Executive Summary

Q1 2024 revenue was $1.74M and GAAP EPS was $(0.34); per Seeking Alpha, both missed consensus (revenue miss by ~$1.11M; EPS miss by ~$0.03). Management highlighted an improving PFS trend in GRANITE’s Phase 2 MSS-CRC trial, with mature PFS data expected in Q3 2024 .
Preliminary randomized MSS-CRC data showed a favorable PFS trend (HR 0.82 overall; 0.52 in high-risk subgroup), and ctDNA dynamics favored GRANITE vs. control; company aims to engage regulators later in 2024 on potential Phase 3 design .
Infectious disease: BARDA-backed CORAL Phase 2b start was delayed to incorporate GMP-grade materials; company will launch “as soon as able,” shifting from prior Fall 2024 expectation .
Liquidity: Cash, equivalents, marketable securities and restricted cash were $52.8M at 3/31/24, plus $32.5M gross equity financing in April; earlier 8-K indicated cash runway into Q3 2024, with incremental capital sources under evaluation .

What Went Well and What Went Wrong

What Went Well
- Early but favorable PFS and ctDNA trends in GRANITE Phase 2 MSS-CRC; high-risk subgroup showed HR 0.52, with ctDNA conversion to low VAF more frequent vs. control (56% vs. 22%) .
- Platform recognition: Nature Medicine publication on SLATE and AI/LLM-enabled advances to EDGE, with >80% Class I presentation prediction accuracy claimed; EDGE-II improving Class II performance .
- April equity raise added $32.5M gross proceeds, extending liquidity beyond Q1 period-end .
What Went Wrong
- Infectious disease CORAL Phase 2b start delayed to use fully GMP-grade materials, pushing timing from Fall 2024 guidance to “as soon as able” and removing calendar specificity .
- Operating loss widened Y/Y: total operating expenses rose to $41.5M from $37.3M, driven by R&D ($33.0M) and G&A ($8.5M), including one-time severance .
- Consensus misses on revenue and EPS per Seeking Alpha (Rev $1.74M vs. higher expectation; EPS $(0.34) vs. $(0.31)), reflecting lower grant/collaboration revenue timing and ongoing cost base .

Financial Results

Revenue, EPS, and Net Loss vs prior periods and estimates

Metric	Q2 2023	Q3 2023	Q1 2024	vs. Estimates (Q1 2024)
Revenue ($M)	$1.96	$1.57	$1.74	$1.74 vs ~$2.85 (miss by ~$1.11)
GAAP Net Loss ($M)	$(35.26)	$(38.43)	$(40.39)	—
GAAP Diluted EPS	$(0.31)	$(0.33)	$(0.34)	$(0.34) vs $(0.31) (miss by ~$0.03)
Total Operating Expenses ($M)	$37.68	$40.17	$41.54	—

Revenue composition

Revenue Component ($M)	Q2 2023	Q3 2023	Q1 2024
Collaboration & License	$0.40	$0.36	$0.05
Grants (CEPI/BARDA/Gates, etc.)	$1.56	$1.20	$1.69
Total	$1.96	$1.57	$1.74

Operating expense detail and cash

KPI	Q2 2023	Q3 2023	Q1 2024
R&D Expense ($M)	$30.97	$32.76	$33.04
G&A Expense ($M)	$6.72	$7.41	$8.50
Cash, Equivalents, Mkt Secs & Restricted ($M)	$122.3 (6/30/23)	$90.5 (9/30/23)	$52.8 (3/31/24)
Post-Q1 Financing	—	—	$32.5 gross (Apr-24)

Notes: Q4 2023 was reported on a full-year basis (no standalone quarterly P&L provided) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
GRANITE Phase 2 readout timing (MSS-CRC)	2024	Preliminary data expected 1Q 2024	Mature PFS and additional ctDNA data expected in Q3 2024	Timing shifted later (prelim → mature in Q3)
CORAL Phase 2b start (BARDA)	2024	Initiation expected 1Q 2024; later updated to Fall 2024	Launch “as soon as able” after incorporating GMP-grade materials	Delayed/less specific timing
Cash runway	2024	Into Q3 2024 (as of Feb-12 8-K)	Not updated on 5/9; April $32.5M gross raise completed	Liquidity improved post-raise, explicit runway not restated

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3 2023, Q4 2023)	Current Period (Q1 2024)	Trend
GRANITE efficacy signal in MSS-CRC	Preliminary Phase 2 data expected; focus on cold tumors	Favorable PFS trend (HR 0.82 overall; 0.52 high-risk); mature readout in Q3 2024, potential Phase 3 engagement	Strengthening narrative with early efficacy signal
ctDNA as efficacy surrogate	ctDNA primary endpoint in Phase 2; Friends’ ctMoniTR collaboration	ctDNA shifts favor GRANITE (e.g., 56% high-risk conversion to low VAF vs 22% control)	Reinforced translational signal
EDGE AI/LLM platform	EDGE Class II poster; broad platform positioning	>80% accuracy Class I prediction; EDGE-II improving Class II; LLM-driven advances	Elevated AI-tech leadership
CORAL BARDA timing	Awarded; study prep; init expected 1Q’24	Delay for GMP-grade materials; launch “as soon as able”	Timing risk increased
NCI SLATE-KRAS + TCR-T	IND cleared; study to begin; collaboration ongoing	Study ongoing under NCI; KRAS focus emphasized	Steady execution

Management Commentary

“The preliminary Phase 2 data we recently shared are very promising as they suggest that GRANITE is potentially driving benefit in metastatic CRC patients… The emerging trend in progression-free survival… is particularly encouraging as it puts us in a strong position to potentially engage regulators later this year regarding a Phase 3 study” — Andrew Allen, President & CEO .
“EDGE now predicts HLA Class I presentation… with >80% accuracy… We are also advancing EDGE-II… leveraging advances in protein large language models and in-house immunopeptidomics” .
“We plan to incorporate GMP-grade materials in the manufacture of our samRNA candidate, resulting in a delay of the CORAL Phase 2b study… Gritstone is currently preparing to launch the study and will do so as soon as the company is able” .

Q&A Highlights

Data maturity and interpretation: Management emphasized that median PFS in front-line MSS-CRC is ~11 months and the Phase 2 dataset cut in early March was immature (>60% censored), yet hazard ratio trends below 1.0 suggest benefit that may improve with maturity .
Financials/liquidity: CFO discussed Q1 net loss of ~$40.4M and capital structure; management noted ongoing collaborations and potential strategic funding approaches to support ID programs .
CORAL/BARDA timeline: Clarified the rationale for shifting to GMP-grade materials and that start would occur as soon as operationally feasible .

Estimates Context

S&P Global consensus data were unavailable via our API for GRTS this quarter (mapping issue). As a proxy, Seeking Alpha indicates Q1 2024 EPS of $(0.34) missed by ~$0.03 and revenue of $1.74M missed by ~$1.11M .
Given the immaturity of oncology data (PFS/ctDNA maturing in Q3) and a delayed CORAL Phase 2b start, we expect Street models to shift revenue timing later in 2024/2025 and to increase focus on oncology value inflection in 2H 2024 .

Key Takeaways for Investors

The GRANITE Phase 2 MSS-CRC signal is the core near-term catalyst; mature PFS and ctDNA in Q3 2024 could drive regulatory engagement and repricing if hazard ratios strengthen and durability persists .
Delayed CORAL Phase 2b start adds execution risk to ID timelines; oncology is likely to dominate near-term narrative and valuation until BARDA study initiates .
Operating spend remains elevated with R&D at ~$33M and G&A at ~$8.5M in Q1; April financing helps, but additional capital or partnerships would de-risk runway beyond 2024 .
AI-enabled EDGE and SLATE-KRAS/NCI collaboration reinforce platform depth and optionality beyond GRANITE, supporting a multi-asset oncology thesis if lead data remain positive .
Trading setup: Expect stock to be sensitive to any interim GRANITE updates, Q3 readout timing clarity, and concrete CORAL initiation milestones; near-term sentiment skews to oncology efficacy risk/reward .

Appendix: Additional Detail

Selected clinical datapoints (Q1 2024 press release)

PFS hazard ratios: overall HR 0.82 (95% CI 0.34–1.67; 62% censored); high-risk subgroup HR 0.52 (95% CI 0.15–1.38; 44% censored) .
ctDNA shifts: high-risk conversion to low VAF in 56% (9/16) GRANITE vs 22% (2/9) control; PD observed 44% vs 78% respectively .

Liquidity and expenses (Q1 2024)

Cash, equivalents, marketable securities, restricted cash: $52.8M at 3/31/24; April offering added $32.5M gross .
R&D $33.0M (+$2.5M Y/Y; includes one-time severance); G&A $8.5M (+$1.8M Y/Y; includes one-time severance) .

References

Q1 2024 8-K/Press Release and financials
Q4 2023 full-year 8-K (context, guidance history, workforce reduction)
Q3 2023 8-K (BARDA contract, CORAL timing, quarterly financials)
Q2 2023 8-K (GRANITE enrollment completion, EDGE advances, quarterly financials)
Feb 12, 2024 8-K (runway into Q3 2024; CORAL timing update, FDA/GMP)
Earnings call transcript excerpts (estimates context, tone)

Gritstone bio, Inc. (GRTS)·Q1 2024 Earnings Summary