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 regarding the status of the Company’s
various clinical research programs and reported its financial
results for the quarter ended September 30, 2021.
“In the third quarter of 2021, we continued
executing across our pipeline,” said Geoff Green, CEO of
Longeveron. “With a growing base of encouraging clinical data, we
continue to make excellent progress in advancing our lead
candidate, Lomecel-B, into next phase trials. In addition to the
ongoing Phase 1 and 2 trials in flu and COVID-related Acute
Respiratory Distress Syndrome (ARDS), and Hypoplastic Left Heart
Syndrome (HLHS), we anticipate initiating our Phase 2 Alzheimer’s
disease and Japanese Phase 2 Aging Frailty studies by year end, or
in the first quarter of 2022.”
Business Update:
Lomecel-B Clinical Research
Developments:
Hypoplastic Left Heart
Syndrome:
- In July, Longeveron announced
initiation of enrollment for the Phase 2 randomized, double-blind,
controlled clinical trial evaluating Lomecel-B intraventricular
injection in infants with HLHS (“ELPIS II” trial). With a target
enrollment of 38 infants, the Company anticipates ELPIS II will
enroll across several children’s hospitals in major metropolitan
centers located throughout the United States. ELPIS II is being
funded in part by a grant from the National Institute of Health’s
National Heart, Lung, and Blood Institute (NHLBI; Grant number
1UG3HL148318).
Aging Frailty:
- Longeveron previously announced in
August the initial results of the Phase 2b U.S. Aging Frailty
trial. Clinical safety and efficacy data continue to be evaluated,
as well as the blood-based biomarker data, as the Company evaluates
the next step in this research program. Results from Longeveron’s
other Aging Frailty trial, the Phase 1/2 “HERA” study, are
anticipated in the first quarter of 2022. The primary objectives of
the HERA study are to assess safety and tolerability, and explore
the effect of Lomecel-B on the frail immune system and other
frailty endpoints, in subjects receiving the influenza
vaccine.
- The planned Japanese Aging Frailty
Phase 2 trial is currently on track to initiate in first quarter
2022. This is an investigator-initiated randomized,
placebo-controlled, double-blind single infusion study being
conducted by our clinical partners at the National Center for
Geriatrics & Gerontology (NCGG; Nagoya), and Juntendo
University Hospital (Tokyo).
- In September, we entered into an
agreement with Kinesiometrics Inc. (“Kinesiometrics”) to provide a
digital data-driven solution for objective real-time measurement of
functional capacity and quality of life in Longeveron’s clinical
studies.
- Subject data is accessible to
Longeveron and recipients of Lomecel-B via an application
downloadable on the subjects’ mobile phones. Kinesiometrics may
provide a patented Software-as-a-Solution (SaaS), mobile-phone
based platform that can collect not only years of historical data
regarding a subject’s activity levels via steps, distance walked,
flights climbed and energy expenditure, but also real-time response
information for comparison of activity level changes pre- and
post-Lomecel-B infusion. This data may be used to understand and
gauge outcomes of treatment regimens.
Alzheimer’s Disease:
- Longeveron presented data from the
Phase 1 Alzheimer’s disease clinical data as a poster presentation
at the 2021 Annual Alzheimer’s Association International Conference
(AAIC) Annual Meeting in July. We anticipate initiation of a Phase
2 study in Alzheimer’s disease subjects by first quarter 2022.
Acute Respiratory Distress Syndrome Due
to COVID-19 Infection:
- The Phase 1 trial continues to
screen subjects at three participating centers in the U.S. We
expect enrollment to continue into 2022.
Financial Results for Third Quarter
Ended September 30, 2021
Revenue: Revenue in the third
quarter 2021 was $0.2 million compared to $1.8 million in the same
period in 2020. The difference was largely due to a decrease in
grant revenue, as follows:
-
Clinical trial revenue, which derives from the Company’s Bahamas
Registry Trial, was $0.2 million in the third quarter of 2021
compared to less than $0.1 million in the same period in 2020, an
increase of $0.2 million, or 100%. COVID-19-related travel concerns
continues to negatively impact clinical trial revenue
generally.
-
Third quarter 2021 grant revenue was less than $0.1 million
compared to $1.8 million in the same period in 2020, a decrease of
$1.7 million, or 96%. The reduction in grant revenue is due to the
completion of several grant-funded clinical trials and
corresponding completion of the grant.
R&D Expenses: Research and
development expenses in the third quarter of 2021 were $2.0 million
compared to $0.6 million for the same period in 2020. The increase
of $1.4 million, or 250%, was primarily due to an increase in
research and development expenses that were not reimbursable by
grants, related to the completion of clinical trials; as well as
$0.9 million of equity-based compensation expense recorded for
Restricted Stock Units (“RSUs”) and stock options granted during
the quarter.
G&A Expenses: General and
administrative expenses in the third quarter of 2021 were $3.0
million compared to $0.7 million for the same period in 2020. The
increase of approximately $2.3 million, or 327%, was primarily
related to an increase in compensation, insurance and professional
expenses incurred during the current period; including $1.6 million
of equity-based compensation expense recorded during the
quarter.
Net Loss: Net loss was $4.9
million in the third quarter 2021 compared to $0.9 million for the
same period in 2020.
Per Share: Net loss per share
was $0.25 in the third quarter 2021 compared to $0.06 for the same
period in 2020.
Cash and Short Term
Investments: Cash and short term investments was $19.0
million compared to $1.4 million as of September 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
8:30 a.m. Eastern Time to discuss the Company’s third 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 +1 929-526-1599 for
international callers and using entry code 397367. An audio replay
of the call will be available through November 18, 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.aspx by
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 November 12,
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
September 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 PayneStern Investor RelationsTel: (212) 362-1200Email:
Brendan.payne@sternir.com
Source: Longeveron IncSource: LGVN
(tables follow)
LONGEVERON INC.SELECTED
BALANCE SHEET DATA(in thousands)
|
|
|
September 30, 2021 |
|
December 31, 2020 |
|
|
|
(unaudited) |
|
|
Cash |
|
|
$ |
9,738 |
|
$ |
816 |
Short-term investments |
|
|
|
9,232 |
|
|
- |
Property and equipment |
|
|
|
3,070 |
|
|
3,597 |
Intangible assets |
|
|
|
2,358 |
|
|
1,547 |
Other assets |
|
|
|
2,752 |
|
|
3,280 |
Total assets |
|
|
$ |
27,150 |
|
$ |
9,240 |
Total liabilities |
|
|
|
4,817 |
|
|
7,283 |
Total
members’ equity and stockholders’ equity |
|
|
|
22,333 |
|
|
1,957 |
Total
liabilities, member’s equity and stockholders’ equity |
|
|
$ |
27,150 |
|
$ |
9,240 |
Longeveron Inc.Condensed
Statements of Operations(In thousands, except per share
data)(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September
30, |
|
|
|
Nine months endedSeptember
30, |
|
|
2021 |
|
2020 |
|
|
2021 |
|
|
|
2020 |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
68 |
|
|
$ |
1,788 |
|
|
$ |
554 |
|
|
$ |
3,602 |
|
|
Clinical trial revenue |
|
164 |
|
|
30 |
|
|
|
543 |
|
|
|
792 |
|
|
Contract revenue |
|
- |
|
|
47 |
|
|
|
- |
|
|
|
55 |
|
|
Total revenues |
|
232 |
|
|
1,865 |
|
|
|
1,097 |
|
|
|
4,449 |
|
|
Cost of revenues |
|
68 |
|
|
1,492 |
|
|
|
576 |
|
|
|
3,152 |
|
|
Gross profit |
|
164 |
|
|
373 |
|
|
|
521 |
|
|
|
1,297 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
2,996 |
|
|
702 |
|
|
|
8,454 |
|
|
|
2,029 |
|
|
Research and development |
|
2,048 |
|
|
585 |
|
|
|
5,359 |
|
|
|
1,523 |
|
|
Selling and marketing |
|
25 |
|
|
44 |
|
|
|
132 |
|
|
|
140 |
|
|
Total operating expenses |
|
5,069 |
|
|
1,331 |
|
|
|
13,945 |
|
|
|
3,692 |
|
|
Loss from operations |
|
(4,905 |
) |
|
(958 |
) |
|
|
(13,424 |
) |
|
|
(2,395 |
) |
|
Other income and
(expenses) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forgiveness of Paycheck Protection Program loan |
|
- |
|
|
- |
|
|
|
300 |
|
|
|
- |
|
|
Interest expense |
|
(1 |
) |
|
(4 |
) |
|
|
(3 |
) |
|
|
(4 |
) |
|
Other income, net |
|
51 |
|
|
24 |
|
|
|
151 |
|
|
|
34 |
|
|
Total other income and
(expenses), net |
|
50 |
|
|
20 |
|
|
|
448 |
|
|
|
30 |
|
|
Net loss |
|
$ |
(4,855 |
) |
|
$ |
(938 |
) |
|
$ |
(12,976 |
) |
|
$ |
(2,365 |
) |
|
Basic and diluted net loss per share |
|
$ |
(0.25 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.70 |
) |
|
$ |
(0.15 |
) |
|
Basic and diluted
weighted average common shares outstanding |
|
|
19,115,152 |
|
|
|
16,040,864 |
|
|
|
18,543,024 |
|
|
|
16,017,469 |
|
|
Source: Longeveron Inc.Source: LGVN
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