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Bolt Biotherapeutics, Inc. (BOLT) is a clinical-stage biopharmaceutical company specializing in novel immunotherapies for cancer treatment. Originating from Dr. Engleman's lab at Stanford University, the company leverages groundbreaking technology to develop tumor-targeted therapies, capitalizing on the combined power of the innate and adaptive immune systems. Backed by top-tier life sciences investors, Bolt is on a promising growth trajectory, dedicated to bringing innovative and curative therapies to patients.
The company’s proprietary Boltbody™ ISAC (Immune-Stimulating Antibody Conjugate) platform is the cornerstone of its therapeutic pipeline, which includes candidates like BDC-1001 and BDC-3042. This platform merges tumor-targeting antibodies with immune-stimulating linker-payloads designed to reprogram the tumor microenvironment, fostering a robust anti-cancer response.
BDC-1001 targets HER2-positive cancers and has shown durable clinical responses and a favorable safety profile in Phase 1 trials. Notably, the FDA granted Orphan Drug Designation to BDC-1001 for gastric cancer treatment, underlining its potential to address unmet medical needs. Phase 2 trials are underway for various cancers, including breast, colorectal, and endometrial cancers.
BDC-3042 targets Dectin-2, a receptor expressed by tumor-associated macrophages (TAMs), and aims to convert these cells from tumor-supportive to tumor-destructive. Having received FDA clearance for its Investigational New Drug (IND) application, BDC-3042 is set to enter Phase 1 trials.
Bolt's pipeline also includes multiple Boltbody ISAC collaboration programs with leading biopharmaceutical companies, further validating its platform technology. The company’s financial health is robust, with strategic plans to fund ongoing and future clinical programs.
For more information, visit Bolt Biotherapeutics, Inc. website.
Bolt Biotherapeutics (BOLT) reported its financial results for Q4 and the full year 2021, showcasing a cash balance of $271.6 million to fund operations through 2024. The company is progressing with BDC-1001, a treatment for HER2-expressing solid tumors, expected to reach Phase 2 dose identification later in 2022. The ongoing combination study with OPDIVO® is advancing well, showing promising stability and partial responses. R&D expenses rose to $75.7 million, reflecting increased clinical trial costs. Total revenue for 2021 was $1.3 million, marking growth from $0.2 million in 2020.
Bolt Biotherapeutics (Nasdaq: BOLT) will present three preclinical pipeline programs at the AACR Annual Meeting 2022 from April 8-13 in New Orleans. The company is focused on immuno-oncology therapeutics combining antibody precision with immune system power. Key presentations include BDC-2034, targeting CEA, expected to enter clinical development in late 2022; BDC-3042, a Dectin-2 targeting antibody anticipated for 2023; and a PD-L1-targeting ISAC. Each program shows promise in anti-tumor activity and future clinical development.
Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biotechnology firm, recently announced upcoming presentations at two key conferences in February 2022. The first is the Guggenheim 2022 Oncology Virtual Conference on February 9 at 10:00 a.m. PT, followed by the SVB Leerink Global Healthcare Conference on February 16 at 2:00 p.m. PT. Both events will feature fireside chats, available for live streaming on Bolt's website, with archived replays accessible for 90 days post-event.
Bolt focuses on innovative immuno-oncology agents, particularly its lead candidate, BDC-1001, targeting HER2-expressing tumors.
Bolt Biotherapeutics (Nasdaq: BOLT) announced the first patient has been dosed in a new combination arm of its Phase 1/2 clinical trial for BDC-1001, which is being evaluated alongside Bristol Myers Squibb’s OPDIVO® (nivolumab). This trial targets HER2-expressing solid tumors. Preliminary findings from the single-agent portion showed a safe profile, supporting the promising potential of BDC-1001. Bristol Myers Squibb is providing OPDIVO for the trial, while Bolt is responsible for execution costs.
Bolt Biotherapeutics (Nasdaq: BOLT) has appointed Nicole Onetto, M.D., to its Board of Directors as of December 14, 2021. Dr. Onetto brings 30 years of oncology experience from various pharmaceutical and biotech companies. Her expertise in clinical development will be crucial as Bolt advances its immuno-oncology programs. Dr. Ashish Khanna is stepping down from the board after serving since July 2018. The company focuses on developing innovative immuno-oncology agents, particularly using its Boltbody™ ISAC approach to treat HER2-expressing solid tumors.
Bolt Biotherapeutics (Nasdaq: BOLT) announced interim clinical data from its Phase 1/2 study of BDC-1001 at the ESMO I-O Congress 2021. The study involved 57 subjects with HER2-expressing solid tumors, showcasing a favorable safety profile and early signs of clinical activity. Notably, 13 of 40 evaluable subjects displayed clinical activity, with one maintaining a durable partial response for 52 weeks. The company plans to continue dose-escalation studies and initiate combination therapy with Opdivo® by year-end 2021, aiming for optimized drug exposure levels.
Bolt Biotherapeutics (BOLT) has announced the presentation of interim clinical data for BDC-1001 at the ESMO I-O Congress 2021, scheduled from December 8-11, 2021. This data includes insights from over 50 patients and highlights safety, tolerability, and early signs of clinical activity. The presentation will inform an ongoing Phase 1/2 study and support the initiation of a combination dose-escalation study with Opdivo by year-end. The poster will be accessible online starting December 6, 2021, at 12 p.m. CET, with a company conference call planned for the same date at 8:00 a.m. ET.
Bolt Biotherapeutics (Nasdaq: BOLT) announces the appointments of Brian O’Callaghan and Frank D. Lee to its Board of Directors, while Peter Moldt steps down. O’Callaghan brings 30 years of biopharmaceutical experience, crucial for advancing Bolt's immuno-oncology pipeline. Lee, with over 25 years in product development, enhances the company’s commercial strategy. CEO Randall Schatzman highlights the transformative year for Bolt, marked by its IPO and progress in clinical trials. The company focuses on developing immune-stimulating therapeutics targeting HER2-expressing tumors, with promising collaborations established.
Bolt Biotherapeutics, Inc. presented new preclinical data at the 2021 SITC Annual Meeting, highlighting the potential of its Boltbody™ ISAC candidates for cancer treatment. Key presentations included BDC-2034, targeting CEA, which showed promising tumor clearance and immune activation in CEA-expressing cancers. Additional data on a PD-L1-targeted ISAC demonstrated improved anti-tumor efficacy. The company also validated Dectin-2 as a novel target for reprogramming tumor-associated macrophages. Bolt aims to initiate clinical development of BDC-2034 in 2022.
Bolt Biotherapeutics (BOLT) reported Q3 2021 financial results, revealing a cash position of $290.5 million, expected to fund operations through 2023. The company is making progress in its BDC-1001 Phase 1/2 trial for HER2-expressing solid tumors, with interim data from over 50 patients to be presented at the ESMO Immuno-Oncology Congress in December. Collaboration revenue reached $0.8 million, while R&D expenses increased to $19.3 million. The loss from operations for Q3 was $23.5 million, compared to $12.4 million in the same period last year.