Core Viewpoint - BioRestorative Therapies, Inc. is set to release its second quarter 2025 financial results on August 12, 2025, followed by a conference call for a business update [1][2]. Company Overview - BioRestorative Therapies, Inc. focuses on developing therapeutic products using adult stem cells, with two main clinical development programs targeting disc/spine disease and metabolic disorders [3]. - The company operates a commercial BioCosmeceutical platform, offering products designed to reduce cosmetic signs of aging [5]. Clinical Development Programs - **Disc/Spine Program (brtxDISC™)**: The lead candidate, BRTX-100, is derived from a patient's own mesenchymal stem cells and aims to treat painful lumbosacral disc disorders. A Phase 2 clinical trial is underway for chronic lower back pain due to degenerative disc disease, with FDA IND clearance obtained for chronic cervical discogenic pain [3]. - **Metabolic Program (ThermoStem)**: This program focuses on using brown adipose-derived stem cells to develop therapies for obesity and metabolic disorders. Initial research suggests that increased brown fat may enhance caloric burning and lower glucose and lipid levels, potentially reducing obesity and diabetes risk [4]. BioCosmeceuticals - The company has a commercial BioCosmeceutical platform that includes a cell-based secretome product aimed at improving cosmetic appearance. Future plans involve expanding the product line to include more cell-based aesthetic products and therapeutics [5].

Core Insights - BioRestorative Therapies, Inc. is a clinical stage regenerative medicine company focused on stem cell-based therapies and products [1] - The CEO, Lance Alstodt, will be interviewed during the Benzinga All-Access Show on June 18, 2025 [1][2] Company Overview - BioRestorative develops therapeutic products using adult stem cells, with two main clinical development programs targeting disc/spine disease and metabolic disorders [3] - The company also operates a commercial BioCosmeceutical platform [5] Clinical Development Programs - **Disc/Spine Program (brtxDISC)**: The lead candidate, BRTX-100, is formulated from autologous cultured mesenchymal stem cells from the patient's bone marrow, aimed at treating painful lumbosacral disc disorders and is currently in Phase 2 clinical trials for chronic lower back pain [3] - **Metabolic Program (ThermoStem)**: This program focuses on using brown adipose-derived stem cells to target obesity and metabolic disorders, with preclinical research indicating potential benefits in caloric burning and reduced glucose and lipid levels [4] Commercial BioCosmeceuticals - The company has a commercial BioCosmeceutical product that is a cell-based secretome designed to reduce fine lines and wrinkles, with plans to expand its offerings in the aesthetic products and therapeutics space [5]

Core Viewpoint - BioRestorative Therapies, Inc. is set to present new preliminary clinical data from its Phase 2 trial of BRTX-100 for chronic lumbar disc disease at the ISSCR 2025 Annual Meeting, highlighting significant safety and efficacy signals from a larger patient cohort [1][3]. Company Overview - BioRestorative is a clinical-stage biotechnology company focused on developing stem cell-based therapies for serious musculoskeletal conditions, with BRTX-100 as its lead candidate targeting chronic lumbar disc disease [6]. - The company also has a pipeline that includes ThermoStem, aimed at treating obesity and metabolic disorders, and operates a commercial BioCosmeceutical platform [6]. Clinical Trial Details - The ongoing Phase 2 trial of BRTX-100 is a randomized, double-blinded, placebo-controlled study involving 99 patients across up to 16 U.S. clinical sites, with a 2:1 randomization to receive either BRTX-100 or placebo [3]. - The trial specifically evaluates the safety and functional improvement of BRTX-100 through intradiscal injections of hypoxic-cultured mesenchymal stem cells [3][4]. Presentation Information - The presentation at ISSCR 2025 will be delivered by Francisco Silva, Vice President of Research and Development, on June 13, 2025, focusing on patient-reported pain and function metrics, as well as safety endpoints [2][4]. - ISSCR 2025 is a significant global event for stem cell research, attracting nearly 4,000 participants from over 80 countries, providing a high-profile platform for BioRestorative to share its advancements [5].

Financial Data and Key Metrics Changes - For Q1 2025, revenues were $25,000, down from $35,000 in the same period last year, indicating a decrease of approximately 29% [7] - Deferred revenues for Q1 2025 were $150,000 compared to nil in Q1 2024, reflecting a timing difference in revenue recognition [7] - The loss from operations for Q1 2025 was $4,800,000, compared to $4,100,000 for Q1 2024, showing an increase in operational losses [8] - The net loss for Q1 2025 was $5,300,000 or $0.64 per share, compared to a net loss of $2,200,000 or $0.33 per share in Q1 2024, primarily due to a gain on the exchange of warrants in the previous year [8] Business Line Data and Key Metrics Changes - The lead clinical stage candidate, BRTX-100, is being evaluated in a Phase II trial for chronic lumbar disc disease (CLDD) with positive preliminary data trends observed [10][12] - The company is also developing ThermoStem, a cell-based therapy targeting obesity and metabolic disorders, with ongoing efforts to protect its intellectual property [14][15] Market Data and Key Metrics Changes - The FDA granted Fast Track designation for BRTX-100, facilitating development and review processes for serious conditions [13] - BRTX-100 is now the first and only stem cell-based product candidate cleared by the FDA for evaluation in cervical degeneration disc disease [14] Company Strategy and Development Direction - The company is focused on advancing its two core clinical development programs, BRTX-100 and ThermoStem, while managing resources efficiently [17][19] - There are ongoing discussions regarding potential licensing agreements for ThermoStem metabolic disease programs [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing Phase II trial for BRTX-100, with expectations that data will continue to trend positively [17] - The company is actively engaging with the FDA to discuss endpoints and regulatory processes as they progress towards potential BLA approval [38][46] Other Important Information - The company ended Q1 2025 with cash, cash equivalents, and marketable securities totaling $9,100,000 and no outstanding debt, indicating a strong financial position [9][19] Q&A Session Summary Question: Clarification on efficacy endpoint - Management confirmed that the primary endpoint is safety, with a secondary efficacy endpoint of a 30% improvement, and the term "preliminary" indicates it is not the primary focus [21][22] Question: Interim analysis status - Management stated that an interim analysis is still a potential option but has not been determined yet, as it could impact long-term development [23][24] Question: Enrollment pace and characteristics - Management indicated that enrollment is picking up due to new recruitment strategies and that they expect to counteract any typical summer slowdown [36][37] Question: Morphological changes observed - Management provided details on encouraging morphological changes observed in patients, including increased hydration and decreased protrusion in some cases [42][44]

Financial Data and Key Metrics Changes - For Q1 2025, revenues were $25,000, a decrease from $35,000 in the same period last year [6] - Deferred revenues for Q1 2025 were $150,000 compared to nil in Q1 2024, indicating a timing difference in revenue recognition [6] - The loss from operations for Q1 2025 was $4,800,000, compared to $4,100,000 for Q1 2024 [7] - The net loss for Q1 2025 was $5,300,000 or $0.64 per share, compared to a net loss of $2,200,000 or $0.33 per share in Q1 2024 [7] - Cash used in operating activities in Q1 2025 was $2,800,000, with cash, cash equivalents, and marketable securities totaling $9,100,000 and no outstanding debt [8][19] Business Line Data and Key Metrics Changes - The lead clinical stage candidate, BRTX-one hundred, is being evaluated in a Phase II trial for chronic lumbar disc disease (CLDD) [10] - Preliminary data from the trial shows positive trends in safety and efficacy, with no serious adverse events reported [11][12] - The FDA granted Fast Track designation for BRTX-one hundred, facilitating its development and review process [13] Market Data and Key Metrics Changes - The company is developing ThermoStem, a cell-based therapy targeting obesity and metabolic disorders, using brown adipose-derived stem cells [14] - The company has built a comprehensive patent portfolio to protect its intellectual property in both US and international markets [15] Company Strategy and Development Direction - The company is focused on advancing its two core clinical development programs: BRTX-one hundred and ThermoStem [16] - There are ongoing discussions regarding a potential licensing agreement for the ThermoStem metabolic disease programs [15][19] - The company aims to leverage positive preliminary data to potentially shorten the regulatory process for BLA approval [45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing Phase II trial for BRTX-one hundred, expecting data to remain consistent with previous trends [17] - The company is actively managing resources while executing strategic goals, ending the quarter with a strong financial position [19] Other Important Information - The company is preparing for a presentation of data from 45 subjects at an upcoming conference in June [26] - Management emphasized the importance of maintaining a clean and valid data set for the trial [36] Q&A Session Summary Question: Clarification on efficacy endpoint - Management confirmed that the primary endpoint is safety, with a secondary efficacy endpoint of greater than or equal to 30% improvement [22] Question: Interim analysis status - Management stated that an interim analysis is still a potential option but has not been determined yet [23][24] Question: Enrollment pace and characteristics - Management indicated that enrollment is picking up due to new recruitment strategies and that they expect to counteract any summer slowdown [36] Question: FDA emphasis on pain or function - Management noted that both pain reduction and functional improvement are being collected, with ongoing discussions with the FDA [38] Question: Morphological changes observed - Management provided details on encouraging morphological changes observed in patients, including increased hydration and decreased protrusion size [42][44]

Core Viewpoint - BioRestorative Therapies, Inc. reported its first quarter 2025 financial results and highlighted significant advancements in its clinical programs, particularly in stem cell-based therapies for disc/spine and metabolic disorders [1][2]. Corporate Highlights - The company has successfully achieved key clinical program milestones since the beginning of 2025 and is focused on executing its growth strategy while managing resources effectively [2]. - BioRestorative confirmed no material exposure to newly imposed U.S. tariffs, attributing this to its 'made-in-America' production strategy [5]. - The CEO participated in an interview at the Benzinga All-Access Show, discussing the company's progress [5]. - The company presented positive preliminary data from its ongoing Phase 2 clinical trial of BRTX-100 for chronic lumbar disc disease (cLDD) at the Orthopaedic Research Society Annual Meeting [5]. - The FDA granted Fast Track designation to the BRTX-100 program for cLDD, which may lead to Priority Review and Accelerated Biologics License Application approval [5]. - The FDA also cleared the Investigational New Drug application for BRTX-100 for chronic cervical discogenic pain, expanding the clinical pipeline [5]. Clinical Programs - The BRTX-100 program aims to treat chronic lower back pain from degenerative disc disease and has shown promising preliminary efficacy trends [5][11]. - The company is developing the ThermoStem metabolic disease platform, targeting obesity and metabolic disorders using brown adipose-derived stem cells [12]. - BioRestorative operates a commercial BioCosmeceutical platform, focusing on cell-based secretome products for cosmetic applications [13]. Financial Results - First quarter 2025 revenues were $25,000, down from $35,000 in the same period last year [7]. - The company reported a loss from operations of $4.8 million for the first quarter of 2025, compared to a loss of $4.1 million in the same period of 2024 [7]. - The net loss for the first quarter of 2025 was $5.3 million, or $0.64 per share, compared to a net loss of $2.2 million, or $0.33 per share, in the first quarter of 2024 [8]. - Cash used in operating activities was $2.8 million in Q1 2025, compared to $2.3 million in Q1 2024 [8]. - The company ended the first quarter of 2025 with $9.1 million in cash and cash equivalents, with no outstanding debt [9].

Financial Data and Key Metrics Changes - For the 12-month period ending December 31, 2024, BioRestorative's revenue grew 175% year-over-year to $401,000 [10] - The company's loss from operations was $11.6 million, a 24% improvement from the $15.2 million loss for 2023 [10] - The net loss for 2024 was $9 million, or $1.16 per share, a 14% improvement from a net loss of $10.4 million, or $2.47 per share, for 2023 [10] - Cash used in operating activities in 2024 was $8.2 million, with the company ending the year with cash, cash equivalents, and marketable securities of $10.7 million and no outstanding debt [10] Business Line Data and Key Metrics Changes - The lead clinical stage candidate, BRTX-100, is being evaluated in a Phase 2 study for chronic lumbar disc disease, with positive preliminary data showing no serious adverse events and promising trends in patient outcomes [12][14][15] - The FDA granted Fast Track designation for BRTX-100, facilitating development and review processes [16] - The company is also advancing its ThermoStem program, targeting obesity and metabolic disorders, with promising preclinical data indicating significant weight loss and blood glucose level reductions [19][20] Market Data and Key Metrics Changes - The company is leveraging its data from the lumbar trial to expedite the regulatory pathway for cervical disc disease, potentially saving time and costs associated with preclinical studies [18][39] - The ThermoStem program is expanding its intellectual property portfolio to ensure long-term market exclusivity [21] Company Strategy and Development Direction - The company is focused on advancing its two clinical development programs, BRTX-100 and ThermoStem, while managing resources efficiently [23] - There is a strategic intent to expand BRTX-100 beyond lumbar and cervical applications to other musculoskeletal indications [37][41] - The company aims to build a comprehensive patent portfolio to protect its innovations and attract potential licensing partners [21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's financial performance and projected growth plans, indicating a pathway to reduced dependence on capital markets [26] - The management team highlighted the importance of FDA interactions and the potential for accelerated regulatory approvals [25][43] Other Important Information - The company is in discussions with a commercial-stage regenerative medicine company regarding potential licensing agreements for its ThermoStem programs [22] - The company is exploring regulatory opportunities to potentially shorten the trial duration for BRTX-100 [51] Q&A Session Questions and Answers Question: Regarding the resolution of annular tears and decreased protrusion size - Management indicated that such improvements are not expected to happen spontaneously, especially in cases of degenerative disease [33][34] Question: Expansion of BRTX-100 to cervical indications - Management confirmed that the cervical space was strategically chosen, and they aim to leverage lumbar data to facilitate regulatory processes [36][39] Question: Enrollment update in the lumbar trial and cash burn estimation for 2025 - Management stated that enrollment is progressing well and cash burn in 2025 is expected to be similar to 2024, with potential reductions in future years [48][49] Question: Future revenues from Cartessa - Management expects revenues to become more consistent as the commercial relationship develops, while also exploring additional commercial opportunities [58][62]