Applied Therapeutics (APLT) Q2 2025 earnings summary

Executive summary

• Report covers the quarter ended June 30, 2025, for a clinical-stage biopharmaceutical company focused on rare diseases and diabetic complications.

• Lead candidate AT-007 (govorestat) is in development for Classic Galactosemia and CMT-SORD; NDA for Galactosemia received a Complete Response Letter from FDA in Nov 2024.

• Advanced CMT-SORD program with FDA meeting scheduled in Q3 2025 to discuss govorestat NDA submission.

• Out-licensed AT-001 for diabetic cardiomyopathy to Biossil, Inc. in July 2025, receiving $1M upfront and potential future royalties.

• Launched a sponsored sorbitol assay to aid CMT-SORD diagnosis, available at no cost to providers.

Financial highlights

• Cash and cash equivalents were $30.4M as of June 30, 2025, down from $79.4M at December 31, 2024.

• Net loss was $21.3M for Q2 2025, compared to net income of $2.9M in Q2 2024; net loss per share was $(0.15) for Q2 2025.

• Research and development expenses for Q2 2025 were $9.9M, flat year-over-year; general and administrative expenses increased to $13.2M from $10.6M.

• Revenue for Q2 2025 was $0, down from $0.1M in Q2 2024, due to lower deferred revenue recognition.

• Total assets were $37.3M and stockholders' equity was $17.4M as of June 30, 2025.

Outlook and guidance

• Management expects continued significant operating losses and negative cash flows as clinical programs advance.

• Substantial doubt exists regarding ability to continue as a going concern for 12 months beyond the filing date without additional capital.

• Focused on regulatory alignment and potential NDA submission for govorestat in CMT-SORD following FDA meeting.

• Company is actively pursuing financing options and business development partnerships.