outstanding but subject to forfeiture and cancellation by the Company (e.g., the Forfeitable Shares (as defined in Note 3)) are excluded from the weighted-average number of shares until the period in which such shares are no longer subject to forfeiture. In periods in which there is net income, the Company would apply the two-class method to compute net income per share. Under this method, earnings are allocated to common stock and participating securities based on their respective rights to receive dividends, as if all undistributed earnings for the period were distributed. The two-class method does not apply in periods in which a net loss is reported.

Income Taxes

The Company accounts for income taxes using the asset-and-liability method in accordance with ASC 740, Income Taxes (“ASC 740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on the deferred tax assets and liabilities of a change in tax rate is recognized in the period that includes the enactment date. A valuation allowance is recorded if it is more-likely-than-not that some portion or all the deferred tax assets will not be realized in future periods. At September 30, 2024 and December 31, 2023, the Company recorded a full valuation allowance on its deferred tax assets.

The Company follows the guidance in ASC Topic 740-10 in assessing uncertain tax positions. The standard applies to all tax positions and clarifies the recognition of tax benefits in the financial statements by providing for a two-step approach of recognition and measurement. The first step involves assessing whether the tax position is more-likely-than-not to be sustained upon examination based upon its technical merits. The second step involves measurement of the amount to be recognized. Tax positions that meet the more-likely than-not threshold are measured at the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate finalization with the taxing authority. The Company recognizes the impact of an uncertain income tax position in the financial statements if it believes that the position is more likely than not to be sustained by the relevant taxing authority. The Company will recognize interest and penalties related to tax positions in income tax expense as applicable.

Deferred Offering and Merger Costs

Offering and merger costs, consisting of legal, accounting, printer and filing fees were deferred to be offset against proceeds received when the Business Combination was completed. As of December 31, 2023, there were no deferred transaction costs because upon the close of the Business Combination, they were recorded against net proceeds in additional paid-in capital. For further discussion on the Business Combination, see Note 3.

Defined Contribution Plan

The Company has a defined retirement savings plan under Section 401(k) of the Internal Revenue Code. This plan allows eligible employees to defer a portion of their annual compensation on a pre-tax basis. Effective January 1, 2023, the Company participates in a matching safe harbor 401(k) Plan with a Company contribution of up to 3.5% of each

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eligible participating employee’s compensation. Safe harbor contributions vest immediately for each participant. During the three and nine months ended September 30, 2024, the Company made $85,000 and $307,000, respectively, in contributions under this safe harbor 401(k) Plan. During the three and nine months ended September 30, 2023, the Company made $98,000 and $279,000, respectively, in contributions under this safe harbor 401(k) Plan.

Comprehensive Loss

Comprehensive loss is comprised of net loss and changes in unrealized gains and losses on the Company’s available-for-sale investments.

Segment Reporting

Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company has determined it operates in one segment.

New Accounting Standards

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”) to update reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and information used to assess segment performance. ASU 2023-07 requires companies to disclose all annual disclosures about segments in interim periods. The amendments in ASU 2023-07 are effective for all public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is currently evaluating the effect of this update on its consolidated financial statements and related disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires additional income tax disclosures in the annual consolidated financial statements. The amendments in ASU 2023-09 are intended to enhance the transparency and decision usefulness of income tax disclosures. For public entities, ASU 2023-09 is effective for annual periods beginning after December 15, 2024, with early adoption permitted. As an emerging growth company that has not opted out of the extended transition period for complying with new or revised financial accounting standards, the amendments in ASU 2023-09 are effective for the Company for fiscal years beginning after December 15, 2025, with early adoption permitted.

3. Business Combination and Recapitalization

On January 26, 2023, Legacy Orchestra and HSAC2 consummated the Business Combination, with Legacy Orchestra surviving as a wholly owned subsidiary of HSAC2. As part of the Business Combination, HSAC2 changed its name to Orchestra BioMed Holdings, Inc. Upon the closing of the Business Combination (the “Closing”), the Company’s certificate of incorporation provided for, among other things, a total number of authorized shares of capital stock of 350,000,000 shares, of which 340,000,000 shares were designated Company Common Stock, and of which 10,000,000 shares were designated preferred stock, $0.0001 par value per share.

The Business Combination is accounted for as a reverse recapitalization in accordance with U.S. GAAP. Under this method of accounting, HSAC2 is treated as the “acquired” company and Legacy Orchestra is treated as the acquirer for financial reporting purposes. Accordingly, for accounting purposes, the Business Combination was treated as the equivalent of Legacy Orchestra issuing stock for the net assets of HSAC2, accompanied by a recapitalization. The net assets of HSAC2 are stated at historical cost, with no goodwill or intangible assets recorded.

In connection with the Business Combination, HSAC2 Holdings, LLC (the “Sponsor”) agreed that 25% or 1,000,000 shares of its shares of Company Common Stock will be forfeited to the Company (the “Forfeitable Shares”) on the first business day following the fifth anniversary of the Closing unless, as to 500,000 shares, the volume-weighted average price of the Company Common Stock is greater than or equal to $15.00 per share over any 20

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trading days within any 30-trading day period (the “Initial Milestone Event”), and as to the remaining 500,000 shares, the volume-weighted average price of the Company Common Stock is greater than or equal to $20.00 per share over any 20 trading days within any 30-trading day period (the “Final Milestone Event”). Further, the Sponsor and HSAC2’s other initial shareholders prior to HSAC2’s initial public offering (the “HSAC2 IPO”) agreed to subject (i) the 4,000,000 shares of Company Common Stock issued to HSAC2’s initial shareholders prior to the HSAC2 IPO (the “Insider Shares”) and (ii) the 450,000 shares of Company Common Stock purchased in a private placement simultaneously with the HSAC2 IPO (the “Private Shares”) to a lock-up for up to 12 months following the Closing, and the Sponsor forfeited 50% of its 1,500,000 warrants in HSAC2 purchased upon consummation of the HSAC2 IPO (the “Private Warrants”), comprising 750,000 Private Warrants, for no consideration, immediately prior to the Closing (the “Sponsor Forfeiture”). Pursuant to the terms of the Merger Agreement, immediately following the Sponsor Forfeiture and prior to the Closing, HSAC2 issued 750,000 warrants to purchase Company Common Stock to eleven specified employees and directors of Legacy Orchestra (the “Officer and Director Warrants”). The Officer and Director Warrants have substantially similar terms to the forfeited Private Warrants, except that 50% of the Officer and Director Warrants will become exercisable 24 months after the Closing and the remaining 50% will become exercisable 36 months after the Closing, in each case, subject to the holder’s continued employment or service with the Company or one of its subsidiaries through such date. As of the issuance date of these financial statements, 90,000 Officer and Director Warrants have been forfeited as a result of the departures of an executive officer and a director of the Company. On April 12, 2023, the Initial Milestone Event was achieved, and, as a result, 500,000 of the Forfeitable Shares are no longer subject to forfeiture.

In connection with the Business Combination, existing Legacy Orchestra stockholders also had the opportunity to elect to participate in an earnout (the “Earnout”) pursuant to which each such electing stockholder (an “Earnout Participant”) may receive a portion of additional contingent consideration of up to 8,000,000 shares of Company Common Stock in the aggregate (“Earnout Consideration”). Each Earnout Participant agreed to extend their applicable lock-up period from 6 months to 12 months after the Closing, pursuant to an Earnout Election Agreement and such Earnout Participants will collectively be entitled to receive: (i) 4,000,000 shares of the Earnout Consideration, in the aggregate, in the event that, from the time beginning immediately after the Closing until the fifth anniversary of the Closing Date (the “Earnout Period”), the Initial Milestone Event occurs; and (ii) an additional 4,000,000 shares of the Earnout Consideration, in the aggregate, in the event that, during the Earnout Period, the Final Milestone Event occurs. Approximately 91% of Legacy Orchestra stockholders elected to participate in the Earnout. On April 12, 2023, the Initial Milestone Event was achieved, and each Earnout Participant was issued their Pro Rata Portion (as such term is defined in the Merger Agreement) of 4,000,000 shares of Company Common Stock, resulting in a total of 3,999,987 shares of Company Common Stock being issued (less than 4,000,000 due to rounding).

Simultaneously with the execution of the Merger Agreement, HSAC2 and Legacy Orchestra entered into separate forward purchase agreements (each, as amended, a “Forward Purchase Agreement” and, together, the “Forward Purchase Agreements”) with certain funds managed by RTW Investments, LP (the “RTW Funds”) and Covidien Group S.à.r.l., an affiliate of Medtronic plc (“Medtronic” and the RTW Funds, each a “Purchasing Party”), pursuant to which each of the Purchasing Parties agreed to purchase $10 million of ordinary shares of HSAC2 (“HSAC2 Ordinary Shares”) immediately prior to the Domestication (as defined below), less the dollar amount of HSAC2 Ordinary Shares holding redemption rights that the Purchasing Party acquired and held until immediately prior to the Domestication (such HSAC2 Ordinary Shares either purchased from HSAC2 or acquired and held until immediately prior to the Domestication, the “Forward Purchase Shares”). The RTW Funds completed their purchases of HSAC2 Ordinary Shares under their Forward Purchase Agreement on or before July 22, 2022. Medtronic completed approximately $9.9 million of purchases of HSAC2 Ordinary Shares under its Forward Purchase Agreement on or before January 20, 2023. Medtronic subsequently completed $0.1 million in purchases of HSAC2 Ordinary Shares and/or Company Common Stock on or before January 30, 2023.

Simultaneously with the execution of the Merger Agreement and Forward Purchase Agreements, HSAC2, Legacy Orchestra and the RTW Funds entered into a Backstop Agreement (the “Backstop Agreement”), pursuant to which the RTW Funds, jointly and severally, agreed to purchase such number of HSAC2 Ordinary Shares at a price of $10.00 per share to the extent that the amount of cash remaining in HSAC2’s working capital and trust account as of immediately prior to the closing of the Merger was less than $60 million (which calculation excludes amounts received pursuant to Medtronic’s Forward Purchase Agreement or are otherwise held in HSAC2’s trust account established pursuant to the HSAC2 IPO (the “HSAC2 Trust Account”) in respect of Medtronic’s Forward Purchase Shares, but is inclusive of amounts received pursuant to the RTW Funds’ Forward Purchase Agreement and otherwise held in the HSAC2 Trust Account in

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respect of the RTW Funds’ Forward Purchase Shares). Pursuant to the Backstop Agreement, the RTW Funds purchased 1,808,512 HSAC2 Ordinary Shares on January 25, 2023, immediately prior to the Domestication.

Immediately prior to the closing of the Business Combination, each issued and outstanding share of Legacy Orchestra preferred stock (the “Legacy Orchestra Preferred Stock”) was canceled and converted into shares of Legacy Orchestra common stock (the “Legacy Orchestra Common Stock”) based on predetermined ratios (see Note 9).

Upon the consummation of the Business Combination, each issued and outstanding share of Legacy Orchestra Common Stock was canceled and converted into the right to receive shares of Company Common Stock based upon the Exchange Ratio. The shares and corresponding capital amounts and loss per share related to Legacy Orchestra Common Stock prior to the Business Combination have been retroactively restated to reflect the Exchange Ratio.

Outstanding stock options, whether vested or unvested, to purchase shares of Legacy Orchestra Common Stock (“Legacy Orchestra Options”) granted under the Orchestra BioMed, Inc. 2018 Stock Incentive Plan (“2018 Plan”) (see Note 11) converted into stock options to purchase shares of Company Common Stock upon the same terms and conditions that were in effect with respect to such stock options immediately prior to the Business Combination, after giving effect to the Exchange Ratio (the “Exchanged Options”).

The following table details the number of shares of Company Common Stock issued immediately following the consummation of the Business Combination:

​

​

​

​

​

​

    

Number of

​

​

​

Shares

Common stock of HSAC2, outstanding prior to the Business Combination

​

 

6,762,117

Less: Redemption of HSAC2 shares

​

 

(1,597,888)

Company Common Stock held by former HSAC2 shareholders

​

 

5,164,229

HSAC2 sponsor shares

​

 

4,450,000

Shares issued related to Backstop Agreement

​

 

1,808,512

Total shares outstanding prior to issuance of merger consideration to Legacy Orchestra stockholders

​

 

11,422,741

Shares issued to Legacy Orchestra stockholders – Company Common Stock(1)

​

 

20,191,338

Total shares of Company Common Stock immediately after Business Combination(2)

​

 

31,614,079

(1)The number of shares of Company Common Stock issued to Legacy Orchestra equity holders was determined based on (i) 2,522,214 shares of Legacy Orchestra Common Stock outstanding immediately prior to the closing of the Business Combination converted based on the Exchange Ratio and (ii) 35,694,179 shares of Legacy Orchestra Preferred Stock outstanding immediately prior to the Closing, which pursuant to their terms converted into Legacy Orchestra Common Stock immediately prior to the Closing and then converted into Company Common Stock based on the Exchange Ratio. All fractional shares were rounded down.
(2)Excludes 8,000,000 shares of Company Common Stock issued or to be issued based on satisfaction of the Initial Milestone Event and the Final Milestone Event. On April 12, 2023, the Initial Milestone Event was achieved, and each Earnout Participant was issued their Pro Rata Portion (as such term is defined in the Merger Agreement) of 4,000,000 shares of Company Common Stock, resulting in a total of 3,999,987 shares of Company Common Stock being issued (less than 4,000,000 due to rounding).

The following table reconciles the elements of the Business Combination to the Company’s condensed consolidated statements of stockholders’ equity (deficit) (in thousands):

​

​

​

​

​

​

    

Amount

​

Cash – HSAC2’s trust (net of redemption)

​

$

51,915

​

Cash – Backstop Agreement

​

 

18,085

​

Gross proceeds

​

 

70,000

​

Less: HSAC2 and Legacy Orchestra transaction costs paid

​

 

(15,698)

​

Effect of Business Combination, net of redemptions and transaction costs

​

$

54,302

​

​

The $54.3 million above differs from the $56.8 million effect of the Business Combination on the condensed consolidated statements of cash flows, due to $2.5 million of transaction costs paid by Legacy Orchestra in 2022.

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4. Terumo Agreement

In June 2019, Legacy Orchestra entered into the Terumo Agreement, pursuant to which Terumo secured global commercialization rights for Virtue SAB in coronary and peripheral vascular indications. Under the Terumo Agreement, Legacy Orchestra received an upfront payment of $30 million and an equity commitment of up to $5 million of which $2.5 million was invested in June 2019 as part of the Legacy Orchestra Series B-1 financing and $2.5 million was invested in June 2022 as part of the Legacy Orchestra Series D-2 financing. The Company was initially eligible to receive up to $65 million in additional payments based on the achievement of certain development and regulatory milestones and is also eligible to earn royalties on future sales by Terumo based on royalty rates ranging from 10 – 15%. Of these milestone payments, $35 million relate to achieving certain milestones by specified target achievement dates. As of the issuance date of these financial statements, the target achievement date for three $5 million milestone payments has already passed. In addition, due to delays in the Company’s Virtue SAB program resulting from the COVID-19 pandemic, supply chain issues and unexpected changes to regulatory requirements, including increased testing and other activities related to chemistry, manufacturing, and control, increased nonclinical and good laboratory practice preclinical data requirements, including biocompatibility, as well as a requirement to repeat good laboratory practice preclinical studies already performed based on changes to source of component materials and a change in manufacturing site, the Company is unlikely to be able to complete the remaining time-based milestones by the specified target achievement dates to earn the remaining $20 million in time-based milestone payments pursuant to the Terumo Agreement.

​

As previously disclosed, the Company and Terumo have been negotiating for mutually agreeable adjustments to the Terumo Agreement with the purpose of restructuring milestone payments as well as making other potential material modifications to that agreement including additional financial commitments by Terumo to Orchestra and the Virtue SAB program. If negotiations are not completed to the Company’s satisfaction or to the satisfaction of Terumo, clinical study, product development, and commercialization plans for Virtue SAB may continue to be adversely impacted.

​

Pursuant to the terms of the Terumo Agreement, Legacy Orchestra licensed intellectual property rights to Terumo and the Company is primarily responsible for completing the development of the product in the United States to support premarket approval by the FDA for the ISR indication. These research and development services to be provided by the Company include (i) manufacturing, testing and packaging the drug required for the clinical trials, (ii) supplying Terumo with information related to the design and manufacture of the delivery device and the technology transfer needed for Terumo to ultimately commence manufacture of the delivery device, and (iii) carrying out regulatory activities related to clinical trials in the United States for the ISR indication.

​

The Company has concluded that the license granted to Terumo is not distinct from the research and development services that will be provided to Terumo through the completion of the development of ISR indication, as Terumo cannot obtain the benefit of the license without the related research and development services. Accordingly, the Company will recognize revenues for this combined performance obligation over the estimated period of research and development services using a proportional performance model. The Company measures proportional performance based on the costs incurred relative to the total estimated costs of the research and development services.

In 2019, Legacy Orchestra received a total of $32.5 million from Terumo related to the stock purchase and the revenue generating elements of the Terumo Agreement. The Company recorded the estimated fair value of the shares of $2.5 million in stockholders’ equity, as the value paid by Terumo is consistent with the value paid by other third-party stockholders in Legacy Orchestra’s offering of its Series B-1 Preferred Stock. The Company allocated the remaining $30 million to the transaction price of the Terumo Agreement. The Company considers the future potential development and regulatory milestones to be variable consideration, which are fully constrained from the transaction price as of September 30, 2024 and December 31, 2023, as the achievement of such milestone payments are uncertain and highly susceptible to factors outside of the Company’s control. The Company plans to re-evaluate the transaction price at each reporting period and as uncertain events are resolved or other changes in circumstances occur. In addition, the arrangement also includes sales-based royalties on product sales by Terumo subsequent to commercialization ranging from 10 - 15%, none of which have been recognized to date.

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The Company recorded the $30 million upfront payment received from Terumo in 2019 within deferred revenue. The following table presents the changes in the Company’s deferred revenue balance from the Terumo Agreement during the nine months ended September 30, 2024 and 2023 (in thousands):  

​

​

​

​

Deferred Revenue – December 31, 2023

    

$

17,433

Revenue recognized

​

 

(1,928)

Deferred Revenue – September 30, 2024

​

$

15,505

​

​

​

​

​

Deferred Revenue – December 31, 2022

    

$

19,539

Revenue recognized

​

 

(2,018)

Deferred Revenue – September 30, 2023

​

$

17,521

The Company’s balance of deferred revenue contains the transaction price from the Terumo Agreement allocated to the combined license and research and development performance obligation, which was partially unsatisfied as of September 30, 2024. The Company expects to recognize approximately $4.1 million of its deferred revenue during the next twelve months and recognize the remaining approximately $11.4 million through the remainder of the performance period, which is currently estimated to be completed in 2029 and may be impacted by the actual clinical and regulatory timelines of the program.

As of each quarterly reporting date, the Company evaluates its estimates of the total costs expected to be incurred through the completion of the combined performance obligation and updates its estimates as necessary. For the three months ended September 30, 2024 and 2023, the expenses incurred related to the Terumo Agreement were approximately $3.6 million and $3.4 million, respectively. For the nine months ended September 30, 2024 and 2023, the expenses incurred related to the Terumo Agreement were approximately $10.5 million and $11.7 million, respectively. The estimated total costs associated with the Terumo Agreement through completion increased by approximately 2.6% as of September 30, 2024, as compared to the estimates as of December 31, 2023, and increased by approximately 7.0% as of September 30, 2023, as compared to the estimates as of December 31, 2022. While the Company believes it has estimated total costs associated with the Terumo Agreement through completion, these estimates encompass a broad range of expenses over a multi-year period and, as such, are subject to periodic changes as new information becomes available. The impact of the changes in estimates resulted in an increase of partnership revenues of $33,000 and a decrease of $558,000 for the three months ended September 30, 2024 and 2023, respectively, as compared to the amounts that would have been recorded based on the previous estimates. The impact of the changes in estimates resulted in a reduction of partnership revenues of $371,000 and $882,000 for the nine months ended September 30, 2024 and 2023, respectively, as compared to the amounts that would have been recorded based on the previous estimates. The impact of these changes in estimates on the net loss per share attributable to common stockholders, basic and diluted, for the three months ended September 30, 2024 was de minimis and for the nine months ended September 30, 2024 was an increase of $0.01. The impact of these changes in estimates on the net loss per share attributable to common stockholders, basic and diluted, for the three and nine months ended September 30, 2023 was an increase of $0.02 and $0.03, respectively.

The Company will also manufacture, or have manufactured, SirolimusEFR and has exclusive rights to sell it on a per unit basis to Terumo for use in the Virtue SAB product. The Company has determined that this promise does not contain a material right as the pricing is based on standalone selling prices. Through September 30, 2024, there have been no additional amounts recognized as revenue under the Terumo Agreement other than the recognition of a portion of the upfront payment described above.

5. Medtronic Agreement

In June 2022, Legacy Orchestra, BackBeat and Medtronic entered into the Medtronic Agreement for the development and commercialization of AVIM therapy for the treatment of pacemaker-indicated patients with uncontrolled HTN despite the use of antihypertensive medications (the “Primary Field”). Under the terms of the Medtronic Agreement, the Company will sponsor a multinational pivotal study, which has commenced, to support regulatory approval of AVIM therapy in the Primary Field and be financially responsible for development, clinical and regulatory costs associated with this pivotal study. AVIM therapy has been integrated into the Medtronic top-of-the-line, commercially available dual-chamber

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pacemaker system specifically for use in the pivotal trial and will provide development, clinical and regulatory resources in support of the pivotal trial, for which the Company will reimburse Medtronic at cost.

Under the terms of the Medtronic Agreement, Medtronic will have exclusive rights to commercialize AVIM therapy-enabled pacing systems globally following receipt of regulatory approval. Medtronic would be entirely responsible for global commercialization following receipt of regulatory approvals, including manufacturing, sales, marketing and distribution costs.

The Company is expected to receive between $500 and $1,600 per AVIM therapy-enabled device sold based on a formula of the higher of (1) a fixed dollar amount per AVIM therapy-enabled device (amount varies materially on a country-by-country basis) or (2) a percentage of the AVIM therapy-generated sales. Procedures using the AVIM therapy-enabled pacemakers are expected to be billed under existing reimbursement codes.

Medtronic has a right of first negotiation through FDA approval of AVIM therapy in the Primary Field, to expand its global rights to AVIM therapy for the treatment of HTN patients not indicated for a pacemaker.

The Company assessed whether the Medtronic Agreement fell within the scope of ASC 808 and concluded that the Medtronic Agreement is a collaboration within the scope of ASC 808. In addition, the Company determined that Medtronic is a customer for a good or service that is a distinct unit of account, and therefore, the transactions in the Medtronic Agreement should be accounted for under ASC 606.

The Company has concluded that the license granted to Medtronic is not distinct from the development and implementation services that will be provided to Medtronic through the completion of the development of HTN indication, as Medtronic cannot obtain the benefit of the license without the related development and implementation services. ASC 606-10-55-65 includes an exception for the recognition of revenue relating to licenses of intellectual property with sales-based or usage-based royalties. Under this exception, royalty revenue is not recorded until the subsequent sale or usage occurs, or the performance obligation has been satisfied, whichever is later.

The Company concluded that the exemption applies and therefore, the royalty revenue associated with these performance obligations will be recognized as the underlying sales occur. Additionally, pursuant to the Medtronic Agreement, expenses incurred by Medtronic in connection with clinical device development and regulatory activities performed will be reimbursed by the Company. The Company will record such expenses as research and development expenses as incurred. During the three and nine months ended September 30, 2024, the Company incurred approximately $2.8 million and $5.9 million, respectively, of research and development costs related to these reimbursements pursuant to the Medtronic Agreement, of which $4.3 million is included within accounts payable and accrued expenses in the Company’s September 30, 2024 condensed consolidated balance sheet. During the three and nine months ended September 30, 2023, the Company incurred approximately $854,000 and $3.1 million, respectively, of research and development costs related to these reimbursements pursuant to the Medtronic Agreement. 

Concurrently with the close of the Medtronic Agreement, Legacy Orchestra also received a $40 million investment from Medtronic in connection with Legacy Orchestra’s Series D-2 Preferred Stock financing. The equity was purchased at a fair value consistent with the price paid by other investors at that time, and accordingly, the proceeds received were recorded as an equity investment.

Through September 30, 2024, there have been no amounts recognized as revenue under the Medtronic Agreement.

6. Financial Instruments and Fair Value Measurements

The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

    

September 30, 2024

(in thousands)

​

Level 1

    

Level 2

    

Level 3

    

Total

Assets

 

​

  

 

​

  

 

​

  

 

​

  

Money market fund (included in cash and cash equivalents)

​

$

13,231

​

$

—

​

$

—

​

$

13,231

Marketable securities (Corporate debt securities)

​

 

—

​

 

41,321

​

 

—

​

 

41,321

Total assets

​

$

13,231

​

$

41,321

​

$

—

​

$

54,552

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​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

    

December 31, 2023

(in thousands)

​

Level 1

    

Level 2

    

Level 3

    

Total

Assets

 

​

  

 

​

  

 

​

  

 

​

  

Money market fund (included in cash and cash equivalents)

​

$

27,592

​

$

—

​

$

—

​

$

27,592

Investment in Motus GI (see Note 7)

​

 

68

​

 

—

​

 

—

​

 

68

Marketable securities (Corporate and Government debt securities)

​

 

—

​

 

56,968

​

 

—

​

 

56,968

Total assets

​

$

27,660

​

$

56,968

​

$

—

​

$

84,628

​

The Level 2 assets consist of government and corporate debt securities which are valued using market observable inputs, including the current interest rate and other characteristics for similar types of investments, whose fair value may not represent actual transactions of identical securities. There were no transfers between Levels 1, 2 or 3 for the periods presented.

Prior to the closing of the Business Combination, the Company’s warrant liability was measured at fair value on a recurring basis using unobservable inputs and were classified as Level 3 inputs, and any change in fair value was recognized as change in fair value of warrant liability in the Company’s condensed consolidated statements of operations and comprehensive loss. As of the Closing Date, all Legacy Orchestra liability classified warrants were reclassified to equity. Refer to Note 10 for the valuation technique and assumptions used in estimating the fair value of the warrants and discussion on the change in classification.

The following table presents a roll-forward of the aggregate fair values of the Company’s liabilities for which fair value is determined by Level 3 inputs (in thousands):

​

​

​

​

​

    

Warrant

​

​

Liability

Balance—December 31, 2022

​

$

2,089

Warrants exercised prior to the Business Combination

​

 

(10)

Change in fair value of warrants

​

 

294

Warrants reclassified to equity

​

 

(2,373)

Balance—September 30, 2023

​

$

—

​

​

​

7. Marketable Securities and Strategic Investments

Marketable Securities

The following is a summary of the Company’s marketable securities as of September 30, 2024 and December 31, 2023:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

    

September 30, 2024

​

​

Amortized

    

Unrealized

    

Unrealized

    

Fair

(in thousands)

​

Cost Basis

​

Gains

​

Losses

​

Value

Corporate debt securities

​

$

41,223

​

$

100

​

$

(2)

​

$

41,321

Total

​

$

41,223

​

$

100

​

$

(2)

​

$

41,321

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

    

December 31, 2023

​

​

Amortized

    

Unrealized

    

Unrealized

    

Fair

(in thousands)

​

Cost Basis

​

Gains

​

Losses

​

Value

Corporate debt securities

​

$

8,655

​

$

—

​

$

(8)

​

$

8,647

Government debt securities

​

 

48,323

​

 

7

​

 

(9)

​

 

48,321

Total

​

$

56,978

​

$

7

​

$

(17)

​

$

56,968

​

The Company believes it is more likely than not that its marketable securities in an unrealized loss position will be held until maturity or the recovery of the cost basis of the investment. To date, the Company has not recorded any allowance for credit losses on its investment securities. The Company determined that the unrealized losses were not attributed to credit risk but were primarily driven by the broader change in interest rates. As of September 30, 2024, $5.6

21

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million of the Company’s marketable securities had maturities of 12 to 36 months while the remaining marketable securities had maturities of less than 12 months.

For the three and nine months ended September 30, 2024, the Company recognized realized gains of $10,000 and $11,000, respectively, on its marketable securities. For the nine months ended September 30, 2023, the Company recognized realized losses on its marketable securities of $102,000 but did not recognize any realized gains or losses for the three months ended September 30, 2023.

Strategic Investments

The Company’s long-term strategic investments as of September 30, 2024 represent investments made in Vivasure in 2020, 2021 and 2022 that were originally recorded at cost. There were no observable price changes or impairments identified during the nine months ended September 30, 2024 and 2023 related to these investments.

In May 2022, Vivasure announced a Series D private placement, in which it received a material investment from Haemonetics Corporation, a new strategic investor. In conjunction with a €30 million investment in Vivasure, Haemonetics Corporation also secured an option to acquire Vivasure based on the achievement of certain milestones. As a result, Legacy Orchestra’s existing convertible redeemable notes converted into Series D Preferred Stock of Vivasure in May 2022. The investment in the Vivasure Series D Preferred Stock represents an observable price change in an orderly transaction for an identical instrument of the same issuer, and accordingly, the Company recognized a gain on its strategic investment in Vivasure of $1.9 million in the second quarter of 2022. This amount represents a portion of the previously impaired investment balance described below.

During the fourth quarter of 2019, the Company identified indicators of impairment of Vivasure strategic investments held at that time as a result of adverse changes in Vivasure’s business operations, including liquidity concerns. As a result, the Company recorded an impairment charge in the fourth quarter of 2019 of $5.8 million, which represents the cumulative impairment charges recorded on Vivasure strategic investments to date.

The Company measured the fair value of its historic strategic investment in equity securities of Motus GI using the listed share price on the Nasdaq Capital Market on each valuation date until Motus GI announced its liquidation and dissolution during the second quarter of 2024. In the second quarter of 2024, the Company recorded the carrying value of the Motus GI investment to zero representing aggregate losses of $68,000 for the nine months ended September 30, 2024. There were no further adjustments to the Motus GI investment during the three months ended September 30, 2024. During the three and nine months ended September 30, 2023, aggregate losses of $293,000 and $276,000, respectively, were recorded to adjust the Motus GI investment to $68,000 at December 31, 2023. The Motus GI investment is classified as strategic investments within current assets on the accompanying condensed consolidated balance sheets.

8. Balance Sheet Components

Property and Equipment, Net

Property and equipment, net consists of the following:

​

​

​

​

​

​

​

​

​

    

September 30, 

    

December 31, 

(in thousands)

​

2024

​

2023

Equipment

​

$

1,878

​

$

1,777

Office furniture

 

​

437

 

​

343

Leasehold improvements

 

​

158

 

​

203

Property and equipment, gross

 

​

2,473

 

​

2,323

Less accumulated depreciation and amortization

 

​

(1,219)

 

​

(1,044)

Total Property and equipment, net

​

$

1,254

​

$

1,279

​

Depreciation and amortization expense was $76,000 and $71,000 for the three months ended September 30, 2024 and 2023, respectively. Depreciation and amortization expense was $224,000 and $215,000 for the nine months ended September 30, 2024 and 2023, respectively.

22

Table of Contents

Accrued Expenses

Accrued expenses consist of the following:

​

​

​

​

​

​

​

​

​

    

September 30, 

    

December 31, 

(in thousands)

​

2024

​

2023

Accrued compensation

​

$

2,630

​

$

2,661

Clinical trial accruals

 

​

3,228

 

​

1,409

Other accrued expenses

 

​

1,176

 

​

1,079

Total accrued expenses

​

$

7,034

​

$

5,149

​

​

9. Common and Preferred Stock

Common Stock

The Company is authorized to issue up to 340,000,000 shares of Company Common Stock.

As discussed in Note 3, the Company has retroactively adjusted the shares issued and outstanding prior to January 26, 2023 to give effect to the Exchange Ratio to determine the number of shares of Company Common Stock into which they were converted.

Preferred Stock

The Company is authorized to issue 10,000,000 shares of preferred stock with a par value of $0.0001 per share. The board of directors of the Company (the “Board”) has the authority to issue preferred stock and to determine the rights, privileges, preferences, restrictions, and voting rights of those shares. As of September 30, 2024, no shares of preferred stock were outstanding.

At-the-Market Offering and Shelf Registration Statement

​

On May 15, 2024, the Company entered into an Open Market Sale AgreementSM (the “Prior Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which the Company could offer and sell, from time to time through Jefferies, up to $100 million of shares of Company Common Stock (the “Prior ATM Shares”) by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act.

​

Also on May 15, 2024, the Company filed a shelf registration statement on Form S-3 with the SEC (the “Shelf Registration Statement”), which contains a base prospectus, covering up to a total aggregate offering price of $300 million of Company Common Stock, preferred stock, debt securities, warrants, right and/or units, and a prospectus supplement that covered the offering, issuance and sale of the Prior ATM Shares, which are included in the $300 million of securities that may be offered, issued and sold by the Company pursuant to the Shelf Registration Statement.

​

On July 11, 2024, the Company sold 2,000,000 shares of Company Common Stock under the Prior Agreement resulting in aggregate gross proceeds to the Company of approximately $15.5 million and net proceeds to the Company of approximately $15.0 million.

​

On August 12, 2024, the Company entered into a sales agreement (the “Sales Agreement”) with TD Securities (USA) LLC, as agent (“TD Cowen”), pursuant to which the Company may offer and sell, from time to time through TD Cowen, up to $100 million of shares of Company Common Stock (the “Offering”) by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act. The Offering is being made pursuant to the Shelf Registration Statement, filed with the SEC on May 15, 2024 and declared effective on May 24, 2024, a base prospectus, dated May 24, 2024, included as part of the Shelf Registration Statement, and a prospectus supplement, dated August 12, 2024 filed with the SEC pursuant to Rule 424(b)(5) on August 12, 2024. As of September 30, 2024, no sales had been made under the Sales Agreement.

  

23

Table of Contents

Termination of Prior Agreement

 

In connection with the entry into the Sales Agreement, on August 12, 2024, the Company terminated the Prior Agreement between the Company and Jefferies (the “Termination”), in accordance with its terms and with the mutual agreement of Jefferies. The purpose of the Termination is to eliminate restrictions under certain SEC rules relating to the publication or dissemination of new research reports on the Company’s business by Jefferies in light of its role as sales agent under the Prior Agreement. The Company had $84.5 million remaining available under the Prior Agreement. The Company cannot make any further sales of Company Common Stock pursuant to the Prior Agreement.

​

10. Warrants

The Company evaluates its outstanding warrants to determine if the instruments qualify for equity or liability classification.

Private Warrants

Prior to the Merger, HSAC2 had outstanding 1,500,000 Private Warrants, which were issued in connection with the HSAC2 IPO to the Sponsor. Each Private Warrant entitles the holder thereof to purchase one share of Company Common Stock at a price of $11.50 per share, subject to adjustment as provided therein. The Private Warrants became exercisable 30 days after the completion of the Business Combination and will expire five years after the completion of the Business Combination. Each Private Warrant is non-redeemable and may be exercised on a cashless basis. Since these warrants are indexed to the Company’s publicly traded Company Common Stock, they are classified within equity.

As described in Note 3, the Sponsor and HSAC2’s other initial shareholders prior to the HSAC2 IPO agreed to subject (i) the 4,000,000 Insider Shares and (ii) the 450,000 Private Shares to a lock-up for up to 12 months following the Closing and the Sponsor forfeited 50% of its 1,500,000 Private Warrants, comprising 750,000 Private Warrants, for no consideration, immediately prior to the Closing. Pursuant to the terms of the Merger Agreement, immediately following the Sponsor Forfeiture and prior to the Closing, HSAC2 issued 750,000 Officer and Director Warrants to eleven specified employees and directors of Legacy Orchestra. The Officer and Director Warrants have substantially similar terms to the forfeited Private Warrants, except that 50% of the Officer and Director Warrants will become exercisable 24 months after the Closing and the remaining 50% will become exercisable 36 months after the Closing, in each case, subject to the holder’s continued employment or service with the Company or one of its subsidiaries through such date. As of the issuance date of these financial statements, 90,000 Officer and Director Warrants have been forfeited as a result of the departures of an executive officer and a director of the Company.

Avenue Warrants

On October 6, 2023, the Company issued equity-classified warrants (the “Avenue Warrants”) to purchase 27,707 shares of Company Common Stock at an exercise price of $7.67 per share in lieu of a cash payment of approximately $212,500 to Avenue Venture Opportunities Fund, L.P. (“Avenue I”) and Avenue Venture Opportunities Fund II, L.P. (“Avenue II,” and, collectively with Avenue I, “Avenue”). The warrants were issued to settle certain fees related to the termination and repayment of the loan and security agreement with Avenue (the “2022 Loan and Security Agreement”). As of October 6, 2023, the Company valued the Avenue Warrants using the Black-Scholes option-pricing model and determined the fair value at $66,000. The key inputs to the valuation model included the annualized volatility of 42.0% and a risk-free rate of 4.98%.

Assumed Legacy Orchestra Warrants

Prior to the close of the Business Combination, the majority of Legacy Orchestra’s warrants (the “Legacy Orchestra Warrants”) were required to be accounted for as liabilities as certain features within the warrant agreements contained features that were not considered “fixed for fixed” pursuant to ASC 815, and therefore, the fair value of the warrant liability was marked-to-market at each balance sheet date, with the change in fair value recorded in the Company’s condensed consolidated statements of operations and comprehensive loss within other income (expense). Upon the close of the Business Combination, all liability classified Legacy Orchestra Warrants became equity classified on that date, as the

24

Table of Contents

warrant agreements became “fixed for fixed.” As a result, the warrant liability was fair valued and adjusted from $2.1 million as of December 31, 2022 to $2.4 million as of January 26, 2023, and then subsequently reclassified into stockholders’ equity. In addition, Legacy Orchestra also had outstanding other equity classified warrants recorded within additional paid-in capital at the time of issuance at fair value that were not subject to subsequent remeasurement.

The Company calculates the fair value of the outstanding warrant liability at each reporting date by estimating the equity value of the Company, and then utilizing option pricing models to allocate the total equity value to the shares and warrants outstanding. The inputs used in the valuation models for the Company’s warrant liability are as follows:

​

​

​

​

​

    

Period from

    

​

​

January 1, 2023

​

​

​

to January 26, 2023

​

Expected volatility

​

44 – 49

%  

Risk-free interest rate

​

3.60 – 4.80

%  

Remaining term in years

 

0.35 – 5.00

 

Exercise price of common warrants

​

$1.08 – $30.11

​

Company Common Stock price

​

$10.63

​

Expected dividend yield

​

0

%  

​

The Company’s warrant liability related to Legacy Orchestra warrant activity rollforward is as follows, with the warrants having been converted to reflect the effect of the Merger:

​

​

​

​

​

​

​

    

Common

    

​

​

(in thousands, except share data)

​

Warrants

​

Amount

Balance December 31, 2022

​

1,327,074

​

$

2,089

Warrants exercised prior to the business combination

 

(1,163)

 

​

(10)

Change in fair value of warrants as of January 26, 2023

 

—

 

​

294

Warrants reclassified to equity

 

(1,325,911)

 

​

(2,373)

Balance March 31, 2023

​

—

​

​

—

Balance June 30, 2023

​

—

​

​

—

Balance September 30, 2023

 

—

​

$

—

​

Private Warrants, Avenue Warrants and Assumed Legacy Orchestra Warrants

The following table summarizes outstanding warrants to purchase shares of Company Common Stock as of September 30, 2024 and December 31, 2023:

​

​

​

​

​

​

​

​

​

​

    

Number of Shares

    

​

    

    

​

​

September 30, 

​

December 31, 

​

Exercise 

​

​

​

​

2024

    

2023

​

Price

​

Term

Equity-classified Warrants

​

​

​

​

​

​

​

​

Legacy Orchestra Warrants

 

507,841

 

507,841

​

$1.08 – $30.11

 

0.10 – 8.75

Avenue Warrants (Note 14)

​

27,707

​

27,707

​

$7.67

​

2.50

Private Warrants Held by Sponsor

 

750,000

 

750,000

​

$11.50

 

4.32 – 4.57

Private Warrants Held by Employees (Note 11)

 

660,000

 

660,000

​

$11.50

 

4.32

Total Outstanding

 

1,945,548

 

1,945,548

​

  

 

  

​

​

11. Stock-Based Compensation

As of September 30, 2024, the only equity compensation plan from which the Company may currently issue new awards is the Company’s 2023 Equity Incentive Plan (the “2023 Plan”), as more fully described below.

Orchestra BioMed, Inc. 2018 Stock Incentive Plan

Prior to the Merger, Legacy Orchestra maintained the 2018 Plan, under which Legacy Orchestra granted incentive stock options, non-qualified stock options and restricted stock awards to its employees and certain non-employees, including consultants, advisors and directors. The maximum aggregate shares of Legacy Orchestra Common Stock that

25

Table of Contents

was subject to awards and issuable under the 2018 Plan was 5.2 million shares prior to the Merger. Employees, consultants, and directors were eligible for awards granted under the 2018 Plan, which generally have a contractual life of up to 10 years and may be exercisable in cash or as otherwise determined by the Board. Vesting generally occurs over a period of not greater than three years.

As described in Note 3, in connection with the Merger, each Legacy Orchestra Option that was outstanding and unexercised immediately prior to the time that the Merger became effective (the “Effective Time”) (whether vested or unvested) was assumed by the Company and converted into an option to purchase an adjusted number of shares of Company Common Stock at an adjusted exercise price per share, based on the Exchange Ratio, and will continue to be governed by substantially the same terms and conditions, including vesting, as were applicable to the former option. Each Exchanged Option is exercisable for a number of whole shares of Company Common Stock equal to the product of the number of shares of Legacy Orchestra Common Stock underlying such Legacy Orchestra Options multiplied by the Exchange Ratio, and the per share exercise price of such Exchanged Option is equal to the quotient determined by dividing the exercise price per share of the Legacy Orchestra Option by the Exchange Ratio. Following the closing of the Merger, no new awards may be made under the 2018 Plan.

The Company accounted for the Exchanged Options as a modification of the existing options. Incremental compensation costs, measured as the excess, if any, of the fair value of the modified options over the fair value of the original options immediately before its terms are modified, is measured based on the fair value of the underlying shares and other pertinent factors at the modification date. The impact of the option modifications were de minimis.

Orchestra BioMed Holdings, Inc. 2023 Equity Incentive Plan

At the Effective Time, the Company adopted the 2023 Plan which permits the granting of incentive stock options, non-qualified options, stock appreciation rights, restricted stock, restricted stock units, performance awards and other stock-based award to employees, directors, and non-employee consultants and/or advisors. As of September 30, 2024, approximately 1.2 million shares of Company Common Stock are authorized for issuance pursuant to awards under the 2023 Plan. The pool of available shares will be automatically increased on the first day of each calendar year, beginning January 1, 2024 and ending January 1, 2032, by an amount equal to the lesser of (i) 4.8% of the outstanding shares of the Company Common Stock determined on a fully-diluted basis as of the immediately preceding December 31 and (ii) 3,036,722 shares of Company Common Stock, and (iii) such number of shares of Company Common Stock determined by the Board or the Compensation Committee prior to January 1st of a given year.  

In addition, any awards outstanding under the 2018 Plan upon the Closing, after adjustment for the Business Combination, remain outstanding. If any of those awards subsequently expire, terminate, or are surrendered or forfeited for any reason without issuance of shares after the closing of the Business Combination, the shares of Company Common Stock underlying those awards will automatically become available for issuance under the 2023 Plan.

Total stock-based compensation related to option issuances was as follows:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

    

Three Months Ended September 30, 

    

Nine Months Ended September 30, 

(in thousands)

​

2024

    

2023

​

2024

    

2023

Research and development

​

$

514

​

$

391

​

$

1,331

​

$

1,206

Selling, general and administrative

 

​

637

 

​

610

 

​

1,828

 

​

1,979

Total stock-based compensation

​

$

1,151

​

$

1,001

​

$

3,159

​

$

3,185

​

As of September 30, 2024, there was approximately $7.3 million of unrecognized stock-based compensation expense associated with the stock options noted above that is expected to be recognized over a weighted average period of approximately 2.5 years.

26

Table of Contents

Total stock-based compensation related to restricted stock awards and restricted stock units was as follows:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

    

Three Months Ended September 30, 

    

Nine Months Ended September 30, 

(in thousands)

​

2024

    

2023

​

2024

    

2023

Research and development

​

$

202

​

$

643

​

$

941

​

$

643

Selling, general and administrative

​

 

747

​

 

1,595

​

 

2,820

​

 

2,142

Total stock-based compensation

​

$

949

​

$

2,238

​

$

3,761

​

$

2,785

​

As of September 30, 2024, there was approximately $10.7 million of unrecognized restricted stock-based compensation expense associated with the restricted stock noted above that is expected to be recognized over a weighted average period of approximately 2.3 years.

As previously discussed in Note 3 and Note 10, pursuant to the terms of the Merger Agreement, immediately following the Sponsor Forfeiture and prior to the Closing, the Company issued 750,000 warrants to purchase Company Common Stock to eleven specified employees and directors of Legacy Orchestra. The Officer and Director Warrants have substantially similar terms to the forfeited Private Warrants, except that 50% of the Officer and Director Warrants will become exercisable 24 months after the Closing and the remaining 50% will become exercisable 36 months after the Closing. The estimated grant-date fair value of these warrant awards issued concurrent with the close of the Business Combination was calculated using the Black-Scholes option pricing model. Assumptions used were an expected term (in years) of 5.00, expected volatility of 50%, risk-free interest rate of 3.54%, expected dividend yield of 0%, and the fair value of the Company Common Stock of $10.63. During the year ended December 31, 2023, 90,000 Officer and Director Warrants were forfeited resulting in 660,000 Officer and Director Warrants remaining outstanding at December 31, 2023. There were no forfeitures of Officer and Director Warrants during the three and nine months ended September 30, 2024.

Total stock-based compensation related to warrants was as follows:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

    

Three Months Ended September 30, 

    

Nine Months Ended September 30, 

(in thousands)

​

2024

    

2023

​

2024

    

2023

Research and development

​

$

120

​

$

120

​

$

361

​

$

328

Selling, general and administrative

​

 

144

​

 

150

​

 

432

​

 

408

Total stock-based compensation

​

$

264

​

$

270

​

$

793

​

$

736

​

As of September 30, 2024, there was approximately $1.4 million of unrecognized stock-based compensation expense associated with the warrants noted above that is expected to be recognized over a weighted average period of approximately 1.3 years.

Stock Option Activity

The following table summarizes the stock option activity of the Company under the 2018 Plan and the 2023 Plan:

​

​

​

​

​

​

​

​

​

​

​

​

​

    

​

    

Weighted

    

Weighted

    

Aggregate

​

​

Shares

​

Average

​

Average

​

Intrinsic

​

​

Underlying

​

Exercise

​

Remaining

​

Value

​

​

Options

​

Price

​

Term (years)

​

(in thousands)

Outstanding at January 1, 2024

​

4,438,868

 

$

7.72

 

7.70

​

$

8,186

Granted

 

1,089,535

 

​

5.59

 

—

 

​

—

Exercised

 

(45,159)

 

​

4.19

 

—

 

​

—

Forfeited/canceled

 

(106,045)

 

​

10.00

 

—

 

​

—

Outstanding September 30, 2024

 

5,377,199

 

$

7.27

 

7.53

​

$

1,280

Exercisable at September 30, 2024

 

3,306,947

 

$

7.44

 

6.59

​

$

1,098

​

The weighted average grant-date fair value of stock options granted during the nine months ended September 30, 2024 and 2023 was $3.77 and $4.01 per share, respectively.

27

Table of Contents

The following table summarizes the restricted stock awards and restricted stock units activity of the Company under the Plan:

​

​

​

​

​

​

​

Restricted Stock

​

Weighted Average

​

Awards/Units

​

Grant Date Fair

​

Outstanding

​

Value

Outstanding January 1, 2024

1,701,208

​

$

7.39

Granted

809,744

​

​

5.14

Vested

(144,577)

​

​

7.60

Forfeited/canceled

—

​

​

—

Outstanding September 30, 2024

2,366,375

​

$

6.64

​

No performance-based stock awards were granted in the nine months ended September 30, 2024.

​

Determination of Stock Option Awards Fair Value

The estimated grant-date fair value of all the Company’s option awards was calculated using the Black-Scholes option pricing model, based on the following weighted average assumptions:

​

​

​

​

​

​

​

​

​

​

    

Nine Months Ended September 30, 

 

​

​

2024

​

2023

 

Expected term (in years)

 

​

6.12

 

​

6.09

​

Expected volatility

 

​

72

%

​

46

%

Risk-free interest rate

 

​

4.35

%  

​

3.86

%

Expected dividend yield

 

​

0

%  

​

0

%

Fair value of Company Common Stock

​

$

5.59

​

$

8.19

​

​

The fair value of each stock option grant was determined by the Company using the methods and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment and estimation by management.

Expected Term — The expected term represents the period that stock-based awards are expected to be outstanding. The Company’s historical share option exercise information is limited due to a lack of sufficient data points and did not provide a reasonable basis upon which to estimate an expected term. The expected term for option grants is therefore determined using the “simplified” method, as prescribed in the SEC’s Staff Accounting Bulletin (SAB) No. 107. The simplified method deems the expected term to be the midpoint between the vesting date and the contractual life of the stock-based awards.

Expected Volatility — The Company consummated the Business Combination on January 26, 2023 and lacks sufficient company-specific historical and implied volatility information. Therefore, it derives expected stock volatility using a weighted average blend of historical volatility of comparable peer public companies and its own historical volatility, over a period equivalent to the expected term of the stock-based awards.

Risk-Free Interest Rate — The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the date of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the stock-based awards’ expected term.

Expected Dividend Yield — The expected dividend yield is zero as neither the Company nor Legacy Orchestra has paid, and the Company does not anticipate paying, any dividends on its Company Common Stock in the foreseeable future.

Fair Value of Common Stock — Prior to the Business Combination, as the Legacy Orchestra Common Stock has not historically been publicly traded, its board of directors periodically estimated the fair value of its common stock considering, among other things, contemporaneous valuations of its common stock prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants 2013 Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. Subsequent to the Business Combination, the Company utilizes the price of its publicly-traded Company Common Stock to determine the grant date fair value of awards.

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12. Leases

Office Lease

In August 2024, the Company entered into an additional addendum to the lease agreement for office space in New Hope, PA originally entered into by Legacy Orchestra in December 2009 (as amended, the “New Hope Lease”). The New Hope Lease covers 8,052 square feet and will expire in September 2027. Monthly fees under the New Hope Lease will be between $17,000 and $19,000 for the period from the August 2024 addendum through expiration.

In November 2019, Legacy Orchestra entered into a new lease agreement for approximately 5,200 square feet of office space in New York, NY. In November 2022, Legacy Orchestra entered into an amendment for this lease which increased the office space square footage to approximately 7,800 and amended the expiration to April 2028. Monthly fees will be between $28,000 and $40,000 for the period from commencement through expiration.

In January 2020, Legacy Orchestra entered into an agreement for the use of portions of the office space of Motus GI, a former related party, in Fort Lauderdale, Florida. In May 2022, Legacy Orchestra entered into an amendment for this lease which amended the expiration to November 2024. Monthly fees were between $7,000 and $23,000 for the period from commencement of the amendment through expiration. The amount paid is estimated to be proportionate to the percentage of space used by the Company applied to the monthly rent paid by Motus GI to its landlord.

In September 2024, the Company entered into a new lease for 6,496 square feet of office space in Fort Lauderdale, Florida which includes the previously leased office space from Motus GI. The agreement will expire in December 2027. The monthly fees will commence in November 2024, the commencement date of the agreement, and will be between $16,000 and $17,000 for the period from commencement through expiration.

Operating cash flow supplemental information for the nine months ended September 30, 2024:

Cash paid for amounts included in the present value of operating lease liabilities was $681,000 during the nine months ended September 30, 2024 compared to $669,000 during the nine months ended September 30, 2023.

​

​

​

​

​

As of September 30, 2024:

    

    

 

Weighted average remaining lease term – operating leases, in years

 

3.39

​

Weighted average discount rate – operating leases

 

9.91

%

​

Operating Leases

Rent/lease expense for office and lab space was approximately $230,000 and $209,000 for the three months ended September 30, 2024 and 2023, respectively. Rent/lease expense for office and lab space was approximately $672,000 and $626,000 for the nine months ended September 30, 2024 and 2023, respectively. The table below shows the future minimum rental payments, exclusive of taxes, insurance, and other costs, under the leases as of September 30, 2024:

​

​

​

​

​

​

    

Operating

​

​

Leases

Year ending December 31:

​

(in thousands)

2024 (remaining three months)

​

$

144

2025

 

​

551

2026

 

​

682

2027

 

​

643

2028

 

​

159

Thereafter

 

​

—

Total future minimum lease payments

​

$

2,179

Imputed interest

​

 

(341)

Total liability

​

$

1,838

​

​

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13. Related Party Transactions

In addition to transactions and balances related to cash and stock-based compensation to officers and directors, the Company had the following transactions and balances with current related parties during the year ended December 31, 2023 and the nine months ended September 30, 2024:

Motus GI Investments

On September 12, 2023, Motus GI, a former related party, and the Company entered into an agreement to terminate the rights of previously held royalty certificates in exchange for 701,522 additional shares of Motus GI common stock resulting in a gain of $349,000 (see Note 7).

Following the announcement of its liquidation and dissolution in the second quarter of 2024, on August 9, 2024, Motus GI filed a Form 15 with the SEC to deregister its common stock under Section 12(g) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and to suspend its reporting obligations under Section 15(d) of the Exchange Act. As a result of its liquidation and dissolution, the Company has concluded that Motus GI is no longer a related party.

14. Debt Financing

In June 2022, Legacy Orchestra entered into the 2022 Loan and Security Agreement. The terms of the 2022 Loan and Security Agreement included a term loan of up to $20 million available in two tranches with the first tranche of $10 million that was drawn at closing in June of 2022, and a second tranche of $10 million was available at closing of the Legacy Orchestra Series D-2 Preferred Stock financing which was not drawn. Additionally, the Company may have had access to a third tranche of $30 million subject to certain financing milestones. The term loan was scheduled to mature on June 1, 2026. In addition, the lender had the right, at its discretion, but not the obligation, to convert any portion of the outstanding principal amount of the loans up to $5 million into shares of Company Common Stock at a price per share equal to $12.00 (the “Conversion Option”), subject to adjustment; provided, however, the Conversion Option could not be exercised by lender during the six (6) month period after completion of the Business Combination.

Pursuant to the terms of the 2022 Loan and Security Agreement, Legacy Orchestra issued the Avenue Warrants that will be exercisable for 100,000 shares of Company Common Stock, and the estimated fair value of the warrants of $178,000 was recorded as debt discount on the date of issuance and was being amortized to interest expense over the term of the 2022 Loan and Security Agreement. In addition, other financing costs totaling $405,000 were also recorded as debt discount and were being amortized to interest expense over the term of the facility.

The term loan accrued interest at a floating per annum rate equal to the Wall Street Journal prime rate plus 6.45%. The repayment terms of the loan included monthly payments over a 4-year period, consisting of an initial 2-year interest-only period, followed by 24 monthly principal payments of $417,000 plus interest. In addition, there was a final payment equal to 4.25% of the initial commitment amount of $20 million, which was accrued over the term of the loan using the effective-interest method.

Concurrent with the closing of the 2022 Loan and Security Agreement, Legacy Orchestra terminated and repaid an existing 2019 Loan and Security Agreement with Silicon Valley Bank (the “2019 Loan and Security Agreement”), which resulted in a loss on extinguishment of $682,000. Pursuant to the terms of the 2019 Loan and Security Agreement, Legacy Orchestra issued Silicon Valley Bank a warrant that, to the extent Legacy Orchestra made draws on the 2019 Loan and Security Agreement, was exercisable for a number of shares of Legacy Orchestra Common Stock equal to 2% of the amount drawn divided by the exercise price of $1.33 per share of Legacy Orchestra Common Stock. As a result of the draw in December of 2020, Legacy Orchestra issued 150,000 Legacy Orchestra Common Stock warrants to Silicon Valley Bank, and the estimated fair value of the warrants of $544,000 was recorded as debt discount on the date of issuance and was being amortized to interest expense over the term of the credit facility. These warrants have been exercised and are no longer outstanding. The 2019 Loan and Security Agreement accrued interest at a floating per annum rate equal to the greater of (i) the Wall Street Journal prime rate plus 1.00% or (ii) 6.25%. In addition, there was a final payment equal to 8.25% of the original aggregate principal amount which accrued over the term of the loan using the effective-interest

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method. Total interest expense recorded on these facilities during the three and nine months ended September 30, 2023 was approximately $469,000 and $1.4 million, respectively, while there was no interest expense for the three and nine months ended September 30, 2024.

On October 6, 2023, the Company terminated and repaid the 2022 Loan and Security Agreement in an aggregate amount of $10.9 million (the “Payoff Amount”), which resulted in a loss on extinguishment of approximately $1.2 million. The Payoff Amount includes $10 million of principal and approximately $849,000 of net interest, prepayment fees, and legal fees. The Company issued warrants to purchase 27,707 shares of Company Common Stock at an exercise price of $7.67 in lieu of a cash payment of approximately $212,500 of the Payoff Amount. The Company valued the Avenue Warrants using the Black-Scholes option-pricing model and determined the fair value at $66,000.

15. Net Loss Per Share

Basic net loss per share of Company Common Stock is computed by dividing net loss by the weighted-average number of shares of Company Common Stock. Shares of Company Common Stock outstanding but subject to forfeiture and cancellation by the Company (e.g., the Forfeitable Shares – see Note 3) are excluded from the weighted-average number of shares until the period in which such shares are no longer subject to forfeiture.

As discussed in Note 3, in connection with the Business Combination, existing Legacy Orchestra stockholders had the opportunity to elect to participate in the Earnout pursuant to which each such Earnout Participant may receive a portion of additional contingent consideration of up to 8,000,000 shares of Earnout Consideration. On April 12, 2023, the Initial Milestone Event was achieved, and each Earnout Participant was issued their Pro Rata Portion (as such term is defined in the Merger Agreement) of 4,000,000 shares of Company Common Stock, resulting in a total of 3,999,987 shares of Company Common Stock being issued (less than 4,000,000 due to rounding). Additionally, 500,000 of the Forfeitable Shares are no longer subject to forfeiture as a result of the Initial Milestone Event.

Diluted net loss per share of Company Common Stock includes the effect, if any, from the potential exercise or conversion of securities, such as stock options, Legacy Orchestra Warrants and Private Warrants, and Forfeitable Shares and Earnout Consideration, which would result in the issuance of incremental shares of Company Common Stock, unless their effect would be anti-dilutive.

The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share for the three and nine months ended September 30, 2024 and September 30, 2023, as their effect is anti-dilutive:

​

​

​

​

​

​

​

    

​

​

​

Three and Nine Months Ended September 30, 

​

​

2024

    

2023

Stock options

 

5,377,199

 

4,579,065

Company common stock warrants

 

1,945,548

 

1,934,258

Unvested restricted stock awards

 

2,366,375

 

1,740,221

Conversion option

​

—

​

416,667

Forfeitable shares

 

500,000

 

500,000

Earnout consideration

 

4,000,000

 

4,000,000

Total

 

14,189,122

 

13,170,211

​

​

16. Subsequent Events

On November 6, 2024 (the “Closing Date”), the Company and certain of its subsidiaries (together with the Company, the “Borrower”) entered into a Loan and Security Agreement (the “2024 LSA”), by and among the Borrower, the several banks and other financial institutions or entities party thereto, as lenders (collectively, the “Lenders”), and Hercules Capital, Inc., as administrative agent and collateral agent for itself and the Lenders. The 2024 LSA provides a secured term loan facility of up to $50.0 million available in up to four tranches (collectively, the “Term Loans”), with the first tranche of $15.0 million that was drawn on the Closing Date, a second and third tranche of up to an aggregate of $15.0 million available upon achievement of certain performance and financing milestones. Additionally, the Company may have access to a fourth tranche of $20.0 million subject to future approval.    

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​

The Term Loans accrue interest at a floating per annum rate equal to the greater of (i) (x) the Prime Rate (as reported in The Wall Street Journal) plus (y) 2.0%, and (ii) 9.50%. The repayment terms of the Term Loans include monthly payments over a 4-year period, consisting of an initial two year interest-only period, followed by 24 monthly principal payments plus interest, although the interest-only period can be extended under certain circumstances set forth in the 2024 LSA. In addition, the Company will pay an end of term charge of 6.35% upon the prepayment or repayment of the Term Loans and a facility charge of 0.75% upon any draws of the Term Loans.

​

In connection with the entry into the 2024 LSA, on the Closing Date, the Company issued each of the Lenders a warrant to purchase Company Common Stock (each a “Warrant” and, collectively, the “Warrants”). Pursuant to the terms of the Warrants, each Lender may purchase that number of shares of Company Common Stock equal to (i)(x) 0.02, multiplied by (y) the aggregate principal amount of all Term Loan Advances (as defined in the 2024 LSA) made to the Company by the applicable Lender, divided by (ii) $5.74, which is the Exercise Price of the Warrants. Each Warrant is exercisable for seven years from the Closing Date.

​

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Unless otherwise indicated or the context otherwise requires, references to “Orchestra,” “Orchestra’s,” “the Company,” “we,” “its” and “our” refer to Orchestra BioMed Holdings, Inc. and its consolidated subsidiaries. All references to years, unless otherwise noted, refer to the Company’s fiscal years, which end on December 31.

The following discussion should be read together with “Special Note Regarding Forward-Looking Statements” and the Company’s unaudited condensed consolidated financial statements, together with the related notes thereto, included elsewhere in this Quarterly Report (the “Consolidated Financial Statements”), and the Company’s audited consolidated financial statements, together with the related notes thereto, included in the 2023 10K.

Closing of Business Combination

Prior to January 26, 2023, the Company was a special purpose acquisition company formed for the purpose of entering into a merger, amalgamation, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. On January 26, 2023, we consummated the business combination contemplated by the Agreement and Plan of Merger, dated as of July 4, 2022 (as amended by Amendment No. 1 to Agreement and Plan of Merger, dated July 21, 2022, and Amendment No. 2 to Agreement and Plan of Merger, dated November 21, 2022, the “Merger Agreement”) by and among Health Sciences Acquisitions Corporation 2, a special purpose acquisition company incorporated as a Cayman Islands exempted company in 2020 and Orchestra’s predecessor (“HSAC2”), HSAC Olympus Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of HSAC2 (“Merger Sub”), and Orchestra BioMed, Inc. (“Legacy Orchestra”). Pursuant to the Merger Agreement, (i) HSAC2 deregistered in the Cayman Islands in accordance with the Companies Act (2022 Revision) (As Revised) of the Cayman Islands and domesticated as a Delaware corporation in accordance with Section 388 of the Delaware General Corporation Law (the “Domestication”) and (ii) Merger Sub merged with and into Legacy Orchestra, with Legacy Orchestra as the surviving company in the merger and, after giving effect to such merger, continuing as a wholly owned subsidiary of Orchestra (the “Merger” and, together with the Domestication and the other transactions contemplated by the Merger Agreement, the “Business Combination”). As part of the Domestication, we changed our name from “Health Sciences Acquisitions Corporation 2” to “Orchestra BioMed Holdings, Inc.” On January 27, 2023, our common stock (“Company Common Stock”) began trading on the Nasdaq Global Market under the symbol “OBIO.” For additional information, see Note 3 to the Consolidated Financial Statements.

Reverse Recapitalization

The Business Combination is accounted for as a reverse recapitalization (the “Reverse Recapitalization”) in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Under this method of accounting, HSAC2 is treated as the “acquired” company and Legacy Orchestra is treated as the acquirer for financial reporting purposes. As a result, the consolidated assets, liabilities and results of operations prior to the Reverse Recapitalization are those of Legacy Orchestra. Additionally, the shares and corresponding capital amounts and losses per share, prior to the Business Combination, have been retroactively restated based on the exchange ratio established in the Merger Agreement (the “Exchange Ratio”). For additional information on the Business Combination and the Exchange Ratio, see Note 3 to the Consolidated Financial Statements.

Overview

We are a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Our partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products we develop. We are led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development. Our business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by our founding team.

Our flagship product candidates are atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (“BackBeat CNT”)), for the treatment of hypertension (“HTN”), a significant risk

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factor for death worldwide, and Virtue Sirolimus AngioInfusion Balloon (“Virtue SAB”) for the treatment of artery disease, the leading cause of mortality worldwide. We have an exclusive license and collaboration agreement with Medtronic, Inc. for the development and commercialization of AVIM therapy for the treatment of pacemaker-indicated patients with uncontrolled HTN despite the use of antihypertensive medications, and we have a strategic collaboration with Terumo Medical Corporation (“Terumo”) for the development and commercialization of Virtue SAB for the treatment of coronary and peripheral artery disease.

Since Legacy Orchestra’s inception, we have devoted the substantial majority of our resources to performing research and development and clinical activities in support of our product development and collaboration efforts. We have funded our operations primarily through the issuance of convertible preferred stock and proceeds from the Business Combination, as well as through proceeds from our distribution agreement with Terumo (the “Terumo Agreement”), borrowings under debt arrangements and, to a lesser extent, from product revenue from our subsidiary, FreeHold Surgical, LLC. (“FreeHold”). Through September 30, 2024, we have raised a cumulative $252.3 million in gross proceeds through the issuance of convertible preferred stock, proceeds from the Business Combination and other equity sales, and have received $30.0 million from the Terumo Agreement. We have incurred net losses each year since inception. Our net losses were $44.9 million and $36.3 million for the nine months ended September 30, 2024 and 2023, respectively. We expect to continue to incur significant losses for the foreseeable future. As of September 30, 2024, we had an accumulated deficit of $293.7 million.

Legacy Orchestra, our wholly owned subsidiary, was incorporated in Delaware in 2017 and completed a recapitalization and mergers with Caliber Therapeutics, Inc., a Delaware corporation that has, among other things, the rights to the Virtue SAB product candidate and BackBeat Medical, Inc., a Delaware Corporation that has, among other things, the rights to the Backbeat CNT product candidate, in 2018. Legacy Orchestra completed the conversions of Caliber Therapeutics, Inc. to Caliber Therapeutics, LLC, a Delaware limited liability company, and BackBeat Medical, Inc. to BackBeat Medical, LLC, a Delaware limited liability company, in 2019.

Recent Developments

At the Market Offerings

On May 15, 2024, we entered into an Open Market Sale AgreementSM (the “Prior Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which we were able to offer and sell, from time to time through Jefferies, up to $100 million of shares of Company Common Stock by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act. In connection with the entry into the Sales Agreement (as defined below), on August 12, 2024, we terminated the Prior Agreement with Jefferies (the “Termination”), in accordance with its terms and with the mutual agreement of Jefferies. The purpose of the Termination was to eliminate restrictions under certain SEC rules relating to the publication or dissemination of new research reports on our business by Jefferies in light of its role as sales agent under the Prior Agreement. Prior to the Termination, $15.5 million of shares of Company Common Stock had been sold under the Prior Agreement, with $84.5 million remaining available under the Prior Agreement. We cannot make any further sales of Company Common Stock pursuant to the Prior Agreement.

​

On August 12, 2024, we entered into a sales agreement (the “Sales Agreement”) with TD Securities (USA) LLC, as agent (“TD Cowen”), pursuant to which we may offer and sell, from time to time through TD Cowen, up to $100 million of shares of Company Common Stock (the “Offering”) by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act. The Offering is being made pursuant to a shelf registration statement on Form S-3, filed with the SEC on May 15, 2024 and declared effective on May 24, 2024 (the “Shelf Registration Statement”), a base prospectus, dated May 24, 2024, included as part of the Shelf Registration Statement, and a prospectus supplement, dated August 12, 2024, filed with the SEC pursuant to Rule 424(b)(5) on August 12, 2024. As of September 30, 2024, no sales had been made under the Sales Agreement.

​

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2024 Loan and Security Agreement

​

On November 6, 2024 (the “Closing Date”), we and certain of our subsidiaries (together with us, the “Borrower”) entered into a Loan and Security Agreement (the “2024 LSA”), by and among the Borrower, the several banks and other financial institutions or entities party thereto, as lenders (collectively, the “Lenders”), and Hercules Capital, Inc. (“Hercules”), as administrative agent and collateral agent for itself and the Lenders. The 2024 LSA provides a secured term loan facility of up to $50.0 million available in up to four tranches (collectively, the “Term Loans”), with the first tranche of $15.0 million that was drawn on the Closing Date, a second and third tranche of up to an aggregate of $15.0 million available upon achievement of certain performance and financing milestones. Additionally, we may have access to a fourth tranche of $20.0 million subject to future approval.

​

The Term Loans accrue interest at a floating per annum rate equal to the greater of (i) (x) the Prime Rate (as reported in The Wall Street Journal) plus (y) 2.0%, and (ii) 9.50%. The repayment terms of the Term Loans include monthly payments over a 4-year period, consisting of an initial two year interest-only period, followed by 24 monthly principal payments plus interest, although the interest-only period can be extended under certain circumstances set forth in the 2024 LSA. In addition, we will pay an end of term charge of 6.35% upon the prepayment or repayment of the Term Loans and a facility charge of 0.75% upon any draws of the Term Loans.

​

In connection with the entry into the 2024 LSA, on the Closing Date, we issued each of the Lenders a warrant to purchase Company Common Stock (each a “Warrant” and, collectively, the “Warrants”). Pursuant to the terms of the Warrants, each Lender may purchase that number of shares of Company Common Stock equal to (i)(x) 0.02, multiplied by (y) the aggregate principal amount of all Term Loan Advances (as defined in the 2024 LSA) made to us by the applicable Lender, divided by (ii) $5.74, which is the Exercise Price of the Warrants. Each Warrant is exercisable for seven years from the Closing Date.

​

BACKBEAT Pivotal Study Amendment

​

We are currently implementing an amendment to the BACKBEAT global pivotal study protocol with existing and newly activated study sites that was approved by the U.S. FDA during the third quarter of 2024. The protocol amendment is intended to improve patient engagement processes and significantly expand the window for screening and enrolling patients. Specifically, the updated protocol allows patients to consent and have initial blood pressure assessment prior to pacemaker implant and be screened and enrolled 30 days prior to and up to 365 days post-implant procedure. Previously, patients could not consent prior to implant and could only be screened and enrolled up to 90 days post-implant, substantially limiting the pool of eligible patients. The updated protocol also streamlines site coordinator and patient visit activities. We are evaluating the impact of the protocol amendment on the rate of enrollment and anticipate providing an update on the timeline for completion of enrollment at the time of filing of our Annual Report on Form 10-K for the year ending December 31, 2024, which we expect to file at the end of the first quarter of 2025.

​

Registration Statement

Due to the significant number of redemptions of HSAC2’s ordinary shares in connection with the Business Combination, there was a significantly lower number of HSAC2 ordinary shares that converted into shares of Company Common Stock in connection with the Business Combination. Pursuant to the Amended and Restated Registration Rights Agreement we entered into in connection with the closing of the Business Combination and certain warrant agreements, we filed a registration statement (the “Registration Statement”), which was declared effective on May 9, 2024, that registers, among other things, the resale of an aggregate of 18,586,201 shares of Company Common Stock, which constitutes approximately 49% of the outstanding Company Common Stock as of August 7, 2024. Additionally, some of the shares of the Company Common Stock being registered for resale were originally purchased by selling stockholders pursuant to investments in Legacy Orchestra or HSAC2 at prices considerably below the current market price of the Company Common Stock. These selling stockholders may realize a positive rate of return on the sale of their shares of Company Common Stock covered by the Registration Statement and therefore will have an incentive to sell their shares. Public shareholders may not experience a similar rate of return on shares of Company Common Stock they purchased. This discrepancy in purchase prices may have an impact on the market perception of the Company Common Stock’s value and could increase the volatility of the market price of the Company Common Stock or result in a significant decline

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in the public trading price of the Company Common Stock. The registration of these shares of Company Common Stock for resale creates the possibility of a significant increase in the supply of the Company Common Stock in the market. The increased supply, coupled with the potential disparity in purchase prices, may lead to heightened selling pressure, which could negatively affect the public trading price of the Company Common Stock.

Components of Our Results of Operations

Partnership Revenue

To date, our partnership revenues have related to the Terumo Agreement described below. In future periods, partnership revenues may also include revenues related to the Exclusive License and Collaboration Agreement, dated as of September 30, 2022, by and among, Legacy Orchestra, BackBeat Medical, LLC and Medtronic, Inc. (an affiliate of Medtronic plc) (the “Medtronic Agreement”), discussed in Note 5 to the Consolidated Financial Statements.

Legacy Orchestra entered into the Terumo Agreement in June 2019, and has determined that the arrangement represents a contract with a customer and is therefore in scope of ASC 606, Revenues from Contracts with Customers (“ASC 606”). Under the Terumo Agreement, Legacy Orchestra received an upfront payment of $30.0 million in 2019 and an equity commitment of up to $5 million of which $2.5 million was invested in June 2019 as part of the Legacy Orchestra Series B-1 financing and $2.5 million was invested in June 2022 as part of the Legacy Orchestra Series D-2 financing.

Under the Terumo Agreement, we were initially eligible for certain milestone payments in the amount of $65 million from Terumo upon completion of certain minimum enrollments in clinical studies, making certain filings and submissions, and obtaining certain regulatory approvals and certifications, and are also eligible to earn royalties on future sales by Terumo based on royalty rates ranging from 10 - 15%. Of these milestone payments, $35 million relate to achieving certain milestones by specified target achievement dates. As of the date of this Quarterly Report, we have already passed the target achievement dates for three $5 million milestone payments, in each case, without achieving the related milestones. In addition, due to delays in our Virtue SAB program resulting from the COVID-19 pandemic, supply chain issues and unexpected regulatory delays and requirements, including increased testing and other activities related to chemistry, manufacturing, and control, increased nonclinical and good laboratory practice preclinical data requirements, including biocompatibility, as well as a requirement to repeat good laboratory practice preclinical studies already performed based on changes to source of component materials and a change in manufacturing site, that caused us to amend our original project plan, we are unlikely to be able to complete the remaining time-based milestones by the specified target achievement dates to earn the remaining $20 million in time-based milestone payments pursuant to the Terumo Agreement. Further, Terumo has the right to terminate the agreement, or certain of its obligations thereunder, if certain milestones are not achieved.

As previously disclosed, we and Terumo have been negotiating for mutually agreeable adjustments to the Terumo Agreement with the purpose of restructuring milestone payments as well as making other potential material modifications to that agreement including additional financial commitments by Terumo to Orchestra and the Virtue SAB program. If negotiations are not completed to our satisfaction or to the satisfaction of Terumo, clinical study, product development, and commercialization plans for Virtue SAB may continue to be adversely impacted.

​

We recorded the $30.0 million upfront payment received in 2019 from Terumo within deferred revenue and are recognizing the upfront payment over time based on a proportional performance model based on the costs incurred to date relative to the total costs expected to be incurred through the completion of the development of the Coronary ISR indication, for which we are primarily responsible. We have recognized $14.5 million in cumulative partnership revenues from 2019 through September 30, 2024. There were no other proceeds received pursuant to the Terumo Agreement from 2019 through September 30, 2024.

In June 2022, Legacy Orchestra entered into the Medtronic Agreement for the development and commercialization of AVIM therapy for the treatment of pacemaker-indicated patients with uncontrolled HTN despite the use of antihypertensive medications. We have determined that the arrangement is a collaboration within the scope of ASC 808, Collaborative Arrangements (“ASC 808”). In addition, we concluded that Medtronic, Inc., an affiliate of Medtronic plc (“Medtronic”), is a customer for a good or service that is a distinct unit of account, and therefore, the transactions in the

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Medtronic Agreement should be accounted for under ASC 606. Through September 30, 2024, there have been no amounts recognized as revenue under the Medtronic Agreement.

Product Revenue

Product revenues related to sales of FreeHold’s intracorporeal organ retractors and such revenues are recognized at a point-in-time upon the shipment of the product to the customer given payment terms are typically 30 days. FreeHold products are currently only sold in the United States.

Cost of Product Revenue and Gross Margin

Cost of product revenue consists primarily of costs of finished goods components for use in FreeHold’s products and assembled, warehoused and inventoried by a third-party vendor. We expect the cost of finished goods product revenue to increase in absolute terms as our revenue grows.

Our gross margin has been, and will continue to be, affected by a variety of factors, including finished goods manufactured component parts, as well as the cost to assemble and warehouse the FreeHold product finished goods inventory.

Research and Development Expenses

Research and development expenses consist of applicable personnel, consulting, materials and clinical study expenses. Research and development expenses include:

●Certain personnel-related expenses, including salaries, benefits, bonus, travel and stock-based compensation;
●Cost of clinical studies to support new products and product enhancements, including expenses for clinical research organizations and site payments;
●Product device materials and drug supply, and manufacturing used for internal research and development, and clinical activities;
●Allocated overhead including facilities and information technology expenses; and
●Cost of outside consultants who assist with device and drug development, regulatory affairs, clinical affairs and quality assurance.

Research and development costs are expensed as incurred. Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical studies. In the future, we expect research and development expenses to increase in absolute dollars as we continue to develop new products, enhance existing products and technologies, initiate clinical studies, manufacture drug supply for internal research and development and clinical trial supply and perform activities related to obtaining additional regulatory approvals. We do not track expenses by product candidate, unless tracking such expenses is required pursuant to the revenue recognition model for a collaborative arrangement.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consist of personnel-related expenses, including salaries, benefits, bonus, travel and stock-based compensation. Other selling, general and administrative expenses include professional services fees, including legal, audit, investor/public relations, and insurance costs, outside consultants costs, employee recruiting and training costs, and non-income taxes. Moreover, we incur and expect to continue to incur additional expenses associated with operating as a public company, including legal, accounting, insurance, exchange listing and SEC

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compliance and investor relations. We expect quarterly selling, general and administrative expenses, excluding stock-based compensation expense, to continue to increase as a public company.

Interest Income, Net

Interest income reflects the income generated from marketable securities during the year. Interest expense is attributable to loan interest.

In June 2022, Legacy Orchestra entered into a loan and security agreement (the “2022 Loan and Security Agreement”) with Avenue Venture Opportunities Fund, L.P. (“Avenue I”) and Avenue Venture Opportunities Fund II, L.P. (“Avenue II,” and, collectively with Avenue I, “Avenue”). As part of the 2022 Loan and Security Agreement, Legacy Orchestra paid off the balance of the 2019 Loan and Security Agreement (as defined below) with Silicon Valley Bank. The terms of the 2022 Loan and Security Agreement included a term loan of up to $20 million available in two tranches with the first tranche of $10 million that was drawn at closing in June of 2022, and a second tranche of $10 million available at closing of the Series D-2 Financing that was not drawn. Additionally, we may have had access to a third tranche of $30 million subject to certain financing milestones. The term loan had a maturity date of June 1, 2026 and accrued interest at a floating per annum rate equal to the Wall Street Journal prime rate plus 6.45%. On October 6, 2023, the 2022 Loan and Security Agreement was repaid in full and terminated. Refer to Note 14 to our Consolidated Financial Statements.

In December 2019, Legacy Orchestra entered into a Loan and Security Agreement with Silicon Valley Bank for a term loan as described in Note 14 to our Condensed Consolidated Financial Statements (the “2019 Loan and Security Agreement”). The 2019 Loan and Security Agreement provided Legacy Orchestra with capital for development and general corporate purposes. On December 31, 2020, Legacy Orchestra borrowed $10.0 million under the 2019 Loan and Security Agreement which was repaid in connection with entering into the 2022 Loan and Security Agreement.

Loss on Fair Value Adjustment of Warrant Liability

Certain of Legacy Orchestra’s outstanding warrants contained features that required the warrants to be accounted for as liabilities. The warrants were subject to re-measurement at each balance sheet date with gains and losses reported through Legacy Orchestra’s condensed consolidated statements of operations and comprehensive loss as loss on fair value adjustment of warrant liability. Upon closing of the Business Combination, all liability classified warrants of Legacy Orchestra became equity classified on that date as they are now considered “fixed for fixed.”

Loss on Debt Extinguishment

The loss on debt extinguishment represents charges incurred as a result of the payoff of each of the 2019 Loan and Security Agreement and the 2022 Loan and Security Agreement.

Loss on Fair Value of Strategic Investments

The loss on fair value of strategic investments represents a change in the preferred shares and convertible notes of Vivasure Medical Limited (“Vivasure”), a privately-held company and related party, and fair value of our investment in Motus GI Holdings, Inc. (“Motus GI”), a previously publicly-held company and a former related party. The investments in Vivasure do not have readily determinable fair values and are recorded at cost, less any impairment, plus or minus changes resulting from observable price changes in orderly transactions for identical or similar investments of the same issuer. The shares held of Motus GI represent equity securities with a readily determinable fair value and are required to be measured at fair value at each reporting period using readily determinable pricing available on a securities exchange, in accordance with the provisions of ASU 2016-01.

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Results of Operations

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

The following table presents our statement of operations data for the nine months ended September 30, 2024 and 2023, and the dollar and percentage change between the two periods (in thousands):

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Nine Months Ended September 30, 

​

​

    

2024

​

2023

​

Change $

​

Change %

​

Revenue:

 

​

  

 

​

  

 

​

  

 

​

  

​

Partnership revenue

​

$

1,928

​

$

2,018

​

$

(90)

​

​

(4)

%

Product revenue

​

 

457

​

 

480

​

 

(23)

​

 

(5)

%

Total revenue

​

 

2,385

​

 

2,498

​

 

(113)

​

 

(5)

%

Expenses:

​

 

  

​

 

  

​

 

  

​

 

​

​

Cost of product revenues

​

 

146

​

 

139

​

 

7

​

 

5

%

Research and development

​

 

31,833

​

 

25,311

​

 

6,522

​

 

26

%

Selling, general and administrative

​

 

18,030

​

 

16,073

​

 

1,957

​

 

12

%

Total expenses

​

 

50,009

​

 

41,523

​

 

8,486

​

 

20

%

Loss from operations

​

 

(47,624)

​

 

(39,025)

​

 

(8,599)

​

 

(22)

%

Other income (expense):

​

 

  

​

 

  

​

 

  

​

 

​

​

Interest income, net

​

 

2,834

​

 

2,741

​

 

93

​

 

3

%

Loss on fair value adjustment of warrant liability

​

 

—

​

 

(294)

​

 

294

​

 

100

%

(Loss) gain on fair value of strategic investments

​

 

(68)

​

 

276

​

 

(344)

​

 

(125)

%

Other expense

​

 

(11)

​

​

—

​

​

(11)

​

​

NM

*

Total other income

​

 

2,755

​

 

2,723

​

 

32

​

 

1

%

Net loss

​

$

(44,869)

​

$

(36,302)

​

$

(8,567)

​

​

(24)

%

*Note: NM denotes that the computed amount is not meaningful.

​

Partnership Revenue

Partnership revenue decreased by $90,000, or approximately 4%, to $1.9 million in the nine months ended September 30, 2024 from $2.0 million for the nine months ended September 30, 2023. Partnership revenue relates to the recognition of the combined performance obligation for the license granted to Terumo and the ongoing research and development services over the estimated performance period for the Virtue SAB coronary ISR indication, using a proportional performance model, based on the costs incurred relative to the total estimated costs of the research and development services. As of each quarterly reporting date, we evaluate our estimates of the total costs expected to be incurred through the completion of the combined performance obligation and update our estimates as necessary.

For the nine months ended September 30, 2024 and 2023, the expenses incurred related to the Terumo Agreement were approximately $10.5 million and $11.7 million, respectively. The estimated total costs associated with the Terumo Agreement through completion increased by approximately 2.6% as of September 30, 2024 as compared to the estimates as of December 31, 2023, and increased by approximately 7.0% as of September 30, 2023, as compared to the estimates as of December 31, 2022.

While we believe we have estimated total costs associated with the Terumo Agreement through completion, these estimates encompass a broad range of expenses over a multi-year period and, as such, are subject to periodic changes as new information becomes available.

Product Revenue

Product revenue decreased by $23,000, or approximately 5%, to $457,000 in the nine months ended September 30, 2024 from $480,000 for the nine months ended September 30, 2023.

Product revenue consisted of the sale of FreeHold Duo and Trio intracorporeal organ retractors and revenue is recognized when product is shipped to customers. The decrease in product revenue was primarily due to a decrease in the

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purchase volume of FreeHold Duo and Trio intracorporeal organ retractors. There were no changes to the per unit sale price in either period presented.

Cost of Product Revenue

Cost of product revenue increased by $7,000, or approximately 5%, to $146,000 in the nine months ended September 30, 2024 from $139,000 for the nine months ended September 30, 2023. The increase was primarily due to higher production costs per unit of FreeHold Duo and Trio intracorporeal organ retractors.

Research and Development Expenses

The following table summarizes our research and development expenses for the nine months ended September 30, 2024 and 2023 (in thousands):

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

    

Nine Months Ended September 30, 

​

​

​

​

​

​

​

​

2024

    

2023

Personnel and consulting costs

​

​

​

​

​

​

​

$

14,416

​

$

12,928

Non-clinical development costs

​

​

​

​

​

​

​

​

13,424

​

 

9,377

Clinical development costs

​

​

​

​

​

​

​

 

3,993

​

 

3,006

Total research and development expenses

​

​

​

​

​

​

​

$

31,833

​

$

25,311

​

Research and development expenses increased by $6.5 million, or approximately 26%, to $31.8 million for the nine months ended September 30, 2024 from $25.3 million for the nine months ended September 30, 2023. This is primarily due to an increase in support of ongoing work to advance the BACKBEAT pivotal study and to advance Virtue SAB into a planned pivotal study and included an increase in personnel related expenses of $1.0 million due to increased headcount and associated expenses, along with increased stock-based compensation of $456,000, an increase of $4.0 million in non-clinical development costs, and an increase of $986,000 in research and development program costs, supplies, and testing.

The total research and development expenses summarized above include $10.4 million for the nine months ended September 30, 2024 and $11.7 million for the nine months ended September 30, 2023 related to the Terumo Agreement. The decrease of $1.3 million is due to decreased expense activity related to the Terumo Agreement during the 2024 period.

Selling, General and Administrative Expenses

Selling, general and administrative expenses increased by $2.0 million, or approximately 12%, to $18.0 million for the nine months ended September 30, 2024, from $16.1 million of expense for the nine months ended September 30, 2023. The increase primarily resulted from an increase in personnel-related expenses of $673,000 due to increased headcount and associated expenses, along with increased stock-based compensation of $552,000 and an increase of $1.1 million of accounting, finance, legal, investor relations and public relations expenses incurred in connection with the overall growth of the business and being a public company.

Interest Income, Net

Interest income, net, increased by $93,000, or approximately 3%, to $2.8 million of income for the nine months ended September 30, 2024, from $2.7 million of income for the nine months ended September 30, 2023. The net interest income in the 2024 period consisted primarily of interest earned from marketable securities while the net interest income in the 2023 period consisted primarily of interest earned from marketable securities offset by monthly interest expense incurred resulting from the 2022 Loan and Security Agreement.

Loss on Fair Value Adjustment of Warrant Liability

The loss on fair value adjustment of warrant liability was $294,000 for the nine months ended September 30, 2023 and was the result of the final valuation of our outstanding warrants when they had become equity classified and no longer

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subject to market adjustment upon the close of the Business Combination. There were no additional charges for the adjustment of fair value for warrant liability for the nine months ended September 30, 2024.

(Loss) Gain on Fair Value of Strategic Investments

The loss on fair value of strategic investments was $68,000 for the nine months ended September 30, 2024, as compared a gain of $276,000 for the nine months ended September 30, 2023. The amounts recognized for the nine months ended September 30, 2024 and 2023 related to the change in fair value in our common stock holdings of Motus GI. During the nine months ended September 30, 2024, Motus GI announced a resolution to liquidate and dissolve, at which time we concluded the fair value to be zero and expensed the remaining carrying value of our investment in Motus GI.

During the nine months ended September 30, 2023, we and Motus GI entered into an agreement, pursuant to which royalty certificates previously issued to us and other holders were amended to terminate the rights of royalty certificate holders to receive royalties in exchange for shares of Motus GI common stock. As a result of the agreement, we received 701,522 shares of Motus GI common stock in exchange for our royalty certificates, which had a de minimis carrying value.

​

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

The following table presents our statement of operations data for the three months ended September 30, 2024 and 2023, and the dollar and percentage change between the two periods (in thousands):

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Three Months Ended September 30, 

​

​

    

2024

​

2023

​

Change $

​

Change %

​

Revenue:

 

​

  

 

​

  

 

​

  

 

​

  

​

Partnership revenue

​

$

803

​

$

271

​

$

532

​

$

196

%

Product revenue

​

 

184

​

 

148

​

 

36

​

 

24

%

Total revenue

​

 

987

​

 

419

​

 

568

​

 

136

%

Expenses:

​

 

  

​

 

  

​

 

  

​

 

​

​

Cost of product revenues

​

 

68

​

 

41

​

 

27

​

 

66

%

Research and development

​

 

11,595

​

 

8,558

​

 

3,037

​

 

35

%

Selling, general and administrative

​

 

5,666

​

 

6,344

​

 

(678)

​

 

(11)

%

Total expenses

​

 

17,329

​

 

14,943

​

 

2,386

​

 

16

%

Loss from operations

​

 

(16,342)

​

 

(14,524)

​

 

(1,818)

​

 

(13)

%

Other income (expense):

​

 

  

​

 

  

​

 

  

​

 

​

​

Interest income, net

​

 

916

​

 

915

​

 

1

​

 

0

%

Gain on fair value of strategic investments

​

 

—

​

 

293

​

 

(293)

​

 

(100)

%

Total other income

​

 

916

​

 

1,208

​

 

(292)

​

 

(24)

%

Net loss

​

$

(15,426)

​

$

(13,316)

​

$

(2,110)

​

$

(16)

%

​

Partnership Revenue

Partnership revenue increased by $532,000, or approximately 196%, to $803,000 in the three months ended September 30, 2024 from $271,000 for the three months ended September 30, 2023. Partnership revenue relates to the recognition of the combined performance obligation for the license granted to Terumo and the ongoing research and development services over the estimated performance period for the Virtue SAB coronary ISR indication, using a proportional performance model, based on the costs incurred relative to the total estimated costs of the research and development services. As of each quarterly reporting date, we evaluate our estimates of the total costs expected to be incurred through the completion of the combined performance obligation and update our estimates as necessary.

For the three months ended September 30, 2024 and 2023, the expenses incurred related to the Terumo Agreement were approximately $3.6 million and $3.4 million, respectively. The estimated total costs associated with the Terumo Agreement through completion as of September 30, 2024 as compared to the estimates as of June 30, 2024 remained substantially the same however the estimated total costs increased by approximately 4.4% as of September 30, 2023, as compared to the estimates as of June 30, 2023.

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While we believe we have estimated total costs associated with the Terumo Agreement through completion, these estimates encompass a broad range of expenses over a multi-year period and, as such, are subject to periodic changes as new information becomes available.

Product Revenue

Product revenue increased by $36,000, or approximately 24%, to $184,000 in the three months ended September 30, 2024 from $148,000 for the three months ended September 30, 2023.

Product revenue consisted of the sale of FreeHold Duo and Trio intracorporeal organ retractors and revenue is recognized when product is shipped to customers. The increase in product revenue was primarily due to an increase in the purchase volume of FreeHold Duo and Trio intracorporeal organ retractors. There were no changes to the per unit sale price in either period presented.

Cost of Product Revenue

Cost of product revenue increased by $27,000, or approximately 66%, to $68,000 in the three months ended September 30, 2024 from $41,000 for the three months ended September 30, 2023. The increase was primarily due to increased sales and increased production costs per unit of FreeHold Duo and Trio intracorporeal organ retractors.

Research and Development Expenses

The following table summarizes our research and development expenses for the three months ended September 30, 2024 and 2023 (in thousands):

​

​

​

​

​

​

​

​

​

​

​

​

​

​

    

​

​

​

​

​

    

Three Months Ended September 30, 

​

​

​

​

​

​

​

​

2024

    

2023

Personnel and consulting costs

​

​

​

​

​

​

​

$

4,800

​

$

4,839

Non-clinical development costs

​

​

​

​

​

​

​

​

5,349

​

 

2,776

Clinical development costs

​

​

​

​

​

​

​

 

1,446

​

 

943

Total research and development expenses

​

​

​

​

​

​

​

$

11,595

​

$

8,558

​

Research and development expenses increased by $3.0 million, or approximately 35%, to $11.6 million for the three months ended September 30, 2024, from $8.6 million for the three months ended September 30, 2023. This is primarily due to an increase in support of ongoing work to advance BackBeat CNT and Virtue SAB into planned pivotal studies during 2024 and included an increase of $2.6 million in non-clinical development costs and an increase of $503,000 in research and development program costs, supplies, and testing.

​

The total research and development expenses summarized above include $3.6 million for the three months ended September 30, 2024 and $3.4 million for the three months ended September 30, 2023 related to the Terumo Agreement. The increase of $200,000 is due to increased expense activity related to the Terumo Agreement during the 2024 period.

Selling, General and Administrative Expenses

Selling, general and administrative expenses decreased by $678,000, or approximately 11%, to $5.7 million for the three months ended September 30, 2024, from $6.3 million of expense for the three months ended September 30, 2023. The decrease was primarily due to a decrease in stock-based compensation of $827,000 and a decrease in outside consulting expense of $198,000, partially offset by an increase in personnel related expenses of $375,000 due to increased headcount.

Interest Income, Net

Interest income, net, increased by $1,000 to $916,000 of income for the three months ended September 30, 2024, from

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Table of Contents

$915,000 of income for the three months ended September 30, 2023. The net interest income in the 2024 period consisted primarily of interest earned from marketable securities while the net interest income in the 2023 period consisted primarily of interest earned from marketable securities offset by monthly interest expense incurred resulting from the 2022 Loan and Security Agreement.

Gain on Fair Value of Strategic Investments

There was no adjustment to strategic investments for the three months ended September 30, 2024, as compared to a gain of $293,000 for the three months ended September 30, 2023, which was related to the change in fair value in our common stock holdings of Motus GI.

During the three months ended September 30, 2023, we and Motus GI entered into an agreement, pursuant to which royalty certificates previously issued to us and other holders were amended to terminate the rights of royalty certificate holders to receive royalties in exchange for shares of Motus GI common stock. As a result of the agreement, we received 701,522 shares of Motus GI common stock in exchange for our royalty certificates, which had a de minimis carrying value.

Liquidity and Capital Resources

From inception through September 30, 2024, we have incurred significant operating losses and negative cash flows from our operations. Our net losses were $44.9 million and $36.3 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $293.7 million. We have funded our operations primarily through the issuance of convertible preferred stock, proceeds from the Business Combination and other equity sales, as well as through proceeds from the Terumo Agreement, borrowings under debt arrangements and, to a lesser extent, from FreeHold product revenue. Through September 30, 2024, we have raised a cumulative $252.3 million in gross proceeds through the issuance of convertible preferred stock, proceeds from the Business Combination and other equity sales, and have received $30.0 million under the Terumo Agreement. We had $25.6 million in cash and cash equivalents at September 30, 2024, which consisted primarily of bank deposits and money market funds. We also had $41.3 million of short-term marketable securities at September 30, 2024, which consisted primarily of our investments in corporate debt securities.

On August 12, 2024, we entered into the Sales Agreement with TD Cowen, pursuant to which we may offer and sell, from time to time through TD Cowen, up to $100 million of shares of Company Common Stock by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act. As of September 30, 2024, all of the $100 million shares are available under this Sales Agreement. In connection with the entry into the Sales Agreement, on August 12, 2024, we terminated our Prior Agreement with Jefferies, in accordance with its terms and with the mutual agreement of Jefferies of which $15.5 million of shares of Company Common Stock were sold. We cannot make any further sales of the Company Common Stock pursuant to the Prior Agreement.

​

On November 6, 2024, the Company and certain of its subsidiaries entered into the 2024 LSA. The 2024 LSA provides a secured term loan facility of up to $50.0 million available in up to four tranches (collectively, the “Term Loans”), with the first tranche of $15.0 million that was drawn on the Closing Date, a second and third tranche of up to an aggregate of $15.0 million available upon achievement of certain performance and financing milestones. Additionally, the Company may have access to a fourth tranche of $20.0 million subject to future approval.

​

The Term Loans accrue interest at a floating per annum rate equal to the greater of (i) (x) the Prime Rate (as reported in The Wall Street Journal) plus (y) 2.0%, and (ii) 9.50%. The repayment terms of the Term Loans include monthly payments over a 4-year period, consisting of an initial two-year interest-only period, followed by 24 monthly principal payments plus interest, although the interest-only period can be extended under certain circumstances set forth in the 2024 LSA. In addition, the Company will pay an end of term charge of 6.35% upon the prepayment or repayment of the Term Loans and a facility charge of 0.75% upon any draws of the Term Loans.

​

In addition, the exercise price of our warrants, in certain circumstances, may be higher than the prevailing market price of the Company Common Stock and the cash proceeds to us associated with the exercise of our warrants are contingent upon the price of the Company Common Stock. The value of the Company Common Stock may fluctuate and

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Table of Contents

may not exceed the exercise price of the warrants at any given time. As of the date of this Quarterly Report, a significant portion of our warrants are “out of the money,” meaning the exercise price is higher than the market price of the Company Common Stock. Holders of such “out of the money” warrants are not likely to exercise such warrants. As a result, we may not receive any proceeds from the exercise of such warrants. There can be no assurance that such warrants will be in the money prior to their respective expiration dates, and therefore, we may not receive any cash proceeds from the exercise of such warrants to fund our operations.

As a result, we have neither included nor intend to include any potential cash proceeds from the exercise of our warrants in our short-term or long-term liquidity projections. We will continue to evaluate the probability of warrant exercise over the life of our warrants and the merit of including potential cash proceeds from the exercise in our liquidity projections. We do not expect to rely on the exercise of our warrants to fund our operations.

Funding Requirements  

We continue to prioritize planned spending on our AVIM therapy program and the execution of our BACKBEAT pivotal study, for which we announced the commencement of enrollment on January 8, 2024. With regard to our AVIM therapy program and our planned BACKBEAT pivotal study, we currently expect operating expenses to increase to support clinical study costs as well as additional research and development expenses in support of future potential regulatory approval and commercialization of AVIM therapy-enabled Medtronic pacemakers. As previously disclosed, we reduced our 2024 planned spending related to our Virtue SAB program and the execution of our Virtue ISR-US pivotal study, for which we announced conditional investigational device exemption approval from the FDA on August 8, 2023, in order to focus on (1) optimizing the design of our Virtue ISR-US study in light of the March 2024 FDA approval of BSC’s AGENT paclitaxel DCB for the treatment of coronary ISR; and (2) restructuring our partnership agreement with Terumo in a manner that provides us with a satisfactory amount of additional capital, whether from milestone payments or other financial arrangements, which additional capital we may not receive..

Based on current internally prepared budget estimates that reflect our operating plans, including the assumptions that we proceed with an optimized Virtue ISR-US study in the first half of 2025 and we successfully restructure the agreement with Terumo, we anticipate that our cash, cash equivalents, marketable securities, and potential future proceeds described below are sufficient to fund our operations into the second half of 2026. The amount and timing of our future funding requirements may change from this current estimate and are dependent on many factors, including the cost and pace of execution of clinical studies and research and development activities, the strength of results from clinical studies and other research, development and manufacturing efforts, as well as the potential receipt of revenues or other payments or investments under a restructured Terumo Agreement, the Medtronic Agreement and/or future collaborations, and the realization of cash from the potential sale of our holdings in Vivasure. There are no assurances that any of these factors will be favorable to us, and we may need to seek additional sources of liquidity to meet our funding requirements earlier than current estimates, including the issuance of new equity, additional drawdowns under the 2024 LSA to the extent we meet the financing and performance requirements to be eligible for such drawdowns, drawdowns on new loan facilities that we may enter into, and/or other financing structures. In this regard, as of the date of this Quarterly Report, we may sell from time to time, up to approximately $100.0 million of shares of Company Common Stock under the Sales Agreement.

As noted above, the sale of Company Common Stock pursuant to the Registration Statement may result in a decline in the value of the Company Common Stock, which may make it more difficult and more dilutive to the existing holders of Company Common Stock to raise funds from the sale of our equity securities.

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Cash Flows

The following table summarizes our cash flow data for the periods indicated (in thousands):

​

​

​

​

​

​

​

​

​

​

​

​

​

​

    

​

​

​

​

​

​

Nine Months Ended September 30, 

​

​

​

​

​

​

​

​

2024

    

2023

Net cash used in operating activities

​

​

​

​

​

​

​

$

(37,020)

​

$

(35,153)

Net cash provided by (used in) investing activities

​

​

​

​

​

​

​

 

16,842

​

 

(22,464)

Net cash provided by financing activities

​

​

​

​

​

​

​

 

15,224

​

 

56,911

Net decrease in cash and cash equivalents

​

​

​

​

​

​

​

$

(4,954)

​

$

(706)

​

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

Net Cash Flows from Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2024 was $37.0 million and primarily consisted of our net loss of $44.9 million, partially offset by non-cash charges of $7.3 million and changes in net operating assets and liabilities of $598,000. Our non-cash charges primarily consisted of stock-based compensation of $7.7 million, partially offset by $1.3 million related to accretion and interest of marketable securities. The net change in operating assets and liabilities was primarily due to an increase in accounts payable and accrued expenses of $3.7 million and a decrease in deferred revenue of $1.9 million.

Net cash used in operating activities for the nine months ended September 30, 2023 was $35.2 million and primarily consisted of our net loss of $36.3 million, and changes in net operating assets and liabilities of $3.2 million, which was partially offset by non-cash charges of $4.3 million. Our non-cash charges primarily consisted of a loss on fair value adjustment of warrant liability of $294,000 and stock-based compensation of $6.7 million, offset by $3.2 million related to accretion and interest of marketable securities. The net change in operating assets and liabilities was primarily due to a decrease in accounts payable and accrued expenses of $348,000, an increase in prepaid expenses and other assets of $458,000, and a decrease in deferred revenue of $2.0 million.

Net Cash Flows from Investing Activities

Net cash provided by investing activities for the nine months ended September 30, 2024 was $16.8 million, which primarily consisted of the sale of $69.4 million of marketable securities, partially offset by the purchase of $52.4 million of marketable securities.

Net cash used in investing activities for the nine months ended September 30, 2023 was $22.5 million, which primarily consisted of the purchase of $138.1 million of marketable securities offset by the sale of $115.7 million of marketable securities.

Net Cash Flows from Financing Activities

Net cash provided by financing activities of $15.2 million for the nine months ended September 30, 2024 was primarily attributable to the proceeds of $15.0 million, net of issuance costs, from the at-the-market offering under the Prior Agreement with Jefferies.

Net cash provided by financing activities of $56.9 million for the nine months ended September 30, 2023 was primarily attributable to net proceeds from the Business Combination. For additional information, see Note 3 to the Consolidated Financial Statements.  

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Contractual Obligations and Commitments

The following table summarizes our contractual obligations and commitments as of September 30, 2024 (in thousands):

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

    

Payments Due by Period

​

​

​

​

​

Less than

​

1-3

​

3-5 

​

More than

​

​

Total

    

1 Year

    

Years

    

Years

    

5 Years

Operating lease obligations

​

$

2,179

​

$

556

​

$

1,345

​

$

278

​

$

—

Total

​

$

2,179

​

$

556

​

$

1,345

​

$

278

​

$

—

We enter into agreements in the normal course of business with clinical research organizations for work related to clinical trials and with vendors for preclinical studies and other services and products for operating purposes, which are cancelable at any time by us, generally upon 30 days prior written notice. These payments are not included in the above table of contractual obligations and commitments. In addition, the above table does not include our obligations to make interest and principal payments under the 2024 LSA, which was entered into after September 30, 2024.

Critical Accounting Policies and Estimates

Our financial statements are prepared in accordance with U.S. GAAP. The preparation of the financial statements in conformity with U.S. GAAP requires our management to make a number of estimates and assumptions relating to the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the period. We evaluate our significant estimates on an ongoing basis, including estimates related to the total costs expected to be incurred though the completion of the combined performance obligation of the Terumo Agreement, research and development prepayments, accruals and related expenses and stock-based compensation. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates.

We believe that the accounting policies described below involve a significant degree of judgment and complexity. Accordingly, we believe these are the most critical to aid in fully understanding and evaluating our financial condition and results of operations. For further information, see Note 2 to the Consolidated Financial Statements.

Revenue Recognition

We recognize revenue under the core principle according to ASC 606 to depict the transfer of control to our customers in an amount reflecting the consideration we expect to be entitled to. In order to achieve that core principle, we apply the following five step approach: (1) identify the contract with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when a performance obligation is satisfied.

Our revenues are currently comprised of partnership revenues under the Terumo Agreement related to the development and commercialization of Virtue SAB, and product revenue from the sale of FreeHold’s intracorporeal organ retractors.

Partnership Revenues

To date, our partnership revenues have related to the Terumo Agreement described below. In future periods, partnership revenues may also include revenues related to the Medtronic Agreement, discussed in Note 5 to the Consolidated Financial Statements.

Legacy Orchestra entered into the Terumo Agreement as further described in Note 4 to the Consolidated Financial Statements. We assessed whether the Terumo Agreement fell within the scope of ASC 808 based on whether the

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arrangement involved joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. We determined that the Terumo Agreement did not fall within the scope of ASC 808. We then analyzed the arrangement pursuant to the provisions of ASC 606 and determined that the arrangement represents a contract with a customer and is therefore within the scope of ASC 606.

The promised goods or services in the Terumo Agreement include (i) license rights to our intellectual property and (ii) research and development services. We also have optional additional items in the Terumo Agreement, which are considered marketing offers and are accounted for as separate contracts with the customer if such option is elected by the customer, unless the option provides a material right which would not be provided without entering into the contract. Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer. Promised goods or services are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources or (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct in the Terumo Agreement, we considered factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own or whether the required expertise is readily available.

We estimate the transaction price for the Terumo Agreement performance obligations based on the amount expected to be received for transferring the promised goods or services pursuant to the Terumo Agreement. The consideration includes both fixed consideration and variable consideration. At the inception of the Terumo Agreement, as well as at each reporting period, we evaluate the amount of potential payment and the likelihood that the payments will be received. We utilize either the most likely amount method or expected amount method to estimate the amount expected to be received based on which method better predicts the amount expected to be received. If it is probable that a significant revenue reversal would not occur, the variable consideration is included in the transaction price.

The Terumo Agreement contains development and regulatory milestone payments. At contract inception and at each reporting period, we evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, we re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect partnership revenues and earnings in the period of adjustment.

The Terumo Agreement also includes sales-based royalties and the license is deemed to be the predominant item to which the royalties relate. Accordingly, we will recognize royalty revenue when the related sales occur. To date, we have not recognized any royalty revenue under the arrangement.

We have determined that intellectual property licensed to Terumo and the research and development services to be provided to support the premarket approval by the FDA for the ISR indication represent a combined performance obligation that is satisfied over time, which is currently estimated to be completed in 2029, and that the appropriate method of measuring progress for purposes of recognizing revenues relates to a proportional performance model that measures the proportional performance based on the costs incurred to date relative to the total costs expected to be incurred through the completion of the performance obligation. We evaluate the measure of progress at each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.

In the nine months ended September 30, 2024, we updated our estimates of the total costs expected to be incurred through the completion of the combined performance obligation. The impact of the changes in estimates resulted in a reduction in partnership revenues of $371,000, which resulted in a $0.01 effect on net loss per share, basic and diluted. In the nine months ended September 30, 2023, the impact of the changes in estimates resulted in a reduction of partnership revenues of $882,000, which resulted in a $0.03 effect on net loss per share, basic and diluted.

We receive payments from Terumo based on billing schedules established in the contract. Such billings for milestone related events have 10-day terms from the date the milestone is achieved, royalty payments are 20-day terms after the close of each quarter, any optional services are 20 days after receipt of an invoice and sales of SirolimusEFR are within 30 days after receipt of the shipping invoices. Upfront payments are recorded as deferred revenue upon receipt or when due until

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we perform our obligations under these arrangements. Amounts are recorded as accounts receivable when the right to consideration is unconditional.

In June 2022, Legacy Orchestra, BackBeat Medical, LLC and Medtronic entered into the Medtronic Agreement for the development and commercialization of AVIM therapy for the treatment of pacemaker-indicated patients with uncontrolled HTN despite the use of antihypertensive medications. We determined that the arrangement is a collaboration within the scope of ASC 808. In addition, we concluded Medtronic is a customer for a good or service that is a distinct unit of account, and therefore the transactions in the Medtronic Agreement should be accounted for under ASC 606. Through September 30, 2024, there have been no amounts recognized as revenue under the Medtronic Agreement.

Product Revenues

Product revenues related to sales of FreeHold’s intracorporeal organ retractors are recognized at a point-in-time upon the shipment of the product to the customer, and there are no significant estimates or judgments related to estimating the transaction price. The product revenues consist of a single performance obligation, and the payment terms are typically 30 days. Product revenues are recognized solely in the United States.

Research and Development Prepayments, Accruals and Related Expenses

We incur costs of research and development activities conducted by our third-party service providers, which include the conduct of preclinical and clinical studies. We are required to estimate our prepaid and accrued research and development costs at each reporting date. These estimates are made as of the reporting date of the work completed over the life of the individual study in accordance with agreements established with our service providers. We determine the estimates of research and development activities incurred at the end of each reporting period through discussion with internal personnel and outside service providers, as to the progress or stage of completion of trials or services, as of the end of the reporting period, pursuant to contracts with the third parties and the agreed upon fees to be paid for such services. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are accepted by us or the services are performed. Accruals are recorded for the amounts of services provided that have not yet been invoiced.

Warrants

We evaluate our warrants to determine if the contracts qualify as liabilities in accordance with ASC 480-10, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging. If the warrant is determined to meet the criteria to be liability classified, the warrant liability is marked-to-market each balance sheet date and recorded as a liability, with the change in fair value recorded in our condensed consolidated statements of operations and comprehensive loss as gain (loss) on fair value adjustment of warrant liability within other income or expense.

In bundled transactions, the proceeds received from any debt instruments and liability classified warrants are allocated to the warrant at fair value first, and the residual value is then allocated to the debt instrument. Upon conversion or exercise of a warrant that is subject to liability treatment, the instrument is marked to fair value at the conversion or exercise date and the fair value is reclassified to equity. Equity classified warrants are recorded within additional paid-in capital at the time of issuance at fair value as of the issuance date and are not subject to subsequent remeasurement.

Stock-Based Compensation

We account for share-based payments at fair value. The fair value of stock options is measured using the Black-Scholes option-pricing model and the fair value of restricted stock is measured based on the fair value of the Company Common Stock underlying the award as of the grant date, described further below. For share-based awards that vest subject to the satisfaction of a service requirement, the fair value measurement date for stock-based compensation awards is the date of grant and the expense is recognized on a straight-line basis, over the vesting period. We account for forfeitures as they occur.

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Prior to the Business Combination, due to the absence of an active market for Legacy Orchestra’s common stock, Legacy Orchestra utilized methodologies, approaches, and assumptions consistent with the American Institute of Certified Public Accountants’ Audit and Accounting Practice Guide: Valuation of Privately-Held Company Equity Securities Issued as Compensation to estimate the fair value of its common stock. The fair value of Legacy Orchestra’s common stock was determined based upon a variety of factors, including valuations of Legacy Orchestra’s common stock performed with the assistance of independent third-party valuation specialists; Legacy Orchestra’s stage of development and business strategy, including the status of research and development efforts of its product candidates, and the material risks related to its business and industry; Legacy Orchestra’s business conditions and projections; Legacy Orchestra’s results of operations and financial position, including its levels of available capital resources; the valuation of publicly traded companies in the life sciences and biotechnology sectors, as well as recently completed mergers and acquisitions of peer companies; the lack of marketability of Legacy Orchestra’s common stock as a private company; the prices of Legacy Orchestra’s convertible preferred stock sold to investors in arm’s length transactions and the rights, preferences and privileges of its convertible preferred stock relative to those of its common stock; the likelihood of achieving a liquidity event for the holders of Legacy Orchestra’s common stock, such as an initial public offering or a sale of Legacy Orchestra given prevailing market conditions; trends and developments in its industry; the hiring of key personnel and the experience of management; and external market conditions affecting the life sciences and biotechnology industry sectors. Significant changes to the key assumptions underlying the factors used could result in different fair values of Legacy Orchestra’s common stock at each valuation date. In determining the exercise prices for options granted and fair value of restricted stock, we have considered the fair value of the common stock as of the grant date.

Prior to the Business Combination, valuation analyses were conducted utilizing a probability weighted expected return method, in which the probability of a public company scenario was considered via either an initial public offering or special purpose acquisition company transaction. Subsequent to the Business Combination, fair value was determined by market prices of the Company Common Stock.

We classify stock-based compensation expense in our condensed consolidated statements of operations and comprehensive loss in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified.

The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model, which is based on the assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment and estimation by management.

●Expected Term — The expected term represents the period that stock-based awards are expected to be outstanding. Our historical share option exercise information is limited due to a lack of sufficient data points and does not provide a reasonable basis upon which to estimate an expected term. The expected term for option grants is therefore determined using the “simplified” method, as prescribed in the SEC’s Staff Accounting Bulletin (SAB) No. 107. The simplified method deems the expected term to be the midpoint between the vesting date and the contractual life of the stock-based awards.
●Expected Volatility — We consummated the Business Combination on January 26, 2023 and lack sufficient company-specific historical and implied volatility information. Therefore, we derived expected stock volatility using a weighted average blend of historical volatility of comparable peer public companies and our own historical volatility, over a period equivalent to the expected term of the stock-based awards.
●Risk-Free Interest Rate — The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the date of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the stock-based awards’ expected term.
●Expected Dividend Yield — The expected dividend yield is zero as neither we nor Legacy Orchestra has paid, and we do not anticipate paying, any dividends on the Company Common Stock in the foreseeable future.
●Common Stock Valuation — Prior to the Business Combination, given the absence of a public trading market for Legacy Orchestra’s common stock, Legacy Orchestra’s board of directors considered numerous subjective and

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objective factors to determine the best estimate of fair value of Legacy Orchestra’s common stock underlying the stock options granted to its employees and non-employees. In determining the grant date fair value of Legacy Orchestra’s common stock, Legacy Orchestra’s board considered, among other things, contemporaneous valuations of its common stock prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants 2013 Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. Following the Business Combination, our board of directors determines the fair value of the Company Common Stock based on the closing price of the Company Common Stock on or around the date of grant.

During the three months ended September 30, 2024 and 2023, stock-based compensation was $2.4 million and $3.5 million, respectively. During the nine months ended September 30, 2024 and 2023, stock-based compensation was $7.7 million and $6.7 million, respectively. As of September 30, 2024, we had approximately $19.4 million of total unrecognized stock-based compensation, which we expect to recognize over a weighted-average period of approximately 2.3 years.

Recently Issued Accounting Pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2, Summary of Significant Accounting Policies, to the Consolidated Financial Statements.

Emerging Growth Company and Smaller Reporting Company Status

We are an “emerging growth company,” as defined in Section 2(a) of the Securities Act of 1933 (the “Securities Act”), as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As such, we are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation in its periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

Further, Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class of securities registered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) are required to comply with the new or revised financial accounting standards. The JOBS Act provides that an emerging growth company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. We have elected not to opt out of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This may make comparison of our Consolidated Financial Statements with another public company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used.

We will remain an emerging growth company until the earliest of (1) the last day of the fiscal year following the fifth anniversary of the closing of the initial public offering of HSAC2, (2) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion, (3) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of the Company Common Stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year, or (4) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.

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We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as (i) the market value of our voting and non-voting Company Common Stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or (ii)(a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting Company Common Stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Not applicable.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures.

We maintain “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), that are designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit 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 provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure.

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2024, the end of the period covered by this Quarterly Report. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of September 30, 2024.

Changes in Internal Control Over Financial Reporting.

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

Inherent Limitation on the Effectiveness of Internal Control.

Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures, or our internal controls, will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected.

PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

From time to time, we may become involved in various claims and legal proceedings that arise in the ordinary course of our business. We are not currently a party to any material legal proceedings and are not aware of any pending or

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threatened legal proceeding against us that we believe would have a material adverse effect on our business, operating results or financial condition.

Item 1A. Risk Factors.

Our operations and financial results are subject to various risks and uncertainties, including those described under the heading “Item 1A. Risk Factors” in the 2023 10-K, which could adversely affect our business, financial condition, results of operations, liquidity and the trading price of Company Common Stock. There have been no material changes to the risk factors previously disclosed in the 2023 10-K, except as set forth below.

​

We may not be able to borrow additional funds under the 2024 LSA, and the terms of the 2024 LSA place restrictions on our operating and financial flexibility.

​

In November 2024, we entered into the 2024 LSA pursuant to which a term loan facility in an aggregate principal amount up to $50.0 million is available to us in four tranches, with the first tranche of $15.0 million drawn on the Closing Date, and a second and third tranche of up to an aggregate of $15.0 million available upon achievement of certain performance and financing milestones. Additionally, we may have access to a fourth tranche of up to $20.0 million subject to the sole discretion of the Lenders. There is no assurance that we will be able to achieve the performance and financing milestones necessary to draw additional amounts under the 2024 LSA or that the Lenders will provide funds under the fourth tranche.

​

The 2024 LSA is secured by a lien on substantially all of our assets, including our intellectual property. The 2024 LSA includes affirmative and negative covenants that limit our operating flexibility and events of default applicable to us. The affirmative covenants include, among others, covenants requiring us to permit representatives of Hercules and the Lenders to, among other things, inspect the collateral for the 2024 LSA, keep such collateral clear from any legal process or liens, deliver certain financial reports and maintain insurance coverage. The negative covenants include, among others, restrictions on making changes to the nature of our business, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, and engaging in transactions with affiliates. The 2024 LSA also includes a liquidity covenant that commences on April 1, 2025, or, if certain financing milestones are satisfied, December 1, 2025. There is no guarantee that we will be able to comply with this financial covenant or pay the principal and interest on the 2024 LSA when due.

​

Events of default under the 2024 LSA include, among other things and subject to customary exceptions: (i) insolvency, liquidation, bankruptcy or similar events; (ii) failure to pay any debts due under the 2024 LSA or other related loan documents on a timely basis; (iii) failure to observe certain covenants under the 2024 LSA; (v) occurrence of a "material adverse effect” as set forth in the 2024 LSA; (vi) material misrepresentation by us; (vii) occurrence of any default under any other agreement involving material indebtedness; and (viii) certain material money judgments. If we default under the 2024 LSA, Hercules may accelerate all of our repayment obligations and take control of our pledged assets, potentially requiring us to renegotiate the 2024 LSA on terms less favorable to us or to immediately cease operations. Further, if we are liquidated, the Lenders’ right to repayment would be senior to the rights of the holders of Company Common stock to receive any proceeds from the liquidation. Any declaration by Hercules of an event of default could significantly harm our business and prospects and could cause the price of the Company Common Stock to decline. If we raise any additional debt financing in the future, the terms of such additional debt could further restrict our operating and financial flexibility.

​

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None.

Item 3. Defaults Upon Senior Securities.

None.

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Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

Darren Sherman Bonus

The information included in this portion of Part II, Item 5 of this Quarterly Report is provided in lieu of filing such information on a Current Report on Form 8-K under Item 5.02 (Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers).

On November 7, 2024, the Compensation Committee of the Board approved a one-time cash bonus of $150,000 (the “Bonus”) to Darren Sherman, our President and Chief Operating Officer and a director, to be paid on November 15, 2024 in light of Mr. Sherman’s performance and continued contributions to the Company. Pursuant to the terms of the Bonus, Mr. Sherman is required to repay the Bonus as follows in the event of (i) his voluntary resignation without Good Reason, or (ii) the termination of his employment for Cause (as Good Reason and Cause are defined in Mr. Sherman’s January 26, 2023 Orchestra BioMed Holdings, Inc. Amended and Restated Employment Agreement), in either case before May 15, 2026:

●if his employment terminates prior to May 15, 2025, he shall repay all $150,000 of the Bonus;
●if his employment terminates on or after May 15, 2025 but prior to November 15, 2025, he shall repay $100,000 of the Bonus;
●if his employment terminates on or after November 15, 2025 but prior to May 15, 2026, he shall repay $50,000 of the Bonus; and
●if his employment terminates on or after May 15, 2026, he shall not be required to repay any of the Bonus.

​

The foregoing description of the Bonus does not purport to be complete and is subject to and qualified in its entirety by reference to the full text of the Bonus Letter Agreement, dated November 8, 2024, by and between the Company and Darren Sherman, which is filed as Exhibit 10.2 hereto and is incorporated herein by reference.

​

2024 Security and Loan Agreement

The information included in this portion of Part II, Item 5 of this Quarterly Report on Form 10-Q is provided in lieu of filing such information on a Current Report on Form 8-K under Item 1.01 (Entry into a Material Definitive Agreement). Item 2.03 (Creation of a Direct Financial Obligation or an Obligation Under an Off-Balance Sheet Arrangement of a Registrant) and Item 3.02 (Unregistered Sales of Equity Securities).

On November 6, 2024 (the “Closing Date”), the Company and certain of its subsidiaries (together with the Company, the “Borrower”) entered into a Loan and Security Agreement (the “2024 LSA”), by and among the Borrower, the several banks and other financial institutions or entities party thereto, as lenders (collectively, the “Lenders”), and Hercules Capital, Inc., as administrative agent and collateral agent for itself and the Lenders.

Amount. The 2024 LSA provides a secured term loan facility of up to $50.0 million (collectively, the “Term Loans”), consisting of:

(a)An initial tranche of Term Loans in an aggregate amount of $15.0 million, which was funded on the Closing Date.
(b)Subject to the terms and conditions of the 2024 LSA, an additional tranche of Term Loans in an aggregate amount of up to $7.5 million, which will be available beginning on the Financing Milestone I Date (as defined in the 2024 LSA) and continuing through the earlier to occur of (A) the date that is 120 days from the Financing Milestone I Date and (B) April 30, 2026 (Tranche 2-A Advances”).

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(c)Subject to the terms and conditions of this Agreement, any time beginning on the Performance Milestone Date (as defined in the 2024 LSA) and continuing through the earlier to occur of (A) the date that is 120 days from the Performance Milestone Date and (B) September 30, 2026, the Borrower may request and the Lenders shall severally (and not jointly) make up to three additional advances in minimum increments of $5,000,000 (or if less, the remaining amount of advances available to be drawn) in an aggregate principal amount up to the difference of $15,000,000 minus the aggregate original principal amount of all Tranche 2-A Advances made by the Lenders.
(d)Subject to the terms and conditions of this Agreement, Borrower may request and Lenders shall severally (and not jointly) make, on or prior to the Amortization Date (as defined in the 2024 LSA) but only following and conditioned on the approval by the Lender’s investment committee in its sole and unfettered discretion, in each case, one or more additional Term Loan advances in minimum increments of $5,000,000 (or if less, the remaining amount of Term Loan advances available to be drawn pursuant to this provision in an aggregate principal amount up to $20,000,000.

Interest Rate. Borrowings under the 2024 LSA bear interest at a per annum rate equal to the greater of (i) (x) the Prime Rate (as reported in The Wall Street Journal) plus (y) 2.0%, and (ii) 9.50%.

Terms of Repayment and Facility Charges. The Term Loans are repayable in monthly interest-only payments until: (i) December 1, 2026 or (ii) June 1, 2027, if the Financing Milestone I Date has occurred on or prior to November 6, 2026; or (iii) December 1, 2027, if the Performance Milestone Date has occurred on or prior to May 6, 2027. After the expiration of the interest-only payment period, the Term Loans are repayable in equal monthly payments of principal and accrued interest until maturity. The Term Loans will mature on November 6, 2028.

At the Company’s option, the Company may prepay all or a portion of the outstanding Term Loans, subject to a prepayment premium equal to (a) 3.0% of the Term Loans being prepaid if the prepayment occurs during the twelve months following the Closing Date, (b) 2.0% of the Term Loans being prepaid if the prepayment occurs after 12 months following the Closing Date but on or prior to 24 months following the Closing Date, and (c) 1.0% of the Term Loans being prepaid if the prepayment occurs after 24 months following the Closing Date and prior to the maturity date. In addition, the Company will pay an end of term charge of 6.35% upon the prepayment or repayment of the Term Loans and a facility charge of 0.75% upon any draws of the Term Loans.

Covenants, Representations and Warranties, Events of Default. The 2024 LSA includes customary affirmative and negative covenants and representations and warranties, including a covenant against the occurrence of a “change in control,” financial reporting obligations, and certain limitations on indebtedness, liens, investments, distributions (including dividends), collateral, transfers, mergers or acquisitions, taxes, corporate changes, and bank accounts. The 2024 LSA also includes customary events of default, including payment defaults, breaches of covenants following any applicable cure period, the occurrence of certain events that could reasonably be expected to have a “material adverse effect” as set forth in the 2024 LSA, cross acceleration to third-party indebtedness and certain events relating to bankruptcy or insolvency. Upon the occurrence of an event of default, Hercules may declare all outstanding obligations immediately due and payable and take such other actions as set forth in the 2024 LSA.

Beginning on the Testing Effective Date (as defined in the 2024 LSA), the Company must maintain Qualified Cash (as defined in the 2024 LSA) in an amount greater than or equal to (x) the outstanding principal amount of the Term Loan advances, multiplied by (y) (1) prior to December 1, 2025, 35% or (2) on and after December 1, 2025, (A) if the Performance Milestone Date has not occurred on or prior to December 1, 2025, 50% until the date on which the Performance Milestone Date has occurred and (B) on and after the Performance Milestone Date, 35% (the “Minimum Cash Covenant”). The Minimum Cash Covenant will be waived if the Company’s Market Capitalization (as defined in the 2024 LSA) exceeds $500.0 million.

Security. The Term Loans are secured by a lien on substantially all of the assets of the Company.

Right to Invest. While the Term Loans remain outstanding, the Lenders shall have the right to participate in any equity financing of the Company of at least $10,000,000 in an aggregate amount of up to $5,000,000 on the same terms, conditions and pricing afforded to others participating in any such equity financing.

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Warrants. In connection with the entry into the 2024 LSA, on the Closing Date, the Company issued each of the Lenders a warrant to purchase the Company’s common stock (each a “Warrant” and, collectively, the “Warrants”). Pursuant to the terms of the Warrants, each Lender may purchase that number of shares of Company Common Stock equal to (i)(x) 0.02, multiplied by (y) the aggregate principal amount of all Term Loan Advances (as defined in the 2024 LSA) made to the Company by the applicable Lender, divided by (ii) $5.74, which is the Exercise Price of the Warrants. Each Warrant is exercisable for seven years from the Closing Date. The Warrants and the shares of Company Common Stock issuable exercise of the Warrants shall be tradeable in accordance with the provisions of Rule 144 of the Securities Act of 1933, as amended (the “Securities Act”). The Warrants include a customary net exercise provision and customary anti-dilution adjustments with respect to stock splits, stock dividends and the like, among other customary provisions for instruments of this type.

The Warrants were issued in reliance on the exemption from the registration requirements of the Securities Act provided by Section 4(a)(2) of the Securities Act. The Company has relied this exemption from registration based in part on representations made by the Lenders in the Warrant Agreements.

The foregoing descriptions of the 2024 LSA and the Warrants do not purport to be complete and are subject to and qualified in their entirety by reference to the full text of the 2024 LSA and the form of Warrant Agreement, which are filed as Exhibits 10.1 and 4.1 hereto, respectively, and are incorporated herein by reference.

Rule 10b5-1 Trading Arrangements

​

During the three months ended September 30, 2024, no director or officer (as defined in Rule 16a-1(f) of the Exchange Act) informed us of the adoption or termination of a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement”, as each term is defined in Item 408(c) of Regulation S-K.

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Item 6. Exhibits.

Exhibit

    

Description

3.1

​

Certificate of Incorporation of Orchestra BioMed Holdings, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed with the SEC on January 31, 2023).

3.2

​

Amended and Restated Bylaws of Orchestra BioMed Holdings, Inc. (incorporated by reference to Exhibit 3.2 to the Quarterly Report on Form 10-Q filed with the SEC on August 12, 2024).

4.1+#

​

Form of Warrant Agreement, dated November 6, 2024, issued in connection with the Loan and Security Agreement, dated November 6, 2024, by and among the Company and certain of its subsidiaries, the lenders named therein and Hercules Capital, Inc., as administrative agent and collateral agent for itself and the lenders.

10.1+#

​

Loan and Security Agreement, dated November 6, 2024, by and among the Company and certain of its subsidiaries, the lenders named therein and Hercules Capital, Inc., as administrative agent and collateral agent for itself and the lenders.

10.2+˄

​

Bonus Letter Agreement, dated November 8, 2024, by and between the Company and Darren Sherman.

10.3+#

​

Commercial Lease, by and between Caliber Therapeutics, Inc. and Union Square, L.P. for facilities at 150 and 140 Union Square Drive, New Hope, Pennsylvania, dated December 14, 2009 and amended June 22, 2010, February 1, 2011, September 18, 2012, January 15, 2015, January 20, 2017, August 8, 2017, January 29, 2019, August 30, 2019 and August 8, 2024.

31.1+

​

Certification of Chief Executive Officer, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2+

​

Certification of Chief Financial Officer, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1+*

​

Certification of Chief Executive Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2+*

​

Certification of Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS

​

Inline XBRL Instance Document.

101.SCH

​

Inline XBRL Taxonomy Extension Schema Document.

101.CAL

​

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF

​

Inline XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB

​

Inline XBRL Taxonomy Extension Label Linkbase Document.

101.PRE

​

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

104

​

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

+Filed herewith.

#

Certain identified information in this exhibit has been omitted in accordance with Item 601 of Regulation S-K. The Registrant hereby undertakes to furnish supplemental copies of the unredacted exhibit upon request by the SEC.

​

˄Indicates a management contract or compensatory plan.

​

*

This exhibit shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section. Such exhibit shall not be deemed incorporated into any filing under the Securities Act or the Exchange Act.

​

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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.

​

​

​

ORCHESTRA BIOMED HOLDINGS, INC.

​

​

Dated: November 12, 2024

/s/ Andrew Taylor

​

Andrew Taylor

​

Chief Financial Officer

​

(Principal Financial Officer)

​

​

​

​

​

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