Core Viewpoint - BioRestorative Therapies, Inc. reported strong execution in its business and key clinical milestones in 2025, with a focus on growth strategy and resource management [2] Corporate Developments - The company is in discussions with a commercial stage regenerative medicine company regarding a potential license for its ThermoStem metabolic intellectual property [4] - BioRestorative's Board of Directors authorized a stock repurchase program for up to $2 million of its common stock through June 16, 2026 [6] - Sandy Lipkins joined the company to lead strategic alliances and licensing agreements [6] Clinical Programs - The ongoing Phase 2 clinical trial of BRTX-100 for chronic lumbar disc disease (cLDD) showed promising preliminary data, with over 50% improvement in both the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) [6] - The FDA requires a greater than 30% improvement in ODI and a greater than 30% reduction in VAS for trial progression and Biologics License Application (BLA) approval [6] Financial Results - For Q2 2025, the company reported revenues of approximately $303,000, a 240% increase compared to Q2 2024 [7] - The net loss for Q2 2025 was $2.7 million, or $0.30 per share, compared to a net loss of $4.0 million, or $0.50 per share, in Q2 2024 [8] - The company ended Q2 2025 with $7.4 million in cash and no outstanding debt [8]

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].

Summary of BioRestorative Therapies Conference Call Company Overview - **Company**: BioRestorative Therapies - **Ticker**: BRTX - **Industry**: Stem Cell Therapy, specifically targeting chronic lumbar disc disease Key Points and Arguments Phase II Trial Results - Preliminary data from the Phase II trial of BRTX-one hundred showed that over 74% of subjects had more than 50% improvement in function based on the ODI scale, and over 72% reported more than 50% reduction in pain based on the VOS scale, both exceeding the FDA's clinically meaningful threshold of 30% [5][10][12] - The trial involved 36 patients, and the results were presented at the International Society for Stem Cell Research's Annual Meeting in Hong Kong [5][6] Unique Treatment Approach - BRTX-one hundred is an autologous stem cell therapy using the patient's own bone marrow-derived stem cells, which are cultured to mimic the environment of damaged spinal discs [8] - The therapy targets the root cause of disc degeneration rather than just masking pain, differentiating it from other treatments like opioids and steroids [8][10] - The effects of BRTX-one hundred can last up to seven years in some patients, providing a long-term solution [9] Market Potential - Chronic lumbar disc disease represents a multibillion-dollar industry in the U.S., with significant growth potential as new cell therapy modalities are approved [11][13] - Current treatments include pharmacological solutions and surgical interventions, both of which are deemed inadequate by the company [12] - The company aims to capture a meaningful share of this market with its first-in-class therapy [17] Future Plans - BioRestorative aims to enroll up to 99 patients in total for the trial, with plans to accelerate enrollment in the second half of the year [19][20] - The company has received FDA Fast Track designation for BRTX-one hundred, positioning it for regulatory milestones and potential commercialization [16][20] Clinical Development Strategy - The trial is designed to be randomized and placebo-controlled, with a focus on scaling validation and preparing for a pivotal Phase III trial [20] - Increased physician interest and patient demand are expected following the positive trial data [20] Additional Important Information - The company emphasizes the need for thoughtful and deliberate approaches in expanding its clinical trials and market presence [13] - The discussion highlighted the ongoing opioid crisis and the need for better treatment options for chronic back pain [12]

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. has announced a stock repurchase program authorizing the repurchase of up to $2 million of its outstanding common stock, reflecting confidence in its clinical development pipeline and business outlook [1][2] Company Overview - BioRestorative is a clinical stage regenerative medicine company focused on stem cell-based therapies and products [1] - The company develops therapeutic products primarily involving adult stem cells, with core clinical programs targeting disc/spine disease and metabolic disorders [4] 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, intended for non-surgical treatment of lumbosacral disc disorders. A Phase 2 clinical trial for chronic lower back pain has commenced, and FDA IND clearance has been obtained for chronic cervical discogenic pain [4] - **Metabolic Program (ThermoStem)**: This program focuses on developing cell-based therapies targeting obesity and metabolic disorders using brown adipose derived stem cells (BADSC) to generate brown adipose tissue (BAT). Initial research suggests that increased brown fat may enhance caloric burning and reduce glucose and lipid levels [5] - **BioCosmeceuticals**: The company operates a commercial platform for BioCosmeceuticals, with a current product that is a cell-based secretome designed to reduce fine lines and wrinkles. Future plans include expanding the product line and pursuing FDA approvals in the BioCosmeceuticals space [6] Stock Repurchase Program Details - The stock repurchase program allows the company to repurchase shares in the open market or through private transactions, with the timing and amount at management's discretion based on market conditions and other factors [2][3] - The program is intended to enhance long-term shareholder value, as the company believes its current share price does not reflect its intrinsic value [2]

Core Insights - BioRestorative Therapies, Inc. presented promising preliminary data for its BRTX-100 therapy at the ISSCR 2025 Annual Meeting, showing over 50% improvement in pain and function for chronic lumbar disc disease (cLDD) patients [1][4][5] - The number of evaluated subjects in the ongoing Phase 2 clinical trial has more than doubled, indicating significant progress towards full enrollment [1][5] Clinical Trial Data - In the Phase 2 trial, 67.57% of subjects showed over 50% improvement in function (ODI) and 73.82% reported over 50% reduction in pain (VAS) at 12 weeks [4] - By 52 weeks, over 74% of subjects demonstrated over 50% improvement in function and over 72% reported significant pain reduction [5] - The trial aims to enroll up to 99 subjects across 16 U.S. sites, with a randomized, double-blinded, placebo-controlled design [6] Safety and Efficacy - No serious adverse events or dose-limiting toxicities were reported between 26 and 104 weeks at the target dose of 40 million cells, indicating an excellent safety profile [5] - Each new data analysis has shown an upward trend in efficacy markers, enhancing confidence in the therapy's potential to meet FDA thresholds for approval [5][4] Company Overview - BioRestorative focuses on developing stem cell-based therapies for serious musculoskeletal conditions, with BRTX-100 as its lead candidate for treating painful lumbosacral disc degeneration [7] - The company also has a metabolic program targeting obesity and metabolic disorders, and a commercial BioCosmeceutical platform aimed at aesthetic applications [8][9]

Core Insights - BioRestorative Therapies, Inc. has appointed Sandy Lipkins as a leader in technology commercialization and business development, effective June 9, 2025, to enhance strategic alliances and licensing agreements [1][2][3] Company Overview - BioRestorative Therapies focuses on regenerative medicine, particularly stem cell-based therapies, with two main clinical development programs targeting disc/spine disease and metabolic disorders [5] - The company operates a commercial BioCosmeceutical platform, which includes a cell-based secretome product designed to reduce fine lines and wrinkles [7] Leadership Background - Sandy Lipkins brings over 30 years of experience in venture capital, finance, and sales, with a strong focus on anti-aging and wellness sectors, and has a proven track record in scaling companies and expanding market reach [2][3] - His expertise in stem cells and regenerative medicine is expected to drive significant value creation for BioRestorative as it advances its clinical pipeline and commercial offerings [3][4] Clinical Development Programs - The Disc/Spine Program includes BRTX-100, a cell therapy candidate for treating painful lumbosacral disc disorders, currently in Phase 2 clinical trials [5] - The Metabolic Program, ThermoStem, aims to develop therapies targeting obesity and metabolic disorders using brown adipose-derived stem cells [6] Future Aspirations - The company aims to accelerate growth and expand its BioCosmeceuticals platform under Lipkins' leadership, with a focus on bringing transformative regenerative solutions to both domestic and international markets [4][3]

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].

Company Performance - Biorestorative Therapies, Inc. reported a quarterly loss of $0.56 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.32, marking an earnings surprise of -75% [1] - The company posted revenues of $0.03 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 91.67%, compared to revenues of $0.04 million a year ago [2] - Over the last four quarters, Biorestorative Therapies has surpassed consensus EPS estimates three times, but has only topped consensus revenue estimates once [2] Stock Performance - Biorestorative Therapies shares have increased by approximately 19.9% since the beginning of the year, significantly outperforming the S&P 500's gain of 0.1% [3] - The current Zacks Rank for the stock is 3 (Hold), indicating that shares are expected to perform in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the coming quarter is -$0.33 on revenues of $0.5 million, and for the current fiscal year, it is -$1.08 on revenues of $2.3 million [7] - The outlook for the Medical - Biomedical and Genetics industry is positive, as it is currently in the top 30% of over 250 Zacks industries, suggesting that stocks in this sector are likely to outperform [8]

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]