CDI(CODX) - 2024 Q4 - Annual Report

PART I Item 1. Business. Co-Diagnostics develops and sells nucleic acid-based tests for infectious diseases using proprietary Co-Primers technology for clinical and portable PCR platforms Overview - Co-Diagnostics develops, manufactures, and sells reagents for nucleic acid-based diagnostic tests, primarily for infectious diseases[16] - Proprietary Co-Primers technology reduces primer-dimer amplification (false positives) in PCR tests[16] - Current regulatory-approved PCR tests include COVID-19, influenza, tuberculosis, hepatitis B/C, HPV, malaria, chikungunya, dengue, and Zika virus, cleared for clinical labs[16] - Developing Co-Dx™ PCR platform (PCR Pro™ instrument, test cup, mobile app) for affordable, reliable point-of-care and at-home PCR testing[17] - First FDA 510(k) application for Co-Dx PCR COVID-19 Test (OTC use) was withdrawn in June 2024 due to shelf-life stability concerns, with plans to submit an enhanced version[17] Technology - Proprietary Co-Primers technology allows for enhanced, faster, and more economical genetic material detection, aiming for significant margins as a low-cost provider[18] - The company was the first US-based company to receive a CE-marking for a COVID-19 test in early 2020, demonstrating rapid development capability[18] - Co-Primers technology is protected by over 20 granted or pending US and foreign patents, reducing the need for third-party patent royalties[20] - Technology is ideally suited for applications requiring high specificity, such as multiplexing, enhanced SNP detection, and next-generation sequencing[19] Co-Dx PCR Platform - The Co-Dx PCR platform is designed for affordable, reliable PCR testing at point-of-care and at-home, providing results in about 30 minutes[25][26] - The initial COVID-19 PCR test for this platform is saliva or nasal swab-based and does not require RNA/DNA extraction[27] - Received $1.2 million from NIH RADx Tech program for developing a multiplex test for influenza A/B, RSV, and COVID-19 for the platform[28] - Awarded $6.8 million for a TB test and $987,000 for an HPV test by the Bill & Melinda Gates Foundation for development on the Co-Dx PCR platform[29] Infectious Disease Product Offering - Co-Diagnostics and CoSara Diagnostics (India JV) sell PCR diagnostic tests for various diseases globally[30] - Received CE marking for Logix Smart COVID-19 test in Feb 2020 and FDA EUA in April 2020[30] - Tests are cleared for sale in the European Community, India, Mexico, Australia, and registered in many other countries[30][37] - CoSara manufactures and sells 14 tests under the SaraGene brand in India, including COVID-19, TB, malaria, hepatitis B/C, HPV, and influenza multiplex tests[35][36] Market Opportunity - The molecular diagnostics market is a fast-growing segment of in vitro diagnostics[42] - PCR tests offer advantages such as higher specificity, sensitivity, multiplexing, and ability to test for drug resistance or individual genes[42] - The COVID-19 pandemic enabled the company to build a worldwide distribution network[41] Mosquito Vector Control Services - Introduced Vector Smart PCR tests in June 2019 for mosquito-borne pathogens[43] - Offers multiplex tests for West Nile, western equine encephalitis, St. Louis encephalitis, Zika, chikungunya, and dengue[44] - These tests provide rapid, in-house results, allowing municipalities to focus mosquito control efforts[44] Competitive Advantages of Co-Diagnostics - Affordability: Lower-cost test kits, a low-cost Co-Dx Box, and an affordable Co-Dx PCR platform for at-home and point-of-care testing[48] - Speed: Rapid assay design system software, demonstrated by 30-day CE marking for Logix Smart COVID-19 test[48] - Low-Cost Provider: Proprietary platform technology avoids patent royalties, enabling lower prices and maintained profit margins[48] - Multiplexing: Co-Primers-designed tests can accurately test for multiple targets in one sample without distortion[48] Intellectual Property - Flagship Co-Primers technology is covered by two U.S. patents and foreign counterparts[49] - Filed international and U.S. patent applications for NGS Library Preparation, Allele-Specific Design of Cooperative Primers, Reverse Transcription, and Automated Self-Contained Biological Analysis (PCR platform)[49] - Protects technology and know-how as trade secrets and uses/registers trademarks[50] Major Customers - One customer generated approximately 31% of product revenue in 2024[51] - Two granting agencies accounted for approximately 95% of grant revenue in 2024[51] - Loss of these major customers or granting agencies could have a material adverse effect on financial condition[51] Competition - The molecular diagnostics industry is extremely competitive, with many larger firms having greater financial resources and established market positions[52] - Competitors include BioMerieux, Siemens, Qiagen, Roche Diagnostics, Cepheid, Abbott Laboratories, Becton Dickinson, and Johnson and Johnson[52] - Faces competitive price pressure in certain regions, particularly Asia and Latin America, from companies selling tests at lower prices[52] Government Regulation - Regulated by the FDA in the US, requiring approval, clearance, or authorization for IVD sales[55] - Granted EUA for Logix Smart COVID-19 test for CLIA labs in the US[55] - Operates under an ISO 13485:2016 certified quality management system, facilitating global regulatory clearances like CE marking[55] - Has CE markings for multiple tests, including COVID-19, tuberculosis, Zika, and triplex tests[55] Employees - 132 full-time and part-time employees as of December 31, 2024[56] - Focus on maintaining a strong culture, diversity, competitive compensation, organizational development, employee health, and effective communication[57] Organizational History and Corporate Information - Incorporated in Utah on April 18, 2013[58] - Principal executive office at 2401 S. Foothill Drive, Salt Lake City, Utah 84109[58] Item 1A. Risk Factors. The company faces substantial risks from its limited operating history, product development, regulatory hurdles, competition, financial viability, and litigation Risks Related to Our Business and Industry - Limited operating history and uncertainty of achieving future profitability[59] - Future success is dependent on the development and regulatory approval of the Co-Dx PCR platform and other diagnostic tests[60] - The diagnostic market is highly competitive, with larger, well-established companies having significant advantages[61][62] - Dependence on a limited number of third-party suppliers for key raw materials poses supply chain risks[63] - Loss of senior management, scientific team, or key advisors could harm the business[65][67] - Significant disruptions in IT systems or cybersecurity incidents could adversely affect business, operations, and financial condition[68][69] Risks Related to Our Capital Resources and Impairments - Requires additional financing; failure to obtain funding would delay or eliminate product development and commercialization efforts[70][71] - Independent auditors included an explanatory paragraph regarding the company's ability to continue as a going concern due to recurring losses and need for financing[72] - Raising additional capital through equity or convertible debt will likely dilute existing stockholders[73] Risks Related to Regulatory Approval of Our Products and Other Government Regulations - FDA may revoke Emergency Use Authorization (EUA) for the Logix Smart COVID-19 test, negatively impacting US marketability[74][75] - Withdrew 510(k) application for PCR platform in Feb 2025; long-term success depends on timely regulatory clearance/approval, which is costly and time-consuming[76][77] - Subject to complex and evolving anti-kickback, fraud and abuse, false claims, transparency, and health information privacy/security laws (e.g., HIPAA, GDPR, CCPA) in the US and internationally[79][80][82][94][97][98] - Non-compliance with data protection laws could result in significant fines, litigation, reputational harm, and operational changes[81][86][92] Risks Related to Our Intellectual Property - Inadequate protection of proprietary technology (patents, trade secrets, contracts) could harm commercialization efforts[102] - Issued patents can be challenged, and pending applications may not result in broad protection[103] - Risk of intellectual property litigation (infringement claims) which could be costly, divert management, require damages, or prevent product marketing[106][107] - Reliance on trademarks and trade names for brand recognition; risk of challenges, infringement, or dilution[108] Risks Related to Litigation from Operating Our Business - Subject to current and future legal proceedings, including two securities class actions and three derivative actions[109] - Litigation is unpredictable and can result in excessive verdicts, injunctive relief, substantial costs, and diversion of management's attention[109] - Adverse publicity from legal actions could damage reputation and reduce demand for products[109] General Risk Factors - The market price of common stock may fluctuate substantially due to various internal and external factors[110] - Anti-takeover provisions in charter documents and Utah law could discourage, delay, or prevent a change of control[112][113] - Does not currently intend to pay dividends on common stock[114] - As a 'smaller reporting company,' reduced disclosure requirements may make common stock less attractive to investors[115] - Incurs substantial costs as a public company and management devotes significant time to compliance programs[116][117] - Received a NASDAQ notice on Jan 10, 2025, for failing to meet the minimum $1.00 bid price requirement, with a compliance date of July 9, 2025[121] Item 1B. Unresolved Staff Comments. The company reported no unresolved staff comments from the SEC - No unresolved staff comments[123] Item 1C. Cybersecurity The company integrates NIST-based cybersecurity processes into its risk assessment, employing monitoring, training, and multi-factor authentication, with Audit Committee oversight - Cybersecurity processes are integrated into overall risk assessment, based on NIST frameworks[124] - Engages a third-party cybersecurity firm for network/endpoint monitoring, cloud system assessment, and incident response[124] - Undertakes activities like monitoring evolving standards, risk assessments, vendor security assessments, mandatory employee training, multi-factor authentication, phishing simulations, and cyber insurance[131] - The Audit Committee oversees cybersecurity risk assessment, management, and incident response, with leadership from the Chief Technology Officer[129][130] Item 2. Properties. The company's Salt Lake City headquarters leases approximately 54,000 square feet for operations, with leases expiring between 2026 and 2028, deemed sufficient - Headquarters located at 2401 S. Foothill Drive, Salt Lake City, Utah[133] - Leases approximately 54,000 square feet for laboratory, manufacturing, storage, and office space[133] - Leases expire between 2026 and 2028, and current facilities are believed to be sufficient[133] Item 3. Legal Proceedings. The company is involved in various legal proceedings, including securities class actions, shareholder derivative lawsuits, and commercial litigations, which it intends to vigorously defend - Gelt Securities Class Action: Filed in District of Utah, alleging overstated accuracy of COVID-19 test. Company's motion for summary judgment granted on March 4, 2025[135] - Shareholder Derivative Lawsuits: Multiple lawsuits filed in District of Utah and Utah State Court, piggybacking on Gelt Litigation. Some have been voluntarily dismissed, others are ongoing[136][137][138] - Stadium Capital Securities Class Action: Filed in Southern District of New York, alleging overstated demand for COVID-19 test. Motion to dismiss partially granted, fact discovery closed, expert discovery ongoing[140] - Commercial Litigation (Hukui Technology): Company filed for declaratory judgment; Hukui counterclaimed. Company granted summary judgment on all claims, Hukui appealed to Utah Court of Appeals[141] - Commercial Litigation (Pantheon International Advisors): Company obtained default judgment in Utah. Pantheon subsequently filed a claim against the company in the UK for alleged breach of contract[142][143] Item 4. Mine Safety Disclosures. This item is not applicable to the company - Not applicable[144] PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. The company's common stock trades on NASDAQ under 'CODX,' with no anticipated cash dividends as earnings are reinvested into business development - Common stock quoted on NASDAQ under "CODX" since July 12, 2017[146] - As of March 21, 2025, there were approximately 154 record holders and the last reported sales price was $0.46 per share[147] - The company has never declared or paid cash dividends and does not anticipate paying them in the foreseeable future, prioritizing reinvestment in business development[148] - No recent sales of unregistered securities[150] Item 6. [Reserved.] This item is reserved and contains no information - This item is reserved[152] Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations. The company experienced a 43% revenue decrease and a $37.6 million net loss in 2024, with recurring operating losses raising substantial doubt about its going concern ability Business Overview - Develops, manufactures, and sells reagents for DNA/RNA diagnostic tests, including molecular tools for infectious diseases[153] - Proprietary Co-Primers technology reduces false positives in PCR amplification[153] - Developing the Co-Dx PCR platform for affordable, reliable point-of-care and at-home testing, currently under FDA review[154] - Withdrew its first FDA 510(k) application for the Co-Dx PCR COVID-19 Test due to shelf-life stability, planning to submit an enhanced version[154] Technology - Proprietary and patented molecular diagnostics technology (Co-Primers) enables faster, more economical disease detection with significant margins[155] - The technology is protected by over 20 granted or pending US and foreign patents, avoiding third-party patent royalties[157] - Co-Primers technology is well-suited for applications requiring high specificity, such as multiplexing and enhanced SNP detection[156] - Rapidly developed and obtained CE-marking for its Logix Smart COVID-19 test in just over 30 days in early 2020[155] Results of Operations for the Years Ended December 31, 2024 and 2023 Consolidated Statements of Operations Summary (Years Ended December 31, 2024 and 2023) | Metric | 2024 (USD) | 2023 (USD) | Change (USD) | Change (%) | | :-------------------------- | :----------- | :----------- | :----------- | :--------- | | Product revenue | $770,048 | $991,473 | $(221,425) | -22% | | Grant revenue | $3,145,112 | $5,820,565 | $(2,675,453) | -46% | | Total revenue | $3,915,160 | $6,812,038 | $(2,896,878) | -43% | | Cost of revenue | $999,124 | $4,184,949 | $(3,185,825) | -76% | | Gross profit | $2,916,036 | $2,627,089 | $288,947 | 11% | | Total operating expenses | $42,997,346 | $45,333,323 | $(2,335,977) | -5% | | Loss from operations | $(40,081,310) | $(42,706,234) | $2,624,924 | -6% | | Total other income, net | $2,499,670 | $4,595,678 | $(2,096,008) | -46% | | Loss before income taxes | $(37,581,640) | $(38,110,556) | $528,916 | -1% | | Income tax provision (benefit) | $57,368 | $(2,777,691) | $2,835,059 | -102% | | Net loss | $(37,639,008) | $(35,332,865) | $(2,306,143) | 7% | - Revenues decreased by $2.9 million (43%) in 2024, primarily due to lower grant revenues as most prior year grant revenue was recognized[164] - Cost of revenues decreased by $3.2 million (76%) in 2024, leading to an 11% increase in gross profit and a higher gross margin percentage due to prior year inventory reserves[165] - Operating expenses decreased by $2.3 million (5%) in 2024, mainly from reduced stock-based compensation, bad debt, and Co-Dx PCR platform development/clinical trial expenses, partially offset by higher legal and personnel costs[166] - Other income decreased by $2.1 million (46%) in 2024, primarily due to changes in fair value of contingent consideration, increased loss from joint venture investment, and decreased realized gains on investments[170] - Net loss increased by $2.3 million (7%) to $37.6 million in 2024, also impacted by a shift from an income tax benefit to an income tax provision due to a full valuation allowance[172] Liquidity and Capital Resources - Cash and cash equivalents: $2.9 million (Dec 31, 2024) vs. $14.9 million (Dec 31, 2023)[173][205] - Marketable investment securities: $26.8 million (Dec 31, 2024) vs. $43.6 million (Dec 31, 2023)[173][205] - Net cash used in operating activities: $29.2 million in 2024, an increase from $22.1 million in 2023[174][211] - Substantial doubt exists about the company's ability to continue as a going concern due to recurring operating losses and dependence on obtaining additional financing[179][217] - Has an Equity Distribution Agreement (ATM Agreement) for up to $17.1 million, with $0.2 million sold as of December 31, 2024, and $16.9 million remaining[178][286] Critical Accounting Policies and Estimates - Accounts Receivable: Management estimates allowance for doubtful accounts based on historical losses, market conditions, customer financial health, and payment patterns[181][182] - Intangible Assets: Indefinite-lived intangible assets (e.g., in-process R&D) are tested for impairment annually or when circumstances indicate, requiring significant judgment[183][201] - Inventories: Periodically reviewed for obsolescence and declines in selling prices, with write-downs based on assumptions about future demand and market value[185] - Income Taxes: Significant judgment in determining provision, current/deferred tax assets/liabilities, and valuation allowances, especially given cumulative losses[186][237][238] Item 7A. Quantitative and Qualitative Disclosures About Market Risk. The company states that this item is not required - Not required[188] Item 8. Financial Statements and Supplementary Data. Audited financial statements for 2024 and 2023 show a fair view, but the auditor's report highlights substantial doubt about the company's going concern ability Report of Independent Registered Public Accounting Firm - Unqualified opinion on consolidated financial statements for 2024 and 2023[195] - Explanatory paragraph on "Going Concern" due to recurring losses and need for additional financing, raising substantial doubt[196] - Critical Audit Matter: Impairment of Intangible Assets, specifically the assessment of indefinite-lived in-process research and development assets, which required significant auditor judgment[200][201][202] Consolidated Balance Sheets Consolidated Balance Sheet Summary (December 31, 2024 vs. 2023) | Asset/Liability/Equity | Dec 31, 2024 (USD) | Dec 31, 2023 (USD) | Change (USD) | | :-------------------------------- | :----------------- | :----------------- | :----------- | | Cash and cash equivalents | $2,936,544 | $14,916,878 | $(11,980,334) | | Marketable investment securities | $26,811,098 | $43,631,510 | $(16,820,412) | | Total current assets | $32,291,698 | $62,141,108 | $(29,849,410) | | Total assets | $63,999,919 | $95,320,660 | $(31,320,741) | | Total current liabilities | $7,315,718 | $5,747,570 | $1,568,148 | | Total liabilities | $9,688,001 | $9,307,045 | $380,956 | | Total stockholders' equity | $54,311,918 | $86,013,615 | $(31,701,697) | Consolidated Statements of Operations and Comprehensive Loss Consolidated Statements of Operations Summary (Years Ended December 31, 2024 and 2023) | Metric | 2024 (USD) | 2023 (USD) | Change (USD) | Change (%) | | :------------------------------------------ | :----------- | :----------- | :----------- | :--------- | | Product revenue | $770,048 | $991,473 | $(221,425) | -22% | | Grant revenue | $3,145,112 | $5,820,565 | $(2,675,453) | -46% | | Total revenue | $3,915,160 | $6,812,038 | $(2,896,878) | -43% | | Cost of revenue | $999,124 | $4,184,949 | $(3,185,825) | -76% | | Gross profit | $2,916,036 | $2,627,089 | $288,947 | 11% | | Total operating expenses | $42,997,346 | $45,333,323 | $(2,335,977) | -5% | | Loss from operations | $(40,081,310) | $(42,706,234) | $2,624,924 | -6% | | Total other income, net | $2,499,670 | $4,595,678 | $(2,096,008) | -46% | | Loss before income taxes | $(37,581,640) | $(38,110,556) | $528,916 | -1% | | Income tax provision (benefit) | $57,368 | $(2,777,691) | $2,835,059 | -102% | | Net loss | $(37,639,008) | $(35,332,865) | $(2,306,143) | 7% | | Basic and Diluted Loss per common share | $(1.24) | $(1.20) | $(0.04) | 3% | Consolidated Statement of Changes in Stockholders' Equity Consolidated Statement of Changes in Stockholders' Equity (Years Ended December 31, 2024 and 2023) | Metric | Dec 31, 2024 (USD) | Dec 31, 2023 (USD) | | :-------------------------------- | :----------------- | :----------------- | | Common Stock (Shares) | 37,902,222 | 36,108,346 | | Common Stock (Amount) | $37,902 | $36,108 | | Treasury Stock | $(15,575,795) | $(15,575,795) | | Additional Paid-in Capital | $102,472,210 | $96,808,436 | | Accumulated Other Comprehensive Income | $418,443 | $146,700 | | Accumulated Earnings (Deficit) | $(33,040,842) | $4,598,166 | | Total Stockholders' Equity | $54,311,918 | $86,013,615 | - Net loss of $37.6 million significantly reduced accumulated earnings (deficit)[209] - Stock-based compensation expense contributed $5.4 million to additional paid-in capital in 2024[209] - Issuance of common stock from at-the-market offering generated $0.2 million in net proceeds in 2024[209] Consolidated Statements of Cash Flows Consolidated Statements of Cash Flows Summary (Years Ended December 31, 2024 and 2023) | Cash Flow Activity | 2024 (USD) | 2023 (USD) | Change (USD) | | :------------------------------------ | :----------- | :----------- | :----------- | | Net cash used in operating activities | $(29,155,045) | $(22,081,865) | $(7,073,180) | | Net cash provided by investing activities | $17,070,797 | $15,388,869 | $1,681,928 | | Net cash provided by (used in) financing activities | $103,914 | $(1,363,929) | $1,467,843 | | Net decrease in cash and cash equivalents | $(11,980,334) | $(8,056,925) | $(3,923,409) | | Cash and cash equivalents at end of period | $2,936,544 | $14,916,878 | $(11,980,334) | - Increase in cash used in operating activities primarily due to decreases in revenue, grant funding, and realized gains on investments[174] - Increase in cash provided by investing activities mainly from proceeds from maturities of marketable investment securities[175] - Shift to cash provided by financing activities in 2024 due to common stock issuances from the at-the-market offering, compared to share repurchases in 2023[176] Notes to Consolidated Financial Statements - Overview and Basis of Presentation: Highlights "going concern" uncertainty due to recurring losses and dependence on future financing[217][218] - Cash, Cash Equivalents, and Financial Instruments: Details marketable investment securities (U.S. treasury securities) and cash, with fair values[249] - Fair Value Measurements: Financial instruments measured at fair value include marketable securities (Level 2) and contingent consideration liabilities (Level 3), with changes in fair value of contingent consideration noted[254][255][256] - Property and Equipment: Net fixed assets were $2.76 million in 2024, down from $3.04 million in 2023[259] - Intangible Assets: Net intangible assets were $26.10 million in 2024, primarily in-process research and development, which is an indefinite-lived asset[260] - Accrued Expenses: Legal fees increased significantly to $1.67 million in 2024 from $0.50 million in 2023[261] - Revenue: Total revenue was $3.9 million in 2024, with 90% from the United States and 10% from the Rest of World[262] - Deferred Revenue: Balance decreased to $40,857 in 2024 from $362,449 in 2023, with $301,972 of revenue recognized from prior deferred amounts[263] - Loss per Share: Basic and diluted loss per share was $(1.24) in 2024, compared to $(1.20) in 2023[264] - Stock-Based Compensation: Total expense was $5.4 million in 2024, down from $8.3 million in 2023. Unrecognized RSU expense was $4.8 million as of Dec 31, 2024[274][270] - Income Taxes: Recorded an income tax provision of $57,368 in 2024 (vs. benefit in 2023) and a full valuation allowance of $14.9 million against deferred tax assets due to cumulative losses[275][276] - Commitments and Contingencies: Details lease obligations and ongoing litigation[279][283] - Related Party Transactions: Discloses compensation to CEO's sons and President's indirect interest in acquisition contingent consideration[287][288] - Subsequent Events: Received NASDAQ notice on Jan 10, 2025, regarding minimum bid price deficiency[290] Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. The company reported no changes or disagreements with its independent registered public accounting firm on financial disclosure - No changes in or disagreements with accountants on accounting and financial disclosure[293] Item 9A. Controls and Procedures. Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2024, with no material changes in Q4 2024 - Disclosure controls and procedures were evaluated and deemed effective as of December 31, 2024[295] - No material changes in internal control over financial reporting during the fourth quarter of 2024[296] - Management's assessment concluded that internal control over financial reporting was effective as of December 31, 2024, based on the COSO framework[298] - Acknowledges inherent limitations on the effectiveness of controls, providing reasonable, not absolute, assurance[301] Item 9B. Other Information. No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements in Q4 2024 - No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements in Q4 2024[302] Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. The company has no disclosures regarding foreign jurisdictions that prevent inspections - No disclosures regarding foreign jurisdictions that prevent inspections[303] PART III Item 10. Directors, Executive Officers and Corporate Governance. The company's leadership includes key executives and a five-member board, mostly independent, operating through committees for governance and risk oversight, adhering to ethical codes Executive Officers - Dwight Egan: CEO, President, and Chairman since April 2013, with prior experience in private investment and co-founding Broadcast International[307] - Brian Brown: CFO since February 2021, a licensed CPA with experience in finance, accounting, and SEC reporting for public companies[308][309] - Richard Abbott: President since March 2024, previously President of Advanced Conceptions, Inc., with a background in medical device design and technology[310] Directors - Eugene Durenard: Founder/CEO of Hyperbolic Holdings, with a PhD in Mathematics from Harvard and extensive experience in life sciences and finance[312] - James Nelson: Retired Chairman/CEO of Sunworks, Inc., with a background in private equity, marketing, and business strategy[313] - Richard Serbin: Consultant in healthcare, with prior roles as President of Corporate Development at Life Science Institute and experience in patent/FDA law[314] - Edward Murphy: Senior Vice President and partner at Dover Investments Ltd., with experience in investment analysis and serving on boards of public companies[315] Involvement in Certain Legal Proceedings - No material involvement in bankruptcy, criminal proceedings, or significant judgments/injunctions for directors or executive officers in the last ten years[317] Board and Committee Matters - Board consists of five members, with four independent non-employee directors[318] - Maintains Audit, Compensation, Corporate Governance, and Nominating Committees, all composed of independent directors[319][320] - All directors attended more than 75% of board and committee meetings in 2024[318][321] - Mr. Durenard is designated as an "audit committee financial expert"[322] Board Nominations - Bylaws set forth procedures for stockholders to recommend board nominees, requiring timely written notice to the company secretary[328][329] - Nominations must include detailed information about the stockholder, beneficial owner, and proposed nominee, as required by SEC regulations[329][330] - Board considers factors such as experience, education, employment history, special talents, and diversity in evaluating candidates[326] Communication with the Board - Informal process for shareholder communications with the board; all communications are forwarded to all directors[331] Conflicts of Interests - Directors and executive officers are obligated to disclose transactions and avoid conflicts of interest annually[332] - Conflicts of interest involving executive officers or directors are generally resolved by the board[332] Role of the Board in Risk Oversight - Board of directors, through its committees, is responsible for oversight of risk management[333] - Audit Committee: Considers major financial risk exposures[334] - Corporate Governance Committee: Monitors effectiveness of governance guidelines[334] - Compensation Committee: Assesses if compensation policies encourage excessive risk-taking[334] - Nominating Committee: Assesses board effectiveness and succession planning[334] Code of Ethics - Adopted a code of ethics for principal executive officer and senior finance officers[335] Insider Trading Policy - Adopted an insider trading policy to promote compliance with insider trading laws and NASDAQ listing standards[336] Family Relationships - No family relationships among directors and executive officers[337] Item 11. Executive Compensation. Executive compensation decreased in 2024 for the CEO and CFO, determined by the compensation committee, with a Change in Control Severance Plan and director compensation Summary Compensation Table Summary Compensation Table (Years Ended December 31, 2024 and 2023) | Name and Principal Position | Year | Salary (USD) | Bonus (USD) | Stock Awards (USD) | Total Compensation (USD) | | :-------------------------- | :--- | :----------- | :---------- | :----------------- | :----------------------- | | Dwight Egan, CEO | 2024 | $391,667 | $20,000 | $305,250 | $716,917 | | | 2023 | $375,000 | $40,750 | $845,550 | $1,261,300 | | Brian Brown, CFO | 2024 | $313,333 | $15,000 | $249,750 | $578,083 | | | 2023 | $300,000 | $32,000 | $701,550 | $1,033,550 | | Richard Abbott, President | 2024 | $276,666 | $15,000 | $133,200 | $424,866 | - Dwight Egan's total compensation decreased by approximately 43% from 2023 to 2024[340] - Brian Brown's total compensation decreased by approximately 44% from 2023 to 2024[340] Narrative Disclosure to Summary Compensation Table - Executive officers serve on an at-will basis without written employment agreements[342] - Compensation committee determines base salaries and performance-based cash bonuses based on responsibilities, seniority, financial position, and achievement of objectives[342] Outstanding Equity Awards at Fiscal Year-End 2024 Outstanding Equity Awards at Fiscal Year-End 2024 for Named Executive Officers | Name | Exercisable Options () | Unvested RSUs () | Market Value of Unvested RSUs (USD) (1) | | :---------------- | :---------------------- | :---------------- | :-------------------------------------- | | Dwight Egan | 100,000 | 464,167 | $348,125 | | Brian Brown | - | 380,833 | $285,625 | | Richard Abbott | - | 150,438 | $112,829 | - (1) Based on $0.75 per share, the closing price of common stock on December 31, 2024[344] Potential Payments Upon Termination or Change of Control - Change in Control Severance Plan provides benefits to designated management upon qualifying termination after a change in control[347] - CEO Dwight Egan has a Severance Multiplier of three times, and CFO Brian Brown has a Severance Multiplier of two times their severance benefit[347] - Severance benefit equals the multiplier times the sum of annual base salary and the greater of target bonus or average of three highest annual cash bonuses over five preceding years[348] Director Compensation - Non-employee directors receive $100,000 cash compensation per year, paid quarterly[353] - In 2024, non-employee directors received 110,000 RSUs, vesting 1/6 equally in November 2024, 2025, 2026 and May 2025, 2026, 2027[353] - All stock options granted to outside directors are immediately exercisable[353] Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. As of March 21, 2025, Vanguard Group and company insiders held significant common stock ownership, with the 2015 Long-term Incentive Plan having shares for outstanding options and future issuance Beneficial Ownership Table Beneficial Ownership as of March 21, 2025 | Holder | Number of Shares Beneficially Owned | Percentage of Class | | :------------------------------------ | :---------------------------------- | :------------------ | | Vanguard Group | 1,781,283 | 5.3% | | Dwight Egan (CEO) | 622,858 | 1.8% | | Brian Brown (CFO) | 419,905 | 1.3% | | Richard Abbott (President) | 604,731 | 1.8% | | All Directors and Executive Officers as a Group | 2,436,271 | 7.2% | - Applicable percentage ownership is based on 33,572,643 shares outstanding as of March 21, 2025, plus exercisable securities within 60 days[358] Equity Compensation Plan Information - Shares to be issued upon exercise of outstanding options and rights: 3,782,888[362] - Weighted-average exercise price of outstanding options and rights: $2.19[362][363] - Number of securities remaining available for future issuance under equity compensation plans: 3,061,949[362] Item 13. Certain Relationships and Related Transactions, and Director Independence. The company engages in related party transactions, including compensation to the CEO's sons and an indirect interest for the President, with the Corporate Governance Committee overseeing review Related Party Transactions - Compensation paid to Seth Egan (CEO's son, Chief Commercialization Officer) was $0.4 million in 2024[364] - Compensation paid to Winston Egan (CEO's son, Director of Customer Experience) was $0.1 million in 2024[364] - President Richard Abbott has an indirect 50% interest in contingent common shares and warrants from the Advanced Conceptions acquisition[365] - Recognized $0.6 million expense in 2024 from a services agreement with CoSara, its equity method investment[289] Policy for Review of Related Party Transactions - Corporate Governance Committee oversees the policy for reviewing related party transactions[366] Director Independence - Refer to Item 10 for information on director independence[367] Item 14. Principal Accountant Fees and Services. The company paid Tanner LLC $194,923 in total fees in 2024, with audit fees increasing slightly, and the audit committee requires advance approval for services exceeding $15,000 Principal Accountant Fees and Services (Years Ended December 31, 2024 and 2023) | Fee Type | 2024 (USD) | 2023 (USD) | | :----------------- | :----------- | :----------- | | Audit fees | $176,078 | $154,811 | | Audit related fees | $18,845 | $- | | Other consulting fees | $- | $287,838 | | Tax fees | $- | $- | | Total fees | $194,923 | $442,649 | - Audit committee policy requires advance approval for all services from the independent auditor exceeding $15,000[370] PART IV Item 15. Exhibits and Financial Statement Schedules. This section lists all exhibits and financial statement schedules filed as part of the Annual Report on Form 10-K, including key corporate and governance documents - Includes Consolidated Financial Statements (Part II, Item 8)[374] - Lists various exhibits such as merger agreements, articles of incorporation, bylaws, equity incentive plans, and certifications[373][375][376] - Financial statement schedules are not included as they are either not applicable or the information is in the consolidated financial statements/notes[374] Item 16. Form 10-K Summary. This item is not applicable - None[379]