• ELPIS II Study Exceeds 50% Enrollment Threshold for Phase 2 Trial of Lomecel-B™ in HLHS
  
• Top Line Results for CLEAR MIND Alzheimer’s disease Phase 2a Trial Anticipated by October 2023
• Company Strengthens Leadership Team and Board of Directors with Distinguished New Additions
• Company to Hold Conference Call and Webcast Today, August 11, 2023 at 8am Eastern Time

MIAMI, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, announced today its results for the quarter ended June 30, 2023 and provided a corporate update.

“During our second quarter and in recent weeks, we made significant progress advancing our Lomecel-B™ clinical programs, exceeding the 50% enrollment threshold for our ELPIS II trial in hypoplastic left heart syndrome (HLHS) patients and announcing new long-term survival data from our ELPIS I study,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “HLHS patients are in critical need of new therapeutic options to improve outcomes in this rare and life-threatening indication, and we look forward to completing enrollment in the ELPIS II trial by mid-2024. Additionally, we are on track and expect to report top-line results from our CLEAR MIND Phase 2a trial of Lomecel-B™ treatment of Alzheimer’s disease by October 2023, and we continue to enroll patients in Phase 2 of Lomecel-B™ in patients with Aging-related Frailty at centers in Japan. Finally, we are pleased to welcome distinguished new colleagues to both our leadership team and Board of Directors. We look forward to their guidance and counsel as we advance Lomecel-B™ in areas of significant unmet medical needs.”

Recent Highlights

Lomecel-B™ for Hypoplastic Left Heart Syndrome (HLHS):

• Announced achievement of exceeding 50% enrollment threshold for Phase 2 ELPIS II trial of Lomecel-B™ in HLHS.
• Announced new long-term survival data from ELPIS I Trial of Lomecel-B™ for HLHS.
  • Children in the ELPIS I trial had 100% survival up to five years of age after receiving Lomecel-B™ compared to approximate 20% mortality rate observed from historical control data.
  • Data reinforce potential survival benefit of Lomecel-B™ for patients in this indication.

Lomecel-B™ for Alzheimer’s Disease:

• In November 2022, Longeveron announced it had completed enrollment in its Phase 2a trial of Lomecel-B™ for the treatment of Alzheimer’s disease (AD). The Phase 2a trial, called the CLEAR MIND trial, is a 48 patient, 4-arm, parallel design, randomized (1:1:1:1) clinical trial of Lomecel-B™ and is intended to evaluate the safety of a single and multiple infusions of two different dose levels compared to placebo in patients with mild AD. The primary endpoint is safety as measured by the occurrence of serious adverse events (SAEs) within the first 30 days after administration of Lomecel-B™. The secondary and exploratory endpoints include brain volumetry by magnetic resonance imaging (MRI), biomarkers relevant to inflammation and endothelial/vascular systems, and measures of cognitive function.
• The Company expects to share top line results from CLEAR MIND by October 2023.

Lomecel-B™ for Aging-Related Frailty:

• Enrollment continues in the Company’s Phase 2 study evaluating Lomecel-B™ in patients with Aging-Related Frailty in Japan.
• The Phase 2 clinical trial is a 3-arm, parallel design, randomized (1:1:1), placebo-controlled, double-blind infusion study of two different dose levels of Lomecel-B™. The trial is expected to enroll 45 patients and has a primary objective of evaluating the safety of Lomecel-B™ as a treatment for Aging-related Frailty.
• The Phase 2 trial is being conducted in partnership with the National Center for Geriatrics & Gerontology (NCGG; Nagoya) and Juntendo University Hospital (Tokyo).

Corporate Updates

• Leadership team strengthened with the appointments of Lisa Locklear as Chief Financial Officer and Dr. Nataliya Agafonova as Chief Medical Officer.
• Board of Directors enhanced with the election of distinguished biotechnology and corporate management experts, Khoso Baluch, Jeffrey Pfeffer, and Wa’el Hashad at the Company’s June Annual Meeting of Stockholders.
• On June 27, 2023 the Company filed a registration statement with the SEC to conduct a tradeable subscription rights offering for up to $30.0 million of shares of Class A common stock to stockholders and holders of warrants to purchase common stock as of a future record date to be determined. An amendment to the registration statement was filed with the SEC on July 28, 2023 with additional details regarding the proposed offering.

Financial Results for Quarter Ended June 30, 2023

• Revenues, Cost of Revenues and Gross Profit: Revenues for each of the three months ended June 30, 2023 and 2022 were approximately $0.2 million and $0.5 million, respectively. Grant revenue for the three months ended June 30, 2023 and 2022 was $0 and $0.1 million, respectively. The decrease of $0.1 million, or 100%, was primarily due to a reduction in grant funds available due in part to the completion of the grant-funded clinical trials. Clinical trial revenue, which is derived from The Bahamas Registry Trial, for the three months ended June 30, 2023 and 2022 was $0.2 million and $0.3 million, respectively. This was approximately $0.1 million, or 36%, lower when compared to the same period in 2022 as a result of a decrease in participant demand.

• Related cost of revenues was approximately $0.1 million and $0.3 million for the three months ended June 30, 2023 and 2022, respectively. The decrease of $0.2 million, or 59%, was primarily due to the decrease in the revenues earned from The Bahamas Registry Trial. This resulted in a gross profit of approximately $0.1 million and $0.2 million for the three months ended June 30, 2023 and 2022, respectively.
• General and Administrative Expense: General and administrative expenses for the three months ended June 30, 2023 increased to approximately $3.4 million, compared to $2.4 million for the same period in 2022. The increase of approximately $1.0 million, or 39%, was primarily related to an increase of $0.7 million in compensation and benefit expenses during the current year period and expenses related to professional fees.
• Research and Development Expenses: Research and development expenses for the three months ended June 30, 2023 increased to approximately $2.3 million, from approximately $1.7 million for the same period in 2022. The increase of $0.6 million, or 33%, was primarily due to an increase of $0.5 million in research and development expenses that were not reimbursable by grants.
• Selling and Marketing Expenses: Selling and marketing expenses for the three months ended June 30, 2023 and 2022 were approximately $0.1 million and $0.2 million, respectively. Selling and marketing expenses consist primarily of investor and public relations expenses.
• Non-Operating Lawsuit Expense: Non-operating lawsuit expense for the three months ended June 30, 2023 and 2022 was $0 and approximately $1.4 million, respectively.
• Other Income (Expense): Other income for the three months ended June 30, 2023 was $0.1 million, which consisted of interest income. Other expense for the three months ended June 30, 2022 was less than $0.1 million.
• Net Loss: Net loss was approximately $5.6 million for the three-month periods ended June 30, 2023 and 2022.

Financial Results for Six Months Ended June 30, 2023

• Revenues, Cost of Revenues and Gross Profit: Revenues for each of the six months ended June 30, 2023 and 2022 were approximately $0.5 million and $0.8 million, respectively. Revenues for the six months ended June 30, 2023 were approximately $0.3 million, or 41% lower when compared to the same period in 2022. Grant revenue for the six months ended June 30, 2023 and 2022 was less than $0.1 million and $0.2 million, respectively. Grant revenue for the six months ended June 30, 2023 was approximately $0.1 million, or 78% lower when compared to the same period in 2022, primarily due to a reduction in grant funds available due in part to the completion of the grant-funded clinical trials. Clinical trial revenue, which is derived from the Bahamas Registry Trial, for the six months ended June 30, 2023 and 2022 was $0.5 million and $0.6 million, respectively. Clinical trial revenue for the six months ended June 30, 2023 was approximately $0.1 million, or 30%, lower when compared to the same period in 2022. During the first half of 2023, clinical trial revenue decreased as a result of a decrease in participant demand.
• Related cost of revenues was approximately $0.3 million and $0.4 million for the six months ended June 30, 2023 and 2022, respectively. Cost of revenues for the six months ended June 30, 2023 was $0.1 million, or 13%, less when compared to the same period in 2022, primarily due to the corresponding decrease in the revenues earned from the Bahamas Registry Trial. This resulted in a gross profit of approximately $0.2 million and $0.5 million for the six months ended June 30, 2023 and 2022, respectively.
• General and Administrative Expense: General and administrative expenses for the six months ended June 30, 2023 increased to approximately $5.2 million, compared to $4.4 million for the same period in 2022. The increase of approximately $0.8 million, or 19%, was primarily related to an increase of $0.8 million in compensation and benefit expenses.
• Research and Development Expenses: Research and development expenses for the six months ended June 30, 2023, increased to approximately $5.1 million, from approximately $3.1 million for the same period in 2022. The increase of $1.9 million, or 61%, was primarily due to an increase of $1.4 million in research and development expenses that were not reimbursable by grants, an increase of $0.3 million in supplies to manufacture Lomecel-B™, an increase in equity-based compensation allocated to research and development expenses, of $0.2 million.
• Selling and Marketing Expenses: Selling and marketing expenses for the six months ended June 30, 2023 and 2022 were approximately $0.3 million and $0.5 million, respectively. Selling and marketing expenses consist primarily of investor and public relations expenses.
• Non-Operating Lawsuit Expense: Non-operating lawsuit expense for the six months ended June 30, 2023 and 2022 was $0 and approximately $1.4 million, respectively.
• Other Income (Expense): Other income for the six months ended June 30, 2023 was $0.1 million. Other income consisted of interest income. Other expense for the six months ended June 30, 2022was $0.1 million.
• Net Loss: Net loss increased to approximately $10.3 million for the six months ended June 30, 2023, from a net loss of $9.1 million for the same period in 2022. The increase in the net loss of $1.2 million, or 13%, was a result of the items outlined above.
• Cash and short-term investments: As of June 30, 2023, the Company had cash and cash equivalents of $2.7 million, marketable securities of $5.9 million and working capital of approximately $6.2 million. As of December 31, 2022, cash, and cash equivalents was $10.5 million, marketable securities were $9.2 million and working capital was approximately $15.4 million.
• Certain reclassifications have been made to prior year financial statements to conform to classifications used in the current year. These reclassifications had no impact on net loss, shareholders’ equity or cash flows as previously reported.
• Financial Outlook: Based on the Company’s current operating plan and financial resources, we believe that our existing cash and short-term investments will be sufficient to cover expenses and capital requirements into the first quarter of 2024.
  
  

Conference Call and Webcast

Management will host a conference call today at 8:00 a.m. ET to discuss the Company’s second quarter 2023 financial results and provide a business update.

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 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 advancing Lomecel-B™ through clinical trials in three indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s Disease, and Aging-Related Frailty. Additional information about the Company is available at www.longeveron.com.

Forward-Looking Statements

Certain statements in this 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. 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, statements about the ability of Longeveron’s clinical trials to demonstrate safety and efficacy of the Company’s product candidates, and other positive results; the timing and focus of the Company’s 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 the Company’s product candidates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the Company’s product candidates; the Company’s ability to obtain and maintain regulatory approval of its product candidates in the U.S., Japan and other jurisdictions; the Company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; the Company’s plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and the Company’s ability to attract and retain such personnel; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s need to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive impact it may have on its investors; the Company’s financial performance and ability to continue as a going concern, and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditure requirements. 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, 2022, filed with the SEC on March 14, 2023 and its Quarterly Report on Form 10-Q for the first quarter of 2023 filed with the SEC on May 12, 2023. The forward-looking statements contained in this release are made as of the date of this 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
Mike Moyer
LifeSci Advisors
Tel: 617-308-4306
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