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Applied Therapeutics
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.Q3 2025 earnings summary13 Nov, 2025
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.
CMT-SORD: Next steps for Phase 3 trial design?
Classic Galactosemia: Address CRL and warning letter.
Cash runway: Funding beyond current cash?
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Next Applied Therapeutics earnings date
Q4 20259 Mar, 2026
Applied Therapeutics
Next Applied Therapeutics earnings date
Q4 20259 Mar, 2026
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Frequently asked questions
Applied Therapeutics Inc. is a clinical-stage biopharmaceutical company engaged in discovering and developing innovative drugs for conditions with significant unmet medical needs. The company focuses on novel drug candidates targeting validated molecular pathways in diseases such as Galactosemia, Diabetic Cardiomyopathy, Diabetic Peripheral Neuropathy, and other areas with high unmet medical needs. Among its pipeline, notable drug candidates include AT-001, an aldose reductase inhibitor for diabetic complications; AT-007 for rare diseases such as SORD Deficiency; and AT-003, designed for diabetic retinopathy. Additionally, Applied Therapeutics is exploring AT-104, a PI3K inhibitor for orphan hematological oncology, specifically T Cell Acute Lymphoblastic Leukaemia. Applied Therapeutics is headquartered in New York, NY, and its shares are listed on the NASDAQ.
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