Q4 2023 Longeveron Inc Earnings Call

Okay.

Operator: Ladies and gentlemen, good afternoon, and welcome to the Longeveron fourth quarter and full year 2023 earnings conference call. At this time, all participants are in a listen-only mode.

Ladies and gentlemen, good afternoon.

Welcome to the love Chevron fourth quarter and.

And full year 2023 earnings conference call.

At this time.

The participants are in a listen only mode a brief.

Operator: A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Moyer, Managing Director of Lifesky Advisors.

Question and answer session will follow the formal presentation.

If anyone should have final paid during the conference. Please press star and fetal on your telephone keypad.

As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host Mike Boyle, managing director of lifestyle Advisors. Please go ahead.

Mike Moyer: Thank you, operator. Good afternoon, everyone, and welcome to Longeveron's 2023 Year-End Results conference call. Today, we will discuss financial results for the year ended December 31st, 2023 and provide a business update. After the market closed today, we issued a press release with these results, which can be found in the investor section of the Longeveron website. I'm joined on the call today by the following members of Longeveron's management: Mr. Wael Hashad, Chief Executive Officer, Dr. Natalia Agafonova, Chief Medical Officer, and Lisa Locklear, Chief Financial Officer. Mr. Rashad will begin with a brief corporate update, then Dr. Agafonovo will review Longeveron's progress in its clinical programs, and Ms. Locklear will review the financial results for 2023. Following the company's prepared remarks, we will open the call to questions from covering analysts.

Thank you operator.

Good afternoon, everyone and welcome to the longevity runs 2023 year end results conference call today, we will discuss financial results.

From the year ended December 31, 2023, and provide a business update after the market close today.

We issued a press release with these results, which can be found under the investors section of the launch of our own website.

I'm joined on the call today by the following members of longevity runs management team Mr. Wilders Szot, Chief Executive Officer, Dr. <unk> Italiana, I got to know about Chief Medical Officer, and Lisa Lochner, Chief Financial Officer, Mr. Ryszard will begin with a brief corporate update that Doctor I got for Novo will review lunch everyone's progress in its clinical programs I missed a lot there.

We will review the financial results for 2023.

Following the Companys prepared remarks, we will open the call to questions from covering analysts as a reminder, during this call. We will make 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.

Mike Moyer: As a reminder, during this call, we will make forward-looking statements that 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 reports 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 Longeveron. Wael?

And the risk factors discussed in our filings with the SEC, including our quarterly reports 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.

Like to turn the call over to Mr. Wild Schott, Chief Executive officer of longevity well.

Yeah.

Wael Hashad: Thank you, Mike. Good afternoon, everyone. We are pleased to be speaking with you today. On this call, we briefly recap the major highlights for our year in 2023 and outline strategic priorities for 2024. Then, we will be happy to answer any questions you have. 2023 was a productive year for Longeveron.

Thank you Mike good afternoon, everyone.

We are pleased speaking with you today.

This call we briefly recap of the major highlights for our year in 2023 and outline our strategic priorities for 2024.

Then we would be happy to answer any questions you have.

2023 was a productive year for as long as you brought up.

Wael Hashad: During this year, that is 2023, we made significant progress advancing our lead asset, Lomacell B, to important milestones, including presenting long-term survival data from our ALPES-1 clinical trial in hypoplastic left heart syndrome at the American Heart Association annual meeting in Philadelphia and announcing clinically meaningful results from our Phase 2a Clear Mind Trial in Alzheimer's Disease. We also took steps to strengthen our balance sheet, securing $6.4 million of gross proceeds from equity financing during the fourth quarter.

During this year and that's 2023 we made significant progress advancing our lead athletes not months there'll be so important milestones.

Presenting long term survival data from our Opus, one clinical trial and Hypoplastic left heart syndrome at the American Heart Association annual meeting in Philadelphia, and announcing clinically meaningful result.

From our phase two a clear mind trial in Alzheimer's disease.

Yeah.

We also took steps to strengthen our balance sheet, securing $6 4 million dollar of gross proceeds from equity financing during the fourth quarter.

Okay.

Wael Hashad: For 2024, our strategic priorities are focused on our LEAD program and hypoplastic left heart syndrome, or HLHS. With the goal of completing enrollment in our LPS2 Phase 2 clinical trial this year, LPS2 has exceeded its 50% enrollment threshold, and we are working with the clinical investigators to expedite enrollment. HLHS is our top priority program, and we believe it is our most important value driver in the near term.

For 2024, our strategic priorities are focused on our lead program and Hypoplastic left heart syndrome or HLA chess.

With the goal of completing enrollment in our phase two phase two clinical trial this year.

Phase two has exceeded its 50% in goldman's Nashville, and we are working with our clinical investigators.

Expedite enrollment.

And so my chest is our top priority program.

And we believe our most important value driver in the near term.

Wael Hashad: Accordingly, we made the strategic decision to discontinue our Phase II clinical program in aging-related frailty in Japan in order to focus on our available resources for HLHS and LH2 enrollment. We are also exploring opportunities to advance our Alzheimer's disease program through potential partnerships or other sources of funding. These steps will allow us to focus our available resources on completing enrollment in our ELPIS-II study in 2024. The data that we have generated in HLHS and Alzheimer's disease all support broader potential for Lomacell-B as a regenerative medical therapy for a range of unmet medical needs.

Accordingly, we made the strategic decision to discontinue our phase II clinical program in aging related frailty in Japan.

Order to focus on our available resources on actually Chad and Apis to enrollment.

We are also exploring opportunities to advance our Alzheimer's disease program through potential partnership or other sources of funding.

These steps will allow us to focus our available resources on completing enrollment in our opus two study in 2024.

The data that we have generated and estrella chats in alzheimer disease, all support broader potential for lummus upbeat as a regenerative medical therapy for a range of unmet medical need.

Wael Hashad: 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 in the best interest of the patients, investors, and our shareholders. With that, I will turn the call over to Dr. Akshanova to provide you with a review of the recent data on our clinical program so far. Natalia

Though we remain confident in the broader therapeutic potential of this asset we believe that narrowing our focus in the near term on <unk> is the best interest of the patient investors and our shareholders.

With that I will turn the call to Dr. I can never to provide you a review of the recent data on our clinical program.

So far Natalia.

Thank you what have you and good afternoon everyone.

Dr. Natalia Agafonova: Thank you, Ariel, and good afternoon, everyone. Today I will provide a brief overview of our HLHS program, discuss the extended survival data we presented from our LPIS-1 trial results at the AHA Scientific Session, and update our progress in enrolling patients for our LPIS-2 study. Then I will review the additional results we announced from our ClearMind study in Alzheimer's disease. HLHS, for those who might not know, is a rare congenital and devastating birth defect in which the left ventricle of the heart is either severely underdeveloped or missing. The condition affects approximately 1,000 babies per year in the United States. Babies born with this condition have severely diminished systemic blood flow, which requires children to undergo a complex three-stage heart reconstruction surgery process over the course of the first five years of their lives. While these children can now leap into adulthood with surgical intervention, only 50 to 60 percent of affected individuals survive to adolescence due to right ventricle failure, which is often unable to handle the increased load required to support systemic circulation.

So that will provide a brief overview our HOA chest program just got the extended survival data, we presented from our Elk. This one trial results and the E cheap sainte succession and update our progress in enrollment for our eldest to study that.

I can't believe you did you spend all the results. We are now from a clear mind study in Alzheimer's disease.

H only chance for those who may not know is a rare congenital and devastating birth defects in Vichy that left again she calls the heart, it's either severely underdeveloped or niche in the condition affects approximately thousand babies per year in the United States.

Babies born with this condition have severely you mean your systemic blocks little niche require children to undergo a complex D stage heart reconstruction. So generic courses over the course of the first five years of their life.

While these children can now leave into adulthood. This surgical intervention only 50% to 60% of affected individuals survive, although lessons, Utah right ventricle radio reaches often unable to handle the increased load required to support <unk>.

Circulation.

Dr. Natalia Agafonova: Furthermore, even those children with successful surgical intervention are at elevated risk of short-term mortality, delayed development, and long-term complications, including organ failure. 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. As Vael mentioned, the latest long-term survival data from our LPS-1 study, a Phase I of Lomi cell B in children with HLHS, were presented as a poster at the scientific sessions of the American Heart Association. Ten patients participated in the ALPES-1 trial, during which Lomis-LB was injected into the right ventricle, concordant with the stage 2 surgery, also known as the gland procedure.

Furthermore, even though children get successful surgical intervention are at elevated risk of short term mythology delayed development and long term complications including organ failure.

As such there is an important unmet medical needs to improve rising in sequel of function in these patients to improve both short and.

And long term patient outcomes.

It's why you mentioned a lot of their latest long term survival data from our <unk>. One study in five phase one offload them yourselves be in children with H O H yeah.

Presented as a poster at the scientific session of the American Heart Association.

Recent participated in Altice, one trials, you're in vitro Michelle B was injected into the right ventricle concourse at this stage to surgery also known as the Gwen procedure.

In the presented the Dr. Dan Peterson way I'm Mani thoughtful up to five years after treatment.

Dr. Natalia Agafonova: In the presented data, 10 patients were monitored for up to five years after treatment. The data show that 100% of the 10 patients who participated in the LPS1 trial survived and remained heart transplant free for up to 5 years of age after receiving Lomis-LB during their stage 2 surgery. The extended follow-up data on all patients enrolled in the study now includes monitoring for up to five years following treatment with Longishield. The average age at the time of the last follow-up visit was four and a half years, with two patients being five years old.

The data showed that <unk> hundred percent of the say on pay Houston, who participated at the <unk>. One trial survived and remain heart transplant free for up to five years of age after receiving lumi Sobey you were in their stage two so cheap.

And it's full of data on all patients enrolled in the study now includes mine your door and for up to five years following treatment as long as they'll be.

The.

Average age at the time of the law school off because it was a four and half years to patients being five years of age.

Dr. Natalia Agafonova: Additional long-term follow-up is ongoing in the LPS 1 petition. However, historical results from outside studies have shown that children with HLHF have approximately 20% mortality by five years. The LPS-1 data were highly encouraging and reinforced our enthusiasm for low SLB as a potential treatment to transform care for patients with HLA-2. Our LPS-II trial is designed to assess the potential of Lomis-LB to improve right ventricular function and long-term outcomes. The trial is a 38 patient-controlled phase 2 clinical trial evaluating the safety and efficacy of Lomicell B as an adjunct therapeutic to standard of care HLHS.gov. The primary outcome measure is the change in right ventricular ejection practice from baseline to 12 months.

Additional long term follow up but it's not a buoyant in the L. P. One participants here.

Historical results from outside studies have shown that children get a chili chia has approximately three 2% modality by five years.

The L. P for one data were highly encouraging and reinforced our enthusiasm for long as they'll be as a potential treatment to transform care for patients with H only true.

Our L. Pic school trial is designed to assess the potential of long as they'll be doing pulse right to call a function and longer term outcomes. The trial is a story he patient controlled phase two clinical trial evaluating the safety and <unk>.

Could feel polonius Tobey as an adjunct therapeutic to standard of care, a chilly Chesterfield shape there.

The primary outcome measure is the change in right ventricular ejection fraction from baseline to developed months.

Dr. Natalia Agafonova: The trial is funded by grants from the National Institute of Health, National Heart, Lung, and Blood Institute. Our LTSTU trial is more than 50% enrolled, and we are working with clinical investigators and trial sites to expedite enrollment. Completion of LPS II is our priority, and our focus and current plan is to complete enrollment in this trial in 2024. I will turn now to our Phase IIa trial of Lomicelle B for mild Alzheimer's disease; we call it the clear mind trial. A 48 patient, four-arm parallel design randomized clinical trial of Lomicell B designed to evaluate the safety of single and multiple infusions of two different dose levels of Lomicell B compared to placebo in patients with mild Alzheimer's disease.

The trial is funded by grants from the National Institute of Health National Heart lung and Blood Institute.

Our eldest two trial is more than 50% enrolled and we are working with clinical investigators trial sites to expedite and home.

Completion of Lps do without priority and our focus and current plan is to complete enrollment in this trial.

It means it means before.

I don't know two our phase two a M.

A trial as long as they'll be full mild diagnose disease, Nicole it's clear mind trial at 48 basis.

O arm parallel design randomized clinical trial of Felonious L. B.

Designed to evaluate the safety of single and multiple infusion.

Your first dose level of mommy, so be compared to placebo in patients with mild Alzheimer's disease.

Dr. Natalia Agafonova: We announced top-line results from this trial in October 2023 and additional positive clinical data and MRI data results last December. To recap these results, the study met the primary safety endpoint, and no patients experienced Alzheimer-related imaging abnormalities. The study also met its secondary endpoint, a pre-specified composite Alzheimer's disease endpoint with a pre-specified p-value of less than 0.1.

We announced topline results from this trial in October it means it means your tea and additional positive clinical data and MRI data results last December.

During this resolves the study met the primary safety endpoint and no patients experienced I meant related imaging ophthalmologist.

The study also met its secondary endpoint of print at pre specified companies Zeiner disease and point to get pre specified P value less than 0.1.

Dr. Natalia Agafonova: The additional clinical data and MRI data we announced in December showed improvements in clinical and MRI endpoints in specific LOMI cell B groups compared to placebo, the city clear. Cognitive function improved as measured by MOCA, the Montreal Cognitive Assessment Score, with a p-value of 0.05. Daily life activity increased as assessed by the caregiver and measured by the Alzheimer's Disease Cooperative Study activity daily living at p-value, point zero five. Brain MRI demonstrated whole brain volume loss slowed accompanied by significant preservation of less hypocompal volume, bought this p-value 0.5. Brain regions near inflammation and measured by diffuse tensor imaging DTI also diminish with p-value 0.01.

The additional clinical data and MRI data will be announced in December showed improvements in clinical and MRI endpoints in specific would you still be group compared to placebo.

Specifically.

Native function impulse as measured by a more car Montreal cognitive assessment score with a P value point you're fine.

Daily life of T V kit increased as I said by the caregiver and measured by our designers each quarter just started the activities of daily living with P value.

You're right.

Brain MRI demonstrated whole brain volume loss flow accompanied by significant preservation of lap hypocaust boil him.

What gives us the P value 0.5.

Brain near inflammation as measured by diffused tens tens or imaging D. T. I also diminish with P value 0.01.

We believe these results support the therapeutic potential of long as they'll be in the treatment of mild Alzheimer's disease and provide evidence based support for further clinical development.

Lisa Locklear: We believe this result supports the therapeutic potential of Lomicel B in the treatment of mild Alzheimer's disease and provides evidence-based support for further clinical development. We intend to present clear-mind results at major medical meetings in 2024. As Vael mentioned, we are seeking appropriate partnership and source of non-dilutive findings to support further development of Lomicel B in Alzheimer's patients. With that, I'd now like to turn the call over to Lisa Leclerc, our CFO, to discuss our financial results for 2023. Lisa?

Time to present clearer minds results at major medical meetings in the range of three to four <unk>.

That's why you mentioned they are seeking appropriate partnership and source of non dilutive funding to support further development of long as though let me so be in Alzheimers disease.

With that I'd now like to turn the call overly silica layer all tier four to discuss our financial results with me to thank the team Lisa.

Thanks Italia and good afternoon, everyone. Most of what I'll be covering this afternoon is presented in more detail in our condensed financial statements and in our management's discussion and analysis of operations in our annual report on Form 10-K, which we filed today.

Lisa Locklear: Thanks, Natalia, and good afternoon, everyone. Most of what I'll be covering this afternoon is presented in more detail in our condensed financial statements and in our management discussion and analysis of operations in our annual report on Form 10-K, which we filed today. Revenues for the years ended December 31, 2023, and 2022 were $0.7 million and $1.2 million, respectively. 2023 revenues decreased $0.5 million, or 42 percent, when compared to 2022 as a result of decreased grant revenue and lower participant demand for our Bahamas Registry trial. Grant revenue for the years ended December 31, 2023, and 2022 was less than $0.1 million and $0.3 million, respectively.

Revenues for the years ended December 31st 2023, and 2022 we're 0.7 million and $1 2 million, respectively, 2023 revenues decreased zero point $5 million or 42% when compared to 2022 as a result of decreased grant revenue and lower participant.

And for our Bahamas registry trial.

Net revenue for the years ended December 31, 'twenty, two 'twenty, three and 2022 with less than zero point $1 million and zero point $3 million respectively.

The decrease of 0.2 million when compared to 2022 was primarily due to a reduction in grant funds available due in part to the completion of the grant funded clinical trial.

Lisa Locklear: The decrease of $0.2 million when compared to 2022 was primarily due to a reduction in grant funds available, due in part to the completion of the grant-funded clinical trials. Clinical trial revenue, which is derived from the Bahamas registry trial for the years ended December 31, 2023, and 2022, was $0.7 million and $0.9 million, respectively. 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. Related cost of revenues was $0.5 million and $0.7 million for the years ended December 31, 2023 and 2022, respectively. The decrease of $0.2 million was primarily due to a decrease in revenues earned from the Mojave registry trial and reduced direct costs associated with our grants program.

Clinical trial revenue, which is derived from the Bahamas registry trial for the years ended December 31, 2023, and 2022.

Zero point $7 million and 0.9 million respectively.

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 demands.

Related cost of revenues was zero point $5 million and zero point $7 million for the years ended December 31, 2020 Grand in 2022 respectively.

Chris The 0.2 million was primarily due to the decrease in the revenues earned from the Bahamas registry trial and reduced direct cost associated with our grants program.

Lisa Locklear: This resulted in a gross profit of approximately $0.2 million for the year ended December 31, 2023, a decrease of $0.3 million when compared with a gross profit of $0.5 million for 2020. General and administrative expenses for the year ended December 31, 2023 increased to approximately $11.4 million, compared to $8.1 million for the same period in 2022. The increase of approximately $3.3 million was primarily related to an increase of $1.6 million in compensation and benefit expenses, which included $0.4 million of separation costs and $1 million in higher legal, professional, and consulting fees.

This resulted in a gross profit of approximately zero point $2 million for the year ended December 31 2023.

When compared.

Seven zero point $3 million when compared with a gross profit of 0.5 million for 2022.

General and administrative expenses for the year ended December 31, 2023 increased to approximately $11 $4 million compared to $8 $1 million for the same period in 2022.

The increase of approximately $3 $3 million was primarily related to an increase of $1 6 million for compensation and benefit expenses, which included 0.4 million of separation costs.

$1 million in higher legal professional and consulting fees.

Lisa Locklear: $0.4 million of public company expenses and $0.2 million higher equity-based compensation costs allocated to general administrative expenses and $0.1 million for higher board fees. 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. The decrease of $0.3 million was primarily due to decreases of $0.5 million in equity-based compensation allocated to research and development expenses and $0.3 million in compensation and benefits, offset by increases of $0.4 million in supplies and costs to manufacture Lomacell B and $0.2 million in research and development expenses that were not reimbursable by grant. Selling and marketing expenses for the years ended December 31, 2023, and 2022 were $0.8 million and $1.1 million The decrease of $0.3 million was primarily due to decreases in investor relations and international development expenses.

Zero point $4 million of public company expenses.

And.

0.2 million higher equity based compensation costs allocated to general and administrative expenses and 0.1 million for higher board piece.

Research and development expenses for the year ended December 31st 2023 decreased to approximately $9 1 million from approximately $9 4 million for the same period in 2022.

The decrease of zero point $3 million was primarily due to decreases of zero point $5 million in equity based compensation allocated to research and development expenses.

And zero point $3 million in compensation and benefits.

Set by increases of zero point $4 million in supply and cost to manufacture lummus there'll be and zero point $2 million in research and development expenses that were not reimbursable by grants.

Selling and marketing expenses because of the years ended December 31, 2023, and 2022 we're 0.8 million and $1 $1 million, respectively. A decrease of zero point $3 million was primarily due to decreases in investor Relations and international development expenses.

Lisa Locklear: Other expense for the years ended December 31, 2023 and 2022 was $0.4 million and $0.8 million, respectively. Other expense for 2023 decreased mainly as a result of non-operating lawsuit expenses of $1.4 million in 2022 compared to less than $0.1 million in 2023. This decrease was partially offset by realized losses on sales and marketable securities of $0.3 million, write-off of intangible assets of $0.3 million, and a reduced benefit of tax credits of $0.3 million.

Other expense for the years ended December 31, 2023 and 2022 was zero point $4 million and zero point $8 million respectively.

Other expense for 'twenty, two 'twenty three decreased mainly as a result of non operating loss at expenses of $1 4 million in 2022 compared to less than zero point $1 million. In 2023. This decrease was partially offset by realized losses on sales of marketable securities and 0.3 million.

Write off of intangible assets of zero point $3 million and reduced benefit of tax credits of zero point $3 million.

So recorded in other income in 2022 was approximately 27000 for a gain resulting from foreign currency changes and 27000, a sublease rental income.

Lisa Locklear: Also recorded in other income in 2022 was approximately $27,000 for a gain resulting from foreign currency changes and $27,000 of subleased rental income. 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 increase in the net loss of $2.6 million was for the reasons I explained previously.

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 periods in 2022.

The increase in the net loss of $2 6 million was for the reasons I explained previously.

As of December 31st 2023, we had $5 4 million in cash cash equivalents and marketable securities. We believe that our existing cash cash equivalents marketable securities will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 'twenty two.

Lisa Locklear: As of December 31st, 2023, we had $5.4 million in cash, cash equivalents, and marketable securities. We believe that our existing cash and cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of twenty twenty four.

Four we.

We are actively seeking financing opportunities to extend our cash runway, while taking measures to reduce our cash expenditures as we focus our resources on our primary strategic program in H L. H S. These cost saving measures include the discontinuation of our aging related frailty clinical trial in Japan relate.

The staff reductions and continued prudent management of our discretionary spend.

Lisa Locklear: We are actively seeking financing opportunities to extend our cash runway while taking measures to reduce our cash expenditures as we focus our resources on our primary strategic program in HLHS. These cost-saving measures include the discontinuation of our aging-related frailty clinical trial in Japan, related staff reductions, and continued prudent management of our discretionary funds. I would also like to share a key subsequent event. On February 21, 2024, the company's stockholders approved an amendment to the company's Certificate of Incorporation to effect a reverse stock split of its outstanding shares of Class A common stock and Class B common stock at a ratio ranging from 1 for 5 to 1 for 15, with the exact ratio to be set within that range at the discretion of its Board of Directors without further approval or authorization of its stock The date of our reverse stock split and the ratio have not yet been determined. The reverse stock split is intended to address the current stock price, which has been trading below the NASDAQ minimum requirement of $1 per share for nearly a month.

I'd also like to Cherokee subsequent event on February 21, 2024 at the company's stockholders approved an amendment to the company's certificate of incorporation to effect a reverse stock split of its outstanding shares of class a common stock and class B common stock at a ratio ranging from one per foot.

I have two one for 15 with the exact ratio to be set within that range at the discretion of the board of directors without further approval or authorization of its stockholders. The date of our reverse stock split at a ratio have not yet been determined.

The reverse stock split is intended to address the current stock price, which has been trading below the NASDAQ minimum requirement of $1 per share for nearly a month.

With that I, Thank you and I will turn the call over to weigh out.

Yeah.

Thank you Lisa.

So to conclude our focus and 'twenty 'twenty four is on advancing our clinical program and actually chess and completing up as to enrollment.

We also are leveraging the data from our clear mind study with the goal of securing an appropriate partnership for continued advancement of lummus there'll be an alzheimer disease indication.

We are taking appropriate measures to support our effort within currently available resources.

Wael Hashad: With that, I thank you, and I will turn the call over to Yael. Thank you, Lisa. So to conclude, our focus in 2024 is on advancing our clinical program in HLHS and completing office two enrollment. We also are leveraging the data from our ClearMind study with the goal of securing an appropriate partnership for continued advancement of Lomacil B and Alzheimer's disease indication. We are taking appropriate measures to support our efforts within currently available resources, managing our cash spending, and are seeking additional financing opportunities to help realize Lomacell B's potential.

Managing our cash spending and are seeking additional financing opportunities to help realize long they'll be full potential.

Supported by data obtained from up its one unclear mine, we are confident that loomis, albeit a presents an important potential breakthrough for patients and an attractive value proposition for our investors.

Now I would like to open the call for questions. Operator, Please open the line to our covering analysts.

Thank you.

Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question. Please press star and one on your telephone keypad.

Wael Hashad: Supported by data obtained from OfficeOne and ClearMind, we are confident that Lomacell B represents an important potential breakthrough for patients and an attractive value proposition for our investors. Now, I would like to open the call for questions. Operator, please open the line to our covering analyst.

Confirmation tone will indicate your line is in the question queue.

You May press star two if you'd like to remove your question from the queue.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the stock east.

Operator: Thank you. Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question, please press star and 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Ladies and gentlemen, we will wait for a moment, while we poll for questions.

Our first question is from the line of well balanced attach and with H C. Wainwright. Please go ahead.

Hi, This is get passed on behalf of propelling the H C. Wainwright I had several questions.

Operator: You may press stars and 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button. Ladies and gentlemen, we will wait for a moment while we poll for questions. Our first question is from the line of Boo Ballon, Sacha Achan with HC Wainwright. Please go ahead. Hi, this is Dipesh on behalf of Bupalan HC Wainwright.

The first is with respect to the H L. Hs study can you give us.

Additional granularity on the timing of the enrollment completion, so you're looking at might be third quarter, or 24, or a full quarter of 'twenty four.

Fourth quarter of 'twenty four.

Sorry, what was that third quarter you said.

Fourth quarter of 'twenty 'twenty four.

Okay. Thank you.

And then second question you recently presented L. P. S. One trial survival data at the American Heart Society presentation.

Wael Hashad: I had several questions. The first is with respect to the HLHS study. Can you give us additional granularity on the timing of the enrolment completion? So are you looking at maybe the third quarter of 24 or fourth quarter of 24? Thank you.

Can you give us a general sense of the response that you received mainly from the physicians who are treating H L Hs patients.

And that's how you do do you want to take that question.

Sure.

Sure. Thank you so much I had enough, but thank you for the question I had an opportunity to be in front of the poster and reply to questions Oh, some teaching physicians surgeons who are.

Wael Hashad: Fourth quarter of 2024. Okay, thank you. And then, second question: you recently presented ALPIS-1 trial survival data at an American Heart Society presentation. Can you give us a general sense of the response that you received, mainly from the physicians who are treating HLHS patients? Natalia, do you want to take that question?

Came to the poster.

Overall, it's our excitement in the area and you know HLA chess, even if its addressed by the soldiers are you bought the three stages of Thornsberry. There are still limitations and so we're just in a everybody who taken care of these patients also.

Can afford the opportunities to improve lives of these patients are mostly.

Improved our long term survival and you Lee or even not to have heart transplantation. So there is a overall excitement that there is an option for these patients and for patients and there the feedback was overwhelmingly positive.

Dr. Natalia Agafonova: Sure, thank you so much. Thank you for the question. I had an opportunity to be in front of the poster and reply to questions from some treating physicians and surgeons who came to the poster. Overall, there's excitement in the area. As you know, HLHS, even if it's addressed by surgery, but in three stages of surgery, there are still limitations, and surgeons and everybody who takes care of these patients are also looking for opportunities to improve the lives of these patients and mostly improve long-term survival and delay or even not have heart transplantation.

Great. Thank you for that additional car T and I've got one last question can you characterize the ex U S interest in law must sell bes potential in HLA chess treatment.

Do you believe you could out license the asset, but ex U S commercialization and so any information that you can share around the ex U S partnership interests would be appreciated. Thank you.

Dr. Natalia Agafonova: So there is overall excitement that there is an option for this patient, and the feedback was overwhelmingly positive. Great. Thank you for that additional clarification. And I've got one last question. Can you characterize the ex-U.S. interest in Lomacell B's potential for HLHS treatment? Do you believe you could out-license the asset for ex-U.S. commercialization?

Sure I'll take that question.

First and foremost I would say that we are open for as I mentioned in our earning call.

That we are open to any partnership opportunity that are that may come both in the U S and outside of the U S.

Wael Hashad: And so any information that you can share about the ex-U.S. partnership interest would be appreciated. Thank you. Sure. I'll take that question.

We remain confident that we can launch the product in the U S and outside the U S on our own for etch L. A chess.

Particularly for larger indication, we will need a bigger support.

Wael Hashad: First and foremost, I would say that we are open to, as I mentioned in our earnings call, any partnership opportunity that may come both in the U.S. and outside of the U.S. We remain confident that we can launch the product in the U.S. and outside the U.S. on our own for HLHS. Definitely, for larger indications, we will need bigger support. As for the opportunity for HLHS outside of the United States, the prevalence of the disease is fairly similar to the prevalence of the disease in the United States, and it represents a total number of accessible patients of more than 5,000 outside of the United States. Many of them will be in Europe, but there are also a considerable number of HLHS in Japan and other countries as well.

So the opportunity for <unk> outside of the United States the prevalence of the disease.

It's fairly similar to the prevalence of the disease in the United States.

And it's a present of total opportunity.

Accessible patients of more than 5000 outside of the United States Mint.

Many of them will be in Europe, but there is also a considerable amount of etch IHS in Japan and other countries as well.

That's what presents a very good opportunity for the international market.

I would say that we believe our trial.

Once completed.

It will be used as a submission trial for a filing the same application outside the United States, including Europe.

And the one nice thing that I would add on this one and mentioned it before is that the treating community for until it just it's very.

Wael Hashad: That represents a very good opportunity for the international market. I would say that we believe our trial, once completed, could also be used as a submission trial for filing the same application outside the United States, including Europe. And the one nice thing that I will add to this one, and I mentioned it before, is that the treating community for HLHS is a very small community, and that represents a very good commercial opportunity. It just represents a much easier path for commercialization in general with that, I would say, small community.

Very small community.

And that's represents a very good commercial opportunity. It just represents a much easier path for commercialization in general.

Would that Oh, it's a small community.

Yeah.

Thank you I appreciate the details while Natalia thanks for the update.

Thank you.

Thank you.

Next question is from Michael I'll kind of itch with Maxim Group. Please go ahead.

Thank you for taking my questions Tonight.

Uh huh.

First off I would like to see if you could help quantify what kind of impact on your expense profile. We can see from the termination of the frailty program in Japan.

Wael Hashad: Thank you. I appreciate the details, YL Natalia. Thanks for the update. Thank you. Our next question is from Michael Okonowicz with Maxim Group. Please go ahead.

Yeah.

Michael I would tell you that.

No the trial wasn't a significant from a number of patients and there is still some.

Closing costs that we need to to.

To do before we close the trial as a whole.

Lisa Locklear: Thank you for taking my questions tonight. First off, I would like to see if you can help quantify what kind of impact on your expense profile we can see from the termination of the frailty program in Japan. Michael, I will tell you that, as you know, the trial wasn't significant in a number of patients, and, um, there is still, um, some. All right.

Definitely we had a lot of expenses as well in 2025 and and some are even late lead into 2020 six I can tell you that all the 'twenty five 'twenty six.

The expenses will be saved in addition to a significant savings in 2024, how much exactly we have not finalized as I said, because we haven't closed the older costs, but it would be.

Round it to about a million dollars potentially from Japan.

Alright, thank you for that.

Yeah.

Dr. Natalia Agafonova: Thank you for that. And then, at the beginning of the call, you did mention that you're taking some steps to expedite enrollment in L-52. Could you help provide some color on what steps you are taking?

And then at the top of the call you did mentioned that you're taking some steps to expedite enrollment and help it to could you help provide some color on what steps you are taking.

Dr. Natalia Agafonova: Yes, I can have Natalia take the first tab on this one, and I'm happy to add any further, but I'm sure Natalia can answer that question. Thank you so much. So there are a few measures we've taken to expedite enrollment and to help to complete enrollment in 2024. One of the steps we are currently in the middle of activating four new sites, and they are very prominent sites with the potential to enroll many patients in the trial. And then we do have other measures to investigate our meetings and internal communications, etc. But the most probably important is to engage other investigators by enrolling new sites. Currently, we have seven sites activated, and with four additional sites, we are confident that enrollment will be completed in 2020.

Yes, I can have Natalia take the first stab at this one and I'm happy to add any further but I'm feeling that I can answer that question.

Thank you so much. So there are a few measures to be taken to expedite and whole mindset to help do a complete enrollment and thank you. Thank you for one of the steps. We are currently in the need to look at T V and four new sites and they are very poor minutes sites.

Let's put it this potential to enroll many patients to the trial.

And then we do have other measures will be used to get their needs then and Inferno.

Communications et cetera, but the more stuff probably are important is to engage our they investigate there by enrolling new sites. Currently we have seven sites activated and are at least four additional the I'll come to them.

That the enrollment will be complete the can things are changing for them.

Michael Let me add a couple of things to what I think that's how you had alluded to them briefly one as the investigator meeting we planning on doing an investigator meeting that is we believe is an important step as you as you heard from the Italian we're adding four new site.

Wael Hashad: Michael, let me add a couple of things to what I think Natalia has alluded to them briefly. One is the investigator meeting. We're planning on doing an investigator meeting. That is, we believe, is an important step. As you heard from Natalia, we're adding four new sites. 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 have been there already. As you also know, that was a trial that has been going on now for over one and a half years.

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.

As you also know that was a trial that has been going now for Oh for one and a half year.

Wael Hashad: Sometimes sites get that fatigue, so we believe that the investigator meeting will be used to or utilized to reinvigorate the sites and the excitement around the study and enable us to. And the last thing that I will add is that the team, also Natalia's team, is working with advocacy groups and so on to increase the level of awareness among patients. I remind you that this is still a very small population, so it has all the challenges of rare diseases, but we are committed to, as I said, working with advocacy groups to drive awareness about our trial and the work that we're doing. All right, thank you. And then just one last one from me, and then I'll hop back into the queue.

Sometimes sites gets up the keg so do we.

We believe that the investigator meeting would be used to or utilized to reinvigorate the sites and the excitement around the study and enable us to complete.

The last thing that I'll add is that the team also in the Italian team is working with advocacy groups and so on to increase the level of awareness among the patients I remind you that this is still a very small population.

So it.

It is you know it has all the challenges of rare diseases, but we are committed to as I said working with advocacy group and drive awareness about Oh trial and are in the works that we're doing.

Alright. Thank you and then just one last one for me and I'll hop back into the queue. So you know over the last couple of months, we have seen some activity for meso blast and HLA, Jeff specifically.

Dr. Natalia Agafonova: So, you know, over the last couple of months, we have seen some activity for mesoblasts in HLHS, specifically some FDA designations in the publication back in December. So, could you, I guess, give us an idea of how the drugs stack up beyond Lomacell, obviously, being in a more advanced stage, specifically, I guess, if there are any key differences in the signaling profiles that might provide a competitive advantage? And then further, given that you are in a potentially pivotal trial, does this provide some additional validation for stem cells as a modality in HLHS overall? Um, Natalia, do you want to take a first stab at this one?

Some FDA designated tens in the publication back in December So could you just give us an idea how.

The drugs stack up beyond Loma sell obviously being in a more advanced stage.

Specifically I guess, if there are any key differences.

[laughter] profiles that might provide a competitive advantage and then further given that you are in a potentially pivotal trial does this provide some additional validation for stem cells as a modality NHL I just overall.

And that's how you do you want to take a first stab on this one I'm happy to add also from a competitive standpoint.

Dr. Natalia Agafonova: I'm happy to add from a competitive standpoint, too. The Mental Blood Study in Boston Children's Hospital, which was just published, even though it involves kids with HLHS, it's a different degree of HLHS, and they inject stem cells into the left ventricle, so they just basically try to regenerate the left ventricle. So the severity of those cases is slightly different. So even though it's the same disease, it's not. So the mechanism which we are trying to achieve long-term survival and transplant-free survival is to inject into the right heart and increase the right injection ventricle function, which is a surrogate endpoint, proof of a surrogate endpoint for a long-term great outcome. So again, it is the same disease, but the severity and the safety and then the kids with this disease are slightly different.

Sure.

That means the block's study in our Boston Children's Hospital, which was just published.

Even door involved keeps this HLA chest its a different degree of each only chess and they inject stem cells into the left ventricle cause. He tries to basically tried to regenerate left against you go so the severity of the all those pieces are slightly east.

So even though he's a completed there and oh it seems like the same diseases not.

So then you can use them because you are trying to achieve our long term survival and transplant free survival is injected into the right car.

And to increase the right injunction against you called Vinci called function, which is so heavily endpoint pull sort of data points for the long term a great outcome. So.

Again it is a it is the same thing here, but do you ever see the safety and then B Keith.

These are slightly different.

Wael Hashad: I hope I addressed that part of the question. I will just add that I really, although it is very hard to speculate why Mise-en-Sclase made the decision, but I really believe that their approach is very different from ours. We are there to go as an adjunct therapy to the current standard of care. We are at a much more advanced stage. And I also believe that the type of data that we have presented so far is going to get more people to be excited about that field, but I do believe that we are ahead of them from the clinical development standpoint and even the possibility of validating our mechanism as well. Yeah, thank you. It's certainly extremely helpful.

I hope I did address that part of the question.

And why you don't maybe you can all cause he yes Uh huh.

I want to just add that I I really although it is very hard to speculate why music last made a decision.

But I I I really believe that their approach is very different than our approach where we are there to to go as an adjunct therapy to the current standard of care.

We are in a much more advanced stage and I also believe there could be oh, so with that with that type of data that we have presented so far that this is going to get more people to be excited about that theory, but I do believe that we are.

Ahead of them from the clinical development standpoint, and even the possibility validating or any kind of them as well Michael.

Yes. Thank you certainly extremely helpful.

Wael Hashad: Thank you. Our next question is from the line of Brad Sorensen with Zach's Research. Please go ahead.

Thank you.

Our next question is from the line of Brad Sorenson, but Zacks research. Please go ahead.

Yeah.

Wael Hashad: Thank you. Good to talk to you guys, and a good presentation. I just wondered if I could get a little more color on the progress of the Alzheimer's research. It seems like there have been some pretty positive results from that. And I just wondered if you were...

Yeah. Thank you good to talk to you guys and good presentation.

Wonder if I could get a little more color on the.

Progress of the Alzheimers research and it seemed like there's been some pretty positive results from that and I just wondered if you were.

You said you were looking for additional partners in funding.

Wael Hashad: He said you were looking for additional partners and funding. Is that on the back burner until you get that funding, or are you going to continue the research while concurrently looking for that funding? Just a little more color on that would be great. I'll take that question.

Is that on the back burner until you get that funding are you going to continue to research while concurrently with looking for that funding just a little more color on that would be appreciated.

I'll take that question.

Wael Hashad: So, so, Brad, we realized that advancing our work 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. This phase 2 really showed, I would say, a signal that this is definitely getting everybody, and we have reviewed this with the scientific community. And I think everybody agrees that further development and progress of this program is warranted, and with that, we want to get into being more pragmatic and practical here. And there is a lot of, what are we doing? We are pursuing possibly a partnership business through a business development opportunity or a partnership. We're also evaluating whether there is a big, as in, available public funding and private funding actually, for that matter, to support the development of medicines to treat Alzheimer's disease. It is 1 of the biggest public health crises that we have saved in recent years, and there are a lot of people who make quick money.

So Brad.

We realize that advancing our work first I wanted to say that we are extremely excited and happy with the results that we have seen out of the clear mind trial.

The phase Iia have really showed a I would say it signaled that that definitely getting everybody and we have reviewed this with our thought leaders in the scientific community and I think everybody agrees that.

Further development and progress of this program and I'll tell you Mike is warranted.

And with that we want to get into being a more pragmatic and practical here and there is a lot of what are we doing we are pursuing possibly a partnership to a business development opportunity or a partnership. We're also evaluating there is a big.

As you know available public funding and private funding actually for that matter.

To support that.

The development of a medicine to treat Alzheimer's disease. It is one of the biggest public health crisis.

That we have faced in recent years and there is a lot of people work with money. So what we're doing is we're pursuing the two parallel path and we are trying to secure funding. We're also doing a lot of analysis of our data and formulating a lot of opinion about the possible design of the next trial.

Wael Hashad: So, what we're doing is we're pursuing the two parallel paths, and we are trying to secure funding. We're also doing a lot of analysis of our data and formulating our opinion about the possible design of the next trial and the progress. So we are not slowing down or not doing anything.

So we are not slowing down or not doing anything.

Wael Hashad: But we're definitely trying to do this in a very responsible and financially responsible way and focus our resources on the areas where it brings the fastest and the greatest return on investment. I have no doubt that we'll continue developing our program for Alzheimer's disease, and we'll continue to do all the set-up work that is needed, and we will vigorously pursue partnership and other sources of funding like non-diluted funding and so on. Thank you. Yeah, the positive results, and like you said, it's a major problem in the United States, so I think you should be able to find partners, so I just wanted to make sure we were going to continue the progress that we're seeing on that. I appreciate it. Yep, definitely. They are vigorously seeking partners, I would say.

But we're definitely trying to do this in a very responsible and finally financially responsible and Ah and and and focus our resources on the areas where it brings the fastest in the greatest return on investment I have no doubt that we will continue developing our program for Alzheimer's disease.

And we'll continue to do all the set up work that is needed and we will vigorously.

Pursue partnership and then and other sources of funding like non dilutive funding and so on.

Yeah.

Okay. Thank you yeah, just yeah positive results and like you said, it's a major problem in the United States. So I just wanted to I think you should be able to find partners. So I just wanted to make sure we are going to continue the <unk>.

Progress that we're seeing on that so I appreciate it.

Yeah definitely.

Roughly speaking button ourselves okay.

Thank you.

Wael Hashad: Thank you. As there are no further questions, I would now hand the conference over to Vail Harshad for his closing comments. All right. Well, thank you everyone for attending today's call. 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. Thank you. The conference of Longeveron has now concluded. Thank you for your participation. You may now disconnect your lines. If you liked this video, please share it with a friend with access?? eczema, rhinitis, varicose veins; was it cared for completely?

As there are no further questions I would now hand, the conference over to rail hotshot for his closing comments.

Alright, well. Thank you everyone for attending today's call on behalf of the launch of her own I would like to thank you for your continued interest and support and wish you a good day today. Thank you.

Okay. The.

The conference off launch everyone has now concluded. Thank you for your participation you may now disconnect your lines.

Okay.

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