Core Insights - BioRestorative Therapies, Inc. has received a Type B meeting with the FDA to discuss an accelerated Biologics License Application pathway for its BRTX-100 program targeting chronic lumbar disc disease [1][2] - The company aims to present positive safety and efficacy data from its ongoing Phase 2 clinical trial during the FDA meeting and seeks an expedited timeline for a Phase 3 trial [2] Company Overview - BioRestorative is focused on regenerative medicine, particularly stem cell-based therapies, and has two main clinical development programs: the Disc/Spine Program and the Metabolic Program [6][8] - BRTX-100 is the lead candidate in the Disc/Spine Program, designed to treat chronic lumbar disc disease through a cell-based therapeutic approach [5][6] - The company also operates a BioCosmeceutical platform, developing products aimed at cosmetic applications using cell-based technologies [9] Clinical Development - The BRTX-100 Phase 2 clinical trial has been granted Fast Track designation by the FDA, facilitating its development and review process [3] - The trial involves up to 99 subjects across 16 clinical sites in the U.S., with a randomized 2:1 allocation to BRTX-100 or placebo [5] - Chronic lumbar disc disease affects a significant portion of the adult population, with at least 80% experiencing lower back pain at some point in their lives [4] Market Context - Chronic lumbar disc disease is a major cause of disability and economic burden in the U.S., with current treatments focusing on symptomatic relief rather than reversing disc degeneration [4] - The FDA's Fast Track designation for BRTX-100 indicates its potential to address significant unmet medical needs in this area [3]

Core Insights - Biorestorative Therapies, Inc. (BRTX) reported a quarterly loss of $0.38 per share, consistent with the Zacks Consensus Estimate, compared to a loss of $0.13 per share a year ago [1] - The company posted revenues of $0.01 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 97%, and down from $0.23 million year-over-year [2] - Biorestorative Therapies shares have declined approximately 1.4% year-to-date, while the S&P 500 has gained 16.4% [3] Financial Performance - The company has surpassed consensus EPS estimates two times over the last four quarters [1] - The current consensus EPS estimate for the upcoming quarter is -$0.28 on revenues of $0.5 million, and for the current fiscal year, it is -$1.55 on revenues of $1.23 million [7] Market Outlook - The earnings outlook and estimate revisions will significantly influence the stock's price movement [4] - The Zacks Rank for Biorestorative Therapies is currently 3 (Hold), indicating expected performance in line with the market [6] - The Medical - Biomedical and Genetics industry is ranked in the top 34% of over 250 Zacks industries, suggesting a favorable industry outlook [8]

Financial Data and Key Metrics Changes - Third quarter 2025 revenues were $11.8 million, a significant decrease from $233.6 million in Q3 2024, primarily due to the timing of orders for the developing biocosmeceutical revenue stream [5] - The company's loss from operations in Q3 2025 was $3.7 million, compared to $2.3 million in the same period of 2024 [5] - The net loss per share for Q3 2025 was $3.03, compared to a net loss of $1.13 per share in Q3 2024 [5] - The company ended the quarter with cash, cash equivalents, and marketable securities of $4.5 million, with no outstanding debt [6] Business Line Data and Key Metrics Changes - The biocosmeceutical business is gaining momentum, with a focus on rebuilding commercial infrastructure, including supply chain and sales coverage [14] - The company is working to broaden distribution capabilities beyond the exclusive agreement with Cartesa, aiming for a three-prong approach to capture a larger market share [26] Market Data and Key Metrics Changes - The global obesity market is projected to exceed $100 billion annually by the end of the decade, driven by demand for GLP-1 therapies, which the company's ThermoSTEM program aims to address [10] - The biocosmeceutical market opportunity is estimated at $63 billion, indicating significant growth potential for the company [25] Company Strategy and Development Direction - The company is focused on advancing its two core development programs: BRTX-100 for chronic lumbar disc disease and ThermoSTEM for obesity and metabolic disorders [7][10] - The management emphasizes the importance of having a commercial business capable of generating revenue alongside clinical programs, which is expected to contribute significantly in 2026 and beyond [14] - The company is committed to building a comprehensive patent portfolio to protect its intellectual property, with recent milestones achieved in Japan [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the enrollment in the BRTX-100 clinical trial, indicating that it is approaching completion and may lead to a Type B FDA meeting in December [16][39] - The management highlighted the strength of recent financing, which is expected to support the company's clinical and commercial milestones [18] - The company is optimistic about the potential for accelerated BLA approval for BRTX-100, which could significantly enhance its market position [40] Other Important Information - The company has appointed Crystal Romano as the Global Head of Commercial Operations to strengthen its commercial strategy [14] - The management is exploring direct-to-consumer opportunities for biocosmeceutical products, which could further enhance revenue streams [27] Q&A Session Summary Question: Significance of the biocosmeceuticals opportunity and market dynamics - Management indicated that the biocosmeceutical market is a $63 billion opportunity and emphasized the company's unique position in the microcap biotech space [25][26] Question: Impact of biocosmeceuticals focus on clinical development - Management clarified that resources can be managed effectively without detracting from clinical development, with potential synergies from using cell lines for both clinical and cosmetic products [31][32] Question: Update on BRTX-100 data release and enrollment - Management reported that enrollment is over three-quarters complete, with expectations to finalize enrollment soon, while data will remain blinded for strategic reasons [38][40] Question: Status of the cervical trial - Management stated that resources have not been dedicated to the cervical trial due to financial constraints, focusing instead on the lumbar spine program [45] Question: Potential for biocosmeceutical revenues in Q4 - Management expressed uncertainty about Q4 revenues but noted that some products have been sold since the new leadership was onboarded [47]

Financial Performance - For the three months ended September 30, 2025, revenues were $11,800, a decrease of 95% compared to $233,600 for the same period in 2024[93] - Revenues for the nine months ended September 30, 2025, were $340.1 million, a decrease of 4.9% compared to $357.7 million for the same period in 2024[101] - The net loss for the three months ended September 30, 2025, was $3,038,277, compared to a net loss of $1,091,416 for the same period in 2024[93] - Net loss for the nine months ended September 30, 2025, was $11.03 million, compared to a net loss of $7.34 million for the same period in 2024[101] Expenses - Research and development expenses increased by $1,141,387, or 78.5%, to $2,594,750 for the three months ended September 30, 2025, compared to $1,453,363 in 2024[96] - Research and development expenses increased by $2.46 million, or 49.2%, to $7.47 million for the nine months ended September 30, 2025, primarily due to increased costs for clinical trials and lab supplies[103] - General and administrative expenses rose by $66,504, or 6.3%, totaling $1,115,491 for the three months ended September 30, 2025, compared to $1,048,987 in 2024[97] - General and administrative expenses rose by $479,000, or 11.4%, to $4.67 million for the nine months ended September 30, 2025, driven by higher stock-based compensation and consulting expenses[105] Cash Flow and Capital - Cash and cash equivalents increased to $602,444 as of September 30, 2025, from $547,890 at the end of 2024[110] - Working capital decreased by $6.12 million to $1.27 million as of September 30, 2025, primarily due to cash used in operations[110] - Net cash used in operating activities was $8.37 million for the nine months ended September 30, 2025, compared to $5.88 million for the same period in 2024[114] - Net cash provided by investing activities was $6.50 million for the nine months ended September 30, 2025, primarily from the sale of marketable securities[116] Financial Challenges - The accumulated deficit as of September 30, 2025, was $166,713,054, indicating ongoing financial challenges[83] - The company anticipates continued net losses and negative cash flows from operations as it executes its development plans[111] - The company may face challenges in raising sufficient additional capital, which could impact its ability to continue operations[113] Product Development - The company is pursuing the development of BRTX-100 for chronic lumbar disc disease and has received FDA authorization for a Phase 2 clinical trial[85] Revenue Sources - The company generated $2,900 in royalty revenue from the sublicense agreement with SCTC for the three months ended September 30, 2024, compared to $11,800 in 2025, reflecting an increase due to more disc procedures[94] - The company reported $0 in cosmetic product sales revenue for the three months ended September 30, 2025, down from $230,700 in 2024, attributed to the timing of orders[95] - Interest income decreased to $57,740 for the three months ended September 30, 2025, from $158,547 in 2024, primarily due to a lower average balance of marketable securities[98] - The change in fair value of warrant liabilities resulted in a gain of $612,064 for the three months ended September 30, 2025, compared to a gain of $1,036,464 in 2024[100]

Financial Results - BioRestorative Therapies, Inc. announced its financial results for Q3 2025 on November 12, 2025[3]. - The company provided a business update alongside the financial results in the press release[3]. Press Release Information - The press release is available as Exhibit 99.1 and includes details regarding the conference call to discuss the results[3]. - The information in the press release should be considered in the context of the company's filings with the SEC[4]. - The press release is not deemed "filed" under the Exchange Act, and its information will not be incorporated by reference into other filings unless specifically identified[5]. Company Classification - The company is classified as an emerging growth company under the Securities Act[2]. Report Signing - The report was signed by Robert Kristal, Chief Financial Officer, on November 12, 2025[11].

Core Insights - BioRestorative Therapies, Inc. reported its third quarter financial results for 2025, highlighting strong clinical development and business momentum, with a focus on near- and mid-term value opportunities [2][9] Corporate Developments - The company anticipates a Type B meeting with the FDA regarding an accelerated Biologics License Application (BLA) for its BRTX-100 program aimed at treating chronic lumbar disc disease [4] - BioRestorative achieved a significant intellectual property milestone with the Japanese Patent Office granting a Notice of Allowance for its ThermoStem platform, which focuses on treating obesity and metabolic disorders [5] - The appointment of Crystal Romano as Head of Global Commercial Operations aims to accelerate growth in the cell-based product portfolio [6][8] Financial Highlights - For Q3 2025, the company reported revenues of approximately $11,800, a decrease from $233,600 in Q3 2024, primarily due to the timing of orders for BioCosmeceutical sales [9] - The loss from operations for Q3 2025 was $3.7 million, compared to $2.3 million in the same period of 2024, with a net loss of $3.0 million or $0.33 per share [10] - The company ended Q3 2025 with cash and equivalents of $4.5 million, excluding approximately $1.085 million from a recent financing [11] Business Strategy - The company is focused on executing its near-term revenue strategy within the BioCosmeceutical platform while advancing clinical stage programs, which represent multi-billion dollar market opportunities [2] - BioRestorative is developing cell-based therapies targeting obesity and metabolic disorders, utilizing brown adipose-derived stem cells [14][15] - The company operates a commercial BioCosmeceutical platform, with plans to expand its offerings to include a broader range of cell-based aesthetic products [16]

Core Insights - Several biotechnology and pharmaceutical stocks experienced significant price increases during after-hours trading, driven by upcoming data releases, recent earnings reports, and prior corporate updates [1] Company Summaries - InflaRx N.V. (IFRX) saw a surge of 63.41% to $2.01 after hours, following a 2.50% gain at the close, due to plans to release topline data from its Phase 2a trial of oral C5aR inhibitor INF904, expected on Monday morning alongside its third-quarter financial results [2] - Rallybio Corp. (RLYB) rose 12.84% to $0.71 after reporting a third-quarter net income of $16.0 million, or $0.36 per share, reversing a prior-year loss of $11.5 million, although revenue for the quarter was $0.2 million, slightly below the $0.3 million reported in the same period last year [3] - FibroBiologics Inc. (FBLG) climbed 13.51% to $0.40 after hours, building on a 5.13% gain during regular trading, following the release of its third-quarter financial results and a corporate update on October 31 [4] - AbCellera Biologics Inc. (ABCL) advanced 6.51% to $4.16 after hours, recovering from a 13.69% decline earlier in the day, reporting a third-quarter net loss of $57.1 million, or $(0.19) per share, compared to a loss of $51.1 million in the same quarter last year, while revenue increased to $9.0 million from $6.5 million year-over-year [5] - BioRestorative Therapies Inc. (BRTX) gained 11.68% to $1.53 in after-hours trading, following a Notice of Allowance from the Japanese Patent Office for its ThermoStem platform announced on October 27, with third-quarter results scheduled for release on November 12 [6] - Cellectis S.A. (CLLS) rose 6.58% to $3.40 after hours, reporting a third-quarter net income of $589 thousand, or $0.01 per share, compared to a $23.1 million loss in the prior year, with total revenues and other income more than doubling to $37.2 million from $18.1 million [7]

Core Insights - BioRestorative Therapies, Inc. will release its third quarter 2025 financial results on November 12, 2025, after market close, followed by a conference call for a business update [1][2] Company Overview - BioRestorative is focused on regenerative medicine, particularly stem cell-based therapies and products [3] - The company has two main clinical development programs: the Disc/Spine Program and the Metabolic Program, along with a commercial BioCosmeceutical platform [3][4] Disc/Spine Program - The lead cell therapy candidate, BRTX-100, is derived from a patient's own cultured mesenchymal stem cells and is intended for non-surgical treatment of lumbosacral disc disorders [3] - BRTX-100 is currently in a Phase 2 clinical trial for chronic lower back pain due to degenerative disc disease and has received FDA IND clearance for chronic cervical discogenic pain [3] Metabolic Program - The ThermoStem® program aims to develop therapies targeting obesity and metabolic disorders using brown adipose-derived stem cells (BADSC) [4] - Initial preclinical 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 operates a commercial BioCosmeceutical platform, offering a cell-based secretome product designed to reduce fine lines and wrinkles [5] - Future plans include expanding the product line to include more cell-based aesthetic products and therapeutics, with the goal of obtaining FDA approvals [5]

Core Insights - BioRestorative Therapies, Inc. has achieved a significant intellectual property milestone with the Japanese Patent Office issuing a Notice of Allowance for its ThermoStem platform, which focuses on stem cell-based therapies for obesity and metabolic disorders [1][2] Company Developments - The newly allowed patent provides broad protection for BioRestorative's allogeneic, off-the-shelf brown adipose-derived stem cell (BADSC) technology, covering therapeutic cells and various methods of encapsulation and delivery [2] - This patent strengthens BioRestorative's position in developing next-generation, cell-based alternatives to GLP-1 drugs, which are rapidly growing in the therapeutic market [3][4] - The CEO of BioRestorative highlighted that the patent allowance validates the progress made with ThermoStem and positions the company favorably in the commercial landscape, especially as discussions with potential strategic partners continue [4] Market Context - The global obesity market is projected to exceed $100 billion annually by the end of the decade, driven by demand for GLP-1 therapies, which BioRestorative aims to address with its ThermoStem platform [4] - BioRestorative's ThermoStem platform is designed to provide an alternative to chronic GLP-1 injections, mitigate muscle loss, and reduce cardiovascular risks associated with current therapies [6] Clinical Programs - BioRestorative is developing two core clinical programs: - The Disc/Spine Program (brtxDISC) focuses on a cell therapy candidate, BRTX-100, for treating lumbosacral disc disorders and has commenced a Phase 2 clinical trial [5] - The Metabolic Program (ThermoStem) targets obesity and metabolic disorders using BADSC to generate brown adipose tissue, with initial preclinical research indicating potential benefits in caloric burning and metabolic regulation [6][7] Commercial Initiatives - BioRestorative operates a BioCosmeceutical platform, offering a cell-based secretome product aimed at cosmetic applications, with plans to expand its offerings in the aesthetic product space [8]

Core Insights - BioRestorative Therapies, Inc. has appointed Crystal Romano to lead its global commercial operations and innovation, marking a significant step in the company's growth strategy [1][3] Company Overview - BioRestorative is focused on regenerative medicine, particularly stem cell-based therapies and products, with two main clinical development programs targeting disc/spine disease and metabolic disorders [4] - The company also operates a commercial BioCosmeceutical platform, developing products that utilize cell-based secretome containing exosomes, proteins, and growth factors [6][7] Leadership and Strategy - Crystal Romano brings over 19 years of experience in the medical and regenerative industries, recognized for her expertise in product development, commercialization, and navigating FDA regulations [2] - The CEO of BioRestorative emphasized the importance of Romano's role at a critical time for the company, aiming to expand its commercial footprint and unlock revenue opportunities [3] Clinical Development Programs - The Disc/Spine Program includes BRTX-100, a cell therapy candidate derived from a patient's own mesenchymal stem cells, currently in Phase 2 clinical trials for chronic lower back pain [4] - The Metabolic Program, ThermoStem, focuses on using brown adipose-derived stem cells to target obesity and metabolic disorders, with promising preclinical research indicating potential benefits for weight loss and metabolic health [5] Future Directions - BioRestorative aims to expand its BioCosmeceutical offerings through IND-enabling studies, seeking to pioneer FDA approvals in the emerging market [7]