On May 12, 2026 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, 2026, and provided a business update.
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"We are encouraged by what we have seen thus far in patients treated with BDC‑4182, a next‑generation Boltbody ISAC. BDC-4182 has a unique mechanism of action , that has the potential to combine the power of ADCs with the durability of T-cell engagers and unlock a new frontier in cancer treatment," said Willie Quinn, President and Chief Executive Officer. "We continue to enroll patients with gastric and gastroesophageal cancer in our ongoing clinical trial, and we look forward to reporting initial data in the third quarter of 2026."
Recent Highlights and Anticipated Milestones
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Initial clinical data from BDC-4182 Phase 1/2 study for patients with gastric and gastroesophageal cancer expected in the third quarter of 2026. BDC-4182 is a next-generation BoltbodyTM ISAC targeting claudin 18.2, a clinically validated target with expression in gastric cancer, gastroesophageal junction cancer, pancreatic cancer, and other tumor types. In preclinical models, including cancer models with low claudin 18.2 expression, BDC-4182 demonstrated significant anti-tumor activity, induced immunological memory, and outperformed cytotoxic ADCs. Bolt has implemented step-up dosing, which has been successfully used commercially for T-cell engagers, as a strategy to get to higher doses safely. The clinical trial in gastric and gastroesophageal cancers is ongoing, and the Company expects to present initial clinical data in the third quarter of 2026.
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Next-generation Boltbody ISACs targeting CEA and PD-L1. Two additional ISAC programs in Bolt’s pipeline are currently on hold. Once BDC-4182 demonstrates proof-of-concept for the ISAC approach, Bolt plans to resume development of these programs. Both programs are close to clinical candidate selection.
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Bolt’s CEA-targeted ISAC comprises a novel, fully human antibody with high affinity and selectivity to CEACAM5 (CEA) conjugated to a proprietary next-generation TLR7/8 agonist via a non-cleavable linker. Bolt’s CEA ISAC induced complete and durable anti-tumor responses in preclinical models and demonstrated superior activity versus a Topo1-based ADC. The CEA ISAC was well tolerated in a non-GLP toxicology study.
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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 with the potential for enhanced immune activation and antitumor activity.
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Cash, cash equivalents, and marketable securities were $23.9 million as of March 31, 2026. Cash on hand is expected to fund operations into 2027.
First Quarter 2026 Financial Results
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Collaboration Revenue – Total collaboration revenue was $26,000 for the quarter ended March 31, 2026, compared to $1.2 million for the same quarter in 2025. Revenue in the comparative periods was generated from services performed under the R&D collaborations as we fulfill our performance obligations.
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Research and Development (R&D) Expenses – R&D expenses were $4.8 million for the quarter ended March 31, 2026, compared to $9.5 million for the same quarter in 2025. The decrease between the comparable periods was mainly due to a continued decrease in salary and related expenses primarily as a result of our restructuring, reduced clinical trial expenses and lower research and development expenses.
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General and Administrative (G&A) Expenses – G&A expenses were $2.8 million for the quarter ended March 31, 2026, compared to $3.8 million for the same quarter in 2025. The decrease between the comparable periods was mainly due to a continued decrease in salary and related expenses primarily as a result of our restructuring.
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Loss from Operations – Loss from operations was $7.6 million quarter ended March 31, 2026, compared to $12.1 million for the same quarter 2025.
(Press release, Bolt Biotherapeutics, MAY 12, 2026, View Source [SID1234665527])