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Yahoo
7 hours ago
- Business
- Yahoo
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
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]
