Praxis Q2 2021 Earnings Report
Key Takeaways
Praxis Precision Medicines reported a net loss of $36.4 million for the second quarter of 2021. As of June 30, 2021, the company's cash and investments totaled $339.2 million, expected to fund operations into the second quarter of 2023. The company is advancing its clinical programs with multiple trials across CNS disorders.
Initiated PRAX-114 Phase 2 Acapella Study for adjunctive treatment of Major Depressive Disorder (MDD).
Enrollment on track for 1H22 topline results in PRAX-114 Phase 2/3 Aria Study for monotherapy treatment of MDD.
PRAX-944 Phase 2b study for treatment of essential tremor to initiate in 3Q21; Phase 2a topline results expected by the end of 2021.
PRAX-562 Phase 1 healthy volunteer study completed with dose up to 150 mg and favorable safety profile.
Praxis
Praxis
Forward Guidance
Praxis Precision Medicines is focused on advancing its clinical programs and expects key milestones in the coming quarters. They have multiple trials across CNS disorders.
Positive Outlook
- Topline results from the Acapella Study are expected in the first half of 2022.
- Topline results from the ongoing PRAX-114 Phase 2/3 Aria Study expected in the first half of 2022.
- Praxis plans to initiate a PRAX-114 Phase 2 placebo-controlled study for treatment of post-traumatic stress disorder (PTSD) in the second half of 2021.
- The Company expects to initiate a PRAX-944 Phase 2b study for treatment of essential tremor (ET) in the US in the third quarter of 2021.
- Praxis plans to initiate a Phase 2 trial of PRAX-562 for treatment of developmental epileptic encephalopathies (DEEs), including SCN8A-DEE and SCN2A-DEE, in the first half of 2022.
Challenges Ahead
- Delays in recruitment in Australia for the PRAX-944 Phase 2a trial.
- Uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials.
- Risk that interim results from a clinical trial will not be predictive of the final results of the trial.
- Risk that preclinical studies or earlier clinical studies will not be predictive of the results of future trials.
- Risk that Praxis’ cash resources will not be sufficient to fund Praxis’ foreseeable and unforeseeable operating expenses and capital expenditure requirements.