Longeveron Inc.

Greetings and welcome to Longevity 2025 Full Year Financial Results and Business Update. At this time, all participants are on a 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. As a reminder, this conference call is being recorded. I would now like to introduce your host, Jenny Coben. Thank you, you may begin.

Good afternoon, everyone, and thank you for joining us today to review Longevron's 2025 full-year financial results and business updates. After the U.S. markets closed today, we issued a press release with the financial results for 2025, which can be found under the Investors section of the Longevron website. On the call today are Stephen Willard, Chief Executive Officer, Joshua Hare, Co-Founder, Chief Science Officer and Executive Chairman of the Board, Natalia Agafanova, Chief Medical Officer, and Lisa Locklear, Chief Financial Officer. 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 Stephen Willard, CEO. Steve?

Thank you, Jenny, and thank you all for joining us today. I am excited and honored to join Longeviron at this pivotal moment for the company. The strength of the company's stem cell science and success in multiple clinical trials across several indications positions Longeviron to be a leader in the stem cell field. Upon assuming the role of CEO, I have had an immediate focus on three critical areas. First, securing necessary financial resources and planning efficient capital allocation. I'm delighted to report, as you have hopefully seen from our prior press releases, that we have secured $15 million in new capital from, among others, what I believe are two of the premier fundamental institutional investors in biopharma. Coastlands Capital, that's Matthew Perry, and Janus Henderson Investments. We also have the potential to close a second tranche of an additional 15 million upon meeting certain milestones. We are grateful for their investment, support, and shared vision of advancing stem cell therapies for the benefit of patients and their families. The initial capital from the financing provides runway comfortably into the fourth quarter of 2026. Second, this capital enables us to complete and deliver the results of the ELPAS-2, our anticipated pivotal phase 2B study in HLHS, and potentially, if supported by the data, begin preparation of the company's first BLA with the US FDA. Enrollment of the clinical trial was completed in June of last year, and we remain on track for reporting results in the third quarter of this year. Third, strategic partnering. We plan to pursue a robust partnering strategy across all of our development programs to accelerate potential time to market, increase capital use efficiency, and leverage the greater resources of larger organizations. For HLHS, we believe that the optimal timing to secure a potential BLA and commercialization partner will be following the readout of the ELPAS II clinical trial results in the third quarter of this year. For Alzheimer's disease, we plan to leverage the strength of our phase two data and clarity on the clinical pathway to a potential BLA for Alzheimer's disease to engage with potential funding commercialization partners. For pediatric dilated cardiomyopathy, or PDCM, we intend to execute a single pivotal phase two registrational study under our active FDA IND, leveraging an efficient development strategy appropriate for a rare pediatric disease. If successful, this study could form the basis of a potential BLA submission pending FDA alignment. Upon successful completion, we intend to pursue strategic partnership opportunities to support regulatory approval and commercialization. Finally, and potentially very significantly, are our opportunities for priority review vouchers, or PRVs. Our HLHS program has been granted rare pediatric disease designation by the FDA, which makes it eligible to receive a PRV upon approval of a BLA. And the same opportunity may exist for our PDCM program to also be eligible for a PRV. Companies can either use the PRV to secure a speedier FDA review of a future therapy or sell it to another company. Since August of 2024, vouchers have been sold for between $150 and $205 million each. Securing one or more PRVs would obviously be a tremendous financial outcome for the company and shareholders. In our recent private placement, we agreed to pursue a sale of a PRV received for HLHS, if granted, and that the investors would be entitled to 50% of the proceeds received from the potential future sale of the HLHS PRV. It is an exciting time for Leromestosil, the patients we serve, Longeviron, and our shareholders. With that, I will turn the call over to Dr. Aga Vinova, our Chief Medical Officer, to touch on the clinical development programs. Natalia?