Q2 2025 BioRestorative Therapies Inc Earnings Call

We are in a listen only mode.

A 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. Please note. This conference is being recorded I will now turn the conference over to your host Stephen Kilmer Investor Relations you may begin.

Thank you Holly good afternoon, everyone. Let me start by pointing out that this conference call will include forward looking statements within the meaning of the private Securities Litigation Reform Act of 995.

All forward looking statements are based on bio restorative therapies current beliefs assumptions and expectations and.

Such statements involve known and unknown risks uncertainties and other factors that may cause actual results performance or achievements to be materially different from those implied by such statements.

No forward looking statement can be guaranteed.

For details on factors among others that could affect that expectations seem part one item <unk> of our annual report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission.

Listeners are cautioned not to place undue reliance on these forward looking statements, which speak only as the date of this conference call.

By the way started off undertakes no obligation to publicly update or revise any forward looking statements, whether as a result of new information future events or otherwise other than as required by law.

On the call today, representing the company are Atlanta outside <unk>.

<unk>, <unk>, chairman and Chief Executive Officer.

Francisco Silicon, it's vice President of research and development and Robert Crystal The company's Chief Financial Officer.

With that said I'll now turn the call over to Les.

Thanks, Steve Good afternoon, everyone and welcome on behalf of the management team and everyone at by restorative I'd like to thank you for your interest in the company and for those of you who are shareholders. We appreciate your support as you can see from the press release, we executed very well across all areas of the business in the second quarter.

A continuation really from Q1, and we have a lot of exciting things to look forward to as we move through the second half of the year with that said I'd like to ask Rob Crystal our CFO to provide a brief overview of our second quarter financial results.

Thanks, Lance good afternoon, everyone to streamline a presentation of the financial results all the numbers I will referred to have been rounded. So they are proximate set.

Second quarter 2025 revenues were 303000 compared to 89000 in the same period last year. This represents an increase of 240% primarily resulting from our contract manufacturing agreement on Biopharmaceuticals.

The company's second quarter 2025 loss from operations was $3 3 million compared to $2 5 million for the comparable period of 2020 for the company's second quarter 2025, net loss was $2 7 million or <unk> 30 per share compared to a net loss of $4 million or <unk> 50 per share for the second quarter of 2020 for the <unk>.

We ended the quarter in a strong financial position with cash cash equivalents and marketable securities of $7 4 million and no outstanding debt with that I'll now turn the call over to Francesco.

Thanks, Rob.

For the benefit of those who are new to the virus sort of story I would like to take a moment to summarize our developmental programs. Our lead clinical stage candidates. <unk> 100 is a novel cell based therapeutic engineered to target areas of the body that has little blood flow. The product is formulated from autologous or a person's own culture.

<unk> income will stem cells collected from the patients bone marrow.

Safety and efficacy of <unk> 100 in treating chronic lumbar disc disease, where <unk> is being evaluated in an ongoing phase II prospective randomized double blinded and controlled study.

A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites across the United States.

Subjects, including the trial will be randomized two to one to receive either <unk> hundred or placebo.

In a recent presentation that I gave a few weeks ago as part of the clinical innovations track at the International Society for stem cell research.

<unk> 2025 annual meeting in Hong Kong I reviewed very promising blinded data from the first 36 subjects enrolled in the phase II trials.

By the way that number of subjects was up more than twofold. Since my previous presentation ICT back just in May.

To help put the preliminary final results in perspective, the FDA is requiring a lease at least a greater than 30% improvement in function.

Western disability index or ODI.

And a greater than 30% reduction in pain on the visual analog scale or baas and determining whether the clinical trial. We are allowed to proceed and ultimately gain BLA approval.

Thus far BRT X 100 is doing much better than that.

As I presented at <unk>.

Over 74% of the subjects showed greater than 50% improvement in function by 52 weeks over 72% of the subjects reported greater than 50% reduction in pain by 52 weeks.

And combined greater than 50% improvement in both ODI and Baas measures was achieved by a meaningful portion of subjects across all time points.

From a safety perspective, again, no serious adverse events or dose limiting toxicities were reported reported between 26 and 104 weeks at the target dose of 40 million cells.

The data presented at <unk> was meaningful and demonstrated a strong signal for safety and efficacy and has helped us in connection with the increased enrollment rate in fact, I am pleased to report that we are now more than halfway through enrollment over 99 subject enrollment goal.

In addition, again based on the positive preliminary data, we intend to meet with the FDA in connection with a proposed type B meeting in order to accelerate the regulatory pathway towards a BLA license of our <unk> 100 candidates.

It is really exciting news and we hope to be in a position to discuss further in the coming weeks.

Moving to our core preclinical metabolic program dermis, Kim we are developing cell based therapy candidates to targeted <unk> and metabolic disorders, using bound fat or fat derived stem cells to generate brown adipose tissue or bad as well as exosomes secreted buys about ourselves.

That is intended to many of the naturally occurring brown adipose depots that regulate metabolic homeostasis in humans and is involved in weight loss. While further work is needed to fully understand the mechanism of action of <unk> and its impact on weight loss, we have not seen nor do we expect the same negative secondary effects of GOP, one pharmaceuticals such.

Loss of muscle mass and negative cardiovascular effects.

As awareness of the promise that our thermostat base back.

<unk> holds for the treatment of obesity and related metabolic disorders continues to grow it is important that this.

Tinsley game changing opportunities, while protecting both for us and any current and future potential licensing partners or accordingly, we have been methodically building a comprehensive portfolio of issued patents that cover the U S and international markets.

And we are pleased to see our previously reported substantive discussions with an undisclosed commercial state regenerative medicine company with regard to a potential license agreement for a thermostat a metabolic disease programs are continuing while we cannot provide interim progress updates not provide any assurances that we will come to a mutually acceptable agreement we are committed to closing the loop.

This as soon as practical.

With that I will turn the call over back to Lynch.

Thanks Francisco.

As you can see from what Francisco and Rob just reviewed we have had an exciting and productive second quarter and while that progress continues we are carefully managing our resources as we advance our core clinical development programs <unk> hundred thermo stem, while ramping our commercial opportunities on regenerative.

Biologics secret selling products with respect to the ladder. We're in advanced discussions with key partners and Influencers to help accelerate the growth of this program and look forward to reporting more catalyst and news from it going forward. So to summarize we're making great progress with our phase II trial for <unk> hundred to treat.

C L D D and while the data is still blinded the initial trends continue to be very encouraging.

Great safety profile.

And also highlighted by a 50 or greater than 50% improvement in pain and function and a significant portion of C. L. D D subjects.

We intend to present more data from this trial with a larger patient population and we are very optimistic that this data will be consistent with the previous trends. In addition.

And as highlighted by Francisco, we're very optimistic about our regulatory pathway now that we have gotten very close to about three quarters of the trial enrolled.

So we look forward to having that upcoming meeting with the FDA. We continue to be in substantive discussions with regard to a potential license of the thermostat metabolic IP and we're also in substantive discussions with partners on the commercial bio Kosmos vehicle platform to help expand our contract manufacturing business.

<unk> and finally, we ended the second quarter and a very strong financial position with cash cash equivalents in marketable securities of $7 4 million as of June 32025.

We will continue to efficiently manage our cash reserves, while executing upon our strategic goals.

With that I. Thank you all.

With.

Given that some of our introductory comments and we're happy to take any questions you may have.

Certainly at this time, we will be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.

You May press Star two if you would like to remove your question from the queue.

For participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys. Once again that is star one to ask a question one moment. Please while we poll for questions.

Your first question for today is from Jonathan Aschoff with Roth Capital Partners.

Thank you very much guys could you say anything about the timing for the start of the <unk> trial and the size of that trial.

No we did not comment on the cervical trial.

We could we could we could effectively pursue.

A variety of different indications as everyone knows are.

Our cervical trial has been approved to initiate a phase two.

And we probably could get the same sort of status on a variety of other <unk>.

Vascular zones, being hips, knees and shoulders, and I think what we really want to focus in laser focus in on is our lumbar trial and getting that into a BLA. So we're really encouraged by the tremendous growth that we've seen in enrollment over the quarter very proud of the team and <unk>.

Sure.

And our service providers in assisting us in that process.

And our goal right now is to drive that.

Into a phase III and hopefully we'll have some really good insight in terms of how the FDA is thinking about it given how much we've enrolled recently.

Okay.

The revenue side with Kosmos pseudo-code driving it do you think that versus the last couple of quarters that this is pretty much up and up from here or is it too lumpy to say to that.

I think it's a little early up and up with is a difficult comment to react too because it's summer.

Part of our growing business I think what we'll see is a tremendous increase in visibility as you know we've hired Sandy lipkin, who is as an innovator and a pioneer within the space.

And he has been doing a lot of the groundwork making sure that.

Some of the meaningful consumers of these products are aware of us and from a back office perspective, we've been making sure that we're appropriately documented and qualified and validated in order to commercialize these programs at a rate that would be consistent with some of our expectations. So.

We think it is up and up and from the standpoint of.

Starting.

At a certain base, but I don't have a whole lot of guidance for you in terms of what we should expect quarterly going forward.

Okay.

<unk> should we is this is probably more for Rob should we expect the same SG&A expense trend. This year like last year heavy in the first quarter similar but lighter.

Much lighter quarters two through four.

Yes that would be appropriate.

Excellent that's all I have for you guys. Thank you.

And I would also I would just add to that just to give you a little bit more insight Jonathan is as we turned the corner and get into 2026, and if our enrollment continues to.

Ticket the pace at which it is and we have some of these very positive developments with the FDA in terms of our regulatory pathway, we could expect.

Sort of a cool down in SG&A as it relates to not having to enroll the the amount of patients in the first couple of quarters of 2026, as we sort of gear up for a phase III.

Okay.

Lastly, yes, Cogs looked really kind of low for at 303, K and that revenue is that.

Can you kind of look like going forward in a kind of a lot higher cogs in that.

Yes.

I think our margin related to some of the secret film products or.

Without giving specific numbers I think you know this is not.

Not by coincidence that this is a business that we want to be and not only is it a huge market and we don't need much of a penetration rate to put up some pretty big revenue numbers, but it's at quite a high margin as well.

And Jonathan language that add to the Cogs, specifically that we improved some.

We improve their efficiencies a little bit in terms of making product and then the packaging costs as well we improved some pricing there.

By shopping really some different vendors for particular things we need in the packaging.

Thanks, a lot Rob.

Okay.

Jonathan I appreciate it.

Yeah.

Your next question is from Michael a corner, which with Maxim.

Hey, Michael.

Hey, guys. Thank you so much for taking my questions today Gratz on all the great progress.

Yep. Thanks.

So I guess just to kick things off we have seen some vocal support from FDA leadership for stem cells. You have a controlled study in phase two you previously mentioned the desire to bring this as a registrational and know that type B meeting as planned so have there been any.

New recent interactions with FDA, suggesting there may be further support for that expedited pathway.

I can tell you anecdotally, what we've heard which would which would.

Okay.

Which would imply that there is a lot of wind at our backs with respect to an accelerated pathway.

However.

We have not learned directly through our conversations with the FDA that.

We have been designated other than just our fast track designation anything more than what we've disclosed.

Alright, Thank you and then.

With regards to phase two.

The threshold with FDA is 30% on pain and function, but thats from baseline correct. So what would you need to show versus placebo is that a comparison based on the proportion of responders magnitude just to give a bit more color on that.

Yes, so that's it.

It's based on 30% minimum of at least 30%.

In both pain and function as compared to baseline and then that cohort as compared to the.

The control group that is.

Not undergoing.

Any type of.

Into diesel injection, it's a sham.

And then comparing both cohorts and looking at the responder rate.

And Michael I would also add just in case, there is any ambiguity our primary endpoint.

Safety and.

We have not had as Francisco mentioned, we've not had any material adverse events or dose limiting toxicity so to.

To use <unk> words, not not our own this is probably the best safety profile that they've ever seen so the FDA doesn't even look at some of the secondary efficacy endpoints unless you have a pretty clean bill of health from a safety perspective, so we feel like.

Based on the data that we've that we've talked about and that we've analyzed at least on a blinded basis not only is this product extremely safe, but we are seeing tremendous signal from a from an effect from an effectiveness perspective.

No what we've seen so far is certainly encouraging.

Actually just follow up on that.

Can you give a sense of when we could start to see some unwind of data is there a potential for an unblinded interim how are we going to have to wait for the full 99 or is this something that will be better asked on the back end of that type B meeting.

I think it's better asked on the back half because it will really help shape, what the regulatory strategy will be.

We may be in a position to through blinded data get to the next stage.

And maybe even get to the next stage prematurely, which would be phenomenal news and it would be.

Huge cost savings and put us in a position.

Driving the phase III and if that is the decision and if that is the nature of the conversation and remember the tides have turned at least from the administration's perspective on cell based therapies. So we feel like this winded our back could drive to that potential outcome and if so we wouldn't want to give up.

The alpha associated with an interim analysis.

Yes, no that makes a lot of sense and it's certainly an encouraging time going to be looking forward to hearing the results of that.

I will tell you for as long as we've been here, we've never been so encouraged about where we are as it relates to the enrolment of the results the regulatory environment and some of these upcoming conversations as well as all cylinders kind of hitting on bio Kosmos surgical so.

I think youre going to see a big change in our profile and what we what the opportunity set looks like going forward into the back half of the year.

We have reached the end of the question and answer session and I will now turn the call over to Lance I'll start for closing remarks.

Again, I appreciate everyones attention to the company are following us diligently great questions as usual from the analyst community and thank you again to our investors for your continued interest and support we look forward to talking to you. All soon thank you.

This concludes today's conference and you may disconnect. Your lines at this time. Thank you for your participation.