VNRX on NYSE

VOLITIONRX LTD

VOLITIONRX LTD is an American in vitro and in vivo diagnostic substances company based in Henderson.1 Its shares trade on NYSE under the symbol VNRX.1

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Last updated Oct 20, 2026.

Overview

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  • TickerVNRX on NYSE1
  • IndustryIn Vitro & In Vivo Diagnostic Substances1
  • HeadquartersHenderson, Nevada1
  • Incorporated inDE2
  • Business address1489 West Warm Springs Road, Suite 110, Henderson, Nv 890142
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

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We have based our forward-looking statements on our current assumptions, expectations and projections about trends affecting our business and industry and other future events. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. Forward-looking statements are subject to substantial known and unknown risks and uncertainties that could cause our future business, financial condition, results of operations or performance to differ materially from our historical results or those expressed or implied in any forward-looking statement contained in this Report.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

-1258.5%Operating margin5
-1352.2%Net margin5
40.0%Revenue growth, 20255
-$19.8MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$10.1M

Out of $1.7M in revenue.5 The company lost money this year.

Financial statements

Revenue6789105$1.7M in 2025+10004% since 2019
0$500.0K$1.0M$1.5M$2.0M2019: $17.1K$17.1K20192020: $13.4K$13.4K2020−21%2021: $90.0K$90.0K2021+570%2022: $306.4K$306.4K2022+240%2023: $775.3K$775.3K2023+153%2024: $1.2M$1.2M2024+59%2025: $1.7M$1.7M2025+40%
Operating income6789105-$21.7M in 2025+36% since 2019
-$40.0M-$30.0M-$20.0M-$10.0M02019: -$16.0M-$16.0M20192020: -$21.2M-$21.2M2020+32%2021: -$28.3M-$28.3M2021+33%2022: -$31.8M-$31.8M2022+12%2023: -$36.0M-$36.0M2023+13%2024: -$27.0M-$27.0M2024−25%2025: -$21.7M-$21.7M2025−20%
Net income6789105-$23.4M in 2025+45% since 2019
-$40.0M-$30.0M-$20.0M-$10.0M02019: -$16.1M-$16.1M20192020: -$20.4M-$20.4M2020+27%2021: -$27.0M-$27.0M2021+32%2022: -$30.6M-$30.6M2022+13%2023: -$35.7M-$35.7M2023+17%2024: -$27.0M-$27.0M2024−24%2025: -$23.4M-$23.4M2025−13%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Service$450.8K$228.1K
Product$1.3M$1.0M
Total Revenues$1.7M$1.2M
Research and development$10.1M$14.4M
General and administrative$9.5M$8.5M
Sales and marketing$3.9M$5.4M
Total Operating Expenses$23.5M$28.3M
Operating Loss-$21.7M-$27.0M
Grant income$516.5K$103.4K
Gain /( Loss) on disposal of fixed assets$1.8K-$34.7K
Interest income$600$9.9K
Interest expense-$532.2K-$340.4K
Amortization of debt discount-$2.0M$0
Gain on change in fair value of warrant liability$76.9K$28.8K
Gain on change in fair value of derivative liability$128.7K$0
Total Other Income (Expenses)-$1.8M-$233.0K
Net Loss-$23.5M-$27.3M
Net Loss attributable to Non-Controlling Interest$146.3K$290.1K
Net Loss attributable to VolitionRx Limited Stockholders-$23.4M-$27.0M
Foreign currency translation adjustments-$680.7K$141.7K
Net Comprehensive Loss-$24.2M-$27.1M
Loss Per Common Share Attributable to Common Stockholders - Basic and Diluted-$0.22-$0.31
Weighted Average Number of Shares Outstanding, Diluted106.8M shares86.5M shares

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Corporate structure

VOLITIONRX LTD sits at the top of its group. 7 entities, 4 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of VOLITIONRX LTD

  • Lagoda Investment Management, L.P. Filed SCHEDULE 13D/A on VOLITIONRX LTD, latest Sep 16, 2026 (12 filings since Feb 14, 2022)
  • ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on VOLITIONRX LTD, latest Feb 17, 2026 (6 filings since Nov 14, 2024)
  • Cameron John Reynolds Filed SC 13D/A on VOLITIONRX LTD, latest Feb 9, 2024
  • VOLITIONRX LTD Henderson, Nevada
    • Belgian Volition SRL (100% subsidiary of Singapore Volition Pte. Limited) Subsidiary · Belgium
    • Singapore Volition Pte. Limited (100% subsidiary of VolitionRx Limited) Subsidiary · Singapore
    • Volition America, Inc. (100% subsidiary of Belgian Volition SRL) Subsidiary · Delaware, United States
    • Volition Diagnostics UK Limited (100% subsidiary of Belgian Volition SRL) Subsidiary · United Kingdom
    • Volition Global Services SRL (100% subsidiary of VolitionRx Limited) Subsidiary · Belgium
    • Volition Veterinary Diagnostics Development LLC. ( 87.5% subsidiary of Belgian Volition SRL) Subsidiary · Texas, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What VOLITIONRX LTD 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

ItemLatestA year beforeChange
Property and equipment, before depreciation$10.4M5 Dec 31, 2025$9.4M5 Dec 31, 2024+10.8%
Accumulated depreciation$6.4M5 Dec 31, 2025$5.0M5 Dec 31, 2024+28.5%
Property and equipment, net$4.0M5 Dec 31, 2025$4.4M5 Dec 31, 2024−9.1%
Operating-lease assets (leased space)$495.7K5 Dec 31, 2025$599.8K5 Dec 31, 2024−17.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$1.1M5 Dec 31, 2025$3.3M5 Dec 31, 2024−65.8%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, net$316.7K5 Dec 31, 2025$313.7K5 Dec 31, 2024+0.9%

Properties, in its own words

Listed below are our current facilities as of December 31, 2025:

Location · Primary Function · Approx. Square Feet · Leased or Owned

The rest of Item 2

Namur, Belgium (1) · Research and development · 17,300 · Owned

Namur, Belgium (2) · Manufacturing · 9,688 · Owned

London, UK (3) · Sales and marketing · 323 · Leased, expiring 2027

Henderson, Nevada (4) · Administration · 301 · Leased, expiring 2027

Carlsbad, California (5) · Research and development · 6,645 · Leased, expiring 2027

(1) · Belgian Volition purchased property located in Namur, Belgium, in October 2016, to be used as a laboratory facility for R&D. The purchase price for the property was €1.2 million, exclusive of any closing costs.

(2) · Belgian Volition purchased property located in Namur, Belgium, in December 2020, to be used as a manufacturing facility. The purchase price for the property was €0.6 million, exclusive of any closing costs.

(3) · Volition Diagnostics signed a new 12-month lease for this property located at 93-95 Gloucester Place, London, W1U 6JQ, United Kingdom, commencing February 1, 2026 until January 31, 2027, at an annual rent of £71,400 GBP.

(4) · Volition America signed a new one-year lease for this property, commencing on April 1, 2026, located at 1489 West Warm Springs Road, Suite 110, Henderson, Nevada 89014, at an annual rent of $20,925.

(5) · Volition America signed a sixty-two month lease for this property, commencing on February 1, 2022, located at 6086 Corte Del Cedro, Carlsbad, California 92011 at an annual rent of $99,714.

Item 2 of the 10-K filed Mar 31, 2026.4

Leadership

Who has led VOLITIONRX LTD, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Alexander B. Magallano2011
  2. Cameron John Reynolds2013–2020
  3. Jasmine Kway2020–2021
  4. Salvatore Thomas Butera2021–now

President

  1. Cameron John Reynolds2013–now

Chief financial officer

  1. David Matthew Kratochvil2015–2016
  2. David Cecil Vanston2017–2020
  3. Terig Hughes2021–now

Chief operating officer

  1. Michel Gaetan2021–now
201520202025
Board members and other officers (25)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerGaetan Thomas Michel named Mar 26, 2024 to Jan 28, 202643
  • Executive OfficerLouise Batchelor named Jan 28, 202643
  • Executive OfficerLOUISE ARCHIBALD BATCHELOR named Mar 26, 202444

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Belgian Volition SRL (100% subsidiary of Singapore Volition Pte. Limited) Belgium3
  • Singapore Volition Pte. Limited (100% subsidiary of VolitionRx Limited) Singapore3
  • Volition America, Inc. (100% subsidiary of Belgian Volition SRL) Delaware3
  • Volition Diagnostics UK Limited (100% subsidiary of Belgian Volition SRL) United Kingdom3
  • Volition Global Services SRL (100% subsidiary of VolitionRx Limited) Belgium3
  • Volition Veterinary Diagnostics Development LLC. ( 87.5% subsidiary of Belgian Volition SRL) Texas3

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • STANDARD CAPITAL CORPDec 6, 1999 to Sep 29, 20112

Timeline

  1. Sep 25, 20268-K Unregistered sale of shares45
  2. Sep 15, 20268-K Unregistered sale of shares46
  3. Sep 14, 20268-K Other events47
  4. Sep 2, 20268-K Unregistered sale of shares48
  5. Sep 2, 20268-K Entered a material agreement49
  6. Aug 24, 20268-K Unregistered sale of shares50
  7. Aug 13, 20268-K Results of operations51
  8. Aug 7, 20268-K Unregistered sale of shares52
  9. Jul 21, 20268-K Bylaws or fiscal year changed; Shareholder vote53
  10. Jun 18, 20268-K Unregistered sale of shares54
  11. Jun 10, 20268-K Entered a material agreement; Other events55
  12. May 22, 20268-K Entered a material agreement56
  13. May 4, 2021New chief executive Salvatore Thomas Butera becomes CEO13
  14. Apr 15, 2020New chief executive Jasmine Kway becomes CEO14
  15. Aug 27, 2013New chief executive Cameron John Reynolds becomes CEO15
  16. Apr 22, 2011New chief executive Alexander B. Magallano becomes CEO16

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.80) a share, on Nov 13, 2025.57

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results51
  2. May 14, 2026Reported quarterly or annual results58
  3. Mar 31, 2026Reported quarterly or annual results59
  4. Nov 13, 2025Reported quarterly or annual results60
  5. Oct 14, 2025Reported quarterly or annual results61
  6. Aug 14, 2025Reported quarterly or annual results62
  7. May 15, 2025Reported quarterly or annual results63
  8. Mar 31, 2025Reported quarterly or annual results64

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

580 filings to the SEC since October 2021: 6 annual reports, 16 quarterly reports, 70 major events, 399 insider forms, 19 large holders, 3 private raises, 67 other. The latest 20:

  1. Sep 30, 20264 EDGAR
  2. Sep 30, 20264 EDGAR
  3. Sep 25, 20268-K EDGAR
  4. Sep 16, 2026SCHEDULE 13D/A EDGAR
  5. Sep 15, 20268-K EDGAR
  6. Sep 14, 20268-K EDGAR
  7. Sep 9, 2026EFFECT EDGAR
  8. Sep 9, 2026S-3/A EDGAR
  9. Sep 8, 2026S-3/A EDGAR
  10. Sep 4, 2026SCHEDULE 13D EDGAR
  11. Sep 2, 20268-K EDGAR
  12. Sep 2, 20268-K EDGAR
  13. Aug 28, 2026S-3 EDGAR
  14. Aug 24, 20268-K EDGAR
  15. Aug 21, 2026S-8 EDGAR
  16. Aug 14, 2026SCHEDULE 13G/A EDGAR
  17. Aug 13, 202610-Q EDGAR
  18. Aug 13, 20268-K EDGAR
  19. Aug 7, 20268-K EDGAR
  20. Jul 21, 20268-K EDGAR

The 580 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

60 open-market trades by officers, directors and large owners since October 2021: 56 buys and 4 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Nov 17, 2025Reynolds Cameron JohnPresident and CEOBuy20,000$0.35$7.0KForm 4
Oct 14, 2025Reynolds Cameron JohnPresident and CEOBuy110,000$0.51$56.1KForm 4
Oct 14, 2025Innes Guy ArchibaldDirectorBuy96,153$0.51$49.0KForm 4
Oct 14, 2025STILL TIMOTHY IDirectorBuy48,076$0.51$24.5KForm 4
Sep 12, 2025Reynolds Cameron JohnPresident and CEOBuy15,000$0.66$9.9KForm 4
Aug 5, 2025Innes Guy ArchibaldDirectorBuy78,125$0.64$50.0KForm 4
Aug 5, 2025Reynolds Cameron JohnPresident and CEOBuy78,125$0.64$50.0KForm 4
Jun 12, 2025Reynolds Cameron JohnPresident and CEOBuy12,500$0.59$7.4KForm 4
Jun 3, 2025Innes Guy ArchibaldDirectorBuy20,000$0.54$10.8KForm 4
May 19, 2025Micallef Jacob VincentChief Scientific OfficerBuy50,000$0.43$21.5KForm 4
May 19, 2025Reynolds Cameron JohnPresident and CEOBuy20,000$0.44$8.8KForm 4
Mar 26, 2025Reynolds Cameron JohnPresident and CEOBuy181,818$0.55$100.0KForm 4
Mar 26, 2025Innes Guy ArchibaldDirectorBuy181,818$0.55$100.0KForm 4
Dec 9, 2024Innes Guy ArchibaldDirectorBuy174,764$0.57$99.6KForm 4
Dec 9, 2024STILL TIMOTHY IDirectorBuy87,382$0.57$49.8KForm 4
Dec 9, 2024Micallef Jacob VincentChief Scientific OfficerBuy43,691$0.57$24.9KForm 4
Dec 9, 2024Reynolds Cameron JohnPresident and CEOBuy139,811$0.57$79.7KForm 4
Aug 20, 2024Innes Guy ArchibaldDirectorBuy150,000$0.67$100.5KForm 4
Jan 2, 2024Eight Corp Ltd10% ownerSale20,000$0.90$18.0KForm 4
Dec 18, 2023Butera Salvatore ThomasCEO - Volition VeterinaryBuy10,000$0.83$8.3KForm 4

All 60 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.

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.

YearExecutiveAgeSalaryTotal pay
2025Cameron Reynolds55$473.9K$638.2K68
2025Dr. Salvatore Thomas Butera$296.1K$501.0K68
2025Dr. Gaetan Michel53$178.2K$439.6K68
2024President and Chief Executive Officer$351.9K$554.0K68
2024Chief Operating Officer$293.6K$455.3K68
2024Chief Executive OfficerVolition Vet$289.0K$388.2K68

Money raised

Private offerings the company reported to the SEC on Form D.

  1. May 20, 2025Raised $22.6 million in a private offering of debt Form D: 1 investor so far Form D
  2. Mar 12, 2024Raised $100,000 in a private offering of equity Form D: 1 investor so far Form D

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.

FundSharesValueShare of the fundChange
Lagoda Investment Management, L.P.1,455,950$2.0M1.1%New
Luminus Management LLC156,897$211.8K0.1%New
Geode Capital Management, LLC55,537$75.0K0.0%New
Vanguard Capital Management LLC50,684$68.4K0.0%New
Wealthspire Advisors, LLC45,000$60.8K0.0%New
State Street Corp33,995$45.9K0.0%New
XTX Topco Ltd25,381$34.3K0.0%New
Vanguard Fiduciary Trust Co25,133$33.9K0.0%New
BlackRock, Inc.22,308$30.1K0.0%New
Northern Trust Corp12,978$17.5K0.0%New
Silverberg Bernstein Capital Management LLC12,520$16.9K0.0%New
Squarepoint Ops LLC10,685$14.4K0.0%New
Tower Research Capital LLC (TRC)5,768$7.8K0.0%New
Arax Advisory Partners5,552$7.5K0.0%New
UBS Group AG4,419$6.0K0.0%New
Group One Trading LLC2,500$3.4K0.0%New
Simplex Trading, LLC2,174$2.9K0.0%New
Northwestern Mutual Wealth Management Co1,999$2.7K0.0%New
Integrated Wealth Concepts LLC1,000$1.4K0.0%New
Barclays PLC357$4820.0%New
SBI Securities Co., Ltd.188$2540.0%New
Morgan Stanley31$420.0%New
Osaic Holdings, Inc.21$280.0%New
Bnp Paribas Financial Markets14$190.0%New
Caitong International Asset Management Co., Ltd1$10.0%New

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How VOLITIONRX LTD is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARVOLITIONRX LTD1
  • CIK0000093314
  • Employer ID (EIN)91-19490784
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2835 In Vitro & In Vivo Diagnostic Substances1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address1489 West Warm Springs Road, Suite 110, Henderson, NV 890141
  • Phone1 (512) 774-89301
  • Shares outstanding13,649,384 as of Aug 11, 202612
  • Public float$72.9M as of Jun 30, 20254
  • AuditorSadler, Gibb & Associates, LLC, Draper, UT PCAOB ID 3627; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceDec 6, 19991
  • Filings1,150 in all: 4 (569), 8-K (146), 10-Q (55), 3 (28), 424B5 (28), CORRESP (28), 10QSB (24), UPLOAD (21)1
    All 53 form types

    10-K (18), DEF 14A (16), EFFECT (16), SC 13G (16), 5 (14), D (14), SC 13D/A (13), PRE 14A (12), SC 13G/A (12), 424B3 (11), S-3 (11), SCHEDULE 13G/A (11), S-8 (10), 10KSB (8), 8-K/A (8), 10QSB/A (6), S-1/A (6), SC 13D (6), S-3/A (5), 4/A (4), S-1 (4), 10KSB/A (3), DEFA14A (3), 10-KT/A (2), 10-Q/A (2), 10-K/A (1), 10-KT (1), 10SB12G (1), 3/A (1), 424B1 (1), 424B4 (1), 425 (1), 8-A12B (1), AW (1), CERTNYS (1), D/A (1), NT 10-K (1), NT 10-Q (1), POS AM (1), RW (1), RW WD (1), SB-2 (1), SB-2/A (1), SCHEDULE 13D (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 31, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Jun 2, 2026
    Latest 8-K (8-K) Sep 25, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareVNRXNYSE

From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks VOLITIONRX LTD names in Item 1A of its 10-K filed Mar 31, 2026: 43 risks under these headings, as written.4

  • Certain statements made in this section constitute “forward-looking statements,” which are subject to numerous risks and uncertainties including those described in this section. Refer to the section entitled “Cautionary Note Regarding Forward-Looking Statements” within this Report for additional information.
  • Risks Associated with Our Company
  • Risks Related to Our Business and Business Strategy
  • Risks Related to Product Development, Commercialization and Sales of Our Products
  • Risks Related to Governmental Regulation and Reimbursement
  • Risks Related to Our Intellectual Property
  • Risks Related to Our Securities
  • We may need to raise additional capital in the future. If we are unable to secure adequate funds on terms acceptable to us, we may be unable to execute our plan of operations.
  • We have incurred significant losses, and we may never achieve profitability.
  • It is difficult to forecast our future performance, which may cause our financial results to fluctuate unpredictably.
  • Servicing our existing and future debt, including the Lind Notes, may require a significant amount of cash, and we may not have sufficient cash flow from our business to pay our indebtedness.
  • The diagnostics market is highly competitive and subject to rapid technological change; accordingly, we will face fierce competition, including from companies with greater resources and experience than us, and our intended products may not achieve significant market penetration and/or may become obsolete.
The other 37 risks
  • Our management has broad discretion over the use of our available cash and might not allocate cash in ways that increase the value of your investment.
  • Our future success depends on our ability to retain our officers and directors, scientists, and other key employees and to attract, retain and motivate qualified personnel.
  • If any of our facilities or our laboratory equipment were damaged or destroyed, or if we experience a significant disruption in our operations for any reason, our ability to continue to operate our business could be materially harmed.
  • Failure in our information technology, storage systems or our clinical laboratory equipment could significantly disrupt our operations and our research and development efforts and subject us to liability.
  • Our business and reputation will suffer if we are unable to establish and comply with stringent quality standards to assure that the highest level of quality is observed in the performance of our tests.
  • Declining global economic conditions may have a negative impact on our business.
  • We may engage in acquisitions that are not successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources.
  • If the marketplace does not accept the products in our development pipeline or any other diagnostic products we might develop, we may be unable to generate sufficient revenue to sustain and grow our business.
  • Our business is dependent not only on our ability to successfully develop and commercialize diagnostic products but also the ability of our licensing partners. If we/they fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations.
  • Failure to successfully develop, manufacture, market, and sell our future products will have a material adverse effect on our business, financial condition, and results of operations.
  • The results of pre-clinical studies and completed clinical trials are not necessarily predictive of future results, and our current product candidates may not have favorable results in later studies or trials which, in turn, could have a material adverse effect on our business.
  • Our research and development efforts will be hindered if we are not able to obtain samples, contract with third parties for access to samples or complete timely enrollment in future clinical trials.
  • If the third parties on which we increasingly rely to assist us with our current and anticipated pre-clinical development or clinical trials do not perform as expected, we may not be able to obtain regulatory clearance or approval or commercialize our products.
  • We expect to expand our product development, research and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • We have limited experience with sales and marketing and any failure to build and manage a sales and marketing team effectively, or to successfully engage and maintain third party providers for such services, could have a material adverse effect on our business.
  • We rely on third parties to clinically validate manufacture and supply our intended products. Any problems experienced by these third parties could result in a delay or interruption in the supply of our intended products to our customers, which could have a material negative effect on our business.
  • We depend on third-party distributors to market and sell our products, which will subject us to a number of risks.
  • The manufacturing operations of our third-party manufacturers will likely be dependent upon third-party suppliers, making us vulnerable to supply shortages and price fluctuations, which could harm our business.
  • Defects in our products may subject us to substantial damages which could materially harm our business or financial condition.
  • Our failure to obtain necessary regulatory clearances or approvals on a timely basis would significantly impair our ability to distribute and market our future products on the clinical IVD market.
  • Reductions or changes in reimbursement policies could limit our ability to sell our products.
  • If we are found to have violated laws concerning the privacy and security of patient health information or other personal information, we could be subject to civil or criminal penalties, which could increase our liabilities and harm our reputation or our business.
  • If the patents we rely on to protect our intellectual property prove to be inadequate, our ability to successfully commercialize our products will be harmed and we may never be able to operate our business profitably.
  • If third parties assert that we have infringed their patents and proprietary rights or challenge the validity of our patents and proprietary rights, we may become involved in intellectual property disputes and litigation that would be costly, time consuming, and delay or prevent the development or commercialization of our products.
  • If we are unable to protect our trade secrets, we may be unable to protect our interests in proprietary technology, processes and know-how that is not patentable or for which we have elected not to seek patent protection.
  • The market prices and trading volume of our stock may be volatile.
  • We have identified material weaknesses in our internal control over financial reporting that have not yet been remediated, and although we are working to address such weaknesses, the failure to address these material weaknesses, or the identification of any others, could impact the reliability of our financial reporting and harm investors’ views of us, which could adversely impact our stock price.
  • We have a “going concern” opinion from our auditors, indicating the possibility that we may not be able to continue to operate.
  • If we fail to regain compliance with the NYSE American’s continued listing requirements, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
  • Lind has conversion rights under each of the Lind Notes, the exercise of which could result in the issuance of a substantial amount of our common stock at a significant discount to the trading price of our common stock.
  • Our Second Amended and Restated Certificate of Incorporation exculpates our officers and directors from certain liability to our Company and our stockholders.
  • Our corporate governance documents, certain corporate laws applicable to us, and share ownership by executive officers and directors, could make a takeover attempt, which may be beneficial to our stockholders, more difficult.
  • We do not expect to pay dividends in the foreseeable future.
  • We may in the future issue additional shares of our common stock which would reduce investors’ ownership interests in the Company, and which may cause our stock price to decline.
  • Future sales of our common stock could depress the market price of our common stock.
  • If equity research analysts do not publish research or reports about our business, or if they do publish such reports but issue unfavorable commentary or downgrade our common stock, the price and trading volume of our common stock could decline.
  • We are a smaller reporting company and a non-accelerated filer and we cannot be certain if the reduced disclosure requirements applicable to our filing status, as well as the exemption from the requirement to provide an auditor’s attestation report regarding the effectiveness of our internal controls, will make our common stock less attractive to investors.

Legal proceedings

In the ordinary course of business, we may be subject to claims, counter claims, suits and other litigation of the type that generally arise from the conduct of our business. We are not aware of any threatened or pending litigation that we expect will have a material adverse effect on our business operations, financial condition or results of operations.

The opening of Item 3, Legal Proceedings.4

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