Longeveron(LGVN)
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Longeveron(LGVN) - 2021 Q2 - Quarterly Report
2021-08-13 20:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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 June 30, 2021 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 001-40060 | | 47-2174146 | | --- | --- | ...
Longeveron(LGVN) - 2021 Q1 - Quarterly Report
2021-05-14 20:08
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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, 2021 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: 001-38295 Longeveron Inc. (Exact name of registrant as specified in its charter) | Delaware | 001-40060 | 47-2174146 | | --- | --- ...
Longeveron(LGVN) - 2021 Q1 - Earnings Call Transcript
2021-05-14 17:20
Financial Data and Key Metrics Changes - Revenues for Q1 2021 were approximately $0.4 million, a decrease of 78% compared to $1.7 million in Q1 2020, primarily due to a decrease in clinical trial revenue and grant revenue [28] - Grant revenue for Q1 2021 was $0.2 million, down 78% from $0.9 million in Q1 2020, resulting from less research grant funds as various clinical trial programs concluded [29] - Research and development expenses increased to approximately $1.4 million in Q1 2021 from $0.3 million in Q1 2020, a rise of 367% due to increased non-reimbursable expenses and equity-based compensation [31] - General and administrative expenses rose to approximately $2.2 million in Q1 2021 from $0.7 million in Q1 2020, an increase of 221% primarily related to compensation insurance and professional expenses [32] - Net loss increased to approximately $3.1 million in Q1 2021 from a net loss of $0.2 million in Q1 2020 [33] - Cash as of March 31, 2021, was $24.5 million, significantly up from $0.8 million as of December 31, 2020, due to the completion of the company's IPO [33] Business Line Data and Key Metrics Changes - The Lomecel-B cell therapy program is progressing with three data readouts in three trials expected over the next two quarters, and three new Phase 2 trials planned for the second half of 2021 [6][7] - The Alzheimer's disease program showed promising preliminary efficacy results, with the low dose Lomecel-B group experiencing a slower decline in cognitive function compared to the placebo group over 52 weeks [10][11] - The Aging Frailty program is evaluating Lomecel-B as a treatment, with two U.S. clinical studies completed and data expected to be announced in Q3 2021 [15][16] Market Data and Key Metrics Changes - The company is targeting the aging-related diseases market, which is significant due to the increasing prevalence of chronic diseases associated with aging [8] - The Japanese market presents a favorable regulatory environment for regenerative medicine, offering expedited pathways to market, which is seen as a significant opportunity for the company [20] Company Strategy and Development Direction - The core business strategy is to become a world-leading regenerative medicine company through the development and commercialization of novel cell therapy products for unmet medical needs, particularly in aging-related indications [26] - The company is focused on advancing Lomecel-B through clinical trials in various indications, with significant milestones expected in the near term [25] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the upcoming data releases and the transition to Phase 2 trials, particularly in Alzheimer's disease and Aging Frailty, which are seen as major steps towards commercialization [38][39] - The company is optimistic about the potential treatment options for aging-related frailties and the significance of their research in this area [39] Other Important Information - Participation in the Bahamas Registry Trial has slowed due to COVID-19, but an increase in interest is anticipated as travel restrictions ease and vaccination rates rise [22] - The company is currently enrolling subjects in a Phase 1 trial for Acute Respiratory Distress Syndrome (ARDS) and expects to complete this trial with data in 2022 [24] Q&A Session Summary Question: What are the most significant upcoming milestones from an investor's standpoint? - Management highlighted the transition from Phase 1 to Phase 2 trials, particularly in Alzheimer's disease, as a significant event that could drive value for the company [37][38] - The lack of approved therapies for Aging Frailty makes the upcoming trials in this area particularly noteworthy, with expectations for data releases that could indicate potential treatments [39]
Longeveron(LGVN) - 2020 Q4 - Annual Report
2021-03-30 20:51
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, 2020 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: 001-38295 LONGEVERON INC. | Large accelerated filer | ☐ | Accelerated filer | ☐ | | | --- | --- | --- | --- | --- | | Non-accelerated fi ...
Longeveron(LGVN) - 2020 Q4 - Earnings Call Transcript
2021-03-30 16:43
Longeveron, Inc. (NASDAQ:LGVN) Q4 2020 Earnings Conference Call March 30, 2021 8:30 AM ET Company Participants Natalya Rudman – Senior Vice President-Crescendo Communications Geoff Green – Chief Executive Officer Joshua Hare – Co-Founder, Chief Science Officer and Chairman James Clavijo – Chief Financial Officer Conference Call Participants Operator Ladies and gentlemen, welcome to the Longeveron Inc. 2020 Year-End Earnings Call. My name is Abby, and I’ll be coordinating your call today. [Operator Instructi ...