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 March 31, 2024


☐	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: 001-39856

CULLINAN THERAPEUTICS, INC.

(Exact name of Registrant as specified in its Charter)


Delaware	81-3879991
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

One Main Street Suite 1350 Cambridge, MA	02142
(Address of principal executive offices)	(Zip Code)

(617) 410-4650

(Registrant’s telephone number, including area code)

Cullinan Oncology, Inc.

(Former name, former address and former fiscal year, if changed since last report)

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


Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	CGEM	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, 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. ☐

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

The number of shares of the Registrant’s common stock outstanding as of May 8, 2024 was 57,634,234.

Table of Contents


		Page
PART I.	FINANCIAL INFORMATION
Item 1.	Financial Statements (unaudited)	1
	Consolidated Balance Sheets	1
	Consolidated Statements of Operations and Comprehensive Income (Loss)	2
	Consolidated Statements of Stockholders’ Equity	3
	Consolidated Statements of Cash Flows	4
	Notes to the Consolidated Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	11
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	17
Item 4.	Controls and Procedures	18

PART II.	OTHER INFORMATION
Item 1.	Legal Proceedings	19
Item 1A.	Risk Factors	19
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	19
Item 3.	Defaults Upon Senior Securities	19
Item 4.	Mine Safety Disclosures	19
Item 5.	Other Information	19
Item 6.	Exhibits	20
	Signatures	21

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would”, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed in our Annual Report on Form 10-K for the year ended December 31, 2023 (the "2023 10-K") and other filings with the Securities Exchange Commission (the “SEC”), including the following:

•

the commercial success, cost of development, and timing of the approval of our clinical-stage product candidates;

•

the initiation, timing, progress, results, and cost of our research and development programs, and our current and future preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or clinical trials and related preparatory work, and the period during which the results of the trials will become available;

•

our ability to submit, and obtain clearance of, any investigational new drug applications on our expected timelines, or at all;

•

our ability to initiate, recruit, and enroll patients in and conduct our clinical trials at the pace that we project;

•

our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations, or warnings in the label of any of our product candidates, if approved;

•

our ability to compete with companies currently marketing therapies or developing product candidates with targets or indications similar to our product candidates’ targets or indications;

•

our reliance on third parties to conduct our clinical trials and to manufacture drug substance and drug product for use in our clinical trials;

•

the size and growth potential of the markets for any of our current and future product candidates, and our ability to serve those markets;

•

our ability to identify and advance through clinical development any additional product candidates;

•

the commercialization of our current and future product candidates, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current and future product candidates;

•

our ability to identify research priorities and apply a risk-mitigated strategy to efficiently discover and develop current and future product candidates;

•

our ability to retain and recruit key personnel;

•

our ability to obtain and maintain adequate intellectual property rights;

•

our expectations regarding government and third-party payor coverage, pricing, and reimbursement;

•

our estimates of our expenses, ongoing losses, capital requirements, the sufficiency of our current resources, and our needs for or ability to obtain additional financing;

•

the milestone payments that we may receive from Taiho Pharmaceutical Co., Ltd.;

•

potential investments in our pipeline and the potential for such product candidates;

•

the potential benefits of strategic collaboration agreements, our ability to enter into additional strategic collaborations or arrangements, and our ability to attract collaborators with development, regulatory, and commercialization expertise; and

•

developments and projections relating to our competitors or our industry.

These factors are discussed more fully in our 2023 10-K and elsewhere in this Quarterly Report on Form 10-Q and other reports we file with the SEC. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and investors should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in the forward-looking statements we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or investments we may make or collaborations or strategic partnerships we may enter into.

You should read this Quarterly Report on Form 10-Q and the documents that we reference herein and have filed or incorporated by reference as exhibits hereto completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This Quarterly Report on Form 10-Q also contains estimates, projections, and other information concerning our industry, our business, and the markets for our product candidates. Information that is based on estimates, forecasts, projections, market research, or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market, and other data from our own internal estimates and research, as well as from reports, research surveys, studies, and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources. While we are not aware of any misstatements regarding any third-party information presented in this Quarterly Report on Form 10-Q, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties and are subject to change based on various factors, including those discussed under the section titled “Risk Factors” in our 2023 10-K and elsewhere in this Quarterly Report on Form 10-Q.

iii

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

CULLINAN THERAPEUTICS, INC.

Consolidated Balance Sheets

(unaudited)

(in thousands, except share amounts)


	March 31, 2024			December 31, 2023
Assets
Current assets:
Cash and cash equivalents	$	74,228		$	98,434
Short-term investments		358,783			368,633
Prepaid expenses and other current assets		12,710			13,124
Total current assets		445,721			480,191
Property and equipment, net		913			989
Operating lease right-of-use assets		2,336			2,543
Other assets		460			459
Total assets	$	449,430		$	484,182
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable	$	3,707		$	2,493
Accrued expenses and other current liabilities		16,889			24,204
Operating lease liabilities, current		1,329			1,440
Total current liabilities		21,925			28,137
Long-term liabilities:
Operating lease liabilities, net of current portion		1,840			2,150
Total liabilities		23,765			30,287
Commitments and contingencies (Note 10)
Stockholders' equity:
Preferred stock, $0.0001 par value, 10,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 647,500 shares issued and outstanding as of March 31, 2024 and December 31, 2023.		—			—
Common stock, $0.0001 par value, 150,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 43,065,645 and 42,900,083 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively		4			4
Additional paid-in capital		663,997			654,685
Accumulated other comprehensive loss		(331	)		(129	)
Accumulated deficit		(238,005	)		(200,857	)
Total Cullinan stockholders' equity		425,665			453,703
Noncontrolling interests		—			192
Total stockholders' equity		425,665			453,895
Total liabilities and stockholders' equity	$	449,430		$	484,182

See accompanying notes to the unaudited consolidated financial statements.

CULLINAN THERAPEUTICS, INC.

Consolidated Statements of Operations and Comprehensive INCOME (LOSS)

(unaudited)

(in thousands, except per share amounts)


	Three Months Ended March 31,
	2024			2023
Operating expenses:
Research and development	$	30,646		$	52,096
General and administrative		12,343			10,660
Total operating expenses		42,989			62,756
Loss from operations		(42,989	)		(62,756	)
Other income (expense):
Interest income		5,693			4,508
Other income (expense), net		(44	)		107
Net loss		(37,340	)		(58,141	)
Net loss attributable to noncontrolling interests		(192	)		(179	)
Net loss attributable to common stockholders of Cullinan	$	(37,148	)	$	(57,962	)

Comprehensive income (loss):
Net loss	$	(37,340	)	$	(58,141	)
Unrealized gain (loss) on investments		(202	)		1,359
Comprehensive loss		(37,542	)		(56,782	)
Comprehensive loss attributable to noncontrolling interests		(192	)		(179	)
Comprehensive loss attributable to Cullinan	$	(37,350	)	$	(56,603	)

Net loss per share attributable to common stockholders of Cullinan:
Basic and diluted	$	(0.86	)	$	(1.42	)
Weighted-average shares used in computing net loss per share attributable to common stockholders of Cullinan:
Basic and diluted		43,011			40,682

See accompanying notes to the unaudited consolidated financial statements.

CULLINAN THERAPEUTICS, INC.

Consolidated Statements of STOCKHOLDERS’ EQUITY

(unaudited)

(in thousands, except share amounts)


	Preferred Stock				Common Stock				Additional Paid-In		Accumulated Other Comprehensive			Accumulated			Noncontrolling			Total Stockholders'
	Shares		Amount		Shares		Amount		Capital		Loss			Deficit			Interests			Equity
Balances at December 31, 2023		647,500	$	—		42,900,083	$	4	$	654,685	$	(129	)	$	(200,857	)	$	192		$	453,895
Net issuance of common stock under equity-based compensation plans		—		—		165,562		—		1,085		—			—			—			1,085
Equity-based compensation		—		—		—		—		8,227		—			—			—			8,227
Unrealized gain on investments		—		—		—		—		—		(202	)		—			—			(202	)
Net loss		—		—		—		—		—		—			(37,148	)		(192	)		(37,340	)
Balances at March 31, 2024		647,500	$	—		43,065,645	$	4	$	663,997	$	(331	)	$	(238,005	)	$	—		$	425,665


	Preferred Stock				Common Stock						Additional Paid-In			Accumulated Other Comprehensive			Accumulated			Noncontrolling			Total Stockholders'
	Shares		Amount		Shares			Amount			Capital			Loss			Deficit			Interests			Equity
Balances at December 31, 2022		—	$	—		45,796,449		$	5		$	585,320		$	(2,601	)	$	(47,695	)	$	—		$	535,029
Contributions from noncontrolling interests		—		—		—			—			—			—			—			179			179
Issuance of preferred stock in exchange for common stock		647,500		—		(6,475,000	)		(1	)		1			—			—			—			—
Net issuance of common stock under equity-based compensation plans		—		—		22,152			—			(36	)		—			—			—			(36	)
Equity-based compensation		—		—		—			—			7,259			—			—			—			7,259
Unrealized gain on investments		—		—		—			—			—			1,359			—			—			1,359
Net loss		—		—		—			—			—			—			(57,962	)		(179	)		(58,141	)
Balances at March 31, 2023		647,500	$	—		39,343,601		$	4		$	592,544		$	(1,242

SEC Form 10-Q filed by Cullinan Therapeutics Inc.