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Longeveron (LGVN) Investor Presentation - Slideshow
2022-09-14 13:40
| --- | --- | --- | --- | --- | |---------------------------------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Cell-Based Therapies | | | | | | | | | | | | A Regenerative Medicine Company | | | | | | September 2022 | | | | | Forward Looking Statements Certain statements in this presentation that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economi ...
Longeveron(LGVN) - 2022 Q2 - Earnings Call Transcript
2022-08-14 06:02
Longeveron Inc. (NASDAQ:LGVN) Q2 2022 Earnings Conference Call August 12, 2022 8:30 AM ET Company Participants Elsie Yau - Stern Investor Relations Chris Min - Interim Chief Executive Officer & Chief Medical Officer James Clavijo - Chief Financial Officer Joshua Hare - Co-Founder, Chief Science Officer & Chairman Conference Call Participants Michael Okunewitch - Maxim Group Operator Ladies and gentlemen, thank you for standing by. Welcome to the Longeveron 2022 Second Quarter Earnings Call. My name is Irene ...
Longeveron(LGVN) - 2022 Q2 - Quarterly Report
2022-08-12 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, 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) (State or Other Jurisdiction of Incorporation) Dela ...
Longeveron(LGVN) - 2022 Q1 - Earnings Call Transcript
2022-05-17 18:16
Longeveron Inc. (NASDAQ:LGVN) Q1 2022 Earnings Conference Call May 13, 2022 8:30 AM ET Company Participants Elsie Yau - Stern Investor Relations, IR Geoff Green - CEO Chris Min - Chief Medical Officer James Clavijo - CFO Joshua Hare - Chief Science Officer Conference Call Participants Michael Okunewitch - Maxim Group Constantine Davides - EF Hutton Operator Hello everyone and welcome to the Longeveron Inc. 2022 First Quarter Earnings Call. My name is Juan and I will be coordinating your call today. All part ...
Longeveron(LGVN) - 2022 Q1 - Quarterly Report
2022-05-13 20:06
Funding and Financials - Longeveron has received over $16.0 million in non-dilutive funding from various organizations, including $11.9 million directly awarded, which is recognized as revenue upon meeting performance obligations[134]. - Revenues for Q1 2022 were approximately $0.4 million, remaining consistent with Q1 2021, while grant revenue decreased by 72% to $0.1 million due to reduced available funds[154]. - Clinical trial revenue from the Bahamas Registry Trial increased by approximately $0.1 million or 88% to $0.3 million in Q1 2022 compared to Q1 2021, attributed to reduced COVID-19 travel restrictions[154]. - General and administrative expenses rose to approximately $2.0 million in Q1 2022, an increase of $0.3 million or 16% from Q1 2021, primarily due to higher compensation and insurance costs[156]. - Net loss for Q1 2022 increased to approximately $3.5 million, a rise of $0.4 million or 13% compared to a net loss of $3.1 million in Q1 2021[161]. - Cash used in operating activities for Q1 2022 was $4.2 million, compared to $3.0 million in Q1 2021, reflecting ongoing operational expenses[164]. - The company anticipates needing additional capital to fund operations, which may come from equity or debt financings, collaborations, or licensing arrangements[167]. - The company has raised approximately $77.2 million in gross proceeds from equity issuance since its formation[168]. - As of March 31, 2022, the company had cash and cash equivalents of $22.1 million and working capital of approximately $29.5 million[168]. - The IPO sold 2,910,000 shares at $10.00 per share, generating gross proceeds of $29.1 million[169]. - The company closed a PIPE offering on December 3, 2021, raising $20.5 million from the sale of 1,169,288 shares at an initial exercise price of $17.50 per share[171]. - The company has been awarded approximately $11.9 million in grants to fund clinical trials and R&D[173]. - The company believes existing cash will fund operations through the first half of 2024, but future funding needs may arise sooner[179]. - As of March 31, 2022, the company has $3.0 million in operating lease obligations and $3.6 million in contract research organization obligations[183]. - The company recognizes grant revenue when related expenses are incurred, with $19,000 recognized from deferred revenue in Q1 2022[190]. Clinical Trials and Product Development - The company is advancing its lead product, Lomecel-B, into later stage clinical trials for multiple indications, including Aging Frailty and Alzheimer's disease[130][134]. - A Phase 2a clinical trial for Lomecel-B in mild Alzheimer's disease has been initiated, enrolling 48 patients across four treatment groups[140]. - The ELPIS II trial for Lomecel-B in infants with Hypoplastic Left Heart Syndrome (HLHS) is ongoing, with all seven planned clinical sites activated for screening and enrollment[140]. - The Phase 1 trial for Lomecel-B in Acute Respiratory Distress Syndrome (ARDS) continues to screen subjects, although enrollment has been slower than expected due to fewer hospitalizations[142]. - The planned Japanese Aging Frailty Phase 2 trial is on track to initiate in the first half of 2022, with top-line results from the Phase 1/2 "HERA" trial expected in the same timeframe[23]. - The company is exploring international expansion, with Japan selected as the first non-U.S. territory for a clinical trial evaluating Lomecel-B for Aging Frailty[134]. Operational and Strategic Focus - Longeveron operates a GMP-compliant manufacturing facility to produce its product candidates, aiming for cost-effective manufacturing to meet future commercial demand[134]. - The company is focused on expanding its intellectual property portfolio to protect its business strategy and enhance the value of its product candidates[134]. - The company aims to leverage collaboration arrangements and out-licensing opportunities to commercialize Lomecel-B and other products domestically and internationally[134]. - Operating costs are expected to increase substantially due to advancements in clinical development and expansion of personnel[178]. Market and Regulatory Status - The company is classified as an "emerging growth company," allowing it to take advantage of reduced reporting requirements under the JOBS Act[199]. - The company will remain an "emerging growth company" until it achieves total annual gross revenues of $1.07 billion or more[200]. - The company will also transition out of this status if it issues more than $1.0 billion in nonconvertible debt within three years[200]. - The company is considered a large accelerated filer if it has a market value exceeding $700 million held by non-affiliates and has been public for at least 12 months[200]. - There were no material changes in the company's exposure to market risk since the last disclosure in the 2021 10-K[203]. Impact of COVID-19 - The impact of the COVID-19 pandemic has been monitored, with minimal disruption to cell production but some challenges in clinical trial follow-ups due to patient reluctance and regional restrictions[135][137].
Longeveron(LGVN) - 2021 Q4 - Annual Report
2022-03-11 22:00
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, 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 47-2174146 (State or Other Jurisdiction of Inc ...
Longeveron(LGVN) - 2021 Q4 - Earnings Call Transcript
2022-03-11 21:50
Longeveron Inc. (NASDAQ:LGVN) Q4 2021 Results Conference Call March 11, 2022 8:30 AM ET Company Participants Brendan Payne - Stern IR Geoff Green - Chief Executive Officer Dr. Joshua Hare - Co-Founder, Chief Science Officer and Chairman James Clavijo - Chief Financial Officer Operator Hello and welcome to Longeveron's call today to discuss the Company's 2021 Fourth Quarter and Year-End Financial Results. All participants are currently in a listen-only mode. Following the formal presentation, we will open th ...
Longeveron(LGVN) - 2021 Q3 - Earnings Call Transcript
2021-11-12 21:55
Longeveron Inc. (NASDAQ:LGVN) Q3 2021 Earnings Conference Call November 12, 2021 8:30 AM ET Company Participants Brendan Payne - Stern IR Geoff Green - Chief Executive Officer Joshua Hare - Co-Founder, Chief Science Officer and Chairman James Clavijo - Chief Financial Officer Operator Greetings, and welcome to Longeveron's call today to discuss the results of the company's Third Quarter of 2021 Financial Results. All participants are currently in listen-only mode. Following the formal presentation, we will ...
Longeveron(LGVN) - 2021 Q3 - Quarterly Report
2021-11-12 21:02
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 September 30, 2021 Commission file number: 001-40060 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Longeveron Inc. (Exact name of registrant as specified in its charter) | Delaware | 001-40060 | 47-2174146 | | --- | ...
Longeveron(LGVN) - 2021 Q2 - Earnings Call Transcript
2021-08-14 21:45
Financial Data and Key Metrics Changes - Revenues for Q2 2021 were $0.5 million, a decrease of 44% compared to $0.9 million in Q2 2020, primarily due to a reduction in grant revenue [30] - Grant revenue decreased by 68% from $0.9 million in Q2 2020 to $0.3 million in Q2 2021, attributed to the completion of grant-funded clinical trials [30] - Net loss increased to approximately $5 million in Q2 2021 from a net loss of $1.2 million in Q2 2020 [33] - Cash and short-term investments as of June 30, 2021, were $21.4 million, significantly up from $0.8 million as of December 31, 2020, due to the completion of the IPO [33] Business Line Data and Key Metrics Changes - Clinical trial revenue from the Bahamas Registry Trial was $0.2 million in Q2 2021, a 100% increase compared to zero in Q2 2020 [30] - Research and development expenses rose to $2 million in Q2 2021, a 205% increase from $0.7 million in Q2 2020, due to non-reimbursable expenses and increased equity-based compensation [32] - General and administrative expenses increased to $3.2 million in Q2 2021 from $0.6 million in Q2 2020, primarily due to higher compensation and professional expenses [32] Market Data and Key Metrics Changes - The company is actively pursuing multiple clinical trials, including those for Aging Frailty, Alzheimer's disease, and Hypoplastic Left Heart Syndrome, indicating a broad market focus [24][26] - The Phase 2b trial for Lomecel-B showed promising results, with a statistically significant dose-response relationship observed at day 180 [16] Company Strategy and Development Direction - Longeveron aims to advance Lomecel-B as a treatment for Aging Frailty and other chronic diseases, focusing on cell therapies for conditions with no approved treatments [22] - The company is committed to engaging with the FDA and other regulatory bodies to explore clinical and regulatory pathways for future approvals [19] - Plans to initiate a larger Phase 2 study for Alzheimer's disease later this year, indicating a strategic focus on expanding therapeutic applications [25] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the Phase 1 Alzheimer's study results, highlighting the need for further research [25] - The company is well-positioned financially to advance its clinical programs and meet upcoming milestones [35] - Management emphasized the importance of ongoing discussions with regulatory bodies to support the development of Lomecel-B [19] Other Important Information - The Phase 2b trial for Lomecel-B involved 148 subjects and evaluated the safety and efficacy of various doses [9] - The company has received over $15 million in grant funding to support its research initiatives [27] - The upcoming presentation of full trial results at the International Conference of Frailty & Sarcopenia Research is anticipated [19] Q&A Session Summary - The call concluded without any recorded questions or answers, indicating a focus on the presentation of results and updates rather than interactive discussion [36][37]