Core Insights - Co-Diagnostics, Inc. has conducted an in silico analysis of its CoDx™ Logix Smart® Mpox (2-Gene) RUO test, confirming that the test maintains full reactivity against circulating mpox strains, including clade Ib [1] - The Africa CDC and WHO have declared mpox a public health emergency, with over 22,800 cases and 622 deaths reported in Africa, highlighting the increased transmissibility and severity of clade Ib compared to other strains [2] - Co-Diagnostics has developed two RUO tests for mpox on its patented Co-Primers® platform, with the 2-gene version showing superior detection capabilities from saliva samples in a study published in December 2023 [3] Company Developments - The CEO of Co-Diagnostics emphasized the company's commitment to advancing PCR testing solutions, including a new at-home and point-of-care PCR platform aimed at tracking infectious disease outbreaks [4] - The company has received numerous requests from global distributors and customers for test kits for performance validation, reinforcing its vision to enhance global access to high-quality infectious disease diagnostics [5] - Co-Diagnostics, Inc. specializes in molecular diagnostics, focusing on the development and marketing of advanced diagnostic technologies that analyze nucleic acid molecules [7]

Financial Data and Key Metrics Changes - Total revenue for Q2 2024 increased to $2.7 million compared to $0.2 million in the same period last year [20] - Gross profit for the quarter increased to $2.4 million from a loss of $0.3 million in the prior year [20] - Net loss for Q2 2024 was $7.6 million, or a loss of $0.25 per fully diluted share, compared to a net loss of $8.9 million, or a loss of $0.31 per fully diluted share in the prior year [21] - Adjusted EBITDA loss improved to $5.9 million from a loss of $9.6 million in the prior year [21] - Cash position at the end of the quarter was $44.9 million [21] Business Line Data and Key Metrics Changes - Grant revenue in Q2 2024 was $2.5 million, while product revenue was $0.2 million [20] - Research and development expenses decreased to $5.6 million from $6.0 million in the prior year [20] - Total operating expenses decreased to $10.1 million from $11.7 million in the second quarter of 2023 [20] Market Data and Key Metrics Changes - The global total addressable market for tuberculosis (TB) testing is projected to exceed $3.6 billion within the next four years [11] - Approximately 17 million near point-of-care TB tests are performed annually in South and East Asia, with an additional 10 million in Africa [11] Company Strategy and Development Direction - The company is focused on commercializing its Co-Dx PCR platform, with a 510(k) application submitted to the FDA for over-the-counter use [5][6] - Plans to target high-volume care centers and skilled nursing facilities for the initial rollout of the Co-Dx PCR platform [8] - The company aims to expand its test pipeline, including tests for tuberculosis, respiratory multiplex, HPV, and strep [10][12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in the first half of the year and the potential of the Co-Dx PCR platform to transform diagnostics [5][17] - The company is committed to maintaining a healthy balance sheet and operational efficiencies to support long-term growth [21][22] Other Important Information - The company attended two major trade shows, FIME and ADLM, to showcase its Co-Dx PCR platform and engage with potential customers [9] - The vector control business is expanding, with new offerings for mosquito-borne illness surveillance [15] Q&A Session Summary Question: Has there been any feedback from the FDA regarding the 510(k) submission? - Management confirmed regular contact with the FDA but could not comment on specific regulatory decisions [24][25] Question: Are there potential customers showing interest in placing orders once the 510(k) is cleared? - Management indicated constructive conversations with potential customers but emphasized that sales cannot occur until FDA clearance is obtained [26] Question: Is the potential market primarily domestic or international? - Management stated that interest in the product spans both domestic and international markets, with sales in over 50 countries [27]

Co-Diagnostics, Inc. (CODX) came out with a quarterly loss of $0.25 per share versus the Zacks Consensus Estimate of a loss of $0.34. 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 26.47%. A quarter ago, it was expected that this company would post a loss of $0.21 per share when it actually produced a loss of $0.31, delivering a surprise of -47.62%. Over the last four quarters, the company has ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock CODX The Nasdaq Capital Market FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 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 ...

Exhibit 99.1 Co-Diagnostics, Inc. Reports Second Quarter 2024 Financial Results SALT LAKE CITY, August 8, 2024— 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 June 30, 2024. Second Quarter 2024 Financial Results: ● Revenue of $2.7 million, up from $0.2 million during the prior year primarily due to the achievement of certain milestones under variou ...

Core Insights - Co-Diagnostics, Inc. is participating in the ADLM annual meeting and expo from July 28 to August 1, 2024, in Chicago, IL, showcasing its advancements in molecular diagnostics [1][2]. 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 [4]. Product Development - The company is introducing its new at-home and point-of-care Co-Dx™ PCR platform aimed at addressing the global diagnostics gap, with a focus on various indications including tuberculosis (TB) [2][6]. - The first FDA 510(k) application for a COVID-19 test was submitted in mid-June, with additional tests in the pipeline to cater to a diverse global market [2][3]. Presentation and Engagement - A special company presentation will be held on July 30, featuring CEO Dwight Egan and Executive VP Joseph Featherstone, discussing the company's role in the global initiative to end TB by 2030 [6]. - The Co-Dx booth will also showcase the Co-Dx PCR Pro™ instrument, which is currently under FDA review and not available for sale [3][7].

Core Insights - Co-Diagnostics, Inc. will release its second quarter 2024 financial results on August 8, 2024, 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 and institutional investors [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]

SALT LAKE CITY, July 2, 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 use of the Company's vector control technology will expand to the 15th U.S. state following an installation in Nevada next week. About Co-Diagnostics, Inc.: SOURCE Co-Diagnostics Co-Dx vector control technology includes Vector Smart® PCR tests used in environmental ...

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]