Core Viewpoint - Co-Diagnostics, Inc. is actively participating in the Life Sciences Day on the Hill event, showcasing its innovative molecular diagnostic testing platform aimed at detecting infectious diseases [1][4]. Company Overview - Co-Diagnostics, Inc. is a molecular diagnostics company based in Utah, specializing in the development, manufacturing, and marketing of advanced diagnostic technologies that utilize nucleic acid detection and analysis [6]. Event Details - The Life Sciences Day on the Hill is organized by the Utah Life Sciences Innovation Caucus, the Utah Governor's Office of Economic Opportunity, and BioUtah, featuring over 25 life sciences companies from Utah [2][4]. - The event is scheduled for January 30, 2025, from 11:00 AM to 2:00 PM MST [4]. Product Showcase - Co-Diagnostics will present its at-home and point-of-care Co-Dx PCR testing platform, which is designed to detect various infectious diseases, including COVID-19, influenza, RSV, HPV, and tuberculosis [4]. - The platform features cloud-based analysis for tracking infectious disease outbreaks and is operated via a user-friendly smartphone interface [4]. Regulatory Status - The Co-Dx PCR platform, including its associated tests and software, is currently under review by the FDA and is not yet available for sale [5].

Core Viewpoint - Co-Diagnostics, Inc. is set to participate in Nasdaq's Live from MarketSite broadcast, highlighting its innovative molecular diagnostic tests and future health crisis preparedness [1][2]. Company Overview - Co-Diagnostics, Inc. is a molecular diagnostics company that develops and markets advanced diagnostic technologies, focusing on nucleic acid detection and analysis [7]. Product Pipeline - The upcoming Co-Dx PCR platform will include tests for COVID-19, tuberculosis, HPV, and an upper respiratory multiplex panel, with a focus on addressing future infectious disease threats [2][6]. - The Co-Dx™ Logix Smart® ABC Test detects all known circulating strains of H5N1 and is available as a Research Use Only assay in the U.S. and as an in vitro diagnostic in CE-marking regions [3]. - An updated 3-gene version of the Co-Dx™ Logix Smart® Mpox test is prepared for launch, retaining full reactivity against circulating mpox strains [4]. Market Context - A post-holiday surge in COVID-19 cases indicates the virus remains a persistent threat in the U.S., emphasizing the need for continued vigilance and effective diagnostic solutions [5].

Financial Data and Key Metrics Changes - Total revenue for Q3 2024 decreased to $0.6 million, down from $2.5 million in the same period last year [35] - Gross profit for the quarter decreased to $0.3 million compared to $2.2 million in the prior year [35] - Net loss for Q3 2024 was $9.7 million, or a loss of $0.32 per fully diluted share, compared to a net loss of $6.0 million, or a loss of $0.20 per fully diluted share in the prior year [37] - Adjusted EBITDA was a loss of $8.8 million, compared to an adjusted EBITDA loss of $6.5 million in the prior year [38] - Cash, cash equivalents, and marketable investment securities at the end of the quarter totaled $37.7 million [38] Business Line Data and Key Metrics Changes - Grant revenue in Q3 2024 was $0.4 million, while product revenue was $0.2 million [35] - Research and development expenses decreased to $4.9 million from $5.8 million in the prior year [36] - Operating expenses decreased to $10.6 million from $11.1 million in the third quarter of 2023, primarily due to reduced stock-based compensation and clinical trial expenses [36] Market Data and Key Metrics Changes - The company is focusing on expanding its market reach in regions with unmet needs, including Central and South America, Africa, and India [10][42] - The primary markets for tuberculosis testing are identified as India and South Africa, while the U.S. remains a key market for upper respiratory tests [43] Company Strategy and Development Direction - The company is advancing the development of its Co-Dx PCR platform, which includes a low-cost, portable testing instrument and mobile app [6] - Plans to initiate clinical trials for tuberculosis tests in South Africa and India in early 2025 [17] - The company aims to broaden its potential reach by developing tests for tuberculosis, respiratory multiplex, HPV multiplex, and Strep A [7][20][22] - The focus is on international markets where there is a high demand for decentralized, portable, low-cost testing systems [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the quality and integrity of the Co-Dx PCR platform despite uncertainties in the FDA review timeline [7] - The company remains optimistic about its future developments and pipeline initiatives, particularly for 2025 [39] - Management highlighted the importance of operational and manufacturing efficiencies to reduce expenses [38] Other Important Information - The company has been actively engaging with NGOs and potential customers to support its go-to-market strategy for tuberculosis testing [19][28] - The expansion of the oligo synthesis facility in India is nearly complete, which will enhance manufacturing capacity [31] Q&A Session Summary Question: Any feedback from the FDA for the 510(k) application? - Management stated that discussions with the FDA are ongoing, but they cannot comment on regulatory decisions or timelines [42] Question: How is demand split between the U.S. and global customers? - Historically, revenues have been evenly split between international and domestic customers, depending on the indication [43][44]

Financial Performance - Co-Diagnostics, Inc. reported a quarterly loss of $0.32 per share, slightly better than the Zacks Consensus Estimate of a loss of $0.33, but worse than the loss of $0.20 per share a year ago [1] - The company posted revenues of $0.64 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 60.25%, compared to revenues of $2.46 million in the same quarter last year [2] - Over the last four quarters, Co-Diagnostics has surpassed consensus EPS estimates two times and topped consensus revenue estimates two times [2] Stock Performance - Co-Diagnostics shares have declined approximately 9% since the beginning of the year, while the S&P 500 has gained 24.3% [3] - The current Zacks Rank for Co-Diagnostics is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.33 on revenues of $0.4 million, and for the current fiscal year, it is -$1.23 on revenues of $3.88 million [7] - The estimate revisions trend for Co-Diagnostics is mixed, and changes in earnings expectations could impact stock performance [6] Industry Context - The Medical Services industry, to which Co-Diagnostics belongs, is currently ranked in the bottom 45% of over 250 Zacks industries, which may affect the stock's performance [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that industry outlook can materially impact stock performance [5][8]

Revenue Performance - For the three months ended September 30, 2024, the company generated revenues of $641,141, a decrease of 74.0% compared to $2,457,098 for the same period in 2023[72]. - Grant revenue accounted for $434,265 of total revenue for the three months ended September 30, 2024, down from $2,320,565 in the prior year, primarily due to timing of milestone achievements[72]. - For the nine months ended September 30, 2024, total revenues were $3,765,835, an increase of 15.6% compared to $3,256,861 for the same period in 2023[81]. Net Loss and Expenses - The company recorded a net loss of $9,696,455 for the three months ended September 30, 2024, compared to a net loss of $5,982,194 for the same period in 2023, reflecting a 62.5% increase in net loss[80]. - The net loss for the nine months ended September 30, 2024, was $26,607,816, compared to a net loss of $20,656,410 for the same period in 2023, primarily due to changes in fair value of acquisition contingencies and income taxes[89]. - Total operating expenses for the three months ended September 30, 2024 were $10,578,675, a decrease of 5.0% from $11,137,277 in the prior year[75]. - The company incurred total operating expenses of $31,196,065 for the nine months ended September 30, 2024, a decrease of 5.2% from $32,920,793 in the prior year[84]. - Research and development expenses for the three months ended September 30, 2024 were $4,880,315, down from $5,788,789 in the same period in 2023, indicating a decrease of 15.7%[78]. Cash Flow and Assets - Cash and cash equivalents as of September 30, 2024, totaled $10,797,630, with marketable investment securities amounting to $26,864,571, leading to total current assets of $40,103,158 against current liabilities of $5,797,977[90]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $20,924,039, an increase from $17,303,239 in the prior year, mainly due to decreased cash collections[91]. - Net cash provided by investing activities was $16,804,791 for the nine months ended September 30, 2024, compared to $5,773,590 in the same period of 2023, primarily from maturities of marketable investment securities[92]. - There were no financing activities in the nine months ended September 30, 2024, compared to $1,204,256 in the prior year due to share repurchases[93]. Future Outlook and Financing - The company believes existing capital resources and future sales will meet projected operating requirements for the next 12 months, but may need additional financing for strategic opportunities[96]. - An Equity Distribution Agreement was entered into on March 16, 2023, allowing the company to sell up to $50 million in common stock, with a reduced amount of $17.1 million available as of October 18, 2024[96]. Regulatory and Legal Matters - The company is developing a portable diagnostic device and test system for point-of-care and at-home use, with the Co-Dx™ PCR platform currently under FDA review[64]. - The company has received acknowledgment from the FDA for its 510(k) application for the Co-Dx™ PCR Pro™ instrument, which is under review[64]. - The proprietary test design process involves optimizing PCR tests using predictive mathematical algorithms, with over 20 patents protecting the technology[68]. - Income tax expense for the nine months ended September 30, 2024, was $65,543, a significant change from an income tax benefit of $6,611,712 for the same period in 2023, attributed to a full valuation allowance[89]. - The company has not experienced any changes in internal control over financial reporting that materially affect its financial reporting as of September 30, 2024[98]. - There have been no material developments in legal proceedings previously disclosed in the annual report for the fiscal year ended December 31, 2023[98].

Financial Performance - Revenue for Q3 2024 was $0.6 million, a decline of 76% from $2.5 million in Q3 2023, primarily due to timing of grant revenue recognition[2] - Net loss for Q3 2024 was $9.7 million, compared to a net loss of $6.0 million in the prior year, representing a loss of $0.32 per fully diluted share[2] - Adjusted EBITDA loss was $8.8 million for the quarter[2] - Net loss for the three months ended September 30, 2024, was $9,696,455, compared to a net loss of $5,982,194 for the same period in 2023[15] - Adjusted EBITDA for the three months ended September 30, 2024, was $(8,825,436), an increase in loss from $(6,513,311) in the prior year[15] Operating Expenses - Operating expenses decreased by 5% to $10.6 million compared to the prior year, attributed to higher expenses in 2023 related to platform development and regulatory submission preparation[2] - Stock-based compensation expense was $1,045,583 for the three months ended September 30, 2024, down from $2,172,165 in the same period last year[15] - Depreciation and amortization increased to $351,235 in the three months ended September 30, 2024, compared to $296,340 in the prior year[15] Cash and Assets - Cash, cash equivalents, and marketable securities totaled $37.7 million as of September 30, 2024[2] - The total assets decreased from $95.3 million at the end of 2023 to $72.4 million as of September 30, 2024[11] Regulatory and Business Developments - The company is actively engaging with the FDA regarding its 510(k) application and advancing tests in its pipeline towards regulatory submission and commercialization[3] - An oligonucleotide manufacturing facility in India is preparing for inauguration in early December 2024[3] - The company expanded its vector control business line to customers across 15 states[3] Investment and Income - Interest income decreased to $(263,335) from $(322,877) year-over-year[15] - Realized gain on investments was $(293,067) for the three months ended September 30, 2024, compared to $(425,446) in the same period last year[15] - Income tax provision showed a benefit of $22,189, contrasting with a benefit of $(2,113,581) in the prior year[15] - Change in fair value of contingent consideration was $11,927, compared to $(140,296) in the same period last year[15] - Gain on disposition of assets was $(3,513) for the three months ended September 30, 2024, compared to a gain of $2,578 in the prior year[15] Product Development - The Co-Dx™ Logix Smart® Mpox 2-Gene RUO test showed full reactivity against newer strains in in silico analysis[3]

Core Viewpoint - Co-Diagnostics, Inc. reported a significant decline in revenue for Q3 2024, primarily due to the timing of grant revenue recognition, while also highlighting ongoing advancements in their diagnostic test pipeline and regulatory submissions [2][3]. Financial Results - Revenue for Q3 2024 was $0.6 million, down from $2.5 million in the same quarter last year, with grant revenue at $0.4 million and product revenue at $0.2 million [2]. - Operating expenses decreased by 5.0% to $10.6 million compared to the previous year, attributed to higher expenses in 2023 related to platform development and regulatory submissions [2]. - The operating loss was $10.2 million, compared to an operating loss of $8.9 million in Q3 2023 [2]. - The net loss for the quarter was $9.7 million, or $0.32 per fully diluted share, compared to a net loss of $6.0 million, or $0.20 per fully diluted share, in the prior year [2][10]. - Adjusted EBITDA loss was reported at $8.8 million [2]. Business Highlights - The company completed an in silico analysis of the Co-Dx™ Logix Smart® Mpox 2-Gene RUO test, confirming its sensitivity against newer strains of mpox [3]. - Co-Diagnostics expanded its vector control business line to customers across 15 states [3]. - Participation in key industry events, including ADLM 2024 and the 16th Next Generation Dx Summit, to discuss advancements in diagnostics [3]. - An oligonucleotide manufacturing facility in India is set to be inaugurated in early December 2024 [3]. - The CEO expressed optimism about the progress in the development of the company's diagnostic tests and ongoing dialogue with the FDA regarding regulatory submissions [3]. Balance Sheet Overview - As of September 30, 2024, cash, cash equivalents, and marketable securities totaled $37.7 million [2]. - Total assets decreased to $72.4 million from $95.3 million at the end of 2023 [9]. - Current liabilities were reported at $5.8 million, with total liabilities at $8.6 million [9]. Conference Call Information - Co-Diagnostics will host a conference call and webcast to discuss financial results with analysts and institutional investors [4].

SALT LAKE CITY, Nov. 5, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: 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 it will be hosting a booth and delivering a presentation at the MEDICA 2024 trade fair in Düsseldorf, Germany on November 11-14.MEDICA has become the largest medical B2B trade fair in the world, attracting 83,000 visitors and over 5,300 exhibitors from almost 70 ...

SALT LAKE CITY, Oct. 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 third quarter 2024 results on Thursday, November 7, 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 will in ...

SALT LAKE CITY, Oct. 21, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: 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 Co-Diagnostics will be hosting a booth at Africa Health/Medlab Africa in Cape Town, South Africa on October 22-24, 2024.The conference website describes it as the largest gathering of healthcare companies, technology, products and services in the sub-Saharan reg ...