Executive Summary

Q1 2024 was a steady execution quarter: revenue of $0.235M, net loss of $15.491M, and EPS of -$0.23 as clinical spend ramped with Phase 3 EFZO-FIT and Phase 2 EFZO-CONNECT; cash and investments ended at $87.7M .
Company maintained guidance for cash runway sufficient to fund operations through the filing of a BLA for efzofitimod in pulmonary sarcoidosis; Phase 3 EFZO-FIT enrollment expected to complete in Q2 2024, positioning near-term clinical catalysts .
Versus third-party consensus, Q1 EPS beat by $0.01 (actual -$0.23 vs -$0.24) and revenue exceeded by ~$0.13M (actual $0.235M vs $0.11M); SPGI consensus was unavailable, so treat this as indicative only .
Strategic progress included continued global enrollment (>90 centers across 9 countries) and EAP availability post-EFZO-FIT completion; scientific visibility via ATS 2024 posters supports the efzofitimod narrative .

What Went Well and What Went Wrong

What Went Well

Continued execution on pivotal EFZO-FIT and Phase 2 EFZO-CONNECT studies with expected EFZO-FIT enrollment completion in Q2 2024: “we look forward to completing enrollment in this study, which is anticipated this quarter.” — CEO Sanjay Shukla .
Cash runway reiterated through BLA filing for efzofitimod, supporting funding clarity through key regulatory milestone .
Scientific momentum: ATS 2024 poster on efzofitimod and presentation of ATYR0750 mechanistic data (FGFR4 binding), enhancing external validation of the platform .

What Went Wrong

Operating expenses increased YoY and sequentially (Total OpEx: $16.871M vs $12.787M YoY; R&D: $13.364M vs $9.379M YoY) as trials and manufacturing scaled, deepening net loss to $15.491M .
Cash and investments declined to $87.710M from $101.650M at year-end 2023, reflecting burn from heightened clinical activity .
Revenue remained de minimis and non-recurring in nature (collaboration/product material sales to Kyorin), limiting reported P&L leverage in the absence of commercial operations .

Financial Results

Quarterly P&L and Cash (oldest → newest)

Metric	Q3 2023	Q4 2023	Q1 2024
Revenue ($USD Millions)	$0.353	$0.000	$0.235
R&D Expense ($USD Millions)	$10.319	$12.755	$13.364
G&A Expense ($USD Millions)	$2.649	$3.204	$3.507
Total Operating Expenses ($USD Millions)	$12.968	$15.959	$16.871
Net Loss ($USD Millions)	$11.340	$14.760	$15.491
Diluted EPS ($USD)	-$0.20	-$0.25	-$0.23
Shares Used (basic & diluted)	57,885,393	59,261,219	66,080,593
Cash, Restricted Cash & Investments ($USD Millions)	$105.582	$101.650	$87.710

YoY Comparison (Q1 2024 vs Q1 2023)

Metric	Q1 2023	Q1 2024
Revenue ($USD Millions)	$0.000	$0.235
R&D Expense ($USD Millions)	$9.379	$13.364
G&A Expense ($USD Millions)	$3.408	$3.507
Total Operating Expenses ($USD Millions)	$12.787	$16.871
Net Loss ($USD Millions)	$11.951	$15.491
Diluted EPS ($USD)	-$0.29	-$0.23

Actual vs Estimates (SPGI unavailable)

Metric	SPGI Consensus	Third-Party Consensus	Actual	Beat/Miss
EPS ($USD)	Unavailable	-$0.24	-$0.23	Beat by $0.01
Revenue ($USD Millions)	Unavailable	$0.11	$0.235	Beat by ~$0.13
Note: S&P Global consensus was unavailable for LIFE this quarter; third-party figures shown for directional context.

KPIs (Clinical execution)

KPI	Q3 2023	Q4 2023	Q1 2024
EFZO-FIT centers enrolling	U.S., Europe, Japan; expanding to Brazil	>90 centers across 9 countries (status referenced)	>90 centers across 9 countries
EFZO-FIT intended enrollment (patients)	Up to 264	Up to 264	Up to 264
EFZO-FIT dosing regimen	3 mg/kg, 5 mg/kg, placebo; monthly x12	Same	Same
EFZO-CONNECT (SSc-ILD) status	First patient dosed	Enrolling	Enrolling (U.S.)
EAP availability post-EFZO-FIT	Announced EAP	EAP launched	Eligible to participate

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
EFZO-FIT enrollment completion timing	Q3 2023	Early Q2 2024	—	—
EFZO-FIT enrollment completion timing	Q4 2023	Anticipated Q2 2024	—	—
EFZO-FIT enrollment completion timing	Q1 2024	—	Anticipated Q2 2024	Maintained vs Q4 2023
Cash runway	Q2 2023	Extends into 2026	—	—
Cash runway	Q3 2023	Sufficient through BLA filing	—	Updated from “into 2026”
Cash runway	Q1 2024	—	Sufficient through BLA filing	Maintained vs Q3/Q4 2023
Revenue/OpEx/Tax guidance	Q1 2024	Not provided	Not provided	—

Earnings Call Themes & Trends

Note: No Q1 2024 earnings call transcript was found in the document catalog; trends compiled from press releases.

Topic	Previous Mentions (Q3 2023, Q4 2023)	Current Period (Q1 2024)	Trend
R&D execution (EFZO-FIT)	Positive DSMB review; enrollment in US/EU/JP; Brazil expansion potential	Enrollment on track; completion anticipated Q2 2024	Stable/on track
R&D execution (EFZO-CONNECT)	First patient dosed; initiating/ongoing enrollment	Enrolling at multiple U.S. centers	Progressing
EAP program	EAP announced/launched for EFZO-FIT completers	Patients eligible post-study to participate	Implemented
Scientific visibility	ERS/ACR posters; exposure-response publication	ATS 2024 efzofitimod poster; ATYR0750 FGFR4 mechanistic poster	Increasing
Cash runway	Updated to “through BLA filing”	Maintained “through BLA filing”	Maintained
Collaboration revenue	$0.353M in Q3 via Kyorin material	Minimal/none in Q4; $0.235M in Q1 via Kyorin material	Variable, non-recurring

Management Commentary

“During the first quarter of 2024 we continued to execute on our two clinical studies for our lead therapeutic candidate, efzofitimod, in interstitial lung disease (ILD).” — Sanjay S. Shukla, M.D., M.S., President & CEO .
“We… look forward to completing enrollment in this study, which is anticipated this quarter.” — on EFZO-FIT (pulmonary sarcoidosis) .
Financial posture: “Cash, cash equivalents, restricted cash and investments as of March 31, 2024, were $87.7 million… we believe its cash runway will be sufficient to fund the Company’s operations through the filing of a BLA for efzofitimod in pulmonary sarcoidosis.” .

Q&A Highlights

A Q1 2024 earnings call transcript was not available in the document catalog; no Q&A highlights to report based on primary sources.

Estimates Context

S&P Global consensus was unavailable for LIFE for Q1 2024; we anchor to SPGI by default and note its unavailability for this quarter.
Third-party consensus indicated: EPS -$0.24 vs actual -$0.23 (Beat by $0.01) and revenue $0.11M vs actual $0.235M (Beat by ~$0.13M). Treat as indicative only and not a substitute for SPGI .

Key Takeaways for Investors

Near-term catalyst: EFZO-FIT enrollment completion expected in Q2 2024, setting up the path toward pivotal readouts and subsequent BLA activities; maintain focus on timelines and any DSMB or operational updates .
Funding clarity: Cash runway sufficient through BLA filing in pulmonary sarcoidosis mitigates financing overhang through regulatory filing stage, though burn remains elevated due to trial execution .
Clinical breadth: Parallel progress in EFZO-CONNECT (SSc-ILD) plus EAP availability for EFZO-FIT completers supports continuity of patient access and potential data accumulation post-trial .
Scientific validation: ATS 2024 and mechanism posters (efzofitimod, ATYR0750) add external touchpoints to the efzofitimod thesis and platform signaling capabilities (NRP2 and FGFR4) .
P&L profile: Expect continued non-recurring collaboration revenues and operating losses until clinical/regulatory inflection; monitor R&D cadence and manufacturing scaling as EFZO-FIT approaches completion .
Trading lens: Stock sensitivity likely tied to EFZO-FIT operational milestones (enrollment completion, timeline confirmations) and any additional regulatory or safety updates.
Medium-term thesis: Successful EFZO-FIT outcomes in pulmonary sarcoidosis would unlock BLA filing and first commercial pathway in ILD; watch for label-enabling data and potential partner economics (e.g., Kyorin-related activities) .

Sources: Q1 2024 8-K and press release including financial statements and corporate update ; Q4 2023 8-K and press release ; Q3 2023 8-K and press release ; Q2 2023 8-K and press release ; Company news release page corroborating Q1 2024 highlights .

aTYR PHARMA INC (LIFE)·Q1 2024 Earnings Summary