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Applied Therapeutics (APLT) investor relations material
Applied Therapeutics Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
Reported a net loss of $18.99 million for Q3 2025 and $62.1 million for the nine months ended September 30, 2025, with an accumulated deficit of $636.4 million.
Advanced regulatory discussions with the FDA for govorestat in CMT-SORD and Classic Galactosemia, with new meetings planned and prior Complete Response Letter and warning addressed.
Published and presented new positive clinical data on govorestat for PMM2-CDG, supporting further development.
Announced Board leadership transition with the resignation of the Executive Chairman for personal reasons.
Cash and cash equivalents were $11.9 million as of September 30, 2025, raising substantial doubt about the ability to continue as a going concern.
Financial highlights
Q3 2025 revenue: $1.0 million (vs. $0.1 million Q3 2024); nine months: $1.0 million (vs. $0.5 million prior year period).
Net loss per share: $(0.13) for Q3 2025 (vs. $(0.48) Q3 2024); $(0.43) for nine months (vs. $(1.09) prior year period).
R&D expenses for Q3 2025: $9.6 million (down from $14.8 million Q3 2024); nine months: $27.4 million (down from $37.0 million prior year).
G&A expenses for Q3 2025: $8.2 million (down from $15.0 million Q3 2024); nine months: $39.0 million (up from $34.7 million prior year, due to legal settlements and insurance recoveries).
Cash used in operations for nine months: $67.4 million (vs. $64.8 million prior year).
Outlook and guidance
Management expects continued significant operating losses and negative cash flows, with substantial additional funding required for ongoing operations and clinical development.
There is substantial doubt about the ability to continue as a going concern for 12 months beyond the filing date without additional capital.
The company is actively pursuing financing and business development opportunities but cannot assure success.
Plans to submit an additional Type C meeting request with the FDA to further discuss Phase 3 trial design for CMT-SORD.
Ongoing commitment to advancing govorestat development in multiple rare disease indications.
- Key votes include director election, auditor ratification, and a reverse stock split to maintain listing.APLT
Proxy Filing - Key votes include director election, auditor ratification, and a reverse stock split to maintain listing.APLT
Proxy Filing - Key votes include director election, auditor ratification, and a proposed reverse stock split.APLT
Proxy Filing - Net loss widened, cash declined, pipeline advanced, but major regulatory and funding risks remain.APLT
Q2 2025 - Govorestat nears approval for two rare diseases, with launches expected in late 2024 and early 2025.APLT
2024 Cantor Fitzgerald Global Healthcare Conference - Q2 net income of $2.9M and $122.2M cash support late-stage regulatory progress.APLT
Q2 2024 - Govorestat nears dual rare disease launches, backed by strong efficacy, safety, and market readiness.APLT
UBS Global Healthcare Conference 2024 - Govorestat nears regulatory decisions as net loss widens and cash reserves strengthen.APLT
Q3 2024 - Govorestat nears regulatory milestones for two rare diseases, with robust clinical and commercial readiness.APLT
Baird's 2024 Global Healthcare Conference
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