Q3 2023 Longeveron Inc Earnings Call
Greetings and welcome to the launch of friends 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.
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 <unk> third quarter 2023 results conference call today, we will discuss financial results for the quarter ended September 32023 provides a business update earlier. This morning, we issued a press release with these results, which can be found under the investors section of our website.
I'm joined today by the following members of longevity runs management team Mr. Wireless Schott, Chief Executive Officer Italia, I got up to Nova Chief Medical Officer, and Lisa Lochner, Chief Financial Officer, Mr. Sha will begin with a brief corporate overview and Doctor I got to know the will review on chaperones recent progress.
Clinical programs and it's like there will be financial results for the third quarter. Following the company's prepared remarks, we will open the call to questions recovery.
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 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 in your.
Our report on Form 10-K unfortunate 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.
Mr Weil of Shah Chief Executive Officer of longevity.
No.
Thank you Mike.
Good morning, everyone welcome to the larger Brown third quarter, 2022 brakemen update and financial results call.
We are pleased to be speaking with you today and look forward to sharing our progress in developing regenerative medicines for unmet medical need.
Our third quarter and recent weeks have been very productive backed by top line results, we announced from the Korea mind Hi, Mike.
The trial, which at first the safety profile of Brahma Shelby and provided a clear efficacy signal.
We are also presenting extended survival data on altice, one time abnormal there'll be an hypoglycemic left heart syndrome.
Also no one actually I'll, let you answer that.
I think the expression of the American Heart Association.
And took steps to strengthen our balance sheet, securing $4 million of gross proceeds before expenses from equity financing.
Of course, our continued advancement with deep clinical program.
I will turn the call over to my colleague Dr.
And these are lots that are in a moment.
Got it.
First I'll begin with a brief overview.
Oh Mcrobie our product candidate.
The living cell product need from a specialized cells isolated from Bombardier.
Healthy donor age equaling to a 45.
These special lifestyle I've known in the literature, I mean, there's been all signaling sell or exit.
And essentially our endogenous or built in by lots of appropriate for everything.
And then he's had been shown to perform a number of complex functions in our.
Our body, including the formation here.
They also had been shown to Poland, I respond to that type of injury or disease.
Bioactive faster.
Modulus story and be generous.
We believe that Lam is gonna be has multiple potential mechanisms.
Sure.
That may lead to actually Enzymatically pro basketball.
A big part.
Therefore, they have a broader application of the range of rare and each one of them.
Neither.
We have ongoing program Hyperplastic left heart syndrome are actually Chad.
In the beginning and agent related crap.
Our phase two trial and actually check it.
Exceeded 50% and Goldman Russell.
And we have activated additional clinical sites to expedite enrollment.
This is our priority program and are focused on completing enrollment in this trial in 2024 as I mentioned.
We also announced positive topline results from our clear mind phase Iia trial for as long as they'll be made in the last month and expect full data from this trial and the common equity.
In engine related frailty enrollment continue to progress in our phase II study in Japan.
The data we have generated in China.
Hi, Meyer all.
All supports a broader potential lama there'll be a regenerative medicine.
They're asking you for a range of unmet need and we are excited about the progress we are making.
With that I'll turn over the call to docs are Natasha I forgot about that.
Provide more detailed overview of our clinical programs and recent progress.
Yeah.
Thank you Danielle.
I don't begin to get a brief review of our generic disease program and the topline results. We recently presented from all clear mind started.
Based on the growing body of preclinical and clinical data from various sources, we believe Hello, Michelle B may prevent the clinical progression of Alzheimers.
D G S by reviews from disease related brain inflammation, you all know.
So death caused by earlier and substantial neuro inflammation is a significant contributor to that but the gymnast yourself I'm sorry emergencies.
In preclinical models of Alzheimer's disease, and let's see if this Clark's Kirk do you used to extend the law. The law Michelle B has been shown to cross the blood brain barrier potentially if I'm to inform my three effects importing endothelial function and promotion.
Genesis the protest so from your own formation in the brain.
Oh phase II, a trial offload Michelle b for mild Alzheimer's disease called a clear mind trial.
Completed enrollment in November with Grainger debenture to clear.
Claire minds is a 48 patient for arm parallel design randomized clinical trial offload Michelle B designed to evaluate the safety of single and multiple infusions of two different dose levels of blood Michelle B.
<unk> to placebo in patients with mild Alzheimer's disease.
The primary endpoint is safety as measured by the occurrence of serious adverse events you get in the first 30 days after administration of luggage Tobey.
Secondary and exploratory endpoints include measures so cognitive function.
And radiological biomarkers relevant to inflammation and the female basketball Ashish Gupta.
In a previously completed phase one studies, we have demonstrated a preliminary safety of luggage there'll be patients with mild to moderate disease.
Yes.
Results from clear mine, so that the primary end point of safety here wasn't Mad based on statistical and medical assessment.
There was one serious adverse events reported on each well Michelle be treatment of golf and none on placebo. Each SCE was reviewed and assessed by the data and safety monitoring board with no safety issues trade.
This study is safety data were consistent with established safety profile with no incidental HEICO shouldn't see G. D. G is no cases, so far assignment related imaging abnormalities, no clinically symptomatic Mika Hey, Mara just as relevant by really.
Revealed by the Moc nature, MRI and no notable changes in laboratory evaluation and electrocardiogram.
In the secondary endpoint of change from baseline to week 49 in costs reaches that composite.
Core buy.
<unk> results were demonstrated at the Prespecified statistical level will be less than 0.12 tables.
But it gives you a significant improvement in the extremely denied in cards was absorbed for la Michelle B at dose level three to 5 million vis a statistical significant 0.091 versus placebo.
The pole loading and so group consist of three to 5 million dose 125 million dose 400 million shelf four doses if statistical significance 0.099.
In terms of specific components of the Cod score composite can point evaluate it at the level of a point.
052 deals one yourself be.
Dose three to 5 million once demonstrated statistically significant slowing of disease progression in less Hypo Campbell board of them get statistical significance.
She's chief the D O 15 related to placebo.
E D C. S E T O score, which stands for Oh.
He's courtyard gifts doggy activities of daily living and less type of combo volume at weeks 49 were statistically significant for them.
Hello, Michelle would be cheap mango.
With just two placebo with P value 0.0, 47, and zero 48, respectively.
Other indulge us demonstrated numerical slowing and prevention of does use divorce worst opinion relative to placebo in composite score that's cognitive score cognition and function space, our scale and that's T V chip daily living scale matters.
By the caregiver and left Hypo Campbell volume at week 39.
We believe these results provide important validation of Bosch, the safety and therapeutic potential automotive show beach in the treatment of angina disease and provide a box support for additional clinical trials and other indications as well.
You mentioned, we expect the full dataset from this trial in the coming weeks.
Now for an update on our HOA channel program.
For those who might not know a chilly cheese is a rare condition can change adult and devastating birth defects.
Which the left ventricle or the heart is either severely under developed omission.
The condition effect of approximately half a thousand babies per year in the United States babies born with this condition have severely diminished systemic blocked slow which requires children to undergo a complex three stage heart.
Reconstruction soldiery protests over the course of the first five years of their lives.
While these children can now leave into adulthood, as surgical intervention only 50% to 60% of our affected thing Judy Joe survived a dollar since you have to write the electrical failure, which is often unable to handle the increased load required to support this is Jim.
Circulation.
Furthermore, even those children get successful surgical intervention or elevate the cheesecake sharp there mythology delayed development and long term complications, including Oregon Trail U.
As such there is an important unmet medical needs to improve right ventricle function in these patients to improve both short term and long term patient outcome.
It's why you mentioned to be a prevention the latest long term survival from our eldest one sky D. A phase one study offload Michelle B in children with a chilly shifts at the scientific session of the American Heart Association, which begins tomorrow.
Then patients participated in L. P. 's one trial during beachfront, Michelle B was injected.
Concurrent to stage two surgery also known as the Glen Christy Chair in.
In the data set to be presented their patients have been mine your door for up to five years after treatment.
Early in launch door to them.
Paul I'll follow up data from this trial was announced previously that Florida has shortened the hundred percent of the time patients who participated in L. P. One trial survived and remain heart transplant free for up to five years of age as compared to their historic.
Clean clinical trial results showing that children with a chilly Czechs, who undergo the Glen procedure pizza.
Typically have about 15 to three 2% mythology by five years of age. The Lp's one data are highly encouraging and reinforced our enthusiasm for what Michelle b as a potential treatment to transform care for patients with H M E check.
Our Lp's two trial is designed to assess the potential for a moment, so b to improve right and Chick Fil a function and a long term outcome data.
The trial is the 38 patients controlled phase two clinical trial evaluating the safety and efficacy of one if so be isn't a junk therapeutic to stem the standard of care H L. A chance sort of journey.
The primary outcome measure is the change in the right ventricle ejection fraction from baseline to divulge much there.
The trial is funded by a grant from the National Institute of Health.
Sure No heart lung and Blood Institute.
Isn't it a notch.
B O L. P stood trial has exceeded its enrollment threshold of 50% the ultra and now the activation of our eight clinical site location one more than the seventh originally planned.
Completion of this too is our priority program in and our focus is on completing enrollment in this trial in trying to clean up before.
I will conclude with a comfortable to give a brief update of our aging related frailty pogrom.
Aging related trail is an H, especially the decline of course Mark.
People physiological system, leading to the inability to cope with trust us.
It is characterized by mobility impairment weakness fatigue weight loss slow and low activity.
It puts individuals at high risk for poor clinical outcome, such as infections falls fractures hospitalization and even death.
At lunch and dinner on these being evaluate them the effect oney. So be may have one health and function of elderly or frail patients, particularly.
When they are physically physical and immune system function with clinical development tried to Jim.
Aging related trials in focused on Japan. It countries. It's one of the oldest population in the world.
Our phase two clinical trial evaluating allow me so be impatient, it's aging related frailty and Japan did.
The phase two trial is a three arm parallel design randomized evenly split one to one to one or placebo as well as two different law, Michele a b C and infusions.
Enrollment discontinued and the trial is expected to enroll 45 patients by the end of 'twenty two plentiful.
The primary endpoint is to evaluate safety B, then overarching goal of providing support for an eventual limit the approval under the Japan arc over the safety in Virginia, where it gets made a ship or a S. R M, which recognizes the tremendous support.
The initial therapeutic potential of cell therapy.
With that I'd now like to turn the call over to Lisa Leclair I'll share four to discuss our financial results.
Fourth quarter of two major things you're pretty Lisa.
Thanks, Natalia 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 30th 'twenty, 'twenty, three and 2022 where approximately 0.2 million zero point $3 million respectively.
Grant revenue for the three months ended September 32023, and 2022 zero.
A real quick 1 million respectively. The decrease was primarily due to a reduction in grant funds available due to the completion of the grant funded clinical trials.
Clinical trial revenue, which is derived from the Bahamas registry trial for the three months period ended September 30th 2023 and 2022 with 0.2 million clinical trial revenue for the three months ended September 30th play play through decreased by less than 0.1 million compared to the same peer.
And 2022 as a result of a decrease in participant demand.
Related cost of revenues was approximately 0.1 million 0.2 million for the three months ended September 30th 'twenty, 'twenty, three and 2022 respectively.
Kris and 0.1 million or 45% was primarily due 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 months period ended September 30th 'twenty, 'twenty, three and 2022.
General and administrative expenses for the three months ended September 30th 2023 increased to approximately $3 1 million compared to $2 1 million for the same period in 2022.
Increase of approximately 1 million was primarily related to increases.
Your point $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.
This increase was for parts, partially offset by a decrease of 0.1 million in stock based compensation expense.
Research and development expenses for the three months ended September 32023 decreased to approximately $1 8 million for approximately 3 million for the same period in 2022.
The decrease of $1 1 million was primarily due to a decrease of $1 million in research and development expenses, driven by lower spend on clinical trials and supplies.
Selling and marketing expenses for the three months ended September 30th 'twenty, 'twenty, three and 2022 where approximately zero point $3 million and 0.2 million respectively.
Selling and marketing expenses consist primarily of investor and public relations expenses.
Other income for the three months ended September 30th 2023 with 0.1 million, which consisted of interest income.
Other expense for the three months ended September 30th 'twenty, 'twenty, two with less than 0.1 million.
Our net loss was approximately $5 1 million and $5 2 million for the three months period ended September 30th 'twenty, 'twenty, three and 2022 respectively.
As of September 30th playing 23, the company had cash and cash equivalents of $2 million marketable securities of $2 million and working capital of approximately $1 7 million as.
As of December 31st 2022, cash and cash equivalents was $10 5 million marketable securities were $9 2 million and working capital was approximately $15 4 million.
Subsequent to the end of the quarter.
On October 13, 2023, the company closed a registered direct equity offering priced at the market under NASDAQ rules and a concurrent private placement with gross proceeds of approximately $4 million before deducting the placement agent fees and other offering expenses payable by lunch everyone.
When Chevron currently intends to use the net proceeds from the offering to fund the ongoing clinical and regulatory development of Globus they'll be for capital expenditures working capital and general corporate purposes.
Based on the company's current operating plan and financial resources, we believe that our existing cash and short term investments will be sufficient to cover expenses and capital requirements into the first quarter of 'twenty 'twenty four.
With that thank you and I'll turn the call over to lay out well.
Thank you Lisa.
Hi, everyone.
Everyone have here today with the announcement of positive results from that clear from our clear mind study.
And the full data expected in the coming weeks results from Opus, one trial and I'll, let Chad being presented at the American Heart Association and others to continuing the its enrollment and our phase II program.
Later crappy progressing in Japan, as well, we are looking forward to meaningful milestones in the near term.
We are making steady progress in advancing alarmist they'll be across these three indications and.
Fully realizing that put up very quickly so oklahoma.
I would now like to open the call for questions. Operator, Please open the line to our covering analysts.
Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.
Confirmation tone will indicate your line is in the question queue you.
You May press Star two where she would 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 star keys, one moment, while we poll for questions.
Our first question comes from Michael I'll call niche. Please proceed.
Hey, well thank you for taking the question today.
I guess two are.
Things off I, just wanted to ask something about your strategy regarding <unk> just given that you have this strong data from al It's one.
What's 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 you know presenting data at conferences and.
Strategically selecting sites for the Opus two study.
Hi, Michael Good morning. Thank you for that question I think it is.
Great question, and I will pass it onto Natasha <unk>, who have been since she came she started reaching out to our advocacy groups and our other communities within the Hyperplastic left heart syndrome. As you as you know actually tested the rare and ultra rare actually.
Matter I'll try their disease. So there are not too many communities, but there are some communities and I will have Natalia I'd give you a little bit but I'm a big examples that we are working on Natalia.
Thank you so much why you all and thank you so much Michael for your question.
And you're absolutely right because it's a rare disease are you know.
You know my first probably action when I came to the company was so how do the AR increase awareness and there are a few steps. We are currently doing a the largest advocacy groups existing for this particular indication even not just for rare disease, but for even for HOA chess.
Its course used thereby hark.
Really child chiefs, thereby Hartley a collaboration right now to engage.
Appearance them engage with physicians, who are teaching this disease just to increase awareness.
That's our trial legs, you spend do everything possible for basic corporate for parents for four communities here.
Two to be aware. In addition, besides that of course, we are very actively engaged with all sites, they're easy Jim them, we understand more about their this patient care about their disease.
And.
D V, reaching more other potential programs, which exist as a network for parents to be aware about HLA chess and this is in progress.
Yes and of course, Michael you know we did also won a key opinion leader event that is Ah Ah Ah was hosted by by three top key opinion leader to educate everyone on the type of plastic that's hard syndrome.
It was conducted by doctors Sanjay Shah Doctor Roms of Romanian.
Dr. Josh here.
And it's available also has an enduring materials I'm on both our website and our lifestyle I, our investor relation know portola as well.
Alright, yeah. Thank you for that.
One more for me and I'll hop back into the queue I just want to see.
Oh.
Data coming up in the next few weeks.
Are there any.
Particularly our additional analyses that you think we should be keeping our eye out for.
Yeah. So of course that that this would be a complete study report. So it will include the data that we disclosed.
But as Natasha has mentioned we are going to also announced additional analysis from that additional scale that we have not presented a cognitive scales such as and M. S. E. Moca, we're also gonna be presenting more detailed MRI.
Uh Huh and of course, all the biomarker data, which is the large dataset. That's why they take a lot of time to do the analysis. So there will be a lot of additional analysis is coming.
But those are the three that cognitive scales.
The 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.
Once again, if he would like to ask a question. Please press star one on your telephone keypad.
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This concludes our question and answer session I would like to turn the floor back over to awhile have Sean for closing comments.
Alright, Thank you operator, all right well thanks, everyone for attending the call today.
On behalf of the launch of Corona I would like to thank you for your continued interest and support and wish you a good day. Thank you.
Yeah.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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