圣诺医药-B2023中期报告

4 26 37 66 68 70 72 73 117 122 公司資料 Michael V. Molyneaux David Mark Evans Sirnaomics, Inc.20511 Seneca Meadows Parkway, Suite 200GermantownMD 20876U.S. 218A4415 18346 公司資料 1 PO Box 309, Ugland HouseGrand Cayman, KY1-1104Cayman Islands Wells Fargo Bank, N.A.420 Montgomery StreetSan FranciscoCA 94104U.S. Maples Fund Services (Cayman) LimitedPO Box 1093, Boundary HallCricket SquareGrand Cayman, KY1-1102Cayman Islands 127 183171712–1716 A23 8835 Maples and Calder (Hong Kong) LLP1826 99 www.sirnaomics.com 12 Marina BoulevardDBS Asia CentralMarina Bay Financial Centre Tower 3Singapore 018982 2257 管理層討論與分析 Sirnaomics2007RNASirnaomics— PNPGalAheadTM STP705STP707(NMSC)PNP2023FDAIISTP705isSCCNMSCRNAi STP705isSCCsiRNASTP705IFDAIIGalNAcGalAhead™mxRNAmuRNAGalAhead™STP122GFDAISTP122GGalAhead™ RNAi 管理層討論與分析 RNARNAimRNARNAe RNASirnaomicsRNAimmunemRNAEDIRNA SirnaomicsSTP705STP707STP122GRNAimmunemRNARV-1730I 管理層討論與分析 STP705 STP705(STP705)TGF-ß1COX-2pixofisiran INNlixadesiran INNPNPTGF-ß1COX-2TGF-ß1COX-2STP705PNPNMSCSTP705 STP707 STP707(STP707)STP705siRNAISTP707 STP122G STP122GGalAhead™siRNAGalNAcISTP122G(DVT) STP705STP707STP122G 管理層討論與分析 siRNAPNPGalAhead™RNAimmuneLNP PNP STP355 STP355TGF-ß1VEGFR2siRNA(TME)STP355PNP(HKP+H)(IV)STP355STP355IND GalAhead™ STP125G STP125GC3 (APoC3)siRNAsiRNAGalNAcAPoC3-GalNAc-siRNAGMP2023FDAIND 管理層討論與分析 STP144G STP144GBsiRNAsiRNAGalNAcSTP144GGMPSTP144GGalAhead™2024IND LNP RV-1730 RV-1730(SARS-CoV-2)LNPDeltaSARS-CoV-2mRNAINDFDARV-1730RNAimmunemRNA RNA(1)PNPRNAi(2)GalNAcRNAiGalAhead™siRNA PNP16PNPPNP——RNA—RNAPNPPNPPNPRNA 管理層討論與分析 GalNAcRNAiGalAhead™SirnaomicsRNAiRNAmRNAmxRNA™muRNA™mxRNA™30ntmuRNA™ASGPRsiRNA GMPPNPPNPPNPCDMO(API)(PPQ)PNP GalAhead™CDMO 20212023GalAhead™STP122GGalAhead™ 管理層討論與分析 20232023 STP705 isSCCSTP705 69isSCCSTP705 IIaIIb30BCCII20232FDAIIFDAIIaIIbSTP705isSCCFDASirnaomics20236192023IIIIII STP705I 20225RNAiSTP705I20236ISTP705(LSR)98STP705(P < 0.05)240g/1.0ml 管理層討論與分析 RNAi2023ISTP705 STP707 STP707 STP70750STP707283 mg6 mg12 mg24 mg36 mg48 mg284STP70774%(SD)(RECIST) TGF-ß1COX-2TSTP707PD-L1ISTP707 STP122G STP122GI 20234GalNAcSTP122GI(FXI)FXIGalNAcsiRNA 管理層討論與分析 SirnaomicssiRNAGalNAc RNAiGalAhead™FXI(DVT) 20236STP122GISTP122G RV-1730 RV-1730FDAIND 20234mRNARNAimmuneFDAINDRV-1730SARS-CoV-2IRV-1730mRNASARS-CoV-2RV-1730 IFDARNAimmuneRV-1730RNAimmunemRNA IND 2023STP125GINDINDCMCIND 2024STP144GIND 202112 管理層討論與分析 GMP2023STP707GMPGMP50,000150,000200,000 2023STP7072RGalAhead™STP122GGalAhead™ EDIRNA EDIRNA2022RNASirnaomicsEDIRNAEdit-to -Cure Therapeutics™ RNARNARNAEDIRNA 20237Francois LebelFrancois LebelSirnaomics20238RNAi RNAimmuneGeorge JiDavidMark Evans 管理層討論與分析 Sirnaomics2021RNAimmuneEDIRNARNA(1)RNA(2)(3) SirnaomicsRNAimmuneEDIRNASirnaomics82(1) RNA(2) SirnaomicsRNARNAi STP705STP707 STP705STP705isSCCSTP705BCCSTP707STP705 管理層討論與分析 isSCCSTP7052023IIFDAIIaIIbSTP705isSCCFDASirnaomics20236192023IIIIIIBCCSTP70520232023STP705STP705 isSCCSTP705STP705 STP705isSCCBCCSTP707PNPSTP707PNPSirnaomicsRNASTP707IISTP707CCAHCCIISTP707STP707 管理層討論與分析 — 20236ISTP70542STP705RNAi2023FDA siRNA 2023GalAhead™STP122GmRNARV-1730IND GalAhead™GalAhead™INDSTP122GGalAhead™STP125GSTP144G20232024IND STP705STP707GalAhead™STP122GSTP125GSTP144G 管理層討論與分析 STP705isSCCisSCCSTP705Francois LebelSTP705STP7052023isSCCIII20252025FDAFDAFDAFDA (i)(ii)(iii)(iv)(v)(vi)(vii)(viii)(ix)(x)(xi)(xii)(xiii) 管理層討論與分析 2023630202363041.1202263046.1 2023630 管理層討論與分析 (i)(ii) 202363020226300.90.228%1.120226300.120236300.820226300.720236300.2 (i)(ii) 202363020226300.50.2(i)20226300.5202363047,000(ii)20236300.2 RNAimmuneRNAimmuneA 202363020226302.92.585%0.4RNAimmune 管理層討論與分析 (i)(ii) 2023630202263011.10.33%10.8 管理層討論與分析 (i)(ii)(iii)CRO(iv)(v)(vi)CRO 2023630202263032.11.44%30.7 2023630150,000 管理層討論與分析 202363020226300.40.122%0.5 2023630 202263046.1202363041.1(i)(ii) 202263045.47.116%202363038.3 20226309.13.538%20236305.6 管理層討論與分析 202263012.920236303.820236303.72022630RNAimmuneA8.26.1 20236302023630 2023630 202363020221231105.257.3 202363074.257.316.9202363017.514.40.70.22.2 202363020221231111.668.820221231105.2202363057.3 管理層討論與分析 20236300% 2022123115.020236305202212292023112 202363020.25%2023630155,000150,000 2023630 2023630 2023630 2023630 管理層討論與分析 20236301802023630 202363011.91.8202263010.228,000 — 董事及高級管理層 67siRNA 1994420004Genetic Therapy,Inc.2000520015DigeneCorporation20016Intradigm Corp.20071 19982009920129201020121220141150—70 2008SirnaomicsRNAi2012SirnaomicsRNAi11-512-5 1982119841219876198712199041990419923 董事及高級管理層 60 200020111ValueMeasure Investments Limited20123Trinity Power Limited20018 20001200112600181200761200120022004300142200520159201712600422 198371988719989199811199912John N. Ablelson MichaelV.MolyneauxMolyneaux53MolyneauxKOL 董事及高級管理層 Molyneaux20MolyneauxCollege of Family Physicians of CanadaAmericanBoard of Family Medicine CertificationMolyneaux Molyneaux20022008