FLORHAM PARK, N.J., Aug. 28, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (the "Company"), a regenerative and cellular medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, announced today the appointment of Richard J. Berman, to its Board of Directors. Mr. Berman is an experienced public company director whose career spans over 40 years of venture capital, senior management, and merger and acquisitions experience. He has served as a director a ...

For the first quarter 2024, Celularity expects combined net sales of $14.8 million for its advanced biomaterial product and biobanking businesses, compared to the $10.25 million to $11.5 million guidance range previously announced in February. Celularity's expected combined net sales for the first half 2024 are $25.8 to $27.8 million compared to $6.9 million of net sales in the first of 2023 at the midpoint of the 2024 range. Celularity reiterated it is on track to file a 510(k) premarket submission for its ...

For the first quarter 2024, Celularity expects combined net sales of $14.8 million for its advanced biomaterial product and biobanking businesses, compared to the $10.25 million to $11.5 million guidance range previously announced in February. Celularity's expected combined net sales for the first half 2024 are $25.8 to $27.8 million compared to $6.9 million of net sales in the first of 2023 at the midpoint of the 2024 range. Celularity reiterated it is on track to file a 510(k) premarket submission for its ...

细胞治疗和生物材料产品开发 - 公司正在开发用于治疗与老龄化相关的退化性疾病和疾病的现成胎盘来源异基因细胞疗法和先进生物材料产品[21] - 公司开发的先进生物材料产品包括Biovance®、Biovance®3L、Biovance® 3L Ocular、Interfyl®和CentaFlex®等[28] - 公司正在开发三种先进生物材料产品:Celularity Tendon Wrap (CTW)、Celularity Bone Void Filler (CBVF)和Celularity Placental Matrix (CPM)，用于治疗与老龄化相关的退行性疾病[36] - 公司正在研发多种来自胎盘的异基因细胞治疗产品，包括CAR-T细胞、NK细胞、MLASCs和外泌体[67] - 公司正在开发多种胎盘来源的生物材料产品，如肌腱包裹物、骨缺损填充物和胎盘基质敷料等，用于治疗退行性疾病[80,83] 公司的Celularity IMPACT平台 - 公司的Celularity IMPACT平台可从单一来源材料获得四种异基因细胞类型，包括T细胞、NK细胞、MLASC和HPDSC[34] - 公司的Celularity IMPACT平台利用胎盘细胞的独特生物学特性，针对癌症、再生医学和免疫疾病等领域的退行性疾病进行细胞治疗产品的开发[37,38,40] - 公司的Celularity IMPACT制造流程是一个无缝、完全集成的过程，旨在优化速度和规模[39] 公司的细胞治疗产品 - 公司正在开发针对肿瘤、自身免疫和老龄相关疾病的T细胞和NK细胞产品[35] - 公司正在研究使用健康年轻NK细胞攻击和破坏衰老细胞的"senoablation"方法[35] - 公司正在探索APPL-001基因修饰MLASC在克罗恩病、FSHD和肌肉萎缩症等适应症的应用[35] - 公司开发了一种从胎盘干细胞衍生的异基因CAR-T细胞和NK细胞产品,具有潜在的抗肿瘤活性[56,57,60] - 公司开发了一种名为MLASCs的新型胎盘来源间充质样细胞,具有免疫调节和抗炎活性,正在开发用于治疗退行性疾病的下一代基因修饰产品[61] - 公司的异基因胎盘细胞治疗产品具有"现成"的优势，可以大规模生产和提供，有望使生命救助性疗法更广泛地惠及更多患者[66] - 公司的胎盘来源T细胞具有免疫特权和低毒性的特点，可以通过基因工程进一步优化安全性和疗效[70] 公司的知识产权和竞争格局 - 公司拥有358项专利和专利申请,构建了强大的全球知识产权组合[33] - 公司正在积极建立围绕Celularity IMPACT平台、四种异基因细胞类型及其治疗候选药物的知识产权组合[97] - 公司的专利组合包括CAR-T细胞、未修饰NK细胞、基因修饰NK细胞、MLASC和外泌体等方面的专利[98][99] - 公司正在采取多层面的专利保护策略,包括成分、制造方法和使用方法等[100] - 公司面临来自异基因CAR-T细胞、NK细胞、MLASC和外泌体等领域的竞争[103][104] - 公司还面临来自非细胞疗法的竞争,包括大型制药公司的产品[106] 监管和商业化挑战 - 公司的细胞治疗产品需要经过临床试验并获得生物制品许可才能上市[111] - 公司需要完成临床前试验、提交IND申请、获得IRB批准、进行临床试验I/II/III期、提交BLA申请等一系列监管程序才能获得上市批准[114,115,118,119,120] - 公司需要建立符合cGMP和GTP标准的生产制造工艺和质量控制体系，并接受FDA的现场检查[123,124,129] - FDA会对BLA申请进行审查，评估产品的安全性、纯度和有效性，可能会要求公司进行IV期临床试验[126,128] - 公司需要支付相关的用户费用才能获得FDA的审查和批准[127] - 产品的覆盖范围和报销水平存在很大不确定性,可能会对公司收入产生不利影响[172][173][174][175] - 医疗改革法案可能会对公司产品的定价和报销产生持续的下行压力[176][177][178][179][180][181] 公司的财务状况和融资需求 - 公司自成立以来一直亏损,目前没有获批上市的细胞治疗产品[198,199] - 公司预计未来将持续大幅亏损,截至2023年12月31日累计亏损8.418亿美元,现金和现金等价物仅有0.2亿美元[199,200] - 公司目前存在持续经营能力的重大不确定性,需要大量额外融资支持运营[201] - 公司需要大量额外资金来开发治疗产品并实施经营计划,但能否如期筹集到所需资金存在重大不确定性[202,203,204,205] 公司的技术风险 - 公司使用基因编辑技术修饰某些胎盘来源的细胞类型,以降低毒性风险或提高疗效潜力[211] - 基因编辑技术相对较新,如果无法在预期的治疗候选药物中使用,将严重限制公司的收益机会[210] - 公司依赖许可的基因编辑技术用于未来的细胞治疗产品候选药物[215] - 如果供应商拒绝提供所需的基因编辑技术,将对公司开发改良NK细胞和MLASC产生负面影响[216] 公司的战略决策风险 - 公司必须专注于特定的治疗途径

FLORHAM PARK, N.J., June 03, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (NASDAQ:CELU) ("Celularity"), a regenerative and cellular medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, announced today that it presented in vivo data from its T-cell therapy platform at this year's ASCO Annual Meeting in Chicago. These data show that PT-CD16VS, Celularity's T-Cell preclinical asset, has potent in vitro and in vivo activity and has the potential to be combined w ...

FLORHAM PARK, N.J., June 03, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (NASDAQ: CELU) (“Celularity”), a regenerative and cellular medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, announced today that it presented in vivo data from its T-cell therapy platform at this year’s ASCO Annual Meeting in Chicago. These data show that PT-CD16VS, Celularity’s T-Cell preclinical asset, has potent in vitro and in vivo activity and has the potential to be combined ...

FLORHAM PARK, N.J., May 24, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (the “Company”), a regenerative medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, announced today that on May 21, 2024, the Company received notification from the Listing Qualifications department of the Nasdaq Stock Market LLC (“Nasdaq”) stating that because the Company has not yet filed its Form 10-Q for the quarter ended March 31, 2024 (“Q1 2024 Form 10-Q”), and bec ...

财务预测 - Celularity Inc.预计2023年12月31日季度净收入约为1210万美元[2] - Celularity Inc.预计2024年3月31日季度净收入约为1480万美元[2] 业务更新 - Celularity Inc.将于2024年5月21日举行投资者和分析师研发日，提供业务更新和总结[5]

FLORHAM PARK, N.J., May 14, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (NASDAQ:CELU) ("Celularity"), a regenerative and cellular medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, announced today that the Journal for ImmunoTherapy of Cancer, a peer-reviewed online journal of the Society for Immunotherapy of Cancer, published data highlighting the potential advantages of Celularity's T-Cell platform for future immunotherapies including chimeric antigen re ...

FLORHAM PARK, N.J., April 22, 2024 (GLOBE NEWSWIRE) --   Celularity Inc. (NASDAQ:CELU) ("Celularity"), a regenerative and cellular medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, announced today it will host an on-site and virtual Investor and Analyst Research & Development (R&D) Day. The Investor and R&D Day, scheduled for Tuesday, May 21, 2024, from 12:00 p.m. to 4:00 p.m. ET in Florham Park, NJ, will showcase progress and advancements of Celulari ...