Company: BOLT
Filing Date: 2025-03-24
Form Type: 10-K
Source: 0000950170-25-043873
Chunk: 13

Company: Bolt Biotherapeutics, Inc.
Filing Date: 2025-03-24
Form: 10-K
Item: Item 1
Chunk 13
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 our next-generation BDC-4182, for the treatment of patients with gastric cancer. We are in the final stages of preparing for the first clinical trial of BDC-4182, expected to start in the second quarter of 2025. BDC-4182 is the only claudin 18.2-targeting ISAC in development. Based on our preclinical studies, we believe BDC-4182 has the potential to outperform cytotoxic ADCs. We are conducting a first-in-human dose escalation and expansion study with the normal Phase 1 goals of demonstrating safety and selecting a dose, as well as with the goal of demonstrating anti-tumor activity.  

•Selectively enter into collaborations to expand and enhance our proprietary Boltbody ISAC approach and myeloid expertise and increase the impact of our product candidates. In order to advance treatment options for patients, we may selectively collaborate with other companies with complementary technology or resources that could maximize the value of our product candidates and expand our pipeline. Such collaborations may provide us with novel technologies, targets, agents or approaches that complement our myeloid expertise and innovative Boltbody ISAC approach to improve the lives of patients with cancer. Collaborations can also provide significant funding for our research activities. Our collaborations with Genmab and Toray are examples of this approach.

•Continue to invest modestly in our Boltbody ISAC platform to provide future product candidates for our pipeline. This is exemplified by our work on the CEA ISAC and the PD-L1 ISAC programs. 

•In October 2024, we successfully established a wholly-owned subsidiary in Australia, Bolt Biotherapeutics Australia PTY LTD, to expand our global footprint and better serve our research and development programs in the region. This strategic move enhances our ability to deliver localized solutions and it aligns with Australia's tax regime, which provides certain eligible companies with tax benefits for research and development activities.

Collaboration Agreements 

Joint Development and License Agreement with Toray Industries 

In March 2019, we entered into a Joint Development and License Agreement, or the Toray Agreement, with Toray, to develop and commercialize a Boltbody ISAC containing a proprietary antibody owned by Toray targeting Caprin-1. Under the Toray Agreement, we exchanged co-exclusive (with each other) licenses to certain patents and know-how covering our respective technologies. Each party is required to use commercially reasonable efforts to conduct development and regulatory activities assigned to it under a development plan. Toray will be solely responsible