Table of Contents WHITEHAWK THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number: 00 ...

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. Recent Operational Highlights: Secon ...

Forward-Looking Statements Certain statements contained in this presentation regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Act of 1995, known as the PSLRA. These include statements regarding management's intention, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. Forwar ...

Summary of Whitehawk Therapeutics Fireside Chat - June 26, 2025 Company Overview - Whitehawk Therapeutics, formerly known as Adi Bioscience, underwent a transformation completed in Q1 2025, focusing on developing an advanced ADC (antibody-drug conjugate) portfolio after selling its mTOR inhibitor product to Kaken Pharmaceuticals for $100 million [3][4][15]. Pipeline and Technology - The company is developing a three-asset ADC portfolio targeting various cancers, including lung, ovarian, and gastrointestinal cancers, with a focus on established tumor biology and clinically validated tumor markers [4][5][14]. - All three programs are currently in preclinical stages, with IND (Investigational New Drug) filings anticipated by mid-2026 [6][13]. - The ADC platform utilizes a linker payload technology designed for greater stability, reduced off-target toxicity, and improved therapeutic index [5][12][13]. Key Programs 1. **HAWK 007 (PTK7-targeted ADC)** - PTK7 is broadly overexpressed in various solid tumors, with expression rates of 60-70% in cancer patients [20][21]. - The program aims to demonstrate differentiation from previous compounds, with a focus on lung cancer, ovarian cancer, and triple-negative breast cancer [24][26]. - Initial phase one trials will target patients with moderate to high expression of PTK7, aiming for a minimum response rate of 40% in lung cancer and 50% in ovarian cancer [56]. 2. **HAWK 016 (MUC16-targeted ADC)** - MUC16 is a circulating biomarker in ovarian cancer, with the approach focusing on targeting the membrane-bound portion to avoid complications from circulating biomarkers [60][63]. - The program will initially focus on gynecological cancers, with potential expansion into pancreatic and non-small cell lung cancers in the future [70]. 3. **HAWK 206 (SEZ6-targeted ADC)** - This program is in the early stages, with a biparatopic approach aimed at enhancing internalization and efficacy in neuroendocrine tumors and small cell lung cancer [71][78]. Competitive Landscape - The ADC market is competitive, with other companies like Zymeworks and Day One Pharmaceuticals developing next-generation ADCs. Whitehawk believes its platform offers superior optimization in terms of linker stability, hydrophilicity, and therapeutic index [36][46]. - The company aims to differentiate its products by demonstrating better efficacy and safety profiles compared to existing therapies [30][46]. Financial Position and Future Outlook - Whitehawk started Q2 2025 with approximately $185 million in cash, providing operational runway into early 2028 to generate clinical data before seeking additional funding [88][90]. - The company plans to release more preclinical data in 2026, focusing on a comprehensive view of its products' potential before public disclosures [89][90]. Conclusion - Whitehawk Therapeutics is positioned to make significant advancements in the ADC space with its innovative platform and targeted therapies. The upcoming IND filings and clinical trials will be critical in validating its approach and establishing its market presence.

Summary of Whitehawk Therapeutics Conference Call Company Overview - **Company Name**: Whitehawk Therapeutics (formerly Adi Biosciences) [4] - **CEO**: Dave Lennon [2] - **Focus**: Advanced Antibody-Drug Conjugates (ADCs) targeting various cancers [2][4] Key Developments - **Strategic Transactions**: - In-licensed three ADCs from Ushia Biologics [4] - Divested Fiaro to Kaken Pharmaceuticals [4] - Completed a $100 million PIPE financing [4] - **Transition to Whitehawk**: The company relaunched as Whitehawk Therapeutics in March 2025, focusing on ADC therapeutics [4][5] ADC Portfolio - **Portfolio Composition**: Three ADC assets targeting validated tumor markers: PTK7, MUC16, and SCC6 [8][9] - **Clinical Strategy**: - All three INDs (Investigational New Drug applications) expected to be filed by mid-2026 [7][17] - Cash reserves of approximately $185 million to fund operations into 2028 [7] Targeted Tumor Markers 1. **PTK7**: - Overexpressed in various tumors, particularly in non-small cell lung cancer and gynecological cancers [9][18] - No approved ADCs targeting PTK7 currently exist [9] - Expected to have a significant patient population, with 60-70% of patients expressing PTK7 during their cancer journey [18] 2. **MUC16**: - Targets a glycoprotein overexpressed in female-origin tumors, including ovarian cancer [10][21] - Previous studies by Genentech showed high response rates but required high doses due to the antigen sink effect [21][22] - Whitehawk's approach targets the membrane-bound portion to avoid this effect [22] 3. **SCC6**: - Targets a CNS-limited protein overexpressed in neuroendocrine tumors, particularly small cell lung cancer [11][24] - Whitehawk plans to utilize a biparatopic approach to enhance efficacy and safety [25] Technology Platform - **CPT113**: Advanced ADC technology platform with a proprietary TOPO-one inhibitor payload and stable linker chemistry [12][13] - **Advantages**: - Improved stability and reduced off-target toxicity compared to first-generation ADCs [13][14] - Expected efficacy gains of 15-30% over existing therapies [16] Market Potential - **Expansion Opportunities**: Significant unmet needs in targeted cancers, with potential for expansion into various indications [17][18] - **Competitive Landscape**: Acknowledgment of competition from other ADCs, particularly from AbbVie, but with a focus on improving safety and efficacy profiles [34] Financial Outlook - **Cash Runway**: Sufficient funds to support operations and clinical trials through early 2028 [27][41] - **Future Funding**: No plans to raise additional funds until clarity on the portfolio's next steps is achieved [43] Conclusion - Whitehawk Therapeutics is positioned to leverage its advanced ADC technology and validated tumor targets to address significant unmet needs in cancer treatment, with a well-capitalized structure to support its clinical development plans [26][27]

Summary of Whitehawk Therapeutics FY Conference Call Company Overview - **Company Name**: Whitehawk Therapeutics - **Background**: Whitehawk Therapeutics was formed from the previous company Adi Biosciences, which commercialized an mTOR inhibitor called Fiaro, generating approximately $25 million in annual sales in the US. The company underwent a transformation by selling Fiaro to a Japanese pharmaceutical company and raised about $250 million to license a portfolio of antibody-drug conjugates (ADCs) for oncology treatments [4][5][6]. Core Points and Arguments - **Focus on Oncology**: Whitehawk is focused on developing a portfolio of ADCs for various cancers, marking its first participation in the ASCO conference as a newly branded entity [4][6]. - **Strategic Partnerships**: The company partnered with WuXi Biologics and Hangzhou DAC to access innovative ADC platforms, paying $44 million upfront for three next-generation ADC assets [10][12]. - **Technology Differentiation**: The ADC platform is differentiated by its targeting approach, linker system, and payload delivery, which are optimized for stability and efficacy [15][16][20]. - **Clinical Development**: Whitehawk plans to bring its ADC portfolio into clinical trials over the next year, with IND filings for three ADCs (HAWK007, MUC16, and SCC6) planned in rapid succession [6][41][42]. Important Insights - **Market Opportunity**: There is significant unmet need in the oncology space, particularly for patients with EGFR wild-type lung cancer, where ADCs have not yet made substantial inroads [28][30]. - **Precedent Data**: The three ADC targets (PTK7, MUC16, and SCC6) have shown promising efficacy signals in previous programs, which were discontinued due to safety concerns with first-generation ADCs [39][40]. - **Potential for Best-in-Class**: Whitehawk believes its next-generation ADCs can outperform existing therapies, with the potential for improved overall response rates and progression-free survival [46][51]. - **Focus on Specific Indications**: The company aims to build on existing data by focusing on specific indications, such as lung and ovarian cancer, rather than a broad approach, to demonstrate efficacy [50][51]. Additional Noteworthy Content - **Clinical Experience**: Early data from Hangzhou DAC's internal programs indicate good tolerability and potency, which supports Whitehawk's investment in this platform [32][33]. - **Payload Variations**: The company is utilizing a proprietary topoisomerase inhibitor payload, which is believed to have a better safety profile compared to existing options [25][26]. - **Future Directions**: Whitehawk is considering expanding its focus to include endometrial cancer due to high expression levels of PTK7 and unmet medical needs in that area [52][53]. This summary encapsulates the key points discussed during the conference call, highlighting Whitehawk Therapeutics' strategic direction, technological innovations, and market opportunities in the oncology sector.

Company Strategy & Portfolio - Whitehawk Therapeutics is transitioning into an ADC-focused company, leveraging advanced ADC technology and targeting significant patient populations[6, 7] - The company's portfolio includes three assets (HWK-007, HWK-016, and HWK-206) rapidly progressing to clinical trials, with all three INDs anticipated in the next 15 months[7, 9] - Whitehawk's ADC platform is engineered for minimal off-target toxicity, greater stability, and a higher therapeutic index[9, 12] ADC Technology & Efficacy - Whitehawk utilizes a proprietary TOPO1 inhibitor payload and a highly stable, cleavable linker to improve the therapeutic index of its ADCs[13] - Switching to an advanced ADC platform technology delivers efficacy gains compared to 1st generation ADCs, as demonstrated by increased Overall Response Rates (ORR) in various cancer indications[17] - For example, in SEZ6 targeting for Small Cell Lung Cancer (SCLC), next-wave ADCs like ABBV-706 achieved a 61% ORR, compared to 19% with 1st generation ADCs[17] Target & Clinical Development - HWK-007 targets PTK7, which is overexpressed in a broad spectrum of cancers, including Non-Small Cell Lung Cancer (NSCLC) and Ovarian cancer, with potential to outperform current ADC benchmarks[20, 29, 31] - HWK-016 targets MUC16, a glycoprotein overexpressed in cancers affecting women, with a Phase 1 trial planned in ovarian cancer[40, 50] - HWK-206 targets SEZ6, a CNS protein upregulated in tumors of neuroendocrine origin, with a Phase 1 trial planned in SCLC and Neuroendocrine Neoplasms (NENs)[55, 65] Financial Outlook - The company's cash runway is expected to fund operations into 2028, including anticipated key clinical data[3, 67]

Financial Performance - FYARRO generated net product sales of $7.1 million for Q1 2025, compared to $5.4 million in Q1 2024, reflecting a 31.6% year-over-year increase[153]. - The company recorded net income of $73.0 million for the three months ended March 31, 2025, primarily due to a gain on the sale of FYARRO, compared to a net loss of $18.3 million for the same period in 2024[179][187]. - Product sales for FYARRO were $7.1 million for the three months ended March 31, 2025, an increase of $1.7 million from $5.4 million in the same period in 2024, driven by stronger demand[180]. - Total operating expenses decreased to $22.4 million for the three months ended March 31, 2025, from $24.9 million in the same period in 2024[179]. - Research and development expenses decreased to $8.8 million for the three months ended March 31, 2025, down from $13.6 million in 2024, primarily due to reduced personnel and clinical development costs[183]. - Selling, general and administrative expenses increased to $12.8 million for the three months ended March 31, 2025, from $10.6 million in 2024, largely due to higher consulting and insurance expenses related to the divestiture of FYARRO[181]. - The accumulated deficit as of March 31, 2025, was $259.6 million, reflecting ongoing losses primarily from research and development and operational costs[187]. - The company expects to continue incurring significant expenses and operating losses in the foreseeable future due to ongoing research and development activities[167][187]. Divestiture and Acquisitions - The FYARRO Divestiture resulted in a cash payment of $102.4 million to the company from KAKEN for the acquisition of Aadi Subsidiary, closing on March 25, 2025[153]. - The divestiture of FYARRO was completed on March 25, 2025, and the company no longer commercializes this product[169]. Research and Development - The company plans to submit three IND applications to the FDA by mid-2026, targeting solid tumors, cancers of female origin, and neuroendocrine cancers[150]. - The company anticipates pursuing multiple cancer indications with high potential in large patient populations through its ADC pipeline[150]. - The company plans to increase investment in research and development related to ADC Therapies, with upfront non-refundable license fees of $6.0 million and $38.0 million paid to WuXi Biologics in 2024 and 2025, respectively[169]. - The company has ongoing contracts for research and development activities, which can be modified or canceled with written notice[205]. Financing Activities - The 2024 PIPE Financing raised $94.5 million through the sale of 21,592,000 shares at $2.40 each and 20,076,500 pre-funded warrants[156]. - The company entered into a Sales Agreement with Cowen for an "at the market offering" of common stock with gross proceeds of up to $75.0 million, with no shares sold as of March 31, 2025[189]. - The Shelf Registration Statement allows the company to sell up to $150.0 million of various securities, providing flexibility for future capital needs[191]. - The 2022 PIPE Financing resulted in the sale of 3,373,526 shares at $12.50 per share, generating net proceeds of $72.2 million after expenses[192]. - Cash provided by financing activities included $100.0 million from the sale of common stock and pre-funded warrants to the 2024 PIPE Investors[200]. Leadership and Organizational Changes - The company appointed David Dornan, PhD, as Chief Scientific Officer, bringing over 20 years of oncology drug discovery experience[155]. - The company changed its name from Aadi Bioscience, Inc. to Whitehawk Therapeutics, Inc. on March 18, 2025, following the FYARRO Divestiture[156]. Cash Flow and Investments - As of March 31, 2025, the company had $231.1 million in cash, cash equivalents, and short-term investments, which is expected to support operations until 2028[167]. - For the three months ended March 31, 2025, cash used in operating activities was $11.9 million, with a net income of $73.0 million and $85.6 million in non-cash adjustments[196]. - Cash provided by investing activities for the same period was $115.5 million, primarily from the sale of business and maturities of short-term investments[194]. - The company entered into a License Agreement with WuXi Biologics, paying $6.0 million and $38.0 million for exclusive rights to certain patents and know-how[206]. Rent and Lease Expenses - The company recorded rent expenses of $0.1 million for both the Pacific Palisades and Morristown leases for the three months ended March 31, 2025[203].

Financial Performance - Total revenue for Q1 2025 was $7.1 million, an increase from $5.4 million in Q1 2024, representing a 32.5% year-over-year growth[7] - Net income for Q1 2025 was $73.0 million, including a gain of $87.4 million from the sale of Aadi Subsidiary, compared to a net loss of $18.3 million in Q1 2024[7] - Basic net income per share for Q1 2025 was $1.84, compared to a loss of $0.68 per share in Q1 2024[16] Cash and Investments - Cash, cash equivalents, and short-term investments as of March 31, 2025, were $231.1 million, up from $47.2 million as of December 31, 2024[7] - The company expects to have approximately $185 million in cash and cash equivalents post-transaction payments, which is anticipated to fund operations into 2028[7] Operational Highlights - Operating expenses for Q1 2025 totaled $22.4 million, a decrease from $24.9 million in Q1 2024[16] - The company completed a $100 million PIPE financing and divested Aadi Subsidiary for $102.4 million[7] - The total assets as of March 31, 2025, were $234.0 million, significantly higher than $70.3 million as of December 31, 2024[14] Development Pipeline - The company aims to bring all three ADC assets to IND by mid-2026, with the first IND expected to be filed in Q4 2025[3] - The ADC portfolio targets PTK7, MUC16, and SEZ6, which are believed to have broad clinical impact potential comparable to established targets like HER2 and TROP2[3]

Financial Performance - For the fiscal year ended December 31, 2024, the company recorded net revenue from product sales of $26.0 million, compared to $24.4 million in the fiscal year ended December 31, 2023, reflecting a growth of 6.6%[558] - The company reported a net loss of $63.7 million for the fiscal year ended December 31, 2024, an improvement from a net loss of $65.8 million in the previous fiscal year[558] - The company recorded royalties on net product sales of $1.9 million for the year ended December 31, 2024, compared to $1.8 million for the year ended December 31, 2023[562] - The company incurred a net loss of $63.7 million for the year ended December 31, 2024, compared to a net loss of $65.8 million in 2023, indicating a slight improvement in financial performance[581] - The company has an accumulated deficit of $332.7 million as of December 31, 2024, reflecting ongoing net losses since inception[571] - Cash used in operating activities for 2024 was $59.6 million, slightly lower than $59.7 million in 2023, driven by net losses and changes in operating assets and liabilities[595][596] - Other income, net for the year ended December 31, 2024, was $3.8 million, a decrease from $6.2 million in 2023, primarily due to a decrease in short-term investments[586] - The company incurred net losses of $63.7 million in 2024 and $65.8 million in 2023, contributing to an accumulated deficit of $332.7 million as of December 31, 2024[588] Research and Development - The company entered into a License Agreement with WuXi Biologics for the development and commercialization of three next-generation antibody drug conjugates (ADCs), with an upfront payment of $6.0 million and an additional $38.0 million expected by April 17, 2025[559] - The ADC Therapies are targeting tumor antigens MUC16, PTK7, and SEZ6, with plans to submit three investigational new drug (IND) applications to the FDA within the next 12 to 24 months[555] - Research and development expenses increased to $51.0 million in 2024 from $48.9 million in 2023, with significant costs related to clinical development and upfront payments to WuXi Biologics[584] - The company expects to pay $38 million in April 2025 for in-licensing ADC Therapies, indicating ongoing investment in research and development[570] - The company anticipates continued significant expenses and operating losses due to ongoing research and development activities related to ADC Therapies[572] Corporate Changes - The company changed its name from Aadi Bioscience, Inc. to Whitehawk Therapeutics, Inc. on March 18, 2025, following the divestiture of the FYARRO Business[559] - The company completed the divestiture of its FYARRO Business for $102.4 million in cash, which closed on March 25, 2025[558] - The arbitration panel ruled in favor of the company, concluding that it did not breach the EOC License Agreement, thus avoiding any liability for damages[561] Cash and Investments - As of December 31, 2024, the company had $47.2 million in cash, cash equivalents, and short-term investments, which increased to approximately $202.4 million by March 26, 2025, following strategic transactions[570] - Cash provided by investing activities in 2024 was $25.2 million, compared to $83.2 million in 2023, reflecting maturities of short-term investments[597][598] - Cash provided by financing activities was $0.1 million in 2024, down from $0.3 million in 2023, primarily related to the employee stock purchase plan[599][600] Expenses - Total operating expenses for the year ended December 31, 2024, were $93.4 million, a decrease from $96.3 million in 2023, primarily due to reduced selling, general, and administrative expenses[581] - Selling, general, and administrative expenses decreased by $7.8 million in 2024, primarily due to reductions in commercial and marketing expenses and personnel costs[583] - Share-based compensation expense for the year ended December 31, 2024, totaled $10.839 million, a decrease from $11.954 million in 2023[617] - Selling, general and administrative expenses related to share-based compensation were $6.782 million in 2024, down from $7.450 million in 2023[617] - Research and development expenses related to share-based compensation were $4.057 million in 2024, compared to $4.504 million in 2023[617] Securities and Offerings - The company has a Sales Agreement with Cowen for an "at the market offering" of up to $75 million, but no shares have been sold under this agreement as of December 31, 2024[589][590] - The Shelf Registration Statement allows the company to sell up to $150 million of various securities, providing flexibility for future capital needs[591] Stock Options and Compensation - As of December 31, 2024, total unrecognized compensation cost related to stock options was $9.9 million, expected to be recognized over a weighted average period of 1.8 years[617] - The intrinsic value of all outstanding stock options as of December 31, 2024, was $1.8 million[618] - The intrinsic value of all outstanding restricted stock units as of December 31, 2024, was $0.8 million[618] - Unrecognized compensation cost related to restricted stock units was $0.4 million, expected to be recognized over a weighted average period of 3.2 years[618] Company Classification - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[620]