11/10/2023

speaker
Operator
Conference Operator

Greetings and welcome to the Longevron 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. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Moyer. Mike, please proceed.

speaker
Mike Moyer
Host

Thank you, Operator. Good morning, everyone, and welcome to Longevron's third quarter 2023 results conference call. Today, we will discuss financial results for the quarter ended September 30th, 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 Longevron's website. I'm joined today by the following members of Longevron's management team. Mr. Wael Ashad, Chief Executive Officer. Natalia Agata-Fanova, Chief Medical Officer, and Lisa Locklear, Chief Financial Officer. Mr. Ashab will begin with a brief corporate overview, then Dr. Agata-Fanova will review Longeviron'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. Wael Ashad, Chief Executive Officer of Longeviron. Wael?

speaker
Wael Ashad
Chief Executive Officer

Thank you, Mike, and good morning, everyone. Welcome to the Longeviron 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 we announced from the ClearMind Alzheimer's Disease Trial, which affirmed the safety profile of Lomacil-B and provided a clear efficacy signal. We are also presenting extended survival data from LPS1 trial of Lomacil-B in hypoplastic left heart syndrome, also known as HLHS. at the scientific session of the American Heart Association and took steps to strengthen our balance sheet, securing $4 million gross proceeds before expenses from equity financing to support our continued advancement of these clinical programs. I will turn the call over to my colleagues, Dr. Akpanova and Lisa Locklear, in a moment to review the development in detail. But first, I'll begin with a brief overview of the Lomasol B. Our product candidate, Lomasol B, is a living cell product made from a specialized cell isolated from a bone marrow of young healthy adult donor age 18 to 45. These specialized cells are known in the literature as medicinal signaling cells or MSCs. and are essential to our endogenous or built-in biological repair mechanisms. MSCs have been shown to perform a number of complex functions in our body, including the formation of new tissues. They also have been shown to hone and respond to sites of injury or disease and to create bioactive factors that are immunomodulatory and regenerative. We believe that Lomacil-B has multiple potential mechanisms of action that may lead to anti-inflammatory, probascular regenerative response, and therefore may have a broader application of a range of rare and aging-related diseases. We have ongoing programs in hypoplastic left heart syndrome, or HLHS, Alzheimer's disease, and aging-related frailty. Our LPH2 trial in HLHS has exceeded its 50% enrollment threshold, and we have activated additional clinical sites to further expedite enrollment. This is our priority program and our focus on completing enrollment in this trial in 2024. As I mentioned, we also announced positive top-line results from our ClearMind Phase 2A trial for Lomacil-B treatment in Alzheimer's disease last month. and expect full data from this trial in the coming weeks. In aging-related priority, enrollment continues to progress in our Phase II study in Japan. The data we have generated in HLHS Alzheimer all supports a broader potential of Lomacil-B as a regenerative medicine therapy for a range of unmet needs, and we are excited about the progress we are making. With that, I will turn over the call to Dr. Natalia Akvanova to provide more detailed overview of our clinical program and recent progress. Natalia?

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