Lance Alstodt, CEO of BioRestorative Therapies BRTX, was recently a guest on Benzinga's All-Access.
BioRestorative Therapies is a regenerative medicine company that wants to alleviate chronic lower back pain, obesity and diabetes and is developing stem cell therapies to meet that end. The company's flagship program, BRTX-100, which is in a phase 2 clinical trial, uses a patient's stem cells to alleviate chronic back pain. Meanwhile, ThermoStem® uses adipose-derived (brown fat) stem cells to generate new brown fat tissue to target metabolic diseases, including obesity and type 2 diabetes. Both are addressing unmet health needs that inflict pain and suffering on millions of people around the world.
BioRestorative Therapies is a regenerative medicine company that wants to alleviate chronic lower back pain, obesity and diabetes and is developing stem cell therapies to meet that end. The company's flagship program, BRTX-100, which is in a phase 2 clinical trial, uses a patient's stem cells to alleviate chronic back pain. Meanwhile, ThermoStem® uses adipose-derived (brown fat) stem cells to generate new brown fat tissue to target metabolic diseases, including obesity and type 2 diabetes. Both are addressing unmet health needs that inflict pain and suffering on millions of people around the world.
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00:00And it is my pleasure to welcome in the Chairman and CEO of BioRestorative Therapies, Lance Allstott.
00:10Fantastic to be with you today, Lance.
00:12Dan, thank you for having me. Appreciate it.
00:15Hey, the pleasure. I guess we are in good hands with Allstott.
00:18I've heard that once before, but I enjoy that comment every now and then.
00:24Well, I'm thinking about Tampa Bay Buccaneers running back Mike Allstott.
00:27Mike Allstott, not a relative, not a relative, but spelled a little bit differently.
00:32That guy was a beast.
00:34Both of you amazing people, though.
00:36Can you start out here, Lance, and give us an overview of BioRestorative Therapies?
00:41Sure. BioRestorative, NASDAQ-listed, emerging growth cell therapy company.
00:47And what we're doing is really advancing stem cell science to address unmet needs in chronic pain and metabolic disease.
00:56We do this through three primary platform technologies.
01:01We have an autologous cell therapy, meaning we use the patient's own cells to address chronic pain and musculoskeletal pain.
01:10Within that platform, we are in a clinical stage and enrolling patients in our Phase II clinical trial
01:17to validate our product candidate for chronic lumbar degenerative disc disease or lower back pain.
01:24We say it's not a matter of if, it's when you get lower back pain.
01:28So what we're talking about is a massive market opportunity.
01:32We recently also just received great FDA news pertaining to that trial and that specific product technology.
01:41Our second platform is something called ThermoStem, and it's an allogeneic or an off-the-shelf cell therapy.
01:50It's a cell line that's derived from adipose fat tissue, and it's used for metabolic disease.
01:56So obesity and type 2 diabetes, for example, we're really targeting the most massive health care issues, for example, in the world today.
02:08So another huge market opportunity for us.
02:11We have preclinical data from a mouse model with respect to this technology.
02:17It showed tremendous efficacy, and we think this technology has a high degree of mitochondria,
02:23which will provide great effectiveness and broad applicability throughout the body.
02:30And lastly, in terms of the overall description of the company,
02:34we have a commercial platform harnessing our expertise in molecular biology and cell manufacturing.
02:41We formulate a cosmeceutical product, which is a secretone-based product used for topical use, cosmetic use.
02:50We have very big expectations from this program, given the potency and the quality of this product relative to the competition.
02:59And we have a lot of catalysts related to this program that we're going to talk about in the months to come.
03:06That's very incredible and important work you guys are doing.
03:09And I wanted to talk about how your stem cell therapies work.
03:13Yeah.
03:14So, for example, let me walk through a patient experience in our lower lumbar study.
03:22Patient has, remember, this is an autologous product.
03:26And when I say autologous, I mean we use the patient's own cells.
03:30So the patient goes and gets their cells harvested.
03:34We harvest it from the iliac crest.
03:36It's through a very modified bone marrow aspiration, which means we harvest these cells.
03:43Very pain-free, 11-minute procedure.
03:48We take those cells.
03:49We don't need a lot of cells because what we're doing with this cell matter is we're bringing it to our GMP ISO-certified 7 clean room facility here in New York, where we're going to expand and culture these cells to hundreds of millions of cells.
04:09And we do it in this hypoxic condition, meaning a low oxygen tension.
04:14The reason we do it in hypoxia, which is really where most of the IP around our novel technology resides, is what we're trying to do is condition these cells to survive the harsh elements of these avascular zones in the body.
04:31So the disc, for example, is a very harsh environment, very difficult for cells to live, to expand, to proliferate in these harsh conditions, low blood flow, low oxygen, low pH.
04:45So we try to really create this environment for the cells to grow within that environment, to resist that really harsh microenvironment of the disc.
04:56We then take those cells and we combine it with the patient's own autologous platelet lysate, which serves as a carrier.
05:04So it brings the cells together with the carrier to keep those cells from dying off prematurely.
05:12And we cryopreserve the product.
05:14We send it to the clinic.
05:16The clinic prepares it very uniformly, thaws it, and injects it directly into the nucleus of the disc under fluoroscopy.
05:25It's a very simple procedure.
05:27It's sophisticated.
05:28It's elegant relative to the alternatives, which is a traumatic open surgical intervention or conservative therapy where we're using pharmacological solutions like opioids, which is a whole separate conversation that we can have.
05:43But the process is incredibly safe.
05:49It's autologous.
05:50There's a strong bioenvironmental match because it's your own cells.
05:54And we're seeing tremendous efficacy related to this as we expect that the cells begin to scaffold and proliferate within that disc environment.
06:04And what it does is it takes a tremendous amount of inflammation out of the area and starts to regenerate that disc.
06:12And what we're looking to really fix are herniated discs, lacerations within the annulus tissue, and a variety of other structural issues that this product technology can actually regenerate and reform and solve the problem.
06:30That's really fascinating stuff, Lance.
06:32I know, as you mentioned, you're doing a lot of cutting-edge stuff.
06:35How is your approach to the stem cell therapy novel?
06:38Well, it's novel in that we do it under hypoxia.
06:44And like I said, that's really where this low oxygen tension.
06:47So we use about less than 5% oxygen tension.
06:53The air that we breathe, for example, is normoxic.
06:55Many of our competitors and other cell therapy companies do not use hypoxia.
07:00So the idea that a cell will survive in normoxic conditions in that expansion process and then the implementation or injection process into the disc space is somewhat preposterous.
07:15We don't think that from a long-term data perspective, normoxic cells going into these harsh environments will ultimately survive long enough to do the job they're intended to do.
07:29And, Dan, these are miracle cells.
07:32These are cells that are so well-conditioned for that bioenvironment that we just need for them to be in residence for a long enough period of time such that they can do what they're intended to do.
07:44Absolutely. What a time to be alive, Lance. That's for sure.
07:48Let's talk about your plans to accelerate your thermostem brown fat program.
07:53Sure. Thank you for asking.
07:54So we have advanced discussions with strategic partners outside of the U.S. to initiate a first-in-man study on the clinical side.
08:03So getting out of that preclinical into clinical, we had, like I mentioned earlier, some mouse models that we did looked at weight loss and increase of cardiovascular respiratory conditions.
08:18Now we're looking to get into humans and we're doing it potentially with a strategic partner outside of the U.S.
08:25We are in advanced discussions with strategic partners in terms of licensing this technology outside of the U.S.
08:33and hopefully taking a lot of that data, collecting it, and then using it in connection with an FDA-organized study.
08:41For sure.
08:42Let's tell you, as you well know, Lance, the biocosmeceutical space you've entered is massive.
08:46I know you currently have an agreement with Carteson to manufacture XOCR.
08:50What other plans do you have to bolster commercialization within this specific industry?
08:55Yeah, I mean, like you said, this is a massive market, the cosmetic market, the biocosmeceutical market.
09:01In a good economy, in a bad economy, recessive economy, people want to look better, feel better.
09:09We've got the best technology out there given our expertise in molecular biology and manufacturing of cell-based products.
09:17We formulated something that's extremely potent relative to the competitive landscape and truly a product of a biotechnology organization.
09:28And we intend to bring on very shortly, and this is news that I'm even giving a wink to it,
09:35a veteran in the industry to help us accelerate our commercialization strategy within this type of technology.
09:41We've begun to test a family of Secretone products for a variety of cosmetic applications and for hair loss as well.
09:51So we've basically created a post-procedure and a shelf-stabilized product,
09:57really broadening our capabilities and our product offering within this category.
10:02I'm all in for the hair loss stuff, my man.
10:04I need some help with that.
10:05You know, we've been testing a lot of people right now.
10:09The results are fabulous.
10:10It's for men and for women.
10:12You'd be surprised how many women are really interested in the hair product to thicken their hair
10:18and to eliminate pattern baldness.
10:21So we're very happy with the preliminary results.
10:25Yeah, no, a massive market.
10:26And some organ news, you know, you recently received fast-track designation approval from the FDA on BRTX 100.
10:32Can you explain the significance of the approval?
10:35Yeah, I mean, this is a major milestone for the company, something we're really proud of.
10:39This will ensure that we have clear communication with the FDA, and the goalposts will be very clearly defined for what we need to do to pursue a BLA license,
10:49which is our ability to commercialize the BRTX 100 technology for chronic lower lumbar disease.
10:56Our expectations include perhaps reducing the number of patients enrolled in our study, as well as the timing of our trial and our ability to reach a BLA in a shorter period of time,
11:08which means, you know, less dollars being spent in connection with that clinical process.
11:13And to you, Lance, what are the most exciting developments or, you know, trends you're seeing right now in cell therapy at the moment?
11:22Look, cell therapy is back, exclamation point.
11:26The remaining companies are very limited because we're really the ones that truly had the superior technology and strong management teams
11:35and the strong capitalization to survive the trend, if you will, back in 2010.
11:41So the ones that are remaining are the ones that are really driving the quality of the efficacy that we're starting to see.
11:48For the first time, there's been cell therapies approved by the FDA recently.
11:53The new administration is generally very supportive and favorable to finding solutions rather than just repeating transactional-based medicine,
12:04which bodes very well for what we're doing.
12:07And it feels like the agency is becoming, you know, much more interested in cell therapies overall in a variety of ways.
12:14And we're encouraged to take advantage of this moment in time where some of our key data will soon be available to review
12:21and acknowledge the safety and efficacy of this really important product technology.
12:27A lot of incredible stuff going on at BioRestorative Therapies right now, it's for sure.
12:31It was an absolute pleasure talking with you, Neil L.A.
12:33I'm seeing you so much.
12:34Likewise.
12:35Likewise.
12:35Really appreciate it.