MIAMI, April 15, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that it has been accepted for a Featured Research Oral Presentation to present the Company's CLEAR MIND Phase 2a study results. CLEAR-MIND is a Phase 2a randomized clinical trial evaluating Lomecel-BTM in mild Alzheimer's Disease. In addition to the clinical study results, the Company has been accepted for a poster presentation at the 2024 Alzheim ...

All right, thank you. And then just one last one for me and then I'll hop back into the queue. So over the last couple of months, we have seen some activity from Mesoblast in HLHS, specifically some FDA designations in the publication back in December. So could you just, I guess, give us an idea of how the drugs stack up beyond Lomecel-B, obviously, being in a more advanced stage. Specifically, I guess, if there are any key differences in the signaling profiles that might provide a competitive advantage. An ...

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) (State or Other Jurisdiction of Incorporation or Organi ...

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. Company Participants Conference Call Participants Operator Thank you, operator. Good morning, everyone and welcome to LongeveronÂ's third quarter 2023 results conference call. Today we will discuss financial results for the quarter ended September 30, 2023 and provide a business update. Earlier this morning, we issued a press release with these results, which can be found under the Investor s ...

ASRM approval can lead to revenue generation years before BLA application with FDA or conditional approval by PMDA Clinical Trial in Japan (N=45) ‒ NCGG (Nagoya) and Juntendo University (Tokyo) selected as clinical sites *Frailty/Aging-Related Frailty" presently does not have a consensus definition of the indication for regulatory purposes; however, it is likely that safety as observed in the proposed Phase 2 trial in Japan combined with the US Frailty 2b study will result in ASRM approval • Previous therap ...

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 ...

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 Michael Okunewitch - Maxim Group James Clavijo Wa'el Hashad Since I joined the company in March, I have been very pleased with the progress we have made in advancing Lomecel-B for our suite of rare diseases and aging indications. We have ongoing trials on Hypoplastic Left Heart Syndrome or HLHS, Alzheimer's disease and recently, we dosed the first patient in our Phase 2 study evaluating, Lomecel-B for Aging-Related Frailt ...