GRI Bio, Inc. reported a net loss of $8.2 million for the fiscal year ending December 31, 2024, a significant improvement compared to a net loss of $13.0 million in the previous year. The company's total operating expenses decreased to $8.2 million from $11.4 million in 2023, primarily due to a reduction in general and administrative expenses, which fell from $8.2 million to $4.5 million. This decrease was attributed to lower costs associated with accounting, legal, and investment banking fees following a merger, as well as a reduction in personnel costs. Research and development expenses increased slightly to $3.8 million, driven by costs related to the development of the lead product candidate, GRI-0621.
In terms of strategic developments, GRI Bio is advancing its lead product candidate, GRI-0621, an oral inhibitor of type 1 invariant Natural Killer T (iNKT) cells, which is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). The company has received FDA clearance for its Investigational New Drug (IND) application and commenced enrollment for a Phase 2a biomarker study in December 2023, with topline results expected in the third quarter of 2025. Additionally, GRI Bio is developing GRI-0803, an oral agonist of diverse Natural Killer T (dNKT) cells, targeting autoimmune disorders such as systemic lupus erythematosus (SLE), with plans to file an IND for this candidate in 2025.
Operationally, GRI Bio has faced challenges in patient enrollment for its clinical trials, notably halting a pilot Phase 2a trial in hepatically impaired chronic liver disease patients after enrolling only 14 out of the intended 60 due to recruitment difficulties. The company currently has four employees and is focused on expanding its workforce to support its clinical development efforts. As of December 31, 2024, GRI Bio had approximately $5.0 million in cash and cash equivalents, which it expects to last into the second quarter of 2025, necessitating additional capital to fund ongoing operations and development activities.
Looking ahead, GRI Bio faces significant risks, including the need for substantial additional capital to finance its operations and the uncertainty surrounding regulatory approvals for its product candidates. The company has expressed concerns about its ability to continue as a going concern if it cannot secure adequate funding. Furthermore, the competitive landscape in the biopharmaceutical industry poses challenges, as GRI Bio must navigate the complexities of clinical development, regulatory compliance, and market acceptance of its therapies. The company is actively seeking to establish collaborations and partnerships to enhance its development capabilities and market reach.
About GRI BIO, Inc.
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