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Longeveron Inc. Provides Corporate Update and Reports Third Quarter 2022 Financial Results -- Achieved key clinical and regulatory milestones across clinical pipeline, including the completion of enrollment in Longeveron

Key Takeaway: Longeveron Inc. Provides Corporate Update and Reports Third Quarter 2022 Financial Results -- Achieved key clinical and regulatory milestones across clinical pipeline, including the completion of enrollment in Longeveron's Phase 2a trial for Alzheimer's -Conference call sched

Full Press Release Details

Longeveron Inc. Provides Corporate
Update and Reports Third Quarter 2022 Financial Results
-- Achieved key clinical and regulatory
milestones across clinical pipeline, including the completion of enrollment in Longeveron's Phase 2a trial for Alzheimer's
-Conference call scheduled
for 8:30 a.m. ET today-
Miami, Florida - November 14, 2022-
Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "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 third quarter ended September
"This quarter, we continued to make robust
progress across our 3 clinical programs," said Chris Min, M.D., Ph.D., Interim Chief Executive Officer, and Chief Medical Officer.
"The FDA granted Fast Track Designation to Lomecel-BTM for infants with Hypoplastic Left Heart Syndrome (HLHS), a key
step forward in our mission to transform the current standard-of-care in this disease area where there is a large unmet need. Additionally,
we completed enrollment in our Phase 2a trial of Lomecel-BTM for patients with mild Alzheimer's Disease, and have all
approvals in place to initiate enrollment in our phase 2 trial for Aging Frailty in Japan. We were pleased to successfully execute on
these key milestones and look forward to continuing to advance Lomecel-B."
Third Quarter Business Updates:
Lomecel-B for Alzheimer's Disease:
for Hypoplastic Left Heart Syndrome (HLHS):
Results for Third quarter Ended September 30, 2022
Revenue for the third quarters of 2022 and 2021 was $0.3 million and $0.2 million, respectively. Revenue consisted of:
Expenses: Research and development expenses in the third quarter 2022 were $2.9 million compared to $2.0 million for the same period
in 2021. The increase of $0.9 million, or 45%, was primarily due to an increase of $1.8 million in research and development expenses
that were not reimbursable by grants. This increase was partially offset by a decrease in equity-based compensation allocated to research
and development expenses which decreased from $0.9 million for the three months ended September 30, 2021, to $0.1 million for the same
Expenses: General and administrative expenses in the third quarter 2022 were $2.1 million compared to $3.0 million for the same period
in 2021. The decrease of approximately $0.9 million, or 31%, was primarily related to a decrease of $1.2 million in equity-based compensation
expenses allocated to general and administrative expenses. However, expenses related to legal and consulting services increased by $0.3
million in the three months ended September 30, 2022, compared to the same period in 2021.
Loss: Net loss was $5.2 million in the third quarter 2022 compared to $4.9 million for the same period in 2021.
Share: Net loss per share was $0.25 in each of the third quarters 2022 and 2021.
and short-term investments: Cash and short-term investments was $22.3 million and $35.0 million as of September 30, 2022, and December
31, 2021, respectively.
believe, based on the current operating plan and financial resources, that our existing cash and short-term investments will be sufficient
to cover expenses and capital requirements into the first half of 2024.
will host a conference call today at 8:30 a.m. Eastern Time to discuss the Company's third quarter 2022 financial results and provide
Dial-in Number: 844-200-6205
Dial-in Number: 833-950-0062
Other Locations Dial-in Number: 929-526-1599
Replay Dial-in Number: 866-813-9403
Replay Dial-in Number: 226-828-7578
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 a multi-modal mechanism of action that is pro-vascular, pro-regenerative, and anti-inflammatory,
promoting tissue repair and healing with broad potential applications across a spectrum of disease areas. Longeveron is advancing Lomecel-B
through clinical trials in three indications: Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's Disease, and Aging Frailty. Additional
information about the Company is available at www.longeveron.com.
Note Regarding Forward-Looking Statements
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 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; the Company's plans relating to the further development of its product candidates,
including additional disease states or indications it may pursue; existing regulations and regulatory developments in the U.S., Japan
and other jurisdictions; 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 expenditures 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, 2021, filed with the SEC on March 11, 2022, and the Company's Quarterly
Report on Form 10-Q for the period ended March 31, 2022. 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.
September 30, 2022 (unaudited) December 31, 2021
Cash $ 13,574 $ 25,658
Short-term investments 8,742 9,385
Property and equipment 3,064 3,062
Intangible assets 2,373 2,334
Other assets 2,762 2,327
Total assets $ 30,515 $ 42,766
Total liabilities 5,890 5,313
Total stockholders' equity 24,615 37,453
Total liabilities and stockholders' equity $ 30,515 $ 42,766
Statements of Operations
thousands, except per share data)
Three months ended September 30, Nine months ended September 30,
2022 2021 2022 2021
Revenues
Clinical trial revenue $ 210 $ 164 $ 860 $ 543
Grant revenue 55 68 241 554
Total revenues 265 232 1,101 1,097
Cost of revenues 173 68 549 576
Gross profit 92 164 552 521
Operating expenses
General and administrative 2,074 2,996 6,481 8,454
Research and development 2,960 2,048 6,107 5,359
Selling and marketing 245 25 766 132
Total operating expenses 5,279 5,069 13,354 13,945
Loss from operations (5,187 ) (4,905 ) (12,802 ) (13,424 )
Other (expense) and income
Non-operating lawsuit expense - - (1,398 ) -
Forgiveness of Paycheck Protection Program loan - - - 300
Interest expense - (1 ) (1 ) (3 )
Other income, net (57 ) 51 (177 ) 151
Total other (expenses) and income, net (57 ) 50 (1,576 ) 448
Net loss $ (5,244 ) $ (4,855 ) $ (14,378 ) $ (12,976 )
Basic and diluted net loss per share $ (0.25 ) $ (0.25 ) $ (0.69 ) $ (0.70 )
Basic and diluted weighted average common shares outstanding 21,001,613 19,115,152 20,952,569 18,543,024
Last updated: Nov 14, 2022