GRI Bio, Inc.

Company overview

GRI Bio, Inc. is a clinical-stage biopharmaceutical company focused on discovering, developing, and potentially commercializing therapies that target dysregulated immune responses in inflammatory, fibrotic, and autoimmune diseases. The company’s core approach is to regulate invariant Natural Killer T (iNKT) and diverse NKT (dNKT) cell activity to reset pathogenic immune processes that drive disease.

Product candidates and programs

• GRI-0621

  • Oral inhibitor of iNKT cells; active ingredient tazarotene (RAR-beta and gamma selective agonist).
  • Primary focus: idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases.
  • Phase 2a in IPF completed; topline results met primary safety and tolerability endpoints and showed biomarker signals of anti-fibrotic activity.
  • Phase 2b planned, subject to funding or partnerships.
  • Regulatory considerations include potential use of the FDA 505(b)(2) pathway and possible EU conditional approval pathways; orphan-disease considerations are being evaluated.

• GRI-0803

  • Oral activator of diverse NKT (dNKT) cells.
  • Initial focus: autoimmune disorders, with emphasis on systemic lupus erythematosus (SLE) and lupus nephritis.
  • IND-enabling studies planned; IND filing and Phase 1a/1b in healthy volunteers planned for 2026.
  • Preclinical data in lupus models showed inhibition of iNKT activity, reduced inflammatory cytokines, and improved survival in lupus nephritis models.

• Other assets

  • A library of 500+ compounds related to GRI-0124 (miltefosine); lead GRI-0803 derived from this library.
  • GRI-0729 and GRI-0124 families include multiple granted patents and extensive foreign patent protection.

• Pipeline positioning

  • The company retains global development and commercialization rights for its candidates.
  • Strategy includes pursuing collaborations or strategic partnerships to support development, funding, and global reach.

Market opportunity and indications

• Idiopathic pulmonary fibrosis (IPF)

  • IPF is a life-threatening fibrotic lung disease with substantial patient populations in the US and globally.
  • Estimated US IPF population: ~140,000 patients; up to 40,000 new US cases per year; global estimates near 3 million.
  • Current therapies slow lung function decline but have not demonstrated improvements in overall survival and are associated with adverse events.

• Potential expansion areas (based on preclinical or partial rationale)

  • MASH (metabolic/dyslipidemia-related liver disease), alcoholic liver disease (ALD), renal fibrosis, acute liver injury, drug-induced liver injury (DILI), SLE, multiple sclerosis (MS), ulcerative colitis (UC), and other inflammatory/autoimmune conditions.

Clinical signals in IPF

In the Phase 2a IPF trial, GRI-0621 treatment produced changes in fibrotic biomarkers and immune cell activity consistent with potential anti-fibrotic effects (for example, serum collagen biomarkers, BAL and PBMC signals, T cell markers). A post-hoc analysis showed modest improvements in FVC.

Financial position and liquidity (selected figures)

• Revenue: none reported.
• Net loss: $12.0 million in 2025; $8.2 million in 2024.
• Accumulated deficit: approximately $51.7 million as of December 31, 2025.
• Cash and cash equivalents: approximately $8.2 million as of December 31, 2025.
• Management indicates ongoing fundraising needs to support planned clinical activities.
• Planned use of funds: finance continued clinical development (including Phase 2b for GRI-0621), IND-enabling and Phase 1 studies for GRI-0803, discovery efforts, manufacturing development, and corporate activities associated with being a public company.

Headcount and operations

• As of January 30, 2026: four employees (three full-time, one part-time).
• The company relies on external CROs, consultants, and advisors for clinical development and regulatory activities.

Corporate structure and location

• Corporate identity: GRI Bio, Inc. (formerly Vallon Pharmaceuticals, Inc.). GRI Bio Operations, Inc. is a wholly owned subsidiary following a merger.
• Principal office: 2223 Avenida De La Playa #208, La Jolla, CA 92037.
• The company retains worldwide development and commercial rights for its candidates and is pursuing partnerships to scale operations.

Intellectual property

• GRI-0621: one patent family with 3 US patents granted and 20 foreign patents (Australia, Brazil, Canada, China, Europe, Hong Kong, Japan, Korea, Mexico, Russia, etc.); estimated expiration around 2032.
• GRI-0803: one US patent family (3 US patents granted) and 17 foreign patents (including Canada, Europe, Hong Kong); pending US application; estimated expiration around 2032.
• GRI-0729: 4 US patents granted and 13 foreign patents; estimated expiration around 2032.
• GRI-0124: US and foreign patents granted with additional pending US applications; estimated expiration around 2035.
• The company plans to seek patent term extensions where available and to use data exclusivity and other regulatory protections. Enforcement of IP rights may involve litigation or licensing across jurisdictions.

Manufacturing and third-party reliance

• GRI-0621 and GRI-0803 are manufactured by third-party contract manufacturers.
• The company depends on a limited number of suppliers and, for some products, a single manufacturer; disruption could delay development timelines.
• Manufacturing comparability and cGMP compliance are factors in switching or adding manufacturers and would apply to post-approval supply arrangements.

Regulatory and development path

• Regulatory strategy includes FDA pathways for NDAs, potential use of 505(b)(2), and consideration of orphan designation, data exclusivity, and post-approval obligations.
• The company plans engagement with EU and other regional regulatory systems and will address requirements such as post-marketing commitments where applicable.

People and leadership

• Small internal team supplemented by external partners for execution.
• Leadership: W. Marc Hertz, Ph.D. (CEO); Albert Agro, Ph.D. (CMO); Vipin Kumar Chaturvedi, Ph.D. (CSO).

Commercial readiness

• The company does not yet have a commercial sales or marketing organization.
• Plans include pursuing collaborations or strategic partnerships to enable commercialization in rare indications in the US/EU, while retaining the option to commercialize with a targeted domestic team if regulatory progress supports that approach.