Hand Deformities, Congenital

FYARRO® sales of $7.2 million for Q3 2024, reflecting 21% year over year sales growth Aadi continues to focus on FYARRO commercial business and comprehensive strategic review to maximize shareholder value LOS ANGELES, Nov. 6, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI) today announced financial results for the third quarter ended September 30, 2024, and provided recent corporate progress. "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). More information on the Company is available on the Aadi website at 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 . 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: [email protected] SOURCE Aadi Bioscience WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Following the news, Aadi’s stock also took a significant hit and was down by over 30% in premarket trading today, compared to the market close on 19 August. Image Credit: Wafi Zimamul / Shutterstock. Aadi Biosciences has instituted cash-saving measures after the company decided to halt the registrational Phase II PRECISION1 trial for its mTOR inhibitor, nab-sirolimus. The company’s decision to discontinue the trial was made after an analysis done by the Independent Data Monitoring Committee (IDMC) found the “study was unlikely to exceed an efficacy threshold necessary to support an accelerated approval”. Concurrently, Aadi also decided to pause enrolment in two other Phase II trials of nab-sirolimus for advanced or recurrent endometrioid-type endometrial cancer (EEC) and neuroendocrine tumours (NETs), respectively. As part of the cash savings initiative, Aadi is also reducing its research & development headcount by 80%. The pipeline and workforce restructure are expected to extend Aadi’s cash runway into H2 2026. The company reported cash reserves of $78.6m as of 30 June 2024. The news broke after markets closed on 20 August, causing Aadi’s stock to also take a significant hit. The company’s stock was down by more than 30% in premarket trading today. See Also: Innovent’s Dupert approved in China to treat lung cancer Pathalys secures $105m to advance SHPT drug through approval This is not the first time that the PRECISION1 trial (NCT05103358) data significantly impacted Aadi’s stock price. In December, the company stock fell by almost 57% after it released interim data from the PRECISION1 study . In the analysis done with the first 40 participants, at a minimum of 4.5 months of follow-up, 22 and ten participants in the TCS1 and TCS2 arms achieved an overall response rate of 26% and 11%, respectively. Despite the data being largely positive, it did not sway the company’s investors. “While nab-sirolimus showed monotherapy activity in the study population, the trial fell short of delivering what we believe would be required to support an accelerated approval in the broad TSC1/TSC2 inactivating mutations indication. We look forward to providing the full trial analysis at a later date,” said David Lennon, president and CEO of Aadi Bioscience. “Given the change in the development pipeline, we have taken the necessary steps to immediately preserve cash runway, and have hired an advisory firm to explore all options to maximize value for shareholders.” The open-label Phase II trial (NCT05997056) of nab-sirolimus in NETs has enrolled 10 out of the 21 expected participants. The Phase II study (NCT05997017) of the therapy in advanced or recurrent EEC has enrolled 20 out of 29 expected participants. Aadi noted that the current levels of recruitment in the two trials are expected to be “sufficient” to assess initial efficacy signals, which is expected by the end of the year. Nab-sirolimus is a sirolimus protein-bound particle that targets the mechanistic target of rapamycin (mTOR), which plays a pivotal role in cell growth and proliferation. Aadi’s nab-sirolimus is marketed as Fyarro and was approved by the US Food and Drug Administration (FDA) for adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumour (PEComa), in 2021. Following the pipeline restructure, Aadi plans to shift its focus to commercial activities Fyarro in PEComa. The therapy generated $24.4m in sales last year, as per the company’s financials. While Fyrro sales dipped by 8.8% in Q1, these were back on track and grew to $6.2m in Q2 this year.

FYARRO® sales of $6.2 million for Q2 2024, a 15% quarter over quarter sales growth Interim analysis of two-thirds of fully enrolled PRECISION1 trial planned for Q3 2024 Conference call to be held today at 8:30 am EDT LOS ANGELES, Aug. 7, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage, precision oncology company focused on developing and commercializing therapies for cancers with alterations in the mTOR pathway, today announced financial results for the second quarter ended June 30, 2024, and highlighted recent corporate progress. "The second quarter saw quarter over quarter sales growth for FYARRO, as anticipated, and an increase in demand across both new and existing accounts, including from major oncology centers. Approximately 80 percent of accounts have ordered multiple times already this year, reflecting the clinical value of FYARRO for patients with advanced malignant PEComa," said Dave Lennon, President and CEO of Aadi Bioscience. "Looking ahead, we will provide the next interim update from PRECISION1, a tumor-agnostic study that enrolled any tumor type presenting with qualifying TSC1 or TSC2 inactivating alterations, later in the third quarter. With this study, nab-sirolimus has the potential to demonstrate a meaningful impact on the lives of patients who have already received standard therapies appropriate for their tumor type and stage of disease." Recent Operational Highlights FYARRO net product sales were $6.2 million in the second quarter, an increase of 15 percent from Q1 2024 and in line with the prior year period. Two-thirds interim analysis of registration-intended PRECISION1 trial is planned for Q3 2024. PRECISION1 is exploring nab-sirolimus in solid tumors with TSC1 or TSC2 inactivating alterations. The trial is fully enrolled, and study completion is expected by year-end. Enrollment into two additional Phase 2 trials is ongoing, with initial data expected by the end of the year. These tumor specific, open-label trials are investigating the potential of nab-sirolimus for difficult-to-treat mTOR-driven cancers: advanced or recurrent endometrioid-type endometrial cancer (EEC) in combination with letrozole, and neuroendocrine tumors (NETs) of the lung, gastrointestinal tract and pancreas. Second Quarter 2024 Financial Results Cash, cash equivalents and short-term investments as of June 30, 2024, were $78.6 million as compared to $108.8 million as of December 31, 2023, which is expected to fund operations into Q4 2025 based on current plans. Total revenue for the quarter ended June 30, 2024, was $6.2 million, resulting from sales of FYARRO. Net loss for the three months ended June 30, 2024, was $14.6 million as compared to $18.0 million for the three months ended June 30, 2023. Conference Call Information The Aadi management team is hosting a conference call and webcast today at 8:30 am EDT (5:30 am PDT) to provide a corporate update and discuss results for the second quarter 2024. Participants may access a live webcast of the call and the associated slide presentation on the "Investors & News" page of the Aadi Bioscience website at aadibio.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company's website for at least 30 days. About Aadi Bioscience Aadi is a commercial-stage precision oncology company focused on the development and commercialization of therapies for cancers with alterations in the mTOR pathway, a key regulator of cell growth and cancer progression. To unlock the full potential of mTOR inhibition, Aadi uniquely combines nanoparticle albumin-bound (nab) technology with the potent mTOR inhibitor, sirolimus. Aadi received FDA approval and commercializes FYARRO® for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). Aadi is exploring nab-sirolimus in PRECISION1, a Phase 2 tumor-agnostic registration-intended trial in mTOR inhibitor-naïve malignant solid tumors harboring TSC1 or TSC2 inactivating alterations. Aadi is also exploring nab-sirolimus in two tumor specific Phase 2 trials for difficult-to-treat mTOR-driven cancers: neuroendocrine tumors (NETs) of the lung, gastrointestinal tract and pancreas, and advanced or recurrent endometrioid-type endometrial cancer (EEC) in combination with letrozole. More information on the Company's development pipeline is available on the Aadi website at 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 the fourth quarter of 2025; the anticipated timing of commencement, enrollment, data releases and completion of the Company's clinical trials, including the expected PRECISION1 two-thirds interim analysis in Q3 2024 and study completion by year-end and Phase 2 trials in EEC and NETs later in 2024; the Company's expectations regarding a return to sales growth and continued advancements, including in potential additional indications; expectations regarding the beneficial characteristics, safety, efficacy, therapeutic effects and the size of the potential targeted markets with respect to FYARRO, including in TSC1, TSC2, NETs and EEC; plans and potential for success relating to commercializing FYARRO; 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, uncertainties associated with the clinical development and regulatory approval of FYARRO in additional indications, including potential delays in the commencement, enrollment and completion of clinical trials for additional indications; risks associated with the ability to successfully commercialize FYARRO; failure to demonstrate the efficacy of FYARRO in clinical trials for additional indications; the risk that unforeseen adverse reactions or side effects may occur in the course of commercializing, developing and testing FYARRO; 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 . 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: [email protected] SOURCE Aadi Bioscience