Bolt Biotherapeutics(US:BOLT)2021-04-16 22:41BDC-1001 Clinical Trial & Data - BDC-1001 is undergoing Phase 1/2 clinical trials for HER2-expressing solid tumors and has been well-tolerated in 20 patients as of January 29, 2021, showing signs of clinical activity including a Partial Response (PR)[3, 8, 51] - Preliminary clinical results for BDC-1001 demonstrate promising clinical activity, including a 39% reduction in tumor lesions in a patient with MSS colon cancer after 4 cycles of treatment [14, 16] - Additional patients treated with BDC-1001 showed evidence of disease control, including confirmed stable disease in patients with endometrial and metastatic colorectal cancer [18, 19] Boltbody™ ISAC Platform & Pipeline - Bolt Biotherapeutics is pioneering a new class of immuno-oncology products with its first-in-class Boltbody™ ISAC, BDC-1001, and a broadly enabling platform technology [3, 51] - The company's pipeline includes BDC-2034, a CEA-directed Boltbody ISAC, and a PD-L1 Boltbody ISAC program, targeting various solid tumors [6, 33] - Preclinical data demonstrates that ISACs of diverse tumor-targeting antibodies have dramatically improved efficacy [3, 51] Financial Position & Milestones - Bolt Biotherapeutics has pro-forma cash of $316.4 million expected to fund operations into 2023, supporting key milestones for BDC-1001 and BDC-2034 [3, 51] - Meaningful catalysts to drive value include data from the BDC-1001 monotherapy dose escalation study in 2H21, initiation of monotherapy dose expansions & anti-PD-1 combination dose escalation in 2H21, and initiation of a first-in-human clinical trial for BDC-2034 in 2022 [5, 53] HER2+ Breast Cancer Market Opportunity - The annual drug-treated breast cancer incidence includes 75,800 HER2+ patients, 86,900 HER2 Low (IHC 2+/ISH-) patients, and 155,500 HER2 Low (IHC 1+/ISH-) patients, indicating a significant unmet need in HER2-low cancers [21]