Applied Therapeutics (APLT) Q3 2025 earnings summary

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.