- First-in-class immune-stimulating antibody conjugate BDC-4182 Phase 1/2 study ongoing, initial clinical data expected in 3Q 2026
- Cash balance of $23.9 million as of March 31, 2026 anticipated to fund operations into 2027, including completion of the dose escalation portion of the ongoing BDC-4182 Phase 1/2 study
REDWOOD CITY, Calif., May 12, 2026 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today reported financial results for the first quarter ended March 31, 2026, and provided a business update.
"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
- 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 Boltbody 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
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.
About Bolt Biotherapeutics, Inc.
Bolt Biotherapeutics is a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer. Bolt Biotherapeutics' pipeline reflects the Company's expertise in myeloid biology and cancer drug development. The Company's lead program is BDC-4182, a next-generation Boltbody Immune-Stimulating Antibody Conjugate (ISAC) clinical candidate targeting claudin 18.2. BDC-4182 is currently in a Phase 1/2 trial that includes patients with gastric and gastroesophageal cancer. The Company has strategic collaborations with Genmab and Toray built around the Company's Boltbody ISAC platform technology. The rest of the Company's pipeline is currently on hold, including BDC-3042, a Dectin-2 agonist that completed a first-in-human Phase 1 dose escalation trial, as well as its preclinical ISAC programs targeting CEA and PD-L1. For more information, please visit https://www.boltbio.com/
Forward-Looking Statements
This press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding our ability to partner our CEA ISAC and PD-L1 ISAC, the advancement and success of our BDC-4182 clinical trials, the timing of initial data from our Phase 1 dose-escalation study of BDC-4182, the timing of our ISAC programs, the anti-tumor potency, safety and tolerability, and characteristics of our product candidates, the initiation of future clinical trials, the potential value of collaborations, and the expected duration of our cash runway and ability to fund key milestones into 2027, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "on track," "plan," "potential," "predict," "project," "should," "will," or "would," or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized; and our ability to maintain our current collaborations and establish further collaborations. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC's website at www.sec.gov
Investor Relations and Media Contact:
Matthew DeYoung
Argot Partners
(212) 600-1902
boltbio@argotpartners.com
| BOLT BIOTHERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share amounts) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Collaboration revenue | - | 26 | - | 1,222 | ||||
| Operating expenses: | ||||||||
| Research and development | 4,829 | 9,512 | ||||||
| General and administrative | 2,798 | 3,825 | ||||||
| Total operating expense | 7,627 | 13,337 | ||||||
| Loss from operations | (7,601 | - | (12,115 | - | ||||
| Other income (expense), net: | ||||||||
| Interest income, net | 276 | 1,053 | ||||||
| Other income, net | 81 | 22 | ||||||
| Total other income, net | 357 | 1,075 | ||||||
| Net loss | (7,244 | - | (11,040 | - | ||||
| Net unrealized gain (loss) on marketable securities | 10 | (57 | - | |||||
| Comprehensive loss | - | (7,234 | - | - | (11,097 | - | ||
| Net loss per share, basic and diluted | - | (4.31 | - | - | (5.76 | - | ||
| Weighted-average shares outstanding, basic and diluted | 1,680,445 | 1,916,943 | ||||||
| BOLT BIOTHERAPEUTICS, INC. CONSOLIDATED BALANCE SHEETS (In thousands) | ||||||||
| March 31, | December 31, | |||||||
| 2026 | 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | - | 11,609 | - | 11,703 | ||||
| Short-term investments | 11,283 | 15,802 | ||||||
| Restricted cash | 200 | 200 | ||||||
| Prepaid expenses and other current assets | 2,660 | 2,555 | ||||||
| Total current assets | 25,752 | 30,260 | ||||||
| Property and equipment, net | 1,042 | 1,245 | ||||||
| Operating lease right-of-use assets | 18,564 | 19,230 | ||||||
| Restricted cash, non-current | 1,538 | 1,538 | ||||||
| Long-term investments | 1,019 | 4,337 | ||||||
| Other assets | 112 | 138 | ||||||
| Total assets | - | 48,027 | - | 56,748 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | - | 1,736 | - | 1,443 | ||||
| Accrued expenses and other current liabilities | 2,021 | 3,717 | ||||||
| Deferred revenue | 630 | 449 | ||||||
| Operating lease liabilities | 2,956 | 2,826 | ||||||
| Total current liabilities | 7,343 | 8,435 | ||||||
| Operating lease liabilities, net of current portion | 19,352 | 20,132 | ||||||
| Deferred revenue, non-current | 1,352 | 1,544 | ||||||
| Other long-term liabilities | 158 | 132 | ||||||
| Total liabilities | 28,205 | 30,243 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock | - | - | ||||||
| Additional paid-in capital | 487,856 | 487,305 | ||||||
| Accumulated other comprehensive loss | (11 | - | (21 | - | ||||
| Accumulated deficit | (468,023 | - | (460,779 | - | ||||
| Total stockholders' equity | 19,822 | 26,505 | ||||||
| Total liabilities and stockholders' equity | - | 48,027 | - | 56,748 | ||||
| BOLT BIOTHERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | - | (7,244 | - | - | (11,040 | - | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 203 | 399 | ||||||
| Stock-based compensation expense | 545 | 709 | ||||||
| Accretion of discount on marketable securities | (45 | - | (209 | - | ||||
| Gain on sale of property and equipment | (31 | - | (288 | - | ||||
| Non-cash lease expense | 666 | 615 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other assets | (79 | - | (169 | - | ||||
| Accounts payable and accrued expenses | (1,403 | - | (2,511 | - | ||||
| Operating lease liabilities | (650 | - | (500 | - | ||||
| Deferred revenue | (11 | - | (503 | - | ||||
| Other long-term liabilities | 26 | 132 | ||||||
| Net cash used in operating activities | (8,023 | - | (13,365 | - | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Proceeds from sales of property and equipment | 31 | 963 | ||||||
| Purchases of marketable securities | (1,230 | - | (992 | - | ||||
| Maturities of marketable securities | 9,122 | 14,580 | ||||||
| Net cash provided by investing activities | 7,923 | 14,551 | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Proceeds from issuance of common stock | 6 | - | ||||||
| Net cash provided by financing activities | 6 | - | ||||||
| NET (DECREASE) INCREASE IN CASH | (94 | - | 1,186 | |||||
| Cash, cash equivalents and restricted cash at beginning of year | 13,441 | 8,970 | ||||||
| Cash, cash equivalents and restricted cash at end of period | - | 13,347 | - | 10,156 | ||||
| Reconciliation of cash, cash equivalents and restricted cash: | ||||||||
| Cash and cash equivalents | - | 11,609 | - | 8,391 | ||||
| Restricted cash | 1,738 | 1,765 | ||||||
| Total cash, cash equivalents and restricted cash | - | 13,347 | - | 10,156 | ||||
