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

Thank you so much. Hey Zingers, and welcome back to All Access. I got that wonderful guest for you today, another one, and that's Lance Alstodt, the Chairman and CEO of BioRestorative Therapies. The NASDAQ ticker is BRTX. He's joining us for another exclusive talk today. All Access starts right now. And it is my pleasure to welcome back in the Chairman and CEO of BioRestorative Therapies. Lance Alstodt, it's fantastic to be with you again, Lance.

Dan, great to see you again.

Yes. Like I said, it's a great time to be alive and when I'm with Lance Alstodt, I'm in great hands. So very excited for another discussion with you.

Let's start with this. I know that, Lance, BioRestorative Therapies just released some new preliminary data from the Phase II trial of BRTX-100 for the treatment of chronic lumbar disc disease at The International Society for Stem Cell Research Annual Meeting. Can you tell us about the results of the 30-patient trial? And did the preliminary data meet the endpoints of the trial?

Yes. Thank you for the question, and thank you for having me on again. It's great to see you. Last time I was on, we were preparing for this conference. It's one of the most prestigious conferences in our industry. So we were really excited about the composition of data that we were putting together. The preliminary blinded data from the first 36 patients treated in the Phase II trial of BRTX-100 are really highly encouraging. So at 52 weeks, over 74% of subjects demonstrated a greater than 50% improvement in function based on the ODI scale and over 72% reported a greater than 50% reduction in pain based on the VAS scale. Both 2 are very commonly used scales for these types of subjective measures, both substantially exceeding the FDA's clinically meaningful threshold of 30%. These results, which were presented at this ISSCR conference in Hong Kong last week, I think, made a big splash and really affirmed the powerful potential of BRTX-100 to transform how we treat chronic lumbar disc disease, a condition with very limited therapeutic options and a very large unmet need.

So great to hear great news on your guys, Lance. And you kind of alluded to this when it comes to the International Society for Stem Cell Research, it's a very prestigious conference. What was the reasoning behind making sure that you presented there? And how important was it for the company to present the data at that meeting?

Well, I think it's an honor to present the data at the meeting and to attend that meeting, not just as a bystander, but as a participant with a paper, with a podium and an audience, and that's something that you have to qualify for, and it's not something that you just sort of sign up for. So it was an honor to be selected and the fact that our data was as strong as it was, I think, is a testament to the combination of us being excited of being there and of course, the invitation to present.

Sounds fantastic. Let's talk about BRTX-100. What it does and what makes it different from other drugs in development for chronic lumbar disc disease, which we know obviously affects a lot of people?

Right. So for those that aren't aware, it's an autologous stem cell therapy, meaning it uses the patient's own bone marrow-derived stem cells, which are especially cultured under low oxygen or hypoxic condition really to mimic the environment of the spine's damaged disc. We then inject those enhanced cells directly into the affected disc where they reduce inflammation, they promote repair and help regenerate disc tissue with the source of the problem. So what makes BRTX-100 truly a differentiated product is that we're not masking the pain. We're targeting the root cause of the disc degeneration with a biologically active regenerative approach, most other treatments like opioids, steroids or even some emerging injectables, they only offer temporary pain relief. So they're really just treating the symptoms. Others in the regenerative space often use an allogeneic or a donor-derived cell, which comes with certain immunity risks and variability. While we think there is room because of the size of this market for many modalities within cellular therapy, we believe the current solutions for musculoskeletal-related disorders is totally unacceptable. Our therapy is personalized, meaning it comes directly from the patient's own body. It's targeted, meaning it's precisely injected into the damaged discs and it's durable with effects lasting up to 7 years in some patients. So this makes BRTX-100 really first-in-class candidate with the potential to redefine how we treat chronic lumbar disc disease, offering patients long-term relief without surgery and creating a differentiated high-value opportunity for investors.

Now Lance, speaking of chronic lumbar disc disease, how big of a problem is it in the U.S. and internationally? And right now, what are the current treatments? How much money is spent to treat chronic back pain? And what do you believe is the forecasted growth of the market?

Well, it's a multibillion-dollar industry, and that's just in the U.S. alone. So we always like to multiply that by 2 when we're thinking about rest of world. And today, I would say the most frequently used modalities include pharmacological solutions like opioids, and other anti-inflammatories, and we can spend an hour on that discussion alone because that problem is getting worse, not better, and it's a huge issue with over 200,000 Americans alone dying each year of opioid addiction. Alternatively, there is surgical intervention, which makes up billions of dollars of instrumentation and costs related to keeping people outside of work and recovery and trauma. So we really don't believe there are acceptable solutions today. We think we provide a very sophisticated elegant solution, and we create that chasm of opportunity between conservative therapy and surgical intervention. This is a market that we think has a very strong growth factor on it once some of these modalities in cell therapy are approved at the federal level. There are states that are starting to open up now where we're exploring that. We have a keen interest in being first mover in some of these states, but we want to make sure that we're doing the right thing and being extremely thoughtful and deliberate in our approach.

That's definitely the perfect way to encapsulate that to be. And Lance, I know you already announced data from a Phase II trial of 15 patients. What were the results of that trial? And it was clearly enough, obviously, to double it to 30 patients.

Well, it's very similar, and that's what we like to see. So we're seeing that as we're scaling on this trial, regardless of whether there are 15 patients or 36 patients and who knows there could be an announcement around the corner related to more patients, because we're really excited about our pace and the acceleration of our enrollment, especially in the back half of this year. We think that the data that we've seen today and the results that we've seen across the board, 15 patients, 36 patients, what comes next, we're hopeful and optimistic that we're going to have the same type of results. Results that are meaningfully more significant than what is held out for us by the FDA as their minimum threshold.

For sure. Let's talk, Lance, about what's next. When does BioRestorative expect to enroll more patients in the trial? And is that goal still to enroll as many as 90 patients?

That's a really good question. The -- well, first of all, let me just say that the results, I believe, are significantly derisked in the program. BRTX-100 is now tracking towards regulatory milestones with strong clinical momentum. The product has FDA Fast Track designation. We believe these Phase II outcomes really set the stage for a successful Phase II trial and beyond with a focus on accelerating to a commercial license. From a market perspective, chronic lumbar disc disease, we talked about, it affects millions of people globally, very few nonsurgical solutions. And we're really a first-in-class autologous stem cell therapy positioning to capture very meaningful share in a multibillion-dollar market opportunity.

That's fascinating stuff, Lance. And spin it forward here a little bit, if you would. Tell us a little bit about the future road map that you see for BRTX-100 beyond this Phase II trial.

So our goal is -- I mean, I just want to stay focused. So our goal remains to enroll up to 99 patients in total for the trial. And we are kind of right on track with a compelling, safety and efficacy data from the first 30 patients. Now in hand -- first 36 patients now in hand and the presentation that we did in Hong Kong last week, we're entering this key expansion phase. So we expect to accelerate the enrollment throughout the second half of the year with new clinical sites coming online. And I think because of the data, increased physician interest now that this data has been made public. So the trial is designed to be randomized and placebo-controlled and we're seeing growth momentum from both investigators and patients, especially given the unmet need in chronic lumbar disc disease. The next phase of enrollment is really about scaling that validation, building on the strong signal we've seen so far. So preparing some of the groundwork for a potential pivotal Phase III trial. We believe that these steps are essential as we work towards all of the regulatory milestones in front of us and ultimately position BRTX-100 as a first-in-class therapy in a market with very few options.

Well, wishing you and everyone at BioRestorative of the best with this going forward. Lance, an absolute pleasure talking with you again. And I just really want to thank you a lot for your time and what you guys...

Dan, awesome to see you. You look great. The walk-in is definitely working. And we look forward to speaking to you again soon.

If only I can look as good as you said, at least close to that, Lance. Thanks so much.

Cell therapy, get up for screen, everyone.

I'm ready. I'm ready. Thanks so much. That was the Chairman and CEO of BioRestorative Therapies. Lance Alstodt, their NASDAQ ticker is BRTX.