Group 1 - Biorestorative Therapies, Inc. reported a quarterly loss of $0.3 per share, which was better than the Zacks Consensus Estimate of a loss of $0.41, representing an earnings surprise of +26.83% [1] - The company posted revenues of $0.3 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 51.50%, compared to revenues of $0.09 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] Group 2 - The stock has underperformed the market, losing about 1.4% since the beginning of the year, while the S&P 500 has gained 8.4% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to those expectations [4] - The current consensus EPS estimate for the coming quarter is -$0.43 on $0.3 million in revenues, and -$1.76 on $0.93 million in revenues for the current fiscal year [7] Group 3 - The Zacks Industry Rank for Medical - Biomedical and Genetics is currently in the bottom 43% of over 250 Zacks industries, indicating potential challenges for stocks in this sector [8] - The estimate revisions trend for Biorestorative Therapies was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, suggesting it is expected to perform in line with the market [6]

Financial Data and Key Metrics Changes - In Q2 2025, revenues increased to $303,000 from $89,000 in the same period last year, representing a 240% increase primarily due to a contract manufacturing agreement on BioCosaceuticals [8] - The loss from operations for Q2 2025 was $3.3 million, compared to $2.5 million for the same period in 2024 [9] - The net loss for Q2 2025 was $2.7 million or $0.30 per share, compared to a net loss of $4 million or $0.50 per share for 2024 [9] - The company ended the quarter with cash, cash equivalents, and marketable securities of $7.4 million and no outstanding debt [9][20] Business Line Data and Key Metrics Changes - The lead clinical stage candidate, BRTX-100, is in a Phase 2 trial for chronic lumbar disc disease (CLDD), with promising preliminary data showing over 74% of subjects achieving greater than 50% improvement in function and over 72% reporting greater than 50% reduction in pain by 52 weeks [12][13] - The enrollment for the BRTX-100 trial is progressing well, with more than halfway through the goal of 99 subjects [14] - The core preclinical metabolic program, THERMACEM, is focused on developing cell-based therapies for obesity and metabolic disorders, with ongoing discussions for potential licensing agreements [15][16] Market Data and Key Metrics Changes - The company is in advanced discussions with key partners to accelerate the growth of its regenerative biologic secretone products [17] - The market for secretone products is significant, and the company aims to achieve high margins in this business [30] Company Strategy and Development Direction - The company is focused on advancing its two core clinical development programs, BRTX-100 and ThermoStem, while ramping up commercial opportunities in regenerative biologics [17] - There is a strategic emphasis on obtaining FDA approval for BRTX-100 and exploring various indications for future trials [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the regulatory environment and the progress of the BRTX-100 trial, highlighting a strong safety profile and encouraging trends in efficacy [19][41] - The company is committed to efficiently managing cash reserves while executing strategic goals, with expectations of a potential reduction in SG&A expenses as enrollment stabilizes [28][20] Other Important Information - The company has been methodically building a comprehensive portfolio of issued patents to protect its metabolic disease programs [15] - Management noted that the FDA's support for stem cell therapies could facilitate an expedited regulatory pathway for BRTX-100 [37] Q&A Session Summary Question: Timing for the start of the CCDT trial and its size - The company did not comment on the cervical trial but emphasized the focus on the lumbar trial and its progression towards a BLA [22] Question: Revenue growth expectations for Cosmoceutical - Management indicated that while growth is expected, it is difficult to predict exact quarterly performance due to the nature of the growing business [24] Question: SG&A expense trends - Management confirmed that SG&A expenses are expected to follow a similar trend as last year, with heavier expenses in the first quarter and lighter in subsequent quarters [26] Question: Recent interactions with the FDA regarding expedited pathways - Management noted anecdotal support from the FDA for an accelerated pathway but did not disclose any new designations beyond the fast track designation [38] Question: Comparison of Phase 2 trial results to placebo - The primary endpoint is safety, with a minimum requirement of 30% improvement in pain and function compared to baseline and a control group [40][41] Question: Potential for unblinded interim data - Management suggested that discussions with the FDA could shape the regulatory strategy, potentially allowing for an interim analysis [43]

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the unaudited condensed consolidated financial statements and management's analysis for BioRestorative Therapies, Inc [Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) Unaudited Q2 and H1 2025 financial statements show significant losses and negative cash flow, raising going concern doubts [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$8.5 million** from **$12.3 million** as of June 30, 2025, with stockholders' equity declining to **$4.8 million** Condensed Consolidated Balance Sheet Highlights (in USD) | Balance Sheet Item | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $1,555,251 | $547,890 | | Investments held in marketable securities | $5,825,685 | $10,184,701 | | **Total Assets** | **$8,516,559** | **$12,279,799** | | Total Current Liabilities | $3,671,235 | $3,748,406 | | **Total Liabilities** | **$3,671,235** | **$3,748,406** | | Accumulated deficit | $(163,674,777) | $(155,678,715) | | **Total Stockholders' Equity** | **$4,845,324** | **$8,531,393** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q2 2025 revenues increased, net loss decreased to **$2.7 million**; H1 2025 net loss widened to **$8.0 million** due to higher R&D Statement of Operations Summary (in USD) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $303,300 | $89,100 | $328,300 | $124,100 | | Research and development | $2,225,882 | $1,454,000 | $4,872,782 | $3,531,278 | | General and administrative | $1,373,976 | $1,097,417 | $3,556,701 | $3,164,391 | | Loss From Operations | $(3,305,287) | $(2,468,807) | $(8,112,821) | $(6,578,059) | | **Net Loss** | **$(2,656,263)** | **$(4,028,562)** | **$(7,996,062)** | **$(6,251,817)** | | Net Loss Per Share | $(0.30) | $(0.50) | $(0.94) | $(0.84) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) H1 2025 net cash used in operations increased to **$5.5 million**; net cash from investing was **$4.5 million**, and cash increased to **$1.6 million** Cash Flow Summary for the Six Months Ended June 30 (in USD) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | $(5,472,653) | $(4,182,945) | | Net Cash Provided By (Used In) Investing Activities | $4,499,158 | $(1,954,831) | | Net Cash Provided By Financing Activities | $1,980,856 | $7,505,646 | | **Net Increase In Cash and Cash Equivalents** | **$1,007,361** | **$1,367,870** | | **Cash and Cash Equivalents - End of Period** | **$1,555,251** | **$2,252,247** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail business operations, accounting policies, and disclose substantial doubt about the company's ability to continue as a going concern - The company's financial condition raises substantial doubt about its ability to continue as a going concern for at least twelve months, due to a net loss of **$8.0 million** and negative operating cash flows of **$5.5 million** for the first six months of 2025[25](index=25&type=chunk) - The company develops therapeutic products using adult stem cells, focusing on its Disc/Spine Program (brtxDISC), ThermoStem Program for metabolic disorders, and a biologics-based cosmetic products business[23](index=23&type=chunk) - During the first six months of 2025, the company raised approximately **$2.0 million** in gross proceeds by selling **965,424 shares** of common stock through its at-the-market (ATM) offering agreement[26](index=26&type=chunk)[65](index=65&type=chunk) - On June 16, 2025, the Board of Directors authorized a common stock repurchase program for up to **$2.0 million** of its outstanding common stock, though no repurchases were made as of June 30, 2025[66](index=66&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, business overview, and liquidity, noting increased revenues, higher R&D, and ongoing going concern doubts requiring future financing - The company has commenced a Phase 2 clinical trial for its lead product candidate, BRTX-100, for the treatment of chronic lower back pain from degenerative disc disease[80](index=80&type=chunk) - The company's working capital decreased by **$3.5 million** to **$3.9 million** as of June 30, 2025, primarily due to cash used to fund operations[103](index=103&type=chunk) - Management states that current funds may not be sufficient for at least twelve months, raising substantial doubt about the company's ability to continue as a going concern[104](index=104&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Q2 and H1 2025 revenues increased due to cosmetic sales, but R&D and G&A expenses rose; Q2 net loss narrowed, H1 net loss widened Comparison of Results for the Three Months Ended June 30 (in USD) | Metric | 2025 | 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $303,300 | $89,100 | +240.4% | | Research and Development | $2,225,882 | $1,454,000 | +53.1% | | General and Administrative | $1,373,976 | $1,097,417 | +25.2% | | Net Loss | $(2,656,263) | $(4,028,562) | -34.1% | Comparison of Results for the Six Months Ended June 30 (in USD) | Metric | 2025 | 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $328,300 | $124,100 | +164.5% | | Research and Development | $4,872,782 | $3,531,278 | +38.0% | | General and Administrative | $3,556,701 | $3,164,391 | +12.4% | | Net Loss | $(7,996,062) | $(6,251,817) | +27.9% | - The increase in R&D expenses for H1 2025 was primarily due to a **$1.18 million** increase in recruitment and other costs for the Phase 2 clinical trial[97](index=97&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity is strained with **$3.9 million** working capital, an **$8.0 million** net loss, and negative operating cash flow, raising going concern doubts Liquidity Metrics (in USD) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $1,555,251 | $547,890 | | Investments held in marketable securities | $5,825,685 | $10,184,701 | | Working capital | $3,926,572 | $7,395,815 | - The company anticipates continued net losses and negative cash flows and believes it may not have sufficient cash for the next twelve months, raising substantial doubt about its ability to continue as a going concern[104](index=104&type=chunk) - Future capital requirements depend on factors like product commercialization and the need for collaborations; the company may be unable to raise sufficient capital or may do so on unattractive terms[105](index=105&type=chunk)[107](index=107&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, BioRestorative Therapies, Inc. is exempt from providing market risk disclosures - As a smaller reporting company, BioRestorative Therapies, Inc. is not required to provide quantitative and qualitative disclosures about market risk[116](index=116&type=chunk) [Controls and Procedures](index=30&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective as of June 30, 2025, due to material weaknesses in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were not effective as of June 30, 2025[119](index=119&type=chunk) - Material weaknesses in internal control over financial reporting continued to exist, including: lack of adherence to formal policies, inadequate risk assessment, ineffective controls over financial reporting and journal entries, and ineffective controls over accounting for warrants[121](index=121&type=chunk)[122](index=122&type=chunk) - A remediation plan is underway, which includes oversight from the CFO, engagement of an external financial consulting firm, and documentation of key procedures[121](index=121&type=chunk)[122](index=122&type=chunk) [PART II. OTHER INFORMATION](index=32&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section includes references to risk factors, details on unregistered sales of equity securities, and a list of exhibits filed with the report [Risk Factors](index=32&type=section&id=ITEM%201A.%20Risk%20Factors) Investors are directed to the Annual Report on Form 10-K for a comprehensive discussion of significant risks associated with investing in the company's common stock - The company refers to the "Risk Factors" section of its Annual Report on Form 10-K for the year ended December 31, 2024, for a detailed discussion of risks associated with an investment in its common stock[126](index=126&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=32&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 June 30, 2025 - The company had no unregistered sales of equity securities during the three months ended June 30, 2025[127](index=127&type=chunk) [Exhibits](index=32&type=section&id=ITEM%206.%20Exhibits) This section lists the certifications by the Principal Executive Officer and Principal Financial Officer, along with Inline XBRL documents, filed as exhibits - Exhibits filed with the report include CEO and CFO certifications (31.1, 31.2, 32.1) and Inline XBRL data files[128](index=128&type=chunk)

[Form 8-K Current Report](index=1&type=section&id=Form%208-K%20Current%20Report) [Item 2.02: Result of Operations and Financial Condition](index=2&type=section&id=Item%202.02.%20Result%20of%20Operations%20and%20Financial%20Condition.) BioRestorative Therapies, Inc. announced Q2 2025 financial results via a press release on August 12, 2025, which is furnished, not filed, under the Securities Exchange Act - The company announced its financial results for the second quarter ended June 30, 2025, through a press release issued on August 12, 2025[3](index=3&type=chunk) - The press release, furnished as Exhibit 99.1, also contained a business update and information regarding a conference call to discuss the results[3](index=3&type=chunk) - The information furnished under this item, including Exhibit 99.1, is not deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934 and is not incorporated by reference into other filings unless explicitly stated[5](index=5&type=chunk) [Item 7.01: Regulation FD Disclosure](index=2&type=section&id=Item%207.01%20Regulation%20FD%20Disclosure.) This section clarifies that the press release information is furnished under Regulation FD, not filed, and is not automatically incorporated by reference or deemed material - The information provided in the press release is being furnished, not filed, and will not be incorporated by reference into any registration statement unless specifically identified[6](index=6&type=chunk) - The company states that furnishing the information does not mean it is material, complete, or necessary for an investment decision[6](index=6&type=chunk) [Item 9.01: Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits.) This section lists the exhibits filed with the Form 8-K, including the Q2 2025 financial results press release and the interactive data file Exhibits Filed | Exhibit Number | Description | | :--- | :--- | | 99.1 | Press release, dated August 12, 2025, issued by BioRestorative Therapies, Inc. | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signatures](index=3&type=section&id=SIGNATURES) The report was officially signed and authorized by Robert Kristal, Chief Financial Officer of BioRestorative Therapies, Inc., on August 12, 2025 - The report was signed on behalf of the company by Robert Kristal, Chief Financial Officer[11](index=11&type=chunk) - Date of signature: August 12, 2025[11](index=11&type=chunk)

"We have continued to execute well across our business, including the achievement of key clinical program milestones, since the start of 2025," said Lance Alstodt, Chief Executive Officer of BioRestorative. "Moving forward, we remain focused on aggressively executing our growth strategy while carefully managing our resources, and see many potential value enhancing inflection points ahead." Recent Highlights MELVILLE, N.Y., Aug. 12, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. ("BioRestorative", " ...

Core Viewpoint - BioRestorative Therapies, Inc. is set to release its second quarter 2025 financial results on August 12, 2025, followed by a conference call for a business update [1][2]. Company Overview - BioRestorative Therapies, Inc. focuses on developing therapeutic products using adult stem cells, with two main clinical development programs targeting disc/spine disease and metabolic disorders [3]. - The company operates a commercial BioCosmeceutical platform, offering products designed to reduce cosmetic signs of aging [5]. Clinical Development Programs - **Disc/Spine Program (brtxDISC™)**: The lead candidate, BRTX-100, is derived from a patient's own mesenchymal stem cells and aims to treat painful 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 focuses on using brown adipose-derived stem cells to develop therapies for obesity and metabolic disorders. 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 aimed at improving cosmetic appearance. Future plans involve expanding the product line to include more cell-based aesthetic products and therapeutics [5].

Summary of BioRestorative Therapies Conference Call Company Overview - **Company**: BioRestorative Therapies - **Ticker**: BRTX - **Industry**: Stem Cell Therapy, specifically targeting chronic lumbar disc disease Key Points and Arguments Phase II Trial Results - Preliminary data from the Phase II trial of BRTX-one hundred showed that over 74% of subjects had more than 50% improvement in function based on the ODI scale, and over 72% reported more than 50% reduction in pain based on the VOS scale, both exceeding the FDA's clinically meaningful threshold of 30% [5][10][12] - The trial involved 36 patients, and the results were presented at the International Society for Stem Cell Research's Annual Meeting in Hong Kong [5][6] Unique Treatment Approach - BRTX-one hundred is an autologous stem cell therapy using the patient's own bone marrow-derived stem cells, which are cultured to mimic the environment of damaged spinal discs [8] - The therapy targets the root cause of disc degeneration rather than just masking pain, differentiating it from other treatments like opioids and steroids [8][10] - The effects of BRTX-one hundred can last up to seven years in some patients, providing a long-term solution [9] Market Potential - Chronic lumbar disc disease represents a multibillion-dollar industry in the U.S., with significant growth potential as new cell therapy modalities are approved [11][13] - Current treatments include pharmacological solutions and surgical interventions, both of which are deemed inadequate by the company [12] - The company aims to capture a meaningful share of this market with its first-in-class therapy [17] Future Plans - BioRestorative aims to enroll up to 99 patients in total for the trial, with plans to accelerate enrollment in the second half of the year [19][20] - The company has received FDA Fast Track designation for BRTX-one hundred, positioning it for regulatory milestones and potential commercialization [16][20] Clinical Development Strategy - The trial is designed to be randomized and placebo-controlled, with a focus on scaling validation and preparing for a pivotal Phase III trial [20] - Increased physician interest and patient demand are expected following the positive trial data [20] Additional Important Information - The company emphasizes the need for thoughtful and deliberate approaches in expanding its clinical trials and market presence [13] - The discussion highlighted the ongoing opioid crisis and the need for better treatment options for chronic back pain [12]

Core Insights - BioRestorative Therapies, Inc. is a clinical stage regenerative medicine company focused on stem cell-based therapies and products [1] - The CEO, Lance Alstodt, will be interviewed during the Benzinga All-Access Show on June 18, 2025 [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 company also operates a commercial BioCosmeceutical platform [5] 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, aimed at treating painful lumbosacral disc disorders and is currently in Phase 2 clinical trials for chronic lower back pain [3] - **Metabolic Program (ThermoStem)**: This program focuses on using brown adipose-derived stem cells to target obesity and metabolic disorders, with preclinical research indicating potential benefits in caloric burning and reduced glucose and lipid levels [4] Commercial BioCosmeceuticals - The company has a commercial BioCosmeceutical product that is a cell-based secretome designed to reduce fine lines and wrinkles, with plans to expand its offerings in the aesthetic products and therapeutics space [5]

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]