Longeveron Inc.

Good day and welcome to the Longevron 2024 Full-Year Financial Results Conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to hand the call over to Derek Cole of Investor Relations Advisory Solutions. Please go ahead.

Thank you, Paul. Good afternoon, everyone, and thank you for joining us today to review Longevron's 2024 full-year financial results and our business update. After the U.S. markets closed today, we issued a press release with financial results for 2024, which can be found under the investor section of the Longevron website. On the call with me today are Wael Hashad, Chief Executive Officer, Natalia Agafanova, Chief Medical Officer, Lisa Locklear, Chief Financial Officer, and Dr. Joshua Herr, co-founder, chief science officer, and chairman of the board. As a reminder, during this call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties that could cause actual results to differ materially from these statements. Any such statements should be considered in conjunction with cautionary statements in our press releases and risk factors discussed in the company's filings with the Securities Exchange Commission, which we encourage you to review. Following the company's prepared remarks, we will open the call to questions from our covering analysts. With that, let me hand the call over to Wael Hashad, Chief Executive Officer. Wael?

Thank you, Derek. Good afternoon, everyone, and thank you very much for joining us today. We are very pleased to update you on a highly productive year in 2024 and provide an overview of what to expect in potentially transformational 2025 for Langevin Roms. As a reminder for those of you new to our story, Longevaron is a regenerative medicine company developing cutting-edge cellular therapies. Our stem cell therapy, Lamacel-B, or laramestral cell, represents a pipeline and a product opportunity that has delivered several positive initial results across five clinical trials in three indications. phase one and two in Alzheimer's disease, phase one and two in aging-related frailty, and phase one in HLHS or hypoplastic left heart syndrome, a rare pediatric disease condition. The company development program for these three initial indications address U.S. market opportunity of approximately $5-plus billion approximately $4-plus billion, and up to $1 billion, respectively. Longevron continued to make progress in 2024 with both the LMSLB and HLHS and Alzheimer's disease programs. Hypoplastic left heart syndrome, or HLHS, is a key strategic priority for us. We believe the HLHS program has high probability of success and the shortest path to potential regulatory approval and commercialization across our pipeline. In 2024, we continue to advance enrollment in our ongoing Phase 2b study, UPS2, which is evaluating Glomacil-B as a potential adjunct treatment for HLHS. UPS2 has now achieved more than 90% enrollment, and we expect to complete enrollment in the second quarter of this year. Also importantly, last year we completed a meeting with the U.S. Food and Drug Administration, the FDA, which confirmed that ELPAS-2 is a pivotal and, if positive, acceptable for biological license application or BLA submission for full traditional approval. This significantly accelerated the potential regulatory path for Lomacil-B and if supported by clinical data from Opus 2, would allow us to initiate a rolling submission of a BLA with the FDA in 2026. We also continue to advance the Alzheimer's disease program. Results from our ClearMind Phase 2A clinical trial was presented in a featured research oral presentation at the 2024 Alzheimer's Association International Conference, AAIC. Based on the ClearMind Phase IIa clinical data and prior Phase I data, the FDA granted Lomacil-B both regenerative medicine advanced therapy designation, also known as RMAT, and fast-track designation for the treatment of mild Alzheimer's disease. Lomacil-B appeared to be the first cellular therapy candidate to receive RMAT designation for Alzheimer's disease. With this data in hand, we anticipate meeting with the FDA later this quarter to review future clinical and regulatory strategy for continuing this important program. 2025 has the potential to be a transformative year for Longibron, with achieving clarity on Alzheimer's development pathway, completing enrollment for the HLHS Phase II trial, which would establish a potential timeline for our first BLA submission in 2026. It's starting the year off well. In February, the International Non-Proprietary Name, INN, Expert Committee of the World Health Organization approved ladder master cell for the non-proprietary name of the company's cellular therapy, Lomacil-B. This naming approval is an important step in the development and the potential commercialization of LMSLB. I am thoroughly excited by the opportunity for LMSLB, Longeviron, patients, and our stockholders. With that, I will turn the call to Dr. Agafenova to provide update on our clinical development program. Natalia?