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]

Financial Data and Key Metrics Changes - Total revenues increased by 154% sequentially, from $35,000 in Q1 2024 to $89,000 in Q2 2024, driven by initial product revenue from the Cartessa agreement [6][7] - Loss from operations for Q2 2024 was $2.5 million, a 19% year-over-year improvement from the $3.1 million loss in Q2 2023, and a 39% sequential improvement from the $4.1 million loss in Q1 2024 [7][8] - Cash used in operating activities in Q2 2024 was $1.9 million, with the company ending the quarter with $14.7 million in cash, cash equivalents, and marketable securities, and no outstanding debt [8][20] Business Line Data and Key Metrics Changes - The company began to derive initial product revenue from its exclusive supply agreement with Cartessa, which is expected to grow materially in the future [6][7] - The BRTX-100 program is in a Phase II study targeting chronic lumbar disc disease, with 99 subjects being enrolled across 16 clinical sites [9][12] - The ThermoStem program is developing a cell-based therapy candidate targeting obesity and metabolic disorders, with promising preclinical data indicating significant weight loss potential [10][14] Market Data and Key Metrics Changes - The company is focusing on the BioCosmeceuticals market through its agreement with Cartessa, which is expected to validate its platform and drive revenue growth [19][39] - The company is exploring additional distribution opportunities outside the U.S. for its ExoCR product, indicating potential for market expansion [39] Company Strategy and Development Direction - The company aims to achieve sustainable profitability by managing resources effectively while advancing its clinical development programs and leveraging cash flow from the Cartessa agreement [18][20] - The company is committed to expanding its intellectual property portfolio to protect its technologies and facilitate future licensing opportunities [14][19] - The company is actively pursuing strategic licensing discussions for its ThermoStem metabolic disease program, indicating a focus on partnerships to enhance growth [15][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing Phase II study of BRTX-100 and expects full enrollment by the end of 2024, with optimism about the data being consistent with previous trends [18][19] - The company highlighted the importance of the FDA's protocol amendment for the Phase II study, which is expected to enhance patient safety and data integrity [12][18] - Management is optimistic about the potential for multiple licensing agreements related to the ThermoStem program, indicating a proactive approach to business development [36] Other Important Information - The company has entered into substantive discussions with a commercial-stage regenerative medicine company regarding a potential licensing agreement for the ThermoStem program [15] - The company plans to roll out new product lines in the BioCosmeceutical space in the fall of 2024, which could further enhance revenue [39] Q&A Session Summary Question: Are you seeing blinded data with a 2 to 1 split of activity similar to the previous 3 to 1 split? - Management confirmed that the first four patients had a 3 to 1 randomization, while subsequent patients are randomized 2 to 1, with early signs of improvement in pain reduction and function [21][22] Question: Can you provide details on the minimum Cartessa purchase quantities? - Management indicated that the agreement represents a low multimillion-dollar revenue contract over the first year, with a five-year exclusivity [22] Question: When is the 10-Q coming out? - Management confirmed that the 10-Q would be filed before the end of the day [24] Question: Will you proceed with the ThermoStem study regardless of a partnership? - Management stated that they would move forward with the DMS filing and first-in-human studies, regardless of a signed partnership [28] Question: How long will you be able to follow up with patients in the trial? - Management indicated that the primary efficacy endpoint is at the 52-week mark, which is when they expect to disclose data [29] Question: Is the DMF a rate-limiting step for potential agreements? - Management clarified that while the DMF is not a rate-limiting step, it is a key element for facilitating out-licensing opportunities [33][34] Question: Have you seen an acceleration in patient enrollment since the protocol amendment? - Management noted that the combination of the protocol change and hiring a marketing organization has positively impacted patient recruitment [35] Question: Are you considering multiple ThermoStem transactions? - Management acknowledged the possibility of multiple deals for different indications, particularly in obesity and metabolic syndrome [36] Question: Do you see opportunities to expand the commercial agreement with Cartessa? - Management expressed optimism about expanding the agreement and rolling out new products in the BioCosmeceutical space [39]

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 ...