Financial Data and Key Metrics Changes - For the full year 2025, total revenue was $0.6 million, a decrease from $3.9 million in 2024, primarily due to lower grant revenue [19] - Product revenue for 2025 was $0.4 million, down from $0.8 million in 2024, reflecting limited commercial activity [19] - Total operating expenses increased to $50.6 million in 2025 from $43.0 million in 2024, driven by a non-cash impairment charge of approximately $18.9 million [19][20] - Net loss for 2025 was $46.9 million, or a loss of $35.25 per share, compared to a net loss of $37.6 million, or $37.22 per share in 2024 [22] - Adjusted EBITDA was a loss of $28.0 million for 2025, compared to a loss of $33.5 million in 2024 [22] Business Line Data and Key Metrics Changes - Research and development expenses were $19.1 million in 2025, down from $21.0 million in 2024, reflecting disciplined investment in the Kodiak PCR platform [20] - Sales and marketing expenses decreased to $2.4 million in 2025 from $4.5 million in 2024, primarily due to lower personnel and consulting expenses [21] - General and administrative expenses were $9.1 million in 2025, down from $16.2 million in the prior year, driven by lower legal and consulting expenses [21] Market Data and Key Metrics Changes - CoSara has expanded its commercial and distribution territory across South Asia, including Bangladesh, Pakistan, Nepal, and Sri Lanka, increasing the addressable market to approximately $13 billion [9] - The global TB diagnostics market is expected to grow significantly, with the company well-positioned to participate in that growth [16] Company Strategy and Development Direction - The company is focused on four primary growth pillars: advancing the clinical pipeline, expanding CoSara in India, executing the CoMira joint venture in Saudi Arabia, and enhancing AI-driven capabilities [7][8] - CoSara is preparing to manufacture the PCR Pro instrument locally in India, which is a key step towards commercialization [9] - The CoMira joint venture aims to establish local manufacturing and distribution capabilities in Saudi Arabia, providing a competitive advantage [12] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of executing their multi-pronged growth strategy and expressed confidence in the company's progress towards commercialization [5][18] - The company plans to continue generating operating losses in the near term while focusing on advancing the clinical pipeline and achieving regulatory milestones [24] Other Important Information - The company has received international patents covering key components of the Kodiak PCR platform, enhancing its competitive positioning [14] - The company is actively exploring strategic alternatives for CoSara, including a potential SPAC transaction to support capital needs [9] Q&A Session Questions and Answers Question: What is the status of the sample accrual for the three target panel? - Management clarified that the decision to drop COVID from the multiplex test was due to the lack of COVID samples during the clinical trial, allowing for a more expedient submission to the FDA [26][27] Question: How quickly could COVID be added back to the test? - Management indicated that adding COVID back would not require redesign and would depend on negotiations with the FDA regarding sample requirements [29] Question: Can you discuss the South Asia distribution expansion? - Management noted that the expansion into countries like Nepal, Pakistan, and Bangladesh is driven by similar disease burdens and increases the total addressable market [34][35] Question: What are the immediate next steps for the PCR Pro device in India? - Management stated that technology transfer operations are underway, and they expect to begin clinical trials for tuberculosis in India, aiming for commercialization by the third quarter of 2026 [39]

Financial Data and Key Metrics Changes - For the full year 2025, total revenue was $0.6 million, a decrease from $3.9 million in 2024, primarily due to lower grant revenue [19] - Product revenue for 2025 was $0.4 million, down from $0.8 million in 2024, reflecting limited commercial activity [19] - Total operating expenses for 2025 were $50.6 million, compared to $43.0 million in 2024, driven by a non-cash impairment charge of approximately $18.9 million [19][20] - Net loss for 2025 was $46.9 million, or a loss of $35.25 per share, compared to a net loss of $37.6 million, or $37.22 per share in 2024 [22] - Adjusted EBITDA was a loss of $28.0 million for 2025, compared to a loss of $33.5 million in 2024 [22] Business Line Data and Key Metrics Changes - Research and development expenses were $19.1 million in 2025, down from $21.0 million in 2024, reflecting disciplined investment in the Kodiak PCR platform [20] - Sales and marketing expenses decreased to $2.4 million in 2025 from $4.5 million in 2024, primarily due to lower personnel and consulting expenses [21] - General and administrative expenses were $9.1 million in 2025, down from $16.2 million in the prior year, driven by lower legal and consulting expenses [21] Market Data and Key Metrics Changes - CoSara has expanded its commercial and distribution territory across South Asia, including Bangladesh, Pakistan, Nepal, and Sri Lanka, increasing the addressable market to approximately $13 billion [9] - The global TB diagnostics market is expected to grow significantly, with the company well-positioned to participate in that growth [16] Company Strategy and Development Direction - The company is focused on four primary growth pillars: advancing the clinical pipeline, expanding CoSara in India, executing the CoMira joint venture in Saudi Arabia, and enhancing AI-driven capabilities [7][8] - CoSara is preparing to manufacture the PCR Pro instrument locally in India, which is a key step towards commercialization [9] - The CoMira joint venture aims to establish local manufacturing and distribution capabilities in Saudi Arabia, providing a competitive advantage [12] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of executing their multi-pronged growth strategy and expressed confidence in the company's progress towards commercialization [5][18] - The company plans to continue generating operating losses in the near term while focusing on advancing the clinical pipeline and achieving regulatory milestones [24] Other Important Information - The company has received international patents covering key components of the Kodiak PCR platform, enhancing its competitive positioning [14] - The Kodiak Primer AI platform is being expanded to improve operational efficiency and support predictive insights [17] Q&A Session Summary Question: Status of sample accrual for the three-target panel and potential to add COVID back - Management clarified that the decision to drop COVID was due to its limited presence during the clinical trial, allowing for a more expedient submission to the FDA [26][27] Question: Expansion into South Asia and its implications - Management noted that the disease burden in South Asia is similar to India, and the expansion increases the total addressable market [34] Question: Sample requirements for the U.S. FDA study - Management indicated that over 1,200 patients have been enrolled for the study, nearing conclusion [36] Question: Next steps for commercialization in India - Management expects to have TB tests commercialized in India by the third quarter of 2026, leveraging existing infrastructure and expertise [39]

Financial Data and Key Metrics Changes - For the full year 2025, total revenue was $0.6 million, down from $3.9 million in 2024, primarily due to lower grant revenue [18] - Product revenue for 2025 was $0.4 million, compared to $0.8 million in 2024, reflecting limited commercial activity [18] - Total operating expenses increased to $50.6 million in 2025 from $43.0 million in 2024, driven by a non-cash impairment charge of approximately $18.9 million [18] - Net loss for 2025 was $46.9 million, or a loss of $35.25 per share, compared to a net loss of $37.6 million, or $37.22 per share in 2024 [20] - Adjusted EBITDA was a loss of $28.0 million for 2025, compared to a loss of $33.5 million in 2024 [21] Business Line Data and Key Metrics Changes - Research and development expenses were $19.1 million in 2025, down from $21.0 million in 2024, reflecting disciplined investment in the Kodiak PCR platform [19] - Sales and marketing expenses decreased to $2.4 million in 2025 from $4.5 million in 2024, primarily due to lower personnel and consulting expenses [19] - General and administrative expenses were $9.1 million in 2025, down from $16.2 million in 2024, driven by lower legal and consulting expenses [19] Market Data and Key Metrics Changes - CoSara has expanded its commercial and distribution territory across South Asia, including Bangladesh, Pakistan, Nepal, and Sri Lanka, increasing the addressable market to approximately $13 billion [9] - The global TB diagnostics market is expected to grow significantly, with the company well-positioned to participate in that growth [15] Company Strategy and Development Direction - The company is focused on four primary growth pillars: advancing the clinical pipeline, expanding CoSara in India, executing the CoMira joint venture in Saudi Arabia, and enhancing AI-driven capabilities [6] - CoSara is expected to stand on its own as a public entity, with a potential SPAC transaction being explored to support capital needs [9] - The CoMira joint venture aims to establish local manufacturing and distribution capabilities in Saudi Arabia, providing a competitive advantage [12] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of advancing clinical programs and achieving regulatory milestones to position the business for future revenue growth [23] - The company remains focused on disciplined capital allocation and evaluating financing alternatives to support objectives [23] - Management expressed confidence in the upcoming clinical studies for TB diagnostics, aligning with WHO guidelines [10] Other Important Information - The company has received international patents covering key components of the Kodiak PCR platform, enhancing its competitive positioning [13] - The Kodiak Primer AI platform is being expanded to unify efforts across diagnostics, data analytics, and operational efficiency [16] Q&A Session Summary Question: Status of sample accrual for the three target panel and potential to add COVID back - Management clarified that the decision to drop COVID was due to its limited presence during the clinical trial, allowing for a more expedient submission to the FDA [25] - Adding COVID back would not require redesign and would depend on negotiations with the FDA regarding sample requirements [27] Question: Expansion into South Asia and its implications - Management indicated that the disease burden in South Asia is similar to India, and the expansion increases the total addressable market from $11 billion to $13 billion [32] Question: Sample requirements for the U.S. FDA study - Management stated that over 1,200 patients have been enrolled for the study, nearing conclusion and preparation for FDA submission [35] Question: Next steps for commercialization in India - Management expects quick progression of clinical trials for TB diagnostics in India, with commercialization anticipated by the third quarter of 2026 [38]

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]