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AP

Acasti Pharma Inc. (ACST)·Q4 2024 Earnings Summary

Executive Summary

  • Fiscal Q4 2024 reporting came via a year-end 8-K: Acasti reiterated STRIVE-ON Phase 3 enrollment is on track, targeting a GTX-104 NDA submission in 1H calendar 2025, and maintained projected cash runway into 2Q 2026 .
  • FY 2024 net loss narrowed materially to $12.9M ($1.35 loss/share) from $42.4M ($5.71 loss/share) on the absence of prior-year impairments and cost realignment, with no product revenue reported; operations consisted of R&D and G&A .
  • Prior two quarters show improving net loss per share: Q2 FY24 $(0.43) and Q3 FY24 $(0.21), reflecting tighter OpEx and interest income tailwinds, with cash of ~$27.0M at Q2-end and $18.5M at Q3-end before ending FY with $23.0M .
  • No Q4 call transcript was found in our document catalog; investor narrative centered on clinical execution, NDA timing, and cash runway stability (unchanged vs. prior quarter) .

What Went Well and What Went Wrong

What Went Well

  • STRIVE-ON Phase 3 execution momentum: “Enrollment has proceeded steadily… on track for a potential NDA submission… in the first half of calendar 2025” (CEO) .
  • Liquidity visibility: “cash runway is expected to extend into the second calendar quarter of 2026,” reaffirmed at year-end .
  • Structural cost progress and cleaner P&L: FY net loss improved to $12.9M vs. $42.4M YoY as FY23 impairments did not recur and realignment lowered OpEx run-rate .

What Went Wrong

  • Continued development-stage profile with no product revenue; FY and recent quarters reflect only operating expenses and losses (no revenue lines reported) .
  • Restructuring and derivative warrant overhang: FY24 included $1.5M restructuring cost and recognition of derivative warrant liabilities on the balance sheet .
  • Longer-term financing need beyond runway: filings note additional capital will be required after the current runway period to fund operations and commercialization beyond GTX-104 milestones .

Financial Results

Note: Q4 FY2024 was reported as part of year-end; the company did not provide standalone Q4 revenue/EPS. We therefore present FY comparisons and trend context from the prior two quarters.

FY results (USD)

MetricFY 2023FY 2024
Net Loss ($M)$(42.4) $(12.9)
Basic/Diluted EPS$(5.71) $(1.35)
R&D Expense ($M)$10.0 $4.7
G&A Expense ($M)$7.6 $6.4
Cash & Cash Equivalents (period-end, $M)$27.9 $23.0
Total Shareholders’ Equity ($M)$68.0 $61.7

Quarterly trend (prior two quarters; USD)

MetricQ2 FY2024 (Sep 30, 2023)Q3 FY2024 (Dec 31, 2023)
Net Loss ($M)$(3.27) $(2.39)
Basic/Diluted EPS$(0.43) $(0.21)
Cash & Cash Equivalents (period-end, $M)$26.99 $18.55
  • Margins/Revenue: No product revenue reported; statements present operating expenses and losses without revenue line items .
  • Segment/KPIs: No commercial segments. Primary KPIs are clinical and liquidity milestones (see KPIs below).

Key KPIs (operational/liquidity)

KPIQ2 FY2024Q3 FY2024Q4 FY2024 (Year-End)
STRIVE-ON statusFirst patient dosed; protocol aligned with FDA Enrollment ongoing; on track for 1H’25 NDA Enrollment on track; investigators’ meeting held; 1H’25 NDA reiterated
Cash RunwayInto 2Q’26 Into 2Q’26 Into 2Q’26

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
GTX-104 NDA timing1H CY20251H CY2025 (Q3 FY24) 1H CY2025 (Year-end FY24) Maintained
STRIVE-ON enrollment trajectoryThrough late 2024/early 2025On track (Q3 FY24) On track; investigators meeting held (Year-end FY24) Maintained
Cash runwayThrough 2Q CY20262Q CY2026 (Q3 FY24) 2Q CY2026 (Year-end FY24) Maintained

Earnings Call Themes & Trends

Note: No Q4 FY2024 call transcript was found in our document catalog; themes reflect company press materials for the respective periods.

TopicPrevious Mentions (Q2 FY24, Nov 2023)Previous Mentions (Q3 FY24, Feb 2024)Current Period (Q4 FY24, Jun 2024)Trend
GTX-104 clinical progressInitiated STRIVE-ON; KOL webinar; PK data positioning Enrollment underway; poster at ISC; NDA 1H’25 reiterated Enrollment “steadily” proceeding; investigators meeting; NDA 1H’25 reiterated Steady execution; timelines intact
Regulatory pathway (505(b)(2))FDA alignment noted; protocol aligned 505(b)(2) path reaffirmed NDA timeline reiterated; safety trial primary endpoint context Consistent
Liquidity/runwayPrivate placement closed; runway to 2Q’26 Runway to 2Q’26 Runway to 2Q’26 Stable
Cost structure/realignmentStrategic realignment highlighted Ongoing OpEx discipline FY net loss reduced vs. FY23; lower R&D YoY Cost focus sustained
Pipeline prioritizationFocus on GTX-104; 102/101 deprioritized Focus reiterated Focus reiterated Unchanged

Management Commentary

  • “Since initiating STRIVE-ON and dosing the first patient last October, enrollment has proceeded steadily, and we believe the trial is on track for a potential NDA submission to the FDA in the first half of calendar 2025.” — Prashant Kohli, CEO (Year-end FY24 PR) .
  • “With our balance sheet enhanced by the $7.5 million private placement… our cash runway is expected to extend into the second calendar quarter of 2026, well beyond our planned submission of the GTX-104 NDA.” — CEO (Year-end FY24 PR) .
  • “Having dosed the first patient in October, we’ve continued to enroll more patients and sites since that time.” — CEO (Q3 FY24 PR) .

Q&A Highlights

  • No Q4 FY2024 earnings call transcript was available in our document catalog; no Q&A content to report for the period. Company communications emphasized STRIVE-ON enrollment status, 1H’25 NDA timing, and runway adequacy .

Estimates Context

  • Wall Street consensus (S&P Global) for ACST was unavailable via our estimates tool at the time of review; as a development-stage company without revenue, coverage may be limited. We therefore cannot present “vs. consensus” comparisons for Q4 FY2024 or FY2024.

Key Takeaways for Investors

  • Clinical execution remains the core driver: timely completion of STRIVE-ON and a 1H’25 NDA filing are the primary catalysts ahead; any acceleration/slippage in enrollment is likely to move the stock .
  • Liquidity sufficient through expected NDA submission and review preparation; runway into 2Q’26 reduces near-term financing overhang, though additional capital will be needed beyond the runway to scale commercialization if approved .
  • P&L de-risked vs. FY2023: net loss narrowed with FY23 impairments not recurring and OpEx rationalization; trend in prior quarters shows improving per-share losses even as development spending is focused on GTX-104 .
  • Regulatory path clarity under 505(b)(2) with a safety-focused Phase 3; continued consistency of messaging across Q2–Q4 supports confidence in the timeline and plan .
  • Watch for operational updates: total enrollment progress, site activation cadence, and any pre-NDA interactions will be key indicators into 1H’25 filing probability .
  • Non-core assets GTX-102/101 remain optionality; potential licensing/sale could provide non-dilutive funding but are deprioritized near term .
  • Risk skew: clinical and regulatory outcomes dominate; financing and warrant dynamics are secondary but relevant if timelines extend .

Additional Detail and Source Documents

  • Year-End FY2024 8-K (Item 2.02) with press release and financial statements: net loss, OpEx, cash, runway, and STRIVE-ON updates .
  • Q3 FY2024 8-K (Item 2.02) with press release and interim financials: quarterly loss/EPS, cash, STRIVE-ON enrollment progress .
  • Q2 FY2024 8-K (Item 2.02) with press release and interim financials: quarterly loss/EPS, cash, financing update, trial initiation .

Notes on Data Availability

  • The company did not disclose standalone Q4 FY2024 revenue or EPS figures; year-end FY2024 results and commentary were provided instead .
  • No earnings call transcript for Q4 FY2024 was found in our document catalog at the time of analysis.