Summary of Whitehawk Therapeutics FY Conference Call Company Overview - Whitehawk Therapeutics is an ADC (Antibody-Drug Conjugate) company that recently relaunched from Addy Biosciences, having en-licensed an ADC portfolio from WuXi Biologics targeting validated but not overly crowded tumor targets [3][4] Pipeline and Assets - The company has three assets in total, with two IND filings expected in Q4 2025 and a third in mid-2026, aiming to be a three-clinical asset company by early 2027 [3][4] - Lead asset HWK-007 targets PCK7, a broadly expressing tumor target across various cancers, potentially treating hundreds of thousands of patients [4][5] Market Potential - The PCK7 target is gaining traction in the ADC field, with several companies entering the market [4][5] - HWK-007 is positioned to demonstrate superior activity compared to first-generation compounds, particularly those based on ME or tubulin inhibitors [5][9] Competitive Landscape - Competitors include Xencor and Day One, both advancing next-generation ADCs against similar targets. Whitehawk differentiates itself through unique linker technology that enhances stability and reduces toxicity [9][11] - The company is aware of the challenges faced by competitors, such as high neutropenia rates observed in early data from similar programs [10][11] Trial Design and Biomarker Strategy - Phase one trials will focus on high-profile PCK7 expressing tumors: non-small cell lung cancer, ovarian cancers, and endometrial cancer [15][16] - The biomarker strategy will initially target high expressors in gynecological cancers while allowing for a broader approach in non-small cell lung cancer, aiming to include 85% of the market [18] Additional Assets - HWK-016 targets MUC16, a highly expressed tumor marker in gynecological cancers. Whitehawk's approach targets the membrane-bound portion of MUC16 to avoid issues with circulating biomarkers [20][21] - HWK-206 is designed to improve specificity and internalization using a biparatopic antibody, aiming for a best-in-class profile compared to AbbVie’s compound [34][36] Financial Position - As of Q2, Whitehawk has $178 million in cash, providing operational runway into early 2028, allowing for data release in early 2027 [49][50] Conclusion - Whitehawk Therapeutics is strategically positioned in the ADC market with a robust pipeline and a clear differentiation strategy against competitors. The company is well-funded to advance its clinical trials and aims to generate significant data sets in the near future [49][50]

Summary of Whitehawk Therapeutics FY Conference Call Company Overview - **Company**: Whitehawk Therapeutics (NasdaqCM:AADI) - **Focus**: Development of antibody-drug conjugates (ADCs) targeting various oncology indications, including lung cancer and gynecological cancers [1][2] Strategic Focus and Pipeline - **ADC Candidates**: Three clinical-stage ADC candidates licensed from WuXi Biologics, with plans to enter the clinic within the next six to nine months [2][3] - **Partnership**: Licensing agreement with WuXi Biologics valued at $46 million upfront, with an additional $90 million in development and approval milestones for each asset [4][5] Targeted Programs 1. **HWK-007 (PTK7 Directed ADC)**: - Target: PTK7, a broadly overexpressed tumor antigen with potential applications in lung cancer and gynecological cancers [8][11] - Competitive Landscape: Opportunity to be first or second to market due to limited competition [1] 2. **HWK-016 (MUC16 Targeting ADC)**: - Target: MUC16, associated with the biomarker CA125, prevalent in gynecological cancers [9][15] - Differentiation: New targeting approach to avoid issues faced by previous programs, focusing on the surface portion of MUC16 [15] 3. **HWK-206 (SEZ6 Targeting ADC)**: - Target: SEZ6, relevant for small cell lung cancer and neuroendocrine tumors [20][22] - Competitive Advantage: Utilizing a biparatopic antibody for better internalization and a stable linker payload for improved safety [21][22] Clinical Development and Expectations - **Initial Data Goals**: Aim to demonstrate differentiation in early phase one trials, targeting a 40% overall response rate in non-small cell lung cancer and 50% in ovarian cancers [19] - **Future Readouts**: Anticipated data from PTK7 and MUC16 expected in 2026, with SEZ6 data projected for early to mid-2027 [23][24] Key Takeaways for Investors - **Milestones**: Focus on IND filings and initiation of clinical trials in the upcoming year [25] - **Competitive Position**: Emphasis on a best-in-class platform targeting validated but not saturated tumor antigens, providing multiple opportunities for success [25] Additional Insights - **Market Positioning**: Whitehawk aims to leverage its unique linker payload technology to enhance the therapeutic index of its ADCs, potentially leading to better efficacy and safety profiles compared to existing treatments [10][12] - **Long-term Vision**: The company is preparing to release preclinical data in 2026, which will support its strategic positioning in the competitive ADC landscape [25]

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Condensed Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Financial%20Statements) This section presents unaudited condensed financial statements for June 30, 2025, reflecting the company's strategic pivot to ADCs [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Total assets increased to **$180.8 million** by June 30, 2025, driven by cash from a private placement and FYARRO sale Condensed Balance Sheet Highlights | Account | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $144,936 | $28,670 | | Total current assets | $178,671 | $61,287 | | Total assets | $180,822 | $70,319 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $8,756 | $17,074 | | Total liabilities | $8,756 | $17,841 | | Total stockholders' equity | $172,066 | $52,478 | | Total liabilities and stockholders' equity | $180,822 | $70,319 | [Condensed Statements of Operations and Comprehensive (Loss) Income](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20(Loss)%20Income) Q2 2025 saw a **$52.6 million** net loss due to increased R&D, while the six-month period achieved **$20.4 million** net income from the FYARRO sale Statement of Operations Summary | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Six Months 2025 (in thousands) | Six Months 2024 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Product sales, net | $0 | $6,179 | $7,145 | $11,532 | | Research and development | $48,809 | $13,093 | $57,597 | $26,686 | | Selling, general and administrative | $5,940 | $7,892 | $18,755 | $18,512 | | Gain on sale of business | $0 | $0 | $87,443 | $0 | | Net (loss) income | $(52,615) | $(14,583) | $20,401 | $(32,872) | | Basic EPS | $(0.76) | $(0.54) | $0.37 | $(1.22) | [Condensed Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity grew to **$172.1 million** by June 30, 2025, driven by a **$94.5 million** private placement and net income from the FYARRO sale - A private placement in Q1 2025 resulted in the issuance of 21,592,000 shares of common stock, providing net proceeds of **$94.5 million**[16](index=16&type=chunk) - The accumulated deficit was reduced by a net income of **$73.0 million** in Q1 2025, but increased by a net loss of **$52.6 million** in Q2 2025, resulting in a net decrease of the deficit for the six-month period[16](index=16&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Cash increased by **$116.2 million** for the six months ended June 30, 2025, driven by financing and investing activities Six-Month Cash Flow Summary | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(64,821) | $(28,810) | | Net cash provided by investing activities | $86,672 | $6,984 | | Net cash provided by financing activities | $94,351 | $77 | | **Net increase (decrease) in cash** | **$116,202** | **$(21,749)** | [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes detail the company's name change, **$102.4 million** FYARRO divestiture, in-licensing of three preclinical ADCs, and related financing activities - On March 25, 2025, the company completed the divestiture of its FYARRO Business for a cash payment of **$102.4 million**, resulting in a recorded net gain of **$87.4 million**[26](index=26&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk) - The company entered into a license agreement with WuXi Biologics for a portfolio of three ADC therapies, making upfront payments totaling **$44.0 million** (**$6.0 million** in Dec 2024 and **$38.0 million** in Apr 2025)[24](index=24&type=chunk)[140](index=140&type=chunk) - The company raised aggregate net proceeds of **$94.4 million** from a private investment in public equity (PIPE) financing, which closed on March 4, 2025[105](index=105&type=chunk) - Following the FYARRO divestiture, the company is now a preclinical-stage biopharmaceutical company with three preclinical products in development and expects to continue to incur net losses[31](index=31&type=chunk)[38](index=38&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section details the strategic pivot to developing three preclinical ADCs, cessation of product revenue post-FYARRO divestiture, increased R&D, and a strong **$177.2 million** liquidity - The company has shifted its focus to developing a portfolio of three next-generation ADCs licensed from WuXi Biologics after divesting its legacy FYARRO business for **$102.4 million**[160](index=160&type=chunk)[165](index=165&type=chunk) - The company anticipates submitting three Investigational New Drug (IND) applications to the FDA by mid-2026 for its new ADC therapies[162](index=162&type=chunk) Research and Development Expense Comparison | Expense Category | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Six Months 2025 (in thousands) | Six Months 2024 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Personnel expenses | $2,301 | $5,519 | $6,102 | $11,816 | | External clinical development | $41,737 | $4,872 | $44,126 | $9,303 | | Clinical drug product manufacturing | $4,280 | $2,189 | $6,365 | $4,366 | | **Total R&D Expenses** | **$48,809** | **$13,093** | **$57,597** | **$26,686** | - The significant increase in R&D expenses for Q2 and the first six months of 2025 was primarily driven by the **$38.0 million** up-front license fee and a **$2.3 million** VAT tax paid to WuXi Biologics[192](index=192&type=chunk)[193](index=193&type=chunk) - As of June 30, 2025, the company had **$177.2 million** in cash, cash equivalents, and short-term investments, which is believed to be sufficient to fund planned operations into 2028[176](index=176&type=chunk)[197](index=197&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Whitehawk Therapeutics, Inc. is exempt from providing market risk disclosures - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[224](index=224&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[227](index=227&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[228](index=228&type=chunk) [PART II. OTHER INFORMATION](index=43&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) As of June 30, 2025, the company reports no ongoing legal proceedings or claims with recorded liabilities - As of June 30, 2025, the company has no ongoing legal proceedings where a liability has been recorded[136](index=136&type=chunk)[232](index=232&type=chunk) [Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) This section details risks including preclinical stage status, dependence on new ADCs, net losses, capital needs, regulatory hurdles, and reliance on Chinese manufacturers - The company is a preclinical-stage biopharmaceutical company with a limited operating history, and its success is highly dependent on the development of its three new ADC therapies[235](index=235&type=chunk)[252](index=252&type=chunk) - The company relies on WuXi Biologics and Hangzhou DAC, both located in China, for manufacturing, exposing it to geopolitical risks, trade policy changes, and potential impacts from the proposed BIOSECURE Act, which identifies WuXi Biologics as a 'company of concern'[530](index=530&type=chunk)[531](index=531&type=chunk)[533](index=533&type=chunk) - The company has a history of significant net losses and will require additional capital to finance its operations; failure to raise capital could force delays or elimination of its development programs[240](index=240&type=chunk)[246](index=246&type=chunk) - The company faces substantial competition in the oncology and ADC fields from larger, more established companies with greater financial and technical resources[314](index=314&type=chunk)[316](index=316&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=115&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[568](index=568&type=chunk) [Defaults Upon Senior Securities](index=115&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[569](index=569&type=chunk) [Mine Safety Disclosures](index=115&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[570](index=570&type=chunk) [Other Information](index=115&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the last fiscal quarter - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the last fiscal quarter[571](index=571&type=chunk) [Exhibits](index=116&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed as part of the Quarterly Report, including corporate documents, agreement amendments, and officer certifications - The report includes exhibits such as amendments to the Intellectual Property License Agreement with WuXi Biologics and the Sales Agreement with TD Securities, along with required officer certifications[573](index=573&type=chunk)[574](index=574&type=chunk)

[Whitehawk Therapeutics Second Quarter 2025 Financial Results and Recent Highlights](index=1&type=section&id=Whitehawk%20Therapeutics%20Second%20Quarter%202025%20Financial%20Results%20and%20Recent%20Highlights) [Corporate and Operational Highlights](index=1&type=section&id=Corporate%20and%20Operational%20Highlights) Whitehawk Therapeutics advances its ADC portfolio with IND filings by mid-2026, supported by a strong cash position funding operations into 2028 - The company is on track to submit IND applications for all three ADC assets by **mid-2026**, with the first two planned for **year-end 2025**[3](index=3&type=chunk)[5](index=5&type=chunk) - Based on current plans, the company's capital is expected to provide a financial runway into **2028**, supporting initial clinical data readouts[3](index=3&type=chunk)[5](index=5&type=chunk) [Second Quarter 2025 Financial Results](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results) Whitehawk Therapeutics reported a **$52.6 million net loss** in Q2 2025, largely due to a **$38.0 million upfront payment**, with cash and equivalents at **$177.2 million** Key Financial Metrics (Q2 2025) | Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | | :--- | :--- | :--- | | **Net Loss** | $52.6 | $14.6 | | **Cash, cash equivalents and short-term investments (as of period end)** | $177.2 (as of June 30, 2025) | $47.2 (as of Dec 31, 2024) | - The increased net loss in Q2 2025 includes the remaining portion of an upfront payment of **$38.0 million** related to the Wuxi ADC agreement[5](index=5&type=chunk) [Financial Position (Balance Sheet)](index=3&type=section&id=Financial%20Position%20%28Balance%20Sheet%29) As of June 30, 2025, Whitehawk's total assets increased to **$180.8 million**, driven by cash, with liabilities decreasing and equity strengthening to **$172.1 million** Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2025 (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | **Cash and cash equivalents** | $144,936 | $28,670 | | **Total current assets** | $178,671 | $61,287 | | **Total assets** | $180,822 | $70,319 | | **Total liabilities** | $8,756 | $17,841 | | **Total stockholders' equity** | $172,066 | $52,478 | [Financial Performance (Statement of Operations)](index=4&type=section&id=Financial%20Performance%20%28Statement%20of%20Operations%29) Q2 2025 saw no product sales and a **$52.6 million net loss** due to R&D, while the six-month period recorded a **$20.4 million net income** from a business sale Statement of Operations Summary - Three Months Ended June 30 (in thousands, except per share data) | Metric | 2025 (USD) | 2024 (USD) | | :--- | :--- | :--- | | **Total Revenue** | $0 | $6,179 | | **Research and development** | $48,809 | $13,093 | | **Loss from operations** | $(54,749) | $(15,584) | | **Net Loss** | $(52,615) | $(14,583) | | **Net Loss Per Share (Basic)** | $(0.76) | $(0.54) | Statement of Operations Summary - Six Months Ended June 30 (in thousands, except per share data) | Metric | 2025 (USD) | 2024 (USD) | | :--- | :--- | :--- | | **Total Revenue** | $7,145 | $11,532 | | **Gain on sale of business** | $87,443 | $0 | | **Net (Loss) Income** | $20,401 | $(32,872) | | **Net (Loss) Income Per Share (Basic)** | $0.37 | $(1.22) | [Company Overview](index=1&type=section&id=Company%20Overview) Whitehawk Therapeutics is an oncology company advancing cancer treatments via modern technologies, with three ADC assets in-licensed from WuXi Biologics - The company's strategy involves applying advanced technologies to established tumor biology for improved cancer treatments[2](index=2&type=chunk)[4](index=4&type=chunk) - Its portfolio comprises three ADC assets in-licensed from WuXi Biologics for exclusive global development and commercialization[4](index=4&type=chunk) [Forward-Looking Statements](index=1&type=section&id=Forward-Looking%20Statements) Forward-looking statements regarding development timelines, ADC potential, and financial runway are subject to significant risks detailed in SEC filings - Statements regarding development timing, ADC portfolio efficacy, and cash runway are forward-looking and not guarantees of future performance[6](index=6&type=chunk) - Key risks encompass uncertainties in preclinical and clinical development, potential trial delays, failure to demonstrate efficacy, and unforeseen adverse reactions[6](index=6&type=chunk) - For a comprehensive understanding of risks, the company refers to its Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the SEC[7](index=7&type=chunk)

Company Transition and Focus - Whitehawk Therapeutics relaunched in March 2025, marking a transition into an ADC-focused company[6] - The company's strategy involves advancing a portfolio of ADC assets rapidly towards clinical trials[7, 9] - Whitehawk anticipates filing INDs for all three assets by mid-2026[9] ADC Technology Platform - Whitehawk utilizes an advanced ADC technology platform engineered for minimal off-target toxicity, greater stability, and a higher therapeutic index[9, 12] - The platform incorporates a proprietary TOPO1 inhibitor payload and a highly stable, cleavable linker[13] - The goal is to improve the therapeutic index compared to first-generation ADCs[14, 15] ADC Programs and Targets - HWK-007 targets PTK7, an oncofetal pseudokinase overexpressed in various tumors, including NSCLC (~63K US metastatic cases annually) and ovarian cancer (~4K)[11, 18] - HWK-016 targets MUC16, a glycoprotein overexpressed in cancers affecting women, such as ovarian (~4K), endometrial, and cervical cancers[11, 18] - HWK-206 targets SEZ6, a CNS protein upregulated in tumors of neuroendocrine origin, including SCLC (~18K) and neuroendocrine tumors (~5K)[11, 18] Financial and Strategic Positioning - Whitehawk's cash runway is expected to fund operations into 2028, including anticipated key clinical data[20]

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].