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Mar 31, 2020
Scholar Rock Q1 2020 Earnings Report
Scholar Rock reported financial results and highlighted business progress.
Key Takeaways
Scholar Rock reported a net loss of $17.1 million, or $0.58 per share, for the quarter ended March 31, 2020. Revenue was $5.0 million, related to the Gilead collaboration. As of March 31, 2020, Scholar Rock had $160.6 million in cash, cash equivalents, and marketable securities.
Progressing TOPAZ Phase 2 clinical trial of SRK-015 in patients with Spinal Muscular Atrophy; interim efficacy and safety results delayed by approximately one quarter to 4Q20 due to impact of COVID-19 pandemic on clinical trial sites
Commenced dosing of patients with solid tumors that exhibit primary resistance to anti-PD(L)1 therapy in the DRAGON Phase 1 clinical trial of SRK-181; update on dose escalation expected in 4Q20
Enrollment of the TOPAZ proof-of-concept trial was completed in January 2020 with 58 patients with Type 2 or Type 3 SMA enrolled across the three cohorts.
The DRAGON Phase 1 dose escalation and dose expansion trial evaluating SRK-181 in patients with locally advanced or metastatic solid tumors was initiated in the first quarter of 2020.
Forward Guidance
Scholar Rock anticipates interim efficacy and safety data from the TOPAZ Phase 2 trial in the fourth quarter of 2020 and expects an update on dose escalation from the DRAGON Phase 1 trial in the fourth quarter of 2020.
Challenges Ahead
- COVID-19-related restrictions have impacted patient access to clinical trial sites, leading to missed or delayed doses or assessments in some patients.
- Scholar Rock's ability to monitor trial data collected by sites has been affected by COVID-19 restrictions.
- Top-line data for the 12-month treatment period are now expected in the first half of 2021 as compared to the previous guidance of the fourth quarter of 2020 and first quarter of 2021.
- The pace of enrollment in the DRAGON Phase 1 trial may be impacted by the COVID-19 pandemic.
- Timing of data read-outs may be further impacted by the COVID-19 pandemic.
Historical Earnings Impact
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