The Company will be participating in the Utah booth, displaying the new Co-Dx™ PCR platform*, for which a 510(k) application has been recently submitted to the U.S. Food and Drug Administration for OTC clearance. Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or R ...

Core Insights - The company has completed its first FDA application for 510(k) clearance for the Co-Dx PCR Pro instrument and the Co-Dx PCR COVID-19 Test for OTC use, marking a significant milestone in its growth [8] - The company plans to pursue POC clearance for the Co-Dx PCR COVID-19 test shortly, with additional tests in development to cater to a global market [1][2] - The Co-Dx PCR platform aims to decentralize access to gold-standard PCR diagnostics, traditionally available only in high-complexity laboratories, by enabling point-of-care and at-home testing [9] Company Overview - Co-Diagnostics, Inc. is a molecular diagnostics company that develops, manufactures, and markets advanced diagnostic technologies, focusing on nucleic acid detection and analysis [5] - The company utilizes proprietary technology to create specific tests for its Co-Dx PCR platform, which includes at-home and point-of-care applications [5] Product Development - The Co-Dx PCR platform includes various components such as the PCR Home™, PCR Pro™, and a mobile app, all of which are currently under FDA review [4] - Other diagnostics in development include tests for tuberculosis, human papillomavirus, strep A, and a multiplex respiratory test that detects influenza A and B, COVID-19, and RSV [10] - The company anticipates that the upcoming tests will be transformative and is actively working to complete clinical evaluations and regulatory submissions for these products [11]

Co-Diagnostics, Inc. (NASDAQ:CODX) Q1 2024 Earnings Conference Call May 9, 2024 4:30 PM ET Company Participants Andrew Benson - Head, Investor Relations Dwight Egan - Chief Executive Officer Brian Brown - Chief Financial Officer Conference Call Participants Operator Good day, and welcome to the Co-Diagnostics First Quarter 2024 Earnings Conference Call. All participants will be in a listen-only mode. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference o ...

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, 2024 OR (Exact Name of Registrant as Specified in Its Charter) (State or other jurisdiction of incorporation or organization) Utah 46-2609396 (I.R.S. Employer Identification Number) 2401 S. Foothill Drive, Suite D, Salt Lake City, Utah 84109 (Address of principal executive offices and zip code) (801) ...

[Co-Diagnostics, Inc. Q1 2024 Financial Results](index=1&type=section&id=Co-Diagnostics%2C%20Inc.%20Reports%20First%20Quarter%202024%20Financial%20Results) [First Quarter 2024 Financial & Business Highlights](index=1&type=section&id=First%20Quarter%202024%20Financial%20%26%20Business%20Highlights) Co-Diagnostics reported a Q1 2024 net loss of $9.3 million while making operational progress on its new manufacturing facility and product pipeline [Financial Performance](index=1&type=section&id=Financial%20Performance) Q1 2024 revenue decreased to $0.5 million while the net loss widened to $9.3 million, driven by higher R&D expenses Q1 2024 Key Financial Metrics | Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | **Total Revenue** | $0.5 million | $0.6 million | Down | | **Operating Loss** | $10.3 million | $10.0 million | Increased Loss | | **Net Loss** | $9.3 million | $5.8 million | Increased Loss | | **Loss per Share** | $0.31 | $0.20 | Increased Loss | | **Adjusted EBITDA Loss** | $8.4 million | $7.2 million | Increased Loss | | **Cash & Marketable Securities** | $50.0 million | N/A | N/A | - The 4.4% increase in operating expenses was primarily driven by **higher research and development costs** for pipeline tests[4](index=4&type=chunk) [Business & Operational Highlights](index=1&type=section&id=Business%20%26%20Operational%20Highlights) The company strengthened its leadership team and advanced manufacturing capabilities with new facilities in Salt Lake and India - Key executive appointments were made: Richard Abbott as President, David Nielsen as COO, Christopher Thurston as CTO, and Seth Egan as CCO[5](index=5&type=chunk) - A new manufacturing facility was inaugurated in South Salt Lake to produce **Co-Primers®, the Co-Dx™ PCR Pro™ instrument, and test cups**[5](index=5&type=chunk) - The CoSara manufacturing facility in India is being expanded to **increase capacity for in-house manufacturing** of reagents, equipment, and consumables, including Co-Primers[5](index=5&type=chunk) [Management Commentary](index=1&type=section&id=Management%20Commentary) Management is focused on a near-future 510(k) submission for its PCR platform and advancing its infectious disease test pipeline - The company remains committed to delivering a **510(k) submission to the FDA** for its new instrument and COVID-19 test kit in the near future[5](index=5&type=chunk) - Development of **TB, multiplex respiratory, and HPV tests** will be a key focus for the remainder of the year[5](index=5&type=chunk) - **Clinical evaluations for the company's multiplex test** are planned to begin later in 2024[5](index=5&type=chunk) [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) The statements detail a financial position with $86.7 million in assets and a quarterly net loss of $9.3 million [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to $86.7 million as of March 31, 2024, reflecting a reduction in marketable investment securities Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $23.1 million | $14.9 million | | **Marketable investment securities** | $26.9 million | $43.6 million | | **Total current assets** | $53.7 million | $62.1 million | | **Total assets** | $86.7 million | $95.3 million | | **Total current liabilities** | $5.3 million | $5.7 million | | **Total liabilities** | $8.3 million | $9.3 million | | **Total stockholders' equity** | $78.4 million | $86.0 million | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) For Q1 2024, total revenue was $467,854, and the net loss widened to $9.3 million from $5.8 million year-over-year Consolidated Statement of Operations (Unaudited, Three Months Ended March 31) | Account | 2024 | 2023 | | :--- | :--- | :--- | | **Total revenue** | $467,854 | $601,957 | | **Gross profit** | $233,349 | $99,716 | | **Research and development** | $5,679,678 | $5,014,060 | | **Total operating expenses** | $10,492,736 | $10,050,366 | | **Loss from operations** | ($10,259,387) | ($9,950,650) | | **Net loss** | ($9,312,043) | ($5,755,391) | | **Loss per share (basic and diluted)** | ($0.31) | ($0.20) | [Non-GAAP Financial Measures](index=2&type=section&id=Non-GAAP%20Financial%20Measures) The adjusted EBITDA loss increased to $8.4 million in Q1 2024 from $7.2 million in the prior-year period - Adjusted EBITDA is defined as net income excluding depreciation, amortization, income tax, net interest, realized gains on investments, and stock-based compensation[9](index=9&type=chunk) Reconciliation of Net Loss to Adjusted EBITDA (Unaudited) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | **Net loss** | ($9,312,043) | ($5,755,391) | | **Adjusted EBITDA** | ($8,428,535) | ($7,188,576) | [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) Future plans for product submissions and clinical evaluations are outlined, subject to considerable risks and uncertainties - Forward-looking statements include plans for a **near-future 510(k) submission** for the new instrument and COVID-19 test, and the start of clinical evaluations for the multiplex test later in the year[11](index=11&type=chunk) - The company cautions that actual results may differ materially and directs readers to the **Risk Factors disclosure in its Form 10-K**[11](index=11&type=chunk)

SALT LAKE CITY, April 25, 2024 /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 first quarter 2024 financial results on Thursday, May 9, 2024, 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 and institutional investors.  Management on the call ...

SALT LAKE CITY, April 24, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that the Company will be hosting a booth and delivering a presentation at the 9th Asia Pacific Region Conference (APRC) of the International Union Against Tuberculosis and Lung Disease on April 26-29, 2024 in Taipei, Taiwan. The theme for the 2024 conference is "Shapin ...

Ribbon-cutting included support from Mayor Wood of South Salt Lake and other dignitariesSALT LAKE CITY, April 12, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it held the ribbon cutting event for its new manufacturing facility yesterday in the City of South Salt Lake. The facility has been designed to manufacture the Co-Dx Pro™ instr ...

SALT LAKE CITY, April 4, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx™" or the "Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that last month the Board of Directors appointed Richard Abbott as President of Co-Diagnostics, Inc., concurrent with the Company naming David Nielsen to be its Chief Operations Officer (COO), Christopher Thurston as its Chief Technology Officer (CTO), and Seth Egan as ...

Presentation included announcement of the opening of the new manufacturing facility in Salt Lake City, UT SALT LAKE CITY, March 21, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that in his keynote address at the 5th Annual MarketsandMarkets conference in London, Company CEO Dwight Egan shared an update on the new manufacturing facilities ...