UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM___________TO___________ Commission File Number 001-40656 TENAYA THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) Delaware 81-3789973 (Stat ...

业绩总结 - Tenaya预计在2022年提交2份IND申请，专注于MYBPC3基因疗法项目[12] - Tenaya的现金储备足以支持至少到2023年下半年[12] - 公司预计在2022年提交TN-201的IND申请[56] - TYA-11631的IND启用研究已启动，预计将在2022年提交IND申请[69] - Tenaya预计在2023年提交PKP2和DWORF的IND申请[96] 用户数据 - 美国超过3000万成年人被诊断为心脏病，每年约有35000名儿童出生时患有先天性心脏病[9] - Tenaya的管道中，针对心力衰竭的DWORF项目在美国的患病率约为400万[18] - MYBPC3基因治疗项目针对美国超过115,000名患者的肥厚型心肌病（HCM）进行研究[39] - HDAC6i小分子项目针对美国超过300万HFpEF患者，处于IND启用阶段[59] - PKP2基因治疗项目针对美国超过7万名患者的心律失常，旨在解决其遗传病因[72] 新产品和新技术研发 - Tenaya拥有超过40种人类iPSC衍生心肌细胞模型，模拟人类疾病表型[21] - Tenaya筛选了超过10亿种病毒载体，优化了心脏选择性和肝脏去靶向性[26] - Tenaya的AAV载体在非人灵长类动物中显示出5倍更好的心脏与肝脏转导比[27] - AAV:MYBPC3治疗在严重模型中显示出显著的疾病逆转和生存益处，单次给药后18个月效果维持[41] - TN-201在临床相关剂量下显示出剂量依赖性疾病逆转，心脏收缩功能改善超过20%[44] 市场扩张和并购 - Tenaya的cGMP设施已投入运营，能够支持首次人体试验研究[12] - 公司在cGMP设施的投资将支持MYBPC3项目及未来的AAV基础项目[36] 负面信息 - HFpEF患者中，曾住院的患者在5年内的死亡率高达75%[59] - 心肌梗死幸存者中，约5%-10%在第一年内死亡，约50%在一年内再次住院[89] - DCM患者的标准治疗未能有效降低早期发病率和死亡率，亟需新疗法[81] 其他新策略和有价值的信息 - Tenaya的领导团队在基因疗法、心血管研发、制造和商业化方面拥有丰富经验[14] - 通过专有的心脏特异性启动子，MYBPC3 mRNA表达比标准cTnT启动子高出2-3倍[52] - TYA-11631在HFpEF模型中显示出左心室舒张功能的改善，LV舒张压显著降低，P值为<0.01[61] - TYA-11631在HFpEF模型中改善了左心室壁厚度，P值为0.0039，肺部质量改善的P值为0.064[63] - TYA-11631在饮食诱导的肥胖小鼠模型中改善了葡萄糖耐受性，单次给药后血糖水平显著降低[65]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) 171 Oyster Point Boulevard, 5th Floor South San Francisco, CA 94080 (Address of principal executive offices) (Zip Code) Delaware 81-3789973 (I.R.S. Employer Identification No.) (650) 825-6900 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly per ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to _________ Commission File Number: 001-40656 TENAYA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 81-3789973 (Sta ...