Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $0.1 million, a decrease from $0.6 million in the same period last year, with all revenue recognized coming from product sales in the current quarter [19] - Total operating expenses decreased to $7.1 million in Q3 2025 from $10.6 million in Q3 2024, reflecting a focus on operational efficiency [19] - Net loss for Q3 2025 was $5.9 million, or a loss of $0.16 per fully diluted share, compared to a $9.7 million loss, or $0.32 per fully diluted share in the same period last year [20] - Adjusted EBITDA was a loss of $6.3 million in Q3 2025, improved from a loss of $8.8 million in Q3 2024 [21] - The company ended the quarter with $11.4 million in cash, cash equivalents, and marketable investment securities [21] Business Line Data and Key Metrics Changes - The company is focused on four main growth pillars: strategic alternatives for the Indian joint venture, international expansion through the Comera joint venture, innovation via the AI business unit, and clinical evaluations for new tests [4][5] - The upcoming upper respiratory multiplex test is designed to detect Flu A, Flu B, COVID-19, and RSV, marking a significant addition to the product portfolio [13][14] Market Data and Key Metrics Changes - The global market size for infectious disease diagnostics is expected to grow to $73.56 billion by 2030, with North America being the largest geographical market [15] - The respiratory infectious disease testing market in the Middle East is expanding, driven by investments in public health initiatives [15] Company Strategy and Development Direction - The company is pursuing a SPAC transaction for its Indian joint venture, Cosera Diagnostics, to unlock value and support long-term funding strategies [5][7] - The Comera joint venture aims to localize the CODEX PCR platform in the Middle East and North Africa, enhancing the company's international footprint [9][10] - The AI business unit is focused on developing AI-powered diagnostics and improving operational efficiency, positioning the company for growth in healthcare technology [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about multiple commercial launches expected in 2026 and ongoing development within the test pipeline [22] - The company is strategically allocating resources to support development priorities and regulatory submissions [21][22] Other Important Information - The company closed two strategic direct offerings totaling gross proceeds of $10.8 million, strengthening its balance sheet [17] - The RADxTech grant from the NIH supports the clinical evaluation of the upper respiratory multiplex test, underscoring its public health relevance [13][15] Q&A Session Summary Question: Performance of Cosera and Comera - Management is pleased with the performance of both Cosera and Comera, highlighting the established footprint in India and the strategic importance of the joint venture in Saudi Arabia [25][26][28] Question: Interaction of Cosera spin-out with MTB and HPV programs - Management indicated a concrete plan in India to address tuberculosis and HPV, emphasizing the need for accessible and accurate diagnostics [33][35] Question: Affordability of PCR Pro - The company aims to produce the PCR Pro at a price point of $300-$500, leveraging a fresh approach in engineering and the use of co-primers for multiplexing [37][39] Question: Relevance of products for the Comera market - All current pipeline products are deemed relevant for the Comera market, particularly the upper respiratory multiplex test [40]

Core Insights - Co-Diagnostics is entering a critical phase of growth, focusing on operational, financial, and strategic resilience to create lasting shareholder value [1][4][20] Financial Performance - For Q3 2025, total revenue was $100,000, down from $600,000 in the same period last year, with all revenue coming from product sales [23] - Total operating expenses decreased to $7.1 million from $10.6 million year-over-year, reflecting improved operational efficiency [23] - Net loss for Q3 2025 was $5.9 million, or $0.16 per fully diluted share, compared to a loss of $9.7 million, or $0.32 per share, in Q3 2024 [24] - Adjusted EBITDA loss improved to $300,000 from a loss of $8.8 million in the prior year [24] - The company ended the quarter with $11.4 million in cash and equivalents, indicating a focus on maintaining a healthy balance sheet [24] Strategic Initiatives - The company is engaging Maxim Group to explore strategic alternatives for its Indian joint venture, Kocera Diagnostics, potentially including a merger with a SPAC [4][6] - The Comira joint venture with Arabian Eagle aims to expand Co-Diagnostics' presence in Saudi Arabia and 18 additional MENA nations [4][9] - The AI business unit is focused on enhancing operational efficiency and developing proprietary AI-powered diagnostics [11][12] - Upcoming clinical evaluations for an upper respiratory multiplex test will validate the company's scientific leadership and support regulatory submissions [14][16] Market Expansion - The Comira joint venture will localize the Kodiak PCR platform across the MENA region, with a focus on manufacturing and distribution [9][10] - The partnership aligns with Saudi Vision 2030, emphasizing technology localization and healthcare innovation [10] - The company is also advancing its tuberculosis and HPV multiplex tests, supported by grants from the Bill and Melinda Gates Foundation, to address unmet needs in international markets [19][20] Future Outlook - Co-Diagnostics anticipates multiple commercial launches in 2026, supported by a robust development pipeline and strategic resource allocation [26] - The company is committed to optimizing its operating footprint to drive efficiency gains and cost savings [24][26] - The introduction of competitively priced diagnostics is expected to position Co-Diagnostics as a leader in point-of-care PCR diagnostics [20][36]