Executive Summary

Q1 2025 marked steady execution on GRI-0621 with favorable interim safety/biomarker signals and completion of enrollment for the 6-week interim cohort (n=24); topline from the Phase 2a biomarker study is now guided to Q3 2025, with a 6-week interim readout in Q2 2025 .
Operating loss widened year over year as R&D ramped for GRI-0621; net loss was $3.0M, R&D $1.6M, G&A $1.4M; cash was $3.3M at quarter-end. Cash runway improved to “through Q3 2025” after an April $5.0M offering and ATM proceeds .
EPS of $(5.80) missed S&P Global consensus ($(3.79)*) largely on higher OpEx supporting the trial; revenue remains $0 in line with expectations for a clinical-stage biotech .
Near-term stock catalysts center on the Q2 2025 6-week interim biomarker analysis and the Q3 2025 topline readout in IPF; structural overhangs eased by a February 1-for-17 reverse split and March Nasdaq minimum bid price compliance notice .

What Went Well and What Went Wrong

What Went Well
- Completed enrollment for 6-week interim (n=24) and >2/3 overall enrollment; IDMC-reviewed 2‑week biomarker data showed PRO‑C3 changes “suggestive of anti-fibrotic effect.” Management emphasized momentum and potential to “build near- and long-term value” .
- Favorable safety at 2 weeks (no meaningful HDL/LDL/TG changes at 4.5mg QD); interim committee recommended study continuation as planned .
- Balance sheet actions extended cash runway through Q3 2025 (April $5.0M gross proceeds; incremental ATM sales), reducing near-term financing risk vs prior disclosures .
What Went Wrong
- Timelines slipped: guidance for GRI‑0621 moved from interim Q4’24/topline Q1’25 (Q2’24 update) to interim Q2’25/topline Q3’25 (current), reflecting execution realities in multi-region IPF study .
- OpEx rose YoY with R&D up to $1.6M and G&A to $1.4M driving net loss to $3.0M (vs $1.9M in Q1’24) .
- Capital structure dilution and complexity increased (reverse split; warrants across multiple tranches) even as the company regained Nasdaq bid-price compliance in March .

Metric	Q1 2024	Q3 2024	Q1 2025
Revenues ($M)	$0.00	$0.00	$0.00
R&D Expense ($M)	$0.93	$1.13	$1.64
G&A Expense ($M)	$0.96	$1.00	$1.41
Operating Expenses ($M)	$1.90	$2.13	$3.05
Net Loss ($M)	$(1.89)	$(2.12)	$(3.05)
Diluted EPS	$(101.05)	$(0.67)	$(5.80)
Cash & Equivalents ($M)	$4.09 (period end)	$4.75 (period end)	$3.28 (period end)

Notes: GRI is pre-revenue; margins and segment reporting are not applicable (single biotechnology research segment) .

KPIs and trial/operational metrics:

KPI	Q1 2024	Q3 2024	Q1 2025
GRI‑0621 Phase 2a enrollment	–	Ongoing; global site initiation/authorizations	6‑week interim cohort fully enrolled (n=24); >2/3 overall enrollment
Interim safety (2‑week)	–	–	No meaningful LDL/HDL/TG changes; continue study
Biomarker signal (2‑week)	–	–	PRO‑C3 change suggestive of anti‑fibrotic effect (IDMC review)
Cash runway (mgmt.)	–	Into mid‑Q1’25	Through Q3’25

Metric/Item	Period	Previous Guidance	Current Guidance	Change
GRI‑0621 Phase 2a interim readout	Timing	Q4 2024 (Q2’24 update)	Q2 2025	Lowered/Delayed
GRI‑0621 Phase 2a topline	Timing	Q1 2025 (Q2’24 update)	Q3 2025	Lowered/Delayed
Cash runway	Horizon	Into mid‑Q1 2025 (Q3’24 PR) ; Into Q2 2025 (FY’24 PR)	Through Q3 2025	Raised/Extended
Listing status	Nasdaq bid price	Non‑compliant as of Sept 2024	Regained compliance Mar 10, 2025	Improved
Capital structure	Reverse split	–	1‑for‑17 effective Feb 21, 2025	Implemented
Financing	Equity	$4.0M gross (Jun ’24)	$5.0M gross (Apr 2, 2025) ; ATM usage continued	Raised/Extended

(No Q1 2025 earnings call transcript was filed; themes compiled from press releases and the 10‑Q.)

Topic	Q2 2024 Mentions	Q3 2024 Mentions	Current (Q1 2025)	Trend
Clinical timelines (GRI‑0621 IPF)	Interim Q4’24; topline Q1’25	Interim Q1’25; topline Q2’25	6‑wk interim Q2’25; topline Q3’25	Slipping timelines
Safety/biomarkers	Preclinical supportive	–	2‑wk safety clean; PRO‑C3 signal	Positive signals emerging
Financing/liquidity	Cash into Q1’25	Into mid‑Q1’25	Through Q3’25 after $5M raise	Improved runway
Nasdaq/listing	–	Re‑triggered bid price deficiency (Sept)	Compliance regained Mar 10	Overhang reduced
IP and external validation	Multiple patent grants, KOL activity	IP expansion in Japan; KOL events	Patents in Europe/Japan; ATS abstract selection	Continued momentum

“We continue to make very encouraging progress with our ongoing Phase 2a trial of our lead program, GRI‑0621 … we believe we are well‑positioned to build near‑ and long‑term value for shareholders.” – Marc Hertz, PhD, CEO .
Interim committee and IDMC recommended the study continue as planned with “no safety concerns” to date; PRO‑C3 changes are “suggestive of anti‑fibrotic effect” .

No Q1 2025 earnings call transcript was available; no Q&A published in company filings or transcripts database [Search: none found].

Interpretation: Q1 2025 EPS missed consensus (actual $(5.80) vs $(3.79)*) as OpEx increased with clinical progress; revenues were in line at $0 .

Two clear catalysts within the next 1–2 quarters: 6‑week interim biomarker analysis in Q2 2025 and topline Phase 2a results in Q3 2025; trading likely to key off biomarker strength (e.g., PRO‑C3 trajectory) and any pulmonary function trends .
Positive early safety and biomarker signals de‑risk the mechanism, but the study’s accelerated timelines have slipped more than once; build scenario analyses around scheduling risk .
Runway now through Q3 2025 reduces immediate financing risk, though additional capital will be needed beyond topline; monitor warrant exercises/ATM usage and potential dilution pathways .
Structural overhangs lighter post reverse split and Nasdaq compliance; this may broaden the investor base and reduce delisting risk into data readouts .
Operating expenses will remain elevated into topline; model near-term losses and cash burn consistent with an active Phase 2a program (R&D $1.6M; G&A $1.4M this quarter) .
A strong anti‑fibrotic biomarker package and an acceptable safety profile could position GRI‑0621 for expedited discussions and partnering interest in IPF, a market with prior licensing/BD precedents; upside optionality hinges on data quality .

Citations: