SALT LAKE CITY, Dec. 17, 2025 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it has performed an in silico analysis of the Co-Primers® used in its Logix Smart® ABC test* for the detection of influenza A, influenza B and COVID-19. The analysis showed a high homology against 3,900 influenza sequences, confirming comparable reactivity of the p ...

Ongoing Phase II preclinical study data for Co-Dx PCR MTB and HPV tests support advancement to clinical performance testing Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are utilized for tests that are designed to detect and/or analyze nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-hom ...

Core Insights - Co-Diagnostics, Inc. (CODX) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3] - The Zacks rating system is based on changes in earnings estimates, providing a more objective measure for investors compared to traditional Wall Street ratings [2][9] Earnings Estimates and Stock Performance - The correlation between changes in earnings estimates and stock price movements is strong, influenced by institutional investors who adjust their valuations based on these estimates [4][5] - CoDiagnostics is expected to earn -$0.72 per share for the fiscal year ending December 2025, with no year-over-year change, but the Zacks Consensus Estimate has increased by 8.9% over the past three months [8] Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a proven track record of Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [7] - The upgrade of CoDiagnostics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10]

Core Insights - Co-Diagnostics, Inc. reported a quarterly loss of $0.16 per share, better than the Zacks Consensus Estimate of a loss of $0.19, and an improvement from a loss of $0.32 per share a year ago, resulting in an earnings surprise of +15.79% [1] - The company posted revenues of $0.15 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 51.67%, and a decline from $0.64 million in the same quarter last year [2] - Co-Diagnostics shares have decreased by approximately 47.2% year-to-date, contrasting with the S&P 500's gain of 16.5% [3] Earnings Outlook - The earnings outlook for Co-Diagnostics is uncertain, with current consensus EPS estimates at -$0.16 on $0.3 million in revenues for the upcoming quarter and -$0.79 on $0.81 million in revenues for the current fiscal year [7] - The estimate revisions trend for Co-Diagnostics was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] Industry Context - The Medical Services industry, to which Co-Diagnostics belongs, is currently ranked in the bottom 39% of over 250 Zacks industries, suggesting potential challenges for stock performance [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact investor sentiment [5]

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]

Financial Performance - For the three months ended September 30, 2025, the company generated revenues of $0.1 million, a decrease of 83.3% compared to $0.6 million for the same period in 2024[90] - Total operating expenses for the three months ended September 30, 2025 were $7.1 million, down 33% from $10.6 million for the same period in 2024[92] - The net loss for the three months ended September 30, 2025 was $5.9 million, an improvement of 39.2% compared to a net loss of $9.7 million for the same period in 2024[97] - For the nine months ended September 30, 2025, revenues were $0.4 million, a significant decrease of 89.5% from $3.8 million for the same period in 2024[98] - Total operating expenses for the nine months ended September 30, 2025 were $23.9 million, a decrease of 23.4% compared to $31.2 million for the same period in 2024[101] - The company reported a net loss of $21.2 million for the nine months ended September 30, 2025, an improvement from a net loss of $26.6 million for the same period in 2024[107] Research and Development - Research and development expenses for the nine months ended September 30, 2025 were $14.0 million, down 13.6% from $16.2 million for the same period in 2024[104] - The company plans to submit a new version of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance after collecting clinical evaluation data[82] - The proprietary Co-Primers technology is being utilized for applications beyond infectious disease testing, including genetic trait identification in plants and animals[89] Joint Ventures and Approvals - A joint venture was formed with Arabian Eagle Manufacturing to develop and commercialize Co-Dx technologies in Saudi Arabia and 18 other countries[83] - The company has received regulatory approval for PCR diagnostic tests for various diseases, including COVID-19 and influenza, in multiple countries[88] Cash Flow and Financing - Cash and cash equivalents stood at $11.4 million as of September 30, 2025, with total current assets of $14.1 million compared to total current liabilities of $3.7 million[109] - Net cash used in operating activities increased to $22.9 million for the nine months ended September 30, 2025, compared to $20.9 million for the same period in 2024[110] - Net cash provided by investing activities rose to $26.6 million for the nine months ended September 30, 2025, up from $16.8 million in the prior year[111] - The company raised approximately $3.8 million from a registered direct offering of 9,619,000 shares at $0.40 per share on September 18, 2025[115] - A new Equity Distribution Agreement was established with Maxim Group LLC, allowing for an at-the-market equity offering program of up to $10.0 million[108] - The company completed another registered direct offering in October 2025, generating gross proceeds of approximately $7.0 million[118] - The company anticipates continued operating losses and cash usage in the near term, indicating a potential need for additional financing[114] Compliance and Controls - The company has no off-balance sheet arrangements[121] - Disclosure controls and procedures were evaluated as effective as of September 30, 2025[122]

Financial Performance - Revenue for Q3 2025 was $0.1 million, a decrease of 83.4% compared to $0.6 million in Q3 2024, primarily due to a reduction in grant revenue[7] - Operating expenses were approximately $7.1 million, a decrease of 32.6% year-over-year from $10.6 million in Q3 2024[7] - Net loss for Q3 2025 was $5.9 million, or $0.16 per fully diluted share, compared to a net loss of $9.7 million, or $0.32 per fully diluted share in Q3 2024[7] - The operating loss for Q3 2025 was $7.0 million, a decrease from $10.2 million in Q3 2024[7] - For the three months ended September 30, 2025, the net loss was $5,886,823, an improvement from a net loss of $9,696,455 in the same period of 2024, representing a reduction of approximately 39%[18] - Adjusted EBITDA for Q3 2025 was $(6,301,839), compared to $(8,825,436) in Q3 2024, indicating a year-over-year improvement of about 29%[18] - Stock-based compensation expense decreased to $500,585 in Q3 2025 from $1,045,583 in Q3 2024, reflecting a reduction of approximately 52%[18] - Interest income, net, decreased to $(13,194) in Q3 2025 from $(263,335) in Q3 2024, indicating a decline of about 95%[18] - Depreciation and amortization expenses were $267,383 in Q3 2025, down from $351,235 in Q3 2024, representing a decrease of approximately 24%[18] - The realized gain on investments was $(41,542) in Q3 2025, compared to $(293,067) in Q3 2024, indicating a reduction of about 86%[18] - The income tax provision showed a benefit of $(1,166,593) in Q3 2025, contrasting with a provision of $22,189 in Q3 2024, marking a significant change[18] - Gain on disposition of assets was $(4,000) in Q3 2025, slightly higher than $(3,513) in Q3 2024[18] Cash and Funding - Cash, cash equivalents, and marketable securities totaled $11.4 million as of September 30, 2025, up from $2.9 million at the end of 2024[7] - The company closed a Registered Direct Offering (RDO) with gross proceeds of approximately $3.8 million before expenses, and subsequently closed another RDO with gross proceeds of approximately $7.0 million[7] Strategic Initiatives - Co-Diagnostics launched a dedicated AI business unit to integrate existing and planned AI applications into the Co-Dx Primer Ai platform[5] - The company signed a definitive agreement with Arabian Eagle Manufacturing to develop and commercialize Co-Dx technologies in Saudi Arabia and 18 additional MENA markets[7] - The company is pursuing a strategic transaction with Maxim Group, which may include a SPAC transaction for its India joint venture, CoSara[5] - The company developed a proprietary sample preparation instrument to streamline workflow for point-of-care Co-Dx PCR Mycobacterium Tuberculosis Test[7] Operational Efficiency - The company continues to focus on improving operational efficiency and reducing losses as indicated by the overall financial metrics[18]

Core Insights - Co-Diagnostics, Inc. reported its financial results for Q3 2025, highlighting a strategic shift with the establishment of CoMira Diagnostics in Saudi Arabia and plans for a potential SPAC transaction with its Indian joint venture, CoSara [4][6]. Business Highlights - The new joint venture, CoMira Diagnostics, aims to enhance the company's presence in Saudi Arabia and 18 additional MENA markets, supporting the localization of advanced molecular diagnostics [4]. - The company has launched a dedicated AI business unit to integrate its AI applications under the Co-Dx Primer Ai platform [4]. - Co-Diagnostics is preparing to initiate clinical evaluations for its upper-respiratory multiplex test, supported by a grant from the NIH's RADx Tech® program [4]. Financial Results - Revenue for Q3 2025 was $0.1 million, a decrease from $0.6 million in Q3 2024, primarily due to reduced grant revenue [6]. - Operating expenses were approximately $7.1 million, down 32.6% year-over-year [6]. - The operating loss was $7.0 million, compared to $10.2 million in Q3 2024, while the net loss was $5.9 million, or $0.16 per fully diluted share, compared to a net loss of $9.7 million, or $0.32 per fully diluted share in the prior year [6][16]. Cash Position - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $11.4 million [6].

Group 1 - The Annual General Meeting (AGM) for Zip Co Limited was officially opened by the Chair of the Board, Diane Smith-Gander, confirming that a quorum was present [1] - The meeting is being conducted virtually, with a note that technology issues may require a short recess or adjournment [2] - Diane Smith-Gander acknowledged the traditional custodians of the land, the Gadigal people of the Eora Nation, and paid respects to their Elders [3] Group 2 - The meeting introduced key members of the Board and Zip executives, including CEO Cynthia Scott and Independent Nonexecutive Directors [4] - There was a mention of a technical difficulty affecting the attendance of Kevin Moss, who is expected to join virtually from the United States [4]