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GRI Bio, Inc. (GRI)·Q4 2024 Earnings Summary

Executive Summary

  • FY 2024 results: Net loss was $8.2M; cash and equivalents were $5.0M; management expects runway into Q2 2025 .
  • Key timeline changes: Interim Phase 2a IPF biomarker data for GRI‑0621 shifted from Q4 2024 to Q2 2025; topline shifted from Q1 2025 to Q3 2025 versus earlier disclosures—representing two sequential quarter slips across Q2→Q3→Q4 updates .
  • Funding actions in Q4: Warrant exercises and ATM capacity increase strengthened liquidity and helped bridge to data readouts; gross proceeds raised totaled ~$13.9M in 2024 with an additional ~$0.8M from October warrant exercises .
  • Near-term stock catalyst: Q2 2025 interim IPF biomarker readout; runway extension into Q2 2025 reduces immediate financing risk but timeline slippage is a watch-point .

What Went Well and What Went Wrong

  • What Went Well

    • Liquidity bridge and extended runway: ~$13.9M gross proceeds raised since the start of 2024 plus ~$0.8M from October exercises; runway now into Q2 2025 .
    • Pipeline momentum and IP expansion: Positive preclinical presentations; European patent coverage for GRI‑0803 and the 500+ compound library .
    • CEO tone confident on 2025 data cadence: “We remain confident that the data observed to date and the additional data readouts anticipated this year, will position us to build momentum and drive value for shareholders” .
  • What Went Wrong

    • Clinical timeline slips: Interim GRI‑0621 IPF data moved Q4’24→Q1’25→Q2’25; topline moved Q1’25→Q2’25→Q3’25—introducing execution risk and potential investor frustration .
    • Continuing operating losses with limited near-term revenue visibility: FY 2024 net loss $8.2M; pre-revenue profile persists .
    • Dilution/financing overhang: Warrant repricings/issuance and ATM expansion support funding, but add potential dilution risk if additional capital is needed pre-data .

Financial Results

MetricQ1 2024Q2 20249M 2024Q4 2024 (Derived)
Net Loss ($USD Millions)$1.9 $2.4 $6.3 ~$1.9 (FY $8.2 − 9M $6.3)
Research & Development ($USD Millions)$0.9 $0.9 $2.9 ~$0.9 (FY $3.8 − 9M $2.9)
General & Administrative ($USD Millions)$1.0 $1.4 $3.3 ~$1.2 (FY $4.5 − 9M $3.3)
Revenue ($USD)N/AN/AN/AN/A

Notes:

  • Q4 values are derived from FY 2024 minus 9M 2024 totals (company-reported figures cited in cells) .

KPIs

KPIQ1 2024 (3/31)Q2 2024 (6/30)Q3 2024 (9/30)FY 2024 (12/31)
Cash & Equivalents ($USD Millions)$4.1 $6.4 $4.7 $5.0
Cash Runway (Mgmt Guidance)Into Q3 2024 Into Q1 2025 Into mid‑Q1 2025 Into Q2 2025

Segment breakdown: Not applicable (no commercial segments disclosed) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
GRI‑0621 Phase 2a Interim IPF Biomarker DataTimingQ4 2024 (Aug) Q2 2025 (Mar) Delayed
GRI‑0621 Phase 2a Topline IPF Biomarker DataTimingQ1 2025 (Aug) Q3 2025 (Mar) Delayed
Cash RunwayThroughInto Q1 2025 (Aug) / mid‑Q1 2025 (Nov) Into Q2 2025 (Mar) Extended

Earnings Call Themes & Trends

(Note: No Q4 2024 earnings call transcript found in filings; themes below reflect quarter press releases.)

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
Clinical timelines (GRI‑0621 IPF)Interim Q4 2024; topline Q1 2025 Interim Q2 2025; topline Q3 2025 Slipping by ~2 quarters across H2 ’24–Q1 ’25
Liquidity/runwayInto Q1 2025; financing closed in Q2 Runway into Q2 2025; 2024 gross proceeds ~$13.9M; Oct warrant exercises ~$0.8M Improved near-term runway
Regulatory/clinical executionUK MHRA CTA; Australia HREC approval Readouts reaffirmed for 2025; continued biomarker focus Steady progress; timing pushed
IP/Preclinical validationPositive preclinical data; patent grants Positive iNKT/IPF data; EU patent on GRI‑0803/library Strengthening IP and scientific narrative

Management Commentary

  • CEO on momentum: “We remain confident that the data observed to date and the additional data readouts anticipated this year, will position us to build momentum and drive value for shareholders in the near and long term” (Marc Hertz, PhD) .
  • CEO on execution (Q3): “We continue to make fundamental progress… With our strengthened cash position and Phase 2a study execution, we believe we are poised to drive value for shareholders” .

Q&A Highlights

N/A – No public Q4 2024 earnings call transcript available in the filings set reviewed (analysis based on press releases) .

Estimates Context

  • Wall Street consensus from S&P Global was not available at the time of this analysis due to retrieval limits; the company’s press releases do not include Street comparisons .
  • Given timeline slippage and limited near‑term revenue visibility, any Street models likely will shift readout timing and cash needs post‑interim data.

Key Takeaways for Investors

  • Liquidity bridge achieved: ~$13.9M gross proceeds in 2024 and October warrant exercises extended runway into Q2 2025; near‑term financing overhang reduced pre‑interim data .
  • Execution risk persists: Interim and topline IPF biomarker data for GRI‑0621 have slipped by ~two quarters since August guidance; focus on study enrollment cadence is critical to the timeline .
  • Data cadence is the major catalyst: Q2 2025 interim biomarker readout could be stock‑moving; topline in Q3 2025 sets up subsequent regulatory dialogue .
  • Operating discipline: FY 2024 net loss $8.2M with R&D $3.8M and G&A $4.5M; Q4 implied OpEx consistent with prior quarters, emphasizing lean spend into readouts .
  • Trading setup: Into Q2 2025, focus on interim biomarker potency (iNKT inhibition, pulmonary function signals) and any partner interest in IPF; financing actions and timeline updates will drive sentiment .
  • Medium‑term thesis: If biomarker/PD signals are compelling, the iNKT upstream mechanism could attract strategic interest in IPF; conversely, further delays or mixed signals would likely pressure shares and raise capital needs .