Core Insights - Bolt Biotherapeutics announced promising preclinical results for its next-generation Boltbody™ Immune-Stimulating Antibody Conjugates (ISACs) targeting CEACAM5 and PD-L1 at the AACR Annual Meeting [1][2] - The CEA-targeted ISAC demonstrated complete and durable anti-tumor responses in mice and was well-tolerated in non-human primates (NHPs) [2][5] - PD-L1 ISACs showed the ability to activate and reprogram PD-L1-expressing myeloid cells, promoting both innate and adaptive anti-tumor immunity [5][6] Group 1: CEA-targeted ISAC - The CEA ISAC is designed with a fully human antibody that specifically targets CEACAM5, commonly found in gastrointestinal cancers [2][4] - It enhances phagocytosis of CEA-positive tumor cells and stimulates the production of immune-activating cytokines such as IL-12p70, IFNg, and TNFa [2][5] - In a non-GLP NHP toxicity study, the CEA ISAC was well-tolerated at doses up to 15 mg/kg, with no significant drug-related adverse events observed [5] Group 2: PD-L1 ISAC - The PD-L1 ISAC utilizes a novel human anti-PD-L1 antibody conjugated to a next-generation TLR7/8 agonist, targeting both tumor and immune cells expressing PD-L1 [3][5] - It has shown complete regressions and the induction of immunological memory in models resistant to PD-1/PD-L1 checkpoint inhibitors [5] - The efficacy of PD-L1 ISACs does not rely on the blockade of the PD-1/PD-L1 axis, suggesting a complementary mechanism to existing therapies [5] Group 3: Company Overview - Bolt Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies for cancer treatment [7] - The company's pipeline includes BDC-3042, an agonist antibody targeting dectin-2, and BDC-4182, a next-generation Boltbody™ ISAC targeting claudin 18.2, with clinical trials expected to begin in Q2 2025 [7]

Core Insights - BDC-3042 demonstrated a favorable safety profile and biological activity in a Phase 1 clinical study, with no dose-limiting toxicities or serious adverse events reported [1][4][5] - The drug showed signs of anti-tumor activity, particularly in non-small cell lung cancer (NSCLC) patients, with 80% of evaluable patients achieving stable disease or better [1][4] - Bolt Biotherapeutics is seeking a partnership to accelerate the development and commercialization of BDC-3042, highlighting its significant commercial potential [2][6] Clinical Study Findings - The Phase 1 study enrolled 17 patients across seven dose cohorts, with a median of four prior lines of therapy [3] - The recommended Phase 2 dose (RP2D) was established at 10 mg/kg every two weeks, with further exploration of other doses and schedules planned [3] - Evidence of target engagement was confirmed, with 100% of patient samples showing detectable dectin-2 staining [4] Safety and Efficacy - BDC-3042 was well tolerated, with no grade 4 or 5 drug-related adverse events reported [4] - The most common drug-related adverse events included fatigue, flatulence, and nausea, each occurring in 12% of patients [4] - The study indicated that patients previously treated with PD-(L)1 inhibitors may have improved outcomes due to higher dectin-2 expression [3][5] Company Overview - Bolt Biotherapeutics is focused on developing novel immunotherapies for cancer treatment, with BDC-3042 being a first-in-class agonist antibody targeting dectin-2 [6] - The company is also advancing BDC-4182, a next-generation immune-stimulating antibody conjugate, with clinical trials expected to begin in the second quarter of 2025 [6]

Core Insights - Bolt Biotherapeutics is set to present data from its Phase 1 dose-escalation clinical study of BDC-3042 at the AACR Annual Meeting in April 2025, focusing on patients with advanced cancers [1][2] Group 1: Clinical Study Details - BDC-3042 is a proprietary agonist antibody targeting dectin-2, an immune-activating receptor found in tumor-associated macrophages, and is being evaluated in patients with metastatic or unresectable solid tumors, including non-small cell lung cancer (NSCLC) [2][7] - The Phase 1 clinical study is a single-agent, dose-escalation trial assessing the safety and efficacy of BDC-3042 [2][7] Group 2: Presentation Information - The poster presentation titled "BDC-3042, a first-in-class Dectin-2 agonist, in patients with advanced malignancies: Results from the first-in-human dose-escalation study" will be presented by Dr. Ecaterina E. Dumbrava on April 29, 2025 [4] - Additional presentations will include preclinical data on Boltbody™ ISACs targeting CEA and PD-L1, showcasing the company's innovative approaches to cancer treatment [2][4] Group 3: Boltbody™ ISAC Platform - The Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) platform combines tumor-targeting antibodies with immune stimulants to enhance anti-cancer responses by activating myeloid cells [5] - This platform aims to create a robust immune response within the tumor microenvironment, potentially leading to durable therapeutic outcomes for cancer patients [5] Group 4: Company Overview - Bolt Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies for cancer treatment, leveraging expertise in myeloid biology and cancer drug development [6][7] - The company's pipeline includes BDC-3042 and BDC-4182, with the latter expected to enter clinical trials in the second quarter of 2025 [7]

Financial Performance and Losses - The company has incurred significant operating losses since inception, with net losses of $63.1 million and $69.2 million for the years ended December 31, 2024 and 2023, respectively, resulting in an accumulated deficit of $427.4 million as of December 31, 2024[135]. - The company has not generated any product revenue since its inception in 2015 and anticipates continuing to incur significant expenses and operating losses for the foreseeable future[135]. - The company expects its cash and cash equivalents of $70.2 million as of December 31, 2024, may be sufficient to fund operations through mid-2026, but there is substantial doubt about its ability to continue as a going concern[140]. - The company will require substantial funding to pursue its business objectives and may face delays or reductions in product development if unable to raise capital on favorable terms[139]. Product Development and Regulatory Challenges - The company discontinued the development of its first Boltbody ISAC program due to insufficient efficacy, highlighting the speculative nature of its biopharmaceutical product development[134]. - The company has no products that have received regulatory approval and is in the early stages of clinical development for its lead product candidate, BDC-3042[151]. - The company faces risks related to the regulatory approval process, which could delay or prevent the commercialization of its product candidates[151]. - The company anticipates significant commercialization expenses if it obtains marketing approval for any of its product candidates[139]. - The company may seek accelerated approval for some product candidates, but the FDA may require additional clinical trials before considering a Biologics License Application[162]. - Clinical trials are expensive and time-consuming, with uncertain outcomes, and the company cannot guarantee that any trials will be completed on schedule[163]. - The company may face significant delays in clinical trials due to various factors, including regulatory authority consensus and patient enrollment challenges[166]. - If clinical trials yield inconclusive results or safety concerns arise, the company may face increased drug development costs and impaired commercialization prospects[169]. - The company may prioritize certain product candidates over others, potentially missing out on more profitable opportunities[171]. - Any adverse developments in one of the company’s programs may significantly impact the perceived success and value of its other programs[155]. Competition and Market Risks - The company faces substantial competition in the development and commercialization of new drug products, particularly in the cancer treatment segment[184]. - The successful commercialization of product candidates will depend on obtaining adequate coverage and reimbursement from governmental authorities and health insurers[191]. - The company expects pricing pressures due to increasing efforts by payors to cap or reduce healthcare costs, which may limit coverage and reimbursement for newly approved products[195]. - The market acceptance of product candidates, if approved, will depend on factors such as efficacy, pricing, and the willingness of physicians and patients to adopt new therapies[190]. - The market acceptance of the company's product candidates is influenced by the acceptance of other cancer immunotherapies, with potential adverse events in clinical trials impacting demand[200]. - If any product candidates are approved but fail to achieve adequate acceptance from patients, physicians, and payors, the company may not generate sufficient revenue to remain profitable[201]. Intellectual Property and Legal Risks - The company has two issued U.S. patents solely owned and four issued U.S. patents co-owned with Stanford, with additional foreign patents[249]. - The patent prosecution process is costly and time-consuming, with risks of failing to file necessary patent applications in a timely manner[251]. - The company is heavily dependent on licensed intellectual property, and losing rights to such licenses could significantly impact the development and commercialization of product candidates[257]. - The company may face challenges in enforcing its patents, which could lead to invalidation or narrowing of patent rights, impacting its competitive position and business prospects[267]. - The company relies on trade secrets and confidentiality agreements to protect its proprietary information, which may be difficult to enforce[294]. - The company faces significant risks related to litigation that could increase operating losses and reduce resources for development activities[271]. - The company may struggle to protect its intellectual property rights globally, with potential limitations in foreign jurisdictions impacting competitive positioning[272]. Operational and Management Challenges - The company initiated a restructuring and reduction-in-force in May 2024, appointing a new President and CEO, which may create uncertainty and impact operations[306]. - Retaining key personnel is critical for the company's success in the competitive immuno-oncology and pharmaceutical industries[305]. - The company faces intense competition for hiring qualified personnel, which has led to unwanted employee attrition and may continue to limit its growth strategy[308]. - The company has implemented a flexible work-from-home policy, which may negatively impact productivity and disrupt business operations[302]. - The company may face difficulties in managing growth and operational expansion, which could disrupt business plans and lead to increased costs[309]. Compliance and Regulatory Environment - Compliance with healthcare laws is crucial, as non-compliance could result in substantial penalties[235]. - The company is subject to stringent U.S. and foreign laws related to data privacy and security, with potential civil or criminal penalties for non-compliance[238]. - The California Consumer Privacy Act (CCPA) allows for civil penalties of up to $7,500 per violation, increasing compliance costs and potential liabilities[240]. - The company must comply with evolving data privacy laws across multiple states, complicating compliance efforts and increasing legal risks[241]. - The EU GDPR imposes fines of up to €20 million or 4% of annual global revenue for data processing violations, significantly impacting operations[242]. Market and Economic Conditions - The trading price of the company's common stock may be volatile, influenced by various factors including regulatory decisions, clinical trial results, and market conditions[320]. - Global economic volatility, including inflation and geopolitical conflicts, may adversely affect the company's financial condition and share price[322]. - Macroeconomic uncertainties, including inflation and supply chain disruptions, are expected to adversely affect the company's operations and clinical development timelines[302].

Exhibit 99.1 Bolt Biotherapeutics Reports Fourth Quarter and Full-Year 2024 Financial Results and Provides Business Update REDWOOD CITY, CA, Mar. 24, 2025 – Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today reported financial results for the third quarter ended December 31, 2024, and provided a business update. "2024 was a transformational year for Bolt as we focused the company on efficient development of the ...

BDC-4182 on track to start a clinical trial in gastric cancer in second quarter 2025BDC-3042 Phase 1 clinical trial fully enrolled the highest dose cohort with no dose-limiting toxicities (DLTs), results will be reported in second quarter 2025Cash balance of $70.2 million as of December 31, 2024 anticipated to fund key milestones through mid-2026 REDWOOD CITY, Calif., March 24, 2025 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (NASDAQ:BOLT), a clinical-stage biopharmaceutical company developing novel immunother ...

REDWOOD CITY, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today announced that management will participate in two upcoming conferences in March: TD Cowen 45th Annual Health Care ConferenceCompany presentation on Tuesday, March 4, 2025 at 3:10 p.m. EST (1:10 p.m. PST) Leerink Partners Global Healthcare ConferenceParticipating in 1x1 meetings on Monday, March 10, 2025 Abo ...

-- Targeting Unmet Needs for Treating Solid Tumors-- REDWOOD CITY, Calif., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc., announced today that the target of their worldwide co-development collaboration with Toray Industries, Inc. is Caprin-1, a novel cancer target discovered by Toray. The collaborators are developing a Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) targeting Caprin-1, which is applicable to multiple solid tumor types. Under the existing Joint Development and License A ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39988 Bolt Biotherapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 47-2804636 (State or other ...

Exhibit 99.1 Bolt Biotherapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update • Advanced to the highest dose level in the Phase 1 dose-escalation clinical study of BDC3042 in patients with advanced cancers • Presented updated preclinical activity of BDC-4182 and key learnings from Phase 1 doseescalation trial of BDC-1001 at the SITC 39th Annual Meeting • BDC-4182 on track to start clinical trials in second quarter 2025 • Cash balance of $84.4 million as of September 30, 2024 an ...