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Dec 31, 2021
Praxis Q4 2021 Earnings Report
Praxis Precision Medicines reported financial results for the fourth quarter and full year 2021 and provided a corporate update.
Key Takeaways
Praxis Precision Medicines reported a net loss of $58.6 million for the fourth quarter of 2021. As of December 31, 2021, Praxis had $275.9 million in cash, cash equivalents and marketable securities.
PRAX-114 Phase 2/3 monotherapy MDD Aria Study topline results expected in June 2022
PRAX-944 Phase 2a ET topline results expected in May 2022; to include open-label and placebo-controlled withdrawal data
PRAX-222 seamless study in SCN2A-DEE expected to initiate in 2Q22
Cash and investments of $275.9 million as of December 31, 2021 supports runway into 2Q23
Praxis
Praxis
Forward Guidance
Praxis expects topline results from multiple studies across its pipeline in 2022 and intends to initiate a Phase 3 trial in MDD later this year. The company's cash, cash equivalents and marketable securities as of December 31, 2021 are expected to fund operations into the second quarter of 2023.
Positive Outlook
- Topline results from the PRAX-114 Phase 2/3 Aria Study for MDD expected in June 2022.
- Topline results from the PRAX-114 Phase 2 Acapella Study for MDD expected in mid-2022.
- Topline results from the PRAX-114 Phase 2 study for PTSD expected in the second half of 2022.
- Topline open-label and placebo-controlled results from the PRAX-944 Phase 2a trial for ET expected in May 2022.
- Topline results from the PRAX-944 Phase 2b Essential1 Study for ET expected in the second half of 2022.
Challenges Ahead
- Uncertainties inherent in clinical trials.
- The expected timing of submissions for regulatory approval or review by governmental authorities.
- Regulatory approvals to conduct trials.
- Risks, uncertainties and assumptions regarding the impact of the continuing COVID-19 pandemic on Praxis’ business, operations, strategy, goals and anticipated timelines.
- Praxis’ ability to initiate, enroll, conduct or complete ongoing and planned clinical trials and Praxis’ timelines for regulatory submissions.