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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 September 30, 2022

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: 001-38914

 

Celularity Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

83-1702591

(State or other jurisdiction of incorporation or organization)

(I.R.S. Employer Identification No.)

 

170 Park Ave, Florham Park, NJ

(Address of principal executive offices)

07932

(Zip Code)

 

 

(908) 768-2170

(Registrant’s telephone number, including area code)

 

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

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Class A Common Stock, par value $0.0001 per share

 

CELU

 

The Nasdaq Stock Market LLC

Warrants, each exercisable for one share of Class A Common Stock at an exercise price of $11.50 per share

 

CELUW

 

The Nasdaq Stock Market LLC

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 4, 2022, the registrant had 145,013,313 shares of Class A common stock, $0.0001 par value per share, outstanding.

 

 


 

Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements

1

 

Condensed Consolidated Balance Sheets

1

 

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

2

 

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

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

33

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

41

Item 4.

Controls and Procedures

41

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

43

Item 1A.

Risk Factors

43

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

43

Item 3.

Defaults Upon Senior Securities

43

Item 4.

Mine Safety Disclosures

43

Item 5.

Other Information

43

Item 6.

Exhibits

44

Signatures

45

 

On July 16, 2021, we consummated the previously announced merger pursuant to that certain Merger Agreement and Plan of Reorganization, dated January 8, 2021, or the Merger Agreement, by and among us, our wholly-owned merger subs and Celularity LLC (formerly known as Celularity Inc.), or Legacy Celularity.

Pursuant to the terms of the Merger Agreement, we effected the business combination through the (a) merger of our wholly-owned merger sub with and into Legacy Celularity with Legacy Celularity surviving as our wholly-owned subsidiary and (b) immediately following the first merger and as part of the same overall transaction, the merger of the Legacy Celularity, as surviving corporation of the first merger, with and into a second wholly-owned merger sub, with such second wholly-owned merger sub as the surviving entity of the second merger, which ultimately resulted in Legacy Celularity becoming our wholly-owned direct subsidiary. We refer to these mergers as the “Mergers” and, collectively with the other transactions described in the Merger Agreement, the “Business Combination”. On the Closing Date, we changed our name from GX Acquisition Corp. to Celularity Inc.

Unless the context indicates otherwise, references in this quarterly report to the “Company,” “Celularity,” “we,” “us,” “our” and similar terms refer to Celularity Inc. (f/k/a GX Acquisition Corp.) and its consolidated subsidiaries (including Legacy Celularity). References to “GX” refer to the predecessor company prior to the consummation of the Business Combination.

The Celularity logo, Celularity IMPACT, Biovance, Interfyl, Lifebank, CentaFlex and other trademarks or service marks of Celularity Inc. appearing in this quarterly report are the property of Celularity Inc. This quarterly report on Form 10-Q also contains registered marks, trademarks and trade names of other companies. All other trademarks, registered marks and trade names appearing herein are the property of their respective holders

 

i


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

Some of the statements contained within this quarterly report on Form 10-Q, including the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations, constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts. These statements relate to our future events, including our anticipated operations, research, development and commercialization activities, clinical trials, operating results and financial condition and may include, but are not limited to, statements about:

the success, cost, timing and potential indications of our cellular therapy candidate development activities and clinical trials;
the timing of the initiation, enrollment and completion of planned clinical trials in the United States and foreign countries;
our ability to obtain and maintain regulatory approval of our therapeutic candidates in any of the indications for which we plan to develop them, and any related restrictions, limitations, and/or warnings in the label of any approved therapeutic;
our ability to obtain funding for our operations, including funding necessary to complete the clinical trials of any of our therapeutic candidates;
our ability to attract and retain collaborators with development, regulatory and commercialization expertise;
the size of the markets for our therapeutic candidates, and our ability to serve those markets;
our ability to successfully commercialize our therapeutic candidates;
our ability to develop and maintain sales and marketing capabilities, whether alone or with potential future collaborators;
our expenses, future revenues, capital requirements and needs for additional financing;
our use of cash and other resources; and
our expectations regarding our ability to obtain and maintain intellectual property protection for our therapeutic candidates, degenerative disease products, and our ability to operate our business without infringing on the intellectual property rights of others.

These forward-looking statements are based on information available as of the date of this quarterly report, and current expectations, forecasts and assumptions, and involve a number of risks and uncertainties that could cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Some factors that could cause actual results to differ include:

We have incurred net losses in every period since our inception, have no cellular therapeutic candidates approved for commercial sale and we anticipate that we will incur substantial net losses in the future.
We believe that our cash and cash equivalents as of September 30, 2022, will fund our current operations into the first quarter of 2023. We do not have any guaranteed financing and will need substantial additional financing to develop our therapeutics and implement our operating plans. If we fail to obtain additional financing, we may be unable to complete the development and commercialization of our therapeutic candidates and could be required to adjust our development plan to reduce expenses.
We could be required to make cash payments under our pre-paid advance agreement with Yorkville and may not have sufficient cash available when due, which could impact our liquidity and require us to modify our operations to meet any prepayment obligations.
Our placental-derived cellular therapy candidates represent a novel approach to cancer, infectious and degenerative disease treatments that creates significant challenges.
Our historical operating results indicate substantial doubt exists related to our ability to continue as a going concern.

ii


 

Our business could be materially adversely affected by the effects of health pandemics or epidemics, including the ongoing COVID-19 pandemic and future outbreaks of the disease, in regions where we or third parties on which we rely have concentrations of clinical trial sites or other business operations.
Our commercial business may be impacted if regulatory authorities determine that certain of our products that are, or are derived from, human cells or tissues do not qualify for reimbursement.
Our business is highly dependent on the success of our lead therapeutic candidates. If we are unable to obtain regulatory approval for our lead candidates and effectively commercialize our lead therapeutic candidates for the treatment of patients in approved indications, our business would be significantly harmed.
We rely on CAR-T viral vectors from Sorrento Therapeutics, Inc., or Sorrento, for our CYCART-19 therapeutic candidate and termination of this license, or any future licenses, could result in the loss of significant rights, which would harm our business.
We rely and will continue to rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of, or commercialize, our therapeutic candidates.
The U.S. Food and Drug Administration, or FDA, regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory of our therapeutic candidates.
We may not be able to file Investigational New Drug, or IND, applications to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed without additional information (such as with our recent IND submission for CYCART-19) or at all, and if so, we may encounter substantial delays in our clinical trials or may not be able to conduct our trials on the timelines we expect.
We operate our own manufacturing and storage facility, which requires significant resources; manufacturing or other failures could adversely affect our clinical trials and the commercial viability of our therapeutic candidates and our biobanking and degenerative diseases businesses.
We rely on donors of healthy human full-term post-partum placentas to manufacture our therapeutic candidates, and if we do not obtain an adequate supply of such placentas from qualified donors, development of our placental-derived allogeneic cells may be adversely impacted.
Our clinical trials may fail to demonstrate the safety and/or efficacy of any of our therapeutic candidates, which would prevent or delay regulatory approval and commercialization.
If our effort to protect the proprietary nature of the intellectual property related to our technologies are inadequate, we may not be able to compete effectively in our market.
We are, and in the future may be, party to agreements with third parties. Disputes may arise with such third parties regarding the terms of such agreements, including terms governing payment obligations, contractual interpretation, or related intellectual property ownership or use rights, which could materially adversely impact us, including by requiring the payment of additional amounts, or requiring us to invest time and money in litigation or arbitration.
Our therapeutic candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
Our relationship with customers, physicians, and third-party payors are subject to numerous laws and regulations. If we or our employees, independent contractors, consultants, commercial partners and vendors violate these laws, we could face substantial penalties.
We will continue to incur significant costs as a result of operating as a public company, and our management will be required to devote substantial time to various compliance initiatives.

For a further discussion of these and other factors that could cause our future results, performance or transactions to differ significantly from those expressed in any forward-looking statement, please see the section titled “Risk Factors” in our annual report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2022, as amended July 15, 2022, or the 2021 Form 10-K.

iii


 

Given these risks, you should not place undue reliance on any forward-looking statements, which are based only on information currently available to us (or to third parties making the forward-looking statements). While forward-looking statements reflect our good faith beliefs, they are not guarantees of future performance. Except to the extent required by applicable law, we are under no obligation (and expressly disclaim any such obligation) to update or revise their forward-looking statements whether as a result of new information, future events, or otherwise.

 

iv


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

Celularity Inc.

Condensed Consolidated Balance Sheets (Unaudited)

(in thousands, except share and per share data)

 

 

 

September 30,
2022

 

 

December 31,
2021

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

42,649

 

 

$

37,240

 

Accounts receivable, net of allowance of $1,264 and $283 as of September 30,
   2022 and December 31, 2021, respectively

 

 

4,452

 

 

 

2,745

 

Notes receivable

 

 

3,920

 

 

 

2,488

 

Inventory

 

 

5,239

 

 

 

9,549

 

Prepaid expenses and other current assets

 

 

6,837

 

 

 

7,078

 

Total current assets

 

 

63,097

 

 

 

59,100

 

Property and equipment, net

 

 

77,032

 

 

 

90,625

 

Goodwill

 

 

123,304

 

 

 

123,304

 

Intangible assets, net

 

 

121,547

 

 

 

123,187

 

Right-of-use assets - operating leases

 

 

13,042

 

 

 

-

 

Restricted cash

 

 

14,832

 

 

 

14,836

 

Inventory, net of current portion

 

 

23,861

 

 

 

2,721

 

Other long-term assets

 

 

401

 

 

 

355

 

Total assets

 

$

437,116

 

 

$

414,128

 

Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

9,216

 

 

$

9,317

 

Accrued expenses and other current liabilities

 

 

18,507

 

 

 

11,661

 

Current portion of financing obligation

 

 

-

 

 

 

3,051

 

Short-term debt ($39,255 at fair value and $40,000 unpaid principal balance at September 30, 2022)

 

 

39,255

 

 

 

-

 

Deferred revenue

 

 

2,241

 

 

 

2,196

 

Total current liabilities

 

 

69,219

 

 

 

26,225

 

Deferred revenue, net of current portion

 

 

2,120

 

 

 

1,871

 

Acquisition-related contingent consideration

 

 

158,781

 

 

 

232,222

 

Noncurrent lease liabilities - operating

 

 

27,917

 

 

 

-

 

Financing obligations

 

 

-

 

 

 

28,085

 

Warrant liabilities

 

 

14,094

 

 

 

25,962

 

Deferred income tax liabilities

 

 

10

 

 

 

10

 

Other liabilities

 

 

740

 

 

 

335

 

Total liabilities

 

 

272,881

 

 

 

314,710

 

Commitments and Contingencies (Note 10)

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

Preferred stock, $0.0001 par value, 10,000,000 shares authorized, none issued and outstanding at September 30, 2022 and December 31, 2021

 

 

-

 

 

 

-

 

Common Stock, $0.0001 par value, 730,000,000 shares authorized, 144,524,190 issued
   and outstanding as of September 30, 2022;
730,000,000 shares authorized, 124,307,884 issued
   and outstanding as of December 31, 2021

 

 

14

 

 

 

12

 

Additional paid-in capital

 

 

833,915

 

 

 

763,087

 

Accumulated other comprehensive income

 

 

236

 

 

 

-

 

Accumulated deficit

 

 

(669,930

)

 

 

(663,681

)

Total stockholders’ equity

 

 

164,235

 

 

 

99,418

 

Total liabilities, redeemable convertible preferred stock and stockholders’ equity

 

$

437,116

 

 

$

414,128

 

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

1


 

Celularity Inc.

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited)

(in thousands, except share and per share data)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net revenues

 

 

 

 

 

 

 

 

 

 

 

 

Product sales and rentals

 

$

1,041

 

 

$

849

 

 

$

2,920

 

 

$

2,734

 

Services

 

 

1,405

 

 

 

1,343

 

 

 

4,061

 

 

 

4,204

 

License, royalty and other

 

 

1,689

 

 

 

8,430

 

 

 

6,865

 

 

 

9,541

 

Total revenues

 

 

4,135

 

 

 

10,622

 

 

 

13,846

 

 

 

16,479

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenues (excluding amortization of acquired intangible assets)

 

 

 

 

 

 

 

 

 

 

 

 

Product sales and rentals

 

 

812

 

 

 

638

 

 

 

1,711

 

 

 

2,025

 

Services

 

 

899

 

 

 

923

 

 

 

3,112

 

 

 

2,218

 

Licenses, royalties and other

 

 

5,502

 

 

 

750

 

 

 

9,595

 

 

 

750

 

Research and development

 

 

20,351

 

 

 

23,765

 

 

 

67,373

 

 

 

63,666

 

Selling, general and administrative

 

 

14,907

 

 

 

21,644

 

 

 

46,941

 

 

 

58,133

 

Change in fair value of contingent consideration liability

 

 

(33,243

)

 

 

(48,549

)

 

 

(73,441

)

 

 

(17,845

)

Amortization of acquired intangible assets

 

 

553

 

 

 

553

 

 

 

1,640

 

 

 

1,640

 

Total operating expenses

 

 

9,781

 

 

 

(276

)

 

 

56,931

 

 

 

110,587

 

(Loss) income from operations

 

 

(5,646

)

 

 

10,898

 

 

 

(43,085

)

 

 

(94,108

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

108

 

 

 

55

 

 

 

155

 

 

 

324

 

Interest expense

 

 

-

 

 

 

(843

)

 

 

-

 

 

 

(2,412

)

Change in fair value of warrant liabilities

 

 

9,333

 

 

 

39,937

 

 

 

31,613

 

 

 

2,258

 

Change in fair value of debt

 

 

(291

)

 

 

-

 

 

 

(291

)

 

 

-

 

Other income (expense), net

 

 

1,278

 

 

 

(109

)

 

 

1,366

 

 

 

(2,140

)

Total other income (expense)

 

 

10,428

 

 

 

39,040

 

 

 

32,843

 

 

 

(1,970

)

Income (loss) before income taxes

 

 

4,782

 

 

 

49,938

 

 

 

(10,242

)

 

 

(96,078

)

Income tax benefit

 

 

(17

)

 

 

-

 

 

 

-

 

 

 

-

 

Net income (loss)

 

$

4,799

 

 

$

49,938

 

 

$

(10,242

)

 

$

(96,078

)

Change in fair value of debt due to change in credit risk, net of tax

 

 

236

 

 

 

-

 

 

 

236

 

 

 

-

 

Other comprehensive income

 

 

236

 

 

 

-

 

 

 

236

 

 

 

-

 

Comprehensive income (loss)

 

$

5,035

 

 

$

49,938

 

 

$

(10,006

)

 

$

(96,078

)

Share information:

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share - basic

 

$

0.03

 

 

$

0.47

 

 

$

(0.07

)

 

$

(2.00

)

Weighted average shares outstanding - basic

 

 

142,676,953

 

 

 

106,369,910

 

 

 

137,787,645

 

 

 

48,071,685

 

Net income (loss) per share - diluted

 

$

0.03

 

 

$

0.40

 

 

$

(0.07

)

 

$

(2.00

)

Weighted average shares outstanding - diluted

 

 

150,546,268

 

 

 

123,582,822

 

 

 

137,787,645

 

 

 

48,071,685

 

 

 

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

2


 

Celularity Inc.

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) (Unaudited)

(in thousands, except share amounts)

 

 

 

Series A Redeemable
Convertible Preferred
Stock

 

 

Series B Redeemable
Convertible Preferred
Stock

 

 

Series X Redeemable
Convertible Preferred
Stock

 

 

 

Common Stock

 

 

Treasury Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated Other Comprehensive

 

 

Total
Stockholders’ Equity

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income

 

 

(Deficit)

 

Balances at December 31, 2021

 

 

-

 

 

$

-

 

 

 

-

 

 

$

-

 

 

 

-

 

 

$

-

 

 

 

 

124,307,884

 

 

$

12

 

 

 

-

 

 

$

-

 

 

$

763,087

 

 

$

(663,681

)

 

$

-

 

 

$

99,418

 

Cumulative effect adjustment ASU 2016-02

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

3,996

 

 

 

-

 

 

 

3,996

 

Reclassification of previously exercised stock options

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

131,253

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

441

 

 

 

-

 

 

 

-

 

 

 

441

 

Exercise of warrants

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

13,281,386

 

 

 

2

 

 

 

-

 

 

 

-

 

 

 

46,483

 

 

 

-

 

 

 

-

 

 

 

46,485

 

Exercise of stock options

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

10,255

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

21

 

 

 

-

 

 

 

-

 

 

 

21

 

Purchase and retirement of common shares

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

(3,058

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(11

)

 

 

-

 

 

 

-

 

 

 

(11

)

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

2,422

 

 

 

-

 

 

 

-

 

 

 

2,422

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-