Product Development - GRI Bio's lead product candidate, GRI-0621, 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 in the U.S. annually [95] - GRI Bio plans to initiate a Phase 2a trial in 36 IPF patients in the second half of 2023, with topline results expected in the second half of 2024 [95] - The company intends to file an IND for GRI-0803, targeting systemic lupus erythematosus (SLE), in the first half of 2024 [96] Financial Performance - Total operating expenses for the three months ended September 30, 2023, were $2.4 million, compared to $0.2 million in 2022, resulting in a loss from operations of $2.4 million [110] - The net loss for the nine months ended September 30, 2023, was $11.0 million, compared to a net loss of $0.9 million in 2022, indicating a significant increase in losses [122] - As of September 30, 2023, the company had an accumulated deficit of $29.5 million and $3.5 million in cash [130] Expenses - Research and development expenses increased to $1.2 million for the three months ended September 30, 2023, compared to $0.1 million in the same period of 2022, reflecting a $1.1 million rise primarily due to GRI-0621 development costs [111] - General and administrative expenses rose to $1.3 million for the three months ended September 30, 2023, from $0.1 million in 2022, with a $1.2 million increase attributed to professional fees and personnel expenses [112] - Research and development expenses increased to $2.2 million for the nine months ended September 30, 2023, compared to $0.2 million in 2022, reflecting a $2.0 million rise primarily due to GRI-0621 development costs [117] - General and administrative expenses rose to $7.2 million in 2023 from $0.4 million in 2022, a $6.8 million increase mainly due to professional fees related to the Merger and increased personnel expenses [118] Cash Flow - Net cash used in operating activities was $3.4 million for the nine months ended September 30, 2023, compared to $0.2 million in 2022, reflecting a $3.2 million increase in cash outflow [125] - Net cash provided by financing activities was $6.9 million for the nine months ended September 30, 2023, primarily from proceeds of $12.3 million from the Equity SPA [127] - The company anticipates that existing cash and cash equivalents will be sufficient to fund operations into the first quarter of 2024 [131] Warrant Liability - The change in fair value of warrant liability was a decrease of $0.1 million during the three months ended September 30, 2023 [113] - The change in fair value of warrant liability was a decrease of $0.2 million during the nine months ended September 30, 2023 [119] - The Series T Warrants issued in connection with the Merger are not currently subject to forced exercise due to unmet equity conditions [132] Corporate Actions - GRI Bio completed a merger with Vallon Pharmaceuticals on April 21, 2023, changing its name to GRI Bio, Inc. [97] - The company issued warrants to purchase 1,269,210 shares at an initial exercise price of $13.51 per share as part of the merger financing [99] - The company expects to continue incurring significant operating losses and will need substantial additional funding to support ongoing operations and clinical trials [132]
VALLON PHARMACEU(VLON) - 2023 Q3 - Quarterly Report