公司概况 - 公司专注于开发和商业化创新性自体和异体细胞疗法，利用专有的SNK平台[195] - 公司于2023年9月29日完成与Graf Acquisition Corp. IV的业务合并[197] - 公司已获得FDA对SNK02用于实体瘤的IND批准，以及SNK01用于阿尔茨海默病和帕金森病的IND批准[200] - SNK01在阿尔茨海默病I/IIa期临床试验中显示有效性和安全性[201,202] - SNK02在实体瘤I期临床试验中表现良好，未出现严重不良事件[203] 研发投入 - 公司预计未来几年内将持续大量投入研发,导致持续亏损[204,205,206] - 公司研发支出主要包括临床试验、生产工艺开发等[208,209,210,211] - 三个月期间研发费用总额减少96.3万美元,降幅24%[222] - 直接研发费用减少61.4万美元,降幅82%,主要由于临床费用减少[223] - 间接研发费用减少34.9万美元,降幅11%,主要由于人员相关成本减少34.3万美元,降幅17%[224] - 研发供应品和服务费用减少10.4万美元,降幅11%,主要由于咨询和监管事务费用减少[225] - 分摊的设施、设备和其他费用增加9.8万美元,增幅27%,主要由于401K费用和维修维护费用增加[225] - 六个月期间研发费用总额减少132.6万美元,降幅17%[220] - 总研发费用下降1.3百万美元，降幅17%[227] - 直接研发费用下降0.7百万美元，降幅69%[227] - 间接研发费用下降0.6百万美元，降幅9%[227] - 人员相关成本下降0.7百万美元，降幅17%[229] - 研发耗材和服务费用下降0.1百万美元，降幅8%[229] - 分摊的设施、设备和其他费用增加0.2百万美元，增幅36%[230] 一般及行政费用 - 公司未来还将增加一般及行政费用,以应对作为上市公司的合规要求[212,213] - 一般及行政费用增加1.8百万美元，增幅71%[231] 财务费用 - 利息费用增加0.6百万美元[233] - 发行金融工具损失1.32亿美元[236,237] - 修订金融工具损失5.2百万美元[239,240] 持续经营困难 - 公司存在持续经营困难，存在重大不确定性[252][254] - 公司需要立即筹集额外资金以维持业务运营[252][253] 融资活动 - 公司已发行多种债务工具以筹集资金,包括可转换票据、桥贷款等[255][256][259][260] - 公司与东西银行签订了有担保的循环信贷额度[257][249] - 公司与关联方NKMAX存在多笔贷款[257][258] - 公司通过私募配售等方式筹集了部分资金[262] - 公司发行了PIPE认股权证并收到部分认购款[265][266] - 公司未从发行工资资本认股权证获得任何收益,但可能在行使时获得收益[267] - 公司未从公开发行认股权证获得任何收益,但可能在行使时获得收益[267] - 公司在首次公开募股时同时发行了472.1533万份私募认股权证给Graf Acquisition Partners IV LLC,但未获得任何额外收益[267] - 公司于2024年7月12日、7月28日和7月29日与FPA投资者签订了修订协议,获得了总计120万美元的现金收益[268,269] - 公司于2024年8月12日和8月26日发行了总计280万美元的2024年可转换票据,并附带相关认股权证和对价股份[270] - 公司于2024年7月和8月偿还了30万美元的负债[270] 现金流 - 公司2024年上半年经营活动现金流出1,003.3万美元,较2023年同期增加40万美元[271,272,273] - 公司2024年上半年投资活动现金流入2万美元,较2023年同期增加6万美元[274] - 公司2024年上半年筹资活动现金流入1,006.6万美元,较2023年同期减少180万美元[274,275] 会计处理 - 公司根据FASB会计准则对金融工具进行分类评估,将其划分为负债或权益工具[289,290,291,292] - 公司采用公允价值会计处理负债工具,权益工具仅在初始确认时采用公允价值[291,297] - 公司使用不同估值方法计算负债工具的公允价值,包括二叉树模型、蒙特卡罗模拟、数字看涨期权定价模型等[298,299,300,301,302,303,304,305] 监管政策 - 公司作为新兴成长公司可享受JOBS法案的相关豁免政策[307] - 公司在业务合并后被视为新兴成长公司,直到最早的以下时间点:(i)公司成立后第五个财年结束之日，(ii)公司总年收入达到12.35亿美元的财年结束之日，(iii)公司被认定为"大型加速成长公司"的财年结束之日(市值超过7亿美元),或(iv)公司过去3年内发行超过10亿美元的非可转换债券[308] - 公司符合"小型报告公司"的定义,意味着公司市值和最近一年收入均较小(分别小于7亿美元和1亿美元)[309] - 作为小型报告公司,公司可以选择在年报中仅披露最近两个财年的经审计财务报表,并可豁免部分高管薪酬信息披露[309] - 作为小型报告公司,公司无需提供市场风险的量化和定性披露[310]

Two of the first three patients in the Phase 1 cohort of the Phase 1/2a clinical trial, treated at the highest dose of 6 billion cells per treatment, were found to have improved CDR-SB cognitive scores, resulting in a clinical upgrade from moderate AD to mild AD after only three months on therapy. First patient dosed in the Phase 2 cohort of the trial, continuing at the highest dose of 6 billion cells per treatment. With the advancement to Phase 2 of the trial, SNK01 will now be referred to by its INN name, ...

SNK01, a cryopreserved autologous non-genetically modified NK cell product, is able to effectively reduce α-synuclein (α-syn) protein levels in the cerebral spinal fluid (CSF) of Alzheimer's patients; an important finding since increased α-syn has been correlated with worse cognitive performance and is not a target for any currently approved Alzheimer's treatments SNK01 treatment appears to stabilize or improve cognitive function and reduce α-synuclein levels in CSF in addition to improving previously repor ...

SANTA ANA, Calif., July 18, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that it will present new biomarker data on SNK01 (autologous non-genetically modified NK cell therapy) in Alzheimer’s disease during a poster presentation at the upcoming Alzheimer’s Association Internat ...

SANTA ANA, Calif., July 18, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (NASDAQ:NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer ("NK") cell therapeutics, today announced that it will present new biomarker data on SNK01 (autologous non-genetically modified NK cell therapy) in Alzheimer's disease during a poster presentation at the upcoming Alzheimer's Association Internati ...

SANTA ANA, Calif., July 15, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced the appointment of Dr. Marco Gottardis as a director and member of the Company’s Audit Committee, Compensation Committee and Nominating and Corporate Governance Committee, effective July 11, 2024. Dr. Go ...

SANTA ANA, Calif., June 12, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today presented details on its novel allogeneic blood-derived NK cell therapy (“SNK02”) commercial manufacturing and cryopreservation process by Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen, entitled, ...

SANTA ANA, Calif., June 12, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today presented details on its novel allogeneic blood-derived NK cell therapy (“SNK02”) commercial manufacturing and cryopreservation process by Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen, entitled, ...

SANTA ANA, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech, will present details on their cryopreserved allogeneic NK cell therapy platform as well as updated Phase 1 data on its use in ...

SANTA ANA, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer (“NK”) cell therapeutics, today announced that Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech, will present details on their cryopreserved allogeneic NK cell therapy platform as well as updated Phase 1 data on its use in ...