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]
Whitehawk Therapeutics (NasdaqCM:AADI) FY Conference Transcript