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| Statement |
|---|
| The ELPIS I data were highly encouraging and reinforce our enthusiasm for Lomecel-B as a potential treatment to transform care for patients with HLHS |
| Supported by data obtained from ELPIS I and CLEAR MIND, we are confident that Lomecel-B represents an important potential breakthrough for patients and an attractive value proposition for our investors |
| Many of them will be in Europe, but there is also a considerable amount of HLHS in Japan and other countries as well that represents a very good opportunity for the international market |
| And that represents a very good commercial opportunity |
| First, I want to say that we are extremely excited and happy with the results that we have seen out of the CLEAR MIND trial |
| We also took steps to strengthen our balance sheet, securing $6.4 million of gross proceeds from equity financing during the fourth quarter |
| As such, there is an important unmet medical need to improve right ventricular function in these patients to improve both short-term and long-term patient outcomes |
| We believe these results support the therapeutic potential of Lomecel-B in the treatment of mild Alzheimer’s disease and provide evidence-based support for further clinical development |
| We remain confident that we can launch the product in the U.S |
| The data that we have generated in HLHS and Alzheimer's disease all support broader potential for Lomecel-B as a regenerative medical therapy for range of unmet medical needs |
| In order to accelerate this, we believe that one of the best mechanisms is to share some of the best practices from the sites that has been there |
| Though we remain confident in the broader therapeutic potential of this asset, we believe that narrowing our focus in the near-term on HLHS is the best interest of the patients, investors and our shareholders |
| We are pleased speaking with you today |
| During this year, that's 2023, we made significant progress advancing our lead assets, Lomecel-B, to important milestones |
| Overall, it's excitement in the area |
| And I also believe there could be also with the type of data that we have presented so far, that this is going to get more people to be excited about that view |
| There is an option for this patient – for patients and the feedback was overwhelmingly positive |
| I can tell you that all the 2025, 2026 expenses will be saved in addition to a significant saving in 2024 |
| We announced top line results from this trial in October 2023, an additional positive clinical data and MRI data results last December |
| Specifically, cognitive function improved as measured by MOCA, Montreal Cognitive Assessment Score, with p-value 0.05 |
| Net loss increased to approximately $21.4 million for the year ended December 31, 2023, from a net loss of $18.8 million for the same period in 2022 |
| The additional clinical data and MRI data we announced in December showed improvement in clinical and MRI endpoints in specific Lomecel-B growth compared to placebo |
| 2023 was a productive year for Longeveron |
| As you know, HLHS even if it's addressed by the surgery, but the three stages of surgery, there are still limitations and surgeons and everybody who taken care of these patients, also looking for the opportunities to improve lives of these patients and mostly improve the long-term survival and delay or even not to have heart transplantation |
| HLHS is our top priority program, and we believe our most important value driver in near-term |
| That's certainly extremely helpful |
| So there is an overall excitement |
| Good to talk to you guys and good presentation |
| Yes, yes, the positive results, and like you said, it's a major problem in the United States |
| On behalf of Longeveron, I would like to thank you for your continued interest and support and wish you a good day today |
| Statement |
|---|
| Clinical trial revenue for the year ended December 31, 2023, decreased by $0.2 million when compared to 2022 as a result of decreased participant demand |
| 2023 revenues decreased $0.5 million or 42% when compared to 2022 as a result of decreased grant revenue and lower participant demand for our Bahamas Registry Trial |
| Furthermore, even those children this successful surgical intervention are at elevated trees of short-term mortality, delayed development and long-term complications, including organ failure |
| Brain neuroinflammation as measured by diffuse tensor imaging, DTI also diminished with p-value 0.01 |
| The decrease of $0.2 million was primarily due to the decrease in the revenues earned from Bahamas Registry Trial and reduced direct costs associated with our Grants program |
| It is one of the biggest public health crisis that we have faced in recent years, and there is a lot of people who want to put money |
| This resulted in a gross profit of approximately $0.2 million for the year ended December 31, 2023, when compared – a decrease of $0.3 million when compared with a gross profit of $0.5 million for 2022 |
| Research and development expenses for the year ended December 31, 2023, decreased to approximately $9.1 million from approximately $9.4 million for the same period in 2022 |
| As you also know, that was a trial that has been going now for over 1.5 year, sometimes sites gets a fatigue |
| HLHS, for those who might not know, is a rare congenital and devastating birth defect in which the left the ventricle of the heart is either severely underdeveloped or missing |
| While these children can now live into adulthood with surgical intervention, only 50% to 60% of affected individuals survive to adolescents due to right ventricle failure, which is often unable to handle the increased load required to support systemic circulation |
| Babies born with this condition have severely diminished systemic blood flow which require children to undergo a complex three-stage heart reconstruction surgery process over the course of the first five years of their life |
| Brain MRI demonstrated whole brain volume loss slowed accompanied by significant preservation of left hippocampal volume |
| I had several questions |
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