HOUSTON, Dec. 23, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics”), a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, announced that it has entered into a Standby Equity Purchase Agreement (the “SEPA”) with YA II PN LTD. (“Yorkville”), an investment fund managed by Yorkville Advisors Global, LP. The agreement all ...

HOUSTON, Nov. 19, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) , a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, announced the filing of a patent application covering methods for treatment of splenomegaly using a cell-based therapeutic approach. Splenomegaly, or an enlarged spleen, often occurs in connection with immune-relat ...

HOUSTON, Nov. 14, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, announced the filing of a patent application with the United States Patent and Trademark Office covering methods employing fibroblasts or other Tissue Factor (TF)-expressing cells to prevent IBMIR ...

Preparations for Phase 1/2 clinical trial in Australia utilizing fibroblast-based spheroids product candidate, CYWC628, to treat diabetic foot ulcers are proceeding with plans to initiate in the second quarter of 2025 HOUSTON, Nov. 12, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 160+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived m ...

财务亏损状况 - 截至2024年9月30日现金及现金等价物约780万美元累计亏损约3240万美元[49] - 2024年前9个月净亏损约810万美元2023年同期约680万美元[49] - 未来几年预计继续产生重大费用和运营亏损[49] - 2024年前三季度净亏损806.2万美元2023年为676.8万美元[54] - 2024年第三季度净亏损50万美元2023年为219.3万美元[54] - 截至2024年9月30日公司现金及现金等价物约780万美元累计亏损约3230万美元[63] - 公司无产品获批销售且未产生客户合同收入[66] - 预计在可预见未来持续亏损且亏损将增加[66] - 截至2024年9月30日累计赤字约3240万美元[66] 研发项目进展 - CYWC628预计2024年底完成剩余临床前研究[50] - 已与CDMO和CRO签订协议推进CYWC628的I/II期临床试验[50] - 公司CYPS317项目在银屑病治疗研究中有积极成果[50] - 已向美国专利局提交两项新专利申请[50] 费用情况 - 研发费用未来将大幅增加[52] - 一般行政及其他费用将继续增加[53] - 2024年前三季度研发费用为314.8万美元较2023年增加155.3万美元[56] - 2024年第三季度研发费用为121.3万美元较2023年增加64.2万美元[54][55] - 2024年前三季度一般行政及其他费用为687.7万美元较2023年增加206.3万美元[59] - 2024年第三季度一般行政及其他费用为213.9万美元较2023年增加65.9万美元[54][58] 现金流量情况 - 2024年前三季度经营活动现金净流出882.8万美元2023年为480万美元[64] - 2024年前三季度投资活动现金净流出8.5万美元2023年为49.3万美元[64] - 2024年前三季度融资活动现金净流入757.7万美元2023年为1379.3万美元[64] 公司财务相关其他情况 - 至今未产生产品销售收入且短期内预计也不会[51] - 未来资金需求取决于多种因素包括临床试验等[66] - 非可取消租赁未来最低租赁付款约160万美元其中50万美元一年内到期[67] - 财务报表按GAAP编制需做估计判断假设[68] - 2024年9月30日结束的九个月内有特定会计处理[68] - 自2023年12月31日以来除特定情况无重大会计政策变化[68] - 公司为小型报告公司无需提供特定市场风险信息[68]

HOUSTON, Oct. 29, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc., (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblastderived materials, announced promising new findings from its artificial thymus organoid program. Recent results from the artificial thymus organoid program showed that fibroblasts and thymus-derived cell organoids c ...

文章核心观点 - 公司与Charles River Laboratories建立了主服务协议,双方将合作开发和制造FibroBiologics的治疗性主细胞库、工作细胞库和纤维细胞球产品CYWC628,用于2025年开始的糖尿病足溃疡临床试验 [1][3] - 公司正在研究使用纤维细胞及其衍生材料的免疫调节和再生能力来治疗慢性疾病,包括伤口愈合、多发性硬化症、椎间盘退行性疾病、银屑病、胸腺退化逆转和癌症 [2] - 公司与Charles River的合作有助于加快公司治疗方法的临床进程,为患者带来更快的治疗 [4][5] 公司概况 - 公司是一家处于临床阶段的生物技术公司,拥有160多项已获得和待批的专利,专注于使用纤维细胞和纤维细胞衍生材料开发治疗方法和潜在治愈慢性疾病的方法 [2][8] - 公司总部位于休斯顿,代表了细胞治疗领域的下一代医疗进步 [8] 合作情况 - 公司与Charles River完成了技术转让和可行性研究,双方签署了主服务协议,Charles River将作为合同开发和制造机构(CDMO)为公司的临床试验生产药品 [3] - Charles River的细胞和基因疗法CDMO业务有助于简化复杂的供应链,满足对质粒DNA、病毒载体和细胞疗法服务日益增长的需求 [3] - 双方的合作有助于加快公司治疗方法的临床进程,为患者带来更快的治疗 [4][5]

HOUSTON, Oct. 16, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics , a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, announced the issuance of a patent from the European Patent Office (Patent Number 19795975.2) covering methods and compositions for the treatment of cancer utilizing fibroblasts that have been modi ...

HOUSTON, Oct. 11, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced that Pete O'Heeron, Chief Executive Officer of FibroBiologics, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on Wednesday, October 16, 2024 at 10: ...

HOUSTON, Sept. 30, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblastderived materials, today announced that Chief Scientific Officer, Hamid Khoja, Ph.D., will present at the 2024 Cell & Gene Meeting on the Mesa Conference taking place October 7-9 in Phoenix, Arizona. "We always look ...