PRAX — Praxis Precision Medicines, Inc.

PRAXIS PRECISION MEDICINES Q1 2026 EARNINGS CALL SUMMARY

1. Key Financial Results and Metrics:

• Operating Expenses: Approximately $106 million, with $78 million allocated to R&D and $28 million to SG&A, reflecting increased commercial launch preparations.
• Cash Position: As of March 31, 2026, Praxis had $1.4 billion in cash, cash equivalents, and marketable securities, up from $926 million at the end of 2025, primarily due to a follow-on public offering.
• Cash Burn: Operating cash expenditure was $86 million, compared to $53 million in Q1 2025, indicating increased clinical trial activity and headcount growth.

2. Strategic Updates and Business Highlights:

• Late-Stage Assets: Praxis is advancing four late-stage assets with a combined peak sales potential exceeding $20 billion.
• NDA Submissions: The FDA accepted NDAs for ulixacaltamide and relutrigine, with PDUFA dates set for January 29, 2027, and September 27, 2026, respectively.
• EMBOLD Study: Recruitment for the EMBOLD study in the broad DEE population has been completed, with top-line results expected in Q4 2026, potentially supporting a supplemental NDA.
• Commercial Preparations: Significant progress in building commercial infrastructure, including hiring a leadership team and establishing a distribution network for ulixacaltamide.
• Positive Clinical Results: EMBRAVE Part A results showed a 77% placebo-adjusted reduction in monthly seizures for easinersen in SCN2A early onset DEE.

3. Forward Guidance and Outlook:

• Upcoming Milestones: Anticipation of results from the POWER1 study for lamotrigine later this quarter, with the potential for multiple NDA submissions within the next year.
• Financial Longevity: Current cash reserves are projected to fund operations into 2028, allowing for continued investment in R&D and commercial activities.

4. Bad News, Challenges, or Points of Concern:

• Increased Cash Burn: The significant rise in cash burn may raise concerns about operational sustainability without immediate revenue from product launches.
• Market Competition: Potential competition from other epilepsy treatments, including those from Xenon, could impact market share and pricing strategies.
• Regulatory Risks: While the FDA has accepted NDAs, there remains uncertainty regarding approval outcomes and any potential delays in the regulatory process.

5. Notable Q&A Insights:

• EMBOLD Study Expectations: Analysts inquired about the data supporting relutrigine's efficacy in broader DEE populations, with management expressing confidence based on preclinical and clinical data.
• Commercial Strategy for Ulixacaltamide: Feedback from physicians indicated strong interest in the drug, emphasizing the need for targeted treatments for essential tremor.
• Patient Enrollment Dynamics: Management highlighted the rapid enrollment in EMBOLD, attributing it to strong physician interest and the urgent need for effective treatments in the DEE population.
• Flexibility in Dosing: The company plans to offer multiple dosing options for vormatrigine to provide flexibility for physicians treating diverse patient needs.
• Market Education Needs: There is a recognized gap in the number of patients actively seeking treatment for essential tremor, attributed to stigma and lack of awareness, which the company aims to address through educational campaigns.

Overall, Praxis is positioned for significant growth with a robust pipeline and strong financial backing, though it must navigate competitive pressures and regulatory challenges ahead.