Company: BOLT
Filing Date: 2025-11-12
Form Type: 10-Q
Source: 0001193125-25-277549
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Company: Bolt Biotherapeutics, Inc.
Filing Date: 2025-11-12
Form: 10-Q
Item: Part II, Item 1A
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There are no material changes from the risk factors previously disclosed in Item 1A of our Annual Report on Form 10-K for the period ended December 31, 2024, filed with the SEC on March 24, 2025, other than as set forth below. 

We will need substantial funding to pursue our business objectives. If we are unable to raise capital when needed or on terms favorable to us, we could be forced to delay, reduce or terminate our product development and other operations.

Identifying and developing potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and begin selling any approved products. We expect our expenses to increase in connection with our ongoing activities, particularly as we conduct our ongoing and planned preclinical studies, initiate additional clinical trials for our product candidates and seek regulatory approval for our current product candidates and any future product candidates we may develop. Our expenses could increase beyond our current expectations if the FDA requires us to perform clinical trials and other studies in addition to those that we currently anticipate. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or terminate our research and development programs or future commercialization efforts. 

We have incurred net losses and negative cash flows from operations since our inception, with an accumulated deficit of $454.1  million as of September 30, 2025 and anticipate continuing to incur net losses for the foreseeable future. Under our current plan, which includes income from collaboration arrangements, we believe our cash and cash equivalents and marketable securities of $38.8 million as of September 30, 2025 may be sufficient to fund our operations into 2027. However, due to the significant uncertainty in our plans, including the achievement of our collaboration income, we have concluded that there is substantial doubt about our ability to continue as a going concern within one year after the issuance of the consolidated financial statements.

Similarly, our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements as of, and for the year ended, December 31, 2024, describing the existence of substantial doubt about our ability to