PRPO on Nasdaq

Precipio, Inc.

In its 2026 annual report the company says: “We are a healthcare biotechnology company with a mission to battle the systemic problem of disease misdiagnosis, by focusing on improving cancer diagnostics, particularly, hematologic malignancies. Our objective is to enhance diagnostic accuracy and accessibility while building a sustainable business model that supports ongoing innovation.”5 It is headquartered in New Haven, United States.2 Its shares trade on Nasdaq under the symbol PRPO.2

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Last updated Oct 21, 2026.

Overview

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  • TickerPRPO on Nasdaq2
  • IndustryLaboratory Analytical Instruments2
  • HeadquartersNew Haven, United States2
  • Incorporated inDE3
  • Business address4 Science Park, New Haven, Ct 065113
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI54930079ULTBRXUQNR892
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O THE CORPORATION TRUST COMPANY, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 32571272

We are a healthcare biotechnology company with a mission to battle the systemic problem of disease misdiagnosis, by focusing on improving cancer diagnostics, particularly, hematologic malignancies. Our objective is to enhance diagnostic accuracy and accessibility while building a sustainable business model that supports ongoing innovation. We aim to achieve this through a combination of clinical laboratory services and proprietary diagnostic product development. By integrating diagnostic services with product development, our service business doubles as a self-funded research and development (“R&D”) unit, enabling us to achieve rapid and cost-efficient innovation rather than being a major cost center for us.5 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

44.2%Gross margin6
-5.0%Operating margin6
-1.5%Net margin6
30.5%Revenue growth, 20256
-2.5%Return on equity6
0.00×Debt to equity6
$359.0KFree cash flow6

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Service revenue, net brought in 89% of the revenue Precipio, Inc. broke down this way in fiscal 2025.

  1. Service revenue, net$21.5M689%up 35% from 2024
  2. Product$2.7M611%up 5% from 2024
Products and services by year
Products and services20242025
Service revenue, net$16.0M$21.5M
Product$2.6M$2.7M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue55¢$13.3M
  • Research and development7¢$1.6M
  • Other costs38¢$9.3M

Out of $24.2M in revenue.6 The company lost money this year.

Where each dollar of operating cash went, fiscal 2025

  • Capital spending48¢$326.0K
  • Kept or used elsewhere52¢$359.0K

Out of $685.0K of cash from operations.6

Financial statements

Revenue78910116$24.2M in 2025+492% since 2019
0$10.0M$20.0M$30.0M2019: $4.1M$4.1M20192020: $7.4M$7.4M2020+81%2021: $8.7M$8.7M2021+17%2022: $9.8M$9.8M2022+13%2023: $15.4M$15.4M2023+57%2024: $18.6M$18.6M2024+21%2025: $24.2M$24.2M2025+31%
Gross profit78910116$10.7M in 2025+4789% since 2019
0$5.0M$10.0M$15.0M2019: $219.0K$219.0K20192020: $1.1M$1.1M2020+425%2021: $2.4M$2.4M2021+108%2022: $2.5M$2.5M2022+5%2023: $6.0M$6.0M2023+140%2024: $7.6M$7.6M2024+26%2025: $10.7M$10.7M2025+42%
Operating income78910116-$1.2M in 2025−89% since 2019
-$15.0M-$10.0M-$5.0M02019: -$11.0M-$11.0M20192020: -$9.1M-$9.1M2020−17%2021: -$9.6M-$9.6M2021+5%2022: -$12.8M-$12.8M2022+33%2023: -$7.6M-$7.6M2023−40%2024: -$4.2M-$4.2M2024−45%2025: -$1.2M-$1.2M2025−71%
Net income128910116-$363.0K in 2025−97% since 2019
-$15.0M-$10.0M-$5.0M02019: -$13.2M-$13.2M20192020: -$10.6M-$10.6M2020−20%2021: -$8.5M-$8.5M2021−20%2022: -$12.2M-$12.2M2022+43%2023: -$5.9M-$5.9M2023−52%2024: -$4.3M-$4.3M2024−27%2025: -$363.0K-$363.0K2025−92%

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Revenue, net of contractual allowances and adjustments$24.2M$18.6M
Adjustment for allowance for credit losses-$197.0K-$44.0K
Net sales$24.0M$18.5M
Total cost of sales$13.3M$11.0M
Gross profit$10.7M$7.6M
Operating expenses$11.9M$11.8M
OPERATING LOSS-$1.2M-$4.2M
Interest expense, net-$73.0K-$74.0K
Gain on settlement of liability$143.0K
Employee Retention Credit$789.0K
Other expense-$20.0K
Total other income (expense)$839.0K-$74.0K
LOSS BEFORE INCOME TAXES-$363.0K-$4.3M
INCOME TAX EXPENSE$0$0
NET LOSS-$363.0K-$4.3M
BASIC LOSS PER COMMON SHARE-$0.23-$2.93
BASIC WEIGHTED-AVERAGE SHARES OF COMMON STOCK OUTSTANDING1.6M shares1.5M shares
DILUTED LOSS PER COMMON SHARE-$0.23-$2.93
DILUTED WEIGHTED-AVERAGE SHARES OF COMMON STOCK OUTSTANDING1.6M shares1.5M shares

Compare Precipio, Inc. with another company

Corporate structure

Precipio, Inc. sits at the top of its group. 3 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Precipio, Inc.

  • Leviticus Partners LP Filed SCHEDULE 13G/A on Precipio, Inc., latest Feb 10, 2026 (3 filings since Sep 22, 2025)
  • David A. Eklund Filed SC 13G on Precipio, Inc., latest Aug 2, 2024
  • Precipio, Inc. New Haven, Connecticut, United States
    • Precipio Diagnostics, LLC Subsidiary · Delaware, United States
    • Precipio SPV, Inc. Subsidiary · Delaware, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); 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 Precipio, 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
Property and equipment, before depreciation$2.6M6 Dec 31, 2025$2.3M6 Dec 31, 2024+10.6%
Accumulated depreciation$1.9M6 Dec 31, 2025$1.6M6 Dec 31, 2024+14.7%
Property and equipment, net$729.0K6 Dec 31, 2025$719.0K6 Dec 31, 2024+1.4%
Finance-lease assets$998.0K6 Dec 31, 2025$517.0K6 Dec 31, 2024+93.0%
Operating-lease assets (leased space)$2.6M6 Dec 31, 2025$395.0K6 Dec 31, 2024+549.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$2.7M6 Dec 31, 2025$1.4M6 Dec 31, 2024+90.9%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$10.9M6 Dec 31, 2025$11.9M6 Dec 31, 2024−8.0%

Inventory

ItemLatestA year beforeChange
Inventory, total$935.0K6 Dec 31, 2025$724.0K6 Dec 31, 2024+29.1%

Properties, in its own words

We currently lease approximately 15,298 square feet of laboratory and office space in New Haven, Connecticut, which we occupy under leases expiring in February 2030 with annual rental payments between $0.4 million and $0.6 million. We also lease approximately 6,808 square feet of laboratory space in Omaha, Nebraska, which we occupy under a lease expiring in July 2030 with annual rental payments of $0.1 million. We believe that these facilities are adequate to meet our current and planned needs. We believe that if additional space is needed in the future, we could find alternate space at competitive market rates as needed.

Item 2 of the 10-K filed Mar 30, 2026.5

Leadership

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

Board members and other officers (28)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Precipio Diagnostics, LLC Delaware4
  • Precipio SPV, Inc. Delaware4

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

Former names

  • TRANSGENOMIC INCMar 10, 2000 to Jun 30, 20173

Timeline

  1. Aug 14, 20268-K Results of operations52
  2. Jul 31, 20268-K Regulation FD disclosure53
  3. Jun 15, 20268-K Shareholder vote54
  4. May 6, 20268-K Regulation FD disclosure55
  5. Feb 27, 20268-K Results of operations56
  6. Dec 29, 20258-K Executive or director change57
  7. Nov 6, 20258-K Regulation FD disclosure58
  8. Sep 3, 20258-K Ended a material agreement59
  9. Aug 18, 20258-K Regulation FD disclosure60
  10. Jul 31, 20258-K Regulation FD disclosure61
  11. Jun 17, 20258-K Shareholder vote62
  12. May 15, 20258-K Results of operations63
  13. Jul 3, 2017New chief executive Ilan Danieli becomes CEO15
  14. Oct 3, 2013New chief executive Paul Kinnon becomes CEO16
  15. Jul 13, 2006New chief executive Craig James Tuttle becomes CEO17
  16. Jul 10, 2000Founded Precipio, Inc. is founded2

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/202664

When it reported results

  1. Aug 14, 2026Reported quarterly or annual results52
  2. Feb 27, 2026Reported quarterly or annual results56
  3. May 15, 2025Reported quarterly or annual results63
  4. Feb 28, 2022Reported quarterly or annual results65

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

Filings

250 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 50 major events, 138 insider forms, 4 large holders, 38 other. The latest 20:

  1. Aug 14, 20268-K EDGAR
  2. Aug 14, 202610-Q EDGAR
  3. Jul 31, 20268-K EDGAR
  4. Jul 16, 20264 OWNERSHIP DOCUMENT EDGAR
  5. Jul 16, 20264 OWNERSHIP DOCUMENT EDGAR
  6. Jul 16, 20264 OWNERSHIP DOCUMENT EDGAR
  7. Jun 15, 20268-K EDGAR
  8. May 26, 20264 OWNERSHIP DOCUMENT EDGAR
  9. May 21, 20264 OWNERSHIP DOCUMENT EDGAR
  10. May 19, 2026144 EDGAR
  11. May 14, 202610-Q EDGAR
  12. May 6, 20268-K EDGAR
  13. Apr 28, 2026ARS EDGAR
  14. Apr 28, 2026DEFA14A EDGAR
  15. Apr 28, 2026DEF 14A EDGAR
  16. Apr 17, 20264 OWNERSHIP DOCUMENT EDGAR
  17. Apr 17, 20264 OWNERSHIP DOCUMENT EDGAR
  18. Apr 17, 20264 OWNERSHIP DOCUMENT EDGAR
  19. Apr 10, 20264 OWNERSHIP DOCUMENT EDGAR
  20. Mar 30, 202610-K EDGAR

The 250 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

36 open-market trades by officers, directors and large owners since October 2021: 28 buys and 8 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 21, 2026SANDBERG RICHARD ADirectorSale900$25.02$22.5KForm 4
May 20, 2026SANDBERG RICHARD ADirectorSale2,534$24.91$63.1KForm 4
May 19, 2026SANDBERG RICHARD ADirectorSale600$24.42$14.7KForm 4
Apr 1, 2026Sabet Ahmed ZakiChief Operating OfficerBuy19$27.93$531Form 4
Jan 2, 2026Sabet Ahmed ZakiChief Operating OfficerBuy20$23.40$468Form 4
Jan 2, 2026Sabet Ahmed ZakiChief Operating OfficerBuy20$23.40$468Form 4
Oct 1, 2025Sabet Ahmed ZakiChief Operating OfficerBuy25$19.50$488Form 4
Oct 1, 2025Sabet Ahmed ZakiChief Operating OfficerBuy25$19.50$488Form 4
Sep 8, 2025LAPORTE KATHLEENDirectorSale6,152$20.06$123.4KForm 4
Jul 8, 2025Sabet Ahmed ZakiChief Operating OfficerBuy31$16.30$505Form 4
Jul 8, 2025Sabet Ahmed ZakiChief Operating OfficerBuy31$16.30$505Form 4
May 30, 2025SANDBERG RICHARD ADirectorBuy1,399$10.00$14.0KForm 4
May 27, 2025SANDBERG RICHARD ADirectorBuy101$9.80$990Form 4
May 22, 2025SANDBERG RICHARD ADirectorBuy500$9.33$4.7KForm 4
May 21, 2025SANDBERG RICHARD ADirectorBuy8,035$9.27$74.5KForm 4
May 20, 2025SANDBERG RICHARD ADirectorBuy4,251$8.47$36.0KForm 4
May 20, 2025SANDBERG RICHARD ADirectorBuy4,251$8.47$36.0KForm 4
May 19, 2025SANDBERG RICHARD ADirectorBuy714$8.21$5.9KForm 4
May 19, 2025SANDBERG RICHARD ADirectorBuy714$8.21$5.9KForm 4
Apr 2, 2025Sabet Ahmed ZakiChief Operating OfficerBuy79$6.00$474Form 4

All 36 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
2025Ilan DanieliChief Executive Officer54$300.0K$472.7K68
2025Ayman MohamedChief Technology Officer$250.0K$312.1K68
2025Ahmed Zaki SabetChief Operations Officer$250.0K$308.7K68
2024Ilan DanieliChief Executive Officer54$300.0K$462.1K68
2024Ayman MohamedChief Technology Officer$200.0K$403.4K68
2024Ahmed Zaki SabetChief Operations Officer$200.0K$399.1K68

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
Vanguard Capital Management LLC46,148$1.1M0.0%+20,665
BlackRock, Inc.34,655$858.1K0.0%+5,633
Geode Capital Management, LLC18,691$462.9K0.0%−120
Renaissance Technologies LLC16,199$401.1K0.0%−3,101
Citadel Advisors LLC14,714$364.3K0.0%−402
XTX Topco Ltd9,450$234.0K0.0%New
Vanguard Fiduciary Trust Co9,407$232.9K0.0%+62
Dimensional Fund Advisors LP8,396$207.9K0.0%New
UBS Group AG343$8.5K0.0%+116
Wells Fargo & Company/mn50$1.2K0.0%No change
Tower Research Capital LLC (TRC)32$7920.0%−106
Morgan Stanley7$1730.0%New
Allworth Financial LP3$750.0%No change
IFP Advisors, Inc3$740.0%No change
Fmr LLC2$540.0%No change
Citigroup Inc1$250.0%New
Caitong International Asset Management Co., Ltd1$250.0%New
Royal Bank Of Canada11$00.0%No change

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

SEC filer profile

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

  • Name on EDGARPrecipio, Inc.1
  • CIK0001043961
  • Employer ID (EIN)91-17893575
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)3826 Laboratory Analytical Instruments1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address4 Science Park, New Haven, CT 065111
  • Phone203 787 78881
  • Shares outstanding1,790,188 as of Aug 10, 202614
  • Public float$15.2M as of Jun 30, 20255
  • AuditorCBIZ CPAs P.C., New Haven, CT PCAOB ID 199; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceMar 10, 20001
  • Filings1,283 in all: 4 (347), 8-K (329), 10-Q (79), SC 13G/A (54), SC 13D/A (43), 3 (36), 4/A (35), DEF 14A (30)1
    All 51 form types

    10-K (26), SC 13G (24), DEFA14A (23), UPLOAD (22), CORRESP (21), EFFECT (18), 424B3 (17), D (15), 424B5 (14), S-1 (14), S-3 (14), S-1/A (12), S-8 (11), S-3/A (10), NT 10-Q (9), PRE 14A (9), 10-K/A (7), 144 (7), 8-K/A (6), NT 10-K (6), SC 13D (6), 10-Q/A (5), ARS (5), CT ORDER (4), 8-A12B (2), CERTNAS (2), DEFR14A (2), FWP (2), PRER14A (2), SCHEDULE 13G/A (2), 25-NSE (1), 424B1 (1), 8-A12G (1), D/A (1), DEFM14A (1), NT 10-Q/A (1), POS462B (1), PREM14A (1), REGDEX (1), RW (1), S-1MEF (1), S-8 POS (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 30, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Aug 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.01 par value per sharePRPONasdaq

From the cover page of the 10-K filed Mar 30, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Precipio, Inc. names in Item 1A of its 10-K filed Mar 30, 2026: 70 risks under these headings, as written.5

  • Risks Related to Our Business and Strategy
  • There is substantial doubt about our ability to continue as a going concern.
  • Our ability to expand our business may depend on access to additional capital.
  • We are subject to concentrations of revenue risk and concentrations of credit risk in accounts receivable.
  • We may become subject to costly litigation, which could adversely affect our business, financial condition and results of operations.
  • Failure to Comply with Insider Trading Regulations and Policies Could Result in Significant Legal and Reputational Consequences.
  • The commercial success of our diagnostic products, including those we are developing, will depend upon the degree of market acceptance of these products among physicians, patients, health care payers and the medical community and on our ability to successfully market our products.
  • If we cannot compete successfully with our competitors, including new entrants in the market, we may be unable to increase or sustain our revenue or achieve and sustain profitability.
  • We may not be able to develop new products or enhance the capabilities of our systems to keep pace with rapidly changing technology and customer requirements, which could have a material adverse effect on our business and operating results.
  • International expansion of our business could expose us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.
  • The sales of our products in the EU and the UK are regulated through a process that either requires self-certification or certification by a notified body in order to affix a CE mark. Such processes are uncertain, particularly in light of changes to the regulatory framework in the EU and UK. There may be a risk of delay in placing such products on the market and, once on the market, a risk of review and challenges to certain certified statuses.
  • Changes to the UK regulations may require additional review of our devices and there is a risk our devices may not be compliant with any revised UK regulations.
The other 59 risks
  • Our products are subject to evolving regulatory requirements in Great Britain, Northern Ireland and the EU. In Great Britain, medical devices are subject to MHRA registration requirements, and manufacturers established outside the United Kingdom must appoint a UK Responsible Person to satisfy certain regulatory obligations. In addition, the UK government is continuing to implement changes to its medical devices regime, including revised post market surveillance requirements and potential future changes to pre market authorization requirements and reliance mechanisms.
  • Unfavorable U.S. or global economic conditions could adversely affect our business, financial condition or results of operations.
  • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect the Company’s current and projected business operations and its financial condition and results of operations.
  • Failure to obtain and retain new customers, the loss of existing customers or material contracts, or a reduction in services or tests ordered or specimens submitted by existing customers, or the inability to retain existing and/or create new relationships with health systems could impact our ability to successfully grow its business.
  • Global climate change could negatively affect our business.
  • We may be impacted by economic and supply disruptions associated with events beyond our control, such as war, including the current conflicts between Russia and Ukraine and between Israel and Hamas, acts of terror, political unrest, public health concerns, labor disputes or natural disasters.
  • Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations.
  • We depend upon a limited number of key personnel, and if we are not able to retain them or recruit additional qualified personnel, the execution of our strategy, management of our business and commercialization of our product candidates could be delayed or negatively impacted.
  • We will need to increase the size of our organization, and we may experience difficulties in managing growth.
  • We currently have limited experience in marketing products. If we are unable to establish marketing and sales capabilities and retain the proper talent to execute on our sales and marketing strategy, we may not be able to generate product revenue.
  • We need to ensure strong product performance and reliability to maintain and grow our business.
  • We are subject to stringent and changing laws, regulations and standards, and contractual obligations relating to privacy, data protection, and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions (which could include civil or criminal penalties), fines and sanctions, private litigation and/or adverse publicity and could negatively affect our operating results and business.
  • Our use of new and evolving technologies, such as artificial intelligence, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
  • Cybersecurity risks could compromise our information and expose us to liability, which may harm our ability to operate effectively and may cause our business and reputation to suffer.
  • Changes in tax law could adversely affect our business and financial condition.
  • U.S. federal, state and local and non-U.S. tax laws are subject to change through legislative, administrative and judicial actions. Changes to tax laws or regulations, or changes in interpretations of existing laws (which changes may have retroactive effect), could increase our tax liability, reduce available tax benefits, or otherwise adversely affect our financial condition and results of operations.
  • In addition, changes in tax policy, including the potential expiration or modification of provisions enacted under prior tax reform legislation, the imposition of new income or non-income taxes (such as payroll, sales, use, value-added, digital or other taxes), or changes in international tax rules, could increase our compliance costs or overall tax burden. As we expand our business activities, including internationally, our exposure to tax law changes may increase. Any such changes could materially adversely affect our financial condition and results of operations.
  • Our ability to use net operating loss carryforwards to offset future taxable income for U.S. federal tax purposes is subject to limitation and risk that could further limit our ability to utilize our net operating losses.
  • The testing, manufacturing and marketing of diagnostics entails an inherent risk of product liability and personal injury claims.
  • All of our diagnostic technology development and our clinical services are performed at two laboratories, and in the event either or both of these facilities were to be affected by a termination of the lease or a man-made or natural disaster, our operations could be severely impaired.
  • An impairment in the carrying value of our intangible assets could negatively affect our results of operations.
  • Reimbursement and Regulatory Risks Relating to Our Business
  • Governmental payers and health care plans have taken steps to control costs, which could negatively affect our business.
  • Changes in payer mix could have a material adverse impact on our net sales and profitability.
  • Our laboratories require ongoing CLIA certification, and we cannot guarantee that our laboratories will pass all future certification inspections.
  • Our products that we sell as research use only products and/or that we offer as laboratory developed tests could become subject to government regulations requiring marketing authorization, and the marketing authorization and maintenance process for such products may be expensive, time-consuming and uncertain in both timing and outcome.
  • Failure to comply with HIPAA could be costly.
  • Our failure to comply with any applicable government laws and regulations or otherwise respond to claims relating to improper handling, storage or disposal of hazardous chemicals that we use may adversely affect our results of operations.
  • We may become subject to the Anti-Kickback Statute, Stark Law, False Claims Act, Civil Monetary Penalties Law and may be subject to analogous provisions of applicable state laws and could face substantial penalties if we fail to comply with such laws.
  • Anti-Kickback Statute
  • False Claims Act
  • Civil Monetary Penalties Law
  • The use of artificial intelligence in diagnostic or laboratory applications may subject us to additional regulatory and liability risks.
  • Intellectual Property Risks Related to Our Business
  • We cannot be certain that measures taken to protect our intellectual property will be effective.
  • If any of our owned patent applications do not issue as patents in any jurisdiction, we may not be able to compete effectively.
  • We depend on certain technologies that are licensed to us. We do not control these technologies and any loss of our rights to them could prevent us from selling some of our products.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Third-party claims of intellectual property infringement, misappropriation or other violations may prevent or delay our product discovery and development efforts and have a material adverse effect on 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 become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.
  • Changes to the patent law in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • Third parties may assert ownership or commercial rights to inventions we develop.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Risks Related to Our Common Stock
  • The price of our common stock may fluctuate significantly, which could negatively affect us and holders of our common stock.
  • The price of our stock may be vulnerable to manipulation.
  • If we cannot continue to satisfy Nasdaq listing maintenance requirements and other rules, our securities may be delisted, which could negatively impact the price of our securities.
  • Increased costs associated with corporate governance compliance may significantly impact our results of operations.
  • Our internal control over financial reporting and our disclosure controls and procedures may not prevent all possible errors that could occur.
  • We have not paid dividends on our common stock in the past and do not expect to pay dividends on our common stock for the foreseeable future. Any return on investment may be limited to the value of our common stock.
  • We may be at an increased risk of securities class action litigation.
  • If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our diagnostic technologies or current or future development programs.
  • The issuance of our common stock to creditors or litigants may cause significant dilution to our stockholders and cause the price of our common stock to fall.
  • Improper timing of equity awards could result in regulatory scrutiny and reputational harm.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
  • Our amended and restated bylaws, as amended, designate specific courts in as the exclusive forum for certain litigation that may be initiated by the Company’s stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us.
  • Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control, which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.
  • 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.

Legal proceedings

The healthcare industry is subject to numerous laws and regulations of federal, state and local governments. These laws and regulations include, but are not limited to, matters such as licensure, accreditation, government healthcare program participation requirement, reimbursement for patient services and Medicare and Medicaid fraud and abuse. Government activity has increased with respect to investigations and allegations concerning possible violations of fraud and abuse statutes and regulations by healthcare providers.

Violations of these laws and regulations could result in expulsion from government healthcare programs together with the imposition of significant fines and penalties, as well as significant repayments for patient services previously billed. Management believes that the Company is in compliance with fraud and abuse regulations, as well as other applicable government laws and regulations. While no material regulatory inquiries have been made, compliance with such laws and regulations can be subject to future government review and interpretation, as well as regulatory actions unknown or unasserted at this time.

The outcome of legal proceedings and claims brought against us are subject to significant uncertainty. If one or more of these legal matters were resolved against us in the same reporting period for amounts in excess of management’s expectations, our financial statements for such reporting period could be materially and adversely affected. In general, the resolution of a legal matter resolved against us, could also prevent us from offering our services or products to others, could be material to our financial condition or cash flows, or both, or could otherwise adversely affect our operating results.

The opening of Item 3, Legal Proceedings.5

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