"The third quarter saw strong sales growth for FYARRO, backed by continued account momentum, increased demand and a nearly 90 percent reorder rate – all reinforcing the clinical value of FYARRO for patients with advanced malignant PEComa," said Dave Lennon, President and CEO of Aadi Bioscience. "Our comprehensive review of strategic options to maximize value for shareholders is ongoing, and we will provide further updates when available."
Recent Operational Highlights:
FYARRO net product sales were $7.2 million in the third quarter, an increase of 17 percent from Q2 2024 and 21 percent compared to the prior-year period. This increase is primarily driven by continued momentum from top accounts and strong demand.
Aadi completing wind-down of the PRECISION1 trial of nab-sirolimus in patients with solid tumors harboring TSC1 or TSC2 inactivating alterations. All patients who were still receiving benefit at the time the study was halted were transitioned to an expanded access protocol, and a report out of the PRECISION1 trial is expected to be provided in 2025.
The Phase 2 trials of nab-sirolimus for advanced or recurrent endometrioid-type endometrial cancer (EEC) and neuroendocrine tumors (NETs) enrolled 24 and 12 patients, respectively. Both studies enrolled sufficient patients to assess initial efficacy signals later this year.
Aadi remains actively engaged in a comprehensive strategic review to maximize shareholder value. Aadi has not provided a specific timeline to complete this process and will provide further updates when appropriate.
Third Quarter 2024 Financial Results:
Cash, cash equivalents and short-term investments as of September 30, 2024, were $62.6 million as compared to $108.8 million as of December 31, 2023, which is expected to fund operations into at least 2H 2026 based on current plans.
Total revenue for the quarter ended September 30, 2024, was $7.2 million, resulting from sales of FYARRO.
Operating expenses for the third quarter September 30, 2024, were $20.6 million as compared to $23.8 million in the prior year quarter and included $2.6 million of restructuring expenses.
Net loss for the three months ended September 30, 2024, was $12.5 million as compared to $16.3 million for the three months ended September 30, 2023.
About Aadi Bioscience:
Aadi is a precision oncology company focused on the commercialization of FYARRO® for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
For more information please visit, www.aadibio.com
