CDI(CODX) - 2024 Q3 - Quarterly Report

Revenue Performance - For the three months ended September 30, 2024, the company generated revenues of $641,141, a decrease of 74.0$2,457,098 for the same period in 2023[72]. - Grant revenue accounted for $434,265 of total revenue for the three months ended September 30, 2024, down from$2,320,565 in the prior year, primarily due to timing of milestone achievements[72]. - For the nine months ended September 30, 2024, total revenues were $3,765,835, an increase of 15.6$3,256,861 for the same period in 2023[81]. Net Loss and Expenses - The company recorded a net loss of $9,696,455 for the three months ended September 30, 2024, compared to a net loss of$5,982,194 for the same period in 2023, reflecting a 62.5% increase in net loss[80]. - The net loss for the nine months ended September 30, 2024, was $26,607,816, compared to a net loss of$20,656,410 for the same period in 2023, primarily due to changes in fair value of acquisition contingencies and income taxes[89]. - Total operating expenses for the three months ended September 30, 2024 were $10,578,675, a decrease of 5.0$11,137,277 in the prior year[75]. - The company incurred total operating expenses of $31,196,065 for the nine months ended September 30, 2024, a decrease of 5.2$32,920,793 in the prior year[84]. - Research and development expenses for the three months ended September 30, 2024 were $4,880,315, down from$5,788,789 in the same period in 2023, indicating a decrease of 15.7%[78]. Cash Flow and Assets - Cash and cash equivalents as of September 30, 2024, totaled $10,797,630, with marketable investment securities amounting to$26,864,571, leading to total current assets of $40,103,158 against current liabilities of$5,797,977[90]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $20,924,039, an increase from$17,303,239 in the prior year, mainly due to decreased cash collections[91]. - Net cash provided by investing activities was $16,804,791 for the nine months ended September 30, 2024, compared to$5,773,590 in the same period of 2023, primarily from maturities of marketable investment securities[92]. - There were no financing activities in the nine months ended September 30, 2024, compared to $1,204,256 in the prior year due to share repurchases[93]. Future Outlook and Financing - The company believes existing capital resources and future sales will meet projected operating requirements for the next 12 months, but may need additional financing for strategic opportunities[96]. - An Equity Distribution Agreement was entered into on March 16, 2023, allowing the company to sell up to$50 million in common stock, with a reduced amount of $17.1 million available as of October 18, 2024[96]. Regulatory and Legal Matters - The company is developing a portable diagnostic device and test system for point-of-care and at-home use, with the Co-Dx™ PCR platform currently under FDA review[64]. - The company has received acknowledgment from the FDA for its 510(k) application for the Co-Dx™ PCR Pro™ instrument, which is under review[64]. - The proprietary test design process involves optimizing PCR tests using predictive mathematical algorithms, with over 20 patents protecting the technology[68]. - Income tax expense for the nine months ended September 30, 2024, was$65,543, a significant change from an income tax benefit of $6,611,712 for the same period in 2023, attributed to a full valuation allowance[89]. - The company has not experienced any changes in internal control over financial reporting that materially affect its financial reporting as of September 30, 2024[98]. - There have been no material developments in legal proceedings previously disclosed in the annual report for the fiscal year ended December 31, 2023[98].