Executive Summary

Q3 FY2024 (three months ended December 31, 2023) showed continued disciplined spending and pipeline focus: net loss improved to $2.39M ($0.21 loss per share) from $3.89M ($0.52) YoY, primarily on lower R&D, while G&A was flat .
Liquidity remains solid: cash, cash equivalents and short-term investments were $25.1M at quarter-end; management projects cash runway into Q2 2026, extending one year beyond prior guidance (Q2 2025) and well past a potential GTX-104 NDA submission in 1H 2025 .
Operational execution: STRIVE-ON pivotal Phase 3 safety trial for GTX-104 progressed with ongoing enrollment; visibility enhanced via a poster at the 2024 International Stroke Conference .
Estimates context: S&P Global consensus estimates for ACST were unavailable for Q3 FY2024; comparisons vs Street were not possible.

What Went Well and What Went Wrong

What Went Well

Cash runway extended: Management now expects runway into Q2 2026, materially de-risking financing risk ahead of the 1H 2025 NDA target. “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” .
Trial execution on track: STRIVE-ON enrollment continued in Q3; program progress highlighted publicly with a poster at the 2024 International Stroke Conference .
Cost discipline: R&D expense fell to $1.44M from $2.45M YoY in Q3 as resources were prioritized to GTX-104 under the realignment plan; net loss improved by $1.50M YoY .

What Went Wrong

Pre-revenue profile persists: No commercial revenue reported; results remain driven by operating expenses and financing/derivative mark-to-market .
P&L volatility from warrants: In recent quarters, changes in fair value of warrant liabilities impacted reported results (e.g., $(1.83)M in Q2), introducing non-operational noise .
Continued cash burn: Despite discipline, operating loss was $3.04M in Q3; liquidity support remains essential until commercialization or out-licensing .

Financial Results

Quarterly P&L and Cash Trends (oldest → newest)

Metric	Q1 FY2024 (6/30/2023)	Q2 FY2024 (9/30/2023)	Q3 FY2024 (12/31/2023)
Net Loss ($USD Millions)	$4.023	$3.273	$2.391
Loss per Share (Basic & Diluted)	$0.54	$0.43	$0.21
R&D Expense ($USD Millions)	$1.095	$0.460	$1.443
G&A Expense ($USD Millions)	$1.763	$1.589	$1.570
Sales & Marketing ($USD Millions)	$0.111	$0.043	$0.030
Loss from Operating Activities ($USD Millions)	$4.454	$2.092	$3.043
Change in Fair Value of Warrant Liabilities ($USD Millions)	$0.000	$(1.826)	$0.125
Weighted-Average Shares Outstanding	7,435,533	7,552,677	11,506,257
Cash & Cash Equivalents ($USD Millions)	$21.633	$26.991	$18.545
Short-term Investments ($USD Millions)	$0.015	$0.015	$6.569
Cash + STI ($USD Millions)	$21.648	$27.006	$25.114

Q3 YoY Comparison (three months ended Dec 31)

Metric	Q3 FY2023 (12/31/2022)	Q3 FY2024 (12/31/2023)
Net Loss ($USD Millions)	$3.889	$2.391
Loss per Share	$0.52	$0.21
R&D Expense ($USD Millions)	$2.450	$1.443
G&A Expense ($USD Millions)	$1.600	$1.570

Segment breakdown: Not applicable; ACST is a development-stage biopharma with no reported segments and no commercial revenues .

KPIs: Operating focus and liquidity

KPI	Q1 FY2024	Q2 FY2024	Q3 FY2024
Cash Runway Guidance	Q2 2025	Well beyond anticipated 1H 2025 NDA (post $7.5M financing)	Into Q2 2026
STRIVE-ON Trial Status	FDA alignment; first patient expected by end-2023	First patient dosed; enrollment active	Enrollment continued; poster at ISC 2024
NDA Timing (GTX-104)	1H 2025 target	1H 2025 target maintained	1H 2025 target maintained

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Corporate	Projected to Q2 2025 (inclusive of potential NDA submission)	Projected into Q2 2026	Raised (extended)
GTX-104 NDA Submission	1H 2025	Anticipated 1H 2025	Anticipated 1H 2025	Maintained
STRIVE-ON Trial Milestones	2023–2025	First patient expected by end-2023	Enrollment continued; on track for NDA timeline	Maintained/Progressing

No quantitative guidance provided for revenue, margins, OpEx ranges, OI&E, tax rate, or dividends in Q3 materials .

Earnings Call Themes & Trends

Note: ACST did not publish a Q3 FY2024 earnings call transcript in filings; themes are drawn from quarterly press materials.

Topic	Previous Mentions (Q1 & Q2)	Current Period (Q3)	Trend
Trial Execution (STRIVE-ON)	Q1: FDA alignment; first patient expected by end-2023 . Q2: First patient dosed; enrollment active .	Enrollment continued; ISC 2024 poster increased visibility .	Positive momentum; on track for NDA timeline .
Regulatory Path (NDA)	1H 2025 NDA target introduced and reiterated .	1H 2025 NDA target maintained .	Stable timeline .
Liquidity/Financing	Q2: $7.5M private placement; “funding well beyond anticipated NDA submission” .	Cash runway extended into Q2 2026 .	Strengthened liquidity profile .
Cost Discipline	Q1 restructuring to prioritize GTX-104 . Q2 average monthly spend reduced to ~$1.0M vs ~$1.6M YoY for six months ended Sept. 30 .	R&D down YoY; operating loss narrowed YoY .	Ongoing cost control .
Medical Affairs Visibility	Q2: PK poster at NCS 2023; KOL event -.	ISC 2024 poster on STRIVE-ON .	Elevated engagement .

Management Commentary

“During the third quarter we continued to execute our focused strategy around our biggest value driver program GTX-104 and its pivotal Phase 3 STRIVE-ON safety trial… we’ve continued to enroll more patients and sites since that time” – 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” .
Q2 context: “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… the potential of GTX-104… reinforced in the virtual webinar… highlighted the key potential advantages of our novel injectable formulation over oral nimodipine” -.

Q&A Highlights

No public Q3 FY2024 earnings call transcript was identified in company filings; management commentary was provided via press release .

Estimates Context

S&P Global consensus estimates for ACST’s Q3 FY2024 EPS and revenue were unavailable; as a development-stage, pre-revenue biopharma, the Street often does not publish quarterly forecasts for this profile. Where estimates are absent, no beat/miss comparisons can be made.

Key Takeaways for Investors

Liquidity de-risked: Runway into Q2 2026 materially reduces near-term financing overhang and supports execution through the 1H 2025 NDA filing for GTX-104 .
Execution on pivotal trial: Ongoing enrollment and broader medical visibility (ISC 2024) reinforce operational progress; regulatory alignment remains intact .
Operating discipline: Meaningful YoY improvement in net loss and reduced R&D spend reflects targeted allocation to GTX-104, supporting a lean pathway to NDA .
P&L noise persists: Derivative warrant liability mark-to-market can introduce quarter-to-quarter EPS volatility unrelated to operations; interpret EPS with caution .
Near-term catalysts: Additional STRIVE-ON enrollment updates, regulatory interactions, and potential pre-NDA activities; medium-term inflection with NDA submission and review .
Commercial thesis hinges on GTX-104: With an estimated U.S. addressable market of ~$300M and potential administration/PK advantages over oral nimodipine, pivotal safety and regulatory outcomes drive value realization .
Monitoring priorities: Trial enrollment cadence, cash burn trajectory vs runway, and any changes to NDA timing or submission package guidance .

Sources: Q3 FY2024 8-K press release and financials -; Q2 FY2024 8-K press release and financials -; Q1 FY2024 8-K press release and financials -.

Acasti Pharma Inc. (ACST)·Q3 2024 Earnings Summary