Greetings, and welcome to the Longeveron’s Third Quarter 2023 Earnings call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions]. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Moyer. Mike, please proceed.

Thank you, operator. Good morning, everyone and welcome to Longeveron’s third quarter 2023 results conference call. Today we will discuss financial results for the quarter ended September 30, 2023 and provide a business update. Earlier this morning, we issued a press release with these results, which can be found under the Investor section of Longeveron’s website. I am joined today by the following members of Longeveron’s management team. Mr. Wa’el Hashad, Chief Executive Officer; Nataliya Agafonova, Chief Medical Officer; and Lisa Locklear, Chief Financial Officer. Mr. Hashad will begin with a brief corporate overview then Dr. Agafonova will review Longeveron’s recent progress in its clinical programs; and Ms. Locklear will review financial results for the third quarter. Following the company’s prepared remarks, we will open the call to questions from covering analysts. As a reminder, during this call, we will 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 statements should be considered in conjunction with cautionary statements in our press releases and risk factors discussed in our filings with the SEC, including our quarterly report on Form 10-Q and Annual Report on 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 Mr. Wa’el Hashad, Chief Executive Officer of Longeveron. Wa’el? Wa’el Hashad: Thank you Mike and good morning everyone. Welcome to the Longeveron third quarter 2023 business update and financial results call. We are pleased to be speaking with you today and look forward to sharing our progress developing regenerative medicines for unmet medical needs. Our third quarter and recent weeks have been very productive led by top line results…

Thank you Wa’el. I will begin with a brief review of our Alzheimer's disease program and the top line results we recently presented from our Clear Mind Study. Based on the growing body of preclinical and clinical data from various sources, we believe Lomecel-B may prevent the clinical progression of Alzheimer's disease by reducing disease related brain inflammation. Neuronal cell death caused by earlier and substantial neuro-inflammation is a significant contributor to the pathogenesis of Alzheimer's disease. In preclinical models of Alzheimer's disease, MSCs with characteristics similar to Lomecel-B has been shown to cause the blood brain barrier, potentially with anti-inflammatory effect, improving endothelial function and promoting neurogenesis, the process of neuron formation in the brain. Our Phase 2A trial of Lomecel-B for mild Alzheimer disease called the Clear Mind Trial completed enrollment in November of 2022. Clear Mind is a 48 patient forearm parallel design, randomized clinical trial of Lomecel-B designed to evaluate the safety of single and multiple infusions of two different dose levels of Lomecel-B compared to placebo in patients with mild Alzheimer disease. The primary endpoint is safety as measured by the occurrence of serious adverse events within the first 30 days after administration of Lomecel-B. Secondary and exploratory endpoints include measures of cognitive function, fluid, and radiological biomarkers relevant to inflammation and the failure of vascular systems. In a previously completed Phase 1 study, we demonstrated a preliminary safety of Lomecel-B patients with mild to moderate Alzheimer disease. Results from Clear Mind show that the primary endpoint of safety was met based on statistical and medical assessment. There was one serious adverse event reported on each Lomecel-B treatment group and none on placebo. Each SAE was reviewed and assessed by the data and Safety Monitoring Board with no safety issues raised. The study of safety…

Thanks, Nataliya, and good morning, everyone. What I'm covering this morning will be presented in more detail in our condensed financial statements and in our management's discussion and analysis of operations in our quarterly report on Form 10-Q, which we filed yesterday. Revenues for each of the three months ended September 30, 2023 and 2022 were approximately $0.2 million and $0.3 million, respectively. Grant revenue for the three-months ended September 30, 2023 and 2022 was 0 and $0.1 million, respectively. The decrease was primarily due to a reduction in grant funds available due to the completion of the grant-funded clinical trial. Clinical trial revenue, which is derived from the Bahamas registry trial, for the three-month periods ended September 30, 2023 and 2022 was $0.2 million. Clinical trial revenue for the three-months ended September 30, 2023, decreased by less than $0.1 million compared to the same period in 2022 as a result of a decrease in participant demand. Related cost of revenues was approximately $0.1 million and $0.2 million for the three-months ended September 30, 2023 and 2022, respectively. The decrease of $0.1 million or 45% was primarily due to the decrease in revenues earned from the Bahamas registry trial. This resulted in a gross profit of approximately $0.1 million for both of the three-month periods ended September 30, 2023 and 2022. General and administrative expenses for the three-months ended September 30, 2023, increased to approximately $3.1 million compared to $2.1 million for the same period in 2022. The increase of approximately $1 million was primarily related to increases -- $0.3 million in compensation and benefit expenses, $0.4 million of expenses related to legal and professional fees, and $0.4 million of expenses related to the subscription rights offering. These increases were partially offset by a decrease of $0.1 million in stock-based…

Thank you. [Operator Instructions]. Our first question comes from Michael Okunewitch. Please proceed.

Hey Wa’el. Thank you for taking the questions today. I guess to kick things off, I just want to ask something about your strategy regarding HLHS given that you have this strong data from ELPIS I. What sort of community outreach and awareness building are you doing or given the rare nature of the disease, the unmet need is there not really a need to do all that much more than presenting data at conferences and strategically selecting sites for the ELPIS II study? Wa’el Hashad: Hi Michael, good morning and thank you for the question. I think it's a great question and I will pass it on to Nataliya, who have been since she came, she started reaching out to advocacy groups and other communities within the Hypoplastic Left Heart Syndrome. As you know, HLHS is a rare, ultra-rare actually for that matter, ultra-rare disease. So there are not too many communities, but there are some communities and I will have Nataliya give you a little bit of some of the examples that we are working on. Nataliya?

Thank you so much, Wa'el and thank you so much, Michael, for your question. And you're absolutely right, because it's a rare disease, my first probably action when I came to the company was so, how do we increase awareness. And there are few steps we are currently doing. The largest advocacy group existing for this particular indication even not just for rare disease, but even for HLHS, it's called Sisters by Heart. We reach out Sisters by Heart, we are collaborating right now to engage with parents, engage with physicians who are treating this disease just to increase awareness that our trial exists and do everything possible for patients, for parents, for community to be aware. In addition, besides that, of course, we are very actively engaged with our sites. We are visiting them. We understand more about this patient care, about the disease. And we are reaching more other potential programs which exist as a network for parents to be aware about HLHS, and this is in progress. Wa’el Hashad: Yes. And of course, Michael, we did also one key opinion leader event that was hosted by three top key opinion leaders to educate everyone on the Hypoplastic Left Heart Syndrome. It was conducted by Dr. Sanjay Kaushal, Dr. Ram Subramanian, and Dr. Josh Hare. And it's available also as an enduring material on both our website and LifeSci our Investor Relations portal as well.

Alright, yes. Thank you for that. And then one more for me and I'll hop back into the queue. I just want to see with the full Clear Mind data coming up in the next few weeks, are there any particular additional analyses that you think we should be keeping our eye up for? Wa’el Hashad: Yes, of course. This will be a complete study report, so it will include the data that we disclosed. But as Nataliya has mentioned, we are going to also announce additional analysis from additional scales that we have not presented, cognitive scales, such as MMSC, [indiscernible]. We're also going to be presenting more detailed MRI data. And of course, all the biomarker data, which is a large data set, that's why it's taking a lot of time to do the analysis. So there will be a lot of additional analysis is coming, but those are the three. The cognitive scales, the MRI data, and the biomarker data are the three things that people have not seen before. And I think they all will be interesting.

Alright, thank you. We're looking forward to it.

Thank you.

[Operator Instructions]. This concludes our question-and-answer session. I would like to turn the floor back over to Wa'el Hashad for closing comments. Wa’el Hashad: Alright, thank you, operator. Alright, well thanks everyone for attending the call today. On behalf of Longeveron, I would like to thank you for your continued interest and support and wish you a good day today. Thank you.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.