On May 12, 2025 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the first quarter ended March 31, 2025, and provided a business update (Press release, Bolt Biotherapeutics, MAY 12, 2025, View Source [SID1234652870]).
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"We continue to make progress advancing our pipeline of first-in-class, novel immunotherapies," said Willie Quinn, Chief Executive Officer. "We recently presented promising early clinical data for BDC-3042 at AACR (Free AACR Whitepaper) and launched a process to find a partner to accelerate BDC-3042 development. We also just opened enrollment for the first next-generation Boltbody ISAC in our pipeline, BDC-4182. We are excited to see what our ISAC platform technology can do for gastric and gastroesophageal cancer patients. We continue to be good stewards of capital as we execute against our mission to deliver new treatment options to patients with cancer."
Recent Highlights and Anticipated Milestones
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Clinical data from Phase 1 dose-escalation study of BDC-3042 presented at AACR (Free AACR Whitepaper) Annual Meeting 2025 in April 2025. BDC-3042 is a proprietary agonist antibody that targets dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). This single-agent, dose-escalation Phase 1 clinical study is evaluating BDC-3042 in patients with metastatic or unresectable solid tumors including non-small cell lung cancer (NSCLC). The dose-escalation data support the selection of 10 mg/kg q2w as a recommended Phase 2 dose (RP2D), alongside potential exploration of other doses and schedules. The results support further clinical development in NSCLC and other post-immunotherapy settings, as patients previously treated with PD-(L)1 inhibitors appear to have more dectin-2 expression and may experience improved outcomes. Bolt is running a process to find a partner with resources to accelerate development and optimize commercialization.
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BDC-4182 Phase 1 study for patients with gastric and gastroesophageal cancer opened for enrollment in April 2025. BDC-4182 is a next-generation BoltbodyTM ISAC clinical candidate targeting claudin 18.2, a clinically validated target in oncology with expression in gastric/gastroesophageal junction cancer, pancreatic cancer, and other tumor types. Preclinically, monotherapy treatment with BDC-4182 generated complete regressions in multiple models and BDC-4182 was tolerated in toxicology studies. BDC-4182 outperformed cytotoxic claudin 18.2 ADCs, using MMAE or TOPO1, in multiple preclinical studies.
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Presented preclinical results for next-generation Boltbody ISACs targeting CEA and PD-L1 at AACR (Free AACR Whitepaper) Annual Meeting 2025 in April 2025.
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Bolt’s lead CEA-targeting ISAC comprises a novel, fully human antibody with high affinity and selectivity to CEACAM5 (CEA), and not to other members of the CEACAM family, conjugated to a propriety TLR7/8 agonist via a non-cleavable linker. This ISAC drives enhanced phagocytosis of CEA-positive tumor cells and stimulates production of critical immune-activating cytokines including IL-12p70, IFNg, and TNFa. The next-generation CEA ISAC induced complete and durable anti-tumor responses in mice and was well-tolerated in NHPs.
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Bolt’s PD-L1 ISAC utilizes a novel human anti-PD-L1 antibody conjugated to a TLR7/8 agonist via a non-cleavable linker. This ISAC leverages a unique mechanism of action due to its ability to target both tumor and immune cells that express PD-L1. Preclinical results demonstrated that PD-L1 ISACs represent a compelling new approach to treat cancer, leveraging mechanisms that are distinct from and potentially complementary to conventional PD-1/PD-L1 blockade.
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Collaborations with Genmab and Toray continue to progress. Genmab and Bolt have now selected a second product to advance into development, while the companies also continue research and development on additional programs. The Toray collaboration combines the Company’s immunostimulatory linker-payloads with Toray antibodies targeting Caprin-1, a tumor-specific antigen that is strongly expressed on the cell membrane in multiple solid tumor types.
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Cash, cash equivalents, and marketable securities were $58.0 million as of March 31, 2025. Cash on hand is expected to fund multiple milestones and operations through mid-2026.
First Quarter 2025 Financial Results
• Collaboration Revenue – Total collaboration revenue was $1.2 million for the quarter ended March 31, 2025, compared to $5.3 million for the same quarter in 2024. Revenue in the comparative periods was generated from services performed under the R&D collaborations as we fulfill our performance obligations. The decrease in revenue in the comparative period was mainly due to the $3.5 million revenue recognized under the Amended Innovent Agreement, as we completed our performance obligation to Innovent.
• Research and Development (R&D) Expenses – R&D expenses were $9.5 million for the quarter ended March 31, 2025, compared to $16.5 million for the same quarter in 2024. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses, a decrease in clinical expenses primarily related to the discontinued development of trastuzumab imbotolimod, formerly known as BDC-1001 in May 2024.
• General and Administrative (G&A) Expenses – G&A expenses were $3.8 million for the quarter ended March 31, 2025, compared to $5.8 million for the same quarter in 2024. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of the May 2024 restructuring.
• Loss from Operations – Loss from operations was $12.1 million for the quarter ended March 31, 2025, compared to $17.1 million for the same quarter in 2024.
About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer.