CDI(US:CODX)2025-08-14 20:11markdown [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)