Overview
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- TickerNVNO on Nasdaq2
- IndustrySurgical & Medical Instruments & Apparatus2
- HeadquartersIrvine, United States2
- Incorporated inDE3
- Business address70 Doppler, Irvine, Ca 926183
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI549300KF5KREFECSNV872
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O Corporation Service Company, 19808 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 31471202
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Each valve is supposed to open as blood passes through, and then close as blood progresses up the veins of the leg to the next valve.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 2019
Where the money goes
Where each dollar of revenue went, fiscal 2019
- Research and development31¢$2.2M
- Selling, general and admin69¢$4.9M
Out of $31.2K 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.9
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development expenses | $10.0M | $12.2M |
| Selling, general and administrative expenses | $10.9M | $11.6M |
| Loss from operations | -$20.9M | -$23.8M |
| Realized gain from sales of trading securities | $1.1M | $1.6M |
| Unrealized loss from trading securities | -$391.0K | -$22.0K |
| Interest income | $692.0K | $389.0K |
| Total other income | $1.4M | $2.0M |
| Net loss | -$19.5M | -$21.8M |
| Net loss per basic common share | -$33.06 | -$44.53 |
| Net loss per diluted common share | -$33.06 | -$44.53 |
| Basic | 589.0K shares | 490.0K shares |
| Diluted | 589.0K shares | 490.0K 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.9
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $3.1M | $1.8M | |
| Short-term investments | $25.1M | $41.4M | |
| Prepaid expenses and other current assets | $614.0K | $581.0K | |
| Total current assets | $28.8M | $43.7M | |
| Property and equipment, net | $51.0K | $182.0K | |
| Operating lease right-of-use assets, net | $654.0K | $1.0M | |
| Security deposits and other assets | $31.0K | $31.0K | |
| Total assets | $29.6M | $45.0M | |
| Accounts payable, accrued expenses and other current liabilities | $1.7M | $1.7M | |
| Current portion of operating lease liabilities | $390.0K | $364.0K | |
| Total current liabilities | $2.1M | $2.1M | |
| Long-term operating lease liabilities | $310.0K | $700.0K | |
| Total liabilities | $2.4M | $2.8M | |
| Additional paid-in capital | $198.5M | $194.0M | |
| Accumulated deficit | -$171.3M | -$151.9M | |
| Total stockholders equity | $27.1M | $42.2M | $46.2M |
| Total liabilities and stockholders equity | $29.6M | $45.0M | |
| Preferred stock, par value | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 10.0M shares | 10.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 250.0M shares | 250.0M shares | |
| Common stock, shares issued | 656.0K shares | 501.0K shares | |
| Common stock, shares outstanding | 656.0K shares | 501.0K shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $3.1M | $1.8M | |
| Short-term investments | $25.1M | $41.4M | |
| Prepaid expenses and other current assets | $614.0K | $581.0K | |
| Total current assets | $28.8M | $43.7M | |
| Property and equipment, net | $51.0K | $182.0K | |
| Operating lease right-of-use assets, net | $654.0K | $1.0M | |
| Security deposits and other assets | $31.0K | $31.0K | |
| Total assets | $29.6M | $45.0M | |
| Accounts payable, accrued expenses and other current liabilities | $1.7M | $1.7M | |
| Current portion of operating lease liabilities | $390.0K | $364.0K | |
| Total current liabilities | $2.1M | $2.1M | |
| Long-term operating lease liabilities | $310.0K | $700.0K | |
| Total liabilities | $2.4M | $2.8M | |
| Additional paid-in capital | $198.5M | $194.0M | |
| Accumulated deficit | -$171.3M | -$151.9M | |
| Total stockholders equity | $27.1M | $42.2M | $46.2M |
| Total liabilities and stockholders equity | $29.6M | $45.0M | |
| Preferred stock, par value | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 10.0M shares | 10.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares authorized | 250.0M shares | 250.0M shares | |
| Common stock, shares issued | 656.0K shares | 501.0K shares | |
| Common stock, shares outstanding | 656.0K shares | 501.0K 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.9
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$19.5M | -$21.8M |
| Stock-based compensation | $3.4M | $4.1M |
| Depreciation and amortization | $136.0K | $189.0K |
| Amortization of right-of-use assets | $353.0K | $339.0K |
| Unrealized loss from investments | $391.0K | $22.0K |
| Prepaid expenses and other current assets | -$33.0K | -$70.0K |
| Accounts payable, accrued expenses and other current liabilities | $1.0K | $698.0K |
| Operating lease liabilities | -$364.0K | -$338.0K |
| Net cash used in operating activities | -$15.6M | -$16.8M |
| Maturities of investments | $61.9M | $56.9M |
| Purchase of investments | -$46.0M | -$55.6M |
| Purchases of property and equipment | -$5.0K | -$37.0K |
| Net cash provided by investing activities | $15.9M | $1.3M |
| Proceeds from the sale of common stock and pre-funded warrants in public offering, net of fees | $13.6M | |
| Proceeds from sale of common stock in At-the-Market offering, net of fees | $782.0K | |
| Proceeds from exercise of warrants | $241.0K | |
| Proceeds from exercise of stock options | $46.0K | |
| Net cash provided by financing activities | $1.0M | $13.6M |
| Net increase (decrease) in cash and cash equivalents | $1.3M | -$1.9M |
No quarter-by-quarter statement was filed.
Corporate structure
enVVeno Medical Corp 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 enVVeno Medical Corp
- Lichti Braeden Filed SCHEDULE 13D/A on enVVeno Medical Corp, latest Sep 15, 2026 (3 filings since Feb 10, 2026)
- PERCEPTIVE ADVISORS LLC Filed SCHEDULE 13G/A on enVVeno Medical Corp, latest Aug 14, 2026 (8 filings since Feb 14, 2022)
- KINGDON CAPITAL MANAGEMENT, L.L.C. Filed SCHEDULE 13G/A on enVVeno Medical Corp, latest May 15, 2026 (2 filings since Sep 9, 2025)
- NORTHSTRIVE FUND II LP Filed SCHEDULE 13D on enVVeno Medical Corp, latest Feb 20, 2026 (2 filings since Feb 10, 2026)
- Thomas A. Satterfield Jr. Filed SCHEDULE 13G on enVVeno Medical Corp, latest Nov 19, 2025
- Nantahala Capital Management, LLC Filed SCHEDULE 13G/A on enVVeno Medical Corp, latest Nov 14, 2025 (3 filings since Feb 14, 2024)
- CVI Investments, Inc. Filed SC 13G/A on enVVeno Medical Corp, latest Feb 14, 2022
- INTRACOASTAL CAPITAL, LLC Filed SC 13G/A on enVVeno Medical Corp, latest Feb 11, 2022
- Empery Asset Management, LP Filed SC 13G/A on enVVeno Medical Corp, latest Jan 19, 2022
- enVVeno Medical Corp Irvine, California, 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 enVVeno Medical Corp 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 | $1.4M9 Dec 31, 2025 | $1.4M9 Dec 31, 2024 | +0.3% |
| Accumulated depreciation | $1.4M9 Dec 31, 2025 | $1.3M9 Dec 31, 2024 | +10.8% |
| Property and equipment, net | $51.0K9 Dec 31, 2025 | $182.0K9 Dec 31, 2024 | −72.0% |
| Operating-lease assets (leased space) | $654.0K9 Dec 31, 2025 | $1.0M9 Dec 31, 2024 | −35.1% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $3.1M9 Dec 31, 2025 | $1.8M9 Dec 31, 2024 | +74.7% |
| Marketable securities, current | $25.1M9 Dec 31, 2025 | $41.4M9 Dec 31, 2024 | −39.3% |
Properties, in its own words
As of December 31, 2025, we lease a 14,507 square foot manufacturing facility in Irvine, California under a lease that expires on September 30, 2027. Our facility is designed expressly for the manufacture of biologic vascular grafts and is equipped for research and development, prototype fabrication, cGMP manufacturing and shipping for Class III medical devices, including biologic cardiovascular devices. We believe that our facilities are sufficient for the near future as there is present capacity to manufacture up to approximately 20,000 venous valves per year to meet potential market demands.
Item 2 of the 10-K filed Mar 26, 2026.4
Leadership
Who has led enVVeno Medical Corp, and when. Pick a name to see everywhere that person has worked.
Chief financial officer
- Chief financial officerJennifer Bright May 20, 2025 to now10
- Chief financial officerCraig Glynn Feb 23, 2021 to Dec 7, 202311
- Chief financial officerRobert A. Rankin Jul 25, 2018 to Jul 25, 201812
Board members and other officers (11)
- Chief Technology OfficerHamed Alavi Jan 31, 2023 to now13
- Chief Medical Officer, OUSBenedict Broennimann May 30, 2018 to Nov 29, 201814
- OfficerMarc H. Glickman May 30, 2018 to now15
- OfficerSusan Montoya May 30, 2018 to May 30, 201816
- OfficerWilliam R. Abbott May 30, 2018 to May 30, 201817
- Board memberMatthew Jenusaitis Oct 21, 2020 to now18
- Board memberSteven Girgenti May 30, 2018 to May 30, 201819
- Board memberYury Zhivilo May 30, 2018 to Feb 14, 201920
- Board memberMarcus W. Robins Oct 12, 2018 to Nov 29, 201821
- Board memberSanjay Shrivastava Oct 12, 2018 to now22
- Board memberFrancis Duhay Dec 4, 2018 to now23
Former names
- Hancock Jaffe Laboratories, Inc.Dec 15, 2015 to Sep 22, 20213
Timeline
- Jul 14, 20268-K Regulation FD disclosure24
- Apr 29, 20268-K Results of operations; Regulation FD disclosure; Other events25
- Feb 4, 20268-K Results of operations; Other events26
- Jan 20, 20268-K Bylaws or fiscal year changed27
- Dec 12, 20258-K Shareholder vote28
- Nov 20, 20258-K Bylaws or fiscal year changed29
- Nov 14, 20258-K Regulation FD disclosure30
- Oct 30, 20258-K Entered a material agreement31
- Oct 10, 20258-K Listing notice or transfer32
- Aug 20, 20258-K Regulation FD disclosure33
- May 20, 20258-K Executive or director change34
- Apr 21, 20258-K Change of auditor35
- Dec 22, 1999Founded enVVeno Medical Corp is founded2
Calendar
Coming up
- Oct 30, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($8.07) a share, on Oct 31, 2025.36
When it reported results
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
163 filings to the SEC since October 2021: 7 annual reports, 16 quarterly reports, 23 major events, 55 insider forms, 22 large holders, 40 other. The latest 20:
- Sep 15, 2026SCHEDULE 13D/A EDGAR
- Sep 14, 20264 EDGAR
- Sep 11, 2026144 EDGAR
- Aug 21, 2026S-3 EDGAR
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Jul 30, 202610-Q EDGAR
- Jul 14, 20268-K EDGAR
- Jun 12, 20264 EDGAR
- Jun 11, 2026144 EDGAR
- May 15, 2026SCHEDULE 13G/A EDGAR
- May 15, 2026SCHEDULE 13G/A EDGAR
- May 6, 202610-Q EDGAR
- Apr 29, 20268-K EDGAR
- Mar 26, 2026S-8 EDGAR
- Mar 26, 202610-K EDGAR
- Mar 13, 20264 EDGAR
- Mar 12, 2026144 EDGAR
- Feb 20, 2026SCHEDULE 13D EDGAR
- Feb 20, 2026SCHEDULE 13D EDGAR
- Feb 17, 2026SCHEDULE 13G/A EDGAR
The 163 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
16 open-market trades by officers, directors and large owners since October 2021: 10 buys and 6 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Sep 11, 2026 | Duhay FrancisDirector | Sale | 11 | $11.21 | $123 | Form 4 |
| Jun 11, 2026 | Duhay FrancisDirector | Sale | 140 | $10.31 | $1.4K | Form 4 |
| Mar 12, 2026 | Duhay FrancisDirector | Sale | 140 | $11.52 | $1.6K | Form 4 |
| Dec 11, 2025 | Duhay FrancisDirector | Sale | 4,900 | $0.36 | $1.8K | Form 4 |
| Sep 15, 2025 | Duhay FrancisDirector | Sale | 4,900 | $0.83 | $4.1K | Form 4 |
| Dec 31, 2024 | Duhay FrancisDirector | Buy | 81,433 | $3.07 | $250.0K | Form 4 |
| Dec 31, 2024 | Gray RobertDirector | Buy | 3,500 | $2.94 | $10.3K | Form 4 |
| Dec 24, 2024 | Shrivastava SanjayDirector | Buy | 5,400 | $2.90 | $15.7K | Form 4 |
| Dec 19, 2024 | Jenusaitis MatthewDirector | Buy | 9,620 | $2.53 | $24.3K | Form 4 |
| Dec 19, 2024 | BERMAN ROBERT ANDREWChief Executive Officer | Buy | 12,000 | $2.55 | $30.6K | Form 4 |
| Mar 13, 2024 | Alavi HamedChief Technology Officer | Sale | 8,334 | $6.22 | $51.8K | Form 4 |
| Aug 16, 2022 | Duhay FrancisDirector | Buy | 7,751 | $6.14 | $47.6K | Form 4 |
| Jun 30, 2022 | Shrivastava SanjayDirector | Buy | 1,000 | $3.85 | $3.9K | Form 4 |
| Jun 27, 2022 | BERMAN ROBERT ANDREWChief Executive Officer | Buy | 2,500 | $3.80 | $9.5K | Form 4 |
| Nov 19, 2021 | BERMAN ROBERT ANDREWChief Executive Officer | Buy | 2,000 | $7.43 | $14.9K | Form 4 |
| Nov 16, 2021 | BERMAN ROBERT ANDREWChief Executive Officer | Buy | 2,000 | $7.87 | $15.7K | 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.
- Lichti BraedenSCHEDULE 13D/A, 3 filings Feb 10, 2026 to Sep 15, 202637
- PERCEPTIVE ADVISORS LLCSCHEDULE 13G/A, 8 filings Feb 14, 2022 to Aug 14, 202638
- KINGDON CAPITAL MANAGEMENT, L.L.C.SCHEDULE 13G/A, 2 filings Sep 9, 2025 to May 15, 202639
- NORTHSTRIVE FUND II LPSCHEDULE 13D, 2 filings Feb 10, 2026 to Feb 20, 202640
- Thomas A. Satterfield Jr.SCHEDULE 13G, 1 filing Nov 19, 202541
- Nantahala Capital Management, LLCSCHEDULE 13G/A, 3 filings Feb 14, 2024 to Nov 14, 202542
- CVI Investments, Inc.SC 13G/A, 1 filing Feb 14, 202243
- INTRACOASTAL CAPITAL, LLCSC 13G/A, 1 filing Feb 11, 202244
- Empery Asset Management, LPSC 13G/A, 1 filing Jan 19, 202245
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2024 | Robert A. BermanChief Executive Officer | 62 | $500.0K | $1.2M46 |
| 2024 | Marc H. Glickman, M.D.Chief Medical Officer and Senior Vice President | 76 | $367.5K | $626.6K46 |
| 2024 | Dr. Hamed AlaviSenior Vice President & Chief Technology Officer | 42 | $300.0K | $521.9K46 |
| 2024 | Craig GlynnChief Financial Officer | $250.0K | $302.2K46 | |
| 2023 | Robert A. BermanChief Executive Officer | 62 | $500.0K | $1.9M46 |
| 2023 | Marc H. Glickman, M.D.Chief Medical Officer and Senior Vice President | 76 | $367.5K | $776.4K46 |
| 2023 | Dr. Hamed AlaviSenior Vice President & Chief Technology Officer | 42 | $300.0K | $669.2K46 |
| 2023 | Craig GlynnChief Financial Officer | $250.0K | $527.3K46 |
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 |
|---|---|---|---|---|
| Kingdon Capital Management, L.l.c. | 36,166 | $387.3K | 0.1% | No change |
| CM Management, LLC | 35,714 | $382.5K | 0.2% | No change |
| Vanguard Capital Management LLC | 6,287 | $67.4K | 0.0% | No change |
| Jpmorgan Chase & Co | 5,208 | $59.1K | 0.0% | −1 |
| Vanguard Fiduciary Trust Co | 2,184 | $23.4K | 0.0% | No change |
| Westside Investment Management, Inc. | 1,525 | $16.3K | 0.0% | −64 |
| Mirae Asset Global Investments Co., Ltd. | 539 | $5.8K | 0.0% | New |
| BlackRock, Inc. | 414 | $4.4K | 0.0% | −1,426 |
| Tower Research Capital LLC (TRC) | 331 | $3.5K | 0.0% | −211 |
| Wells Fargo & Company/mn | 114 | $1.2K | 0.0% | No change |
| Allied Private Wealth LLC | 88 | $978 | 0.0% | New |
| Vanguard Global Advisers, LLC | 77 | $825 | 0.0% | No change |
| Morgan Stanley | 59 | $632 | 0.0% | −17 |
| Osaic Holdings, Inc. | 7 | $74 | 0.0% | No change |
| Barclays PLC | 2 | $21 | 0.0% | New |
| Group One Trading LLC | 2 | $21 | 0.0% | No change |
| UBS Group AG | 1 | $11 | 0.0% | −242 |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How enVVeno Medical Corp is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARenVVeno Medical Corp1
- CIK0001661053
- Employer ID (EIN)33-09361804
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
- SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
- Business address70 Doppler, Irvine, CA 926181
- Phone949-261-29001
- Shares outstanding682,722 as of Jul 28, 20268
- Public float$76.1M as of Jun 30, 20254
- AuditorCBIZ CPAs P.C., New York, NY PCAOB ID 199; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceDec 15, 20151
- Filings412 in all: 4 (86), 8-K (57), CORRESP (28), 10-Q (25), 3 (21), UPLOAD (20), EFFECT (15), S-1/A (14)1
All 47 form types
144 (12), SC 13G/A (11), SC 13G (10), DEF 14A (9), FWP (9), 10-K (8), 424B5 (8), S-1 (8), D (6), S-3 (6), S-8 (6), SCHEDULE 13G/A (6), 424B4 (5), SCHEDULE 13G (4), 3/A (3), 424B3 (3), S-3/A (3), 10-K/A (2), 4/A (2), DEFA14A (2), DRS (2), POS AM (2), S-1MEF (2), SCHEDULE 13D (2), 10-Q/A (1), 25-NSE (1), 5 (1), 8-A12B (1), 8-A12B/A (1), 8-K/A (1), CERT (1), D/A (1), DEFR14A (1), NT 10-Q (1), PRE 14A (1), PRER14A (1), SC 13D (1), SC 13D/A (1), SCHEDULE 13D/A (1)
- Latest filingsAnnual report (10-K) Mar 26, 2026
Quarterly report (10-Q) Jul 30, 2026
Proxy statement (DEF 14A) Oct 30, 2025
Latest 8-K (8-K) Jul 14, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.00001 par value | NVNO | 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 enVVeno Medical Corp names in Item 1A of its 10-K filed Mar 26, 2026: 36 risks under these headings, as written.4
- Risks Related to Our Business and Strategy
- We have incurred losses since our inception, expect to incur losses in the future and may never achieve or sustain profitability.
- We currently depend entirely on the successful and timely regulatory approval and commercialization of our current product candidate, and any future product candidates, which may not receive regulatory approval or, if any of our product candidates do receive regulatory approval, we may not be able to successfully commercialize them.
- If we are unable to successfully raise additional capital, our future clinical trials and product development could be limited and our long-term viability may be threatened.
- We may never be able to generate sufficient revenue from the commercialization of our product candidates to achieve and maintain profitability.
- We only utilize a few suppliers for porcine tissue for our product candidates and the loss of a supplier could have an adverse impact on our business.
- We depend upon third-party suppliers for certain components of our product candidates, making us vulnerable to supply problems and price fluctuations, which could harm our business.
- If we successfully develop product candidates, which at this time will likely take several years at a minimum, we will have to demonstrate the efficacy and financial viability of our products to doctors, hospitals, insurance companies, and other stakeholders.
- We may be unable to convince hospital facilities to approve the use of our product candidates.
- We face significant competition and our business prospects will depend on our ability to develop and commercialize our current product candidates and may also depend on our ability to develop additional product candidates.
- If we are unable to produce an adequate supply of our product candidates for use in our current and planned clinical trials or for commercialization because of our limited manufacturing resources or our facility is damaged or becomes inoperable, our regulatory, development and commercialization efforts may be delayed.
- We currently have no sales and limited marketing infrastructure and we may not be able to build a sales and marketing infrastructure sufficient for us to commercialize our current product candidate or future product candidates, if approved, and may be unable to do so or may never generate sufficient revenue to achieve or sustain profitability.
The other 25 risks
- Product liability lawsuits against us could cause us to incur substantial liabilities, limit sales of our existing product candidates and limit commercialization of any products that we may develop.
- The loss of our executive officers or our inability to attract and retain qualified personnel may adversely affect our business, financial conditions and results of operations.
- Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
- Risks Related to Regulatory Approval and Other Governmental Regulations
- Our business and product candidates are subject to extensive governmental regulation and oversight, and our failure to comply with applicable regulatory requirements could harm our business.
- The Company received a not-approvable letter from the FDA.
- Our product candidates will be subject to extensive governmental regulation in foreign jurisdictions, such as the EEA, and our failure to comply with applicable requirements could cause our business, results of operations and financial condition to suffer.
- The FDA regulatory approval, clearance and license process is complex, time-consuming and unpredictable.
- Even if our product candidates are approved by regulatory authorities, if we fail to comply with ongoing regulatory requirements, or if we experience unanticipated problems with our product candidates, our product candidates could be subject to restrictions or withdrawal from the market.
- We are required to report certain malfunctions, deaths and serious injuries associated with our products once approved by regulatory bodies, which can result in voluntary corrective actions or agency enforcement actions.
- Legislative or regulatory reforms in the United States or the EU may make it more difficult and costly for us to obtain regulatory clearances or approvals for product candidates or to manufacture, market or distribute product candidates after clearance or approval is obtained.
- We are subject to federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with such laws and regulations could have a material and adverse effect on our business.
- Regulatory healthcare reform measures and other legislative changes may have a material and adverse effect on business, results of operations and financial condition.
- Our relationships with physician consultants, owners and investors could be subject to additional scrutiny from regulatory enforcement authorities and could subject us to possible administrative, civil or criminal sanctions.
- Our company and many of our collaborators and potential collaborators are required to comply with the Federal Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act and implementing regulation affecting the transmission, security and privacy of health information, and failure to comply could result in significant penalties.
- We are currently, and in the future may be, subject to various governmental regulations related to the manufacturing of product candidates, and we may incur significant expenses to comply with, experience delays in our product commercialization as a result of and be subject to material sanctions if we or our contract manufacturers violate these regulations.
- Risks Related to Our Intellectual Property
- If we are unable to adequately protect our proprietary technology or obtain and maintain issued patents that are sufficient to protect our product candidates, others could compete against us more directly, which could harm our business, financial condition and results of operations.
- Obtaining and maintaining our patent protection depends on compliance with various procedures, document submission requirements, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights to, or use of, our technology.
- Risks Related to Ownership of Our Securities
- The trading price of our securities has been and is likely to continue to be volatile and could be subject to wide fluctuations in response to a variety of factors.
- We have issued a significant number of options and warrants and may continue to do so in the future. The vesting and, if applicable, exercise of these securities and the sale of the shares of common stock issuable thereunder may dilute your percentage ownership interest and may also result in downward pressure on the price of our common stock.
- We will need to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or difficult to obtain and can be expected to dilute current stockholders’ ownership interests.
- Future sales or issuances of substantial amounts of our common stock could result in significant dilution.
- Our failure to meet the continued listing requirements of Nasdaq could result in a de-listing of our Common Stock.
- Provisions of our charter documents or Delaware law could delay or prevent an acquisition of us, even if the acquisition would be beneficial to our stockholders, which could make it more difficult for you to change management.
- We do not anticipate paying any cash dividends on our common stock in the foreseeable future and, as such, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future.
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 11SEC EDGARCraig Glynn, Chief financial officer
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- 15SEC EDGARMarc H. Glickman, Officer
- 16SEC EDGARSusan Montoya, Officer
- 17SEC EDGARWilliam R. Abbott, Officer
- 18SEC EDGARMatthew Jenusaitis, Board member
- 19SEC EDGARSteven Girgenti, Board member
- 20SEC EDGARYury Zhivilo, Board member
- 21SEC EDGARMarcus W. Robins, Board member
- 22SEC EDGARSanjay Shrivastava, Board member
- 23SEC EDGARFrancis Duhay, Board member
- 24SEC EDGARRegulation FD disclosure
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- 26SEC EDGARResults of operations; Other events
- 27SEC EDGARBylaws or fiscal year changed
- 28SEC EDGARShareholder vote
- 29SEC EDGARBylaws or fiscal year changed
- 30SEC EDGARRegulation FD disclosure
- 31SEC EDGAREntered a material agreement
- 32SEC EDGARListing notice or transfer
- 33SEC EDGARRegulation FD disclosure
- 34SEC EDGARExecutive or director change
- 35SEC EDGARChange of auditor
- 36NasdaqNasdaq calendar
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