SEC Filing - Bolt Biotherapeutics

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10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2023


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number 001-39988

Bolt Biotherapeutics, Inc.

(Exact name of Registrant as specified in its Charter)


Delaware	47-2804636
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

900 Chesapeake Drive Redwood City, CA	94063
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (650) 665-9295

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.00001 par value	BOLT	The Nasdaq Global Select Market

Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 2, 2023, the registrant had 37,965,870 shares of common stock outstanding.

Table of Contents


		Page
PART I FINANCIAL INFORMATION
Item 1.	Financial Statements (unaudited)	1
	Condensed Balance Sheets as of September 30, 2023 and December 31, 2022	1
	Condensed Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2023 and 2022	2
	Condensed Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2023 and 2022	3
	Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2023 and 2022	5
	Notes to the Condensed Financial Statements	6
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	21
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	31
Item 4.	Controls and Procedures	31

PART II OTHER INFORMATION
Item 1.	Legal Proceedings	31
Item 1A.	Risk Factors	31
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	31
Item 3.	Defaults Upon Senior Securities	32
Item 4.	Mine Safety Disclosures	32
Item 5.	Other Information	32
Item 6.	Exhibits	33
	Signatures	34

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

BOLT BIOTHERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(Unaudited, in thousands, except share and per share amounts)


	September 30,			December 31,
	2023			2022
Assets
Current assets:
Cash and cash equivalents	$	9,160		$	9,244
Short-term investments		110,564			159,644
Prepaid expenses and other current assets		5,742			3,858
Total current assets		125,466			172,746
Property and equipment, net		5,266			6,453
Operating lease right-of-use assets		19,878			22,072
Restricted cash		1,765			1,565
Long-term investments		21,638			23,943
Other assets		1,342			1,028
Total assets	$	175,355		$	227,807
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	3,682		$	3,594
Accrued expenses and other current liabilities		10,451			15,140
Deferred revenue		1,938			1,993
Operating lease liabilities		2,680			2,391
Total current liabilities		18,751			23,118
Operating lease liabilities, net of current portion		18,177			20,220
Deferred revenue, non-current		10,125			12,921
Other long-term liabilities		43			42
Total liabilities		47,096			56,301
Commitments and contingencies (Note 7)
Stockholders' equity:
Preferred stock, $0.00001 par value, authorized shares—10,000,000 shares authorized at September 30, 2023 and December 31, 2022; zero shares issued and outstanding at September 30, 2023 and December 31, 2022		—			—
Common stock, $0.00001 par value; 200,000,000 shares authorized at September 30, 2023 and December 31, 2022; 37,965,870 and 37,797,902 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively		1			—
Additional paid-in capital		474,814			467,513
Accumulated other comprehensive loss		(174	)		(919	)
Accumulated deficit		(346,382	)		(295,088	)
Total stockholders' equity:		128,259			171,506
Total liabilities and stockholders' equity	$	175,355		$	227,807

The accompanying notes are an integral part of these unaudited condensed financial statements.

BOLT BIOTHERAPEUTICS, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited, in thousands, except share and per share amounts)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2023			2022			2023			2022
Collaboration revenue	$	2,528		$	2,112		$	5,787		$	4,318
Operating expenses:
Research and development		14,951			18,973			45,220			56,278
General and administrative		5,760			5,485			16,997			17,321
Total operating expense		20,711			24,458			62,217			73,599
Loss from operations		(18,183	)		(22,346	)		(56,430	)		(69,281	)
Other income, net
Interest income, net		1,926			587			5,136			1,180
Total other income, net		1,926			587			5,136			1,180
Net loss		(16,257	)		(21,759	)		(51,294	)		(68,101	)
Net unrealized gain (loss) on marketable securities		55			94			745			(1,388	)
Comprehensive loss	$	(16,202	)	$	(21,665	)	$	(50,549	)	$	(69,489	)
Net loss per share, basic and diluted	$	(0.43	)	$	(0.58	)	$	(1.36	)	$	(1.83	)
Weighted-average shares outstanding, basic and diluted		37,868,480			37,454,340			37,768,308			37,293,121

The accompanying notes are an integral part of these unaudited condensed financial statements.

BOLT BIOTHERAPEUTICS, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited, in thousands, except share amounts)


	Three Months Ended September 30, 2023
							Accumulated
					Additional		Other						Total
	Common				Paid-In		Comprehensive			Accumulated			Stockholders'
	Shares		Amount		Capital		Loss			Deficit			Equity
Balance at June 30, 2023		37,950,986	$	1	$	472,485	$	(229	)	$	(330,125	)	$	142,132
Vesting of restricted stock units		14,884		—		—		—			—			—
Stock-based compensation		—		—		2,329		—			—			2,329
Unrealized gain on available-for-sale investments		—		—		—		55			—			55
Net loss		—		—		—		—			(16,257	)		(16,257	)
Balance at September 30, 2023		37,965,870	$	1	$	474,814	$	(174	)	$	(346,382	)	$	128,259

	Three Months Ended September 30, 2022
							Accumulated
					Additional		Other						Total
	Common				Paid-In		Comprehensive			Accumulated			Stockholders'
	Shares		Amount		Capital		Loss			Deficit			Equity
Balance at June 30, 2022		37,641,459	$	—	$	463,103	$	(1,803	)	$	(253,332	)	$	207,968
Vesting of restricted stock units		19,434		—		—		—			—			—
Stock-based compensation		—		—		2,143		—			—			2,143
Unrealized gain on available-for-sale investments		—		—		—		94			—			94
Net loss		—		—		—		—			(21,759	)		(21,759	)
Balance at September 30, 2022		37,660,893	$	—	$	465,246	$	(1,709	)	$	(275,091	)	$	188,446

BOLT BIOTHERAPEUTICS, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited, in thousands, except share amounts)


	Nine Months Ended September 30, 2023
							Accumulated
					Additional		Other						Total
	Common				Paid-In		Comprehensive			Accumulated			Stockholders'
	Shares		Amount		Capital		Loss			Deficit			Equity
Balance at December 31, 2022		37,797,902	$	—	$	467,513	$	(919	)	$	(295,088	)	$	171,506
Vesting of restricted stock units		44,901		—		—		—			—			—
Issuance of common stock under employee stock purchase plan		118,566		1		140		—			—			141
Issuance of common stock upon exercise of stock options		4,501		—		6		—			—			6
Stock-based compensation		—		—		7,155		—			—			7,155
Unrealized gain on available-for-sale investments		—		—		—		745			—			745
Net loss		—		—		—		—			(51,294	)		(51,294	)
Balance at September 30, 2023		37,965,870	$	1	$	474,814	$	(174	)	$	(346,382	)	$	128,259

	Nine Months Ended September 30, 2022
							Accumulated
					Additional		Other						Total
	Common				Paid-In		Comprehensive			Accumulated			Stockholders'
	Shares		Amount		Capital		Loss			Deficit			Equity
Balance at December 31, 2021		37,399,694	$	—	$	457,430	$	(321	)	$	(206,990	)	$	250,119
Vesting of restricted stock units		65,301		—		—		—			—			—
Issuance of common stock under employee stock purchase plan		136,711		—		224		—			—			224
Issuance of common stock upon exercise of stock options		59,187		—		135		—			—			135
Vesting of early exercised options		—		—		4		—			—			4
Stock-based compensation		—		—		7,453		—			—			7,453
Unrealized loss on available-for-sale investments		—		—		—		(1,388	)		—			(1,388	)
Net loss		—		—		—		—			(68,101	)		(68,101	)
Balance at September 30, 2022		37,660,893	$	—	$	465,246	$	(1,709	)	$	(275,091	)	$	188,446

The accompanying notes are an integral part of these unaudited condensed financial statements.

BOLT BIOTHERAPEUTICS, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited, in thousands)


	Nine Months Ended September 30,
	2023			2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(51,294	)	$	(68,101	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		1,387			1,204
Stock-based compensation expense		7,155			7,453
Accretion (amortization) of premium/discount on marketable securities		(3,299	)		655
Non-cash lease expense		2,194			2,520
Changes in operating assets and liabilities:
Prepaid expenses and other assets		(2,198	)		(713	)
Accounts payable and accrued expenses		(4,601	)		2,481
Operating lease liabilities		(1,754	)		(1,966	)
Deferred revenue		(2,851	)		(2,079	)
Other long-term liabilities		1			(6	)
Net cash used in operating activities		(55,260	)		(58,552	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment		(200	)		(1,769	)
Purchases of marketable securities		(132,828	)		(155,345	)
Maturities of marketable securities		188,257			198,541
Net cash provided by investing activities		55,229			41,427
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock		147			359
Net cash provided by financing activities		147			359
Net increase (decrease) in cash		116			(16,766	)
Cash, cash equivalents and restricted cash at beginning of year		10,809			28,948
Cash, cash equivalents and restricted cash at end of period	$	10,925		$	12,182
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents	$	9,160		$	10,617
Restricted cash		1,765			1,565
Total cash, cash equivalents and restricted cash	$	10,925		$	12,182
Supplemental schedule of non-cash investing and financing activities:
Purchases of property and equipment included in accounts payable and accrued liabilities	$	—		$	182
Deferred offering costs in accounts payable and accrued liabilities	$	102		$	102
Right of use assets obtained in exchange for operating lease obligations	$	—		$	852

The accompanying notes are an integral part of these unaudited condensed financial statements.

BOLT BIOTHERAPEUTICS, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

1. 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.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed financial statements as of September 30, 2023 and for the three and nine months ended September 30, 2023 and 2022 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 and certain immaterial reclassifications, 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, 2022 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, 2022.

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 September 30, 2023, the Company had cash and cash equivalents and marketable securities of $141.4 million and an accumulated deficit of $346.4 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. In the near term, the Company's primary uses of cash will be to fund the completion of key milestones for BDC-1001 and BDC-3042 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 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.

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.

Marketable Securities

The Company classifies its marketable securities as available-for-sale and records such assets at estimated fair value in the balance sheets, with unrealized gains and non-credit related losses that are determined to be temporary, if any, reported as a component of other comprehensive income (loss) within the statements of operations and comprehensive loss and as a separate component of stockholders’ equity. The Company classifies marketable securities with remaining maturities greater than three months but less than one year as short-term investments, and those with remaining maturities greater than one year are classified as long-term investments. The Company invests its excess cash balances primarily in corporate debt securities. Realized gains and losses are calculated on the specific identification method and recorded as interest income and were immaterial for all periods presented.

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 September 30, 2023 and December 31, 2022, 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

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments- Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, and subsequent amendments to the initial guidance under ASU 2018-19, ASU 2019-04, ASU 2019-05, ASU 2020-03, and ASU 2020-02. The standard changes how entities will measure credit losses for most financial assets and certain other instruments that are not measured at fair value through net income. Financial assets measured at amortized cost will be presented at the net amount expected to be collected by using an allowance for credit losses. The Company adopted ASU 2016-13 as of January 1, 2023. The adoption of ASU 2016-13 did not have a material impact on the Company's unaudited condensed financial statements.

3. 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 are not 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 nine months ended September 30, 2023, 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 nine months ended September 30, 2023 or 2022.

Marketable securities, all of which are classified as available-for-sale securities, consisted of the following at September 30, 2023 and December 31, 2022 (in thousands):

September 30, 2023

Amortized

Unrealized