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]

Clinical Trial Data (BDC-1001) - Early signs of disease control were observed, even below the target exposure level[1] - Durable disease control (SD or PR) was noted in 13 out of 40 evaluable subjects (32.5%)[1] - A subject with metastatic CRC confirmed PR at 36 weeks, maintained for >52 weeks[3] - In a case study, a 66-year-old male with metastatic adenocarcinoma of colon experienced a 32% and 37% decrease in tumor size at 12 weeks[19] - A clinical trial subject with breast cancer on BDC-1001 showed a two-fold increase in CD8+ T cell infiltration and activation compared to baseline[22] Financial Status - The company had a cash balance of $209.6 million as of September 30, 2022[4] - The cash on hand is expected to fund key milestones through 2025[4] Pipeline and Programs - The company is developing BDC-1001, a HER2-targeting Boltbody™ Immune-stimulating Antibody Conjugate (ISAC)[7, 13] - The company is also developing BDC-3042, a Dectin-2 agonist antibody[13, 37] - The company is pursuing multiple next-generation ISAC programs with collaborators[13]

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 ...

Financial Status - Bolt Biotherapeutics had $2236 million in cash, cash equivalents, and marketable securities as of June 30, 2022[4] - The company's pipeline and operations are funded to achieve multiple milestones through 2025[14] BDC-1001 (HER2 Boltbody™ ISAC) - BDC-1001 is in Phase 1/2 clinical development targeting HER2-expressing solid tumors[15] - Early signs of disease control were noted in 13 out of 40 evaluable subjects[7] - The company anticipates completing monotherapy dose escalation and determining RP2D in the second half of 2022[14] - The company also anticipates completing Opdivo® combination dose escalation and determining RP2D in the second half of 2022[14] BDC-3042 (Dectin-2 agonist mAb) - IND-enabling studies for BDC-3042 are underway, with an IND filing and Phase 1 trial planned for 2023[12, 14] - BDC-3042 mediates anti-tumor activity, with a 33% mean tumor growth inhibition at 1 mg/kg and a 35% mean tumor growth inhibition with Pembrolizumab at 5 mg/kg in humanized mice bearing triple-negative breast tumors[31] Collaborations - The company is pursuing multiple ISAC programs with collaborators who fund research & development through initial proof-of-concept[3]

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 | --- | --- | --- | --- | --- | --- | --- | --- | |------------------------------------------------------------------- ...

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, 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 | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |------------------------------------------ ...

[PART I FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section provides the unaudited financial statements and management's discussion and analysis for the first quarter [Item 1. Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed financial statements for Q1 2021, including balance sheets, operations, equity, and cash flows, with explanatory notes [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) This section provides a snapshot of the company's financial position at March 31, 2021, and December 31, 2020 | Metric | March 31, 2021 (in thousands) | December 31, 2020 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $95,481 | $5,542 | | Short-term investments | $171,188 | $17,296 | | Total current assets | $271,210 | $25,361 | | Total assets | $324,637 | $46,542 | | **Liabilities & Equity** | | | | Total liabilities | $21,389 | $46,193 | | Total stockholders' equity (deficit) | $303,248 | $(104,947) | - The company's financial position strengthened significantly following its IPO in February 2021, with total assets increasing from **$46.5 million** to **$324.6 million**, and stockholders' deficit of **$104.9 million** converting to stockholders' equity of **$303.2 million** between December 31, 2020, and March 31, 2021[14](index=14&type=chunk) [Condensed Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's financial performance, including revenue, expenses, and net loss for Q1 2021 and Q1 2020 | Metric | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | | :--- | :--- | :--- | | Collaboration revenue | $0 | $164 | | Research and development | $14,127 | $6,787 | | General and administrative | $4,299 | $2,122 | | Loss from operations | $(18,426) | $(8,745) | | Net loss | $(24,454) | $(8,633) | | Net loss per share, basic and diluted | $(1.14) | $(4.16) | - Net loss for the first quarter of 2021 increased to **$24.5 million** from **$8.6 million** in the prior year period, driven by a doubling of Research and Development and General and Administrative expenses, and a **$6.1 million** non-cash charge[15](index=15&type=chunk) [Condensed Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=6&type=section&id=Condensed%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Equity%20(Deficit)) This section outlines changes in the company's equity structure, including preferred stock issuance and conversion, and the impact of the IPO - In Q1 2021, the company issued Series C-2 convertible preferred stock for **$51.9 million** and subsequently converted all outstanding convertible preferred stock into **20,843,334 shares** of common stock upon its IPO[18](index=18&type=chunk) - The company raised net proceeds of **$242.0 million** from its IPO, which significantly increased additional paid-in capital from **$3.5 million** at year-end 2020 to **$436.2 million** at March 31, 2021[18](index=18&type=chunk)[27](index=27&type=chunk) [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section details the company's cash inflows and outflows from operating, investing, and financing activities for Q1 2021 and Q1 2020 | Cash Flow Activity | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(16,559) | $(9,638) | | Net cash used in investing activities | $(190,521) | $(13,608) | | Net cash provided by financing activities | $297,019 | $34 | - Financing activities provided **$297.0 million** in cash, primarily from **$245.0 million** in net proceeds from the IPO and **$51.9 million** from the issuance of preferred stock[23](index=23&type=chunk)[118](index=118&type=chunk) - Investing activities used **$190.5 million**, mainly for the purchase of marketable securities following the capital raise[23](index=23&type=chunk)[117](index=117&type=chunk) [Notes to the Condensed Financial Statements](index=9&type=section&id=Notes%20to%20the%20Condensed%20Financial%20Statements) This section provides detailed explanations of the accounting policies and significant transactions impacting the condensed financial statements - On February 9, 2021, the company completed its IPO, selling **13,225,000 shares** of common stock at **$20.00 per share** for net proceeds of approximately **$242.0 million**[27](index=27&type=chunk) - As of March 31, 2021, the company had cash, cash equivalents, and marketable securities of **$302.9 million** and an accumulated deficit of **$132.9 million**, with management believing existing cash is sufficient to fund operations for at least the next 12 months[29](index=29&type=chunk)[114](index=114&type=chunk) - In January 2021, the company issued **5,611,059 shares** of Series C-2 convertible preferred stock for net proceeds of **$51.9 million**, settling a contractual obligation and reclassifying the related purchase right liability to equity[74](index=74&type=chunk) - Stock-based compensation expense increased to **$2.1 million** for Q1 2021, up from **$0.2 million** in Q1 2020[80](index=80&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and operational results for Q1 2021, highlighting increased expenses from R&D and the impact of the February 2021 IPO on liquidity [Overview](index=20&type=section&id=Overview) This section provides a high-level summary of the company's business, its lead product candidate, and funding sources - The company is a clinical-stage biotechnology firm pioneering **Boltbody™ ISAC** (immune stimulating antibody conjugate) technology, with its lead product candidate, **BDC-1001**, in a Phase 1/2 trial for HER2-expressing solid tumors[86](index=86&type=chunk) - Operations have been funded through private placements and the February 2021 IPO, which raised approximately **$242.0 million** in net proceeds[87](index=87&type=chunk) - The company anticipates continued significant expenses and operating losses as it advances its clinical trials and R&D programs[88](index=88&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) This section analyzes the key drivers behind the company's financial performance, including changes in revenue and expenses | Metric | Three Months Ended March 31, 2021 (in thousands) | Three Months Ended March 31, 2020 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | Collaboration revenue | $0 | $164 | $(164) | | Research and development | $14,127 | $6,787 | $7,340 | | General and administrative | $4,299 | $2,122 | $2,177 | | Loss from operations | $(18,426) | $(8,745) | $(9,681) | | Net loss | $(24,454) | $(8,633) | $(15,821) | - Research and development expenses increased by **$7.3 million** year-over-year, primarily due to a **$3.8 million** increase in manufacturing expenses for BDC-1001 and BDC-2034 and a **$2.5 million** increase in personnel-related costs from higher headcount[109](index=109&type=chunk) - General and administrative expenses rose by **$2.2 million**, driven by a **$1.5 million** increase in personnel costs and a **$0.9 million** increase in professional services fees for accounting and legal services[110](index=110&type=chunk) - A **$6.0 million** expense was recognized from the change in fair value of the convertible preferred stock purchase right liability, which was settled in January 2021[112](index=112&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its financial obligations and fund future operations, focusing on cash position and capital raises - As of March 31, 2021, the company had **$302.9 million** in cash, cash equivalents, and marketable securities, with an accumulated deficit of **$132.9 million**[114](index=114&type=chunk) - Net cash provided by financing activities in Q1 2021 was **$297.0 million**, primarily from the IPO (**$245.0 million** net) and the issuance of Series C-2 preferred stock (**$51.9 million** net)[118](index=118&type=chunk) - Management believes that existing cash, cash equivalents, and marketable securities will be sufficient to fund operations for at least the next 12 months[120](index=120&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide the information requested under this item - As a smaller reporting company, Bolt Biotherapeutics is exempt from providing quantitative and qualitative disclosures about market risk[128](index=128&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management identified a material weakness in internal control over financial reporting due to insufficient accounting personnel and policies, initiating remediation efforts - Management identified a **material weakness** in its internal control over financial reporting[130](index=130&type=chunk) - The weakness stems from not having a sufficient number of professionals with the appropriate level of accounting knowledge and experience, leading to a lack of formal accounting policies, procedures, and controls[131](index=131&type=chunk) - Remediation efforts have commenced, including increasing accounting personnel and engaging third-party experts to help design and implement effective controls[133](index=133&type=chunk) [PART II OTHER INFORMATION](index=28&type=section&id=PART%20II%20OTHER%20INFORMATION) This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and equity sales [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that there are currently no pending legal claims or actions that are expected to have a material adverse effect on its financial condition or results of operations - As of the filing date, the company is not involved in any legal proceedings that would materially impact its business[138](index=138&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) The company states that there have been no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2020 - No material changes have occurred to the risk factors disclosed in the company's 2020 Form 10-K[139](index=139&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details unregistered equity sales, including Series C-2 preferred stock, and confirms the use of IPO proceeds as described in the prospectus - In January 2021, the company issued **5,611,059 shares** of Series C-2 convertible preferred stock for aggregate proceeds of **$51.9 million** in an unregistered sale[140](index=140&type=chunk) - The company completed its IPO on February 9, 2021, raising net proceeds of approximately **$242.0 million**[144](index=144&type=chunk) - There has been no material change in the planned use of the net proceeds from the IPO as described in the prospectus[145](index=145&type=chunk) [Item 3. Defaults Upon Senior Securities](index=29&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[146](index=146&type=chunk) [Item 4. Mine Safety Disclosures](index=29&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[147](index=147&type=chunk) [Item 5. Other Information](index=29&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this item - None[148](index=148&type=chunk) [Item 6. Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents and officer certifications - The report includes exhibits such as the Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws, and Sarbanes-Oxley Act certifications[151](index=151&type=chunk)[153](index=153&type=chunk)