AI Earnings Predictions for Whitehawk Therapeutics Inc. (WHWK)

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PRESS RELEASE

Whitehawk Therapeutics Reports Second Quarter 2026 Financial Results and Recent Highlights

Phase 1 trials for HWK-007 and HWK-016 continue to enroll; the Phase 1 trial for HWK-206 is on track to initiate in Q3 2026

Cash, cash equivalents and short-term investments balance of $190.0 million as of June 30, 2026, anticipated to fund operations into 2H 2028

MORRISTOWN, NJ, August 6, 2026 /PRNewswire/ -- Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, today announced financial results for the quarter ended June 30, 2026, and provided recent corporate highlights.

“The second quarter saw meaningful progress for our three assets. We continued enrollment in our Phase 1 studies for HWK-007 and HWK-016 and remain on track to initiate the Phase 1 trial for HWK-206 in Q3. We extended our anticipated runway into 2H 2028 following our recent upsized financing and we believe we are well positioned to support clinical execution against these programs,” said Dave Lennon, PhD, President and Chief Executive Officer of Whitehawk Therapeutics. “While our focus, investment priorities and execution efforts remain on our existing portfolio, we also took steps to enhance the long-term potential of our Whitehawk platform. The Hangzhou DAC option agreement reflects our conviction in CPT113, while our collaboration with Biocytogen provides access to bispecific antibody formats. These selective opportunities support future programs and our ambition to deliver new ADC INDs in the next 12-24 months.”

Q2 2026 and Recent Operational Highlights:

• In May 2026, Whitehawk announced an $87.5M private placement equity financing. The financing included participation from existing investors including Avoro Capital, QVT, Coastlands Capital, KVP Capital, ADAR1 Capital Management, Acuta Capital Partners, StemPoint Capital LP, Invus, as well as members of the Whitehawk's executive team.

• Continued to enroll patients into ongoing Phase 1 trials for HWK-007 and HWK-016.

o HWK‑007 is being evaluated in patients with non-squamous, EGFR wild-type non-small cell lung cancer; platinum-resistant ovarian cancer; and endometrial cancer (NCT07444814). The study design was presented as a Trials-in-Progress poster at the American Society of Clinical Oncology (ASCO) 2026.

o HWK‑016 is being evaluated in patients with advanced ovarian and endometrial cancers (NCT07470853).

• Entered into a new option agreement with Hangzhou DAC for access to CPT113 for use in up to five additional ADC programs. Whitehawk's ADC platform leverages CPT113 as the core linker-payload technology, adding its own proprietary Carbon Bridge Cysteine Re-pairing (CBCR) bioconjugation process to support improved stability and therapeutic index. Per the terms of the option agreement, Whitehawk will select targets

PRESS RELEASE

and source antibodies, while retaining global rights and full program control for the new ADC programs. Whitehawk anticipates submitting Investigational New Drug (IND) applications for multiple new programs over the next 12-24 months.

• Presented real-world analysis confirming SEZ6 as a highly expressed, clinically relevant target for small-cell lung cancer (SCLC) and other neuroendocrine tumors at ASCO 2026. SEZ6 expression exceeds that of approved and emerging ADC targets in SCLC. SEZ6 expression is positively correlated with DLL3 expression across neuroendocrine carcinomas, indicating potential for combination with DLL3-targeted therapies.

• Entered into a global collaboration with Biocytogen for bispecific antibody ADC (BsADC) development. Biocytogen will provide access to up to five bispecific antibodies using its proprietary RenLite® platform, and Whitehawk will evaluate these in combination with its ADC linker-payload platform technologies. Whitehawk then has the option to advance any resulting BsADC candidates as part of its pipeline.

Second Quarter 2026 Financial Results:

• Cash, cash equivalents and short-term investments as of June 30, 2026, were $190.0 million as compared to $145.7 million as of December 31, 2025. Cash is anticipated to fund operations into 2H 2028 based on current plans.

• Research and development expenses were $12.9 million for the three months ended June 30, 2026, as compared to $48.8 million for the three months ended June 30, 2025. The prior year quarter included the $38.0 million up-front license fee paid to WuXi Biologics.

• Net loss for the three months ended June 30, 2026, was $16.6 million as compared to $52.6 million for the three months ended June 30, 2025.

Anticipated Milestones:

• HWK-206 – a Phase 1 study in small-cell lung cancer and neuroendocrine tumors is planned to initiate in Q3 2026.

• HWK-007 and HWK-016 – ongoing recruitment into Phase 1 trials, with initial re

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PRESS RELEASE

Whitehawk Therapeutics Reports First Quarter 2026 Financial Results and Recent Highlights

Phase 1 trials for HWK-007 and HWK-016 are ongoing; an IND submission for HWK-206 is on track for mid-2026

Cash, cash equivalents and short-term investments balance of $123.0 million as of March 31, 2026, anticipated to fund operations into 2028

MORRISTOWN, NJ, May 7, 2026 /PRNewswire/ -- Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, today announced financial results for the quarter ended March 31, 2026, and provided recent corporate highlights.

“This quarter reflects continued progress across our pipeline as we advance Phase 1 dose-escalation studies for HWK-007 and HWK-016, with a third IND planned for HWK-206 mid-year,” said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. “We remain focused on high quality execution as we build toward initial data anticipated in 1H 2027, with the goal of delivering meaningful benefits for patients.”

Q1 2026 and Recent Operational Highlights:

• Continued to enroll patients into ongoing Phase 1 dose-escalation trials for HWK-007 and HWK-016.

o HWK‑007 is being evaluated in patients with non-squamous, EGFR wild-type non-small cell lung cancer; platinum-resistant ovarian cancer; and endometrial cancer (NCT07444814).

o HWK‑016 is being evaluated in patients with advanced ovarian and endometrial cancers (NCT07470853).

• Presented comprehensive data highlighting preclinical proof-of-concept for Whitehawk’s next-generation ADC portfolio underpinned by its proprietary Carbon Bridge Cysteine Re-pairing (CBCR) platform. Data presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 demonstrate a consistent preclinical profile for HWK-007, HWK-016 and HWK-206 characterized by potent tumor regressions, high plasma stability and favorable tolerability in non‑human primates, coupled with low systemic levels of free payload.

• Presented real-world analysis confirming MUC16 as a highly expressed clinically relevant target for gynecologic cancers. Whitehawk presented data at the Society of Gynecologic Oncology (SGO) 2026 Annual Meeting that established MUC16 as the highest-expressing ADC target in ovarian cancer, at least two-fold higher than other emerging targets, and showed MUC16 is highly and stably expressed in the most aggressive and most common subtypes of endometrial cancer.

PRESS RELEASE

First Quarter 2026 Financial Results:

• Cash, cash equivalents and short-term investments as of March 31, 2026, were $123.0 million as compared to $145.7 million as of December 31, 2025. Cash is anticipated to fund operations into 2028 based on current plans.

• Research and development expenses were $17.2 million for the three months ended March 31, 2026, including development milestone expenses of $5.3 million under our license agreement with WuXi Biologics, as compared to $8.8 million for the quarter ended March 31, 2025.

• Net loss for the three months ended March 31, 2026, was $22.2 million as compared to a net income of $73.0 million for the three months ended March 31, 2025. The prior year quarter included an $87.4 million gain on the sale of Aadi Subsidiary.

Anticipated Milestones:

• HWK-206 – plan to submit an Investigational New Drug application to the U.S. Food and Drug Administration in mid-2026 for HWK-206 in small-cell lung cancer and neuroendocrine tumors; Phase 1 recruitment planned to start in Q3 2026.

• HWK-007 and HWK-016 – ongoing recruitment into Phase 1 trials, with initial results expected in 1H 2027.

About Whitehawk Therapeutics

Whitehawk Therapeutics is a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved cancer treatments. Whitehawk's advanced three-asset ADC portfolio is engineered to overcome the limitations of first-generation predecessors to deliver a meaningful impact for patients with difficult-to-treat cancers. These assets are in-licensed from WuXi Biologics under an exclusive development and global commercialization agreement. More information on the Company is available at www.whitehawktx.com and connect with us on LinkedIn.

Forward-Looking Statements

This press release contains certain forward-looking statements regarding the business of Whitehawk Therapeutics 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 potential therapeutic value and market opportunity for the Company's ADC portfolio; plans related to the Company's development of its portfolio of ADC as

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Exhibit 99.1

PRESS RELEASE

Whitehawk Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Recent Highlights

Actively recruiting Phase 1 trials for PTK7-targeted antibody-drug conjugate (ADC) HWK-007 and MUC16-targeted ADC HWK-016

HWK-206 on track for planned IND submission in mid-2026 and Phase 1 start in Q3

Cash, cash equivalents and short-term investments balance of $145.7M at YE2025, anticipated to fund operations into 2028

MORRISTOWN, NJ, March 12, 2026 /PRNewswire/ -- Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, today announced financial results for the fourth quarter and full-year ended December 31, 2025, and provided recent corporate highlights.

“Last year marked our evolution into Whitehawk Therapeutics, a boldly pragmatic company developing the next generation of ADC cancer treatments. We progressed three programs through IND-enabling work in tandem, while building the capabilities required to execute efficiently in the clinic as we enter 2026,” said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. “Whitehawk combines established but underexploited tumor targets with a differentiated ADC platform. With two active Phase 1 studies for HWK-007 and HWK-016, and a third IND submission for HWK-206 planned mid-year, we are energized by the opportunity to translate our strategy into clinical data with the potential to have a meaningful impact for patients.”

Q4 2025 and Recent Operational Highlights:

• Advanced development of PTK7-targeted HWK-007 and MUC16-targeted HWK-016 into Phase 1. In January, Whitehawk announced regulatory progress for these programs, which are both now actively recruiting Phase 1 trials.

o The HWK-007 Phase 1 trial will initially evaluate activity in lung and ovarian cancers, two PTK7-expressing tumor types with established precedent data, as well as endometrial cancer, one of the highest PTK7-expressing tumor types.

o The HWK-016 Phase 1 trial will initially evaluate activity in two high MUC16-expressing gynecologic cancers, ovarian and endometrial.

• Strengthened Management with new CMO. In December 2025, Whitehawk appointed Margaret Dugan, MD, as Chief Medical Officer (CMO). Dr. Dugan brings more than 30 years of global oncology drug development experience, with extensive expertise in early-stage clinical development and regulatory strategy.

• Presented real-world analysis confirming PTK7 as a broadly expressed, clinically relevant target across solid tumors. Whitehawk presented data at the AACR-NCI-EORTC meeting that established PTK7 as the third most highly expressed tumor marker

Exhibit 99.1

PRESS RELEASE

among clinically validated and emerging ADC targets, present in ~70% of tumors. We believe these findings support the potential of PTK7 as a pan-tumor target.

Fourth Quarter and Full Year 2025 Financial Results:

• Cash, cash equivalents and short-term investments as of December 31, 2025, were $145.7 million as compared to $47.2 million as of December 31, 2024. Cash is anticipated to fund operations into 2028 based on current plans.

• Net loss for the three months ended December 31, 2025, was $23.3 million as compared to $18.3 million for the three months ended December 31, 2024. Net loss for the full-year ended December 31, 2025, was $20.6 million, as compared to $63.7 million for the same period in 2024. The full-year net loss includes an $87.3 million gain on the divestiture of AADI Subsidiary.

Anticipated Milestones:

• Preclinical data – expect to present preclinical data across the portfolio at an upcoming medical congress in Spring 2026.

• HWK-206 – plan to submit an Investigational New Drug application to the U.S. Food and Drug Administration in mid-2026 for HWK-206 in small-cell lung cancer and neuroendocrine tumors; Phase 1 recruitment planned to start in Q3 2026.

• HWK-007 and HWK-016 – ongoing recruitment into Phase 1 trials, with initial results expected in 1H 2027.

About Whitehawk Therapeutics

Whitehawk Therapeutics is a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved cancer treatments. Whitehawk's advanced three-asset ADC portfolio is engineered to overcome the limitations of first-generation predecessors to deliver a meaningful impact for patients with difficult-to-treat cancers. These assets are in-licensed from WuXi Biologics under an exclusive development and global commercialization agreement. More information on the Company is available at www.whitehawktx.com and connect with us on LinkedIn.

Forward-Looking Statements

This press release contains certain forward-looking statements regarding the business of Whitehawk Therapeutics that are not a description of historical facts with

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EXHIBIT 99.1

PRESS RELEASE

Whitehawk Therapeutics Reports Third Quarter 2025 Financial Results and Recent Highlights

MORRISTOWN, NJ, November 6, 2025 /PRNewswire/ -- Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, today announced financial results for the third quarter ended September 30, 2025, and provided recent corporate progress.

“The third quarter was marked by executional focus, and we remain on track with our planned IND filings for HWK-007 and HWK-016 by the end of the year. We continue to deploy capital efficiently, maintaining strong financial discipline as we prepare to enter the clinic and deliver potentially value-creating milestones,” said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. “I’m proud of our role in adding to the scientific understanding of PTK7 with the data we presented at AACR-NCI-EORTC. Confirming PTK7 as the third most highly expressed tumor marker among clinically validated and emerging ADC targets, these data underscore the tremendous opportunity we have with our first ADC candidate, HWK-007, to make a difference for the nearly 750,000 patients in the US with PTK7-expressing cancers.”

Recent Operational Highlights:

• Presented real-world analysis at AACR-NCI-EORTC confirming PTK7 as a broadly expressed, clinically relevant target across solid tumors. The analysis was part of a collaboration between Whitehawk and Tempus AI.

• On track to bring all three assets to IND by mid-2026. IND submissions are planned by year-end 2025 for HWK-007 and HWK-016. An IND for HWK-206 is expected by mid-2026.

• Focused execution and capital efficiency support anticipated runway into 2028. Based on current plans, cash position enables initial clinical data readouts across the portfolio.

Third Quarter 2025 Financial Results:

• Cash, cash equivalents and short-term investments as of September 30, 2025, were $162.6 million as compared to $47.2 million as of December 31, 2024. Cash is anticipated to fund operations into 2028 based on current plans.

• Net loss for the three months ended September 30, 2025, was $17.7 million as compared to $12.5 million for the three months ended September 30, 2024.

About Whitehawk Therapeutics

Whitehawk Therapeutics is an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved cancer treatments. Whitehawk’s advanced three-asset ADC portfolio is engineered to overcome the limitations of first-generation

EXHIBIT 99.1

PRESS RELEASE

predecessors to deliver a meaningful impact for patients with difficult-to-treat cancers. These assets are in-licensed from WuXi Biologics under an exclusive development and global commercialization agreement. More information on the Company is available at www.whitehawktx.com and connect with us on LinkedIn.

Forward-Looking Statements

This press release contains certain forward-looking statements regarding the business of Whitehawk Therapeutics 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 potential of clinical value-creating milestones for the Company’s product candidates; the potential therapeutic value and market opportunity for HWK-007; the anticipated timing of the Company's development of its portfolio of ADC assets, including the expected timing to bring all three assets to IND by mid-2026, with the first two INDs filed by year-end; expectations regarding the beneficial characteristics, safety, efficacy, therapeutic effects and the size of the potential targeted markets with respect to the Company’s ADC assets; the Company's cash runway extending into 2028 based on current plans; 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, including through initial clinical data readouts for the Company’s product candidate portfolio. 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 preclinical and clinical development of the ADC portfolio, including potential delays in the commencement, enrollment and completion of clinical trials; failure to demonstrate the efficacy of the ADC portfolio in preclinical and clinical studies; the risk that unforeseen adverse reactions or side effects may occur in the course of testing of the ADC assets; and risks related to the Company's estimates regarding future expenses, capital requirements

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Exhibit 99.1

PRESS RELEASE

Whitehawk Therapeutics Reports Second Quarter 2025 Financial Results and Recent Highlights

MORRISTOWN, NJ, August 7, 2025 /PRNewswire/ -- Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved ADC cancer treatments, today announced financial results for the second quarter ended June 30, 2025, and provided recent corporate progress.

“We’re pleased with the progress made in Q2 to advance our ADC portfolio and remain on track to file INDs for our first two programs – HWK-007 and HWK-016 – by year-end 2025, with the third program, HWK-206, to follow in mid-2026,” said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. “We believe we are well-positioned to advance our pipeline and generate key clinical data across the portfolio with our existing cash position.”

Recent Operational Highlights:

• On track to bring all three assets to IND by mid-2026. IND submissions are planned by year-end 2025 for HWK-007 and HWK-016. An IND for HWK-206 is expected by mid-2026.

• Focused execution and capital efficiency support anticipated runway into 2028. Based on current plans, cash position enables initial clinical data readouts across the portfolio.

Second Quarter 2025 Financial Results:

• Cash, cash equivalents and short-term investments as of June 30, 2025, were $177.2 million as compared to $47.2 million as of December 31, 2024. Cash is anticipated to fund operations into 2028 based on current plans.

• Net loss for the three months ended June 30, 2025, was $52.6 million as compared to $14.6 million for the three months ended June 30, 2024. This includes the remaining portion of the upfront payment of $38.0 million under the Wuxi ADC agreement.

About Whitehawk Therapeutics

Whitehawk Therapeutics is an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved cancer treatments. Whitehawk’s advanced three-asset ADC portfolio is engineered to overcome the limitations of first-generation predecessors to deliver a meaningful impact for patients with difficult-to-treat cancers. These assets are in-licensed from WuXi Biologics under an exclusive development and global commercialization agreement. More information on the Company is available at www.whitehawktx.com and connect with us on LinkedIn.

Forward-Looking Statements

This press release contains certain forward-looking statements regarding the business of Whitehawk Therapeutics that are not a description of historical facts within the meaning of the

Exhibit 99.1

PRESS RELEASE

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 anticipated timing of the Company's development of its portfolio of ADC assets, including the expected timing to bring all three assets to IND by mid-2026, with the first two INDs filed by year-end; expectations regarding the beneficial characteristics, safety, efficacy, therapeutic effects and the size of the potential targeted markets with respect to the Company’s ADC assets; the Company's cash runway extending into 2028; 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 preclinical and clinical development of the ADC portfolio, including potential delays in the commencement, enrollment and completion of clinical trials; failure to demonstrate the efficacy of the ADC portfolio in preclinical and clinical studies; the risk that unforeseen adverse reactions or side effects may occur in the course of testing of the ADC assets; 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, 2024, including under the caption "Item 1A. Risk Factors," and in Whitehawk’s subsequent Quarterly Reports on Form 10-Q, and elsewhere in Whitehawk’s reports and other documents that Whitehawk 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, Whitehawk undertakes no obligation to revise or update any forward-looking statement, or to m

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PRESS RELEASE

Exhibit 99.1

Whitehawk Reports First Quarter 2025 Financial Results and Recent Highlights

MORRISTOWN, NJ, May 8, 2025 /PRNewswire/ -- Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved ADC cancer treatments, today announced financial results for the first quarter ended March 31, 2025, and provided recent corporate progress.

“By uniting novel approaches to tumor targeting with next wave technologies, our goal at Whitehawk Therapeutics is to efficiently deliver improved ADC therapies for patients with difficult-to-treat cancers. In the first quarter of 2025, we made meaningful progress in advancing our portfolio toward the clinic and remain on track to bring all three assets to IND by mid-2026, with the first IND filed in Q4 this year,” said Dave Lennon, President and CEO of Whitehawk Therapeutics. “Our assets target PTK7, MUC16 and SEZ6 – which we believe have the potential for broad clinical impact comparable to well-established targets like HER2 and TROP2, but with less competition and greater opportunity for differentiation. Coupled with our TOPO1-based leading next wave platform, we are confident in the strength of our strategy and remain committed to advancing with urgency and purpose.”

Recent Operational Highlights:

•Relaunched as Whitehawk Therapeutics marking evolution into ADC company. Launched with a three-asset portfolio consisting of clinically validated tumor targets that are upregulated in high-potential cancer indications, including lung and ovarian. These assets are engineered to produce minimal off-target toxicity, with a higher therapeutic index and greater stability than first-generation predecessors.

•Completed strategic transactions. Closed $100 million PIPE financing and the divestiture of Aadi Subsidiary, Inc. (“Aadi Sub”) to Kaken Pharmaceuticals (“Kaken”) for $102.4 million, including specified purchase price adjustments. Kaken assumed ownership of Aadi Sub on March 25, 2025, including the Aadi name, trademark and the FYARRO® business.

First Quarter 2025 Financial Results:

•Cash, cash equivalents and short-term investments as of March 31, 2025, were $231.1 million as compared to $47.2 million as of December 31, 2024.

•After completion of transaction-related payments, including the payment of the upfront fees under the Wuxi ADC agreement, we expect to have cash and cash equivalents of approximately $185 million, which we anticipate will fund operations into 2028 based on current plans.

•Total revenue for the quarter ended March 31, 2025, was $7.1 million, resulting from sales of FYARRO through March 25, 2025, the closing date of the divestiture to Kaken.

•Net income for the three months ended March 31, 2025 was $73.0 million, including a gain of $87.4 million on the sale of Aadi Sub, as compared to a net loss of $18.3 million for the three months ended March 31, 2024. Excluding the gain on the sale of Aadi Sub, net loss for the first quarter of 2025 was $14.4 million.

About Whitehawk Therapeutics

Whitehawk Therapeutics is an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved cancer treatments. Whitehawk’s advanced three-asset ADC portfolio is engineered to overcome the limitations of first-generation predecessors to deliver a meaningful impact for patients with difficult-to-treat cancers. These assets are in-licensed from WuXi Biologics under an exclusive development and global commercialization agreement. More information on the Company is available at www.whitehawktx.com and connect with us on LinkedIn.

Forward-Looking Statements

This press release contains certain forward-looking statements regarding the business of Whitehawk Therapeutics 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 anticipated timing of the Company's development of its portfolio of ADC assets, including the expected timing to bring all three assets to IND by mid-2026, with the first IND filed in Q4 this year; expectations regarding the beneficial characteristics, safety, efficacy, therapeutic effects and the size of the potential targeted markets with respect to the Company’s ADC assets; the Company's cash runway extending into 2028; 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 precl

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Exhibit 99.1

Aadi Bioscience Relaunches as Whitehawk Therapeutics Marking Evolution into ADC Company

New name reflects focus on accelerating portfolio of advanced ADC therapies with speed, agility and precision

Upon closing of strategic transactions, cash expected to fund operations into 2028 enabling anticipated key clinical data readouts for its ADC assets

Company shares to trade on Nasdaq under the symbol “WHWK” effective March 19, 2025

Company reports financial results for the fourth quarter and full-year 2024, and will host a conference call tomorrow, March 19 at 8:30 ET

MORRISTOWN, NJ, Mar. 18, 2025 /PRNewswire/ — Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), formerly known as Aadi Bioscience, Inc., an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved cancer treatments, today announced it changed its name to Whitehawk Therapeutics, reflecting the Company’s evolution and focus on accelerating its portfolio of antibody drug conjugates (ADCs) with speed, agility and precision. The Company’s common stock will begin trading under the ticker “WHWK” effective March 19, 2025.

The three assets in the portfolio are in-licensed from WuXi Biologics and utilize HANGZHOU DAC’s advanced ADC

technology platform, which consists of a highly stable yet cleavable linker that delivers a Topoisomerase I (TOPO1) inhibitor payload. The platform is coupled with clinically validated tumor targets that are upregulated in high-potential cancer indications, including lung and ovarian. These assets are engineered to produce minimal off-target toxicity, with a higher therapeutic index and greater stability than first-generation predecessors.

“Today marks a transformative moment as we reintroduce ourselves as Whitehawk Therapeutics – a focused oncology company combining science, strategy and execution to swiftly advance our portfolio of promising ADC assets,” said David Lennon, President and CEO, Whitehawk Therapeutics. “By leveraging the foundation of well-established tumor biology and integrating cutting-edge technologies, our strategy is designed to address the challenges of treating the most difficult cancers efficiently and effectively. Our goal is to bring all three assets to IND in the next 15 months. Importantly, we believe our robust balance sheet will enable us to see these three assets through early clinical inflections. We are invigorated by the opportunity we have to overcome the limitations of first-generation ADCs to make a meaningful impact for patients.”

Recent Operational Highlights:

•

All proposals were approved at the Company’s Special Meeting of Stockholders on February 28, 2025. Subsequently, the $100 million PIPE financing closed. The closing of the divestiture of Aadi Subsidiary, Inc. (“Aadi Sub”) to Kaken Pharmaceuticals (“Kaken”) is pending.

•

Aadi Bioscience divided into two organizations. Upon the divestiture of Aadi Sub to Kaken, Kaken will assume ownership of Aadi Sub, including the Aadi name, trademark and the FYARRO® business. As of March 18, 2025, the Aadi parent company has become Whitehawk Therapeutics, with a focus on its portfolio of ADC assets.

Fourth Quarter and Full-year 2024 Financial Results:

•

Cash, cash equivalents and short-term investments as of December 31, 2024, were $47.2 million as compared to $108.8 million as of December 31, 2023.

•

Following closing of the strategic transactions, we expect to have cash and cash equivalents in the range of $170 million to $180 million, including the payment of the upfront and early milestones under the Wuxi ADC agreement.

•

Total revenue for the quarter ended December 31, 2024, was $7.2 million, and $26.0 million for the full-year ended December 31, 2024, resulting from sales of FYARRO.

•

Net loss for the three months ended December 31, 2024, was $18.3 million as compared to $16.3 million for the three months ended December 31, 2023. Net loss for the full-year ended December 31, 2024, was $63.7 million, as compared to $65.8 million for the same period in 2023.

About the ADC Portfolio

•

HWK-007 represents a differentiated opportunity to potentially be

among the first next-wave ADCs in clinical development for high PTK7 expressing cancers. HWK-007 is being evaluated in IND-enabling studies. The Phase 1 trial is planned in non-small cell lung cancer and platinum resistant ovarian cancer, with potential to expand into novel indications (e.g. gastrointestinal, gynecological).

•

HWK-016 is the first ADC that targets the membrane-bound portion

of MUC16, a glycoprotein often overexpressed in cancers of female origin. HWK-016 is currently being evaluated in IND-enabling studies. The Phase 1 trial is planned in ovarian cancer, with potential to expand into additional indications (e.g. endometrial, cervical).

•

HWK-206 is designed to address the neuronal target, SEZ6, which is

often overexpressed in cancers of neuro

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PRESS RELEASE

Exhibit 99.1

Aadi Bioscience Announces Financial Results for the Third Quarter 2024 and Provides Corporate Update

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, CA, November 6, 2024 – 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 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

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PRESS RELEASE

Exhibit 99.1

Aadi Bioscience Announces Financial Results for the Second Quarter 2024 and Provides Corporate Update

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, CA, August 7, 2024 – 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 www.aadibio.com and connect with us on Twitter and Lin

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PRESS RELEASE

Exhibit 99.1

Aadi Bioscience Announces Financial Results for the First Quarter 2024 and Provides Corporate Update

Fully enrolled registration-intended PRECISION1 trial; two-thirds interim analysis planned for Q3 2024

FYARRO® sales of $5.4 million for Q1 2024, reflects distributor ordering patterns and fewer commercial patient initiations at the start of the year

Conference call to be held today at 8:30 am EDT

LOS ANGELES, CA, May 8, 2024 – 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 first quarter ended March 31, 2024, and highlighted recent corporate progress.

“I’m pleased to announce that PRECISION1 is now fully enrolled across a broad array of tumor types and our promising development plan continues to gain momentum. We look forward to providing the two-thirds interim analysis in the third quarter, and full results in early 2025. Additionally, the recently initiated Phase 2 trials in EEC and NETs are enrolling well, and we anticipate initial data from these later this year,” said Dave Lennon, President and CEO of Aadi Bioscience. “On the commercial side, FYARRO continues to perform well and has cemented its position as the preferred treatment for malignant PEComa after just two years on the market. The impacts to sales in the first quarter are well-understood events and we expect to return to sales growth in Q2.”

Recent Operational Highlights

•FYARRO net product sales were $5.4 million in the first quarter of 2024. This decrease of 8.8% from the prior year period reflects impacts from distributor ordering patterns and fewer new patient initiations than the historical average, which we anticipate will correct in subsequent quarters.

•Registration-intended PRECISION1 trial is now fully enrolled. PRECISION1 is exploring nab-sirolimus in solid tumors with TSC1 or TSC2 inactivating alterations. The two-thirds interim analysis is expected in Q3 2024, and study completion is expected by year-end.

•Enrollment into two Phase 2 trials ongoing. These tumor specific 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).

•At Aadi’s request, Mirati/Bristol Myers Squibb and Aadi mutually agreed to terminate their collaboration and clinical supply agreement. Aadi is prioritizing investment in its Phase 2 trials in EEC and NETs. The Phase 1/2 trial with Mirati/Bristol Myers Squibb evaluated the combination of nab-sirolimus + adagrasib in non-small cell lung cancer with a KRASG12C mutation.

First Quarter 2024 Financial Results

•Cash, cash equivalents and short-term investments as of March 31, 2024, were $88.3 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 March 31, 2024, was $5.4 million, resulting from sales of FYARRO.

•Net loss for the three months ended March 31, 2024, was $18.3 million as compared to $15.2 million for the three months ended March 31, 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 first quarter 2024.

Participants may access a live webcast of the call 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 diffic

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Exhibit 99.1

Aadi Bioscience Announces Financial Results for the Fourth Quarter and Full-Year 2023 and Provides Corporate Update

FYARRO® sales of $6.3 million for Q4 2023 and $24.4 million for FY 2023 representing year-over-year growth of 21% and 60%, respectively

Registration-directed PRECISION1 trial of nab-sirolimus in solid tumors with TSC1 or TSC2 inactivating alterations on track to complete enrollment by May; two-thirds interim analysis planned for Q3 2024

Phase 2 trials in Endometrial Cancer and Neuroendocrine Tumors (NETs) actively enrolling patients

Conference call to be held today at 8:30 am EDT

LOS ANGELES, CA, March 13, 2024 – 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 fourth quarter and full-year ended December 31, 2023, and highlighted recent corporate progress.

“With strong execution against our commercial and development goals, 2023 was a year of progress and momentum for Aadi,” said Dave Lennon, President and CEO of Aadi Bioscience. “As the preferred treatment for malignant PEComa, FYARRO saw significant growth and high penetration in academic and community settings. Clinically, we were encouraged by the interim results from the registration-directed PRECISION1 trial, and look forward to the two-thirds readout expected in Q3. We also initiated enrollment of two Phase 2 trials in what we believe are promising mTOR-driven cancer targets, endometrial cancer and neuroendocrine tumors, as we further characterize the potential of nab-sirolimus. With a commercial foundation, bold development vision and solid cash runway in to Q4 2025, we believe we are well-positioned to realize our ambition of becoming a multi-indication precision oncology company.”

Recent Operational Highlights

•FYARRO net product sales were $6.3 million in the fourth quarter, or 21% growth over the prior year period, and $24.4 million for full-year 2023, representing 60% growth year-over-year.

•PRECISION1 on track to complete enrollment by May 2024, with the two-thirds interim analysis expected in Q3 2024. Early data presented in December 2023 demonstrated sustained tumor reductions in heavily pre-treated population from investigator-assessed responses in first 40 patients across both arms. The safety profile was consistent with the nab-sirolimus label and the mTOR inhibitor drug class.

•Enrollment of two single-indication Phase 2 trials underway to investigate the potential of nab-sirolimus for difficult-to-treat mTOR-driven cancers: neuroendocrine tumors (NETs), and advanced or recurrent endometrioid-type endometrial cancer (EEC) in combination with letrozole.

◦NETs are rare, ~3,500 cases a year, with low response rates to existing recommended treatments. Preclinical models indicate improved target suppression relative to other mTORs in the NETS population.

◦Endometrial cancer is the most common cancer of the female reproductive organs and one of the few cancers with increasing mortality. There are an estimated 10,000 cases of EEC diagnosed annually. Prior clinical studies with mTOR inhibitors and letrozole have yielded promising results in EEC.

Fourth Quarter and Full-year 2023 Financial Results

•Cash, cash equivalents and short-term investments as of December 31, 2023, were $108.8 million as compared to $172.6 million as of December 31, 2022, which is expected to fund operations into Q4 2025 based on current plans.

•Total revenue for the quarter ended December 31, 2023, was $6.3 million, and $24.4 million for the full-year ended December 31, 2023, resulting from sales of FYARRO.

•Net loss for the three months ended December 31, 2023, was $16.3 million as compared to $13.9 million for the three months ended December 31, 2022. Net loss for the full-year ended December 31, 2023, was $65.8 million, as compared to $60.5 million for the same period in 2022.

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 fourth quarter and full-year 2023.

Participants may access a live webcast of the call 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

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PRESS RELEASE

Exhibit 99.1

Aadi Bioscience Reports Financial Results for the Third Quarter 2023 and Provides Corporate Update

PRECISION1 trial of nab-sirolimus in solid tumors with TSC1 or TSC2 inactivating alterations on track for presentation of early interim analysis by mid-December 2023; multiple 2024 catalysts expected

Latest real-world, next generation sequencing (NGS) analysis reinforces large unmet need in TSC1 and TSC2 mutated cancers

FYARRO® sales of $6.0 million in the third quarter, an increase of 40% year-over-year

Conference call to be held today at 8:30 am EST

LOS ANGELES, CA, November 8, 2023 – Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, today announced financial results for the quarter ended September 30, 2023, and highlighted recent corporate progress.

“The third quarter was marked by strong execution by our Aadi Bio team. Our PRECISION1 tumor-agnostic trial continued rapid enrollment, and we look forward to sharing an early interim analysis on the first third of patients by mid-December,” said Dave Lennon, President and CEO of Aadi Bioscience. “FYARRO continued to demonstrate the importance of a tumor-targeting mTOR inhibitor for PEComa patients, and we are progressing in our previously announced development strategy with the initiation of new Phase 2 studies for endometrial cancer and in neuroendocrine tumors.”

Key Operational Highlights

•PRECISION 1 interim analysis on track for mid-December 2023. Presentation of an interim analysis on the first third of trial participants (n=40) with a minimum of 4.5 months of follow-up is planned for mid-December 2023. The presentation is expected to include safety and investigator-assessed response in approximately 20 patients in each of the TSC1 and TSC2 arms.

•PRECISION1 catalysts expected in 2024. The trial is expected to reach full enrollment (n=120) with approximately 60 patients per arm in the spring of 2024 with trial completion expected by the end of 2024. Presentation of an additional interim analysis is planned when two-thirds of trial patients reach six months of follow-up, currently anticipated in the third quarter of 2024.

•Presentations at 2023 EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics highlight real-world impact of TSC1 and TSC2 inactivating alterations in cancer. Real-world NGS analysis of nearly 440,000 patients with advanced cancer showed that TSC1 or TSC2 known or likely pathogenic alterations occurred in approximately 2% of all advanced cancers. TSC1 or TSC2 inactivating alterations most commonly occurred in lung, gastrointestinal, genitourinary, breast and gynecological tumors. Posters with this and other related data are available on the Aadi Bio website under “Publications and Abstracts.”

•Dave Lennon, Ph.D., appointed President and CEO. In early October, Aadi announced the appointment of Dave Lennon, Ph.D. as President and Chief Executive Officer. Dr. Lennon brings more than twenty years of experience leading global biotechnology and pharmaceutical teams, with significant expertise in development and commercialization in mTOR-driven diseases.

•Initiation of Phase 2 combination trial in endometrial cancer. The Phase 2 trial investigating the combination of nab-sirolimus with letrozole for the treatment of advanced or recurrent endometrioid-type endometrial cancer (EEC) has been initiated and is currently enrolling patients. The Company

presented a trials-in-progress poster on the EEC Phase 2 study at the International Gynecologic Cancer Society (IGCS) 2023 Annual Global Meeting earlier in November.

•Initiation of Phase 2 study in neuroendocrine tumors (NETs). The Phase 2 study in neuroendocrine tumors (NETs) has been initiated and is currently enrolling patients. This multicenter, open-label, single-arm trial is evaluating nab-sirolimus in adult patients with functional or non-functional, well-differentiated, locally advanced unresectable or metastatic NETs of the GI tract, lung, or pancreas who have received no more than two prior lines of therapy.

Third Quarter 2023 Financial Results

•Total revenue resulting from sales of FYARRO for the quarter ended September 30, 2023, was $6.0 million. This compares to the prior year period of $4.2 million.

•Cash, cash equivalents and short-term investments as of September 30, 2023, were $119.3 million as compared to $172.6 million as of December 31, 2022, which is expected to fund operations into 2025 based on current plans.

•Net loss for the three months ended September 30, 2023, was $16.3 million as compared to $14.5 million for the three months ended September 30, 2022.

Conference Call Information

The Aadi management team is hosting a conference call and webcast today at 8:30 am ET (5:30 am PT) to provide a

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PRESS RELEASE

Exhibit 99.1

Aadi Bioscience Announces Financial Results for the Second Quarter 2023 and Provides

Corporate Update

Continued growth in total revenue on FYARRO® with sales of $6.2 million for 2Q 2023

On-track for interim analysis on 40 patients in PRECISION1 trial before the end of 2023

Expanding pipeline to include programs in Endometrial Cancer and Neuroendocrine Tumors (NETs)

Conference call to be held today at 8:30 am EST

LOS ANGELES, CA, August 9, 2023 – Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, today provided a corporate update and announced financial results for the second quarter of 2023.

“We are seeing continued growth in FYARRO sales and are pleased with the positive feedback we are receiving from the treatment community,” said Scott Giacobello, Interim CEO and President and CFO of Aadi. “The PRECISION1 trial is progressing well, and we are looking forward to providing results of an interim analysis on 40 patients with appropriate follow-up before the end of the year. We expect to complete enrollment as planned in the spring of 2024.”

“With PRECISION1 on track, we are excited to announce the expansion of our pipeline to further investigate mTOR pathway inhibition in endometrial cancer and NETs,” continued Giacobello. “We are encouraged by the positive feedback received from clinicians, and we believe our preclinical data supporting these programs is promising. We look forward to harnessing the unique pharmacology of nab-sirolimus, both in combination and as monotherapy, to provide enhanced therapeutic benefit in these indications with meaningful patient populations and high unmet need.”

Second Quarter 2023 Updates and Recent Operational Highlights

•Interim analysis from PRECISION1 expected before the end of 2023. An interim analysis from the tumor agnostic PRECISION1 trial on 40 patients with appropriate follow-up is on track with data expected before the end of 2023. Enrollment continues to be well-balanced between the two arms, and as previously reported, more than 15 discrete tumor types have been enrolled, supporting the thesis that TSC1 and TSC2 alterations occur broadly across different solid tumors.

•FYARRO net product sales were $6.2 million in the second quarter, reflecting growth of approximately 6% over Q1 2023 and 80% over the prior year quarter.

•Planned initiation of Phase 2 combination trial in endometrial cancer. The Company is initiating a Phase 2 trial investigating the combination of nab-sirolimus with letrozole for the treatment of advanced or recurrent endometrioid-type endometrial cancer (EEC). This is a Phase 2 open-label, multi-institutional study to evaluate the efficacy and safety of nab-sirolimus and letrozole in patients with advanced or recurrent endometrioid endometrial carcinoma. Prior clinical studies with mTOR inhibitors and letrozole in endometrial cancer patients have yielded promising results. In preclinical models, intravenous nab-sirolimus demonstrates significantly higher tumor growth inhibition, intra-tumoral drug accumulation, and greater mTOR target suppression compared with oral inhibitors. The Company is exploring whether the combination of nab-sirolimus with endocrine therapy may produce synergistic anti-tumor activity in patients with EEC. Initiation of this trial is expected in the fourth quarter of 2023.

•Planned initiation of Phase 2 study in neuroendocrine tumors (NETs). The Phase 2 study is a multicenter, open-label, single-arm trial that is evaluating adult patients with functional or non-functional, well-differentiated, locally advanced unresectable or metastatic NETs of the GI tract, lung, or pancreas who have received no more than two prior lines of therapy. In preclinical animal models, nab-sirolimus demonstrated improved target suppression relative to similar weekly doses of sirolimus and everolimus, supporting further exploration of nab-sirolimus in NETs. Initiation of this trial is expected in the fourth quarter of 2023.

•Initiated Phase 1/2 trial in KRASG12C in collaboration with Mirati Therapeutics. The first patient has been dosed in a Phase 1/2 trial evaluating the combination of adagrasib with nab-sirolimus in this collaborative study. The open-label Phase 1/2 trial is intended to determine the optimal dose and recommended Phase 2 dose in patients with KRASG12C mutant solid tumors.

•Multiple posters presented at ASCO Annual Meeting 2023. Aadi presented a company-sponsored TIP update from the PRECISION1 Phase 2 study and combination data of nab-sirolimus and pazopanib (PAZO) from an ongoing Investigator Initiated Trial at ASCO 2023. The posters are available on the investor relations page of the Aadi website at www.aadibio.com.

Second Quarter 2023 Financial Results

•Total revenue res

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PRESS RELEASE

Exhibit 99.1

Aadi Bioscience Announces Financial Results and Operational Update for the

First Quarter 2023 and Provides Update on PRECISION 1 Tumor Agnostic Trial

Total 1Q 2023 revenue on FYARRO® sales of $5.9 million

PRECISION 1 tumor agnostic trial enrolling equally in TSC1 and TSC2 arms with more than 15 discreet tumor types represented

Interim analysis on 40 patients with appropriate follow-up in PRECISION 1 trial expected by end of 2023

Conference call to be held today at 8:30 am EDT

LOS ANGELES, CA, May 10, 2023 – Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, today announced financial results for the first quarter of 2023 and provided an initial update on the tumor-agnostic PRECISION 1 trial, a registration-directed Phase 2 study of nab-sirolimus in patients with solid tumors with pathogenic inactivating alterations in TSC1 or TSC2 genes.

“We are excited about the uptake of FYARRO and its continued sales growth after our first year on the market and believe we are operating from a position of strength with solid cash balances into 2025,” said Scott Giacobello, Interim CEO and President and CFO of Aadi. “We are also encouraged by initial PRECISION 1 enrollment data, indicating more than 15 different tumor types on study, shaping the foundation for a truly tumor agnostic trial. We believe in the potential of this study and given the importance of maintaining its integrity, we will provide the results of an efficacy analysis later in the year when response data is unblinded in conjunction with a pre-planned interim analysis on 40 patients with appropriate follow-up.”

First Quarter 2023 Updates and Recent Operational Highlights

•Based on initial information from the PRECISION 1 trial, enrollment is well-balanced, and the trial is accruing evenly between the TSC1 and TSC2 arms. More than 15 discreet tumor types have been enrolled with no more than three of any type, supporting the thesis that TSC1 and TSC2 alterations occur broadly across different solid tumors. A pre-planned interim analysis on 40 patients with appropriate follow-up is expected by the end of 2023.

•FYARRO net product sales were $5.9 million in the first quarter, continued double-digit growth of 12% quarter-over-quarter.

•The appointment of Mohammad Hirmand, M.D., to Board of Directors. Dr. Hirmand, previously Chief Medical Officer of Turning Point Therapeutics prior to its acquisition by BMS, is the co-founder of Avenzo Therapeutics, Inc., and serves as executive vice president and chief medical officer of this privately held biotechnology company focused on oncology therapeutics.

•Multiple presentations at AACR Annual Meeting 2023. Aadi presented an encore trials-in-progress (TIP) poster for the ongoing PRECISION 1 trial; results on the anti-tumor activity of nab-sirolimus in combination with KRASG12C inhibitors in xenograft models; and results of a biomarker analysis from AMPECT correlating response to nab-sirolimus with TSC1 and TSC2 inactivating alterations. The AACR posters can be found here on the Aadi website.

•Multiple presentations at SGO Annual Meeting 2023. Aadi presented a TIP poster for the ongoing PRECISION 1 trial and additional data with nab-sirolimus from its AMPECT trial at SGO 2023. The SGO posters can be found here on the Aadi website.

•Upcoming presentations at ASCO Annual Meeting 2023. Aadi will present a company-sponsored TIP update from the PRECISION 1 Phase 2 study and combination data of nab-sirolimus and pazopanib (PAZO) from an ongoing Investigator Initiated Trial at ASCO 2023, taking place June 2-6, 2023, in Chicago. Following Aadi's presentation at ASCO, the posters will be made available on the investor relations page of the Aadi website at www.aadibio.com.

•Initiation of Phase 1/2 trial in KRASG12C is expected to begin with first patient dosing in the second quarter of 2023. The study will evaluate the combination of adagrasib with nab-sirolimus in collaboration with Mirati Therapeutics. The open-label Phase 1/2 trial is intended to determine the optimal dose and recommended Phase 2 dose in patients with KRASG12C mutant solid tumors.

First Quarter 2023 Financial Results

•Total revenue resulting from sales of FYARRO for the quarter ended March 31, 2023 was $5.9 million. This compares to the prior year period of $2.3 million and $5.2 million in the fourth quarter 2022.

•Cash, cash equivalents and short-term investments as of March 31, 2023 were $151.2 million as compared to $172.6 million as of December 31, 2022, which is expected to fund operations into 2025 based on current plans.

•Net loss for the three months ended March 31, 2023 was $15.2 million as compared to $13.9 million for the three months ended March 31, 2022.

Conference Call Information

The Aadi man

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Exhibit 99.1

Aadi Bioscience Announces Financial Results for the Fourth Quarter and Full-Year 2022 and Provides Corporate Update

Total revenue on FYARRO® sales of $15.2 million for FY 2022

PRECISION 1 trial preliminary data expected in the second quarter of 2023

Conference call to be held today at 8:30 am EDT

LOS ANGELES, CA, March 28, 2023 – Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, today provided a corporate update and announced financial results for the fourth quarter and full-year 2022.

“2022 was a year marked by successive milestones with the launch of FYARRO, the start of the PRECISION 1 trial, strengthening our balance sheet with a $72.5 million financing, taking our cash runway into 2025, and collaborating on a new combination of nab-sirolimus with Mirati’s adagrasib,” said Scott Giacobello, CFO and interim President and CEO of Aadi Biosciences. “We look forward to another year of advancements as we enter 2023 including the progression in our first collaboration, which is expected to initiate in the second quarter. As planned, we will provide preliminary data on patients in the PRECISION 1 trial in the second quarter of 2023.”

Fourth Quarter 2022 Updates and Recent Operational Highlights

•FYARRO net product sales were $5.2 million in the fourth quarter, or 23% growth quarter-over-quarter, and were $15.2 million for full-year 2022, representing 10 months of sales.

•Continued advancement of the PRECISION 1 registrational-directed trial in patients with tumor agnostic TSC1 and TSC2 inactivating alterations is advancing with continued enrollment and the Company plans to provide preliminary data on a meaningful number of patients in the second quarter of 2023.

•Announced the appointment of Mohammad Hirmand, M.D., Board of Directors. Dr. Hirmand is the co-founder of Avenzo Therapeutics, Inc., and serves as executive vice president and chief medical officer of this privately held biotechnology company focused on oncology therapeutics. Previously, Dr. Hirmand served as executive vice president and chief medical officer of Turning Point Therapeutics, a publicly traded precision oncology company, where he was responsible for clinical development, clinical operations and regulatory affairs, from December 2019 until its acquisition by Bristol Myers Squibb in August 2022.

•Closed on a $72.5M financing during the fourth quarter, extending the Company’s cash runway into 2025.

•Signed a clinical collaboration agreement during the fourth quarter with Mirati Therapeutics on combination of adagrasib with nab-sirolimus. The Phase 1/2 trial is expected to begin in the second quarter of 2023.

Fourth Quarter and Full-year 2022 Financial Results

•Cash, cash equivalents and short-term investments as of December 31, 2022 were $172.6 million as compared to $148.9 million as of December 31, 2021, which is expected to fund operations into 2025 based on current plans.

•Total revenue for the quarter ended December 31, 2022 was $5.2 million, and $15.2 million for the full-year ended December 31, 2022, resulting from sales of FYARRO.

•Net loss for the three months ended December 31, 2022 was $13.9 million as compared to $16.0 million for the three months ended December 31, 2021. Net loss for the full-year 2022 ended December 31, 2022 was $60.5 million, as compared to $110.1 million for the period in 2021 (The prior year included the non-cash impairment charge of $74.2 million related to the acquired contract intangible asset incurred in conjunction with the Aerpio merger).

Conference Call Information

The Aadi management team is hosting a conference call and webcast today at 8:30 am ET (5:30 am PT) to provide a corporate update and discuss results for the fourth quarter and full-year 2022.

Participants may access a live webcast of the call on the “Investors & News” page of the Aadi Biosciences 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 FYARRO®

FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

About the PRECISION 1 Trial

The PRECISION 1 trial is a multi-center, open-label, tumor-agnostic pivotal study, of nab-sirolimus designed as a basket trial that will evaluate approximately 120 adult and adolescent patients with solid tumors harboring pathogenic inactivating alterations in TSC1

EX-99.1

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EX-99.1

EX-99.1

Exhibit 99.1

Aadi Bioscience Announces Financial Results for the Third Quarter of 2022 and Provides Corporate Update

Completed $72.5 million PIPE financing extending cash runway into 2025

PRECISION 1 trial on-track with preliminary data expected in the first half of 2023

24% revenue growth of FYARRO® (nab-sirolimus) over the second quarter 2022

Appointment of Neil Desai to Executive Chairman and transition of Brendan Delaney to CEO effective January 1, 2023

Conference call to be held today at 8:30 am ET

LOS ANGELES, CA, November 9, 2022 – Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, today provided a corporate update and announced financial results for the third quarter of 2022.

“The last several months have been transformational for Aadi, most recently having strengthened our balance sheet with a $72.5 million PIPE financing. In addition, we saw continued progress in patient enrollment for the PRECISION 1 trial targeting TSC1 and TSC2 inactivating alterations, and we anticipate providing preliminary data on a meaningful number of patients from PRECISION 1 in the first half of 2023,” said Neil Desai, Ph.D., Founder and Chief Executive Officer of Aadi. “We also expanded our pipeline through the recent clinical collaboration with Mirati to explore the combination of nab-sirolimus with the KRAS inhibitor adagrasib, which we believe could potentially overcome tumor resistance.”

“We have made great progress in the last year, positioning us well for the next phase of growth. In preparation for the advancements to come, we are also realigning our management structure. We announced last evening that I am moving into the role of Executive Chairman while our current COO, Brendan Delaney, will transition to President and CEO,” continued Desai. “Brendan’s proven expertise, committed leadership and broad strategic vision have been key drivers of our success. Going forward, Brendan will assume leadership of the Company while my personal focus will turn toward advancement of our scientific initiatives.”

Brendan Delaney, current Chief Operating Officer of Aadi commented, “It’s such an exciting time at Aadi, and I couldn’t be more pleased with the execution our team has demonstrated. I am honored to have been selected to lead this organization as we move forward and execute on the strategies that will support further growth. Our oncology franchise is growing, and I believe we are well-positioned to achieve our goal of becoming a leading precision oncology company that delivers on providing therapeutic benefit to patients in need.”

Corporate Updates for the Third Quarter 2022 and Recent Highlights

•

Closed on a $72.5M financing and extended cash runway into 2025. The proceeds from the financing will be used to support the continued advancement of the PRECISION 1 trial and growing FYARRO commercial efforts, and to fund research and development of additional clinical opportunities with FYARRO and for working capital and general corporate purposes.

•

Continued advancement of the PRECISION 1 registrational-directed trial. The PRECISION 1 Phase 2 trial in patients with tumor agnostic TSC 1 and 2 inactivating mutations is advancing and on track to deliver preliminary data in the first half of 2023.

•

Grew FYARRO net product sales. For the three months ended September 30, 2022, net product sales of FYARRO showed continued growth, ending with $4.2 million in sales in the third quarter, a 24% increase over the second quarter.

•

Leadership transition. Current CEO, Dr. Neil Desai, has been appointed Executive Chairman, effective January 1, 2023. Current COO, Brendan Delaney, will transition to President and CEO, and will be joining the board of directors, effective January 1, 2023.

•

Signed a clinical collaboration agreement with Mirati Therapeutics on combination of adagrasib with nab-sirolimus. The companies will conduct an open-label Phase 1/2 trial to determine the optimal dose and recommended Phase 2 dose for the combination of adagrasib and nab-sirolimus in patients with KRASG12C - mutant solid tumors. The trial builds on preclinical data showing enhanced anti-tumor efficacy with the combination of adagrasib and nab-sirolimus relative to either agent alone. Initiation of the Phase 1/2 trial is expected in the first half of 2023.

•

Presented combination data of KRAS inhibitors and nab-sirolimus

at the 34th EORTC-NCI-AACR Symposium. The results of these studies showed that combining nab-sirolimus with either of the KRASG12C inhibitors sotorasib or adagrasib significantly improved response against KRASG12C mutant lung cancer and bladder cancer tumors in vivo and nab-sirolimus also showed significantly greater potency in the combination compared to everolimus.

Third Quarter 2022 Financial Results

•

Cash, cash eq

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EX-99.1

Exhibit 99.1

Aadi Bioscience Announces Financial Results for the Second Quarter of 2022 and Provides Corporate Update

FYARRO® (nab-sirolimus) net product sales reached $3.4 million for the second quarter of 2022

PRECISION 1 Phase 2 tumor-agnostic registration-directed trial continues enrollment and rapid site activation at major cancer centers and large community networks; preliminary data expected 1H23

Conference call to be held today at 8:30 am EDT

LOS ANGELES, CA, August 10, 2022 – Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, today provided a corporate update and announced financial results for the second quarter of 2022.

“We continue to progress in key areas after our first full quarter following FYARRO’s launch. We are excited to see FYARRO reaching more patients through continued account adoption and steady growth in overall sales,” said Neil Desai, Ph.D., Founder, President and Chief Executive Officer of Aadi. “We are also encouraged by the progress on our tumor agnostic PRECISION 1 trial targeting TSC1 and TSC2 inactivating alterations which continues to ramp up, with activation of additional clinical trial sites and patient enrollment. We anticipate providing preliminary data on a meaningful number of patients in this trial during the first half of 2023. In addition, we continue to evaluate strategies for new clinical indications of nab-sirolimus either as single agent or in combination with other targeted therapies with the potential for new programs as early as 2023.”

Corporate Updates for the Second Quarter 2022

•

FYARRO net product sales for the three months ended June 30, 2022 were $3.4 million, the first full quarter of sales following the product launch late in the first quarter.

•

A product-specific permanent J-code (J9331) for FYARRO from Centers for

Medicare and Medicaid Services (CMS) became effective on July 1, 2022. This code is expected to further facilitate reimbursement for FYARRO.

•

The Company announced its addition to both the U.S. small cap Russell 2000® Index and broad-market Russell 3000® Index at the conclusion of the 2022 Russell indexes annual reconstitution, which captures the 4,000 largest U.S. stocks, ranking them by total market capitalization.

•

Partnerships with prominent next generation sequencing (NGS) providers and leaders in genomic testing and profiling was announced during the quarter, which included Foundation Medicine, Tempus and others. The Company is leveraging these partnerships to expedite patient identification and recruitment for the ongoing PRECISION 1 trial of nab-sirolimus in patients harboring tumors with inactivating alterations in TSC1 or TSC2 genes, and is making significant progress toward opening the trial in at least 20 major cancer centers and upward of 120 treatment sites in the U.S. by the end of 2022.

•

A poster presentation entitled, “nab-Sirolimus for patients with advanced malignant PEComa with or without prior mTOR inhibitors: Biomarker results from AMPECT and an expanded access program” was presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The data included exploratory biomarker results reported from the final analysis of mTOR inhibitor-naïve advanced malignant PEComa patients treated with nab-sirolimus in the Advanced Malignant PEComa Trial (AMPECT) trial as well as an analysis of prior mTOR inhibitor exposed advanced malignant PEComa patients treated with nab-sirolimus in the Expanded Access Program (EAP) through June 2021. Findings from both the AMPECT study and the EAP showed greater clinical benefit in patients with TSC1 or TSC2 inactivating alterations who received nab-sirolimus compared to all evaluable patients, regardless of prior mTOR inhibitor exposure.

•

The Company sponsored a poster at the Annual Meeting of the American Association for Cancer Research (AACR) which indicated the incidence of advanced cancer patients carrying TSC1 or TSC2 inactivating gene alterations numbered approximately 12,000 annually in the US, thus potentially rendering these patients eligible for nab-sirolimus therapy.

Second Quarter 2022 Financial Results

•

Cash and cash equivalents on June 30, 2022 were $118.7 million, compared to $149.0 million as of December 31, 2021. Based on current plans, the Company expects cash and cash equivalents to fund operations into 2024.

•

Total revenue for the quarter ended June 30, 2022 was $3.4 million resulting from sales of FYARRO.

•

In the second quarter of 2022, the Company recorded a non-cash impairment charge of $3.7 million to write-off the value of an intangible asset related to the Gossamer license agreement with the Company’s predecessor, Aerpio.

•

Net loss for the three months ended June 30, 2022 was $18.3 million compared to $1.5 million for the

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Exhibit 99.1

Aadi Bioscience Reports First Quarter 2022 Financial Results and Provides a Corporate Update

•

FYARRO net product sales of $2.3 million in partial first quarter

•

Dosing of patients initiated in PRECISION 1, a Phase 2 tumor-agnostic registration-directed trial evaluating nab-sirolimus in TSC1 or TSC2 altered solid tumors

LOS ANGELES, CA, May 12, 2022 – Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced financial results for the first quarter of 2022 and provided a corporate update.

“We are very pleased and encouraged by the strong demand for FYARRO since its February 22nd launch despite the ultra-rare nature of advanced malignant PEComa,” commented Neil Desai, Ph.D., Founder, President and Chief Executive Officer of Aadi. “A number of factors are believed to have contributed to the sales in Q1 including pent up demand since FYARRO’s approval on November 22, 2021, transition of expanded access and clinical trial patients to the commercial drug, significant physician awareness and favorable reimbursement,” he added.

Dr. Desai continued, “Our clinical team has been focused on advancing nab-sirolimus and the first patient was dosed in our PRECISION 1 tumor-agnostic registration-directed trial in March. Based on data recently presented at AACR, TSC1 and TSC2 genetic alterations within tumors represent one of the larger opportunities within targeted oncology. We have also partnered with large community oncology center networks and next generation sequencing (NGS) providers to identify these patient candidates for our trial, which we believe will augment the pace of enrollment in the PRECISION 1 trial. We anticipate initial clinical data to be available in the first half of next year.”

Recent and First Quarter 2022 Corporate Highlights

•

In May, Aadi was granted a product-specific permanent J-code (J9331) for FYARRO that will become effective on July 1, 2022. This code is expected to further facilitate reimbursement for the drug.

•

Also in May, Aadi announced a partnership with NGS providers and leaders in genomic testing and profiling, including Foundation Medicine, Tempus and others, to assist with identifying patients for its PRECISION 1 trial. Aadi plans to leverage these partnerships and others to expedite patient recruitment and increase physician familiarity with FYARRO.

•

Aadi announced a poster presentation at the Annual Meeting of the American Association for Cancer Research (AACR), held April 8-13, 2022 in New Orleans, LA. The project determined the incidence of advanced cancer patients on an annual basis carrying TSC1 or TSC2 alterations and characterized approximately 12,000 patients who may carry “definite impact” mutations (frameshift, nonsense, splice-site mutations and deep deletions). These data confirmed Aadi’s initial projections on the size of the patient population that could be addressed by a potential nab-sirolimus tumor-agnostic therapy. The study also found that TSC1 alterations were most frequent in bladder, kidney, and lung squamous cell cancers, while TSC2 alterations were most frequent in hepatobiliary, ovarian cancers, and soft tissue sarcomas.

•

In April, Aadi opened an additional office location in Morristown, New Jersey.

•

In March, Aadi dosed its first patient in its Phase 2 tumor-agnostic registration-directed trial, PRECISION 1, to evaluate nab-sirolimus in adult and adolescent patients 12 years and older with solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. The trial consists of two separate arms of 60 patients each for TSC1 or TSC2 alterations. Initial clinical data from PRECISION 1 are expected in the first half of 2023.

•

In February, Aadi announced the launch and commercial availability of FYARRO (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant PEComa.

•

Also in February, FYARRO was added to the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN® Guidelines) as the only preferred treatment regimen for malignant PEComa.

First Quarter 2022 Financial Highlights

As of March 31, 2022, cash and cash equivalents totaled $129.8 million, compared to $149.0 million as of December 31, 2021. Based on our current plans, we expect cash and cash equivalents to fund operations into 2024.

For the three months ended March 31, 2022, net product sales were $2.3 million resulting from the launch of FYARRO in February. This compares to $0.1 million of grant revenue during the three months ended March 31, 2021. No grant revenue was recognized during the three months ended March 31, 2022.

Operating expenses for the three months ended March 31

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EX-99.1

Exhibit 99.1

Aadi Reports Fourth Quarter and Full Year 2021 Financial Results

and Provides Business Update

-FYARRO™ approved November 22, 2021 and launched February 23, 2022-

-FYARRO added to NCCN® Guidelines as the only preferred therapy to treat malignant PEComa-

-PRECISION 1 tumor agnostic study for TSC1 or TSC2 alterations open for enrollment-

-Ended fourth quarter 2021 with $149.0 million in cash and cash equivalents-

LOS ANGELES, March 17, 2022 – Aadi Bioscience, Inc. (“Aadi”) (Nasdaq: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a business update.

“We are well-positioned in 2022 with a strong team, a solid balance sheet, and a highly promising recently approved drug,” stated Neil Desai, Ph.D., Founder, President and Chief Executive Officer of Aadi. “With our recent launch of FYARRO and a new tumor-agnostic registrational trial for nab-sirolimus underway, Aadi is on track with our previously outlined goals and our vision of offering a new cancer treatment to underserved patient populations.”

FYARRO: Recent Highlights

•

In February 2022, Aadi announced the launch and commercial availability of FYARRO (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant PEComa.

•

FYARRO (also known as nab-sirolimus) was added to the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN® Guidelines) as the only preferred treatment regimen for malignant PEComa.

•

A seasoned commercial team has been hired to call on key centers of excellence that target the majority of the malignant PEComa U.S. patient population, and a distribution network has been established to support the launch of FYARRO. Payer coverage is tracking positively, and product orders have already been received and sent to patients in need.

•

Aadi opened enrollment for its Phase 2 tumor-agnostic registrational trial, PRECISION 1, to evaluate nab-sirolimus in adult and adolescent patients 12 years and older with solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes in February 2022. The trial consists of two separate arms for TSC1 or TSC2 alterations. Initial clinical data from PRECISION 1 are expected in the first half of 2023.

2021 Corporate Development and Operational Highlights

FYARRO Approval

•

On November 22, 2021, Aadi received U.S. Food and Drug Administration (FDA) approval of its first proprietary product. FYARRO is the first and only FDA-approved treatment for advanced malignant PEComa in adults and was approved in less than four months after the NDA acceptance, and priority review designation was announced on July 26, 2021.

Merger Completion and Public Listing on Nasdaq

•

On August 26, 2021, Aadi completed its merger with Aerpio Pharmaceuticals, Inc. (“Aerpio”), a publicly traded biotechnology company (previously traded on the Nasdaq Global Select Market under “ARPO”), and the combined company began trading on the Nasdaq Capital Market as “AADI” post-merger. As part of the merger, each share of private Aadi common stock was converted into the right to receive 0.3172 shares of Aerpio common stock following a 15:1 reverse split of Aerpio’s common stock.

•

Concurrent to the closing of the merger, the combined company closed the previously announced $155 million private investment in a public equity (PIPE) financing of its common stock.

Board and Leadership: Key Appointments

•

Aadi’s board and leadership team were strengthened with the following appointments in 2021:

•

Emma Reeve was appointed to Aadi’s Board of Directors and as chair of the Audit Committee. Ms. Reeve brings over 25 years of value creation in pharmaceutical, medical device and bio-pharma service companies and a successful track record of transitioning companies from private to public.

•

Brendan Delaney was appointed to the role of Chief Operating Officer. Mr. Delaney has had an established career in oncology-focused commercial leadership roles, launching multiple groundbreaking new products and building effective and cohesive commercial teams. As Chief Commercial Officer at Immunomedics, Inc., Brendan led the launch of TRODELVY®, the first TROP-2 directed antibody-drug conjugate for the treatment of triple-negative breast cancer. Immunomedics was acquired by Gilead Sciences, Inc. for $21 billion.

•

Scott M. Giacobello, CPA, was appointed to the role of Chief Financial Officer and Treasurer. Most recently, Mr. Giacobello was the Chief Financial Officer of GW Pharmaceuticals plc until its $7.2 billion acquisition by Jazz Pharmaceuticals.

•

Loretta M. Itri, M.D., FACP® was appointed