Summary of Whitehawk Therapeutics FY Conference Call Company Overview - **Company**: Whitehawk Therapeutics (NasdaqCM:AADI) - **Focus**: Development of antibody-drug conjugates (ADCs) for solid tumors - **Recent Developments**: Formed through the in-licensing of a three-asset ADC portfolio from Ushi Biologics, initiated in December of the previous year and completed earlier this year [4][4] Key Programs and Platforms ADC Platform - **Evolution**: Transition from tubulin inhibitor-based payloads to topoisomerase class ADCs, focusing on stability and payload release [6][6] - **Unique Features**: High-stability ADCs that limit free payload release, aiming for better potency with fewer side effects [7][7] Lead Assets 1. **HAWK-007 (PTK7-targeted ADC)** - **Target Validation**: Previously targeted by Pfizer and AbbVie, showing early efficacy but suffering from side effects [13][13] - **Clinical Development**: IND submission planned for this year, with preclinical data expected in the first half of 2026 [14][14] - **Tumor Relevance**: Broadly expressed in 70% of tumors, initially targeting lung, ovarian, and endometrial cancers [16][16] - **Efficacy Benchmarks**: Aiming for 35%-40% overall response rate (ORR) in non-small cell lung cancer and 50% in gynecological cancers [19][19] 2. **HAWK-016 (MUC16-targeted ADC)** - **Target Characteristics**: Highly expressed in gynecological cancers, with a unique approach to bypass circulating CA125 [23][23] - **Clinical Timeline**: IND submission in Q4, with trials starting in Q1 2026 [25][25] - **Potential Expansion**: Possible relevance in pancreatic cancer and non-small cell lung cancer [26][26] 3. **HAWK-206 (SEZ6-targeted ADC)** - **Target Validation**: Overexpressed in small cell lung cancer and neuroendocrine neoplasia, with a focus on improving safety and efficacy [34][34] - **Clinical Development**: IND submission planned for mid-2026, with trials starting in the second half of the year [38][38] - **Efficacy Benchmarks**: Aiming for 50%-60% ORR in small cell lung cancer and above 30% in neuroendocrine neoplasia [39][39] Competitive Landscape - **Emerging Competitors**: Increased interest in PTK7, with companies like Day One and Lilly entering the space [20][20] - **MUC16 Competition**: Previous attempts by Genentech faced challenges due to targeting issues; Regeneron is also pursuing a similar approach [27][27][29][29] - **SEZ6 Market Dynamics**: Limited competition in neuroendocrine cancers, with potential advantages over DLL3 and B7-H3 programs [40][40][41][41] Financial Position and Future Outlook - **Cash Runway**: Sufficient funds through early 2028, starting with $163 million from recent financing [45][45] - **Data Expectations**: Initial clinical data for all three programs expected around Q1 2027, with preclinical data anticipated in the first half of 2026 [31][31][50][50] - **Strategic Focus**: Emphasis on executing current programs and potential for future partnerships, particularly for high-potential assets like PTK7 [46][46] Conclusion - **Transition Year**: 2026 is positioned as a pivotal year for Whitehawk, moving from preclinical to clinical stages with a focus on demonstrating differentiation and efficacy across its ADC portfolio [48][48][49][49]

Summary of Whitehawk Therapeutics Conference Call Company Overview - **Company**: Whitehawk Therapeutics (NasdaqCM:AADI) - **Focus**: Development of next-generation antibody drug conjugates (ADCs) targeting various cancer indications [2][4] Key Points Industry and Market Position - Whitehawk is positioned in the biotechnology sector, specifically in the ADC market, which is experiencing growth due to advancements in targeted cancer therapies [2][4] - The company aims to differentiate itself through a unique ADC platform that combines validated targets with advanced linker payload technology [4][12] Product Pipeline - **Portfolio**: Whitehawk's ADC portfolio includes three main assets: HAWK-007, HAWK-016, and HAWK-206, targeting PTK7, MUC16, and SEZ6 respectively [12][23] - **Clinical Development**: HAWK-007 and HAWK-016 are expected to file Investigational New Drug (IND) applications soon, with HAWK-206 to follow [13][22] Targeted Indications - **PTK7**: Found in approximately 70% of solid tumors, with an estimated 750,000 patients in the US having PTK7-positive cancers. Previous ADCs targeting PTK7 have shown efficacy but were discontinued due to side effects [14][15][16] - **MUC16**: Highly expressed in gynecological cancers, particularly ovarian cancer, with potential for better selectivity and efficacy compared to existing ADCs [17][18][19] - **SEZ6**: A validated target where Whitehawk plans to utilize a biparatopic approach to enhance competition [23] Technological Differentiation - **Linker Payload Technology**: Whitehawk employs a carbon-bridge cysteine repairing method that enhances ADC stability and reduces free payload release, addressing common issues seen in competitor products [9][11][12] - **Potency and Safety**: The platform demonstrates 3-10 times lower doses needed for tumor reduction compared to conventional ADCs, with 5-25 times lower levels of free payload in plasma, leading to a 2-3 times higher safety margin [11][12] Financial Position - Whitehawk ended the last quarter with over $160 million in cash, providing a runway into 2028 and supporting anticipated key clinical data milestones [5] Future Outlook - The company is focused on establishing its ADC platform as potentially best-in-class through clear differentiation and rapid clinical advancement [20][22] - Initial data readouts for HAWK-007 and HAWK-016 are expected in early 2027, with ongoing monitoring of competitor developments in the PTK7 space [22][30] Collaborations and Partnerships - Whitehawk has licensed its technology to Hangzhou DAC in China, which is developing ADCs on different targets and is expected to report data by 2026 [26] Safety and Efficacy Considerations - The company aims to address common adverse effects associated with topo-1 inhibitors, particularly hematological toxicities, by utilizing a heme-sparing payload [28][29] Conclusion Whitehawk Therapeutics is advancing a differentiated ADC platform with a focus on high-potential cancer targets. The company is well-capitalized and positioned to make significant strides in clinical development, with a strong emphasis on safety, efficacy, and technological innovation in the ADC space [24][30]

Financial Performance - The company recognized net product sales of $7.1 million for the nine months ended September 30, 2025, from its lead drug product FYARRO, which was launched in the U.S. for the treatment of advanced malignant PEComa[164]. - Total revenue for the nine months ended September 30, 2025, was $7.1 million, down from $18.7 million in 2024, primarily due to the cessation of FYARRO sales[188]. - The company reported a net income of $2.7 million for the nine months ended September 30, 2025, compared to a net loss of $45.4 million for the same period in 2024[199]. - Other income for the nine months ended September 30, 2025, was $92.2 million, significantly up from $3.1 million in 2024, primarily due to a gain on the sale of a business[197]. Research and Development - The company plans to submit three investigational new drug (IND) applications to the FDA by mid-2026, targeting solid tumors, cancers of female origin, and neuroendocrine cancers[161][162]. - The company plans to increase investment in research and development related to ADC Therapies, continuing to incur significant expenses in this area[182]. - Research and development expenses for the three months ended September 30, 2025, increased to $14.3 million from $10.0 million in 2024, driven by higher clinical drug product manufacturing costs[192]. - Research and development expenses for the nine months ended September 30, 2025, were $71.9 million, up from $36.7 million in 2024, reflecting a $38.0 million upfront license fee paid to WuXi Biologics[193]. Cash and Investments - The company has $162.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025, which is expected to support operations into 2028[175]. - Cash used in operating activities for the nine months ended September 30, 2025, was $80.2 million, compared to $44.5 million for the same period in 2024[207][210]. - Cash provided by financing activities for the nine months ended September 30, 2025, was $94.4 million, primarily from the 2024 PIPE Financing[213]. - Cash used in investing activities for the nine months ended September 30, 2025, included $125.8 million for short-term investments[211]. Business Transactions - The company completed the divestiture of the FYARRO Business for a cash payment of $102.4 million on March 25, 2025, resulting in a significant gain on sale contributing to net income for the nine months ended September 30, 2025[165]. - The company entered into a License Agreement with WuXi Biologics for the development and commercialization of three next-generation antibody drug conjugates (ADCs), with potential milestone payments totaling $805 million[166]. - 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 September 30, 2025[201]. - The Shelf Registration Statement allows the company to sell up to $150.0 million of various securities, providing flexibility for future capital needs[203]. Management and Strategy - The company has a strong management team with extensive experience in oncology therapeutics, positioning it well to execute its strategy for ADC Therapies and future pipeline assets[163]. - The company has incurred an accumulated deficit of $330.0 million as of September 30, 2025, primarily due to research and development costs and operational expenses[175]. - The accumulated deficit as of September 30, 2025, was $330.0 million, with net losses incurred in each year since inception except for the nine months ended September 30, 2025[199]. - The company expects to continue incurring significant expenses and operating losses in the foreseeable future due to ongoing research and development activities[175]. Expenses - Selling, general and administrative expenses for the three months ended September 30, 2025, were $5.2 million, down from $7.2 million in 2024, a decrease of $2.0 million[189]. - Rent expense for the Pacific Palisades and Morristown leases was $34.0 thousand and $0.1 million for the three months ended September 30, 2025, respectively[217].

Financial Performance - Third quarter 2025 net loss was $17.7 million, compared to a net loss of $12.5 million in the same period of 2024, representing a 41.6% increase in losses year-over-year[5] - Total operating expenses for the three months ended September 30, 2025, were $19.5 million, slightly down from $20.6 million in the same period of 2024[16] - The company reported no product sales in Q3 2025, down from $7.2 million in Q3 2024, reflecting a shift in focus towards R&D[16] - The weighted average shares outstanding increased to 69.2 million in Q3 2025 from 27.0 million in Q3 2024, indicating significant dilution[16] Liquidity and Assets - Cash, cash equivalents, and short-term investments as of September 30, 2025, were $162.6 million, up from $47.2 million as of December 31, 2024, indicating a significant increase in liquidity[5] - Total assets as of September 30, 2025, were $167.0 million, compared to $70.3 million as of December 31, 2024, indicating a substantial growth in asset base[14] - The company anticipates its cash runway will extend into 2028 based on current operational plans[5] Research and Development - Research and development expenses increased to $14.3 million in Q3 2025, compared to $10.0 million in Q3 2024, reflecting a 43.5% increase year-over-year[16] - The company is on track to submit IND filings for HWK-007 and HWK-016 by the end of 2025, with all three assets expected to reach IND by mid-2026[3] - Whitehawk Therapeutics confirmed PTK7 as the third most highly expressed tumor marker among ADC targets, highlighting the potential market opportunity for HWK-007, which targets PTK7-expressing cancers affecting nearly 750,000 patients in the US[3]

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.