Bolt Biotherapeutics Inc

Previous 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.

Current wording

The following discussion and analysis of our financial condition as of September 30, 2024 and results of operations for the three and nine months ended September 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

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.

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 six 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 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.

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 and will extend through July 2025.

Previous 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:

Current wording

We have incurred operating losses since our inception. Our net losses were $15.2 million and $47.2 million for the three and nine months ended September 30, 2024, respectively, and $16.3 million and $51.3 million for the same periods in 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $411.5 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

Comparison of the three and six months ended June 30, 2024 and 2023

Current wording

Comparison of the three and nine months ended September 30, 2024 and 2023

Previous 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.

Current wording

Revenue was $1.1 million and $7.7 million for the three and nine months ended September 30, 2024, respectively, and $2.5 million and $5.8 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, partially offset by increased revenue recognized from our other collaborations as we fulfill our performance obligations to our collaboration partners. The increase in the comparable nine-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 $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.

Current wording

The increase of $0.5 million between the comparable nine-month periods was due to a $2.3 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 $0.9 million increase in contract manufacturing expenses related to the timing of batch production of our product candidates and a $0.2 million increase in research and development contract service expenses offset by a $1.7 million decrease in salary and related expenses primarily due to a decrease in headcount related to the reduction in workforce, a $0.7 million decrease in facilities expenses and a $0.4 million decrease in consulting expenses.

Previous wording

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 wording

General and administrative expenses were $3.8 million and $14.5 million for the three and nine months ended September 30, 2024, respectively, and $5.8 million and $17.0 million for the same periods in 2023, respectively. The decrease of $2.0 million between the comparable three-month periods was mainly due to a $1.6 million decrease in salary, bonus and related expenses as a result of the restructuring plan and a $0.4 million decrease in consulting and professional expenses primarily related to decrease in legal expenses. The $2.5 million decrease in expenses between the comparable nine-month periods was mainly due to a $2.1 million decrease in salary, bonus and related expenses as a result of the restructuring plan, a $0.5 million decrease in consulting and professional expenses primarily related to a decrease in legal expenses, offset by a $0.2 million increase in facilities expenses.

Previous wording

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 wording

Restructuring charges were $3.6 million for the nine months ended September 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 three months ended September 30, 2024 and in the three and nine months ended September 30, 2023.

Previous 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.

Current wording

Interest income was $1.3 million and $4.3 million for the three and nine months ended September 30, 2024, respectively, and $1.9 million and $5.1 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 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.

Current wording

Other income was zero and $4.7 million for the three and nine months ended September 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 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.

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 September 30, 2024, we had cash and cash equivalents and marketable securities of $84.4 million and an accumulated deficit of $411.5 million. Our net losses were $15.2 million and $47.2 million for the three and nine months ended September 30, 2024, respectively, and $16.3 million and $51.3 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 $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.

Current wording

Net cash used in operating activities was $46.9 million and $55.3 million for the nine months ended September 30, 2024 and 2023, respectively. Net cash used in operating activities for the nine months ended September 30, 2024 was due to our net loss of $47.2 million, adjusted down for $7.6 million of non-cash charges and up for a $7.2 million change in operating assets and liabilities. The non-cash charges were comprised of $6.2 million for stock-based compensation, $2.4 million of non-cash lease-related expense, and $1.4 million for depreciation and amortization expense, partially offset by $2.3 million for accretion of discount on marketable securities and $0.1 million gain on sale of property and equipment. The change in net operating assets was primarily due to a $5.5 million decrease in our deferred revenue, a $2.2 million decrease in our accounts payable and accrued expenses, and a $2.0 million decrease in operating lease liabilities, offset by a $2.5 million decrease in our prepaid expenses and other current assets. Net cash used in operating activities for the nine months ended September 30, 2023 was due to our net loss of $51.3 million, adjusted down for $7.4 million of non-cash charges and up for a $11.4 million change in operating assets and liabilities. The non-cash charges were comprised of $7.2 million for stock-based compensation, $3.3 million for accretion of discount on marketable securities, $2.2 million of non-cash lease-related expense, and $1.4 million for depreciation and amortization expense. The change in net operating assets was primarily due to a $4.6 million decrease in our accounts payable and accrued expenses, and the remaining changes contributed to a $2.9 million decrease in our deferred revenue and a $1.8 million decrease in our operating lease liabilities, and a $2.2 million increase in our prepaid expenses and other current assets.

Previous 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.

Current wording

Net cash provided by investing activities was $45.3 million and $55.2 million for the nine months ended September 30, 2024 and 2023, respectively. The net cash provided by investing activities for the nine months ended September 30, 2024 was due to $120.8 million in maturities of marketable securities, offset by $75.6 million in purchases of marketable securities. The net cash provided by investing activities for the nine months ended September 30, 2023 was due to a $188.3 million maturities of marketable securities, offset by a $132.8 million in purchases of marketable securities.

Previous wording

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 wording

Net cash provided by financing activities was $0.1 million for each of the nine months ended September 30, 2024 and 2023. The net cash provided by financing activities for the nine months ended September 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.