Core Viewpoint - Co-Diagnostics, Inc. reported its financial results for the fourth quarter and full year ended December 31, 2024, highlighting a decline in revenue and ongoing development efforts for its diagnostic tests [1][2]. Financial Results - Total revenue for 2024 was $3.9 million, down from $6.8 million in 2023, primarily due to a decrease in grant revenue [7]. - Product revenue was $0.8 million, while grant revenue totaled $3.1 million [7]. - Operating expenses decreased by 5.2% to $43.0 million from $45.3 million in the prior year [7]. - The operating loss was $40.1 million, an improvement from a loss of $42.7 million in 2023 [7]. - The net loss for 2024 was $37.6 million, compared to a net loss of $35.3 million in 2023, resulting in a loss of $1.24 per fully diluted share [7][14]. - Adjusted EBITDA loss was $33.5 million for 2024 [7][16]. Business Highlights - The company withdrew its 510(k) application for the Co-Dx PCR Pro and Co-Dx PCR COVID-19 test from the FDA to gather updated clinical data for a new submission [4]. - Progress was made on the tuberculosis test, with clinical evaluations anticipated for this indication, as well as for HPV multiplex and upper respiratory multiplex tests later in 2025 [4]. - The company inaugurated a new oligonucleotide synthesis facility in India and a manufacturing facility in South Salt Lake [7]. - Co-Diagnostics attended several trade shows and expos throughout 2024, enhancing its visibility in the diagnostics market [7]. Balance Sheet Overview - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $29.7 million, a decrease from $58.5 million in 2023 [7][12]. - Total assets were $64.0 million, down from $95.3 million in the previous year [12]. - Total liabilities increased slightly to $9.7 million from $9.3 million in 2023 [12]. Operational Strategy - The company is focused on achieving operational efficiencies to offset development costs as it advances its diagnostic test pipeline [4]. - Management expressed confidence in the potential of its platform and the company's ability to positively impact global health [4].

Core Viewpoint - Co-Diagnostics, Inc. is set to release its fourth quarter and full year 2024 financial results on March 27, 2025, after market close, followed by a conference call to discuss these results with analysts [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) and include proprietary designs for its Co-Dx PCR at-home and point-of-care platform [3].

Core Viewpoint - Co-Diagnostics, Inc. achieved a complete dismissal of a securities class action lawsuit, which was a significant legal victory for the company [1][5][6]. Legal Proceedings - The lawsuit was initiated by Gelt Trading, Ltd. on June 15, 2020, alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 against Co-Diagnostics and certain directors and officers [2]. - The case centered around a May 1, 2020, press release claiming that the Logix Smart® COVID-19 test had "100% sensitivity and 100% specificity," which the plaintiff argued was misleading and caused artificial inflation of the stock price [3]. Court Rulings - BakerHostetler, the legal firm representing Co-Diagnostics, successfully argued for summary judgment, asserting that the plaintiff could not prove any material fact supporting liability for the Section 10(b) claim [4]. - On March 4, 2025, the court granted the defendants' motion to exclude the plaintiff's expert testimony on loss causation and ruled that the plaintiff failed to demonstrate that the May 1 press release caused any losses [5]. Company Outlook - Following the dismissal, Co-Diagnostics expressed optimism about the potential for prevailing in any appeal and aims to focus on its mission of enhancing the availability of high-quality molecular diagnostics globally [6]. Company Profile - Co-Diagnostics, Inc. is a molecular diagnostics company based in Utah, specializing in the development, manufacturing, and marketing of advanced diagnostic technologies, particularly those involving nucleic acid detection and analysis [7].

Core Viewpoint - Co-Diagnostics, Inc. and CoSara Diagnostics Pvt. Ltd. are hosting a symposium on March 4, 2025, to raise awareness about HPV and its link to cancer, coinciding with International HPV Awareness Day [1][2] Group 1: Symposium Details - The symposium titled "HPV and Cancer: Exploring Advances in Prevention and Care" will feature speakers from Co-Dx, CoSara, and experts in cancer diagnostics and oncology from India [2] - The event aims to educate the public about HPV, reduce stigma, and empower individuals to take action against the virus [2] Group 2: Cancer Statistics and Impact - The National Cancer Institute estimates that high-risk HPV subtypes are responsible for approximately 5% of all cancers globally, including cervical cancer, which caused an estimated 350,000 deaths in 2022 [3] - About 94% of cervical cancer deaths occur in low- and middle-income countries (LMICs), where access to diagnostics, vaccinations, and screenings can significantly reduce mortality [3] Group 3: Co-Diagnostics' Initiatives - Co-Diagnostics is completing the assay development for its HPV multiplex test, designed to identify 8 high-risk HPV subtypes from cervical swab samples, aiming to provide an affordable screening tool for patients, especially in LMICs [4] - The CEO of Co-Dx emphasized the importance of early diagnosis in effective treatment and limiting the spread of HPV [5] - CoSara's Saragene® Human Papillomavirus-High Risk real-time PCR test has been cleared for use in India to detect high-risk HPV genotypes [5]

Core Viewpoint - Co-Diagnostics, Inc. has withdrawn its 510(k) application for the Co-Dx™ PCR COVID-19 Test based on FDA feedback regarding shelf-life stability, opting to submit an enhanced version of the test instead [1][3]. Group 1: FDA Interaction and Submission Withdrawal - The decision to withdraw the submission was made after discussions with the FDA concerning the detection of potential deterioration of a test component related to shelf-life stability [3]. - Co-Diagnostics expressed satisfaction with the productive engagement with the FDA regarding the initial regulatory submission and the test's performance in clinical evaluations [2][3]. Group 2: Future Plans and Enhancements - The company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance after collecting clinical evaluation data to support the new test's performance [4]. - The new submission will allow the incorporation of recent developments in the Co-Dx PCR platform, aiming to enhance operational and manufacturing efficiencies [4]. - Co-Diagnostics aims to execute a robust development and commercialization plan for the Co-Dx PCR platform, with additional tests for tuberculosis, upper-respiratory multiplex, and multiplex HPV tests expected to follow [5]. Group 3: Company Overview - Co-Diagnostics, Inc. is a molecular diagnostics company that develops, manufactures, and markets advanced diagnostic technologies, utilizing proprietary technology for tests designed to detect and analyze nucleic acid molecules [7].

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].