Aadi Bioscience Announces Financial Results for the Third Quarter 2024 and Provides Corporate Update
Aadi Bioscience (NASDAQ: AADI) reported Q3 2024 financial results with FYARRO® sales reaching $7.2 million, showing 21% year-over-year growth and 17% quarter-over-quarter increase. The company reported cash reserves of $62.6 million, expected to fund operations into at least 2H 2026. Operating expenses were $20.6 million, down from $23.8 million in the prior year quarter. Net loss improved to $12.5 million compared to $16.3 million in Q3 2023. The company is winding down the PRECISION1 trial while maintaining Phase 2 trials for endometrial cancer and neuroendocrine tumors.
Aadi Bioscience (NASDAQ: AADI) ha riportato i risultati finanziari del terzo trimestre del 2024, con le vendite di FYARRO® che raggiungono $7,2 milioni, evidenziando una crescita del 21% rispetto all’anno precedente e un incremento del 17% rispetto al trimestre precedente. L’azienda ha segnalato riserve di liquidità di $62,6 milioni, che dovrebbero finanziare le operazioni almeno fino alla seconda metà del 2026. Le spese operative sono state di $20,6 milioni, in calo rispetto ai $23,8 milioni dello stesso trimestre dell’anno precedente. La perdita netta è migliorata a $12,5 milioni rispetto ai $16,3 milioni del terzo trimestre del 2023. L’azienda sta concludendo lo studio PRECISION1 mentre mantiene in corso le sperimentazioni di fase 2 per il cancro endometriale e i tumori neuroendocrini.
Aadi Bioscience (NASDAQ: AADI) informó los resultados financieros del tercer trimestre de 2024, con las ventas de FYARRO® alcanzando $7,2 millones, mostrando un crecimiento del 21% interanual y un aumento del 17% frente al trimestre anterior. La compañía reportó reservas de efectivo de $62,6 millones, que se espera que financien las operaciones hasta al menos la segunda mitad de 2026. Los gastos operativos fueron de $20,6 millones, por debajo de los $23,8 millones del trimestre del año anterior. La pérdida neta mejoró a $12,5 millones en comparación con los $16,3 millones del tercer trimestre de 2023. La empresa está finalizando el ensayo PRECISION1 mientras mantiene los ensayos de fase 2 para el cáncer endometrial y los tumores neuroendocrinos.
아디 바이오사이언스 (NASDAQ: AADI)는 2024년 3분기 재무 결과를 보고하며, FYARRO®의 매출이 720만 달러에 달한다고 밝혔습니다. 이는 전년 대비 21% 성장하고 전 분기 대비 17% 증가한 수치입니다. 회사는 6,260만 달러의 현금 보유액을 보고했으며, 이는 최소 2026년 하반기까지 운영 자금을 지원할 것으로 예상됩니다. 운영 비용은 2,060만 달러로, 지난해 같은 분기의 2,380만 달러에서 감소하였습니다. 순손실은 1,250만 달러로 2023년 3분기의 1,630만 달러와 비교하여 개선되었습니다. 회사는 PRECISION1 시험을 종료하고 있으며 자궁내막암 및 신경내분비 종양에 대한 2상 임상을 유지하고 있습니다.
Aadi Bioscience (NASDAQ: AADI) a annoncé les résultats financiers du troisième trimestre 2024, les ventes de FYARRO® atteignant 7,2 millions de dollars, montrant une croissance de 21 % par rapport à l'année précédente et une augmentation de 17 % par rapport au trimestre précédent. La société a rapporté des réserves de liquidités de 62,6 millions de dollars, qui devraient financer ses opérations jusqu'à au moins le deuxième semestre 2026. Les dépenses d'exploitation se sont élevées à 20,6 millions de dollars, en baisse par rapport à 23,8 millions de dollars au même trimestre de l'année précédente. La perte nette s'est améliorée à 12,5 millions de dollars contre 16,3 millions de dollars au troisième trimestre 2023. L'entreprise met fin à l'essai PRECISION1 tout en maintenant les essais de phase 2 pour le cancer de l'endomètre et les tumeurs neuroendocrines.
Aadi Bioscience (NASDAQ: AADI) hat die Finanzzahlen des dritten Quartals 2024 veröffentlicht, wobei die Verkäufe von FYARRO® 7,2 Millionen Dollar erreichten, was einem Wachstum von 21% im Jahresvergleich und einem Anstieg von 17% im Quartalsvergleich entspricht. Das Unternehmen berichtete von Bargeldreserven in Höhe von 62,6 Millionen Dollar, die voraussichtlich die Geschäftstätigkeit bis mindestens zur zweiten Jahreshälfte 2026 finanzieren werden. Die Betriebskosten betrugen 20,6 Millionen Dollar, im Vergleich zu 23,8 Millionen Dollar im Vorjahresquartal. Der Nettoverlust verbesserte sich auf 12,5 Millionen Dollar im Vergleich zu 16,3 Millionen Dollar im dritten Quartal 2023. Das Unternehmen beendet die PRECISION1-Studie, während es die Phase-2-Studien für Endometriumkarzinom und neuroendokrine Tumoren fortsetzt.
- FYARRO sales grew 21% year-over-year to $7.2 million
- Operating expenses decreased by 13.4% year-over-year
- Net loss improved by 23.3% compared to Q3 2023
- 90% reorder rate for FYARRO indicating strong product demand
- Cash runway extended into second half of 2026
- Discontinuation of PRECISION1 trial
- Operating loss continues with -$12.5 million in Q3
- Cash position decreased from $108.8M to $62.6M since December 2023
Insights
This quarterly report reveals mixed signals for Aadi Bioscience. While FYARRO sales showed encouraging growth of
The ongoing strategic review and trial wind-downs suggest a company in transition, potentially seeking partnerships or strategic alternatives. While the cash runway extends into 2H 2026, the
The commercial performance of FYARRO in the niche PEComa market shows promise with strong reorder rates and account momentum. However, the wind-down of the PRECISION1 trial and scope of ongoing Phase 2 trials (24 patients in EEC and 12 in NETs) suggest a strategic pivot. The company's focus on maximizing shareholder value through a strategic review could indicate potential M&A opportunities, especially given the current
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 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 - 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 $108.8 million - Total revenue for the quarter ended September 30, 2024, was
$7.2 million - Operating expenses for the third quarter September 30, 2024, were
$20.6 million $23.8 million $2.6 million - Net loss for the three months ended September 30, 2024, was
$12.5 million $16.3 million
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 at www.aadibio.com and connect with us on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains certain forward-looking statements regarding the business of Aadi Bioscience that are not a description of historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on the Company's current beliefs and expectations and may include, but are not limited to, statements relating to: the Company's cash runway extending into at least the second half of 2026; the Company's ongoing strategic review; the anticipated timing of data releases and reports of the Company's clinical trials; and the sufficiency of the Company's existing capital resources and the expected timeframe to fund the Company's future operating expenses and capital expenditure requirements. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks associated with the ability to successfully commercialize FYARRO; risks related to successfully identifying strategic options and implementing such options as part of the Company's ongoing strategic review; and risks related to the Company's estimates regarding future expenses, capital requirements and need for additional financing.
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 December 31, 2023, including under the caption "Item 1A. Risk Factors," and in Aadi's subsequent Quarterly Reports on Form 10-Q, and elsewhere in Aadi's reports and other documents that Aadi has filed, or will file, with the SEC from time to time and available at www.sec.gov.
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
AADI BIOSCIENCE, INC. | ||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||
(In thousands) | ||||
(Unaudited) | ||||
September 30, | December 31, | |||
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 | ||
AADI BIOSCIENCE, INC. | |||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
(In thousands, except share data and earnings per share amounts) | |||||||||
(Unaudited) | |||||||||
Three months ended | Nine months ended | ||||||||
September 30, | September 30, | ||||||||
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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SOURCE Aadi Bioscience
FAQ
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