Company: BOLT
Filing Date: 2025-08-14
Form Type: 10-Q
Source: 0001641281-25-000007
Chunk: 6

Company: Bolt Biotherapeutics, Inc.
Filing Date: 2025-08-14
Form: 10-Q
Item: Part I, Item 2
Chunk 6
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 of gastric/gastroesophageal junction cancer, pancreatic cancer, and other tumor types. Clinical candidate selection was supported by in vitro and in vivo experiments demonstrating potent anti-tumor activity in multiple preclinical models, safety and tolerability in toxicology studies, and enhanced preclinical efficacy compared to cytotoxic ADCs in murine tumor models.  Data on our claudin 18.2 Boltbody ISAC program was presented at the Society for Immunotherapy of Cancer’s (SITC) Annual Meetings in both November of 2024 and 2023. The first-in-human Phase 1 dose escalation trial of BDC-4182 opened for enrollment in April 2025.  

BDC-3042, our dectin-2 agonist antibody program, is being developed to repolarize critical cells in the tumor microenvironment known as tumor associated macrophages (TAMs). Dectin-2 agonism changes these TAMs from tumor-supportive macrophages to tumor-destructive macrophages that elicit durable anti-tumor immune responses in preclinical models. We received the Investigational New Drug Application, or IND, clearance from the FDA in July 2023. In October 2023, we dosed the first patient with BDC-3042 in the Phase 1 dose-escalation study in patients with a broad range of solid tumors. In April 2025, we reported results from our dose escalation trial of BDC-3042, demonstrating a favorable safety profile, dose-dependent biologic activity, and monotherapy anti-tumor activity. We have launched a formal partnering process to secure a partner for future development of BDC-3042.  

In May 2024, we announced a strategic pipeline prioritization and restructuring plan pursuant to which we reduced overall operating expenses and discontinued development of trastuzumab imbotolimod, formerly known as BDC-1001, in order to focus on our Phase 1 asset, BDC-3042, and our next generation Boltbody™ ISAC platform including our claudin 18.2 ISAC BDC-4182. The restructuring plan reduced our workforce by approximately 50 employees, or approximately 50% of our workforce. We estimate total restructuring charges of $3.6 million, including $2.9 million in one-time termination benefits, such as severance costs and related benefits, and $0.7 million in non-cash stock-based compensation expenses. The severance payments commenced in