
Financial Performance - The company reported no revenues for the three months ended March 31, 2025, and 2024, maintaining an accumulated deficit of $243.4 million[147][156]. - The net loss for the three months ended March 31, 2025, was $6.1 million, compared to a net loss of $2.9 million in the same period of 2024, representing an increase in loss of approximately 115%[151]. - The company anticipates continuing to incur significant losses for the foreseeable future, with substantial doubt about its ability to continue as a going concern without additional capital[162][163]. Expenses - Research and development expenses decreased to $22,235 in Q1 2025 from $2.5 million in Q1 2024, a reduction of approximately 99% due to decreased clinical trial costs and reduced headcount[152]. - General and administrative expenses fell to $1.3 million in Q1 2025 from $2.6 million in Q1 2024, a decrease of approximately 50% attributed to lower employee compensation expenses[153]. - Adjusted non-cash charges for Q1 2025 were $4.8 million, including $20,783 for stock-based compensation, while in Q1 2024, non-cash charges increased by $1.4 million[165][166]. Cash Flow and Working Capital - The company experienced a cash outflow from operating activities of $1.1 million in Q1 2025, compared to an outflow of $3.6 million in Q1 2024, indicating improved cash management[164]. - As of March 31, 2025, the company had working capital of $5.4 million, an increase of $3.9 million from a working capital deficit of $1.5 million as of December 31, 2024[164]. - Net cash used in operating activities for Q1 2025 was $1.1 million, compared to $3.6 million in Q1 2024, reflecting a net loss of $6.1 million in 2025 versus $2.9 million in 2024[165][166]. - Changes in working capital had a positive impact of $0.2 million on cash in Q1 2025, while in Q1 2024, it had a negative impact of $2.1 million[165][166]. - Net cash provided by financing activities was $5.3 million in Q1 2025, primarily from warrant exercises and equity issuance, compared to $1.8 million in Q1 2024[168]. Financing Activities - The company raised gross proceeds of $9 million from a registered offering on January 23, 2025, which was partially used to repay existing notes[143][155]. - The company made a $2.9 million payment on notes payable during Q1 2025[168]. Licensing and Product Development - The company entered into a License Agreement with New Day Diagnostics LLC, involving an upfront payment of $525,000 and potential milestone payments of up to $17.15 million[144][145]. - The company has no products approved for commercial sale in the U.S., but three diagnostic tests related to the New Day licensing agreement have CE marks and are eligible for sale in Europe[156]. Cash Position - As of March 31, 2025, the company had $4.6 million in cash, down from $13.1 million as of March 31, 2024[165][166]. - There were no cash flows from investing activities in both Q1 2025 and Q1 2024[167].