• Top Line Results from CLEAR MIND Alzheimer’s disease Trial Affirm Safety Profile of Lomecel-B™ and Provide Efficacy Signal; Full Study Data Remains on Track to Share in Coming Weeks
  
• Long-term Survival Data from ELPIS 1 Trial to be Presented at the 2023 Scientific Sessions of the American Heart Association
• $4 Million in Equity Financing Secured in Registered Direct Offering
• ELPIS II Phase 2 Trial of Lomecel-B™ in HLHS Continues Enrollment; Completion of Study Enrollment Anticipated in 2024
• Company to Hold Conference Call and Webcast Today, November 10, 2023 at 8:30am Eastern Time

MIAMI, Nov. 10, 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 September 30, 2023 and provided a corporate update.

“During our third quarter and in recent weeks, we continued to advance our Lomecel-B™ clinical programs, highlighted by postive top-line results from our CLEAR MIND clinical trial of Lomecel-B™ in the treatment of mild Alzheimer’s disease and acceptance of ELPIS I long-term survival data for presentation at the American Heart Association annual meeting,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “We also took steps to strengthen our balance sheet, securing $4 million of gross proceeds from an equity financing to support our continued advancement of these critical programs.”

“As we announced in October, the results from our CLEAR MIND trial provide important validation of both the safety and therapeutic potential of Lomecel-B™ in the treatment of mild Alzheimer’s disease. In addition to achieving the study’s safety endpoints, the study provided statistically significant evidence of slowing disease progression as compared to placebo. We believe these results provide a robust foundation for additional clinical programs with Lomecel-B™ in Alzheimer’s disease as well as other indications, and look forward to reporting the full study data from this trial in the coming weeks once the remaining data is received and analyzed.

“We are also pleased to see our poster, which details the five-year long-term survival data from our ELPIS I trial in hypoplastic left heart syndrome (HLHS), accepted for presentation at the upcoming American Heart Association (AHA) meeting. HLHS patients are in critical need of new therapeutic options to improve outcomes in this rare and life-threatening indication. To that end, enrollment in our follow-on ELPIS II study has exceeded the 50% threshold, and we anticipate completing study enrollment in 2024,” concluded Mr. Hashad.

Recent Highlights

Postive Topline Data Announced from CLEAR MIND Trial

• In October 2023, Longeveron announced topline results from the CLEAR MIND trial— a Phase 2a trial of Lomecel-B™ for the treatment of mild Alzheimer’s disease (AD). CLEAR MIND is a 48 patient, 4-arm, parallel design, randomized (1:1:1:1) clinical trial of Lomecel-B™ 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 of safety was met based on statistical and medical assessment. There was one Serious Adverse Event (SAE) reported on each Lomecel-B™ treatment group and none on placebo. Each SAE was reviewed and assessed by the Data and Safety Monitoring Board (DSMB) with no safety issues raised.
• The secondary endpoint of change from baseline to week 39 in CADS demonstrated positive results at the prespecified statistical level of p<0.1, 2-tailed; statistically significant improvement at Week 39 in CADS was observed for the Lomecel-B™ 25 x 106 cells (25M) x 1 dose (p=0.091) versus placebo and for the pooled Lomecel-B™ Groups (25M x 1 dose, 25M x 4 doses, 100 x 106 cells (100M) x 4 doses) (p=0.099).
• Lomecel-B™ at the 25M x 1 dose demonstrated statistically significant slowing of disease progression in left hippocampal volume (p=0.015) relative to placebo; ADCS-ADL and left hippocampal volume at Week 39 were statistically significant for the pooled Lomecel-B™ treatment groups (25M x 1 dose, 25M x 4 doses, 100M x 4 doses) relative to placebo (p=0.047) and (p=0.038), respectively; other doses demonstrated numerical slowing and prevention of disease worsening relative to placebo in CADS, ADAS-cog13, CDR-SB, ADCS-ADL and left hippocampal volume at Week 39.
• Complete study data remains on track to be shared in the coming weeks once the full data is received and analyzed.

ELPIS 1 Long-term Survival Data Accepted for Presentation at AHA 2023

• An abstract highlighting long-term survival data from the ELPIS 1 trial of Lomecel-B™ for patients with hypoplastic left heart syndrome (HLHS) has been accepted for presentation as a poster at the upcoming annual meeting of the AHA.
• Previously announced long-term survival data from ELPIS I Trial of Lomecel-B™ for HLHS showed:
  • 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.

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 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).

Financial Results for Quarter Ended September 30, 2023

• Revenues, Cost of Revenues and Gross Profit: Revenues for each of the three months ended September 30, 2023 and 2022 were approximately $0.2 million and $0.3 million, respectively. Grant revenue for the three months ended September 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-month periods ended September 30, 2023 and 2022 was $0.2 million. Clinical trial revenue for the three months ended September 30, 2023 decreased by less than $0.1 million, or 29%, 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 $0.2 million for the three months ended September 30, 2023 and 2022, respectively. The decrease of $0.1 million, or 45%, 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 for both of the three month-periods ended September 30, 2023 and 2022.
• General and Administrative Expense: General and administrative expenses for the three months ended September 30, 2023 increased to approximately $3.1 million, compared to $2.1 million for the same period in 2022. The increase of approximately $1.0 million, or 49%, was primarily related to increases of $0.3 million in compensation and benefit expenses, $0.4 million of expenses related to legal and professional fees and $0.4 million of expenses related to the subscription rights offering. These increases were partially offset by a decrease of $0.1 million in stock-based compensation expense.
• Research and Development Expenses: Research and development expenses for the three months ended September 30, 2023 decreased to approximately $1.8 million, from approximately $3.0 million for the same period in 2022. The decrease of $1.1 million, or 38%, was primarily due to a decrease of $1.0 million in research and development expenses driven by lower spend on clinical trials and supplies.
• Selling and Marketing Expenses: Selling and marketing expenses for the three months ended September 30, 2023 and 2022 were approximately $0.3 million and $0.2 million, respectively. Selling and marketing expenses consist primarily of investor and public relations expenses.
• Other Income (Expense): Other income for the three months ended September 30, 2023 was $0.1 million, which consisted of interest income. Other expense for the three months ended September 30, 2022 was less than $0.1 million.
• Net Loss: Net loss was approximately $5.1 million and $5.2 million for the three-month periods ended September 30, 2023 and 2022, respectively.
• Cash and short-term investments: As of September 30, 2023, the Company had cash and cash equivalents of $2.0 million, marketable securities of $2.0 million and working capital of approximately $1.7 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.
• Subsequent Events: On October 13, 2023 the Company closed a registered direct equity offering priced at-the-market under Nasdaq rules and concurrent private placement, with gross proceeds of approximately $4 million, before deducting the placement agent’s fees and other offering expenses payable by Longeveron. Longeveron currently intends to use the net proceeds from the offering to fund the ongoing clinical and regulatory development of Lomecel-B™ and for capital expenditures, working capital and general corporate purposes.
• 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 8:30 a.m. ET to discuss the Company’s third 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 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 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 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. 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, the anticipated use of proceeds from the offering, as well as 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; market and other conditions; 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 Securities and Exchange Commission on March 14, 2023 and its Quarterly Reports on Form 10-Q filed with the SEC. 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
Mike Moyer
LifeSci Advisors
Tel: 617-308-4306
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

See accompanying notes to unaudited condensed financial statements.

See accompanying notes to unaudited condensed financial statements.