Announcement • Apr 30
Bolt Biotherapeutics, Inc., Annual General Meeting, Jun 10, 2026 Bolt Biotherapeutics, Inc., Annual General Meeting, Jun 10, 2026. Announcement • May 01
Bolt Biotherapeutics Presents Preclinical Results for Next-Generation Boltbody ISACs Targeting Cea and PD-L1 At AACR Annual Meeting 2025 Bolt Biotherapeutics announced preclinical results from its next-generation Boltbody ISACs targeting CEACAM5 and PD-L1 at the American Association for Cancer Research (AACR) Annual Meeting. This ISAC drives enhanced phagocytosis of CEA-positive tumor cells and stimulates production of critical immune-activating cytokines including IL-12p70, IFNg, and TNFa. Key results with the next-gen CEA ISAC are below: Antigen-dependent induction of immune-stimulating cytokines in human, NHP and mouse effector cells Complete responses in CEA transgenic syngeneic model demonstrates robust efficacy. Induction of immunological memory demonstrates potential for durable responses. In a non-GLP NHP tox study, the next-generation CEA ISAC was well-tolerated with no significant drug-related adverse events observed up to 15 mg/kg, the highest tested dose. Bolt's PD-L1 ISAC utilizes a novel human anti-PD-L1 antibody conjugated to a next-generation TLR7/8 agonist load 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. Key results are below: PD-L1 ISACs directly activate and reprogram PD-L1-expressing myeloid cells in the TME to promote innate and adaptive antitumor immunity. PD-L1 ISAC's elicit complete regressions and immunological memory in models that are resistant to PD-1/PD-L1 checkpoint inhibitor therapy. Mechanistic studies indicate that PD-L1 expression by either tumor or immune cells is sufficient to drive antitumor efficacy. Blockade of the PD-1/PD- L1 axis is not required for PD-L1 ISAC efficacy but may be a supportive mechanism and complementary combination strategy. Favorable safety profile was demonstrated in non-GLP NHP toxicology studies supporting use in combination with SoC therapies & other agents. Details about the poster presentations can be found on the AACR website. Additionally, a copy of each poster is available on the Publications page of the Bolt Biotherapeutics website. 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. Announcement • Apr 26
Bolt Biotherapeutics Presents Results from the Phase 1 Dose-Escalation Clinical Study of BDC-3042 At AACR Annual Meeting 2025 Bolt Biotherapeutics announced results from its Phase 1 dose-escalation clinical study of BDC-3042 at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois. Dectin-2 is a C-type lectin receptor best known for its role in pathogen recognition and induction of protective immune responses against fungi and other microbes. This single-agent, dose-escalation Phase 1 clinical study is evaluating BDC-3042 in patients with metastatic or unresectable triple-negative breast cancer (TNBC), clear cell renal cell carcinoma (ccRCC), colorectal cancer (CRC), melanoma, non-small cell lung cancer (NSCLC), and ovarian cancer. Key Clinical Study Findings: Seventeen patients with six different tumor types and a median of four prior lines of therapy were enrolled across the seven dose cohorts. Across all dose cohorts: No grade 4 or 5 drug-related adverse events (AEs) were reported; No drug-related serious adverse events (SAEs) were reported; No drug -related treatment discontinuations; The most frequent drug-related AEs were fatigue (12%), flatulence (12%), and nausea (12%) BDC-3042 demonstrated favorable pharmacokinetics (PK) providing ample exposure and flexibility to widen the dosing interval; Biological activity was confirmed, with evidence of target engagement and peripheral immunostimulatory effects consistent with preclinical studies; 100% (5/5) of patient samples had detectable dectin-2 staining when assessed by immunohistochemistry (IHC); The study provided evidence of monotherapy anti-tumor activity; One NSCLC patient from the 10 mg/kg cohort had an unconfirmed partial response and remains on study beyond 18 weeks; 80% of evaluable patients (12/15) had SD or better as their best response; Four out of five patients who had progressed after previous treatment with PD-1/PD-L1 blockers had SD with some reduction in tumor size; All three NSCLC patients had SD or better with some reduction in tumor size. 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. Announcement • Apr 17
Bolt Biotherapeutics, Inc., Annual General Meeting, May 27, 2025 Bolt Biotherapeutics, Inc., Annual General Meeting, May 27, 2025. Reported Earnings • Nov 14
Third quarter 2024 earnings released: US$0.40 loss per share (vs US$0.43 loss in 3Q 2023) Third quarter 2024 results: US$0.40 loss per share (improved from US$0.43 loss in 3Q 2023). Revenue: US$1.14m (down 55% from 3Q 2023). Net loss: US$15.2m (loss narrowed 6.6% from 3Q 2023). Revenue is expected to decline by 76% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Europe are expected to grow by 22%. Over the last 3 years on average, earnings per share has increased by 27% per year but the company’s share price has fallen by 58% per year, which means it is significantly lagging earnings. Announcement • Nov 08
Bolt Biotherapeutics Presents Updated Preclinical Data for BDC-4182 and Key Learnings from Phase 1 Dose-Escalation Trial of BDC-1001 at SITC 39th Annual Meeting Bolt Biotherapeutics presented updated preclinical data for BDC-4182, a next-generation Boltbody™? ISAC clinical candidate targeting claudin 18.2, and provided key learnings from its Phase 1 dose-escalation trial of BDC-1001 at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held in Houston, Texas from November 6-10, 2024. BDC-4182 has advanced into IND-enabling activities, supported by in vitro and in vivo experiments demonstrating potent anti-tumor activity in multiple preclinical models, with clinical trial initiation expected in 2025. In vivo assessment of anti-tumor activity was performed with a murine surrogate of BDC-4182 using xenograft and syngeneic tumor models with different levels of claudin 18.2 expression. 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. Board Change • Oct 01
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Director Jakob Dupont was the last director to join the board, commencing their role in 2024. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Announcement • Sep 05
Bolt Biotherapeutics, Inc. Announces Changes to Its Board of Directors Bolt Biotherapeutics, Inc. announced the appointment of Jakob Dupont, M.D., to its Board of Directors. Dr. Dupont brings more than two decades of experience in the field of oncology and immuno-oncology. With the appointment of Dr. Dupont, Executive Partner at Sofinnova Investments, Dr. Jim Healy, M.D., Ph.D., also at Sofinnova, will be stepping down as Lead Independent Director. In addition, Frank D. Lee will be departing the Board and Brian O’Callaghan, CEO of Deep Genomics, will be assuming the role of Chair. Dr. Dupont is Executive Partner, Private Equity at Sofinnova Investments. Prior to joining Sofinnova, Dr. Dupont was Global Head of Research & Development and Executive Vice President at Atara Biotherapeutics, where he led the development and regulatory approval of EBVallo®. He also served as Chief Medical Officer at Gossamer Bio. Before Gossamer Bio, Dr. Dupont served as Vice President and Global Head of Breast and Gynecologic Cancer Development for Genentech/Roche, where he was responsible for the global development of Herceptin®, Perjeta®, Kadcyla®, and Tecentriq®, among others, and where he previously led the development of Avastin® for Gynecologic and Breast Cancers when starting his industry career. He serves as a Board Member for Avenzo Therapeutics, Pyxis Oncology, and Imugene, and is on the Scientific Advisory Board for Flagship Pioneering. Dr. Dupont earned his bachelor’s degree from Vassar College, his master’s degree from New York University, and his M.D. from the Joan & Sanford I. Weill Medical College of Cornell University. Reported Earnings • Aug 15
Second quarter 2024 earnings released: US$0.56 loss per share (vs US$0.48 loss in 2Q 2023) Second quarter 2024 results: US$0.56 loss per share (further deteriorated from US$0.48 loss in 2Q 2023). Revenue: US$1.28m (down 11% from 2Q 2023). Net loss: US$21.2m (loss widened 17% from 2Q 2023). Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 37% per year but the company’s share price has fallen by 62% per year, which means it is significantly lagging earnings. Announcement • Jul 05
Bolt Biotherapeutics Receives Written Notice from Nasdaq Due to Non-Compliance with the Minimum Bid Requirement under Nasdaq Listing Rule 5450(a)(1) On July 2, 2024, Bolt Biotherapeutics, Inc. received a written notice from the Listing Qualifications Department of The Nasdaq Stock Market, LLC (‘Nasdaq’) notifying the company that on July 1, 2024, the average closing price of its common stock over the prior 30 consecutive trading days had fallen below $1.00 per share, which is the minimum average closing price required to maintain listing on the Nasdaq Global Select Market under Nasdaq Listing Rule 5450(a)(1) (the ‘Minimum Bid Requirement’). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the company has 180 calendar days to regain compliance with the Minimum Bid Requirement (the ‘Grace Period’), subject to a potential 180 calendar day extension. To regain compliance, the closing bid price of its common stock must be at least $1.00 per share for a minimum of ten consecutive business days within the Grace Period. If the company do not achieve compliance with the Minimum Bid Requirement by December 30, 2024, the end of the Grace Period, the company may be eligible for an additional 180 calendar day period to regain compliance. To qualify, the company would be required to meet the continued listing requirement for the market value of the company’s publicly held shares and all other Nasdaq initial listing standards, with the exception of the bid price requirement, and would need to provide written notice of the company’s intention to cure the deficiency during the second compliance period by effecting a reverse stock split if necessary. However, if it appears to Nasdaq staff that the company will not be able to cure the deficiency, or if the company do not meet the other listing standards, Nasdaq could provide notice that the company’s common stock will be subject to delisting. In the event the company receive notice that the company’s common stock is being delisted, the company would be entitled to appeal the determination to a Nasdaq Listing Qualifications Panel and request a hearing. The company intend to actively monitor the closing bid price of its common stock and will evaluate available options to regain compliance with the Minimum Bid Requirement. There can be no assurance that the company will be able to regain compliance with the Minimum Bid Requirement or maintain compliance with the other listing requirements. The notice has no immediate effect on the listing or trading of the company’s common stock, which will continue to be listed and traded on the Nasdaq Global Select Market, subject to the company's compliance with the other Nasdaq listing requirements. Board Change • Jun 18
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Founder & Member of Scientific Advisory Board Ed Engleman was the last director to join the board, commencing their role in 2024. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • May 16
First quarter 2024 earnings released: US$0.28 loss per share (vs US$0.45 loss in 1Q 2023) First quarter 2024 results: US$0.28 loss per share (improved from US$0.45 loss in 1Q 2023). Revenue: US$5.27m (up 189% from 1Q 2023). Net loss: US$10.8m (loss narrowed 36% from 1Q 2023). Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 58% per year but the company’s share price has fallen by 62% per year, which means it is significantly lagging earnings. Announcement • Apr 28
Bolt Biotherapeutics, Inc., Annual General Meeting, Jun 12, 2024 Bolt Biotherapeutics, Inc., Annual General Meeting, Jun 12, 2024, at 11:00 Pacific Standard Time. Agenda: To elect our two nominees for Class III directors to serve until our 2027 Annual Meeting of Stockholders; to ratify the selection by the audit committee of the Board of Directors of PricewaterhouseCoopers LLP as independent registered public accounting firm for the year ending December 31, 2024; and to conduct any other business properly brought before the 2024 Annual Meeting of Stockholders. New Risk • Apr 07
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 9.9% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (9.9% average weekly change). Earnings are forecast to decline by an average of 2.1% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$51m net loss in 3 years). Market cap is less than US$100m (€46.8m market cap, or US$50.7m). Reported Earnings • Mar 22
Full year 2023 earnings released: US$1.83 loss per share (vs US$2.36 loss in FY 2022) Full year 2023 results: US$1.83 loss per share (improved from US$2.36 loss in FY 2022). Net loss: US$69.2m (loss narrowed 22% from FY 2022). Revenue is forecast to grow 30% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Germany. Announcement • Dec 05
Bolt Biotherapeutics Enrolls First Patient in Phase 2 Clinical Study Evaluating Bdc-1001 in Patients with Her2-Positive Breast Cancer Previously Treated with Enhertu Bolt Biotherapeutics, Inc. announced that the first patient has been dosed in the Phase 2 clinical trial investigating BDC-1001, a HER2-targeting Boltbody™? Immune-Stimulating Antibody Conjugate (ISAC), as a single agent and in combination with the HER2-targeting antibody pertuzumab. The first patient was treated at City of Hope, by Irene Kang, M.D., Medical Director, Women's Health Medical Oncology, and Assistant Professor, Department of Medical Oncology and Therapeutics Research at City of Hope's cancer center in Irvine, California. Preclinical research combining pertuzumab with a BDC-1001 surrogate demonstrated enhanced anti-tumor efficacy in multiple models and was originally reported in Ackerman SE, et al. Nat Cancer. 2021;2(1):18-33. A full dataset was presented at the 38th Annual Meeting of the Society for Immunotherapy of Cancer in San Diego in November (Pearson C, et al. SITC 2023. Abstract #821), demonstrating that the combination significantly enhanced anti-tumor effectiveness in multiple HER2-expressing tumor models and providing a compelling mechanistic rationale for conducting a clinical trial to evaluate the potential benefit for patients. Pertuzumab, which binds a distinct HER2 epitope from the trastuzumab component of BDC-1001, may increase the amount of clustered Fc or "eat me signals" on the surface of the tumor. Following the successful completion of the BDC-1001 dose-escalation trial for the treatment of patients with HER2-expressing solid tumors, Bolt is now conducting two Phase 2 clinical trials in the U.S., Europe, and South Korea: NCT04278144 for patients with colorectal, endometrial, and gastroesophageal cancers and NCT05954143 for patients with breast cancer as described above. Announcement • Oct 24
Bolt Biotherapeutics, Inc. Presents Updated Clinical Data from Phase 1 Dose-Escalation Trial of BDC-1001 as Monotherapy and in Combination with Nivolumab in HER2-Expressing Tumors at ESMO 2023 Congress Bolt Biotherapeutics, Inc. presented updated data from its Phase 1 dose-escalation trial of BDC-1001 at the European Society for Medical Oncology (ESMO) 2023 Congress, being held in Madrid, Spain and virtually from October 20-24, 2023. BDC-1001 is an investigational Immune-Stimulating Antibody Conjugate (ISAC) in development for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive cancer. BDC-1001 comprises a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to a proprietary TLR7/8 agonist. The Phase 1 dose-escalation trial enrolled 131 patients with 16 different HER2-expressing solid tumor types across 18 dose levels in two arms, monotherapy and in combination with nivolumab. At enrollment, all patients entered in the study had evidence of tumor progression following prior standard of care treatments, and a majority of the patients were heavily pre-treated. Key findings from the updated Phase 1 BDC-1001 dose escalation study are summarized below: Improved BDC-1001 efficacy was observed since the data presented at ASCO in June 2023 with one new CR, two additional long-term SDs, and three patients who received therapy for at least one year; At the RP2D, one CR was observed in the monotherapy arm in a patient with salivary gland cancer and three PRs were observed at the RP2D; one in the monotherapy arm in a patient with biliary tract cancer and two in the combination arm in patients with colorectal and ovarian cancer. The response rate at the RP2D was 29% in evaluable patients with HER2-positive tumors, both in monotherapy (2/7, 29%) and in combination with nivolumab (2/7, 29%); At the RP2D, among evaluable patients with HER2-positive tumors, 43% (3/7) in the monotherapy arm and 57% (4/7) in the combination arm experienced at least 24 weeks of disease control, and 57% (4/7) in the monotherapy arm and 71% (5/7) in the combination arm achieved tumor shrinkage; BDC-1001 continues to be well tolerated at all dose levels and schedules as both monotherapy and in combination with nivolumab with no increase in toxicity in combination with BDC-1001. The most frequent drug-related treatment-emergent adverse events (TEAEs) were grade 1 or 2 infusion-related reactions, which were observed in 29.8% of subjects. Grade 3 or higher treatment-related TEAEs were seen in ten subjects (7.6%), with only one grade 4 and no grade 5 drug-related AEs; Pharmacodynamic responses in both plasma and tissue were consistent with the mechanism of action for an ISAC. Statistically significant upregulation of TLR signaling pathway gene signature, innate immunity gene signatures and T cell inflamed phenotype was observed in the four patients with clinical benefit. Increases in innate immunity signatures was observed in patients in the q2w cohorts, but not q1w; The once-weekly dosing cohorts experienced higher rates of adverse events versus every-two-week (q2w) dosing, including: grade 3 or higher BDC-1001-related TEAEs (10.0% versus 2.6%), grade 3 or higher LVEF decreases (7.5% versus 2.6%), and infusion-related reactions (40.0% versus 28.2%), providing further support for the selection of 20 mg/kg q2w as the RP2D. Reported Earnings • Aug 08
Second quarter 2023 earnings released: US$0.48 loss per share (vs US$0.61 loss in 2Q 2022) Second quarter 2023 results: US$0.48 loss per share (improved from US$0.61 loss in 2Q 2022). Net loss: US$18.1m (loss narrowed 20% from 2Q 2022). Revenue is forecast to grow 35% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Germany. Announcement • Dec 15
Bolt Biotherapeutics, Inc. Appoints Laura Berner to Board of Directors Bolt Biotherapeutics, Inc. announced the appointment of Laura Berner to its Board of Directors effective December 14, 2022. Laura Berner has extensive biopharma industry experience, in leadership roles spanning corporate strategy, business development, investor relations and law. She currently serves as Chief Operating Officer at TRexBio, a private, venture-backed biotechnology company, with responsibility for corporate and operational functions. Previously, Ms. Berner was Vice President, Head of Business Development & Investor Relations at Myovant Sciences, where she led the execution of global partnerships for the commercialization of the company’s lead products Myfembree® (relugolix, estradiol and norethindrone acetate) and Orgovyx® (relugolix) and supported Myovant through multiple follow-on financings. Earlier in her career, Ms. Berner was a member of the business development team at Roche Pharma Partnering and the transactional law group at Genentech. She began her career as a corporate attorney, first at Ropes & Gray LLP and later in the Office of the General Counsel at Harvard University, advising on general corporate, business development and strategic transactions. Ms. Berner earned her B.A. in biology from Bryn Mawr College, her J.D. from Stanford Law School, and her MBA from the University of Illinois Urbana Champagne Gies College of Business. Announcement • Jun 26
Bolt Biotherapeutics, Inc.(NasdaqGS:BOLT) dropped from Russell 2500 Index Bolt Biotherapeutics, Inc.(NasdaqGS:BOLT) dropped from Russell 2500 Index Board Change • May 02
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Director Brian O'Callaghan was the last director to join the board, commencing their role in 2021. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Apr 01
Full year 2021 earnings released: US$2.97 loss per share (vs US$28.89 loss in FY 2020) Full year 2021 results: US$2.97 loss per share. Net loss: US$98.6m (loss widened 62% from FY 2020). Over the next year, revenue is expected to shrink by 100% compared to a 99% growth forecast for the pharmaceuticals industry in Germany. Announcement • Mar 06
Bolt Biotherapeutics, Inc. Announces Resignation of David Dornan as Chief Scientific Officer, Effective from March 11, 2022 On March 1, 2022, David Dornan, Ph.D. notified Bolt Biotherapeutics, Inc. of his resignation as the company's Chief Scientific Officer, effective from March 11, 2022. Announcement • Jan 07
Bolt Biotherapeutics Doses First Patient with BDC-1001 in Combination with OPDIVO® (nivolumab) in Ongoing Phase 1/2 Clinical Trial for the Treatment of HER2-Expressing Solid Tumors Bolt Biotherapeutics, Inc. announced that the first patient has been dosed in a new combination arm of the ongoing multi-center, multi-dose Phase 1/2 clinical trial of BDC-1001. This arm is evaluating BDC-1001 in combination with Bristol Myers Squibb’s PD-1 checkpoint inhibitor OPDIVO® (nivolumab). In parallel, Bolt continues to advance the single-agent portion of the study, following the presentation of interim dose-escalation data at the European Society of Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2021. BDC-1001 is a HER2-targeting Boltbody™ immune-stimulating antibody conjugate (ISAC) (trastuzumab biosimilar conjugated to a toll-like receptor 7 and 8 agonist) in development for the treatment of patients with HER2-expressing solid tumors. Bristol Myers Squibb will provide Opdivo for the combination dose escalation and combination dose expansion portions of the trial. Bolt Biotherapeutics is the study sponsor and will be responsible for costs associated with the trial execution. BDC-1001 is a human epidermal growth factor receptor 2 (HER2) ISAC comprising a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to an innovative TLR7/8 agonist. It is currently being investigated in a Phase 1/2 clinical trial (NCT04278144) in patients with HER2-expressing solid tumors, including breast, gastroesophageal and colorectal. The trial is being conducted in four parts, and the dose-escalation monotherapy part will continue in parallel with the combination therapy study. Interim monotherapy data presented by Bolt at the European Society of Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2021 demonstrated a safe and well-tolerated profile with early clinical activity, supporting continued dose escalation and evaluation of a weekly dosing regimen. Board Change • Dec 22
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 4 independent directors. 5 non-independent directors. Lead Independent Director Jim Healy was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Announcement • Jun 08
Bolt Biotherapeutics, Inc. announced that it has received $15 million in funding from Genmab A/S On June 7, 2021, Bolt Biotherapeutics, Inc. (NasdaqGS:BOLT) closed the transaction. Announcement • Jun 05
Bolt Biotherapeutics, Inc. Presents Preliminary Results from Phase 1/2 Trial of Lead HER2-targeting Boltbody™ ISAC BDC-1001 at ASCO 2021 Bolt Biotherapeutics, Inc. announced that a poster presentation discussing preliminary data from the Phase 1/2 clinical trial of BDC-1001, Bolt’s lead candidate, was presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, being held virtually from June 4-8, 2021. The poster is titled “Preliminary results from a phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors.” BDC-1001 is a human epidermal growth factor receptor 2, or HER2, ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt’s proprietary TLR7/8 agonists, for the treatment of patients with HER2-expressing solid tumors, including HER2-low tumors. As of January 29, 2021, Bolt had treated 20 patients and BDC-1001 appeared to be well tolerated with mild to moderate adverse events; no dose-limiting toxicities or drug-related serious adverse events were observed. Clinical activity was seen in the form of stable disease, reductions in tumor volume including a confirmed partial response and increases in pharmacodynamic markers that Bolt believes are consistent with its proposed mechanism of action. The BDC-1001 Phase 1/2 trial is expected to enroll up to a total of 390 patients and is being conducted in four parts, with dose-escalation dose-expansion parts exploring both monotherapy and combination with a PD-1 checkpoint inhibitor. The monotherapy dose-escalation part of the trial continues to proceed according to plan, and full results are expected to be presented in the second half of 2021. Bolt plans to advance to the monotherapy Phase 2 dose-expansion cohorts and the dose-escalation combining BDC-1001 with an anti-PD-1 antibody later this year. The Boltbody™ ISAC platform technology harnesses the ability of innate immune agonists to convert cold tumors into immunologically hot tumors, thereby illuminating tumors to the immune system and allowing them to be invaded by tumor-killing cells. Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration as monotherapy in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients. The Phase 1/2, multi-center, open-label study is evaluating the safety, pharmacokinetics, pharmacodynamics and proof of mechanism of BDC-1001 in patients with HER2-expressing solid tumors. The first portion of the study includes a monotherapy dose-escalation phase in which cohorts of patients will receive ascending intravenous doses of BDC-1001 to determine the maximum tolerated dose and/or the recommended dose to advance into expansion cohorts and Phase 2 based on safety and tolerability. The second portion of the study is a dose expansion phase in which patients will receive BDC-1001 monotherapy to further evaluate the safety, tolerability and clinical antitumor activity of the recommended Phase 2 dose. The study also includes similar dose escalation and expansion portions evaluating the combination of BDC-1001 with an anti-PD1 checkpoint inhibitor. Reported Earnings • Apr 03
Full year 2020 earnings released: US$28.89 loss per share (vs US$15.29 loss in FY 2019) Full year 2020 results: Net loss: US$60.7m (loss widened 99% from FY 2019). Products in clinical trials Phase I: 4 