As filed with the Securities and Exchange Commission on February 10, 2026. Registration No. 333-293322 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 (Amendment No. 1) REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIORESTORATIVE THERAPIES, INC. (Exact name of registrant as specified in its charter) incorporation or organization) Classification Code Number) Identification Number) Nevada 8099 30-1341024 (State or other jurisdiction of (Primary Standard Industrial (I ...

Largest FDA-authorized Phase 2 cell therapy trial conducted in chronic lumbar disc diseaseThe study has enrolled a total of 99 participants, each of whom was randomized to receive either BRTX-100 or placeboProspective, randomized, double-blind, sham-controlled single-disc study — gold-standard clinical designEnrollment completion strengthens regulatory pathway toward Phase 3 and potential BLA filing MELVILLE, N.Y., Feb. 10, 2026 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or ...

As filed with the Securities and Exchange Commission on February 9, 2026. Registration No. 333-_________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIORESTORATIVE THERAPIES, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) Classification Code Number) Identification Number) Nevada 8099 30-1341024 4 ...

Core Insights - Healthcare and biotechnology stocks experienced significant movements in after-hours trading, with several companies showing strong gains despite limited news flow [1] Company Summaries - Novo Nordisk A/S (NVO) saw a notable increase of 9.48%, closing at $52.66, following FDA approval of its Wegovy pill, the first oral GLP-1 medicine for obesity in the U.S., which is also approved to reduce cardiovascular risks [2] - Neumora Therapeutics, Inc. (NMRA) advanced 16.02% to $2.10, indicating investor interest possibly driven by broader sector momentum or speculative trading, as there were no specific news updates [3] - BioRestorative Therapies, Inc. (BRTX) rose 6.90% to $1.24, with investors reacting to a prior announcement regarding an FDA Type B meeting to discuss a potential accelerated BLA pathway for its BRTX-100 program for chronic lumbar disc disease [4] - RenovoRx, Inc. (RNXT) added 4.44% to close at $0.94, with earlier news of an accepted abstract submission for the ASCO Gastrointestinal Cancers Symposium 2026 contributing to investor interest [5] - IDEAYA Biosciences, Inc. (IDYA) gained 6.49% to $37.81, following the full enrollment of 435 patients in its Phase 2/3 trial for darovasertib, with expected data reporting in Q1 2026 [6] - Healthcare Triangle, Inc. (HCTI) climbed 6.72% to $1.43, with a recent announcement of an Advance Agreement for acquiring AI-powered customer experience firms, enhancing its position in global AI-driven solutions [7] - Alphatec Holdings, Inc. (ATEC) posted a modest gain of 2.80%, rising to $21.28, benefiting from ongoing investor confidence in the spine surgery provider [8]

As filed with the Securities and Exchange Commission on November 18, 2025 Registration No. 333-_________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIORESTORATIVE THERAPIES, INC. (Exact name of registrant as specified in its charter) incorporation or organization) Classification Code Number) Identification Number) (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer Nevada 8099 30-1341024 4 ...

Core Insights - Several small-cap biotech and therapeutics companies experienced significant gains in after-hours trading, driven by earnings updates, financial guidance, and regulatory developments [1] Company Summaries - Inotiv, Inc. (NOTV) saw a 36.61% increase in after-hours trading to $0.94, recovering from a 33.20% decline at the close, following preliminary Q4 revenue expectations of $137.5 million to $138.5 million and full-year revenue projections of $512.5 million to $513.5 million [2] - Applied Therapeutics, Inc. (APLT) rose 16.89% to $0.33 after a 30.19% gain at the close, with investors reacting positively to a narrower Q3 net loss of $19.0 million, or $0.13 per share, compared to a $68.6 million loss, or $0.48 per share, in the same quarter last year [3] - Alumis Inc. (ALMS) advanced 7.09% to $5.97, despite reporting a Q3 net loss of $110.8 million, wider than the $93.1 million loss in the prior year, with $2.1 million in collaboration income potentially boosting investor confidence [4] - TELA Bio, Inc. (TELA) increased 7.89% to $1.23 after a 14.08% gain at the close, reporting a reduced Q3 net loss of $8.6 million compared to $10.4 million a year earlier, with revenue growth of 9% to $20.7 million and revised 2025 guidance projecting at least 16% revenue growth over 2024 [5] - Corcept Therapeutics Inc. (CORT) gained 4.90% to $78.80, reflecting continued investor interest despite no specific news released [6] - BioRestorative Therapies, Inc. (BRTX) jumped 8.06% to $1.34, rebounding from a 6.77% decline at the close, following the announcement of a Type B meeting with the FDA to discuss a potential accelerated Biologics License Application pathway for its BRTX-100 program [7]

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]