BioRestorative Therapies, Inc. (BRTX) Q4 2024 Earnings Report, Transcript and Summary

Good afternoon, everyone, and welcome to the BioRestorative Therapies 2024 Results Conference Call. At this time all participants are in a listen-only mode [Operator Instructions] Please note this conference is being recorded. I will now turn the conference over to your host, Stephen Kilmer, Investor Relations. Sir, the floor is yours.

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 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, which will be 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 statements, whether as a result of new information, future events or otherwise, other than as required by law. On the call representing the company are Lance Alstodt, BioRestorative’s Chairman and Chief Executive Officer; Francisco Silva, its Vice President of Research and Development; and Rob Kristal, the company’s Chief Financial Officer. With that said, I’ll now turn the call over to Lance.

Thank you, 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, of course, appreciate your support. As you can see from the press release we issued a short time ago, we continue to execute well across all areas of our business in 2024, and we have a lot of exciting things to look forward to as we move through 2025. With that said, I’d like to ask Rob, our Chief Financial Officer, to provide a brief overview of our 2024 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. For the 12-month period ending December 31, 2024, BioRestorative’s revenue grew 175% year-over-year to $401,000. Company’s loss from operations was $11.6 million, a 24% improvement from the $15.2 million loss for 2023. The company’s 2024 net loss was $9 million, or $1.16 per share, a 14% improvement from a net loss of $10.4 million, or $2.47 per share, for 2023. Cash used in operating activities in 2024 was $8.2 million, and the company ended the year in a strong financial position with cash, cash equivalents and marketable securities of $10.7 million and no outstanding debt. With that, I’ll turn the call over to Francisco.

Thanks, Rob. For the benefit of those that are new to BioRestorative story, I would like to take a moment to summarize our developmental programs. Our lead clinical stage candidate, BRTX-100, is a novel cell-based therapeutic engineered to target areas of the body that have little blood flow. The product is formulated from autologous or your own cultured mesenchymal stem cells collected from the patient’s bone marrow. The safety and efficacy of BRTX-100 in treating chronic lumbar disc disease, or CLDD, is being evaluated in our ongoing Phase 2 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-100 or placebo. At a presentation I gave at the 2025 Orthopedic Research Society Annual Meeting last month, I reviewed 26 to 52 week blinded data from the first 15 patients of the CLDD study enrolled in the trial. No serious adverse events were reported, and there was no dose-limiting toxicity at 26 to 52 weeks. Preliminary blinded Visual Analog Scale, or VAS, or Oswestry Disability Index, or ODI, data collected at weeks 26 and 52 post-injection demonstrated an exceptionally positive trend compared to baseline. We were also really excited to see that the 52-week comparison of MRI images to baseline appears to demonstrate morphological changes that potentially demonstrate disc microenvironment remodeling. If these positive trends continue, we believe that the Phase 2 trial will meet its primary and secondary endpoints. Partly based on the preliminary data, we have achieved two important FDA milestones last month. One of those was the FDA granted Fast Track designation for BRTX-100 chronic lumbar disc disease program. The FDA’s Fast Track program is aimed to facilitate the development and expedite the review of investigational treatments that are designed to treat serious conditions and have a potential to address significant unmet medical needs. Benefits of the program include early and frequent interactions with the FDA during the clinical development process and stem cell product tags with Fast Track designations may also be eligible for Priority Review and Accelerated Biologics License Application Approval, BLA approval. Achieving Fast Track designation is an important milestone for BioRestorative and we look forward to working more closely with the FDA as we continue to advance our lead BRTX-100 clinical program. The FDA has also cleared our IND application for a Phase 2 clinical trial for BRTX-100 targeting chronic cervical discogenic pain or cCDP. As a result, BRTX-100 is now the first and only stem cell product candidate in the world cleared by the FDA to be evaluated in the cervical degenerative disc disease setting. Through leveraging our data related to our lumbar trial, we can now avoid having to perform preclinical animal studies and a Phase 1 before initiating our Phase 2 cervical study, it follows that being cleared by the FDA to go directly into a Phase 2, we’ll be in a position to evaluate both the safety and efficacy of this product in the cervical disc, saving potentially tens of millions of dollars and three to five years of animal studies and a Phase 1 trial to get to this point. This also allows us to be the only company able to leverage our technology platform across both neck and lower back musculoskeletal indications. Moving to our core preclinical metabolic program, ThermoStem, we are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose-derived stem cells or BADSCs to generate brown adipose tissue or BAT, as well as exosomes secreted by brown adipose-derived stem cells. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans and is involved in weight loss. Previously published peer-reviewed preclinical data from a study conducted in collaboration with the University of Utah School of Medicine demonstrated that functional brown adipose-derived stem cells formulated using our patent in ThermoStem platform produced significant reductions in weight consistent with losses achieved by GLP-1 drugs and blood glucose levels in diet-induced obesity models in mice. It’s also important to note that although 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 some negative secondary effects of GLP-1 pharmaceuticals such as a loss of muscle mass and negative cardiovascular events. As awareness of the promise that our ThermoStem-based 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 us and any current and our future potential licensing partners. To that end, we continue to methodically build a comprehensive portfolio of issued patents that cover both U.S. and international markets, and we are pleased to see that our already formidable IP estate expanded again in the fourth quarter. On a final note, our previously reported substantial discussions with an undisclosed commercial stage regenerative medicine company with regards to potential license agreements of our ThermoStem 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 committed to closing the loop on this as soon as practical. With that, I will turn the call over back to Lance.

Thanks, Francisco. And as you can see from what Francisco and Rob just reviewed, we’ve had a very exciting and extremely productive 2024, and we’re energized by the many potential value-enhancing inflection points we see ahead. Our financial results demonstrate that we’re starting to make progress on our path to sustainable profitability, and we’re continuing to focus on carefully managing our resources as we advance our two clinical development programs, BRTX-100 and ThermoStem. So to summarize, we’re making great progress with our Phase 2 trial for BRTX-100 to treat chronic lumbar degenerative disc disease. And while the data is still blinded, the initial trends are very encouraging. Reflecting the positive preliminary Phase 2 trial data seen to date, the FDA has now granted the Fast Track designation to the program. And as Francisco said, we will have the opportunity to sit in front of the FDA on a number of occasions and really plan out what the balance of the trial and potentially what the Phase 3 could potentially look like. We intend to present more data from this trial with a larger patient population, and we’re optimistic that this data will be very consistent with the previous trends. We’ve now also expanded our advanced clinical pipeline to BRTX-100 to include the treatment of both chronic lower back and neck pain via the FDA clearance of our IND for a Phase 2 trial in the cervical space. We are continuing to proactively expand the already formidable ThermoStem intellectual property estate to help ensure long-term market exclusivity. And finally, we ended 2024 in a very strong financial position with cash, cash equivalents, marketable securities of over $10 million as of 12/31/2024. We’ll continue to efficiently manage our cash reserves while executing upon all of our strategic goals. Our steadily improving financial performance and our projected growth plans provides us with confidence around our financial flexibility and may put us on a pathway to become much less dependent upon the capital markets. That concludes our prepared remarks. Jenny?

Yes. No problem. [Operator Instructions] Your first question is coming from Michael Okunewitch of the Maxim Group. Michael, your line is live.

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

Thanks, Michael. Appreciated.

So I guess to start off, just relating to the resolution of annular tears and the decreased protrusion size that you saw in the imaging, is this something that you would expect to happen spontaneously? Or do patients with degenerative disc not typically improve like on their own?

Yes, definitely not. It’s not something that happens spontaneous, especially with annular tears. In terms of like bulging, there’s the possibility that can happen if it’s like early degeneration and muscle changes are a factor that are affecting that indication or that bulge. But in our case, if it’s degenerative disease where it’s not muscle related, it’s actually the disc is degenerating. So – and that’s on the bulge, but the annular tear, if there’s a tear, you do not expect to see that. So it’s very encouraging that we’re starting to see some resolutions here on some of these indications with these subjects.

And I would also add that what’s encouraging is not only that there are annular tears that are resolved or resolution of other anatomical related issues, but the way in which they’re being resolved, you’re starting to see sort of a more uniform line in the imaging to demonstrate that there’s been some actual regeneration. So again, we’re blinded. So I don’t know which – whether or not that patient received the product or not, but there appears to be in the study and in the imaging a very uniform resolution of the tear in a format that would suggest that some outside product could have potentially been the rationale.

All right. Thank you for that. And then thinking about the cervical program, right? So you’re moving from lower back, looking at cervical. Do you view this more as something of a one-off expansion that’s opportunistic? Or is there a broader strategy you should be thinking about to expand BRTX-100 over time to these other musculoskeletal indications where the Hypoxic environment may be less favorable to other cells?

Yes. I think that’s the goal. We want to – we strategically chosen the cervical space because it just makes sense. If it’s working for lumbar, it should work for cervical. There are some adjustments that we have to contemplate in terms of the volume of the disc that we’ve already addressed and that’s why we have the IND approved. But I think looking at the big picture, if we could get through the process and get BRTX-100 approved, we’re looking outside of the spine. So just as you mentioned, anything that has a Hypoxic nature to it, this cell is amenable to having a good therapeutic value to that particular treatment.

And also leveraging off the data that we see from lumbar, I think puts us in a position to get further along the regulatory pathway with cervical. So being able to eliminate a lot of time and costs associated with getting into that particular label, if you will?

Yes. I mean, just to add to that is the – we didn’t – we went directly to Phase 2 with our lumbar, which was a huge accomplishment for the company and the field actually because it had not been done before in that format. And now we’ve leveraged our lumbar data, which included both safety and efficacy to the FDA, and we got a Phase 2 approved for cervical. So it’s definitely moving in the right direction in terms of potential treatments and furthering applying it to other musculoskeletal indications.

And continuing down that line, right, you do plan to go straight into Phase 2. You have mentioned you expect this to be somewhat of a smaller study. So is there an intent here to potentially design this as a registration enabling study similar to your plans in lumbar disc disease?

Yes, absolutely. And that’s building upon the strategy. So just we need to get a history with the FDA on the clinical path. We’ve received Fast Track Designation. Anatomically, although the cervical is different than the spine, it’s still the, I mean, the lower back is still the spine. So I think we’re going to be able to leverage a lot of the regulatory hurdles while jumping through the lumbar trial with the spine and we could get faster regulatory approvals for both programs.

All right. Thank you very much for taking my questions today guys. And once again, congrats on all the progress.

Thanks a lot, Michael.

Thanks. Thanks, Michael.

Thank you very much. [Operator Instructions] Thank you. Your next question is coming from Elemer Piros of Rodman & Renshaw. Elemer, your line is live.

Thank you. Thank you, Lance. I am sorry, I joined a little bit late and you may have provided an enrollment update in the Lumbar trial, if you wouldn’t mind repeating that. And what would your estimation be for completing the first 100 or the 100 patients that you’re planning to enroll? And the follow-up would be whether you are estimating the cash burn in 2025 to be similar to 2024?

Sure. So I think I’ll take the cash burn question first. I think it will be similar as we’ll be continuing to enroll patients, possibly even a little bit less. I think 2026 will certainly be less because we won’t be enrolling at least as it relates to BRTX-100 lumbar. We haven’t given out numbers on enrollment, but I will tell you that we are considering giving out some numbers shortly. Enrollment is going very well. The reason why we’re not giving out numbers because we don’t want to give an indication as to how far we are from or how far or how short we are from completion. In that we are exploring some regulatory opportunities and strategies that dovetail with our Fast Track designation with the FDA to explore the potential to shorten the trial, limit the number of patients and seek an accelerated regulatory path. So I’d like to have the benefit of having that meeting, speaking with the FDA, getting more clarity on what that looks like before reporting back.

I understand. Thank you very much, Lance.

Sure. Thanks, Elemer.

Thank you very much. [Operator Instructions] And we do have another question in from Michael of the Maxim Group. Michael, your line is live.

Hey, guys. Thank you for taking another one for me.

Couldn’t get enough of us.

I always love talking to you guys. Just when we think about the Cartessa revenues going forward, right? I know it was previously expected somewhere in the range of the low-single digit millions. So is this something that we should expect to be kind of lumpy going forward or more consistent?

Yes, I mean, I think this was just – look, we – this is our first foray into a commercial relationship with a company that’s not a biologics company, rather a laser distributor who has, now enhanced their biologic sales force. Learning about the product, learning what the right call point is, really figuring out the strategies on selling. So, I would expect that going forward it would be a little bit more consistent to some of the numbers that we gave. But again, I don’t want to get ahead of myself here. This is – this hasn’t even been a year since we signed the agreement. So like – like all things, it just takes time to build that. We’re very encouraged by their commitment to us. We have the flexibility and opportunity to drive this product, albeit with a slightly different formulation, through other distributors as well. We will most likely be talking about or having an announcement related to some commercial opportunities shortly related to this product category. So I’m really excited. I just – I don’t want to put – the cart before the horse here, but in terms of human resources and senior level personnel, we’ve been talking to some very experienced people that can help drive this opportunity for us. And there’s more to come on that. So I wouldn’t focus exclusively on Cartessa. I think they will continue to be a good partner for us, but I think that the opportunity for the BioCosmeceuticals platform goes well beyond that relationship.

All right, thank you very much.

Okay, we appear to have reached the end of our question-and-answer session. I will now hand back over to the management team for any closing remarks.

Thanks again for everyone, for your interest and your participation in the call and to the equity research analysts that asked excellent questions. We appreciate that as well. Please continue to follow us once again. This is a very catalyst-rich environment for the company. So, keep us on your screen, and please look out for recent developments that are coming soon. Thank you very much.

Thank you everybody. This does conclude today’s conference. You may disconnect your phone lines at this time and have a wonderful rest of the day. Thanks for your participation.