On August 12, 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 second quarter ended June 30, 2021 and provided an update on recent business highlights (Press release, Bolt Biotherapeutics, AUG 12, 2021, View Source [SID1234586442]).

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"We continue to build strong momentum with our business strategy and remain on target for a BDC-1001 Phase 1/2 clinical data update later this year," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt. "Our recently announced Genmab collaboration expands our proprietary Boltbody platform into novel bispecific ISAC applications, while fortifying our strong cash position. Furthermore, our CEA-targeted candidate BDC-2034 made steady progress towards an IND filing that is expected next year. I am proud of the passionate and experienced team we have assembled at Bolt, including recent additions to our leadership, who share our commitment to advancing targeted immuno-oncology therapies that will benefit patients with cancer."

Recent Business Highlights and Anticipated Milestones

Lead program BDC-1001 on track for anticipated Phase 1/2 trial data update in 2H21 – In June 2021, Bolt presented a poster at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting that expanded on the preliminary data, as of January 29, 2021, from the first 20 patients in an ongoing BDC-1001 Phase 1/2 clinical trial. The monotherapy dose-escalation portion of the trial is proceeding on plan, with a further data update expected in the second half of 2021. This Phase 1/2 trial is being conducted in four parts: [1] Phase 1 monotherapy dose escalation, [2] Phase 1 dose escalation in combination with PD-1 checkpoint inhibitor, [3] Phase 2 monotherapy expansion cohorts, and [4] Phase 2 expansion cohorts in combination with a PD-1 checkpoint inhibitor. Bolt also remains on track to initiate the monotherapy Phase 2 dose-expansion cohorts and the dose-escalation of BDC-1001 in combination with an anti-PD-1 antibody in the second half of 2021.

Announced oncology research and development (R&D) collaboration with Genmab to develop multiple bispecific ISACs – In June 2021, Bolt announced an oncology R&D collaboration with Genmab to discover and evaluate novel bispecific immune-stimulating antibody conjugate (ISAC) products for the treatment of multiple types of cancer. The collaboration will combine Bolt’s BoltBody ISAC platform with Genmab’s proprietary antibodies and bispecific technology, and Genmab will fully fund three programs through initial clinical proof-of-concept. Bolt received a $10 million USD upfront payment and a $15 million USD equity investment from Genmab, is eligible to receive up to $285 million USD for each program exclusively developed and commercialized by Genmab, and has the option to participate in the development and commercialization of one candidate after seeing clinical proof-of-concept data.

Expanded leadership team, adding expertise across research, clinical development, regulatory, quality and technical operations over the last year.
Amreen Husain, M.D., Vice President, Clinical Development and Translational Medicine. Dr. Husain brings more than a decade of experience in oncology drug development with a focus on breast and gynecological cancers and immuno-oncology. Dr. Husain joined Bolt from Roche/Genentech. Prior, Dr. Husain was as a practicing oncologist and clinical researcher at Stanford University Medical Center.
Bruce Hug, M.D., Ph.D., Vice President, Early Development and Research Collaborations. Dr. Hug joins Bolt from GlaxoSmithKline, bringing more than 16 years of oncology, hematology and immunotherapy experience, with a focus on early development.
Karen L. Bergman, Vice President, Communications and Investor Relations. Ms. Bergman has more than two decades of experience in biopharma communications, spanning corporate roles at companies such as ALZA and FibroGen, and 15 years heading a life science practice specializing in strategy, positioning, communications, and investor relations.
Liang Fang, Ph.D., Vice President, Biometrics and Bioinformatics. Dr. Fang brings more than 15 years of experience in developing and applying statistical methods and data sciences to drug development in oncology and the biotechnology industry from MyoKardia, Gilead Sciences, Genentech, and Amgen.
Triona O’Hanlon, Vice President, Program Management. Ms. O’Hanlon joined Bolt from Gilead, where she led program and portfolio management for hematology/oncology and cell therapy. Ms. O’Hanlon brings more than 20 years of experience in program and alliance management from Gilead Sciences, Kite Pharma, Elan Pharmaceuticals, and Ambit Biosciences.
Wesley Burwell, Vice President, Head of Human Resources. Mr. Burwell most recently worked at Global Blood Therapeutics and brings more than 20 years of experience building and driving HR strategy for biopharma companies.

Cash, cash equivalents, and marketable securities were $310.9 million as of June 30, 2021, which is expected to fund operations and the advancement of its oncology product pipeline to achieve multiple key milestones through the end of 2023.
Upcoming Events

Bolt Biotherapeutics will be attending the following conferences in September 2021:
Citi’s 16th Annual Biopharma Virtual Conference, September 8-10
Wells Fargo Virtual Healthcare Conference, September 9-10
Morgan Stanley Global Healthcare Conference, September 9-15
Cantor Fitzgerald Global Healthcare Conference, September 27-30
Second Quarter 2021 Financial Results

Cash Position – Cash, cash equivalents, and marketable securities were $310.9 million as of June 30, 2021, compared to $302.9 million as of March 31, 2021. Bolt expects its cash balance to fund operations through the end of 2023.

Research and Development Expenses – R&D expenses were $19.7 million for the quarter ended June 30, 2021, compared to $9.2 million for the same quarter in 2020, primarily due to increases in manufacturing expenses related to BDC-1001 and BDC-2034, increased personnel expenses relating to an increase in headcount, increased facility-related expenses, and increased clinical trial expenses.

General and Administrative (G&A) Expenses – G&A expenses were $4.1 million for the quarter ended June 30, 2021, compared to $2.0 million for the same quarter in 2020, primarily due to increased personnel expenses relating to an increase in headcount and increased professional services expenses related to consulting services, legal fees and other professional services.

Loss from Operations – Loss from operations was $23.8 million for the quarter ended June 30, 2021 compared to $11.1 million for the same quarter in 2020.