HOUSTON, Aug. 07, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 150+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, has filed its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, with the U.S. Securities and Exchange Commission. The filing can be viewed through a link on FibroBiologics' website at https:/ ...

HOUSTON, Aug. 07, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 150+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, has filed its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, with the U.S. Securities and Exchange Commission. The filing can be viewed through a link on FibroBiologics' website at https:/ ...

产品管线 - 公司正处于临床前期阶段,正在开发用于治疗糖尿病足溃疡的CYWC628产品[71] - 公司正在开发用于治疗多发性硬化症的CYMS101产品,已完成1期临床试验[71] - 公司正在开发用于治疗椎间盘退行性疾病的CybroCell™产品,已获得FDA IND批准[71] - 公司正在开展银屑病、癌症和延长寿命等早期项目[73][74] 研发投入 - 公司预计未来会继续大幅增加研发支出,以推进产品候选药物的临床开发[76] - 研发费用同比增加433,000美元,主要由于增加研究人员和实验材料[79][1] 财务状况 - 公司目前主要通过投资、发行可转换票据和优先股等方式获得资金[71][72] - 公司预计未来一段时间内将持续亏损,需要大量额外资金支持[72] - 负债工具和认股权证公允价值变动产生5,527,000美元收益[80][3] - 远期合同负债公允价值变动产生1,500,000美元损失[81][4] - 承诺费用1,941,000美元[82][5] - 现金及现金等价物较2023年6月30日减少3,190,000美元[86][6] - 2024年1月完成直接上市,并于2024年6月27日向GEM发出增发通知[81][7] - 2024年1月至6月通过GEM融资2,800,000美元[87][8] - 2023年1月与FibroGenesis签订优先谈判权协议,并支付2,600,000美元[83][9] - 2023年6月30日现金及现金等价物为6,000,000美元,无债务[85][10] - 公司尚未获得任何产品的销售批准，也从未从客户合同中产生任何收入[88] - 公司预计在可预见的未来将继续亏损，并且随着当前和未来产品候选的开发和监管批准以及开始商业化任何获批产品，预计亏损将会增加[88] - 公司的未来资金需求将取决于多个因素,包括临床试验、研发、制造、监管审批、知识产权维护等[88] - 公司可能需要通过公开或私募股权融资、债务融资、合作以及其他许可安排等方式筹集额外资金[88] 内部控制 - 公司识别了一项重大内部控制缺陷,即财务报告职能缺乏适当的职责分工,导致披露控制和程序无法有效[93] - 公司将继续增加员工、评估职责分工,并实施改善内部控制的举措[94] 生产 - 公司正在评估未来是否自建GMP生产设施或继续外包生产[71] 临床研究 - 公司最近完成了一项利用成纤维细胞球体治疗银屑病的早期研究,结果显示疗效优于已上市的抗IL-23单抗[73] - 公司最近完成了一项利用人工胸腺小器官治疗免疫缺陷的早期研究,结果显示可以促进T细胞的发育和分化[74]

HOUSTON, July 15, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (NASDAQ:FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 150+ 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 Founder and Chief Executive Officer, Pete O'Heeron, will present at the JonesTrading Healthcare Seaside Summit occurring July 14-16, 2024, in San Diego, California. Details of ...

HOUSTON, July 15, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 150+ 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 Founder and Chief Executive Officer, Pete O’Heeron, will present at the JonesTrading Healthcare Seaside Summit occurring July 14-16, 2024, in San Diego, California. Details of ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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 March 31, 2024. 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: 001-41934 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) Delaware 86-3329066 (State or other jurisdic ...

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, 2023. or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from [—Date—] to [—Date—] Commission File Number: 001-41934 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) Delaware 86-3329066 (State or o ...