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Sep 30, 2023
Praxis Q3 2023 Earnings Report
Praxis Precision Medicines reported financial results for the third quarter 2023.
Key Takeaways
Praxis Precision Medicines reported a net loss of $24.6 million for the third quarter of 2023, with cash and cash equivalents totaling $101.1 million as of September 30, 2023, expected to support operations into Q1 2025. The company progressed its clinical programs, including the initiation of the Essential3 Phase 3 program for ulixacaltamide and the completion of dosing for Part 1 of the EMBRAVE study for elsunersen.
Initiated Essential3 study for ulixacaltamide in essential tremor, with over 600 patients engaged in a pre-recruitment observational study.
Completed final dose for Elsunersen EMBRAVE study and is seeking FDA advice on advancing development.
PRAX-628 data in photo-paroxysmal response (PPR) is expected to be shared in the near future.
Cash and cash equivalents totaled $101.1 million as of September 30, 2023, supporting operations into Q1 2025.
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CapyFin.com Forward Guidance
Praxis Precision Medicines is focused on advancing its clinical programs and expects topline results from multiple studies in the near term.
Positive Outlook
- Initiated Essential3, the Phase 3 program for ulixacaltamide.
- Praxis shared additional analyses from the Essential1 data set.
- Expecting topline results from the PRAX-628 Phase 2a proof-of-concept study evaluating epilepsy patients with PPR in the fourth quarter of 2023.
- Initiate a Phase 2 study to evaluate PRAX-628 for the treatment of focal epilepsy in the first half of 2024.
- Expecting topline results from the PRAX-562 Phase 2 EMBOLD study for the treatment of pediatric patients with developmental and epileptic encephalopathies (DEEs) in the first half of 2024.
Challenges Ahead
- Uncertainties inherent in clinical trials.
- Reported interim data from ongoing studies and trials differing materially from final data from preclinical studies and completed clinical trials.
- The expected timing of clinical trials, data readouts and the results thereof, and submissions for regulatory approval or review by governmental authorities.
- Regulatory approvals to conduct trials.
- Praxis’ anticipated cash runway.