Financial Position - The company has approximately $35.2 million in cash and cash equivalents and marketable securities as of March 31, 2025[116]. - The accumulated deficit as of March 31, 2025, is $75.6 million, with a net loss of $4.9 million for the three months ended March 31, 2025, compared to a net loss of $2.5 million for the same period in 2024, representing a 95% increase in loss[117][128]. - Interest income for the three months ended March 31, 2025, was $0.4 million, a 407% increase from $0.1 million in the same period in 2024, due to higher cash equivalents and marketable securities[133]. - Total operating expenses for the three months ended March 31, 2025, were $7.2 million, a 46% increase from $4.9 million in the same period in 2024[128]. - For the three months ended March 31, 2025, net cash used in operating activities was $3.9 million, compared to $1.4 million for the same period in 2024[140][142]. - Cash used in investing activities for the three months ended March 31, 2025, was $5.4 million due to the purchase of marketable securities[144]. - The net cash outflow from operations for the three months ended March 31, 2025, was primarily due to a net loss of $4.9 million[141]. - The company has no off-balance sheet arrangements that could materially affect its financial condition[148]. Research and Development - Research and development expenses increased by 72% to $4.8 million for the three months ended March 31, 2025, compared to $2.8 million for the same period in 2024, primarily due to increased clinical trial costs[130]. - The company is conducting the RewinD-LB Trial, a Phase 2b study involving 159 participants with DLB, funded primarily by a $21.3 million grant from the NIA[114]. - The company plans to initiate a Phase 2 trial (Restore Trial) evaluating neflamapimod in up to 90 participants recovering from ischemic stroke in Q2 2025[115]. - The company expects to report 32-week results from the Extension of the RewinD-LB Trial in the second half of 2025 and plans to meet with the FDA to discuss Phase 3 plans thereafter[114]. - The company anticipates continued increases in research and development expenses, general and administrative expenses, and capital expenditures[137]. Capital Needs - The company has never been profitable and will continue to require additional capital for the foreseeable future to develop neflamapimod[117]. - The company expects to finance its cash needs through equity offerings, debt financings, or other capital sources, including collaborations and licenses[138]. - The company may need additional funds to advance product candidates through clinical development and to fund operations[138]. - As of March 31, 2025, the company believes its existing cash and cash equivalents will fund operations for at least twelve months[138]. - The company completed a private placement on April 1, 2024, raising approximately $50.0 million, with potential additional proceeds of up to $99.4 million from Series A Warrants[135].
DIFFUSION PHARMA(DFFN) - 2025 Q1 - Quarterly Report