Contract manufacturing services as a new business line has the potential to generate approximately $4-5 million in annual revenues First manufacturing services contract signed with Secretome Therapeutics MIAMI, June 03, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced the launch of its contract development and manufacturing business at ...

MIAMI, May 28, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that the Company will participate in the BIO International Convention taking place June 3-6, 2024 at the San Diego Convention Center. At the conference, members of the Longeveron management team will host meetings with global pharmaceutical company executives to explore pot ...

MIAMI, May 28, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that the Company will participate in the BIO International Convention taking place June 3-6, 2024 at the San Diego Convention Center. At the conference, members of the Longeveron management team will host meetings with global pharmaceutical company executives to explore pot ...

财务数据和关键指标变化 - 第一季度收入为0.5亿美元,同比增长96%,主要由于巴哈马的衰老相关虚弱和认知障碍登记试验参与者需求增加 [40] - 第一季度合同制造收入不到0.1亿美元,但公司计划扩大这一业务以利用其团队的专业知识和先进的GMP制造设施 [41] - 第一季度总运营费用同比下降8%,其中管理费用增加0.2亿美元至2.2亿美元,研发费用下降0.6亿美元至2.2亿美元 [42] - 第一季度净亏损为4.1亿美元,去年同期为4.6亿美元 [43] - 截至2024年3月31日,现金及现金等价物和可供出售证券为2.3亿美元,2024年4月完成11.4亿美元的两次资本募集 [43] 各条业务线数据和关键指标变化 - 公司将HLHS项目作为首要重点,认为这是成功概率最高和最快获批的项目 [15][30] - ELPIS I期1临床试验显示接受Lomecel-B治疗的HLHS患儿5年内100%存活,远高于历史对照组约20%的死亡率 [32] - ELPIS II期2b临床试验正在进行,预计今年底完成入组 [33] - CLEAR MIND期2a临床试验显示Lomecel-B组患者的认知功能恶化速度明显慢于安慰剂组,并在预设的临床和生物标志物指标上取得统计学显著改善 [34][35] 各个市场数据和关键指标变化 - 未提及具体市场数据和关键指标变化 公司战略和发展方向及行业竞争 - 公司认为Lomecel-B在HLHS、阿尔茨海默病等适应症上有广泛潜力,正专注于推进这些关键项目的临床开发 [27] - 公司正优化资源,包括扩大合同制造业务以利用自身制造能力,并已获得首个合同 [24][25] - 公司已启动董事会更新计划,引入多位行业资深人士加入董事会 [46][48][49] 管理层对经营环境和未来前景的评论 - 公司对Lomecel-B在HLHS和阿尔茨海默病适应症上的临床数据和发展前景充满信心 [27][55] - 公司认为2024年将是Longeveron具有转型性的一年,有多个重要催化剂即将到来 [55] 问答环节重要的提问和回答 问题1 **Ram Selvaraju 提问** 如果ELPIS II期2临床试验复制之前ELPIS I期1的积极结果,公司对监管机构的反应和Lomecel-B获得加速批准的可能性有何看法? [58] **Wa'el Hashad 和 Nataliya Agafonova 回答** 公司计划与FDA进行沟通,寻求Lomecel-B在HLHS适应症上获得常规批准,加速批准是备用方案。ELPIS II期2试验采用标准治疗对照,公司正在探索各种方法提高成功概率,包括优化统计学方法等。[59][60][63][64] 问题2 **Ram Selvaraju 提问** FDA最近发布的指南表明,单一临床疗效指标(如ADAS-Cog量表)的改善可能足以支持早期阿尔茨海默病药物的批准,这对Lomecel-B在该适应症的未来开发有何影响?公司还发现Lomecel-B在安全性方面可能优于现有批准药物,这一点如何? [65] **Wa'el Hashad 和 Nataliya Agafonova 回答** FDA的指南为公司在阿尔茨海默病适应症的开发提供了新的机遇。公司CLEAR MIND期2a试验不仅显示了认知功能改善,还观察到大脑体积减少的减缓,这为设计结合影像生物标志物和临床指标的后续期2b试验提供了依据。公司正在积极与FDA和专家沟通,以创新性地设计下一阶段的临床试验。[68][69][70][71][72][73]

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, 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: 001-40060 Longeveron Inc. (Exact name of registrant as specified in its charter) Delaware 47-2174146 (State or Other Jurisdiction (IRS Emplo ...

Richard Kender, retired SVP of Business Development and Corporate Licensing for Merck & Co., Inc., has been appointed to the Longeveron BoardDr. Roger Hajjar, former head of R&D at Ring Therapeutics, has been nominated as a candidate for the Board, subject to election at the Company's Annual Meeting of StockholdersNeha Motwani, former managing director and senior healthcare investment banker at William Blair, Truist, and Oppenheimer and Company, also has been nominated as a candidate for the Board, subject ...

MIAMI, May 02, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that it will report first quarter 2024 financial results and provide a business update on Tuesday, May 14, 2024 after the U.S. financial markets close. The Company will host a conference call and webcast the same day at 5:00 p.m. ET. Conference Call Details:    Conference Call Number:  1.877.407.0789    Conference ID:  13745868    Call meTM Feature ...

MIAMI, April 25, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ:LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that it will participate in the Planet MicroCap Showcase, taking place May 1-2, 2024. Details for the Company's presentation:  Date:Wednesday, May 1, 2024 Time:4:30 p.m. PT Webcast:Click Here    An archived replay of the webcast will be available on the "Events & Presentations" section of the Company's website following the conference. If you wo ...

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 ...

Longeveron Inc. (NASDAQ:LGVN) Q4 2023 Earnings Conference Call February 27, 2024 5:00 PM ET Company Participants Mike Moyer – Managing Director Wa'el Hashad – Chie Executive Officer Nataliya Agafonova – Chief Medical Officer Lisa Locklear – Chief Financial Officer Conference Call Participants Dipesh Patel – H.C. Wainwright Michael Okunewitch – Maxim Group Brad Sorensen – Zacks Research Operator Ladies and gentlemen, good afternoon, and welcome to the Longeveron Fourth Quarter and Full Year 2023 Earnings Con ...