Latest news with #BioRestorative
Yahoo
15-05-2025
- Business
- Yahoo
Q1 2025 BioRestorative Therapies Inc Earnings Call
Stephen Kilmer; Head - Investor Relations; BioRestorative Therapies Inc Lance Alstodt; Chairman of the Board, President, Chief Executive Officer; BioRestorative Therapies Inc Robert Kristal; Chief Financial Officer; BioRestorative Therapies Inc Francisco Silva; Vice President - Research & Development, Secretary, Director; BioRestorative Therapies Inc Jonathan Aschoff; Managing Director, Senior Research Analyst; Roth Capital Partners LLC Jason McCarthy; Analyst; Maxim Group Operator Good afternoon, everyone, and welcome to the BioRestorative Therapies first-quarter 2025 investor call. (Operator Instructions) Please note, this conference is being recorded. I will now turn the conference over to your host, Stephen Kilmer, Investor Relations. Stephen, the floor is yours. Stephen Kilmer Thank you, Jenny. Good afternoon, everyone. Let me start by pointing out that this conference call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are based on BioRestorative Therapies' current beliefs, assumptions, and expectations, and such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. No forward-looking statement can be guaranteed. For details on factors, among others, that could affect expectations, see Part 1 Item 1A of our annual report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. BioRestorative undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by law. On the call today representing the company are Lance Alstodt, BioRestorative's Chairman and Chief Executive Officer; Francisco Silva is Vice President of Research and Development; and Robert Kristal, the company's Chief Financial Officer. With that said, I now I'll now turn the call over to Lance. Lance Alstodt Thank you, Stephen. Good afternoon, everyone. 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. With that said, I'm going to ask Rob to provide a brief overview of our first-quarter financial results. Robert Kristal 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 (sic - "quarter") 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. We are encouraged with the 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. 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. With that, I'll turn the call over to Francisco. Francisco Silva Thanks, Rob. For the benefit of those who are new to the BioRestorative story, I would like to take a moment to summarize our developmental programs. Our lead clinical-stage candidate, BRTX-100, is a novel cell-based therapeutic engineered to target areas of the body that have little or no blood flow. The product is formulated using autologous or a person's own cultured mesenchymal stem cells collected from the patient's bone marrow. The safety and efficacy of BRTX-100 in treating chronic lumbar disc disease, or cLDD, is being evaluated in an ongoing Phase II 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 2:1 to receive either BRTX or sham or placebo. 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 enrolling in the 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 VAS; and Oswestry Disability Index, or ODI, data collected at weeks 26 and 52 post-injection demonstrated an exceptionally positive trend compared to baseline. We were also really excited to see that a 52-week comparison of MRI images compared to baseline that appears to demonstrate morphological changes that potentially demonstrate disc microenvironment remodeling. More recently, just last week, in fact, I presented preliminary 26, 52 and 104-week blinded preliminary Phase II BRTX-100 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 meet its primary and secondary end points. Partly based on the preliminary data, we have achieved two important FDA milestones since the beginning of 2025. The first of those was the FDA granting fast track designation for our BRTX-100 cLDD 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 fast track designation may also be eligible for priority review and accelerated BLA biologics license application approval. Achieving fast track 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 BRTX-100 clinical program. The second milestone achieved since the start of 2025 was the FDA clearing our investigational drug application for a Phase II clinical trial for BRTX-100 in chronic cervical discogenic pain, or CCDP. As a result, BRTX-100 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. 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 BADSCs to generate brown adipose tissue, or BAT, as well as exosome secreted by the BADSC. That 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 ThermoStem's 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 effects. 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 our future potential licensing partners. Accordingly, we have methodically built comprehensive pattern portfolio of issued patents that cover both the US and international markets. And we are pleased to see that our already formidable IP estate expanded again in the first quarter. On a final note, our previously reported substantial discussion with undisclosed commercial stage regenerative medicine company with regard to a potential license agreement for our ThermoStem metabolic disease programs are continuing. While we cannot provide interim progress updates, not 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. With that, I will turn the call over back to Lance. Lance Alstodt 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, BRTX-100 and of course Thermostem. So to summarize, we're making exceptionally good progress with our Phase II trial for BRTX-100, while the data is still blinded, the initial trends continue to be very encouraging. Reflecting the positive preliminary Phase II trial data being to date, the FDA has granted Fast Track designation to the program. 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. We have now also expanded our advanced clinical pipeline for BRTX-100 to include the treatment of both chronic lower back pain and neck pain via the FDA clearance of our IND for a Phase II trial in cervical. As you know, we skipped to Phase I, 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. 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 the ThermoStem metabolic IP and other assets that we possess from a technology perspective. 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 31, 2025, and we will continue to efficiently manage our cash reserves while executing upon our strategic goals. Thank you. And with that concluding our introductory remarks, we're happy to take any questions you may have. Operator (Operator Instructions) Jonathan Aschoff, ROTH. Jonathan Aschoff Congrats on the progress, guys. I had a question. You called the endpoint, the efficacy endpoint of greater than or equal to 30% improvements, a preliminary end point. I've never really heard of an endpoint called preliminary data, yes, not an endpoint. And then then you're showing us greater than 50% improvement in this last week's presentation. So is that some kind of foreshadowing that the endpoint that you're going to have to hit is no longer going to be greater than or equal to 30% and more, like greater than or equal to 50%? Francisco Silva No, no. Good question. But no, we're not changing the endpoint. It's still both just a 30% improvement. Jonathan Aschoff So what's the preliminary word for? Francisco Silva Well, because the primary endpoint is safety of the study. It's not efficacy. But the FDA, the target is the safety since it's the first-in-man study. The word preliminary is there a meaning that it's not the primary. So the secondary endpoints are related to efficacy. Jonathan Aschoff Okay. I noticed in the second slide presentation last week versus February. There was no more line about potential interim analysis of 26 weeks. So is that out? Or will that still be performed? Francisco Silva 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 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 III and potentially leverage this data to shorten the regulatory process for BLA approval. 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. Lance Alstodt I think we -- 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 I appreciate that comment. Jonathan Aschoff Okay. And the last one is the 45 subject data being presented in HK or China. Where are those 45 patients coming from? Francisco Silva From the current study. So these are patients that have already been dosed at different time points within the visitation in the weeks. So some of it might be 26, some of it might be 52. Jonathan Aschoff So when is that presentation? Francisco Silva That's in June. Jonathan Aschoff June. Okay. So the trial a lot more along in enrollment than one would glean from yesterday's press release. Francisco Silva Yeah. Actually, so I just want to be -- Lance Alstodt Yeah, 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 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. Jonathan Aschoff And the 15, they made it to week 12 and not yet to week 26, correct? Francisco Silva The 15 patients at the presentation (multiple speakers) Jonathan Aschoff It's the only way the percentages work out, yeah. Francisco Silva Correct. Jonathan Aschoff Like you had 13 at week 26. It looks like it's 2 out of 15 that give you that 13.3% for 12 weeks. Francisco Silva Right. Operator Jason McCarthy, Maxim Group. Jason McCarthy 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, kind of 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? Lance Alstodt 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 with 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. 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 Got it. And in terms of your interactions with FDA, have there been more emphasis from them on pain or function or do they want to see both? Reduction of pain with functional improvement. Lance Alstodt 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 end points in our primary efficacy end points. 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. So I think what we can look forward to is certainly pain will be a very meaningful end point. 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 or patient characteristics? Are the patients older, younger, middle age, where do you think you're seeing the most response potentially? Francisco Silva Well, it's been ranging. We do have younger patients that are in their early 20s. But then again, we have older patients that are in their late 50s. Blinded data, so we don't know who or who has not been dosed. And so we 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 across the demographics. Jason McCarthy Got it. 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? Francisco Silva Yeah. So -- and again, this is still very early, but it's very encouraging to see these morphological changes, for example, in one subject. And again, we have -- it's more than just one that's experiencing this. But in one particular subject that was presented at baseline, the patient had a protrusion and 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 pertrusion. And really interesting is that you see a decrease in the annular tear signal. So that is showing very aggressive morphological remodeling within the extracellular matrix within the disc 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 purtrusion appears to be very notably worse than compared to baseline, and you could 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. Jason McCarthy Wasn't there also a resolution of annular care in that patient that you're referring to? Francisco Silva Yes. Yes, I mentioned that there's a decrease in the signal that's apparent there baseline what -- there is an annular tear, and then at 52 weeks, the annular tear is nearly resolved. Jason McCarthy Okay. Then just as a follow-up to that, do you think 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? Francisco Silva 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 currently, right now, the environment for cell-based therapies, it's a little bit more positive than it has been ever. So we definitely want to leverage the BRTX product. It's autologous by nature, the safety profile that we're seeing. I mean, 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 looking at the function and pain scales that were going to be presented itself. We're very encouraged. And hopefully, we have positive discussions going forward with the FDA. Operator (Operator Instructions) Okay. We don't appear to have any further questions. I'll now hand back over to the management team for any closing remarks. Lance Alstodt 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. Operator 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. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-05-2025
- Business
- Yahoo
BioRestorative Therapies Reports First Quarter 2025 Financial Results and Provides Business Update
MELVILLE, N.Y., May 14, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. ('BioRestorative', 'BRTX' or the 'Company') (NASDAQ:BRTX), a regenerative medicine innovator focused on stem cell-based therapies and products, today reported financial results for the first quarter ended March 31, 2025 and provided an update on its business. 'We have continued to execute well across our business, including the achievement of key clinical program milestones, since the start of 2025,' said Lance Alstodt, the Company's Chief Executive Officer. 'Moving forward, we remain focused on aggressively executing our growth strategy while carefully managing our resources, and we see many potential value enhancing inflection points ahead.' Recent Highlights Corporate In April, the Company confirmed that it currently faces no material exposure to newly imposed U.S. tariffs. BioRestorative believes that its 'made-in-America' production and manufacturing strategy, combined with its use of domestic inputs, enables it to effectively manage costs amid global supply chain shifts. Also in April, BioRestorative's Chief Executive Officer, Lance Alstodt, was interviewed during the Benzinga All-Access Show. An archive of the interview can be accessed here. Disc/Spine Program In a February podium presentation at the Orthopaedic Research Society ('ORS') Annual Meeting, BioRestorative's Vice President of Research and Development, Francisco Silva, presented 26–52 week blinded data from the first 15 patients with chronic lumbar disc disease ('cLDD') enrolled in the ongoing Phase 2 clinical trial of BRTX-100. No serious adverse events (SAEs) were reported, and there was no dose (40X106 cells) limiting toxicity at 26-52 weeks. Preliminary blinded Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) data collected at weeks 26 and 52 post-injection demonstrated an exceptionally positive trend compared to baseline. Furthermore, 52 week comparison of MRI images to baseline appear to demonstrate morphological changes, such as increase in T2 signal (hydration), decrease in protrusion size, as well as resolutions of annular tears, potentially demonstrating disc microenvironment remodeling as a result of cLDD treatment with BRTX-100. Also in February 2025, the U.S. Food and Drug Administration ('FDA') granted Fast Track designation to the BRTX-100 program for the treatment of cLDD. Fast Track designation reflects the positive preliminary Phase 2 safety and efficacy data reported to date, and may lead to Priority Review and Accelerated Biologics License Application (BLA) Approval for BRTX-100. On the heels of granting BRTX-100 Fast Track designation for cLDD, the FDA cleared the Company's Investigational New Drug (IND) application for BRTX-100 for the treatment of chronic cervical discogenic pain (cCDP), expanding BioRestorative's advanced clinical pipeline for BRTX-100 to include treatment of both chronic lower back and neck pain. Last week, preliminary 26-, 52- and 104-week blinded preliminary data from the first 15 patients with cLDD enrolled in the ongoing Phase 2 clinical trial of BRTX-100 was presented by Mr. Silva at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting. The preliminary blinded data continues to be in-line to meet the primary safety endpoint of the study, and preliminary efficacy trends continue as well. Metabolic Program In March 2025, the European Patent Office issued a Notice of Allowance for a new patent application (European Patent Appl. No. 20798130.9) covering key aspects of BioRestorative's allogeneic, off-the-shelf ThermoStem® metabolic disease platform. The Company's previously reported substantive discussions with an undisclosed commercial stage regenerative medicine company with regard to a potential license of BioRestorative's ThermoStem® metabolic intellectual property are continuing; however, no assurances can be given that a license agreement will be entered into whether on commercially reasonable terms or otherwise. Summary First Quarter 2025 Financial Results First quarter 2025 revenues were $25,000, compared to $35,000 in the same period last year. First quarter 2025 deferred revenues were $150,000, compared to $nil in the first quarter of 2024. For the three months ended March 31, 2025, the Company had a loss from operations of $4.8 million, compared to a loss from operations of $4.1 million for the comparable period of 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. Cash used in operating activities in the first quarter of 2025 was $2.8 million as compared to $2.3 million in the first quarter of 2024. The Company ended the 2025 first quarter in a strong financial position, with cash, cash equivalents, and investments held in marketable securities of $9.1 million, with no outstanding debt. For complete financial results, please see BioRestorative's filings at and on the Company's website at under "SEC Filing" in the Investors and Media section. Conference Call Details BioRestorative management will host a webcasted conference call with an associated slide presentation today at 4:30pm EDT to review its first quarter 2025 financial results and provide a business update. To join the conference call via telephone and participate in the live Q&A session, please dial 888-506-0062 (United States) or 973-528-0011 (International), participant access code 924151. The call will also be webcast live and archived on the investor section of the Company's website at under 'News & Events/IR Calendar'' in the Investors section. About BioRestorative Therapies, Inc. BioRestorative ( develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we also operate a commercial BioCosmeceutical platform: • Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person's own) cultured 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 lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient's bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient's damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease. We have also obtained FDA IND clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain. • Metabolic Program (ThermoStem®): We are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells ('BADSC') to generate brown adipose tissue ('BAT'), as well as exosomes secreted by BADSC. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. BADSC secreted exosomes may also impact weight loss. • BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via Investigational New Drug (IND)-enabling studies, with the aim of pioneering U.S. Food and Drug Administration (FDA) approvals in the emerging BioCosmeceuticals space. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K, filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements. CONTACT: Stephen KilmerInvestor RelationsDirect: (646) 274-3580 Email: skilmer@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
13-05-2025
- Business
- Associated Press
Phase 2 Trial of BRTX-100 in cLDD Continues to Generate Positive Preliminary Blinded Data
MELVILLE, N.Y., May 13, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. ('BioRestorative', 'BRTX' or the 'Company') (NASDAQ: BRTX ), a clinical stage regenerative medicine innovator focused on stem cell-based therapies and products, is pleased to announce that preliminary 26-, 52- and 104-week blinded preliminary data from the first 15 patients with chronic lumbar disc disease ('cLDD') enrolled in the ongoing Phase 2 clinical trial of BRTX-100 was recently presented by Francisco Silva, Vice President of Research and Development, at the International Society for Cell & Gene Therapy ('ISCT') 2025 Annual Meeting. No serious adverse events (SAEs) were reported, and there was no dose (40X106 cells) limiting toxicity at 26-104 weeks. The U.S. Food and Drug Association (FDA) is requiring at least a greater than 30% improvement in both Oswestry Disability Index ('ODI') and Visual Analog Scale ('VAS' ); ongoing clinical data demonstrates trends greater than 30% improvements in both measures. The following is breakdown of the percentage of subjects that had both a greater than 50% improvement in function, as measured by ODI, and a greater than 50% decrease in pain, as measured by VAS: 'We were pleased that blinded data from the ongoing Phase 2 trial of BRTX-100 in cLDD continues to be in-line to meet the primary safety endpoint of study, and that the positive preliminary efficacy trends also continue,' said Lance Alstodt, Chief Executive Officer of BioRestorative. Mr. Silva's ISCT presentation, titled 'Phase 2 Clinical Safety/Efficacy Data of Intradiscal Injection of Hypoxic Mesenchymal Stem Cells for Lumbar Disc Disease,' can be accessed on the Company's new website under 'Scientific Publications' in the Product Candidate section. About the BRTX-100 Phase 2 Trial in cLDD BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is the Company's lead clinical candidate. The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a 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 in the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or placebo. About BioRestorative Therapies, Inc. BioRestorative ( ) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we also operate a commercial BioCosmeceutical platform: • Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person's own) cultured 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 lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient's bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient's damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease. We have also obtained FDA IND clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain. • Metabolic Program (ThermoStem®): We are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells ('BADSC') to generate brown adipose tissue ('BAT'), as well as exosomes secreted by BADSC. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. BADSC secreted exosomes may also impact weight loss. • BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via Investigational New Drug (IND)-enabling studies, with the aim of pioneering U.S. Food and Drug Administration (FDA) approvals in the emerging BioCosmeceuticals space. Forward-Looking StatementsCONTACT: Stephen Kilmer Investor Relations Direct: (646) 274-3580 Email: [email protected]
Yahoo
08-05-2025
- Business
- Yahoo
BioRestorative Therapies to Report First Quarter 2025 Financial Results and Host Conference Call on May 14, 2025
MELVILLE, N.Y., May 08, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. ('BioRestorative', 'BRTX' or the 'Company') (NASDAQ:BRTX), a clinical stage regenerative medicine innovator focused on stem cell-based therapies and products, today announced that it will release its first quarter 2025 financial results after market close on Wednesday, May 14, 2025. Following the announcement, BioRestorative management will host a conference call to review the financial results and provide a business update. First Quarter 2025 Results Conference Call Details: Date: Wednesday, May 14, 2025 Time: 4:30 p.m. ET Domestic: 1-888-506-0062 International: 1-973-528-0011 Access Code: 924151 The call will also be broadcast live and archived on the Company's website under News & Events/IR Calendar in the Investors section. About BioRestorative Therapies, Inc. BioRestorative ( develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we also operate a commercial BioCosmeceutical platform: • Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person's own) cultured 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 lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient's bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient's damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease. We have also obtained FDA IND clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain. • Metabolic Program (ThermoStem®): We are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells ('BADSC') to generate brown adipose tissue ('BAT'), as well as exosomes secreted by BADSC. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. BADSC secreted exosomes may also impact weight loss. • BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via Investigational New Drug (IND)-enabling studies, with the aim of pioneering U.S. Food and Drug Administration (FDA) approvals in the emerging BioCosmeceuticals space. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K, as amended, filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements. CONTACT: Stephen KilmerInvestor RelationsDirect: (646) 274-3580 Email: skilmer@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
16-04-2025
- Business
- Associated Press
BioRestorative Therapies Receives FDA Fast Track Approval For BRTX-100 To Treat Chronic Lumbar Disc Disease
By Meg Flippin Benzinga DETROIT, MICHIGAN - April 16, 2025 ( NEWMEDIAWIRE ) - When it comes to treating back pain, particularly chronic lumbar disc disease (cLDD), the industry is falling short. Sure there's surgery, but that's an invasive option that isn't always a success. Pain pills are another option, but that can lead to addiction and a severe change in a patient's quality of life. With more than 16 million Americans suffering from chronic back pain, curing it is a big need that has yet to be met. It's why the progress BioRestorative Therapies Inc. (NASDAQ: BRTX) is making with BRTX-100, its treatment for chronic back pain, is encouraging. The regenerative medicine company focused on stem cell-based therapies and products was just granted Fast Track designation by the U.S. Food and Drug Administration for BRTX-100, its developmental treatment for cLDD. Giving It A Speedier In FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions where there is an unmet medical need. Companies granted Fast Track status are able to have more frequent meetings and written communications with the FDA to discuss the drug's developmental plan, the design of proposed clinical trials and the use of biomarkers. Fast Track designation may also make the company's drug eligible for Priority Review and Accelerated Biologics License Application (BLA) approval. 'We are thrilled that the FDA has granted Fast Track designation, underscoring the potential of BRTX-100 to fill significant unmet medical needs in the treatment of cLDD resulting from ineffective conservative non-surgical approaches or failed surgical interventions, and reflecting the comparatively very positive preliminary Phase 2 clinical data that we have reported to date,' said Lance Alstodt, Chief Executive Officer of BioRestorative. 'Achieving Fast Track designation is an important milestone for BioRestorative, enabling us to work more collaboratively with the FDA as we continue to advance our lead BRTX-100 clinical program toward BLA approval to bring this important and novel stem cell therapy to the millions of cLDD patients waiting for effective pain relief and functional improvement.' Chronic Back Pain Costs Americans Billions Without a doubt, cLDD fits the bill for a disease with an unmet need, and many large companies like Pfizer, Abbott Laboratories and Eli Lilly are working on solutions. In the U.S. alone around 80% of adults experience at least one episode of lower back pain in their lifetime. What's more, low back pain is the most common cause of disability among adults 45 to 65 and imposes the highest economic burden on the U.S. healthcare system. Pain-related conditions cost the U.S. economy a staggering $635 billion annually in medical expenses and lost productivity. Back pain is by far the biggest culprit. Currently, there is no clinical therapy targeting the reversal of disc degeneration or that addresses intervertebral disc cell homeostasis, reports BioRestorative. It's also a big market opportunity for BioRestorative. The stem cell therapeutics market is projected to reach $54.7 billion by 2033, growing at a CAGR of 12.6% between now and then. It is being driven by demand for regenerative therapies and research grants in this area. BRTX-100's Promising Results BRTX-100 is an autologous stem cell product for chronic lower back pain. It uses a patient's stem cells, which are harvested, cultured and then injected directly into the affected disc to start the repair process. Safety and efficacy endpoints from an ongoing phase 2 trial for the treatment of cLDD have been encouraging, reported BioRestorative. The company said no serious adverse events (SAEs) were reported in any of the 10 first patients of the prospective, randomized, double-blinded and controlled study. BioRestorative said there was also no dose (40X10 6 cells) limiting toxicity at 26-52 weeks. At 26 weeks 70% of the patients reported a greater than 30% increase in function and a more than 30% decrease in pain. If data continues with this trend, the company is confident it will hit its efficacy endpoints for the phase 2 trial. Chronic back pain is costly and greatly reduces the quality of life for the more than 16 million Americans who are suffering. BioRestorative wants to change that and believes BRTX-100 holds the answer. With Fast Track designation the company is working closely with the FDA to hopefully get this treatment in the hands of patients sooner, giving millions of people much-needed relief. Featured photo byGioele FazzerionUnsplash. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. This content was originallypublished on further disclosureshere. View the original release on
