BioRestorative Therapies, Inc. (BRTX) Earnings Call Transcript & Summary

Greetings. Welcome to the BioRestorative Therapies Third Quarter 2025 Results and Business Update Conference Call. [Operator Instructions] 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. 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 BioRestorative 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 expectations, see Part 1, Item 1A 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 of the date of this conference call. BioRestorative 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 Alstodt, BioRestorative's President, Chairman and Chief Executive Officer; Francisco Silva is Vice President of Research and Development; and Robert Kristal, the company's Chief Financial Officer. With that said, I'll now turn the call over to Lance.

Thanks, Steve, and good afternoon, everyone. Welcome on behalf of the management team and everyone at BioRestorative, I'd like to thank you for your interest in our company. And for those of you who are shareholders, we appreciate your continued support. As you can see from the press release we issued just a short time ago, we continue to execute well across all areas of our business in the third quarter. We have a lot of exciting things to look forward to as we move through the last couple of months of the year. With that said, I'd like to ask Rob Kristal, our CFO, to provide a brief overview of our third quarter financial results.

Thanks, Lance. Good afternoon, everyone. To streamline the presentation of the financial results, all the numbers I will refer to have been rounded so they are approximate. Third quarter 2025 revenues were $11,800 and consisted entirely of royalty revenue. This compares to revenues of $233,600 in Q3 2024, the vast majority of which came from BioCosmeceutical sales in connection with our exclusive supply agreement with Cartessa. The overall year-over-year decrease in Q3 2025 revenues was driven by the timing of orders for the developing BioCosmeceutical revenue stream. The company's third quarter 2025 loss from operator was $3.7 million, compared to $2.3 million for the comparable period of 2024. The company's third quarter 2025 net loss was $3 million or $0.33 a share, compared to a net loss of $1 million or $0.13 per share for the third quarter of 2024. The company ended the quarter with cash, cash equivalents and marketable securities of $4.5 million with no outstanding debt. This did not include the gross proceeds of approximately $1.1 million from the company's recent financing, which we completed subsequent to the quarter end. With that, I'll now turn the call over to Francisco.

Thanks, Rob. For the benefit of those who are new to BioRestorative stories, I would like to take a moment to summarize our development programs. Our lead clinical stage candid BRTX-100 is a novel cell-based therapeutic engineered to target areas of the body that have little blood flow. The product is formulated using autologous or own cultured mesenchymal stem cells collected from a patient's bone marrow. The safety and efficacy of BRTX-100 in treating chronic lumbar disc disease is being evaluated in our ongoing Phase II prospective, randomized, double-blinded and sham-controlled study. 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 2:1 to receive either BRTX or placebo. Enrollment in the Phase II study is starting to accelerate and we expect to be able to share more data as appropriate. In February, we announced that the BRTX-100 program in chronic lumbar disc disease was granted Fast Track designation by the FDA. This was a major milestone achievement, which has enabled us to work more collaboratively with the FDA as we continue to advance our lead clinical program towards a biologic license application or BLA approval. In that regard, through the Fast Track designation, we are anticipating that the FDA will grant us a Type B meeting to discuss a potential accelerated BLA approval pathway for the BRTX-100 program, for the treatment of chronic lumbar disc disease. Moving to our core preclinical metabolic program, ThermoStem, we are developing a cell-based therapy candidates to target obesity and related metabolic disorders using brown adipose tissue derived stem cells, which are then used to generate brown adipose tissue-derived stem cell, which are then used to generate brown adipose tissue or BAT as well as exosomes secreted by the brown adipose stem cells. That is intended to mimic naturally occurring brown adipose depots that have been found to regulate metabolic homeostasis in humans and is involved in weight loss. The global obesity market is projected to exceed $100 billion annually by the end of the decade, driven by unprecedented demand for GLP-1 therapies. BioRestorative ThermoStem program is uniquely designed to address this demand by: one, providing an alternative to chronic GLP-1 injections through a regenerative cell-based solution; mitigating tolerability issues such as muscle mass loss or potential cardiovascular risk, some of the most pressing concerns associated with GLP-1 therapies; and three, creating licensing and partnership opportunities. With respect to last point, we are pleased that our previously reported substantial discussions with an undisclosed commercial stage Regenerative Medicine Company with regard to potential license agreement of our ThermoStem metabolic disease program is continuing. While we cannot provide interim progress updates nor provide any assurances that this will come to a mutually acceptable agreement, we are committed to closing the loop as soon as practical. And as awareness of the promise that our ThermoStem-derived, brown adipose-derived 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 and any current or future potential licensing partners. Accordingly, we have been methodically building a comprehensive patent portfolio with issued patents that cover both U.S. and international markets. The most recent example of that came in this past October, we announced a major intellectual property milestone, the Japanese patent office issued a notice of allowance for our ThermoStem platform. The newly allowed patent provides broad protection terms for our allogeneic off-the-shelf brown adipose-derived stem cell technology. These claims are materially stronger than previously granted patents, covering not only the therapy cells themselves, but also multiple methods of encapsulation and delivery, including alginate, microcapsule, cellulose hydrogels, polymer membranes and advanced scaffolding systems. With that, I will turn the call over back to Lance.

Thanks, Francisco. As you can see from what Francisco and Rob just reviewed, we had an exciting and productive third quarter. And while the progress continues, we're carefully managing our resources as we advance our 2 core development programs. Before I close, I want to highlight 2 transformative developments that we believe will reshape BioRestorative commercial and clinical trajectory. First, our BioCosmeceuticals business continues to gain a lot of momentum. Over the last several months, we've rebuilt and strengthened our commercial infrastructure, including supply chain, sales coverage, distribution and customer engagement. A major part of that strategy was bringing in the right commercial leader. As many of you saw in a recent press release, we welcomed Crystal Romano as our Global Head of commercial operations. Crystal is a known commodity to us and to the aesthetic community. She helped lead commercial execution efforts as President of Cartessa, and she understands the physician office and medical spa channels exceptionally well. Having someone with her product experience, account relationships, and hand-on operating background gives us tremendous confidence in her ability to execute and drive scalable revenue growth. The enthusiasm that we're seeing and that from what I'm seeing in the field, combined with Crystal's leadership positions this business for meaningful revenue contribution as we scale. For a company in our position, having a commercial business capable of generating revenue alongside our clinical programs is strategically important, and we believe it can become a very material contributor in 2026 and beyond. Second, and equally as exciting. We believe that enrollment in our Phase II BRTX-100 clinical trial is approaching completion. Each month, we move closer to a fully enrolled study and a more statistically powerful data set. While the data remain blinded, the initial trends continue to mirror our earlier clinical signals, including significant improvement in pain and function for patients suffering from chronic lumbar disc disease. Completing enrollment would be a major milestone for the company, and it positions us exceptionally well heading into a potential Type B FDA meeting in December. As enrollment completes, we intend to present additional data from a larger patient population, and we're optimistic that the results will be consistent with the encouraging trends observed so far. Simply put the pathway to a potential Phase III and ultimately a BLA has never been more visible. In addition, I want to highlight the strength of our recent financing. Following the end of the quarter, we closed a fully subscribed financing that was priced above market. Senior leadership, including myself and several of our existing investors participated in the round. And we believe that level of participation reflects continued confidence in the direction of company, belief in the value of our clinical and commercial strategy and alignment with long-term shareholder interest. Importantly, the financing strengthened our balance sheet and ensures we have the resources needed to advance our short-term -- our short-range clinical and commercial milestones with -- while continuing to manage our cash efficiently. We also remain, as Francisco said, in subsequent discussions with commercial stage Regenerative Medical Company and regarding a potential license of our ThermoStem metabolic program. As we mentioned, we're not providing interim updates on that. We remain committed to closing the loop in that process as soon as practical. We believe that the strength of our expanding intellectual property portfolio further enhances the value of that platform. We've also been able to access that cell line and that platform for the use in our BioCosmeceutical. So we're starting to cross fertilize our cell-based therapy technology into commercially developed products as well. So taken together, accelerating our clinical progress, a growing commercial engine, ongoing licensing discussions and a strengthened balance sheet, we believe BioRestorative is well positioned to deliver meaningful value creation in the quarters ahead. I thank you for your time. And with that concluding our introductory remarks, we're happy to take any questions you may have. Holly, if you wanted to open up for some questions, we'd be happy to do that.

[Operator Instructions] Your first question for today is from Michael Okunewitch with Maxim Group.

Congrats on all the great progress. I guess just with the changes to your leadership and seeming increased focus on this BioCosmeceuticals business, could you just talk a little bit about how significant that overall BioCosmeceuticals opportunity is? And then is this something that you'd be able to tap on your own? Or would you need more Cartessa like deals to penetrate this market? I'd like to just get a better understanding about how you view the market dynamics here.

Sure. I appreciate the question. It is going to be a segmental focus for us going forward and really positioning the company as a hybrid where we're taking opportunity and advantage of near-term revenue opportunities along with the longer-term clinical outcomes. So I think there is no one like us in the microcap biotech space, which I think is, it provides for a very differentiated profile. And one that's extremely interesting for both investors as well as fundamental success to shareholders. In terms of the opportunity, this is a $63 billion market opportunity. This is a huge and growing market. The BioCosmeceutical space, we are a biotech company, and there are not many biotech companies that are fully focused on developing this market. Many companies are marketing companies that are sourcing material that I would describe as low dilution, low quality. We're able to manufacture, formulate, test, quality test, release products coming directly from our lab using different cell lines and different variability. We are approaching this market originally with an exclusive distribution agreement with Cartessa, we've been working with Cartessa, to broaden that scope outside of Cartessa's tests distribution capabilities. That's part of the reason for having Crystal in place. We have more of a three-pronged approach so that we're going to add additional distributors on board, so not just Cartessa, but many others. And those distributors, we have relationships with through Crystal's, large [ Rolodex ] of account relationships. We will also be selling directly into the med spas and aestheticians, the professional channel, where we'll be able to capture that margin that we would have otherwise not been able to capture by selling directly into Cartessa. So that's an exciting accretive opportunity for us. Crystal has tremendous amount of relationships within that professional channel as that was her calling effort as part of Cartessa. So we're excited to really get that underway. And I will tell you, based on some of the -- I mean she's been here for 3 weeks now. So I will tell you that the calls that I've had with her. I'm very confident and optimistic that this is a business that we're going to put the wheels on track very soon and be able to demonstrate some meaningful wins within the first couple of quarters of her being here. I would also like to discuss potentially the idea of going direct-to-consumer with a branded product that we've been discussing and talking about from a business plan perspective, understanding the logistics and the resources that are required in order to do that. And I think this three-pronged approach gives us a really broad approach to this large and growing market with probably one of the best, if not the best, most potent exosome-based secretomes that are out there. And the beauty about our business and our manufacturing capabilities is our ability to work with the customer, customize, whether it's a branded product or a white label product to their specifications, to their customer, networks, dialing up and dialing down the potency, adding different types of peptides, adding different types of growth factors, et cetera. So this is going to be something that we should all keep our eyes on. Obviously, it's a little bit too early to give specific guidance in terms of the revenue ramp. I still maintain the idea that we will see some lumpiness in this business as we're starting out. There may be quarters where we have an outsized revenue number and some quarters in the very beginning where it looks like a miss, but it's really just about the developing business and reaching a broader group of customers. So we're excited about this, and we'll talk more about this going forward.

And then I would like to follow up on that, just talking a little bit about how this impacts the overall business strategy? How you're balancing these now 2 sides of the business and also some potential synergy there? So is your focus on BioCosmeceuticals is that shifting any resources away from clinical development? Or is this truly additive? And then are there any potential synergies in BioCosmeceuticals from having the credibility of a legitimate biotechnology company?

Yes. So the cross synergies I would describe have to do with the cell lines that we're using for clinical purposes. And as you know, we're not commercializing our cell lines domestically as they're governed under the FDA from a BLA license perspective, but we're able to use aspects of those cell lines to develop products for topical use only, for cosmetic use only. I expect that the end users will use these products for topical some. I don't know whether or not they will use it off-label for regenerative purposes. We don't condone that, but I believe that will be also an aspect of the end users application. So in terms of resources, we can manage the resources within a space entirely with the people that we have today. We may add some additional folks on the quality side and on the manufacturing side. But we're going to see a lull in the utilization of our lab as we fulfill our enrollment obligation under our Phase II protocol and then there will be some time of delay between a Phase II and a Phase III. So our expectation is that during that time frame, we can really capitalize on full utilization and focus within the BioCosmeceutical program.

Your next question for today is from Jonathan Aschoff with ROTH Capital.

I was wondering on BRTX-100, can you help us understand when we may see the subsequent data release? Will it still be blinded? Or will it be the final data since it sounds like you're almost enrolled? And also, can you help us out with any maybe numerical enrollment update?

On the numerical side, I'll say that we're more than 3 quarters enrolled, and we have another more than 10 patients in late-stage screening, which could come in more harvest within the next couple of weeks. So if you do the math, we're getting really close. I don't know if we're going to get it just under the wire in terms of the year-end. But to the extent that it's spills into January or first quarter. I think that's a very realistic and pragmatic target for us to hit from an enrollment perspective. As far as far as data, we're going to keep the data blinded because we have a strategy as it relates to communication with the FDA under our Fast Track designation, looking to accelerate the BLA process. So our hope would be to get directly into a Phase III study from a pivotal perspective as opposed to doing 2 Phase IIIs. Most companies do 2 Phase III, so we have such a large and robust data set in connection with our Phase II with 99 patients. The idea would be to keep that data blinded and report on higher numbers with more data on a blinded perspective as we continue to attend and ask to present are material at certain conferences, certain industry-related conferences. So in terms of the FDA and regulatory strategy, I think it's important that people understand that getting a Phase III pivotal while we're still completing the Phase II, which is kind of part of the ask in this upcoming Type B meeting is game changing for us. It would basically shave off about 3 years of time on the calendar and significant costs related to doing another Phase II. If that were the case, then we want to keep our data related to our Phase II blinded and do the appropriate follow-up in our protocol, It's a 24-month protocol -- it's a 24-month follow-up. That being said, it's really important to note that if the FDA does give us that green light. What they're doing is they're saying, our safety profile is pristine and not going to allow us to move forward with a bad safety profile. Today, we have no material adverse events, no dose-limiting toxicities. Everything is really clean. It's an autologous product. We're very comfortable with that, and they'll be looking at a subset of data with respect to efficacy. So getting that green light from them would be tremendous. It would be a major value-enhancing inflection point and would be sort of an acknowledgment that we don't have to unblind the data if we're going to go forward in this pivotal study. If for some reason, they decide like many other biotech companies, we have to do 2 Phase IIIs, that would put us in a position where we would consider unblinding the data after a 12-month follow-up and then report on that data effectively 12 months from the last patient that was enrolled. And like I said, we're expecting enrollment to be complete in the very near term?

All right. So it's enrollment completion is then a Type B meeting where you'll figure out if it's 1 or 2 Phase IIIs. And that Type B looks like...

I think we're going to continue to enroll patients. And then in December, we hope and expect the FDA has been a little bit slow to react just given the shutdown. So we expect that we'll get on the calendar sometime before the end of the year and have that Type B meeting. It's unclear whether we're going to have a definitive response from the FDA, but we'll be able to learn a lot. We'll be able to review what a Phase III protocol looks like and get some buy-in part of the Fast Track designation process is to really sit down with the FDA and explore ways in which we can accelerate that BLA.

Okay. And what's going on with the cervical trial?

So we -- getting that clearance is important. I think that's very meaningful in terms of keeping our pipeline robust. We haven't dedicated resources to developing it. We have a protocol. We have an agreed upon protocol with the FDA. But it's not as if we're starting to go out and recruit sites and recruit patients just given the financial resources. I think this is something that we want to mark, that we have experienced, getting multiple INDs approved. And it's my belief that our focus should really be around the lumbar spine. And if we can get the BLA approved, then it's our expectation that people will be really taking advantage of the broad application of that product in a variety of different avascular zones. But I think we tie that more to a company that has more robust capital resources down the road but I think it shows and demonstrates our strong regulatory capabilities and clinical capabilities by getting approved INDs in a variety of different applications.

Okay. Lastly, do you think your done booking BioCosmeceutical revenues this year? Or you think we might have a recurrence of something in 4Q that might look a little like second quarter was?

I don't know about second quarter because second quarter -- it could be. I mean right now, I don't have the visibility. I know that some products have been sold since Crystal has been on board. But it's probably nascent relative to what I think the opportunity looks like as we begin to scale and she gets her feet under her.

[Operator Instructions] We have reached the end of the question-and-answer session, and I will now turn the call over to Lance for closing remarks.

Thank you, Holly. I Appreciate everyone's time. I think this is a really positive quarter for the company in terms of our clinical progress. And again, I'm really excited about the development and some of the very meaningful changes that we've made in terms of bolstering our commercial program. And I think there's more to talk about next quarter in that regard. And obviously, this upcoming discussion that we hope to have with the FDA should provide us with additional clarity on the regulatory pathway. So thanks again for your participation, and we look forward to talking to you soon.

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