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 to Commission File Number: 001-40060 LONGEVERON INC. (Exact name of registrant as specified in its charter) Delaware 47-2174146 (State or Other Jurisdiction of (I. ...

Longeveron Inc. (NASDAQ:LGVN) Q3 2023 Earnings Conference Call November 10, 2023 8:30 AM ET Company Participants Mike Moyer - Managing Director, LifeSci Advisors, LLC Wa’el Hashad - CEO Nataliya Agafonova - CMO Lisa Locklear - CFO Joshua M. Hare - Co-Founder, Chief Science Officer and Chairman Conference Call Participants Michael Okunewitch - Maxim Group Operator Greetings, and welcome to the Longeveron’s Third Quarter 2023 Earnings call. At this time, all participants are in a listen-only mode. A brief que ...

Cell-Based Therapies A Regenerative Medicine Company ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 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: 001-40060 Longeveron Inc. (Exact name of registrant as specified in its charter) Delaware 47-2174146 (State or Other Jurisdiction (IRS Emp ...

分组1 - 公司宣布新任命的董事会成员包括Khoso Baluch和Jeffrey Pfeffer,他们在生物制药行业和学术界拥有丰富的经验 [10][11][12] - 公司新任命了Nataliya Agafonova为首席医疗官和Lisa Locklear为首席财务官,他们都有丰富的生物制药行业经验 [13][14] - Lomecel-B是公司的主要产品,是一种由年轻健康成人骨髓中分离的特殊细胞制成的活细胞产品,具有多种潜在的作用机制 [16][17][18] - 公司正在进行HLHS、阿尔茨海默病和老年衰弱等适应症的临床试验,取得了积极进展 [19][20][21] 分组2 - HLHS是一种罕见的先天性心脏病,目前的治疗手术存在诸多局限性,公司的ELPIS II试验旨在评估Lomecel-B改善右心室功能的潜力 [24][25][26][27][28] - 公司相信Lomecel-B可能通过减少与阿尔茨海默病相关的大脑炎症来预防、延缓和逆转其临床进展,正在进行CLEAR MIND II期临床试验 [36][37][38][39] - 公司在日本开展了针对老年衰弱的II期临床试验,目标是评估Lomecel-B的安全性,为获得日本再生医疗法的有条件批准提供支持 [43][44] 分组3 - 公司第二季度收入约为200万美元,同比下降60%,主要是由于注册试验收入下降 [47][48][49] - 公司第二季度研发费用增加33%至230万美元,主要是由于未获得补助的研发支出增加 [52][53] - 公司于6月27日向SEC提交了可交易认股权证发行的注册声明,计划筹集最多3000万美元资金 [62][63] 问答环节重要的提问和回答 问题1 **Michael Okunewitch 提问** Mesoblast的BLA被FDA拒绝,这是否会对公司HLHS适应症的Lomecel-B开发产生影响,以及是否增加了公司ELPIS II试验设计的信心 [68] **WaÂ'el Hashad 回答** 公司从一开始就将HLHS项目设计为关键性试验,并努力确保试验满足FDA要求,但最终结果仍需FDA审核 [70] 公司ELPIS II试验采用了对照组设计,这是FDA关注的关键因素 [74] 问题2 **Michael Okunewitch 提问** 公司需要在ELPIS II试验中展现什么样的结果才能作为支持申报的关键性试验 [78] **WaÂ'el Hashad 回答** 公司主要关注右心室射血分数的改善,即使只有5%的改善也可能具有临床意义,同时还关注安全性和生存率等指标 [79] Joshua Hare补充,右心室功能与临床结局关系密切,是一个很有价值的替代终点 [84] 问题3 **Michael Okunewitch 提问** 公司预计ELPIS II试验完成入组到获得数据结果需要多长时间 [86] **WaÂ'el Hashad 回答** 公司预计于明年中完成ELPIS II试验的入组,之后还需要1年时间收集和分析数据 [88][89]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 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: 001-40060 Longeveron Inc. (Exact name of registrant as specified in its charter) Delaware 47-2174146 (State or Other Jurisdiction (IRS Employer ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 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: 001-40060 Longeveron Inc. (Exact name of registrant as specified in its charter) Delaware 47-2174146 (State or Other Jurisdiction (IRS Emplo ...

Longeveron Inc. (NASDAQ:LGVN) Q1 2023 Earnings Conference Call May 12, 2023 8:30 AM ET Company Participants James Clavijo - Chief Financial Officer Wa'el Hashad - Chief Executive Officer Chris Min - Acting Chief Medical Officer & Consultant Conference Call Participants Michael Okunewitch - Maxim Group Operator Good morning, and welcome to Longeveron's call today to discuss the company's 2023 First Quarter and Financial Results. All participants are currently in listen-only mode. Following the formal present ...

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, 2022 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: 001-40060 LONGEVERON INC. (Exact name of registrant as specified in its charter) Delaware 47-2174146 (State or Other Jurisdiction of (I. ...

Longeveron Inc. (NASDAQ:LGVN) Q4 2022 Results Conference Call March 10, 2023 8:30 AM ET Company Participants James Clavijo - CFO Wa’el Hashad - CEO Dr. Chris Min - Chief Medical Officer Conference Call Participants Michael Okunewitch - Maxim Group Operator Good morning, and welcome to Longeveron's call today to discuss the company's 2022 Fourth Quarter and Full Year Financial Results. [Operator Instructions] I would now like to turn the call over to James Clavijo, Longeveron's Chief Financial Officer. James ...