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, 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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from _________ to _________ Commission file number: 001-37603 BIORESTORATIVE THERAPIES, INC. (Exact name of registrant as specified in its charter) (State or other Jurisdicti ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K BioRestorative Therapies, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation) (Commission File Number) Nevada 001-37603 30-1341024 (IRS Employer Identification No.) 40 Marcus Drive Melville, New York 11747 CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): May 14, 2025 (Address of principal ...

MELVILLE, N.Y., May 14, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a regenerative medicine innovator focused on stem cell-based therapies and products, today reported financial results for the first quarter ended March 31, 2025 and provided an update on its business. “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, the Comp ...

MELVILLE, N.Y., May 13, 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 preliminary 26-, 52- and 104-week blinded preliminary data from the first 15 patients with chronic lumbar disc disease (“cLDD”) enrolled in the ongoing Phase 2 clinical trial of BRTX-100 was recently presented by Francisco Silva, Vice President ...

MELVILLE, N.Y., May 08, 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, today announced that it will release its first quarter 2025 financial results after market close on Wednesday, May 14, 2025. Following the announcement, BioRestorative management will host a conference call to review the financial results and provide a business update. Fir ...

About BRTX-100 BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is BioRestorative's lead clinical candidate. The safety and efficacy of BRTX-100 in treating chronic lumbar disc disease ("cLDD") is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study. The U.S. Food and Drug Administration ("FDA") recently granted Fast Track designation to the BRTX- 100 program for the treatment of cLDD, reflecting the positive p ...

MELVILLE, N.Y., April 15, 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, Tuesday, April 15, 2025, at 10:50 a.m. Eastern time. Benzinga All-Access Show Date: Tuesday, April 15, 2025Time: 10:50 a.m. Eastern Time ...

MELVILLE, N.Y., April 15, 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, Tuesday, April 15, 2025, at 10:50 a.m. Eastern time. Benzinga All-Access Show Date: Tuesday, April 15, 2025Time: 10:50 a.m. Eastern Time ...