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]
CDI(CODX) - 2025 Q3 - Quarterly Report