Sana Biotechnology Inc 2025年度报告

Dear Fellow Stockholders, &UHDWLQJWKLVPHGLFLQHUHTXLUHVWKHFRQÀXHQFHRIDGYDQFHVLQWUDQVSODQWLPPXQRORJ\JHQHHGLWLQJVWHPcell biology, and manufacturing sciences. OvercomingLPPXQHUHMHFWLRQRIWUDQVSODQWHGDOORJHQHLFFHOOVZLWKRXWusing immunosuppression has historically been thePRVWVLJQL¿FDQWFKDOOHQJHIRUWKH¿HOG:HGHYHORSHGour hypoimmune platform, or HIP, technology for thisSXUSRVHDQGZHKDYHQRZVKRZQWKDW+,3PRGL¿HGallogeneic pancreatic islet cells transplanted into a patientwith type 1 diabetes evade immune detection, survive,DQGIXQFWLRQIRUDWOHDVWPRQWKVSRVWWUDQVSODQWwithout any immunosuppression. Data from this studywere presented at multiple medical conferences andpublished inThe New England Journal of Medicinelastfall, a meaningful validation of the potential impact ofour HIP technology, particularly in developing a noveltherapeutic for type 1 diabetes. 2025 was a year of progress for SC451, and we are hardDWZRUNWXUQLQJVFLHQWL¿FDGYDQFHVLQWRZKDWZHKRSHwill be a safe, effective, and scalable therapy for patientswith type 1 diabetes. We are currently completing ourpreclinical testing package and transferring manufacturingIURPRXUODEVLQWRDFOLQLFDOWULDOJUDGHPDQXIDFWXULQJfacility. We are eager to begin our clinical trial andbelieve it should provide rapid visibility to clinical proofof concept – evading immune detection and producinginsulin. A successful outcome would represent a pivotalPRPHQWIRUWKHWKHUDS\DQG¿HOG:HZRXOGWKHQQHHGWRunderstand the proper dose and reproducibility of effect ofSC451 across a broad population, which we believe couldbe accomplished over the following several quarters.If successful, our attention will then turn to our abilityto scale manufacturing and move SC451 toward broadregulatory approval. We started Sana with a vision of bringing togetherpeople and technologies to deliver on the promise ofengineered cells as medicines. We prioritized tackling twoVFLHQWL¿FFKDOOHQJHV  RYHUFRPLQJLPPXQHUHMHFWLRQRIallogeneic cells to make cell therapy more effective and FHOOVSHFL¿FGHOLYHU\RIJHQHWLFPDWHULDOLQSDWLHQWVWRmake gene therapy more effective. A bold mission is neverwithout challenges, and we have had them. However,WKH\KDYHFODUL¿HGDQGDOLJQHGRXUYLVLRQVWUDWHJ\priorities, and activities. We are a lean, sharp, and focusedorganization that has prioritized opportunities where webelieve we can deliver differentiated therapies for patients.:HVHHDIXWXUHIRUDWOHDVWWKHQH[W¿YH\HDUVZKHUHRXUimpact and value will be driven by two categories, eachLPSRUWDQWDQGZLWKFRPSOHWHO\XQFRUUHODWHGVFLHQWL¿FULVN  DFHOOWKHUDS\ZLWKFXUDWLYHSRWHQWLDOIRUSDWLHQWVZLWKW\SHGLDEHWHVDQG  in vivoCAR T cells that offercurative potential to patients with certain blood cancersDQG%FHOOPHGLDWHGDXWRLPPXQHGLVHDVHV:HDUHRQWKHSUHFLSLFHRIXQGHUVWDQGLQJKRZRXUVFLHQWL¿FDGYDQFHVtranslate into therapies for people, and by this time nextyear, our future should be much clearer. We view our recently announced collaboration with Mayo&OLQLFDVDVLJQL¿FDQWYDOLGDWLRQRI6&¶VSRWHQWLDOTogether, we aim to develop systems and processes thatenable consistent and safe delivery in various clinicalsettings for this potentially transformative therapy.Overall, SC451 continues to make strong progress, andZHOLNH\RXORRNIRUZDUGWRVHHLQJKRZWKHVFLHQWL¿Fvalidation we have generated to date translates intomaking SC451 a meaningful and valuable therapy. As outlined in last year’s shareholder letter, we viewtype 1 diabetes as a unique, compelling, and valuableopportunity. Almost 10 million people have this diseaseworldwide, and most are seeking a meaningfully bettersolution than current standards of care. We continue toSULRULWL]HLQYHVWPHQWLQWKLVDVVHWKDYHPDGHVLJQL¿FDQWprogress over the past year, and are working to begina clinical trial for SC451 later this year. Our goal forSC451 is straightforward to state, but complex toachieve – a scalable single treatment for patients withW\SHGLDEHWHVWKDWOHDGVWRHXJO\FHPLD QRUPDOEORRGVXJDUOHYHOV ZLWKRXWWKHQHHGIRULQVXOLQWKHUDS\RUimmunosuppression. We are aiming for nothing less than afunctional cure. I now want to spend a bit of time outlining our thoughtson the opportunity forin vivoCAR T cells, an area wehave discussed less frequently outside the company forthe past few years. Over the past decade, autologousCAR T cell therapy has transformed the treatment andoutcomes for many patients with certain lymphomas,leukemias, and multiple myeloma. The opportunity forDSRWHQWLDOO\FXUDWLYHRQHWLPHWUHDWPHQWIRUHYHQWKRVHpatients with cancers refractory to multiple lines oftreatment has changed the possible for people with theseGLVHDVHVDQGWKRXVDQGVRISHRSOHDUHDOLYHDQGFDQFHU VSHFL¿FLW\DQGLQWHJUDWLRQLQWR7FHOO'1$LVXQQHFHVVDU\and may even have potential risks associated with it. It ispossible that we are wrong, and if so, others may m