What changed in Bolt Biotherapeutics, Inc.'s 10-K — 2023 vs 2024
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Paragraph-level year-over-year comparison of Bolt Biotherapeutics, Inc.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.
+105 added−109 removedSource: 10-K (2025-03-24) vs 10-K (2024-03-21)
Top changes in Bolt Biotherapeutics, Inc.'s 2024 10-K
105 paragraphs added · 109 removed · 76 edited across 1 sections
- Item 1C. Cybersecurity+105 / −109 · 76 edited
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
76 edited+29 added−33 removed94 unchanged
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
76 edited+29 added−33 removed94 unchanged
2023 filing
2024 filing
Biggest changeOur information technology department (led by our Director of IT Operations and Security), identifies and assesses risks from cybersecurity threats by monitoring and evaluating our threat environment using various methods including, for example, real-time monitoring of network events, subscribing to reports and services that identify cybersecurity threats, evaluating threats and actors reported to us, conducting scans of the threat environment, evaluating our and our industry’s risk profile, coordinating with law enforcement concerning threats when appropriate, conducting (and working with third parties, as appropriate) assessments and audits for internal and external threats and vulnerabilities, and using of external intelligence feeds. 71 Table of Contents We implement and maintain various technical, physical, and organizational measures, processes, and policies, designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example, an incident detection and response plan; vulnerability management processes; risk assessments; implementation of security standards; encryption of certain data; network security controls; segregation of certain data; access controls including multi-factor authentication for certain Information Systems and Data; physical security; asset management, tracking and disposal; systems monitoring; vendor risk management program; employee training; penetration testing; and cybersecurity insurance.
Biggest changeOur information technology department (led by our Director of IT 69 Table of Contents Operations and Security), identifies and assesses risks from cybersecurity threats by monitoring and evaluating our threat environment using various methods including, for example, real-time monitoring of network events, subscribing to reports and services that identify cybersecurity threats, evaluating threats and actors reported to us, conducting scans of the threat environment, evaluating our and our industry’s risk profile, coordinating with law enforcement concerning threats when appropriate, conducting (and working with third parties, as appropriate) assessments and audits for internal and external threats and vulnerabilities, and using of external intelligence feeds.
In May 2021, we entered into an oncology research and development collaboration with Genmab to evaluate Genmab antibodies and bispecific antibody engineering technologies in combination with our proprietary Boltbody ISAC technology platform, with the goal of discovering and developing next-generation bispecific ISACs for the treatment of cancer.
In May 2021, we entered into an oncology research and development collaboration with Genmab to evaluate Genmab antibodies and bispecific antibody engineering technologies in combination with our proprietary Boltbody ISAC technology platform, with the goal of discovering and developing next-generation bispecific ISACs for the treatment of cancer.
Actual results may differ from these estimates under different assumptions or conditions. While our significant accounting policies are described in more detail in Note 2 to our financial statements included elsewhere in this Annual Report on Form 10-K, we believe the following accounting policies and estimates to be most critical to the preparation of our financial statements.
Actual results may differ from these estimates under different assumptions or conditions. While our significant accounting policies are described in more detail in Note 2 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K, we believe the following accounting policies and estimates to be most critical to the preparation of our consolidated financial statements.
The financial terms of these contracts vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. We reflect research and development expenses in our financial statements by matching those expenses with the period in which services and efforts are expended.
The financial terms of these contracts vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. We reflect research and development expenses in our consolidated financial statements by matching those expenses with the period in which services and efforts are expended.
Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited consolidated financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Our future capital requirements will depend on many factors, including: • the type, number, scope, progress, expansions, results, costs and timing of our clinical trials; • the type, number, scope, results, costs, and timing of preclinical studies for our product candidates or other potential product candidates or indications which we are pursuing or may choose to pursue in the future; • the outcome, timing and costs of regulatory review of our product candidates; 81 Table of Contents • the costs and timing of manufacturing for our product candidates, including commercial manufacturing; • our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal controls over financial reporting; • the costs associated with hiring additional personnel and consultants as our preclinical and clinical activities increase; • the costs and timing of establishing or securing sales and marketing capabilities if any product candidate is approved; • our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; • patients’ willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors; • the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; • the costs of obtaining, maintaining, defending, and enforcing our patent and other intellectual property rights; and • costs associated with any product candidates, products, or technologies that we may in-license or acquire.
Our future capital requirements will depend on many factors, including: • the type, number, scope, progress, expansions, results, costs and timing of our clinical trials; • the type, number, scope, results, costs, and timing of preclinical studies for our product candidates or other potential product candidates or indications which we are pursuing or may choose to pursue in the future; • the outcome, timing and costs of regulatory review of our product candidates; • the costs and timing of manufacturing for our product candidates, including commercial manufacturing; • our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal controls over financial reporting; • the costs associated with hiring additional personnel and consultants as our preclinical and clinical activities increase; • the costs and timing of establishing or securing sales and marketing capabilities if any product candidate is approved; • our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; • patients’ willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors; • the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; • the costs of obtaining, maintaining, defending, and enforcing our patent and other intellectual property rights; and • costs associated with any product candidates, products, or technologies that we may in-license or acquire.
Our future clinical development costs may vary significantly based on factors such as: • the number and scope of preclinical and IND-enabling studies; • per-patient trial costs; • the number of trials required for approval; • the number of sites included in the trials; • the countries in which the trials are conducted; • the length of time required to enroll eligible patients; • the number of patients who participate in the trials; • the number of doses that patients receive; • the drop-out or discontinuation rates of patients; • potential additional safety monitoring requested by regulatory agencies; • the duration of patient participation in the trials and through all follow-up; 78 Table of Contents • the cost and timing of manufacturing our product candidates; • the phase of development of our product candidates; and • the safety and efficacy profile of our product candidates.
Our future clinical development costs may vary significantly based on factors such as: • the number and scope of preclinical and IND-enabling studies; • per-patient trial costs; • the number of trials required for approval; • the number of sites included in the trials; • the countries in which the trials are conducted; • the length of time required to enroll eligible patients; • the number of patients who participate in the trials; • the number of doses that patients receive; • the drop-out or discontinuation rates of patients; • potential additional safety monitoring requested by regulatory agencies; • the duration of patient participation in the trials and through all follow-up; • the cost and timing of manufacturing our product candidates; 76 Table of Contents • the phase of development of our product candidates; and • the safety and efficacy profile of our product candidates.
Critical Accounting Estimates Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP.
Critical Accounting Estimates Our management’s discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP.
The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our financial statements and accompanying notes.
The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements and accompanying notes.
Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our planned clinical trials and preclinical studies, and our expenditures on other research and development activities.
Our net losses may fluctuate significantly from year-to-year, depending on the timing of our planned clinical trials and preclinical studies, and our expenditures on other research and development activities.
Pursuant to Sections 382 and 383 of the Internal Revenue Code, annual use of our NOL and research and development tax credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. 86 Table of Contents Ite m 7A. Quantitative and Qualitative Disclosures About Market Risk.
Pursuant to Sections 382 and 383 of the Internal Revenue Code, annual use of our NOL and research and development tax credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. 85 Table of Contents Ite m 7A. Quantitative and Qualitative Disclosures About Market Risk.
For restricted stock awards, the fair value of the award is the estimated fair value of our common stock on the grant date, as determined by our board of directors. 85 Table of Contents The Black-Scholes option pricing model requires the use of subjective assumptions, including the risk-free interest rate, the expected stock price volatility, the expected term of stock options, the expected dividend yield and the fair value of the underlying common stock on the date of grant.
For restricted stock awards, the fair value of the award is the estimated fair value of our common stock on the grant date, as determined by our board of directors. 84 Table of Contents The Black-Scholes option pricing model requires the use of subjective assumptions, including the risk-free interest rate, the expected stock price volatility, the expected term of stock options, the expected dividend yield and the fair value of the underlying common stock on the date of grant.
The change in net operating assets was due to a $3.6 million decrease in deferred revenue related to collaboration agreements, a $3.4 million decrease in our accounts payable and accrued expenses, a $2.4 million decrease in operating lease liabilities, and a $0.5 million increase in our prepaid expense and other assets.
The change in net operating assets was due to a $3.6 million decrease in deferred revenue related to our collaboration agreements, a $3.4 million decrease in our accounts payable and accrued expenses, a $2.4 million decrease in operating lease liabilities, offset by a $0.5 million increase in our prepaid expense and other assets.
We expect that any collaboration revenue we generate from our current collaborations, and from any future collaboration partners, will fluctuate in the future as a result of the timing and results of development activities and the timing and amount paid, including upfront and milestone payments, and other factors.
We expect that any collaboration revenue we generate from our current collaborations, and from any future collaboration partners, will fluctuate in the future as a result of the timing and outcome of development activities and the timing and amount paid, including upfront and milestone payments, and other factors.
Having explored more than one hundred distinct linker-payloads and multiple tumor targets, we know the importance of both the linker-payload and the antibody and have developed a library of linker-payloads for use in our own development programs and in our collaborations.
Having explored more than one thousand distinct linker-payloads and multiple tumor targets, we know the importance of both the linker-payload and the antibody and have developed a library of linker-payloads for use in our own development programs and in our collaborations.
Including the option exercise, the aggregate net proceeds to us from the offering was approximately $242.0 million, net of underwriting discounts, commissions, and other offering expenses. In May 2021, we issued 821,045 shares of our common stock to Genmab for gross proceeds of approximately $15.0 million. 75 Table of Contents We have not recorded any revenue from product sales.
Including the option exercise, the aggregate net proceeds to us from the offering was approximately $242.0 million, net of underwriting discounts, commissions, and other offering expenses. In May 2021, we issued 821,045 shares of our common stock to Genmab for gross proceeds of approximately $15.0 million. We have not recorded any revenue from product sales.
Recent Repurchases of Equity Securities. None. Recent Sales of Unregistered Securities. None. It em 6. Reserved. Not applicable. 74 Table of Contents Ite m 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Recent Repurchases of Equity Securities. None. Recent Sales of Unregistered Securities. None. It em 6. Reserved. Not applicable. 72 Table of Contents Ite m 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Since our inception and through December 31, 2023, the majority of our third-party expenses were related to the research and development of trastuzumab imbotolimod, BDC-3042, and other product candidates.
Since our inception and through December 31, 2024, the majority of our third-party expenses were related to the research and development of trastuzumab imbotolimod, BDC-3042, and other product candidates.
We will continue to closely monitor and evaluate the nature and extent of these macroeconomic factors on our business, consolidated results of operations, and financial condition. Components of Results of Operations Revenue To date, our only revenue has been collaboration revenue derived from our collaborations with Toray, Genmab, and Innovent.
We will continue to closely monitor and evaluate the nature and extent of these macroeconomic factors on our business, consolidated results of operations, and financial condition. 74 Table of Contents Components of Results of Operations Revenue To date, our only revenue has been collaboration revenue derived from our collaborations with Toray, Genmab, and Innovent.
In February 2021, we completed our initial public offering of 13,225,000 shares of our common stock at a price to the public of $20.00 per share, including the exercise in full by the underwriters of their option to purchase 1,725,000 additional shares of our common stock.
In February 2021, we completed our initial public offering of 13,225,000 shares of our common stock at a price to the public of $20.00 per share, including the exercise in full by the underwriters of their option to purchase 1,725,000 73 Table of Contents additional shares of our common stock.
Similar, and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial condition. 76 Table of Contents The effects of a pandemic or major geopolitical developments, and associated economic conditions, remain difficult to predict due to numerous uncertainties.
Similar, and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial condition. The effects of a pandemic or major geopolitical developments, and associated economic conditions, remain difficult to predict due to numerous uncertainties.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our audited financial statements and related notes thereto included elsewhere in this Annual Report on Form-10K for the period ended December 31, 2023.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our audited consolidated financial statements and related notes thereto included elsewhere in this Annual Report on Form-10K for the period ended December 31, 2024.
As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide this information. 87 Table of Contents
As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide this information. 86 Table of Contents
Our Director of IT Operations and Security and Senior Director of IT are responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into the Company’s overall risk management strategy, reviewing security assessments and other security-related reports, and communicating key priorities to relevant personnel.
Our Director of IT Operations and Security is responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into the Company’s overall risk management strategy, reviewing security assessments and other security-related reports, and communicating key priorities to relevant personnel.
Our headquarters are located in Redwood City, California, where we lease space in two locations totaling approximately 71,600 square feet, of which we have subleased approximately 13,743 square feet to a third party. Our lease expires in 2031. We believe that our headquarters and other offices are adequate for our current needs. Ite m 3. Legal Proceedings.
Our headquarters are located in Redwood City, California, where we lease space in two locations totaling approximately 71,600 square feet, of which we have subleased approximately 25,583 square feet to a third party. Our lease expires in 2031. We believe that our headquarters and other offices are adequate for our current needs. Ite m 3. Legal Proceedings.
See Note 9 to our financial statements included elsewhere in this Annual Report on Form 10-K for information concerning certain of the specific assumptions we used in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted in 2023 and 2022.
See Note 10 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for information concerning certain of the specific assumptions we used in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted in 2024 and 2023.
If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
If we are 81 Table of Contents unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Collaboration Agreements Joint Development and License Agreement with Toray Industries In March 2019, we entered into a Joint Development and License Agreement, or the Toray Agreement, with Toray Industries, Inc., or Toray, to develop and commercialize a Boltbody ISAC containing a proprietary antibody owned by Toray.
Contractual Obligations and Commitments Collaboration Agreements Joint Development and License Agreement with Toray Industries In March 2019, we entered into a Joint Development and License Agreement, or the Toray Agreement, with Toray Industries, Inc., or Toray, to develop and commercialize a Boltbody ISAC containing a proprietary antibody owned by Toray.
Under the 82 Table of Contents Toray Agreement, we exchanged co-exclusive (with each other) licenses to certain patents and know-how covering our respective technologies. Each party is required to use commercially reasonable efforts to conduct development and regulatory activities assigned to it under a development plan.
Under the Toray Agreement, we exchanged co-exclusive (with each other) licenses to certain patents and know-how covering our respective technologies. Each party is required to use commercially reasonable efforts to conduct development and regulatory activities assigned to it under a development plan.
The audit committee receives periodic written and verbal reports from our Chief Financial Officer and directly from the information technology department concerning the Company’s significant cybersecurity threats and risk and the processes the Company has implemented that are intended to address them.
The audit committee receives periodic written and verbal reports from our Principal Accounting Officer and directly from the information technology department concerning the Company’s significant cybersecurity threats and risk and the processes the Company has implemented that are intended to address them.
In conjunction with the collaboration, Toray purchased 717,514 shares of our Series T convertible preferred stock for $10.0 million, which were converted into shares of our common stock upon the completion of our initial public offering in February 2021.
In conjunction with the collaboration, Toray purchased 717,514 shares of our Series T convertible preferred stock for $10.0 million, which were converted into shares of our common stock upon the completion of our IPO in February 2021.
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future, and we further expect our expenses will increase substantially as we: • conduct our ongoing and planned clinical trials; • continue our research and development programs; • expand our clinical, regulatory, quality and manufacturing capabilities; • seek regulatory approvals for our product candidates; and • operate as a public company.
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future as we: • conduct our ongoing and planned clinical trials; • continue our research and development programs; • continue our clinical, regulatory, quality and manufacturing capabilities; • seek regulatory approvals for our product candidates; and • operate as a public company.
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. There are currently no claims or actions pending against us, the ultimate disposition of which we believe could have a material adverse effect on our results of operations, financial condition or cash flows. It em 4. Mine Safety Disclosures.
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. There are currently no claims or actions pending against us, the ultimate disposition of which we believe could have a material adverse effect on our results of operations, financial condition or cash flows.
The board of directors’ audit committee is responsible for overseeing Company’s cybersecurity risk management processes, including oversight of mitigation of risks from cybersecurity threats. Our cybersecurity risk assessment and management processes are implemented and maintained by certain Company management, including our Director of IT Operations and Security, Senior Director of IT, and Chief Financial Officer.
The board of directors’ audit committee is responsible for overseeing Company’s cybersecurity risk management processes, including oversight of mitigation of risks from cybersecurity threats. Our cybersecurity risk assessment and management processes are implemented and maintained by certain Company management, including our Director of IT Operations and Security and Principal Accounting Officer.
The audit committee also receives from the Director of IT Operations and Security or the Senior Director of IT, various written reports, summaries or presentations related to 72 Table of Contents cybersecurity threats, risk, and mitigation. Ite m 2. Properties.
The audit committee also receives from the Director of IT Operations and Security various written reports, summaries or presentations related to cybersecurity threats, risk, and mitigation. Ite m 2. Properties.
In the near term, our primary uses of cash will be to fund the completion of key milestones for trastuzumab imbotolimod and BDC-3042 and to fund our operations, including research and development activities and employee salaries. This includes significant costs relating to clinical trials and manufacturing our product candidates.
In the near term, our primary uses of cash will be to fund the completion of key milestones for clinical programs and to fund our operations, including research and development activities and employee salaries. This includes significant costs relating to clinical trials and manufacturing our product candidates.
In 2023 and 2022, stock-based compensation expense related to stock options was $9.2 million and $9.6 million, respectively. As of December 31, 2023, the unrecognized stock-based compensation expense related to stock options was $9.7 million and is expected to be recognized as expense over a weighted-average period of approximately 1.8 years.
In 2024 and 2023, stock-based compensation expense related to stock options was $7.4 million and $9.2 million, respectively. As of December 31, 2024, the unrecognized stock-based compensation expense related to stock options was $2.8 million and is expected to be recognized as expense over a weighted-average period of approximately 1.28 years.
We have performed a Section 382 study as of September 30, 2023 and expect approximately $2.8 million of federal research and development credits and $51.0 million of California net operating losses to expire unused due to Section 382 limitations.
We have performed a Section 382 study as of September 30, 2023 and expect approximately $2.8 million of federal research and development credits and $51.0 million of California NOL carryforward to expire unused due to Section 382 limitations.
We are not currently under examination in any of these jurisdictions and all its tax years remain effectively open to examination due to net operating loss carryforwards.
We are not currently under examination in any of these jurisdictions and all its tax years remain effectively open to examination due to NOL carryforwards.
Our Chief Financial Officer receives regular reports on the status of our cybersecurity measures, and works with the Company’s incident response team in an effort to help the Company mitigate and remediate cybersecurity incidents of which they are notified, and to assess and determine materiality for reporting purposes.
Our Principal Accounting Officer receives regular reports on the status of our cybersecurity measures, and 70 Table of Contents works with the Company’s incident response team in an effort to help the Company mitigate and remediate cybersecurity incidents of which they are notified, and to assess and determine materiality for reporting purposes.
In August 2021, we entered into an oncology research and development collaboration with Innovent to leverage Innovent’s proprietary therapeutic antibody portfolio and antibody discovery capability against undisclosed oncology targets in combination with our Boltbody ISAC technology and myeloid biology expertise to create up to three new candidates for cancer treatments with the potential to provide significant benefit to patients.
In August 2021, we entered into an oncology research and development collaboration with Innovent, or the Original Innovent Agreement, to leverage Innovent’s proprietary therapeutic antibody portfolio and antibody discovery capability against undisclosed oncology targets in combination with our Boltbody ISAC technology and myeloid biology expertise to create new candidates for cancer treatments.
General and Administrative Expenses General and administrative expenses decreased by $0.4 million from $22.9 million in 2022 to $22.5 million in 2023.
General and Administrative Expenses General and administrative expenses decreased by $4.0 million from $22.5 million in 2023 to $18.5 million in 2024.
Our investment policy prioritizes preservation of principal and availability of cash to meet cash flow requirements, and maximizing total net returns after satisfying the first two conditions. Our policy only allows for investments in fixed-income instruments such as corporate bonds and government securities.
We evaluated our current cash position, historical results, forecasted cash flows and plans with regard to liquidity. Our investment policy prioritizes preservation of principal and availability of cash to meet cash flow requirements, and maximizing total net returns after satisfying the first two conditions. Our policy only allows for investments in fixed-income instruments such as corporate bonds and government securities.
In October 2023, we dosed the first patient with BDC-3042 in the Phase 1 dose-escalation study in patients with a broad range of solid tumors. BDC-3042 has now completed the first three dose escalation cohorts without experiencing a dose-limiting toxicity.
In October 2023, we dosed the first patient with BDC-3042 in the Phase 1 dose-escalation study in patients with a broad range of solid tumors. BDC-3042 has now completed the first six dose escalation cohorts without experiencing a dose-limiting toxicity. We recently selected BDC-4182 as our next clinical candidate.
The change in net operating assets was due to a $2.6 million decrease in operating lease liabilities, a $2.2 million decrease in deferred revenue related to our collaboration agreements, and an $0.9 million increase in our prepaid expense and other assets, offset by a $2.8 million increase in our accounts payable and accrued expenses.
The change in net operating assets was primarily due to a $4.7 million decrease in deferred revenue, a $4.9 million decrease in our accounts payable and accrued expenses, $1.4 million decrease in operating lease liabilities, offset by a $2.6 million increase in our prepaid expense and other assets.
The following table sets forth a summary of our cash flows for each of the periods indicated: Years Ended December 31, 2023 2022 (In thousands) Net cash provided by (used in): Operating activities $ (69,525 ) $ (76,504 ) Investing activities 71,038 57,862 Financing activities 253 503 Net increase (decrease) in cash, cash equivalents and restricted cash $ 1,766 $ (18,139 ) 80 Table of Contents Operating Activities Net cash used in operating activities was $69.5 million and $76.5 million for 2023 and 2022, respectively.
Summary Cash Flows The following table sets forth a summary of our cash flows for each of the periods indicated: Years Ended December 31, 2024 2023 (In thousands) Net cash (used in) provided by: Operating activities $ (61,289 ) $ (69,525 ) Investing activities 57,576 71,038 Financing activities 108 253 Net (decrease) increase in cash, cash equivalents and restricted cash $ (3,605 ) $ 1,766 Operating Activities Net cash used in operating activities was $61.3 million and $69.5 million for 2024 and 2023, respectively.
We believe we will meet longer-term expected future cash requirements and obligations through a combination of cash flows from operating activities, available cash balances, and equity or debt financings or other capital sources, including potential collaborations, licenses, and other similar arrangements.
We believe we will meet longer-term expected future cash requirements and obligations through a combination of cash flows from operating activities, available cash balances, and equity or debt financings or other capital sources, including potential collaborations, licenses, and other similar arrangements, however, there can be no assurance the additional sources will be available at favorable terms or at all.
The non-cash charges were comprised of $9.6 million for stock-based compensation, $3.2 million of non-cash lease related expense, $1.7 million for depreciation and amortization expense, and $0.2 million for accretion of discount on marketable securities.
The non-cash charges were comprised of $7.4 million for stock-based compensation, $2.3 million of non-cash lease-related expense, and $1.8 million for depreciation and amortization expense, partially offset by $2.6 million for accretion of discount on marketable securities and $0.1 million gain on sale of property and equipment.
The net cash provided by financing activities for 2023 was due to net proceeds from the issuance of common stock from the 2021 Employee Stock Purchase Program and exercise of stock options. Net cash provided by financing activities for 2022 was from the issuance of common stock from the 2021 Employee Stock Purchase Program and exercise of stock options.
The net cash provided by financing activities for the same period in 2023 was due to the net proceeds from the issuance of common stock from our employee stock purchase plan and exercise of stock options.
Dividend Policy We have never declared or paid any dividends on our common stock. We currently intend to retain all available funds and any future earnings, if any, to fund the development and expansion of our business and we do not anticipate paying any cash dividends in the foreseeable future.
We currently intend to retain all available funds and any future earnings, if any, to fund the development and expansion of our business and we do not anticipate paying any cash dividends in the foreseeable future.
Research and development expenses include: • costs related to manufacturing our product candidates for clinical trials and preclinical studies, including fees paid to third-party CDMOs; • salaries, payroll taxes, employee benefits and stock-based compensation charges for those individuals involved in research and development efforts; • external research and development expenses, including lab materials and supplies and payments to CROs, investigative sites, and consultants to conduct our clinical trials and preclinical and non-clinical studies; and • facilities and other allocated expenses which include direct and allocated expenses for rent, insurance and other supplies.
Research and development expenses are recognized as incurred and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received. 75 Table of Contents Research and development expenses include: • costs related to manufacturing our product candidates for clinical trials and preclinical studies, including fees paid to third-party CDMOs; • salaries, payroll taxes, employee benefits and stock-based compensation charges for those individuals involved in research and development efforts; • external research and development expenses, including lab materials and supplies and payments to CROs, investigative sites, and consultants to conduct our clinical trials and preclinical and non-clinical studies; and • facilities and other allocated expenses which include direct and allocated expenses for rent, insurance and other supplies.
Net cash used in operating activities for 2022 was due to our net loss of $88.1 million, adjusted for $14.7 million of non-cash charges and a $3.1 million change in operating assets and liabilities.
Net cash used in operating activities for 2024 was due to our net loss of $63.1 million, adjusted for $10.3 million of non-cash charges and a $8.4 million change in operating assets and liabilities.
The Innovent collaboration was amended in March 2024, when we secured global rights to two Boltbody ISAC programs. We expect our collaborations with Toray and Genmab to add additional novel ISACs to our pipeline.
The Innovent collaboration was amended in March 2024, when we secured exclusive worldwide rights to ISAC programs utilizing specified antibodies against two tumor antigen targets. We expect our collaborations with Toray and Genmab to add additional novel ISACs to our pipeline.
These costs will likely include expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with Nasdaq and SEC requirements, director and officer insurance premiums and investor relations costs associated with operating as a public company. Other Income, Net Interest Income, Net Interest income consists of interest on our cash, cash equivalents, and short-term investments.
These costs will likely include expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with Nasdaq and SEC requirements, director and officer insurance premiums and investor relations costs associated with operating as a public company.
The decrease was due to $10.6 million in lower manufacturing expenses related to fewer raw materials purchased and the timing of batch production of our product candidates and $2.2 million in lower research and development lab supplies and contract services expense, offset by $0.7 million in higher personnel-related expenses due to an increase in headcount and $0.6 79 Table of Contents million in higher clinical expenses related to the advancement of trastuzumab imbotolimod clinical trial into Phase 2 in both monotherapy and in combination with nivolumab.
The decrease was due to $4.1 million in lower personnel-related expenses due to a decrease in headcount related to the reduction in workforce, a decrease of $0.9 million in facilities expenses, $0.8 million in lower research and development lab supplies and contract services expense, and a decrease of $0.4 million in consulting expenses, offset by $1.3 million in higher clinical expenses related to the advancement of trastuzumab imbotolimod clinical trial into Phase 2 in both monotherapy and in combination with nivolumab and $1.0 million in higher manufacturing expenses related to more raw materials purchased and the timing of batch production of our product candidates.
We perform the following five steps in determining the appropriate amount of revenue to be recognized as we fulfill our obligations under each of these agreements: • identification of the promised goods and services in the contract; • determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; 84 Table of Contents • measurement of the transaction price, including any constraint on variable consideration; • allocation of the transaction price to the performance obligations; and • recognition of revenue when, or as, we satisfy each performance obligation.
We perform the following five steps in determining the appropriate amount of revenue to be recognized as we fulfill our obligations under each of these agreements: • identification of the promised goods and services in the contract; • determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; • measurement of the transaction price, including any constraint on variable consideration; • allocation of the transaction price to the performance obligations; and • recognition of revenue when, or as, we satisfy each performance obligation. 83 Table of Contents If an agreement includes a license to our intellectual property and that license is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license.
Our cybersecurity incident response and vulnerability management processes are designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including our Chief Financial Officer.
Our Principal Accounting Officer is responsible for helping prepare budgets, helping prepare for cybersecurity incidents, and approving certain cybersecurity processes. Our cybersecurity incident response and vulnerability management processes are designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including our Principal Accounting Officer.
Investing Activities Net cash provided by investing activities was $71.0 million and $57.9 million in 2023 and 2022, respectively. The net cash provided by investing activities in 2023 was due to $236.2 million maturity of marketable securities, offset by $165.0 million in purchases of marketable securities and $0.2 million in purchases of property and equipment.
The net cash provided by investing activities for the same period in 2023 was due to $236.2 million maturities of marketable securities, offset by $165.0 million in purchases of marketable securities and $0.2 million in purchases of property and equipment. Financing Activities Net cash provided by financing activities was $0.1 million and $0.3 million for 2024 and 2023, respectively.
We have incurred operating losses since our inception. Our net losses were $69.2 million and $88.1 million for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, we had an accumulated deficit of $364.3 million.
Our net losses were $63.1 million and $69.2 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $427.4 million.
Except as otherwise indicated herein or as the context otherwise requires, references in this Annual Report on Form 10-K to “Bolt Bio,” “the Company,” “we,” “us” and “our” refer to Bolt Biotherapeutics, Inc. Overview We are a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer.
Except as otherwise indicated herein or as the context otherwise requires, references in this Annual Report on Form 10-K to “Bolt Bio,” “the Company,” “we,” “us” and “our” refer to Bolt Biotherapeutics, Inc. Overview Our mission is to harness the power of the immune system to improve lives and eradicate cancer.
Liquidity and Capital Resources Sources of Liquidity We have incurred net losses and negative cash flows from operations since our inception and anticipate we will continue to incur net losses for the foreseeable future. As of December 31, 2023, we had an accumulated deficit of $364.3 million.
Liquidity and Capital Resources Sources of Liquidity We have incurred net losses, $63.1 million and $69.2 million in 2024 and 2023, respectively, and negative cash flows from operations since our inception, with an accumulated deficit of $427.4 million and anticipate continuing to incur net losses for the foreseeable future.
Our pipeline candidates are built on our deep expertise in myeloid biology and cancer drug development. Our various approaches use pattern recognition receptors in the innate immune system to help the body recognize tumor cells for a productive anti-cancer response. Our proprietary Boltbody ISAC platform technology combines tumor-targeting antibodies with immune-stimulating linker-payloads.
Our various approaches use pattern recognition receptors expressed by the innate immune system to help the body eliminate tumor cells as part of a productive anti-cancer response. Our proprietary Boltbody ISAC platform technology combines tumor-targeting antibodies with immune-stimulating linker-payloads.
Dectin-2 agonism results in these TAMs changing from tumor-supportive macrophages into tumor-destructive macrophages that elicit durable anti-tumor immune responses in preclinical models. We received the Investigational New Drug Application, or IND, clearance from the FDA in July 2023.
BDC-3042, our dectin-2 agonist antibody program, is being developed to repolarize critical cells in the tumor microenvironment known as tumor associated macrophages (TAMs). dectin-2 agonism changes these TAMs from tumor-supportive macrophages to tumor-destructive macrophages that elicit durable anti-tumor immune responses in preclinical models. We received the Investigational New Drug Application, or IND, clearance from the FDA in July 2023.
The federal NOLs not subject to expiration are available to offset up to 80% of taxable income each year indefinitely. The state NOL carryforwards will begin to expire in 2035, unless previously utilized. As of December 31, 2023, we also had federal and state research credit carryforwards of $9.4 million and $5.6 million, respectively.
The state NOL carryforwards will begin to expire in 2035, unless previously utilized. As of December 31, 2024, we also had federal and state research credit carryforwards of $11.5 million and $6.5 million, respectively.
Research and Development Expenses Research and development expenses decreased by $11.6 million from $73.1 million in 2022 to $61.5 million in 2023.
Research and Development Expenses Research and development expenses decreased by $4.0 million from $61.5 million in 2023 to $57.5 million in 2024.
In March 2024, we entered into an amended and restated agreement with Innovent that provides Bolt with worldwide rights to two ISAC programs. Bolt will be assuming all future development costs for the two ISAC programs, and Innovent is eligible to receive commercial and sales milestones as well as royalties on global net sales.
Bolt will be assuming all future development costs for the two ISAC programs, and Innovent is eligible to receive commercial and sales milestones as well as royalties on global net sales. 82 Table of Contents License Agreements License Agreements with Stanford University In May 2015, we entered into a license agreement with Stanford, pursuant to which Stanford granted us an exclusive license to certain inventions.
Prior to February 5, 2021, there was no public market for our common stock. Holders of Common Stock On March 14, 2024, there were approximately 17 holders of record of our common stock. Certain shares are held in “street” name and accordingly, the number of beneficial owners of such shares is not known or included in the foregoing number.
Holders of Common Stock On March 19, 2025, there were approximately 13 holders of record of our common stock. Certain shares are held in “street” name and accordingly, the number of beneficial owners of such shares is not known or included in the foregoing number. Dividend Policy We have never declared or paid any dividends on our common stock.
The increase in revenue in the comparative periods was due to continued progress in our collaborations with Genmab and Innovent as we fulfill our performance obligations to our collaboration partners. We expect to continue to provide services to further our collaborations with our partners.
The increase in revenue in the comparative periods was mainly due to revenue recognized under the Amended Innovent Agreement, as we satisfied our performance obligation to Innovent. The increase was also due to continued progress in our other collaborations as we fulfill our performance obligations to our collaboration partners.
We allocated the entire $5.0 million upfront payment to deferred revenue, which we recognize together with other payments received from Innovent as collaboration revenue over time as we fulfill our performance obligation to Innovent. The Innovent collaboration was amended in March 2024, when we secured global rights to two Boltbody ISAC programs.
Under the Original Innovent Agreement, the Company received an upfront payment of $5.0 million. We allocated the entire $5.0 million upfront payment to deferred revenue, which we recognized together with other payments received from Innovent as collaboration revenue over time as we fulfilled our performance obligation to Innovent.
Net cash provided by investing activities in 2022 was due to $240.5 million maturity of marketable securities, offset by $180.7 million in purchases of marketable securities and $2.0 million in purchases of property and equipment. Financing Activities Net cash provided by financing activities was $0.3 million and $0.5 million for 2023 and 2022, respectively.
Investing Activities Net cash provided by investing activities was $57.6 million and $71.0 million in 2024 and 2023, respectively. The net cash provided by investing activities in 2024 was due to $146.3 million in maturities of marketable securities, offset by $88.9 million in purchases of marketable securities.
Results of Operations Comparison of the Years Ended December 31, 2023 and 2022 Years Ended December 31, 2023 2022 Change (In thousands) Collaboration revenue $ 7,876 $ 5,729 $ 2,147 Operating expenses: Research and development 61,542 73,123 (11,581 ) General and administrative 22,530 22,927 (397 ) Total operating expense 84,072 96,050 (11,978 ) Loss from operations (76,196 ) (90,321 ) 14,125 Other income, net — — Interest income 6,999 2,223 4,776 Total other income, net 6,999 2,223 4,776 Net loss (69,197 ) (88,098 ) 18,901 Net unrealized loss on marketable securities 956 (598 ) 1,554 Comprehensive loss $ (68,241 ) $ (88,696 ) $ 20,455 Collaboration Revenue Revenue was $7.9 million and $5.7 million for the years ended December 31, 2023 and 2022, respectively.
Other Income Other income in 2024 consists of the one-time payment received from Innovent under the Amended Innovent Agreement. 77 Table of Contents Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 Years Ended December 31, 2024 2023 Change (In thousands) Collaboration revenue $ 7,690 $ 7,876 $ (186 ) Operating expenses: Research and development 57,469 61,542 (4,073 ) General and administrative 18,457 22,530 (4,073 ) Restructuring charges 3,343 — 3,343 Impairment charges 1,469 — 1,469 Total operating expenses 80,738 84,072 (3,334 ) Loss from operations (73,048 ) (76,196 ) 3,148 Other income (expense), net: Interest income, net 5,255 6,999 (1,744 ) Other income (expense), net 4,675 — 4,675 Total other income (expense), net 9,930 6,999 2,931 Net loss (63,118 ) (69,197 ) 6,079 Net unrealized gain (loss) on marketable securities 60 956 (896 ) Comprehensive loss $ (63,058 ) $ (68,241 ) $ 5,183 Collaboration Revenue Revenue was $7.7 million and $7.9 million for the years ended December 31, 2024 and 2023, respectively.
Net Operating Loss and Research and Development Carryforwards and Other Income Tax Information As of December 31, 2023, we had federal and state NOL carryforwards of $205.7 million and $278.5 million, respectively.
Net Operating Loss (NOL) and Research and Development Carryforwards and Other Income Tax Information As of December 31, 2024, we had federal and state net operating loss, or NOL, carryforwards of $234.9 million and $324.0 million, respectively. The federal NOL carryforwards generated prior to 2018 and state NOL carryforwards, if not utilized, will expire beginning in 2035.
Pursuant to the license agreement, we will reimburse Stanford’s patent expenses, including reasonable costs incurred in assisting us with prosecuting and maintaining licensed patents. Effective May 10, 2023, the Company terminated a separate license agreement with Stanford entered into in June 2018, after determining it was no longer necessary. The termination did not result in any payments due to Stanford.
Pursuant to the license agreement, we will reimburse Stanford’s patent expenses, including reasonable costs incurred in assisting us with prosecuting and maintaining licensed patents.
The federal NOLs include $4.4 million that may be used to offset up to 100% of future taxable income and will begin to expire in 2035 unless previously utilized and $201.3 million that are not subject to expiration. The net operating loss carryforwards subject to expiration could expire unused and be unavailable to offset future income tax liabilities.
Federal NOL carryforwards aggregating $230.5 million are not subject to expiration.The NOL carryforwards subject to expiration could expire unused and be unavailable to offset future income tax liabilities. The federal NOL carryforwards not subject to expiration are available to offset up to 80% of taxable income each year indefinitely.
Not applicable. 73 Table of Contents PAR T II It em 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock began trading on the Nasdaq Global Select Market on February 5, 2021, and trades under the symbol “BOLT”.
We incorporate by reference into this Item our disclosures made in Note 7 to our Consolidated Financial Statements. It em 4. Mine Safety Disclosures. Not applicable. 71 Table of Contents PAR T II It em 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
The decrease was due to $1.4 million in lower consulting and professional services expenses and $0.9 million in lower facility-related expenses, offset by $1.3 million in higher personnel-related expenses due to an increase in headcount and $0.5 million higher software licensing expenses.
The decrease was due to $3.5 million decrease in salary, bonus and related expenses as a result of the restructuring plan, a decrease of $1.5 million in lower consulting, professional services, marketing expenses, and public relations expenses primarily related to a decrease in legal expenses, offset by $0.9 million in higher facility expenses. 78 Table of Contents Restructuring Charges Restructuring charges were $3.3 million in 2024, consisting of $2.9 million of one-time termination benefits such as severance costs and related benefits and $0.7 million of non-cash stock-based compensation expense as a result of a restructuring plan.
Removed
Our Senior Director of IT has 25 years of IT management experience at various public biotechnology companies. Our Chief Financial Officer is responsible for helping prepare budgets, helping prepare for cybersecurity incidents, and approving certain cybersecurity processes.
Added
We implement and maintain various technical, physical, and organizational measures, processes, and policies, designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example, an incident detection and response plan; vulnerability management processes; risk assessments; implementation of security standards; encryption of certain data; network security controls; segregation of certain data; access controls including multi-factor authentication for certain Information Systems and Data; physical security; asset management, tracking and disposal; systems monitoring; vendor risk management program; employee training; penetration testing; and cybersecurity insurance.
Removed
Our first Boltbody ISAC program is trastuzumab imbotolimod, formerly known as BDC-1001, targeting a tumor antigen known as human epidermal growth factor receptor 2 (HER2) that is often found in cancers such as breast and gastroesophageal cancer.
Added
Market Information Our common stock began trading on the Nasdaq Global Select Market on February 5, 2021, and trades under the symbol “BOLT”. Effective January 6, 2025, our common stock was transferred to and now trades on the Nasdaq Capital Market under the same symbol. Prior to February 5, 2021, there was no public market for our common stock.
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