Core Viewpoint - BioRestorative Therapies, Inc. has announced a change in the timing of its upcoming webcasted conference call to discuss its pipeline update, now scheduled for 10:30am EST on February 27, 2025 [1] Company Overview - BioRestorative Therapies, Inc. is focused on developing therapeutic products using cell and tissue protocols, primarily involving adult stem cells [3] - The company has two core clinical development programs targeting disc/spine disease and metabolic disorders, along with a commercial BioCosmeceutical platform [3] Clinical Development Programs - **Disc/Spine Program (brtxDISC)**: The lead cell therapy candidate, BRTX-100, is formulated from autologous cultured mesenchymal stem cells from the patient's bone marrow, intended for non-surgical treatment of painful lumbosacral disc disorders. A Phase 2 clinical trial has commenced to treat chronic lower back pain from degenerative disc disease [3][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 preclinical research suggests that increased brown fat may enhance caloric burning and reduce glucose and lipid levels [4] BioCosmeceuticals - BioRestorative operates a commercial BioCosmeceutical platform, with a current product that is a cell-based secretome designed to reduce fine lines and wrinkles. The company plans to expand its offerings to include a broader range of cell-based biologic aesthetic products and therapeutics, aiming for FDA approvals [5]

Core Viewpoint - BioRestorative Therapies, Inc. is set to provide a positive clinical pipeline update on February 27, 2025, highlighting significant developments in its regenerative medicine initiatives [1][2]. Clinical Pipeline - The company is focused on two main clinical development programs: the Disc/Spine Program and the Metabolic Program [4][5]. - BRTX-100, the lead candidate in the Disc/Spine Program, is designed for non-surgical treatment of lumbosacral disc disorders and is currently in a Phase 2 clinical trial targeting chronic lower back pain due to degenerative disc disease [4]. - The Metabolic Program, known as ThermoStem, aims to develop therapies targeting obesity and metabolic disorders using brown adipose-derived stem cells, which may enhance caloric burning and reduce glucose and lipid levels [5]. BioCosmeceuticals - BioRestorative operates a commercial BioCosmeceutical platform, offering a cell-based secretome product aimed at reducing fine lines and wrinkles [6]. - The company plans to expand its offerings in the BioCosmeceuticals space, pursuing FDA approvals for additional cell-based aesthetic products and therapeutics [6]. Conference Call Details - A conference call will be held on February 27, 2025, at 8:00 am EST, allowing investors to participate via telephone or through a live webcast [3].

Core Insights - The FDA has granted Fast Track designation to BioRestorative's BRTX-100 program for treating chronic lumbar disc disease (cLDD), highlighting the significant unmet medical need for effective alternatives to opioids and surgical interventions [1][2] - Preliminary Phase 2 clinical data for BRTX-100 has been reported positively, which may facilitate Priority Review and Accelerated Biologics License Application (BLA) approval [1][2] Company Overview - BioRestorative Therapies, Inc. is focused on developing stem cell-based therapies and products, with its lead candidate BRTX-100 targeting chronic lumbar disc disease [1][6] - The company also has a metabolic program targeting obesity and metabolic disorders, and a BioCosmeceutical platform for aesthetic products [8][9] Industry Context - Chronic lumbar disc disease is a prevalent issue, with at least 80% of adults in the U.S. experiencing lower back pain at some point in their lives, making it a leading cause of disability and economic burden [4] - Current treatment options primarily involve conservative non-surgical approaches or surgical interventions, with no existing therapies aimed at reversing disc degeneration [4]

Core Insights - BioRestorative Therapies, Inc. presented promising preliminary data for its lead product BRTX-100 at the ORS annual meeting, indicating significant improvements in pain and function for patients with chronic lumbar disc disease [1][5][7] Company Overview - BioRestorative is a clinical stage regenerative medicine company focused on stem cell-based therapies, particularly for musculoskeletal disorders and metabolic diseases [8] - The company is developing BRTX-100, a cell-based therapy targeting areas with low blood flow, currently in a Phase 2 clinical trial for chronic lumbar disc disease [3][8] Clinical Trial Details - The ongoing Phase 2 trial of BRTX-100 involves up to 99 subjects across 16 clinical sites in the U.S., with a randomized 2:1 allocation to treatment or placebo [3] - Preliminary data from the first 15 patients showed no serious adverse events and no dose-limiting toxicity at the 26-52 week mark [4] Efficacy Results - At 26 weeks, the average improvement in the Visual Analog Scale (VAS) for pain was 71.20%, and at 52 weeks, it was 73.58% [5] - The Oswestry Disability Index (ODI) showed an average improvement of 69.04% at 26 weeks and 65.16% at 52 weeks, both significantly exceeding the FDA's minimum threshold of 30% improvement [5] Imaging Analysis - MRI comparisons at 52 weeks indicated potential disc microenvironment remodeling, including increased hydration and reduced protrusion size, suggesting positive morphological changes due to BRTX-100 treatment [6] Future Outlook - The CEO expressed optimism regarding the trial's ability to meet primary and secondary endpoints, which could lead to FDA approval [7]

Core Insights - BioRestorative Therapies, Inc. has received a Notice of Allowance for a new patent application from the European Patent Office, which covers key aspects of its ThermoStem® metabolic disease platform, expected to provide protection until April 29, 2040 [1][3] Patent and Technology - The new patent covers a method for creating a non-naturally occurring three-dimensional brown adipose derived stem cell aggregate [2] - The patent allowance validates the advancements made in the metabolic disease program, with a focus on transforming the treatment landscape for obesity and related metabolic diseases [3] Market Opportunities - The company sees a significant market opportunity for ThermoStem®-based BADSCs, particularly in regions dominated by GLP-1 treatments for obesity [3] - BioRestorative is in discussions with a commercial stage regenerative medicine company regarding a potential license of its ThermoStem® metabolic intellectual property [3] Clinical Development Programs - BioRestorative's core clinical development programs include: - **Disc/Spine Program (brtxDISC™)**: Focused on treating painful lumbosacral disc disorders using BRTX-100, which is derived from a patient's own cultured mesenchymal stem cells [4] - **Metabolic Program (ThermoStem®)**: Developing therapies targeting obesity and metabolic disorders using brown adipose derived stem cells to generate brown adipose tissue [5] BioCosmeceuticals - The company operates a commercial BioCosmeceutical platform, offering a cell-based secretome product designed to reduce fine lines and wrinkles, with plans to expand its product offerings [6][7]

Financial Data and Key Metrics Changes - The company ended Q3 2024 with cash, cash equivalents, and investments held in marketable securities totaling $13.1 million, with no outstanding debt, indicating a strong financial position [24] Business Line Data and Key Metrics Changes - The preliminary Phase 2 BRTX-100 data showed that 70% of the first 10 patients treated reported improvements in both pain and function at the 26-week mark, with some patients achieving close to 90% improvement [16][22] Market Data and Key Metrics Changes - The ongoing Phase 2 clinical trial for BRTX-100 is evaluating its safety and efficacy in treating chronic lumbar disc disease, with a total of up to 99 eligible subjects to be enrolled across 16 clinical sites in the U.S. [11][12] Company Strategy and Development Direction - The company is contemplating a 26-week preliminary efficacy endpoint interim analysis and is looking to expand the product profile of BRTX-100 to include cervical indications [20] - The management expressed optimism about the potential for accelerated approval from the FDA based on the encouraging data from the trial [39][41] Management's Comments on Operating Environment and Future Outlook - Management highlighted the positive trends in patient-reported outcomes and expressed confidence in meeting efficacy endpoints for the Phase 2 trial, with plans to present more data in early 2025 [23][24] Other Important Information - The company has not experienced any severe adverse events or dose-limiting toxicity in the ongoing trial, which is a positive indicator for the safety of BRTX-100 [18] Q&A Session Summary Question: How many patients are enrolled thus far? - Management confirmed that the number of enrolled patients is considerably more than 10 but did not disclose the exact figure [27] Question: When will the first unblinded data be available? - The unblinded data is expected to be available after an interim analysis, likely in the first half of 2025 [30] Question: Could the data lead to accelerated approval from the FDA? - Management indicated that if the data continues to show positive effects, it could potentially be used for pivotal studies to accelerate commercialization [39][41] Question: Are pain and functional improvements co-primary endpoints? - Yes, both pain and function must improve by at least 30% for a patient to be labeled a responder [48]

Financial Results - BioRestorative Therapies, Inc. announced its financial results for Q3 2024, with a focus on business updates and performance metrics[2]. - The financial press release is intended to provide summary information in the context of the company's SEC filings and public announcements[3]. - The company has not filed the information in the press releases as part of its SEC obligations, indicating it is not subject to certain liabilities[4]. - The CFO, Robert Kristal, signed the report on November 13, 2024, indicating the company's compliance with SEC requirements[10]. Clinical Trials - The company is presenting additional preliminary data from the ongoing Phase 2 clinical trial of BRTX-100 for chronic lumbar disc disease at the ORS symposium[6]. - The conference call discussing Q3 results will also include a review of the BRTX-100 presentation[6]. - The company is committed to transparency regarding its clinical trials and financial performance[7]. - The presentation materials from the symposium may be used in future communications with investors and stakeholders[6]. Research and Development - The company continues to focus on research and development as part of its growth strategy[6]. - The press releases and presentation materials are not incorporated by reference into any registration statement unless specifically identified[7].

Revenue and Sales Performance - For the three months ended September 30, 2024, revenues were $233,600, a significant increase from $30,700 in the same period of 2023, primarily driven by cosmetic product sales[89]. - The company generated $230,700 in cosmetic product sales revenue in connection with its exclusive supply agreement with Cartessa, compared to $0 in the prior year[90]. - Revenues for the nine months ended September 30, 2024, were $57,700, a decrease from $126,500 in the same period of 2023, primarily due to a decrease in disc procedures[99]. Expenses - Research and development expenses increased by $510,206, or 63%, to $1,320,030 for the three months ended September 30, 2024, compared to $874,824 in 2023[91]. - General and administrative expenses decreased by $1,142,999, or 49%, to $1,182,320 for the three months ended September 30, 2024, primarily due to a reduction in stock-based compensation[93]. - Research and development expenses increased by $746,035, or 25%, for the nine months ended September 30, 2024, compared to the same period in 2023, driven by increased lab supply and payroll expenses[100]. - General and administrative expenses decreased by $3,674,608, or 40%, for the nine months ended September 30, 2024, primarily due to a reduction in stock-based compensation[102]. Net Income and Loss - The net loss for the three months ended September 30, 2024, was $1,091,416, a decrease from a net income of $4,768,261 in the same period of 2023[89]. - The company reported a net loss of $7,343,233 for the nine months ended September 30, 2024, an improvement from a net loss of $8,113,710 in the same period of 2023[1]. Cash Flow and Financing - Net cash used in operating activities was $5,882,501 for the nine months ended September 30, 2024, compared to $4,842,249 for the same period in 2023[113]. - Net cash provided by financing activities was $7,505,646 for the nine months ended September 30, 2024, significantly higher than $2,265,700 in the same period of 2023[115]. - Cash and cash equivalents as of September 30, 2024, were $1,489,444, an increase from $884,377 as of December 31, 2023[107]. - The company anticipates requiring additional equity and/or debt financing to continue operations due to an accumulated deficit of $154,042,567 as of September 30, 2024[109]. - The company has entered into an at-the-market offering agreement to issue and sell shares of common stock up to an aggregate offering price of $3,614,170[111]. Clinical Trials and Development Programs - The company has received FDA authorization to commence a Phase 2 clinical trial for BRTX-100, targeting chronic lower back pain from degenerative disc disease[81]. - The company is also developing the ThermoStem Program, which focuses on treating type 2 diabetes and obesity using brown adipose tissue[83]. - A five-year exclusive supply agreement with Cartessa Aesthetics was announced in April 2024, marking a strategic move into the cosmetic products market[85]. Interest Income - Interest income rose to $158,547 for the three months ended September 30, 2024, compared to $61,667 in the same period of 2023, attributed to investments in marketable securities[94]. - Interest income increased to $497,089 for the nine months ended September 30, 2024, compared to $176,070 in the same period of 2023, attributed to investments in marketable securities[103]. Accumulated Deficit - The accumulated deficit as of September 30, 2024, was $154,042,567, reflecting the company's historical losses primarily from operating expenses[79].

Core Insights - BioRestorative Therapies, Inc. has received a provisional license from the New York State Department of Health for processing allogeneic donor tissue material, including stem cells, for medical research [1][3] - The expanded license allows the company to utilize its cGMP manufacturing capabilities for processing, banking, and distribution of clinical-grade allogeneic biologics [2][4] Company Overview - BioRestorative focuses on developing therapeutic products using adult stem cells, with core clinical programs targeting disc/spine disease and metabolic disorders [5] - The lead product, BRTX-100, is designed for non-surgical treatment of lumbosacral disc disorders and is currently in a Phase 2 clinical trial for chronic lower back pain [5] - The ThermoStem program aims to develop therapies targeting obesity and metabolic disorders using brown adipose-derived stem cells [6] - The company also operates a BioCosmeceutical platform, offering products aimed at cosmetic improvements through cell-based secretome technology [7]

Core Insights - BioRestorative Therapies, Inc. is focused on regenerative medicine, particularly stem cell-based therapies and products [1][3] - The CEO, Lance Alstodt, will participate in the 3rd Annual ROTH Healthcare Opportunities Conference on October 9, 2024, in New York City [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 Disc/Spine Program features BRTX-100, a cell therapy candidate for treating painful lumbosacral disc disorders, currently in Phase 2 clinical trials [3] - The Metabolic Program, ThermoStem®, aims to address obesity and metabolic disorders using brown adipose-derived stem cells to generate brown adipose tissue, which may enhance caloric burning and reduce glucose and lipid levels [4] - The company also operates a BioCosmeceutical platform, offering a cell-based secretome product designed to reduce fine lines and wrinkles, with plans to expand into more aesthetic products [5]