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 ...

Core Viewpoint - Biorestorative Therapies, Inc. reported a quarterly loss of $0.50 per share, which was better than the Zacks Consensus Estimate of a loss of $0.56, indicating a positive earnings surprise of 10.71% [1] Financial Performance - The company posted revenues of $0.09 million for the quarter ended June 2024, exceeding the Zacks Consensus Estimate by 196.67%, compared to revenues of $0.07 million in the same quarter last year [2] - Over the last four quarters, Biorestorative Therapies has surpassed consensus EPS estimates three times and has topped consensus revenue estimates three times as well [2] Stock Performance - Biorestorative Therapies shares have declined approximately 17.8% since the beginning of the year, contrasting with the S&P 500's gain of 12.1% [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] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.63 on revenues of $0.03 million, and for the current fiscal year, it is -$2.16 on revenues of $0.13 million [7] - The estimate revisions trend for Biorestorative Therapies is mixed, and future earnings expectations will depend on management's commentary during the earnings call [4][6] Industry Context - The Medical - Biomedical and Genetics industry, to which Biorestorative Therapies belongs, is currently ranked in the top 29% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Revenue and Profitability - For the three months ended June 30, 2024, revenues were $89,100, compared to $64,500 for the same period in 2023, representing an increase of 38.2%[68] - Gross profit for the three months ended June 30, 2024, was $82,610, up from $64,500 in 2023, indicating a significant improvement in profitability[68] - Revenues for the six months ended June 30, 2024, increased to $124.1 million from $95.8 million in 2023, representing a growth of 29.5%[75] - Gross profit for the same period rose to $117.6 million, compared to $95.8 million in 2023, indicating a significant increase[75] Expenses - Research and development expenses increased by $389,291, or 43%, to $1,292,182 for the three months ended June 30, 2024, compared to $902,891 in 2023[69] - General and administrative expenses decreased by $1,018,925, or 45%, to $1,259,235 for the three months ended June 30, 2024, primarily due to a reduction in stock-based compensation[70] - Research and development expenses increased by $215,677, or 10%, to $2,350,313 for the six months ended June 30, 2024, primarily due to higher lab supply and payroll expenses[77] - General and administrative expenses decreased by $2,511,457, or 37%, to $4,345,356, mainly due to a reduction in stock-based compensation[77] Income and Loss - Interest income rose to $175,945 for the three months ended June 30, 2024, compared to $96,187 in the same period of 2023, reflecting improved returns on marketable securities[71] - The net loss for the three months ended June 30, 2024, was $4,028,562, a decrease from a net loss of $5,709,399 in 2023, indicating a reduction in losses[68] - Interest income increased to $338,542 for the six months ended June 30, 2024, compared to $114,403 in 2023, driven by investments in marketable securities[78] Cash Flow and Working Capital - Cash and cash equivalents increased to $2,252,247 as of June 30, 2024, up from $884,377 at the end of 2023[79] - Working capital improved by $900,754 to $9,683,935, supported by $7,505,646 in cash from financing activities[79] - Net cash used in operating activities was $4,182,945 for the six months ended June 30, 2024, compared to $3,662,831 in 2023[84] - Net cash provided by financing activities was $7,505,646 for the six months ended June 30, 2024, a significant increase from $411,701 in 2023[89] Business Development - The company generated $69,300 in cosmetic product sales revenue in connection with its exclusive supply agreement with Cartessa for the three months ended June 30, 2024[69] - The company expects an increase in royalty revenue from its sublicense agreement with SCTC in future periods due to anticipated growth in disc procedures[68] - 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[63] - The company is developing a biologics-based cosmetic products business and has entered into a five-year exclusive supply agreement with Cartessa Aesthetics[65] Gains - The company recognized a gain on exchange of warrants amounting to $1,711,698 for the six months ended June 30, 2024[78]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): August 13, 2024 BioRestorative Therapies, Inc. (Exact name of registrant as specified in its charter) | --- | --- | --- | |--------------------------------------------------------|------------------------------------------------------------------|---------------------------------------| | Nevad ...

"I am deeply honored to have been selected to help launch this important new special section of the Journal of Translational Medicine," Mr. Silva said. "Today, most regenerative medicine research remains confined to the bench rather than the bedside. But if our cell-based therapy development progress at BioRestorative, as well as that at several other companies, is any indication, it may not be long before the full clinical potential of the field is realized. I am energized by this unique opportunity to wor ...