Praxis Precision Medicines (PRAX) Q2 2024 earnings summary

Executive summary

• Four clinical programs are advancing toward registrational phases by 2025, with multiple late-stage readouts and regulatory filings expected in the next few years.

• Lead program ulixacaltamide is in two phase III Essential3 trials for essential tremor, with top-line results expected in 2H 2024 and NDA filing planned for 2025.

• PRAX-628, a next-generation epilepsy treatment, is in late-stage development with the ENERGY program, including RADIANT and POWER studies, with topline results for the first efficacy study expected in H1 2025.

• Relutrigine (PRAX-562) is in phase II EMBOLD studies for pediatric DEEs (SCN2A, SCN8A), with topline results expected in Q3 2024.

• Elanersen (PRAX-222) global registration study initiated in Brazil, with expansion to Europe and the US planned.

Financial highlights

• Q2 2024 operating expenses were $37.8 million: $27.3 million for R&D and $10.6 million for G&A.

• Net loss for Q2 2024 was $32.7 million, compared to $34.3 million in Q2 2023; net loss for six months was $72.2 million.

• Cash, cash equivalents, and marketable securities totaled $433.8 million at June 30, 2024, up from $81 million in December 2023, mainly due to public offerings.

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

• Cash runway extends into 2027, funding all ongoing studies to their readouts.

Outlook and guidance

• Essential3 phase III top-line results expected in late 2024, with NDA filing planned for 2025.

• PRAX-628 RADIANT study top-line results expected in H1 2025; POWER-1 and POWER-2 phase III studies to follow.

• Relutrigine EMBOLD phase II results expected in Q3 2024.

• Elanersen global registration study to expand to Europe and US later in 2024.