Q1 2025 BioRestorative Therapies Inc Earnings Call
Good afternoon, everyone and welcome to the bio restorative therapies third quarter 2025 investor call.
Operator: Good afternoon, everyone, and welcome to the BioRestorative Therapy's first quarter, 2025, invest. At this time, all participants are in a listen-only mode and the floor will be open for questions following the presentation. If anyone should require operator assistance during the conference, please press star zero on your phone.
At this time all participants are in a listen only mode and the floor will be opened for questions. Following the presentation. If anyone should require operator assistance. During the conference. Please press star zero on your phone keypad. Please note. This conference is being recorded I will now turn the conference over to your house.
Stephen Kilmer: This conference is being I will now turn the conference over to your host, Stephen Kilmer, Investor Relations. Stephen, the floor is yours. Thank you, Jenny. Good afternoon, everyone.
Stephen Kilmer: Stephen Kilmer Investor Relations, Steven the floor is yours.
Speaker Change: Thank you Jamie 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.
Stephen Kilmer: Let me start by pointing out that this conference call will include four linking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All four linking statements are based on BioRestorative 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.
Speaker Change: All forward looking statements are based on bio restorative 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.
Stephen Kilmer: 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-linking statements, which speak only as of the date of this conference call. BioRestorative undertakes no obligation to publicly update or revise any forward-linking statement, whether as a result of new information, future events, or otherwise, other than as required by law.
Speaker Change: For details on factors among others could affect expectations in part one item <unk> of our annual report on Form 10-K for the year.
Speaker Change: December 31, 2024 filed with the Securities and Exchange Commission.
Speaker Change: Listeners are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date of this conference call.
Speaker Change: Startup 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.
Stephen Kilmer: On the call today representing the company are Lance Alstodt, BioRestorative's Chairman and Chief Executive Officer, Francisco Silva, its 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. Thank you, Stephen. Good afternoon, everyone.
Speaker Change: On the call today, representing the company are landfill sites.
Speaker Change: <unk>, Chairman and Chief Executive Officer, Francisco, Silver Silver Vice President of research and development and Robert could solve the company's Chief Financial Officer.
Speaker Change: Another call.
Speaker Change: I'll now turn the call over to Wes.
Wes: Thank you, Steve and good afternoon, everyone and welcome to our first quarter conference call on behalf of bio restorative 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.
Lance Alstodt: 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. 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.
Wes: 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 2020 fives 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.
Robert Kristal: With that said, I'm going to ask Rob to provide a brief overview of our first quarter financial results. 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 2025, revenues were $25,000 compared to $35,000 in the same period last year. First year 2025 deferred revenues were $150,000 compared to nil in the first quarter of 2024. I point this number out because it represents a timing difference on when we booked revenue versus when we received such revenue.
Rob: <unk> financial results.
Rob: Thanks, Lance good afternoon, everyone.
Rob: To streamline the presentation of the financial results all of the numbers I will referred to have been rounded. So they are approximate for.
Rob: For the first quarter 2025 revenues were 25000 compared to 35000 in the same period last year.
Rob: First year 2025 deferred revenues were 150000 compared to nil in the first quarter of 2024.
I point this number out because it represents a timing difference on when we booked revenue versus when we received such revenue.
Robert Kristal: We are encouraged with momentum in the underlying fundamentals of this revenue line. The company's first quarter 2025 loss from operations was $4.8 million compared to $4.1 million for the comparable period 2024. The company's first quarter 2025 net loss was $5.3 million, or $0.64 per share, compared to a net loss of $2.2 million, or $0.33 per share, for the first quarter of 2024. The change was primarily due to a gain on the exchange of warrants in Q1 2024.
Rob: We are encouraged with the momentum in the underlying fundamentals of this revenue line.
Rob: The company's first quarter 2025 loss from operations was $4 8 million compared to $4 1 million for the comparable period 2024.
Rob: The company's first quarter 2025, net loss was $5 3 million or <unk> 64 cents per share compared to a net loss of $2 2 million or 33 cents per share for the first quarter of 2024. The change was primarily due to a gain on the exchange of warrants in Q1 2024.
Robert Kristal: Cash used in operating activities in the first quarter of 2025 was $2.8 million and the company ended the quarter in a strong financial position with cash, cash equivalents, and marketable securities of $9.1 million and no outstanding debt.
Rob: Cash used in operating activities in the first quarter of 2025 was $2 8 million and the company ended the quarter in a strong financial position with cash cash equivalents and marketable securities of $9 1 billion and no outstanding debt.
Francisco Silva: With that, I'll turn the call over to Francisco. Thanks, Rob.
Francisco: Is that I will turn the call over to Francisco.
Francisco: Thanks, Rob for the benefit of those who are new to the buyer startup story I would like to take a moment to summarize our developmental programs. Our lead clinical stage candidate. Dr. T. X 100 is a novel cell based therapeutic engineered to target areas of the body to have little or no blood flow.
Francisco Silva: For the benefit of those who are new to the BioRestorative story, I would like to take a moment to summarize our developmental program. Our lead clinical stage candidate, BRTX100, is a novel cell-based therapeutic engineered to target areas of the body that have little or no blood. The product is formulated using autologous or a person's own cultured mesenchymal stem cells collected from the patient's bone marrow.
Francisco: Product is formulated using autologous or a person's own cultured mesenchymal stem cells collected from the patients bone marrow.
Francisco Silva: The safety and efficacy of BRTX-100 in treating chronic lumbar disc disease, or CLDD, is being evaluated in an ongoing Phase 2 prospective, randomized, double-blinded, and 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-to-1 to receive either BRTX or sham or placebo.
Francisco: The safety and efficacy of beer T X 100 in treating chronic lumbar disc disease or C. L. D. D is being evaluated in ongoing phase II prospective randomized double blind and controlled study a.
Francisco: A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites across the United States.
Francisco: Subjects included in the trial will be randomized two to one to receive either Dr T X or sham or placebo.
Francisco Silva: In a podium presentation that I gave in February in 2025 Orthopedic Research Society Annual Meeting, I reviewed 26 to 52-week blinded data from the first 15 subjects with CLDD enrolled in this study. No serious adverse events were reported, and there was no dose-limiting toxicity at 26 to 52 weeks. Preliminary Blinded Visual Analog Scale, or VAAS, and Autoprestory Disability Index, or ODI, data collected at weeks 26 and 52 post-injection demonstrated an exceptionally positive trend compared to baseline.
Francisco: In a podium presentation that I gave in February in 2025, Orthopedic Research Society annual meeting I reviewed 26 to 52 week blinded data from the first 15 subjects with C. L. D D enrollment in this study.
No serious adverse events were reported and there was no dose limiting toxicity at 26 to 52 weeks.
Francisco: Preliminary blinded visual analog scale or baas, and Oswestry disability index or ODI data collected at weeks 26, and 52 post injection demonstrated an exceptionally positive trend compared to baseline.
Francisco Silva: We were also really excited to see that at a 52-week comparison of MRI images compared to baseline, there appears to demonstrate morphological changes that potentially demonstrate disc microenvironment remodeling.
Francisco: We were also really excited to see that a 52 week comparison of MRI images compared to baseline there appears to demonstrate morphological changes that potentially demonstrate disc microenvironment remodeling.
Francisco Silva: More recently, just last week, in fact, I presented preliminary 26, 52, and 104-week blinded preliminary phase 2 BRTx100 data from the same 15 subjects at the International Society for Cell and Gene Therapy 2025 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 need its primary and secondary input.
Speaker Change: More recently just last week in fact, I presented preliminary 26, 52, and 104 week blinded preliminary phase two B R. T X 100 data from the same 15 subjects at the International Society for cell and gene therapy 2025 annual meeting.
Speaker Change: The longer term preliminary blinded data continued to trend positively compared to baseline and if these trends continue we believe that the phase two trial will meet its primary and secondary endpoints.
Francisco Silva: Partly based on the preliminary data, we have achieved two important FDA milestones since the beginning of 2025.
Speaker Change: Based on the preliminary data we have achieved two important FDA milestones since the beginning of 2025.
Francisco Silva: The first of those was the FDA-granting Fast-Track Designation for BRTX-100 field ED 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 conditions 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 FASTRAC designation may also be eligible for priority review and accelerated BLA biologics license application approval. Achieving FAST-TRAC 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-BRTX100 clinical program.
Speaker Change: The first of those was the FDA granted fast track designation for beer T X 100, COPD 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.
Speaker Change: 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 or biologics license application approval.
Speaker Change: But cheating fast track designation was an important milestone for virus started and we look forward to working more closely with the FDA as we continued to advance our lead BRT X 100 clinical program.
Francisco Silva: The second milestone achieved since the start of 2025 was the FDI clearing our investigational drug application for a phase two clinical trial for BRTX-100 in chronic cervical discogenic pain, or CCDP. As a result, DRTX100 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.
Speaker Change: The second milestone achieved since the start of 2025 with the FDA cleared our investigational new drug application for a phase II clinical trial for <unk>, 100, and chronic cervical discogenic clean or C. C. D T S.
Speaker Change: As a result Deere T X 100 is now the first and the only stem cell based product candidate in the world cleared by the F. D E F D a to be evaluated in the cervical degeneration disc disease setting.
Francisco Silva: 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 BADSEs, to generate brown adipose tissue or BAT, as well as exosome secreted by the BAT app. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans and is involved in weight loss.
Speaker Change: Moving to our four preclinical metabolic program thermal stem, we're developing cell based therapy candidates to treat target obesity and metabolic disorders, using brown adipose or fat derived stem cells or b a D. S E T.
To generate brown adipose tissue or bet 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 thermal stem and its impact on weight loss in <unk>.
Francisco Silva: While further work is needed to fully understand the mechanism of action of thermostatin and its impact on weight loss and metabolism, we have not seen, nor do we expect, the same negative secondary effects of GLP-1 pharmaceuticals, such as loss of muscle mass and negative cardiovascular 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 or future potential licensing partners. Accordingly, we have methodically built a comprehensive patent portfolio of issued patents that cover both the U.S.
Speaker Change: With them, we have not seen nor do we expect the same negative secondary effects of G. L. P. One pharmaceuticals, such as loss of muscle mass and negative cardiovascular effects.
Speaker Change: As awareness of the promise that are for the most time based.
Speaker Change: M 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 Change: Accordingly, we have methodically built it.
Speaker Change: Comprehensive.
Speaker Change: <unk> portfolio of issued patents that cover both the U S and international markets and we are pleased to see that our already for middle IP estate expanded again in the first quarter on a final note our producer reported substantial discussions with undisclosed commercial stage regenerative medicine company with regard to a potential license agreement for a thermostat.
Francisco Silva: and international markets, and we are pleased to see that our already formidable IP estate expanded again in the first quarter.
Francisco Silva: On a final note, our previous report of substantial discussions with undisclosed commercial state regenerative medicine companies 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.
Speaker Change: Pollack disease programs are continuing.
Speaker Change: We cannot provide interim progress updates and they'll 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.
Lance Alstodt: With that, I will turn the call over back to Lance. 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, BRTX100 and, of course, ThermoSTEM. So, to summarize, we're making exceptionally good progress with our Phase II trial for BRTX100. While the data is still blinded, the initial trends continue to be very encouraging. Reflecting the positive preliminary Phase II trial data seen to date, the FDA has granted fast-track designation to the program.
Lance: With that I will turn the call over back to Lance.
Lance: Thank you Francisco and as you can see from what Francisco and Rob just reviewed.
Lance: 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 program and spear T X 100 and of course, there most of them. So to summarize we're making exceptionally good progress with our <unk>.
Lance: <unk> two trial for Bureau T X 100, while the data is still blinded. The initial trends continue to be very encouraging reflecting the positive preliminary phase two phase III trial data seen to date. The FDA has granted fast track designation to the program.
Lance Alstodt: 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 trend. We have now also expanded our advanced clinical pipeline for BRTX100 to include the treatment of both chronic lower back pain and neck pain via the FDA clearance of our IND for a phase 2 trial in cervical. As you know, we skipped the phase 1 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.
Lance: 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.
Lance: We have now also expanded our advance clinical pipeline for beer T. X 100 to include the treatment of both chronic lower back pain and neck pain D. O S. T. A clearance of our I N V for a phase two trial in cervical as you know we skipped a phase one and we did not have to do any preclinical.
Lance: Nickel 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.
Lance Alstodt: We are continuing to proactively expand the already formidable Thermostem Intellectual Property Estate to help ensure a long-term market exclusivity. We continue to be in substantive discussions with regard to a potential license of Thermostem Metabolic IP and other assets that we possess from a technology perspective.
Lance: We're continuing to proactively expand the already formidable thermal stem intellectual property estate to help ensure a long term market exclusivity.
Lance: Continue to be in substantive discussions with regard to a potential license or a thermostat a metabolic IP and other assets that we possess from the technology per se perspective.
Lance Alstodt: Finally, we ended the quarter in a very strong financial position with cash, cash equivalents, and marketable securities of $9.1 million as of March 31st, 2025. We will continue to efficiently manage our cash reserves while executing upon our strategic goals.
Lance: Finally, we ended the quarter and a very strong financial position with cash cash equivalents in marketable securities of $9 1 million as of March 31, 2025, we will continue to efficiently manage our cash reserves, while executing upon our strategic goals.
Lance Alstodt: Thank you, and with that concluding our introductory remarks, we're happy to take any questions you may have. Thank you very much.
Lance: And with that concluding our introductory remarks, we're happy to take any questions you may have.
Lance: Thank you very much.
Operator: We will now be conducting our question and answer session.
Lance: We will now be conducting a question and answer session.
Operator: If you would like to ask a question, you can press star 1 on your phone keypad now. A confirmation tone will indicate that your line is open. You may press star 2 if you would like to remove your...
Lance: If you would like to ask a question you can press star one on your phone keypad now a confirmation tone will indicate your line is Nicky you May press star two if you would like to remove your question from Nicky set any participants using speaker equipment it might be necessary to pick up your handset before you press. The keys. Please wait a minute must be pulse.
Operator: For any participants using speaker equipment, it might be necessary to pick up your handset before you begin. Please wait a moment whilst we pause. Thank you.
Lance: Questions.
Lance: Thank you. Your first question is coming from Jonathan Aschoff of Ross Jonathan Your line is live.
Jonathan Aschoff: Your first question is coming from Jonathan Aschoff of... Jonathan, your line is. Thank you, congrats on the progress guys. I have a question. You know, you call the end point, the efficacy end point of greater than or equal to 30% improvements a preliminary end point. I've never really heard of an end point called preliminary data. Yes, but not an end point. And 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 end point that you're going to have to hit is no longer going to be greater than or equal to 30 and more?
Speaker Change: Thank you Ah congrats on the progress guys I had a question.
Speaker Change: You call the endpoint efficacy endpoint.
Speaker Change: Greater than or equal to 30% improvements a preliminary end point that I've never really heard of an endpoint called plain preliminary data, yes, but not an endpoint and then you're showing us.
Speaker Change: Greater than 50% improvement in this last.
Speaker Change: Last week's presentation. So is that some kind of foreshadowing the endpoint that you're going to have to hit is no longer going to be greater than or equal to 30 and more.
Lance Alstodt: like greater than or equal to 50. No, good question. But no, we're not changing the endpoint. It's still both just a 30% improvement. What's the preliminary word for it? Well, because the the the primary endpoint is safety of the study. It's not it's not efficacy by the FDA. The the target is is the 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 Change: Like greater than or equal to 50.
Speaker Change: No. That's a good question, but no we're not we're not changing the endpoint, it's still both just a 30%.
Speaker Change: Improved one.
Speaker Change: Minera reward for it.
Speaker Change: Well because the the primary endpoint is safety of the study it's not it's not efficacy.
Speaker Change: By the F D. A D. The target is a safety since it's a first in man study.
Speaker Change: The word preliminary is there is meaning that it's not the primary so the secondary endpoints are related to efficacy.
Speaker Change: Okay I noticed in the second slide presentation Mall last weeks versus February there was no more in line about a potential interim analysis at 26 weeks. So that is that outs or would that still be performed.
Lance Alstodt: Okay, I noticed in the second slide presentation, last week's versus February, there was no more line about potential interim analysis for 26 weeks. So is that, is that out or will that still be? 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 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 3 and potentially leverage this data to shorten the regulatory process for BLA approval.
Speaker Change: We haven't determined that we're going to do an internal it's our potential and that's that's still something that's on the table as an option.
Speaker Change: We don't want to compromise the trial in terms of having an interim analysis that could impact the long term development.
Speaker Change: Currently right now were.
Speaker Change: I wish we're having strategy talks with our our team internally as well as preparing some FDA communications to see where we could take this trial within the phase III and potentially leverage this data.
Speaker Change: To shorten the regulatory process for BLA approval, so an interim analysis could impact that and since we would have to unwind.
Lance Alstodt: So 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. Jonathan, just to 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 Change: But that's against or it's still something that's on the table, but we removed it from the presentation.
Speaker Change: Okay.
Jonathan Aschoff: I think Jonathan.
Speaker Change: Jonathan just to just to add to that I think we just need some more feedback from the FDA on that and those discussions are ongoing but I appreciate that.
Speaker Change: Amit.
Jonathan Aschoff: Okay, and the last one is the 45 subject data being presented in HK or China, where are those 45 patients? from the current study. So these are patients that have already been dosed and are at different time points within the visitation and the week. So some of it might be 26, some of it might be 52.
Speaker Change: Okay and the last one is the 45 subjects data being presented.
Speaker Change: H K, your China, where those 45 patients.
Speaker Change: From the current study. So these are patients that have already been dosed and are at different time points.
Speaker Change: Within the the visitation in the weeks.
Speaker Change: So some of it might be 26, some of it might be 52.
Lance Alstodt: So when is that presentation? That's in June. So the trials, you know, a lot more along in enrollment than one would glean from yesterday's press conference. Yeah, so I just want to be clear, the 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 and it doesn't represent how many patients have been dosed. That we would comfortably say is significantly higher. And the 15, they made it to week 12 and not yet to week 26, correct?
Speaker Change: When is that presentation.
Speaker Change: That's in June.
Speaker Change: Okay. So that so the trials you know.
Speaker Change: A lot more along enrollment than one would glean from yesterday's press release.
Speaker Change: Yeah, Yeah, so I just wanted to be healthier.
Speaker Change: Yes. The 15 patients is just to keep it sort of consistent with what we've shown in the past.
Speaker Change: And trying to keep those same patients along.
Speaker Change: A longer time period of of looking at metrics, but it doesn't represent the enrollment and it doesn't represent and how many patients have been dosed that we would comfortably say is significantly higher.
Speaker Change: The 15.
Speaker Change: They made it to week 12.
Speaker Change: And not yet to week 26, correct.
Speaker Change: The 15 patients.
Lance Alstodt: The 15 patients. at the presentation. It's the only way the percentages work out. Yeah. Correct. Like you had 13 at week 26, it looks like it's 2 out of 15 that give you that 13.3%. Right. 12.
Speaker Change: The presentation is the only way the percentages workout yeah.
Speaker Change: Correct like you had 13 at week 26, it looks like it's two out of 15 that gave you that 13, 3% or 12 weeks alright.
Jonathan Aschoff: All right, thank you very much. Thank you, Jonathan. Thank you very much.
Speaker Change: Alright, Thank you very much guys.
Jonathan Aschoff: Thank you Jonathan.
Speaker Change: Thank you very much and your next question is coming from Jason Mccarthy of the Max and Great. Jason Your line is live.
Jason Mccarthy: Jason McCarthy of The Maxx. Jason, your line is... 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? What is that pace? And as we head into summer, do you expect enrollment potentially to slow a little bit with people kind of taking holiday?
Jason Mccarthy: Hey, guys. Thanks for taking the questions it looks like Youre, making significant progress in terms of speed of enrollment understand enrollment is much further along than the 15 patient update.
Jason Mccarthy: That we saw do you expect enrollment to continue.
Jason Mccarthy: At its current pace kind of what is that pace and you know as we head into summer Ah do you expect enrollment potentially to slow a little bit as people kind of taking a holiday.
Lance Alstodt: For more information, visit www.FEMA.gov 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, 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.
Jason Mccarthy: Yeah.
Jason Mccarthy: No actually I think just the reverse actually we're starting to see a real uptick in patient because of some of the strategies that we've been employed from a recruitment perspective. So we kind of opened up a whole host of of of new strategies that seem to be working.
Jason Mccarthy: Better than what has been done in the past as you know this is a very difficult.
Jason Mccarthy: And challenging environment in order to find a single desk patient, whereas Discogenic, Spain.
Jason Mccarthy: With given how strict criteria. We obviously believe in the criteria are in order to have the cleanest and most valid.
Jason Mccarthy: Data possible relative to other trials that are out there. So we're going to continue to stay with the protocol I think to your enrollment is picking up.
Lance Alstodt: So, we're going to continue to stay with the protocol. 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 of recruitment.
Jason Mccarthy: Historically, we've seen a bit of a slowdown during the summer, but I think will counteract that where some of the new strategies that we've employed in terms of in terms of recruitment.
Speaker Change: Got it and in terms of your interactions with.
Lance Alstodt: 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, you know, reduction of pain with functional improvement? 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.
Jason Mccarthy: S T a.
Jason Mccarthy: There've been more emphasis from then on paying our folks here or did they want to see.
Jason Mccarthy:
Jason Mccarthy: <unk> pay with functional improvement.
Speaker Change: Well I will tell you that I think it's all open for discussion we havent had specific.
Jason Mccarthy: If you back that.
Jason Mccarthy: For example, a function would be dropped from the protocol.
Jason Mccarthy: I know in some cases it has been in the past, but we continue to collect data on both of our secondary secondary end points and our primary efficacy end points.
Jason Mccarthy: We'll continue to work with the FDA and discuss a whole host of matters, including <unk>.
Jason Mccarthy: What they really want to focus on as we get closer to two enrollment.
So.
Lance Alstodt: I think what we can look forward to is certainly pain will be a very meaningful endpoint function. I think it's something that we have a little bit more flexibility in terms of discussing.
Jason Mccarthy: I think what we can look forward to is certainly painful pain will will be a very meaningful endpoint.
Jason Mccarthy: Function I think is something that we have a little bit more flexibility in terms of discussing.
Jason Mccarthy: And have you provided any additional enrollment? patient characteristics. Are the patients older, younger, middle-aged?
Speaker Change: And have you provided any additional enrolling.
Speaker Change: Our patient characteristics are the patients older younger middle age, where do you think youre seeing the most response potentially.
Lance Alstodt: Where do you think you're seeing the most response potentially? Well, it's been ranging, you know, we do have younger patients that are, you know, in their early 20s. But then again, we have older patients that are in their late 50s. It's blinded data, so we don't know who or who has not been dosed. And so we've 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, you know, across the demographic. Got it.
Speaker Change: Well, it's it's been ranging you know we do have we do have a younger patients that are in their early twenties.
Speaker Change: But then again, we have the older patients that are that are in their late fifties.
Speaker Change: The blinded data. So we don't know who who are who has not been dosed until we got to be careful in terms of how we report the data but from a from a very high level. It looks pretty consistent that that trends are being being formed across the demographics.
Speaker Change: Got it last question.
Lance Alstodt: 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? Yeah, so, and again, this is, you know, still very, 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, you know, at baseline, the patient had a protrusion and an annular tear as well. And at 52 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.
Speaker Change: Can you just give us a little bit more detail on you had mentioned morphological changes in response to the south can you discuss a little bit more about what was observed.
Speaker Change: Yeah, So and again. This is this is I'm still very very early but.
Speaker Change: But it's very encouraging to see these morphological changes for example.
Speaker Change: In one subject and again, we haven't really it's more than just one that's experiencing this but in one particular subject that was presented at.
Speaker Change: At baseline the patient had a protrusion and an annular terror as well.
Speaker Change: And at 52 weeks compared.
Speaker Change: Compared to baseline or using the same MRI magnet we.
Speaker Change: We see that there's increase hydration, so theres a increased T. Two signal within the desk. There's a decrease in size of the protrusion and really interesting is that you see a decrease in the annual or Ter signal. So.
Lance Alstodt: So, that is showing very aggressive morphological remodeling within the extracellular matrix within the disk and the annulus as well. in another patient compared to baseline at 52 weeks. T2 signal begins to decrease, so there's less hydration. The protrusion appears to be very notably worse than compared to baseline. And you can see an evolution of extrusion within the disc lesion. So in that case, the patient got worse as compared to the previous patient that I spoke about. The patient is actually improving. Wasn't there also a resolution of annular tear in that patient that you're referring to?
Speaker Change: So that is that is showing a very aggressive morphological remodeling within the extracellular matrix within the disk and the annulus as well.
Speaker Change: In another patient compared to baseline at 52 weeks.
Speaker Change: T. Two signal begins to decrease so theres less hydration.
Speaker Change: Do you protrusion appears to be very notable.
Speaker Change: Notably worse than compared to baseline and you could see an evolution of an extrusion within the disk lesion.
Speaker Change: So in that case, the patient got worse as compared to the previous patient that I spoke about the patients actually improving.
Speaker Change: Got it. Thank you guys for taking the questions. There also oh, sorry. It isn't there also a resolution of the annular terror and that patient that you're referring to.
Lance Alstodt: Yeah, yeah, I mentioned that that there's a there's a decrease in the signal that's apparent their baseline where there is an annular tear and then at 52 weeks, the annular tear is nearly resolved.
Speaker Change: Yeah, Yeah, I mentioned that that there's a there's a decrease in the signal that's comparing their baseline what there is an annular tear and then at 52 weeks of the annular terrorism unit result.
Lance Alstodt: Okay, then just as a follow-up to that, do you think, you know, 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. 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 want to compromise how we could use this potential data going forward. So, you know, currently, right now, the environment for cell-based therapies, it's a little bit more positive than it has been ever.
Speaker Change: Okay, and then just as a follow up to that do you think you know with more mature a morphological data that that could be.
Speaker Change: Supplemental in your data package to FDA, ultimately and maybe even reduce the size of what could be a registration study next.
Speaker Change: We believe so I mean, that's one of the reasons, we were very careful of how we're managing the trial and the data because we really don't want to compromise.
Speaker Change: How we could use this potential data going forward so.
Speaker Change: Currently right now the environment for cell based therapies, it's a little bit more positive than it has been ever.
Lance Alstodt: So, we definitely want to leverage, you know, 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 going to be presented in Hong Kong. And again, part of that is safety, in addition to, you know, looking at the function and pain scales that were going to be presented. So, we're very encouraged, and hopefully, we have positive discussions going forward with the FDA.
Speaker Change: So we definitely want to leverage the BRT X product, it's autologous by nature of the safety profile that we're seeing I mean, there's again, there's 45 patient data that's going to be presented.
Speaker Change: Hum in Hong Kong and again part of that is safety. In addition to you know.
Speaker Change: Looking at the the function and pain scales that we're going to be presented so we're very encouraged and hopefully we have positive discussions going forward with the F. D. A.
Speaker Change: Great. Thank you guys for taking the questions.
Jason Mccarthy: Great. Thank you guys for taking the question. Thank you, Jason. Thank you very much.
Jason Mccarthy: Thank you Jason.
Speaker Change: Thank you very much just a little reminder, if anyone has any further questions. You can press star one on your telephone keypad.
Operator: Just a little reminder, if anyone has any further questions... Star One. Bye.
Jason Mccarthy: Very much.
Speaker Change: Okay. We don't appear to have any further questions I'll now hand back over to the management team for any closing remarks.
Operator: Okay, we don't appear to have any further questions.
Lance Alstodt: I'll now hand back over to the management team for any closing comments. 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.
Speaker Change: Okay, great well. Thank you very much appreciate everyone in attendance and we look forward to talking to you next quarter if not sooner.
Speaker Change: Have a great day.
Speaker Change: 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.
Operator: Thank you very much, that does conclude You may now disconnect your phone lines at this time and have a Thank you for your time.