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Dec 31, 2023
Praxis Q4 2023 Earnings Report
Praxis Precision Medicines reported financial results and provided a corporate update for Q4 2023.
Key Takeaways
Praxis Precision Medicines reported a net loss of $26.9 million for the fourth quarter of 2023. The company's cash and cash equivalents as of December 31, 2023, combined with proceeds from January 2024 offerings, are expected to fund operations into 2026.
Over 3,000 referrals received to date meet pre-qualifying eligibility criteria for ulixacaltamide Phase 3 studies in the Essential3 program for essential tremor (ET).
Enrollment on track to be completed in 1H 2024 with topline results in 2H 2024.
Topline results from the PRAX-628 study in epilepsy patients with photo-paroxysmal response (PPR) expected in 1Q 2024; preliminary analysis of 15 mg cohort exceeded expectations.
Completed underwritten public offering with over $160 million in net proceeds to extend cash runway into 2026.
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CapyFin.com Forward Guidance
Praxis plans to report topline results from the PRAX-628 study in the first quarter, complete enrollment in Essential3 in the first half of this year and expect topline results from the Phase 2 EMBOLD study of PRAX-562 for the treatment of pediatric patients with DEEs mid-year.
Positive Outlook
- Strong participation in Essential3 Phase 3 studies in ulixacaltamide for essential tremor continues to highlight the significant unmet need for new therapies in essential tremor.
- Encouraged by the latest data supporting our highly differentiated epilepsy portfolio, including elsunersen and PRAX-628.
- PRAX-628 was generally well-tolerated at all tested doses.
- Pharmacokinetic data demonstrated dose-dependent exposure supporting once-daily dosing without titration to achieve potentially therapeutically effective drug concentration levels.
- Further analysis of patients in the Phase 1 study using qEEG data showed a pharmacodynamic effect at all dose levels and was significantly different from placebo.