Praxis Precision Medicines (PRAX) Q2 2024 earnings summary

Executive summary

• Four clinical programs are advancing toward registrational phases, with potential NDA filings expected in the next few years and up to four programs reaching registrational phase by 2025.

• Ulixacaltamide's pivotal Essential3 trials in essential tremor are progressing, with top-line results anticipated in 2H 2024 and an interim analysis planned for Q4 2024.

• PRAX-628's late-stage epilepsy program (Energy) includes multiple studies, with RADIANT results expected in H1 2025 and additional studies to begin in H2 2024.

• Relutrigine (PRAX-562) phase II EMBOLD study in pediatric DEEs will report top-line results in Q3 2024.

• Elanersen (PRAX-222) global registration study initiated in Brazil, with expansion to Europe and the US planned, and received Orphan Drug and Rare Pediatric Disease designations.

Financial highlights

• Q2 operating expenses were $37.8M: $27.3M for R&D and $10.6M for G&A; net loss for Q2 2024 was $32.7M, compared to $34.3M in Q2 2023.

• Cash, cash equivalents, and marketable securities totaled $433.8M at June 30, 2024, up from $81M in December, mainly due to public offerings.

• Collaboration revenue was $0.4M for Q2 2024, down from $0.8M in Q2 2023.

• R&D expenses accounted for 72% of total operating expenses in Q2.

• Other income rose to $4.8M in Q2 2024, mainly from interest income.

Outlook and guidance

• Cash and marketable securities expected to fund operations and capital expenditures into 2027, supporting all ongoing studies through their readouts.

• Essential3 top-line results expected after a planned interim analysis in Q4 2024, with NDA submission targeted for 2025.

• RADIANT study for PRAX-628 to provide key safety and efficacy data in H1 2025; POWER-1 and POWER-2 phase III studies to follow.

• EMBOLD study for relutrigine to report efficacy and safety data in Q3 2024.