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Longeveron Inc. Provides Corporate Update and Reports Third Quarter 2022 Financial Results-- Achieved key clinical and regulatory milestones across clinical pipeline, including the completion of enrollment in Longeveron’s Phase 2a trial for Alzheimer’s Disease -- -- Conference call scheduled for 8:30 a.m. ET today -- MIAMI, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today provided a business update and reported its financial results for the third quarter ended September 30, 2022. “This quarter, we continued to make robust progress across our 3 clinical programs,” said Chris Min, M.D., Ph.D., Interim Chief Executive Officer, and Chief Medical Officer. “The FDA granted Fast Track Designation to Lomecel-BTM for infants with Hypoplastic Left Heart Syndrome (HLHS), a key step forward in our mission to transform the current standard-of-care in this disease area where there is a large unmet need. Additionally, we completed enrollment in our Phase 2a trial of Lomecel-BTM for patients with mild Alzheimer’s Disease and have all approvals in place to initiate enrollment in our Phase 2 trial for Aging Frailty in Japan. We were pleased to successfully execute on these key milestones and look forward to continuing to advance Lomecel-BTM.” Third Quarter Business Updates: Lomecel-BTM for Alzheimer’s Disease:
Lomecel-BTM for Hypoplastic Left Heart Syndrome (HLHS):
Lomecel-BTM for Aging Frailty:
Financial Results for Third quarter Ended September 30, 2022 Revenue: Revenue for the third quarters of 2022 and 2021 was $0.3 million and $0.2 million, respectively. Revenue consisted of:
R&D Expenses: Research and development expenses in the third quarter 2022 were $2.9 million compared to $2.0 million for the same period in 2021. The increase of $0.9 million, or 45%, was primarily due to an increase of $1.8 million in research and development expenses that were not reimbursable by grants. This increase was partially offset by a decrease in equity-based compensation allocated to research and development expenses which decreased from $0.9 million for the three months ended September 30, 2021, to $0.1 million for the same period in 2022. G&A Expenses: General and administrative expenses in the third quarter 2022 were $2.1 million compared to $3.0 million for the same period in 2021. The decrease of approximately $0.9 million, or 31%, was primarily related to a decrease of $1.2 million in equity-based compensation expenses allocated to general and administrative expenses. However, expenses related to legal and consulting services increased by $0.3 million in the three months ended September 30, 2022, compared to the same period in 2021. Net Loss: Net loss was $5.2 million in the third quarter 2022 compared to $4.9 million for the same period in 2021. Per Share: Net loss per share was $0.25 in each of the third quarters 2022 and 2021. Cash and short-term investments: Cash and short-term investments was $22.3 million and $35.0 million as of September 30, 2022, and December 31, 2021, respectively. Financial Outlook We believe, based on the current operating plan and financial resources, that our existing cash and short-term investments will be sufficient to cover expenses and capital requirements into the first half 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 2022 financial results and provide a business update. Dial-in Number U.S. Replay Dial-in Number: 866-813-9403 An audio webcast of the call may also be accessed from the ‘Investors’ page of the Longeveron website at www.longeveron.com. A replay of the call will be available on the Longeveron website shortly after completion of the call. About Longeveron Inc. Cautionary Note Regarding 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 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; the Company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; existing regulations and regulatory developments in the U.S., Japan and other jurisdictions; 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 the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditures 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, 2021, filed with the SEC on March 11, 2022, and the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2022. 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: Elsie Yau Source: Longeveron Inc Longeveron Inc.
Longeveron Inc.
Source: Longeveron Inc. |