Core Insights - Co-Diagnostics (Co-Dx) has entered into a definitive agreement with Arabian Eagle Manufacturing to establish a joint venture named CoMira Diagnostics for the distribution of polymerase chain reaction (PCR) platforms in Saudi Arabia and 18 other countries in the MENA region [1][2] Group 1: Joint Venture Details - The joint venture will focus on the research, development, distribution, and marketing of Co-Dx's technologies and intellectual property, including the PCR point-of-care platform [1][2] - Arabian Eagle will oversee the establishment of a manufacturing facility, manage regulatory approvals, and ensure compliance with local laws as part of the joint venture [2][4] - Co-Dx will provide the joint venture with an exclusive license to utilize, produce, and market its licensed intellectual property, which includes both the upcoming PCR platform and existing laboratory-based diagnostic products [3][6] Group 2: Market Strategy and Growth Potential - The CEO of Co-Dx emphasized the importance of this agreement in expanding healthcare innovations into a region with a significant and growing market for medical devices and point-of-care diagnostics [4][5] - The Kingdom of Saudi Arabia has identified key demand drivers that are expected to support growth in the medical diagnostics sector, which Co-Dx aims to address with its advanced PCR technology [5] - CoMira is set to initiate clinical assessments for various tests, including tuberculosis and multiplex tests for Covid-19, influenza A and B, RSV, and an 8-type HPV multiplex test by the end of the year [5] Group 3: Regulatory Considerations - The companies plan to seek regulatory clearance from the Saudi Food & Drug Administration (SFDA) to facilitate market entry across the broader territory [2][6] - The Co-Dx PCR platform, which includes the PCR Pro, PCR Home, mobile app, and associated tests, is currently pending clearance from the US Food and Drug Administration (FDA) and other regulatory authorities [6]

Financial Data and Key Metrics Changes - Total revenue for the first quarter of 2025 decreased to $100,000 from $500,000 in the same period of the prior year [17][59] - Total operating expenses decreased to $8,600,000 from $10,500,000 year-over-year [18][59] - Research and development expenses were $4,900,000 compared to $5,700,000 in the prior year [18][59] - Net loss for the first quarter was $7,500,000 or a loss of $0.24 per fully diluted share, compared to a net loss of $9,300,000 or a loss of $0.31 per fully diluted share in the prior year [18][60] - Adjusted EBITDA loss improved to $7,400,000 from $8,400,000 in the prior year [18][60] - Cash, cash equivalents, and marketable investment securities at the end of the quarter totaled $21,500,000 [19][60] Business Line Data and Key Metrics Changes - The company is advancing its CoDiEX PCR platform and associated test pipeline, focusing on tests for tuberculosis, COVID-19, a four-plex respiratory panel, and an eight-plex HPV panel [6][48] - The design for the updated COVID-19 test has been completed, and extensive verification testing has been conducted [9][49] - Progress has been made on the TB test, with preliminary analytical studies completed and instruments identified for sample preparation [10][51] - The four-plex respiratory panel is designed to deliver simultaneous PCR test results for flu A and B, COVID-19, and RSV, with significant market interest identified [11][52] - The HPV panel is being prepared for clinical evaluations, supported by a grant from the Bill and Melinda Gates Foundation [12][54] Market Data and Key Metrics Changes - The company expects to begin clinical evaluations for its TB test in India and South Africa in the latter half of 2025 [10][51] - India is identified as a top priority market for TB testing, with significant experience in regulatory, commercial, and manufacturing infrastructure through a joint venture [10][51] - The company plans to pursue regulatory clearance in India for the HPV test before expanding to South Africa and other regions [14][55] Company Strategy and Development Direction - The mission is to increase accessibility to affordable, high-quality diagnostics in the U.S., India, and globally [6][48] - The company aims to bring its Kodiak's PCR platform to market, focusing on operational and manufacturing efficiencies [8][57] - Engagement with local health officials and potential customers is ongoing to evaluate commercialization strategies [10][52] - The company is committed to achieving regulatory objectives and successfully launching the Kodiak's PCR Pro instrument and test kits [15][57] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued progress and future developments within the test pipeline for 2025 [19][61] - The company is focused on managing its spend to maintain a healthy balance sheet for future commercial launches [19][60] - The timeline for clinical trials is influenced by the prevalence of COVID-19, with a focus on effective testing conditions [26][68] - The company anticipates that the HPV and tuberculosis tests may enter clinical trials sooner due to the availability of samples in India [30][73] Other Important Information - The company has hosted events to build awareness of the Kodiak's PCR platform, including a symposium in India and participation in local life sciences events [14][56] - The manufacturing facility build-out in India is on track to be completed by the end of the year, enhancing regional capabilities [16][57] Q&A Session Summary Question: Timeline for COVID test resubmission - Management confirmed that the new design for the COVID test is complete, and they are preparing for clinical evaluations, with a revised submission expected to increase the probability of successful clearance [24][66] Question: Specific submission date for COVID test - The timing for submission is dependent on the prevalence of COVID-19, with management indicating it is a waiting game for effective testing conditions [26][68] Question: Timeline for other products in India and South Africa - All tests, including the multiplex ABCR test, HPV test, and TB test, are expected to enter clinical trials during the remainder of 2025 [28][70] Question: Pricing and gross margins for devices and test cups - The expected cost of the instrument is in the $300 to $500 range, with test cartridges priced at $15 to $20 in developed markets, and lower pricing for low and middle-income countries [36][79]