GRI Bio(US:GRI)2024-11-14 21:16Product Development - GRI Bio's lead product candidate, GRI-0621, is being developed for the treatment of idiopathic pulmonary fibrosis (IPF), which affects approximately 140,000 people in the U.S. with up to 40,000 new cases annually[98] - GRI-0621 has been evaluated in over 1,700 patients for up to 52 weeks, showing good tolerability and inhibition of iNKT cell activity[98] - The FDA has cleared the IND application for GRI-0621, with interim data from the Phase 2a study expected in Q1 2025 and topline results in Q2 2025[98] - GRI Bio 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)[99] - The company plans to file an IND for GRI-0803 in 2025, focusing initially on lupus[100] - The company has received authorization for clinical trials in the UK and Australia for GRI-0621[98] Financial Performance - For the three months ended September 30, 2024, total operating expenses were $2.13 million, a decrease of 12.6% from $2.44 million in the same period of 2023[122] - Research and development expenses for the three months ended September 30, 2024, were $1.13 million, down from $1.19 million in 2023, primarily due to a decrease in personnel expenses[124] - General and administrative expenses decreased to $1.00 million for the three months ended September 30, 2024, from $1.25 million in 2023, mainly due to reduced stock-based compensation[125] - The company incurred a net loss of $2.12 million for the three months ended September 30, 2024, compared to a net loss of $2.14 million in the same period of 2023[122] - For the nine months ended September 30, 2024, research and development expenses increased to $2.94 million from $2.19 million in 2023, primarily due to increased expenses related to the development program of GRI-0621[129] - General and administrative expenses for the nine months ended September 30, 2024, were $3.34 million, significantly down from $7.17 million in 2023, attributed to decreased professional fees and personnel expenses[130] - The company reported a net loss of $6.26 million for the nine months ended September 30, 2024, compared to a net loss of $11.03 million in the same period of 2023[134] - The company reported net losses of $6.3 million for the nine months ended September 30, 2024, compared to $11.0 million for the same period in 2023[146] Funding and Capital Structure - GRI Bio completed multiple equity offerings raising gross proceeds of $10.5 million to meet Nasdaq's stockholders' equity requirement[111] - As of September 30, 2024, GRI Bio sold 2,387,296 shares in an At The Market Offering, raising $2.0 million in gross proceeds[108] - The company raised $9.55 million in financing activities for the nine months ended September 30, 2024, primarily from various purchase agreements[138] - As of September 30, 2024, the company sold 2,387,296 shares at a weighted-average price of $0.83 per share, raising $2.0 million in gross proceeds and $1.9 million in net proceeds[143] - The company entered into a February 2024 Purchase Agreement, resulting in net proceeds of $4.4 million after offering expenses[144] - In connection with a Merger Agreement, the company secured $12.3 million from Altium, resulting in net proceeds of $11.7 million after expenses[145] - The company expects to need substantial additional funding for ongoing operations and clinical trials, indicating a potential reevaluation of operating plans if funding is not secured[148] - The company anticipates that existing cash will be sufficient to fund operations into the middle of the first quarter of 2025[147] Compliance and Legal Matters - The company received a letter from Nasdaq on September 10, 2024, indicating non-compliance with the Minimum Bid Price Requirement due to a closing bid price below $1.00 for 30 consecutive business days, with a compliance deadline of March 10, 2025[113] - The company is classified as an "emerging growth company," allowing it to rely on certain exemptions from disclosure requirements[152] - There were no changes in internal control over financial reporting that materially affected the company during the fiscal quarter[156] - The company is not currently involved in any material legal proceedings that could adversely affect its business[158]