BioRestorative Therapies Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 14, 2025

There are 7 speakers on the call.

Operator

Please note this conference is being recorded. I will now turn the conference over to your host, Stephen Kilmer, Investor Relations. Stephen, the floor is yours.

Speaker 1

Thank you, Jenny. 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 1995. All forward looking statements are based on Bio Restorative Therapy's 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.

Speaker 1

For details on factors among others that could affect expectations, see Part one, Item 1A of our annual report on Form 10 ks for the year ended 12/31/2024 filed with the Securities and Exchange Commission. Listeners are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date of this conference call. Bio Restorative undertakes no obligation to publicly update or revise any forward looking statement, 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 Lance Alspot, Bio Restorative's Chairman and Chief Executive Officer Francisco Silva, its 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.

Speaker 2

Thank you, Stephen. Good afternoon, everyone. Welcome to our first quarter conference call. On behalf of BioRestorative, I'd like to thank you for your interest in our company. And for those of you who are shareholders, as always, we appreciate your support.

Speaker 2

As you can see from the press release we issued just a short time ago, we have continued to execute well across all areas of our business since the start of 2025. And we have a lot of exciting things to look forward to as we move throughout the year. With that said, I'm going to ask Rob to provide a brief overview of our first quarter financial results.

Speaker 3

Thanks, Lance. Good afternoon, everyone. To streamline the presentation of the financial results, all of the numbers I will refer to have been rounded, so they are approximate. For the first quarter twenty twenty five, revenues were $25,000 compared to $35,000 in the same period last year. First year twenty twenty five deferred revenues were 150,000 compared to nil in the first quarter of twenty twenty four.

Speaker 3

I point this number out because it represents a timing difference on when we booked revenue versus when we received such revenue. We are encouraged with the momentum in the underlying fundamentals of this revenue line. The company's first quarter twenty twenty five loss from operations was $4,800,000 compared to $4,100,000 for the comparable period 2024. The company's first quarter twenty twenty five net loss was $5,300,000 or $0.64 per share compared to a net loss of $2,200,000 or $0.33 per share for the first quarter of twenty twenty four. The change was primarily due to a gain on the exchange of warrants in Q1 twenty twenty four.

Speaker 3

Cash used in operating activities in the first quarter of twenty twenty five was $2,800,000 and the company ended the quarter in a strong financial position with cash, cash equivalents and marketable securities of $9,100,000 and no outstanding debt. With that, I'll turn the call over to Francisco.

Speaker 4

Thanks, Rob. For the benefit of those who are new to the Buyer Stewardship story, I would like to take a moment to summarize our developmental programs. Our lead clinical stage candidate, BRTX-one hundred, is a novel cell based therapeutic engineered to target areas of the body that have little or no blood flow. The product is formulated using autologous or a person's own cultured mesenchymal stem cells collected from the patient's bone marrow. The safety and efficacy of BRTX-one hundred in treating chronic lumbar disc disease or CLDD is being evaluated in an ongoing phase two prospective randomized double blinded and controlled study.

Speaker 4

A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites across The United States. Subjects included in the trial will be randomized two to one to receive either DRTX or sham or placebo. In a podium presentation that I gave in February in twenty twenty five Orthopedic Research Society Annual Meeting, I reviewed twenty six to fifty two week blinded data from the first fifteen subjects with CLDD enrolled in this study. No serious adverse events were reported and there was no dose limiting toxicity at twenty six to fifty two weeks. Preliminary Blinded Visual Analog Scale, or VAS, and Othwesterie Disability Index, or ODI, data collected at weeks twenty six and 52 post injection demonstrated an exceptionally positive trend compared to baseline.

Speaker 4

We were also really excited to see that a fifty two week comparison of MRI images compared to baseline, there appears to demonstrate morphological changes that potentially demonstrate disc microenvironment remodeling. More recently, just last week in fact, I presented preliminary twenty six, fifty two, and one hundred and four week blinded preliminary Phase II BRTX-one hundred data from the same 15 subjects at the International Society for Cell and Gene Therapy twenty twenty five Annual Meeting. The longer term preliminary blinded data continues to trend positively compared to baseline. And if these trends continue, we believe that the Phase II trial will meet its primary and secondary endpoints. Partly based on the preliminary data, we have achieved two important FDA milestones since the beginning of 2025.

Speaker 4

The first of those was the FDA granting Fast Track designation for our BRTX-one hundred CLDD program. The FDA's Fast Track program is aimed to facilitate the development and expedite the review of the investigational treatments that are designed to treat serious condition and have the potential to address significant unmet medical needs. Benefits of the program include early and frequent interaction with the FDA during the clinical development process, and stem cell product candidates with Fast Track designation may also be eligible for priority review and accelerated BLA Biologics License Application approval. Achieving Fast Track designation was an important milestone for BioRestorative and we look forward to working more closely with the FDA as we continue to advance our lead VRTX-one hundred clinical program. The second milestone achieved since the start of 2025 was the FDA clearing our investigational new drug application for a phase two clinical trial for BRTX-one hundred in chronic cervical discogenic pain or CCDP.

Speaker 4

As a result, BRTX-one hundred is now the first and only stem cell based product candidate in the world cleared by the FDA to be evaluated in the cervical degeneration disc disease setting. Moving to our core preclinical metabolic program, ThermoStem, we are developing cell based therapy candidates to treat target obesity and metabolic disorders using brown adipose or fat derived stem cells, or BADSCs, to generate brown adipose tissue or BAT, as well as exosomes secreted by the badass. BAT is intended to mimic 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 Thermostem and its impact on weight loss and metabolism, we have not seen nor do we expect the same negative secondary effects of GLP-one pharmaceuticals, such as loss of muscle mass and negative cardiovascular effects. As awareness of the promise that our ThermoStem based stem cells hold for the treatment of obesity and related metabolic disorders continues to grow, it is important that this potentially game changing opportunity is well protected, both for us and any current and our future potential licensing partners.

Speaker 4

Accordingly, we have methodically built a comprehensive patent portfolio of issued patents that cover both The US and international markets. And we are pleased to see that our already formidable IP and state expanded again in the first quarter. On a final note, our previously reported substantial discussions with undisclosed commercial stage regenerative medicine company with regard to a potential license agreement for our thermostat metabolic disease programs are continuing. While we cannot provide interim progress updates nor provide any assurances that we will come to a mutually acceptable agreement, we are committing to closing the loop on this as soon as practical. With that, I will turn the call over back to Lance.

Speaker 2

Thank you, Francisco. And as you can see from what Francisco and Rob just reviewed, we've had an exciting and productive beginning of 2025. And while that progress continues, we're carefully managing all of our resources as we advance our two core clinical development programs, BRTX-one hundred and of course ThermoStem. So to summarize, we're making exceptionally good progress with our Phase two trial for BRTX-one hundred. While the data is still blinded, the initial trends continue to be very encouraging, reflecting the positive preliminary Phase two trial data being to date, the FDA has granted Fast Track designation to the program.

Speaker 2

We intend to present more data from this trial with a larger patient population very soon, and we remain very optimistic that this data will be consistent with the previous trends. We have now also expanded our advanced clinical pipeline for BRTX-one hundred to include the treatment of both chronic lower back pain and neck pain via the FDA clearance of our IND for a Phase II trial in cervical. As you know, we skipped a phase one and we did not have to do any preclinical work within that program. This was a function of our data associated with our lumbar trial and very solid conversations with the FDA. We are continuing to proactively expand the already formidable ThermoStem intellectual property estate to help ensure a long term market exclusivity.

Speaker 2

We continue to be in substantive discussions with regard to a potential license of the Thermostem Metabolic IP and other assets that we possess from a technology perspective. Finally, we ended the quarter in a very strong financial position with cash, cash equivalents and marketable securities of $9,100,000 as of 03/31/2025. We will continue to efficiently manage our cash reserves while executing upon our strategic goals. Thank you. And with that concluding our introductory remarks, we're happy to take any questions you may have.

Speaker 5

You

Operator

very much. We will now be conducting our question and answer session. Thank Your first question is coming from Jonathan Ashoff of Roth. Jonathan, your line is live.

Speaker 6

Thank you. Congrats on the progress, guys. I had a question. You call the efficacy endpoint of greater than or equal to 30% improvement, a preliminary endpoint. I've never really heard of an endpoint called preliminary data, yes, but not an endpoint.

Speaker 6

And then then you're showing us, you know, greater than 50% improvements in this last week's presentation. So is that some kind of foreshadowing that the endpoint that you're gonna have to hit is no longer gonna be greater than or equal to 30 and more, like, greater than or equal to 50?

Speaker 4

No. No. Good question. But, no, we're we're not we're not changing the endpoint. It's still both just a 30% improvement both What's the preliminary word for?

Speaker 4

Well because the primary endpoint is safety of the study. It's not efficacy. By the FDA, target is a safety since it's the first in man study. The word preliminary is there as meaning that it's not the primary. So the secondary endpoints are related to efficacy.

Speaker 6

Okay, I noticed in the second slide presentation, last week's versus February, there was no more line about potential interim analysis at twenty six weeks. So is that out, or will that still be performed?

Speaker 4

We haven't determined that we're going to do an interim. It's a potential and that's still something that's on the table as an option. We don't want to compromise the trial in terms of having an interim analysis that could impact the long term development. Currently right now we're having strategy talks with our team internally as well as preparing some FDA communications to see where we could take this trial within the phase three and potentially leverage this data to shorten the regulatory process for BLA approval. An interim analysis could impact that since we would have to unblind, but that's again still something that's on the table but we removed it from the presentation.

Speaker 4

Jonathan,

Speaker 2

just add to that, I think we just need some more feedback from the FDA on that and those discussions are ongoing, but appreciate that comment.

Speaker 6

Okay, and the last one is the 45 subject data being presented in HK or China, where are those 45 patients coming from?

Speaker 4

From the current study. So these are patients that have already been dosed and are at different time points within the visitation and the weeks. So some of it might be 26, some of it might be 52.

Speaker 6

So when is that presentation?

Speaker 4

That's in June.

Speaker 6

June, okay. So the trials, you know, a lot more along in enrollment than one would glean from yesterday's press release.

Speaker 2

Yeah, absolutely. I just want to be clear, 15 patients is just to keep it sort of consistent with what we've shown in the past and trying to keep those same patients along a longer time period of looking at metrics, but it doesn't represent the enrollment. It doesn't represent how many patients have been dosed we would comfortably say is significantly higher.

Speaker 6

And the 15, they made it to week twelve and not yet to week twenty six, correct?

Speaker 4

The 15 patients at the presentation

Speaker 6

It's the only way the percentages work out. Yeah.

Speaker 4

Correct.

Speaker 6

Like, you had 13 at week twenty six. It looks like it's two out of 15 that give you that 13.3%

Speaker 2

for

Speaker 4

twelve weeks.

Speaker 6

All right, thank you very much guys.

Speaker 4

Thank you, Jonathan.

Operator

Thank you very much. And your next question is coming from Jason McCarthy of the Maxim Group. Jason, your line is live.

Speaker 5

Hey guys, thanks for taking the questions. Looks like you're making significant progress. In terms of speed of enrollment, I understand enrollment is much further along than the 15 patient update that we saw. Do you expect enrollment to continue at its current pace? Kind of what is that pace?

Speaker 5

And as we head into summer, do you expect enrollment potentially to slow a little bit with people kind of taking holiday?

Speaker 2

No, actually, I think just the reverse actually, we're starting to see a real uptick in patients because of some of the strategies that we've been employed from a recruitment perspective. So we've kind of opened up a whole host of new strategies that seem to be working better than what has been done in the past. As you know, this is a very difficult and challenging environment in order to find a single disc patient with discogenic pain with given how strict the criteria is. We obviously believe in the criteria in order to have the cleanest and most valid data possible relative to other trials that are out there. So we're gonna continue to stay with the protocol.

Speaker 2

I think the enrollment is picking up. Historically, we've seen a bit of a slowdown during the summer, but I think we'll counteract that with some of the new strategies that we've employed in terms recruitment.

Speaker 4

Got

Speaker 5

it. And in terms of your interactions with FDA, has there been more emphasis from them on pain or function? Or did they want to see both, reduction of pain with functional improvement?

Speaker 2

Well, I will tell you that I think it's all open for discussion. We haven't had specific feedback that, for example, function would be dropped from the protocol. I know in some cases it has been in the past, but we continue to collect data on both of our secondary endpoints and our primary efficacy endpoints. We'll continue to work with the FDA and discuss a whole host of matters, including what they really want to focus on as we get closer to enrollment. So I think what we can look forward to is certainly pain will be a very meaningful endpoint.

Speaker 2

Function, I think is something that we have a little bit more flexibility in terms of discussing.

Speaker 5

And have you provided any additional enrollment or patient characteristics or the patients older, younger, middle age? Where do you think you're seeing the most response potentially?

Speaker 4

Well, it's been ranging. You know, we do have younger patients that are in their early 20s, but then again, we have older patients that are in their late 50s. Blinded data, so we don't know who or who has not been dosed, and so we got to be careful in terms of how we report the data, but from a very high level, it looks pretty consistent that trends are being formed across the demographics.

Speaker 5

Got it, last question. Can you just give us a little bit more detail on you had mentioned morphological changes in response to the cells? Can you discuss a little bit more about what was observed?

Speaker 4

Yeah, and again, this is still very early, but it's very encouraging to see these morphological changes. For example, in one subject, and again we have more than just one that's experiencing this, but in one particular subject that was presented, at baseline the patient had a protrusion and annular tear as well. And at fifty two weeks compared to baseline using the same MRI magnet, we see that there's increased hydration. So there's an increased T2 signal within the disc, there's a decrease in size of the protrusion and really interesting is that you see a decrease in the annular tear signal. So that is showing very aggressive morphological remodeling within the extracellular matrix, within the disc and the annulus as well.

Speaker 4

In another patient compared to baseline at fifty two weeks, T2 signal begins to decrease so there's less hydration. Protrusion appears to be very notably worse than compared to baseline and you could see an evolution of an extrusion within the disc lesion. So in that case, the patient got worse as compared to the previous patient that spoke about, the patient is actually improving.

Speaker 5

Got it, thank you guys for

Speaker 2

taking the Wasn't there also a resolution of annular tear in that patient that you're referring to?

Speaker 4

Yeah, yeah, I mentioned that there's a decrease in the signal that's apparent there baseline where there is an annular tear and then at fifty two weeks the annular tear is nearly resolved.

Speaker 5

Okay, then just as a follow-up to that, do you think with more mature morphological data that that could be supplemental in your data package to FDA ultimately and maybe even reduce the size of what could be a registration study next?

Speaker 4

We believe so. I mean, that's one of the reasons we're very careful how we're managing the trial and the data because we really don't wanna compromise how we could use this potential data going forward. So, currently right now the environment for cell based therapies, it's a little bit more positive than it has been ever. So we definitely wanna leverage the BRTX product, it's autologous by nature, the safety profile that we're seeing, I mean there's, again, there's 45 patient data that's gonna be presented in Hong Kong. And again, part of that is safety, in addition to looking at the function and pain scales that were going to be presented.

Speaker 4

So we're very encouraged and hopefully we have positive discussions going forward with the FDA.

Speaker 5

Great. Thank you guys for taking the questions.

Speaker 4

Thank you, Jason.

Operator

Thank you very much. Okay. We don't appear to have any further questions. I'll now hand back over to the management team for any closing remarks.

Speaker 2

Okay, great. Well, thank you very much. Appreciate everyone in attendance, and, we look forward to talking to you next quarter, if not sooner. Have a great day.

Operator

Thank you very much. That does conclude today's conference call. You may disconnect your phone lines at this time, and have a wonderful day. We thank you for your participation.

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Key Takeaways

  • BioRestorative closed Q1 2025 with $9.1 million in cash and marketable securities, no debt, and recorded a net loss of $5.3 million (or $0.64 per share).
  • Interim blinded data from the first 15 patients in the Phase II BRTX-100 trial for chronic lumbar disc disease show no serious adverse events and positive trends in pain (VAS), disability (ODI) scores, and MRI-demonstrated disc remodeling through week 52.
  • The FDA granted Fast Track designation to the BRTX-100 CLDD program and cleared an IND for a Phase II trial in chronic cervical discogenic pain, making it the first stem cell–based candidate approved for a neck-pain indication.
  • ThermoStem, the company's preclinical obesity/metabolic program using brown adipose–derived stem cells, continues building a robust global patent estate, and BioRestorative is in active licensing discussions with a commercial-stage regenerative medicine partner.
AI Generated. May Contain Errors.
Earnings Conference Call
BioRestorative Therapies Q1 2025
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