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]

Biomarkers Consistent with Mechanism • Increases myeloid & T cell frequency in tumor • Minimal systemic inflammatory effect in plasma Early Signs of Clinical Disease Control • Early signs of disease control, below target exposure level • Durable disease control (SD or PR) noted in 13/40 evaluable subjects Dose Escalation Nearing Completion • Anticipate achieving threshold exposure with more frequent dosing • Monotherapy and Opdivo combination enrollment complete 7 Opdivo® is a trademark of Bristol-Myers Squ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39988 Bolt Biotherapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 47-2804636 (State or other ...

Bolt Biotherapeutics Corporate Update Presentation September 2022 Disclaimer This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding Bolt Biotherapeutics, Inc. (the "Company," "we," "us," or "our")'s future financial condition, ability to achieve upcoming milestones for our product candidates, the timing of our clinical trials and the success ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39988 Bolt Biotherapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 47-2804636 (State or other juris ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39988 | --- | --- | |--------------------------------------------------------------------------------------------------|-------- ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39988 | --- | --- | --- | |---------------------------------------------------------------------------------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39988 | --- | --- | --- | --- | --- | --- | --- | --- | |------------------------------------------------------------------- ...