Longeveron to hold conference call today at 8:00 AM EDT
MIAMI, Aug. 13, 2021 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today provided a business update and reported its financial results for the quarter ended June 30, 2021.
“We continue to make excellent progress advancing our Lomecel-B clinical research programs forward,” said Geoff Green, CEO of Longeveron. “Today we announced encouraging top-line results from our Phase 2b Aging Frailty trial evaluating the safety and efficacy of four different doses of Lomecel-B compared to placebo in Aging Frailty subjects. And, we anticipate announcing top-line results from our other Phase 1/2 Aging Frailty “HERA” trial this quarter. Furthermore, we anticipate initiation of a Phase 2 Alzheimer’s disease trial and a Phase 2 Japan Aging Frailty trial later this year, and we are thrilled that the first subject was dosed this past June in the Phase 2 Hypoplastic Left Heart Syndrome trial.”
Mr. Green continued, “In July, we presented our Phase 1 Alzheimer’s disease trial data at the Alzheimer’s Association International Conference (AAIC), and have submitted a manuscript of the results for peer-review publication. We look forward to additional presentations regarding our various trials and data at the upcoming International Conference on Frailty and Sarcopenia Research (ICFSR) in late September, and the Gerontological Society of America’s (GSA) Annual Scientific Meeting in November. Finally, we welcomed key personnel to our management team and board of directors, and look forward to a busy and productive second half of 2021.”
Business Update:
Statistically Significant Data from Phase 2b Trial of Lomecel-B in Aging Frailty Subjects:
The pre-specified statistical analysis plan involved a primary analysis and a secondary analysis:
Aging Frailty Phase 1/2 “HERA” Trial Data This Quarter; Japan Phase 2 On Track:
Positive Data from Alzheimer’s Disease Phase 1 Study Presented at AAIC; Phase 2 Trial On Track:
Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS)
Lomecel-B for Acute Respiratory Distress Syndrome Due to COVID 19 Infection:
Executive Appointments:
Financial Results for Second Quarter Ended June 30, 2021
Revenue: Revenue in the second quarter 2021 was $0.5 million compared to $0.9 million in the same period in 2020. The difference was due to a decrease in clinical trial revenue and grant revenue, as follows:
R&D Expenses: Research and development expenses in the second quarter of 2021 were $2.0 million compared to $0.7 million for the same period in 2020. The increase of $1.3 million, or 205%, was primarily due to an increase in research and development expenses that were not reimbursable by grants; including $0.8 million of equity-based compensation recorded for Restricted Stock Units (“RSUs”) and stock options granted during the quarter.
G&A Expenses: General and administrative expenses in the second quarter of 2021 were $3.3 million compared to $0.6 million for the same period in 2020. The increase of approximately $2.6 million, or 401%, was primarily related to an increase in compensation, insurance and professional expenses incurred during the current period; including $1.4 million of equity-based compensation recorded for RSUs and stock options granted during the quarter.
Net Loss: Net loss was $5.0 million in the second quarter 2021 compared to $1.2 million for the same period in 2020.
Per Share: Net loss per share was $0.26 in the second quarter 2021 compared to $0.08 for the same period in 2020.
Cash: Cash on hand was $16.8 million compared to $0.8 million as of June 30, 2021 and 2020, respectively. The increase in cash period over period was the result of the completion of the Company’s initial public offering in February of 2021.
Financial Outlook
Based on the Company’s current operating plan and financial resources, we believe that our existing cash on hand will be sufficient to cover expenses and capital requirements through at least the fourth quarter of 2022.
Conference Call and Webcast
Management will host a conference call today at 8:00 a.m. Eastern Time to discuss the Company’s second quarter 2021 financial results and provide a business update.
The conference call will be available via telephone by dialing toll free 1-844-200-6205 for U.S. callers; 1-646-904-5544 for local callers; or + 44 208-068-2558 for international callers and using entry code 874656. An audio replay of the call will be available through August 19, 2021.
A webcast of the call may be accessed from the “Events & Presentations” page on the Longeveron website at https://investors.longeveron.com/events-and-presentations/default.aspxby selecting today’s date from the “Upcoming Events” calendar followed by the “Webcast” link that appears beneath. The recorded webcast will remain accessible for one year through August 13, 2022.
About Longeveron Inc.
Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company’s lead investigational product is the LOMECEL-B™ cell-based therapy product (“Lomecel-B”), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer’s disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company’s mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release that are not historical facts are forward-looking statements that reflect management’s current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the period ended June 30, 2021. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Brendan Payne
Stern Investor Relations
Tel: (212) 362-1200
Email: Brendan.payne@sternir.com
Source: Longeveron Inc
Source: LGVN
(tables follow)
LONGEVERON INC.
SELECTED BALANCE SHEET DATA
(in thousands)
June 30, 2021 | December 31, 2020 | ||||||
(unaudited) | |||||||
Cash | $ | 16,833 | $ | 816 | |||
Short-term investments | 4,555 | – | |||||
Property and equipment | 3,234 | 3,597 | |||||
Intangible assets | 2,390 | 1,547 | |||||
Other assets | 2,845 | 3,280 | |||||
Total assets | $ | 29,857 | $ | 9,240 | |||
Total liabilities | 5,207 | 7,283 | |||||
Total members’ equity and stockholders’ equity | 24,650 | 1,957 | |||||
Total liabilities, member’s equity and stockholders’ equity | $ | 29,857 | $ | 9,240 |
Longeveron Inc.
Condensed Statements of Operations
(In thousands, except per share data)
(Unaudited)
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||||||||||||
Revenues | ||||||||||||||||||||||||||
Grant revenue | $ | 275 | $ | 868 | $ | 486 | $ | 1,814 | ||||||||||||||||||
Clinical trial revenue | 214 | – | 379 | 762 | ||||||||||||||||||||||
Contract revenue | – | 8 | – | 8 | ||||||||||||||||||||||
Total revenues | 489 | 876 | 865 | 2,584 | ||||||||||||||||||||||
Cost of revenues | 281 | 764 | 508 | 1,660 | ||||||||||||||||||||||
Gross profit | 208 | 112 | 357 | 924 | ||||||||||||||||||||||
Operating expenses | ||||||||||||||||||||||||||
General and administrative | 3,257 | 649 | 5,460 | 1,335 | ||||||||||||||||||||||
Research and development | 1,960 | 642 | 3,309 | 930 | ||||||||||||||||||||||
Selling and marketing | 53 | 47 | 109 | 97 | ||||||||||||||||||||||
Total operating expenses | 5,270 | 1,338 | 8,878 | 2,362 | ||||||||||||||||||||||
Loss from operations | (5,062 | ) | (1,226 | ) | (8,521 | ) | (1,438 | ) | ||||||||||||||||||
Other income and (expenses) | ||||||||||||||||||||||||||
Forgiveness of Paycheck Protection Program loan | – | – | 300 | – | ||||||||||||||||||||||
Interest expense | (2 | ) | – | (1 | ) | – | ||||||||||||||||||||
Other income, net | 54 | 10 | 101 | 10 | ||||||||||||||||||||||
Total other income and (expenses), net | 52 | 10 | 400 | 10 | ||||||||||||||||||||||
Net loss | $ | (5,010 | ) | $ | (1,216 | ) | $ | (8,121 | ) | $ | (1,428 | ) | ||||||||||||||
Basic and diluted net loss per share | $ | (0.26 | ) | $ | (0.08 | ) | $ | (0.44 | ) | $ | (0.09 | ) | ||||||||||||||
Basic and diluted weighted average common shares outstanding | 19,005,007 | 15,970,421 | 18,252,219 | 15,970,421 |
Source: Longeveron Inc.
Source: LGVN
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