Longeveron Inc.

Good day ladies and gentlemen and welcome to Langevin 2024 first quarter financial results earnings call. At this time all participants are in listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference please press star zero on your telephone keypad. Please note that this conference call is being recorded. I would now like to turn the conference over to Derek Cole of Investor Relations Advisory Solutions. You may begin, sir.

Thank you, Judith. Good afternoon, everyone, and thank you for joining us today to review Longevron's first quarter 2024 financial results and business update. After the U.S. markets closed today, we issued a press release with financial results of the first quarter, which can be found under the investor section of the Longevron website. On the call today are Wael Hashad, Chief Executive Officer, Dr. Natalia Akopanova, Chief Medical Officer, Lisa Locklear, Chief Financial Officer, and Joshua Hare, 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 and Exchange Commission, which we encourage you to review. Following the company's prepared remarks, we will open the call to questions from covering analysts. With that, let me hand the call over to Wael Hashad, Chief Executive Officer. Wael.

Thank you, Derek. Good afternoon, everyone. We are pleased to update you on our progress and to share why we're confident in Longevorone's opportunity and its future. As a reminder, for those of you newer to our story, Longevorone is a regenerative medicine company developing cutting-edge cellular therapy. Our lead development compound, a cellular therapy candidate called Lomacil-B, represents a pipeline and a product opportunity that is being evaluated across three important treatment areas, addressing numerous unmet medical needs with U.S. market potential opportunity of approximately 10 to 18 billion U.S. dollars. There are four main reasons that give me confidence in our ability to achieve the opportunity of Lomacil-B. The first is Longeviron's foundation in strong science. Lamisil-B is a proprietary, scalable, allergenic cellular therapy that has delivered positive initial results across five clinical trials. Phase I and II trials in Alzheimer's disease, Phase I and II trials in aging-related frailty, and Phase I in hypoplastic left heart syndrome, or HLHS. Second, is the experience and expertise of the Longeviron team, which makes advancing this research possible across clinical development, regulatory, and manufacturing. Third, is the team dedication and commitment to advance this research for the fourth and most important reason, the patients. Hypoblastic left heart syndrome Alzheimer's disease, aging, frailty, these words convey a lot of information to scientists and doctors, but they can't fully express the devastating impact these disease and conditions have on the patients and their families. It is heartbreaking to see an infant after a heart surgery so early in their young lives or the loss of a memory and cognition associated with Alzheimer's. What really drives everyone here at Launch of Our Own, day in and day out, is the patients and the opportunity to have a positive impact for them. They are why we are working every day to hopefully develop therapeutic solutions for these unmet needs. These four reasons drive my confidence in our ability to make an impact. And that impact starts with HLHS, our strategic priority for this year. As you know, we completed Phase 1 study, known as ALPAS-1, which produced positive results that were the basis for initiating our ongoing Phase 2 study, ALPAS-2, which is evaluating Glomacil-B as a potential adjunct treatment for HLHS. Completing enrollment in this trial by the end of this year is our primary focus with this program. HLHS is our top priority program, as we believe it is the program with the highest probability of success and the shortest path to potential regulatory approval. The ELPAS-1 data were also the basis for the US FDA awarding the HLHS program with three distinct and important designations. Orphan Drug Designation, Fast Track Designation, rare pediatric disease designation, which upon approval may lead to granting of a priority review voucher, a very valuable additional asset, which if granted, enable us to speed up FDA review of another Longeviron NDA or BLA, or to potentially sell the voucher to another company. The selling price of these priority review vouchers has generally been in excess of $100 million. My earlier point about the strengths of our science is further evidenced by the positive data from CLEARMIND Phase 2A clinical trial in mild Alzheimer's disease. We anticipate meeting with the FDA late this year to review future clinical and regulatory strategy for continuing this important program. Our chief medical officer, Dr. Natalia Agassanova, will provide some additional details on both HLHS and the Alzheimer's disease program later in this call. I want to take a moment to highlight two other areas of the company where we are optimizing our resources, and that reinforces the reason I just mentioned for our confidence. Given our preliminary Phase II clinical data suggesting that Lomacil-B may potentially address the problem associated with aging-related frailty, we are gaining additional real-world evidence from our currently enrolling investigational frailty and cognitive impairment registry trial in the Bahamas. Eligible participants may receive Lomacil-B for aging-related frailty, Alzheimer's disease, or other indications at their own expense and are then followed for safety and clinical efficacy. Why this is important. First, it's indicative of the strength of our initial data that supports the authorization for this investigational program in the first place. Second, though, that this investigational registry trial, we are able to collect real-world treatment data to better understand LOMSL-B activity, safety profile, and potential efficacy. LOMSL-B has been safely administered in over 500 patients to date across clinical trials and this registry trial. We believe this data will be important in guiding clinical development program for LOMSL-B. Finally, and importantly, we are able to generate this data in a cost-neutral manner, as participants do so at their own expense. Building on the success of this registry trial so far, we plan to launch an investigational osteoarthritis registry trial in the Bahamas in the fourth quarter of this year. The second area is in regard to Longeviron's manufacturing expertise and capabilities. We have assembled a team of experts in proprietary technology. that enable us to take systematic approach to rapidly develop improved cell therapies. Our state-of-the-art GMP facility in Miami at Life Science and Technology Park consists of 3,000 square feet of clean room space containing eight ISO 7 clean rooms, an ancillary area as well as 1,150 square feet of process development quality control, and warehouse space. All products are manufactured and released based on FDA guidance. While this facility gives us a capacity to manufacture Lomacil-B for clinical trial use and potentially, if approved, for commercial scale, we do not currently need the facility's full capacity. This presents an additional opportunity for us as a company As a company's manufacturing expertise, capabilities and facility are in demand from other pharmaceutical organizations. We plan to expand contract manufacturing operation as part of our overall resource optimization strategy. We have already secured the first contract under this initiative and started preliminary work with the client. We believe this contract manufacturing has the potential to expand the team experience, and generate approximately $4 to $5 million in annual revenue once it's up and running fully, helping offset our clinical development costs and reducing but not eliminating our additional capital needs. Which leads me to the final area of comments, capital allocation and spend. As I hope you can see from my prior comments, we are tightly focused on optimizing our resources and being good stewards of shareholders' capital. With focus on expense control, our total operating expenses are down 8% year over year. In April, we raised $11.4 million, which combined with our existing balance sheet will help us fund continued development of the HLHS program, and regulatory discussion for Alzheimer's disease program into the fourth quarter. The data generated to date in HLHS and Alzheimer's disease all support broad potential for LOMUS-LB as a regenerative medical therapy across multiple indications. The strength of that data, our experienced and committed team, and the unwavering focus on patients give me confidence in the future of Lomas LB and Longevaron. With that, I will turn the call to Dr. Agassinova to provide an update on the clinical development program. Natalia?