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]

Start Time: 16:30 January 1, 0000 5:03 PM ET BioRestorative Therapies, Inc. (NASDAQ:BRTX) Q2 2024 Earnings Conference Call August 13, 2024, 16:30 PM ET Company Participants Lance Alstodt - President, CEO and Chairman Robert Kristal - CFO Francisco Silva - VP, R&D Stephen Kilmer - Head of IR Conference Call Participants Jonathan Aschoff - ROTH MKM Michael Okunewitch - The Maxim Group Elemer Piros - Rodman and Renshaw Operator Good afternoon, and welcome to the BioRestorative Therapies Second Quarter 2024 Inv ...