Praxis Precision Medicines, Inc. (NASDAQ: PRAX) Q2 2025 Earnings | 08/04/2025
AI Summary
Summary of Praxis Precision Medicines Q2 2025 Earnings Call
Key Highlights:
Pipeline Progress: Praxis is advancing four programs toward registration, targeting multi-billion-dollar opportunities in CNS disorders.
Essential Tremor (ET) Program (Ulixacaltamide):
Phase 3 Essential 3 trials (Study 1 & 2) progressing well, with interim analysis expected in Q1 2025.
Decentralized trial design (conducted in patients’ homes) has seen strong enrollment interest.
NDA submission expected in 2025.
Potential expansion into Parkinson’s disease pending ET results.
Epilepsy Portfolio:
Relutrigine (SCN2A/SCN8A DEEs):
Phase 2 EMBOLD trial showed 46% reduction in motor seizures vs. placebo, with 33% of patients seizure-free.
Cohort 2 (80 patients) enrollment underway; broader EMERALD study (all DEEs) planned for 2025.
Vermatrigine (Focal/Generalized Epilepsy):
RADIANCE (open-label) trial on track for H1 2025 data.
POWER 1 (Phase 2/3) results expected late 2025; POWER 2 to start H1 2025.
Exploring pain indications due to fast-acting pharmacology.
Elzinersen (SCN2A ASO):
EMBRAVE study ongoing in Brazil; global regulatory discussions progressing.
Financials:
Cash position: $411.2M (extends runway into 2027).
Q3 operating expenses: $57.1M ($41.9M R&D, $15.3M G&A).
Upcoming Milestones:
Ulixacaltamide (ET): Interim analysis (Q1 2025) → NDA filing (2025).
Relutrigine (DEEs): EMERALD study initiation (2025).
Vermatrigine (Epilepsy): RADIANCE data (H1 2025), POWER 1 data (late 2025).
Commercial & Regulatory Strategy:
ET market opportunity: High unmet need (~77% of patients unsatisfied with current treatments).
DEE market: ~200K U.S. patients, with 70-80% on sodium channel blockers; relutrigine positioned as potential best-in-class.
Global expansion plans for Elzinersen pending regulatory alignment.
About this video
Praxis Precision Medicines, Inc. delivered a pivotal second quarter in 2025 marked by important clinical progress and intensified R&D investment, even as financial losses widened. The company recognized no revenue for the quarter—down from $0.4 million in Q2 2024—following the end of its collaboration with UCB. Research and development expenses more than doubled to $63.0 million (vs. $27.3 million in Q2 2024), primarily driven by increased activity in its Cerebrum™ and Solidus™ platforms and higher personnel costs. General and administrative expenses rose to $13.1 million, up from $10.6 million last year. As a result, Praxis reported a net loss of $71.1 million for Q2 2025—equivalent to $(3.31) per share—compared to a net loss of $32.7 million ($(1.74) per share) in the prior year, missing consensus EPS estimates. The company finished June 2025 with $446.6 million in cash, cash equivalents, and marketable securities, enough to fund operations into 2028. Operational expansion was reflected in a rise in accounts payable ($28.8 million, up from $12.5 million), while weighted average shares outstanding climbed to 21.5 million, up from 18.8 million last year, due to equity funding. Notably, Praxis announced positive topline data from its Phase 2 RADIANT trial for vormatrigine in focal onset seizures, showing a 56.3% median reduction in seizure frequency, with 22% of participants achieving seizure freedom in the last 28 days of the study. The company also moved relutrigine into pivotal trials for developmental and epileptic encephalopathies (DEEs), following FDA Breakthrough Therapy designation. Key clinical milestones expected in late 2025 and 2026 include topline results from pivotal studies in essential tremor (ulixacaltamide) and epilepsy (vormatrigine, POWER1). Praxis is focused on expanding its pipeline for CNS disorders and executing on multiple late-stage clinical programs, remaining well-capitalized despite currently high cash burn and a lack of near-term revenue or updated financial guidance. About Inside Ticker: For more expert analysis and real-time updates on Praxis Precision Medicines, Inc. (NASDAQ: PRAX) and other market movers, follow Inside Ticker and visit http://www.insideticker.com/ for in-depth reports, financial insights, and the latest news on leading companies. #Praxis #PRAX #Q22025 #Earnings #FinancialResults #NetLoss #Research #Epilepsy #CNS #RADIANT #Vormatrigine #ClinicalTrials #BreakthroughTherapy #CashRunway #InsideTicker #2025Outlook
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