- Exploring potential partnership and strategic opportunities for the Company's cellular therapy program in Alzheimer's disease
- Highlighting the Company's cellular therapy contract development and manufacturing business at its 15,000 square feet facility with 8 current Good Manufacturing Practice (cGMP) cleanroom suites
At the conference, members of the Longeveron management team will host meetings with global pharmaceutical company executives to explore potential partnership and strategic opportunities for the Company's cellular therapy program in Alzheimer's disease (AD), which has generated positive data in successful Phase 1 and Phase 2a clinical trials, and to highlight the Company's contract development and manufacturing business at its 15,000 square feet facility with 8 current Good Manufacturing Practice (cGMP) cleanroom suites.
To schedule a meeting with the Longeveron team during the conference, please use the conference partnering system, or email [email protected].
Alzheimer's Disease Program
Longeveron's lead investigational therapeutic candidate is Lomecel-B™, a proprietary, scalable, allogeneic cellular therapy. In a completed Phase 2a clinical trial (CLEAR MIND) in mild Alzheimer's disease, 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™ in the treatment of mild Alzheimer's disease and provided evidence-based support for further clinical development.
Full results from the CLEAR MIND study were presented in a featured research oral presentation at the 2024 Alzheimer's Association International Conference (AAIC). Longeveron previously announced top-line results for CLEAR MIND on October 5, 2023, and reported additional clinical data and imaging biomarker results from CLEAR MIND on December 20, 2023.
The U.S. FDA has granted Lomecel-B™ both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer's disease.
Contract Development and Manufacturing
Longeveron provides contract development and manufacturing services to pharmaceutical company clients at its 15,000 square feet current Good Manufacturing Practice (cGMP) facility in Miami, Florida. 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.
Longeveron has assembled a team of experts and proprietary technologies that enable it to take a systematic approach to rapidly develop improved cell therapies. Longeveron's manufacturing expertise, capabilities and facility provide other pharmaceutical organizations the ability to advance their development programs without building their own manufacturing facility.
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. Lomecel-B™ development programs have received five distinct and important U.S. FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. 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 potential for Lomecel-B™ to be an effective treatment for hypoplastic left heart syndrome or achieve U.S. FDA approval under the Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation programs, or any approval. 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 allogeneic, cell-based therapies for Aging-related Frailty, Alzheimer's Disease, 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 and Media Contact:
Derek Cole
Investor Relations Advisory Solutions
