BioRestorative Therapies, Inc. (BRTX) Business Model Canvas

BioRestorative Therapies, Inc. (BRTX): Business Model Canvas [Dec-2025 Updated]

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You're looking at a clinical-stage biotech, so the business model is heavily weighted toward R&D and future commercialization, not current sales. Honestly, when you see a Q3 2025 operational loss of $3.7 million against only $11,800 in revenue from BioCosmeceuticals, you know the story here is all about the pipeline, specifically that BRTX-100 cell therapy for chronic disc pain. We've mapped out the nine blocks of the Business Model Canvas for BioRestorative Therapies, Inc. (BRTX) to show you exactly where the cash is going, who the key partners are, and what the path to a major payoff looks like. Dive in below to see the structure supporting this high-stakes biotech bet.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Key Partnerships

The Key Partnerships element of the BioRestorative Therapies, Inc. (BRTX) business model centers on strategic alliances necessary for commercialization, clinical development, and regulatory navigation for its cell-based therapies and BioCosmeceutical platform.

Cartessa Aesthetics, LLC for BioCosmeceutical sales represents a critical commercial relationship, established via an exclusive five-year supply agreement for the private-label product Chronos ExoCR, which is engineered to reduce fine lines and wrinkles.

The financial contribution from this partnership shows variability based on order timing:

Reporting Period End Date BioCosmeceutical Revenue Component Total Revenue Reported
September 30, 2025 (Q3 2025) Royalty revenue only $11,800
June 30, 2025 (Q2 2025) Primarily BioCosmeceutical sales $303,000
September 30, 2024 (Q3 2024) Primarily BioCosmeceutical sales $233,600

The Q2 2025 revenue of $303,000 marked a 240% increase over Q2-2024. However, Q3 2025 revenue was approximately $11,800, which consisted exclusively of royalty revenue, compared to $233,600 in Q3-2024, which was mostly BioCosmeceutical sales. This decrease in Q3-2025 is attributed to the specific timing of orders for the developing BioCosmeceutical revenue stream.

Clinical trial sites and principal investigators are essential for the BRTX-100 program, which is currently in a Phase 2, prospective, randomized, double-blinded, and controlled study for chronic lumbar disc disease (cLDD).

  • Total subjects planned for enrollment: up to 99 subjects.
  • Number of clinical sites in the United States: up to 16 leading sites.
  • Subject randomization ratio: 2:1 (BRTX-100 to placebo).

Regulatory bodies like the U.S. FDA for Fast Track process provide a pathway to expedite development and review. The BRTX-100 program received Fast Track designation from the U.S. Food and Drug Administration (FDA) in February 2025.

The company anticipates an FDA Type B meeting scheduled for mid-December 2025 to discuss a potential accelerated Biologics License Application (BLA) approval pathway. The FDA's threshold for determining if the trial can proceed toward BLA approval involves specific efficacy metrics:

  • Required improvement in function (Oswestry Disability Index, ODI): greater than 30%.
  • Required reduction in pain (Visual Analog Scale, VAS): greater than 30%.

Academic and research institutions for scientific collaboration are engaged through presentations of clinical data at major scientific forums. Francisco Silva, Vice President of Research and Development, presented data at the following 2025 events:

  • International Society for Stem Cell Research (ISSCR) 2025 Annual Meeting in Hong Kong.
  • Orthopaedic Research Society (ORS) 2025 annual meeting in Phoenix, AZ.
  • International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Key Activities

You're looking at the core engine of BioRestorative Therapies, Inc. (BRTX) right now, which is heavily weighted toward clinical execution and IP development as of late 2025. Here's the quick math on what they are actively doing to drive value.

Executing the BRTX-100 Phase 2 clinical trial

The primary focus remains the Phase 2 clinical trial for BRTX-100, targeting chronic lumbar disc disease (cLDD). This program secured Fast Track designation from the U.S. Food and Drug Administration (FDA) in February 2025, which is a big deal for potential pathway acceleration. They also have Investigational New Drug (IND) clearance for chronic cervical discogenic pain.

The trial design calls for a total enrollment of 99 patients, randomized 2:1 to receive BRTX-100 or placebo across up to 16 U.S. clinical sites. As of the third quarter of 2025, the Company believes enrollment is nearing completion. Preliminary blinded data has been shared, including 26-, 52-, and 104-week follow-up on the first 15 patients presented at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting, and data from the first 36 subjects presented at the International Society for Stem Cell Research (ISSCR) 2025 Annual Meeting.

This activity demands significant resources. For the three months ended March 31, 2025, research and development expenses increased by $656,196, or 62.0%, compared to the same period in 2024. This increase was driven by lab supply expense of $577,631 and recruitment costs for the Phase 2 clinical trial totaling $68,978. Cash used in operating activities was $2.8 million in the first quarter of 2025, up from $2.3 million in the first quarter of 2024. The loss from operations for the third quarter of 2025 was $3.7 million, compared to $2.3 million for the third quarter of 2024.

Regenerative medicine research and development (R&D)

Beyond the lead candidate, BioRestorative Therapies, Inc. is actively developing its Metabolic Program, which uses allogeneic, off-the-shelf brown adipose-derived stem cell (BADSC) technology, known as ThermoStem®, to target obesity and metabolic disorders. They maintain a laboratory facility in Melville, New York, to support this translational research.

The IP portfolio for this program saw key advancements in 2025:

  • European Patent Office issued a Notice of Allowance for the ThermoStem® platform in March 2025.
  • Japanese Patent Office issued a Notice of Allowance for the ThermoStem® platform in October 2025.

The Company also reported substantive discussions were continuing as of Q1 2025 regarding a potential license for this ThermoStem® intellectual property.

Manufacturing autologous stem cell products (BRTX-100)

The production of BRTX-100 is an autologous process, meaning it uses the patient's own cells. The proprietary technology involves collecting a patient's bone marrow, isolating and culturing the stem cells, and then cryopreserving them for injection. The Company emphasizes a 'made-in-America' production and manufacturing strategy, using domestic inputs to help manage costs amid global supply chain shifts.

Managing and expanding the intellectual property portfolio

The intellectual property management is crucial, securing the platform technologies. As of a September 2025 filing, the portfolio included:

IP Asset Category United States Patents Foreign Patents/Applications
ThermoStem Program 5 9
Disc/Spine Program (BRTX-100) Licenses for 1 patent application N/A
Curved Needle Device 1 N/A

This count reflects the patents obtained related to research and licenses secured for development programs.

Commercial sales and supply of BioCosmeceutical products

The commercial platform involves BioCosmeceutical products, sold under an exclusive supply agreement with Cartessa Aesthetics, LLC. This stream provides near-term revenue while the core clinical programs advance. However, revenue from this segment is subject to order timing.

Revenue figures for the reported periods in 2025 show this variability:

  • Third Quarter (Q3) 2025 Revenue: approximately $11,800, consisting exclusively of royalty revenue related to BRTX-100 technology.
  • Second Quarter (Q2) 2025 Revenue: approximately $303,000, primarily from BioCosmeceutical sales.
  • First Quarter (Q1) 2025 Revenue: $25,000.

For comparison, Q3 2024 revenue was $233,600, primarily from BioCosmeceutical sales, meaning the Q3 2025 revenue represented a year-over-year decrease, while Q2 2025 revenue represented a 240% increase over Q2 2024. The Company appointed Crystal Romano as Head of Global Commercial Operations in October 2025 to accelerate growth across its cell-based product portfolio, targeting what management views as a $63 billion BioCosmeceuticals market opportunity.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Key Resources

You're looking at the core assets BioRestorative Therapies, Inc. (BRTX) is relying on to drive value right now, as of late 2025. These are the tangible and intangible things they absolutely must have to make their business model work.

The company's financial footing, as of the end of the third quarter of 2025, shows a specific level of liquidity to fund ongoing operations and development.

Financial Metric Amount as of Q3 2025 (September 30, 2025) Notes
Cash and equivalents $4.5 million Reported at quarter end, with no outstanding debt.
Post-Quarter Financing Proceeds $1.1 million Gross proceeds from a financing completed subsequent to the quarter close.
Loss from Operations (Q3 2025) $3.7 million Compared to $2.3 million for the comparable period in 2024.
Net Loss Per Share (Q3 2025) $0.33 Compared to $0.13 per share in Q3 2024.

The intellectual property portfolio is central, especially around the lead candidate and the pipeline technology.

Proprietary BRTX-100 autologous stem cell technology is the foundation for the disc/spine program.

  • Formulated from autologous (patient's own) cultured mesenchymal stem cells collected from the patient's bone marrow.
  • Intended for non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapy to surgery.
  • The Phase 2 clinical trial (NCT04042844) is evaluating safety and efficacy in chronic lumbar disc disease (cLDD).
  • The study is designed to enroll up to 99 eligible subjects across up to 16 clinical sites in the United States.

Regulatory advantages are key resources that accelerate development timelines.

FDA Fast Track designation for BRTX-100 cLDD program provides crucial regulatory interaction.

  • Designation granted by the FDA in February 2025.
  • The designation facilitates development and expedites review for treatments addressing serious unmet medical needs.
  • BioRestorative Therapies, Inc. was granted a Type B meeting with the FDA, scheduled for mid-December 2025, to discuss a potential accelerated Biologics License Application (BLA) approval pathway.

The manufacturing and licensing capabilities support both autologous and allogeneic work.

Provisional NYSDOH license for allogeneic tissue processing expands manufacturing scope.

  • Received a provisional license from the New York State Department of Health (NYSDOH) in November 2024.
  • This expanded license allows processing of allogeneic (non-autologous) donor tissue material for isolation, expansion, and cryopreservation for medical research.
  • The facility holds a state-of-the-art cGMP manufacturing certification, supporting clinical grade cell therapy production.

The ThermoStem® platform intellectual property underpins the metabolic pipeline.

IP Asset/Milestone Program Focus Status/Detail
ThermoStem® Platform IP Obesity and metabolic disorders using Brown Adipose-Derived Stem Cells (BADSC) First platform to develop a human stem cell-based therapy using BAT.
Japanese Patent Office Notice of Allowance ThermoStem® technology, including delivery methods Issued in October 2025.
Israeli Patent Office Notice of Allowance ThermoStem® platform, covering BADSC aggregates and encapsulation systems This was the 14th international patent to issue outside the U.S. for the platform, issued in October 2024.

Finance: draft 13-week cash view by Friday.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Value Propositions

Non-surgical, autologous cell therapy for chronic disc pain (BRTX-100)

The value proposition centers on BRTX-100, an autologous mesenchymal stem cell therapy for chronic lumbar disc disease (cLDD) delivered via intradiscal injection. The Phase 2 clinical trial (NCT04042844) is designed to enroll up to 99 patients across up to 16 study sites in the United States, with subjects randomized 2:1 to receive BRTX-100 or placebo. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to this program in February 2025. Preliminary blinded data presented at ISSCR 2025, involving 36 evaluated subjects, showed compelling efficacy signals: over 74% experienced greater than 50% improvement in function (ODI) by 52 weeks, and over 72% reported greater than 50% reduction in pain (VAS) by 52 weeks. Earlier data from 15 patients indicated 100% (n=5 at 52 weeks) achieved a greater than 30% improvement in VAS score at 52 weeks posttreatment. The company also obtained FDA Investigational New Drug (IND) clearance to evaluate BRTX-100 for chronic cervical discogenic pain.

Potential cell-based alternative for obesity/metabolic disorders (ThermoStem®)

The ThermoStem® platform offers a cell-based therapeutic candidate targeting obesity and metabolic disorders, utilizing brown adipose (fat) derived stem cells (BADSC) or exosomes secreted by BADSC to generate brown adipose tissue (BAT). This approach is positioned to potentially offer longer-lasting efficacy with improved safety and dosing advantages compared to GLP-1 drugs. In October 2025, the Japanese Patent Office issued a Notice of Allowance for the company's allogeneic, off-the-shelf BADSC technology. Substantive licensing discussions for this intellectual property are continuing.

BioCosmeceutical products for aesthetic practices

BioRestorative Therapies, Inc. operates a commercial BioCosmeceutical platform, which is a near-term revenue focus, targeting what management views as a $63 billion market. The current commercial product is a cell-based secretome containing exosomes, proteins, and growth factors, manufactured in a cGMP ISO-7 certified clean room. Revenue from this segment is subject to order timing; for example, Q3 2025 revenues were $11,800 (entirely royalty revenue), down from $233,600 in Q3 2024 due to order timing. However, Q2 2025 revenues reached approximately $303,000, a 240% increase over Q2-2024, primarily from sales under the exclusive supply agreement with Cartessa Aesthetics, LLC.

Reduced risk profile due to autologous cell source (BRTX-100)

The autologous nature of BRTX-100, using the patient's own cells, contributes to a favorable safety profile. Clinical data presented in 2025 showed no serious adverse events (SAEs) or dose-limiting toxicity reported at the target dose of 40 million cells between 26 and 104 weeks post-injection across evaluated subjects. The company ended Q3 2025 with $4.5 million in cash, cash equivalents, and marketable securities, with no debt, and subsequently closed a $1.1 million financing. The company has a current ratio of 1.37. Despite this, financial efficiency metrics show a Return on Equity (ROE) of -207.73% and an Altman Z-Score of -47.37, which suggests an increased risk of bankruptcy.

Key Financial and Operational Metrics as of Late 2025

Metric Category Specific Data Point Value/Amount
Clinical Trial (BRTX-100) Total Planned Enrollment (Phase 2) Up to 99 subjects
Clinical Trial (BRTX-100) Number of U.S. Study Sites Up to 16
Clinical Trial (BRTX-100) Reported Subjects Evaluated (ISSCR 2025) 36
Clinical Trial (BRTX-100) % Subjects with >50% Function Improvement (52 Weeks) Over 74%
Clinical Trial (BRTX-100) Dose Tested (Cells) 40 million cells
Financial (Q3 2025) Revenue $11,800
Financial (Q3 2025) Net Loss per Share $0.33
Financial (Q3 2025 End) Cash and Marketable Securities $4.5 million
Financial (Post Q3 2025) Financing Closed $1.1 million
Financial (Late 2025) Market Capitalization $9.5M (per one source) or $10.23 million (per another)
Financial Efficiency Return on Equity (ROE) -207.73%
Operational Fulltime Employees 11

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Customer Relationships

High-touch scientific engagement with clinical investigators

The relationship with clinical investigators is central to the development of the lead candidate, BRTX-100, for chronic lumbar disc disease (cLDD).

  • The Phase 2 clinical trial for BRTX-100 is being conducted across up to 16 clinical sites in the United States.
  • Preliminary blinded data from the first 15 patients was presented at the ISCT 2025 Annual Meeting in May 2025.
  • By the second quarter of 2025, preliminary blinded data from the first 36 subjects was shared at the ISSCR 2025 Annual Meeting.
  • Subjects in the Phase 2 trial are randomized in a 2:1 ratio to receive either BRTX-100 or placebo.

Partner-managed commercial relationship for BioCosmeceuticals

The commercial relationship for the BioCosmeceuticals platform is currently managed through an exclusive supply agreement, though the company is shifting focus to royalty revenue and internal commercial build-out.

Metric Q3 2025 Amount Q3 2024 Amount
Total Revenues $11,800 $233,600
Primary Revenue Source Exclusively royalty revenue Primarily BioCosmeceutical sales
Q2 2025 Revenue (for context) N/A Approx. $303,000 (primarily BioCosmeceutical sales)

The company appointed Crystal Romano as Global Head of Commercial Operations in October 2025 to accelerate growth beyond the existing partnership structure. The Q3 2025 revenue of $11,800 consisted entirely of royalty revenue, compared to Q3 2024 where the vast majority of revenue came from sales under the exclusive supply agreement with Cartessa Aesthetics, LLC.

Active investor relations via conference calls and presentations

BioRestorative Therapies, Inc. maintains active communication with its investor base through scheduled financial updates and participation in industry events.

  • Management hosted conference calls to review financial results for Q1 2025 on May 14, Q2 2025 on August 12, and Q3 2025 on November 12.
  • Investor conference calls use the domestic dial-in number 888-506-0062 and international number 973-528-0011.
  • CEO Lance Alstodt participated in the Benzinga All-Access Show in April 2025.
  • In October 2025, the CEO and VP of Research and Development participated in a panel at the 2025 Maxim Growth Summit.

Regulatory dialogue with the FDA for BLA approval pathway

The relationship with the U.S. Food and Drug Administration (FDA) is focused on advancing the BRTX-100 program toward potential accelerated approval.

The FDA granted Fast Track designation to the BRTX-100 Phase 2 clinical trial in February 2025.

BioRestorative Therapies, Inc. secured a Type B meeting with the FDA scheduled for mid-December 2025 to discuss an accelerated Biologics License Application (BLA) approval pathway for BRTX-100 in cLDD.

The FDA has established performance benchmarks for the trial, requiring at least a greater than 30% improvement in function in the Oswestry Disability Index (ODI) and a greater than 30% reduction.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Channels

You're looking at how BioRestorative Therapies, Inc. (BRTX) gets its science and its commercial products in front of the right people. For a clinical-stage company, the channels are split between proving the science and building the future revenue base.

Clinical trial sites for BRTX-100 patient enrollment and treatment

The primary channel for the lead candidate, BRTX-100, is the Phase 2 clinical trial for chronic lumbar disc disease (cLDD). This channel is critical for generating the data needed for regulatory submission and eventual commercialization. The structure is highly controlled and site-dependent.

The Phase 2 study is a prospective, randomized, double-blinded, placebo-controlled trial. The total target enrollment is up to 99 eligible subjects, randomized in a 2:1 fashion to receive either BRTX-100 or placebo via a single intradiscal injection. Enrollment is managed across up to 16 clinical sites in the United States. As of November 2025, the company believed enrollment was nearing completion.

Here's a snapshot of the trial's progress and data dissemination through this channel:

Metric/Event Value/Date Channel Relevance
Total Target Enrollment 99 subjects Defines the scale of the clinical channel.
Number of U.S. Clinical Sites Up to 16 Geographic reach for patient recruitment.
Reported Evaluated Subjects (June 2025) 36 Data point presented at ISSCR 2025.
Reported Initial Patients (Feb 2025) 15 (up from 10) Early data point shared at ORS 2025.
Randomization Ratio 2:1 (BRTX-100:Placebo) Study design channel for efficacy measurement.

The FDA has granted Fast Track designation to the BRTX-100 program, which influences the regulatory pathway channel, anticipating a Type B meeting to discuss an accelerated Biologics License Application (BLA) approval pathway.

Strategic commercial partner's sales network (Cartessa Aesthetics)

For the BioCosmeceutical platform, the channel is an exclusive, five-year supply agreement with Cartessa Aesthetics, LLC. This leverages their established North American aesthetics market reach for BioRestorative Therapies, Inc.'s commercial product, Chronos ExoCR. This product is a private label cell-based secretome.

The financial performance through this channel shows variability:

  • Q2 2025 revenues were approximately $303,000, representing a 240% increase over Q2-2024, primarily from BioCosmeceutical sales via Cartessa Aesthetics.
  • Q3 2025 revenues dropped to approximately $11,800, consisting exclusively of royalty revenue related to BRTX-100 technology, compared to $233,600 in Q3-2024 from BioCosmeceutical sales.

This partnership is intended to introduce the product, which includes a secretome of exosomes, proteins, and growth factors, to aesthetic providers. The companies may explore expanding this collaboration to include additional cell-based biologic products.

Scientific and medical conferences (e.g., ISSCR 2025)

Conferences serve as a vital channel to communicate clinical progress directly to the scientific community, key opinion leaders, and potential investors. BioRestorative Therapies, Inc. actively presents its data at major industry events.

Key conference channel activity in 2025 included:

  • ISSCR 2025 Annual Meeting in Hong Kong (June 11 - June 14, 2025), where preliminary blinded data from 30 patients was presented on June 13, 2025.
  • ISCT 2025 Annual Meeting in New Orleans, LA (May 7 - May 10, 2025), where an update on the Phase 2 trial was presented.
  • ORS 2025 Annual Meeting in Phoenix, AZ (February 7-11, 2025), where 26-52 week blinded data from the first 15 patients was presented.

The presentation at ISSCR 2025 highlighted that over 74% of participants experienced greater than 50% improvement in function, and over 72% reported a similar reduction in pain after 52 weeks, based on data from 36 evaluated subjects.

Direct-to-investor communications and SEC filings

This channel involves formal regulatory disclosures and direct engagement with the investment community, often tied to financial milestones. The company uses press releases, conference calls, and SEC filings to manage investor expectations.

Key investor communication events and financial data points from 2025:

Communication Type Date Key Financial/Operational Data Point
Q2 2025 Results Conference Call August 12, 2025 Company ended Q2 2025 with $7.4 million in cash, cash equivalents, and marketable securities.
Q3 2025 Results Conference Call November 12, 2025 Q3 2025 loss from operations was $3.7 million; net loss was $3.0 million, or $0.33 per share.
SEC Filing (Form 8-K) August 12, 2025 Furnished press release announcing Q2 2025 results.
Financing Activity (October 2025) Subsequent to Q3 End Sold 678,125 shares at $1.60 per share in a registered direct offering.
Cash Position (End of Q3 2025) September 30, 2025 Ended quarter with $4.5 million in cash, cash equivalents, and investments, with no outstanding debt.

The company also held its Annual Meeting of Stockholders on September 18, 2025, another direct channel for governance communication.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Customer Segments

You're hiring before product-market fit in the clinical pipeline, so understanding the distinct customer groups BioRestorative Therapies, Inc. (BRTX) serves across its three main areas-clinical development and commercial-is key to valuing the enterprise.

Patients with chronic lumbar disc disease (cLDD)

This segment is the primary focus for the lead clinical candidate, BRTX-100. The treatment is intended for patients whose pain hasn't improved with non-invasive methods and who might otherwise face surgery. The Phase 2 clinical trial for cLDD is nearing completion of enrollment. The trial is designed to enroll up to 99 subjects across up to 16 clinical sites in the United States. As of June 13, 2025, 36 subjects had been evaluated. Preliminary blinded data presented in June 2025 showed encouraging efficacy signals: over 74% of subjects demonstrated a greater than 50% improvement in function (ODI) by 52 weeks, and over 72% reported a greater than 50% reduction in pain (VAS) by 52 weeks. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to this program. The FDA's threshold for determining progression toward Biologics License Application (BLA) approval is a greater than 30% improvement in function (ODI) and a greater than 30% reduction in pain (VAS). The pathway to a potential accelerated BLA has never been more visible.

Patients with chronic cervical discogenic pain (cCDP)

This represents a secondary, but important, patient segment for the BRTX-100 program. BioRestorative Therapies, Inc. has obtained U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance to evaluate BRTX-100 specifically for the treatment of chronic cervical discogenic pain. This clearance opens the door to a new patient population for the spine program.

Aesthetic clinics and medical spas (BioCosmeceutical buyers)

This group drives the current commercial revenue stream through the purchase of the BioCosmeceutical platform products, which are proprietary biologic serums engineered to reduce the appearance of fine lines and wrinkles. The company is focused on aggressively executing its near-term revenue strategy within this platform. To accelerate growth, Crystal Romano, an executive with 20 years of leadership in the aesthetics industry, was appointed Head of Global Commercial Operations in October 2025. Revenue from this segment has shown variability based on order timing.

Here's a look at the recent revenue performance, which is primarily driven by these commercial sales, though Q3 2025 revenue was entirely royalty-based:

Reporting Period End Date Reported Revenue Primary Revenue Source
September 30, 2025 (Q3 2025) Approximately $11,800 Royalty Revenue (BRTX-100 Technology)
June 30, 2025 (Q2 2025) Approximately $303,000 BioCosmeceutical Sales (Cartessa Agreement)
March 31, 2025 (Q1 2025) $25,000 BioCosmeceutical Sales
September 30, 2024 (Q3 2024) $233,600 BioCosmeceutical Sales (Cartessa Agreement)

The year-over-year decrease in Q3 2025 revenue compared to Q3 2024 was related to the specific timing of orders for the developing BioCosmeceutical stream.

Pharmaceutical and biotech companies (potential ThermoStem® licensees)

This segment represents a major potential value inflection point through licensing the ThermoStem® platform, which targets obesity and metabolic disorders. The global obesity market is projected to exceed $100 billion annually by the end of the decade. BioRestorative Therapies, Inc. is in active, ongoing negotiations with an undisclosed commercial-stage regenerative medicine company regarding a license for this metabolic disease platform. The intellectual property supporting this platform is well-protected; in October 2025, the Japanese Patent Office issued a Notice of Allowance for a broad patent covering the allogeneic brown adipose-derived stem cell (BADSC) technology. The company ended the third quarter of 2025 with $4.5 million in cash, cash equivalents, and marketable securities, with no outstanding debt, following a financing in October 2025 that brought in gross proceeds of approximately $1.085 million from the sale of 678,125 shares at $1.60 per share.

The key customer characteristics for this segment include:

  • Engagement with a commercial-stage regenerative medicine company.
  • Interest driven by the potential for a cell-based alternative to chronic GLP-1 injections.
  • Value proposition centered on mitigating tolerability issues like muscle mass loss.
  • IP protection across U.S. and international markets, evidenced by the Japanese patent allowance.

The company is actively managing resources to advance clinical trials while pursuing this licensing opportunity.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Cost Structure

You're hiring before product-market fit in a highly regulated space; that means your cost structure is dominated by science and compliance, not sales.

Significant R&D and clinical trial expenses are the primary cost drivers for BioRestorative Therapies, Inc. These costs fund the development of their cell-based therapies, particularly the BRTX-100 program for disc/spine disorders. The company's focus on clinical advancement means these expenditures are substantial relative to revenue.

Personnel costs for scientific and executive teams are embedded heavily within both Research and Development and General and Administrative expenses. The recruitment of specialized talent, like the serial regenerative medicine entrepreneur in a new strategic role in June 2025, adds to this fixed cost base. Honestly, keeping the scientific team fully staffed while advancing trials is a non-negotiable burn rate.

Manufacturing and laboratory operations overhead includes costs associated with maintaining cGMP ISO-7 certified clean room facilities for the BioCosmeceutical platform. BioRestorative Therapies, Inc. emphasizes its 'made-in-America' production strategy, which is intended to help manage costs amid global supply chain shifts, but this still requires significant infrastructure investment.

Legal and regulatory compliance costs are a persistent overhead in the regenerative medicine sector. These expenses cover everything from intellectual property portfolio expansion to filings and adherence to FDA guidelines for clinical programs.

The third quarter of 2025 loss from operations was $3.7 million compared to $2.3 million for the comparable period of 2024. Here's the quick math on the most recent detailed quarterly operating expenses available, which were for the three months ended June 30, 2025, as the specific Q3 2025 breakdown isn't fully itemized in the same way:

Expense Category (3 Months Ended June 30, 2025) Amount (USD)
Research and development $2,225,882
General and administrative $1,373,976
Total Operating Expenses (Q2 2025) $3,599,858
Loss From Operations (Q3 2025) $3,700,000
Loss From Operations (Q3 2024) $2,300,000

The cost structure is clearly weighted toward future value creation, which is typical for a clinical-stage biotech. Still, you need to watch the cash burn rate closely.

  • Q3 2025 Loss from Operations: $3.7 million
  • Q2 2025 Research and Development: $2,225,882
  • Q2 2025 General and Administrative: $1,373,976
  • Cash, cash equivalents, and investments as of September 30, 2025: $4.5 million
  • Authorized stock repurchase program limit: $2 million

Finance: draft 13-week cash view by Friday.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of BioRestorative Therapies, Inc. (BRTX) as of late 2025, and honestly, the picture is one of transition, leaning heavily on early-stage commercial efforts while financing future clinical work. The streams are clearly segmented between near-term product sales and longer-term technology monetization.

The most immediate, though currently small, revenue component is from BioCosmeceutical product sales. This stream is tied to the exclusive supply agreement with Cartessa Aesthetics, LLC. To give you a sense of scale from the prior period, the revenue from these BioCosmeceuticals was the primary driver in Q3-2024, totaling $233,600 for that quarter. The timing of orders for this developing stream impacted the most recent results.

The second established revenue component is Royalty revenue related to BRTX-100 technology. For the third quarter ended September 30, 2025, the total reported revenue was approximately $11,800. What this estimate hides is that this entire amount consisted exclusively of this royalty revenue. So, for Q3 2025, the royalty stream was the only active revenue generator reported.

Future revenue potential is heavily weighted toward clinical program milestones and licensing. Specifically, the ThermoStem® program is a key area where BioRestorative Therapies, Inc. is actively pursuing licensing and partnership deals with commercial-stage regenerative medical companies. These deals would unlock future milestone payments and potential ongoing licensing fees, which are critical for funding the clinical-stage programs like BRTX-100.

To support the ongoing operations and clinical advancement, the company has also recently accessed capital through equity financing. Following the end of the third quarter, BioRestorative Therapies, Inc. completed a financing round, bringing in approximate gross proceeds of $1.085 million. This strengthens the balance sheet to execute on near-term milestones.

Here's a quick look at the key revenue-related financial data points we have for the period:

Revenue Stream Component Most Recent Reported Value/Context Period/Date
Q3 2025 Total Revenue $11,800 Q3 2025
Q3 2025 Royalty Revenue (BRTX-100) $11,800 (100% of total revenue) Q3 2025
BioCosmeceutical Sales Context $233,600 (Primary source in prior period) Q3 2024
Post-Q3 2025 Equity Financing Proceeds $1.085 million (Gross proceeds) Post Q3 2025

The company's focus remains on driving the BioCosmeceutical commercial platform while advancing clinical programs. The revenue breakdown shows a current reliance on the royalty stream while waiting for the next inflection point from licensing or BioCosmeceutical order timing.

  • BioCosmeceutical sales are the near-term commercial engine.
  • Royalty revenue from BRTX-100 technology was the sole reported revenue source for Q3 2025.
  • Future revenue hinges on ThermoStem® licensing and milestone payments.
  • Financing provided approximately $1.085 million in gross proceeds after the quarter closed.

Finance: draft 13-week cash view by Friday.


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