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ATYR

aTyr Pharma, Inc.

aTyr Pharma, Inc. Q4 FY2023 earnings call

March 14, 2024 · fiscal period ended 2023-12

EPS · actual vs est

$-0.25 / $-0.24Miss -4.2%

Revenue · actual vs est

/ $3.4M
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Summary

Generated 2024-03-14

Management highlights

• Sanjay Shukla discussed lead candidate Efzofitimod, including Phase 3 EFZO-FIT study in pulmonary sarcoidosis (enrolling at over 90 centers in 9 countries) and Phase 2 EFZO-CONNECT study in SSc-ILD. • Enhanced mechanistic understanding of Efzofitimod's anti-inflammatory effects. • Implemented individual patient expanded access program (EAP) for patients completing EFZO-FIT based on existing safety data. • Jill Broadfoot reviewed financials: ended 2023 with $101.7M in cash, etc.; collaboration/license revenue $0.4M; R&D expenses $42.3M; G&A expenses $13M; cash runway sufficient to fund until BLA filing for Efzofitimod in pulmonary sarcoidosis.

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Segment performance

No detailed financial performance by product segments provided; focus is on clinical program for Efzofitimod and preclinical candidates.

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Guidance

• Maintained prior financial guidance, with cash runway expected to fund through BLA filing for Efzofitimod in pulmonary sarcoidosis. • Forecast does not include potential milestone payments from Kyorin or other partnerships.

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Risks

• Forward-looking statements involve risks and uncertainties as outlined in SEC filings, including those in the company's 10-K, 10-Q, and other SEC filings.

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Q&A highlights

Q: Gregory Renza asked about the significance of the expanded access program for Efzofitimod, especially with blinded patients undergoing steroid taper, and details on demand from centers.

A: Sanjay Shukla mentioned hearing from dozens of PIs about patient performance, patients not wanting to go back on steroids, and the need to implement EAP early.

Q: Joe Pantginis asked about details of the EAP, logistics, and cost implications.

A: Sanjay Shukla discussed physicians' quandary over patients not wanting to go back on steroids, logistics as classical compassionate use, and potential small grants for patients.

Q: Yasmeen Rahimi asked if EFZO-FIT still needs additional sites and patient numbers continuing to EAP.

A: Sanjay Shukla said 264 is the goal, well-powered, and they're prepared for a substantial number of patients in EAP.

Q: Yale Jen asked about EFZO-FIT enrollment, preclinical programs, and Japan enrollment.

A: Sanjay Shukla said 264 is the goal, preclinical programs have novel potential, and Japan enrollment is on track.

Q: Robert LeBoyer asked about EAP data use in BLA or medical meetings.

A: Sanjay Shukla said EAP is outside protocol, academics may be interested in long-term data, and it could aid Phase 4.

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Key numbers

Reported versus consensus

Earnings calendar feed

MetricReportedConsensusDeltaPrior year
EPS$-0.25$-0.24-4.2%
Revenue$3.4M

Transcript

March 14, 2024

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Prior quarters

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