Aadi Bioscience Announces Financial Results for the Third Quarter 2024 and Provides Corporate Update
AADI 11.06.2024
Drug:UNKNOWN FYARRO
Diseases:PEComa
FYARRO®sales of
Aadi continues to focus on FYARRO commercial business and comprehensive strategic review to maximize shareholder value
"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
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 ofnab-sirolimus in patients with solid tumors harboringTSC1orTSC2inactivating 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 ofnab-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 ofDecember 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 endedSeptember 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). More information on the Company is available on the Aadi website atwww.aadibio.comand connect with us on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains certain forward-looking statements regarding the business of
Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included in the Company's Annual Report on Form 10-K for the fiscal year ended
All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Aadi undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:IR@aadibio.com
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||
(In thousands) | ||||
(Unaudited) | ||||
2024 | 2023 | |||
Assets | ||||
Current assets: | ||||
Cash and cash equivalents | $ 30,537 | $ 62,888 | ||
Short-term investments | 32,082 | 45,957 | ||
Accounts receivable, net | 6,540 | 5,488 | ||
Inventory | 5,468 | 6,427 | ||
Prepaid expenses and other current assets | 2,688 | 3,826 | ||
Total current assets | 77,315 | 124,586 | ||
Property and equipment, net | 5,982 | 4,802 | ||
Operating lease right-of-use assets | 886 | 1,169 | ||
Other assets | 1,515 | 1,866 | ||
Total assets | $ 85,698 | $ 132,423 | ||
Liabilities and stockholders' equity | ||||
Current liabilities: | ||||
Accounts payable | $ 1,374 | $ 5,898 | ||
Accrued liabilities | 14,117 | 14,306 | ||
Operating lease liabilities, current portion | 322 | 434 | ||
Due to licensor payable | - | 5,757 | ||
Total current liabilities | 15,813 | 26,395 | ||
Operating lease liabilities, net of current portion | 624 | 833 | ||
Other liabilities | 393 | - | ||
Total liabilities | 16,830 | 27,228 | ||
Stockholders' equity: | ||||
Common stock | 2 | 2 | ||
Additional paid-in capital | 383,208 | 374,129 | ||
Accumulated other comprehensive income | 39 | 27 | ||
Accumulated deficit | (314,381) | (268,963) | ||
Total stockholders' equity | 68,868 | 105,195 | ||
Total liabilities and stockholders' equity | $ 85,698 | $ 132,423 | ||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
(In thousands, except share data and earnings per share amounts) | |||||||||
(Unaudited) | |||||||||
Three months ended | Nine months ended | ||||||||
2024 | 2023 | 2024 | 2023 | ||||||
Revenue | |||||||||
Product sales, net | $ 7,212 | $ 5,959 | $ 18,744 | $ 18,028 | |||||
Total Revenue | 7,212 | 5,959 | 18,744 | 18,028 | |||||
Operating expenses | |||||||||
Selling, general and administrative | 7,186 | 11,221 | 25,698 | 34,204 | |||||
Research and development | 9,997 | 11,890 | 36,683 | 36,161 | |||||
Restructuring charges | 2,638 | - | 2,638 | - | |||||
Cost of goods sold | 804 | 697 | 2,234 | 1,882 | |||||
Total operating expenses | 20,625 | 23,808 | 67,253 | 72,247 | |||||
Loss from operations | (13,413) | (17,849) | (48,509) | (54,219) | |||||
Other income (expense) | |||||||||
Foreign exchange loss | (1) | - | (4) | (3) | |||||
Interest income | 906 | 1,605 | 3,249 | 4,900 | |||||
Interest expense | (38) | (58) | (154) | (174) | |||||
Total other income (expense), net | 867 | 1,547 | 3,091 | 4,723 | |||||
Net loss | $ (12,546) | $ (16,302) | $ (45,418) | $ (49,496) | |||||
Net loss per share, basic and diluted | $ (0.46) | $ (0.60) | $ (1.68) | $ (1.84) | |||||
Weighted average number of common shares outstanding, basic and diluted | 27,041,327 | 26,946,683 | 27,010,791 | 26,901,810 | |||||
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