• Phase 2b clinical trial evaluating Lomecel-B^TM in rare pediatric disease HLHS on track for completing enrollment by end of 2024
  
• Data from Phase 2a clinical trial evaluating Lomecel-B^TM in Alzheimer’s Disease selected for Featured Research Oral Presentation at 2024 Alzheimer’s Association International Conference
• Completed two financings in April raising gross proceeds of $11.4 million to fund continued clinical development
• Focused expenditure management reduced first quarter Total Operating Expenses 8% year-over-year
• Company to host conference call and webcast today at 5:00pm ET

MIAMI, May 14, 2024 (GLOBE NEWSWIRE) -- 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 March 31, 2024 and provided a business update.

“In the first quarter, we continued to focus on advancing our cutting-edge cellular therapy research and its application through our investigational product candidate, Lomecel-B^TM, in Hypoplastic Left Heart Syndrome (HLHS) and Alzheimer’s disease, both of which are devastating for impacted patients and their families,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “Based on the strength of the data from our positive Phase 1 study in HLHS, we are excited to complete enrollment in our on-going Phase 2b study by the end of this year. The Phase 1 data was the basis for the U.S. FDA awarding the HLHS program with three distinct and important designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation, which, upon approval, may lead to granting of a Priority Review Voucher, a very valuable additional asset. Lastly, in April, we raised $11.4 million of gross proceeds from equity transactions, with participation from certain board members and insiders of the Company, to fund continued clinical development of Lomecel-B.”

Development Programs Update
Longeveron’s lead investigational therapeutic candidate is Lomecel-B^TM, a proprietary, scalable, allogenic 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.

• On-going Phase 2b clinical trial (ELPIS II) enrolling 38 pediatric patients, with enrollment completion anticipated by year end 2024
• ELPIS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH)
• ELPIS II builds on the positive clinical results of ELPIS I, in which children in the trial experienced 100% transplant-free survival up to five years of age after receiving Lomecel-B^TM compared to approximate 20% mortality rate observed from historical control data
• The Company intends to request a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss development strategy for HLHS and expectations for the potential Biologics License Application (BLA) approval

Alzheimer’s Disease (AD) – a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options.

• In a completed Phase 2a clinical trial (CLEAR MIND), Lomecel-B™ treated patients showed an overall slowing/prevention of disease worsening compared to placebo. The trial achieved the primary safety and secondary efficacy endpoints and showed statistically significant improvements in pre-specified clinical and biomarker endpoints in specific Lomecel-B™ groups compared to placebo
• These results support the therapeutic potential of Lomecel-B^TM in the treatment of mild Alzheimer’s disease and provided evidence-based support for further clinical development
• Full results from the CLEAR MIND study have been selected for a featured research oral presentation at the 2024 Alzheimer's Association International Conference (AAIC)
• The Company anticipates meeting with the FDA to review future clinical and regulatory strategy

Recent Corporate Highlights

• In January 2024, the United States Patent and Trademark Office mailed a notice of allowance to the Company for its United States patent application with claims directed to methods for use of allogeneic human mesenchymal stem cells as an adjuvant to benefit patients with Aging-related Frailty who are receiving vaccines for conditions such as Covid and the flu.  (That application issued as U.S. Patent No. 11,975,068, on May 7, 2024.)
• In April, the Company completed two capital raises which resulted in gross proceeds of $11.4 million.

First Quarter 2024 Summary Financial Results

• Revenues, Cost of Revenues and Gross Profit: Revenues for the three months ended March 31, 2024 and 2023 were $0.5 million and $0.3 million, respectively. 2024 revenues increased $0.2 million, or 96%, when compared to 2023 mainly as a result of increased participant demand for our Bahamas Registry Trial. Grant revenue for the three months ended March 31, 2024 and 2023 was $0 and less than $0.1 million, respectively. Clinical trial revenue, which is derived from the Bahamas Registry Trial, for the three months ended March 31, 2024 and 2023 was $0.5 million and $0.2 million, respectively. Clinical trial revenue for the three months ended March 31, 2024 increased by $0.3 million, or 116%, when compared to 2023 as a result of increased participant demand. Contract manufacturing revenue for the three months ended March 31, 2024 and 2023 was less than $0.1 million and $0, respectively.
• Related cost of revenues: Cost of revenues was $0.2 million for the three-month periods ended March 31, 2024 and 2023. The increase of less than $0.1 million, or 8%, was primarily due to the increase in the revenues earned from the investigational Frailty and Cognitive Impairment registry trial in the Bahamas and reduced direct costs associated with our grants program. This resulted in a gross profit of approximately $0.3 million for the three months ended March 31, 2024, an increase of $0.2 million, or 333%, when compared with a gross profit of $0.1 million for 2023.
• General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2024 increased to approximately $2.2 million, compared to $2.0 million for the same period in 2023. The increase of approximately $0.2 million, or 9%, was primarily related to an increase in expenses related to professional fees.
• Research and Development Expenses: Research and development expenses for the three months ended March 31, 2024 decreased to approximately $2.2 million, from approximately $2.8 million for the same period in 2023. The decrease of $0.6 million, or 20%, was primarily due to a decrease of $0.6 million in research and development expenses being incurred for the Alzheimer’s disease clinical trial and reduced costs for the Aging-related Frailty clinical trial following our decision to discontinue trial activities in Japan, reduced cost of supplies of $0.3 million, and a decrease of $0.2 million in equity-based compensation expenses allocated to research and development expenses. These reductions were partially offset by $0.4 million of higher compensation and benefit costs.
• Other Expense (Income), net: Other income for the three months ended March 31, 2024 was less than $0.1 million. Other income consisted of less than $0.1 million from interest earned on money market funds and marketable securities. Other income for the three months ended March 31, 2023 was $0.1 million as result of gains from marketable securities.
• Net Loss: Net loss decreased to approximately $4.1 million for the three months ended March 31, 2024 from a net loss of $4.6 million for the same period in 2023. The decrease in the net loss of $0.5 million, or 13%, was for the reasons outlined above.
• Cash and cash equivalents and marketable securities as of March 31, 2024 were $2.3 million. In April 2024, the Company completed two capital raises which resulted in gross proceeds of $11.4 million. The Company believes its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2024. These estimates are based on assumptions that may prove to be imprecise, and the Company could utilize its available capital resources sooner than it expects.

Conference Call and Webcast

The Company will host a conference call and webcast today at 5:00 p.m. ET.

An archived replay of the webcast will be available on the “Events & Presentations” section of the Company’s website following the conference.

About Longeveron Inc.

Longeveron 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. 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 the private placement. 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, AD, 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 price of our Class A common stock; we could lose our listing on the Nasdaq Capital Market; 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 Contact:
Derek Cole
Investor Relations Advisory Solutions
This email address is being protected from spambots. You need JavaScript enabled to view it.

Longeveron Inc.
Condensed Balance Sheets
(In thousands, except share and per share data)

Longeveron Inc.
Condensed Statements of Operations
(In thousands, except per share data)
(Unaudited)