Longeveron Inc. (NASDAQ: LGVN) (the “Company,” “Longeveron” or
“we,” “us,” or “our”), a clinical stage biopharmaceutical company
developing cellular therapies for chronic, aging-related and
life-threatening conditions, today reported recent business
highlights and key upcoming catalysts for 2022, and its financial
results for the fourth quarter and full year 2021.
“For Longeveron, 2021 was a year defined by
effective execution, successful financings, and significant
progress across our robust Lomecel-B pipeline of clinical trials,”
said Geoff Green, Chief Executive Officer at Longeveron. “Since our
IPO in February of last year, important progress has been made in
advancing Lomecel-B into next phase trials, including initiation of
Phase 2 trials in Alzheimer’s and Hypoplastic Left Heart Syndrome
(HLHS), with the latter receiving both Orphan Drug and Rare
Pediatric Disease designations from the FDA. Additionally, we
successfully closed a $20.5 million private placement of our common
stock in the fourth quarter of 2021 to provide capital that we
believe will be sufficient to support our ongoing research and
operations into 2024. We anticipate 2022 to be another eventful
year as we continue to work to demonstrate the potential
therapeutic benefit of Lomecel-B across many life-threatening
conditions.”
Business Update:
Lomecel-B for Alzheimer’s
Disease:
- In
January 2022, we opened enrollment for our Phase 2a clinical trial
of Lomecel-B for the treatment of Alzheimer’s Disease. The Phase 2a
study, supported by encouraging Phase 1 data announced in 2021, is
designed to evaluate the safety of single and multiple
administrations of two different doses of Lomecel-B compared to
placebo in mild Alzheimer’s disease patients. Other endpoints
include brain volumetry by MRI, biomarkers related to inflammatory
and vascular systems, and various measures of cognitive
function. The first patient has already been treated
(the study has a target enrollment of 48 patients), and we intend
to activate up to 12 clinical sites to facilitate enrollment. We
plan to provide updates on anticipated enrollment rates as
additional sites are activated, and trial completion guidance.
Further details about the trial design can be found on
clinicaltrials.gov by entering trial identifier NCT05233774.
- We have
submitted our Phase 1 results for publication in a peer-reviewed
journal and anticipate acceptance and publication during the first
half of 2022.
Lomecel-B for Hypoplastic Left Heart
Syndrome (HLHS):
- The
ELPIS II trial (Phase 2a) continues to enroll infants in the
randomized, blinded 38 patient trial evaluating the safety and
efficacy of Lomecel-B injection into the right ventricle of
children born with HLHS who are undergoing Stage II reconstructive
cardiac surgery. 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), in collaboration with
Longeveron, and is led by Principal Investigator Sunjay Kaushal,
MD, PhD, Division Head, Cardiovascular-Thoracic Surgery, Ann and
Robert H. Lurie Children’s Hospital of Chicago. All seven clinical
sites have now been activated for screening and enrollment and
additional sites are being considered.
- In
fourth quarter 2021, the U.S. FDA granted Rare Pediatric Disease
Designation and Orphan Drug Designation to Lomecel-B for the
treatment of infants with HLHS. HLHS is a rare congenital heart
defect affecting approximately 1,000 babies per year in the
U.S.
- The
Phase 1 (“ELPIS I”) results have been submitted for publication in
a peer-reviewed journal and we anticipate acceptance and
publication in 2022.
Lomecel-B for Aging
Frailty:
- The
planned Japanese Aging Frailty Phase 2 trial is currently on track
to initiate in the first half of 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).
- Results
from the Phase 1/2 “HERA” Aging Frailty trial are expected to be
announced in the first half of 2022. The HERA Trial is a
multicenter, randomized, placebo-controlled study intended to
evaluate safety, and to explore the effect Lomecel-B may have on
biomarkers of immune system function in Aging Frailty subjects
receiving the influenza vaccine, as well as other signs and
symptoms of Aging Frailty.
- On
January 12, 2022 Longeveron announced publication of the Lomecel-B
Phase 2b Aging Frailty trial design in The Journal of Aging and
Frailty titled: “The Design and Rationale of a Phase 2b,
Randomized, Double-Blinded, and Placebo-Controlled Trial to
Evaluate the Safety and Efficacy of Lomecel-B in Older Adults with
Frailty.”
Lomecel-B for Acute Respiratory Distress
Syndrome Due to COVID 19 Infection:
- Our
Phase 1 trial continues to screen patients at three participating
centers in the U.S. We expect enrollment to continue through
2022.
Board Expansion:
- On
February 17, 2022 we announced the appointment of Todd Girolamo to
our Board of Directors. Mr. Girolamo is a seasoned attorney and
biopharmaceutical executive specializing in health-related
products, currently serving as Chief Legal Officer, Senior Vice
President of Corporate Development and Corporate Secretary for
Caladrius Biosciences, Inc.
Financial Results for Full Year and
Fourth Quarter Ended December 31, 2021
Revenue: Revenue in the fourth
quarter 2021 was $0.2 million compared to $1.2 million in the same
period in 2020. The difference was due to a decrease in clinical
trial revenue and grant revenue, as follows:
- Clinical
trial revenue, which derives from our Bahamas Registry Trial, was
$0.2 million in the fourth quarter of 2021 compared to $0.5 million
in the same period in 2020, a decrease of $0.3 million, or 68%.
Continued COVID-19-related travel concerns have negatively impacted
Registry Trial revenue.
- Fourth
quarter 2021 grant revenue was less than $0.1 million compared to
$0.7 million in the same period in 2020, a decrease of $0.6
million, or 93%. The decrease in grant revenue is due to the
completion of several grant-funded clinical trials and associated
exhaustion of grant revenue.
Revenue for full year 2021 was $1.3 million
compared to $5.6 million in 2020. Clinical trial revenue was $0.7
million for 2021 compared to $1.3 million for 2020, a decrease of
$0.6 million, or 46%. Grant revenue was $0.6 million for 2021
compared to $4.3 million for 2020, a decrease of $3.7 million, or
86%. The difference was due to same reasons outlined above with
respect to our Bahamas Registry Trial and completion of
grant-funded clinical trials.
R&D Expenses: Research and
development expenses in the fourth quarter of 2021 were $1.7
million compared to $1.2 million for the same period in 2020. The
increase of $0.5 million, or 51%, was primarily due to an increase
in research and development expenses related to the completion of
clinical trials that were not reimbursable by grants. R&D
Expenses for full year 2021 were $7.1 million compared to $2.7
million for 2020. The increase of $4.4 million, or 165% was
primarily due to an increase in research and development expenses
related to the completion of clinical trials that were not
reimbursable by grants; including $2.2 million of equity-based
compensation recorded for Restricted Stock Units (“RSUs”) and stock
options granted during the year.
G&A Expenses: General and
administrative expenses in the fourth quarter of 2021 were $2.3
million compared to $0.7 million for the same period in 2020. The
increase of approximately $1.6 million, or 225%, was primarily
related to an increase in compensation, insurance and professional
expenses incurred during the current period; including $0.4 million
of equity-based compensation recorded for RSUs and stock options
granted during the quarter. G&A Expenses for full year 2021
were $10.7 million compared to $2.7 million for 2020. The increase
of $8.0 million, or 293% was primarily due to an increase in
compensation, insurance and professional expenses incurred during
the current period; as well as $1.1 million in investor relation
costs, and including $4.6 million of equity-based compensation
expenses recorded during the year.
Net Loss: Net loss was $4.1
million in the fourth quarter of 2021 compared to $1.4 million for
the same period in 2020. Net loss for full year 2021 was $17.0
million compared to $3.7 million in 2020.
Per Share: Net loss per share
was $0.20 in the fourth quarter of 2021 compared to $0.08 for the
same period in 2020. Net loss per share for full year 2021 was
$0.90 compared to $0.23 in 2020.
Cash and Short Term
Investments: Cash and short-term investments was $35.0
million compared to $0.8 million as of December 31, 2021 and 2020,
respectively. The increase in cash period over period was the
result of proceeds received from our initial public offering in
February 2021 and our subsequent private placement offering in
December 2021.
Financial Outlook
Based on the Company’s current operating plan
and financial resources, we believe that our existing cash and
short-term investments will be sufficient to cover expenses and
capital requirements into 2024.
Conference Call and
Webcast:
Management will host a conference call today at
8:30 a.m. Eastern Time to discuss the Company’s fourth quarter and
year end 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 770734. An audio replay
of the call will be available through March 18, 2022.
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.
The recorded webcast will remain accessible for one year through
March 11, 2023.
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.
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, and the
period over which we estimate our existing cash and cash
equivalents will be sufficient to fund our 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 SEC. 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.
Investors:Brendan PayneStern
Investor RelationsOffice Direct: 212-698-8695 |Office Main:
212-362-1200brendan.payne@sternir.com | www.sternir.com
Source: Longeveron IncSource: LGVN
(tables follow)
Longeveron Inc.Selected
Balance Sheet Data (unaudited) (in
thousands)
|
|
December 31, 2021 |
|
December 31, 2020 |
|
|
|
|
|
Cash |
|
$ |
25,658 |
|
$ |
816 |
Short-term investments |
|
|
9,385 |
|
|
- |
Property and equipment |
|
|
3,062 |
|
|
3,597 |
Intangible assets |
|
|
2,334 |
|
|
1,547 |
Other assets |
|
|
2,327 |
|
|
3,280 |
Total assets |
|
$ |
42,766 |
|
$ |
9,240 |
Total liabilities |
|
|
5,313 |
|
|
7,283 |
Total members’ equity and
stockholders’ equity |
|
|
37,453 |
|
|
1,957 |
Total liabilities, member’s
equity and stockholders’ equity |
|
$ |
42,766 |
|
$ |
9,240 |
|
|
Longeveron Inc.
Statements of Operations
(Unaudited) (In thousands, except per share
data)
|
|
Three months endedDecember
31 |
|
|
|
Year endedDecember 31, |
|
|
2021 |
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
44 |
|
|
$ |
659 |
|
|
$ |
|
598 |
|
|
$ |
4,261 |
|
Clinical trial revenue |
|
165 |
|
|
521 |
|
|
|
|
708 |
|
|
|
1,313 |
|
Contract revenue |
|
- |
|
|
- |
|
|
|
|
- |
|
|
|
55 |
|
Total revenues |
|
209 |
|
|
1,180 |
|
|
|
|
1,306 |
|
|
|
5,629 |
|
Cost of revenues |
|
140 |
|
|
651 |
|
|
|
|
716 |
|
|
|
3,803 |
|
Gross profit |
|
69 |
|
|
529 |
|
|
|
|
590 |
|
|
|
1,826 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
2,280 |
|
|
702 |
|
|
|
|
10,734 |
|
|
|
2,731 |
|
Research and development |
|
1,733 |
|
|
1,151 |
|
|
|
|
7,092 |
|
|
|
2,674 |
|
Selling and marketing |
|
88 |
|
|
59 |
|
|
|
|
220 |
|
|
|
199 |
|
Total operating expenses |
|
4,101 |
|
|
1,912 |
|
|
|
|
18,046 |
|
|
|
5,604 |
|
Loss from operations |
|
(4,032 |
) |
|
(1,383 |
) |
|
|
|
(17,456 |
) |
|
|
(3,778 |
) |
Other income and
(expenses) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forgiveness of Paycheck Protection Program loan |
|
- |
|
|
- |
|
|
|
|
300 |
|
|
|
- |
|
Interest expense |
|
(1 |
) |
|
(3 |
) |
|
|
|
(4 |
) |
|
|
(7 |
) |
Other (expense) income, net |
|
(36 |
) |
|
30 |
|
|
|
|
115 |
|
|
|
64 |
|
Total other (expense) income,
net |
|
(37 |
) |
|
27 |
|
|
|
|
411 |
|
|
|
57 |
|
Net loss |
|
$ |
(4,069 |
) |
|
$ |
(1,356 |
) |
|
$ |
|
(17,046 |
) |
|
$ |
(3,721 |
) |
Basic and diluted net
loss per share |
|
$ |
(0.20 |
) |
|
$ |
(0.08 |
) |
|
$ |
|
(0.90 |
) |
|
$ |
(0.23 |
) |
Basic and diluted
weighted average common shares outstanding |
|
|
20,019,138 |
|
|
|
16,040,864 |
|
|
|
|
18,915,086 |
|
|
|
16,023,349 |
|
|
Source: Longeveron Inc.
Source: LGVN
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