Financial Data and Key Metrics Changes - Total revenue for Q2 2025 decreased to $200,000 compared to $2,700,000 in the same period last year, with revenue from grants in the prior year being $2,500,000 [17] - Total operating expenses decreased to $8,200,000 from $10,100,000 in the prior year, reflecting efforts to improve operational efficiency [17] - Net loss for Q2 2025 was $7,700,000, or a loss of $0.23 per fully diluted share, compared to a net loss of $7,600,000, or a loss of $0.25 per fully diluted share in the prior year [18] - Adjusted EBITDA loss increased to $7,200,000 from $5,900,000 in the previous year [18] - Cash, cash equivalents, and marketable investment securities at the end of Q2 2025 totaled $13,400,000 [18] Business Line Data and Key Metrics Changes - The Kodiak PCR platform is on track to initiate clinical evaluations for all tests in the pipeline during 2025, including tests for COVID-19, flu, tuberculosis, and HPV [5][6] - The Kodiak PCR ABCR four-plex respiratory panel is expected to begin clinical evaluations concurrent with the 2025 North American flu season [9] - The company is focusing on the tuberculosis test, which is expected to begin clinical evaluations in India and South Africa before the end of 2025 [7][8] Market Data and Key Metrics Changes - India accounted for 27% of global TB cases and 26% of global TB deaths in 2023, making it a top priority market for the company's TB testing [8] - The company aims to target primary healthcare facilities in India, where there are nearly 30,000 centers that require advanced molecular technology [34] Company Strategy and Development Direction - The company is committed to increasing the accessibility of affordable, high-quality diagnostics in the U.S., India, and globally [6] - Plans include expanding manufacturing capacity domestically and in India to meet market demand upon platform launch [16] - The company is pursuing a commercialization strategy targeting physician offices, clinics, skilled nursing facilities, and pharmacies in the U.S. [30][34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for multiple commercial launches in 2026 and future developments within the test pipeline [19] - The company anticipates that the clinical trial for the COVID-19 test will be completed by year-end 2025, with a reasonable possibility of FDA clearance by mid-2026 [36][37] Other Important Information - The company is managing its capital requirements through equity or debt financing, additional grant funding, and operational efficiencies [19] - The Kodiak PCR platform is expected to revolutionize PCR infectious disease testing by enhancing affordability, accessibility, and decentralization [16] Q&A Session Summary Question: Expected timeline for clinical trials and applications - Management expects all four tests to enter clinical trials during the remainder of 2025, starting with the COVID-19 test [23] Question: Commercial launch visibility and marketing strategy - Commercialization is planned as soon as FDA clearance is obtained, targeting physician offices, clinics, and pharmacies in the U.S. [30][34] Question: Timeline for commercialization - Management hopes for commercialization before 2026, with a possibility of FDA clearance by mid-2026 [36][37]