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XGN on Nasdaq

Exagen Inc.

Logo: Exagen Inc., CC BY-SA 4.0, via Wikimedia Commons4

Clinical laboratory company based in Vista, founded in 20021

In its 2026 annual report the company says: “We are a medical technology company primarily focused on the design, development and commercialization of a next-generation portfolio of innovative testing products under our AVISE ® brand, which allow for the differential diagnosis, prognosis and monitoring of complex rheumatic, autoimmune and autoimmune-related disease including, among others, systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).”6 Its revenue was $42 million in 2020.1 Its shares trade on Nasdaq under the symbol XGN.1

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Last updated Oct 21, 2026.

Overview

2002Founded1

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  • TickerXGN on Nasdaq1
  • IndustryMedical Laboratories, life sciences1
  • HeadquartersVista1
  • Websiteexagen.com
  • Legal formpublic company1
  • Incorporated inDE5
  • Business address1261 Liberty Way, Vista, Ca 920815
  • Filer categoryNon-accelerated filer, Smaller reporting company5
  • LEI549300JV2CYDOME5OO173
  • StatusActive3
  • LEI statusLapsed (not renewed)3
  • Registered addressC/O The Corporation Trust Company, 19801 Wilmington, United States3
  • Registered withDivision of Corporations, Department of State, 37285713

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We are a medical technology company primarily focused on the design, development and commercialization of a next-generation portfolio of innovative testing products under our AVISE ® brand, which allow for the differential diagnosis, prognosis and monitoring of complex rheumatic, autoimmune and autoimmune-related disease including, among others, systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). We believe our strong focus and extensive background in the field of rheumatology, combined with our commitment to exceptional customer service and support, position us well to respond to the needs of rheumatologists, primary care physicians, other specialists, and the patients they serve.6 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

58.3%Gross margin7
-21.1%Operating margin7
-30.0%Net margin7
19.7%Revenue growth, 20257
-114.3%Return on equity7
1.28×Debt to equity7
-$14.3MFree cash flow7

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue34¢$27.8M
  • Research and development8¢$6.3M
  • Selling, general and admin58¢$46.6M
  • Income tax0¢$51.0K

Out of $66.6M in revenue.7 The company lost money this year.

Financial statements

Revenue891011127$66.6M in 2025+65% since 2019
0$20.0M$40.0M$60.0M$80.0M2019: $40.4M$40.4M20192020: $42.0M$42.0M2020+4%2021: $48.3M$48.3M2021+15%2022: $45.6M$45.6M2022−6%2023: $52.5M$52.5M2023+15%2024: $55.6M$55.6M2024+6%2025: $66.6M$66.6M2025+20%
Gross profit127$38.8M in 2025+32% since 2023
0$10.0M$20.0M$30.0M$40.0M2023: $29.5M$29.5M20232024: $33.1M$33.1M2024+12%2025: $38.8M$38.8M2025+17%
Operating income891011127-$14.1M in 2025+51% since 2019
-$60.0M-$40.0M-$20.0M02019: -$9.3M-$9.3M20192020: -$15.2M-$15.2M2020+63%2021: -$24.1M-$24.1M2021+58%2022: -$46.1M-$46.1M2022+91%2023: -$22.8M-$22.8M2023−50%2024: -$13.6M-$13.6M2024−40%2025: -$14.1M-$14.1M2025+3%
Net income891011127-$20.0M in 2025+66% since 2019
-$60.0M-$40.0M-$20.0M02019: -$12.0M-$12.0M20192020: -$16.7M-$16.7M2020+39%2021: -$26.9M-$26.9M2021+61%2022: -$47.4M-$47.4M2022+76%2023: -$23.7M-$23.7M2023−50%2024: -$15.1M-$15.1M2024−36%2025: -$20.0M-$20.0M2025+32%

Every line of the income statement as filed: the last 2 fiscal years, latest first.7

Period ending2025-12-312024-12-31
Revenue$66.6M$55.6M
Cost of revenue$27.8M$22.5M
Gross profit$38.8M$33.1M
Selling, general and administrative expenses$46.6M$41.4M
Research and development expenses$6.3M$5.4M
Total operating expenses$52.9M$46.7M
Loss from operations-$14.1M-$13.6M
Interest expense-$4.3M-$2.2M
Loss on extinguishment of debt-$295.0K$0
Change in fair value of warrant liability-$1.5M$0
Interest income$289.0K$767.0K
Loss before income taxes-$19.9M-$15.1M
Income tax expense-$51.0K-$12.0K
Net loss-$20.0M-$15.1M
Net loss per share, basic (in dollars per share)-$0.93-$0.83
Net loss per share, diluted (in dollars per share)-$0.93-$0.83
Weighted-average number of shares used to compute net loss per share, basic (in shares)21.6M shares18.2M shares
Weighted-average number of shares used to compute net loss per share, diluted (in shares)21.6M shares18.2M shares

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Corporate structure

Exagen 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 Exagen Inc.

  • Exagen Inc. Vista, 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 Exagen 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

ItemLatestA year beforeChange
Finance-lease assets$3.1M7 Dec 31, 2025$486.0K7 Dec 31, 2024+542.0%
Operating-lease assets (leased space)$1.4M7 Dec 31, 2025$2.4M7 Dec 31, 2024−40.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$32.2M7 Dec 31, 2025$22.0M7 Dec 31, 2024+46.2%

Properties, in its own words

Our corporate headquarters are located in Vista, California, where we lease approximately 27,000 square feet of office and laboratory space under a lease that expires in 2027, with an option to extend a portion of the lease for an additional five-year period.

We also lease approximately 28,000 square feet of additional office space in Carlsbad, California, under a sublease that is co-terminus with our other lease expiring in 2027. We believe that our current facilities are adequate for our current needs and that suitable additional or alternative spaces will be available in the future on commercially reasonable terms, if required.

Item 2 of the 10-K filed Mar 10, 2026.6

Leadership

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

Chief executive

  1. Fortunato R. Rocca2019–2022
  2. John Aballi2022–now

Chair

  1. Tina Susan Nova2023

President

  1. Fortunato R. Rocca2019–2022
  2. John Aballi2022–now

Chief financial officer

  1. Kamal Adawi2019–2024
  2. Jeffrey G. Black2024–now
20052010201520202025
Board members and other officers (17)

Former names

  • EXAGEN DIAGNOSTICS INCDec 29, 2003 to May 18, 20175

Timeline

  1. Aug 4, 20268-K Results of operations36
  2. Jun 9, 20268-K Shareholder vote37
  3. May 11, 20268-K Results of operations38
  4. Apr 23, 20268-K Executive or director change39
  5. Mar 10, 20268-K Results of operations40
  6. Jan 12, 20268-K Results of operations; Other events41
  7. Nov 4, 20258-K Results of operations42
  8. Jul 29, 20258-K Results of operations43
  9. Jul 17, 20258-K Executive or director change; Other events44
  10. Jun 11, 20258-K Shareholder vote45
  11. May 9, 20258-K Other events46
  12. May 8, 20258-K Entered a material agreement; Other events47
  13. Oct 18, 2022New chief executive John Aballi becomes CEO1
  14. Sep 19, 2019Went public Listed on NASDAQ1
  15. Sep 18, 2019New chief executive Fortunato R. Rocca becomes CEO16
  16. 2002Founded Founded1

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.19) a share, on Nov 4, 2025.48

When it reported results

  1. Aug 4, 2026Reported quarterly or annual results36
  2. May 11, 2026Reported quarterly or annual results38
  3. Mar 10, 2026Reported quarterly or annual results40
  4. Jan 12, 2026Reported quarterly or annual results41
  5. Nov 4, 2025Reported quarterly or annual results42
  6. Jul 29, 2025Reported quarterly or annual results43
  7. May 5, 2025Reported quarterly or annual results49
  8. Mar 11, 2025Reported quarterly or annual results50

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

Filings

226 filings to the SEC since October 2021: 5 annual reports, 16 quarterly reports, 51 major events, 79 insider forms, 38 large holders, 37 other. The latest 20:

  1. Sep 2, 20264 EDGAR
  2. Aug 24, 20264/A EDGAR
  3. Aug 19, 20264 EDGAR
  4. Aug 19, 20264 EDGAR
  5. Aug 4, 202610-Q EDGAR
  6. Aug 4, 20268-K 10-Q EDGAR
  7. Jun 22, 20264 EDGAR
  8. Jun 22, 20264 EDGAR
  9. Jun 22, 20264 EDGAR
  10. Jun 9, 20268-K EDGAR
  11. May 27, 2026SCHEDULE 13G EDGAR
  12. May 20, 2026SCHEDULE 13G/A EDGAR
  13. May 12, 2026S-8 EDGAR
  14. May 11, 202610-Q EDGAR
  15. May 11, 20268-K EDGAR
  16. Apr 27, 2026ARS EDGAR
  17. Apr 27, 2026DEFA14A EDGAR
  18. Apr 27, 2026DEF 14A EDGAR
  19. Apr 23, 20268-K EDGAR
  20. Apr 21, 20263/A EDGAR

The 226 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

20 open-market trades by officers, directors and large owners since October 2021: 5 buys and 15 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 1, 2026Black Jeffrey G.Chief Financial OfficerSale20,614$7.22$148.8KForm 4
Mar 3, 2026ABALLI JOHNPresident and CEOSale15,698$3.62$56.8KForm 4
Feb 24, 2026ABALLI JOHNPresident and CEOSale11,430$3.61$41.3KForm 4
Feb 24, 2026Black Jeffrey G.Chief Financial OfficerSale1,584$3.61$5.7KForm 4
Oct 16, 2025ABALLI JOHNPresident and CEOSale31,787$11.82$375.7KForm 4
Sep 2, 2025Black Jeffrey G.Chief Financial OfficerSale20,466$9.79$200.4KForm 4
Mar 25, 2025NMSIC Co-Investment Fund, L.P.10% ownerSale350,000$3.30$1.2MForm 4
Nov 20, 2024Sun Mountain Capital Partners LLC10% ownerSale200,000$3.30$660.0KForm 4
Nov 15, 2024Black Jeffrey G.Chief Financial OfficerBuy22,298$2.98$66.4KForm 4
Nov 14, 2024ABALLI JOHNPresident and CEOBuy24,305$2.81$68.3KForm 4
May 16, 2024ABALLI JOHNPresident and CEOBuy40,401$1.92$77.6KForm 4
Mar 4, 2024Adawi KamalCFO and Corporate SecretarySale12,784$1.91$24.4KForm 4
Feb 6, 2024Adawi KamalCFO and Corporate SecretarySale6,738$1.95$13.1KForm 4
Oct 17, 2023ABALLI JOHNPresident and CEOSale33,819$1.75$59.2KForm 4
Jun 15, 2023TULLIS GROWTH FUND II, L.P.10% ownerBuy167$3.11$519Form 4
Mar 2, 2023Adawi KamalCFO and Corporate SecretarySale3,667$2.30$8.4KForm 4
Mar 2, 2023Hazeltine MarkChief Business OfficerSale3,667Form 4
Feb 8, 2023Hazeltine MarkChief Business OfficerSale5,821$2.69$15.7KForm 4
Feb 8, 2023Adawi KamalCFO and Corporate SecretarySale5,821$2.69$15.7KForm 4
Dec 8, 2022ABALLI JOHNPresident and CEOBuy90,000$2.68$241.2KForm 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.

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
2025John Aballi41$540.0K$1.4M62
2025Jeffrey Black57$465.0K$746.2K62
2024PresidentChief Executive Officer, Director and former Interim Chief Financial Officer$525.0K$1.2M62
2024Chief Financial Officer and Corporate Secretary$141.5K$1.0M62

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 57. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Wexford Capital LP792,855$3.7M0.5%No change
Nano Cap New Millennium Growth Fund L P675,000$3.1M2.4%+90,000
First Eagle Investment Management, LLC613,930$2.9M0.0%+488,688
Vanguard Capital Management LLC612,832$2.8M0.0%−65,820
FourWorld Capital Management LLC596,528$2.8M3.2%+156,578
Silvercrest Asset Management Group LLC514,761$2.4M0.0%−23,109
Kennedy Capital Management LLC485,048$2.3M0.0%−8,612
Mink Brook Asset Management LLC475,944$2.2M1.0%+106,917
Jane Street Group, LLC322,502$1.5M0.0%+85,767
Marshall Wace, Llp306,703$1.4M0.0%+279,414
Flputnam Investment Management Co288,810$1.3M0.0%New
Rtw Investments, LP195,000$906.8K0.0%−200,231
Geode Capital Management, LLC185,654$863.9K0.0%+6,797
Man Group plc167,292$777.9K0.0%+37,582
BlackRock, Inc.142,625$663.2K0.0%+16,739
Perceptive Advisors LLC114,893$534.3K0.0%No change
XTX Topco Ltd111,948$520.6K0.0%−130,337
Sei Investments Co109,005$506.9K0.0%−135,235
Squarepoint Ops LLC108,993$506.8K0.0%−179,832
Vanguard Fiduciary Trust Co108,649$505.2K0.0%+11,350
Gwn Securities Inc.78,034$362.9K0.1%New
State Street Corp71,256$331.3K0.0%No change
Dimensional Fund Advisors LP62,571$291.0K0.0%No change
Two Sigma Investments, LP59,992$279.0K0.0%−97,829
Perkins Capital Management Inc56,796$264.1K0.2%−15,000

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

SEC filer profile

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

  • Name on EDGAREXAGEN INC.2
  • CIK0001274737
  • Employer ID (EIN)20-04348666
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsDecember 312
  • Industry code (SIC)8071 Services-Medical Laboratories2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address1261 Liberty Way, Vista, CA 920812
  • Phone(760) 560-15012
  • Shares outstanding24,225,339 as of Jul 30, 202614
  • Public float$153.6M as of Jun 30, 20256
  • AuditorBDO USA, P.C., San Diego, California PCAOB ID 243; no auditor attestation of internal control over financial reporting6
  • On EDGAR sinceDec 29, 20032
  • Filings417 in all: 4 (133), 8-K (73), SC 13G/A (29), 3 (24), D (24), 10-Q (21), SC 13G (9), DEFA14A (8)2
    All 39 form types

    S-1/A (8), SCHEDULE 13G/A (8), 10-K (7), 424B5 (7), DEF 14A (7), S-8 (7), CORRESP (6), REGDEX (6), ARS (4), EFFECT (4), UPLOAD (4), 4/A (3), S-3 (3), 144 (2), DRS (2), S-1 (2), SCHEDULE 13G (2), 10-K/A (1), 10-Q/A (1), 3/A (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), D/A (1), DRS/A (1), DRSLTR (1), NT 10-Q (1), S-1MEF (1), S-3/A (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Mar 10, 2026
    Quarterly report (10-Q) Aug 4, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Aug 4, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareXGNThe Nasdaq Global Market

From the cover page of the 10-K filed Mar 10, 2026 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks Exagen Inc. names in Item 1A of its 10-K filed Mar 10, 2026: 73 risks under these headings, as written.6

  • any of the following risks are realized, our business, financial condition, results of operations and prospects could be materially and adversely affected. In that event, the trading price of our common stock could decline, and you could lose part or all of your investment. The risks described below are not the only ones that we may face, and additional risks or uncertainties not known to us or that we currently deem immaterial may also impair our business and future prospects.
  • Risks Related to Our Business and Strategy
  • We have a history of losses, we expect to incur net losses in the future and we may not be able to generate sufficient revenue to achieve and maintain profitability.
  • If third-party payors do not provide coverage and adequate reimbursement for our testing products, or they breach, rescind or modify their contracts or reimbursement policies or delay payments for our testing products, or if we or our partners are unable to successfully negotiate payor contracts, our commercial success could be materially compromised.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide. Our estimates regarding profitability and the time in which we may achieve profitability may ultimately be incorrect.
  • In the near-term, we expect that our financial results will depend primarily on sales of our testing products, and we will need to generate sufficient revenue from these testing products to grow our business.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our common stock may decline.
  • We may be unable to manage our growth effectively, which could make it difficult to execute our business strategy.
  • Our commercial success depends upon attaining and maintaining significant market acceptance of our testing products among rheumatologists, patients, third-party payors and others in the medical community.
  • We may experience limits on our revenue if healthcare providers decide not to order our testing products or if we are otherwise unable to create or maintain demand for our testing products.
  • The sizes of the markets for our testing products have not been established with precision and may be smaller than we estimate.
The other 62 risks
  • We may expend our limited resources to pursue a particular testing product and fail to capitalize on other testing products that may be more profitable or for which there is a greater likelihood of success.
  • We rely on sole suppliers for some of the reagents, equipment and other materials used in our testing products, and we may not be able to find replacements or transition to alternative suppliers.
  • If we are unable to support demand for our current testing products or any of our future testing products or solutions, our business could suffer.
  • Billing for our testing products is complex, and we must dedicate substantial time and resources to the billing process to be paid for our testing products.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • If we are unable to maintain or expand our sales and marketing force, as needed, to adequately address our customers’ and future partners’ needs, our business may be adversely affected.
  • If we are unable to compete successfully, we may be unable to increase or sustain our revenue or achieve profitability.
  • Developing new testing products involves a lengthy and complex process, and we may not be able to commercialize on a timely basis, or at all, other testing products we are developing.
  • If we cannot enter into new clinical study collaborations, our product development and subsequent commercialization could be delayed.
  • We may acquire businesses or assets, form joint ventures or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.
  • The diagnostic industry is subject to rapidly changing technology, which could make our current and future testing products obsolete.
  • Our failure to maintain relationships or build new relationships with key opinion leaders could materially adversely impact our business and prospects.
  • If we are sued for errors and omissions or professional liability, we could face substantial liabilities that exceed our resources.
  • The loss of members of our senior management team or our inability to attract and retain highly skilled scientists, technicians and salespeople could adversely affect our business.
  • If our sole clinical laboratory facility becomes damaged or inoperable, we are required to vacate our existing facility or we are unable to expand our existing facility as needed, we will be unable to perform our testing services and our business will be harmed.
  • Our testing process involves the use of sophisticated state-of-the-art equipment that requires precise calibration, and issues affecting such equipment may delay delivery or impact the quality of the test results to rheumatologists or otherwise adversely affect our operations.
  • Failure in our information technology, telephone or other systems could significantly disrupt our operations and adversely affect our business and financial condition.
  • Security breaches, loss of data and other disruptions to us, our third-party service providers or our partners could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could materially and adversely affect our business and our reputation.
  • Our financial condition, commercialization efforts and results of operations have been and may again in the future be adversely affected by outbreaks of contagious diseases.
  • Performance issues, service interruptions or price increases by our shipping carrier could adversely affect our business, results of operations and financial condition, and harm our reputation and ability to provide testing services on a timely basis.
  • Inflation could adversely affect our business and financial results.
  • Changes in U.S. trade policy and the impact of tariffs may have a material adverse effect on our business, results of operations and financial condition.
  • Inadequate funding for the SEC and other government agencies, or a work slowdown or stoppage at those agencies as part of a broader federal government shutdown, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • We maintain cash deposits in excess of federally insured limits. Adverse developments affecting financial institutions, including bank failures, could adversely affect our liquidity and financial performance.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • Our term loan contains restrictions that limit our flexibility in operating our business, and if we fail to comply with the covenants and other obligations under our loan agreement, the lenders may be able to accelerate amounts owed under the facility and may foreclose upon the assets securing our obligations.
  • We may require substantial additional capital to finance our planned operations, which may not be available to us on acceptable terms or at all. Our failure to obtain additional financing when needed on acceptable terms, or at all, could force us to delay, limit, reduce or eliminate our product development programs, commercialization efforts or other operations.
  • We are a smaller reporting company and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
  • Risks Related to Regulatory and Compliance Matters
  • Healthcare policy changes could cause significant harm to our business, operations and financial condition.
  • Complying with numerous regulations pertaining to our business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties.
  • We conduct business in a heavily regulated industry. Complying with the numerous statutes and regulations pertaining to our business is expensive and time-consuming, and any failure by us, our consultants or commercial partners to comply could result in substantial penalties.
  • If we use hazardous materials in a manner that causes contamination or injury, we could be liable for resulting damages.
  • We have previously and may again in the future be required to modify our business practices, pay fines, incur significant expenses or experience losses due to litigation or governmental investigations.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • The FDA may disagree with our assessment that our AVISE® test products and any other tests we may develop are LDTs eligible for enforcement discretion and determine that such test products are fully subject to active compliance enforcement under the FDCA and FDA regulations.
  • The FTC and/or state enforcement or regulatory agencies may object to the methods and materials we use to promote our tests and initiate enforcement against us, which could adversely affect our business and financial condition.
  • Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could materially and adversely affect our business, results of operations and financial condition.
  • Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • Risks Related to our Intellectual Property
  • If we are unable to maintain or obtain intellectual property protection, our competitive position could be harmed.
  • Certain of our testing products utilize unpatented technology that is publicly available and can be used by our competitors.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our testing products.
  • Some of our intellectual property has been discovered through government funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights, and limit our ability to contract with non-U.S. manufacturers.
  • We may not be able to protect our intellectual property rights throughout the world.
  • The patent protection and patent prosecution for some of our testing products may be dependent on third parties.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment 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 not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • Third-party claims alleging intellectual property infringement may prevent or delay our development efforts.
  • We may be involved in proceedings to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
  • Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • Risks Related to Our Common Stock
  • Our stock price may be volatile, and you may not be able to sell shares of our common stock at or above the price you paid.
  • Future sales of shares by existing stockholders could cause our stock price to decline.
  • We have incurred and will continue to incur increased costs and demands upon management as a result of complying with the laws and regulations affecting public companies in the United States, which may adversely affect our results of operations.
  • Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Our executive officers, directors and principal stockholders, if they choose to act together, have the ability to control or significantly influence all matters submitted to stockholders for approval.
  • We have never paid dividends on our capital stock, and we do not anticipate paying dividends in the foreseeable future. Your ability to achieve a return on your investment will depend on appreciation, if any, in the price of our common stock.
  • An active, liquid trading market for our common stock may not be maintained.
  • Our failure to meet the continued listing requirements of Nasdaq or the Nasdaq Stock Market LLC could result in a delisting of our common stock.
  • If securities or industry analysts downgrade our common stock or otherwise issue adverse opinions or commentary regarding our stock or do not publish research or reports about our company, our stock price and trading volume could decline.
  • We could be subject to securities class action litigation.

Legal proceedings

From time to time, we may be involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of the outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained.

Pursuant to a settlement agreement with the DOJ, which has been previously disclosed, we made a single lump-sum remittance to the government in the amount of $0.7 million plus interest in October 2023. The U.S. Attorney’s Office dismissed the “covered conduct” elements in the qui tam with prejudice, while non-covered conduct was dismissed without prejudice. The DOJ excused itself from the case in connection with the settlement. Our ability to participate in federally funded healthcare programs was unaffected by the settlement. In November 2023, the complaint was unsealed and served on us. We filed a motion to dismiss the complaint. In February 2024, the relator filed a motion for leave to amend the complaint. We opposed this motion. In March 2025, the court granted our motion to dismiss with prejudice and denied the relator’s motion for leave to amend. On April 14, 2025, the relator filed an appeal with respect to this ruling. On July 15, 2025, the qui tam case was dismissed with prejudice by the presiding judge. Both the DOJ and the relator’s counsel filed a stipulation of dismissal in the matter.

Items 4. Mine Safety Disclosures.

The opening of Item 3, Legal Proceedings.6

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