Longeveron Announces Contract Development and Manufacturing Business and First Contract – GlobeNewswire

MIAMI, June 03, 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 announced the launch of its contract development and manufacturing business at the Companys 15,000 square feet state-of-the-art Good Manufacturing Practice (GMP) facility. This facility contains 3,000 square feet of cleanroom space, including eight ISO 7 cleanrooms and ancillary areas, as well as 1,150 square feet of process development, quality control and warehousing space. The Company also announced the initiation of work under its first manufacturing services contract with Secretome Therapeutics, a biotechnology company developing first-in-class therapeutics from neonatal mesenchymal stem cells (nMSC).

We are delighted to partner with Secretome Therapeutics to advance their portfolio of therapeutics in this, our first contract manufacturing agreement in a new, revenue generating business line, said Wael Hashad, Chief Executive Officer of Longeveron. With cellular therapy manufacturing expertise and capabilities in high demand, and Longeverons strength in both, we see a significant opportunity to employ currently unused capacity in our state-of-the-art GMP facility. We have assembled a team of experts and proprietary technologies that enable us to take a systematic approach to rapidly develop improved cell therapies. Longeverons manufacturing expertise, capabilities and facility provide other pharmaceutical organizations the ability to advance their development programs without building their own manufacturing facility. We believe this contract manufacturing opportunity can expand our teams experience and has the potential to generate approximately $4-5 million in annual revenues once it is up and running fully.

Our platform of neonatal stem cell-based therapeutics has the potential to revolutionize treatment for a wide range of chronic, inflammatory diseases, said Vinny Jindal, President and Chief Executive Officer of Secretome Therapeutics. As we move our lead product, STM-01, into clinical studies for HFpEF and dilated cardiomyopathy this year, we look forward to tapping into Longeverons extensive cellular therapy knowledge and manufacturing expertise, which has supported the launch of multiple clinical studies.

Longeveron is primarily focused on advancing development of its lead investigational therapeutic candidate, Lomecel-BTM, a proprietary, scalable, allogeneic cellular therapy, across multiple indications, including hypoplastic left heart syndrome (HLHS) (Phase 2 on-going), Alzheimers disease (Phase 2 completed), and Aging-related Frailty (Phase 2 completed).

About Longeveron Inc.

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Companys 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), Alzheimers disease, and Aging-related Frailty. For more information, visit http://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 managements 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 potential demand for Longeverons contract manufacturing services and its ability to enter into additional service agreements. 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, 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 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; 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; 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 Companys results and forward-looking statements are disclosed in the Companys filings with the Securities and Exchange Commission, including Longeverons 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 derek.cole@iradvisory.com

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Longeveron Announces Contract Development and Manufacturing Business and First Contract - GlobeNewswire