Company Overview - Co-Diagnostics, Inc. is a molecular diagnostics company that develops, manufactures, and markets advanced diagnostic technologies designed to detect and analyze nucleic acid molecules (DNA or RNA) [6] - The company utilizes proprietary technology to create specific tests for its Co-Dx PCR at-home and point-of-care platform, as well as to identify genetic markers for applications beyond infectious disease [6] Upcoming Events - Co-Diagnostics will host a booth at the 17th Annual Next Generation Dx Summit, taking place both virtually and in-person at the Capital Hilton in Washington, D.C. from August 18-20, 2025 [1] - Attendees are encouraged to visit Booth 12 to learn about the Co-Dx Logix Smart® suite of clinical laboratory solutions and the upcoming Co-Dx PCR diagnostics platform, which includes tests for upper respiratory infections, tuberculosis, and HPV, expected to enter clinical evaluations in 2025 [3] Industry Context - The Next Generation Dx Summit serves as a platform for international thought leaders to network and discuss advancements in diagnostics and technology innovation, focusing on areas such as point-of-care testing, decentralized testing, infectious diseases, liquid biopsy, and companion diagnostics [2]

Core Viewpoint - Co-Diagnostics, Inc. reported its financial results for Q2 2025, highlighting developments in its Co-Dx PCR testing platform and the need for regulatory approval before market availability [2][3]. Financial Results - The company released its financial results for the second quarter ended June 30, 2025, which are available on its website [2]. Management Remarks - The conference call included prepared remarks from the CEO Dwight Egan and CFO Brian Brown, followed by a Q&A session with analysts [2]. Forward-Looking Statements - The company made forward-looking statements regarding its Co-Dx PCR testing platform, emphasizing that it requires regulatory approval and is not currently for sale [3][4].

Core Viewpoint - Co-Diagnostics, Inc. reported a quarterly loss of $0.23 per share, which was better than the Zacks Consensus Estimate of a loss of $0.25, indicating an earnings surprise of +8.00% [1] Financial Performance - The company posted revenues of $0.16 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 45.67%, and a significant decline from $2.66 million in the same quarter last year [2] - Over the last four quarters, Co-Diagnostics has surpassed consensus EPS estimates three times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.16 on revenues of $0.3 million, and for the current fiscal year, it is -$0.68 on revenues of $0.95 million [7] Stock Performance - Co-Diagnostics shares have declined approximately 64.9% since the beginning of the year, contrasting with a 10% gain in the S&P 500 [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it is expected to perform in line with the market in the near future [6] Industry Outlook - The Medical Services industry, to which Co-Diagnostics belongs, is currently ranked in the bottom 41% of over 250 Zacks industries, indicating potential challenges ahead [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact investor sentiment [5]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 decreased to $200,000 compared to $2,700,000 in the same period last year, with revenue from grants in the prior year being $2,500,000 [17] - Total operating expenses decreased to $8,200,000 from $10,100,000 in the prior year, reflecting efforts to improve operational efficiency [17] - Net loss for Q2 2025 was $7,700,000, or a loss of $0.23 per fully diluted share, compared to a net loss of $7,600,000, or a loss of $0.25 per fully diluted share in the prior year [18] - Adjusted EBITDA loss increased to $7,200,000 from $5,900,000 in the previous year [18] - Cash, cash equivalents, and marketable investment securities at the end of Q2 2025 totaled $13,400,000 [18] Business Line Data and Key Metrics Changes - The Kodiak PCR platform is on track to initiate clinical evaluations for all tests in the pipeline during 2025, including tests for COVID-19, flu, tuberculosis, and HPV [5][6] - The Kodiak PCR ABCR four-plex respiratory panel is expected to begin clinical evaluations concurrent with the 2025 North American flu season [9] - The company is focusing on the tuberculosis test, which is expected to begin clinical evaluations in India and South Africa before the end of 2025 [7][8] Market Data and Key Metrics Changes - India accounted for 27% of global TB cases and 26% of global TB deaths in 2023, making it a top priority market for the company's TB testing [8] - The company aims to target primary healthcare facilities in India, where there are nearly 30,000 centers that require advanced molecular technology [34] Company Strategy and Development Direction - The company is committed to increasing the accessibility of affordable, high-quality diagnostics in the U.S., India, and globally [6] - Plans include expanding manufacturing capacity domestically and in India to meet market demand upon platform launch [16] - The company is pursuing a commercialization strategy targeting physician offices, clinics, skilled nursing facilities, and pharmacies in the U.S. [30][34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for multiple commercial launches in 2026 and future developments within the test pipeline [19] - The company anticipates that the clinical trial for the COVID-19 test will be completed by year-end 2025, with a reasonable possibility of FDA clearance by mid-2026 [36][37] Other Important Information - The company is managing its capital requirements through equity or debt financing, additional grant funding, and operational efficiencies [19] - The Kodiak PCR platform is expected to revolutionize PCR infectious disease testing by enhancing affordability, accessibility, and decentralization [16] Q&A Session Summary Question: Expected timeline for clinical trials and applications - Management expects all four tests to enter clinical trials during the remainder of 2025, starting with the COVID-19 test [23] Question: Commercial launch visibility and marketing strategy - Commercialization is planned as soon as FDA clearance is obtained, targeting physician offices, clinics, and pharmacies in the U.S. [30][34] Question: Timeline for commercialization - Management hopes for commercialization before 2026, with a possibility of FDA clearance by mid-2026 [36][37]

```markdown [Filing Information](index=1&type=section&id=Filing%20Information) This section outlines the company's Form 10-Q filing for Q2 2025, registrant status, and common stock outstanding - Co-Diagnostics, Inc. filed a Quarterly Report on Form 10-Q for the period ended June 30, 2025[2](index=2&type=chunk) Registrant Status | Status | Mark | | :--- | :--- | | Large accelerated filer | ☐ | | Accelerated filer | ☐ | | Non-accelerated filer | ☒ | | Smaller reporting company | ☒ | | Emerging growth company | ☐ | - As of August 12, 2025, **38,523,582 shares** of common stock were outstanding[4](index=4&type=chunk) [PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This part presents the unaudited condensed consolidated financial statements and management's discussion and analysis for the period [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements and related notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position at June 30, 2025, compared to December 31, 2024 Condensed Consolidated Balance Sheets (June 30, 2025 vs. December 31, 2024) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $11,115,181 | $2,936,544 | | Marketable investment securities | $2,247,638 | $26,811,098 | | Total current assets | $15,307,166 | $32,291,698 | | Total assets | $46,465,833 | $63,999,919 | | **Liabilities & Equity** | | | | Total current liabilities | $3,711,248 | $7,315,718 | | Total liabilities | $5,327,439 | $9,688,001 | | Total stockholders' equity | $41,138,394 | $54,311,918 | - Cash and cash equivalents significantly increased from **$2.9 million** at December 31, 2024, to **$11.1 million** at June 30, 2025[9](index=9&type=chunk) - Marketable investment securities substantially decreased from **$26.8 million** to **$2.2 million**[9](index=9&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's revenues, expenses, and net loss for the three and six months ended June 30, 2025 and 2024 Condensed Consolidated Statements of Operations (Three Months Ended June 30) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Product revenue | $162,910 | $161,102 | | Grant revenue | $- | $2,495,738 | | Total revenue | $162,910 | $2,656,840 | | Gross profit | $130,804 | $2,444,692 | | Total operating expenses | $8,188,568 | $10,124,654 | | Loss from operations | $(8,057,764) | $(7,679,962) | | Net loss | $(7,730,117) | $(7,599,318) | | Basic and Diluted Loss per share | $(0.23) | $(0.25) | Condensed Consolidated Statements of Operations (Six Months Ended June 30) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Product revenue | $213,187 | $413,847 | | Grant revenue | $- | $2,710,847 | | Total revenue | $213,187 | $3,124,694 | | Gross profit | $159,491 | $2,678,041 | | Total operating expenses | $16,769,211 | $20,617,390 | | Loss from operations | $(16,609,720) | $(17,939,349) | | Net loss | $(15,263,388) | $(16,911,361) | | Basic and Diluted Loss per share | $(0.47) | $(0.56) | - Total revenue for the three months ended June 30, 2025, significantly decreased to **$0.2 million** from **$2.7 million** in the prior year, primarily due to the absence of grant revenue[10](index=10&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section outlines the cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30 Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(17,033,044) | $(13,694,532) | | Net cash provided by investing activities | $24,427,935 | $12,636,520 | | Net cash provided by financing activities | $783,746 | $- | | Net increase (decrease) in cash and cash equivalents | $8,178,637 | $(1,058,012) | | Cash and cash equivalents at end of period | $11,115,181 | $13,858,866 | - Net cash used in operating activities increased to **$(17.0) million** in 2025 from **$(13.7) million** in 2024[12](index=12&type=chunk) - Net cash provided by investing activities significantly increased to **$24.4 million** in 2025 from **$12.6 million** in 2024, primarily due to maturities of marketable investment securities[12](index=12&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section presents changes in the company's equity components, including common stock, additional paid-in capital, and accumulated deficit Stockholders' Equity Summary (June 30, 2025 vs. December 31, 2024) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Common Stock (Amount) | $41,031 | $37,902 | | Additional Paid-in Capital | $104,843,320 | $102,472,210 | | Accumulated Other Comprehensive Income | $134,068 | $418,443 | | Accumulated Deficit | $(48,304,230) | $(33,040,842) | | Total Stockholders' Equity | $41,138,394 | $54,311,918 | - Total stockholders' equity decreased from **$54.3 million** at December 31, 2024, to **$41.1 million** at June 30, 2025, primarily due to an increase in accumulated deficit[9](index=9&type=chunk)[13](index=13&type=chunk) - Issuance of common stock from at-the-market offerings contributed **$354,746** and **$429,000** to additional paid-in capital during Q1 and Q2 2025, respectively[13](index=13&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations of the company's accounting policies, financial instruments, revenue recognition, and other significant disclosures - Co-Diagnostics, Inc. is a molecular diagnostics company developing, manufacturing, and marketing state-of-the-art diagnostics technologies, including PCR tests and the new Co-Dx™ PCR platform[15](index=15&type=chunk)[77](index=77&type=chunk) - Management concluded substantial doubt exists about the Company's ability to continue as a going concern for 12 months, dependent on financing and profitable operations[18](index=18&type=chunk)[19](index=19&type=chunk) - The Company recognized no grant funding revenue for the three and six months ended June 30, 2025, a significant decrease from **$2.5 million** and **$2.7 million**, respectively, in prior year periods[26](index=26&type=chunk) - Significant customer concentration exists, with three customers accounting for approximately **53% of product revenue** and **82% of accounts receivable** at June 30, 2025[30](index=30&type=chunk)[31](index=31&type=chunk) - The Company's intangible assets, net, primarily consist of **$26.1 million** in in-process research and development with an indefinite useful life[45](index=45&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial performance and condition, highlighting key changes in revenues, expenses, and net loss [Executive Overview](index=21&type=section&id=Executive%20Overview) This section provides an overview of principal factors affecting operations and financial condition, along with forward-looking statement disclosures - The discussion describes principal factors affecting operations, financial condition, and changes in financial condition[76](index=76&type=chunk) - Forward-looking statements are subject to risks and uncertainties, including those discussed in the 'Risk Factors' section of the Annual Report on Form 10-K[73](index=73&type=chunk)[74](index=74&type=chunk) [Business Overview](index=21&type=section&id=Business%20Overview) This section describes the company's core business of developing molecular diagnostic tests and its Co-Dx™ PCR platform - Co-Diagnostics, Inc. develops, manufactures, and sells reagents for molecular diagnostic tests, focusing on infectious diseases using proprietary Co-Primers PCR technology[77](index=77&type=chunk) - The company is developing the portable Co-Dx™ PCR platform for point-of-care and at-home use, currently subject to FDA review[78](index=78&type=chunk) - The 510(k) application for the Co-Dx PCR COVID-19 Test was withdrawn due to FDA discussions on shelf-life stability, with plans for resubmission of an enhanced version[78](index=78&type=chunk) [Technology](index=23&type=section&id=Technology) This section highlights the company's proprietary Co-Primers molecular diagnostics technology and its applications - The company's proprietary and patented Co-Primers molecular diagnostics technology enhances genetic material detection, enabling faster and more economical disease detection[80](index=80&type=chunk)[82](index=82&type=chunk) - Co-Diagnostics was the first US-based company to receive a CE-marking for a COVID-19 test in early 2020, demonstrating rapid test development capabilities[80](index=80&type=chunk) - The technology is protected by over **20 granted or pending US and foreign patents**, providing a competitive advantage by avoiding patent royalties[82](index=82&type=chunk) - Beyond infectious diseases, Co-Primers technology identifies genetic traits in plant and animal genomes and is used for multiplexed tests for mosquito-borne diseases[85](index=85&type=chunk) [RESULTS OF OPERATIONS](index=24&type=section&id=RESULTS%20OF%20OPERATIONS) This section analyzes the company's financial performance, including revenue, operating expenses, and net loss, for the three and six months ended June 30 - Total revenue for the three months ended June 30, 2025, was **$0.2 million**, down from **$2.7 million** in 2024, primarily due to lower grant revenues[86](index=86&type=chunk) - Total operating expenses decreased to **$8.2 million** for the three months ended June 30, 2025, from **$10.1 million** in 2024, driven by reduced stock-based compensation, personnel, and Co-Dx PCR platform development expenses[88](index=88&type=chunk) - Net loss for the three months ended June 30, 2025, was **$7.7 million**, slightly higher than **$7.6 million** in 2024, mainly due to decreased grant revenues offsetting lower operating expenses[93](index=93&type=chunk) - For the six months ended June 30, 2025, total revenue was **$0.2 million**, a significant drop from **$3.1 million** in 2024, due to lower product and grant revenues[94](index=94&type=chunk) - Net loss for the six months ended June 30, 2025, improved to **$15.3 million** from **$16.9 million** in 2024, primarily due to decreases in operating expenses[101](index=101&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its financial obligations, including cash position, investment activities, and financing efforts Liquidity Position (June 30, 2025) | Metric | Amount | | :--- | :--- | | Cash and cash equivalents | $11.1 million | | Marketable investment securities | $2.2 million | | Total current assets | $15.3 million | | Total current liabilities | $3.7 million | - Net cash used in operating activities increased to **$17.0 million** for the six months ended June 30, 2025, from **$13.7 million** in the prior year, driven by higher legal expenses and decreased revenues/grant funding[103](index=103&type=chunk) - Net cash provided by investing activities significantly increased to **$24.4 million** for the six months ended June 30, 2025, from **$12.6 million** in the prior year, primarily due to the timing of investment maturities[104](index=104&type=chunk) - The company raised **$0.8 million** in net cash from financing activities through common stock issuances under an At-the-Market (ATM) agreement[105](index=105&type=chunk)[106](index=106&type=chunk) - Substantial doubt exists about the Company's ability to continue as a going concern, as additional equity/debt financing is not assured and may be dilutive[107](index=107&type=chunk) [Off-Balance Sheet Arrangements](index=26&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of any off-balance sheet arrangements for the company - The Company has no off-balance sheet arrangements[108](index=108&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Co-Diagnostics, Inc. is not required to provide quantitative and qualitative disclosures about market risk under Regulation S-K - Not required under Regulation S-K for 'smaller reporting companies'[109](index=109&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, concluding they were effective [Evaluation of Disclosure Controls and Procedures](index=26&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section confirms management's conclusion that disclosure controls and procedures were effective as of June 30, 2025 - Management, with CEO and CFO participation, concluded that disclosure controls and procedures were effective as of June 30, 2025[110](index=110&type=chunk) [Changes in Internal Control over Financial Reporting](index=27&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section states that no material changes in internal control over financial reporting occurred during the period - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2025[111](index=111&type=chunk) [PART II. OTHER INFORMATION](index=28&type=section&id=PART%20II%20OTHER%20INFORMATION) This part covers other material information not included in the financial statements, such as legal proceedings, equity sales, and exhibits [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) There have been no material developments to the legal proceedings previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 - No material developments to previously disclosed legal proceedings[113](index=113&type=chunk) - The Company is a defendant in one class action, four derivative actions, and three civil actions (two in the US, one in the UK) based on breach of contract claims[65](index=65&type=chunk) - The Company believes these lawsuits are without merit and cannot estimate a range of loss, but an unfavorable outcome could be material[65](index=65&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, Co-Diagnostics, Inc. is not required to provide a separate discussion of risk factors under Regulation S-K in this quarterly report - Not required under Regulation S-K for 'smaller reporting companies'[114](index=114&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Effective June 16, 2025, the Company issued 500,000 shares of common stock in a private placement for financial advisory services, pursuant to Section 4(a)(2) of the Securities Act of 1933 - On June 16, 2025, **500,000 shares** of common stock were issued in a private placement for financial advisory services[114](index=114&type=chunk) - The shares were offered and sold pursuant to exemptions from registration under Section 4(a)(2) of the Securities Act of 1933[114](index=114&type=chunk) [Item 3. Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities during the period - None[116](index=116&type=chunk) [Item 4. Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to Co-Diagnostics, Inc - Not applicable[117](index=117&type=chunk) [Item 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) The Company reported no other information requiring disclosure under this item - None[118](index=118&type=chunk) - The Company has never declared or paid cash dividends and does not anticipate doing so in the foreseeable future, intending to use funds for business development and expansion[115](index=115&type=chunk) - Dividend payments are subject to the Utah Revised Business Corporation Act, which prohibits distributions if the corporation cannot pay debts or if total assets are less than total liabilities plus preferential rights upon dissolution[116](index=116&type=chunk)[119](index=119&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Amended and Restated Equity Distribution Agreement, certifications from the CEO and CFO, and Inline XBRL documents - Includes the Amended and Restated Equity Distribution Agreement (Exhibit 10.1) dated April 25, 2025[121](index=121&type=chunk) - Certifications of Chief Executive Officer and Chief Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 are filed[121](index=121&type=chunk) - Inline XBRL documents (Instance, Schema, Calculation, Definition, Label, Presentation Linkbase Documents) and Cover Page Interactive Data File are included[121](index=121&type=chunk) [Signatures](index=30&type=section&id=Signatures) The report is duly signed on behalf of CO-DIAGNOSTICS, INC. by Dwight H. Egan, Chief Executive Officer, and Brian Brown, Chief Financial Officer, on August 14, 2025 - Report signed by Dwight H. Egan, CEO, and Brian Brown, CFO, on August 14, 2025[126](index=126&type=chunk) ```

[Executive Summary & Business Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Highlights) [Second Quarter 2025 Financial Overview](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Overview) Co-Diagnostics, Inc. reported a significant decline in revenue for Q2 2025 to $0.2 million, primarily due to the absence of grant revenue, recording an operating loss of $8.1 million and a net loss of $7.7 million, or $0.23 per diluted share, while decreasing operating expenses by 19.1% year-over-year Financial Performance Summary | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | Change (%) | | :----------------------- | :----------------- | :----------------- | :--------- | | Revenue | $0.2 | $2.7 | -92.6% | | Operating Expenses | $8.2 | $10.1 | -19.1% | | Operating Loss | $(8.1) | $(7.7) | +5.2% | | Net Loss | $(7.7) | $(7.6) | +1.3% | | Diluted EPS | $(0.23) | $(0.25) | -8.0% | | Adjusted EBITDA Loss | $(7.2) | $(5.9) | +22.0% | - Revenue decline primarily attributed to no grant revenue recognized in Q2 2025, compared to **$2.5 million** in Q2 2024[7](index=7&type=chunk)[15](index=15&type=chunk) - Cash, cash equivalents, and marketable securities stood at **$13.4 million** as of June 30, 2025[7](index=7&type=chunk) [Recent Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) The company is on track to initiate clinical evaluations for all tests in its Co-Dx PCR platform pipeline before year-end, with training for enhanced COVID-19 test participants beginning imminently, and the CEO emphasized the robust framework developed for market entry and confidence in regulatory submissions - Company remains on track to initiate clinical evaluations for all tests in Co-Dx PCR platform pipeline before year-end[4](index=4&type=chunk) - Currently training clinical evaluation sites for enhanced COVID-19 test and expect to begin accepting trial participants imminently[4](index=4&type=chunk) - The Co-Dx PCR platform (including PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to FDA and/or other regulatory bodies' review and is not yet available for sale[6](index=6&type=chunk) [Company Information & Disclosures](index=2&type=section&id=Company%20Information%20%26%20Disclosures) [About Co-Diagnostics, Inc.](index=2&type=section&id=About%20Co-Diagnostics%2C%20Inc.) Co-Diagnostics, Inc. is a Utah-based molecular diagnostics company specializing in developing, manufacturing, and marketing advanced diagnostic technologies that utilize nucleic acid detection and analysis, with proprietary technology also used for its Co-Dx PCR at-home and point-of-care platform and identifying genetic markers beyond infectious diseases - Develops, manufactures, and markets state-of-the-art molecular diagnostics technologies[8](index=8&type=chunk) - Technologies are utilized for tests designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA)[8](index=8&type=chunk) - Uses proprietary technology for Co-Dx PCR at-home and point-of-care platform and to identify genetic markers for non-infectious disease applications[8](index=8&type=chunk) [Non-GAAP Financial Measures](index=2&type=section&id=Non-GAAP%20Financial%20Measures) This section defines Adjusted EBITDA as a non-GAAP measure, explaining its exclusion of items like depreciation, stock-based compensation, and interest, highlighting its utility for management in trend analysis and budgeting, and for investors in evaluating ongoing operations and comparing performance, while also cautioning against its use in isolation from GAAP results - Adjusted EBITDA is a non-GAAP measure defined as net income excluding depreciation, amortization, income tax (benefit) expense, net interest (income) expense, stock-based compensation, change in fair value of contingent consideration, and realized gain (loss) on investments[9](index=9&type=chunk) - Management uses Adjusted EBITDA for trend analyses, budgeting, and planning, believing it provides useful information to investors for evaluating ongoing operating results and comparisons[9](index=9&type=chunk) - Non-GAAP measures should not be considered in isolation or as an alternative/substitute to GAAP results due to the exclusion of significant expenses[10](index=10&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) The company includes a standard disclaimer regarding forward-looking statements, which are based on current facts and predictions, and are subject to inherent uncertainties, risks, and changes in circumstances, specifically mentioning statements about the Co-Dx PCR platform's clinical evaluations, development, regulatory submissions, and its potential role in diagnostic testing accessibility, cautioning investors against undue reliance, and disclaiming any obligation to update these statements unless required by law - Forward-looking statements are identified by words like 'believes,' 'expects,' 'estimates,' and are based on existing facts and future predictions[11](index=11&type=chunk) - Statements include advancement into clinical evaluations, continued development, regulatory submissions for the Co-Dx PCR platform, and its role in transforming global diagnostic testing accessibility[11](index=11&type=chunk) - Actual results may differ materially due to inherent uncertainties and risks, as detailed in SEC filings; investors are cautioned not to place undue reliance on these statements[11](index=11&type=chunk) [Investor Relations Contact](index=2&type=section&id=Investor%20Relations%20Contact) Contact information for investor relations is provided for inquiries - Investor Relations Contact: Andrew Benson, Head of Investor Relations, +1 801-438-1036, investors@codiagnostics.com[12](index=12&type=chunk) [Consolidated Financial Statements](index=3&type=section&id=Consolidated%20Financial%20Statements) [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, Co-Diagnostics, Inc. reported total assets of $46.5 million, a decrease from $64.0 million at December 31, 2024, primarily driven by a significant reduction in marketable investment securities, with total liabilities also decreasing from $9.7 million to $5.3 million, while total stockholders' equity declined from $54.3 million to $41.1 million Consolidated Balance Sheet Summary | Balance Sheet Item | June 30, 2025 (USD) | December 31, 2024 (USD) | Change | | :----------------- | :------------------ | :---------------------- | :----- | | Total Assets | $46,465,833 | $63,999,919 | -27.4% | | Total Liabilities | $5,327,439 | $9,688,001 | -45.0% | | Total Stockholders' Equity | $41,138,394 | $54,311,918 | -24.3% | - Cash and cash equivalents increased significantly from **$2.9 million** to **$11.1 million**, while marketable investment securities decreased from **$26.8 million** to **$2.2 million**[14](index=14&type=chunk) - Current liabilities decreased by **49.3%** from **$7.3 million** to **$3.7 million**, driven by reductions in accounts payable, accrued expenses, and contingent consideration liabilities[14](index=14&type=chunk) [Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended June 30, 2025, total revenue plummeted to $0.16 million from $2.66 million in Q2 2024, primarily due to the absence of grant revenue, with gross profit consequently falling from $2.44 million to $0.13 million, and despite a reduction in total operating expenses by 19.1% to $8.19 million, the company reported an increased loss from operations of $8.06 million and a net loss of $7.73 million Consolidated Statements of Operations Summary | Income Statement Item | Q2 2025 (USD) | Q2 2024 (USD) | Change (%) | | :-------------------- | :------------ | :------------ | :--------- | | Product Revenue | $162,910 | $161,102 | +1.1% | | Grant Revenue | $0 | $2,495,738 | -100.0% | | Total Revenue | $162,910 | $2,656,840 | -93.9% | | Gross Profit | $130,804 | $2,444,692 | -94.6% | | Total Operating Expenses | $8,188,568 | $10,124,654 | -19.1% | | Loss from Operations | $(8,057,764) | $(7,679,962) | +4.9% | | Net Loss | $(7,730,117) | $(7,599,318) | +1.7% | | Basic and Diluted EPS | $(0.23) | $(0.25) | -8.0% | - Research and development expenses decreased by **16.5%** from **$5.6 million** in Q2 2024 to **$4.7 million** in Q2 2025[15](index=15&type=chunk) - Sales and marketing expenses decreased by **41.4%** from **$1.04 million** to **$0.61 million**[15](index=15&type=chunk) [GAAP and Non-GAAP Measures Reconciliation](index=5&type=section&id=GAAP%20and%20Non-GAAP%20Measures%20Reconciliation) The reconciliation of net loss to Adjusted EBITDA shows an Adjusted EBITDA loss of $7.20 million for Q2 2025, an increase from the $5.92 million loss in Q2 2024, with key adjustments including adding back depreciation and amortization, stock-based compensation, and income tax provision, while subtracting interest income and realized gains on investments Reconciliation of Net Loss to Adjusted EBITDA | Reconciliation Item | Q2 2025 (USD) | Q2 2024 (USD) | | :------------------ | :------------ | :------------ | | Net loss | $(7,730,117) | $(7,599,318) | | Interest income, net | $(12,158) | $(342,188) | | Realized gain on investments | $(340,358) | $(74,165) | | Depreciation and amortization | $291,414 | $338,335 | | Stock-based compensation expense | $580,265 | $1,499,658 | | Income tax provision | $12,327 | $20,590 | | **Adjusted EBITDA** | **$(7,199,845)** | **$(5,916,472)** | - Stock-based compensation expense significantly decreased from **$1.50 million** in Q2 2024 to **$0.58 million** in Q2 2025[17](index=17&type=chunk)

Core Insights - Co-Diagnostics, Inc. reported financial results for Q2 2025, highlighting a significant decline in revenue primarily due to the timing of grant revenue recognition [2][8] - The company remains on track to initiate clinical evaluations for its Co-Dx PCR platform tests by year-end, with an enhanced COVID-19 test expected to be the first submitted for regulatory clearance [3][5] Financial Performance - Revenue for Q2 2025 was $0.2 million, down from $2.7 million in Q2 2024, with no grant revenue recognized during the quarter [8] - Operating expenses were approximately $8.2 million, a decrease of 19.1% from the prior year [8] - The operating loss was $8.1 million compared to a loss of $7.7 million in Q2 2024 [8] - The net loss for the quarter was $7.7 million, or $0.23 per fully diluted share, compared to a net loss of $7.6 million, or $0.25 per fully diluted share in Q2 2024 [8][14] - Adjusted EBITDA loss was $7.2 million for Q2 2025 [8][16] Balance Sheet Highlights - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled $13.4 million [8] - Total assets decreased to $46.5 million from $64.0 million at the end of 2024 [12] - Total liabilities were $5.3 million, down from $9.7 million at the end of 2024 [13] Business Developments - The company is training clinical evaluation sites for the enhanced COVID-19 test and expects to begin accepting trial participants imminently [3] - The CEO emphasized the importance of investments made in developing the Co-Dx PCR platform, which are expected to support successful market entry and regulatory submissions [3]

Core Insights - Co-Diagnostics, Inc. will release its second quarter 2025 financial results on August 14, 2025, after market close [1] - A conference call and webcast will be held on the same day at 4:30 p.m. ET to discuss the financial results with analysts [1] - Key management participating in the call includes CEO Dwight Egan, CFO Brian Brown, and Head of Investor Relations Andrew Benson [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) [3] - Co-Diagnostics utilizes proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform, as well as to identify genetic markers for various applications beyond infectious diseases [3]

Company Overview - Co-Diagnostics, Inc. is a molecular diagnostics company based in Utah that develops, manufactures, and markets advanced diagnostic technologies [4] - The company's technologies focus on tests designed for the detection and analysis of nucleic acid molecules (DNA or RNA) [4] - Co-Diagnostics utilizes proprietary technology to create specific tests for its Co-Dx PCR platform, which includes at-home and point-of-care testing [4] Conference Participation - Co-Diagnostics will participate in the D. Boral Capital Inaugural Global Conference on May 14, 2025, in New York City [1] - The conference aims to connect emerging growth issuers across various sectors with institutional investors [2] - Company representatives will engage in one-on-one meetings to present the company's value proposition and the upcoming Co-Dx PCR testing platform [2] Product Information - The Co-Dx PCR platform includes the PCR Home™, PCR Pro™, a mobile app, and associated tests [3] - The platform is currently under review by the FDA and other regulatory bodies and is not yet available for sale [3]

Core Insights - Co-Diagnostics, Inc. reported a quarterly loss of $0.24 per share, better than the Zacks Consensus Estimate of a loss of $0.33, and an improvement from a loss of $0.31 per share a year ago, resulting in an earnings surprise of 27.27% [1] - The company posted revenues of $0.05 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 86.84%, and down from $0.47 million in the same quarter last year [2] - Co-Diagnostics shares have declined approximately 53.3% year-to-date, contrasting with the S&P 500's decline of 4.3% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.33 on revenues of $0.38 million, and for the current fiscal year, it is -$0.91 on revenues of $1.5 million [7] - The estimate revisions trend for CoDiagnostics is currently favorable, leading to a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical Services industry, to which Co-Diagnostics belongs, is currently ranked in the top 22% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8] - Another company in the same industry, Surgery Partners, is expected to report quarterly earnings of $0.08 per share, reflecting a year-over-year decline of 20%, with revenues projected at $796.68 million, an increase of 11.1% from the previous year [9][10]