Core Insights - BioRestorative Therapies, Inc. has appointed Sandy Lipkins as a leader in technology commercialization and business development, effective June 9, 2025, to enhance strategic alliances and licensing agreements [1][2][3] Company Overview - BioRestorative Therapies focuses on regenerative medicine, particularly stem cell-based therapies, with two main clinical development programs targeting disc/spine disease and metabolic disorders [5] - The company operates a commercial BioCosmeceutical platform, which includes a cell-based secretome product designed to reduce fine lines and wrinkles [7] Leadership Background - Sandy Lipkins brings over 30 years of experience in venture capital, finance, and sales, with a strong focus on anti-aging and wellness sectors, and has a proven track record in scaling companies and expanding market reach [2][3] - His expertise in stem cells and regenerative medicine is expected to drive significant value creation for BioRestorative as it advances its clinical pipeline and commercial offerings [3][4] Clinical Development Programs - The Disc/Spine Program includes BRTX-100, a cell therapy candidate for treating painful lumbosacral disc disorders, currently in Phase 2 clinical trials [5] - The Metabolic Program, ThermoStem, aims to develop therapies targeting obesity and metabolic disorders using brown adipose-derived stem cells [6] Future Aspirations - The company aims to accelerate growth and expand its BioCosmeceuticals platform under Lipkins' leadership, with a focus on bringing transformative regenerative solutions to both domestic and international markets [4][3]

Core Viewpoint - BioRestorative Therapies, Inc. is set to present new preliminary clinical data from its Phase 2 trial of BRTX-100 for chronic lumbar disc disease at the ISSCR 2025 Annual Meeting, highlighting significant safety and efficacy signals from a larger patient cohort [1][3]. Company Overview - BioRestorative is a clinical-stage biotechnology company focused on developing stem cell-based therapies for serious musculoskeletal conditions, with BRTX-100 as its lead candidate targeting chronic lumbar disc disease [6]. - The company also has a pipeline that includes ThermoStem, aimed at treating obesity and metabolic disorders, and operates a commercial BioCosmeceutical platform [6]. Clinical Trial Details - The ongoing Phase 2 trial of BRTX-100 is a randomized, double-blinded, placebo-controlled study involving 99 patients across up to 16 U.S. clinical sites, with a 2:1 randomization to receive either BRTX-100 or placebo [3]. - The trial specifically evaluates the safety and functional improvement of BRTX-100 through intradiscal injections of hypoxic-cultured mesenchymal stem cells [3][4]. Presentation Information - The presentation at ISSCR 2025 will be delivered by Francisco Silva, Vice President of Research and Development, on June 13, 2025, focusing on patient-reported pain and function metrics, as well as safety endpoints [2][4]. - ISSCR 2025 is a significant global event for stem cell research, attracting nearly 4,000 participants from over 80 countries, providing a high-profile platform for BioRestorative to share its advancements [5].

Company Performance - Biorestorative Therapies, Inc. reported a quarterly loss of $0.56 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.32, marking an earnings surprise of -75% [1] - The company posted revenues of $0.03 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 91.67%, compared to revenues of $0.04 million a year ago [2] - Over the last four quarters, Biorestorative Therapies has surpassed consensus EPS estimates three times, but has only topped consensus revenue estimates once [2] Stock Performance - Biorestorative Therapies shares have increased by approximately 19.9% since the beginning of the year, significantly outperforming the S&P 500's gain of 0.1% [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] Future Outlook - The current consensus EPS estimate for the coming quarter is -$0.33 on revenues of $0.5 million, and for the current fiscal year, it is -$1.08 on revenues of $2.3 million [7] - The outlook for the Medical - Biomedical and Genetics industry is positive, as it is currently in the top 30% of over 250 Zacks industries, suggesting that stocks in this sector are likely to outperform [8]

Financial Data and Key Metrics Changes - For Q1 2025, revenues were $25,000, down from $35,000 in the same period last year, indicating a decrease of approximately 29% [7] - Deferred revenues for Q1 2025 were $150,000 compared to nil in Q1 2024, reflecting a timing difference in revenue recognition [7] - The loss from operations for Q1 2025 was $4,800,000, compared to $4,100,000 for Q1 2024, showing an increase in operational losses [8] - The net loss for Q1 2025 was $5,300,000 or $0.64 per share, compared to a net loss of $2,200,000 or $0.33 per share in Q1 2024, primarily due to a gain on the exchange of warrants in the previous year [8] Business Line Data and Key Metrics Changes - The lead clinical stage candidate, BRTX-100, is being evaluated in a Phase II trial for chronic lumbar disc disease (CLDD) with positive preliminary data trends observed [10][12] - The company is also developing ThermoStem, a cell-based therapy targeting obesity and metabolic disorders, with ongoing efforts to protect its intellectual property [14][15] Market Data and Key Metrics Changes - The FDA granted Fast Track designation for BRTX-100, facilitating development and review processes for serious conditions [13] - BRTX-100 is now the first and only stem cell-based product candidate cleared by the FDA for evaluation in cervical degeneration disc disease [14] Company Strategy and Development Direction - The company is focused on advancing its two core clinical development programs, BRTX-100 and ThermoStem, while managing resources efficiently [17][19] - There are ongoing discussions regarding potential licensing agreements for ThermoStem metabolic disease programs [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing Phase II trial for BRTX-100, with expectations that data will continue to trend positively [17] - The company is actively engaging with the FDA to discuss endpoints and regulatory processes as they progress towards potential BLA approval [38][46] Other Important Information - The company ended Q1 2025 with cash, cash equivalents, and marketable securities totaling $9,100,000 and no outstanding debt, indicating a strong financial position [9][19] Q&A Session Summary Question: Clarification on efficacy endpoint - Management confirmed that the primary endpoint is safety, with a secondary efficacy endpoint of a 30% improvement, and the term "preliminary" indicates it is not the primary focus [21][22] Question: Interim analysis status - Management stated that an interim analysis is still a potential option but has not been determined yet, as it could impact long-term development [23][24] Question: Enrollment pace and characteristics - Management indicated that enrollment is picking up due to new recruitment strategies and that they expect to counteract any typical summer slowdown [36][37] Question: Morphological changes observed - Management provided details on encouraging morphological changes observed in patients, including increased hydration and decreased protrusion in some cases [42][44]

Financial Data and Key Metrics Changes - For Q1 2025, revenues were $25,000, a decrease from $35,000 in the same period last year [6] - Deferred revenues for Q1 2025 were $150,000 compared to nil in Q1 2024, indicating a timing difference in revenue recognition [6] - The loss from operations for Q1 2025 was $4,800,000, compared to $4,100,000 for Q1 2024 [7] - The net loss for Q1 2025 was $5,300,000 or $0.64 per share, compared to a net loss of $2,200,000 or $0.33 per share in Q1 2024 [7] - Cash used in operating activities in Q1 2025 was $2,800,000, with cash, cash equivalents, and marketable securities totaling $9,100,000 and no outstanding debt [8][19] Business Line Data and Key Metrics Changes - The lead clinical stage candidate, BRTX-one hundred, is being evaluated in a Phase II trial for chronic lumbar disc disease (CLDD) [10] - Preliminary data from the trial shows positive trends in safety and efficacy, with no serious adverse events reported [11][12] - The FDA granted Fast Track designation for BRTX-one hundred, facilitating its development and review process [13] Market Data and Key Metrics Changes - The company is developing ThermoStem, a cell-based therapy targeting obesity and metabolic disorders, using brown adipose-derived stem cells [14] - The company has built a comprehensive patent portfolio to protect its intellectual property in both US and international markets [15] Company Strategy and Development Direction - The company is focused on advancing its two core clinical development programs: BRTX-one hundred and ThermoStem [16] - There are ongoing discussions regarding a potential licensing agreement for the ThermoStem metabolic disease programs [15][19] - The company aims to leverage positive preliminary data to potentially shorten the regulatory process for BLA approval [45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing Phase II trial for BRTX-one hundred, expecting data to remain consistent with previous trends [17] - The company is actively managing resources while executing strategic goals, ending the quarter with a strong financial position [19] Other Important Information - The company is preparing for a presentation of data from 45 subjects at an upcoming conference in June [26] - Management emphasized the importance of maintaining a clean and valid data set for the trial [36] Q&A Session Summary Question: Clarification on efficacy endpoint - Management confirmed that the primary endpoint is safety, with a secondary efficacy endpoint of greater than or equal to 30% improvement [22] Question: Interim analysis status - Management stated that an interim analysis is still a potential option but has not been determined yet [23][24] Question: Enrollment pace and characteristics - Management indicated that enrollment is picking up due to new recruitment strategies and that they expect to counteract any summer slowdown [36] Question: FDA emphasis on pain or function - Management noted that both pain reduction and functional improvement are being collected, with ongoing discussions with the FDA [38] Question: Morphological changes observed - Management provided details on encouraging morphological changes observed in patients, including increased hydration and decreased protrusion size [42][44]

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) The company's Q1 2025 financial statements show a **$5.3 million** net loss, decreased assets and equity, and negative operating cash flow [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$10.3 million** and stockholders' equity declined to **$6.1 million** as of March 31, 2025, primarily due to reduced investments Condensed Consolidated Balance Sheet Highlights (unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $1,228,789 | $547,890 | | Investments held in marketable securities | $7,884,132 | $10,184,701 | | **Total Assets** | **$10,326,821** | **$12,279,799** | | Total Current Liabilities | $4,182,080 | $3,748,406 | | Warrant liabilities | $3,154,970 | $2,520,851 | | **Total Liabilities** | **$4,182,080** | **$3,748,406** | | **Total Stockholders' Equity** | **$6,144,741** | **$8,531,393** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss significantly increased to **$5.34 million** in Q1 2025, driven by higher R&D expenses and a loss on warrant liabilities Statement of Operations Summary (unaudited) | Metric | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Revenues | $25,000 | $35,000 | | Research and development | $1,714,327 | $1,058,131 | | General and administrative | $3,115,298 | $3,086,121 | | Loss From Operations | $(4,807,534) | $(4,109,252) | | Change in fair value of warrant liabilities | $(634,119) | $(137,319) | | **Net Loss** | **$(5,339,799)** | **$(2,223,255)** | | Net Loss Per Share | $(0.64) | $(0.33) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity decreased by **$2.39 million** in Q1 2025, primarily due to the net loss, partially offset by ATM stock sales and stock-based compensation - Total stockholders' equity decreased by **$2.39 million** during the first quarter of 2025[15](index=15&type=chunk) - Key activities impacting equity included a net loss of **$5.34 million**, stock-based compensation of **$2.01 million**, and net proceeds of **$0.90 million** from common stock issuance and sale[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was **$2.8 million** in Q1 2025, offset by investing and financing activities, resulting in a **$0.68 million** net cash increase Cash Flow Summary (unaudited) | Activity | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | $(2,778,786) | $(2,317,780) | | Net Cash Provided By (Used In) Investing Activities | $2,366,967 | $(4,928,006) | | Net Cash Provided By Financing Activities | $1,092,718 | $7,518,489 | | **Net Increase In Cash and Cash Equivalents** | **$680,899** | **$272,703** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes highlight substantial doubt about the company's going concern ability due to recurring losses, negative cash flows, and increased warrant liabilities - The company's financial condition, including a Q1 2025 net loss of **$5.3 million** and negative operating cash flow of **$2.8 million**, raises substantial doubt about its ability to continue as a going concern[26](index=26&type=chunk) - In February 2024, the company raised approximately **$8.1 million** in gross proceeds through a warrant exercise and issuance transaction at a reduced exercise price of **$2.33 per share**[49](index=49&type=chunk) - During Q1 2025, the company sold **492,087 shares** under its ATM program, raising **$1.08 million** in gross proceeds[58](index=58&type=chunk) - The fair value of warrant liabilities was estimated at **$3.15 million** as of March 31, 2025, resulting in a recognized loss of **$0.63 million** for the quarter due to the change in fair value[61](index=61&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the **$5.3 million** net loss in Q1 2025, driven by increased R&D expenses, and acknowledges substantial doubt about the company's going concern ability [Business Overview](index=20&type=section&id=Business%20Overview) The company develops adult stem cell therapeutic products, including BRTX-100 in Phase 2 clinical trials, and is expanding into biologics-based cosmetic products - The company's lead product, **BRTX-100**, is in a Phase 2 clinical trial for treating chronic lower back pain from degenerative disc disease, with FDA authorization to proceed[73](index=73&type=chunk) - The **ThermoStem Program** is a pre-clinical initiative using brown adipose (fat) to treat type 2 diabetes, obesity, and other metabolic disorders, supported by multiple international patents[74](index=74&type=chunk) - The company is developing a biologics-based cosmetic business and entered a **five-year exclusive supply agreement** with Cartessa Aesthetics in April 2024[76](index=76&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Q1 2025 net loss significantly increased by **140.2%** to **$5.34 million**, primarily due to a **62.0%** rise in R&D expenses and higher warrant liability losses Comparison of Operations for the Three Months Ended March 31 | Item | 2025 | 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $25,000 | $35,000 | (28.6%) | | Research and development | $1,714,327 | $1,058,131 | 62.0% | | General and administrative | $3,115,298 | $3,086,121 | 0.9% | | Loss From Operations | $(4,807,534) | $(4,109,252) | 17.0% | | **Net Loss** | **$(5,339,799)** | **$(2,223,255)** | **140.2%** | - The **62.0%** increase in R&D expenses was primarily driven by a **$0.58 million** increase in lab supply expense and a **$0.07 million** increase in recruitment costs for the Phase 2 clinical trial[82](index=82&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is strained with working capital decreasing to **$5.2 million**, and management expresses substantial doubt about its ability to continue as a going concern Liquidity Metrics | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $1,228,789 | $547,890 | | Investments held in marketable securities | $7,884,132 | $10,184,701 | | Working capital | $5,173,241 | $7,395,815 | - The company anticipates continued net losses and negative cash flows, believing it may not have sufficient cash for at least **twelve months**, raising substantial doubt about its ability to continue as a going concern[89](index=89&type=chunk) - Net cash used in operating activities was **$2.8 million** in Q1 2025, while net cash from financing activities was **$1.1 million**, primarily from an ATM offering and option exercises[92](index=92&type=chunk)[93](index=93&type=chunk)[95](index=95&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the registrant is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, the registrant is not required to provide quantitative and qualitative disclosures about market risk[100](index=100&type=chunk) [Controls and Procedures](index=25&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were not effective as of March 31, 2025, due to continued material weaknesses in internal control over financial reporting - Management concluded that disclosure controls and procedures were **not effective** as of March 31, 2025[103](index=103&type=chunk) - Material weaknesses in internal control over financial reporting continued to exist, including lack of adherence to formal policies, risk assessment, effective controls for reporting and disclosures, and accounting for warrants[105](index=105&type=chunk)[108](index=108&type=chunk) - A remediation plan is being implemented, which includes oversight by the CFO, engagement of an external consulting firm, and documentation of key controls[105](index=105&type=chunk)[108](index=108&type=chunk) [PART II. OTHER INFORMATION](index=27&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Risk Factors](index=27&type=section&id=ITEM%201A.%20Risk%20Factors) Investors are advised to review the risk factors detailed in the company's Annual Report on Form 10-K for the year ended December 31, 2024 - Investors are advised to review the risk factors included in the company's Annual Report on Form 10-K for the year ended December 31, 2024[110](index=110&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=27&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the three months ended March 31, 2025 - There were no unregistered sales of equity securities during the first quarter of 2025[111](index=111&type=chunk) [Exhibits](index=27&type=section&id=ITEM%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer - Exhibits filed with the report include CEO and CFO certifications (**31.1, 31.2, 32.1**) and XBRL data files[112](index=112&type=chunk) [Signatures](index=28&type=section&id=SIGNATURES)

Financial Results - BioRestorative Therapies, Inc. announced its financial results for Q1 2025, ending March 31, 2025[3] - The company issued a press release on May 14, 2025, detailing its financial performance and business updates[3] Company Operations - The press release is available as Exhibit 99.1, which includes further insights into the company's operations[7]

Core Viewpoint - BioRestorative Therapies, Inc. reported its first quarter 2025 financial results and highlighted significant advancements in its clinical programs, particularly in stem cell-based therapies for disc/spine and metabolic disorders [1][2]. Corporate Highlights - The company has successfully achieved key clinical program milestones since the beginning of 2025 and is focused on executing its growth strategy while managing resources effectively [2]. - BioRestorative confirmed no material exposure to newly imposed U.S. tariffs, attributing this to its 'made-in-America' production strategy [5]. - The CEO participated in an interview at the Benzinga All-Access Show, discussing the company's progress [5]. - The company presented positive preliminary data from its ongoing Phase 2 clinical trial of BRTX-100 for chronic lumbar disc disease (cLDD) at the Orthopaedic Research Society Annual Meeting [5]. - The FDA granted Fast Track designation to the BRTX-100 program for cLDD, which may lead to Priority Review and Accelerated Biologics License Application approval [5]. - The FDA also cleared the Investigational New Drug application for BRTX-100 for chronic cervical discogenic pain, expanding the clinical pipeline [5]. Clinical Programs - The BRTX-100 program aims to treat chronic lower back pain from degenerative disc disease and has shown promising preliminary efficacy trends [5][11]. - The company is developing the ThermoStem metabolic disease platform, targeting obesity and metabolic disorders using brown adipose-derived stem cells [12]. - BioRestorative operates a commercial BioCosmeceutical platform, focusing on cell-based secretome products for cosmetic applications [13]. Financial Results - First quarter 2025 revenues were $25,000, down from $35,000 in the same period last year [7]. - The company reported a loss from operations of $4.8 million for the first quarter of 2025, compared to a loss of $4.1 million in the same period of 2024 [7]. - The net loss for the first quarter of 2025 was $5.3 million, or $0.64 per share, compared to a net loss of $2.2 million, or $0.33 per share, in the first quarter of 2024 [8]. - Cash used in operating activities was $2.8 million in Q1 2025, compared to $2.3 million in Q1 2024 [8]. - The company ended the first quarter of 2025 with $9.1 million in cash and cash equivalents, with no outstanding debt [9].

Core Insights - BioRestorative Therapies, Inc. has presented preliminary data from its Phase 2 clinical trial of BRTX-100 for chronic lumbar disc disease, showing promising safety and efficacy results [1][3] Group 1: Clinical Trial Data - The ongoing Phase 2 trial of BRTX-100 has shown no serious adverse events and no dose-limiting toxicity at 26-104 weeks [2] - The trial data indicates trends of over 30% improvement in both the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS), with significant improvements observed at various weeks [3] - The percentage of subjects showing greater than 50% improvement in both ODI and VAS is as follows: - Week 2: 0.0% - Week 12: 13.33% - Week 26: 46.15% - Week 52: 70.0% - Week 104: 66.66% [3] Group 2: Product and Company Overview - BRTX-100 is a novel cell-based therapeutic designed to treat areas with low blood flow, specifically targeting chronic lumbar disc disease [5] - The company is conducting a randomized, double-blinded, and controlled study with up to 99 eligible subjects across 16 clinical sites in the U.S. [5] - BioRestorative develops therapeutic products using adult stem cells, focusing on disc/spine disease and metabolic disorders, along with a commercial BioCosmeceutical platform [6][7][8]

Core Viewpoint - BioRestorative Therapies, Inc. is set to release its first quarter 2025 financial results on May 14, 2025, followed by a conference call for a business update [1][2]. Company Overview - BioRestorative Therapies, Inc. focuses on developing stem cell-based therapies and products, primarily targeting disc/spine diseases and metabolic disorders [3]. - The company operates a commercial BioCosmeceutical platform, offering products that utilize cell and tissue protocols, particularly adult stem cells [3]. Clinical Development Programs - **Disc/Spine Program (brtxDISC™)**: The lead candidate, BRTX-100, is derived from a patient's own mesenchymal stem cells and is intended for non-surgical treatment of lumbosacral disc disorders. A Phase 2 clinical trial is underway for chronic lower back pain due to degenerative disc disease, with FDA IND clearance obtained for chronic cervical discogenic pain [3]. - **Metabolic Program (ThermoStem®)**: This program aims to develop therapies targeting obesity and metabolic disorders using brown adipose-derived stem cells (BADSC) to generate brown adipose tissue (BAT). Initial 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 has a commercial BioCosmeceutical platform that includes a cell-based secretome product designed to reduce fine lines and wrinkles. Future plans involve expanding the product line to include more cell-based aesthetic products and therapeutics, with the goal of obtaining FDA approvals [5].