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Sep 30, 2021
Praxis Q3 2021 Earnings Report
Praxis Precision Medicines reported financial results for the third quarter ended September 30, 2021.
Key Takeaways
Praxis Precision Medicines reported a net loss of $44.7 million for the third quarter ended September 30, 2021. The company's cash, cash equivalents, and marketable securities are expected to fund operations into the second quarter of 2023.
Enrollment is on track for topline results for PRAX-114 Phase 2/3 monotherapy MDD Aria Study and for PRAX-114 Phase 2 dose-ranging MDD Acapella Study in the first half of 2022.
PRAX-114 Phase 2 studies in post-traumatic stress disorder and essential tremor (ET), PRAX-562 Phase 2 study in rare adult cephalgias are expected to initiate in 4Q21.
Preliminary results for PRAX-944 Phase 2a study for treatment of ET are expected in 4Q21.
First patient enrolled in PRAX-944 Phase 2b Essential1 Study for treatment of ET; topline results are expected in 2H22.
Praxis
Praxis
Forward Guidance
Praxis Precision Medicines anticipates several milestones and data readouts across its clinical programs.
Positive Outlook
- Topline results from the PRAX-114 Phase 2/3 Aria Study for monotherapy treatment of MDD expected in the first half of 2022.
- Topline results from the PRAX-114 Phase 2 Acapella Study expected in the first half of 2022.
- Plans for the Phase 2b trial of PRAX-114 for treatment of women with menopausal and mood symptoms will be disclosed in the fourth quarter of 2021.
- Topline results from the PRAX-114 Phase 2 PTSD study expected in the second half of 2022.
- Preliminary open-label safety, tolerability and efficacy data from PRAX-944 Phase 2a trial for treatment of essential tremor is expected in the fourth quarter of 2021.
Challenges Ahead
- Uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials.
- Whether interim results from a clinical trial will be predictive of the final results of the trial.
- Whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials.
- The expected timing of submissions for regulatory approval or review by governmental authorities.
- Risks, uncertainties and assumptions regarding the impact of the continuing COVID-19 pandemic on Praxis’ business.