Product 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 FDA has cleared the Investigative New Drug application for GRI-0621, allowing the initiation of clinical trials in the U.S., U.K., and Australia[78] - The company has a proprietary library of over 500 compounds, with GRI-0803 being developed for autoimmune disorders like systemic lupus erythematosus (SLE) and multiple sclerosis (MS)[79] - The company plans to complete IND-enabling studies for GRI-0803 in 2026, pending additional funding[80] - The company is preparing for planned clinical trials of GRI-0621 and GRI-0803, which will require substantial financial resources[113] 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 2024[94] - 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] - Interest income for the nine months ended September 30, 2025, was $16,000, a decrease of 15.8% from $19,000 in 2024[103] - 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] - 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] Funding and Capital - 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] - The company expects to incur significant operating losses for the foreseeable future and will need to secure additional funding to continue operations[115] - The company plans to raise capital through additional issuances of equity securities and/or debt arrangements[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] - As of September 30, 2025, the company had $4.1 million in cash and an accumulated deficit of $49.0 million[104][113]
VALLON PHARMACEU(VLON) - 2025 Q3 - Quarterly Report