Acasti Pharma Inc. (ACST)·Q2 2024 Earnings Summary

Executive Summary

• Q2 FY2024 showed operational progress and a materially improved P&L: net loss narrowed to $3.3M ($0.43 loss per share) versus $5.0M ($0.66 loss per share) in Q2 FY2023, driven primarily by R&D reductions following a strategic realignment to prioritize GTX‑104 .
• Strategic milestones: first patient dosed in pivotal STRIVE‑ON Phase 3 randomized trial for GTX‑104; $7.5M private placement extends funding “well beyond” anticipated NDA submission in 1H 2025 .
• Cash position remained strong with $27.0M cash and equivalents at quarter-end, aided by September financing; average monthly spend fell to ~$1.0M in H1 FY2024 from ~$1.6M a year ago .
• Management reiterated NDA timing (1H 2025) and highlighted GTX‑104’s potential advantages over oral nimodipine; subsequent Q3 FY2024 update extended cash runway into Q2 2026, reinforcing balance sheet flexibility .
• Wall Street consensus (S&P Global) was unavailable for ACST this quarter; therefore, no beat/miss vs estimates can be assessed (S&P Global consensus unavailable).

What Went Well and What Went Wrong

What Went Well

• Initiated pivotal STRIVE-ON Phase 3 safety trial; first patient dosed, with alignment on protocol and NDA submission package with FDA, supporting 1H 2025 NDA timing .
• Strengthened liquidity: $7.5M private placement led by ADAR1 extends funding “well beyond” anticipated NDA submission, reducing near-term financing risk .
• Cost discipline: R&D fell to $0.4M in Q2 (from $3.1M YoY), and average monthly burn declined to ~$1.0M over H1 FY2024, enhancing cash runway .
• Management quote: “With our STRIVE‑ON trial actively enrolling patients and a stronger balance sheet, we are well positioned to advance GTX‑104 and realize its clinical and commercial prospects as a potential new treatment standard for aSAH.”

What Went Wrong

• No product revenue reported; operating results driven exclusively by OpEx and fair value changes, leaving valuation anchored on clinical milestones until commercialization .
• G&A ticked up modestly YoY to $1.4M due to higher professional fees, partially offset by reduced headcount, indicating continued corporate overhead needs despite restructuring .
• Non‑operating volatility: $1.8M expense from change in fair value of warrant liabilities impacted Q2 results, creating earnings variability not tied to operations .

Financial Results

Quarterly Trend (oldest → newest)

Notes: Q3 FY2024 combined cash, cash equivalents and short-term investments were $25.1M .

Q2 2024 YoY Comparison (vs Q2 2023)

Operating Metrics

KPIs

No segment reporting or product revenue was disclosed in the quarter .

Guidance Changes

No revenue, margin, OpEx line-item guidance was provided; management emphasized clinical milestones and runway .

Earnings Call Themes & Trends

Note: A Q2 FY2024 earnings call transcript was not available in our document set; themes below reflect management’s quarterly press materials.

Management Commentary

• “During our second quarter we achieved significant strategic milestones, including initiating our pivotal Phase 3 STRIVE‑ON randomized trial… and securing $7.5 million… to provide funding well beyond the anticipated submission of GTX‑104 NDA… in the first half of 2025.” — Prashant Kohli, CEO .
• “With our STRIVE‑ON trial actively enrolling patients and a stronger balance sheet, we are well positioned to advance GTX‑104 and realize its clinical and commercial prospects as a potential new treatment standard for aSAH.” — Prashant Kohli, CEO .
• “With our balance sheet enhanced by the $7.5 million private placement… our cash runway is now expected to extend into the second calendar quarter of 2026, well beyond our potential submission of GTX‑104 NDA in the first half of 2025.” — Prashant Kohli, CEO (Q3 FY2024) .

Q&A Highlights

A Q2 FY2024 earnings call transcript for ACST was not available in our retrieved documents; therefore, no Q&A summary can be provided for this quarter.

Estimates Context

• Wall Street consensus via S&P Global for Q2 FY2024 EPS and revenue was unavailable for ACST; GetEstimates returned no CIQ mapping for the ticker. As a result, we cannot assess beats/misses vs consensus this quarter (S&P Global consensus unavailable).

Key Takeaways for Investors

• Clinical execution de-risked: the pivotal STRIVE‑ON Phase 3 trial has begun dosing, with FDA alignment on protocol and an NDA package path; NDA submission remains targeted for 1H 2025 .
• Liquidity strengthened: $7.5M financing plus reduced monthly burn extends runway “well beyond” NDA timing; subsequent update pushes runway into Q2 2026, lowering near-term financing overhang .
• P&L improving: net loss and EPS loss narrowed YoY on materially lower R&D; continued discipline on OpEx should support runway and reduce dilution risk .
• Stock reaction catalysts: continued STRIVE‑ON enrollment, regulatory interactions, and NDA preparation milestones; KOL visibility and conference data could lift sentiment, while any adverse safety signals or delays would be negative .
• Commercial thesis: GTX‑104’s IV delivery may address administration challenges and variability of oral nimodipine in aSAH; the U.S. addressable market is estimated at ~$300M, with orphan exclusivity potential post-launch .
• Risk monitors: fair value warrant liability swings, absence of revenue pre-approval, and clinical/regulatory timelines remain primary drivers of valuation .
• Actionable setup: position around clinical/regulatory milestones; any confirmatory safety/operability data from STRIVE‑ON or clarity on NDA acceptance could be near-term catalysts, while cash runway improvements mitigate financing risks .