GRI Bio Q1 2024 Financial Results and Corporate Update

GRI Bio, Inc., a biotechnology firm focused on the development of innovative Natural Killer T (NKT) cell modulators to treat inflammatory, fibrotic, and autoimmune diseases, has shared its financial results for the first quarter ending March 31, 2024, along with significant corporate updates.

CEO Marc Hertz, PhD, emphasized ongoing dedication towards their clinical and corporate objectives. He highlighted the company's efforts in driving the Phase 2a biomarker study in Idiopathic Pulmonary Fibrosis (IPF) and noted the importance of the forthcoming interim data readout. Hertz also pointed out the company's success in expanding their patent holdings and active participation in scientific meetings, which he believes showcases the potential of their lead program, GRI-0621. He expressed confidence in unlocking substantial value in 2024.

The company shared several recent achievements:
- An oral presentation at the 14th International Congress on Autoimmunity.
- Expansion of intellectual property protection with the issuance of a patent in Korea for their proprietary NKT cell modulators.
- Acceptance of a poster presentation at the 2024 American Thoracic Society International Conference.
- Notice of allowance for a Canadian patent covering their proprietary NKT cell modulators.
- Authorization from the UK's MHRA to initiate a Phase 2a biomarker study evaluating GRI-0621 for IPF.
- Successful closing of a public offering, raising $5.5 million from healthcare-focused institutional investors.

GRI-0621, the company's leading program, targets Type 1 invariant NKT (iNKT) cells and is under development for IPF, a rare, chronic, progressive lung disease characterized by abnormal scarring that impedes oxygen transfer into the bloodstream. Current treatments for IPF are limited and often come with significant side effects, leading to low compliance and no impact on survival rates. GRI-0621, a small molecule RAR-βɣ dual agonist, has demonstrated efficacy in inhibiting iNKT cell activity, improving fibrosis in various disease models, and enhancing liver function tests and other markers of inflammation in preliminary trials.

The company has initiated a Phase 2a biomarker study leveraging the 505(b)(2) regulatory pathway to evaluate GRI-0621 for IPF. Key upcoming milestones for GRI-0621 include reporting interim data in Q3 2024 and topline results in Q4 2024.

GRI Bio is also advancing GRI-0803, a novel activator of human type 2 NKT cells aimed at treating systemic lupus erythematosus (SLE), an autoimmune disease where the immune system attacks the body's tissues and organs. SLE is the most common form of lupus, with current treatments primarily involving immunosuppressive therapies.

GRI-0803 has shown promise in preclinical studies, where it inhibited both murine and human iNKT cells and improved survival rates by reducing lupus nephritis. The company plans to complete IND-enabling studies by Q3 2024, file an IND and launch Phase 1a/b trials, and report topline results from these studies by Q4 2024.

Financially, GRI Bio reported a net loss of $1.9 million for the first quarter of 2024, compared to $1.0 million for the same period in the previous year. Research and development expenses rose to $0.9 million from $0.1 million, and general and administrative expenses were $1.0 million, slightly up from $0.9 million in the prior year. The company had approximately $4.1 million in cash and cash equivalents as of March 31, 2024. Following the February 2024 public offering, the company believes its current funds will support its operating expenses and capital requirements into the third quarter of 2024.

GRI Bio remains committed to transforming the treatment landscape for inflammatory, fibrotic, and autoimmune diseases through its innovative therapies targeting NKT cell activity. The company's lead program, GRI-0621, and its pipeline of novel type 2 NKT agonists for SLE, represent significant strides in addressing diseases with substantial unmet medical needs. With a robust intellectual property portfolio and a library of proprietary compounds, GRI Bio is positioned for ongoing growth and development in its field.