Acasti Pharma Inc. (ACST)·Q1 2025 Earnings Summary

Executive Summary

• Net loss narrowed to $2.617M (loss per share $0.24), a $1.4M improvement year-over-year, driven by prior-year restructuring costs and a favorable change in derivative warrant fair value, partially offset by higher R&D to support the Phase 3 STRIVE-ON trial .
• Cash and cash equivalents were $19.394M at June 30, 2024; management reiterated cash runway into the second calendar quarter of 2026, supporting execution through the planned GTX-104 NDA submission .
• Clinical execution advanced: the STRIVE-ON pivotal safety trial surpassed the 50% enrollment milestone; full enrollment is anticipated in late 2024 to early 2025, with NDA submission targeted for 1H calendar 2025 .
• Near-term catalysts: completion of STRIVE-ON enrollment and GTX-104 NDA filing; the company’s focused strategy and cost discipline underpin the runway and development priorities .

What Went Well and What Went Wrong

What Went Well

• Surpassed the 50% enrollment milestone in the Phase 3 STRIVE-ON safety trial; management highlighted strong investigator enthusiasm for GTX-104’s IV alternative to oral nimodipine in aSAH .
• Clear regulatory timeline with NDA submission planned in 1H calendar 2025, reinforcing program momentum and visibility .
• Year-over-year loss reduction of $1.4M driven by the absence of prior-year restructuring charges and a $1.4M positive change in derivative warrant liabilities, despite increased R&D investment .

Quote: “Investigators continue to be very enthusiastic about the potential of GTX-104… Based on enrollment trends… we anticipate randomizing all 100 patients in late 2024 to early 2025. We believe that the STRIVE-ON trial is on track for a potential NDA submission… in the first half of calendar 2025.” — CEO Prashant Kohli .

What Went Wrong

• R&D expenses rose to $2.708M (+$1.613M y/y) to fund the STRIVE-ON trial, increasing operating losses versus prior quarter despite strategic alignment to GTX-104 .
• General & Administrative expenses increased to $2.255M (+$0.381M y/y) on legal/tax/accounting/professional fees related to the proposed jurisdictional change, pressuring opex near-term .
• No earnings call transcript or additional Q1 press materials available in the document set; limits visibility into Q&A clarifications and tone changes versus prior quarters [List: earnings-call-transcript none 6/1–9/30/2024] [List: press-release none 6/1–9/30/2024].

Financial Results

Income Statement and Operating Metrics

Notes:

• Year-over-year net loss reduction of $1.4M cited by management, driven by prior-year restructuring and derivative warrant revaluation, partially offset by increased R&D .
• No product revenue reported; quarterly presentation focuses on operating expenses and losses .

Balance Sheet Snapshot

KPIs and Program Milestones

Guidance Changes

No revenue/margin/OpEx numeric forward guidance was provided beyond the program timelines and runway disclosures .

Earnings Call Themes & Trends

Note: No Q1 FY2025 earnings call transcript available in the document set; themes are derived from press releases/8-K disclosures [List: earnings-call-transcript none 6/1–9/30/2024].

Management Commentary

• “We surpassed the 50% enrollment milestone in our Phase 3 STRIVE-ON safety trial… we anticipate randomizing all 100 patients in late 2024 to early 2025… on track for a potential NDA submission… in the first half of calendar 2025.” — Prashant Kohli, CEO .
• “These patients require intensive management… GTX-104 may provide an effective IV alternative to the current standard of care.” — Management on product rationale .
• Acasti reiterated that its cash runway extends into the second calendar quarter of 2026, supporting the development and filing timeline .

Q&A Highlights

• No Q1 FY2025 earnings call transcript was available within the accessible document set; therefore, no Q&A detail or tone analysis can be provided from primary sources [List: earnings-call-transcript none 6/1–9/30/2024].

Estimates Context

• Wall Street consensus estimates via S&P Global were unavailable for ACST for Q1 FY2025 (missing CIQ mapping for the ticker). As a result, no EPS or revenue consensus comparison can be presented. Values retrieved from S&P Global are unavailable for this period due to mapping limitations.*
• Given the company’s pre-revenue profile and expense-driven P&L, the primary drivers for near-term estimate revisions (when available) would likely be timelines for STRIVE-ON completion and NDA filing rather than traditional revenue/EPS beats/misses .

Key Takeaways for Investors

• Clinical execution is advancing with 50%+ enrollment in STRIVE-ON and a clear timeline to full enrollment and NDA filing; program momentum is a key near-term stock catalyst .
• Operating discipline remains supported by a runway into Q2 2026, enabling the company to reach value-inflection milestones without near-term financing needs per current disclosures .
• Year-over-year net loss improvement was driven by non-recurring restructuring and derivative warrant revaluation, while increased R&D reflects accelerated STRIVE-ON activity — investors should expect opex to track trial progress .
• Absence of a call transcript limits visibility into detailed operational Q&A; monitor future filings or investor events for clarity on enrollment cadence and site activation [List: earnings-call-transcript none 6/1–9/30/2024].
• Portfolio strategy remains concentrated on GTX-104, with GTX-102/101 deprioritized and potentially available for licensing/sale — reducing development complexity and focusing resources on the lead asset .
• Near-term trading implications: sensitivity to clinical enrollment updates and any regulatory interactions; medium-term thesis centers on GTX-104 differentiation in aSAH and NDA timing .

Citations:

• Q1 FY2025 press release and financials (8-K Item 2.02, Exhibit 99.1):
• FY2024 year-end release and financials (8-K Item 2.02, Exhibit 99.1):
• Q3 FY2024 release and interim financials (8-K Exhibit 99.1):
• Document availability checks (earnings call transcript, other press releases): [ListDocuments outputs showing none in 6/1–9/30/2024]