Core Viewpoint - Co-Diagnostics, Inc. (CODX) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, suggesting that upward revisions in earnings estimates can lead to higher stock valuations [4][6]. - CoDiagnostics is expected to earn -$0.91 per share for the fiscal year ending December 2025, reflecting a year-over-year change of 26.6% [8]. Analyst Sentiment and Market Position - Analysts have increased their earnings estimates for CoDiagnostics, with the Zacks Consensus Estimate rising by 22.2% over the past three months [8]. - The upgrade to Zacks Rank 2 places CoDiagnostics in the top 20% of Zacks-covered stocks, indicating strong potential for market-beating returns in the near term [10].

Company Performance - Co-Diagnostics, Inc. reported a quarterly loss of $0.36 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.34, but an improvement from a loss of $0.50 per share a year ago, indicating a year-over-year improvement in loss figures [1] - The company posted revenues of $0.15 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 60.79%, and a significant decline from year-ago revenues of $3.56 million [2] - Over the last four quarters, Co-Diagnostics has surpassed consensus EPS estimates two times and topped consensus revenue estimates two times [2] Stock Performance - Co-Diagnostics shares have declined approximately 44.5% since the beginning of the year, contrasting with the S&P 500's decline of 2.9%, indicating significant underperformance in the market [3] - The current consensus EPS estimate for the upcoming quarter is -$0.34 on revenues of $0.4 million, and for the current fiscal year, it is -$1.17 on revenues of $1.5 million [7] Industry Outlook - The Medical Services industry, to which Co-Diagnostics belongs, is currently ranked in the top 29% of over 250 Zacks industries, suggesting a relatively strong position within the market [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact Co-Diagnostics' stock performance [5]

Co-Diagnostics, Inc. (NASDAQ:CODX) Q4 2024 Earnings Conference Call March 27, 2025 4:30 PM ET Company Participants Andrew Benson - IR Dwight Egan - CEO Brian Brown - CFO Conference Call Participants Operator Good day, and welcome to the Co-Diagnostics Fourth Quarter and Full Year 2024 Earnings Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, that this event ...

PART I [Item 1. Business.](index=5&type=section&id=Item%201.%20Business.) Co-Diagnostics develops and sells nucleic acid-based tests for infectious diseases using proprietary Co-Primers technology for clinical and portable PCR platforms [Overview](index=5&type=section&id=Overview) - Co-Diagnostics develops, manufactures, and sells reagents for nucleic acid-based diagnostic tests, primarily for infectious diseases[16](index=16&type=chunk) - Proprietary Co-Primers technology reduces primer-dimer amplification (false positives) in PCR tests[16](index=16&type=chunk) - 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](index=16&type=chunk) - Developing Co-Dx™ PCR platform (PCR Pro™ instrument, test cup, mobile app) for affordable, reliable point-of-care and at-home PCR testing[17](index=17&type=chunk) - 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](index=17&type=chunk) [Technology](index=6&type=section&id=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](index=18&type=chunk) - 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](index=18&type=chunk) - Co-Primers technology is protected by over **20 granted or pending US and foreign patents**, reducing the need for third-party patent royalties[20](index=20&type=chunk) - Technology is ideally suited for applications requiring high specificity, such as multiplexing, enhanced SNP detection, and next-generation sequencing[19](index=19&type=chunk) [Co-Dx PCR Platform](index=7&type=section&id=Co-Dx%20PCR%20Platform) - 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](index=25&type=chunk)[26](index=26&type=chunk) - The initial COVID-19 PCR test for this platform is saliva or nasal swab-based and does not require RNA/DNA extraction[27](index=27&type=chunk) - 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](index=28&type=chunk) - 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](index=29&type=chunk) [Infectious Disease Product Offering](index=8&type=section&id=Infectious%20Disease%20Product%20Offering) - Co-Diagnostics and CoSara Diagnostics (India JV) sell PCR diagnostic tests for various diseases globally[30](index=30&type=chunk) - Received CE marking for Logix Smart COVID-19 test in Feb 2020 and FDA EUA in April 2020[30](index=30&type=chunk) - Tests are cleared for sale in the European Community, India, Mexico, Australia, and registered in many other countries[30](index=30&type=chunk)[37](index=37&type=chunk) - 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](index=35&type=chunk)[36](index=36&type=chunk) [Market Opportunity](index=10&type=section&id=Market%20Opportunity) - The molecular diagnostics market is a fast-growing segment of in vitro diagnostics[42](index=42&type=chunk) - PCR tests offer advantages such as higher specificity, sensitivity, multiplexing, and ability to test for drug resistance or individual genes[42](index=42&type=chunk) - The COVID-19 pandemic enabled the company to build a worldwide distribution network[41](index=41&type=chunk) [Mosquito Vector Control Services](index=10&type=section&id=Mosquito%20Vector%20Control%20Services) - Introduced Vector Smart PCR tests in June 2019 for mosquito-borne pathogens[43](index=43&type=chunk) - Offers multiplex tests for West Nile, western equine encephalitis, St. Louis encephalitis, Zika, chikungunya, and dengue[44](index=44&type=chunk) - These tests provide rapid, in-house results, allowing municipalities to focus mosquito control efforts[44](index=44&type=chunk) [Competitive Advantages of Co-Diagnostics](index=11&type=section&id=Competitive%20Advantages%20of%20Co-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](index=48&type=chunk) - Speed: Rapid assay design system software, demonstrated by **30-day CE marking** for Logix Smart COVID-19 test[48](index=48&type=chunk) - Low-Cost Provider: Proprietary platform technology avoids patent royalties, enabling lower prices and maintained profit margins[48](index=48&type=chunk) - Multiplexing: Co-Primers-designed tests can accurately test for multiple targets in one sample without distortion[48](index=48&type=chunk) [Intellectual Property](index=12&type=section&id=Intellectual%20Property) - Flagship Co-Primers technology is covered by two U.S. patents and foreign counterparts[49](index=49&type=chunk) - 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](index=49&type=chunk) - Protects technology and know-how as trade secrets and uses/registers trademarks[50](index=50&type=chunk) [Major Customers](index=12&type=section&id=Major%20Customers) - One customer generated approximately **31% of product revenue in 2024**[51](index=51&type=chunk) - Two granting agencies accounted for approximately **95% of grant revenue in 2024**[51](index=51&type=chunk) - Loss of these major customers or granting agencies could have a material adverse effect on financial condition[51](index=51&type=chunk) [Competition](index=12&type=section&id=Competition) - The molecular diagnostics industry is extremely competitive, with many larger firms having greater financial resources and established market positions[52](index=52&type=chunk) - Competitors include BioMerieux, Siemens, Qiagen, Roche Diagnostics, Cepheid, Abbott Laboratories, Becton Dickinson, and Johnson and Johnson[52](index=52&type=chunk) - Faces competitive price pressure in certain regions, particularly Asia and Latin America, from companies selling tests at lower prices[52](index=52&type=chunk) [Government Regulation](index=13&type=section&id=Government%20Regulation) - Regulated by the FDA in the US, requiring approval, clearance, or authorization for IVD sales[55](index=55&type=chunk) - Granted EUA for Logix Smart COVID-19 test for CLIA labs in the US[55](index=55&type=chunk) - Operates under an ISO 13485:2016 certified quality management system, facilitating global regulatory clearances like CE marking[55](index=55&type=chunk) - Has CE markings for multiple tests, including COVID-19, tuberculosis, Zika, and triplex tests[55](index=55&type=chunk) [Employees](index=13&type=section&id=Employees) - **132 full-time and part-time employees** as of December 31, 2024[56](index=56&type=chunk) - Focus on maintaining a strong culture, diversity, competitive compensation, organizational development, employee health, and effective communication[57](index=57&type=chunk) [Organizational History and Corporate Information](index=13&type=section&id=Organizational%20History%20and%20Corporate%20Information) - Incorporated in Utah on April 18, 2013[58](index=58&type=chunk) - Principal executive office at 2401 S. Foothill Drive, Salt Lake City, Utah 84109[58](index=58&type=chunk) [Item 1A. Risk Factors.](index=14&type=section&id=Item%201A.%20Risk%20Factors.) 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](index=14&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) - Limited operating history and uncertainty of achieving future profitability[59](index=59&type=chunk) - Future success is dependent on the development and regulatory approval of the Co-Dx PCR platform and other diagnostic tests[60](index=60&type=chunk) - The diagnostic market is highly competitive, with larger, well-established companies having significant advantages[61](index=61&type=chunk)[62](index=62&type=chunk) - Dependence on a limited number of third-party suppliers for key raw materials poses supply chain risks[63](index=63&type=chunk) - Loss of senior management, scientific team, or key advisors could harm the business[65](index=65&type=chunk)[67](index=67&type=chunk) - Significant disruptions in IT systems or cybersecurity incidents could adversely affect business, operations, and financial condition[68](index=68&type=chunk)[69](index=69&type=chunk) [Risks Related to Our Capital Resources and Impairments](index=17&type=section&id=Risks%20Related%20to%20Our%20Capital%20Resources%20and%20Impairments) - Requires additional financing; failure to obtain funding would delay or eliminate product development and commercialization efforts[70](index=70&type=chunk)[71](index=71&type=chunk) - 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](index=72&type=chunk) - Raising additional capital through equity or convertible debt will likely dilute existing stockholders[73](index=73&type=chunk) [Risks Related to Regulatory Approval of Our Products and Other Government Regulations](index=18&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20of%20Our%20Products%20and%20Other%20Government%20Regulations) - FDA may revoke Emergency Use Authorization (EUA) for the Logix Smart COVID-19 test, negatively impacting US marketability[74](index=74&type=chunk)[75](index=75&type=chunk) - 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](index=76&type=chunk)[77](index=77&type=chunk) - 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](index=79&type=chunk)[80](index=80&type=chunk)[82](index=82&type=chunk)[94](index=94&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) - Non-compliance with data protection laws could result in significant fines, litigation, reputational harm, and operational changes[81](index=81&type=chunk)[86](index=86&type=chunk)[92](index=92&type=chunk) [Risks Related to Our Intellectual Property](index=25&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - Inadequate protection of proprietary technology (patents, trade secrets, contracts) could harm commercialization efforts[102](index=102&type=chunk) - Issued patents can be challenged, and pending applications may not result in broad protection[103](index=103&type=chunk) - Risk of intellectual property litigation (infringement claims) which could be costly, divert management, require damages, or prevent product marketing[106](index=106&type=chunk)[107](index=107&type=chunk) - Reliance on trademarks and trade names for brand recognition; risk of challenges, infringement, or dilution[108](index=108&type=chunk) [Risks Related to Litigation from Operating Our Business](index=26&type=section&id=Risks%20Related%20to%20Litigation%20from%20Operating%20Our%20Business) - Subject to current and future legal proceedings, including two securities class actions and three derivative actions[109](index=109&type=chunk) - Litigation is unpredictable and can result in excessive verdicts, injunctive relief, substantial costs, and diversion of management's attention[109](index=109&type=chunk) - Adverse publicity from legal actions could damage reputation and reduce demand for products[109](index=109&type=chunk) [General Risk Factors](index=27&type=section&id=General%20Risk%20Factors) - The market price of common stock may fluctuate substantially due to various internal and external factors[110](index=110&type=chunk) - Anti-takeover provisions in charter documents and Utah law could discourage, delay, or prevent a change of control[112](index=112&type=chunk)[113](index=113&type=chunk) - Does not currently intend to pay dividends on common stock[114](index=114&type=chunk) - As a 'smaller reporting company,' reduced disclosure requirements may make common stock less attractive to investors[115](index=115&type=chunk) - Incurs substantial costs as a public company and management devotes significant time to compliance programs[116](index=116&type=chunk)[117](index=117&type=chunk) - 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](index=121&type=chunk) [Item 1B. Unresolved Staff Comments.](index=30&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments.) The company reported no unresolved staff comments from the SEC - No unresolved staff comments[123](index=123&type=chunk) [Item 1C. Cybersecurity](index=31&type=section&id=Item%201C.%20Cybersecurity) 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](index=124&type=chunk) - Engages a third-party cybersecurity firm for network/endpoint monitoring, cloud system assessment, and incident response[124](index=124&type=chunk) - Undertakes activities like monitoring evolving standards, risk assessments, vendor security assessments, mandatory employee training, multi-factor authentication, phishing simulations, and cyber insurance[131](index=131&type=chunk) - The Audit Committee oversees cybersecurity risk assessment, management, and incident response, with leadership from the Chief Technology Officer[129](index=129&type=chunk)[130](index=130&type=chunk) [Item 2. Properties.](index=33&type=section&id=Item%202.%20Properties.) 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](index=133&type=chunk) - Leases approximately **54,000 square feet** for laboratory, manufacturing, storage, and office space[133](index=133&type=chunk) - Leases expire between 2026 and 2028, and current facilities are believed to be sufficient[133](index=133&type=chunk) [Item 3. Legal Proceedings.](index=33&type=section&id=Item%203.%20Legal%20Proceedings.) 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](index=135&type=chunk) - 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](index=136&type=chunk)[137](index=137&type=chunk)[138](index=138&type=chunk) - 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](index=140&type=chunk) - 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](index=141&type=chunk) - 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](index=142&type=chunk)[143](index=143&type=chunk) [Item 4. Mine Safety Disclosures.](index=35&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to the company - Not applicable[144](index=144&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.](index=36&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities.) 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](index=146&type=chunk) - As of March 21, 2025, there were approximately **154 record holders** and the last reported sales price was **$0.46 per share**[147](index=147&type=chunk) - 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](index=148&type=chunk) - No recent sales of unregistered securities[150](index=150&type=chunk) [Item 6. [Reserved.]](index=37&type=section&id=Item%206.%20%5BReserved.%5D) This item is reserved and contains no information - This item is reserved[152](index=152&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.](index=37&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) 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](index=37&type=section&id=Business%20Overview) - Develops, manufactures, and sells reagents for DNA/RNA diagnostic tests, including molecular tools for infectious diseases[153](index=153&type=chunk) - Proprietary Co-Primers technology reduces false positives in PCR amplification[153](index=153&type=chunk) - Developing the Co-Dx PCR platform for affordable, reliable point-of-care and at-home testing, currently under FDA review[154](index=154&type=chunk) - 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](index=154&type=chunk) [Technology](index=37&type=section&id=Technology) - Proprietary and patented molecular diagnostics technology (Co-Primers) enables faster, more economical disease detection with significant margins[155](index=155&type=chunk) - The technology is protected by over **20 granted or pending US and foreign patents**, avoiding third-party patent royalties[157](index=157&type=chunk) - Co-Primers technology is well-suited for applications requiring high specificity, such as multiplexing and enhanced SNP detection[156](index=156&type=chunk) - Rapidly developed and obtained CE-marking for its Logix Smart COVID-19 test in just over **30 days** in early 2020[155](index=155&type=chunk) [Results of Operations for the Years Ended December 31, 2024 and 2023](index=38&type=section&id=RESULTS%20OF%20OPERATIONS) 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](index=164&type=chunk) - 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](index=165&type=chunk) - 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](index=166&type=chunk) - 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](index=170&type=chunk) - 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](index=172&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) - Cash and cash equivalents: **$2.9 million** (Dec 31, 2024) vs. **$14.9 million** (Dec 31, 2023)[173](index=173&type=chunk)[205](index=205&type=chunk) - Marketable investment securities: **$26.8 million** (Dec 31, 2024) vs. **$43.6 million** (Dec 31, 2023)[173](index=173&type=chunk)[205](index=205&type=chunk) - Net cash used in operating activities: **$29.2 million** in 2024, an increase from **$22.1 million** in 2023[174](index=174&type=chunk)[211](index=211&type=chunk) - 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](index=179&type=chunk)[217](index=217&type=chunk) - 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](index=178&type=chunk)[286](index=286&type=chunk) [Critical Accounting Policies and Estimates](index=41&type=section&id=CRITICALACCOUNTING%20POLICIES%20AND%20ESTIMATES) - Accounts Receivable: Management estimates allowance for doubtful accounts based on historical losses, market conditions, customer financial health, and payment patterns[181](index=181&type=chunk)[182](index=182&type=chunk) - 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](index=183&type=chunk)[201](index=201&type=chunk) - Inventories: Periodically reviewed for obsolescence and declines in selling prices, with write-downs based on assumptions about future demand and market value[185](index=185&type=chunk) - Income Taxes: Significant judgment in determining provision, current/deferred tax assets/liabilities, and valuation allowances, especially given cumulative losses[186](index=186&type=chunk)[237](index=237&type=chunk)[238](index=238&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk.](index=43&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) The company states that this item is not required - Not required[188](index=188&type=chunk) [Item 8. Financial Statements and Supplementary Data.](index=44&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data.) 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](index=45&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) - Unqualified opinion on consolidated financial statements for 2024 and 2023[195](index=195&type=chunk) - Explanatory paragraph on "Going Concern" due to recurring losses and need for additional financing, raising substantial doubt[196](index=196&type=chunk) - 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](index=200&type=chunk)[201](index=201&type=chunk)[202](index=202&type=chunk) [Consolidated Balance Sheets](index=47&type=section&id=Consolidated%20Balance%20Sheets) 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](index=48&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=49&type=section&id=Consolidated%20Statement%20of%20Changes%20in%20Stockholders'%20Equity) 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](index=209&type=chunk) - Stock-based compensation expense contributed **$5.4 million** to additional paid-in capital in 2024[209](index=209&type=chunk) - Issuance of common stock from at-the-market offering generated **$0.2 million** in net proceeds in 2024[209](index=209&type=chunk) [Consolidated Statements of Cash Flows](index=50&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) 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](index=174&type=chunk) - Increase in cash provided by investing activities mainly from proceeds from maturities of marketable investment securities[175](index=175&type=chunk) - 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](index=176&type=chunk) [Notes to Consolidated Financial Statements](index=51&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) - Overview and Basis of Presentation: Highlights "going concern" uncertainty due to recurring losses and dependence on future financing[217](index=217&type=chunk)[218](index=218&type=chunk) - Cash, Cash Equivalents, and Financial Instruments: Details marketable investment securities (U.S. treasury securities) and cash, with fair values[249](index=249&type=chunk) - 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](index=254&type=chunk)[255](index=255&type=chunk)[256](index=256&type=chunk) - Property and Equipment: Net fixed assets were **$2.76 million** in 2024, down from **$3.04 million** in 2023[259](index=259&type=chunk) - Intangible Assets: Net intangible assets were **$26.10 million** in 2024, primarily in-process research and development, which is an indefinite-lived asset[260](index=260&type=chunk) - Accrued Expenses: Legal fees increased significantly to **$1.67 million** in 2024 from **$0.50 million** in 2023[261](index=261&type=chunk) - Revenue: Total revenue was **$3.9 million** in 2024, with **90% from the United States** and **10% from the Rest of World**[262](index=262&type=chunk) - Deferred Revenue: Balance decreased to **$40,857** in 2024 from **$362,449** in 2023, with **$301,972** of revenue recognized from prior deferred amounts[263](index=263&type=chunk) - Loss per Share: Basic and diluted loss per share was **$(1.24)** in 2024, compared to **$(1.20)** in 2023[264](index=264&type=chunk) - 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](index=274&type=chunk)[270](index=270&type=chunk) - 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](index=275&type=chunk)[276](index=276&type=chunk) - Commitments and Contingencies: Details lease obligations and ongoing litigation[279](index=279&type=chunk)[283](index=283&type=chunk) - Related Party Transactions: Discloses compensation to CEO's sons and President's indirect interest in acquisition contingent consideration[287](index=287&type=chunk)[288](index=288&type=chunk) - Subsequent Events: Received NASDAQ notice on Jan 10, 2025, regarding minimum bid price deficiency[290](index=290&type=chunk) [Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.](index=68&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure.) 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](index=293&type=chunk) [Item 9A. Controls and Procedures.](index=68&type=section&id=Item%209A.%20Controls%20and%20Procedures.) 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](index=295&type=chunk) - No material changes in internal control over financial reporting during the fourth quarter of 2024[296](index=296&type=chunk) - Management's assessment concluded that internal control over financial reporting was effective as of December 31, 2024, based on the COSO framework[298](index=298&type=chunk) - Acknowledges inherent limitations on the effectiveness of controls, providing reasonable, not absolute, assurance[301](index=301&type=chunk) [Item 9B. Other Information.](index=69&type=section&id=Item%209B.%20Other%20Information.) 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](index=302&type=chunk) [Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.](index=69&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections.) The company has no disclosures regarding foreign jurisdictions that prevent inspections - No disclosures regarding foreign jurisdictions that prevent inspections[303](index=303&type=chunk) PART III [Item 10. Directors, Executive Officers and Corporate Governance.](index=69&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance.) 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](index=69&type=section&id=Executive%20Officers) - Dwight Egan: CEO, President, and Chairman since April 2013, with prior experience in private investment and co-founding Broadcast International[307](index=307&type=chunk) - Brian Brown: CFO since February 2021, a licensed CPA with experience in finance, accounting, and SEC reporting for public companies[308](index=308&type=chunk)[309](index=309&type=chunk) - Richard Abbott: President since March 2024, previously President of Advanced Conceptions, Inc., with a background in medical device design and technology[310](index=310&type=chunk) [Directors](index=71&type=section&id=Directors) - Eugene Durenard: Founder/CEO of Hyperbolic Holdings, with a PhD in Mathematics from Harvard and extensive experience in life sciences and finance[312](index=312&type=chunk) - James Nelson: Retired Chairman/CEO of Sunworks, Inc., with a background in private equity, marketing, and business strategy[313](index=313&type=chunk) - Richard Serbin: Consultant in healthcare, with prior roles as President of Corporate Development at Life Science Institute and experience in patent/FDA law[314](index=314&type=chunk) - Edward Murphy: Senior Vice President and partner at Dover Investments Ltd., with experience in investment analysis and serving on boards of public companies[315](index=315&type=chunk) [Involvement in Certain Legal Proceedings](index=72&type=section&id=Involvement%20in%20Certain%20Legal%20Proceedings) - No material involvement in bankruptcy, criminal proceedings, or significant judgments/injunctions for directors or executive officers in the last ten years[317](index=317&type=chunk) [Board and Committee Matters](index=72&type=section&id=Board%20and%20Committee%20Matters) - Board consists of **five members**, with **four independent non-employee directors**[318](index=318&type=chunk) - Maintains Audit, Compensation, Corporate Governance, and Nominating Committees, all composed of independent directors[319](index=319&type=chunk)[320](index=320&type=chunk) - All directors attended more than **75% of board and committee meetings** in 2024[318](index=318&type=chunk)[321](index=321&type=chunk) - Mr. Durenard is designated as an "audit committee financial expert"[322](index=322&type=chunk) [Board Nominations](index=73&type=section&id=Board%20Nominations) - Bylaws set forth procedures for stockholders to recommend board nominees, requiring timely written notice to the company secretary[328](index=328&type=chunk)[329](index=329&type=chunk) - Nominations must include detailed information about the stockholder, beneficial owner, and proposed nominee, as required by SEC regulations[329](index=329&type=chunk)[330](index=330&type=chunk) - Board considers factors such as experience, education, employment history, special talents, and diversity in evaluating candidates[326](index=326&type=chunk) [Communication with the Board](index=74&type=section&id=Communication%20with%20the%20Board) - Informal process for shareholder communications with the board; all communications are forwarded to all directors[331](index=331&type=chunk) [Conflicts of Interests](index=74&type=section&id=Conflicts%20of%20Interests) - Directors and executive officers are obligated to disclose transactions and avoid conflicts of interest annually[332](index=332&type=chunk) - Conflicts of interest involving executive officers or directors are generally resolved by the board[332](index=332&type=chunk) [Role of the Board in Risk Oversight](index=75&type=section&id=Role%20of%20the%20Board%20in%20Risk%20Oversight) - Board of directors, through its committees, is responsible for oversight of risk management[333](index=333&type=chunk) - Audit Committee: Considers major financial risk exposures[334](index=334&type=chunk) - Corporate Governance Committee: Monitors effectiveness of governance guidelines[334](index=334&type=chunk) - Compensation Committee: Assesses if compensation policies encourage excessive risk-taking[334](index=334&type=chunk) - Nominating Committee: Assesses board effectiveness and succession planning[334](index=334&type=chunk) [Code of Ethics](index=75&type=section&id=Code%20of%20Ethics) - Adopted a code of ethics for principal executive officer and senior finance officers[335](index=335&type=chunk) [Insider Trading Policy](index=75&type=section&id=Insider%20Trading%20Policy) - Adopted an insider trading policy to promote compliance with insider trading laws and NASDAQ listing standards[336](index=336&type=chunk) [Family Relationships](index=75&type=section&id=Family%20Relationships) - No family relationships among directors and executive officers[337](index=337&type=chunk) [Item 11. Executive Compensation.](index=75&type=section&id=Item%2011.%20Executive%20Compensation.) 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](index=75&type=section&id=Summary%20Compensation%20Table) 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](index=340&type=chunk) - Brian Brown's total compensation decreased by approximately **44%** from 2023 to 2024[340](index=340&type=chunk) [Narrative Disclosure to Summary Compensation Table](index=76&type=section&id=Narrative%20Disclosure%20to%20Summary%20Compensation%20Table) - Executive officers serve on an at-will basis without written employment agreements[342](index=342&type=chunk) - Compensation committee determines base salaries and performance-based cash bonuses based on responsibilities, seniority, financial position, and achievement of objectives[342](index=342&type=chunk) [Outstanding Equity Awards at Fiscal Year-End 2024](index=77&type=section&id=Outstanding%20Equity%20Awards%20at%20Fiscal%20Year-End%202024) 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](index=344&type=chunk) [Potential Payments Upon Termination or Change of Control](index=77&type=section&id=Potential%20Payments%20Upon%20Termination%20or%20Change%20of%20Control) - Change in Control Severance Plan provides benefits to designated management upon qualifying termination after a change in control[347](index=347&type=chunk) - 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](index=347&type=chunk) - 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](index=348&type=chunk) [Director Compensation](index=78&type=section&id=Director%20Compensation) - Non-employee directors receive **$100,000 cash compensation** per year, paid quarterly[353](index=353&type=chunk) - In 2024, non-employee directors received **110,000 RSUs**, vesting 1/6 equally in November 2024, 2025, 2026 and May 2025, 2026, 2027[353](index=353&type=chunk) - All stock options granted to outside directors are immediately exercisable[353](index=353&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.](index=80&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters.) 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](index=80&type=section&id=Beneficial%20Ownership%20Table) 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](index=358&type=chunk) [Equity Compensation Plan Information](index=80&type=section&id=Equity%20Compensation%20Plan%20Information) - Shares to be issued upon exercise of outstanding options and rights: **3,782,888**[362](index=362&type=chunk) - Weighted-average exercise price of outstanding options and rights: **$2.19**[362](index=362&type=chunk)[363](index=363&type=chunk) - Number of securities remaining available for future issuance under equity compensation plans: **3,061,949**[362](index=362&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence.](index=82&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence.) 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](index=82&type=section&id=Related%20Party%20Transactions) - Compensation paid to Seth Egan (CEO's son, Chief Commercialization Officer) was **$0.4 million** in 2024[364](index=364&type=chunk) - Compensation paid to Winston Egan (CEO's son, Director of Customer Experience) was **$0.1 million** in 2024[364](index=364&type=chunk) - President Richard Abbott has an indirect **50% interest** in contingent common shares and warrants from the Advanced Conceptions acquisition[365](index=365&type=chunk) - Recognized **$0.6 million expense** in 2024 from a services agreement with CoSara, its equity method investment[289](index=289&type=chunk) [Policy for Review of Related Party Transactions](index=82&type=section&id=Policy%20for%20Review%20of%20Related%20Party%20Transactions) - Corporate Governance Committee oversees the policy for reviewing related party transactions[366](index=366&type=chunk) [Director Independence](index=82&type=section&id=Director%20Independence) - Refer to Item 10 for information on director independence[367](index=367&type=chunk) [Item 14. Principal Accountant Fees and Services.](index=82&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services.) 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](index=370&type=chunk) PART IV [Item 15. Exhibits and Financial Statement Schedules.](index=83&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules.) 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](index=374&type=chunk) - Lists various exhibits such as merger agreements, articles of incorporation, bylaws, equity incentive plans, and certifications[373](index=373&type=chunk)[375](index=375&type=chunk)[376](index=376&type=chunk) - Financial statement schedules are not included as they are either not applicable or the information is in the consolidated financial statements/notes[374](index=374&type=chunk) [Item 16. Form 10-K Summary.](index=86&type=section&id=Item%2016.%20Form%2010-K%20Summary.) This item is not applicable - None[379](index=379&type=chunk)

Exhibit 99.1 Co-Diagnostics, Inc. Reports Full Year 2024 Financial Results SALT LAKE CITY, March 27, 2025— Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced financial results for the fourth quarter and full year ended December 31, 2024. Full Year 2024 Financial Results: Full Year 2024 and Recent Business Highlights: ● Revenue of $3.9 million, which declined from $6.8 million during the prio ...

Core Viewpoint - Co-Diagnostics, Inc. reported its financial results for the fourth quarter and full year ended December 31, 2024, highlighting a decline in revenue and ongoing development efforts for its diagnostic tests [1][2]. Financial Results - Total revenue for 2024 was $3.9 million, down from $6.8 million in 2023, primarily due to a decrease in grant revenue [7]. - Product revenue was $0.8 million, while grant revenue totaled $3.1 million [7]. - Operating expenses decreased by 5.2% to $43.0 million from $45.3 million in the prior year [7]. - The operating loss was $40.1 million, an improvement from a loss of $42.7 million in 2023 [7]. - The net loss for 2024 was $37.6 million, compared to a net loss of $35.3 million in 2023, resulting in a loss of $1.24 per fully diluted share [7][14]. - Adjusted EBITDA loss was $33.5 million for 2024 [7][16]. Business Highlights - The company withdrew its 510(k) application for the Co-Dx PCR Pro and Co-Dx PCR COVID-19 test from the FDA to gather updated clinical data for a new submission [4]. - Progress was made on the tuberculosis test, with clinical evaluations anticipated for this indication, as well as for HPV multiplex and upper respiratory multiplex tests later in 2025 [4]. - The company inaugurated a new oligonucleotide synthesis facility in India and a manufacturing facility in South Salt Lake [7]. - Co-Diagnostics attended several trade shows and expos throughout 2024, enhancing its visibility in the diagnostics market [7]. Balance Sheet Overview - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $29.7 million, a decrease from $58.5 million in 2023 [7][12]. - Total assets were $64.0 million, down from $95.3 million in the previous year [12]. - Total liabilities increased slightly to $9.7 million from $9.3 million in 2023 [12]. Operational Strategy - The company is focused on achieving operational efficiencies to offset development costs as it advances its diagnostic test pipeline [4]. - Management expressed confidence in the potential of its platform and the company's ability to positively impact global health [4].

Core Viewpoint - Co-Diagnostics, Inc. is set to release its fourth quarter and full year 2024 financial results on March 27, 2025, after market close, followed by a conference call to discuss these results with analysts [1]. Company Overview - Co-Diagnostics, Inc. is a molecular diagnostics company based in Utah, specializing in the development, manufacturing, and marketing of advanced diagnostic technologies [3]. - The company's technologies focus on tests that detect and analyze nucleic acid molecules (DNA or RNA) and include proprietary designs for its Co-Dx PCR at-home and point-of-care platform [3].

Core Viewpoint - Co-Diagnostics, Inc. achieved a complete dismissal of a securities class action lawsuit, which was a significant legal victory for the company [1][5][6]. Legal Proceedings - The lawsuit was initiated by Gelt Trading, Ltd. on June 15, 2020, alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 against Co-Diagnostics and certain directors and officers [2]. - The case centered around a May 1, 2020, press release claiming that the Logix Smart® COVID-19 test had "100% sensitivity and 100% specificity," which the plaintiff argued was misleading and caused artificial inflation of the stock price [3]. Court Rulings - BakerHostetler, the legal firm representing Co-Diagnostics, successfully argued for summary judgment, asserting that the plaintiff could not prove any material fact supporting liability for the Section 10(b) claim [4]. - On March 4, 2025, the court granted the defendants' motion to exclude the plaintiff's expert testimony on loss causation and ruled that the plaintiff failed to demonstrate that the May 1 press release caused any losses [5]. Company Outlook - Following the dismissal, Co-Diagnostics expressed optimism about the potential for prevailing in any appeal and aims to focus on its mission of enhancing the availability of high-quality molecular diagnostics globally [6]. Company Profile - Co-Diagnostics, Inc. is a molecular diagnostics company based in Utah, specializing in the development, manufacturing, and marketing of advanced diagnostic technologies, particularly those involving nucleic acid detection and analysis [7].

Core Viewpoint - Co-Diagnostics, Inc. and CoSara Diagnostics Pvt. Ltd. are hosting a symposium on March 4, 2025, to raise awareness about HPV and its link to cancer, coinciding with International HPV Awareness Day [1][2] Group 1: Symposium Details - The symposium titled "HPV and Cancer: Exploring Advances in Prevention and Care" will feature speakers from Co-Dx, CoSara, and experts in cancer diagnostics and oncology from India [2] - The event aims to educate the public about HPV, reduce stigma, and empower individuals to take action against the virus [2] Group 2: Cancer Statistics and Impact - The National Cancer Institute estimates that high-risk HPV subtypes are responsible for approximately 5% of all cancers globally, including cervical cancer, which caused an estimated 350,000 deaths in 2022 [3] - About 94% of cervical cancer deaths occur in low- and middle-income countries (LMICs), where access to diagnostics, vaccinations, and screenings can significantly reduce mortality [3] Group 3: Co-Diagnostics' Initiatives - Co-Diagnostics is completing the assay development for its HPV multiplex test, designed to identify 8 high-risk HPV subtypes from cervical swab samples, aiming to provide an affordable screening tool for patients, especially in LMICs [4] - The CEO of Co-Dx emphasized the importance of early diagnosis in effective treatment and limiting the spread of HPV [5] - CoSara's Saragene® Human Papillomavirus-High Risk real-time PCR test has been cleared for use in India to detect high-risk HPV genotypes [5]

Core Viewpoint - Co-Diagnostics, Inc. has withdrawn its 510(k) application for the Co-Dx™ PCR COVID-19 Test based on FDA feedback regarding shelf-life stability, opting to submit an enhanced version of the test instead [1][3]. Group 1: FDA Interaction and Submission Withdrawal - The decision to withdraw the submission was made after discussions with the FDA concerning the detection of potential deterioration of a test component related to shelf-life stability [3]. - Co-Diagnostics expressed satisfaction with the productive engagement with the FDA regarding the initial regulatory submission and the test's performance in clinical evaluations [2][3]. Group 2: Future Plans and Enhancements - The company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance after collecting clinical evaluation data to support the new test's performance [4]. - The new submission will allow the incorporation of recent developments in the Co-Dx PCR platform, aiming to enhance operational and manufacturing efficiencies [4]. - Co-Diagnostics aims to execute a robust development and commercialization plan for the Co-Dx PCR platform, with additional tests for tuberculosis, upper-respiratory multiplex, and multiplex HPV tests expected to follow [5]. Group 3: Company Overview - Co-Diagnostics, Inc. is a molecular diagnostics company that develops, manufactures, and markets advanced diagnostic technologies, utilizing proprietary technology for tests designed to detect and analyze nucleic acid molecules [7].