Greetings and welcome to Longeveron's call today to discuss the results of the company's Phase 2b Aging Frailty trial and Second Quarter 2021 Financial Results. All participants are currently in a listen-only mode. Following the formal presentation, we will open the call up for question-and-answer session. [Operator Instructions] I'd now like to turn the call over to Brendan Payne from Stern IR. Brendan, you may proceed.

Thank you, operator. Good morning everyone and welcome to Longeveron's call today to discuss the results of its U.S. Phase 2b trial of Lomecel-B and the Aging Frailty, and second quarter 2021 business update and financial results. Earlier this morning, Longeveron issued a press release summarizing its second quarter 2021 financial results with a corporate update that we will discuss on today's call. Concurrent with the aforementioned release, Longeveron also issued a press release this morning, announcing the top-line results from its recently completed Phase 2b clinical trial with Lomecel-B and subjects with Aging Frailty. You can access both press releases by going to the new section of Longeveron's website longeveron.com. I'm joined on the call today with the following members of Longeveron's management team. Mr. Geoff Green, Chief Executive Officer; Mr. Joshua Hare, Co-Founder, Chief Science Officer and Chairman; and James Clavijo, the Chief Financial Officer. We're going to begin the update with a detailed overview of the top-line data from the Phase 2b trial, which was announced this morning. This clinical trial results discussion will be provided by Dr. Hare. After that Mr. Green will give a brief general update and summary of recent events, and we will conclude with a recap of our financial results from the second quarter of 2021, followed by Q&A period. As a reminder, during this call, we'll be making forward-looking statements which are subject to various risks and uncertainties that could cause our actual results to differ materially from these statements. Any such statement should be considered in conjunction with cautionary statements in our press releases and risk factors discussion in our filings with the SEC, including our last Annual Report, or Form 10-K, and cautionary statements made during this call. We assume no obligation to update any of these forward-looking statements or information. Now, I'd like to turn the call over to Dr. Joshua Hare, Co-Founder, Chief Science Officer and Chairman of Longeveron. Dr. Hare?

Thank you, Brendan. It's a pleasure to speak with – to you today and I'm excited to discuss the results of our lead clinical trial, Lomecel-B. To start let me review the background and various initiatives of our Aging Frailty program for the benefit of the listeners. Several years ago, we launched two clinical trials evaluating Lomecel-B and older individuals diagnosed with mild to moderate Aging Frailty. One was to study the effects of Lomecel-B primarily on endurance exercised to tolerance and mobility. We referred to this trial as the Phase 2b trial. And the second trial designated to evaluate with Lomecel-B can improve immune response in at-risk frail subjects receiving the influenza vaccine. We referred to this as the HERA trial. Both of these trials were awarded grants along the way with substantial funding received from the National Institute of Health, National Institute of Aging for the Phase 2b and a Maryland Stem Cell Research Fund TEDCO award for the HERA trial. As announced earlier this year, we completed both of these trials and we now have the data for the Phase 2b. We anticipate announcing data from the HERA trial later in this third quarter. In addition to the U.S. frailty trials, our Japanese Phase 2 Aging Frailty clinical study is on track to initiate later this year being led by our partners at the National Center for Geriatrics & Gerontology in Japan. And finally, we sponsor a registry in the Bahamas under the approval and authority of the National Stem Cell Ethics Committee while like in the U.S. and Japan, Lomecel-B is considered investigational and not approved for commercial sale under the approval terms from the Ethics Committee, we are permitted to charge a fee to participants, which offsets the costs of sponsoring the Registry Trial. Our…

Yes.

The secondary analysis of the primary endpoint was to determine whether a dose response relationship exists using the multiple comparisons and modeling approach described by Bretz et. al. We were extremely pleased to see a clear statistically significant dose response curve at day 180. Among the various dose response curves evaluated, which are statistical modeling techniques, Emax, Linear, Exponential, Quadratic, and Sigmoid Emax all had a p-value of less than 0.05 bonds with the Sigmoid Emax model having the most significant dose-response relationship p equals 0.017. This was one of the primary objectives of the study, and we believe that this may be one of the very first MSCs studies to show a dose response based on review of previously published studies in the public domain. The study's key secondary endpoints were day 180 change in the patient reported outcome questionnaire PROMIS, Physical Function, Short Form 20a, SF-20a, total score and day 180 change in serum levels of tumor necrosis factor alpha, an inflammatory cytokine. The Lomecel-B cohorts did not show a statistically significant difference compared to the placebo cohort in the SF-20a score, and the TNF-α analysis is still pending as of the rest of the biomarkers. The remainder of the efficacy endpoints, which included assessment of physical function, sexual function, fear and risk of falling, depression, cognition, frailty status, pulmonary function, and clinical outcomes, were considered exploratory and Lomecel-B-treated groups did not show significant differences versus placebo at most of the time points for any of these endpoints. Based on the results observed at 270 days, we believe that a larger and/or extended trial would have a greater likelihood of achieving statistical significance and that there is strong evidence to support a continued dose dependence response. Baseline demographics and the trial will balance between the treatment groups and analysis of adverse events, laboratory tests, vital signs, and body weights demonstrated that patients on active Lomecel-B dose groups were generally comparable to the placebo group with respect to safety. There were no serious adverse events reports that were considered related to Lomecel-B infusion. The full body of results of the study will be exceptionally valuable to inform the continued advancement of Lomecel-B for the treatment of Aging Frailty in addition to the other disease indications, which we are investigating as we engage in further discussion with the FDA and other international regulatory bodies. Based on these results, Longeveron is committed and determined to continue pursuing Lomecel-B as a pioneering treatment to ameliorate the detrimental symptoms and address the critical and medical unmet medical need in Aging Frailty. We look forward to presenting the full results of this trial next month at the upcoming 2021 International Conference of Frailty & Sarcopenia Research on September 29th. I thank you for your attention. And at this point, I would like to turn the call over to Geoff Green, CEO of Longeveron for a general business update. Geoff?

Thank you, Dr. Hare. Good morning everyone and thanks again for attending Longeveron's second quarter 2021 business update and earnings call. I'm excited about the Phase 2b results and to share the tremendous progress we have made this quarter and this year. It's been busy and productive quarter. I'm going to start with an update on our various research programs, provide progress updates, and then anticipated near-term catalysts for 2021. And following this James Clavijo will go through the financial performance for the quarter. And since we're still a relatively new public company and there may be a first time listeners on the call, I'm going to spend a minute reintroducing the company and our lead therapeutic product to the audience. So Longeveron is a leading clinical stage biotechnology company that's developing cell therapies for chronic aging related diseases and other life-threatening conditions for which there are no approved treatments. So aging is the number one risk factor for chronic disease stem cell exhaustion, cellular senescence and chronic inflammation together referred to as inflammaging compromises our ability to repair and regenerate damaged tissues and organs. Inflammaging is linked to the rise of progressive chronic diseases such as Alzheimer's disease and Aging Frailty. Our focus since day one has been to develop safe and effective allogeneic cell therapy solutions for the treatment and prevention of these diseases. Our lead therapeutic investigational product called Lomecel-B is a living cell biologic made from the specialized cells isolated from the bone marrow of young healthy adult donors. These cells called medicinal signaling cells, or MSCs, reside within various tissues in our bodies and are considered to be the body's indogenous or built-in repair mechanism that promotes regeneration of damaged tissues and organs. When we're young, we have an adequate supply of these cells and…

Thank you, Geoff. Good morning, everyone. Most of what I'll be covering this morning has been presented in more detail in our consolidated financial statements and our management's discussion and analysis operations for the three months ended June 30th, 2021, which has been filed – which will be filed today. Second quarter ended March – revenues for the three months ended June 30, 2021 and 2020 were $0.5 million and $0.9 million respective. The $0.4 million or 44% decrease when compared to the same period in 2020 was primarily due to a decrease in grant revenue year-over-year and grant revenue compared to that recorded in 2020. Grant revenue for the three months ended June 30, 2021 and 2020 was $0.3 million and $0.9 million respectable. The $0.6 million or 68% decrease when compared to the same period of 2020 was primarily due to a reduction in grant funds available to the completion – due to the completion of the grant funded clinical trials. Clinical trial revenue, which comes from The Bahamas Registry Trial for the three months ended June 30, 2021 and 2020 was $0.2 million and zero dollars respectable. Clinical trial revenue for the three months ended June 30, 2021 was $0.2 million or 100% higher when compared to the same period in 2020. During the second quarter of 2020 clinical trial revenue, which is comprised of a Bahamas Registry Trial was negatively impacted by COVID-19 travel restrictions as participants face travel restrictions, as well as concerns for international travel. Related cost of revenue was $0.3 million and $0.8 million for the three months ended June 30, 2021 and 2020 respectively. The $0.5 million or 63% decrease when compared to the same period in 2020 was primarily due to lower costs of revenues for grants incurred in 2021. This…

Thank you, James. So as Dr. Hare explained in detail, we have wealth of data from our now completed Phase 2b trial, and we will love to move to the next step of clinical development of Lomecel-B for treatment of Aging Frailty. And we'll also be receiving more data shortly related to the biomarkers from that trial as well as the data from the HERA trial expected this – later this quarter. And we'd like to thank the clinical investigators and patients and our research partners who participated in the Phase 2 trial. Our dedicated employees for their diligence efforts, the NIA of course for their funding and support and our committed shareholders for their ongoing support. We're excited to be underway on the Phase 2 HLHS trial and look forward to initiating both the Phase 2 Alzheimer’s disease and Japanese Aging Frailty trials later this year, and we'll continue to provide updates as progress is made. We're well-positioned in terms of capital to advance these programs forward and hit the milestones and catalysts that I've outlined during this update. At this point, I'd like to open the call for questions. Operator?

Thank you. So I think we've done the concluding remarks and at this point I'd like to thank everybody for attending the call and I look forward to further updates.

This now completed today's call. Thank you everyone for joining. You may now disconnect.