Passage Bio, Inc.
Passage Bio, Inc. Q1 FY2022 earnings call
May 16, 2022 · fiscal period ended 2022-03
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2022-05-16
Management highlights
- Progress across clinical programs: Positive interim safety and efficacy data from Imagine-1 trial for GM1, dosing in GALax-C trial for Krabbe disease, opening sites for upliFT-D trial for FTD. Submitted IND for PBML04 in MLD. - Strategic prioritization: Focus on ongoing clinical programs, preclinical pipeline focus, rights returned for some programs, retained CNS portfolio balance. - Operational changes: 13% workforce reduction, slowed investment in pilot manufacturing suite, extended cash runway into Q2 2024.
Segment performance
No detailed segment performance by product with revenue contribution provided in the transcript. R&D expenses were $26.2 million for Q1 2022 compared to $25 million in Q1 2021, primarily due to increases in clinical manufacturing, development, and facility expenses offset by decreases in some R&D and personnel-related expenses. G&A expenses were $15.1 million in Q1 2022 compared to $12.5 million in Q1 2021, driven by personnel and severance expenses.
Guidance
- Expect to report initial data from Cohorts 2 and 3 in Imagine-1 trial in the second half of 2022. - Expect initial safety and biomarker data from GALax-C trial by the end of 2022. - Expect to dose the first patient in upliFT-D trial by mid-2022.
Risks
- Forward-looking statements subject to risks and uncertainties such as COVID-19 impact, ability to fund R&D, collaborator execution, etc. - Krabbe disease trial had a Grade-4 adverse event of acute hydrocephalus, with uncertainty around whether it was drug, procedure, or disease-related, and implementing additional screening and monitoring to address this.
Q&A highlights
Q: On the Krabbe hydrocephalus event, how to think about distinction between drug vs procedure-related and relation to other ICM injection programs?
A: Bruce Goldsmith discussed imaging showing changes in ventricles prior, possible disease-related but hard to tease out, implementing additional monitoring.
Q: Key outcomes to look for in GM1 presentation at ASGCT?
A: Bruce Goldsmith mentioned updated data including safety, biomarkers, and clinical outcomes.
Q: Changes to inclusion criteria for PBFT02 to accelerate enrollment?
A: Bruce Goldsmith said inclusion criteria was changed late last year to broaden entry, hoping to impact enrollment.
Q: Number of patients screened with genetic test for FTD and prevalence of FTD-GRN?
A: Bruce Goldsmith said they're continuing to move forward, prevalence estimate is based on papers but exact number unknown.
Q: Data readout timeline for GM1 Cohort 3?
A: Bruce Goldsmith said they'll report safety and biomarker data this year, with longer follow-up data to be released incrementally.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.79 | $-0.88 | +10.2% | — |
| Revenue | — | — | — | — |
Transcript
May 16, 2022Full transcript unavailable for redistribution
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