Table of Contents p UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR o 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 001-38560 WHITEHAWK THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) Delaware 61-1547850 (St ...

PRESS RELEASE Exhibit 99.1 Whitehawk Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Recent Highlights Actively recruiting Phase 1 trials for PTK7-targeted antibody-drug conjugate (ADC) HWK-007 and MUC16- targeted ADC HWK-016 HWK-206 on track for planned IND submission in mid-2026 and Phase 1 start in Q3 Cash, cash equivalents and short-term investments balance of $145.7M at YE2025, anticipated to fund operations into 2028 MORRISTOWN, NJ, March 12, 2026 /PRNewswire/ -- Whitehawk ...

Summary of Whitehawk Therapeutics FY Conference Call Company Overview - **Company**: Whitehawk Therapeutics (NasdaqCM:AADI) - **Focus**: Development of next-generation antibody-drug conjugates (ADCs) targeting various cancer indications [2][3] Key Points Product Pipeline - Whitehawk has advanced two ADC assets into clinical trials: - **HWK-007**: Targets PTK7, a broadly expressed tumor target [2][15] - **HWK-016**: Targets MUC16, highly expressed in gynecological cancers [2][15] - A third asset, **SEZ6**, is expected to enter Phase 1 trials in Q3 2026 [14][16] Differentiation and Technology - Whitehawk's ADCs are based on a novel topoisomerase I inhibitor and advanced linker payload technology, aiming for improved therapeutic index [4][12] - The company emphasizes the importance of bioconjugation techniques that enhance stability and reduce toxicity compared to traditional methods [10][11] - Whitehawk's platform reportedly offers 5-25 times more stability in circulation, contributing to a 3-10x improvement in potency and a 2-3x higher safety margin in non-primate studies [13] Clinical Development and Safety - The company is focused on achieving best-in-class efficacy benchmarks, with target overall response rates (ORR) of 35%-40% for non-small cell cancer and 50% for gynecological cancers [40] - Safety concerns include hematological toxicities and interstitial lung disease (ILD), with a focus on minimizing these risks through engineering [46][45] Market Potential and Expansion - HWK-007 has potential applications in multiple cancer types, including breast, gastrointestinal, prostate, and head and neck cancers [15] - HWK-016 is positioned as a best-in-class treatment for ovarian and gynecological cancers, with potential expansion into less targeted tumors like mesothelioma and pancreatic cancer [16] - SEZ6 targets neuroendocrine tumors and is expected to be competitive in a crowded market [60] Financial Position and Strategy - Whitehawk ended Q3 2025 with over $160 million in cash, providing a runway into 2028 [5] - The company operates with a capital-efficient model, burning approximately $15 million-$17 million per quarter [63] - Strategic prioritization of programs will depend on clinical data outcomes, with a focus on maximizing the value of each asset [64] Underappreciated Aspects - The company has three clinical programs running in parallel, which is seen as a significant opportunity for value inflection compared to peers with fewer programs [65] Additional Insights - Whitehawk's management team has extensive experience in ADC development, which is critical for operational success [5] - The company aims to leverage clinical validation from previous ADC generations to target high-potential cancer indications with unmet needs [3]

Summary of Whitehawk Therapeutics FY Conference Call Company Overview - **Company Name**: Whitehawk Therapeutics (NasdaqCM:AADI) - **Founded**: 2025, initially launched with in-licensing of a 3 ADC portfolio from WuXi Biologics [2][3] - **Current Status**: Clinical stage company with two assets in the clinic and a third expected to enter clinical trials in Q3 2026 [3][4] Financial Position - **Cash Position**: $160 million as of Q3 2025, providing a runway to operate into 2028 [4] Product Pipeline ADC Portfolio 1. **HWK-007**: - Target: PTK7-ADC, focused on gynecological cancers [3][10] - Clinical Status: In the clinic, with initial phase I dose-escalation studies [10][11] - Potency: 3-10x greater than average Topo 1 inhibitor ADCs, with 5-25 times more stability [9][10] - Comparison: Shows improved efficacy over Pfizer's cofetuzumab pelidotin, with significant tumor regression at lower doses [15][17] 2. **HWK-016**: - Target: MUC16, focusing on ovarian and endometrial cancers [11][18] - Clinical Status: Currently recruiting patients for phase I dose-escalation trial [11][26] - Expression: 3-10 times more highly expressed in ovarian cancer compared to other ADC targets [18][20] - Innovation: Targets a portion of MUC16 that remains on the cell surface, avoiding issues with circulating biomarkers [22][24] 3. **HWK-206**: - Target: SEZ6, expected to file IND by mid-2026 and start clinical trials in Q3 2026 [11][27] - Competitive Edge: Designed to improve upon existing programs like ABBV-706, with enhanced targeting and internalization [27] Technology Differentiation - **ADC Design**: Focus on three components: 1. **Targeting**: High-affinity antibody selection and clinically validated targets [5][6] 2. **Bioconjugation**: Utilizes a paired carbon-bonded linker for improved stability and reduced payload loss [7][8] 3. **Linker Payload**: Smart delivery system that minimizes toxicity while maximizing tumor killing [8][9] Clinical Strategy - **Focus**: Targeting clinically validated but underdeveloped tumor targets to build best-in-class ADCs [27][28] - **Patient Population**: Selective focus on homogeneous patient populations for clinical trials to demonstrate efficacy and safety [25][26] Upcoming Milestones - **Clinical Data Readouts**: Anticipated in the first half of 2027 for both HWK-007 and HWK-016 [26][28] - **Preclinical Data Release**: Expected in spring 2026, showcasing profiles for each program [29] Conclusion - Whitehawk Therapeutics is positioned to leverage its innovative ADC technology and strong financial backing to advance its clinical programs, with a focus on differentiated therapeutic profiles and robust clinical data expected in the near future [28]

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]