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:
- On August 13th,
2021 we announced the top-line results of the Phase 2b US Aging
Frailty trial. One hundred and forty-eight (148) subjects were
randomized and received a single peripheral intravenous infusion of
Lomecel-B (25 million cells, 50 million cells, 100 million cells or
200 million cells), or placebo, followed by a 52-week observation
period to evaluate safety and efficacy.The pre-specified
statistical analysis plan involved a primary analysis and a
secondary analysis:
- Primary
analysis of the primary efficacy endpoint: The primary
analysis compared the change from baseline in 6MWT distance for the
four Lomecel-B cohorts to the placebo cohort at Day 180. There were
statistically significant increases in the highest 3 doses--50
million, 100 million and 200 million Lomecel-B cohorts--and no
significant changes in the placebo or lowest dose of Lomecel-B (25
million=7.8 meters, p=0.5040; 50 million=35.8 meters, p=0.0053; 100
million=24.9 meters p=0.0443; 200 million=49.3 meters, p=0.0065;
placebo=8.0 meters, p=0.5371). However, after adjusting for
multiple comparisons using the Hochberg method (1988), the four
Lomecel-B cohorts did not show a statistically significant
placebo-adjusted difference (Δ) (25 million Δ=-0.2, p=0.9902; 50
million Δ=27.7, p=0.1279; 100 million Δ=16.8, p=0.3472; 200 million
Δ=41.3, p=0.0635).
-
Secondary analysis of the primary efficacy
endpoint: The secondary analysis was to determine whether
a dose-response relationship exists using the multiple comparisons
and modeling approach by Bretz et. al (2003). The results showed a
clear, statistically significant dose-response curve at day 180.
Among the various dose-response curves evaluated (Emax, Linear,
Exponential, Quadratic, and Sigmoid Emax), all had p-values of less
than 0.05, with the Sigmoid Emax model having the most significant
dose-response relationship (p=0.0170).
- Despite not
achieving the statistical significance for the pairwise comparison
to placebo at Day 180, significant differences from placebo were
observed at Day 270, which was a pre-specified exploratory endpoint
(25 million Δ=27.5, p=0.1530; 50 million Δ=49.2, p=0.0122; 100
million Δ=31.0, p=0.1071; 200 million Δ=63.4, p=0.0077).
- The study’s key
secondary endpoints were day 180 change in the patient reported
outcome questionnaire PROMIS—Physical Function—Short Form 20a
(SF-20a) total score and day 180 change in serum levels of tumor
necrosis factor alpha (TNF-α), an inflammatory cytokine. Lomecel-B
cohorts did not show a statistically significant difference
compared to the placebo cohort in the SF-20a score, and the TNF-α
analysis is pending. The remainder of the endpoints, which included
assessments of physical function, sexual function, fear and risk of
falling, depression, cognition, frailty status, pulmonary function,
and clinical outcomes, were considered exploratory and
Lomecel-B-treated groups did not show significant differences
versus placebo at most of the time points for any of the
endpoints.
- Lomecel-B
infusion was safe and well-tolerated with no Serious Adverse Events
reported that were considered related to the product.
- The Company plans to present
clinical data from the Aging Frailty Phase 2b trial at the 2021
International Conference on Frailty & Sarcopenia Research
(ICFSR) on September 29th. ICFSR’s scientific committee has invited
the Company’s scientists to present during a round table
presentation.
- The Company has submitted a
manuscript for peer-reviewed publication on the Phase 2b trial
design, and will present the trial design at the upcoming
Gerontological Society of America’s (GSA) Annual Scientific Meeting
November 10-13 in Phoenix, AZ.
Aging Frailty Phase 1/2 “HERA” Trial
Data This Quarter; Japan Phase 2 On Track:
- The Company expects to report
top-line data this quarter from the recently completed Phase 1/2
Aging Frailty “HERA” trial evaluating Lomecel-B infusion effect on
immune response in Aging Frailty subjects receiving the influenza
vaccine.
- The planned Japanese Aging Frailty
Phase 2 trial is on track to initiate in the second half of 2021.
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).
- The Company submitted two abstracts
that have been accepted for on demand presentations at the 2021
International Conference on Frailty & Sarcopenia Research
(ICFSR) on September 29th:
- OC34 • A Phase 2, Randomized,
Double-Blind, Placebo-Controlled Study in Japan to Investigate the
Safety and Efficacy of Lomecel-B administration by Longeveron in
subjects with Aging Frailty: Study Design and Rationale Kevin N.
Ramdas, MD, Longeveron Inc., Miami, FL (USA)
- OC58 • Study Design and Rationale
for HERA: a Phase I/II Study Evaluating the Effects of Intravenous
Delivery of Lomecel-B on Vaccine-Specific Antibody Responses in
Subjects with Aging Frailty Kevin N. Ramdas, MD, Longeveron Inc.,
Miami, FL (USA)
Positive Data from Alzheimer’s Disease
Phase 1 Study Presented at AAIC; Phase 2 Trial On
Track:
- An abstract outlining Longeveron’s
Phase 1 results of Lomecel-B infusion in Alzheimer’s disease
subjects was accepted for poster presentation at the 2021 Annual
Alzheimer's Association International Conference (AAIC), which took
place Jul 26-30, 2021. The Phase 1 study was funded by an
Alzheimer’s Association Part the Cloud Challenge on
Neuroinflammation research grant award.
- The results of the Phase 1 trial,
which have been previously reported, showed that single intravenous
infusion of Lomecel-B at 20 million and 100 million cell doses was
safe and well tolerated, with no Serious Adverse Events (SAEs)
reported that were considered related to the investigational
product, nor any evidence of Amyloid Related Imaging Abnormalities
(ARIA). Among other findings, subjects receiving the 20 million
cell dose showed a statistically significantly slower rate of
decline in cognitive function compared to placebo at 13 weeks and
39 weeks, as measured by the Mini Mental State Exam (MMSE)
score.
- A manuscript of the trial results
has been submitted for peer-review and publication.
- The Company will present the
completed Phase 1 Alzheimer’s Disease trial design at the upcoming
Gerontological Society of America’s (GSA) Annual Scientific Meeting
November 10-13 in Phoenix, AZ.
- Building from encouraging Phase 1
trial results, the Company anticipates initiation of a Phase 2
study in Alzheimer’s disease subjects later this year. The Phase 2
trial is expected to be a randomized, placebo-controlled, trial
designed to evaluate biomarkers, change in cognitive function, and
other disease-specific endpoints. Further details about trial
design, endpoints and target enrollment will be provided once the
protocol is finalized.
Lomecel-B for Hypoplastic Left Heart
Syndrome (HLHS)
- On July 6, 2021 Longeveron
announced that the first subject was administered Lomecel-B in the
Phase 2 randomized, double-blind, controlled clinical trial
evaluating Lomecel-B intraventricular injection in infants with
HLHS. With a target enrollment of 38 infants, the trial will be
enrolling in seven children’s hospitals in major metropolitan
centers located throughout the United States.
- The trial’s funding agency, the
National Heart, Lung, and Blood Institute (NHLBI), approved the
transition of the grant to UH3 phase, which means the program met
its preliminary milestones and has been approved for full
funding.
- Top-line Phase 1 safety results
(n=10), which have been previously reported by the Company, showed
that intraventricular injection of Lomecel-B was safe and well
tolerated, with no Major Adverse Cardiac Events (MACE), nor any
treatment-related infections within the first 30 days post
administration. The Company anticipates announcing additional data
from this trial in Q3 2021.
Lomecel-B for 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. The
Company expects enrollment to continue through 2021, with results
expected late 2022.
Executive Appointments:
- On May 18, 2021 Longeveron added
the experience and skills of Dan Gincel, Ph.D. to its management
team in the role of Senior Vice President, Strategic Collaborations
& Scientific Affairs. Dan brings over 20 years leadership
experience overseeing development and commercialization of
regenerative medicines, including cell and gene therapies. He will
be assisting Longeveron in evaluating strategic collaborations,
both in the U.S. and abroad, as well as grant applications and
strategy, and in-licensing new technologies to further progress and
potentially expand the overall product pipeline.
- On May 25, 2021 Longeveron welcomed
the appointment of former federal U.S. District Court Judge Ursula
Ungaro to its board of directors. In her time on the federal bench,
Ms. Ungaro presided over and ruled in numerous major civil and
criminal cases in legal domains ranging from constitutional
principles, equal rights, securities issues, and the use of
non-embryonic stem cell therapies, amongst many others. At the time
of joining Longeveron’s board, Ms. Ungaro specifically remarked how
propelling the growth and success of Longeveron was a key part of
her decision to retire from the judiciary.
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:
-
Clinical trial revenue, which derives from the Company’s Bahamas
Registry Trial, was $0.2 million in the second quarter of 2021
compared to zero revenue in the same period in 2020, an increase of
$0.2 million, or 100%. During 2020, COVID-19-related travel
restrictions into the Bahamas resulted in zero participation in the
Registry, and although activity has increased in 2021,
participation continues to be negatively impacted by
COVID-19-related travel concerns.
-
Second quarter 2021 grant revenue was $0.3 million compared to $0.9
million in the same period in 2020, a decrease of $0.6 million, or
68%. The reduction in grant revenue is due to the completion of
several grant-funded clinical trials.
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 PayneStern Investor RelationsTel: (212) 362-1200Email:
Brendan.payne@sternir.com
Source: Longeveron IncSource: 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 endedJune 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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