On August 7, 2023 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the second quarter ended June 30, 2023 and provided an update on the continued advancement of its clinical programs (Press release, Bolt Biotherapeutics, AUG 7, 2023, View Source [SID1234633866]).

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"We have extended our leadership position in immunotherapy as the first company to initiate a Phase 2 program for an ISAC," said Randall Schatzman, Ph.D., Chief Executive Officer. "The FDA has also cleared the IND for BDC-3042, the first and only program targeting Dectin-2 with an agonist antibody. This is our second successful IND and we expect to begin this first-in-human clinical trial later this year. We presented positive data at ASCO (Free ASCO Whitepaper) and look forward to presenting more data at ESMO (Free ESMO Whitepaper) and other upcoming major medical meetings. Our team is highly motivated by all of this positive momentum and the opportunities for us to make a difference for cancer patients."

"The data in the Phase 1 dose-escalation trial of BDC-1001 included durable objective clinical responses and a favorable safety profile. Importantly, these data provide clinical validation of our Boltbody ISAC approach, which has the potential to deliver a novel mechanism for the treatment of HER2-positive cancers and shows promise for patients who are resistant to current therapies on the market."

Recent Highlights and Anticipated Milestones

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Comprehensive safety and efficacy data from the BDC-1001 Phase 1 dose-escalation study presented at the American Society of Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2023 by Bob T. Li, M.D., Ph.D., MPH, medical oncologist and principal investigator at Memorial Sloan Kettering Cancer Center (MSK). BDC-1001 achieved a 29% objective response rate in evaluable patients with HER2-positive tumors, both as monotherapy and in combination with nivolumab at the recommended Phase 2 dose (RP2D). The percentage of evaluable patients with HER2-positive tumors who experienced PRs or at least 24 weeks of disease control was 43% in the monotherapy arm and 57% in combination with nivolumab.

These data supported the selection of 20 mg/kg dosed every other week (q2w) as the RP2D for the BDC-1001 Phase 2 clinical program.

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First patients dosed in BDC-1001 Phase 2 dose-expansion study in August 2023. This study is investigating BDC-1001 initially as single-agent monotherapy in three separate cohorts: HER2-positive colorectal, endometrial, and gastroesophageal cancer.

A second Phase 2 study is evaluating BDC-1001 as monotherapy and in combination with pertuzumab for the treatment of patients with HER2-positive metastatic breast cancer whose disease has progressed following treatment with Enhertu.

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FDA clears IND for BDC-3042 in July 2023. BDC-3042 is a proprietary agonist antibody that targets Dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). The Company remains on track to initiate a Phase 1 clinical study of BDC-3042 in solid tumors later in 2023.
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Additional BDC-1001 clinical and biomarker data will be presented in a mini-oral session at ESMO (Free ESMO Whitepaper) Congress 2023. The presentation, "Recommended phase 2 dose (RP2D) selection and pharmacodynamic (PD) data of the first-in-human immune-stimulating antibody conjugate (ISAC) BDC-1001 in patients (pts) with advanced HER2-expressing solid tumors," will be made by Bob T. Li, M.D., Ph.D., MPH, October 20-24 in Madrid, Spain.
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Cash, cash equivalents, and marketable securities were $157.1 million as of June 30, 2023. Cash on hand is expected to fund multiple milestones and operations through 2025.

Upcoming Events

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Bolt Biotherapeutics will participate in upcoming conferences:
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BTIG Virtual Biotechnology Conference 2023, August 7-9
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Morgan Stanley Annual Global Healthcare Conference, September 11-13 in New York, NY
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H.C. Wainwright 25th Annual Global Investment Conference, September 11-13 in New York, NY

Second Quarter 2023 Financial Results

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Collaboration Revenue – Collaboration revenue was $1.4 million for each of the quarters ended June 30, 2023, and 2022. Revenue in the comparative periods were generated from the services performed under the R&D collaborations as we fulfill our performance obligations.

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Research and Development (R&D) Expenses – R&D expenses were $15.6 million for the quarter ended June 30, 2023, compared to $18.9 million for the same quarter in 2022. The decrease in R&D expenses was due to lower manufacturing expenses related to the timing of batch production of our product candidates and lower lab supplies and contract service expenses, offset by higher clinical expenses related to the ongoing BDC-1001 clinical trial.

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General and Administrative (G&A) Expenses – G&A expenses were $5.6 million for the quarter ended June 30, 2023, compared to $5.5 million for the same quarter in 2022.

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Loss from Operations – Loss from operations was $19.8 million for the quarter ended June 30, 2023, compared to $23.1 million for the same quarter in 2022. This is in part a reflection of proactive cost-containment measures taken in June 2022.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to reprogram the tumor microenvironment to generate 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 lower 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.