10-Q
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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 June 30, 2023

OR

 

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 ONCOLOGY, 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)

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 July 31, 2023 was 42,734,644.

 


The number of shares of the Registrant’s non-voting preferred stock outstanding as of July 31, 2023 was 647,500. Each share of the preferred stock will be convertible into 10 shares of common stock at the option of the holder at any time, subject to certain limitations, including that the holder will be prohibited from converting preferred stock into common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own a number of shares of common stock more than 9.99% of the total common stock then issued and outstanding immediately following the conversion of such shares of preferred stock. Shares of preferred stock will generally have no voting rights, except as required by law and except that the consent of a majority of the holders of the outstanding preferred stock will be required to amend the terms of the preferred stock. In the event of the Registrant's liquidation, dissolution or winding up, holders of preferred stock will participate pari passu with any distribution of proceeds to holders of common stock. The preferred stock ranks (i) senior to any class or series of capital stock of the Registrant hereafter created specifically ranking by its terms junior to the preferred stock; (ii) on parity with the common stock and any class or series of capital stock of the Registrant created specifically ranking by its terms on parity with the preferred stock; and (iii) junior to any class or series of capital stock of the Registrant created specifically ranking by its terms senior to any preferred stock, in each case, as to distributions of assets upon liquidation, dissolution or winding up of the Registrant, whether voluntarily or involuntarily.

 

 


 

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

 

5

 

Notes to the Consolidated Financial Statements

 

6

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

15

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

22

Item 4.

Controls and Procedures

 

23

 

 

 

 

PART II.

OTHER INFORMATION

 

 

Item 1.

Legal Proceedings

 

24

Item 1A.

Risk Factors

 

24

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

25

Item 3.

Defaults Upon Senior Securities

 

25

Item 4.

Mine Safety Disclosures

 

25

Item 5.

Other Information

 

25

Item 6.

Exhibits

 

26

 

Signatures

 

27

 

i


 

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, 2022 (the "2022 10-K") and other filings with the Securities Exchange Commission (the “SEC”), including the following:

the success, cost and timing 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 trials and related preparatory work, the period during which the results of the trials will become available;
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;
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 oncology therapies and any of our current product candidates or other product candidates we may identify and pursue, 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 product candidates and any other product candidates we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates we may identify and pursue;
our ability to identify research priorities and apply a risk-mitigated strategy to efficiently discover and develop 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 and reimbursement;
our estimates of our expenses, ongoing losses, capital requirements, and our needs for or ability to obtain additional financing;
the milestone payments that we may receive from Taiho Pharmaceutical Co., Ltd.;
the anticipated development and commercialization of zipalertinib;
potential investments in our pipeline and the potential for such product candidates;
our cash runway;
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;
our financial performance; and

ii


 

developments and projections relating to our competitors or our industry.

These factors are discussed more fully in our 2022 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 2022 10-K and elsewhere in this Quarterly Report on Form 10-Q.

 

iii


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

CULLINAN ONCOLOGY, INC.

Consolidated Balance Sheets

(unaudited)

(in thousands, except share amounts)

 

 

June 30, 2023

 

 

December 31, 2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

141,834

 

 

$

156,152

 

Short-term investments

 

 

349,964

 

 

 

311,140

 

Prepaid expenses and other current assets

 

 

6,437

 

 

 

7,180

 

Total current assets

 

 

498,235

 

 

 

474,472

 

Property and equipment, net

 

 

1,158

 

 

 

1,174

 

Operating lease right-of-use assets

 

 

3,501

 

 

 

4,130

 

Other assets

 

 

459

 

 

 

459

 

Long-term investments

 

 

18,631

 

 

 

80,882

 

Total assets

 

$

521,984

 

 

$

561,117

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

2,493

 

 

$

2,660

 

Accrued expenses and other current liabilities

 

 

15,531

 

 

 

14,135

 

Income tax payable

 

 

 

 

 

4,282

 

Operating lease liabilities, current

 

 

1,652

 

 

 

1,421

 

Total current liabilities

 

 

19,676

 

 

 

22,498

 

Long-term liabilities:

 

 

 

 

 

 

Operating lease liabilities, net of current portion

 

 

2,734

 

 

 

3,590

 

Total liabilities

 

 

22,410

 

 

 

26,088

 

Commitments and contingencies (Note 11)

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value, 10,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 647,500 and no shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively.

 

 

 

 

 

 

Common stock, $0.0001 par value, 150,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 42,735,304 and 45,796,449 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively

 

 

4

 

 

 

5

 

Additional paid-in capital

 

 

639,066

 

 

 

585,320

 

Accumulated other comprehensive loss

 

 

(1,625

)

 

 

(2,601

)

Accumulated deficit

 

 

(137,871

)

 

 

(47,695

)

Total Cullinan stockholders' equity

 

 

499,574

 

 

 

535,029

 

Noncontrolling interests

 

 

 

 

 

 

Total stockholders' equity

 

 

499,574

 

 

 

535,029

 

Total liabilities and stockholders' equity

 

$

521,984

 

 

$

561,117

 

See accompanying notes to the unaudited consolidated financial statements.

 

1


 

CULLINAN ONCOLOGY, INC.

Consolidated Statements of Operations and Comprehensive INCOME (LOSS)

(unaudited)

(in thousands, except per share amounts)

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

27,391

 

 

$

26,411

 

 

$

79,487

 

 

$

50,947

 

General and administrative

 

 

10,214

 

 

 

10,695

 

 

 

20,874

 

 

 

18,816

 

Total operating expenses

 

 

37,605

 

 

 

37,106

 

 

 

100,361

 

 

 

69,763

 

Gain on sale of Cullinan Pearl

 

 

 

 

 

276,785

 

 

 

 

 

 

276,785

 

Income (loss) from operations

 

 

(37,605

)

 

 

239,679

 

 

 

(100,361

)

 

 

207,022

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

5,322

 

 

 

697

 

 

 

9,830

 

 

 

894

 

Other income (expense), net

 

 

69

 

 

 

(241

)

 

 

176

 

 

 

(241

)

Net income (loss) before income taxes

 

 

(32,214

)

 

 

240,135

 

 

 

(90,355

)

 

 

207,675

 

Income tax expense

 

 

 

 

 

66,070

 

 

 

 

 

 

46,502

 

Net income (loss)

 

 

(32,214

)

 

 

174,065

 

 

 

(90,355

)

 

 

161,173

 

Net loss attributable to noncontrolling interests

 

 

 

 

 

(833

)

 

 

(179

)

 

 

(1,627

)

Net income (loss) attributable to common stockholders of Cullinan

 

$

(32,214

)

 

$

174,898

 

 

$

(90,176

)

 

$

162,800

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

(32,214

)

 

$

174,065

 

 

$

(90,355

)

 

$

161,173

 

Unrealized gain (loss) on investments

 

 

(383

)

 

 

(499

)

 

 

976

 

 

 

(2,795

)

Comprehensive income (loss)

 

 

(32,597

)

 

 

173,566

 

 

 

(89,379

)

 

 

158,378

 

Comprehensive loss attributable to noncontrolling interests

 

 

 

 

 

(833

)

 

 

(179

)

 

 

(1,627

)

Comprehensive income (loss) attributable to Cullinan

 

$

(32,597

)

 

$

174,399

 

 

$

(89,200

)

 

$

160,005

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.82

)

 

$

3.90

 

 

$

(2.24

)

 

$

3.65

 

Diluted

 

$

(0.82

)

 

$

3.77

 

 

$

(2.24

)

 

$

3.51

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares used in computing net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

39,952

 

 

 

44,873

 

 

 

40,315

 

 

 

44,654

 

Diluted

 

 

39,952

 

 

 

46,381

 

 

 

40,315

 

 

 

46,389

 

See accompanying notes to the unaudited consolidated financial statements.

 

2


CULLINAN ONCOLOGY, INC.

Consolidated Statements of STOCKHOLDERS’ EQUITY

(unaudited)

(in thousands, except share amounts)

 

 

Preferred Stock

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Noncontrolling
Interest in

 

 

Total Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Subsidiaries

 

 

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

)

 

 

(105,657

)

 

 

 

 

 

485,649

 

Issuance of common stock

 

 

 

 

 

 

 

 

3,310,000

 

 

 

 

 

 

38,388

 

 

 

 

 

 

 

 

 

 

 

 

38,388

 

Net issuance of common stock under equity-based compensation plans

 

 

 

 

 

 

 

 

81,703

 

 

 

 

 

 

214

 

 

 

 

 

 

 

 

 

 

 

 

214

 

Equity-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7,920

 

 

 

 

 

 

 

 

 

 

 

 

7,920

 

Unrealized loss on investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(383

)

 

 

 

 

 

 

 

 

(383

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(32,214

)

 

 

 

 

 

(32,214

)

Balances at June 30, 2023

 

 

647,500

 

 

$

 

 

 

42,735,304

 

 

$

4

 

 

$

639,066

 

 

$

(1,625

)

 

$

(137,871

)

 

$

 

 

$

499,574

 

 

3


 

CULLINAN ONCOLOGY, INC.

Consolidated Statements of STOCKHOLDERS’ EQUITY

(unaudited)

(in thousands, except share amounts)

 

 

Preferred Stock

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Noncontrolling
Interest in

 

 

Total Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Subsidiaries

 

 

Equity

 

Balances at December 31, 2021

 

 

 

 

$

 

 

 

44,292,102

 

 

$

4

 

 

$

584,714

 

 

$

(838

)

 

$

(158,909

)

 

$

403

 

 

$

425,374

 

Contributions from noncontrolling interests

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,153

 

 

 

1,153

 

Net issuance of common stock under equity-based compensation plans

 

 

 

 

 

 

 

 

367,924

 

 

 

 

 

 

1,566

 

 

 

 

 

 

 

 

 

 

 

 

1,566

 

Equity-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,559

 

 

 

 

 

 

 

 

 

6

 

 

 

6,565

 

Unrealized loss on investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,296

)

 

 

 

 

 

 

 

 

(2,296

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,098

)

 

 

(794

)

 

 

(12,892

)

Balances at March 31, 2022

 

 

 

 

 

 

 

 

44,660,026

 

 

 

4

 

 

 

592,839

 

 

 

(3,134

)

 

 

(171,007

)

 

 

768

 

 

 

419,470

 

Contributions from noncontrolling interests