Full Press Release Details
Inc. Provides Corporate Update and Reports First Quarter 2023 Financial Results
New long-term survival data disclosed from ELPIS I trial of Lomecel-BTM for Hypoplastic Left Heart Syndrome; Data reinforce
potential mortality benefit --
First patient dosed in Phase 2 clinical trial of Lomecel-BTM for Aging-Related Frailty in Japan --
Conference call scheduled for 8:30 a.m. ET today --
Florida - May 12, 2023- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or the "Company"), a clinical
stage biotechnology company developing regenerative medicines for unmet medical needs, today provided a business update and reported
its financial results for the first quarter ended March 31, 2023.
2023, we have continued to make steady progress advancing Lomecel-BTM, our lead investigational product, across three clinical
programs," said Wa'el Hashad, Chief Executive Officer. "Since joining the Company in March, I am very excited about
the progress of Lomecel-BTM in HLHS, a rare and life-threatening congenital heart disease. Earlier this week, we provided
long-term follow-up data from our ELPIS I trial of Lomecel-BTM for infants with HLHS, which showed a 100% survival rate up
to 5 years. Also notably, the first patient was treated with Lomecel-BTM in our Phase 2 clinical trial in patients with Aging-Related
Frailty in Japan. We plan to continue to execute on key milestones across our three clinical programs, and from our Phase 2a CLEAR MIND
trial for Alzheimer's Disease, we expect to announce topline results by the end of this year."
Quarter Business Updates:
for Hypoplastic Left Heart Syndrome (HLHS):
for Aging-Related Frailty:
for Alzheimer's Disease:
Results for First Quarter Ended March 31, 2023
Revenue for the first quarters of 2023 and 2022 was $0.3 million and $0.4 million, respectively. Revenue consisted of:
Expenses: Research and development expenses in the first quarter 2023 were $2.8 million compared to $1.4 million for the same period
in 2022. The increase of $1.4 million, or 94%, was primarily due to an increase of $1.1 million in research and development expenses
that were not reimbursable by grants. Equity-based compensation allocated to research and development expenses increased to $0.3 million
for the three months ended March 31, 2023, from $0.1 million for the same period in 2022.
Expenses: General and administrative expenses in the first quarter 2023 were $1.9 million compared to $2.0 million for the same period
in 2022. The decrease of approximately $0.1 million, or 5%, was primarily related to a decrease in equity-based compensation expenses
allocated to general and administrative expenses.
Loss: Net loss was $4.6 million in the first quarter 2023 compared to $3.5 million for the same period in 2022.
Share: Net loss per share was $0.22 in the first quarter 2023 compared to $0.17 for the same period in 2022.
Cash and marketable securities:
Cash and marketable securities was $13.7 million and $19.6 million as of March 31, 2023, and December 31, 2022, respectively.
reclassifications have been made to prior year financial statements to conform to classifications used in the current year. These reclassifications
had no impact on net loss, shareholders' equity or cash flows as previously reported.
on the Company's current operating plan and financial resources, we believe that our existing cash and marketable securities will
be sufficient to cover expenses and capital requirements into the second quarter of 2024.
will host a conference call today at 8:30 a.m. ET to discuss the Company's first quarter 2023 financial results and provide a business
Dial-in Number: 833-470-1428
Dial-in Number: 833-950-0062
Other Locations Dial-in Number: 929-526-1599
Replay Dial-in Number: 866-813-9403
Other Locations Dial-in Number: 44-204-525-0658
audio webcast of the call may also be accessed from the Investors' page of the Longeveron website at www.longeveron.com.
A replay of the call will be available on the Longeveron website shortly after completion of the call.
is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company's lead
investigational product is Lomecel-B , an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow
of young, healthy adult donors. Lomecel-B has multiple mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory,
and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently advancing
Lomecel-B through clinical trials in three indications: hypoplastic left heart syndrome (HLHS), Alzheimer's Disease, and
Aging-Related Frailty. Additional information about the Company is available at www.longeveron.com.
statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995, which reflect management's current expectations, assumptions, and estimates
of future operations, 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. Factors that could cause actual results to differ materially
from those expressed or implied in any forward-looking statements in this release include, but are not limited to, statements about the
ability of Longeveron's clinical trials to demonstrate safety and efficacy of the Company's product candidates, and other
positive results; the timing and focus of the Company's ongoing and future preclinical studies and clinical trials and the reporting
of data from those studies and trials; the size of the market opportunity for the Company's product candidates, including its estimates
of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available;
the beneficial characteristics, safety, efficacy and therapeutic effects of the Company's product candidates; the Company's
ability to obtain and maintain regulatory approval of its product candidates in the U.S., Japan and other jurisdictions; the Company's
plans relating to the further development of its product candidates, including additional disease states or indications it may pursue;
the Company's plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms
where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel
and the Company's ability to attract and retain such personnel; the Company's estimates regarding expenses, future revenue,
capital requirements and needs for additional financing; the Company's need to raise additional capital, and the difficulties it
may face in obtaining access to capital, and the dilutive impact it may have on its investors; the Company's financial performance,
and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses
and capital expenditure requirements. 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 Longeveron's Annual Report
on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 14, 2023. 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.
| March 31, 2023 (unaudited) | December 31, 2022 | |||||||
| Cash | $ | 4,984 | $ | 10,503 | ||||
| Marketable securities | 8,693 | 9,155 | ||||||
| Property and equipment | 2,810 | 2,949 | ||||||
| Intangible assets | 2,425 | 2,409 | ||||||
| Other assets | 2,896 | 2,397 | ||||||
| Total assets | $ | 21,808 | $ | 27,413 | ||||
| Total liabilities | 5,490 | 6,910 | ||||||
| Total stockholders' equity | 16,318 | 20,503 | ||||||
| Total liabilities and stockholders' equity | $ | 21,808 | $ | 27,413 |
Statements of Operations
(In thousands, except per share data)
| Three months ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Revenues | ||||||||
| Grant revenue | $ | 41 | $ | 60 | ||||
| Clinical trial revenue | 238 | 310 | ||||||
| Total revenues | 279 | 370 | ||||||
| Cost of revenues | 203 | 205 | ||||||
| Gross profit | 76 | 165 | ||||||
| Operating expenses | ||||||||
| General and administrative | 1,855 | 1,980 | ||||||
| Research and development | 2,780 | 1,292 | ||||||
| Selling and marketing | 157 | 287 | ||||||
| Total operating expenses | 4,792 | 3,559 | ||||||
| Loss from operations | (4,716 | ) | (3,394 | ) | ||||
| Other income (expense) | ||||||||
| Other income (expense), net | 69 | (116 | ) | |||||
| Total other income and (expense), net | 69 | (116 | ) | |||||
| Net loss | $ | (4,647 | ) | $ | (3,510 | ) | ||
| Basic and diluted net loss per share | $ | (0.22 | ) | $ | (0.17 | ) | ||
| Basic and diluted weighted average common shares outstanding | 21,033,610 | 20,911,203 |
accompanying notes to unaudited condensed financial statements.