Full Press Release Details
Longeveron Inc. Provides
Corporate Update and Reports First Quarter 2021 Financial Results
Miami, Florida - May 14th, 2021-
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 a number of ongoing clinical
trials, and also reported its financial results for the first quarter ended March 31, 2021.
"Aging is the number one risk factor for
chronic disease," said Geoff Green, CEO. "Stem cell exhaustion, cellular senescence, and chronic inflammation, together referred
to as "inflammaging", compromises our ability to repair and regenerate damaged tissues and organs. Inflammaging is linked
to the rise of progressive chronic diseases such as Alzheimer's disease and Aging Frailty. Our focus since day one has been to develop
safe and effective allogeneic cell therapy solutions for the treatment and prevention of these diseases."
In April, Longeveron announced the results of
its Phase 1 Alzheimer's disease clinical study, and the Company has confirmed that it currently remains on track to initiate a Phase
2 study in the second half of the year. The Company has submitted the data for publication and plans to present at the 2021 Alzheimer's Association
International Conference (AAIC). The Phase 1 study was funded in part by an Alzheimer's Association Part the Cloud Challenge
on Neuroinflammation research grant award.
Additionally, Longeveron has re-iterated that
it expects to announce top-line results from its two recently completed US Phase 2 Aging Frailty trials in the third quarter of this year.
The Company plans to present the data at the 2021 International Conference on Frailty & Sarcopenia Research (ICFSR) on September
29th. ICFSR's scientific committee has invited the Company to present the data during a round table presentation. In
addition, the Company has been invited to deliver oral presentations on trial design for its Phase 1/2 Aging Frailty and Influenza Vaccine
trial (HERA Trial), and its Phase 2 Japanese Aging Frailty trial at the ICFSR conference.
Alzheimer's Disease Phase 1 Study:
A summary of Phase 1 trial results can be found on Longeveron's
website www.longeveron.com.
About the planned Phase 2 Alzheimer's
disease Clinical Trial:
Longeveron plans to initiate a Phase 2 trial of
Lomecel-B infusion in mild Alzheimer's disease subjects in the second half of 2021. The study is expected to be a randomized, placebo-controlled,
multidose trial designed to further evaluate biomarkers, change in cognitive function, and other disease-specific endpoints. Additional
details about trial design, endpoints and target enrollment will be provided once the protocol is finalized.
Aging Frailty Clinical Trials
Phase 2 Japanese Aging Frailty trial: The planned
Japanese Aging Frailty clinical trial is on track to initiate in the second half of 2021. Trial planning continues with our clinical partners
at the National Center for Geriatrics & Gerontology, and Juntendo University Hospital, and the services of a Japan-based Contract
Research Organization have been engaged.
Update on Other Lomecel-B Clinical Programs:
Upcoming Conferences
As previously announced, Longeveron has been selected
to present at the 2021 World Stem Cell Summit taking place virtually on June 14-18, in combination with the Wake Forest Institute for
Regenerative Medicine (WFIRM) and Regenerative Medicine Foundation (RMF). Dr. Joshua Hare, Co-Founder and Chief Science Officer, is scheduled
to present in a session titled "The Longevity Agenda: Canceling the Pathologies of Aging." Longeveron will also provide a
pre-recorded 4-5 minute presentation as part of the Investment & Commercialization Forum Track of the Summit.
Financial Results for First Quarter Ended March
Revenue: Revenue was $0.4 million
compared to $1.7 million in the same period in 2020. The difference was due to a decrease in clinical trial revenue and grant revenue,
R&D Expenses: Research and
development expenses were $1.4 million compared to $0.3 million for the same period in 2020. The increase of $1.1 million, or 367%, was
primarily due to an increase in research and development expenses that were not reimbursable by grants; including $0.4 million of equity-based
compensation recorded for the RSUs granted.
G&A Expenses: General and
administrative expenses were $2.2 million compared to $0.7 million for the same period in 2020. The increase of approximately $1.5 million,
or 221%, was primarily related to an increase for compensation, insurance and professional expenses incurred during the current period;
including $0.8 million of equity-based compensation recorded for the RSUs granted.
Net Loss: Net loss was $3.1
million compared to $0.2 million for the same period in 2020.
Cash: Cash on hand was $24.5
million compared to $0.8 million as of December 31, 2020. The increase in cash period over period was the result of the completion of
the Company's initial public offering (IPO) in February of 2021.
Cash in the first quarter of 2021 was increased
by the $29.1 million (gross) in funds received from the IPO. As of March 31, 2021, the Company's cash position was $24.5 million.
The Company believes, based on the current operating plan and financial resources, that 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 first 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 20-8068-2558 for international callers
and using entry code 460592. You may also pre-register for the event. A webcast of the call may be accessed here or on the Company's
website at https://www.longeveron.com/.
An audio replay of the of the call will be available
through May 21, 2021 and can be accessed here and by entering the access code: 402451, and will remain online for one year through May
About the Longeveron Alzheimer's Phase
Funded in part by an Alzheimer's Association
"Part the Cloud Challenge on Neuroinflammation" grant, the Longeveron Alzheimer's Phase 1 trial was a randomized, placebo-controlled
double-blind trial designed to evaluate the safety and efficacy of intravenous (i.v.) administration of Lomecel-B, an allogeneic bone
marrow-derived medicinal signaling cell (MSC) product, in subjects with mild Alzheimer's disease. This randomized, placebo-controlled,
double-blind trial enrolled a total of 33 subjects. Subjects were randomized to receive a single peripheral intravenous infusion of Lomecel-B
20 million cells ("low-dose"; (n=15)), Lomecel-B 100 million cells ("high-dose"; n=10)), or placebo (n=8), and
followed for 52 weeks post-infusion. Subjects were followed for 52 weeks post-infusion.
About the US Phase 2b Aging Frailty Trial:
The primary objective of this multi-center study
is to assess the effect of Lomecel-B treatment on exercise tolerance and endurance via the six-minute walk test (6MWT). Additional endpoints
included gait speed, grip strength, short physical performance battery (SPPB), Performance Oriented Mobility Assessment (POMA; measures
subject's risk of falling), the Falls Efficacy Scale (measures subject's fear of falling), depression, sexual function, cognition,
and various patient reported outcomes (PROs) and activities of daily living (ADLs), and blood-based biomarkers. 149 subjects were randomized
to receive 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 Phase 2b trial was conducted at 8 hospitals
and clinics, primarily in South Florida, including the Miami VA Healthcare System, and was funded by a Small Business Administration Grant
(SBIR) grant from the NIH's National Institute on Aging (NIA).
About the US Phase 1/2 Aging Frailty Influenza
Vaccine Trial ("HERA" Study):
The HERA trial was designed to evaluate whether
Lomecel-B can improve immune response to influenza ("flu") vaccine in subjects with Aging Frailty through measurement of serum
antibodies. The two-phase, 59 subject, multicenter, randomized, double-blinded, placebo-controlled study was conducted at 7 hospitals
and clinics throughout Florida and Maryland, and was supported in part by a grant from Maryland Stem Cell Research Program (MSCRF) under
the Maryland Technology Development Corporation (TEDCO) and the National Institute on Aging (NIA). Additional efficacy measures include
assessments of physical strength and endurance, quality-of-life (QOL) and activities of daily living (ADL) assessments, cognitive function,
and blood-based biomarkers.
About the Japanese Phase 2 Aging Frailty Trial: