[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)

Company remains on track to initiate clinical evaluations for all tests in Co-Dx PCR platform* pipeline before year-end, and is currently training clinical evaluation sites for enhanced COVID-19 test and expects to begin accepting trial participants imminently Dwight Egan, Chief Executive Officer of Co-Diagnostics, remarked, "The investments made during the course of developing the Co-Dx PCR platform from the ground-up have all contributed to the robust manufacturing, development, and regulatory framework r ...

SALT LAKE CITY, July 31, 2025 /PRNewswire/ -- Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today it will release its second quarter 2025 financial results on Thursday, August 14, 2025, after the market close. The Company will also host a conference call and webcast on the same day at 4:30 p.m. ET to discuss its financial results with analysts.  Management on the call will include Dwight Egan ...

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]

Co-Diagnostics, Inc. (CODX) came out with a quarterly loss of $0.24 per share versus the Zacks Consensus Estimate of a loss of $0.33. This compares to loss of $0.31 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 27.27%. A quarter ago, it was expected that this company would post a loss of $0.34 per share when it actually produced a loss of $0.36, delivering a surprise of -5.88%.Over the last four quarters, the company has sur ...

Financial Data and Key Metrics Changes - Total revenue for the first quarter of 2025 decreased to $100,000 from $500,000 in the same period of the prior year [17][59] - Total operating expenses decreased to $8,600,000 from $10,500,000 year-over-year [18][59] - Research and development expenses were $4,900,000 compared to $5,700,000 in the prior year [18][59] - Net loss for the first quarter was $7,500,000 or a loss of $0.24 per fully diluted share, compared to a net loss of $9,300,000 or a loss of $0.31 per fully diluted share in the prior year [18][60] - Adjusted EBITDA loss improved to $7,400,000 from $8,400,000 in the prior year [18][60] - Cash, cash equivalents, and marketable investment securities at the end of the quarter totaled $21,500,000 [19][60] Business Line Data and Key Metrics Changes - The company is advancing its CoDiEX PCR platform and associated test pipeline, focusing on tests for tuberculosis, COVID-19, a four-plex respiratory panel, and an eight-plex HPV panel [6][48] - The design for the updated COVID-19 test has been completed, and extensive verification testing has been conducted [9][49] - Progress has been made on the TB test, with preliminary analytical studies completed and instruments identified for sample preparation [10][51] - The four-plex respiratory panel is designed to deliver simultaneous PCR test results for flu A and B, COVID-19, and RSV, with significant market interest identified [11][52] - The HPV panel is being prepared for clinical evaluations, supported by a grant from the Bill and Melinda Gates Foundation [12][54] Market Data and Key Metrics Changes - The company expects to begin clinical evaluations for its TB test in India and South Africa in the latter half of 2025 [10][51] - India is identified as a top priority market for TB testing, with significant experience in regulatory, commercial, and manufacturing infrastructure through a joint venture [10][51] - The company plans to pursue regulatory clearance in India for the HPV test before expanding to South Africa and other regions [14][55] Company Strategy and Development Direction - The mission is to increase accessibility to affordable, high-quality diagnostics in the U.S., India, and globally [6][48] - The company aims to bring its Kodiak's PCR platform to market, focusing on operational and manufacturing efficiencies [8][57] - Engagement with local health officials and potential customers is ongoing to evaluate commercialization strategies [10][52] - The company is committed to achieving regulatory objectives and successfully launching the Kodiak's PCR Pro instrument and test kits [15][57] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued progress and future developments within the test pipeline for 2025 [19][61] - The company is focused on managing its spend to maintain a healthy balance sheet for future commercial launches [19][60] - The timeline for clinical trials is influenced by the prevalence of COVID-19, with a focus on effective testing conditions [26][68] - The company anticipates that the HPV and tuberculosis tests may enter clinical trials sooner due to the availability of samples in India [30][73] Other Important Information - The company has hosted events to build awareness of the Kodiak's PCR platform, including a symposium in India and participation in local life sciences events [14][56] - The manufacturing facility build-out in India is on track to be completed by the end of the year, enhancing regional capabilities [16][57] Q&A Session Summary Question: Timeline for COVID test resubmission - Management confirmed that the new design for the COVID test is complete, and they are preparing for clinical evaluations, with a revised submission expected to increase the probability of successful clearance [24][66] Question: Specific submission date for COVID test - The timing for submission is dependent on the prevalence of COVID-19, with management indicating it is a waiting game for effective testing conditions [26][68] Question: Timeline for other products in India and South Africa - All tests, including the multiplex ABCR test, HPV test, and TB test, are expected to enter clinical trials during the remainder of 2025 [28][70] Question: Pricing and gross margins for devices and test cups - The expected cost of the instrument is in the $300 to $500 range, with test cartridges priced at $15 to $20 in developed markets, and lower pricing for low and middle-income countries [36][79]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File No. 001-38148 CO-DIAGNOSTICS, INC. (Exact Name of Registrant as Specified in Its Charter) (State or other jurisdiction of incorpor ...

Exhibit 99.1 Co-Diagnostics, Inc. Reports First Quarter 2025 Financial Results SALT LAKE CITY, May 8, 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 quarter ended March 31, 2025. First Quarter 2025 Financial Results: First Quarter Business Highlights: "During the quarter, Co-Diagnostics continued to make significant progress in the development of our test ...

Core Viewpoint - Co-Diagnostics, Inc. reported its financial results for Q1 2025, highlighting a decline in revenue but a reduction in operating losses, while continuing to advance its product pipeline and operational efficiency [1][4][3]. Financial Results - Revenue for Q1 2025 was $0.1 million, down from $0.5 million in Q1 2024, primarily due to the timing of grant revenue recognition [4][13]. - Operating expenses decreased by 18.2% to $8.6 million compared to $10.5 million in Q1 2024 [4][13]. - The operating loss for Q1 2025 was $8.6 million, an improvement from the $10.3 million loss in Q1 2024 [4][13]. - The net loss was $7.5 million, compared to a net loss of $9.3 million in Q1 2024, resulting in a loss of $0.24 per fully diluted share, improved from a loss of $0.31 per share in Q1 2024 [4][13]. - Adjusted EBITDA loss was $7.4 million for Q1 2025 [4][15]. Business Highlights - The company is on track to initiate clinical evaluations for four tests in its product pipeline and complete its manufacturing facility in India by the end of 2025 [3]. - Co-Diagnostics hosted a symposium in India to honor International HPV Awareness Day 2025 [3]. - The CEO emphasized the importance of the Co-Dx PCR platform in enhancing global accessibility to diagnostic testing solutions [3]. Cash Position - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $21.5 million [4]. Operational Developments - The company is preparing for pre-clinical and pre-analytical studies for its HPV test to be utilized on the Co-Dx PCR Pro instrument [5]. - Co-Diagnostics showcased its upcoming at-home and point-of-care Co-Dx PCR platform at BioUtah's Life Sciences Day [5]. Balance Sheet Overview - Total assets as of March 31, 2025, were $55.1 million, down from $64.0 million at the end of 2024 [12]. - Total liabilities decreased to $7.2 million from $9.7 million at the end of 2024 [12]. Summary of Operations - The company reported a gross profit of $28,687 for Q1 2025, significantly lower than $233,349 in Q1 2024 [13]. - Total operating expenses for Q1 2025 were $8.6 million, down from $10.5 million in the same period last year [13].

SALT LAKE CITY, April 29, 2025 (GLOBE NEWSWIRE) -- Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today it will release its first quarter 2025 financial results on Thursday, May 8, 2025, after the market close. The Company will also host a conference call and webcast on the same day at 4:30 p.m. ET to discuss its financial results with analysts. Management on the call will include Dwight Egan, ...