On November 10, 2022 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the third quarter ended September 30, 2022 and provided a business update (Press release, Bolt Biotherapeutics, NOV 10, 2022, View Source [SID1234623722]).
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"In the third quarter, our clinical development team advanced BDC-1001 for patients with HER2-expressing solid tumors through dose-escalation monotherapy and combination studies with Opdivo while exploring biweekly and weekly schedules. We look forward to announcing topline data and our recommended Phase 2 dose for the monotherapy and combination dose-expansion trials during the first quarter of 2023, with full data to be presented at an upcoming scientific conference," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt Biotherapeutics. "We also continue to make strong progress in our proprietary BDC-3042 program, which is progressing through IND-enabling activities supporting initiation of clinical studies in 2023, and our collaboration programs. Our work with strategic partners on new ISAC pipeline programs positions Bolt to continuously innovate targeted immunotherapies with the potential to improve the treatment of cancer. Finally, I’d like to recognize how our talented research and development teams, have established our leadership position in ISACs, as they advance our promising next-generation immuno-oncology therapeutics."
Recent Highlights and Anticipated Milestones
BDC-1001 – The monotherapy and combination dose-escalation trial is on track to complete enrollment by year-end. Topline data, the recommended Phase 2 dose (RP2D), and Phase 2 dose-expansion study design are expected during the first quarter of 2023, with full data to follow later in 2023. Biweekly and weekly dosing regimens of BDC-1001, a HER2-targeting Boltbody immune-stimulating antibody conjugate (ISAC), are currently being evaluated in a Phase 1/2 multi-dose, multi-center study in monotherapy and combination studies with Bristol Myers Squibb’s PD-1 checkpoint inhibitor Opdivo (nivolumab). To date, BDC-1001 has demonstrated a favorable safety profile, changes in plasma and tumor biomarkers consistent with its novel mechanism of action, and signs of durable clinical disease control.
BDC-3042 on track to enter the clinic in 2023 – Investigational New Drug (IND)-enabling activities for BDC-3042, an agonist antibody that stimulates Dectin-2, are on track to support an IND filing and initiation of clinical development in 2023. Preclinical studies demonstrate that Dectin-2 agonist antibodies reprogram tumor-associated macrophages to drive anti-tumor immunity.
Cash, cash equivalents, and marketable securities were $209.6 million as of September 30, 2022 – Cash on hand, coupled with growing collaboration revenues, is expected to fund multiple key milestones and operations through 2025.
Upcoming Events
BDC-3042 poster presentation highlighting new preclinical data will be presented at the 2022 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). Bolt Biotherapeutics’ Justin Kenkel, Ph.D., will present a poster entitled, "BDC-3042: A Dectin-2 agonistic antibody for tumor-associated macrophage-directed immunotherapy."
Authors: Justin Kenkel, Rishali Gadkari, Jess Nolin, Fang Xiao, Po Ho, Cindy Kreder, Laughing Bear Torrez, David Omstead, Katelynn McEachin, Jason Ptacek, Lu Xu, Duy Nguyen, Karla Henning, Steven Chapin, David Dornan, Michael Alonso, Shelley Ackerman
Poster Number: 1348
Presentation Date: Friday, Nov. 11, 2022, 9:00 a.m. – 8:30 p.m. EST, Poster Hall, Boston Convention and Exhibition Center
Stifel 2022 Healthcare Conference. Management will be available for meetings with the investment community on Wednesday, November 16th, 2022, with a corporate presentation at 1:15 p.m. ET in New York, New York.
Third Quarter 2022 Financial Results
Collaboration Revenue – Collaboration revenue was $2.1 million for the third quarter ended September 30, 2022, compared to $0.8 million for the same quarter in 2021. This represents 50% growth over the second quarter of 2022 as Bolt continues to ramp up activities supporting its collaborations. Revenue in 2022 was generated from the services performed under the R&D collaborations with Genmab A/S and Innovent Biologics, Inc.
Research and Development (R&D) Expenses – R&D expenses were $19.0 million for the third quarter ended September 30, 2022, compared to $19.3 million for the same quarter in 2021.
General and Administrative (G&A) Expenses – G&A expenses were $5.5 million for the third quarter ended September 30, 2022, compared to $4.9 million for the same quarter in 2021, primarily due to increases in personnel-related expenses relating to an increase in headcount.
Loss from Operations – Loss from operations was $22.3 million for the third quarter ended September 30, 2022, compared to $23.5 million for the same quarter in 2021.
About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform unites the precision of antibodies with the power of the innate and adaptive immune system to reprogram the tumor microenvironment for 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 lowering 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.