Overview
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- TickerCODX on Nasdaq2
- IndustrySurgical & Medical Instruments & Apparatus2
- HeadquartersSalt Lake City, United States2
- Incorporated inUT3
- Business address2401 S Foothill Drive, Suite D, Salt Lake City, Ut 841093
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI549300Z1JPESYWFM1R932
- StatusActive2
- LEI statusIssued and current2
- Registered addressc/o BRIAN BROWN, 2401 South Foothill Drive; Suite D, 84109 Salt Lake City, United States2
- Registered withUtah Division of Corporations & Commercial Code (Department of Commerce), 8650065-01422
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Nucleotide Polymorphism (“SNP”) detection and enrichment for next generation sequencing.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
What sells
Revenue by product, business segment and region, as the company reports it to the SEC.
Products and services
Product brought in 67% of the revenue Co-Diagnostics, Inc. broke down this way in fiscal 2025.
Products and services by year
| Products and services | 2024 | 2025 |
|---|---|---|
| Product | $770.0K | $418.2K |
| Grant | $3.1M | $204.3K |
Regions
United States brought in 93% of the revenue Co-Diagnostics, Inc. broke down this way in fiscal 2025.
Regions by year
| Regions | 2024 | 2025 |
|---|---|---|
| United States | $3.5M | $581.5K |
| Outside the United States | $391.8K | $40.9K |
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Cost of revenue1¢$222.4K
- Research and development91¢$19.1M
- Income tax8¢$1.6M
Out of $622.5K in revenue.6 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.6
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Total revenue | $622.5K | $3.9M |
| Cost of revenue | $222.4K | $999.1K |
| Gross profit | $400.1K | $2.9M |
| Sales and marketing | $2.4M | $4.5M |
| General and administrative | $9.1M | $16.2M |
| Research and development | $19.1M | $21.0M |
| Depreciation and amortization | $1.1M | $1.4M |
| Impairment charges | $18.9M | |
| Total operating expenses | $50.6M | $43.0M |
| Loss from operations | -$50.2M | -$40.1M |
| Interest income, net | $292.9K | $1.1M |
| Realized gain on investments | $683.4K | $870.7K |
| Gain (loss) on disposition of assets | -$82.4K | $8.3K |
| Gain on remeasurement of acquisition contingencies | $805.9K | $714.9K |
| Loss on equity method investment in joint ventures | -$46.3K | -$186.1K |
| Total other income, net | $1.7M | $2.5M |
| Loss before income taxes | -$48.5M | -$37.6M |
| Income tax provision (benefit) | -$1.6M | $57.4K |
| Net loss | -$46.9M | -$37.6M |
| Change in net unrealized gains (losses) on marketable securities, net of tax | -$418.4K | $271.7K |
| Total other comprehensive income (loss) | -$418.4K | $271.7K |
| Comprehensive loss | -$47.3M | -$37.4M |
| Basic | -$35.25 | -$37.22 |
| Diluted | -$35.25 | -$37.22 |
| Basic | 1.3M shares | 1.0M shares |
| Diluted | 1.3M shares | 1.0M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 4 fiscal years (annual) or 4 quarters (quarterly), latest first.6
| Period ending | 2025-12-31 | 2025-11-30 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $11.9M | $2.9M | ||
| Marketable investment securities | $26.8M | |||
| Accounts receivable, net | $190.4K | $132.6K | $303.9K | |
| Inventory, net | $992.4K | $1.1M | ||
| Income taxes receivable | $44.6K | |||
| Prepaid expenses and other current assets | $581.5K | $1.3M | ||
| Total current assets | $13.7M | $32.3M | ||
| Property and equipment, net | $2.3M | $2.8M | ||
| Operating lease right-of-use asset | $1.2M | $2.1M | ||
| Intangible assets, net | $7.2M | $26.1M | ||
| Investment in joint ventures | $350.6K | $294.3K | ||
| Total assets | $24.7M | $63.6M | ||
| Accounts payable | $1.9M | $3.3M | ||
| Accrued expenses | $865.3K | $2.6M | ||
| Operating lease liability, current | $662.3K | $915.6K | ||
| Contingent consideration liabilities, current | $119.0K | $502.8K | ||
| Deferred revenue | $14.8K | $40.9K | $362.4K | |
| Total current liabilities | $3.5M | $7.3M | ||
| Income taxes payable | $713.6K | |||
| Operating lease liability | $574.3K | $1.2M | ||
| Contingent consideration liabilities | $422.1K | |||
| Total long-term liabilities | $574.3K | $2.4M | ||
| Total liabilities | $4.1M | $9.7M | ||
| Common stock, $0.001 par value; 100,000,000 shares authorized; 2,256,654 shares issued and 2,095,031 shares outstanding as of December 31, 2025 and 1,263,408 shares issued and 1,101,785 shares outstanding as of December 31, 2024 | $67.7K | $37.9K | ||
| Treasury stock, at cost; 161,623 shares held as of December 31, 2025 and December 31, 2024, respectively | -$15.6M | -$15.6M | ||
| Additional paid-in capital | $116.5M | $102.5M | ||
| Accumulated other comprehensive income | $418.4K | |||
| Accumulated deficit | -$80.4M | -$33.5M | ||
| Total stockholders equity | $20.6M | $53.9M | $85.6M | |
| Total liabilities and stockholders equity | $24.7M | $63.6M | ||
| Convertible preferred stock, par value | $0.00 | $0.00 | ||
| Convertible preferred stock, shares authorized | 5.0M shares | 5.0M shares | ||
| Convertible preferred stock, shares issued | 0 shares | 0 shares | ||
| Convertible preferred stock, shares outstanding | 0 shares | 0 shares | ||
| Common stock, par value | $0.00 | $0.00 | ||
| Common stock, shares authorized | 100.0M shares | 100.0M shares | ||
| Common stock, shares issued | 2.3M shares | 30 shares | 1.3M shares | |
| Common stock, shares outstanding | 2.1M shares | 30 shares | 1.1M shares | |
| Treasury stock, shares | 161.6K shares | 161.6K shares |
| Period ending | 2025-12-31 | 2025-11-30 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $11.9M | $2.9M | ||
| Marketable investment securities | $26.8M | |||
| Accounts receivable, net | $190.4K | $132.6K | $303.9K | |
| Inventory, net | $992.4K | $1.1M | ||
| Income taxes receivable | $44.6K | |||
| Prepaid expenses and other current assets | $581.5K | $1.3M | ||
| Total current assets | $13.7M | $32.3M | ||
| Property and equipment, net | $2.3M | $2.8M | ||
| Operating lease right-of-use asset | $1.2M | $2.1M | ||
| Intangible assets, net | $7.2M | $26.1M | ||
| Investment in joint ventures | $350.6K | $294.3K | ||
| Total assets | $24.7M | $63.6M | ||
| Accounts payable | $1.9M | $3.3M | ||
| Accrued expenses | $865.3K | $2.6M | ||
| Operating lease liability, current | $662.3K | $915.6K | ||
| Contingent consideration liabilities, current | $119.0K | $502.8K | ||
| Deferred revenue | $14.8K | $40.9K | $362.4K | |
| Total current liabilities | $3.5M | $7.3M | ||
| Income taxes payable | $713.6K | |||
| Operating lease liability | $574.3K | $1.2M | ||
| Contingent consideration liabilities | $422.1K | |||
| Total long-term liabilities | $574.3K | $2.4M | ||
| Total liabilities | $4.1M | $9.7M | ||
| Common stock, $0.001 par value; 100,000,000 shares authorized; 2,256,654 shares issued and 2,095,031 shares outstanding as of December 31, 2025 and 1,263,408 shares issued and 1,101,785 shares outstanding as of December 31, 2024 | $67.7K | $37.9K | ||
| Treasury stock, at cost; 161,623 shares held as of December 31, 2025 and December 31, 2024, respectively | -$15.6M | -$15.6M | ||
| Additional paid-in capital | $116.5M | $102.5M | ||
| Accumulated other comprehensive income | $418.4K | |||
| Accumulated deficit | -$80.4M | -$33.5M | ||
| Total stockholders equity | $20.6M | $53.9M | $85.6M | |
| Total liabilities and stockholders equity | $24.7M | $63.6M | ||
| Convertible preferred stock, par value | $0.00 | $0.00 | ||
| Convertible preferred stock, shares authorized | 5.0M shares | 5.0M shares | ||
| Convertible preferred stock, shares issued | 0 shares | 0 shares | ||
| Convertible preferred stock, shares outstanding | 0 shares | 0 shares | ||
| Common stock, par value | $0.00 | $0.00 | ||
| Common stock, shares authorized | 100.0M shares | 100.0M shares | ||
| Common stock, shares issued | 2.3M shares | 30 shares | 1.3M shares | |
| Common stock, shares outstanding | 2.1M shares | 30 shares | 1.1M shares | |
| Treasury stock, shares | 161.6K shares | 161.6K 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.6
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$46.9M | -$37.6M |
| Depreciation and amortization | $1.1M | $1.4M |
| Impairment charges | $18.9M | |
| Stock-based compensation expense | $2.2M | $5.4M |
| Common stock issued for financial advisory services | $135.0K | |
| Change in fair value of acquisition contingencies | -$805.9K | -$714.9K |
| Non-cash lease expense | -$8.2K | $13.5K |
| Realized gain on investments | -$683.4K | -$870.7K |
| Loss from equity method investment | $46.3K | $186.1K |
| (Gain) loss on disposition of assets | $82.4K | -$8.3K |
| Recoveries of credit losses | -$26.0K | -$15.0K |
| Inventory obsolescence expense (recovery) | -$50.9K | $326.5K |
| Accounts receivable | -$31.8K | $186.4K |
| Prepaid expenses and other assets | $585.9K | $412.1K |
| Inventory | $131.3K | $265.5K |
| Deferred revenue | -$26.1K | -$321.6K |
| Income taxes payable | -$713.6K | $54.5K |
| Accounts payable, accrued expenses and other liabilities | -$3.1M | $2.2M |
| Net cash used in operating activities | -$29.1M | -$29.2M |
| Purchases of property and equipment | -$700.0K | -$748.4K |
| Proceeds from maturities of marketable investment securities | $33.7M | $58.8M |
| Purchases of marketable securities | -$6.6M | -$40.8M |
| Investment in joint ventures | -$102.6K | -$143.8K |
| Net cash provided by investing activities | $26.3M | $17.1M |
| Proceeds from exercise of options | $12.5K | |
| Issuance of common stock related to at-the-market offering, net of offering costs | $1.8M | $103.9K |
| Issuance of common stock related to registered direct offering, net of offering costs | $10.0M | |
| Net cash provided by financing activities | $11.8M | $103.9K |
| Net increase (decrease) in cash and cash equivalents | $8.9M | -$12.0M |
| Cash received for income taxes | -$858.9K | |
| Receivable from issuance of common stock, collected in 2025 | $126.8K |
No quarter-by-quarter statement was filed.
Corporate structure
Co-Diagnostics, Inc. sits at the top of its group. 4 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Co-Diagnostics, Inc.
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G on Co-Diagnostics, Inc., latest Aug 14, 2026
- JANE STREET GROUP, LLC Filed SCHEDULE 13G/A on Co-Diagnostics, Inc., latest Aug 10, 2026 (2 filings since Jun 3, 2026)
- Ayrton Capital LLC Filed SCHEDULE 13G/A on Co-Diagnostics, Inc., latest Feb 11, 2026 (2 filings since Nov 13, 2025)
- Orca Capital AG Filed SCHEDULE 13G/A on Co-Diagnostics, Inc., latest Oct 30, 2025 (4 filings since Sep 18, 2025)
- VANGUARD GROUP INC Filed SCHEDULE 13G/A on Co-Diagnostics, Inc., latest Oct 30, 2025 (4 filings since Feb 9, 2022)
- Co-Diagnostics, Inc. Salt Lake City, Utah, United States
- Advanced Conceptions, Inc. Subsidiary · Utah, United States
- DNA Logix, Inc. Subsidiary · Utah, United States
- Idaho Molecular, Inc. Subsidiary · Idaho, 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 Co-Diagnostics, 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
| Item | Latest | A year before | Change |
|---|---|---|---|
| Accumulated depreciation | $3.9M6 Dec 31, 2025 | $3.3M6 Dec 31, 2024 | +19.2% |
| Property and equipment, net | $2.3M6 Dec 31, 2025 | $2.8M6 Dec 31, 2024 | −17.7% |
| Operating-lease assets (leased space) | $1.2M6 Dec 31, 2025 | $2.1M6 Dec 31, 2024 | −42.9% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $11.9M6 Dec 31, 2025 | $2.9M6 Dec 31, 2024 | +304.7% |
| Marketable securities, current | $26.8M6 Dec 31, 2024 | $43.6M11 Dec 31, 2023 | −38.6% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Intangible assets, net (excluding goodwill) | $7.2M6 Dec 31, 2025 | $26.1M6 Dec 31, 2024 | −72.3% |
| Finite-lived intangibles, gross | $8.3M6 Dec 31, 2025 | $27.2M6 Dec 31, 2024 | −69.4% |
| Accumulated amortization | -$1.1M6 Dec 31, 2025 | -$1.1M6 Dec 31, 2024 | 0% |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $992.4K6 Dec 31, 2025 | $1.1M6 Dec 31, 2024 | −7.5% |
| Raw materials | $480.2K6 Dec 31, 2025 | $505.4K6 Dec 31, 2024 | −5.0% |
| Finished goods | $512.2K6 Dec 31, 2025 | $567.3K6 Dec 31, 2024 | −9.7% |
Properties, in its own words
Our headquarters are located at 2401 S. Foothill Drive, Salt Lake City, Utah. Our current facilities have approximately 50,000 square feet of laboratory, manufacturing, storage and office space under leases that expire in 2026 through 2028. We believe the facilities we lease are sufficient to meet our needs for the foreseeable future.
Item 2 of the 10-K filed Mar 31, 2026.5
Leadership
Who has led Co-Diagnostics, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
- Chief executive officerDwight H. Egan Aug 16, 2017 to now14
- PresidentRichard David Abbott Mar 20, 2024 to now15
- PresidentDwight H. Egan Aug 16, 2017 to Aug 16, 201714
- Chief financial officerReed L. Benson Aug 16, 2017 to Nov 30, 202016
Board members and other officers (11)
- EVP of Finance & AccountingDaniel Bohrer Sep 14, 2026 to now17
- Chief Science OfficerBrent Satterfield Aug 16, 2017 to Aug 19, 202118
- Board memberEugene Durenard Jun 4, 2020 to now19
- Board memberJames B. Nelson Nov 15, 2019 to now20
- Board memberEdward L. Murphy Nov 19, 2019 to now21
- Board memberBrent Satterfield Aug 16, 2017 to May 15, 201818
- Board memberDwight H. Egan Aug 16, 2017 to now14
- Board memberEdward Borkowski Aug 16, 2017 to Aug 16, 201722
- Board memberFrank J. Kiesner Aug 16, 2017 to Aug 16, 201723
- Board memberRichard S. Serbin Aug 16, 2017 to now24
- General counselReed L. Benson May 21, 2021 to May 26, 202125
Named in SEC Form D filings
People the company listed in its private-offering notices.
- SecretaryBrian Brown named Jan 14, 202226
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Timeline
- Oct 15, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares27
- Oct 15, 20268-K Shareholder vote28
- Oct 13, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares29
- Oct 5, 20268-K Shareholder vote30
- Sep 25, 20268-K Shareholder vote31
- Sep 16, 20268-K Other events32
- Sep 16, 20268-K Regulation FD disclosure33
- Sep 15, 20268-K Other events34
- Sep 4, 20268-K Shareholder vote35
- Sep 4, 20268-K Executive or director change36
- Aug 13, 20268-K Results of operations; Regulation FD disclosure37
- Jul 31, 20268-K Entered a material agreement; Unregistered sale of shares38
- Aug 16, 2017New chief executive Dwight H. Egan becomes CEO14
- Apr 18, 2013Founded Co-Diagnostics, Inc. is founded2
Calendar
Coming up
- Nov 12, 2026Reports results for the quarter ending Sep/202639
When it reported results
- Aug 13, 2026Reported quarterly or annual results37
- May 14, 2026Reported quarterly or annual results40
- Mar 31, 2026Reported quarterly or annual results41
- Mar 10, 2026Reported quarterly or annual results42
- Nov 13, 2025Reported quarterly or annual results43
- Aug 14, 2025Reported quarterly or annual results44
- May 8, 2025Reported quarterly or annual results45
- Mar 27, 2025Reported quarterly or annual results46
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, 15 quarterly reports, 58 major events, 99 insider forms, 13 large holders, 1 private raises, 35 other. The latest 20:
- Oct 15, 20268-K EDGAR
- Oct 15, 20268-K/A EDGAR
- Oct 13, 20268-K EDGAR
- Oct 5, 20268-K EDGAR
- Sep 25, 20268-K EDGAR
- Sep 21, 2026PRE 14A EDGAR
- Sep 16, 20268-K EDGAR
- Sep 16, 20268-K EDGAR
- Sep 15, 20268-K EDGAR
- Sep 14, 20263 EDGAR
- Sep 4, 20268-K EDGAR
- Sep 4, 2026DEFA14A EDGAR
- Sep 4, 20268-K EDGAR
- Sep 1, 2026EFFECT EDGAR
- Aug 24, 2026S-3 EDGAR
- Aug 14, 2026SCHEDULE 13G EDGAR
- Aug 13, 202610-Q EDGAR
- Aug 13, 20268-K EDGAR
- Aug 10, 2026SCHEDULE 13G/A EDGAR
- Jul 31, 20268-K 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
1 open-market trades by officers, directors and large owners since October 2021: 1 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Mar 20, 2023 | Brown Brian LeeChief Financial Officer | Buy | 3,000 | $1.90 | $5.7K | 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.
- ARMISTICE CAPITAL, LLCSCHEDULE 13G, 1 filing Aug 14, 202647
- JANE STREET GROUP, LLCSCHEDULE 13G/A, 2 filings Jun 3, 2026 to Aug 10, 202648
- Ayrton Capital LLCSCHEDULE 13G/A, 2 filings Nov 13, 2025 to Feb 11, 202649
- Orca Capital AGSCHEDULE 13G/A, 4 filings Sep 18, 2025 to Oct 30, 202550
- VANGUARD GROUP INCSCHEDULE 13G/A, 4 filings Feb 9, 2022 to Oct 30, 202551
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 |
|---|---|---|---|---|
| 2025 | Dwight EganPresident & Chief Executive Officer | 72 | $400.0K | $528.8K52 |
| 2025 | Brian BrownChief Financial Officer and Secretary | 50 | $320.0K | $421.2K52 |
| 2025 | Richard AbbottPresident | 54 | $290.0K | $360.0K52 |
| 2024 | Dwight EganPresident & Chief Executive Officer | 72 | $391.7K | $716.9K52 |
| 2024 | Brian BrownChief Financial Officer and Secretary | 50 | $313.3K | $578.1K52 |
| 2024 | Richard AbbottPresident | 54 | $276.7K | $424.9K52 |
Money raised
Private offerings the company reported to the SEC on Form D.
- Dec 31, 2021Raised $46.6 million in a private offering of equity Form D: $47.2 million offered in all 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.
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Co-Diagnostics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARCo-Diagnostics, Inc.1
- CIK0001692415
- Employer ID (EIN)46-26093965
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; a shell company5
- Incorporated inUtah5
- 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 address2401 S Foothill Drive, Suite D, Salt Lake City, UT 841091
- Phone80143810361
- Shares outstanding6,252,319 as of Aug 11, 202613
- Public float$10.0M as of Jun 30, 20255
- AuditorTanner LLP, Salt Lake City, Utah PCAOB ID 270; no auditor attestation of internal control over financial reporting5
- On EDGAR sinceDec 29, 20161
- Filings387 in all: 4 (141), 8-K (83), 10-Q (28), 3 (15), 424B5 (11), CORRESP (10), DEF 14A (10), 10-K (9)1
All 33 form types
UPLOAD (9), SC 13G (8), EFFECT (7), SC 13G/A (7), S-3 (6), SCHEDULE 13G/A (6), PRE 14A (4), S-1/A (4), SCHEDULE 13G (4), DRS (3), S-8 (3), 4/A (2), 424B4 (2), 8-K/A (2), D (2), DEFA14A (2), 10-Q/A (1), 5 (1), 8-A12B (1), CERTNAS (1), DRS/A (1), DRSLTR (1), FWP (1), S-1 (1), S-8 POS (1)
- Latest filingsAnnual report (10-K) Mar 31, 2026
Quarterly report (10-Q) Aug 13, 2026
Proxy statement (DEF 14A) Jul 21, 2026
Latest 8-K (8-K) Oct 15, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock | CODX | Nasdaq |
From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).5
Risk factors and legal proceedings
The risks Co-Diagnostics, Inc. names in Item 1A of its 10-K filed Mar 31, 2026: 25 risks under these headings, as written.5
- Risks Related to Our Business and Industry
- We have limited commercial history upon which to base our prospects and are not certain that we will achieve profitability in the future.
- Our future success is dependent on our development of our Co-Dx PCR platform and securing regulatory approval for the platform including the PCR Pro instrument and related diagnostic tests, demand for infectious disease diagnostics and upon our ability to develop and market other commercially accepted diagnostic tests for our PCR platform.
- The diagnostic market is highly competitive, and we may not be able to compete effectively against the larger, well-established companies that dominate this market or emerging and small innovative companies that may seek to obtain or increase their share of the market.
- We depend on a limited number of third-party suppliers for key raw materials used in the manufacturing of our products, and the loss of these third-party suppliers or their inability to supply us with adequate raw materials could harm our business.
- In order to be successful, we must expand our available product lines by commercializing new product candidates, but we may not be able to do so in a timely fashion and at expected costs, or at all.
- We are dependent on our senior management team, scientific team, and external advisors, and the loss of any of them could harm our business, including by adversely affecting our ability to effectuate our business strategy.
- If we experience significant disruptions in our information technology systems, our business, results of operations and financial condition could be adversely affected.
- Cybersecurity risks and the failure to maintain the integrity of company, employee or customer data could expose us to data loss, litigation and liability, and our reputation could be significantly harmed.
- Risks Related to Our Capital Resources and Impairments
- We will require additional financing and our failure to obtain additional funding would force us to delay, reduce or eliminate our product development programs or commercialization efforts.
- Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements. We may be unable to continue to operate without the threat of liquidation for the foreseeable future.
The other 15 risks
- Raising additional capital by issuing securities or through debt financings or licensing arrangements will likely cause dilution to existing stockholders, restrict our operations or require us to relinquish proprietary rights.
- Risks Related to Regulatory Approval of Our Products and Other Government Regulations
- We received Emergency Use Authorization or EUA for our Logix Smart COVID-19 test in the US. For our existing EUA and any new EUA, the FDA may revoke any EUA where it is determined that the underlying health emergency no longer exists or warrants such authorization, which would adversely impact our ability to market our COVID-19 test in the United States.
- Our long-term success depends substantially on our ability to obtain regulatory clearance or approval and thereafter commercialize our product candidates; we cannot be certain that we will be able to do so in a timely manner or at all.
- Our current and future relationships with third-party payers and current and potential customers in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm administrative burdens and diminished profits and future earnings.
- We are subject to evolving global data protection and privacy laws, and compliance with such laws may be costly and may expose us to liability.
- Risks Related to Our Intellectual Property
- If the combination of patents, trade secrets and contractual provisions that we rely on to protect our intellectual property is inadequate, our ability to commercialize our products successfully will be harmed, and we may not be able to operate our business profitably.
- We could become subject to intellectual property litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages, prevent us from marketing our commercially available products or product candidates and/or reduce the margins we may realize from our products that we may commercialize.
- We rely substantially on our trademarks and trade names. 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 harmed.
- Risks Related to Litigation from Operating Our Business
- Current or future litigation, government investigations and other legal proceedings may harm our business.
- General Risk Factors
- The price of our common stock may fluctuate substantially.
- Anti-takeover provisions in our charter documents and Utah law could discourage, delay, or prevent a change of control of our Company and may affect the trading price of our common stock.
- We do not currently intend to pay dividends on our common stock.
- 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.
- We incur substantial costs as a result of being a public company and our management expects to devote substantial time to public company compliance programs.
- We incur substantial costs as a result of being a public company and are subject to the continued listing requirements of the NASDAQ Capital Market, our management expects to devote substantial time to public company compliance programs.
Legal proceedings
In the ordinary course of business, we are at times subject to various legal proceedings and disputes, including the proceedings specifically discussed below. We assess our liabilities and contingencies in connection with outstanding legal proceedings utilizing the latest information available. Where it is probable that we will incur a loss and the amount of the loss can be reasonably estimated, we record a liability in our consolidated financial statements. These legal reserves may be increased or decreased to reflect any relevant developments on a quarterly basis. Where a loss is not probable or the amount of loss is not estimable, we do not accrue legal reserves. While the outcome of legal proceedings is inherently uncertain, based on information currently available and available insurance coverage, our management believes that it has established appropriate legal reserves. Any incremental liabilities arising from pending legal proceedings are not expected to have a material adverse effect on our consolidated financial position, consolidated results of operations, or consolidated cash flows. However, it is possible that the ultimate resolution of these matters, if unfavorable, may be material to our consolidated financial position, consolidated results of operations, or consolidated cash flows.
Class Actions and Shareholder Derivative Suits
Shareholder Derivative Lawsuits (District of Utah & Utah State Court)
The opening of Item 3, Legal Proceedings.5
Sources
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- 15SEC EDGARRichard David Abbott, President
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- 19SEC EDGAREugene Durenard, Board member
- 20SEC EDGARJames B. Nelson, Board member
- 21SEC EDGAREdward L. Murphy, Board member
- 22SEC EDGAREdward Borkowski, Board member
- 23SEC EDGARFrank J. Kiesner, Board member
- 24SEC EDGARRichard S. Serbin, Board member
- 25SEC EDGARReed L. Benson, General counsel
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- 28SEC EDGARShareholder vote
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- 30SEC EDGARShareholder vote
- 31SEC EDGARShareholder vote
- 32SEC EDGAROther events
- 33SEC EDGARRegulation FD disclosure
- 34SEC EDGAROther events
- 35SEC EDGARShareholder vote
- 36SEC EDGARExecutive or director change
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