Scholar Rock Q1 2020 Earnings Report
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.
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Scholar Rock Revenue by Segment
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.