Full Press Release Details
Announces Full-Year 2024 Financial Results and Provides Business Update
February 28, 2025 -- 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 full-year ended December
31, 2024 and provided a business update.
2024, we continued to advance the development of our investigational cellular therapy candidate, Lomecel-BTM, as a potential
treatment for both Hypoplastic Left Heart Syndrome, or HLHS, and mild Alzheimer's disease," said Wa'el Hashad, Chief
Executive Officer of Longeveron. "We are now approaching multiple potentially transformational milestones over the next 12 months,
including, completion of enrollment in our pivotal Phase 2b clinical trial in HLHS, which may establish the timeline for a potential
Biological License Application, or BLA, submission for full traditional approval for HLHS, and our upcoming meeting with the FDA to determine
the development pathway for the Alzheimer's disease program. Our team's expertise in clinical development and manufacturing,
combined with several positive initial results across five clinical trials in three indications, continues to position Longeveron as
a leader in stem cell therapy research and, potentially, commercialization of cellular therapeutics."
investigational therapeutic candidate is Lomecel-BTM, a proprietary, scalable, allogeneic cellular therapy being evaluated
in multiple indications.
February 2025, the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) approved "laromestrocel"
for the non-proprietary name of Lomecel-B .
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 severely underdeveloped.
disease (AD) - a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited
therapeutic options.
Summary Financial Results
Call and Webcast Details:
| Conference Call Number: | 1.877.407.0789 |
| Conference ID: | 13751432 |
| Call me TM Feature: | Click Here |
| Webcast: | Click Here |
archived replay of the webcast will be available on the "Events & Presentations" section of the Company's website
following the conference.
is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company's lead
investigational product is Lomecel-B , an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow
of young, healthy adult donors. Lomecel-B 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.
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 known and unknown risks, uncertainties, and other important factors
that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the
statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "anticipate,"
"believe," "contemplate," "continue," "could," "estimate," "expects,"
"intend," "looks to," "may," "on condition," "plan," "potential,"
"predict," "preliminary," "project," "see," "should," "target,"
"will," "would," 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, statements about the various below-listed factors.
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, our cash position and need to raise additional capital, the difficulties we may face in obtaining
access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going
concern; 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; 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, and the reporting
of data from those studies and trials; the size of the market opportunity for certain of our product candidates, including our estimates
of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the product
candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics,
safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product
candidates in the U.S. and other jurisdictions; our plans relating to the further development of our product candidates, including additional
disease states or indications we may pursue; 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; the need to
hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue,
capital requirements and needs for additional financing.
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, 2024, filed with the Securities and Exchange Commission on February 28, 2025, its Quarterly Reports on Form 10-Q, and its Current
Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and
it is not possible for the Company's management to predict all such factors that may arise nor assess the impact of such factors
or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any
forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release
based on information available as of the date of this press release, are inherently uncertain, 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 Relations Advisory Solutions
thousands, except share and per share data)
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 19,232 | $ | 4,949 | ||||
| Marketable equity securities | - | 412 | ||||||
| Prepaid expenses and other current assets | 308 | 376 | ||||||
| Accounts and grants receivable | 84 | 111 | ||||||
| Total current assets | 19,624 | 5,848 | ||||||
| Property and equipment, net | 2,449 | 2,529 | ||||||
| Intangible assets, net | 2,401 | 2,287 | ||||||
| Operating lease asset | 882 | 1,221 | ||||||
| Other assets | 202 | 193 | ||||||
| Total assets | $ | 25,558 | $ | 12,078 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 99 | 638 | ||||||
| Accrued expenses | 1,820 | 2,152 | ||||||
| Current portion of operating lease liability | 623 | 593 | ||||||
| Deferred revenue | 40 | 506 | ||||||
| Total current liabilities | 2,582 | 3,889 | ||||||
| Long-term liabilities: | ||||||||
| Long-term portion of operating lease liability | 824 | 1,448 | ||||||
| Other liabilities | 265 | - | ||||||
| Total long-term liabilities | 1,089 | 1,448 | ||||||
| Total liabilities | 3,671 | 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 December 31, 2024 and December 31, 2023 | - | - | ||||||
| Class A common stock, $0.001 par value per share, 84,295,000 shares authorized, 13,407,441 shares issued and outstanding at December 31, 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 December 31, 2024; 1,485,560 issued and outstanding at December 31, 2023 | 1 | 1 | ||||||
| Additional paid-in capital | 131,480 | 91,823 | ||||||
| Stock subscription receivable | - | (100 | ) | |||||
| Accumulated deficit | (109,607 | ) | (84,984 | ) | ||||
| Total stockholders' equity | 21,887 | 6,741 | ||||||
| Total liabilities and stockholders' equity | $ | 25,558 | $ | 12,078 |
accompanying notes to unaudited condensed financial statements.
Statements of Operations
thousands, except per share data)
| Year Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenues | ||||||||
| Clinical trial revenue | $ | 1,402 | $ | 668 | ||||
| Contract manufacturing lease revenue | 503 | - | ||||||
| Contract manufacturing revenue | 487 | - | ||||||
| Grant revenue | - | 41 | ||||||
| Total revenues | 2,392 | 709 | ||||||
| Cost of revenues | 508 | 488 | ||||||
| Gross profit | 1,884 | 221 | ||||||
| Operating expenses | ||||||||
| General and administrative | 10,269 | 12,184 | ||||||
| Research and development | 8,137 | 9,066 | ||||||
| Total operating expenses | 18,406 | 21,250 | ||||||
| Loss from operations | (16,522 | ) | (21,029 | ) | ||||
| Other income and (expense) | ||||||||
| Lawsuit expense | - | (30 | ) | |||||
| Other refundable tax credits | - | 23 | ||||||
| Other income (expense), net | 549 | (377 | ) | |||||
| Total other income (expenses), net | 549 | (384 | ) | |||||
| Net loss | $ | (15,973 | ) | $ | (21,413 | ) | ||
| Deemed dividend - warrant inducement offers | (8,650 | ) | (798 | ) | ||||
| Net loss attributable to common stockholders | $ | (24,623 | ) | $ | (22,211 | ) | ||
| Basic and diluted net loss per share | $ | (2.62 | ) | $ | (10.22 | ) | ||
| Basic and diluted weighted average common shares outstanding | 9,411,164 | 2,173,490 |
accompanying notes to unaudited condensed financial statements.