Full Press Release Details
Announces Third Quarter 2024 Financial Results and Provides Business Update
MIAMI, November 12, 2024 -- Longeveron Inc. (NASDAQ:
LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related
conditions, today reported financial results for the quarter ended September 30, 2024 and provided a business update.
"In the third quarter, we continued to advance
the development of our investigational cellular therapy candidate, Lomecel-BTM, as a potential treatment for both Hypoplastic
Left Heart Syndrome (HLHS) and mild Alzheimer's disease," said Wa'el Hashad, Chief Executive Officer of Longeveron.
"The ELPIS II clinical trial in HLHS is a key priority and we are delighted to have achieved more than 80% enrollment. Our recent
positive Type C meeting with the FDA confirmed ELPIS II is pivotal and, if positive, acceptable for Biological License Application (BLA)
submission for full traditional approval. Similarly, we are excited by the strength of the CLEAR MIND Phase 2a clinical data in mild Alzheimer's
disease and the interest it is garnering with the data selected as a featured research oral presentation at the 2024 Alzheimer's Association
International Conference (AAIC) in July, and additional data selected for Late Breaking poster presentation at the Clinical Trials on
Alzheimer's Disease Conference (CTAD24). We believe stem cell therapy has the potential to become a mainstream treatment for many
conditions with significant unmet medical needs and that Longeveron is well positioned to be a leader in stem cell research and potential
Development Programs Update
investigational therapeutic candidate is Lomecel-BTM,
a proprietary, scalable, allogeneic cellular therapy being evaluated in multiple indications.
Hypoplastic Left Heart Syndrome (HLHS)
- a rare pediatric congenital heart birth defect in which the left ventricle (one of the pumping chambers of the heart) is either
severely underdeveloped or missing.
Alzheimer's disease (AD) -
a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options.
Year to Date 2024 Summary Financial Results
Conference Call and Webcast
The Company will host a conference call and webcast
today at 4:30 p.m. ET.
| Conference Call Number: | 1.877.407.0789 |
| Conference ID: | 13749428 |
| Call me TM Feature: | Click Here |
| Webcast: | Click Here |
An archived replay of the webcast will be available
on the "Events & Presentations" section of the Company's website following the conference.
Longeveron is a clinical stage biotechnology
company developing regenerative medicines to address unmet medical needs. The Company's lead investigational product is Lomecel-BTM,
an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-BTM
has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and
healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline
indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and Aging-related Frailty. Lomecel-BTM development
programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation,
and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast
Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram.
Forward-Looking Statements
Certain 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 operations, 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 and include, but are not limited to, the anticipated use of proceeds from recent
offerings. 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, market and other conditions, our limited operating history and lack of products approved
for commercial sale; adverse global conditions, including macroeconomic uncertainty; inability to raise additional capital necessary to
continue as a going concern; our history of losses and inability to achieve profitability going forward; the absence of FDA-approved allogenic,
cell-based therapies for Aging-related Frailty, Alzheimer's disease, or other aging-related conditions, or for HLHS or other cardiac-related
indications; ethical and other concerns surrounding the use of stem cell therapy or human tissue; our exposure to product liability claims
arising from the use of our product candidates or future products in individuals, for which we may not be able to obtain adequate product
liability insurance; the adequacy of our trade secret and patent position to protect our product candidates and their uses: others could
compete against us more directly, which could harm our business and have a material adverse effect on our business, financial condition,
and results of operations; if certain license agreements are terminated, our ability to continue clinical trials and commercially market
products could be adversely affected; the inability to protect the confidentiality of our proprietary information, trade secrets, and
know-how; third-party claims of intellectual property infringement may prevent or delay our product development efforts; intellectual
property rights do not necessarily address all potential threats to our competitive advantage; the inability to successfully develop and
commercialize our product candidates and obtain the necessary regulatory approvals; we cannot market and sell our product candidates in
the U.S. or in other countries if we fail to obtain the necessary regulatory approvals; final marketing approval of our product candidates
by the FDA or other regulatory authorities for commercial use may be delayed, limited, or denied, any of which could adversely affect
our ability to generate operating revenues; we may not be able to secure and maintain research institutions to conduct our clinical trials;
ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations;
if we receive regulatory approval of Lomecel-B or any of our other product candidates, we will be subject to ongoing regulatory
requirements and continued regulatory review, which may result in significant additional expense; being subject to penalties if we fail
to comply with regulatory requirements or experience unanticipated problems with our therapeutic candidates; reliance on third parties
to conduct certain aspects of our preclinical studies and clinical trials; interim, "topline" and preliminary data from our
clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification
procedures that could result in material changes in the final data; the volatility of the price of our Class A common stock; provisions
in our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change in control of our company
or changes in our management and, therefore, depress the market price of our Class A common stock; we have never commercialized a product
candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or
together with suitable collaborators; and in order to successfully implement our plans and strategies, we will need to grow our organization,
and we may experience difficulties in managing this growth. 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, 2023, filed with the Securities and Exchange Commission
on February 27, 2024, as amended by the Annual Report on Form 10-K/A filed March 11, 2024, its Quarterly Reports on Form 10-Q, and its
Current Reports on Form 8-K. 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.
Investor and Media Contact:
Investor Relations Advisory Solutions
Condensed Balance Sheets
(In thousands, except share and per share data)
| September 30, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 22,778 | $ | 4,949 | ||||
| Marketable securities | - | 412 | ||||||
| Prepaid expenses and other current assets | 609 | 376 | ||||||
| Accounts and grants receivable | 380 | 111 | ||||||
| Total current assets | 23,767 | 5,848 | ||||||
| Property and equipment, net | 2,622 | 2,529 | ||||||
| Intangible assets, net | 2,347 | 2,287 | ||||||
| Operating lease asset | 970 | 1,221 | ||||||
| Other assets | 203 | 193 | ||||||
| Total assets | $ | 29,909 | $ | 12,078 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 887 | $ | 638 | ||||
| Accrued expenses | 1,479 | 2,152 | ||||||
| Current portion of lease liability | 616 | 593 | ||||||
| Deferred revenue | 118 | 506 | ||||||
| Total current liabilities | 3,100 | 3,889 | ||||||
| Long-term liabilities: | ||||||||
| Lease liability | 983 | 1,448 | ||||||
| Other liabilities | 199 | - | ||||||
| Total long-term liabilities | 1,182 | 1,448 | ||||||
| Total liabilities | 4,282 | 5,337 | ||||||
| Commitments and contingencies (Note 9) | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.001 par value per share, 5,000,000 shares authorized, no shares issued and outstanding at September 30, 2024, and December 31, 2023 | - | - | ||||||
| Class A common stock, $0.001 par value per share, 84,295,000 shares authorized, 13,352,770 shares issued and outstanding at September 30, 2024; 1,025,183 issued and outstanding at December 31, 2023 | 13 | 1 | ||||||
| Class B common stock, $0.001 par value per share, 15,705,000 shares authorized, 1,484,005 shares issued and outstanding at September 30, 2024; 1,485,560 issued and outstanding at December 31, 2023 | 1 | 1 | ||||||
| Additional paid-in capital | 131,139 | 91,823 | ||||||
| Stock subscription receivable | - | (100 | ) | |||||
| Accumulated deficit | (105,525 | ) | (84,984 | ) | ||||
| Accumulated other comprehensive loss | (1 | ) | - | |||||
| Total stockholders' equity | 25,627 | 6,741 | ||||||
| Total liabilities and stockholders' equity | $ | 29,909 | $ | 12,078 |
See accompanying notes to unaudited condensed
financial statements.
Condensed Statements of Operations
(In thousands, except per share data)
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues | ||||||||||||||||
| Clinical trial revenue | $ | 210 | $ | 150 | $ | 1,012 | $ | 605 | ||||||||
| Contract manufacturing revenue | 563 | - | 777 | - | ||||||||||||
| Grant revenue | - | - | - | 41 | ||||||||||||
| Total revenues | 773 | 150 | 1,789 | 646 | ||||||||||||
| Cost of revenues | 91 | 96 | 435 | 423 | ||||||||||||
| Gross profit | 682 | 54 | 1,354 | 223 | ||||||||||||
| Operating expenses | ||||||||||||||||
| General and administrative | 3,125 | 3,372 | 7,447 | 8,902 | ||||||||||||
| Research and development | 2,206 | 1,843 | 6,148 | 6,910 | ||||||||||||
| Total operating expenses | 5,331 | 5,215 | 13,595 | 15,812 | ||||||||||||
| Loss from operations | (4,649 | ) | (5,161 | ) | (12,241 | ) | (15,589 | ) | ||||||||
| Other income | ||||||||||||||||
| Other income, net | 230 | 55 | 349 | 204 | ||||||||||||
| Total other income, net | 230 | 55 | 349 | 204 | ||||||||||||
| Net loss | $ | (4,419 | ) | $ | (5,106 | ) | $ | (11,892 | ) | $ | (15,385 | ) | ||||
| Deemed dividend - warrant inducement offers | (149 | ) | (798 | ) | (8,650 | ) | (798 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (4,568 | ) | $ | (5,904 | ) | $ | (20,542 | ) | $ | (16,183 | ) | ||||
| Basic and diluted net loss per share | $ | (0.34 | ) | $ | (2.79 | ) | $ | (2.71 | ) | $ | (7.29 | ) | ||||
| Basic and diluted weighted average common shares outstanding | 13,627,793 | 2,117,877 | 7,572,601 | 2,110,646 |
See accompanying notes to unaudited condensed
financial statements.