On November 9, 2021 Bolt Biotherapeutics, Inc. (NASDAQ: BOLT) a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported financial results for the third quarter ended September 30, 2021 and provided an update on recent business highlights (Press release, Bolt Biotherapeutics, NOV 9, 2021, View Source [SID1234594893]).
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"This quarter was notable for the significant progress we made across our entire pipeline of novel ISACs and with successful partnering of Bolt’s pioneering technology. We continued robust enrollment of the dose escalation portion of the BDC-1001 Phase 1/2 trial and we anticipate initiation of the combination dose escalation with Opdivo by year-end," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt Biotherapeutics. "We look forward to providing an update on our progress with BDC-1001 at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress in December."
Recent Business Highlights and Anticipated Milestones
Progress in the BDC-1001 Phase 1/2 trial in HER2-expressing solid tumors, with a monotherapy interim update in Q4 2021 – Interim data from more than 50 patients treated at increasing exposure levels will be presented in December at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021. The presentation will provide further details of the continued favorable safety and tolerability profile along with insights from data on phamacokinetics, tumor and serum biomarkers and early signs of clinical activity. The positive data support continued investigation of an optimal dosing regimen and Phase 2 initiation in 2022.
R&D collaboration with Innovent Biologics to develop up to three anti-cancer ISAC candidates – In August 2021, Bolt Biotherapeutics announced an R&D collaboration to apply Innovent’s proprietary therapeutic antibody portfolio and discovery capability and Bolt’s ISAC platform technology and myeloid biology expertise with the goal of creating up to three new cancer treatments with the potential to provide significant benefit to patients. Bolt Biotherapeutics received an upfront payment of $5.0 million in cash from Innovent at signing and a possible future equity investment of up to $10.0 million, as well as milestones and royalties. Bolt Biotherapeutics retains the option to license global rights outside of Greater China for one program and North American rights for another program.
Clinical collaboration and supply agreement with Bristol Myers Squibb to investigate BDC-1001 in combination with Opdivo (nivolumab) – In September 2021, Bolt Biotherapeutics announced a clinical collaboration and supply agreement with Bristol Myers Squibb Company (BMS) to investigate BDC-1001 in combination with BMS’ PD-1 checkpoint inhibitor Opdivo. BMS will provide Opdivo for the combination dose escalation and combination dose expansion portions of the Phase 1/2 clinical trial in patients with HER2-expressing solid tumors, including breast, gastroesophageal and colorectal. The combination portion of the trial is expected to start in the fourth quarter of 2021.
IND-enabling studies with BDC-2034 (CEA-targeting ISAC) remain on track. GLP toxicology studies are expected to commence in first quarter of 2022 and IND filing in mid-2022.
Cash, cash equivalents, and marketable securities of $290.5 million as of September 30, 2021, plus the $5.0 million upfront payment received in October 2021 for the R&D collaboration with Innovent Biologics, is expected to fund operations and the advancement of the company’s product pipeline to achieve multiple key milestones through the end of 2023.
Upcoming Events
At the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, company scientists will be presenting data on three proprietary, early-stage oncology pipeline programs, including two Boltbody ISAC candidates and a novel agonist antibody targeting Dectin-2 (previously known as TAM1). Information about these presentations can be found below and on the 2021 SITC (Free SITC Whitepaper) Annual Meeting website. All poster presentations will take place from 7:00 a.m. – 8:30 p.m. ET on Saturday, November 13, 2021.
William G. Mallet, Ph.D., will present a poster entitled "BDC-2034: Discovery of a CEA-targeting Immune-Stimulating Antibody Conjugate (ISAC) for Solid Tumors."
Justin A. Kenkel, Ph.D., will present a poster entitled "Dectin-2, a novel target for tumor macrophage reprogramming in cancer immunotherapy."
Marcin Kowanetz, Ph.D., will present a poster entitled "PD-L1-targeted ISAC combines myeloid cell activation, immune-checkpoint inhibition and ADCP to improve anti-tumor efficacy over anti-PD-L1 antibodies in preclinical models."
At the Stifel 2021 Virtual Healthcare Conference, management will participate in a virtual fireside chat and be available for meetings with the investment community on Tuesday, November 16, 2021.
At the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021, interim results will be presented from the monotherapy dose-escalation portion of a Phase 1/2 study of BDC-1001 for the treatment of patients with advanced HER2-expressing solid tumors, including breast, gastroesophageal and colorectal cancer. ESMO (Free ESMO Whitepaper) I/O is being held in Geneva, Switzerland in person and virtually from December 8-11, 2021.
Title: 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
Presenter: Manish R. Sharma, M.D., Associate Director of Clinical Research, START Midwest
Presentation Number: 164P
Details: December 8-11, 2021, ePoster presentation
Third Quarter 2021 Financial Results
Cash Position – Cash, cash equivalents, and marketable securities were $290.5 million as of September 30, 2021, compared to $310.9 million as of June 30, 2021. Bolt Biotherapeutics expects this cash balance to fund operations through the end of 2023.
Collaboration Revenue – Revenue was $0.8 million for the quarter ended September 30, 2021, compared to zero for the same quarter in 2020. Revenue in 2021 was generated from services performed under the R&D collaboration with Genmab.
Research and Development Expenses – R&D expenses were $19.3 million for the quarter ended September 30, 2021, compared to $9.5 million for the same quarter in 2020, with the largest two increases due to manufacturing expenses related to BDC-1001 and BDC-2034 and personnel expenses relating to an increase in headcount.
General and Administrative (G&A) Expenses – G&A expenses were $4.9 million for the quarter ended September 30, 2021, compared to $2.9 million for the same quarter in 2020, with the largest increase due to personnel expenses relating to an increase in headcount.
Loss from Operations – Loss from operations was $23.5 million for the quarter ended September 30, 2021, compared to $12.4 million for the same quarter in 2020.
Opdivo is a trademark of Bristol-Myers Squibb Company.