Bolt Biotherapeutics Inc
For the period ended Jun 30, 2024. Filed Aug 13, 2024.
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Jun 30, 2024 · Filed Aug 13, 2024
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Notes to the Condensed Financial Statements
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Unaudited)
- Description of the Business
Bolt Biotherapeutics, Inc. (the “Company”) is a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer. The Company’s pipeline candidates are built on the Company’s deep expertise in myeloid biology and cancer drug development, uniting the targeting precision of antibodies with the power of the innate and adaptive immune system to reprogram the tumor microenvironment for a productive anti-cancer response.
- Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed financial statements as of June 30, 2024 and for the three and six months ended June 30, 2024 and 2023 have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and pursuant to applicable rules and regulations of the SEC regarding interim financial reporting. Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed financial statements include only normal and recurring adjustments, which are normal in nature, that the Company believes are necessary to a fair statement of the Company’s financial position and the results of its operations and cash flows. The balance sheet as of December 31, 2023 was derived from the audited financial statements as of that date. These interim financial results are not necessarily indicative of results to be expected for the full year or any other period. These unaudited condensed financial statements and the notes accompanying them should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
Risks and Uncertainties
The Company is subject to a number of risks similar to other early-stage biopharmaceutical companies, including, but not limited to, changes in any of the following areas that the Company believes could have a material adverse effect on its future financial position or results of operations: risks related to the successful discovery and development of its product candidates, ability to raise additional capital, development of new technological innovations by its competitors, delay or inability to obtain chemical or biological intermediates from such suppliers required for the synthesis of the Company’s product candidates, protection of intellectual property rights, litigation or claims against the Company based on intellectual property rights, and regulatory clearance and market acceptance of the Company’s products.
Global economic and business activities continue to face widespread macroeconomic uncertainties, including pandemics, labor shortages, inflation and monetary supply shifts, recession risks and potential disruptions from major geopolitical conflicts. The Company continues to actively monitor the impact of these macroeconomic factors on its financial condition, liquidity, operations, and workforce. The extent of the impact of these factors on the Company’s operational and financial performance, including its ability to execute its business strategies and initiatives in the expected time frame, will depend on future developments, which are uncertain and cannot be predicted; however, any continued or renewed disruption resulting from these factors could negatively impact the Company’s business.
The Company relies on single source manufacturers and suppliers for the supply of its product candidates. Disruption from these manufacturers or suppliers would have a negative impact on the Company’s business, financial position, and results of operations.
Liquidity
The Company has incurred net losses and negative cash flows from operations since its inception and anticipates continuing to incur net losses for the foreseeable future. As of June 30, 2024, the Company had cash and cash equivalents and marketable securities of $97.5 million and an accumulated deficit of $396.3 million. Based upon the Company's current operating plans, the Company believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations for at least the next 12 months following the issuance date of this Quarterly Report on Form 10-Q. The Company will need to raise additional capital to continue the advancement of its programs. In the near term, the Company's primary uses of cash will be to fund the completion of key milestones for clinical programs and to fund its operations, including research and development activities and employee salaries. This includes significant costs relating to clinical trials and manufacture of the Company's product candidates. The Company's uses of cash in the long term will be similar as the Company advances its research and development activities and pays employee salaries. Most pharmaceutical products require larger clinical trials as development progresses, and the Company expects its funding requirements to grow with the advancement of its programs. The Company's long-term funding requirements will depend on many factors, which are uncertain but include its portfolio prioritization decisions and the success of its collaborations. In turn, the Company's ability to raise additional capital through equity or partnering will depend on the general economic environment in which it operates and its ability to achieve key milestones.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to revenue recognition, stock-based compensation, restructuring costs, long-lived assets impairment assessment, and accrued liabilities. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from those estimates.
Restructuring charges consist primarily of employee severance, contract termination costs and other costs. Liabilities for costs associated with a restructuring activity are recognized when the liability is incurred and are measured at fair value. For one-time employee terminations benefits, the Company recognizes the liability in full on the communication date when future services are not required or amortizes the liability ratably over the service period, if required. The fair value of termination benefits reflects the Company’s estimate of expected utilization of certain Company-funded post-employment benefits. One-time termination benefits include severance, continuation of health insurance coverage for certain employees, and other company funded benefits.
Long-lived Assets Impairment Assessment
Long-lived assets, including operating lease assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The recoverability of assets to be held and used is measured by a comparison of the carrying amount of the asset group to future net cash flows estimated by the Company to be generated by such assets. If such asset group is considered to be impaired, the impairment to be recognized is the amount by which the carrying amount of the asset group exceeds the fair value of the asset group. During the three months ended June 30, 2024, the Company performed an evaluation of the impact of the May 2024 announcement and restructuring plan on the carrying value of its long-lived assets and concluded that there wasno impairment charge to be recognized on the long-lived assets.
Allowance for Credit Losses
For available-for-sale securities in an unrealized loss position, the Company first assesses whether it intends to sell, or if it is more likely than not that the Company will be required to sell, the security before recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the security’s amortized cost basis is written down to fair value through earnings. For available-for-sale securities that do not meet the aforementioned criteria, the Company evaluates whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, the Company considers the severity of the impairment, any changes in interest rates, market conditions, changes to the underlying credit ratings and forecasted recovery, among other factors. The credit-related portion of unrealized losses, and any subsequent improvements, are recorded in interest income through an allowance account. Any impairment that has not been recorded through an allowance for credit losses is included in other comprehensive income (loss) on the statements of operations and comprehensive loss.
The Company elected the practical expedient to exclude the applicable accrued interest from both the fair value and amortized costs basis of its available-for-sale securities for purposes of identifying and measuring an impairment. Accrued interest receivable on available-for-sale securities is recorded within cash and cash equivalents on the Company's condensed balance sheets. The Company's accounting policy is to not measure an allowance for credit loss for accrued interest receivable and to write-off any uncollectible accrued interest receivable as a reversal of interest income in a timely manner, which the Company considers to be in the period in which it determines the accrued interest will not be collected by the Company.
Concentrations of Credit Risk
Financial instruments that potentially subject the Company to concentration of credit risk consist of cash, cash equivalents and marketable securities. As of June 30, 2024 and December 31, 2023, most of the Company’s funds were invested with a registered investment manager and custodied at one financial institution, with operating cash kept at a separate financial institution, and account balances may at times exceed federally insured limits. Management believes that the Company is not subject to unusual or significant credit risk beyond the normal credit risk associated with commercial banking relationships.
Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, convertible preferred stock, stock options, common stock subject to repurchase related to unvested restricted stock awards and early exercise of stock options are considered potentially dilutive securities. Basic and diluted net loss per share is presented in conformity with the two-class method required for participating securities as the convertible preferred stock is considered a participating security because it participates in dividends with common stock. The Company also considers the shares issued upon the early exercise of stock options subject to repurchase to be participating securities because holders of such shares have non-forfeitable dividend rights in the event a dividend is paid on common stock. The holders of all series of convertible preferred stock and the holders of early exercised shares subject to repurchase do not have a contractual obligation to share in the Company’s losses. As such, the net loss was attributed entirely to common stockholders. Because the Company has reported a net loss for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as potentially dilutive securities were anti-dilutive.
Recent Accounting Standards
From time to time, new accounting standards are issued by the Financial Accounting Standards Board (the “FASB”), or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption.
In November 2023, the FASB issued ASU 2023-07 Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which requires entities to disclose incremental segment information on an annual and interim basis. ASU 2023-07 requires entities with a single reportable segment to provide all the disclosures required by the amendments in ASU 2023-07 and all existing segment disclosures in Segment Reporting (Topic 280). ASU 2023-07 is effective for annual periods beginning on January 1, 2024, and interim periods beginning on January 1, 2025. The Company does not expect the adoption of ASU 2023-07 to have a material impact on its financial statements and related disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). ASU 2023-09 requires enhanced annual disclosures regarding the rate reconciliation and income taxes paid information. ASU 2023-09 is effective for annual periods beginning on January 1, 2025 and may be adopted on a prospective or retrospective basis. Early adoption is permitted. The Company is evaluating the impact of this guidance on its financial statements and related disclosures.
- Fair Value Measurements and Fair Value of Financial Instruments
The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:
Level 1—Quoted prices in active markets for identical assets or liabilities.
Level 2—Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that arenot active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
During the three and six months ended June 30, 2024, financial assets measured on a recurring basis consist of cash invested in money market accounts, short-term investments, and long-term investments. The fair value of short- and long-term investments is based upon market prices quoted on the last day of the fiscal period or other observable market inputs. The Company obtains pricing information from its investment manager and generally determines the fair value of investment securities using standard observable inputs, including reported trades, broker/dealer quotes, bids and/or offers.
There were no transfers within the hierarchy during the three and six months ended June 30, 2024 or 2023.
Marketable securities, all of which are classified as available-for-sale securities, consisted of the following at June 30, 2024 and December 31, 2023 (in thousands):
| Amortized | Unrealized | Unrealized | Estimated | |
|---|---|---|---|---|
| Cost | Gains | Losses | Fair Value | |
| Asset-backed securities | $24,982 | $3 | $(12) | $24,973 |
| U.S. treasury securities | 25,730 | — | (13) | 25,717 |
| Other government agency securities | 6,481 | — | (11) | 6,470 |
| Commercial paper | 7,986 | — | (5) | 7,981 |
| Corporate debt securities | 29,157 | 9 | (15) | 29,151 |
| Total | $94,336 | $12 | $(56) | $94,292 |
| Amortized | Unrealized | Unrealized | Estimated | |
|---|---|---|---|---|
| Cost | Gains | Losses | Fair Value | |
| Asset-backed securities | $17,347 | $10 | $(15) | $17,342 |
| U.S. treasury securities | 43,924 | 34 | (11) | 43,947 |
| Other government agency securities | 13,371 | — | (15) | 13,356 |
| Commercial paper | 20,351 | 4 | (10) | 20,345 |
| Corporate debt securities | 22,763 | 41 | (2) | 22,802 |
| Total | $117,756 | $89 | $(53) | $117,792 |
As of June 30, 2024, the unrealized losses for available-for-sale investments were primarily due to changes in interest rates and not due to increased credit risks associated with specific securities. The contractual terms of those investments do not permit the issuer to settle the securities at a price less than the amortized cost bases of the investments. The Company does not currently intend to sell the investments and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases, which may be at the time of maturity. As of June 30, 2024, no allowance for credit losses was recorded and the Company did not recognize any impairment losses related to investments.
The tables below show the gross unrealized losses and fair value of the Company's available-for-sale securities with unrealized losses that are not deemed to have credit losses (in thousands), aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position at June 30, 2024 and December 31, 2023, respectively:
| Less Than 12 Months | More Than 12 Months | Total | ||||
|---|---|---|---|---|---|---|
| Estimated | Unrealized | Estimated | Unrealized | Estimated | Unrealized | |
| Fair Value | Losses | Fair Value | Losses | Fair Value | Losses | |
| Asset-backed securities | $6,485 | $(2) | $18,488 | $(10) | $24,973 | $(12) |
| U.S. treasury securities | 14,839 | (6) | 10,878 | (7) | 25,717 | (13) |
| Other government agency securities | — | — | 6,470 | (11) | 6,470 | (11) |
| Commercial paper | 7,981 | (5) | — | — | 7,981 | (5) |
| Corporate debt securities | 18,816 | (8) | 10,335 | (7) | 29,151 | (15) |
| Total | $48,121 | $(21) | $46,171 | $(35) | $94,292 | $(56) |
| Less Than 12 Months | More Than 12 Months | Total | ||||
|---|---|---|---|---|---|---|
| Estimated | Unrealized | Estimated | Unrealized | Estimated | Unrealized | |
| Fair Value | Losses | Fair Value | Losses | Fair Value | Losses | |
| Asset-backed securities | $4,686 | $— | $12,656 | $(15) | $17,342 | $(15) |
| U.S. treasury securities | 34,104 | — | 9,843 | (11) | 43,947 | (11) |
| Other government agency securities | 2,477 | (1) | 10,879 | (14) | 13,356 | (15) |
| Commercial paper | 20,345 | (10) | — | — | 20,345 | (10) |
| Corporate debt securities | 9,566 | (1) | 13,236 | (1) | 22,802 | (2) |
| Total | $71,178 | $(12) | $46,614 | $(41) | $117,792 | $(53) |
Accrued interest receivable on available-for-sale securities were $0.4 million and $0.3 million at June 30, 2024 and December 31, 2023, respectively, which are recorded in cash and cash equivalents line item on the Company's condensed balance sheets. The Company has not written off any accrued interest receivables for the three and six months ended June 30, 2024.
As of June 30, 2024 and December 31, 2023, the fair values of the Company’s assets, which are measured at fair value on a recurring basis, were determined using the following inputs (in thousands):
| Total | (Level 1) | (Level 2) | (Level 3) | |
|---|---|---|---|---|
| Money market funds | $1,990 | $1,990 | $— | $— |
| Asset-backed securities | 24,973 | — | 24,973 | — |
| U.S. treasury securities | 25,717 | 6,422 | 19,295 | — |
| Other government agency securities | 6,470 | — | 6,470 | — |
| Commercial paper | 7,981 | — | 7,981 | — |
| Corporate debt securities | 29,151 | — | 29,151 | — |
| Total | $96,282 | $8,412 | $87,870 | $— |
| Total | (Level 1) | (Level 2) | (Level 3) | |
|---|---|---|---|---|
| Money market funds | $8,641 | $8,641 | $— | $— |
| Asset-backed securities | 17,342 | — | 17,342 | — |
| U.S. treasury securities | 43,947 | 33,001 | 10,946 | — |
| Other government agency securities | 13,356 | — | 13,356 | — |
| Commercial paper | 20,345 | — | 20,345 | — |
| Corporate debt securities | 22,802 | — | 22,802 | — |
| Total | $126,433 | $41,642 | $84,791 | $— |
- Balance Sheet Components
Property and Equipment, net
Property and equipment, net, consist of the following (in thousands):
| June 30,2024 | December 31,2023 | |
|---|---|---|
| Laboratory equipment | $10,075 | $10,038 |
| Office equipment | 386 | 386 |
| Leasehold improvements | 286 | 285 |
| Total property and equipment | 10,747 | 10,709 |
| Less accumulated depreciation and amortization | (6,668) | (5,752) |
| Total | $4,079 | $4,957 |
Depreciation expense related to property and equipment was $0.4 million for each of thethree months ended June 30, 2024 and 2023 and $0.9 million for each of thesix months ended June 30, 2024 and 2023.
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of the following (in thousands):
| June 30,2024 | December 31,2023 | |
|---|---|---|
| Accrued research and development | $4,019 | $6,092 |
| Accrued compensation | 2,889 | 5,820 |
| Accrued restructuring charges | 2,900 | — |
| Accrued other | 446 | 574 |
| Total | $10,254 | $12,486 |
- Collaborations
Joint Development and License Agreement with Toray Industries, Inc.
In March 2019, the Company entered into a Joint Development and License Agreement (the “Toray Agreement”) with Toray Industries, Inc. (“Toray”) to jointly develop and commercialize a Boltbody™ immune-stimulating antibody conjugate (“ISAC”) containing Toray’s proprietary antibody to treat cancer. The Company determined that the Toray Agreement is a contract with a customer and should be accounted for under ASC 606. In conjunction with the Toray Agreement, the Company entered into a Series T Convertible Preferred Stock Purchase Agreement (the “Series T Agreement”) for the issuance of 717,514 shares of Series T convertible preferred stock to Toray. These contracts have been evaluated together and the consideration in excess of the fair value of the Series T convertible preferred stock of $1.5 million has been allocated to the Toray Agreement and included in the total consideration for collaboration revenue. In February 2021, in connection with the Company’s initial public offering ("IPO"), all outstanding shares of Series T convertible preferred stock were converted into shares of the Company’s common stock.
In the Toray Agreement, the Company has identified one bundled performance obligation which includes the license rights, research and development services and services associated with participation on a joint steering committee. The transaction price includes the $1.5 million allocated from the Series T convertible preferred stock and $1.9 million of estimated variable consideration related to compensation for research and development services at the agreed upon full-time employee rate and third-party costs. Collaboration revenue is recognized over time proportionate to the costs that the Company has incurred to perform the services using an input method as a measure of progress towards satisfying the performance obligation, which is based on project hours. Amounts are billed based on estimated variable consideration in the quarter ahead of performance and are trued up on the subsequent quarter’s invoice following the work performed. The cumulative effect of revisions to estimated hours to complete the Company’s performance obligation will be recorded in the period in which changes are identified and amounts can be reasonably estimated. As of June 30, 2024, receivables of $0.2 million related to research and development services performed under the Toray Agreement were recorded as part of the prepaid expenses and other current assets line item on the Company's condensed balance sheet. Deferred revenue allocated to the unsatisfied performance obligation is recorded as a contract liability on the Company's condensed balance sheet and will be recognized over time as the services are performed. As of June 30, 2024, contract liabilities totaling $1.0 million at period-end were recorded in deferred revenue with $0.4 million in current liabilities and $0.6 million in non-current liabilities on the Company's condensed balance sheet based on the forecasted periods of performance.
| Balance at December 31, 2023 | $1,502 |
|---|---|
| Addition—amount billed or accrued for research and development services | 285 |
| Revenue recognized | (814) |
| Balance at June 30, 2024 | $973 |
The Company recorded $0.2 million and $0.8 million revenue during thethree and six months ended June 30, 2024, respectively, andzero in the same periods in 2023. The Toray Agreement includes both fixed and variable considerations. Under the Toray Agreement, the Company will be compensated for early-stage development and manufacturing activities based on agreed full-time equivalent rates and actual out-of-pocket costs incurred through the completion of the first Phase 1 clinical trial for the lead product candidate and Toray is entitled to reimbursement for 50% of such development costs from the Company’s share of revenues collected from the sale or licensing of collaboration products. Although the legal term of the agreement is until collaboration products are no longer sold in the territories covered under the agreement, the parties have present enforceable rights and obligations through the end of the first Phase 1 clinical trial, after which both parties can opt out of continued development under the agreement. As such, the accounting term of the Toray Agreement was considered to terminate upon completion of the first Phase 1 clinical trial. After the conclusion of the first Phase 1 clinical trial, the parties will share equally all costs of development activities necessary for obtaining regulatory approval of collaboration products in the indications in the territories covered under the agreement, unless either party elects to opt out of its co-funding obligations or reduce them by half, which election can be on a region-by-region basis or for the territories covered under the agreement as a whole. Such optional additional items will be accounted for as contract modifications when development advances past certain milestones and the parties both exercise their opt-in rights.
Oncology Research and Development Collaboration with Genmab A/S
In May 2021, the Company entered into a License and Collaboration Agreement (the “Genmab Agreement”) with Genmab A/S (“Genmab”). Together, the companies will evaluate Genmab antibodies and bispecific antibody engineering technologies in combination with the Company’s Boltbody ISAC technology platform, with the goal of discovering and developing next-generation bispecific ISACs for the treatment of cancer. Under this research collaboration, the companies will evaluate multiple bispecific ISAC concepts to identify up to three clinical candidates for development. Genmab will fund the research, along with the preclinical and clinical development of these candidates through initial clinical proof of concept. Under the Genmab Agreement, the Company received an upfront payment of $10.0 million. The Company has determined that the Genmab Agreement is a contract with a customer and should be accounted for under ASC 606. In conjunction with the Genmab Agreement, the Company entered into a stock purchase agreement (the “Genmab SPA”) for the issuance of 821,045 shares of the Company’s common stock to Genmab for a total purchase price of $15.0 million. These contracts have been evaluated together and the consideration in excess of the fair value of the common stock of $1.4 million has been allocated to the Genmab Agreement and included in the total consideration for collaboration revenue.
In the Genmab Agreement, the Company has identified one bundled performance obligation that includes the license rights, research and development services, and services associated with participation on a joint research committee. The transaction price includes the $10.0 million upfront payment, the $1.4 million allocated from the Genmab SPA, and $28.6 million of estimated variable consideration related to compensation for research and development services at the agreed upon full-time employee rate and third-party costs. Collaboration revenue is recognized over time proportionate to the costs that the Company has incurred to perform the services using an input method as a measure of progress towards satisfying the performance obligation, which is based on project hours. Compensation for the research and development services are billed in the quarter based on actual hours incurred to satisfy the performance obligation. The cumulative effect of revisions to estimated hours to complete the Company’s performance obligation will be recorded in the period in which changes are identified and amounts can be reasonably estimated. As of June 30, 2024, receivables of $0.5 million related to research and development services performed under the Genmab Agreement were recorded as part of the prepaid expenses and other current assets line item on the Company's condensed balance sheet. Deferred revenue allocated to the unsatisfied performance obligation is recorded as a contract liability on the Company's condensed balance sheet and will be recognized over time as the services are performed. As of June 30, 2024, contract liabilities totaling $5.6 million were recorded in deferred revenue with $1.6 million in current liabilities and $4.0 million in non-current liabilities on the Company's condensed balance sheet based on the forecasted periods of performance.
| Balance at December 31, 2023 | $6,664 |
|---|---|
| Addition—amount billed for research and development services | 1,169 |
| Revenue recognized | (2,263) |
| Balance at June 30, 2024 | $5,570 |
The Company recorded $1.0 million and $2.3 million in revenue earned during thethree and six months ended June 30, 2024, respectively, and $0.8 million and $1.8 million in the same periods in 2023, respectively, based on services performed under the Genmab Agreement during the period. Under the Genmab Agreement, the Company will be compensated for research and development services at the agreed upon full-time employee rate and third-party costs through initial clinical proof of concept of the therapeutic candidates, which also represents the period of time both parties have enforceable rights and obligations. As such, the accounting term of the Genmab Agreement was considered to terminate upon completion of the initial clinical proof of concept of the therapeutic candidates, after which Genmab has the option to develop and commercialize up to three therapeutic candidates and the Company has the option to participate in development and commercialization of one candidate. The Genmab Agreement includes optional additional items which will be accounted for as contract modifications after initial clinical proof of concept of the therapeutic candidates. With respect to each candidate for which a party has exercised its program opt-in rights and has exclusive global rights, the other party is eligible to receive potential development and sales-based milestone payments and tiered royalties, subject to certain customary reductions, the amount of all such considerations will vary based on the market potential of the applicable territory for which such party has exercised its program opt-in rights. Under the Genmab Agreement, the Company is eligible to receive total potential milestone payments of up to $125.0 million in development milestones and $160.0 million in sale milestones per therapeutic candidate exclusively developed and commercialized by Genmab, along with tiered royalties at rates from a single-digit to mid-teens percentage based on net sales of each therapeutic candidate. However, given the current phase of development of therapeutic candidates under the Genmab Agreement, the Company cannot estimate the probability or timing of achieving these milestones, and, therefore, has excluded all milestone and royalty payments from the transaction prices of the agreement.
Oncology Research and Development Collaboration with Innovent Biologics, Inc.
In March 2024, the Company entered into an amended and restated license and collaboration agreement with Innovent Biologics, Inc. (the “Amended Innovent Agreement”), which amends the original license and collaboration agreement with Innovent Biologics, Inc. ("Innovent") dated August 25, 2021 (the “Original Innovent Agreement”). Under the Original Innovent Agreement, the Company and Innovent leveraged Innovent’s proprietary therapeutic antibody portfolio and antibody discovery capability against undisclosed oncology targets in combination with the Company's Boltbody ISAC technology and myeloid biology expertise to create new candidates for cancer treatments. Innovent funded the initial research, along with the preclinical development of these candidates through the contract modification date. Under the Original Innovent Agreement, the Company received an upfront payment of $5.0 million and was compensated for research and development services at the agreed upon full-time employee rate and third-party costs.
As part of the Amended Innovent Agreement, Innovent paid the Company a one-time payment of $4.7 million to be relieved from certain future funding and developmental obligations under the Original Innovent Agreement. Additionally, the Company secured exclusive worldwide rights to ISAC programs utilizing specified antibodies against two tumor antigen targets and assumed all future development and commercialization costs for any such ISAC program. Under the Amended Innovent Agreement, the Company has the right, but not the obligation, to further develop and commercialize the ISAC programs. Innovent and its affiliates are eligible to receive total potential milestones payments of up to $112.7 million, as well as royalties in low single digits on global net sales.
The Company determined that the Amended Innovent Agreement no longer meets the criteria under ASC 606. Therefore, $2.5 million of deferred revenue allocated to the unsatisfied performance obligation as of the contract modification date, was recognized as revenue and the $4.7 million one-time payment received was recognized as other income on the condensed statement of operations and comprehensive loss in the first quarter of 2024.
| Balance at December 31, 2023 | $3,142 |
|---|---|
| Addition—amount billed for research and development services | 331 |
| Revenue recognized | (3,473) |
| Balance at June 30, 2024 | $— |
The Company recorded zero and $3.5 million in revenue earned during thethree and six months ended June 30, 2024, respectively, and $0.6 million and $1.5 million in the same periods in 2023, respectively, based on services performed to satisfy the performance obligation under the Innovent collaboration during the periods.
Oncology Clinical Trial Collaboration and Supply Agreement with Bristol-Myers Squibb
In September 2021, the Company entered into a clinical collaboration and supply agreement with Bristol-Myers Squibb Company (“BMS”) to study trastuzumab imbotolimod in combination with BMS’s PD-1 checkpoint inhibitor nivolumab, for the treatment of HER2-expressing solid tumors (the “BMS Agreement”). Under the BMS Agreement, BMS granted the Company a non-exclusive, non-transferable, royalty-free license (with a right to sublicense) under its intellectual property to use nivolumab in a clinical trial for a combination therapy of nivolumab and trastuzumab imbotolimod, formerly known as BDC-1001. On May 14, 2024, the Company announced a strategic pipeline prioritization and restructuring plan pursuant to which it will discontinue developing trastuzumab imbotolimod, which includes the clinical trial for a combination therapy of nivolumab and trastuzumab imbotolimod.
Clinical Supply Agreement with F. Hoffmann-La Roche Ltd
In September 2022, the Company entered into a clinical supply agreement with Roche to study trastuzumab imbotolimod in combination with Roche’s pertuzumab (Perjeta®), a compound approved for the treatment of HER2-positive breast cancer (the "Roche Agreement"). Under the Roche Agreement, Roche granted the Company a non-exclusive, non-sublicensable, royalty-free license under its intellectual property to use pertuzumab in a clinical trial for a combination therapy of pertuzumab and trastuzumab imbotolimod. On May 14, 2024, the Company announced a strategic pipeline prioritization and restructuring plan pursuant to which it will discontinue developing trastuzumab imbotolimod, which includes the clinical trial for a combination therapy of pertuzumab and trastuzumab imbotolimod.
- Commitments and Contingencies
Leases
The Company has operating leases for its corporate office, laboratory and vivarium space in Redwood City, California. On August 7, 2020, the Company executed a non-cancellable lease agreement for 71,646 square feet of space (the “Chesapeake Master Lease”), which consist of 25,956 square feet under an existing lease and 45,690 square feet of additional space, for its corporate office, laboratory and vivarium space in Redwood City, California. The Chesapeake Master Lease has an initial term often years from the commencement date, with anoption to extend the lease for an additional eight-year term. The Chesapeake Master Lease contains rent escalation, and the Company is also responsible for certain operating expenses and taxes throughout the lease term. In addition, the Company is entitled to up to $4.8 million of tenant improvement allowance, which was paid directly by the landlord to various vendors. Upon execution of the non-cancellable lease agreement, the Company took control of 10,000 square feet of space, which was subleased as further described below. The remaining 35,690 square feet of additional office, laboratory and vivarium space commenced in June 2021.
In connection with the execution of the Chesapeake Master Lease, the Company entered into two operating lease agreements to sublease portions of the premises to two unrelated third parties. The first sublease agreement, to sublease 10,000 square feet, commenced in August 2020 and expired on August 31, 2022. The second sublease agreement, to sublease 10,500 square feet, commenced in June 2021 and expired on July 31, 2023. In August 2022, the second sublease agreement was amended to expand the subleased premises to 11,655 square feet in the first year and further increase to 13,743 square feet in the second year. In addition, the expiration date of the second sublease was also amended to the expiration date of the Chesapeake Master Lease. The subtenant has an early termination option with the early termination date no earlier than September 30, 2024, andno option to extend the sublease term. Rent for the second sublease is subject to scheduled annual increases and the subtenant is responsible for certain operating expenses and taxes throughout the term under the sublease agreement. Sublease income under the two sublease agreements was approximately $0.2 million for each of thethree months ended June 30, 2024 and 2023 and $0.4 million for each ofsix months ended June 30, 2024 and 2023.
At June 30, 2024 and December 31, 2023, finance right-of-use leases were used to finance capital equipment such as printers or ozone generators, and are immaterial.
The weighted-average remaining lease term and discount rate related to the Company’s lease liabilities as of June 30, 2024 were 6.4 years and 11.2%, respectively, for the operating leases. The weighted-average remaining lease term and discount rate related to the Company’s lease liabilities as of December 31, 2023 were 6.7 years and 11.1%, respectively, for the operating leases. The Company lease discount rates are based on estimates of its incremental borrowing rate, as the discount rates implicit in the Company’s leases cannot be readily determined. As the Company does not have any outstanding debt, the Company estimates the incremental borrowing rate based on its estimated credit rating and available market information.
The components of lease expense were as follows (in thousands):
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Total operating lease cost | $1,119 | $1,119 | $2,239 | $2,239 |
Supplemental cash flow information related to leases was as follows (in thousands):
| Six Months Ended June 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Operating cash flows from operating leases | $2,411 | $2,332 |
The following is a schedule by year for future maturities of the Company’s operating lease liabilities and sublease income to be received as of June 30, 2024 (in thousands):
| Operating Leases · Sublease Income | ||
|---|---|---|
| 2024 | $2,475 | $183 |
| 2025 | 4,340 | — |
| 2026 | 3,484 | — |
| 2027 | 3,602 | — |
| 2028 | 3,724 | — |
| Thereafter | 9,514 | — |
| Total minimum lease payments/sublease income | 27,139 | 183 |
| Less imputed interest | (8,248) | — |
| Total | $18,891 | $183 |
Supply Agreement
In January 2022, the Company entered into an amended and restated supply agreement with EirGenix, Inc. (the “Amended Supply Agreement”), which amends the original supply agreement with EirGenix, Inc. (“EirGenix”), dated March 10, 2019, pursuant to which EirGenix agreed to supply to the Company, on a non-exclusive basis, bulk drug substance of EG12014, its monoclonal antibody being developed as a biosimilar of trastuzumab, which the Company uses in the manufacture of trastuzumab imbotolimod. Under the Amended Supply Agreement, the Company may be required to pay milestone payments upon the achievement of specified regulatory milestones. The Amended Supply Agreement is cancellable by the Company upon delivering the appropriate written notice. On May 14, 2024, the Company announced a strategic pipeline prioritization and restructuring plan pursuant to which it will discontinue developing trastuzumab imbotolimod. As of June 30, 2024, the Company didnot incur any nor have any milestone payments probable under the Amended Supply Agreement.
Guarantees and Indemnifications
In the normal course of business, the Company enters into agreements that contain a variety of representations and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. As of June 30, 2024, the Company did not have any material indemnification claims that were probable or reasonably possible and, consequently, had not recorded related liabilities.
Other Commitments
The Company enters into agreements in the normal course of business, including with contract research organizations for clinical trials, contract manufacturing organizations for certain manufacturing services, and vendors for preclinical studies and other services and products for operating purposes, which are generally cancelable upon written notice.
Legal Proceedings
From time to time, we might be subject to various legal proceedings relating to claims arising out of our operations. The outcome of litigation is inherently uncertain. If one or more legal matters were resolved against us in a reporting period for amounts above management’s expectations, our business, results of operations, financial position and cash flows for that reporting period could be materially adversely affected. Except as described below, we are not currently involved in any material legal proceedings, the ultimate disposition of which could have a material adverse effect on our operations, financial condition or cash flows.
Securities Class Action
On July 2, 2024, a securities class action complaint was filed against the Company and certain of its directors and executive officers (collectively, the "Defendants") in the United States District Court for the Northern District of California, captioned Nesterenko v. Bolt Biotherapeutics, Inc. et al., Case No. 3:24-cv-03985 , purportedly on behalf of a class of individuals who purchased or otherwise acquired the Company’s common stock between February 5, 2021 and May 14, 2024. The complaint alleges that Defendants made false and/or misleading statements in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended. The complaint seeks unspecified monetary damages and other relief. The Company intends to defend the case vigorously.
- Restructuring
On May 14, 2024, the Company announced a strategic pipeline prioritization and restructuring plan pursuant to which it will discontinue developing trastuzumab imbotolimod in order to focus on the Company’s Phase 1 asset, BDC-3042, a Dectin-2 agonist antibody, and the Company's next generation ISAC platform including new clinical candidate, BDC-4182, targeting Claudin 18.2, and reduce overall operating expenses. The restructuring plan reduced the Company’s workforce by approximately 50%. The Company recorded a total restructuring charge of $3.6 million, which consist 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. No cash payments andno other non-cash settlements or adjustments were made during thethree and six months ended June 30, 2024. As of June 30, 2024, the $2.9 million one-time termination benefits remain payable and are recorded within the accrued expenses and other current liabilities line item on the Company's condensed balance sheet. Severance payments commenced in July 2024 and will extend through July 2025.
- Common Stock
Shelf Registration and At-The-Market Equity Offering
On March 30, 2022, the Company filed a shelf registration statement on Form S-3 (the "Registration Statement"). Pursuant to the Registration Statement, the Company may offer and sell securities having an aggregate public offering price of up to $250.0 million. In connection with the filing of the Registration Statement, the Company also entered into a sales agreement with Cowen and Company, LLC ("Cowen"), as sales agent or principal, pursuant to which the Company may issue and sell shares of its common stock for an aggregate offering price of up to $75.0 million under an at-the-market (the “ATM”) offering program. Pursuant to the ATM, the Company will pay Cowen a commission rate equal to 3.0% of the gross proceeds from the sale of any shares of common stock. The Company isnot obligated to make any sales of shares of its common stock under the ATM. As of June 30, 2024, no shares of the Company's common stock have been sold under this ATM.
- Stock-Based Compensation
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 shares of common stock reserved for issuance under the 2021 Plan automatically increases on the first day of January of each calendar year that commences after the 2021 Plan became effective and continuing through and including January 1, 2031, in an amount equal to 5% of the total number of shares of the Company’s common stock outstanding on December 31, or a lesser number of shares determined by the Company's board of directors or compensation committee. As a result, common stock reserved for issuance under the 2021 Plan was increased by 1,905,730 shares on January 1, 2024. In connection with the workforce reduction described in Note 7 “Restructuring”, the Company entered into consulting agreements with certain officers of the Company, pursuant to which a total of 1,615,713 stock options previously granted to the officers were canceled on July 15, 2024.
In addition, in January 2021, the Company’s board of directors and stockholders adopted the 2021 Employee Stock Purchase Plan (the “ESPP”). The ESPP authorized issuance of up to 420,000 shares of common stock and it became effective upon the execution of the underwriting agreement for the Company’s IPO. The 2021 ESPP permits participants to purchase common stock through payroll deductions of up to 15% of their eligible compensation. Employees purchase shares of common stock at a price per share equal to 85% of the lower of the fair market value at the start or end of six-month purchase periods within thetwo-year offering period. In addition, the number of shares of common stock reserved for issuance under the 2021 ESPP automatically increases on January 1 of each calendar year that commences after the ESPP became effective and continuing through and including January 1, 2031, by the lesser of (1)1% of the total number of shares of the Company's common stock outstanding on December 31 of the preceding calendar year, (2)840,000 shares, and (3) a number of shares determined by the Company's board of directors. As a result, common stock reserved for issuance under the 2021 ESPP was increased by 381,146 shares on January 1, 2024. During thesix months ended June 30, 2024,124,591 shares were issued under the ESPP and 118,566 shares were issued under the ESPP during the same period in 2023.
Performance and Service-Based Stock Options
In September 2020, the compensation committee of the Company’s board of directors granted 526,018 options to employees that would commence vesting upon the closing of the Series C-2 financing and generally vest monthly over 48 months (the “Performance Awards”). The Company recognizes expense based on the fair value of the Performance Awards over the estimated service period (under the graded vesting method) to the extent the achievement of the related performance criteria is estimated to be probable. The Company determined that the financing milestone was achieved during January 2021. Accordingly, the Company recognized stock-based compensation expense related to the Performance Awards of approximately $14,000 and $31,000 for thethree and six months ended June 30, 2024, respectively, and $39,000 and $0.1 million for the same periods in 2023, respectively. The weighted-average grant date fair value of the Performance Awards was $3.24 per share.
Restricted Stock Units
In December 2021, the Company issued 336,000 restricted stock units under the 2021 Plan at a grant date fair value of $4.51 per share. These restricted stock units vest in equal quarterly installments over three years, subject to the employee's continued employment with, or services to, the Company on each vesting date. Each restricted stock unit represents the right to receive one share of the Company's common stock when and if the applicable vesting conditions are satisfied.
Stock-Based Compensation Expense
The following table summarizes the components of stock-based compensation expense recognized in the Company’s statement of operations and comprehensive loss (in thousands):
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Research and development | $1,077 | $905 | $2,057 | $1,931 |
| General and administrative | 1,748 | 1,445 | 3,070 | 2,895 |
| Total | $2,825 | $2,350 | $5,127 | $4,826 |
- Net Loss Per Share
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 repurchase by the Company (in thousands, except share and per share amounts):
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Numerator: | ||||
| Net loss | $(21,195) | $(18,057) | $(32,006) | $(35,037) |
| Denominator: | ||||
| Weighted average common shares outstanding | 38,164,856 | 37,851,141 | 38,141,318 | 37,826,508 |
| Weighted average common stock outstanding subject to repurchase related to unvested early exercised stock options and restricted stock awards | (36,512) | (100,748) | (42,935) | (109,117) |
| Weighted average common shares outstanding - basic and diluted | 38,128,344 | 37,750,393 | 38,098,383 | 37,717,391 |
| Net loss per share attributable to common stockholders, basic and diluted | $(0.56) | $(0.48) | $(0.84) | $(0.93) |
Potentially dilutive shares to be issued under the ESPP as of June 30, 2024 and 2023 were not included in the calculation of diluted net loss per share because they would be anti-dilutive and were immaterial. In addition, potential dilutive securities not included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows (in common stock equivalent shares):
| As of June 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Common stock options issued and outstanding | 12,601,974 | 10,794,785 |
| Common stock outstanding subject to repurchase related to unvested early exercised stock options and restricted stock awards | 25,025 | 89,300 |
| Total | 12,626,999 | 10,884,085 |
SPECIAL Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements, including statements regarding:
our expectations regarding the success of our development and commercialization strategy and our product candidates;
our expectations regarding the operation of our product candidates, collaborations and related benefits;
our beliefs regarding our industry;
our beliefs regarding the success, cost and timing of our product candidate development and collaboration activities and current and future clinical trials and studies;
our beliefs regarding the potential markets for our product candidates, collaborations and our and our collaborators’ ability to serve those markets;
our ability to attract and retain key personnel;
our ability to obtain funding for our operations, including funding necessary to complete further development and any commercialization of our product candidates; and
regulatory developments in the United States (the “U.S.”) and foreign countries, with respect to our product candidates.
These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance and achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terminology such as “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “should,” “will,” or the negative of these terms or other comparable terminology. These forward-looking statements are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions, including those described in Part I, Item 1A, "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 21, 2024. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this prospectus, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.
We have common law trademark rights in the unregistered marks “Bolt Biotherapeutics, Inc.,” “Boltbody,” and the Bolt Biotherapeutics logo in certain jurisdictions. Solely for convenience, trademarks and tradenames referred to in this Quarterly Report on Form 10-Q appear without the® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trademarks and tradenames.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.