- Longeveron management will present at the 25th Annual H.C. Wainwright Global Investment Conference scheduled for September 11-13, 2023, in New York
- Wa’el Hashad, the company’s CEO, will discuss Longeveron’s cellular therapy programs in a pre-recorded presentation. Both he and Lisa Locklear, EVP & Chief Financial Officer, will be at the conference to discuss the company’s investment strategies and clinical trial progress
- The company aims to create awareness among scientists and investors of its clinical trial progress, positive clinical results, and cellular therapy programs
- Longeveron is evaluating its lead investigational product candidate, a cellular product named Lomecel-B(TM), in ongoing clinical trials
- The product candidate is being advanced as a potential treatment for hypoplastic left heart syndrome (“HLHS”), Aging-related Frailty, and Alzheimer’s disease
Longeveron (NASDAQ: LGVN), a clinical-stage company, is focused on developing cellular therapy primarily for conditions with a clear unmet medical need. The company is guided by the mission to advance cell-based product candidates into pivotal Phase 3 trials, with the goal of attaining regulatory approvals and subsequently commercializing the product.
Longeveron has so far made significant strides in line with this mission, progress that the company’s management will share during the 25th Annual H.C. Wainwright Global Investment Conference scheduled for September 11-13, 2023, in New York. On his part, Wa’el Hashad, the company’s CEO, will discuss Longeveron’s cellular therapy programs in a pre-recorded presentation. Both he and Lisa Locklear, Longeveron’s EVP & Chief Financial Officer, will attend the conference in person to discuss the company’s investment strategies and clinical trial progress (https://ibn.fm/99cEG).
The programs and clinical trials are currently anchored in the company’s lead investigational therapeutic candidate, a cellular therapy called Lomecel-B(TM). Lomecel-B is derived from culture-expanded medicinal signaling cells (“MSCs”) isolated from the bone marrow of healthy young adult donors (https://ibn.fm/sYprw). The drug candidate is undergoing evaluation – as part of three separate Phase 2 clinical trials – as a potential treatment for three indications: hypoplastic left heart syndrome (“HLHS”), Aging-related Frailty, and Alzheimer’s disease.
HLHS is a rare congenital heart condition that affects about 1,000 newborns every year in the United States. HLHS patients are born with a severely underdeveloped left ventricle, which is normally responsible for pumping oxygenated blood to the body. The condition is fatal shortly after birth if left untreated. Thus, to avert certain death, the babies undergo three heart surgeries (Stage I, Stage II, and Stage III), staggered over several years, which convert the heart into a functioning 3-chamber heart (instead of a normal 4-chamber heart). In the reconstructed heart, and after the Stage III surgery, the right ventricle entirely takes over the role of pumping oxygenated blood to the body.
Unfortunately, despite these efforts, HLHS babies still have high mortality and morbidity and often still require a heart transplant, mainly due to heart failure. The mortality risk for children with hypoplastic left heart syndrome is highest in the first year of life. For this reason, Longeveron is evaluating Lomecel-B’s potential to improve cardiac function when administered directly to the myocardium (heart muscles) at the time of Stage II surgery. The company completed its safety-focused open-label Phase 1 (“ELPIS I”) study evaluating Lomecel-B(TM) for the treatment of HLHS, reporting positive clinical results.
When cardiac surgeons injected the product directly into the babies’ hearts, the MSCs were well tolerated, with no significant adverse cardiac events and no infections related to the investigational treatment reported. Moreover, the study results showed a 100% survival rate up to 5 years after treatment, with no need for heart transplant, for the ten infants enrolled in the study. By comparison, historical data indicates an approximate 20% mortality rate over the same period of time (see “Other References” below).
The positive Phase 1 data led to the U.S. Food and Drug Administration (“FDA”) granting Rare Pediatric Disease Designation (“RPDD”) (https://ibn.fm/RVvzm), Orphan Drug Designation (“ODD”) (https://ibn.fm/W6ebo), and Fast Track Designation (“FTD”) (https://ibn.fm/uAPT7) for Lomecel-B(TM) for the treatment of HLHS.
Lomecel-B(TM) is currently being evaluated in a Phase 2 clinical trial (“ELPIS II”). A multicenter, randomized, double-blind, controlled clinical trial, ELPIS II is designed to evaluate Lomecel-B(TM) as an adjunct therapy to the standard-of-care Stage II HLHS heart reconstructive surgery. The primary endpoint is to assess whether the treatment improves heart function and improves survival compared to standard-of-care surgery alone. The trial has enrolled more than 50% of the 38 targeted subjects.
Longeveron is also conducting a Phase 2a trial (“CLEAR MIND”) to evaluate multiple doses of Lomecel-B(TM) in patients with mild Alzheimer’s disease. The primary objective of the trial is the safety and tolerability of single and multiple doses of Lomecel-B in patients with mild AD. The study will also evaluate the efficacy of single and multiple doses of Lomecel-B on disease progression in patients with mild Alzheimer’s disease. Longeveron expects the topline data results in October 2023.
Moreover, Longeveron has completed two studies (Phase 2b and a Phase 1/2a trial) in the United States. for the treatment of Aging-related Frailty. The company has also received regulatory approval in Japan, permitting an investigator-sponsored Phase 2 clinical trial for Aging-related Frailty. The Japan clinical trial is ongoing. Aging-related Frailty is a life-threatening geriatric condition that increases the risk of poor clinical outcomes from injury and disease. It does not have an approved treatment, representing an untapped opportunity for Longeveron. The company aims to work with regulatory agencies to advance Lomecel-B(TM) as potentially the first approved drug for Aging-related Frailty.
Looking ahead, Longeveron is looking to create awareness of these cellular therapy programs, the progress made with its clinical trials, and accompanying positive clinical data at conferences and scientific sessions. The upcoming investment conference provides an ideal setting as it brings together investors from all over the world.
For more information, visit the company’s website at www.Longeveron.com.
- Newburger et al. Circulation (2018) 137:2246-2253
- Newburger et al. Circulation (2014) 129:2013-2020
- Ohye et al. N Engl J Med (2010) 362:1980-1992
Certain statements in this article 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 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; 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. Additionally, Longeveron makes no assurance that any public offering of its securities as described herein 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 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 Report on Form 10-Q for the second quarter of 2023 filed with the SEC on August 11, 2023. The forward-looking statements contained in this article are made as of the date of this article, 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.
For more information, visit the company’s website at www.Longeveron.com.
NOTE TO INVESTORS: The latest news and updates relating to LGVN are available in the company’s newsroom at http://ibn.fm/LGVN
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