NEW YORK, June 05, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Bolt Biotherapeutics, Inc. ("Bolt" or the "Company") (NASDAQ: BOLT). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Bolt and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On May 14, 20 ...

Bolt Biotherapeutics, Inc. (NASDAQ:BOLT) Q1 2024 Earnings Conference Call May 14, 2024 4:30 PM ET Company Participants Willie Quinn - Incoming Chief Executive Officer Randy Schatzman - Outgoing Chief Executive Officer Edith Perez - Outgoing Chief Medical Officer Michael Alonso - Co-Founder of Bolt and Senior Vice President of Research Dawn Colburn - Senior Vice President of Clinical Development. Conference Call Participants Jeffrey La Rosa - Leerink Partners Stephen Willey - Stifel Michael Schmidt - Guggenh ...

NEW YORK, May 16, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Bolt Biotherapeutics, Inc. ("Bolt" or the "Company") (NASDAQ: BOLT). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980. Attorney advertising. Prior results do not guarantee similar outcomes. The investigation concerns whether Bolt and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. CONTACT: D ...

| --- | --- | |--------------------------|-------------------------------------------------------------------------------------------------------| | | | | | BOLT BIOTHERAPEUTICS, INC. | | Date: May 14, 2024 | By: /s/ Randall C. Schatzman, Ph.D. | | | Randall C. Schatzman, Ph.D. Chief Executive Officer (Principal Executive Of icer) | | | | | Date: May 14, 2024 | By: /s/ William P. Quinn | | | William P. Quinn Chief Financial Officer (Principal Financial and Accounting Of icer) | 30 None. 27 Item 4. Mine Safe ...

Table of Contents Some of these events could be the basis for FDA action, including injunction, recall, seizure or total or partial suspension of production. In addition, our third-party manufacturers and suppliers are subject to FDA inspection from time to time. Failure by our third-party manufacturers and suppliers to pass such inspections and otherwise satisfactorily complete the FDA approval regimen with respect to our product candidate may result in regulatory actions such as the issuance of FDA Form 4 ...

Exhibit 99.1 Bolt Biotherapeutics Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update – BDC-1001 (trastuzumab imbotolimod) Phase 2 studies in four HER2-positive tumor types advancing toward 2024 milestones – BDC-3042 Phase 1 study successfully cleared safety assessments in the first three dose level cohorts – Cash balance of $128.6 million as of December 31, 2023, anticipated to fund key milestones through late 2025 "We made substantial progress advancing our two proprie ...

Item 1A. Risk Factors. None. 31 None. X X X X SIGNATURES The following table sets forth a summary of our cash flows for each of the periods indicated: License Agreements with Stanford University FORM 10-Q | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |----------------------------------------------------------------------------|-----------------------------------------|-------|-----------|--------|-------------------------------------------------------|------------------|---------|----------- ...

The following table presents changes in the Company contract liability (in thousands): 2021 Equity Incentive Plan and 2021 Employee Stock Purchase Plan In January 2021, the Company's board of directors adopted the 2021 Equity Incentive Plan (the "2021 Plan") and the Company's stockholders approved the 2021 Plan. The 2021 Plan authorized issuance of up to 8,075,000 shares of common stock and it became effective upon the execution of the underwriting agreement for the Company's IPO. In addition, the number of ...

Legal Proceedings 16 2021 Equity Incentive Plan and 2021 Employee Stock Purchase Plan Performance and Service-Based Stock Options The following table summarizes the components of stock-based compensation expense recognized in the Company's statement of operations and comprehensive loss (in thousands): 17 The following table sets forth the computation of the Company's basic and diluted net loss per share attributable to common stockholders, which excludes shares which are legally outstanding, but subject to ...

Regulatory and Compliance - The company's products fall under the centralized authorization procedure in the EU, resulting in marketing authorization valid across all EU member states[396] - The FDA has 10 months to complete its initial review of an original BLA for a new molecular entity and six months for priority review, with possible extensions[394] - Clinical trials must comply with GCP and are conducted in three sequential phases: Phase 1, Phase 2, and Phase 3[392] - Fast Track designation allows for rolling review of BLAs, with greater FDA interaction and potential expedited development and review processes[399] - The Pediatric Research Equity Act (PREA) requires BLAs to include pediatric safety and efficacy data, with exceptions for orphan-designated biologics[402] - Post-approval requirements for biologics include Phase 4 testing, REMS, and ongoing compliance with cGMP[404] - The Hatch-Waxman Amendments permit patent term extensions of up to five years for U.S. patents, subject to FDA regulatory review timelines[406] - Orphan drug designation in Great Britain post-Brexit is based on condition prevalence in Great Britain, with applications reviewed alongside marketing authorization[408] Financial and Operational Challenges - The company has incurred significant losses since inception and anticipates continued losses in the foreseeable future, with no guarantee of achieving profitability[419] - The company expects approximately $2.8 million of federal R&D credits and $51.0 million of California net operating losses to expire unused due to Section 382 limitations[426] - The company's expenses are expected to increase due to ongoing preclinical studies, clinical trials, and potential regulatory requirements, with significant commercialization costs anticipated if any product candidates are approved[422] - The company requires substantial additional funding to support ongoing operations, and failure to raise capital could force delays, reductions, or termination of research and development programs or commercialization efforts[422] Product Development and Risks - The company's lead product candidate, BDC-1001, is in early clinical development and is the only candidate beyond preclinical studies, with significant resources allocated to its development in HER2-positive solid tumors[428] - The company relies heavily on the success of BDC-1001, as failure to obtain regulatory approval or commercialize it could prevent the company from generating revenue or achieving profitability[428] - The company is developing BDC-1001 as a combination therapy with agreements in place with BMS and Roche, but faces risks if the FDA revokes approval of the combination therapies or if safety or supply issues arise[433] - The company's drug development process is highly uncertain, with a high risk of failure, as demonstrated by the discontinuation of BDC-2034 due to off-target toxicity in August 2022[435] - The company may face challenges in competing with established cancer therapies, particularly generic products, if its product candidates are approved at a significant premium[443] - The company's ability to maintain a competitive position depends on staying at the forefront of technological advancements in its Boltbody ISAC approach, with risks of obsolescence or reduced commercial value due to competitor innovations[431] Workforce and Employee Development - The company has 94 full-time employees as of December 31, 2022, with no representation by labor unions or collective bargaining agreements[415] - The company is committed to maintaining and increasing investment in workforce development, including technical training, competency-based workshops, and leadership programs[446] - The company emphasizes individualized development plans and opportunities for promotions to enhance employee engagement and retention[446] Market and Policy Environment - The Biden administration's executive orders and the IRA aim to address high drug prices, with provisions taking effect progressively from fiscal year 2023[412] - The company is not required to provide quantitative and qualitative disclosures about market risk as it qualifies as a "smaller reporting company"[752]