Bolt Biotherapeutics Inc
For the period ended Jun 30, 2024. Filed Aug 13, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 13, 2024
BOLT$6.54+2.5%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-14.
0000950170-24-059564
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-13.
0000950170-24-096200
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 102 previous paragraphs and 106 current paragraphs.
83 unchanged; 15 reworded; 8 added; 4 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (8)
Current report
We recently selected BDC-4182 as our next clinical candidate. BDC-4182 utilizes our next-generation Boltbody™ ISAC technology and targets the Claudin 18.2 tumor associated antigen. Claudin 18.2 is a clinically validated target in oncology with zolbetuximab, a first-in-class Claudin 18.2-targeted monoclonal antibody, receiving commercial approval in Japan in March 2024 for patients with Claudin 18.2-positive, unresectable, advanced or recurrent gastric cancer. Other programs targeting Claudin 18.2 are in development for the treatment of gastric/gastroesophageal junction cancer, pancreatic cancer, and other tumor types. BDC-4182 is currently in IND-enabling activities. Clinical candidate selection was supported by in vitro and in vivo experiments demonstrating potent anti-tumor activity in multiple preclinical models, safety and tolerability in a non-GLP non-human primate toxicology study, and enhanced preclinical efficacy compared to cytotoxic ADCs in murine tumor models. Data on our Claudin 18.2 Boltbody ISAC program was presented at the Society for Immunotherapy of Cancer’s (SITC) 2023 Annual Meeting in October. We expect to initiate our first in human clinical trial in 2025.
Current report
Restructuring charges consist of one-time termination benefits such as severance costs and related benefits and stock-based compensation charges associated with a reduction-in-force.
Current report
General and administrative expenses were $4.9 million and $10.7 million for the three and six months ended June 30, 2024, respectively, and $5.6 million and $11.2 million for the same periods in 2023, respectively. The decrease of $0.7 million between the comparable three-month periods was mainly due to a $0.6 million decrease in salary and related expenses primarily due to a decrease in bonus expense as result of the restructuring plan. The $0.5 million decrease in expenses between the comparable six-month periods was mainly due to decrease in salary and related expenses primarily due to decrease in bonus expense as result of the restructuring plan.
Current report
Restructuring charges were $3.6 million for the three and six months ended June 30, 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. There were no restructuring charges in the three and six months ended June 30, 2023.
Current report
Financing Activities
Current report
Net cash provided by financing activities was $0.1 million for each of the six months ended June 30, 2024 and 2023. The net cash provided by financing activities for the six months ended June 30, 2024 was due to net proceeds from the issuance of common stock from our employee stock purchase plan. The net cash provided by financing activities for the same period in 2023 was due to net proceeds from the issuance of common stock from our employee stock purchase plan and exercise of stock options.
Current report
Long-lived Assets Impairment Assessment
Current report
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 our estimate of future net cash flows 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.
Removed paragraphs (4)
Previous report
Our first Boltbody ISAC program was 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. In 2023, trastuzumab imbotolimod completed the Phase 1 stage of clinical development and advanced into a Phase 2 program that includes four different HER2-positive solid tumor types: breast cancer, gastroesophageal cancer, colorectal cancer, and endometrial cancer. In September 2023, the U.S. Food and Drug Administration, or FDA, granted trastuzumab imbotolimod Orphan Drug Designation for the treatment of gastric cancer, including gastroesophageal junction cancer. In the Phase 2 program we evaluated trastuzumab imbotolimod as a single agent and in combination with the HER2-targeting antibody pertuzumab, and we have determined that the program will not meet its success criteria. We will therefore cease further development of trastuzumab imbotolimod and be focusing resources on our next-generation ISAC platform including new clinical candidate, BDC-4182, targeting Claudin 18.2, and Phase 1 asset, BDC-3042, a dectin-2 agonist antibody and reduce overall operating expenses to preserve cash.
Previous report
In September 2021, we entered into a clinical collaboration and supply agreement with BMS to study trastuzumab imbotolimod in combination with BMS’s nivolumab, a leading PD-1 checkpoint inhibitor, for the treatment of patients with HER2-expressing solid tumors. Under the BMS Agreement, BMS will be providing nivolumab at no cost to us and we will sponsor, fund, and conduct the initial Phase 1/2 clinical trial in accordance with an agreed-upon protocol. We initiated the clinical trial evaluating the combination of nivolumab and trastuzumab imbotolimod in the fourth quarter of 2021. In September 2022, we entered into a clinical supply agreement, or the Roche 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. Under the Roche Agreement, Roche will be providing pertuzumab at no cost to us and we will sponsor, fund, and conduct an initial Phase 2 clinical trial in accordance with an agreed-upon protocol. The original Phase 1/2 clinical trial moved into Phase 2 dose expansions and we have determined that the program will not meet its success criteria, and we will therefore cease further development.
Previous report
Restructuring
Previous report
General and administrative expenses were $5.8 million and $5.6 million for the three months ended March 31, 2024 and 2023, respectively. The increase of $0.2 million between the comparable three month periods was due to increases in salary and related expenses and increases in consulting and professional services expenses.
Reworded paragraphs (15)
Previous wording
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Current wording
Item 2. Management’s Discussion and Analysisof Financial Condition and Results of Operations.
Previous wording
The following discussion and analysis of our financial condition as of March 31, 2024 and results of operations for the three months ended March 31, 2024 and 2023 should be read in conjunction with our condensed financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and in our other SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 21, 2024. Except as otherwise indicated herein or as the context otherwise requires, references in this Quarterly Report on Form 10-Q to “Bolt Bio,” “the Company,” “we,” “us” and “our” refer to Bolt Biotherapeutics, Inc.
Current wording
The following discussion and analysis of our financial condition as of June 30, 2024 and results of operations for the three and six months ended June 30, 2024 and 2023 should be read in conjunction with our condensed financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and in our other SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 21, 2024. Except as otherwise indicated herein or as the context otherwise requires, references in this Quarterly Report on Form 10-Q to “Bolt Bio,” “the Company,” “we,” “us” and “our” refer to Bolt Biotherapeutics, Inc.
Previous wording
Our expertise in myeloid cell biology also forms the foundation for additional, innovative immuno-oncology approaches that complement our Boltbody ISAC platform. For example, BDC-3042, our Dectin-2 agonist antibody program. BDC-3042 is being developed to repolarize critical cells in the tumor microenvironment known as tumor-associated macrophages (TAMs). 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. 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.
Current wording
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. 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 five dose escalation cohorts without experiencing a dose-limiting toxicity.
Previous wording
On May 14, 2024, we announced a strategic pipeline prioritization and restructuring plan pursuant to which we will discontinue developing trastuzumab imbotolimod, formerly known as BDC-1001, in order to focus on our next generation ISAC platform including new clinical candidate, BDC-4182, targeting Claudin 18.2, and our Phase 1 asset, BDC-3042, a Dectin-2 agonist antibody and reduce overall operating expenses to preserve cash. The restructuring plan includes a reduction of our current workforce by approximately 50 employees, or approximately 50% of our workforce. We estimate that we will incur aggregate pre-tax charges between approximately $3.0 million to $4.0 million in connection with the reduction-in-force, primarily consisting of severance payments, employee benefits, and related costs. We expect that the reduction-in-force will be complete by the end of 2024 and that the associated charges will be substantially incurred in the second quarter of 2024. The estimated charges that we expect to incur are subject to a number of assumptions, and actual results may differ materially from these estimates. We may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with the restructuring plan.
Current wording
On May 14, 2024, we announced a strategic pipeline prioritization and restructuring plan pursuant to which we will discontinue developing trastuzumab imbotolimod, formerly known as BDC-1001, in order to focus on our Phase 1 asset, BDC-3042, and our next generation Boltbody™ ISAC platform including new clinical candidate BDC-4182, targeting Claudin 18.2 and reduce overall operating expenses. The restructuring plan reduced our workforce by approximately 50 employees, or approximately 50% of our workforce. We estimate the total restructuring charges amounting to $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. The severance payments commenced in July 2024 an will extend through July 2025.
Previous wording
We have incurred operating losses since our inception. Our net losses were $10.8 million and $17.0 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, we had an accumulated deficit of $375.1 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we:
Current wording
We have incurred operating losses since our inception. Our net losses were $21.2 million and $32.0 million for the three and six months ended June 30, 2024, respectively, and $18.1 million and $35.0 million for the same periods in 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $396.3 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative and restructuring costs associated with our operations. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we:
Previous wording
The effects of a pandemic or major geopolitical developments, and associated economic conditions, remain difficult to predict due to numerous uncertainties. We believe that the direct and indirect impacts of these business conditions and macroeconomic factors are difficult to isolate or quantify. See 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, and the Special Note Regarding Forward-Looking Statements elsewhere in this Quarterly Report for additional details. 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.
Current wording
The effects of a pandemic or major geopolitical developments, and associated economic conditions, remain difficult to predict due to numerous uncertainties. We believe that the direct and indirect impacts of these business conditions and macroeconomic factors are difficult to isolate or quantify. See Part I, Item 1A, Risk Factors below and in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 21, 2024, and the Special Note Regarding Forward-Looking Statements elsewhere in this Quarterly Report for additional details. 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.
Previous wording
Comparison of the three months ended March 31, 2024 and 2023
Current wording
Comparison of the three and six months ended June 30, 2024 and 2023
Previous wording
Revenue was $5.3 million and $1.8 million for the three months ended March 31, 2024 and 2023, respectively. 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.
Current wording
Revenue was $1.3 million and $6.5 million for the three and six months ended June 30, 2024, respectively, and $1.4 million and $3.3 million for the same periods in 2023, respectively. The decrease in the comparative three-month periods was due to no revenue being recognized from the Innovent collaboration as we had satisfied our performance obligation to Innovent in the prior quarter, offset by revenue recognized under the Toray Agreement as we continued development in 2024. The increase in the comparable six-month periods was due to the revenue recognized under the Amended Innovent Agreement in the first quarter of 2024 and the continued progress in our other collaborations as we fulfill our performance obligations to our collaboration partners.
Previous wording
Research and development expenses were $16.5 million and $14.6 million for the three months ended March 31, 2024 and 2023, respectively. The increase of $1.9 million between the comparable three month periods was due to a $1.4 million increase in clinical trial expenses due to continued progress in our clinical trials for trastuzumab imbotolimod and BDC-3042, a $0.7 million increase in research and development contract service expenses and a $0.4 million increase in salary and related expenses primarily due to an increase in headcount, partially offset by a $0.6 million decrease in manufacturing expenses related to timing of batch production of our product candidates.
Current wording
Research and development expenses were $15.4 million and $32.0 million for the three and six months ended June 30, 2024, respectively, and $15.6 million and $30.3 million for the same periods in 2023, respectively. Expenses in the comparative three-month periods were materially consistent. The increase of $1.7 million between the comparable six-month periods was due to a $1.7 million increase in clinical trial expenses due to continued progress in our clinical trial for BDC-3042 and costs related to existing patient and site visits prior to the decision to cease the development of trastuzumab imbotolimod. The increase in expenses was further due to a $0.8 million increase in research and development contract service expenses and a $0.4 million increase in salary and related expenses primarily due to an increase in headcount, partially offset by a $0.7 million decrease in manufacturing expenses related to timing of batch production of our product candidates and a $0.4 million decrease in consulting expenses.
Previous wording
Interest income was $1.6 million and $1.4 million for the three months ended March 31, 2024 and 2023, respectively. The interest income, net was primarily comprised of interest income from marketable securities.
Current wording
Interest income was $1.4 million and $3.0 million for the three and six months ended June 30, 2024, respectively, and $1.8 million and $3.2 million for the same periods in 2023, respectively. The interest income, net was primarily comprised of interest income from marketable securities.
Previous wording
Other income was $4.7 million and zero for the three months ended March 31, 2024 and 2023, respectively. The other income in 2024 was due to the one-time payment received from Innovent under the Amended Innovent Agreement.
Current wording
Other income was zero and $4.7 million for the three and six months ended June 30, 2024, respectively, and zero for the same periods in 2023. The other income in 2024 was due to the one-time payment received from Innovent under the Amended Innovent Agreement.
Previous wording
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 March 31, 2024, we had cash and cash equivalents and marketable securities of $112.8 million and an accumulated deficit of $375.1 million. Our net losses were $10.8 million and $17.0 million for the three months ended March 31, 2024 and 2023, respectively, and we expect to incur additional losses in the future. We evaluated our current cash position, historical results, forecasted cash flows and plans with regard to liquidity.
Current wording
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 June 30, 2024, we had cash and cash equivalents and marketable securities of $97.5 million and an accumulated deficit of $396.3 million. Our net losses were $21.2 million and $32.0 million for the three and six months ended June 30, 2024, respectively, and $18.1 million and $35.0 million for the same periods in 2023, respectively, and we expect to incur additional losses in the future. We evaluated our current cash position, historical results, forecasted cash flows and plans with regard to liquidity.
Previous wording
Net cash used in operating activities was $16.8 million and $23.4 million for the three months ended March 31, 2024 and 2023, respectively. Net cash used in operating activities for the three months ended March 31, 2024 was due to our net loss of $10.8 million, adjusted down for $2.5 million of non-cash charges and up for a $8.4 million change in operating assets and liabilities. The non-cash charges were comprised of $2.3 million for stock-based compensation, $0.8 million of non-cash lease-related expense, and $0.5 million for depreciation and amortization expense, partially offset by $1.0 million for accretion of discount on marketable securities. The change in net operating assets was primarily due to a $4.1 million decrease in our deferred revenue, a $3.5 million decrease in our accounts payable and accrued expenses, a $0.7 million decrease in operating lease liabilities, and a $0.1 million increase in our prepaid expenses and other current assets. Net cash used in operating activities for the three months ended March 31, 2023 was due to our net loss of $17.0 million, adjusted down for $2.8 million of non-cash charges and up for a $9.2 million change in operating assets and liabilities. The non-cash charges were comprised of $2.5 million for stock-based compensation, $0.9 million for accretion of discount on marketable securities, $0.7 million of non-cash lease-related expense, and $0.5 million for depreciation and amortization expense. The change in net operating assets was due to a $6.6 million decrease in our accounts payable and accrued expenses, decreases in our deferred revenue and operating lease liabilities, and increases in our prepaid expenses and other current assets.
Current wording
Net cash used in operating activities was $32.9 million and $38.5 million for the six months ended June 30, 2024 and 2023, respectively. Net cash used in operating activities for the six months ended June 30, 2024 was due to our net loss of $32.0 million, adjusted down for $5.8 million of non-cash charges and up for a $6.7 million change in operating assets and liabilities. The non-cash charges were comprised of $5.1 million for stock-based compensation, $1.6 million of non-cash lease-related expense, and $0.9 million for depreciation and amortization expense, partially offset by $1.8 million for accretion of discount on marketable securities. The change in net operating assets was primarily due to a $4.8 million decrease in our deferred revenue, a $2.6 million decrease in our accounts payable and accrued expenses, and a $1.3 million decrease in operating lease liabilities, offset by a $2.0 million decrease in our prepaid expenses and other current assets. Net cash used in operating activities for the six months ended June 30, 2023 was due to our net loss of $35.0 million, adjusted down for $5.2 million of non-cash charges and up for a $8.7 million change in operating assets and liabilities. The non-cash charges were comprised of $4.8 million for stock-based compensation, $2.0 million for accretion of discount on marketable securities, $1.5 million of non-cash lease-related expense, and $0.9 million for depreciation and amortization expense. The change in net operating assets was primarily due to a $5.4 million decrease in our accounts payable and accrued expenses, and the remaining changes contributed to decreases in our deferred revenue and operating lease liabilities, and increases in our prepaid expenses and other current assets.
Previous wording
Net cash provided by investing activities was $10.2 million and $29.0 million for the three months ended March 31, 2024 and 2023, respectively. The net cash provided by investing activities for the three months ended March 31, 2024 was due to $33.3 million in maturities of marketable securities, offset by $23.1 million in purchases of marketable securities. The net cash provided by investing activities for the three months ended March 31, 2023 was due to $71.9 million in maturities of marketable securities, offset by $42.9 million in purchases of marketable securities.
Current wording
Net cash provided by investing activities was $28.2 million and $42.6 million for the six months ended June 30, 2024 and 2023, respectively. The net cash provided by investing activities for the six months ended June 30, 2024 was due to $83.5 million in maturities of marketable securities, offset by $55.3 million in purchases of marketable securities. The net cash provided by investing activities for the six months ended June 30, 2023 was due to a $139.1 million maturities of marketable securities, offset by a $96.5 million in purchases of marketable securities.
Previous wording
There have been no material changes to our critical accounting policies and estimates as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023.
Current wording
There have been no material changes to our critical accounting policies and estimates as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023, other than as set forth below.