Q2 2024 BioRestorative Therapies Inc Earnings Call and Business Update

BioRestorative BioRestorative

Operator: BioRestorative Good afternoon, and welcome to the BioRestorative Therapies 2nd quarter 2024 Invest. At this time, all participants are in a listen-only mode, and we will open for questions following the presentation. If anyone should require operator assistance during the conference, please press star zero on your phone.

Good afternoon and welcome to the

Speaker Change: At this time, all participants are in a listen-only mode and we will open for questions following the presentation. If anyone should require operator assistance during the conference, please press star zero on your phone keypad.

Operator: Please note, this conference is being recorded. I will now turn the conference over to your host, Stephen Kelmer, Director of Investor Relations. Stephen, the floor is yours.

Speaker Change: Please note this conference is being recorded. I will now turn the conference over to your host, Stephen Kelmer, Investor Relations. Stephen, the floor is yours.

Stephen Kelmer: Thank you. Good afternoon, everyone. Let me start by pointing out that this conference call will include four forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All forward-looking 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 forward

Stephen Kelmer: Thank you. Good afternoon, everyone. Let me start by pointing out that this conference call will include four looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Speaker Change: All forward-looking 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.

Stephen Kelmer: 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, 2023, filed with the Securities and Exchange Commission. Listeners are cautioned not to place undue reliance on these forward-looking statements, as we 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.

Speaker Change: No poor-looking statement can be guaranteed.

Speaker Change: For details on factors among others that could affect expectations, see part one item 1A of our annual report on Form 10-K for the year ended December 31st, 2023 filed with the Securities and Exchange Commission.

Speaker Change: Listeners are cautioned not to place undue reliance on these forward-linking statements. We speak only as of the date of this conference call. BioRestorative undertakes no obligation to publicly update

Speaker Change: 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 Altstotz,

Stephen Kelmer: On the call today representing the company are Lance Alstott, BioRestorative's chairman and chief executive officer, Francisco Silva, our vice president of research and development, and Robert Kristol, the company's chief financial officer. With that said, I'll now turn the call over to Len. Thank you, Steve. And good afternoon, everyone.

Speaker Change: BioRestorative's Chairman and Chief Executive Officer, Francisco Silva, our Vice President of Research and Development, and Robert Kristol, the company's Chief Financial Officer. With that said, I'll now turn the call over to Lance.

Lance Alstott: Welcome to our second quarter quarterly conference call. 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 support. We've had a very interesting and very productive first half of 2024.

Lance Altstotz: Thank You Steve and good afternoon everyone. Welcome to our second quarter quarterly conference call 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 support.

Speaker Change: We've had a very interesting and very productive first half of 2024. We're energized by the many potential value-enhancing inflection points that we see ahead.

Lance Alstott: We're energized by the many potential value-enhancing inflection points that we see ahead. As you can see from the financial results we announced today, we're very pleased with our quarterly and first-half success. The team has executed well on all of our programs, and with the commencement of our commercial platform and the execution of the CARTESA contract, we are also starting to make progress on a path to sustainable profitability. With that said, I'd like to turn the call over to Rob, who's going to provide a brief overview of our second quarter financial results. Thanks, Lance. Good afternoon, everyone.

Speaker Change: As you can see from the financial results we announced today, we're very pleased with our quarterly and first half success.

Speaker Change: The team has executed well on all of our programs, and with the commencement of our commercial platform and the execution of the CARTESA contract, we are also starting to make progress on a path to sustainable profitability.

Speaker Change: With that said, I'd like to turn the call over to Rob, who's going to provide a brief overview on our second quarter financial results.

Robert Kristol: Streamline the presentation of the financial results. All the numbers I will refer to have been rounded, so they are approximate. While it hasn't been fully reflected in our financial results, we did begin to derive some initial product revenue from our exclusive supply agreement with Cartessa in the second quarter. As a reminder, the goal of the agreement is to combine our deep cell-based biologics experience and formulation and clinical manufacturing expertise with Cartessa's extensive professional aesthetics market reach and marketing and distribution capabilities.

Rob: 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.

Speaker Change: While it hasn't been fully reflected in our financial results, we did begin to derive some initial product revenue from our exclusive supply agreement with Cartesa in the second quarter.

Speaker Change: As a reminder, the goal of the agreement is to combine our deep cell-based biologics experience and formulation and clinical manufacturing expertise with CARTES's extensive professional aesthetics market reach and marketing and distribution capabilities.

Robert Kristol: As part of the exclusive five-year agreement, we have agreed to supply significant preset minimum quantities of finished vials of our current cell-based biologic commercial product to CARTESA annually as a private label under CARTESA's Kronos XOCR mark. This product is formulated and manufactured using our DGMP ISO 7 certified clean room and is comprised of a cell-based secretome containing billions of exomes, proteins, Well, the absolute number is still relatively small at this stage.

Speaker Change: As part of the exclusive five-year agreement, we have agreed to supply significant preset minimum quantities of finished vials of our current cell-based biologic commercial product to CARTESA annually as a private label under CARTESA's Kronos XOCR mark.

Speaker Change: This product is formulated and manufactured by using our DGMP ISO7 certified clean room and is comprised of a cell-based secretome containing billions of exomes, proteins, and growth factors.

Robert Kristol: Our initial supply of product to Cartesa contributed to a 154% sequential growth in total revenues, growing from $35,000 in Q1 2024 to $89,000 in Q2 2024. Moving forward, we expect revenues to continue to grow materially both on an absolute and a percentage basis as we supply at least the minimum quantities of finished files of the product under the agreement. For the three-month period ended June 30, 2024, Biorestorative had a loss from operations of $2.5 million, a 19% year-over-year improvement from the $3.1 million loss for the comparable period of 2023 and a 39% improvement sequentially from the $4.1 million loss in the first quarter of 2024. Cash used in operating activities in Q2 2024 was $1.9 million, and the company ended the second quarter in a strong financial position with cash equivalents and marketable securities of $14.7 million and no outstanding debt.

Speaker Change: While the absolute number is still relatively small at this stage, our initial supply of product to Cartessa contributed to a 154% sequential growth in total revenues.

Speaker Change: growing from $35,000 in Q1 2024 to $89,000 in Q2 2024. Moving forward, we expect revenues to continue to grow materially both on an absolute and a percentage basis as we supply at least the minimum quantities of finished files of the product under the agreement.

Speaker Change: For the three-month period ended June 30, 2024, BioRestorative had a loss from operations of $2.5 million, and 19% year-over-year improvement from the $3.1 million loss.

Speaker Change: for the comparable period of 2023 and the 39% improvement sequentially from the 4.1 million loss in the first quarter of 2024.

Speaker Change: Cash used in operating activities in Q2 2024 was $1.9 million and the company ended the second quarter in a strong financial position with cash, cash equivalents and marketable securities of $14.7 million and no outstanding debt.

Francisco Silva: We expect that this cash level, combined with meaningful revenues we expect from our commercial biocosmeceutical business, should make us significantly less reliant than most of our clinical stage life sciences company peers on the capital markets going forward. With that, I'll turn the call over to Francisco for a review and update of our development program. Thanks, Rob.

Speaker Change: We expect that this cash level combined with meaningful revenues we expect from our commercial biocosmeceutical business should make us significantly less reliant than most of our clinical stage life sciences company peers on the capital markets going forward.

Speaker Change: With that, I'll turn the call over to Francisco for a review and update of our development programs.

Francisco Silva: For the benefit of those who are new to Biorestorative Story, I would like to start by taking a moment to briefly describe our clinical BRTX100 and our preclinical thermostem pipeline. Our lead cell therapy 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 your own, cultured mesenchymal stem We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapy to a surgical procedure. The safety and efficacy of BRTX100 in treating chronic lumbar dystasis, or CLDD, are being evaluated in our ongoing Phase II prospective randomized double-blinded control study.

Francisco: Thanks, Rob. For the benefit of those who are new to Biorestorative Story, I would like to start by taking a moment to briefly describe our clinical BRTX100 and our preclinical thermostem pipeline programs.

Francisco: Our lead cell therapy candidate, BRTX100, is a novel cell-based therapeutic engineered to target areas of the body that have little or low blood flow.

Francisco: The product is formulated using autologous or your own cultured mesenchymal stem cells collected from the patient's bone marrow.

Francisco: We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure.

Speaker Change: The safety and efficacy of DR-TX100 in treating chronic lumbar dystasis or CLDD is being evaluated in our ongoing phase 2 prospective randomized double-blinded control study.

Francisco Silva: A total of up to 99 subjects are currently being enrolled at 16 clinical sites in the United States. Subjects included in the study will be randomized two-to-one to either receive BRTX or SHAM. In our core preclinical metabolic program, ThermoSTEM, we are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose, or FAT, derived stem cells, which we call VADSCs, to generate brown adipose tissue, as well as exosomes created by the BATA.

Speaker Change: A total of up to 99 subjects are currently being enrolled at 16 clinical sites in the United States.

Speaker Change: Subjects included in the treatment will be randomized 2-to-1 to either receive BRTX or SHAM.

Speaker Change: In our core preclinical metabolic program, ThermoSTEM, we are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose or fat-derived stem cells.

Speaker Change: which we call VADSCs, to generate brown adipose tissue as well as exosomes created by the badass.

Francisco Silva: BAT is intended to mimic naturally occurring brown adipose depots that are found in the body that can regulate metabolic homeostasis in humans and are involved in weight loss. Previously published preclinical data from a study conducted in collaboration with the University of Utah School of Medicine demonstrated that functional brown adipose-derived stem cells formatted using our Patterton thermostem platform produced significant reductions in weight consistent with losses achieved by G It is important to note that although further work is needed to fully understand the mechanism of action of ThermoSTEM, its impact on weight loss, nor do we expect, the same negative secondary effects of GLP-1 pharmaceuticals, such as loss of muscle mass or negative cardiovascular effects.

Speaker Change: BAT is intended to mimic naturally occurring brown adipose depots that are found in the body that can regulate metabolic homeostasis in humans and is involved in weight loss.

Speaker Change: 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

Speaker Change: formidated using our Patterton thermostim platform produced significant reductions in weight consistent with losses achieved by GLP-1 pharmaceuticals.

Speaker Change: The blood glucose levels in diet-induced obesity model in mice.

Speaker Change: It is important to note that although further work is needed to fully understand the mechanism of action of ThermoSTEM, its impact on weight loss

Speaker Change: We have not seen, nor do we expect, the same negative secondary effects of GLP-1 pharmaceuticals, such as loss of muscle mass or negative cardiovascular effects. We have achieved significant milestones in both of these core developmental programs over the past few weeks and months.

Francisco Silva: You have achieved significant milestones in both of these core developmental programs over the past few weeks and months. With respect to BRTX100, in April, the FDA cleared an important amendment to our Phase 2 study protocol, which removes the saline injection in the control arm of the study and replaces it with a sham injection. With the protocol change, control patients now have a needle placed in close proximity to the target, but the disk is not pierced, nor does it receive saline injected into it. We believe this brings additional safety to our subject participants. In addition, it is well established that thiamine can rehydrate the disc and create a change in the disc microenvironment.

Francisco Silva: This change, although transient, may result in short-term pain relief. Thus, the protocol amendment helps preclude the possibility of transient clinical outcomes in the control group, which could potentially impact end-of-study readouts in trials like this. We believe the FDA clearance of this important amendment highlights our positive relationships with the agency. We remain confident that we will be fully enrolled in the Phase 2 study by the end of 2024 and look forward to providing additional preliminary data updates as we progress. Shifting now to our Pattern and Thermostem platform, we were pleased to announce mid-quarter the development of a novel exosome-based biologic program targeting obesity. Exosomes are small extracellular vesicles secreted by various cells, including stem cells.

Speaker Change: With respect to BRTX100, in April, the FDA cleared an important amendment to our Phase 2 study protocol, which removes the saline injection in the control arm of the study and replaces it with the sham injection.

Speaker Change: With the protocol change, control patients now have a needle placed in close proximity to the target disc, but the disc is not pierced, nor does it receive a saline injected into it.

Speaker Change: We believe this brings additional safety to our subject participants. In addition, it is well established that saline can rehydrate the disc and create a change in the disc microenvironment.

Speaker Change: This change, although transient, may result in short-term pain relief. So the protocol amendment helps preclude the possibility of transient clinical outcomes in the control group, which could potentially impact end-of-study readouts in trials like this.

Speaker Change: We believe, with the FDA clearance of this important amendment, highlights our positive relationships with the agency.

Speaker Change: We remain confident that we will be fully enrolled in the Phase II study by the end of 2024 and look forward to providing additional preliminary data updates as we progress.

Speaker Change: Shifting now to our Pattern of Thermal STEM Platform, we were pleased to announce mid-quarter the development of a novel exosome-based biologic program targeting obesity.

Francisco Silva: They are understood to play an important role as mediators for intracellular communication and have been found to play a role in adipose fat metabolism by transporting cargo such as non-coding RNAs and proteins and other factors that may impact weight. This e-therapeutic candidate has the potential to serve as an adjuvant as well to existing weight loss drugs and programs, potentially allowing for lower doses as well as the prevention or minimization of possible muscle mass loss and negative cardiovascular effects.

Speaker Change: Exosomes are small extracellular vesicles secreted by various cells, including stem cells.

Speaker Change: They are understood to play an important role as being mediators for intracellular communication and have been found to play a role in adipose fat metabolism by transporting cargo such as non-coding RNAs and proteins and other factors that may impact weight loss.

Speaker Change: This new therapeutic candidate has the potential to serve as an adjuvant as well to existing weight loss drugs and programs, potentially allowing for lower dosing as well as the prevention or minimization of possible muscle mass loss and negative cardiovascular effects.

Francisco Silva: Importantly, as awareness of the promise of our thermostat-based BADSE holds 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. We believe that a broad intellectual property portfolio can also be leveraged across drugs that are currently approved or marketed for waste, potentially opening up the door to future big pharma partnership opportunities for the company.

Speaker Change: Importantly, as awareness of the promise of our thermostat-based BADSE holds for the treatment of obesity and related metabolic disorders continues to grow.

Speaker Change: It is important that this potentially game-changing opportunity is well-protected, both for us and any current and or future potential licensing partners.

Speaker Change: We believe that a broad intellectual property portfolio can also be leveraged across drugs that are currently approved or marketed for weight loss, potentially opening up the door for future big pharma partnership opportunities for the company.

Francisco Silva: To that end, we have methodically built a comprehensive portfolio of issued patents that cover both U.S. and international markets, and we are pleased to see that we are ready for middle IPSA expansion in the second quarter via our notice of allowance for the fifth Japanese patent covering the technology. Also in the second quarter, our positive preclinical data and strong intellectual property portfolio began to bear fruit as we entered into substantive discussions with an undisclosed commercial-stage regenerative medicine company with regard to a potential license agreement for a thermostat metabolic disease program.

Speaker Change: To that end, we have methodically built a comprehensive portfolio of issued patents that cover both U.S. and international markets.

Speaker Change: and we are pleased to see that we are already formidable IPSA expanded in the second quarter via our notice of allowance for the fifth Japanese patent covering technology.

Speaker Change: Also, in the second quarter, our positive preclinical data and strong intellectual property portfolio began to bear fruit as we entered in substantive discussions with an undisclosed commercial stage regenerative medicine company with regard to a potential license agreement for a thermostat metabolic disease program.

Francisco Silva: Those discussions are ongoing, and 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. To summarize, we are making good progress with our Phase 2 trial for BRTX100 to treat chronic lumbar disc disease, and we have added a new therapeutic candidate targeting the BCoVR thermostem program.

Speaker Change: Those discussions are continuing and 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.

Speaker Change: To summarize, we are making good progress with our Phase 2 trial for BRTX100 to treat chronic lumbar disc disease.

Lance Alstott: We are involved in substantial discussions for a potential out-licensing agreement for the thermostem metabolic disease program, and we have begun to commercialize our technology with CARTESA in the biocosmeceutical market. Now, I will turn the call back over to Lance. Thank you, Francisco. As you can all see from what the team just reviewed, we've had a great and productive first half of 2024. I'm very energized by many of the upcoming value-enhancing inflection points that we see ahead.

Speaker Change: We have added a new therapeutic candidate targeting the BCAVR thermostem program. We are involved in substantial discussions for a potential outlicensing agreement of the thermostem metabolic disease program, and we have begun to commercialize our technology with CARTESA in the biocosmaceutical markets.

Speaker Change: Now I will turn over the call back over to Lance.

Lance Altstotz: Thank you, Francisco. As you can all see from what the team just reviewed, we've had a great and productive first half of 2024. I'm very energized by many of the upcoming value-enhancing inflection points that we see ahead.

Lance Alstott: Our second quarter financial results also demonstrate that we're starting to make progress on a path to sustainable profitability. As we move forward, we'll drive that by continuing to focus squarely on carefully managing our resources as we advance our two core clinical development programs. While leveraging the significant cash flow, we anticipate coming soon from our transformative biocosmeceutical agreement with Cartesi. So, to summarize... The FDA recently cleared an important amendment to the protocol in the ongoing phase two, replacing saline injection with a sham injection in the control arm.

Speaker Change: Our second quarter financial results also demonstrate that we're starting to make progress on a path to sustainable profitability. As we move forward,

Speaker Change: We'll drive what will drive that by continuing to focus squarely on carefully managing our resources

Speaker Change: as we advance our two core clinical development programs while leveraging the significant cash flow we anticipate coming soon from our transformative biocosmeceutical agreement with CARTESA. So, to summarize...

Speaker Change: The FDA has recently cleared an important amendment to the protocol on the ongoing phase 2.

Lance Alstott: This is great for us, and it's great for patients in the trial. Patient recruitment in the study is going very well with the hiring of Galen, and we expect complete enrollment before the end of 2024. We intend to present more data from this trial, like we did before, on a blinded basis, but with a larger patient population, and we are very optimistic that this data will be consistent with previous trends. Based on our very strong data from our preclinical animal study in obesity, we've enhanced our preclinical metabolic program with a novel exosome-based therapeutic candidate targeting obesity.

Speaker Change: Thank you.

Speaker Change: Replacing saline injection with a sham injection in the control arm. This is great for us.

Speaker Change: and it's great for patients in the trial. Patient recruitment in the study is going very well through the hiring of Galen, and we expect to complete enrollment before the end of 2024. We intend to present more data from this trial, like we did before, on a blinded basis, but with a larger patient population, and we are very optimistic that this data will be consistent with previous trends.

Speaker Change: Based on our very strong data from our preclinical animal study in obesity, we've enhanced our preclinical metabolic program with a novel exosome-based therapeutic candidate targeting obesity.

Lance Alstott: We're continuing to proactively expand the already formidable ThermoSTEM intellectual property estate to help ensure long-term market exclusivity and continued discussions from a strategic licensing perspective. Our promising preclinical work and strong IP estate have resulted in entering into some of these discussions for the ThermoSTEM metabolic disease program and substantive licensing discussions that are ongoing. Our strategic agreement with CARTESA, an established aesthetics market leader, serves to validate our biocosmeceuticals platform and represents a transformative step towards building a strong commercial engine capable of supporting profitable growth while also helping fund the continued advancement of BRTX100 and ThermoSTEM.

Speaker Change: We're continuing to proactively expand the already formidable Thermostem Intellectual Property Estate to help ensure long-term market exclusivity and the continued discussions from a strategic licensing perspective.

Speaker Change: Our promising preclinical work and strong IP estate have resulted in entering into some of these discussions for the Thermostat Metabolic Disease Program and Substantive Licensing Program.

Speaker Change: discussions that are ongoing.

Speaker Change: Our strategic agreement with Carcasa, an established aesthetics market leader.

Speaker Change: serves to validate our biocosmeceuticals platform and represents a transformative step towards our building a strong commercial engine capable of supporting profitable growth while also helping fund the continued advancement of BRTX100 and ThermoSTEM.

Lance Alstott: We intend to add a family of patents protecting our biocosmeceuticals platform and expand the existing relationship with additional product lines before the end of 2024. Finally, we ended the second quarter in a very strong financial position with cash and cash equivalents, and marketable securities of $14.7 million as of June 30, 2024.

Speaker Change: We intend to add a family of patents protecting our biocosmeceuticals platform and expand the existing relationship with additional product lines before the end of 2024.

Operator: Good afternoon and welcome to the BioRestorative Therapies 2nd quarter 2024 Investical. At this time all participants are in a listen-only mode and we will open 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.

Operator: Good afternoon and welcome to the BioRestorative Therapies 2nd quarter 2024 Investical. At this time all participants are in a listen-only mode and we will open 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.

Speaker Change: Finally, we ended the second quarter in a very strong financial position with cash and cash equivalents marketable securities of $14.7 million as of June 30, 2024. That combined with our steady.

Lance Alstott: That, combined with our steadily improving financial performance, provides us with additional financial flexibility and puts us on a pathway to profitability. Thank you. And with that, concluding our introductory remarks, we're happy to take any questions you may have, operator. Thank you very much. We will now be conducting our question and answer session. If you would like to ask a question, please press star 1 on your phone keypad. A confirmation tone will indicate that your line is connected. You may press star 2 if you would like to remove your question from... For anyone using speaker equipment, it may be necessary to pick up your handset before. Please wait a moment while.

Speaker Change: steadily improving financial performance, provides us with an additional flexibility financially, and puts us on the pathway to profitability. Thank you, and with that, concluding our introductory remarks, we're happy to take any questions you may have. Operator?

Stephen Kilmer: I will now turn the conference over to your host Stephen Kilmer investor relations. Stephen the floor issues. Thank you.

Stephen Kilmer: I will now turn the conference over to your host Stephen Kilmer investor relations.

Stephen Kilmer: Good afternoon everyone.

Stephen Kilmer: Stephen the floor issues. Thank you.

Stephen Kilmer: Let me start by pointing out that this conference hall will include four looking statements within the meaning of the private security litigation reform act of 1995. All four looking statements are based on BioRestorative Therapies current beliefs, assumptions and expectations and such statements involve known 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 four looking statement can be guaranteed.

Speaker Change: Thank you very much. We will now be conducting our question and answer session. If you would like to ask a question, please press star 1 on your phone keypad now.

Speaker Change: A confirmation tone will indicate that your line is in the queue. You may press star 2 if you would like to remove your question from the queue. For anyone using speaker equipment, it may be necessary to pick up your handset before you press the keys. Please wait a moment whilst we poll for questions.

Operator: Thank you. Your first question is coming from Jonathan Ashoff of ROTH. Jonathan, your life, Thank you.

Stephen Kilmer: For details on factors among others that could affect expectations, see part 1 item 1a of our annual report on form 10k for the year and December 31st 2023 filed with the Securities and Exchange Commission. Listeners are cautioned not to place undue reliance on these four looking statements. We speak only as of the date of this conference call. BioRestorative undertakes no obligation to publicly update or revise any four looking statement whether results of new information future events or otherwise other than those required by law.

Speaker Change: Thank you. Your first question is coming from Jonathan Ashoff of Roth MKM. Jonathan, your line is live.

Jonathan Ashoff: Good afternoon, guys. I was wondering, given what sounds like apparent BRTX100 data confidence, are you saying that you are already seeing blinded data have a, you know, two-to-one split of activity, kind of like the three-to-one split you reported on in February? The first four patients, as you know, had a three-to-one randomization. The remaining patients after those four were randomized two-to-one. So, the data would be cut that way. And even with that, we are starting to see, again, we're blinded, or at least I am.

Jonathan Ashoff: Thank you. Good afternoon, guys. I was wondering, you know, given what sounds like apparent BRTX 100 data confidence, are you saying that you are already seeing blinded data have a, you know, two-to-one split of activity, kind of like the three-to-one split you reported on in February?

Jonathan Ashoff: Bye.

Speaker Change: The first four patients, as you know, had a three-to-one randomization. The remaining patients...

Stephen Kilmer: On the call today representing the company are Lance Altstadt's BioRestorative Chairman and Chief Executive Officer Francisco Silva, our Vice President of Research and Development and Robert Crystal, the company's chief financial officer. With that said, I'll voucher in the call over the last.

Speaker Change: after those four are randomized two-to-one.

Speaker Change: So, the data would be cut that way, and even with that, we are starting to see, again, we're blinded, so, or at least I am.

Lance Alstott: So, what we see is improvement and reduction of pain and increase in function off of baseline in some of the patients. And then other patients, we're seeing a fairly consistent flat trend relative to baseline. Based on how many patients we're talking about in the randomization, I think there's a very clear signal, as there was with the first four patients. So, I think it's very consistent.

Stephen Kilmer: Good afternoon everyone.

Speaker Change: So, what we see is improvement and reduction of pain and increase in function off of baseline with some of the patients and then other patients we're seeing.

Stephen Kilmer: Let me start by pointing out that this conference hall will include four looking statements within the meaning of the private security litigation reform act of 1995. All four looking statements are based on BioRestorative Therapies current beliefs, assumptions and expectations and such statements involve known 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 four looking statement can be guaranteed.

Stephen Kilmer: For details on factors among others that could affect expectations, see part 1 item 1a of our annual report on form 10k for the year and December 31st 2023 filed with the Securities and Exchange Commission. Listeners are cautioned not to place undue reliance on these four looking statements. We speak only as of the date of this conference call. BioRestorative undertakes no obligation to publicly update or revise any four looking statement whether results of new information future events or otherwise other than those required by law.

Speaker Change: a fairly consistent flat trend relative to baseline.

Speaker Change: Based on how many patients we're talking about in the randomization, I think there's a very clear signal, as there was with the first four patients, so I think it's very consistent.

Lance Altstadt: On the call today representing the company are Lance Altstadt's BioRestorative Chairman and Chief Executive Officer Francisco Silva, our Vice President of Research and Development and Robert Crystal, the company's chief financial officer. With that said, I'll voucher in the call over the last. Thank you Steve and good afternoon everyone.

Lance Alstott: So that's positive about seeing a 2-to-1, with more patients, given the new randomization. Okay, that's definitely encouraging. Can you help us understand anything about, you know, the magnitude of minimum CARTESA purchase quantities, or is that not?

Speaker Change: So that's affirmative to seeing a 2 to 1.

Lance Altstadt: Welcome to our second quarter quarterly conference call 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 support. We've had a very interesting and very productive first half of 2024 where energized by the many potential value enhancing and selection points that we see ahead. As you can see from the financial results we announced today, we're very pleased with our quarterly and first half success.

Speaker Change: trend with more patients given the new randomization. Okay, that's definitely encouraging. Can you help us understand anything about, you know, the magnitude of minimum CARTESA purchase quantities or is that not...

Lance Altstadt: The team is executed well on all of our programs and with the commencement of our commercial platform and the execution of the Cartesa contract. We are also starting to make progress on a path to sustainable profitability.

Robert Kristol: Well, I think I might have given some indication in the past that what we're talking about is a low, multi-million dollar revenue contract over the course of 12 months, and that would represent the first year. Obviously, this is a five-year exclusive agreement, so while we are not giving guidance on quarterly earnings until we feel comfortable with the ebbs and flows and tactical dynamics of how each invoice is booked and paid for, we have clear sight as to what that number will look like over the course of 12 months.

Speaker Change: Well, I think I might have given some indication in the past that what we're talking about is a low-

Robert Crystal: With that said, I'd like to turn the call over to Rob who's going to provide a brief overview on our second 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.

Speaker Change: multi-million dollar revenue contract over the course of 12 months.

Speaker Change: And that would represent, you know, the first year. Obviously, this is a five-year exclusive agreement. So...

Speaker Change: you know, we, while we are not giving guidance on quarterlies until we

Robert Crystal: Well, it hasn't been fully reflected in our financial results. We did begin to derive some initial product revenue from our exclusive supply agreement with Cartesa in the second quarter. As a reminder, the goal of the agreement is to combine our deep cell-based biologics experience and formulation and clinical manufacturing expertise with Cartesa's extensive professional aesthetics market and marketing and distribution capability. As part of the exclusive five-year agreement, we have agreed to supply significant preset minimum quantities of finished files of our current cell-based biologic commercial product to Cartessa annually as a private label under Cartessa's Cronos XOCR mark. This product is formulated and manufactured by using our DGMP ISO7 certified clean room as a price of a cell-based secret home containing billions of exomes, proteins, and growth factors.

Robert Crystal: Well, the absolute number is still relatively small at this stage. Our initial supply of product to Cartessa contributed to a 154 percent sequential growth in total revenues growing from 35,000 in Q1 2024 to 89,000 in Q2 2024. Moving forward, we expect revenues to continue to grow materially both on an absolute and a percentage basis as we supply at least the minimum quantities of finished files of the product under the agreement.

Speaker Change: feel comfortable with the ebbs and flows and tactical dynamics of how each invoice is booked and paid for, you know, we have clear sight as to, you know, what that number will look like over the course of 12 months.

Robert Kristol: And the 81,000 represents how many days of the second quarter that you could have sold and delivered them product. We'll have to calculate that, but the contract was in late April, so you can figure it out. Without being able to spell out the agreement for you, if you're going to do it based on days, you're not going to come up with the right math. There's a series of milestones and other provisions within the agreement that set off the first couple of payments, so I see what you're doing, but it's not a linear equation.

Speaker Change: The $81,000 represents how many days of the second quarter that you could have delivered them product?

Speaker Change: We'll have to calculate that, but yeah, the contract was.

Speaker Change: Um, late April, so, you know, you can, you can figure it out. It's, you know, without, without being able to spell out the agreement for you, it, you know, if you're, if you're going to do it based on days, you're not going to come up with the right math.

Speaker Change: There's a series of milestones and other provisions within the agreement that sets off the first couple of payments, so I see what you're doing, but it's not a linear equation.

Jonathan Ashoff: Right. That should clearly go up. Can I ask you when the 10-Q is coming out? And do you expect any delay like last quarter?

Speaker Change: Right. That should clearly go up. Can I ask you, when is the 10-Q coming out and do you expect any delay like last quarter?

Jonathan Ashoff: No. I believe it's been, you know, if it hasn't been filed yet, it'll be filed at some point before 530 tonight. Thank you, guys. I'm assuming that there's really nothing else you can say about a potential BADSC deal, so I guess that's the end of my questions. Thanks. Okay. Thank you, Jonathan.

Speaker Change: Yeah.

Speaker Change: I believe it's been, you know, if it hasn't been filed yet, it'll be filed, you know, at some point before 530 tonight.

Robert Crystal: For the three-month period ended June 30th, 2024, BioRestorative had a loss from operations of 2.5 million and 19 percent year-over-year improvement from the 3.1 million loss for the comparable period of 2023 and the 39 percent improvement sequentially from the 4.1 million loss in the first quarter of 2024. Cash used in operating activities in Q2 2024 was 1.9 million and the company ended the second quarter in a strong financial position with cash equivalents and marketable securities of 14.7 million and no outstanding debt.

Speaker Change: Thank you, guys. I'm assuming that there's really nothing else you can say about a potential BADSC deal, so I guess that's the end of my questions.

Operator: Thank you very much. Your next question is coming from Michael Akunovic of the Maxim Group. Michael, your line is... Hey guys.

Speaker Change: Thanks. Okay.

Speaker Change: Thank you very much. Your next question is coming from Michael Akunovic of the Maxim Group. Michael, your line is live.

Michael Akunovic: Thank you so much for taking my question. And I wanted to congratulate, um... Hey, so I wanted to congratulate Francisco on becoming the section editor for the Journal of Translational Medicine. That's awesome.

Michael Akunovic: Hey guys, thank you so much for taking my question.

Michael Akunovic: And I wanted to congratulate...

Speaker Change: So I wanted to congratulate Francisco on becoming the section editor for the Journal of Translational Medicine. That's awesome.

Francisco Silva: Yeah, no, thank you. Thank you, Michael. I guess just in relation to the Thermostem partnering, is a part... Would you be looking to launch the study and proceed, you know, as though you weren't going into a partnership? Just based on the timelines for the DMS filing, would you be looking to move into a first-in-human trial, regardless of whether or not you have a signed partnership deal?

Robert Crystal: We expected this cash level combined with meaningful revenues we expect from our commercial bio-caused, mesutical business should make a significantly less reliant than most of our clinical stage life sciences company peers on the capital markets going forward.

Francisco: Yeah. No, thank you. Thank you, Michael.

Francisco: So.

Speaker Change: I guess just in relation to the thermostat partnering.

Speaker Change: Is a part

Francisco Silva: With that, I'll turn the call over to Francisco for review and update of our development programs. Thanks, Rob. For the benefit of those who are new to BioRestorative story, I would like to start by making a moment to briefly describe our clinical BRTX-100 and our pre-chemical thermostamp pipeline programs. Our lead cell therapy candidate, BRTX-100, is a novel cell-based therapeutic engineer to target areas of the body that have little low blood flow.

Speaker Change: Would you be looking to launch the study and proceed, you know, as though you weren't going into a partnership?

Speaker Change: Just based on the timelines for the DMS filing, would you be looking to move into a first in human, regardless of whether or not you have a signed partnership deal?

Francisco Silva: Yeah, I think from the point of view of the DMF, the DMF is strategic in that it allows for, you know, the 3rd parties to reference our preclinical data or CMC section on manufacturing and cell identity. I do believe that with that, our partners could potentially leverage first-in-man studies relatively quickly, whether it happens here in the U.S. or outside the U.S. All right, thank you. And then... You have said that you're looking to provide some preliminary data.

Speaker Change: Yeah, I think from the point of view of the DMS, the DMS is strategic in that it allows for, you know, the third parties to reference our preclinical data, our CMC section on manufacturing and cell identity.

Francisco Silva: The product is formulated using autologous or your own culture and mesenchymal stem cells collected from the patient's bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbar sacral distisorders or as a complementary therapeutic to a surgical procedure. The safety and efficacy of BRTX-100 in treating chronic lumbar distances or CLDD is being evaluated in our ongoing phase two prospective randomized double-blinded control study. A total up to 99 subjects are currently being enrolled at 16 clinical strides in the United States.

Speaker Change: I do believe that with that, we, our partners could potentially leverage first-in-man studies relatively quickly, whether, you know, it happens here in the U.S. or ex-U.S.

Francisco Silva: I think here you say before year-end 24, so I would just like to get an idea of what sort of duration after treatment we could be seeing, just given the timeframe and trial start. What would be the longest we would be able to look at these patients for?

Speaker Change: All right, thank you.

Speaker Change: You have said that you're looking to provide some preliminary data. I think in here you do say before year end 24.

Speaker Change: So, I would just like to get an idea of what sort of duration after treatment we could be seeing just given the time frame and trial start. What would be the longest we would be able to look at these patients for?

Francisco Silva: Subjects included in the treatment will be randomized to the one to receive BRTX or Shen. In our pre-chemical metabolic program thermostamp, we are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose or FAT to write stem cells, which we call VADSC's. To generate the brown adipose tissue, as well as exosomes created by the data. BAT is intended to mimic naturally occurring brown adipose depots that are found in the body that can regulate metabolic homeostasis in humans and is involved in weight loss.

Francisco Silva: Right. So, we've submitted a few abstracts for a few conferences that we expect to get feedback on, and we can begin presenting some of this later-term data that is a follow-up from last year or earlier this year. We're talking about disclosing, again, in a blinded fashion, the 52-week mark on some of these subjects. So, it's one of the key components where, in the trial, we're talking about our first primary efficacy endpoint, which is our 52-week mark.

Speaker Change: So we've submitted a few abstracts for a few conferences that we expect to get feedback and we can present some of this later term data that is a follow-up from last year.

Speaker Change: or early this year. We're talking about disclosing, you know, again, in a blinded fashion, it would be the 52-week mark.

Speaker Change: on some of these subjects. So it's one of the key components where in the trial, we're talking about our first primary efficacy endpoint, which is our 52-week mark. So that's the type of data we're looking to deliver.

Francisco Silva: Previously published peer review of preclinical data from the study conducted in collaboration with the University of Utah School of Medicine demonstrated that functional brown adipose derived stem cells formulated using our patterned thermostem platform produce significant reductions in weight. Consistence with losses achieved by GLP1 pharmaceuticals. The blood glucose levels and diagnosis obesity model in mice, it is important to note that although further work is needed to fully understand the mechanisms of action of thermostem, it's impact on weight loss. We have not seen nor do we expect the same negative secondary effects of GLP1 pharmaceuticals, such as loss of muscle mass or negative cardiovascular effects.

Francisco Silva: So, that's the type of data we're looking to deliver. And then one last one for me, just with regard to the protocol amendment, I know that was cleared in April. So have there been any patients that dosed to randomize into that placebo group prior to it changing to a sham, and then is that something you're going to have to stratify in the data?

Speaker Change: And then one last one for me, just with regards to the protocol amendment. I know that was cleared in April. So have there been any patients that have been

Speaker Change: dose or randomize into that placebo group prior to it changing to a sham and then is that something you're going to have to stratify in the data?

Francisco Silva: Yeah, yeah, I mean, there were a handful of patients that were previously part of the original protocol. We've worked it out with stats, and we're still within, you know, the proper powering numbers that we need to make sure that we can hit our efficacy endpoints considering the change with the group. So, yeah, we feel pretty good with the data that should be coming soon. All right. Well, thank you very much. I'm looking forward to it, and congratulations on all the progress.

Speaker Change: Yeah, I mean there was a handful of patients that were previously part of the original protocol. We've worked it with stats and we're still within, you know, the proper powering.

Francisco Silva: We have achieved significant milestones in both of these core developmental programs over the past few weeks and months. With respect to BRTX100 in April, the FDA cleared an important amendment to our Phase II study protocol which removes the saline injection in the control arm of the study and replace it with the sham injection. With the protocol change, control patients now have a needle placed in close proximity to the target disc, but the disc is not pierced nor does it receive a saline injection into it.

Francisco Silva: We believe this brings additional safety to our subject participants. In addition, it is well established that saline can be hydrated to disc and created change in the disc microenvironment. This change although transient may result in short-term pain relief. So the protocol amendment helps preclude the possibility of transient clinical outcomes in the control group which could potentially impact and the study readouts in trials like this. We believe with the FDA clearance of this important amendment highlights our positive relationships with the agency. We remain confident that we will be fully enrolled in the Phase II study by the end of 2024 and look forward to providing additional pre-liminary data updates as we progress.

Speaker Change: numbers that we need to to make sure that we could hit our efficacy endpoints considering the change you know with the group.

Speaker Change: So, yeah, we feel pretty good with the data that should be coming shortly.

Speaker Change: All right. Well, thank you very much. I'm looking forward to it and congrats on all the progress.

Operator: Thank you. Thank you very much. Your next question is coming from Eleanor Pyrrhus of Rodman & Renfrew. Eliminate your liners.

Speaker Change: Thank you. Thank you.

Speaker Change: Thanks very much. Your next question is coming from Eleanor Pyrrhus of Rodman and Renshaw. Eleanor, your line is live.

Eleanor Pyrrhus: Yes, good afternoon. Lent, by the way, the 10Q is out. It's on Edgar for the last 10 minutes.

Eleanor Pyrrhus: Yes, good afternoon. Lent, by the way, the 10Q is out. It's on Edgar for the last 10 minutes. Oh, okay. Thank you, Oliver. You're welcome. Here you have it, Jonathan.

Lance Alstott: Oh, okay. Thank you, Oliver. You're welcome. Here you have it, John.

Eleanor Pyrrhus: So, I wanted to ask just a little housekeeping question from Rob on the GNA expense for this quarter, which was probably very, very low, and I'm sure that it's an anomaly. Would you please help us to... look at the second half of G&A expenses and where would they sort of average on a quarterly basis? Q1 is usually a little higher than the LMR, so you can kind of take what you have now and divide it by two, but you have to skew up Q1 a little bit.

Speaker Change: I wanted to ask just a little housekeeping question from Rob on the G&A expense for this quarter, which was probably very, very low and I'm sure that it's an anomaly.

Speaker Change: Would you please help us to look at the second half of G&A expenses and where would they sort of average on a quarterly basis?

Francisco Silva: Shifting now to our pattern thermostim platform, we were pleased to announce mid-quarter the development of a novel exosome-based biologic program targeting obesity. Exosomes are small, extracurricular vesicles created by various cells, including stem cells. They understood to play an important role as being mediators for intracurricular communication and have been found to play a role in adipose fat metabolism by transporting cargo, such as non-coding RNAs and proteins and other factors that make impact weight loss.

Speaker Change: Bye.

Speaker Change: Q1's usually a little higher LMR, so you can kind of take what you have now and divide it by two, but you know, you have to skew up Q1 a little bit. It's non-cache, essentially. That is the real difference.

Robert Kristol: It's non-cache, essentially. That is the real difference. Okay. Because I'm looking at... And there are a couple of them, and there may be some timing. There could be some timing issues in there as well. So it's more like in the $2 million on a quarterly basis in that sort of box. Yeah, but there's other things there, right? As the trial enrolls more patients, you would see a trend higher. I'm talking about DNA.

Speaker Change: Okay. Because I'm looking at... And there are a couple of... And there may be some timing. There could be some timing issues in there as well.

Speaker Change: So it's more like in the two million dollar per on a quarterly basis that you would feel comfortable with in that sort of ballpark

Francisco Silva: This youth therapeutic candidate has potentially served as an adjuvant as well to existing weight loss drugs and programs potentially allowing for lower dosing, as well as the prevention or minimization of possible muscle mass loss and negative cardiovascular effects. Importantly, as awareness of the promise of thermostim based DADSE holds for the treatment obesity and related metabolic disorders continues to grow. It is important that this potentially gained changing opportunity is well protected, both for us and in current and future potential licensing partners.

Speaker Change: Yeah but but there's other things there right as the trial enrolls you would see a trend higher.

Speaker Change: I'm talking about DNA only problem.

Francisco Silva: Right, there could be expenses related to G&A though, right? There's vendors, there's considerations. Okay. Thank you. And Francisco, if I heard you correctly, the DMF itself may be a rate-limiting step to conclude or a key element to a potential agreement on ThermoSTEP. Is that what you were alluding to? No, I don't think it's a rate-limiting step, but I think it's a key element to facilitate the out-licensing opportunities with the program. You know, a lot of groups that are interested in cell-based technologies, but they don't want to do a lot of the early work in terms of the CMC section that comes along with it.

Speaker Change: Right, there could be expenses related to G&A though as well right? There's vendors, there's considerations. Okay, cool.

Speaker Change: Thank you. And Francisco, if I hear you correctly, the DMF itself may be a rate limiting step to conclude or a key element to a potential agreement on thermostat. Is that what you were alluding to?

Francisco Silva: We believe that a broad intellectual property portfolio can also be leveraged across drugs that are currently approved or marketed for weight loss. Potentially open up the door for future big farm and partnership opportunities for the country. To that end, we have methodically built a comprehensive portfolio of issued patents that are covered both US and international markets. And we are pleased to see that we are already formidable IPSA expanded in the second quarter via our notice of allowance for the fifth Japanese patent covering the technology.

Speaker Change: No, I don't think it's a rate-limiting step, but I think it's a key element to facilitate the out-licensing opportunities with the program. You know, a lot of groups that are interested in cell-based technologies

Speaker Change: You know, they don't want to do a lot of the early work in terms of the CMC section that comes along with it. And, you know, a DMF is a living document that's consistently being updated.

Francisco Silva: And, you know, a DMF is a living document that's consistently being updated, and that will allow a lot of third parties to begin to reference it. So, right now, it's heavily built on, you know, manufacturing, cell identity, showing the safety from an allogeneic point of view in vitro. And as we develop it into clinical programs, which we're aggressively pursuing, you know, DMF will begin to incorporate a lot of clinical data, which is our key goal with the program.

Francisco Silva: Also in the second quarter, our positive preclinical data and strong intellectual property portfolios get to bear fruit as we entered in substantive discussions with an undisclosed commercial stage regenerative medicine company with regard to a potential license agreement for our thermostat metabolic disease program. Those discussions are continuing and when we cannot provide interim progress updates or provide any assurances that we will come to a mutually acceptable agreement, we are committed to closing the loop on this as soon as possible.

Speaker Change: that will allow for a lot of the third parties to begin to reference.

Speaker Change: So right now it's, you know, it's heavily built on, you know, manufacturing, cell identity.

Speaker Change: showing the safety from an allogeneic point of view in vitro. And as we develop it into the clinical programs, which we're aggressively pursuing, that DMF will begin to...

Francisco Silva: To summarize, we are making good progress with our phase two trial for BRTX 100 to three chronic lumbar disease. We have added a new therapeutic candidate targeting the BC of your thermostat program. We are involved in substantial discussions for our potential out licensing agreement of the thermostat metabolic disease program and we have begun to commercialize our technology with Cartessa in the bio-cosmic use of the cold market.

Speaker Change: incorporate a lot of the clinical data, which is our key goal with the program. So I don't want to say it's rate limiting, but it's a very important component to the program.

Francisco Silva: I don't want to say it's rate-limiting, but it's a very important component to the program that we're launching. It's really a strategic vehicle for us to, you know, facilitate out-licensing and to develop these programs with, you know, strong therapeutic benefits. If I could also just add to that, just to be clear, that it's not, if you think it's dependent on us doing a strategic licensing deal that we've alluded to, it's not necessarily connected in the sense that, you know, it must come first before we have an announceable event, and it will come soon enough. The DMF?

Speaker Change: that we're launching, it's really a strategic vehicle for us to facilitate out-licensing and to develop these programs with strong therapeutics.

Lance Altstadt: Now we will turn over the call back over to LAMS. Thank you, Francisco. You can all see from what the team just reviewed. We have had a great and productive first half of 2024.

Speaker Change: And if I could also just add to that.

Speaker Change: Just to be clear, it's not, if you're thinking it's dependent on us doing a strategic licensing deal that we've alluded to, it's not necessarily connected in the sense that, you know, it must come first before we have an announceable event.

Lance Altstadt: I am very energized by many of the upcoming value enhancing inflection points that we see ahead. Our second quarter financial results also demonstrate that we are starting to make progress on a path to sustainable profitability. As we move forward, we will drive that by continuing to focus squarely on carefully managing our resources as we advance our two core clinical development programs while leveraging the significant cash flow we anticipate coming soon from our transformative bio-cosmic pharmaceutical agreement with Cartessa.

Speaker Change: And it will come soon enough. I mean, you project it to be submitted during the next month and a half or so.

Francisco Silva: Correct. Yes. Yes, we intend to do that soon, and you sound very confident. Enrollment will be marked by the end of the year. Have you seen an acceleration since you amended the protocol, or is that? I think it's a combination of factors.

Speaker Change: The DMF? Correct, yes.

Speaker Change: Yes, we intend to do that soon.

Speaker Change: Okay, and you know, you sound very confident that you could achieve the 99 patient enrollment mark by the end of the year.

Lance Altstadt: To summarize, the FDA has recently cleared an important amendment to the protocol on the ongoing phase two, replacing saline injection with a sham injection and a control arm. This is great for us and it is great for patients in the trial. Patient recruitment in the study is going very well through the hiring of Galen and we expect a complete enrollment before the end of 2024. We intend to present more data from this trial like we did before on a blinded basis but with a larger patient population and we are very optimistic that this data will be consistent with previous trends.

Speaker Change: Have you seen an acceleration since he amended the protocol or is that just an independent factor of that?

Lance Alstott: One of them, I think, can be attributed to the change in protocol, but we've hired Galen, which is an organization that is on the marketing and recruiting side of it, something that we didn't have early on, and they've been able to refer a tremendous amount of patients. So, we're very pleased with that activity, and the numbers are projected to be kind of where we've outlined from a timing perspective. Now, look, in the real world; things can move, they can slip, but where we are right now, we feel pretty good about where this, you know, where this new activity has been coming from.

Speaker Change: I think it's a combination of factors, one of them

Speaker Change: I think can be attributed to the change in protocol, but.

Speaker Change: We've hired Galen, which is a...

Speaker Change: an organization that is on the marketing and recruiting side of it, something that we didn't have early on, and they've been able to refer.

Speaker Change: a tremendous amount of patients, so we're very pleased with that activity.

Speaker Change: and the numbers are projected to be kind of where we've outlined from a timing perspective. Now, look, the real world...

Lance Altstadt: Based on our very strong data from our preclinical animal study in obesity, we have enhanced our preclinical metabolic program with a novel exosome based therapeutic candidate targeting obesity. We are continuing to proactively expand the already formidable thermosteum intellectual property estate to help ensure long-term market exclusivity and the continued discussions from a strategic licensing perspective. Our promising preclinical work and strong IP estate have resulted in entering into some of these discussions for the thermosteum metabolic disease program and substantive licensing discussions that are ongoing.

Speaker Change: Things can move, they can slip, but where we are right now, we feel pretty good about where this new activity has been coming from.

Lance Alstott: And Lance, I don't mean to put words in your mouth, but I've heard you and Francisco alluding to potentially mutable thermal transactions. Thank you. Do you have... Are you thinking about indicating... Geographic potential deals. Possibly multiple deals. I don't want to lean too heavy on those words.

Speaker Change: Okay, and Lance, I don't mean to put words in your mouth, but I've heard you and Francisco alluding to.

Lance Altstotz: potentially multiple thermostat transactions or agreements.

Lance Altstotz: Are you thinking about indication-specific or geographic-specific potential deals?

Lance Altstadt: Our strategic agreement with Carcessa and established aesthetics market leader serves to validate our biocosmaceuticals platform and represents a transformative step towards our building a strong commercial engine capable of supporting profitable growth while also helping fund the continued advancement of BRTX100 and thermosteum. We intend to add a family of patents protecting our biocosmaceuticals platform and expand the existing relationship with additional product lines before the end of 2024. Finally, we ended the second quarter in a very strong financial position with cash and cash equivalence marketable securities of 14.7 million as of June 30, 2024. That combined with our steady steadily improving financial performance provides us with an additional flexibility financially and puts us on the pathway to profitability.

Speaker Change: Multiple, potentially.

Lance Altstotz: Possibly multiple deals. I don't want to lean too heavy on those words.

Lance Alstott: Obviously, we have had a number of conversations with multiple potentially interested parties for different indications. I think, as you know, obesity is one of the things we think would drive and suit the technology very well. Metabolic syndrome can be defined and splintered into a number of other indications as well.

Lance Altstotz: Obviously, we have had a number of conversations with multiple potentially interested parties for different indications. I think...

Lance Altstotz: As you know, obesity is one of the things we think would drive...

Lance Altstotz: and suit the technology very well. Metabolic syndrome can be defined and splintered into a number of other indications as well. So, I guess we'll leave it at that for now.

Lance Alstott: So I guess we'll leave it at that for now. Thank you. Thank you. Your next question is coming from Todd Morrison, who's a private... Torture Linus, Hi guys.

Lance Altstotz: Thank you. Thank you very much.

Lance Altstotz: Thank you. Your next question is coming from Todd Morrison, who's a private investor. Todd, your line is live.

Operator: Congratulations on the quarter. Thank you. There is just one question.

Speaker Change: Hi, guys. Congratulations on the quarter. Thank you.

Lance Altstadt: Thank you and with that concluding our introductory remarks we're happy to take any questions you may have. Thank you very much.

Todd Morrison: I'm excited to see that the CARTESA agreement is finally generating revenues. Do you see the opportunity to possibly expand your commercial agreement with CARTESA or to possibly pursue other agreements in the biocosmeceutical space? That's a great question.

Todd Morrison: Excited to see that the CARTESA agreement is finally generating revenues. Do you see the opportunity to possibly expand your commercial agreement with CARTESA or to possibly pursue other agreements in the biocosmeceutical space?

Operator: We will now be conducting our question and answer session. If you would like to ask a question, please press star one on your phone keypad now. A confirmation tone will indicate that your line is in the key. You may press star two if you would like to remove your question from the key. For anyone using speaker equipment it may be necessary to pick up your handset before you press the keys. Please wait a moment whilst we pull for questions. Thank you.

Lance Alstott: Thank you, Todd, and I'm excited to talk about that because we have XOCR, which is a serum that's used topically on the face, and there we have an exclusive five-year agreement with CARTESA here in the U.S. There are some international opportunities that we can pursue with XOCR. So, from a channel and distribution perspective, we will initiate and have had some preliminary conversations with distribution and sales and marketing outside of the U.S. where we're permitted to.

Speaker Change: That's a great question. Thank you, Todd. And I'm excited to talk about that because we have XOCR, which is a serum that's used topically on the face, and there we have an exclusive five-year agreement.

Jonathan Ashoff: Your first question is coming from Jonathan Ashoff of RothMKM. Jonathan, your line is live. Thank you. Good afternoon, guys. I was wondering, you know, given what sounds like a parent BRTX 100 data confidence, are you saying that you are already seeing blind data have a two-to-one split of activity, kind of like the three-to-one split. You reported on in February? The first four patients, as you know, had a three-to-one randomization, the remaining patients after those four are randomized two-to-one.

Speaker Change: with CARTESA here in the U.S.

Speaker Change: There are some ex-U.S. opportunities that we can pursue with ExoCR, so from a channel and distribution perspective, we will initiate and have had some preliminary conversations

Speaker Change: with distribution and sales and marketing outside of the U.S. where we're permitted to. But more importantly, we have using the basis of this technology to go into other applications.

Lance Alstott: But more importantly, using the basis of this technology to go into other applications, we've developed and formulated some family of products that we will most likely be rolling out in the fall of next year, this year, this upcoming fall, and we will give CARTESA the opportunity to review them and, hopefully, agree to what we're proposing. However, if, for whatever reason, that's not something that would work in their favor, we're happy to market that with the assistance of others.

Speaker Change: We've developed and formulated some family of products.

Jonathan Ashoff: So the data would be cut that way and even with that, we are starting to see, again, we're blinded, so at least I am. So what we see is improvement and reduction of pain and increase in function off of baseline with some of the patients. And then other patients were seeing a fairly consistent flat-trend relative to baseline. Based on how many patients we're talking about in the randomization, I think there's a very clear signal as there was with the first four patients, so I think it's very consistent. So that's affirmative to seeing a two-to-one friend with more patient given the new randomization.

Speaker Change: that we will most likely be rolling out in the fall.

Speaker Change: of next year, of this year, this upcoming fall.

CARTESA: And we will give CARTESA the opportunity to review it and to hopefully agree to what we're proposing. However, if for whatever reason that is, that's not something that...

Lance Alstott: But it seems very logical that this would fit into their family of products using their distribution, sales, and marketing capabilities, as well as some of their key relationships. So, my guess is we would have a larger revenue attributed to this commercial operation in biocosmaceuticals as this year goes on, not just from the existing contract but from future contracts related to the new products in development.

CARTESA: would work in their favor, we're happy to market that with the assistance of others. But it seems very logical that this would fit into their family of products using their distribution, sales, and marketing capabilities.

CARTESA: as well as some of their key relationships.

Jonathan Ashoff: Okay, that's definitely encouraging. Can you help us understand anything about the magnitude of a minimum cartessa purchase quantities, or is that not something we can do? Well, I think I might have given some indication in the past that what we're talking about is a low multi-million dollar revenue contract over the course of 12 months. And that would represent the first year. Obviously, this is a five-year exclusive agreement. So while we are not given guidance on quarterly until we feel comfortable with the ebbs and flows and tactical dynamics of how each invoices booked and paid for, we have clear sight as to what that number will look like over the course of 12 months.

CARTESA: So, my guess is we would.

CARTESA: We would have a larger revenue attributed to this commercial operation in biocosmeceuticals as this year goes on, not just from the existing contract, but a future contract related to the new products in development.

Lance Alstott: Oh, that's terrific. Wow. Thank you very much. Thank you, Todd. I appreciate it. Thank you very much. Well, we appear to have reached the end of our question and answer session. I will now hand the microphone back over to Lance for his closing remarks. I would just say thank you very much again to all of our investors, our shareholders, and our analysts that cover our stock and spend time learning about our company and continuing to support us.

Lance Alstott: And we look forward to speaking to you all soon. Have a great rest of your week. Thank you very much. This does conclude today's conference. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your time. Thank you, Jenny.

Speaker Change: That's terrific. Well, thank you very much.

Speaker Change: Thank you, Todd. Appreciate it.

Speaker Change: Thank you very much. Well we appear to have reached the end of our question and answer session. I will now hand back over to Lance for closing remarks.

Lance Altstotz: I would just say thank you very much to again all of our investors, our shareholders, our analysts that cover our stock and and spend time learning about our company and continuing to support us.

Lance Altstotz: And we look forward to speaking to you all soon. Have a great rest of your week.

Jonathan Ashoff: And the 81,000 represents how many days of the second quarter that you could have sold delivered them product? Well, we'll have to calculate that, but you know, the contract was late April, so, you know, you can, you can figure that it's, you know, without without being able to sell out the agreement for you, you know, if you're, if you're going to do it based on days, you're not going to come up with the right math.

Speaker Change: Thank you very much. This does conclude today's conference. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.

Jenny: Thank you, Jenny.

Speaker Change: Thanks, guys.

Jonathan Ashoff: There's a series of, there's a series of milestones and other provisions within the agreement that, you know, sets off the first couple of payments. So it's, I see what you're doing, but it's not, it's not a linear equation. Right, that should clearly go up. Can I ask you, when is the 10Q coming out? And do you expect any delay like last quarter? No, I believe it's been needing to take it long-cherally. If it hasn't been filed, the ed will be filed at some point before 530 tonight. Thank you guys.

Jonathan Ashoff: I'm assuming that there's really nothing else you can say about a potential BADSC deal, so I guess that's the end of my questions. Thanks. Okay, thank you, Dr. Adam. Thank you very much.

Michael Akunovic: Your next question is coming from Michael Akunovic of the Maxim Group. Michael, your line is life. Hey guys, thank you so much for taking my question.

Michael Akunovic: I wanted to congratulate Francisco on becoming the sectioner for the general translation of medicine. That's awesome. Yeah, no, thank you. Thank you, Michael. So I guess, just in relation to the thermostem partnering, would you be looking to launch the study and proceed as though you weren't going into a partnership just based on the timelines for the DMS filing? Would you be looking to move into a first-in-human, regardless of whether or not you have a signed partnership deal?

Michael Akunovic: Yeah, I think from the point of view of the DMS, the DMS is strategic in that it allows for the third parties to reference our preclinical data or CMC section on manufacturing and cell identity. I do believe that with that, our partners could potentially leverage first-in-man studies relatively quickly, whether it happens here in the U.S, or XUS. All right, thank you, and then you have said that you're looking to provide some preliminary data, thinking here you do say before year end 24.

Michael Akunovic: So I would just like you get an idea of what sort of duration after treatment we could be seeing, just given the time frame and trial start, will be the longest we would be able to look at these patients for. Right, so we've submitted a few abstracts for a few conferences that we expect to get feedback and we can present some of this later term data that we will follow up from last year or earlier this year.

Michael Akunovic: We're talking about disclosing, again, in a blinded fashion, it would be the 52-week mark on some of these subjects. So it's one of the key components where in the trial, we're talking about our first primary efficacy endpoint, which is our 52-week mark. So that's the type of data we're looking to deliver. And then one last one for me, just with regards to the protocol amendment, I know that was cleared in April.

Michael Akunovic: So have there been any patients that have been.., dose to randomize into that placebo group prior to it changing to a sham and then is that something you're going to have to stratify in the data? Yeah, I mean there was there was a handful of patients that were previously part of the original protocol. We've worked it with stats and we're still within you know the proper powering numbers that we need to to make sure that we could hit our efficacy endpoints considering the change you know with the group.

Michael Akunovic: So yeah we feel pretty good with you know with the data that should be coming shortly. All right well thank you very much I'm looking forward to it and congrats on all the progress. Thank you. Thanks very much.

Elemer Pyrrhus: Your next question is coming from Elemer Pyrrhus of Robman and Renjo. Elemer your line is life. Yes good afternoon.

Elemer Pyrrhus: I'll land by the way the 10Q is out. It's on Edgar for the last 10 minutes. Thank you, Elemer. You're welcome. Here you have it.

Elemer Pyrrhus: So I wanted to ask just a little housekeeping question from Rob on the G and A expense for this order which is probably very very low and I'm sure that it's an anomaly.

Rob Crystal: Would you please help us to look at the second half of G and A expenses in their day sort of average on a quarterly basis? Well you two ones usually a little higher element so you can kind of take what you have now and and divide it by two but you know you have to skew up to one a little bit it's not cash essentially that is the real difference. Okay because I'm looking at that.

Rob Crystal: And there are a couple and there may be some timing there could be some timing issues in there as well. So it's more like in the $2 million per on a quarterly basis that you would feel comfortable with in that sort of ballpark. Yeah but there's other things there right as the trial enrolls you would see a trend higher.

Rob Crystal: I'm talking about G and A only problem. Right there could be expenses related to G and A though as well right there's genders there's considerations. Okay cool.

Francisco Silva: Thank you and Francisco if I hear the correctly the DMF itself may be a rate limiting step to conclude or a key element to a potential agreement on thermal step. Is that what you were alluding to? No I don't think it's a rate limiting step but I think it's a key element to facilitate the out licensing opportunities with with the program. You know a lot of a lot of groups that are interested in cell-based technologies.

Francisco Silva: You know they don't want to do a lot of the early work in terms of the CMC section that comes along with it and you know a DMF is a living document that's consistently being updated and that will allow for a lot of the third parties to begin to reference. So right now it's you know it's heavily built on you know manufacturing, cell identity, showing the you know the the safety from the allergenic point of view in vitro and as we develop it into the clinical programs which we're aggressively pursuing you know that DMF will begin to incorporate a lot of the clinical data which is our key goal with the program.

Francisco Silva: So I don't want to say it's rate limiting but it's a very important component to the program that we're launching. It's really a strategic vehicle for us to you know facilitate out licensing and to develop these programs with you know strong therapeutics.

Lance Altstadt: Yeah, if I could, if I could also just add to that just to be clear that it's not if you're thinking it's dependent on us doing a strategic licensing deal that we've alluded to, it's not necessarily connected in the sense that, you know, it must come first before we have an inevitable that and it will come soon enough. I mean you project it to be submitted during the next month and a half or so. The DMS? Correct. Yes. Yes, where we intend to do that.

Lance Altstadt: Okay, and, you know, you're you sound very confident that you could achieve the mighty and my patient enrollment marked by the end of the year. Have you seen an acceleration since you amended the protocol or is that just an independent factor of that? I think it's a protocol combination of factors. One of them I think can be attributed to the to the to the change in protocol, but we've hired Galen, which is an organization that is on the on the marketing and recruiting side of it, something that we didn't have early on and they've been able to refer a tremendous amount of patients.

Lance Altstadt: So we're very pleased with that activity. And the numbers are projected to be kind of where we've outlined from a timing perspective. Now look, the real world, things can can move, they can slip, but where we are right now, we feel pretty good about where this, you know, where this new activity has been coming from.

Lance Altstadt: Okay, and Blancet, I don't mean to put words in your mouth, but I've heard you and Francisco are looting to potentially multiple thermos, them transactions or agreements. Do you have, are you thinking about indications specific or geographic specific potential deals? Multiple potentially. Possibly multiple deals, I don't want to lean too heavy on those words. Obviously, we have had a number of conversations with multiple potentially interested parties for different indications. I think, as you know, obesity is one of the things we think would drive and suit the technology very well. Metabolic syndrome can be defined and splintered into a number of other indications as well.

Lance Altstadt: So I guess we'll leave it at that for now. Thank you, thank you very much.

Todd Morrison: Thank you, your next question is coming from Todd Morrison, who's a private investor? Todd, your line is live. Hi guys, congratulations on the quarter. Thank you. Just one question. Excited to see that the car test agreement is a finally generating revenues. Do you see the opportunity to possibly expand your commercial agreement with car test or to possibly pursue other agreements in the bioconaceutical space? That's a great question. Thank you, Todd.

Lance Altstadt: And I'm excited to talk about that because we have XOCR, which is a serum that's used topically on the face. And there we have an exclusive five-year agreement with Kartezza here in the U.S. There are some XUS opportunities that we can pursue with XOCR. So from a channel and distribution perspective, we will initiate and have had some preliminary conversations with distribution and sales and marketing outside of the U.S, where we're permitted to.

Lance Altstadt: But more importantly, we have using the basis of this technology to go into other applications. We've developed and formulated some family of products that we will most likely be rolling out in the fall of next year, of this year, this upcoming fall. And we will give Kartezza the opportunity to review it and to hopefully agree to what we're proposing. However, if, for whatever reason, that's not something that would work in their favor.

Lance Altstadt: We're happy to market that with the assistance of others. But it seems very logical that this would fit into their family of products using their distribution sales and marketing capabilities, as well as some of their key relationships. So my guess is we would have a larger revenue attributed to this commercial operation in biocosmaceuticals as this year goes on, not just from the existing contracts, but a future contract related to the new products and development.

Todd Morrison: That's terrific. Well, thank you very much. Thank you, Todd. Appreciate it. Thank you very much.

Lance Altstadt: Well, we appear to have reached the end of our question and answer session.

Lance Altstadt: I will now hand back over to Lance for closing remarks. I would just say thank you very much to again, all of our investors or shareholders, our analysts that cover our stock and spend time learning about our company and continuing to support us. And we look forward to speaking to you all soon.

Operator: Have a great rest of your week. Thank you very much.

Operator: This does conclude today's conference. You may disconnect your phone at this time and have a wonderful day. Thank you for your participation.