Overview
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- TickerBRTX on Nasdaq2
- IndustryServices-Misc Health & Allied Services, NEC2
- HeadquartersJupiter, United States2
- Incorporated inNV3
- Business address40 Marcus Drive, Suite One, Melville, Ny3
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI549300I1PJXVT7ISIV912
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O United Corporate Services, Inc., 89703 Carson City, United States2
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Patents related to the ThermoStem Program have been issued in the United States and other jurisdictions.4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2025
What sells
Revenue by product, business segment and region, as the company reports it to the SEC.
Products and services
Product brought in 83% of the revenue BioRestorative Therapies, Inc. broke down this way in fiscal 2025.
Products and services by year
| Products and services | 2024 | 2025 |
|---|---|---|
| Product | $300.0K | $300.0K |
| Royalty | $101.0K | $59.7K |
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Cost of revenue0¢$23.8K
- Research and development100¢$10.1M
Out of $359.7K in revenue.5 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Revenues | $359.7K | $401.0K |
| Cost of goods sold | $23.8K | $28.1K |
| Gross profit | $335.9K | $372.9K |
| Research and development | $10.1M | $6.7M |
| General and administrative | $5.9M | $5.2M |
| Total Operating Expenses | $16.0M | $11.9M |
| Loss From Operations | -$15.6M | -$11.6M |
| Interest income, net | $266.2K | $616.1K |
| Other income | $17.4K | $150.8K |
| Gain on exchange of warrants | $1.7M | |
| Change in fair value of warrant liabilities | $1.1M | $97.2K |
| Total Other Income | $1.4M | $2.6M |
| Net Loss | -$14.2M | -$9.0M |
| Net Loss Per Share - Basic | -$1.58 | -$1.16 |
| Net Loss Per Share - Diluted | -$1.58 | -$1.16 |
| Weighted Average Common Shares Outstanding - Basic | 9.0M shares | 7.8M shares |
| Weighted Average Common Shares Outstanding - Diluted | 9.0M shares | 7.8M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.5
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $1.5M | $547.9K | |
| Investments held in marketable securities | $1.4M | $10.2M | |
| Accounts receivable | $15.5K | $188.4K | |
| Prepaid expenses and other current assets | $168.4K | $223.2K | |
| Total Current Assets | $3.1M | $11.1M | |
| Deferred offering costs | $49.8K | $148.7K | |
| Property and equipment, net | $358.8K | $362.9K | |
| Intangible assets, net | $534.2K | $623.9K | $713.7K |
| Total Assets | $4.1M | $12.3M | |
| Accounts payable | $1.3M | $483.1K | |
| Accrued expenses and other current liabilities | $982.0K | $744.5K | |
| Warrant liabilities | $1.4M | $2.5M | $1.5M |
| Total Current Liabilities | $3.7M | $3.7M | |
| Common stock, $0.0001 par value; 75,000,000 shares authorized; 8,876,242 and 6,919,919 shares issued and outstanding at December 31, 2025 and 2024, respectively | $887 | $692 | |
| Additional paid-in capital | $170.3M | $164.2M | |
| Accumulated deficit | -$169.9M | -$155.7M | |
| Total Stockholders Equity | $356.7K | $8.5M | $10.0M |
| Total Liabilities and Stockholders Equity | $4.1M | $12.3M | |
| Preferred stock, par value | $0.01 | $0.01 | |
| Preferred stock, shares authorized | 20.0M shares | 20.0M shares | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 75.0M shares | 75.0M shares | |
| Common stock, shares issued | 8.9M shares | 6.9M shares | |
| Common stock, shares outstanding | 8.9M shares | 6.9M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $1.5M | $547.9K | |
| Investments held in marketable securities | $1.4M | $10.2M | |
| Accounts receivable | $15.5K | $188.4K | |
| Prepaid expenses and other current assets | $168.4K | $223.2K | |
| Total Current Assets | $3.1M | $11.1M | |
| Deferred offering costs | $49.8K | $148.7K | |
| Property and equipment, net | $358.8K | $362.9K | |
| Intangible assets, net | $534.2K | $623.9K | $713.7K |
| Total Assets | $4.1M | $12.3M | |
| Accounts payable | $1.3M | $483.1K | |
| Accrued expenses and other current liabilities | $982.0K | $744.5K | |
| Warrant liabilities | $1.4M | $2.5M | $1.5M |
| Total Current Liabilities | $3.7M | $3.7M | |
| Common stock, $0.0001 par value; 75,000,000 shares authorized; 8,876,242 and 6,919,919 shares issued and outstanding at December 31, 2025 and 2024, respectively | $887 | $692 | |
| Additional paid-in capital | $170.3M | $164.2M | |
| Accumulated deficit | -$169.9M | -$155.7M | |
| Total Stockholders Equity | $356.7K | $8.5M | $10.0M |
| Total Liabilities and Stockholders Equity | $4.1M | $12.3M | |
| Preferred stock, par value | $0.01 | $0.01 | |
| Preferred stock, shares authorized | 20.0M shares | 20.0M shares | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 75.0M shares | 75.0M shares | |
| Common stock, shares issued | 8.9M shares | 6.9M shares | |
| Common stock, shares outstanding | 8.9M shares | 6.9M shares |
Every line of the cash flow as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$14.2M | -$9.0M |
| Depreciation and amortization | $210.0K | $189.1K |
| Dividend and interest income | -$270.6K | -$623.8K |
| Stock-based compensation | $3.3M | $2.8M |
| Non-cash lease expense | $151.4K | |
| Gain on exchange of warrants | -$1.7M | |
| Change in fair value of warrant liabilities | -$1.1M | -$97.2K |
| Accounts receivable | $172.9K | -$169.1K |
| Prepaid expenses and other current assets | $101.8K | $33.6K |
| Accounts payable | $839.5K | $293.7K |
| Accrued expenses and other current liabilities | $195.3K | $32.8K |
| Lease Liability | -$162.3K | |
| Net Cash Used In Operating Activities | -$10.8M | -$8.2M |
| Sale of marketable securities | $11.7M | $21.5M |
| Purchase of marketable securities | -$2.7M | -$20.9M |
| Purchases of equipment | -$116.1K | -$106.2K |
| Net Cash Provided By Investing Activities | $8.9M | $514.5K |
| Proceeds from issuance of common stock for cash | $3.1M | |
| Payment of issuance costs | -$178.0K | |
| Exercise of stock options | $41.2K | |
| Proceeds from exchange and issuance of warrants, net | $7.5M | |
| Payment of deferred offering costs | -$100.0K | -$148.7K |
| Repayment of financed insurance premiums | -$4.7K | |
| Net Cash Provided By Financing Activities | $2.9M | $7.4M |
| Net Increase (Decrease) In Cash and Cash Equivalents | $963.3K | -$336.5K |
| Return and cancellation of shares in lieu of payroll tax withholding | $48.4K | |
| Issuance of common stock held in abeyance | $28 | $15 |
| Reclassification of deferred offering costs | $217.8K | |
| Deferred offering costs included in accounts payable | $18.9K | |
| Financing of insurance premiums | $47.0K |
No quarter-by-quarter statement was filed.
Corporate structure
BioRestorative Therapies, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of BioRestorative Therapies, Inc.
- Alta Partners LLC Filed SCHEDULE 13G/A on BioRestorative Therapies, Inc., latest Aug 3, 2026 (2 filings since Feb 13, 2026)
- Auctus Fund Management LLC Filed SCHEDULE 13G/A on BioRestorative Therapies, Inc., latest May 15, 2026 (8 filings since Jul 14, 2022)
- Todd Hale Morrison Filed SCHEDULE 13G/A on BioRestorative Therapies, Inc., latest Feb 23, 2026 (7 filings since Jun 21, 2024)
- INTRACOASTAL CAPITAL, LLC Filed SCHEDULE 13G on BioRestorative Therapies, Inc., latest Feb 18, 2026
- Francisco Silva Filed SCHEDULE 13D/A on BioRestorative Therapies, Inc., latest Feb 19, 2025 (3 filings since Feb 17, 2023)
- Lance Alstodt Filed SCHEDULE 13D/A on BioRestorative Therapies, Inc., latest Feb 19, 2025 (3 filings since Feb 17, 2023)
- Dale Broadrick Filed SC 13D/A on BioRestorative Therapies, Inc., latest Mar 6, 2024 (4 filings since Mar 29, 2022)
- Hudson Bay Capital Management LP Filed SC 13G/A on BioRestorative Therapies, Inc., latest Feb 7, 2023 (2 filings since Feb 2, 2022)
- Altium Capital Management LLC Filed SC 13G/A on BioRestorative Therapies, Inc., latest Feb 14, 2022 (2 filings since Nov 16, 2021)
- SABBY MANAGEMENT, LLC Filed SC 13G/A on BioRestorative Therapies, Inc., latest Jan 4, 2022 (2 filings since Nov 9, 2021)
- BioRestorative Therapies, Inc. Jupiter, Florida, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What BioRestorative Therapies, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $1.6M5 Dec 31, 2025 | $1.5M5 Dec 31, 2024 | +7.9% |
| Accumulated depreciation | $1.2M5 Dec 31, 2025 | $1.1M5 Dec 31, 2024 | +10.8% |
| Property and equipment, net | $358.8K5 Dec 31, 2025 | $362.9K5 Dec 31, 2024 | −1.1% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $1.5M5 Dec 31, 2025 | $547.9K5 Dec 31, 2024 | +175.8% |
| Marketable securities, current | $1.4M5 Dec 31, 2025 | $10.2M5 Dec 31, 2024 | −85.8% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Intangible assets, net (excluding goodwill) | $534.2K5 Dec 31, 2025 | $623.9K5 Dec 31, 2024 | −14.4% |
| Finite-lived intangibles, net | $534.2K5 Dec 31, 2025 | $448.7K10 Dec 31, 2024 | +19.0% |
Properties, in its own words
Our principal executive offices and laboratory are located at 40 Marcus Drive, Suite One, Melville, New York. We occupy 6,800 square feet of space at the premises pursuant to a lease that expired in December 2024. The lease provided for a current annual base rental of $173,060. We currently occupy the premises on a month-to-month basis at a monthly rental of $14,422 and are negotiating an extension of the term of the lease. Our premises are suitable and adequate for our current operations.
Item 2 of the 10-K filed Mar 26, 2026.4
Leadership
Who has led BioRestorative Therapies, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
- Chief executive officerLance Alstodt Nov 24, 2020 to now14
- PresidentLance Alstodt Nov 24, 2020 to now14
- Chief financial officerRobert Eugene Kristal Nov 16, 2021 to now15
Board members and other officers (14)
- SVP, Planning and Business DevAdam D. Bergstein Jan 19, 2018 to Jan 19, 201816
- VP, Quality and ComplianceRobert Paccasassi Aug 31, 2018 to Feb 15, 202417
- EVP and Chief Strategy OfficerLance Alstodt Oct 17, 2018 to Sep 10, 201918
- VP of OperationsMandy D. Clark Aug 12, 2011 to Mar 26, 201919
- Board memberKatharyn Field Jun 17, 2026 to now20
- Board memberJatinder Dhaliwal Jun 18, 2026 to now21
- Board memberMika Grasso Jun 18, 2026 to now22
- Board memberEsha Randhawa Jul 30, 2026 to now23
- Board memberDavid A. Rosa Nov 8, 2021 to now24
- Board memberLance Alstodt Nov 24, 2020 to now14
- Board memberRobert B. Catell Feb 23, 2016 to Mar 27, 201925
- Board memberJoseph B. Swiader Jul 1, 2014 to Apr 2, 201526
- Board memberPaul Jude Tonna Jul 1, 2014 to Sep 3, 201927
- Board memberA. Jeffrey Radov Aug 16, 2011 to Aug 29, 201928
Named in SEC Form D filings
People the company listed in its private-offering notices.
Former names
- Stem Cell Assurance, Inc.Nov 16, 2010 to Aug 16, 20113
Timeline
- Oct 9, 20268-K Executive or director change30
- Sep 11, 20268-K Executive or director change31
- Sep 10, 20268-K Change of auditor; Other events32
- Sep 2, 20268-K Change of auditor; Executive or director change33
- Sep 2, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed; Regulation FD disclosure34
- Aug 25, 20268-K Listing notice or transfer35
- Aug 14, 20268-K Other events36
- Jul 16, 20268-K Executive or director change37
- Jun 12, 20268-K Entered a material agreement; Executive or director change38
- Jun 12, 20268-K Executive or director change39
- May 29, 20268-K Executive or director change; Shareholder vote40
- May 1, 20268-K Executive or director change41
- Nov 24, 2020New chief executive Lance Alstodt becomes CEO14
Calendar
Coming up
- Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($7.60) a share, on Nov 12, 2025.42
When it reported results
- Nov 12, 2025Reported quarterly or annual results43
- Aug 12, 2025Reported quarterly or annual results44
- May 14, 2025Reported quarterly or annual results45
- Mar 27, 2025Reported quarterly or annual results46
- Nov 13, 2024Reported quarterly or annual results47
- Aug 13, 2024Reported quarterly or annual results48
- Aug 6, 2024Reported quarterly or annual results49
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
290 filings to the SEC since October 2021: 7 annual reports, 14 quarterly reports, 49 major events, 120 insider forms, 34 large holders, 1 private raises, 65 other. The latest 20:
- Oct 9, 20268-K CURRENT REPORT EDGAR
- Sep 11, 20268-K CURRENT REPORT EDGAR
- Sep 10, 20268-K/A AMENDMENT NO. 1 TO FORM 8-K EDGAR
- Sep 2, 20268-K CURRENT REPORT EDGAR
- Sep 2, 20268-K CURRENT REPORT EDGAR
- Aug 25, 20268-K CURRENT REPORT EDGAR
- Aug 14, 2026NT 10-Q EDGAR
- Aug 14, 20268-K EDGAR
- Aug 3, 2026SCHEDULE 13G/A EDGAR
- Jul 30, 20263 EDGAR
- Jul 24, 20263 PRIMARY DOCUMENT EDGAR
- Jul 16, 20268-K EDGAR
- Jun 18, 20263 EDGAR
- Jun 18, 20263 EDGAR
- Jun 17, 20263 EDGAR
- Jun 12, 20268-K CURRENT REPORT FILING EDGAR
- Jun 12, 20268-K CURRENT REPORT FILING EDGAR
- May 29, 20268-K FORM 8-K DATED MARCH 26, 2026 EDGAR
- May 15, 2026SCHEDULE 13G/A EDGAR
- May 14, 202610-Q EDGAR
The 290 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
91 open-market trades by officers, directors and large owners since October 2021: 86 buys and 5 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Oct 28, 2024 | Broadrick Dale10% owner | Sale | 1,112 | $1.58 | $1.8K | Form 4 |
| Apr 9, 2024 | Silva FranciscoVP of Research and Development | Buy | 6,600 | $1.25 | $8.2K | Form 4 |
| Apr 8, 2024 | Silva FranciscoVP of Research and Development | Buy | 1,708 | $1.16 | $2.0K | Form 4 |
| Feb 9, 2024 | Broadrick Dale10% owner | Buy | 86,041 | $1.32 | $113.6K | Form 4 |
| Feb 8, 2024 | Broadrick Dale10% owner | Buy | 73,959 | $1.25 | $92.4K | Form 4 |
| Feb 8, 2024 | Broadrick Dale10% owner | Buy | 83,626 | $1.34 | $112.1K | Form 4 |
| Feb 7, 2024 | Broadrick Dale10% owner | Buy | 36,374 | $1.38 | $50.2K | Form 4 |
| Dec 1, 2023 | Broadrick Dale10% owner | Sale | 250 | $1.88 | $470 | Form 4 |
| Nov 27, 2023 | Broadrick Dale10% owner | Sale | 278 | $1.89 | $525 | Form 4 |
| Sep 15, 2023 | Broadrick Dale10% owner | Buy | 10,000 | $1.66 | $16.6K | Form 4 |
| Sep 15, 2023 | ALSTODT LANCEPresident, CEO, COB | Buy | 2,200 | $1.70 | $3.7K | Form 4 |
| Sep 14, 2023 | Broadrick Dale10% owner | Buy | 10,000 | $1.54 | $15.4K | Form 4 |
| Sep 13, 2023 | ALSTODT LANCEPresident, CEO, COB | Buy | 800 | $1.53 | $1.2K | Form 4 |
| Sep 7, 2023 | Broadrick Dale10% owner | Buy | 2,000 | $1.86 | $3.7K | Form 4 |
| Sep 6, 2023 | ALSTODT LANCEPresident, CEO, COB | Buy | 2,887 | $1.96 | $5.7K | Form 4 |
| Aug 31, 2023 | Silva FranciscoVP of Research and Development | Buy | 4,954 | $2.22 | $11.0K | Form 4 |
| Jul 28, 2023 | Broadrick Dale10% owner | Buy | 500 | $2.89 | $1.4K | Form 4 |
| Jul 27, 2023 | Broadrick Dale10% owner | Buy | 1,000 | $2.80 | $2.8K | Form 4 |
| Jul 25, 2023 | ALSTODT LANCEPresident, CEO, COB | Buy | 4,200 | $2.44 | $10.2K | Form 4 |
| Mar 31, 2023 | Silva FranciscoVP of Research and Development | Buy | 747 | $3.56 | $2.7K | Form 4 |
All 91 trades can be filtered by person here when JavaScript is on.
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- Alta Partners LLCSCHEDULE 13G/A, 2 filings Feb 13, 2026 to Aug 3, 202650
- Auctus Fund Management LLCSCHEDULE 13G/A, 8 filings Jul 14, 2022 to May 15, 202651
- Todd Hale MorrisonSCHEDULE 13G/A, 7 filings Jun 21, 2024 to Feb 23, 202652
- INTRACOASTAL CAPITAL, LLCSCHEDULE 13G, 1 filing Feb 18, 202653
- Francisco SilvaSCHEDULE 13D/A, 3 filings Feb 17, 2023 to Feb 19, 202554
- Lance AlstodtSCHEDULE 13D/A, 3 filings Feb 17, 2023 to Feb 19, 202555
- Dale BroadrickSC 13D/A, 4 filings Mar 29, 2022 to Mar 6, 202456
- Hudson Bay Capital Management LPSC 13G/A, 2 filings Feb 2, 2022 to Feb 7, 202357
- Altium Capital Management LLCSC 13G/A, 2 filings Nov 16, 2021 to Feb 14, 202258
- SABBY MANAGEMENT, LLCSC 13G/A, 2 filings Nov 9, 2021 to Jan 4, 202259
Money raised
Private offerings the company reported to the SEC on Form D.
- Oct 8, 2025Raised $1.4 million in a private offering of equity Form D: 16 investors so far Form D
SEC filer profile
How BioRestorative Therapies, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARBioRestorative Therapies, Inc.1
- CIK0001505497
- Employer ID (EIN)30-13410244
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; a shell company4
- Incorporated inNevada4
- Fiscal year endsDecember 311
- Industry code (SIC)8090 Services-Misc Health & Allied Services, NEC1
- SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
- Business address40 Marcus Drive, Suite One, Melville, NY1
- Phone(631) 760-81001
- Shares outstanding25,478,170 as of May 14, 202613
- Public float$11.2M as of Jun 30, 20254
- AuditorCBIZ CPAs P.C., Marlton, New Jersey PCAOB ID 199; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceNov 16, 20101
- Filings754 in all: 4 (261), 8-K (172), 10-Q (45), 3 (27), CORRESP (19), DEF 14A (19), SC 13D/A (19), 10-K (15)1
All 46 form types
PRE 14A (12), SCHEDULE 13G/A (12), S-8 (11), UPLOAD (11), S-1/A (10), SC 13G (10), EFFECT (9), SC 13G/A (8), 424B5 (7), S-1 (7), SC 13D (7), NT 10-Q (6), D (5), D/A (5), NT 10-K (5), 424B3 (4), 8-K/A (4), POS AM (4), 10-12G/A (3), 10-Q/A (3), 4/A (3), 424B4 (3), DEFA14A (3), FWP (3), SCHEDULE 13G (3), 10-K/A (2), 8-A12B (2), CT ORDER (2), RW (2), S-3 (2), SCHEDULE 13D/A (2), 10-12G (1), 424B2 (1), CERT (1), DRS (1), PRER14A (1), S-1MEF (1), S-3/A (1)
- Latest filingsAnnual report (10-K) Mar 26, 2026
Quarterly report (10-Q) May 14, 2026
Proxy statement (DEF 14A) Apr 13, 2026
Latest 8-K (8-K) Oct 9, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock $0.0001 par value | BRTX | Nasdaq |
From the cover page of the 10-K filed Mar 26, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks BioRestorative Therapies, Inc. names in Item 1A of its 10-K filed Mar 26, 2026: 55 risks under these headings, as written.4
- Risks Related to Our Business Generally
- Risks Related to Our Cell Therapy Product Development Efforts
- Risks Related to Our Intellectual Property
- Risks Related to Government Regulation
- Risks Related to Our Common Stock
- Risks Associated with Our Nasdaq Listing
- We have a limited operating history; we have incurred substantial losses since inception; we expect to continue to incur losses for the near term; there is substantial doubt about our ability to continue as a going concern within the next twelve months from the date of this filing; the report of our independent registered public accounting firm contains an explanatory paragraph that expresses substantial doubt about our ability to continue as a going concern.
- We will need to obtain a significant amount of financing to complete our clinical trials and implement our business plan.
- Our business strategy is high risk.
- We will need to enter into agreements in order to implement our business strategy.
- We depend on our executive officers and on our ability to attract and retain additional qualified personnel.
- In the event that we are unable to utilize our current premises and need to relocate, we will be required to comply with regulatory requirements as to the operation of our laboratory, which could have had a material adverse effect on the conduct of our clinical trials and on our business.
The other 49 risks
- Our future success is significantly dependent on the timely and successful development and commercialization of BRTX-100, our lead product candidate for the treatment of chronic lumbar disc disease; if we encounter delays or difficulties in the development of this product candidate, as well as any other product candidates, our business prospects would be significantly harmed.
- We may experience delays and other difficulties in enrolling a sufficient number of patients in our clinical trials which could delay or prevent the receipt of necessary regulatory approvals.
- We may have other delays in completing our clinical trials and we may not complete them at all.
- The development of our cell therapy product candidates is subject to uncertainty because autologous cell therapy is inherently variable.
- Any disruption to our access to the media (including cell culture media) and reagents we are using in the clinical development of our cell therapy product candidates could adversely affect our ability to perform clinical trials and seek future regulatory submissions.
- Products that appear promising in research and development may be delayed or may fail to reach later stages of clinical development.
- Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which would prevent or delay regulatory approval and commercialization.
- Even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize a product candidate, and the approval may be for a narrower indication than we seek.
- We may never obtain FDA approval for any of our product candidates in the United States and, even if we do, we may never obtain approval for or commercialize any of our product candidates in any foreign jurisdiction, which would limit our ability to realize our full market potential.
- We presently lack manufacturing capabilities to produce our product candidates at commercial scale quantities and do not have an alternate manufacturing supply at this time, which could negatively impact our ability to meet any future demand for the products.
- The commercial potential and profitability of our products are unknown and subject to significant risk and uncertainty.
- We may have difficulties in sourcing brown adipose (fat) tissue.
- If safety problems are encountered by us or others developing new stem cell-based therapies, our stem cell initiatives could be materially and adversely affected.
- We are vulnerable to competition and technological change, and also to physicians’ inertia.
- We may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
- We have limited experience in the development and marketing of cell therapies and may be unsuccessful in our efforts to establish a profitable business.
- Our cell therapy business is based on novel technologies that are inherently expensive, risky and may not be understood by or accepted in the marketplace, which could adversely affect our future value.
- Our cell therapy product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
- The FDA’s regulation of regenerative medicine products remains unpredictable and we are not certain what impact this will have on the potential approval of our products.
- We may be subject to significant product liability claims and litigation, including potential exposure from the use of our product candidates in human subjects, and our insurance may be inadequate to cover claims that may arise.
- Our internal computer systems, or those that are expected to be used by our clinical investigators, clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of development programs for our product candidates.
- To operate and sell in international markets carries great risk.
- Our inability to obtain reimbursement for our products and services from private and governmental insurers could negatively impact demand for our products and services.
- Our activity as a contract manufacturer of biologic-based cosmetics could result in FDA enforcement for reasons outside of our control, which could disrupt the development of our own product candidates or harm our reputation.
- We may not be able to protect our proprietary rights.
- We may not be able to protect our intellectual property in countries outside of the United States.
- Changes to United States patent law may have a material adverse effect on our intellectual property rights.
- In certain countries, patent holders may be required to grant compulsory licenses, which would likely have a significant and detrimental effect on any future revenues in such country.
- Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory oversight.
- We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
- Our current and future employees, consultants and advisors and our future principal investigators, medical institutions and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
- The failure to receive regulatory approvals for our cell therapy product candidates would likely have a material and adverse effect on our business and prospects.
- If we are unable to conduct clinical studies in accordance with regulations and accepted standards, we may be delayed in receiving, or may never receive, regulatory approvals of our product candidates from the FDA and other regulatory authorities.
- Health care companies have been the subjects of federal and state investigations, and we could become subject to investigations in the future.
- It is uncertain to what extent the government, private health insurers and third-party payors will approve coverage or provide reimbursement for the therapies and products to which our services relate. Availability for such reimbursement may be further limited by reductions in Medicare, Medicaid and other federal healthcare program funding in the United States.
- Unintended consequences of healthcare reform in the United States may adversely affect our business.
- Competitor companies or hospitals in the EU may be able to take advantage of EU rules permitting sales of unlicensed medicines for individual patients to sell competing products without a marketing authorization.
- We pay no dividends.
- There is no assurance that an active trading market for our common stock will be sustained.
- Stockholders who hold unregistered shares of our common stock are subject to resale restrictions pursuant to Rule 144 due to our former status as a “shell company.”
- We have incurred, and will continue to incur, increased costs as a result of being an SEC reporting company.
- Material weaknesses in our internal control over financial reporting have caused and may cause us to fail to timely and accurately report our financial results or result in a material misstatement of our consolidated financial statements.
- Our stock price may fluctuate significantly and be highly volatile and this may make it difficult for a securityholder to resell our securities at the volume, prices and times the securityholder finds attractive.
- There may be significant future issuances or resales of our common stock which may materially and adversely dilute stockholders’ ownership interest and affect the market price of our securities.
- Our common stock is classified as a “penny stock;” the restrictions of the penny stock regulations of the SEC may result in less liquidity for our common stock.
- Anti-takeover provisions and the regulations to which we may be subject may make it more difficult for a third party to acquire control of us, even if the change in control would be beneficial to our securityholders.
- We cannot assure you that we will be able to comply with the minimum bid price requirement of Nasdaq.
- The market price of our common stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our common stock may not improve.
- Our failure to meet the continued listing standards of Nasdaq could result in a delisting of our common stock.
Sources
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- 19SEC EDGARMandy D. Clark, VP of Operations
- 20SEC EDGARKatharyn Field, Board member
- 21SEC EDGARJatinder Dhaliwal, Board member
- 22SEC EDGARMika Grasso, Board member
- 23SEC EDGAREsha Randhawa, Board member
- 24SEC EDGARDavid A. Rosa, Board member
- 25SEC EDGARRobert B. Catell, Board member
- 26SEC EDGARJoseph B. Swiader, Board member
- 27SEC EDGARPaul Jude Tonna, Board member
- 28SEC EDGARA. Jeffrey Radov, Board member
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- 30SEC EDGARExecutive or director change
- 31SEC EDGARExecutive or director change
- 32SEC EDGARChange of auditor; Other events
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- 35SEC EDGARListing notice or transfer
- 36SEC EDGAROther events
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- 42NasdaqNasdaq calendar
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