By David Willey, Benzinga
Longeveron, Inc. (NASDAQ: LGVN) is a clinical-stage biopharmaceutical company focused on therapies for age-related and life-threatening diseases. Longeverons primary drug is Lomecel-B, which is being developed as a potential therapy for Alzheimer's disease, Aging-Frailty, and a rare pediatric disease, hypoplastic left heart syndrome (HLHS).
After almost a decade of research and development (R&D) and collecting safety and efficacy data, the Company is initiating additional phase 2 trials for Lomecel-B as a potential treatment for these indications. To help the Company with its continued growth and development, the Company has brought on additional experienced leaders to its board and leadership team. These leaders bring a wealth of expertise in drug development, regulatory filing and product commercialization.
Longeveron believes that its recent appointments should inspire even greater confidence in its investors as the Company advances its trials for Lomecel-B.
CEO And Board Member Appointments
In March 2023, Longeveron appointed Wael Hashad as its new Chief Executive Officer (CEO). Hashad brings over three decades of experience in global pharmaceutical and biotechnology companies like Amgen (NASDAQ: AMGN) and Eli Lilly and Company (NYSE: LLY), and he has been involved in drug development, mergers and acquisitions and product commercialization. Before joining Longeveron, Hashad spent six years as CEO of Avanir Pharmaceuticals, where he oversaw the companys integration with Otsuka.
I am honored to join Longeveron as CEO, said Hashad. With its robust clinical pipeline, Longeveron is well-positioned as a leader in regenerative medicines. I look forward to working with the Board, management, and the broader Longeveron team to continue the impressive progress to date and advance Lomecel-B as a potential therapy across multiple disease areas.
Hashad was recently appointed to Longeverons Board of Directors, along with prominent biotechnology and corporate management experts Khoso Baluch and Jeffrey Pfeffer. Baluch has 36 years of experience in the biopharmaceutical industry and has held positions at multiple companies including Eli Lilly and CorMedix Inc. and is currently chairman of the board for Poxel SA. Pfeffer also brings extensive management experience to Longeveron as a current and previous board member of more than 10 companies. He is also a respected organizational expert, authoring or co-authoring more than 16 books and serving as a professor at Stanford University Graduate School of Business since the late 1970s.
Other Team Appointments
The Company also announced two other major additions to its leadership team in the past month. On July 11, 2023, Longeveron appointed Nataliya Agafonova, M.D., as the Companys Chief Medical Officer (CMO). Agafonova has spent time at a range of high-profile companies and her cross-therapeutic expertise has contributed to multiple drugs being brought to market. She is heading up Longeverons global clinical development and spearheading its regulatory strategy for its investigational products.
Most recently, the company appointed Lisa Locklear as Longeverons Executive Vice President and Chief Financial Officer, effective as of July 31, 2023. Locklear has held a broad array of senior financial roles across the healthcare and other industry sectors and currently serves as a board member for several institutions and is a part of the National Association of Corporate Directors (NACD).
The Company believes these appointments put Longeveron in an even stronger position as it focuses on advancing its pipeline for Lomecel-B. Lomecel-B is developed from the bone marrow of young and healthy adult donors into an allogeneic medicinal signaling cell (MSC) therapy product to address multiple diseases.
We are a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions.Our lead investigational product is Lomecel-B, which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors. We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult diseases and conditions associated with aging.
Forward-Looking StatementsCertain 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, statements regarding the offer and sale of securities, the terms of the offering, about the ability of Longeverons clinical trials to demonstrate safety and efficacy of the Companys product candidates, and other positive results; the timing and focus of the Companys 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 Companys 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 Companys product candidates; the Companys ability to obtain and maintain regulatory approval of its product candidates in the U.S., Japan and other jurisdictions; the Companys plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; the Companys 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 Companys ability to attract and retain such personnel; the Companys estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Companys 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 Companys 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 expenditure requirements. Additionally, Longeveron makes no assurance that any public offering of its securities as described herein will occur at all, or that any such transaction will occur on the timelines, in the manner or on the terms anticipated due to numerous factors. 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 Longeverons Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 14, 2023. 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.
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Christine Petraglia – TraDigital IR
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