Latest news with #FranciscoSilva
Yahoo
13-06-2025
- Business
- Yahoo
BioRestorative Reports Compelling Preliminary Data for FDA-Fast-Tracked BRTX-100 – an Autologous Stem Cell Therapy to Treat Chronic Lumbar Disc Disease
– The International Society for Stem Cell Research ('ISSCR') 2025 Annual Meeting is the world's foremost gathering of stem cell and regenerative medicine leaders – – Updated data presented at ISSCR 2025 demonstrates >50% improvement in pain and function in a significant portion of cLDD subjects – – Number of evaluated subjects increases by more than two-fold since last update –– MELVILLE, N.Y., June 13, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. ('BioRestorative,' 'BRTX' or the 'Company') (NASDAQ: BRTX), a clinical-stage regenerative medicine company developing stem cell-based therapies for serious musculoskeletal conditions, today announced the presentation of promising preliminary blinded data from the first 36 subjects in its ongoing Phase 2 clinical trial of BRTX-100, an autologous stem cell therapy for chronic lumbar disc disease (cLDD). This data was shared at the prestigious ISSCR 2025 Annual Meeting in Hong Kong by Francisco Silva, Vice President of Research and Development. The U.S. Food and Drug Administration ('FDA') is requiring at least a greater than 30% improvement in function in the Oswestry Disability Index ('ODI') and a greater than 30% reduction in pain on the Visual Analog Scale ('VAS') in determining whether the clinical trial will be allowed to proceed and ultimately gain Biologics License Application (BLA) approval. Key Highlights: Patient Numbers Growing: The number of subjects evaluated has increased from 15 to 36 since the Company's last press release — an important milestone toward full Phase 2 enrollment (up to 99 subjects). Compelling Clinical Signals: Over 74% of subjects showed >50% improvement in function (ODI) by 52 weeks; Over 72% of subjects reported >50% reduction in pain (VAS) by 52 weeks; Combined >50% improvement in both ODI and VAS measures was achieved by a meaningful portion of subjects across all timepoints. Excellent Safety Profile: No serious adverse events (SAEs) or dose-limiting toxicities reported between 26 and 104 weeks at the target dose (40 million cells). Strengthening Data: Each new data analysis has outperformed prior releases, highlighting an upward trend in efficacy markers. The following is a detailed breakdown of the subjects that had greater than 50% improvement in function, as measured by ODI, greater than 50% decrease in pain, as measured by VAS, and greater than 50% improvement in both ODI and VAS: Week Percentage of Subjects With >50% Average Improvement in ODI Percentage of Subjects With >50% Average Improvement in VAS Number of Subjects With >50% Average Improvement in Both ODI and VAS Baseline 0.00 % 0.00 % 0/36 12 67.57 % 73.82 % 5/25 26 74.04 % 76.94 % 6/15 52 74.63 % 72.35 % 8/10 104 75.13 % 68.54 % 2/4 'With every new analysis, our confidence grows that BRTX-100 is positioned to meet and potentially exceed the FDA's functional and pain reduction thresholds,' said Lance Alstodt, Chief Executive Officer of BioRestorative. 'We are excited by the trajectory of this material milestone and its potential to address a massive unmet need in chronic lower back pain — one of the largest global healthcare burdens. We believe this data moves us one step closer to bringing a much-needed, non-surgical therapeutic option to market and should add to further value enhancing inflection points in the near-term.' The data were presented as part of the Clinical Innovations track at ISSCR 2025, an event that attracts the world's top stem cell and regenerative medicine researchers, clinicians, and investors. About the BRTX-100 Phase 2 Trial BRTX-100 is a novel, autologous cell-based therapy designed to treat patients suffering from painful lumbosacral disc degeneration. The Phase 2 trial is a randomized, double-blinded, placebo-controlled study that will enroll up to 99 subjects at 16 leading U.S. sites. Subjects are randomized 2:1 to receive either BRTX-100 or placebo via a minimally invasive outpatient procedure. 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 U.S. Food and Drug Administration ('FDA') Investigational New Drug ('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 IND-enabling studies, with the aim of pioneering 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@
Yahoo
13-06-2025
- Business
- Yahoo
BioRestorative Reports Compelling Preliminary Data for FDA-Fast-Tracked BRTX-100 – an Autologous Stem Cell Therapy to Treat Chronic Lumbar Disc Disease
– The International Society for Stem Cell Research ('ISSCR') 2025 Annual Meeting is the world's foremost gathering of stem cell and regenerative medicine leaders – – Updated data presented at ISSCR 2025 demonstrates >50% improvement in pain and function in a significant portion of cLDD subjects – – Number of evaluated subjects increases by more than two-fold since last update –– MELVILLE, N.Y., June 13, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. ('BioRestorative,' 'BRTX' or the 'Company') (NASDAQ: BRTX), a clinical-stage regenerative medicine company developing stem cell-based therapies for serious musculoskeletal conditions, today announced the presentation of promising preliminary blinded data from the first 36 subjects in its ongoing Phase 2 clinical trial of BRTX-100, an autologous stem cell therapy for chronic lumbar disc disease (cLDD). This data was shared at the prestigious ISSCR 2025 Annual Meeting in Hong Kong by Francisco Silva, Vice President of Research and Development. The U.S. Food and Drug Administration ('FDA') is requiring at least a greater than 30% improvement in function in the Oswestry Disability Index ('ODI') and a greater than 30% reduction in pain on the Visual Analog Scale ('VAS') in determining whether the clinical trial will be allowed to proceed and ultimately gain Biologics License Application (BLA) approval. Key Highlights: Patient Numbers Growing: The number of subjects evaluated has increased from 15 to 36 since the Company's last press release — an important milestone toward full Phase 2 enrollment (up to 99 subjects). Compelling Clinical Signals: Over 74% of subjects showed >50% improvement in function (ODI) by 52 weeks; Over 72% of subjects reported >50% reduction in pain (VAS) by 52 weeks; Combined >50% improvement in both ODI and VAS measures was achieved by a meaningful portion of subjects across all timepoints. Excellent Safety Profile: No serious adverse events (SAEs) or dose-limiting toxicities reported between 26 and 104 weeks at the target dose (40 million cells). Strengthening Data: Each new data analysis has outperformed prior releases, highlighting an upward trend in efficacy markers. The following is a detailed breakdown of the subjects that had greater than 50% improvement in function, as measured by ODI, greater than 50% decrease in pain, as measured by VAS, and greater than 50% improvement in both ODI and VAS: Week Percentage of Subjects With >50% Average Improvement in ODI Percentage of Subjects With >50% Average Improvement in VAS Number of Subjects With >50% Average Improvement in Both ODI and VAS Baseline 0.00 % 0.00 % 0/36 12 67.57 % 73.82 % 5/25 26 74.04 % 76.94 % 6/15 52 74.63 % 72.35 % 8/10 104 75.13 % 68.54 % 2/4 'With every new analysis, our confidence grows that BRTX-100 is positioned to meet and potentially exceed the FDA's functional and pain reduction thresholds,' said Lance Alstodt, Chief Executive Officer of BioRestorative. 'We are excited by the trajectory of this material milestone and its potential to address a massive unmet need in chronic lower back pain — one of the largest global healthcare burdens. We believe this data moves us one step closer to bringing a much-needed, non-surgical therapeutic option to market and should add to further value enhancing inflection points in the near-term.' The data were presented as part of the Clinical Innovations track at ISSCR 2025, an event that attracts the world's top stem cell and regenerative medicine researchers, clinicians, and investors. About the BRTX-100 Phase 2 Trial BRTX-100 is a novel, autologous cell-based therapy designed to treat patients suffering from painful lumbosacral disc degeneration. The Phase 2 trial is a randomized, double-blinded, placebo-controlled study that will enroll up to 99 subjects at 16 leading U.S. sites. Subjects are randomized 2:1 to receive either BRTX-100 or placebo via a minimally invasive outpatient procedure. 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 U.S. Food and Drug Administration ('FDA') Investigational New Drug ('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 IND-enabling studies, with the aim of pioneering 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@
Globe and Mail
09-06-2025
- Business
- Globe and Mail
BioRestorative to Present Major Update on Promising Preliminary Phase 2 BRTX-100 Data at ISSCR 2025
– ISSCR 2025 is the premier global event for stem cell research, drawing nearly 4,000 leaders from academia, biotech, and pharma – – BioRestorative to release new clinical data to the public prior to market open on June 13th – MELVILLE, N.Y., June 09, 2025 — BioRestorative Therapies, Inc. ('BioRestorative,' 'BRTX' or the 'Company') (NASDAQ:BRTX), a clinical-stage regenerative medicine company developing stem cell-based therapies for serious musculoskeletal conditions, today announced that new preliminary, blinded clinical data from 30 patients enrolled in its ongoing Phase 2 trial of BRTX-100 for the treatment of chronic lumbar disc disease (cLDD) will be presented at the prestigious International Society for Stem Cell Research (ISSCR) 2025 Annual Meeting, held June 11–14, 2025, in Hong Kong. The highly anticipated presentation will be delivered by Francisco Silva, Vice President of Research and Development at BioRestorative, on Friday, June 13, at 5:00 p.m. HKT, as part of ISSCR 2025's clinical innovations track. The Company will issue a press release pre-market that day, detailing the newly reported data. 'This represents a milestone moment for BioRestorative,' said Lance Alstodt, Chief Executive Officer. 'With preliminary data from twice as many patients as previously shared, we are seeing strong, consistent signals around both safety and functional improvement. We are eager to bring this update to the global scientific community at the world's most influential stem cell conference.' BRTX-100 is BioRestorative's lead clinical candidate — a hypoxic-cultured, autologous mesenchymal stem cell therapy designed to target areas of the body with limited blood flow, such as damaged spinal discs. The ongoing Phase 2 study is a prospective, randomized, double-blinded, placebo-controlled trial evaluating BRTX-100 in patients with cLDD across up to 16 U.S. clinical sites. A total of 99 patients will be enrolled, randomized 2:1 to receive either BRTX-100 or placebo via a single intradiscal injection. The presentation, titled 'Stem Cell Therapy for Chronic Lumbar Disc Disease: Phase 2 Clinical Safety and Feasibility Data of Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells,' will highlight key preliminary outcomes focused on patient-reported pain and function metrics, as well as safety endpoints. About the ISSCR 2025 Annual Meeting ISSCR 2025 is the largest and most influential gathering of stem cell scientists and regenerative medicine experts globally, attracting nearly 4,000 participants from over 80 countries. It serves as a key venue for groundbreaking clinical and translational research, offering BioRestorative a high-profile platform to share its latest advancements. For more information on ISSCR 2025, visit About BioRestorative Therapies, Inc. BioRestorative (NASDAQ:BRTX) is a clinical-stage biotechnology company developing cell-based therapies using adult stem cells to address unmet needs in musculoskeletal and metabolic diseases. The Company's pipeline includes BRTX-100, a novel therapy targeting chronic lumbar disc disease, and ThermoStem ®, a platform focused on brown adipose (fat) biology for the treatment of obesity and metabolic disorders. The Company also operates a commercial BioCosmeceutical platform. For more information, please visit 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 Kilmer Investor Relations Direct: (646) 274-3580 Email: skilmer@ Featured Image @ Freepik Read more investing news on to the PressReach RSS feeds:
Yahoo
09-06-2025
- Business
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BioRestorative to Present Major Update on Promising Preliminary Phase 2 BRTX-100 Data at ISSCR 2025
– New blinded safety and efficacy data from 30 patients in ongoing Phase 2 trial to be unveiled June 13, 2025 – – ISSCR 2025 is the premier global event for stem cell research, drawing nearly 4,000 leaders from academia, biotech, and pharma – – BioRestorative to release new clinical data to the public prior to market open on June 13th – MELVILLE, N.Y., June 09, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. ('BioRestorative,' 'BRTX' or the 'Company') (NASDAQ: BRTX), a clinical-stage regenerative medicine company developing stem cell-based therapies for serious musculoskeletal conditions, today announced that new preliminary, blinded clinical data from 30 patients enrolled in its ongoing Phase 2 trial of BRTX-100 for the treatment of chronic lumbar disc disease (cLDD) will be presented at the prestigious International Society for Stem Cell Research (ISSCR) 2025 Annual Meeting, held June 11–14, 2025, in Hong Kong. The highly anticipated presentation will be delivered by Francisco Silva, Vice President of Research and Development at BioRestorative, on Friday, June 13, at 5:00 p.m. HKT, as part of ISSCR 2025's clinical innovations track. The Company will issue a press release pre-market that day, detailing the newly reported data. 'This represents a milestone moment for BioRestorative,' said Lance Alstodt, Chief Executive Officer. 'With preliminary data from twice as many patients as previously shared, we are seeing strong, consistent signals around both safety and functional improvement. We are eager to bring this update to the global scientific community at the world's most influential stem cell conference.' BRTX-100 is BioRestorative's lead clinical candidate — a hypoxic-cultured, autologous mesenchymal stem cell therapy designed to target areas of the body with limited blood flow, such as damaged spinal discs. The ongoing Phase 2 study is a prospective, randomized, double-blinded, placebo-controlled trial evaluating BRTX-100 in patients with cLDD across up to 16 U.S. clinical sites. A total of 99 patients will be enrolled, randomized 2:1 to receive either BRTX-100 or placebo via a single intradiscal injection. The presentation, titled 'Stem Cell Therapy for Chronic Lumbar Disc Disease: Phase 2 Clinical Safety and Feasibility Data of Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells,' will highlight key preliminary outcomes focused on patient-reported pain and function metrics, as well as safety endpoints. About the ISSCR 2025 Annual Meeting ISSCR 2025 is the largest and most influential gathering of stem cell scientists and regenerative medicine experts globally, attracting nearly 4,000 participants from over 80 countries. It serves as a key venue for groundbreaking clinical and translational research, offering BioRestorative a high-profile platform to share its latest advancements. For more information on ISSCR 2025, visit About BioRestorative Therapies, Inc. BioRestorative (NASDAQ: BRTX) is a clinical-stage biotechnology company developing cell-based therapies using adult stem cells to address unmet needs in musculoskeletal and metabolic diseases. The Company's pipeline includes BRTX-100, a novel therapy targeting chronic lumbar disc disease, and ThermoStem®, a platform focused on brown adipose (fat) biology for the treatment of obesity and metabolic disorders. The Company also operates a commercial BioCosmeceutical platform. For more information, please visit 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@
Yahoo
15-05-2025
- Business
- Yahoo
BioRestorative Therapies Inc (BRTX) Q1 2025 Earnings Call Highlights: Navigating Challenges ...
Revenue: $25,000 for Q1 2025, compared to $35,000 in Q1 2024. Deferred Revenue: $150,000 in Q1 2025, compared to nil in Q1 2024. Loss from Operations: $4.8 million in Q1 2025, compared to $4.1 million in Q1 2024. Net Loss: $5.3 million, or $0.64 per share, in Q1 2025, compared to $2.2 million, or $0.33 per share, in Q1 2024. Cash Used in Operating Activities: $2.8 million in Q1 2025. Cash, Cash Equivalents, and Marketable Securities: $9.1 million as of March 31, 2025. Outstanding Debt: None as of the end of Q1 2025. Warning! GuruFocus has detected 4 Warning Signs with BRTX. Release Date: May 14, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BioRestorative Therapies Inc (NASDAQ:BRTX) achieved FDA fast track designation for their BRTX-100 program, facilitating development and review processes. The company reported no serious adverse events in their ongoing Phase II study for BRTX-100, indicating a positive safety profile. Preliminary data from the BRTX-100 trial shows promising trends in pain reduction and functional improvement. BioRestorative Therapies Inc (NASDAQ:BRTX) ended the quarter with a strong financial position, holding $9.1 million in cash, cash equivalents, and marketable securities with no outstanding debt. The company has expanded its intellectual property portfolio, enhancing protection for its ThermoStem program targeting obesity and metabolic disorders. BioRestorative Therapies Inc (NASDAQ:BRTX) reported a decrease in quarterly revenues from $35,000 in Q1 2024 to $25,000 in Q1 2025. The company's net loss increased significantly to $5.3 million in Q1 2025 from $2.2 million in Q1 2024. Enrollment challenges persist due to strict criteria for the BRTX-100 trial, although new recruitment strategies are being implemented. There is uncertainty regarding the potential interim analysis of the BRTX-100 trial, which could impact the trial's progression. The company is still in discussions for a potential license agreement for its ThermoStem program, with no assurance of reaching a mutually acceptable agreement. Q: You mentioned a preliminary endpoint of greater than or equal to 30% improvement. Is there a possibility that this endpoint will change to greater than or equal to 50%? A: Francisco Silva, Vice President of Research & Development, clarified that the endpoint remains at a 30% improvement. The term "preliminary" refers to the fact that the primary endpoint is safety, not efficacy, as this is a first-in-man study. Q: Will there be an interim analysis at 26 weeks, as previously mentioned? A: Francisco Silva stated that an interim analysis is still a potential option but has not been determined. The company is considering the impact of unblinding data on the trial's long-term development and is in discussions with the FDA about leveraging data for regulatory processes. Q: Where are the 45 subjects for the upcoming presentation in Hong Kong coming from? A: Francisco Silva explained that these subjects are from the current study, having been dosed at different time points. The presentation is scheduled for June. Q: Do you expect enrollment to slow down during the summer? A: Lance Alstodt, CEO, noted that enrollment is actually picking up due to new recruitment strategies. Historically, there has been a slowdown in summer, but the company is optimistic about maintaining the current pace. Q: Has the FDA emphasized more on pain or function in their feedback? A: Lance Alstodt mentioned that discussions with the FDA are ongoing, and while pain is a meaningful endpoint, there is flexibility in discussing function as an endpoint. Q: Can you provide more details on the morphological changes observed in response to the cells? A: Francisco Silva described encouraging morphological changes, such as increased hydration and decreased protrusion size in some subjects, indicating aggressive remodeling within the disc. Q: Could mature morphological data potentially reduce the size of a registration study? A: Francisco Silva believes that the positive environment for cell-based therapies and the safety profile of BRTX-100 could allow the company to leverage this data in discussions with the FDA to potentially reduce the size of future studies. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. 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
