Clinical Progress and Developments - The company reported significant clinical progress in Q3 2024, particularly with the topline data from the ASPEN-06 Phase 2 trial, where evorpacept demonstrated durable clinical benefits and a well-tolerated safety profile in HER2-positive gastric/GEJ cancer patients [2][3] - Evorpacept achieved a confirmed overall response rate (ORR) of 40.3% compared to 26.6% in the control arm, with a median duration of response of 15.7 months versus 7.6 months in the intent-to-treat population (N=127) [3] - In a pre-specified population with fresh HER2-positive biopsies (n=48), the Evo-TRP combination showed an ORR of 54.8% compared to 23.1% in the control arm [3] - The company initiated patient dosing in September 2024 for a Sanofi-partnered study evaluating evorpacept in combination with SARCLISA and dexamethasone for relapsed or refractory multiple myeloma (RRMM) [3] - The leadership team was strengthened with the appointment of Dr. Alan Sandler to the Board of Directors, bringing over 30 years of oncology and drug development experience [3] Upcoming Clinical Milestones - Breast cancer: Phase 1b/2 trial results for evorpacept combined with zanidatamab in HER2-positive and HER2-low metastatic breast cancer will be presented at the San Antonio Breast Cancer Symposium on December 12, 2024 [4] - Gastric/GEJ cancer: Updated results from the ASPEN-06 Phase 2 trial are expected in the first half of 2025, with a Phase 3 registrational trial initiation planned for mid-2025 [4] - Head and neck squamous cell carcinoma: Topline results from Phase 2 trials (ASPEN-03 and ASPEN-04) with KEYTRUDA are anticipated in the first half of 2025 [4] - Urothelial cancer: Updated results from a Phase 1 trial of ASPEN-07 in combination with PADCEV are expected in the first half of 2025 [4] - Breast cancer: Topline results from a Phase 1b I-SPY TRIAL with ENHERTU are expected in the second half of 2025 [4] Financial Performance - Cash, cash equivalents, and investments totaled 162.6 million as of September 30, 2024, sufficient to fund operations into Q1 2026 [5] - Research and development (R&D) expenses decreased by 19.3 million to 26.5 million in Q3 2024, primarily due to reduced clinical and development costs [5] - General and administrative (G&A) expenses decreased by 1.4 million to 30.7 million, or (51.0 million, or (23.7 million, compared to $44.0 million in Q3 2023 [5] Corporate Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing therapies that enhance the immune system to treat cancer [6] - The company's lead candidate, evorpacept, is being evaluated across multiple clinical trials for various cancer indications, with potential as a cornerstone therapy in immuno-oncology [6]
ALX Oncology Reports Third Quarter 2024 Financial Results and Provides Corporate Update