GRI Bio(US:GRI)2025-11-14 12:45Product Development - GRI-0621, the lead product candidate, has been evaluated in over 1,700 patients for up to 52 weeks, targeting severe fibrotic lung diseases like idiopathic pulmonary fibrosis (IPF), which affects approximately 140,000 people annually in the U.S.[77] - The company expects to release topline results from the Phase 2a biomarker study of GRI-0621 by the end of November 2025[78] - The company has received FDA clearance for its Investigative New Drug application and authorization for clinical trials in the U.S., U.K., and Australia for GRI-0621[78] - The company plans to focus on developing GRI-0803 for autoimmune disorders, pending additional funding and IND clearance, with an expected Phase 1a and 1b trial in 2026[80] - The company has a proprietary library of over 500 compounds, with GRI-0803 being the lead molecule for the treatment of autoimmune disorders like lupus and multiple sclerosis[79] Financial Performance - Total operating expenses for the three months ended September 30, 2025, were $3.4 million, up from $2.1 million in 2024, resulting in a loss from operations of $3.4 million[94] - The company reported a net loss of $3.4 million for the three months ended September 30, 2025, compared to a net loss of $2.1 million in the same period of 2024[94] - Research and development expenses increased to $5.2 million for the nine months ended September 30, 2025, up 80.8% from $2.9 million in 2024[100] - General and administrative expenses rose to $4.1 million for the nine months ended September 30, 2025, an increase of 20.6% from $3.4 million in 2024[101] - The net loss for the nine months ended September 30, 2025, was $9.3 million, compared to a net loss of $6.3 million in 2024, reflecting a 48% increase in losses[104] - Cash used in operating activities was $7.2 million for the nine months ended September 30, 2025, compared to $6.6 million in 2024, indicating a 9.1% increase in cash outflow[106] Funding and Cash Position - The company has raised $6.2 million in gross proceeds from the At The Market Offering, selling 1,680,099 shares at a weighted-average price of $3.67 per share[86] - Net cash provided by financing activities was $6.2 million for the nine months ended September 30, 2025, down from $9.6 million in 2024, a decrease of 35.4%[107][108] - As of September 30, 2025, the company had $4.1 million in cash and an accumulated deficit of $49.0 million[104][113] - The company expects to continue incurring significant operating losses and will need to secure additional funding to support ongoing operations and clinical trials[115] - The company plans to raise capital through additional equity securities and/or debt arrangements, but there are no assurances that financing will be available on acceptable terms[115] Expense Analysis - Research and development expenses increased to $1.8 million for the three months ended September 30, 2025, compared to $1.1 million in the same period of 2024, reflecting a $0.5 million rise in GRI-0621 registration development costs[95] - General and administrative expenses rose to $1.6 million for the three months ended September 30, 2025, from $1.0 million in 2024, primarily due to a $0.5 million increase in personnel expenses[96] - Interest income for the nine months ended September 30, 2025, was $16,000, a decrease of 15.8% from $19,000 in 2024[103]