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 ...

SALT LAKE CITY, Oct. 2, 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 the Utah Health Care Association/Utah Center for Assisted Living (UHCA/UCAL) Convention & Expo at the Mountain America Expo Center in Sandy, Utah on October 2-3, 2024. The UHCA/UCAL Convention includes sessions and events ...

Company Overview - Co-Diagnostics Inc is a molecular diagnostics company specializing in the development, manufacturing, and marketing of advanced diagnostics technologies [5] - The company utilizes proprietary technology to design tests for its Co-Dx PCR platform, targeting at-home and point-of-care use, as well as genetic marker identification for non-infectious disease applications [5] International Expansion - Co-Diagnostics is participating in a World Trade Center Utah trade mission to South Korea and Japan from September 24 to October 5, 2024, as part of its global expansion strategy [1] - The company aims to strengthen international relationships, particularly in the life sciences and innovation sectors, through this trade mission [2] - Co-Diagnostics has established a joint venture in India (CoSara Diagnostics Pvt Ltd) in 2017 and built a network of distributors, partners, and customers in over 50 countries [2] Product Development - The company is preparing to introduce a new PCR diagnostic platform designed for at-home and point-of-care use [2] - Co-Diagnostics' technology focuses on the detection and analysis of nucleic acid molecules (DNA or RNA) for diagnostic tests [5] Strategic Partnerships - Co-Diagnostics is collaborating with Utah Governor Cox and the Governor's Office of Economic Opportunity for the trade mission [1] - The company has distributed millions of COVID-19 PCR tests globally during the pandemic years, establishing a strong international presence [2] Leadership Vision - CEO Dwight Egan emphasizes the importance of building a global network to improve access to high-quality PCR diagnostics worldwide [4] - The company's mission aligns with advancing patient care accessibility and increasing the availability of diagnostic solutions [4]

SALT LAKE CITY, Sept. 5, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that the Company has performed an in silico analysis of the CoDx™ Logix Smart® Mpox (2-Gene) RUO test to evaluate the possible impact of clade Ib mpox on the test. The results of the analysis show that the test should retain full reactivity against mpox strains circulating over ...

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]