BioRestorative Therapies (BRTX) Update / Briefing June 18, 2025 10:50 AM ET Speaker0 Thank you so much. Hey, Zakers, and welcome back to All Access. I got that wonderful guest for you today, another one, and that's Lance Allstott, the Chairman and CEO of Bio Restorative Therapies. The NASDAQ ticker is BRTX. He's joining us for another exclusive talk today. All Access starts right now. And it is my pleasure to welcome back in the Chairman and CEO of BioRestorative Therapies, Lance Allstad. It's fantastic to ...

MELVILLE, N.Y., June 18, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage regenerative medicine innovator focused on stem cell-based therapies and products, is pleased to announce that its Chief Executive Officer, Lance Alstodt, will be interviewed during the Benzinga All-Access Show today, Wednesday, June 18, 2025, at 10:50 a.m. Eastern time. Benzinga All-Access Show Date: Wednesday, June 18, 2025 Time: 10:50 a.m. Eastern Ti ...

Core Viewpoint - BioRestorative Therapies, Inc. has announced a stock repurchase program authorizing the repurchase of up to $2 million of its outstanding common stock, reflecting confidence in its clinical development pipeline and business outlook [1][2] Company Overview - BioRestorative is a clinical stage regenerative medicine company focused on stem cell-based therapies and products [1] - The company develops therapeutic products primarily involving adult stem cells, with core clinical programs targeting disc/spine disease and metabolic disorders [4] Clinical Development Programs - **Disc/Spine Program (brtxDISC)**: The lead candidate, BRTX-100, is formulated from autologous cultured mesenchymal stem cells from the patient's bone marrow, intended for non-surgical treatment of lumbosacral disc disorders. A Phase 2 clinical trial for chronic lower back pain has commenced, and FDA IND clearance has been obtained for chronic cervical discogenic pain [4] - **Metabolic Program (ThermoStem)**: This program focuses on developing cell-based 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 reduce glucose and lipid levels [5] - **BioCosmeceuticals**: The company operates a commercial platform for BioCosmeceuticals, with a current product that is a cell-based secretome designed to reduce fine lines and wrinkles. Future plans include expanding the product line and pursuing FDA approvals in the BioCosmeceuticals space [6] Stock Repurchase Program Details - The stock repurchase program allows the company to repurchase shares in the open market or through private transactions, with the timing and amount at management's discretion based on market conditions and other factors [2][3] - The program is intended to enhance long-term shareholder value, as the company believes its current share price does not reflect its intrinsic value [2]

Core Insights - BioRestorative Therapies, Inc. presented promising preliminary data for its BRTX-100 therapy at the ISSCR 2025 Annual Meeting, showing over 50% improvement in pain and function for chronic lumbar disc disease (cLDD) patients [1][4][5] - The number of evaluated subjects in the ongoing Phase 2 clinical trial has more than doubled, indicating significant progress towards full enrollment [1][5] Clinical Trial Data - In the Phase 2 trial, 67.57% of subjects showed over 50% improvement in function (ODI) and 73.82% reported over 50% reduction in pain (VAS) at 12 weeks [4] - By 52 weeks, over 74% of subjects demonstrated over 50% improvement in function and over 72% reported significant pain reduction [5] - The trial aims to enroll up to 99 subjects across 16 U.S. sites, with a randomized, double-blinded, placebo-controlled design [6] Safety and Efficacy - No serious adverse events or dose-limiting toxicities were reported between 26 and 104 weeks at the target dose of 40 million cells, indicating an excellent safety profile [5] - Each new data analysis has shown an upward trend in efficacy markers, enhancing confidence in the therapy's potential to meet FDA thresholds for approval [5][4] Company Overview - BioRestorative focuses on developing stem cell-based therapies for serious musculoskeletal conditions, with BRTX-100 as its lead candidate for treating painful lumbosacral disc degeneration [7] - The company also has a metabolic program targeting obesity and metabolic disorders, and a commercial BioCosmeceutical platform aimed at aesthetic applications [8][9]

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]

BioRestorative Therapies (BRTX) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Company Participants Stephen Kilmer - Investor RelationsLance Alstodt - Chairman of the Board, President & CEORobert Kristal - CFOFrancisco Silva - Chief Scientist, VP of Research & Development, Secretary and DirectorJason Mccarthy - Senior Managing Director & Head of Biotechnology Research Conference Call Participants Jonathan Aschoff - Managing Director, Senior Research Analyst Operator Please note this conference is being reco ...

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)