GRI BIO, Inc. (GRI)·Q2 2024 Earnings Summary

Executive Summary

• GRI Bio reported a Q2 2024 net loss of $2.25M (–$4.92 per share), with operating expenses down sharply year-over-year as post‑merger professional fees rolled off; the press release rounded net loss to ~$2.4M (no revenue reported) .
• Cash and equivalents were $6.35M, with management reaffirming cash runway “into the first quarter of 2025”; Q2 financing (public offering and ATM) extended liquidity but a going‑concern risk remains given expected funding needs for clinical programs .
• Clinical timelines were adjusted: GRI‑0621 Phase 2a biomarker study interim readout moved to Q4 2024 (from Q3 2024 prior) and topline to Q1 2025 (from Q4 2024 prior); GRI‑0803 IND/Phase 1 shifted to 2025 pending funding .
• Corporate actions reduced listing risk and added capital: a 1‑for‑13 reverse split (June) and subsequent capital raises supported compliance; Nasdaq confirmed the company regained compliance with all listing standards on July 2, 2024 .

What Went Well and What Went Wrong

• What Went Well

  • Operating discipline: General & administrative expenses fell to $1.38M from $5.05M in Q2 2023 as merger‑related professional fees normalized, reducing total operating expenses ~62% YoY .
  • Liquidity improved: Cash rose to $6.35M on June 30, 2024; management guided runway into Q1 2025 after completing a June offering and utilizing the ATM facility .
  • Listing overhang reduced: Company effected a 1‑for‑13 reverse split and subsequently regained Nasdaq compliance, removing a material listing risk .
  • Management tone/quote: “Our focus and priority remain on the successful execution of our Phase 2a biomarker study of GRI‑0621…with interim data by the end of the year and topline data on track for Q1 2025” — CEO Marc Hertz .

• What Went Wrong

  • Clinical timing slippage: GRI‑0621 interim moved to Q4 2024 (prior Q3 2024) and topline to Q1 2025 (prior Q4 2024), pushing catalysts by roughly one quarter .
  • Pipeline deferral: GRI‑0803 IND/Phase 1 shifted to 2025 and is contingent on additional funding, delaying diversification beyond IPF .
  • Continued financing needs/going concern: Despite added capital, management disclosed “substantial doubt” to continue as a going concern without further financing; heavy warrant overhang and repeated reverse splits highlight dilution risk .

Financial Results

Notes: The Q2 2024 press release cited net loss of ~$2.4M (rounded); 10‑Q shows $2.250M (see above) .

Cash and runway

Capital actions (Q2 2024)

• Public offering (June 26): ~$3.17M net proceeds; pre‑funded and common warrants issued (gross ~$4.0M per press release) .
• ATM sales through June 30: $0.96M gross ($0.92M net) .

Estimates vs actual

• Wall Street consensus estimates from S&P Global were unavailable via our data service at this time; as a result, we cannot present EPS/revenue beats or misses for Q2 2024. Comparisons to estimates are therefore not provided.

Guidance Changes

Earnings Call Themes & Trends

No Q2 2024 earnings call transcript was filed in the document set; we reviewed the press release, 10‑Q MD&A, and earnings slides instead.

Management Commentary

• CEO (Q2 release): “Our focus and priority remain on the successful execution of our Phase 2a biomarker study of GRI‑0621 for the treatment of IPF, with interim data by the end of the year and topline data on track for Q1 2025.”
• Strategy/MD&A (timelines): “We now expect interim data from this trial to be available in the fourth quarter of 2024 and topline results to be available in the first quarter of 2025.”
• Resource allocation: GRI‑0803 advancement to IND/Phase 1 “in 2025,” contingent on additional financing (reflects prioritization of GRI‑0621) .

Q&A Highlights

• No Q2 2024 earnings call transcript was available in the filings; consequently, there are no Q&A takeaways to report for the period.

Estimates Context

• S&P Global consensus estimates were not accessible via our service for Q2 2024 at the time of analysis; therefore, we cannot present EPS or revenue beat/miss comparisons to Street expectations for this quarter. If estimates become available, we will update the recap to reflect actual vs. consensus.

Key Takeaways for Investors

• Near‑term catalyst path is intact but delayed: Watch for GRI‑0621 Phase 2a interim biomarker data in Q4 2024 and topline in Q1 2025—events that will drive the narrative and stock reaction given IPF’s high unmet need .
• Liquidity extended into Q1 2025 post‑financing, but going‑concern disclosure underscores a need for additional capital—dilution risk and warrant overhang remain central to the equity case .
• Operating spend is better controlled YoY as G&A normalizes; continued discipline is supportive while the company advances toward data readouts .
• Listing risk reduced: reverse split and subsequent compliance with Nasdaq remove an overhang; share consolidation may improve institutional accessibility but does not change financing needs .
• Pipeline prioritization: resources focus on 0621 in IPF; 0803 in SLE is a 2025 opportunity pending funding—positives for focus, but reduces near‑term diversification .
• For positioning: near‑term trading likely hinges on enrollment cadence and any interim signals around PD biomarker inhibition and safety, with macro (funding markets) influencing dilution expectations into/after data .

Supporting documents reviewed:

• Q2 2024 8‑K earnings press release (Item 2.02) and exhibit slides .
• Q2 2024 10‑Q (financials, MD&A, liquidity, capital actions) .
• Q1 2024 8‑K and 10‑Q (prior guidance, financial baseline) .
• Reverse split (June 14, 2024) ; Nasdaq compliance regained (July 8, 2024) .