crbu-20240331

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

______________________________________

FORM 10-Q

______________________________________

(Mark One)


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

For the quarterly period ended March 31, 2024


o			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: 001-40631

______________________________________

Caribou Biosciences, Inc.

(Exact Name of Registrant as Specified in its Charter)

______________________________________


Delaware						45-3728228
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)

2929 7th Street, Suite 105 Berkeley, California						94710
(Address of principal executive offices)						(Zip Code)

Registrant’s telephone number, including area code: (510) 982-6030

______________________________________

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, par value $0.0001 per share

CRBU

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 x No o

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 x No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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. o

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

As of May 2, 2024, the registrant had 90,317,771 shares of common stock, $0.0001 par value per share, outstanding.

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		Page
PART I.	FINANCIAL INFORMATION	1
Item 1.	Financial Statements (Unaudited)	1
	Condensed Consolidated Balance Sheets	1
	Condensed Consolidated Statements of Operations and Comprehensive Loss	2
	Condensed Consolidated Statements of Stockholders’ Equity	3
	Condensed Consolidated Statements of Cash Flows	4
	Notes to Unaudited Condensed Consolidated Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	20
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	31
Item 4.	Controls and Procedures	31
PART II.	OTHER INFORMATION	33
Item 1.	Legal Proceedings	33
Item 1A.	Risk Factors	33
Item 2.	Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities	33
Item 5.	Other Information	34
Item 6.	Exhibits	35
Signatures		36

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PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

CARIBOU BIOSCIENCES, INC. AND ITS SUBSIDIARIES

Condensed Consolidated Balance Sheets

(Unaudited)

(in thousands, except share and per share amounts)


	March 31, 2024		December 31, 2023
ASSETS
CURRENT ASSETS
Cash and cash equivalents	$	49,400	$	51,162
Marketable securities, short-term	244,588		277,665
Accounts receivable	917		148
Contract assets	971		1,425
Other receivables	1,725		2,286
Prepaid expenses and other current assets	6,913		6,155
Total current assets	304,514		338,841
NON-CURRENT ASSETS
Investments in equity securities	7,753		7,753
Marketable securities, long-term	51,938		43,577
Property and equipment, net	19,167		18,270
Operating lease, right of use assets	21,659		22,182
Other assets	1,794		1,586
TOTAL ASSETS	$	406,825	$	432,209
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable	$	5,940	$	3,120
Accrued expenses and other current liabilities	18,990		21,135
Operating lease liabilities, current	1,264		1,200
Deferred revenue ($2,487 and $2,487 from related party, respectively)	2,827		2,847
Total current liabilities	29,021		28,302
LONG-TERM LIABILITIES
Deferred revenue, net of current portion ($3,108 and $3,730 from related party, respectively)	5,428		6,102
MSKCC success payments liability	2,636		2,939
Operating lease liabilities, non-current	25,895		25,908
Deferred tax liabilities	556		557
Total liabilities	63,536		63,808
COMMITMENTS AND CONTINGENCIES (Note 9)
STOCKHOLDERS’ EQUITY
Common stock, par value $0.0001 per share, 300,000,000 shares authorized at March 31, 2024, and December 31, 2023, respectively; 90,314,501 and 88,448,948 shares issued and outstanding as of March 31, 2024, and December 31, 2023, respectively	9		8
Additional paid-in-capital	684,121		667,648
Accumulated other comprehensive (loss) income	(322)		30
Accumulated deficit	(340,519)		(299,285)
Total stockholders’ equity	343,289		368,401
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	406,825	$	432,209

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

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CARIBOU BIOSCIENCES, INC. AND ITS SUBSIDIARIES

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except share and per share amounts)


	Three Months Ended March 31,
	2024		2023
Licensing and collaboration revenue (including $622 and $0, from a related party, respectively)	$	2,429	$	3,502
Operating expenses:
Research and development	33,788		25,709
General and administrative	14,643		8,909
Total operating expenses	48,431		34,618
Loss from operations	(46,002)		(31,116)
Other income (expense):
Change in fair value of equity securities	—		(15)
Change in fair value of the MSKCC success payments liability	303		255
Other income, net	4,465		2,832
Total other income	4,768		3,072
Net loss	(41,234)		(28,044)
Other comprehensive income (loss):
Net unrealized (loss) gain on available-for-sale marketable securities, net of tax	(352)		788
Net comprehensive loss	$	(41,586)	$	(27,256)
Net loss per share, basic and diluted	$	(0.46)	$	(0.46)
Weighted-average common shares outstanding, basic and diluted	89,302,937		61,186,514

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

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CARIBOU BIOSCIENCES, INC. AND ITS SUBSIDIARIES

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share amounts)


	Common Stock			Additional Paid-In Capital		Accumulated Other Comprehensive Income (Loss)		Accumulated Deficit		Total Stockholders’ Equity
	Shares	Amount
BALANCE—December 31, 2023	88,448,948	$	8	$	667,648	$	30	$	(299,285)	$	368,401
Issuance of common stock upon employee stock plans	122,035	—		667		—		—		667
Issuance of common stock on exercise of options	134,347	—		489		—		—		489
Issuance of common stock in connection with our at-the-market equity offering program, net of offering expenses	1,594,171	1		11,329		—		—		11,330
Issuance of common stock on RSU release	15,000	—		—		—		—		—
Stock-based compensation expense	—	—		3,988		—		—		3,988
Net loss	—	—		—		—		(41,234)		(41,234)
Other comprehensive loss	—	—		—		(352)		—		(352)
BALANCE—March 31, 2024	90,314,501	$	9	$	684,121	$	(322)	$	(340,519)	$	343,289















BALANCE—December 31, 2022	61,029,184	$	6	$	499,598	$	(1,518)	$	(197,215)	$	300,871
Issuance of common stock under employee stock plans	70,271	—		404		—		—		404
Issuance of common stock on exercise of options	55,433	—		115		—		—		115
Issuance of common stock in connection with our at-the-market equity offering program, net of offering expenses	168,635	—		1,007		—		—		1,007
Stock-based compensation expense	—	—		3,131		—		—		3,131
Net loss	—	—		—		—		(28,044)		(28,044)
Other comprehensive income	—	—		—		788		—		788
BALANCE—March 31, 2023	61,323,523	$	6	$	504,255	$	(730)	$	(225,259)	$	278,272

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

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CARIBOU BIOSCIENCES, INC. AND ITS SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(in thousands)


	Three Months Ended March 31,
	2024		2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(41,234)	$	(28,044)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	710		589
Gain on disposal of fixed assets	—		(34)
Change in fair value of equity securities	—		15
Stock-based compensation expense	3,988		3,131
Change in fair value of MSKCC success payments liability	(303)		(255)
Acquired in-process research and development	1,500		—
Accretion of discounts on investments in marketable securities, net	(1,539)		(1,494)
Non-cash lease expense	524		515
Changes in operating assets and liabilities:
Accounts receivable	(770)		(1,331)
Contract assets	454		607
Other receivables	561		545
Prepaid expenses and other current assets	(758)		1,811
Other assets	(209)		62
Accounts payable	2,720		1,502
Accrued expenses and other current liabilities	(2,204)		(4,138)
Deferred revenue, current and long-term	(694)		(1,097)
Operating lease liabilities	51		(323)
Net cash used in operating activities	(37,203)		(27,939)
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from maturities of marketable securities	97,088		98,665
Purchases of marketable securities	(71,184)		(75,931)
Purchases of property and equipment	(1,448)		(2,031)
Payments to acquire in-process research and development	(1,500)		—
Net cash provided by investing activities	22,956		20,703
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercise of stock options	489		519
Proceeds from purchases of common stock under employee stock purchase plan	667		—
Proceeds from issuance of common stock related to our at-the-market equity offering program, net of offering expenses	11,329		1,123
Net cash provided by financing activities	12,485		1,642
NET DECREASE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH	(1,762)		(5,594)
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — BEGINNING OF PERIOD	51,208		58,384
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — END OF PERIOD	$	49,446	$	52,790
RECONCILIATION OF CASH, CASH EQUIVALENTS, AND RESTRICTED CASH
Cash and cash equivalents	$	49,400	$	52,744
Restricted cash	46		46
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH ON THE BALANCE SHEET	$	49,446	$	52,790


SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Purchases of property and equipment included in accounts payable and accrued expenses	$	851	$	1,714
Offering costs included in accrued expenses	$	—	$	116

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

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CARIBOU BIOSCIENCES, INC. AND ITS SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1. Description of the Business, Organization, and Liquidity

Business and Organization

Caribou Biosciences, Inc. (“Company” or “we”) is a clinical-stage Clustered Regularly Interspaced Short Palindromic Repeats (“CRISPR”) genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our genome-editing platform, including our novel chRDNA (CRISPR hybrid RNA-DNA, or “chRDNA,” pronounced “chardonnay”) technology, enables more precise genome editing to develop cell therapies that are armored to improve activity against diseases. We are advancing a pipeline of allogeneic, or off-the-shelf, cell therapies from our chimeric antigen receptor (“CAR”) T (“CAR-T”) cell and CAR-natural killer (“CAR-NK”) cell platforms as readily available therapeutic treatments for patients.

We incorporated in October 2011 as a Delaware corporation and are headquartered in Berkeley, California. We have four wholly owned subsidiaries: Antler Holdco, LLC, incorporated in Delaware in April 2019; Microbe Holdco, LLC, incorporated in Delaware in June 2020; Arboreal Holdco, LLC, incorporated in Delaware in November 2020; and Biloba Holdco, LLC, incorporated in Delaware in April 2021. Our wholly owned subsidiaries hold interests in our equity investments and do not have operating activities.

Liquidity

We have incurred operating losses and negative cash flows from operations since our inception and we had an accumulated deficit of $340.5 million as of March 31, 2024. During the three months ended March 31, 2024, we incurred a net loss of $41.2 million and used $37.2 million of cash in operating activities. We expect to continue to incur substantial losses, and our ability to achieve and sustain profitability will depend on the successful development, regulatory approval, and commercialization of our product candidates and on our ability to generate sufficient revenue to support our cost structure. We may never achieve profitability and, unless and until we do, we will need to continue to raise additional capital. Our management expects that existing cash, cash equivalents, and marketable securities of $345.9 million as of March 31, 2024, will be sufficient to fund our current operating plan for at least the next 12 months from the date of issuance of our unaudited condensed consolidated financial statements.

2. Summary of Significant Accounting Policies

There have been no changes to the significant accounting policies disclosed in Note 2 to the annual consolidated financial statements for the year ended December 31, 2023, included in our Annual Report on Form 10-K (“Form 10-K”).

Basis of Presentation and Principles of Consolidation

Our unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and include our accounts and the accounts of our wholly owned subsidiaries. All intercompany accounts and transactions are eliminated in consolidation.

Use of Estimates

The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires our management to make estimates and assumptions that affect the reported amounts of assets and liabilities; the disclosure of contingent assets and liabilities at the date of our unaudited condensed consolidated financial statements; and the reported amounts of revenue, income, and expenses during the applicable reporting period. On an ongoing basis, we evaluate our estimates and assumptions, including those related to revenue recognition, stock-based compensation expense, accrued expenses related to research and development activities, valuation of the Memorial Sloan Kettering Cancer Center (“MSKCC”) success payments liability, operating lease right-of-use assets and liabilities, and income taxes. Our management bases its estimates on historical experience and various other assumptions that they believe 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.

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Segments

We operate and manage our business as one reportable operating segment, which is the business of developing a pipeline of allogeneic CAR-T and CAR-NK cell therapies. Our president and chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for allocating resources and evaluating financial performance. All long-lived assets are maintained in the United States.

Concentrations of Credit Risk and Other Uncertainties

Financial instruments that potentially subject us to concentration of credit risk consist of cash and cash equivalents, accounts receivable, contract assets, other receivables, and investments in marketable securities and equity securities. Substantially all of our cash and cash equivalents are deposited in accounts at four financial institutions, and our account balances exceed federally insured limits. We mitigate the risks by investing in high-grade instruments, limiting our exposure to one issuer, and we monitor the ongoing creditworthiness of the financial institutions and issuers.

Licensees that represent 10% or more of our revenue and accounts receivable and contract assets were as follows:


	Revenue				Accounts Receivable and Contract Assets
	Three Months Ended				As of March 31, 2024		As of December 31, 2023
	March 31, 2024		March 31, 2023
Licensee A	25.3	%	17.6	%	29.5	%	*
Licensee B	23.1	%	22.0	%	36.6	%	47.5	%
Licensee C	—	%	45.9	%	—	%	*
Licensee D	25.6	%	—	%	—	%	*
Total	74.0	%	85.5	%	66.1	%	47.5	%

*Less than 10%

We monitor economic conditions to identify facts or circumstances that may indicate if any of our accounts receivable are not collectible or if contract assets should be impaired. No allowance for credit losses or contract asset impairment was recorded as of March 31, 2024, or December 31, 2023.

Recent Accounting Pronouncements Not Yet Adopted

In October 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. This ASU aligns the requirements in the Accounting Standards Codification (“ASC”) to the removal of certain disclosure requirements set out in Regulation S-X and Regulation S-K, announced by the U.S. Securities and Exchange Commission (“SEC”). The effective date for each amended topic in the ASC is either the date on which the SEC’s removal of the related disclosure requirement from Regulation S-X or Regulation S-K becomes effective or June 30, 2027, if the SEC has not removed the requirements by that date. Early adoption is prohibited. We are currently evaluating the impact of the new guidance and do not expect that the adoption of ASU 2023-06 will have a material impact on our consolidated financial statements.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This ASU requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. We are currently evaluating the impact of the adoption of ASU 2023-07.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. We are currently evaluating the impact of the adoption of ASU 2023-09.

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In March 2024, the FASB issued ASU No. 2024-01, Compensation - Stock Compensation (Topic 718): Scope Application of Profits Interest and Similar Awards. The amendments in ASU 2024-01 improve consistent application of and simplify U.S. GAAP of Topic 718 by clarifying and amending existing guidance. ASU 2024-01 is effective for fiscal years beginning after December 15, 2024, and for interim periods within those annual periods, with early adoption permitted. We are currently evaluating the impact of the adoption of ASU 2024-01.

In March 2024, the FASB issued ASU No. 2024-02, Codification Improvements - Amendments to Remove References to the Concepts Statements. The amendments in ASU 2024-02 clarify and simplify references to certain concept statements within U.S. GAAP. ASU 2024-02 is effective for fiscal years beginning after December 15, 2024, with early application permitted. We are currently evaluating the impact of the adoption of ASU 2024-02.

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 entireties based on the lowest level of input that is significant to the fair value measurement. Our assessment of the significance of a particular input to the fair value measurement in its entirety requires our management to make judgments and consider factors specific to the asset or liability.

Our financial instruments consist of Level 1, Level 2, and Level 3 financial instruments. We generally classify our marketable securities as Level 1 or Level 2. Instruments are classified as Level 2 when observable market prices for identical securities that are traded in less active markets are used. When observable market prices for identical securities are not available, such instruments are priced using benchmark curves, benchmarking of like securities, sector groupings, matrix pricing, and valuation models. These valuation models are proprietary to the pricing providers or brokers and incorporate a number of inputs including, in approximate order of priority: benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers, and reference data including market research publications. For certain security types, additional inputs may be used, or some of the standard inputs may not be applicable. Evaluators may prioritize inputs differently on any given day for any security based on market conditions, and not all inputs listed are available for use in the evaluation process for each security valuation on any given day. Changes in the ability to observe valuation inputs may result in a reclassification of levels of certain securities within the fair value hierarchy. We recognize transfers into and out of levels within the fair value hierarchy in the period in which the actual event or change in circumstances that caused the transfer occurs. No such transfers occurred during the three months ended March 31, 2024, and 2023. Level 1 financial instruments are comprised of money market fund investments and U.S. Treasury bills. Level 2 financial instruments are comprised of commercial paper, corporate debt securities, and U.S. government agency bonds. Financial assets and liabilities are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies, or similar techniques, and at least one significant model assumption or input is unobservable. Level 3 financial instruments consist of the MSKCC success payments liability.

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The following table sets forth our financial instruments that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):


	Fair Value Measurements as of March 31, 2024
	Total		Level 1		Level 2		Level 3
Assets:
U.S. Treasury bills ($13,904 included in cash and cash equivalents)	$	239,369	$	239,369	$	—	$	—
Commercial paper ($23,858 included in cash and cash equivalents)	51,462		—		51,462		—
U.S. government agency bonds	33,073		—		33,073		—
Money market fund investments (included in cash and cash equivalents)	11,638		11,638		—		—
Corporate debt securities	10,384		—		10,384		—
Total fair value of assets	$	345,926	$	251,007	$	94,919	$	—
Liabilities:
MSKCC success payments liability	$	2,636	$	—	$	—	$	2,636
Total fair value of liabilities	$	2,636	$	—	$	—	$	2,636


	Fair Value Measurements as of December 31, 2023
	Total		Level 1		Level 2		Level 3
Assets:
U.S. Treasury bills ($23,527 included in cash and cash equivalents)	$	262,439	$	262,439	$	—	$	—
Commercial paper ($9,759 included in cash and cash equivalents)	40,373		—		40,373		—
U.S. government agency bonds	40,185		—		40,185		—
Money market fund investments (included in cash and cash equivalents)	17,876		17,876		—		—
Corporate debt securities	11,531		—		11,531		—
Total fair value of assets	$	372,404	$	280,315	$	92,089	$	—
Liabilities:
MSKCC success payments liability	$	2,939	$	—	$	—	$	2,939
Total fair value of liabilities	$	2,939	$	—	$	—	$	2,939

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The fair value and amortized cost of cash equivalents and available-for-sale marketable securities by major security type as of March 31, 2024, and December 31, 2023 are presented in the following tables (in thousands):


	As of March 31, 2024
	Amortized Cost Basis		Unrealized Gains		Unrealized Losses		Estimated Fair Value
U.S. Treasury bills ($13,904 included in cash and cash equivalents)	$	239,568	$	12	$	(211)	$	239,369
Commercial paper ($23,858 included in cash and cash equivalents)	51,491		—		(29)		51,462
U.S. government agency bonds	33,159		—		(86)		33,073
Money market fund investments (included in cash equivalents)	11,638		—		—		11,638
Corporate debt securities	10,393		7		(16)		10,384
Total cash equivalents and marketable securities	$	346,249	$	19	$	(342)	$	345,926

Classified as:
Cash and cash equivalents							$	49,400
Marketable securities, short-term							244,588
Marketable securities, long-term							51,938
Total cash equivalents and marketable securities							$	345,926

As of December 31, 2023

Amortized

Cost Basis

Unrealized

Gains

Unrealized

Losses

SEC Form 10-Q filed by Caribou Biosciences Inc.