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Applied Therapeutics (APLT) investor relations material
Applied Therapeutics Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q2 2025 earnings summary13 Aug, 2025
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.
Impact of new sorbitol assay on CMT-SORD?
Strategic rationale for AT-001 out-licensing?
Reason for Q2 2025 net loss vs. Q2 2024 income?
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Next Applied Therapeutics earnings date
Q3 202510 Nov, 2025
Next Applied Therapeutics earnings date
Q3 202510 Nov, 2025
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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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