CELZ on Nasdaq
CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.
In its 2026 annual report the company says: “We are a commercial stage biotechnology company dedicated to the advancement regenerative therapies in the fields of immunotherapy, endocrinology, urology, neurology and orthopedics. Our subsidiary, Creative Medical Technologies, Inc., was originally created to monetize U.S. Patent No. 8,372,797 and related intellectual property related to the treatment of erectile dysfunction, which it acquired in February 2016.”3 It is headquartered in Phoenix, Arizona.1 Its shares trade on Nasdaq under the symbol CELZ.1
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Last updated Oct 21, 2026.
Overview
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- TickerCELZ on Nasdaq1
- IndustryBiological Products, (No Diagnostic Substances)1
- HeadquartersPhoenix, Arizona1
- Incorporated inNV2
- Business address211 E. Osborn Rd., Phoenix, Az 850122
- Filer categoryNon-accelerated filer, Smaller reporting company2
- Legal formCorporation
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We are a commercial stage biotechnology company dedicated to the advancement regenerative therapies in the fields of immunotherapy, endocrinology, urology, neurology and orthopedics. Our platforms, therapies and products include the following:3 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
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Cost of revenue0¢$2.2K
- Research and development38¢$2.3M
- Selling, general and admin62¢$3.8M
Out of $6.0K in revenue.4 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.4
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Revenues | $6.0K | $11.0K |
| Cost of revenues | $2.2K | $4.4K |
| Gross profit | $3.8K | $6.6K |
| Research and development | $2.3M | $2.4M |
| Selling, general and administrative | $3.8M | $3.2M |
| Amortization of patent costs | $123.3K | $110.5K |
| TOTAL EXPENSES | $6.1M | $5.8M |
| Operating loss | -$6.1M | -$5.7M |
| Interest income | $147.8K | $250.4K |
| Total other income (expense) | $147.8K | $250.4K |
| LOSS BEFORE PROVISION FOR INCOME TAXES | -$6.0M | -$5.5M |
| Provision for income taxes | $0 | $0 |
| NET LOSS | -$6.0M | -$5.5M |
| Net income attributable to non-controlling interest | $0 | $0 |
| NET LOSS ATTRIBUTABLE TO CMTH | -$6.0M | -$5.5M |
| NET LOSS PER SHARE - BASIC AND DILUTED | -$2.52 | -$3.71 |
| WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING - BASIC AND DILUTED | 2.4M shares | 1.5M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 4 fiscal years (annual) or 4 quarters (quarterly), latest first.4
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 | 2016-01-31 |
|---|---|---|---|---|
| Cash | $7.2M | $5.9M | $3.5M | |
| Inventory | $0 | $2.2K | ||
| Note receivable, net of premium | $52.1K | $0 | ||
| Prepaids and other current assets | $138.8K | $192.7K | ||
| Total Current Assets | $7.4M | $6.1M | ||
| Other assets | $3.3K | $3.3K | ||
| Licenses, net of amortization | $407.2K | $530.6K | ||
| TOTAL ASSETS | $7.8M | $6.7M | ||
| Accounts payable | $270.7K | $273.5K | ||
| Accrued expenses | $0 | $39.9K | ||
| Advances from related party | $14.2K | $14.2K | ||
| Total Current Liabilities | $284.9K | $327.6K | ||
| TOTAL LIABILITIES | $284.9K | $327.6K | ||
| Preferred stock, $0.001 par value, 10,000,000 shares authorized at December 31, 2025 and 2024 | $0 | $0 | ||
| Common stock, $0.001 par value, 25,000,000 shares authorized; 3,701,668 and 1,748,428 issued and 3,696,668 and 1,748,428 outstanding at December 31, 2025 and 2024, respectively | $3.1K | $1.7K | $100.0K | |
| Additional paid-in capital | $78.1M | $70.9M | ||
| Accumulated deficit | -$70.6M | -$64.6M | ||
| Treasury stock, at cost, 5,000 and 0 shares as of December 31, 2025 and 2024, respectively | -$10.0K | $0 | ||
| TOTAL STOCKHOLDERS' EQUITY | $7.5M | $6.3M | ||
| Non-controlling interest | $10.0K | $0 | ||
| TOTAL EQUITY ATTRIBUTABLE TO CMTH | $7.5M | $6.3M | $10.3M | |
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $7.8M | $6.7M | ||
| Common stock, shares par value | $0.00 | $0.00 | ||
| Common stock, shares authorized | 25.0M shares | 25.0M shares | ||
| Common stock, shares issued | 3.7M shares | 1.7M shares | ||
| Common stock, shares outstanding | 3.7M shares | 1.7M shares | ||
| Treasury stock, cost | 5.0K shares | 0 shares | ||
| Preferred stock, shares par value | $0.00 | $0.00 | ||
| Preferred stock, shares authorized | 10.0M shares | 10.0M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 | 2016-01-31 |
|---|---|---|---|---|
| Cash | $7.2M | $5.9M | $3.5M | |
| Inventory | $0 | $2.2K | ||
| Note receivable, net of premium | $52.1K | $0 | ||
| Prepaids and other current assets | $138.8K | $192.7K | ||
| Total Current Assets | $7.4M | $6.1M | ||
| Other assets | $3.3K | $3.3K | ||
| Licenses, net of amortization | $407.2K | $530.6K | ||
| TOTAL ASSETS | $7.8M | $6.7M | ||
| Accounts payable | $270.7K | $273.5K | ||
| Accrued expenses | $0 | $39.9K | ||
| Advances from related party | $14.2K | $14.2K | ||
| Total Current Liabilities | $284.9K | $327.6K | ||
| TOTAL LIABILITIES | $284.9K | $327.6K | ||
| Preferred stock, $0.001 par value, 10,000,000 shares authorized at December 31, 2025 and 2024 | $0 | $0 | ||
| Common stock, $0.001 par value, 25,000,000 shares authorized; 3,701,668 and 1,748,428 issued and 3,696,668 and 1,748,428 outstanding at December 31, 2025 and 2024, respectively | $3.1K | $1.7K | $100.0K | |
| Additional paid-in capital | $78.1M | $70.9M | ||
| Accumulated deficit | -$70.6M | -$64.6M | ||
| Treasury stock, at cost, 5,000 and 0 shares as of December 31, 2025 and 2024, respectively | -$10.0K | $0 | ||
| TOTAL STOCKHOLDERS' EQUITY | $7.5M | $6.3M | ||
| Non-controlling interest | $10.0K | $0 | ||
| TOTAL EQUITY ATTRIBUTABLE TO CMTH | $7.5M | $6.3M | $10.3M | |
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $7.8M | $6.7M | ||
| Common stock, shares par value | $0.00 | $0.00 | ||
| Common stock, shares authorized | 25.0M shares | 25.0M shares | ||
| Common stock, shares issued | 3.7M shares | 1.7M shares | ||
| Common stock, shares outstanding | 3.7M shares | 1.7M shares | ||
| Treasury stock, cost | 5.0K shares | 0 shares | ||
| Preferred stock, shares par value | $0.00 | $0.00 | ||
| Preferred stock, shares authorized | 10.0M shares | 10.0M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.4
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$6.0M | -$5.5M |
| Stock-based compensation | $3.5K | $36.6K |
| Amortization of intangible assets | $123.3K | $110.5K |
| Amortization of note receivable premium | -$1.6K | $0 |
| Inventory | $2.2K | $4.4K |
| Prepaids and other current assets | $53.9K | $84.5K |
| Accounts payable | -$2.8K | -$43.9K |
| Accrued expenses | -$39.9K | $0 |
| Advances from related party | $0 | $0 |
| Net cash used in operating activities | -$5.9M | -$5.3M |
| Issuance of note receivable | -$50.5K | $0 |
| Redemptions of investments | $0 | $6.5M |
| Payment of patent purchase obligation - related party | $0 | -$200.0K |
| Net cash provided by (used in) investing activities | -$50.5K | $6.3M |
| Contribution from minority member | $10.0K | $0 |
| Purchase of treasury stock | -$10.0K | -$175.0K |
| Proceeds from sale of common stock and warrants, net of issuance costs | $7.2M | $1.6M |
| Proceeds from sale of Series B preferred stock | $0 | $100 |
| Net cash provided by financing activities | $7.2M | $1.5M |
| NET CHANGE IN CASH | $1.3M | $2.5M |
| Cash payments for interest | $0 | $0 |
| Cash payments for income taxes | $0 | $0 |
| Cancellation of Series B preferred stock within accounts payable | $0 | $100 |
| Cancellation of treasury stock | $0 | $445.9K |
No quarter-by-quarter statement was filed.
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Corporate structure
CREATIVE MEDICAL TECHNOLOGY HOLDINGS, 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 CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.
- Timothy Warbington Filed SCHEDULE 13D on CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC., latest Oct 1, 2026
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC., latest Aug 14, 2025 (2 filings since May 15, 2025)
- John Markey Filed SC 13G/A on CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC., latest May 26, 2023 (2 filings since May 2, 2023)
- Altium Capital Management LLC Filed SC 13G/A on CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC., latest Feb 14, 2022 (2 filings since Dec 20, 2021)
- CVI Investments, Inc. Filed SC 13G/A on CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC., latest Feb 14, 2022 (2 filings since Dec 10, 2021)
- L1 Capital Global Opportunities Master Fund, Ltd. Filed SC 13G/A on CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC., latest Feb 14, 2022 (2 filings since Dec 8, 2021)
- CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC. Phoenix, Arizona
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What CREATIVE MEDICAL TECHNOLOGY HOLDINGS, 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.
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Finite-lived intangibles, net | $407.2K4 Dec 31, 2025 | $530.6K4 Dec 31, 2024 | −23.2% |
| Patents, net | $300.0K4 Dec 31, 2025 |
Inventory
Properties, in its own words
We do not currently own any real property. Our corporate office is located at 211 East Osborn Road, Phoenix, Arizona, which we lease on a month-to-month basis. Management believes that this space is adequate to meet our current and foreseeable needs.
Item 2 of the 10-K filed Mar 20, 2026.3
Leadership
Who has led CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC., and when. Pick a name to see everywhere that person has worked.
Chief executive
- Chief executive officerTimothy Warbington May 20, 2016 to now12
- PresidentTimothy Warbington May 20, 2016 to now12
- PresidentSteven L. White Jan 28, 2009 to May 19, 201613
Board members and other officers (5)
- Board memberSusan H. Snow Jan 5, 2022 to Jan 5, 202214
- Board memberBruce Steven Urdang Dec 13, 2021 to Dec 13, 202115
- Board memberThomas Ichim May 20, 2016 to Jul 22, 202116
- Board memberTimothy Warbington May 20, 2016 to now12
- Board memberSteven L. White Jan 28, 2009 to May 19, 201613
Named in SEC Form D filings
People the company listed in its private-offering notices.
Former names
- JOLLEY MARKETING INCSep 13, 2002 to May 13, 20162
Timeline
- Sep 25, 20268-K Entered a material agreement; Unregistered sale of shares18
- Aug 31, 20268-K Bylaws or fiscal year changed; Shareholder vote19
- Jul 2, 20268-K Entered a material agreement; Unregistered sale of shares; Executive or director change20
- Dec 31, 20258-K Shareholder vote21
- Dec 19, 20258-K Shareholder vote22
- Nov 12, 20258-K Executive or director change23
- Oct 31, 20258-K Entered a material agreement; Unregistered sale of shares24
- May 6, 20258-K Shareholder vote25
- Apr 11, 20258-K Listing notice or transfer26
- Mar 14, 20258-K Executive or director change27
- Mar 7, 20258-K Entered a material agreement; Unregistered sale of shares28
- Dec 26, 20248-K Bylaws or fiscal year changed; Shareholder vote29
- May 20, 2016New chief executive Timothy Warbington becomes CEO12
Calendar
Coming up
- Nov 6, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.48) a share, on Nov 7, 2025.30
Drug trials and FDA: coming up
- Jan 20, 2027Phase 1/2 trial readout expected Phase 1/2 trial of CELZ-201-DDT in Chronic Low-back Pain: primary completion expected Jan 20, 2027 (ClinicalTrials.gov NCT06053242).31
- Jan 31, 2027Phase 1/2 trial readout expected Phase 1/2 trial of CELZ-201 Administration in Type 1 Diabetes: primary completion expected Jan 31, 2027 (ClinicalTrials.gov NCT05626712).32
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar
Filings
140 filings to the SEC since October 2021: 12 annual reports, 15 quarterly reports, 26 major events, 15 insider forms, 11 large holders, 1 private raises, 60 other. The latest 20:
- Oct 1, 2026SCHEDULE 13D EDGAR
- Sep 25, 20264 EDGAR
- Sep 25, 20268-K EDGAR
- Aug 31, 20268-K EDGAR
- Aug 7, 202610-Q EDGAR
- Aug 3, 2026424B3 EDGAR
- Jul 31, 2026EFFECT EDGAR
- Jul 24, 2026S-3 EDGAR
- Jul 14, 2026DEF 14A EDGAR
- Jul 2, 20268-K EDGAR
- Jul 1, 2026PRE 14A EDGAR
- Jun 30, 2026RW EDGAR
- Jun 26, 2026S-1/A EDGAR
- Jun 25, 2026S-1 EDGAR
- May 28, 2026DRS EDGAR
- May 8, 202610-Q EDGAR
- Apr 24, 202610-K/A EDGAR
- Mar 20, 202610-K EDGAR
- Dec 31, 20258-K EDGAR
- Dec 19, 20258-K EDGAR
The 140 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
13 open-market trades by officers, directors and large owners since October 2021: 11 buys and 2 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Feb 19, 2025 | Finger Michael H.Director | Sale | 750 | $5.75 | $4.3K | Form 4 |
| Feb 18, 2025 | Finger Michael H.Director | Sale | 750 | $5.00 | $3.8K | Form 4 |
| Jun 28, 2023 | Warbington TimothyPresident & CEO | Buy | 200 | $4.36 | $872 | Form 4 |
| Jun 27, 2023 | Warbington TimothyPresident & CEO | Buy | 800 | $4.44 | $3.6K | Form 4 |
| Nov 22, 2022 | Warbington TimothyPresident & CEO | Buy | 10,000 | $0.39 | $3.9K | Form 4 |
| Nov 21, 2022 | Warbington TimothyPresident & CEO | Buy | 15,000 | $0.40 | $6.0K | Form 4 |
| Sep 27, 2022 | Finger Michael H.Director | Buy | 2,000 | $0.50 | $1.0K | Form 4 |
| Sep 27, 2022 | Warbington TimothyPresident & CEO | Buy | 20,000 | $0.50 | $10.0K | Form 4 |
| Sep 22, 2022 | Warbington TimothyPresident & CEO | Buy | 12,000 | $0.54 | $6.5K | Form 4 |
| Sep 21, 2022 | Warbington TimothyPresident & CEO | Buy | 30,000 | $0.61 | $18.4K | Form 4 |
| Jun 14, 2022 | Finger Michael H.Director | Buy | 10,000 | $0.70 | $7.0K | Form 4 |
| Jun 6, 2022 | Warbington TimothyPresident & CEO | Buy | 25,000 | $0.91 | $22.9K | Form 4 |
| May 20, 2022 | Finger Michael H.Director | Buy | 6,500 | $1.50 | $9.8K | Form 4 |
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.
- Timothy WarbingtonSCHEDULE 13D, 1 filing Oct 1, 202633
- ARMISTICE CAPITAL, LLCSCHEDULE 13G/A, 2 filings May 15, 2025 to Aug 14, 202534
- John MarkeySC 13G/A, 2 filings May 2, 2023 to May 26, 202335
- Altium Capital Management LLCSC 13G/A, 2 filings Dec 20, 2021 to Feb 14, 202236
- CVI Investments, Inc.SC 13G/A, 2 filings Dec 10, 2021 to Feb 14, 202237
- L1 Capital Global Opportunities Master Fund, Ltd.SC 13G/A, 2 filings Dec 8, 2021 to Feb 14, 202238
Funding
Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.
- Private raises (Form D) $17.0M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2022 | $17.0M | $17.0M |
Private raises
Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Hudson Bay Capital Management LP | 135,170 | $196.0K | 0.0% | New |
| Anson Funds Management LP | 105,549 | $153.0K | 0.0% | New |
| Armistice Capital, LLC | 42,000 | $60.9K | 0.0% | New |
| XTX Topco Ltd | 26,559 | $38.5K | 0.0% | +12,299 |
| Geode Capital Management, LLC | 25,799 | $37.4K | 0.0% | −12,491 |
| Vanguard Capital Management LLC | 20,350 | $29.5K | 0.0% | No change |
| Vanguard Fiduciary Trust Co | 5,518 | $8.0K | 0.0% | No change |
| Tower Research Capital LLC (TRC) | 4,853 | $7.0K | 0.0% | +2,761 |
| Global Retirement Partners, LLC | 4,118 | $6.0K | 0.0% | New |
| UBS Group AG | 2,061 | $3.0K | 0.0% | +2,060 |
| Morgan Stanley | 514 | $745 | 0.0% | −20 |
| Barclays PLC | 54 | $78 | 0.0% | New |
| SBI Securities Co., Ltd. | 43 | $62 | 0.0% | +42 |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARCREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.1
- CIK0001187953
- Employer ID (EIN)87-06222843
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
- Incorporated inNevada3
- Fiscal year endsDecember 311
- Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address211 E. Osborn Rd., Phoenix, AZ 850121
- Phone480-399-28221
- Shares outstanding6,592,557 as of Aug 7, 202611
- Public float$4.6M as of Jun 30, 20253
- AuditorHaynie, Salt Lake City, Utah PCAOB ID 457; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceSep 13, 20021
- Filings409 in all: 8-K (105), 10-Q (53), 4 (52), 10-K (18), D (17), CORRESP (15), UPLOAD (14), 3 (10)1
All 49 form types
10-K/A (9), EFFECT (9), DEF 14A (8), 3/A (6), 424B3 (6), S-1 (6), SC 13G (6), 10-Q/A (5), DEF 14C (5), PRE 14A (5), PRE 14C (5), S-3 (5), SC 13G/A (5), RW (4), S-1/A (4), SC 13D/A (4), NT 10-Q (3), 144 (2), 4/A (2), 8-K/A (2), DRS (2), DRS/A (2), NT 10-K (2), 10-12G (1), 424B4 (1), 424B5 (1), 8-A12B (1), CERT (1), CT ORDER (1), DEFR14C (1), DRSLTR (1), POS AM (1), PRER14A (1), PRER14C (1), REGDEX (1), SB-2 (1), SC 13D (1), SC 14F1 (1), SCHEDULE 13D (1), SCHEDULE 13G (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Mar 20, 2026
Quarterly report (10-Q) Aug 7, 2026
Proxy statement (DEF 14A) Jul 14, 2026
Latest 8-K (8-K) Sep 25, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.001 per share | CELZ | NASDAQ |
From the cover page of the 10-K filed Mar 20, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC. names in Item 1A of its 10-K filed Mar 20, 2026: 32 risks under these headings, as written.3
- Risks Related to our Financial Position and Capital Needs
- We have incurred recent losses and our future profitability is uncertain.
- Even with the proceeds from our securities offerings, we will need additional capital to fund our operations as planned.
- We have generated minimal revenues from our products and do not expect to generate revenues for the foreseeable future. We will not achieve profitability unless we generate increased revenues from our current or proposed products or therapies.
- We expect to continue to incur significant financial losses in the future as we proceed with our Type I Diabetes (CELZ-201 CREATE-1) clinical trial, our AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT) clinical trial, and our other planned clinical trials.
- Risks Related to Product Development, Regulatory Approval and Commercialization
- Our product candidates’ commercial viability remains subject to current and future preclinical studies, clinical trials, regulatory approvals, and the risks generally inherent in the development of biopharmaceutical products. If we are unable to successfully advance or develop our product candidates, our business will be materially harmed.
- We may not be successful in our commercialization efforts for our proposed products and therapies, which may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
- The results of our clinical trials may not support our product claims or may result in the discovery of adverse side effects.
- We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals.
- Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
- Our autologous products are currently not eligible for reimbursement from public or private insurers.
The other 22 risks
- The pharmaceutical business is subject to increasing government regulation and reform, including with respect to price controls, reimbursement, and access to therapies, which could adversely affect our future revenues and profitability.
- United States federal and state privacy laws, and equivalent laws of other nations, may increase our costs of operation and expose us to civil and criminal sanctions.
- Later discovery of previously unknown problems could limit our ability to market or sell our products or therapies and can expose us to product liability claims.
- If we do not obtain required approvals in other countries in which we aim to market our products, we will be limited in our ability to export or sell the products in those markets.
- We rely in part on third parties for research and clinical trials for our products and therapies.
- We currently have a very limited marketing and sales organization and may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products and therapies, we may not be able to generate sufficient revenues to support our operations.
- We rely upon third parties for the manufacture of our CaverStem® and FemCelz® disposable kits and are dependent on their quality and effectiveness.
- We may be unable to compete effectively with marketed therapies or drugs targeting similar indications to our products and therapies.
- Our business and operations would suffer in the event of computer system failures or security breaches.
- We are subject to risks arising from the global outbreak of the COVID-19 coronavirus.
- We are subject to risks arising from the wars in Ukraine and the Gaza Strip.
- Risks Related to Our Intellectual Property
- We may not be able to protect our proprietary rights.
- We are susceptible to intellectual property suits that could cause us to incur substantial costs or pay substantial damages or prohibit us from selling our product candidates.
- We may need to initiate lawsuits to protect or enforce our intellectual property rights, which could be expensive and, if we lose, could cause us to lose some of our intellectual property rights, which would harm our ability to compete in the market.
- Risks Related to Employee Matters
- We are dependent on our executive officers, and we may not be able to pursue our current business strategy effectively if we lose them.
- Our employees, clinical trial investigators, CROs, consultants, vendors and any potential commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards.
- If we fail to comply with the U.S. federal Anti-Kickback Statute and similar state and foreign country laws, we could be subject to criminal and civil penalties and exclusion from federally funded healthcare programs including the Medicare and Medicaid programs and equivalent third country programs, which would have a material adverse effect on our business and results of operations.
- Risks Related To Our Common Stock
- The market price of our common stock is highly volatile, and you could lose all or part of your investment.
- If our shares of common stock are delisted from The Nasdaq Capital Market and become subject to the penny stock rules, it will be more difficult to trade our shares.
- Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of our securities.
- We will indemnify and hold harmless our officers and directors to the maximum extent permitted by Nevada law.
- Because we do not expect to pay dividends for the foreseeable future, investors seeking cash dividends should not purchase shares of common stock.
Legal proceedings
From time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. However, litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business.
The opening of Item 3, Legal Proceedings.3
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 13SEC EDGARSteven L. White, President
- 14SEC EDGARSusan H. Snow, Board member
- 15SEC EDGARBruce Steven Urdang, Board member
- 16SEC EDGARThomas Ichim, Board member
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- 21SEC EDGARShareholder vote
- 22SEC EDGARShareholder vote
- 23SEC EDGARExecutive or director change
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- 25SEC EDGARShareholder vote
- 26SEC EDGARListing notice or transfer
- 27SEC EDGARExecutive or director change
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- 30NasdaqNasdaq calendar
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