UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

For the quarterly period ended September 30, ~~2021~~2022

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

Commission File Number: 000-15006

CELLDEX THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware		No. 13-3191702
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

Perryville III Building, 53 Frontage Road, Suite 220, Hampton, New Jersey 08827

(Address of principal executive offices) (Zip Code)

(908) 200-7500

(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
Common Stock, par value $.001	CLDX	Nasdaq Capital 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. (Check one):

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 October 31, ~~2021, 46,663,872~~2022, 47,099,831 shares of common stock, $.001 par value per share, were outstanding.

Table of Contents

CELLDEX THERAPEUTICS, INC.

FORM 10-Q

For the Quarterly Period Ended September 30, ~~2021~~2022

Table of Contents

		Page
Part I — Financial Information
Item 1. Unaudited Financial Statements		3
Condensed Consolidated Balance Sheets at September 30, ~~2021~~2022 and December 31, ~~2020~~2021		3
Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, ~~2021~~2022 and ~~2020~~2021		4
Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, ~~2021~~2022 and ~~2020~~2021		5
Notes to Unaudited Condensed Consolidated Financial Statements		6
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations		1615
Item 3. Quantitative and Qualitative Disclosures About Market Risk		29
Item 4. Controls and Procedures		3029
Part II — Other Information
Item ~~1. Legal Proceedings~~		31
~~Item~~ 1A. Risk Factors		3130
Item 5. Other Information		3130
Item 6. Exhibits		32
Exhibit Index		32
Signatures		33

Table of Contents

PART I — FINANCIAL INFORMATION

Item 1. Unaudited Financial Statements

CELLDEX THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(In thousands, except share and per share amounts)

September 30,

December 31,

2021

2020
Assets

Current assets:

Cash and cash equivalents

$
72,184

$
43,836
Marketable securities

350,905

150,586
Accounts and other receivables

197

1,802
Prepaid and other current assets

3,269

1,619
Total current assets

426,555

197,843
Property and equipment, net

3,342

3,815
Operating lease right-of-use assets, net

3,016

3,449
Intangible assets, net

27,190

30,690
Other assets

98

41
Total assets

$
460,201

$
235,838
Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$
836

$
1,048
Accrued expenses

10,253

8,459
Current portion of operating lease liabilities

1,366

1,327
Current portion of other long-term liabilities

1,721

3,372
Total current liabilities

14,176

14,206
Long-term portion of operating lease liabilities

1,713

2,154
Other long-term liabilities

7,600

10,121
Total liabilities

23,489

26,481
Commitments and contingent liabilities

Stockholders’ equity:

Convertible preferred stock, $.01 par value; 3,000,000 shares authorized; 0 shares issued and outstanding at September 30, 2021 and December 31, 2020

—

—
Common stock, $.001 par value; 297,000,000 shares authorized; 46,663,340 and 39,603,771 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively

47

40
Additional paid-in capital

1,557,576

1,279,824
Accumulated other comprehensive income

2,548

2,589
Accumulated deficit

(1,123,459)

(1,073,096)
Total stockholders’ equity

436,712

209,357
Total liabilities and stockholders’ equity

$
460,201

$
235,838


	September 30,		December 31,
	2022		2021
Assets
Current assets:
Cash and cash equivalents	$	18,583	$	39,143
Marketable securities		304,888		369,107
Accounts and other receivables		189		172
Prepaid and other current assets		10,939		2,417
Total current assets		334,599		410,839
Property and equipment, net		3,753		3,551
Operating lease right-of-use assets, net		3,580		2,970
Intangible assets, net		27,190		27,190
Other assets		104		104
Total assets	$	369,226	$	444,654
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	2,272	$	1,228
Accrued expenses		11,425		12,000
Current portion of operating lease liabilities		1,438		1,746
Current portion of other long-term liabilities		1,152		1,554
Total current liabilities		16,287		16,528
Long-term portion of operating lease liabilities		2,190		1,296
Other long-term liabilities		5,333		7,354
Total liabilities		23,810		25,178
Commitments and contingent liabilities
Stockholders’ equity:
Convertible preferred stock, $.01 par value; 3,000,000 shares authorized; no shares issued and outstanding at September 30, 2022 and December 31, 2021		—		—
Common stock, $.001 par value; 297,000,000 shares authorized; 47,096,063 and 46,730,198 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively		47		47
Additional paid-in capital		1,574,926		1,561,142
Accumulated other comprehensive income		(112)		1,894
Accumulated deficit		(1,229,445)		(1,143,607)
Total stockholders’ equity		345,416		419,476
Total liabilities and stockholders’ equity	$	369,226	$	444,654

See accompanying notes to unaudited condensed consolidated financial statements

Table of Contents

CELLDEX THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(In thousands, except per share amounts)

Three Months
Ended

Three Months
Ended

Nine Months
Ended

Nine Months
Ended


September 30, 2021

September 30, 2020

September 30, 2021

September 30, 2020
Revenues:

Product development and licensing agreements

$
—

$
12

$
29

$
2,297
Contracts and grants

153

656

4,288

1,336
Total revenues

153

668

4,317

3,633

Operating expenses:

Research and development

13,557

10,708

38,633

32,109
General and administrative

5,821

3,640

14,247

10,833
Intangible asset impairment

3,500

—

3,500

3,500
(Gain) loss on fair value remeasurement of contingent consideration

(1,901)

662

(1,160)

(4,236)
Total operating expenses

20,977

15,010

55,220

42,206

Operating loss

(20,824)

(14,342)

(50,903)

(38,573)
Investment and other income, net

145

118

313

465
Net loss before income tax benefit

(20,679)

(14,224)

(50,590)

(38,108)
Income tax benefit

227

—

227

228
Net loss

$
(20,452)

$
(14,224)

$
(50,363)

$
(37,880)

Basic and diluted net loss per common share

$
(0.45)

$
(0.36)

$
(1.21)

$
(1.44)

Shares used in calculating basic and diluted net loss per share

45,453

39,278

41,582

26,303

Comprehensive loss:

Net loss

$
(20,452)

$
(14,224)

$
(50,363)

$
(37,880)
Other comprehensive income (loss):

Unrealized (loss) gain on marketable securities

(44)

14

(41)

(11)
Comprehensive loss

$
(20,496)

$
(14,210)

$
(50,404)

$
(37,891)


	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2022		September 30, 2021		September 30, 2022		September 30, 2021
Revenues:
Product development and licensing agreements	$	—	$	—	$	30	$	29
Contracts and grants		407		153		714		4,288
Total revenues		407		153		744		4,317

Operating expenses:
Research and development		21,572		13,557		59,359		38,633
General and administrative		6,531		5,821		20,596		14,247
Intangible asset impairment		—		3,500		—		3,500
Gain on fair value remeasurement of contingent consideration		—		(1,901)		(6,862)		(1,160)
Litigation settlement related loss		—		—		15,000		—
Total operating expenses		28,103		20,977		88,093		55,220

Operating loss		(27,696)		(20,824)		(87,349)		(50,903)
Investment and other income, net		912		145		1,511		313
Net loss before income tax benefit		(26,784)		(20,679)		(85,838)		(50,590)
Income tax benefit		—		227		—		227
Net loss	$	(26,784)	$	(20,452)	$	(85,838)	$	(50,363)

Basic and diluted net loss per common share	$	(0.57)	$	(0.45)	$	(1.83)	$	(1.21)

Shares used in calculating basic and diluted net loss per share		46,916		45,453		46,806		41,582

Comprehensive loss:
Net loss	$	(26,784)	$	(20,452)	$	(85,838)	$	(50,363)
Other comprehensive income (loss):
Unrealized gain (loss) on marketable securities		305		(44)		(2,006)		(41)
Comprehensive loss	$	(26,479)	$	(20,496)	$	(87,844)	$	(50,404)

See accompanying notes to unaudited condensed consolidated financial statements

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CELLDEX THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW

(Unaudited)

(In thousands)


	Nine Months Ended		Nine Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2022		September 30, 2021
Cash flows from operating activities:
Net loss	$	(50,363)	$	(37,880)	$	(85,838)	$	(50,363)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		2,291		3,174		2,223		2,291
Amortization and premium of marketable securities, net		(3,407)		(422)		1,366		(3,407)
Gain on sale or disposal of assets		(23)		(29)
Intangible Asset Impairment		3,500		3,500
Loss (gain) on sale or disposal of assets						1		(23)
Intangible asset impairment						—		3,500
Gain on fair value remeasurement of contingent consideration		(1,160)		(4,236)		(6,862)		(1,160)
Non-Cash Income Tax Benefit		(227)		(228)
Non-cash income tax benefit						—		(227)
Stock-based compensation expense		5,813		2,658		11,103		5,813
Changes in operating assets and liabilities:
Accounts and other receivables		1,549		177		(17)		1,549
Prepaid and other current assets		(2,261)		(1,280)		(7,928)		(2,261)
Accounts payable and accrued expenses		1,757		864		720		1,757
Other liabilities		(3,855)		(1,491)		3,262		(3,855)
Net cash used in operating activities		(46,386)		(35,193)		(81,970)		(46,386)
Cash flows from investing activities:
Sales and maturities of marketable securities		129,000		55,600		192,866		129,000
Purchases of marketable securities		(325,342)		(183,394)		(132,613)		(325,342)
Acquisition of property and equipment		(895)		(1,305)		(1,593)		(895)
Proceeds from sale or disposal of assets		25		29		69		25
Net cash used in investing activities		(197,212)		(129,070)
Net cash provided by (used in) investing activities						58,729		(197,212)
Cash flows from financing activities:
Net proceeds from stock issuances		269,893		170,964		—		269,893
Proceeds from issuance of stock from employee benefit plans		2,053		218		2,681		2,053
Issuance of Term Loan		—		2,962
Payment of Term Loan		—		(2,962)
Net cash provided by financing activities		271,946		171,182		2,681		271,946

Net increase in cash and cash equivalents		28,348		6,919
Net (decrease) increase in cash and cash equivalents						(20,560)		28,348
Cash and cash equivalents at beginning of period		43,836		11,232		39,143		43,836
Cash and cash equivalents at end of period	$	72,184	$	18,151	$	18,583	$	72,184

Non-cash investing activities
Accrued construction in progress	$	46	$	63	$	38	$	46

See accompanying notes to unaudited condensed consolidated financial statements

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CELLDEX THERAPEUTICS, INC.

Notes to Unaudited Condensed Consolidated Financial Statements

September 30, ~~2021~~2022

(1) Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared by Celldex Therapeutics, Inc. (the “Company” or “Celldex”) in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and reflect the operations of the Company and its wholly-owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation.

These interim financial statements do not include all the information and footnotes required by U.S. GAAP for annual financial statements and should be read in conjunction with the audited financial statements for the year ended December 31, ~~2020,~~2021, which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on ~~March 29, 2021.~~February 28, 2022. In the opinion of management, the interim financial statements reflect all normal recurring adjustments necessary to fairly state the Company’s financial position and results of operations for the interim periods presented. The year-end condensed balance sheet data presented for comparative purposes was derived from audited financial statements but does not include all disclosures required by U.S. GAAP.

The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for any future interim period or the fiscal year ending December 31, ~~2021.~~2022.

At September 30, ~~2021,~~2022, the Company had cash, cash equivalents and marketable securities of ~~$423.1~~$323.5 million. The Company has had recurring losses and incurred a loss of ~~$50.4~~$85.8 million for the nine months ended September 30, ~~2021.~~2022. Net cash used in operations for the nine months ended September 30, ~~2021~~2022 was ~~$46.4~~$82.0 million. The Company believes that the cash, cash equivalents and marketable securities at the filing date of this Form 10-Q will be sufficient to meet estimated working capital requirements and fund planned operations for at least the next twelve months from the date of issuance of these financial statements.

During the next twelve months and beyond, the Company may take further steps to raise additional capital to meet its long-term liquidity needs including, but not limited to, one or more of the following: the licensing of drug candidates with existing or new collaborative partners, possible business combinations, issuance of debt, or the issuance of common stock or other securities via private placements or public offerings. Although the Company has been successful in raising capital in the past, there can be no assurance that additional financing will be available on acceptable terms, if at all, and the Company’s negotiating position in capital-raising efforts may worsen as existing resources are used. There is also no assurance that the Company will be able to enter into further collaborative relationships. Additional equity financings may be dilutive to the Company’s stockholders; debt financing, if available, may involve significant cash payment obligations and covenants that restrict the Company’s ability to operate as a business; and licensing or strategic collaborations may result in royalties or other terms which reduce the Company’s economic potential from products under development. The Company’s ability to continue funding its planned operations beyond twelve months from the issuance date is also dependent on the timing and manner of payment of ~~contingent milestones from~~amounts due under the ~~acquisition of Kolltan Pharmaceuticals, Inc.~~Settlement Agreement with Shareholder Representative Services LLC (“~~Kolltan”~~SRS”) (refer to Note 13), in the event that the Company achieves the ~~drug candidate~~ milestones related to those payments. The Company, at its option, may decide to pay those milestone payments in cash, shares of its common stock or a combination thereof. If the Company is unable to raise the funds necessary to meet its long-term liquidity needs, it may have to delay or discontinue the development of one or more programs, discontinue or delay ongoing or anticipated clinical trials, license out programs earlier than expected, raise funds at a significant discount or on other unfavorable terms, if at all, or sell all or a part of the Company.

~~Table of Contents~~

~~The~~ COVID-19 ~~pandemic~~ continues to have ~~a major~~an impact in the US and around the world. The availability of vaccines holds promise for the future, though new variants of the virus and potential waning immunity from vaccines may result in continued impact from this pandemic in the future, including supply chain and work force issues which could adversely impact our operations. To date, ~~the Company has~~we have managed delays and disruptions without significant impact in planned and ongoing preclinical and clinical trials, manufacturing or shipping. Potential impacts to our business include delays in planned and ongoing preclinical and clinical trials including enrollment of patients, disruptions in time and resources provided by independent clinical investigators, contract research organizations, and other third-party service providers, temporary closures of our facilities, disruptions or restrictions on our employees’ ability to travel, and delays in manufacturing and/or shipments to and from third-party suppliers and contract manufacturers for APIs and drug product. Any prolonged negative impacts to our business could materially impact our operating results and could lead to impairments of our ~~Intangible~~intangible in-process research and development (“IPR&D”) assets with a carrying value of $27.2 million at September 30, ~~2021.~~2022.

Table of Contents

(2) Significant Accounting Policies

The significant accounting policies used in preparation of these condensed consolidated financial statements on Form 10-Q for the three and nine months ended September 30, ~~2021~~2022 are consistent with those discussed in Note 2 to the financial statements in our Annual Report on Form 10-K for the year ended December 31, ~~2020.~~2021.

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements upon adoption.

In June 2016, the FASB issued guidance on the Measurement of Credit Losses on Financial Instruments. The guidance requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related to credit risks. For available-for-sale debt securities with unrealized losses, the standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. This standard will be effective for the Company on January 1, 2023. ~~We are currently evaluating the potential~~The adoption of this new guidance is not expected to have a material impact ~~that this standard may have~~ on the Company’s consolidated financial statements and related disclosures.

~~Table of Contents~~

(3) Fair Value Measurements

The following tables set forth the Company’s financial assets and liabilities subject to fair value measurements:


	As of								As of
	September 30, 2021		Level 1		Level 2		Level 3		September 30, 2022		Level 1		Level 2		Level 3

	(In thousands)								(In thousands)
Assets:
Money market funds and cash equivalents	$	66,929		—	$	66,929		—	$	10,729		—	$	10,729		—
Marketable securities		350,905		—		350,905		—		304,888		—		304,888		—
	$	417,834		—	$	417,834		—	$	315,617		—	$	315,617		—
Liabilities:
Kolltan acquisition contingent consideration	$	7,107		—		—	$	7,107	$	—		—		—	$	—
	$	7,107		—		—	$	7,107	$	—		—		—	$	—


	As of								As of
	December 31, 2020		Level 1		Level 2		Level 3		December 31, 2021		Level 1		Level 2		Level 3

	(In thousands)								(In thousands)
Assets:
Money market funds and cash equivalents	$	35,066		—	$	35,066		—	$	26,220		—	$	26,220		—
Marketable securities		150,586		—		150,586		—		369,107		—		369,107		—
	$	185,652		—	$	185,652		—	$	395,327		—	$	395,327		—
Liabilities:
Kolltan acquisition contingent consideration	$	8,267		—		—	$	8,267	$	6,862		—		—	$	6,862
	$	8,267		—		—	$	8,267	$	6,862		—		—	$	6,862

The Company’s financial assets consist mainly of money market funds, cash equivalents and marketable securities and are classified as Level 2 within the valuation hierarchy. The Company values its marketable securities utilizing independent pricing services which normally derive security prices from recently reported trades for identical or similar securities, making adjustments based on significant observable transactions. At each balance sheet date, observable market inputs may include trade information, broker or dealer quotes, bids, offers or a combination of these data sources.

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The following table reflects the activity for the Company’s contingent consideration liabilities measured at fair value using Level 3 inputs for the nine months ended September 30, ~~2021~~2022 (in thousands):


	Other Liabilities:		Other Liabilities:
	Contingent		Contingent
	Consideration		Consideration
Balance at December 31, 2020	$	8,267
Balance at December 31, 2021			$	6,862
Fair value adjustments included in operating expenses		(1,160)		(6,862)
Balance at September 30, 2021	$	7,107
Balance at September 30, 2022			$	—

The valuation technique used to measure fair value of the Company’s Level 3 liabilities, which consist of contingent consideration related to the acquisition of Kolltan Pharmaceuticals, Inc. (“Kolltan”) in 2016, was primarily an income approach. The significant unobservable inputs used in the fair value measurement of the contingent consideration are estimates including probability of success, discount rates and amount of time until the conditions of the milestone payments are met. ~~As of~~

During the three and nine months ended September 30, ~~2021,~~2022, the ~~weighted average probability of success used in calculating the~~Company recorded a $0.0 million and $6.9 million gain on fair value remeasurement of contingent consideration, ~~was 48.0% (with a range of 5.1%~~respectively, primarily due to ~~68.6%),~~ the ~~weighted average discount rate was 5.6% ( with a range of 5.1%~~Company’s decision to ~~6.7%) and~~deprioritize the weighted average amount of time until the conditions of the milestone payments are met was 4 years. Weighted averages are calculated based on the relative fair value of our contingent consideration obligations.

~~Table of Contents~~

CDX-1140 program. During the three and nine months ended September 30, 2021, the Company recorded a $~~1.9~~$1.9 million and $~~1.2~~$1.2 million gain on fair value remeasurement of contingent consideration, respectively, primarily due to updated assumptions for the TAM program, changes in discount rates and the passage of time. During the three months ended September 30, 2020, the Company recorded a $0.7 million loss on fair value remeasurement of contingent consideration primarily due to changes in discount rates and the passage of time. During the nine months ended September 30, 2020, the Company recorded a $4.2 million gain on fair value remeasurement of contingent consideration primarily due to updated assumptions for CDX-3379 related milestones due to the discontinuation of the CDX-3379 program, changes in discount rates and the passage of time. The assumptions related to determining the fair value of contingent consideration include a significant amount of judgment, and any changes in the underlying estimates could have a material impact on the amount of contingent consideration adjustment recorded in any given period.

The Company did not have any transfers in or out of Level 3 assets or liabilities duringthe nine months ended September 30, ~~2021.~~2022.

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(4) Marketable Securities

The following is a summary of marketable debt securities, classified as available-for-sale:


	Gross Unrealized								Gross Unrealized
	Amortized						Fair		Amortized							Fair
	Cost		Gains		Losses		Value		Cost			Gains		Losses		Value

	(In thousands)								(In thousands)
September 30, 2021
September 30, 2022
Marketable securities
U.S. government and municipal obligations
Maturing in one year or less	$	24,291	$	5	$	—	$	24,296	$	132,422		$	—	$	(1,042)	$	131,380
Maturing after one year through three years		75,314		2		(17)		75,299		3,912			—		(71)		3,841
Total U.S. government and municipal obligations	$	99,605	$	7	$	(17)	$	99,595	$	136,334		$	—	$	(1,113)	$	135,221
Corporate debt securities
Maturing in one year or less	$	183,504	$	—	$	(10)	$	183,494	$	168,698		$	—	$	(1,548)	$	167,150
Maturing after one year through three years		67,844		8		(36)		67,816		2,564			—		(47)		2,517
Total corporate debt securities	$	251,348	$	8	$	(46)	$	251,310	$	171,262		$	—	$	(1,595)	$	169,667
Total marketable securities	$	350,953	$	15	$	(63)	$	350,905	$	307,596		$	—	$	(2,708)	$	304,888


	Gross Unrealized								Gross Unrealized
	Amortized						Fair		Amortized		��					Fair
	Cost		Gains		Losses		Value		Cost			Gains		Losses		Value

	(In thousands)								(In thousands)
December 31, 2020
December 31, 2021
Marketable securities
U.S. government and municipal obligations
Maturing in one year or less	$	40,328	$	3	$	(2)	$	40,329	$	80,674		$	—	$	(133)	$	80,541
Maturing after one year through three years		—		—		—		—		51,319			—		(184)		51,135
Total U.S. government and municipal obligations	$	40,328	$	3	$	(2)	$	40,329	$	131,993		$	—	$	(317)	$	131,676
Corporate debt securities
Maturing in one year or less	$	110,265	$	2	$	(10)	$	110,257	$	170,034		$	—	$	(28)	$	170,006
Maturing after one year through three years		—		—		—		—		67,782			—		(357)		67,425
Total corporate debt securities	$	110,265	$	2	$	(10)	$	110,257	$	237,816		$	—	$	(385)	$	237,431
Total marketable securities	$	150,593	$	5	$	(12)	$	150,586	$	369,809		$	—	$	(702)	$	369,107

The Company holds investment-grade marketable securities, and ~~NaN~~none were in a continuous unrealized loss position for more than twelve months as of September 30, ~~2021~~2022 and December 31, ~~2020.~~2021. The unrealized losses are attributable to changes in interest rates and the Company does not believe any unrealized losses represent other-than-temporary impairments. Marketable securities include ~~$0.8~~$0.7 million and ~~$0.2~~$1.3 million in accrued interest at September 30, ~~2021~~2022 and December 31, ~~2020,~~2021, respectively.

~~Table of Contents~~

(5) Intangible Assets

At September 30, ~~2021~~2022 and December 31, ~~2020,~~2021, the carrying value of the Company’s indefinite-lived intangible assets was $27.2 ~~million and $30.7 million, respectively.~~million. Indefinite-lived intangible assets consist of acquired IPR&D related to the development of the anti-KIT program, ~~(including~~including barzolvolimab (also referred to as CDX-0159) ~~and~~, which was recorded in connection with the ~~TAM program, a broad antibody discovery effort to generate antibodies that modulate the TAM family of RTKs, comprised of Tyro3, AxL and MerTK. CDX-0159~~Kolltan acquisition. Barzolvolimab is in Phase ~~1 development and the TAM program is in preclinical~~2 development. As of September 30, ~~2021, none of~~2022, the ~~Company’s~~ IPR&D ~~assets~~asset related to the anti-KIT program had not reached technological feasibility nor did ~~any~~the asset have alternative future uses.

The Company performs an impairment test on IPR&D assets at least annually, or more frequently if events or changes in circumstances indicate that IPR&D assets may be impaired. During the fourth quarter of 2020, the Company decided that although it had developed promising data for the AxL target within the TAM program, it would focus its efforts on out-licensing opportunities for its TAM program. As a result, the Company evaluated the TAM program IPR&D asset for potential impairment due to the change in projected development and regulatory timelines related to the program and recorded a non-cash partial impairment charge of $14.5 million for the fourth quarter of 2020. During the third quarter of 2021, the Company evaluated its out-licensing progress since December 31, 2020 and the status and expectation for the TAM program. Despite the Company’s efforts to out-license, there was a lack of interest in the program from third parties. Therefore, the Company evaluated the TAM program IPR&D asset for potential impairment using a discounted cash flow fair value model and concluded that the TAM IPR&D asset was fully impaired. A non-cash impairment charge of $3.5 million was recorded for the three months ended September 30, 2021. As a result of the discontinuation of the CDX-3379 program in the second quarter of 2020, the Company concluded that the CDX-3379 IPR&D asset was fully impaired and a non-cash impairment charge of $3.5 million was recorded in the second quarter of 2020. Due to the nature of IPR&D projects, the Company may experience future delays or failures to obtain regulatory approvals to conduct clinical trials, failures of such clinical trials or other failures to achieve a commercially viable product, and as a result, may recognize further impairment losses in the future.

Table of Contents

(6) Other Long-Term Liabilities

Other long-term liabilities include the following:


	September 30,		December 31,		September 30,		December 31,
	2021		2020		2022		2021

	(In thousands)				(In thousands)
Net deferred tax liabilities related to IPR&D (Note 11)	$	1,613	$	1,840	$	1,613	$	1,613
Contingent milestones (Note 3)		7,107		8,267
Deferred Income From Sale of Tax Benefits						4,650		—
Contingent milestones (Note 3 and Note 13)						—		6,862
Deferred revenue (Note 10)		601		3,386		222		433
Total		9,321		13,493		6,485		8,908
Less current portion		(1,721)		(3,372)		(1,152)		(1,554)
Long-term portion	$	7,600	$	10,121	$	5,333	$	7,354

In March 2022, the Company received approval from the New Jersey Economic Development Authority and agreed to sell New Jersey tax benefits of $5.0 million to an independent third party for $4.7 million. Under the agreement, the Company must maintain a base of operations in New Jersey for five years or the tax benefits must be paid back on a pro-rata basis based on the number of years completed.

(7) Stockholders’ Equity

In May 2016, the Company entered into a controlled equity offering sales agreement (the “Cantor Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) to allow the Company to issue and sell shares of its common stock from time to time through Cantor, acting as agent. At September 30, ~~2021,~~2022, the Company had $50.0 million remaining in aggregate gross offering price available under the Company’s November 2020 prospectus.

~~In July~~The changes in Stockholders’ Equity during the three and nine months ended September 30, 2022 and 2021 the Company issued 6,845,238 shares of its common stock in an underwritten public offering resulting in net proceeds to the Company of $269.9 million, after deducting underwriting fees and offering expenses.are summarized below:


						Accumulated
	Common	Common		Additional		Other				Total
	Stock	Stock Par		Paid-In		Comprehensive		Accumulated		Stockholders’
	Shares	Value		Capital		Income		Deficit		Equity
Consolidated balance at December 31, 2021	46,730,198	$	47	$	1,561,142	$	1,894	$	(1,143,607)	$	419,476
Shares issued under stock option and employee stock purchase plans	24,150		—		304		—		—		304
Stock-based compensation	—		—		3,153		—		—		3,153
Unrealized loss on marketable securities	—		—		—		(1,782)		—		(1,782)
Net loss	—		—		—		—		(23,050)		(23,050)
Consolidated balance at March 31, 2022	46,754,348	$	47	$	1,564,599	$	112	$	(1,166,657)	$	398,101
Shares issued under stock option and employee stock purchase plans	10,355		—		71		—		—		71
Stock-based compensation	—		—		3,454		—		—		3,454
Unrealized loss on marketable securities	—		—		—		(529)		—		(529)
Net loss	—		—		—		—		(36,004)		(36,004)
Consolidated balance at June 30, 2022	46,764,703	$	47	$	1,568,124	$	(417)	$	(1,202,661)	$	365,093
Shares issued under stock option and employee stock purchase plans	331,360		—		2,306		—		—		2,306
Stock-based compensation	—		—		4,496		—		—		4,496
Unrealized gain on marketable securities	—		—		—		305		—		305
Net loss	—		—		—		—		(26,784)		(26,784)
Consolidated balance at September 30, 2022	47,096,063	$	47	$	1,574,926	$	(112)	$	(1,229,445)	$	345,416

Table of Contents

~~The changes in Stockholders’ Equity during the three and nine months ended September 30, 2021 and 2020 are summarized below:~~

Accumulated




Common

Common

Additional

Other

Total

Stock

Stock Par

Paid-In

Comprehensive

Accumulated

Stockholders’

Shares

Value

Capital

Income

Deficit

Equity

(In thousands, except share amounts)
Consolidated balance at December 31, 2020

39,603,771

$
40

$
1,279,824

$
2,589

$
(1,073,096)

$
209,357
Shares issued under stock option and employee stock purchase plans

10,867

—

74

—

—

74
Stock-based compensation

—

—

1,275

—

—

1,275
Unrealized loss on marketable securities

—

—

—

(2)

—

(2)
Net loss

—

—

—

—

(16,538)

(16,538)
Consolidated balance at March 31, 2021

39,614,638

$
40

$
1,281,173

$
2,587

$
(1,089,634)

$
194,166
Shares issued under stock option and employee stock purchase plans

2,058

—

(25)

—

—

(25)
Stock-based compensation

—

—

1,509

—

—

1,509
Unrealized gain on marketable securities

—

—

—

5

—

5
Net loss

—

—

—

—

(13,373)

(13,373)
Consolidated balance at June 30, 2021

39,616,696

$
40

$
1,282,657

$
2,592

$
(1,103,007)

$
182,282
Shares issued under stock option and employee stock purchase plans

201,406

—

2,004

—

—

2,004
Shares issued in underwritten offering, net

6,845,238

7

269,886

—

—

269,893
Stock-based compensation

—

—

3,029

—

—

3,029
Unrealized loss on marketable securities

—

—

—

(44)

—

(44)
Net loss

—

—

—

—

(20,452)

(20,452)
Consolidated balance at September 30, 2021

46,663,340

$
47

$
1,557,576

$
2,548

$
(1,123,459)

$
436,712


						Accumulated											Accumulated
	Common	Common		Additional		Other				Total		Common	Common		Additional		Other				Total
	Stock	Stock Par		Paid-In		Comprehensive		Accumulated		Stockholders’		Stock	Stock Par		Paid-In		Comprehensive		Accumulated		Stockholders’
	Shares	Value		Capital		Income		Deficit		Equity		Shares	Value		Capital		Income		Deficit		Equity

	(In thousands, except share amounts)											(In thousands, except share amounts)
Consolidated balance at December 31, 2019	16,972,077	$	17	$	1,104,706	$	2,619	$	(1,013,316)	$	94,026
Consolidated balance at December 31, 2020												39,603,771	$	40	$	1,279,824	$	2,589	$	(1,073,096)	$	209,357
Shares issued under stock option and employee stock purchase plans	12,573		—		24		—		—		24	10,867		—		74		—		—		74
Shares issued in connection with at the market agreement	746,152		1		1,613		—		—		1,614
Stock-based compensation	—		—		686		—		—		686	—		—		1,275		—		—		1,275
Unrealized loss on marketable securities	—		—		—		(22)		—		(22)	—		—		—		(2)		—		(2)
Net loss	—		—		—		—		(12,625)		(12,625)	—		—		—		—		(16,538)		(16,538)
Consolidated balance at March 31, 2020	17,730,802	$	18	$	1,107,029	$	2,597	$	(1,025,941)	$	83,703
Shares issued in connection with at the market agreement	5,978,452		6		23,686		—		—		23,692
Consolidated balance at March 31, 2021												39,614,638	$	40	$	1,281,173	$	2,587	$	(1,089,634)	$	194,166
Shares issued under stock option and employee stock purchase plans												2,058		—		(25)		—		—		(25)
Stock-based compensation												—		—		1,509		—		—		1,509
Unrealized gain on marketable securities												—		—		—		5		—		5
Net loss												—		—		—		—		(13,373)		(13,373)
Consolidated balance at June 30, 2021												39,616,696	$	40	$	1,282,657	$	2,592	$	(1,103,007)	$	182,282
Shares issued under stock option and employee stock purchase plans												201,406		—		2,004		—		—		2,004
Shares issued in underwritten offering, net	15,384,614		15		141,346		—		—		141,361	6,845,238		7		269,886		—		—		269,893
Stock-based compensation	—		—		722		—		—		722	—		—		3,029		—		—		3,029
Unrealized loss on marketable securities	—		—		—		(3)		—		(3)	—		—		—		(44)		—		(44)
Net loss	—		—		—		—		(11,031)		(11,031)	—		—		—		—		(20,452)		(20,452)
Consolidated balance at June 30, 2020	39,093,868	$	39	$	1,272,783	$	2,594	$	(1,036,972)	$	238,444
Shares issued under stock option and employee stock purchase plans	68,204		—		194		—		—		194
Shares issued in connection with at the market agreement	400,400		1		4,296		—		—		4,297
Stock-based compensation	—		—		1,250		—		—		1,250
Unrealized gain on marketable securities	—		—		—		14		—		14
Net loss	—		—		—		—		(14,224)		(14,224)
Consolidated balance at September 30, 2020	39,562,472	$	40	$	1,278,523	$	2,608	$	(1,051,196)	$	229,975
Consolidated balance at September 30, 2021												46,663,340	$	47	$	1,557,576	$	2,548	$	(1,123,459)	$	436,712

~~Table of Contents~~

(8) Stock-Based Compensation

A summary of stock option activity for the nine months ended September 30, ~~2021~~2022 is as follows:


		Weighted		Weighted		Weighted		Weighted
		Average		Average		Average		Average
		Exercise		Remaining		Exercise		Remaining
		Price		Contractual		Price		Contractual
	Shares	Per Share		Term (In Years)	Shares	Per Share		Term (In Years)
Options outstanding at December 31, 2020	3,042,229	$	28.93	8.2
Options outstanding at December 31, 2021					4,077,667	$	30.02	8.0
Granted	1,350,210	$	28.16		1,584,900	$	22.89
Exercised	(192,464)	$	9.53		(353,622)	$	6.71
Canceled	(70,349)	$	35.62		(118,974)	$	50.12
Options outstanding at September 30, 2021	4,129,626	$	29.46	8.2
Options vested and expected to vest at September 30, 2021	3,982,965	$	29.81	8.2
Options exercisable at September 30, 2021	1,387,147	$	51.75	6.7
Options outstanding at September 30, 2022					5,189,971	$	28.97	8.07
Options vested and expected to vest at September 30, 2022					5,031,072	$	29.21	8.05
Options exercisable at September 30, 2022					1,985,506	$	41.56	6.74
Shares available for grant under the 2021 Plan	3,319,116				1,838,291

The weighted average grant-date fair value of stock options granted during the three and nine months ended September 30, ~~2021~~2022 was ~~$41.34~~$25.38 and ~~$21.86,~~$17.36, respectively.

The aggregate intrinsic value of stock options vested and expected to vest at September 30, ~~2021~~2022 was ~~$140.6~~$45.6 million. The aggregate intrinsic value of stock options exercisable at September 30, ~~2021~~2022 was ~~$47.3~~$23.6 million. As of September 30, ~~2021,~~2022, total compensation cost related to non-vested employee, consultant and non-employee director stock options not yet recognized was approximately ~~$33.7~~$46.7 million, net of estimated forfeitures, which is expected to be recognized as expense over a weighted average period of ~~2.9~~2.8 years.

Stock-based compensation expense for the three and nine months ended September 30, ~~2021~~2022 and ~~2020~~2021 was recorded as follows:


	Three months ended September 30,				Nine months ended September 30,				Three months ended September 30,				Nine months ended September 30,
	2021		2020		2021		2020		2022		2021		2022		2021

	(In thousands)				(In thousands)				(In thousands)				(In thousands)
Research and development	$	1,504	$	642	$	2,927	$	1,294	$	2,342	$	1,504	$	5,754	$	2,927
General and administrative		1,525		608		2,886		1,364		2,154		1,525		5,349		2,886
Total stock-based compensation expense	$	3,029	$	1,250	$	5,813	$	2,658	$	4,496	$	3,029	$	11,103	$	5,813

Table of Contents

The fair values of employee, consultant and non-employee director stock options granted during the three and nine months ended September 30, ~~2021~~2022 and ~~2020~~2021 were valued using the Black-Scholes option pricing model with the following assumptions:

Three months ended September 30,

Nine months ended September 30,

Three months ended September 30,

Nine months ended September 30,

2021

2020

2021

2020

2022

2021

2022

2021

Expected stock price volatility

98%

97 – 98%

91 – 98%

91%

98%

90 – 97%

97 – 98%

Expected option term

6.0 Years

Risk-free interest rate

1.1 – 1.2%

0.5%

0.8 – 1.3%

0.5 – 0.6%

2.9 – 3.5%

1.1 – 1.2%

1.7 – 3.6%

0.8 – 1.3%

Expected dividend yield

NaN

None

~~Table of Contents~~

(9) Accumulated Other Comprehensive Income

The changes in accumulated other comprehensive income, which is reported as a component of stockholders’ equity, for the nine months ended September 30, ~~2021~~2022 are summarized below:


	Unrealized						Unrealized
	Loss on						Loss on
	Marketable		Foreign				Marketable		Foreign
	Securities		Currency Items		Total		Securities		Currency Items		Total

	(In thousands)						(In thousands)
Balance at December 31, 2020	$	(7)	$	2,596	$	2,589
Balance at December 31, 2021							$	(702)	$	2,596	$	1,894
Other comprehensive loss		(41)		—		(41)		(2,006)		—		(2,006)
Balance at September 30, 2021	$	(48)	$	2,596	$	2,548
Balance at September 30, 2022							$	(2,708)	$	2,596	$	(112)

~~NaN~~No amounts were reclassified out of accumulated other comprehensive income during the nine months ended September 30, ~~2021.~~2022.

(10) Revenue

~~Product Development and Licensing Revenue~~

The Company’s agreement with Rockefeller University, as amended (the “Rockefeller Agreement”), provides for the Company to perform manufacturing and development services for Rockefeller University for their portfolio of antibodies against HIV. This portfolio was licensed to Gilead Sciences in January 2020 from Rockefeller University (“Rockefeller Transaction”). Pursuant to the Rockefeller Agreement, the Company received an upfront payment of $1.8 million as a result of the Rockefeller Transaction which was recorded to revenue during the first quarter of 2020. The Company is eligible to receive additional payments from Rockefeller University if this portfolio progresses through clinical and commercial development.

Contract and Grants Revenue

The Company has entered into ~~the~~agreements with Rockefeller ~~Agreement~~University and ~~an agreement with~~ Gilead Sciences pursuant to which the Company performs manufacturing and research and development services on a time-and-materials basis or at a negotiated fixed-price. The Company recognized ~~$0.1~~$0.0 million and ~~$4.0~~$0.2 million in revenue under these agreements during the three and nine months ended September 30, ~~2021,~~2022, respectively, and ~~$0.3~~$0.1 million and ~~$0.9~~$4.0 million during the three and nine months ended September 30, ~~2020,~~2021, respectively.

During the third quarter of 2020, the Company was awarded a Small Business Innovation Research (“SBIR”) grant from the National Institutes of Health (NIH) to support the Company’s CDX-1140 and CDX-301 programs. The Company recognized $0.0 million and $0.3 million in grant revenue under the award during the three and nine months ended September 30, 2021, respectively, and $0.3 million during the three and nine months ended September 30, 2020.

Contract Assets and Liabilities

At September 30, ~~2021~~2022 and December 31, ~~2020,~~2021, the Company’s right to consideration under all contracts was considered unconditional, and as such, there were 0no recorded contract assets. At September 30, ~~2021,~~2022, the Company had ~~$0.6~~$0.2 million in contract liabilities recorded, which is expected to be recognized during the next 12 months as manufacturing and research and development services are performed. At December 31, ~~2020,~~2021, the Company had ~~$3.4~~$0.4 million in contract liabilities recorded. Revenue recognized from contract liabilities as of December 31, ~~2020~~2021 during the three and nine months ended September 30, ~~2021~~2022 was ~~$0.0~~$0.2 million and ~~$3.4~~$0.4 million, respectively.

(11) Income Taxes

The Company has evaluated the positive and negative evidence bearing upon the realizability of its net deferred tax assets and considered its history of losses, ultimately concluding that it is “more likely than not” that the Company will not recognize the benefits of federal, state and foreign deferred tax assets and, as such, has maintained a full valuation allowance on its deferred tax assets as of September 30, ~~2021~~2022 and December 31, ~~2020.~~2021.

~~Table of Contents~~

The net deferred tax liability of $1.6 million ~~and $1.8 million~~ at September 30, ~~2021~~2022 and December 31, ~~2020, respectively,~~2021 relates to the temporary differences associated with the IPR&D intangible assets acquired in previous business combinations and is not deductible for tax purposes. A

~~$0.2~~ ~~million non-cash income tax benefit was recorded during the third quarter~~Table of 2021 and a $0.9 million non-cash income tax benefit was recorded during the fourth quarter of 2020 related to impairments of the TAM program IPR&D asset. A $0.2 million non-cash income tax benefit was recorded during the second quarter of 2020 related to the impairment of the CDX-3379 IPR&D asset.Contents

Massachusetts, New Jersey, New York and Connecticut are the jurisdictions in which the Company primarily operates or has operated and has income tax nexus. The Company is not currently under examination by these or any other jurisdictions for any tax year.

(12) Net Loss Per Share

Basic net loss per common share is based upon the weighted-average number of common shares outstanding during the period, excluding restricted stock that has been issued but is not yet vested. Diluted net loss per common share is based upon the weighted-average number of common shares outstanding during the period plus additional weighted-average potentially dilutive common shares outstanding during the period when the effect is dilutive. In periods in which the Company reports a net loss, there is no difference between basic and diluted net loss per share because dilutive shares of common stock are not assumed to have been issued as their effect is anti-dilutive. The potentially dilutive common shares that have not been included in the net loss per common share calculations because the effect would have been anti-dilutive are as follows:


	Nine Months Ended September 30,		Nine Months Ended September 30,
	2021	2020	2022	2021
Stock Options	4,129,626	3,074,832	5,189,971	4,129,626
Restricted Stock	—	—	—	—
	4,129,626	3,074,832	5,189,971	4,129,626

(13) Kolltan Acquisition

On November 29, 2016, the Company acquired all of the share and debt interests of Kolltan, a clinical-stage biopharmaceutical company, in exchange for 1,217,200 shares of the Company’s common stock plus contingent consideration in the form of development, regulatory approval and sales-based milestones (“Kolltan Milestones”) of up to $172.5 ~~million. The payment of Kolltan Milestones , if any, may be made, at Celldex’s sole election,~~million payable in cash, in shares of Celldex’s common stock or a combination of both, in the sole discretion of Celldex and subject to provisions of the Agreement and Plan of Merger, dated November 1, 2016 (the “Merger Agreement”). Certain Kolltan Milestones related to the METRIC clinical study, TAM partnership closing within two years of the acquisition, CDX-3379 and CDX-0158 have been abandoned and, because of this, as of September 30, 2021, the Company believes that the adjusted amount we may be required to pay for future consideration is up to $107.5 million contingent upon the achievement of the Kolltan Milestones.

In October 2019, the Company received a letter from ~~Shareholder Representative Services LLC (“SRS”),~~SRS, the hired representative of the former stockholders of Kolltan, notifying the Company that it objected to the Company’s characterization of the development, regulatory approval and sales-based Kolltan Milestones relating to CDX-0158 as having been abandoned and contending instead that the related milestone payments are due from Celldex to the Kolltan stockholder. ~~The Company disagrees with their objection and believes their objection to be without merit.~~

On August 18, 2020, Celldex filed a Verified Complaint in the Court of Chancery of the State of Delaware against SRS (acting in its capacity as the representative of the former stockholders of Kolltan pursuant to the Merger Agreement) seeking declaratory relief with respect to the rights and obligations of the parties relating to certain contingent milestone payments under the Merger Agreement relating to the discontinued CDX-0158 ~~program. Specifically, Celldex sought~~program (the “Litigation”).

On June 20, 2022, the ~~entry~~Company entered into a binding settlement term sheet (the “Term Sheet”) with SRS, related to the Litigation, which, upon execution of ~~an order declaring that:~~a definitive settlement agreement and the payment of the Initial Payment (as defined below), would result in the joint dismissal, with prejudice, of all claims and counterclaims in the Litigation. The definitive settlement agreement between the Company and SRS was executed on July 15, 2022 (the “Settlement Agreement”) and the Company and SRS jointly filed a Stipulation of Dismissal with prejudice relating to the Litigation on July 19, 2022.

Pursuant to the terms of the Term Sheet and the Settlement Agreement, all milestone payments provided for by the Merger Agreement are replaced in their entirety with the following payments, each of which is payable only once:

(i)

~~Celldex’s determination to discontinue~~The Company paid $15.0 million upon execution of the ~~development~~Settlement Agreement (the “Initial Payment”).

(ii)

The Company shall pay $15.0 million upon the Successful Completion (as defined in the Term Sheet) of ~~CDX-0158 (formerly known as KTN0158) was proper and valid under~~a Phase 2 Clinical Trial (as defined in the Merger ~~Agreement;~~

Agreement) of CDX-0159, subject to the $2.5 million contractual credit as set forth in the Merger Agreement.

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(iii)

The Company shall pay $52.5 million upon the first United States Food and Drug Administration or European Medicines Agency, or, in each case, any successor organization, regulatory approval of a Surviving Company Product (as defined the Term Sheet).

The above payment obligations replace, in their entirety, the contingent consideration in the form of development, regulatory approval and sales-based milestones of up to $172.5 million contained in the Merger Agreement.

Under the Settlement Agreement, each of the Company and SRS provided broad mutual releases of all claims relating to or arising out of the Merger Agreement, including without limitation, all claims brought in the Litigation or that could have been brought in the Litigation.

The Company paid the Initial Payment in cash during the three months ended September 30, 2022. Any future milestone payments related to the CDX-0159 program, which was subject to the Litigation, will be recorded when and if payment becomes probable and reasonably estimable in accordance with the loss contingency model under ASC 450. Milestones related to the remaining Surviving Company Products are measured at fair value (refer to Note 3). When and if any of the remaining payments described above become due, they shall be payable, at the Company’s sole election, in either cash or stock (as set forth in the Merger Agreement) or a combination thereof.

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~~(ii)~~

the Milestone Abandonment Notice dated December 5, 2018 from Celldex was valid and effective under the Merger Agreement and that the “Successful Completion of Phase I Clinical Trial for KTN0158” Milestone has not been achieved and has properly been abandoned; and

~~(iii)~~

~~under the Merger Agreement, the CDX-0159 program is not a program that results in milestone payments under the Merger Agreement.~~

In SRS’ responsive Answer and Verified Counterclaim, SRS made claims of breach of contract with respect to the Merger Agreement, breach of implied covenant of good faith and fair dealing, declaratory relief, and unjust enrichment regarding abandonment of the CDX-0158 milestones, based in part on SRS’ assertion that the CDX-0159 program is in essence an extension of the CDX-0158 (formerly KTN0158) program. The parties entered into non-binding mediation in May 2021 following SRS’s approach to Celldex about its interest in settlement or mediation discussions, but those discussions did not result in a resolution of the dispute. The case remains ongoing and we are currently unable to predict or estimate the outcome of this matter. The case is currently scheduled for trial in June 2022.

Following the Company’s discontinuation of the CDX-3379 program, the Company sent a milestone abandonment notice to SRS with respect to Kolltan Milestones related to the CDX-3379 program. In October 2020, the Company received notice that SRS has objected to that notice, seeking further information from the Company, which was provided pursuant to the terms of the Merger Agreement.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “will,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future.

There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:

●

our dependence on product candidates, which are still in an early development stage;

●

our ability to successfully complete research and further development, including preclinical and clinical studies, and, if we obtain regulatory approval, commercialization of our drug candidates and the growth of the markets for those drug candidates;

●

our anticipated timing for preclinical development, regulatory submissions, commencement and completion of clinical trials and product approvals;

●

the impact of the COVID-19 pandemic on our business or on the economy generally;

●

whether the COVID-19 pandemic will affect the timing of the completion of our planned and/or currently ongoing preclinical/clinical trials;

●

our ability to negotiate strategic partnerships, where appropriate, for our drug candidates;

●

our ability to manage multiple clinical trials for a variety of drug candidates at different stages of development;

●

the cost, timing, scope and results of ongoing preclinical and clinical testing;

●

our expectations of the attributes of our product and development candidates, including pharmaceutical properties, efficacy, safety and dosing regimens;

●

the cost, timing and uncertainty of obtaining regulatory approvals for our drug candidates;

●

the availability, cost, delivery and quality of clinical management services provided by our clinical research organization partners;

●

the availability, cost, delivery and quality of clinical and commercial-grade materials produced by our own manufacturing facility or supplied by contract manufacturers, suppliers and partners;

●

our ability to develop and commercialize products before competitors that are superior to the alternatives developed by such competitors;

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●

our ability to develop technological capabilities, including identification of novel and clinically important targets, exploiting our existing technology platforms to develop new drug candidates and expand our focus to broader markets for our existing targeted therapeutics;

●

the cost of paying ~~development, regulatory approval and sales-based~~the future milestones, if any, under the ~~merger agreement by which we acquired Kolltan, and the cost, timing, and outcome of our declaratory judgment action against the Kolltan stockholder representative~~Settlement Agreement with ~~respect to certain of those milestones;~~

●

~~our ability to realize the anticipated benefits from the acquisition of Kolltan;~~SRS;

●

our ability to raise sufficient capital to fund our preclinical and clinical studies and to meet our long-term liquidity needs, on terms acceptable to us, or at all. If we are unable to raise the funds necessary to meet our long-term liquidity needs, we may have to delay or discontinue the development of one or more programs, discontinue or delay ongoing or anticipated clinical trials, license out programs earlier than expected, raise funds at significant discount or on other unfavorable terms, if at all, or sell all or part of our business;

●

our ability to protect our intellectual property rights and our ability to avoid intellectual property litigation, which can be costly and divert management time and attention;

●

our ability to develop and commercialize products without infringing the intellectual property rights of third parties; and

●

the risk factors set forth elsewhere in this quarterly report on Form 10-Q and the factors listed under the headings “Business,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in ~~the Company’s~~our annual report on Form 10-K for the year ended December 31, ~~2020~~2021 and other reports that we file with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by reference into this report. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections in good faith, and we believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections will result or be achieved or accomplished.

OVERVIEW

We are a biopharmaceutical company dedicated to developing therapeutic monoclonal and bispecific antibodies that address diseases for which available treatments are inadequate. Our drug candidates include antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with inflammatory diseases and many forms of cancer.

We are focusing our efforts and resources on the continued research and development of:

●

~~CDX-0159,~~Barzolvolimab (also referred to as CDX-0159), a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity, is currently being studied inacross multiple mast cell driven ~~diseases.In October~~diseases including:

Chronic Urticarias: In June and ~~December 2020~~July 2022 respectively, we announced that enrollment had opened and the first patients had been dosed in Phase 1b2 studies in chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). Positive interim data from the ongoing Phase 1b study in CSU were reported in July 2022. Positive interim data from the Phase 1b study in CIndU were reported in July and September 2021 in patients with cold urticaria and symptomatic ~~dermographism. The study has also~~dermographism;

Prurigo Nodularis (PN): In December 2021 we announced that the first patient had been ~~expanded to include patients with cholinergic urticaria and enrollment has opened~~dosed in a Phase 1b study in ~~prurigo nodularis.~~PN; and

Eosinophilic Esophagitis (EoE): We plan to initiate a Phase 2 study in EoE in the first half of 2023.

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●

~~CDX-1140, an agonist monoclonal~~Our next generation bispecific antibody ~~targeted~~platform to ~~CD40, a key activator of immune response, currently~~support pipeline expansion with additional candidates for inflammatory diseases and oncology. Targets are being ~~studied in a Phase 1 study. Dose escalation was completed in solid tumors and lymphoma and the recommended dose for further study was determined~~selected based on new science as well as their compatibility to be ~~1.5 mg/kg for both CDX-1140 monotherapy and~~used in ~~combination. We have initiated multiple expansion cohorts within the study, including a combination cohort~~bispecific antibody formats with ~~KEYTRUDA® (pembrolizumab) in patients refractory~~Celldex’s existing antibody programs. Development is focused on emerging, important pathways controlling inflammatory diseases or immunity to ~~PD1/PDL1 treatment.~~tumors.

●

CDX-527, a bispecific antibody that uses our proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway, for which we initiated a Phase 1 study in advanced solid tumors in August 2020.

We routinely work with external parties to collaboratively advance our drug candidates. In addition to Celldex-led studies, we also have an Investigator Initiated Research (IIR) program with multiple studies ongoing with our drug candidates.

Our goal is to build a fully integrated, commercial-stage biopharmaceutical company that develops important therapies for patients with unmet medical needs. We believe our program assets provide us with the strategic options to either retain full economic rights to our innovative therapies or seek favorable economic terms through advantageous commercial partnerships. This approach allows us to maximize the overall value of our technology and product portfolio while best ensuring the expeditious development of each individual product. Currently, all programs are fully owned by ~~Celldex.~~us.

The expenditures that will be necessary to execute our business plan are subject to numerous uncertainties. Completion of clinical trials may take several years or more, and the length of time generally varies substantially according to the type, complexity, novelty and intended use of a drug candidate. It is not unusual for the clinical development of these types of drug candidates to each take five years or more, and for total development costs to exceed $100 million for each drug candidate. We estimate that clinical trials of the type we generally conduct are typically completed over the following timelines:


		Estimated
		Completion
Clinical Phase		Period
Phase 1		1 - 2 Years
Phase 2		1 - 5 Years
Phase 3		1 - 5 Years

The duration and the cost of clinical trials may vary significantly over the life of a project as a result of differences arising during the clinical trial protocol, including, among others, the following:

●

the number of patients that ultimately participate in the trial;

●

the duration of patient follow-up that seems appropriate in view of results;

●

the number of clinical sites included in the trials;

●

the length of time required to enroll suitable patient subjects; and

●

the efficacy and safety profile of the drug candidate.

We test potential drug candidates in numerous preclinical studies for safety, toxicology and immunogenicity. We may then conduct multiple clinical trials for each drug candidate. As we obtain results from trials, we may elect to discontinue or delay clinical trials for certain drug candidates in order to focus our resources on more promising drug candidates.

An element of our business strategy is to pursue the discovery, research and development of a broad portfolio of drug candidates. This is intended to allow us to diversify the risks associated with our research and development expenditures. To the extent we are unable to maintain a broad range of drug candidates, our dependence on the success of one or a few drug candidates increases.

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Regulatory approval is required before we can market our drug candidates as therapeutic products. In order to proceed to subsequent clinical trial stages and to ultimately achieve regulatory approval, the regulatory agencies must conclude that our clinical data demonstrate that our product candidates are safe and effective. Historically, the results from preclinical testing and early clinical trials (through Phase 2) have often not been predictive of results obtained in later clinical trials. A number of new drugs and biologics have shown promising results in early clinical trials but subsequently failed to establish sufficient safety and efficacy data to obtain necessary regulatory approvals.

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Furthermore, our business strategy includes the option of entering into collaborative arrangements with third parties to complete the development and commercialization of our drug candidates. In the event that third parties take over the clinical trial process for one of our drug candidates, the estimated completion date would largely be under control of that third party rather than us. We cannot forecast with any degree of certainty which proprietary products, if any, will be subject to future collaborative arrangements, in whole or in part, and how such arrangements would affect our development plan or capital requirements. Our programs may also benefit from subsidies, grants, contracts or government or agency-sponsored studies that could reduce our development costs.

As a result of the uncertainties discussed above, among others, it is difficult to accurately estimate the duration and completion costs of our research and development projects or when, if ever, and to what extent we will receive cash inflows from the commercialization and sale of a product. Our inability to complete our research and development projects in a timely manner or our failure to enter into collaborative agreements, when appropriate, could significantly increase our capital requirements and could adversely impact our liquidity. These uncertainties could force us to seek additional, external sources of financing from time to time in order to continue with our business strategy. Our inability to raise additional capital, or to do so on terms reasonably acceptable to us, would jeopardize the future success of our business.

During the past five years through December 31, ~~2020,~~2021, we incurred an aggregate of ~~$350.6~~$301.1 million in research and development expenses. The following table indicates the amount incurred for each of our significant research programs and for other identified research and development activities during the nine months ended September 30, ~~2021~~2022 and ~~2020.~~2021. The amounts disclosed in the following table reflect direct research and development costs, license fees associated with the underlying technology and an allocation of indirect research and development costs to each program.


	Nine Months		Nine Months		Nine Months		Nine Months
	Ended		Ended		Ended		Ended
	September 30, 2021		September 30, 2020		September 30, 2022		September 30, 2021

	(In thousands)				(In thousands)
CDX‑0159/Anti-KIT Program	$	18,264	$	5,233
Barzolvolimab/Anti-KIT Program					$	35,519	$	18,264
CDX‑585						8,638		3,233
CDX‑527						1,659		3,008
CDX‑1140 and CDX-301		4,097		9,093		3,333		4,097
CDX‑527		3,008		7,719
Other Programs		13,264		10,064		10,210		10,031
Total R&D Expense	$	38,633	$	32,109	$	59,359	$	38,633

Clinical Development Programs

~~The~~

COVID-19 ~~pandemic~~ continues to have ~~a major~~an impact in the US and around the world. The availability of vaccines holds promise for the future, though new variants of the virus and potential waning immunity from vaccines may result in continued impact from this pandemic in the future, including supply chain and work force issues which could adversely impact our operations. To date, ~~the Company has~~we have managed delays and disruptions without significant impact in planned and ongoing preclinical and clinical trials, manufacturing or shipping. Potential impacts to our business include delays in planned and ongoing preclinical and clinical trials including enrollment of patients, disruptions in time and resources provided by independent clinical investigators, contract research organizations, and other third-party service providers, temporary closures of our facilities, disruptions or restrictions on our employees’ ability to travel, and delays in manufacturing and/or shipments to and from third-party suppliers and contract manufacturers for APIs and drug product.

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~~CDX-0159~~Barzolvolimab (also referred to as CDX-0159)

~~CDX-0159~~

Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT and potently inhibits its activity. KIT is expressed in a variety of cells, including mast cells, and its activation by its ligand SCF regulates mast cell growth, differentiation, survival, chemotaxis and degranulation. In certain inflammatory diseases, such as chronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria (CIU) and chronic inducible urticaria (CIndU), mast cell degranulation plays a central role in the onset and progression of the disease.

~~CDX-0159~~Barzolvolimab is designed to block KIT activation by disrupting both SCF binding and KIT dimerization. ~~Celldex believes~~We believe that by targeting KIT, ~~CDX-0159~~barzolvolimab may be able to inhibit mast cell activity and decrease mast cell numbers to provide potential clinical benefit in mast cell related diseases.

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In certain inflammatory diseases, such as chronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria (CIU), and chronic inducible urticaria (CIndU), mast cell degranulation plays a central role in the onset and progression of the disease. In June 2020, we completed a randomized, double-blind, placebo-controlled, single ascending dose escalation Phase 1a study of ~~CDX-0159~~barzolvolimab in healthy subjects (n=32; 8 subjects per cohort, 6 ~~CDX-0159;~~barzolvolimab; 2 placebo). Subjects received a single intravenous infusion of ~~CDX-0159~~barzolvolimab at 0.3, 1.0, 3.0, or 9.0 mg/kg or placebo. The objectives of the study included safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (tryptase and stem cell factor) and immunogenicity. Tryptase is an enzyme synthesized and secreted almost exclusively by mast cells and decreases in plasma tryptase levels are believed to reflect a systemic reduction in mast cell burden in both healthy volunteers and in disease. Data from the study were featured in a late breaking presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2020 in June. ~~CDX-0159~~Barzolvolimab demonstrated a favorable safety profile as well as profound and durable reductions of plasma tryptase, consistent with systemic mast cell suppression.

These data supported expansion of the ~~CDX-0159~~barzolvolimab program into mast cell driven diseases, including initially in ~~chronic spontaneous urticaria (CSU)~~CSU and ~~chronic inducible urticaria (CIndU),~~CIndU, diseases where mast cell degranulation plays a central role in the onset and progression of the disease. The prevalence of CSU and CIndU is approximately 0.5-1% of the total population or up to 1 to 3 million patients in the United States alone (Weller et al. 2010. Hautarzt. 61(8), Bartlett et al. 2018. DermNet. Org). CSU presents as itchy hives, angioedema or both for at least six weeks without a specific trigger; multiple episodes can play out over years or even decades. About 50% of patients with CSU achieve symptomatic control with antihistamines or leukotriene receptor antagonists. Omalizumab, an IgE inhibitor, provides relief for roughly half of the remaining antihistamine/leukotriene refractory patients. Consequently, there is a need for additional therapies. CIndUs are forms of urticaria that have an attributable cause or trigger associated with them, typically resulting in hives or wheals. ~~Celldex is~~We are exploring cold-induced, dermographism (scratch-induced) and cholinergic (exercise-induced) urticarias. In June and July 2022 respectively, we announced the initiation of Phase 2 studies in both CSU and CIndU.

In October 2020, we announced that enrollment had opened and the first patient had been dosed in a Phase 1b multi-center study of ~~CDX-0159~~barzolvolimab in CSU. This study is a randomized, double-blind, placebo-controlled clinical trial designed to assess the safety of multiple ascending doses of ~~CDX-0159~~barzolvolimab in up to 40 patients with CSU who remain symptomatic despite treatment with antihistamines. Secondary and exploratory objectives include pharmacokinetic and pharmacodynamic assessments, including measurement of tryptase and stem cell factor levels and clinical activity outcomes (impact on urticaria symptoms, disease control, clinical response) as well as quality of life assessments. ~~CDX-0159~~Barzolvolimab is administered intravenously (0.5, 1.5, 3 and 4.5 mg/kg at varying dosing schedules) as add on treatment to H1-antihistamines, either alone or in combination with H2-antihistamines and/or leukotriene receptor agonists.

In June 2022, we reported positive interim data from the CSU study. As of the data cut-off on May 23, 2022, 34 patients with CSU were enrolled and treated [26 barzolvolimab (n=9 in 0.5 mg/kg; n=8 in 1.5 mg/kg; n=9 in 3.0 mg/kg) and 8 placebo]. The 0.5 mg/kg and 1.5 mg/kg cohorts had completed study participation through 24 weeks; 7 of 12 patients in the 3.0 mg/kg cohort had completed week 12; enrollment in the 4.5 mg/kg cohort was ongoing. Adverse events through data cutoff and hematology data through week 12 were included for all dose groups; clinical activity and tryptase data were included through week 12 for 0.5 mg/kg and 1.5 mg/kg, and through week 8 for 3 mg/kg (ongoing; reflecting the administration of only one dose). Data shows that barzolvolimab results in rapid, marked and durable responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment.

●

Mean reduction from baseline in urticaria activity (Urticaria Activity Score over 7 days or UAS7) of 66.6% in all patients in the 1.5 mg/kg dose group (n=8) at week 12 and 75.1% in all patients in the 3.0 mg/kg dose group (n=9) at week 8 (reflects only one dose), demonstrating clinically meaningful symptom improvements for patients.

●

Complete response (UAS7=0) of 57.1% in the 1.5 mg/kg dose group at week 12 and 44.4% at week 8 (reflects only one dose) in the 3 mg/kg dose group which is a key therapeutic goal.

●

75% well-controlled disease by Urticaria Control Test (UCT) in the 1.5 mg/kg dose group at week 12 and 83.3% in the 3 mg/kg dose group at week 8 (reflects only one dose).

●

Patients with prior omalizumab therapy had similar symptom improvement as all patients.

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●

All three doses of barzolvolimab markedly improved urticaria symptoms and disease control, with rapid improvement in itch and hives. As predicted, the lowest dose of 0.5 mg/kg resulted in suboptimal clinical activity compared to the higher doses.

●

Rapid onset of responses after initial dosing and sustained durability were observed; onset as early as 1 week after the first dose.

●

Tryptase suppression, indicative of mast cell depletion, paralleled symptom improvement, demonstrating the impact of mast cell depletion on CSU disease activity.

●

Barzolvolimab was well tolerated with a favorable safety profile; effects of multiple dose administration were consistent with observations in single dose studies. Most AEs were mild or moderate in severity and resolved while on study, with none leading to treatment discontinuation. The most common treatment emergent adverse events were urinary tract infections, headache, neutropenia and back pain. UTIs, headache and backpain were all reported as unrelated to treatment. Changes in hematologic parameters were consistent with observations in single dose studies, with no pattern of further decreases with multiple doses; hematologic values generally remained within the normal range.

In June 2022, we announced that the first patient has been dosed in a Phase 2 study in patients with CSU who remain symptomatic despite antihistamine therapy. The study will be conducted at more than 75 sites across 10 or more countries. The study is a randomized, double-blind, placebo-controlled, parallel group Phase 2 study evaluating the efficacy and safety profile of multiple dose regimens of barzolvolimab to determine the optimal dosing strategy. Approximately 168 patients will be randomly assigned on a 1:1:1:1 ratio to receive subcutaneous injections of barzolvolimab at 75 mg every 4 weeks, 150 mg every 4 weeks, 300 mg every 8 weeks or placebo during a 16-week placebo-controlled treatment phase. Patients will then enter a 36-week active treatment phase, in which patients not already randomized to barzolvolimab at 150 mg every 4 weeks or 300 mg every 8 weeks will be randomized 1:1 to receive one of these two dose regimens; patients already randomized to these treatment arms will remain on the same regimen as during the placebo-controlled treatment phase. Following the treatment period, patients will enter a 24-week follow up phase. The primary endpoint of the study is mean change in baseline to Week 12 in UAS7 (Urticaria Activity Score over 7 days). Secondary endpoints include safety and other assessments of clinical activity including ISS7 (Itch Severity Score over 7 days), HSS7 (Hive Severity Score over 7 days) and AAS7 (Angioedema Activity Score over 7 days).

In December 2020, we announced that enrollment had opened and the first patient had been dosed in a ~~second~~ Phase 1b study in CIndU being conducted in Germany in patients who are refractory to antihistamines. This study is an open label clinical trial designed to evaluate the safety of a single dose (3 mg/kg) of ~~CDX-0159~~barzolvolimab in patients with cold urticaria (n=10) or symptomatic dermographism (n=10). In March and June 2021, respectively, we added a third cohort (single dose, 3 mg/kg) in patients with cholinergic urticaria (n=10) and a fourth cohort at a lower dose (single dose, 1.5 mg/kg) in cold urticaria. Patient’s symptoms are induced via provocation testing that resembles real life triggering situations. Secondary and exploratory objectives include pharmacokinetic and pharmacodynamic assessments, including changes from baseline provocation thresholds, measurement of tryptase and stem cell factor levels, clinical activity outcomes (impact on urticaria symptoms, disease control, clinical response), quality of life assessments and measurement of tissue mast cells through skin biopsies. ~~CDX-0159~~Barzolvolimab is administered intravenously on Day 1 as add on treatment to H1-antihistamines.

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In July of 2021, we reported positive interim data from the cold urticaria and symptomatic dermographism cohorts. As of the data cut-off on June 11, 2021, 20 patients had received a single intravenous infusion of ~~CDX-0159~~barzolvolimab at 3 mg/kg, including 11 patients with cold urticaria and 9 patients with symptomatic dermographism. Patients had high disease activity as assessed by provocation threshold testing. In patients with cold urticaria and symptomatic dermographism baseline critical temperature thresholds were 18.9°C/66°F (range: 5-27°C/41-80.6°F) and FricTest® thresholds were 3.8 (range: 3-4) of 4 pins. Safety results were reported for all 20 patients; activity results were reported for the 19 patients who received a full dose of ~~CDX-0159.~~barzolvolimab. 14 of 19 patients completed the 12-week study observation period and five were ongoing (range of 2-8 weeks) as of June 11, 2021.

●

All 19/19 ~~(100%)~~(100)% patients experienced a clinical response as assessed by provocation threshold testing; 18/19 ~~(95%)~~(95)% experienced a complete response and 1/19 ~~(5%)~~(5)% experienced a partial response.10/10 ~~(100%)~~(100)% patients with cold urticaria experienced a complete response. 8/9 ~~(89%)~~(89)% patients with symptomatic dermographism experienced a complete response and 1/9 ~~(11%)~~(11)% experienced a partial response. Compete responses were observed in all 3 patients (1 cold urticaria; 2 symptomatic dermographism) with prior Xolair® (omalizumab) experience, including two who were Xolair refractory.

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Rapid onset of responses after dosing and sustained durability were observed. Most patients with cold urticaria and symptomatic dermographism experienced a complete response by week 1 and by week 4, respectively. The median duration of response for patients was 77+ days for cold urticaria and 57+ days for symptomatic dermographism.

●

Improvements in disease activity as reported by physician’s and patient’s global assessment of disease severity were consistent with the complete responses as measured by provocation testing.

●

A single 3 mg/kg dose of ~~CDX-0159~~barzolvolimab resulted in rapid, marked and durable suppression of serum tryptase and depletion of skin mast cells (87% depletion) as measured through biopsy. The kinetics of serum tryptase and skin mast cell depletion mirrored clinical activity. This confirmed that serum tryptase level is a robust pharmacodynamic biomarker for assessing mast cell burden and clinical activity in inducible urticaria and potentially in other diseases with mast cell driven involvement.

●

~~CDX-0159~~Barzolvolimab was generally well tolerated. The most common adverse events were hair color changes, mild infusion reactions, and transient changes in taste perception. Hair color changes (generally small areas of hair color lightening) and taste disorders (generally partial changes of ability to taste salt) are consistent with inhibiting KIT signaling in other cell types and are expected to be fully reversible. As previously reported in March 2021, a single severe infusion reaction of brief loss of consciousness was observed in a patient with a history of fainting. The patient rapidly recovered. Importantly, no evidence of mast cell activation as measured by serum tryptase monitoring was observed. There was no evidence of clinically significant decreases in hematology parameters—an important finding for a KIT inhibitor.

●

One patient with symptomatic dermographism enrolled in the study also had a diagnosis of prurigo ~~nodularis.~~nodularis (PN). After a single dose of ~~CDX-0159,~~barzolvolimab, this patient experienced both a complete response of symptomatic dermographism and notable improvement of the ~~prurigo nodularis.~~PN.

In September of 2021, we reported additional positive data from the study on measurements of symptom control and quality of life. A single dose of ~~CDX-0159~~barzolvolimab (3 mg/kg) resulted in a rapid and sustained improvement in urticaria control and greatly reduced disease impact on quality of life, as measured by the Urticaria Control Test (UCT) and Dermatology Life Quality Index (DLQI).

~~We continue~~

In July 2022 we announced that the first patient has been dosed in a Phase 2 study in patients with CIndU who remain symptomatic despite antihistamine therapy. The study will be conducted at more than 75 sites across 10 or more countries. The randomized, double-blind, placebo-controlled, parallel group Phase 2 study is evaluating the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients with CIndU to ~~assess potential opportunities~~determine the optimal dosing strategy. Approximately 180 patients in 2 cohorts (differentiated by CIndU subtype) including 90 patients with cold urticaria and 90 patients with symptomatic dermographism will be randomly assigned on a 1:1:1 ratio to receive subcutaneous injections of barzolvolimab at 150 mg every 4 weeks, 300 mg every 8 weeks or placebo during a 20-week treatment phase. Patients will then enter a follow-up phase for ~~CDX-0159 in~~an additional 24 weeks. The primary endpoint of the study is the percentage of patients with a negative provocation test at Week 12 (using TempTest(R) and FricTest(R)). Secondary endpoints include safety and other ~~diseases where mast cells play an important role, such as dermatologic, respiratory, allergic, gastrointestinal~~assessments of clinical activity including CTT (Critical Temperature Threshold), CFT (Critical Friction Threshold) and ~~ophthalmic conditions.~~ WI-NRS (Worst itch numeric rating scale).

We have expanded clinical development of ~~CDX-0159~~barzolvolimab into prurigo nodularis (PN),. PN is a chronic skin disease characterized by the development of hard, intensely itchy (pruritic) nodules on the skin. Mast cells through their interactions with sensory neurons and other immune cells are believed to play an important role in amplifying chronic itch and neuroinflammation, both of which are a hallmark of PN. There ~~are~~is currently noonly one FDA approved ~~therapies~~therapy for PN, representing an area of significant unmet need. Industry sources estimate there are approximately 154,000 patients in the United States with PN who have undergone treatment within the last 12 months and, of these, approximately 75,000 would be biologic-eligible. In ~~September, enrollment opened~~December 2021, the first patient was dosed in a Phase 1b multi-center, randomized, double-blind, placebo-controlled study designed to assess the safety and treatment effects across multiple dosing cohorts of ~~CDX-0159~~barzolvolimab in up to 4030 patients with PN.

Table of Contents

Manufacturing activities to support the introduction of the ~~CDX-0159~~barzolvolimab subcutaneous formulation into the clinical program have been completed and, in September of 2021, ~~Celldex~~we initiated ~~and has since completed~~ dosing in a randomized, double-blind, placebo-controlled, Phase 1 study designed to evaluate the safety of single ascending doses of the subcutaneous formulation of ~~CDX-0159~~barzolvolimab in healthy volunteers. In February 2022, we reported that subcutaneous administration of barzolvolimab was well tolerated and that multiple dose levels have been identified that possess promising pharmacokinetic and pharmacodynamic properties. Importantly, subcutaneous delivery of barzolvolimab resulted in dose-dependent, rapid and sustained decreases in serum tryptase compared with placebo and achieved sufficient exposure to produce tryptase suppression levels comparable with the levels that generated impressive clinical activity observed in the Phase 1 CIndU intravenous study. The Phase 2 multi-dose studies in urticaria are designed to evaluate 75mg and 150mg administered every 4 weeks and 300mg administered every 8 weeks. These doses support a 0.5 to 2 ml injection volume, allowing for a single injection as barzolvolimab advances towards potential commercialization. In 2022, we initiated transfer of our current barzolvolimab manufacturing process to a contract manufacturing organization to support late-stage trials and to prepare for potential commercialization.

In February 2022, we also reported interim data after completing the in-life dosing portion of our nine-month chronic toxicology study in non-human primates; a subset of the animals will continue to be followed beyond clearance of the barzolvolimab antibody to study completion. As expected and consistent with other KIT-targeting agents, impact on spermatogenesis was observed which is anticipated to be fully reversible upon clearance of the antibody. There were no other clinically adverse findings reported in the study. We believe these data strongly support our Phase 2 studies in urticaria and in future indications.

In February 2022, we announced that we will be expanding clinical development of barzolvolimab into eosinophilic esophagitis (EoE), the most common type of eosinophilic gastrointestinal disease. EoE is a chronic inflammatory disease of the esophagus characterized by the infiltration of eosinophils. This chronic inflammation can result in trouble swallowing, chest pain, vomiting and impaction of food in the esophagus, a medical emergency. Several studies have suggested that mast cells may be an important driver in the disease, demonstrating that the number and activation state of mast cells are greatly increased in EoE biopsies and that mast cell signatures correlate with markers of inflammation, fibrosis, pain and disease severity. Currently, there is only one FDA approved therapy for EoE, representing an area of significant unmet need. Industry sources estimate there are approximately 160,000 patients in the United States with EoE who have undergone treatment within the last 12 months and, of these, approximately 48,000 would be biologic-eligible. Given the lack of effective therapies for EoE and barzolvolimab’s potential as a mast cell depleting agent, we believe EoE is an important indication for future study.

We continue to assess potential opportunities for barzolvolimab in other diseases where mast cells play an important role, such as dermatologic, respiratory, allergic, gastrointestinal and ophthalmic conditions.

Bispecific Platform

Our next generation bispecific antibody platform is supporting the expansion of our pipeline with additional candidates for inflammatory diseases and oncology. Targets are being selected based on new science as well as their compatibility to be used in bispecific antibody formats with our existing antibody programs. Development is focused on emerging, important pathways controlling inflammatory diseases or immunity to tumors.

CDX-585

CDX-585 combines our proprietary highly active PD-1 blockade and anti-ILT4 blockade to block immunosuppressive signals in T cells and myeloid cells. ILT4 is emerging as an important immune checkpoint on myeloid cells. CDX-585 is currently completing CMC and IND-enabling activities and is expected to enter the clinic in 2023.

CDX-527

CDX-527 uses our proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway to help prime and activate anti-tumor T cell responses through CD27 costimulation, while preventing PD-1 inhibitory signals that subvert the immune response. Our prior clinical experience with combining CD27 activation and PD-1 blockade provide the rationale for linking these two pathways into one molecule and preclinical data demonstrated that CDX-527 is more potent at T cell activation and anti-tumor immunity than the combination of parental monoclonal antibodies.

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In August 2020, we announced the initiation of a Phase 1 dose-escalation study. The study was designed to include up to 40 patients with advanced or metastatic solid tumors that had progressed during or after standard of care therapy to be followed by tumor-specific expansion cohorts. The study included a dose-escalation phase to determine a maximum tolerated dose, or MTD, and to recommend a dose level for further study in a subsequent expansion phase. The expansion was designed to further evaluate the tolerability, and biologic and anti-tumor effects of selected dose level(s) of CDX-527 in specific tumor types. Enrollment to the dose escalation portion (n=18) of the study was completed with no dose-limiting toxicities or treatment related serious adverse events observed and CDX-527 demonstrated promising pharmacodynamic and pharmacokinetic activity, which are important key hurdles for the development of bispecific antibodies. An expansion cohort in ovarian cancer was initiated.

In November 2022, we provided an update on the study. The standard of care in ovarian cancer continues to evolve, making drug development in this indication more challenging. With multiple clinical trials actively recruiting in ovarian cancer, enrollment to the expansion cohort in patients with checkpoint naïve ovarian cancer (n=8) did not meet our internal timelines and a review of the results to date also did not meet internal hurdles for proceeding. Given the evolving environment and our pipeline and resource priorities, we have decided that the study will be closed and the program discontinued.

Other programs:

CDX-1140

CDX-1140 is a fully human agonist monoclonal antibody targeted to CD40, a key activator of immune response, which is found on dendritic cells, macrophages and B cells and is also expressed on many cancer cells. Potent CD40 agonist antibodies have shown encouraging results in early clinical studies; however, systemic toxicity associated with broad CD40 activation has limited their dosing concentrations to levels that may not be optimal for engaging CD40 expressing cells in the tumor microenvironment. CDX-1140 has unique properties relative to other CD40 agonist antibodies: potent agonist activity is independent of Fc receptor interaction, contributing to more consistent, controlled immune activation; CD40L binding is not blocked, leading to potential synergistic effects of agonist activity near activated T cells in lymph nodes and tumors; and the antibody does not promote cytokine production in whole blood assays. CDX-1140 has shown direct anti-tumor activity in preclinical models of lymphoma. Preclinical studies of CDX-1140 clearly demonstrate strong immune activation effects and low systemic toxicity and support the design of the

A Phase 1 study ~~to identify the dose for characterizing single-agent and combination activity.~~

~~In November 2017, we initiated a Phase 1 study of CDX-1140~~was conducted in ~~up to 260~~ patients with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas. ~~The study is designed to determine the maximum tolerated dose, or~~An MTD, during a dose-escalation phase (0.01 to 3.0 mg/kg once every four weeks until confirmed progression or intolerance) and to recommend a dose level for further study in a subsequent expansion phase. Secondary objectives include assessments of safety and tolerability, pharmacodynamics, pharmacokinetics, immunogenicity and additional measures of anti-tumor activity, including clinical benefit rate. We believe that the potential for CDX-1140 will be best defined in combination studies with other immunotherapies or conventional cancer treatments. A combination cohort with CDX-301, a hematopoietic cytokine that uniquely expands dendritic cells and hematopoietic stem cells and a safety run-in combination cohort with gemcitabine/nab-paclitaxel in patients with previously untreated metastatic pancreatic adenocarcinoma have been completed. A combination of CDX-1140 with pembrolizumab has completed the safety run-in phase. Expansion cohorts in patients with checkpoint-refractory/resistant squamous cell head and neck cancer and non-small cell lung cancer are enrolling patients.

~~In November 2020, we reported interim Phase 1 data from patients treated at the maximum tolerated dose (MTD) and recommended dose~~ of 1.5 mg/kg—one of the highest systemic dose levels in the CD40 agonist class. Interim data from the study were presented at the Society for Immunotherapy of Cancer’s (SITC) 35th Annual Meeting 2020 (n=41; 25 mono, 16 with CDX-301kg was established and ~~29 with post-treatment scans). Preliminary safety data from the combination cohort with pembrolizumab (n=9; 4 at 0.72 mg/kg and 5 at 1.5 mg/kg CDX-1140) were also presented. CDX-1140~~clinical activity was observed both as a monotherapy and in combination with ~~pembrolizumab was generally well tolerated with mostly grade 1 or 2 drug related adverse events. Activity at 1.5mg/kg dose~~pembrolizumab. Despite evidence of clinical benefit, questions remain to be answered about CDX-1140, included an ongoing complete response (CR; 18 months as of Oct 2021) in a patient with follicular lymphoma treated with CDX-1140 monotherapy. There was notable tumor shrinkage and/or necrosis in 6 patients with squamous cell head and ~~neck cancer (SCCHN) treated with CDX-1140 alone or in combination with CDX-301 and stable disease (n=10) for 11 to 32 weeks. CDX-1140 provided good systemic exposure and resulted in marked changes in~~ the ~~tumor microenvironment.~~

In November 2021, we provided an update on the ongoing Phase 1 study. Emerging data from the safety run-in cohort of CDX-1140 with gemcitabine/nab-paclitaxel in patients with previously untreated metastatic pancreatic adenocarcinoma and externalbroader CD40 agonist ~~data recently reported using~~class, regarding the ~~same regimen, suggest that simultaneous treatment with chemotherapy~~best clinical settings, regimens, and ~~CD40 activation may~~possible combinations before advancing into additional Celldex-sponsored studies. Given our pipeline priorities and resource requirements, we are not ~~be optimal. Alternative strategies for investigating CDX-1140~~progressing further Company-sponsored studies at this time and are exploring these questions in ~~pancreatic cancer in other regimens are being explored, including through investigator~~third-party sponsored studies. The combination of CDX-1140 with pembrolizumab has completed the safety run-in phase. Expansion cohorts in patients with checkpoint-refractory/resistant squamous cell head and neck cancer and non-small cell lung cancer are enrolling patients. Of the six patients with squamous cell head and neck cancer treated with CDX-1140 at 1.5 mg/kg in combination with pembrolizumab, encouraging preliminary results have been observed including a confirmed partial response and durable stable disease. Of the six evaluable patients with non-small cell lung cancer, four have had stable disease as their best response. Adverse events, such as arthralgia, myalgia and fatigue, have occurred more frequently in combination with pembrolizumab relative to CDX-1140 monotherapy and the protocol has been amended to allow CDX-1140 dose reduction, if necessary, to help manage these toxicities. Enrollment to the study is ongoing.

~~Table of Contents~~

~~CDX-527~~

CDX-527 is the first candidate from Celldex’s bispecific antibody platform. Bispecifics provide opportunities to engage two independent pathways involved in controlling immune responses to tumors. CDX-527 uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway to help prime and activate anti-tumor T cell responses through CD27 costimulation, while preventing PD-1 inhibitory signals that subvert the immune response.

Celldex’s prior clinical experience with combining CD27 activation and PD-1 blockade provide the rationale for linking these two pathways into one molecule. Preclinical data presented at the SITC 34th Annual Meeting in November 2019 demonstrated that CDX-527 is more potent at T cell activation and anti-tumor immunity than the combination of parental monoclonal antibodies.

In August 2020, we announced the initiation of a Phase 1 dose-escalation study. The study includes up to approximately 40 patients with advanced or metastatic solid tumors that have progressed during or after standard of care therapy to be followed by tumor-specific expansion cohorts. The study is designed to determine the maximum tolerated dose, or MTD, during a dose-escalation phase and to recommend a dose level for further study in the subsequent expansion phase. The expansion is designed to further evaluate the tolerability, and biologic and anti-tumor effects of selected dose level(s) of CDX-527 in specific tumor types. Enrollment to the dose escalation portion of the study has been completed and an expansion cohort in ovarian cancer is enrolling patients.

Interim data were presented at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting in June that demonstrated a good safety profile along with promising pharmacodynamic and pharmacokinetic activity, which are important key hurdles for the development of bispecific antibodies. As of the data cut-off (April 16, 2021), 11 patients were enrolled in the first 5 dose escalation cohorts, 0.03 mg/kg through 3 mg/kg.CDX-527 was well tolerated, with no dose-limiting toxicities or treatment related serious adverse events observed. Pharmacokinetics and receptor occupancy demonstrate good exposure starting at the 1 mg/kg dose and no evidence of significant anti-drug antibodies impact. Pharmacodynamic parameters demonstrate biological activity consistent with immune activation including: transient increase in pro inflammatory cytokines/chemokines, upregulation of activation marker on T cells and particularly NK cells and a decrease in regulatory T cells.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

See Note 2 to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for information regarding newly adopted and recent accounting pronouncements. See also Note 2 to our financial statements included in our Annual Report on Form 10-K for the year ended December 31, ~~2020~~2021 for a discussion of our critical accounting ~~policies.~~policies and estimates. There have been no material changes to such critical accounting ~~policies.~~policies or estimates. We believe our most critical accounting policies include accounting for contingent consideration, revenue recognition, intangible and long-lived assets, research and development expenses and stock-based compensation expense.

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RESULTS OF OPERATIONS

Three Months Ended September 30, ~~2021~~2022 Compared with Three Months Ended September 30, ~~2020~~2021


	Three Months Ended				Increase/		Increase/		Three Months Ended				Increase/		Increase/
	September 30,				(Decrease)		(Decrease)		September 30,				(Decrease)		(Decrease)
	2021		2020		$		%		2022		2021		$		%

	(In thousands)								(In thousands)
Revenues:
Product development and licensing agreements	$	—	$	12	$	(12)	(100)	%	$	—	$	—	$	—	n/a
Contracts and grants		153		656		(503)	(77)	%		407		153		254	166	%
Total revenues	$	153	$	668	$	(515)	(77)	%	$	407	$	153	$	254	166	%
Operating expenses:
Research and development		13,557		10,708		2,849	27	%		21,572		13,557		8,015	59	%
General and administrative		5,821		3,640		2,181	60	%		6,531		5,821		710	12	%
Intangible asset impairment		3,500		—		3,500	n/a			—		3,500		(3,500)	(100)	%
(Gain) loss on fair value remeasurement of contingent consideration		(1,901)		662		(2,563)	(387)	%
Total operating expense		20,977		15,010		5,967	40	%
Gain on fair value remeasurement of contingent consideration										—		(1,901)		(1,901)	(100)	%
Total operating expenses										28,103		20,977		7,126	34	%
Operating loss		(20,824)		(14,342)		6,482	45	%		(27,696)		(20,824)		6,872	33	%
Investment and other income, net		145		118		27	23	%		912		145		767	529	%
Net loss before income tax benefit		(20,679)		(14,224)		6,455	45	%		(26,784)		(20,679)		6,105	30	%
Income tax benefit		227		—		227	n/a			—		227		(227)	(100)	%
Net loss	$	(20,452)	$	(14,224)	$	6,228	44	%	$	(26,784)	$	(20,452)	$	6,332	31	%

Net Loss

The ~~$6.2~~$6.3 million increase in net loss for the three months ended September 30, ~~2021,~~2022, as compared to the three months ended September 30, ~~2020,~~2021, was primarily ~~the result of the~~due to an increase in research and development expense, partially offset by a decrease in non-cash intangible asset impairment expense related to the TAM program IPR&D asset and increases in research and development and general and administrative expenses, partially offset by an increase in the gain on fair value remeasurement of contingent consideration.expense.

Revenue

Revenue from product development and licensing agreements for the three months ended September 30, ~~2021~~2022 was consistent with the three months ended September 30, ~~2020.~~2021. The ~~$0.5~~$0.3 million ~~decrease~~increase in contracts and grants revenue for the three months ended September 30, ~~2021,~~2022, as compared to the three months ended September 30, ~~2020,~~2021, was primarily due to ~~a decrease~~an increase in revenue from the Company’s SBIR ~~grant and~~grant. We expect revenue to increase over the next twelve months as a ~~decrease~~result of an increase in services expected to be performed under our contract manufacturing and research and development agreement with Rockefeller University. ~~We expect revenue to remain relatively consistent over the next twelve months, although there may be fluctuations on a quarterly basis.~~

Research and Development Expense

Research and development expenses consist primarily of (i) personnel expenses, (ii) laboratory supply expenses relating to the development of our technology, (iii) facility expenses and (iv) product development expenses associated with our drug candidates as follows:


	Three Months Ended				Increase/				Three Months Ended				Increase/
	September 30,				(Decrease)				September 30,				(Decrease)
	2021		2020		$		%		2022		2021		$		%

		(In thousands)								(In thousands)
Personnel	$	7,155	$	5,680	$	1,475	26	%	$	8,610	$	7,155	$	1,455	20	%
Laboratory supplies		1,255		763		492	64	%		1,075		1,255		(180)	(14)	%
Facility		1,148		1,606		(458)	(29)	%		1,088		1,148		(60)	(5)	%
Product development		3,101		1,852		1,249	67	%		9,271		3,101		6,170	199	%

Table of Contents

Personnel expenses primarily include salary, benefits, stock-based compensation and payroll taxes. The $1.5 million increase in personnel expenses for the three months ended September 30, ~~2021,~~2022, as compared to the three months ended September 30, ~~2020,~~2021, was primarily due to higher stock-based compensation expense and an increase in employee headcount. We expect personnel expenses to increase over the next twelve months as a result of additional headcount to support the expanded development of ~~CDX-0159, although there may be fluctuations on a quarterly basis.~~barzolvolimab.

Laboratory supplies expenses include laboratory materials and supplies, services, and other related expenses incurred in the development of our technology. The ~~$0.5~~$0.2 million ~~increase~~decrease in laboratory supply expenses for the three months ended September 30, ~~2021,~~2022, as compared to the three months ended September 30, ~~2020,~~2021, was primarily due to ~~higher~~lower laboratory materials and supplies purchases. We expect laboratory supplies expenses to remain relatively consistent over the next twelve months, although there may be fluctuations on a quarterly basis.

Facility expenses include depreciation, amortization, utilities, rent, maintenance and other related expenses incurred at our facilities. ~~The $0.5 million decrease in facility~~Facility expenses for the three months ended September 30, ~~2021, as compared to~~2022 was relatively consistent with the three months ended September 30, ~~2020, was primarily due to lower rent as a result of the consolidation of our Massachusetts lab and manufacturing facilities in the second quarter of 2020 and lower repairs expenses.~~2021. We expect facility expenses to remain relatively consistent over the next twelve months, although there may be fluctuations on a quarterly basis.

Product development expenses include clinical investigator site fees, external trial monitoring costs, data accumulation costs, contracted research and outside clinical drug product manufacturing. The ~~$1.2~~$6.2 million increase in product development expenses for the three months ended September 30, ~~2021,~~2022, as compared to the three months ended September 30, ~~2020,~~2021, was primarily due to an increase in ~~contract research and~~barzolvolimab clinical trial and contract manufacturing expenses. We expect product development expenses to increase over the next twelve months as a result of ~~expanded development of CDX-0159, although there may be fluctuations on a quarterly basis.~~further increases in barzolvolimab clinical trial, contract manufacturing and contract research expenses.

General and Administrative Expense

The ~~$2.2~~$0.7 million increase in general and administrative expenses for the three months ended September 30, ~~2021,~~2022, as compared to the three months ended September 30, ~~2020,~~2021, was primarily due to higher ~~personnel~~stock-based compensation and barzolvolimab commercial planning expenses, partially offset by a decrease in legal expenses. We expect general and administrative expenses to ~~increase~~remain relatively consistent over the next twelve months, although there may be fluctuations on a quarterly basis.

Intangible Asset Impairment

(Gain) Loss on Fair Value Remeasurement of Contingent Consideration

The $1.9 million gain on fair value remeasurement of contingent consideration for the three months ended September 30, 2021 was primarily due to updated assumptions for the TAM program. ~~The $0.7 million loss on fair value remeasurement of contingent consideration for the three months ended September 30, 2020 was primarily due to changes in discount rates and the passage of time.~~

Investment and Other Income, Net

~~Investment~~

The $0.8 million increase in investment and other income, net for the three months ended September 30, ~~2021 was consistent with~~2022, as compared to the three months ended September 30, ~~2020.~~2021, was primarily due to higher interest rates on fixed income investments. We expect investment and other income to increase over the next twelve months primarily due to higher ~~levels~~interest rates and higher other income related to our sale of ~~cash as a result of our July 2021 underwritten public offering, although there may be fluctuations on a quarterly basis.~~New Jersey tax benefits.

Income Tax Benefit

A $0.2 million non-cash income tax benefit was recorded related to the impairment of the TAM program IPR&D asset in the third quarter of 2021.

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Nine Months Ended September 30, ~~2021~~2022 Compared with Nine Months Ended September 30, ~~2020~~2021

Nine Months Ended

Increase/

Increase/

September 30,

(Decrease)

(Decrease)


2021

2020

$

%

(In thousands)

Revenues:

Product development and licensing agreements

$
29

$
2,297

$
(2,268)

(99)
%
Contracts and grants

4,288

1,336

2,952

221
%
Total revenues

$
4,317

$
3,633

$
684

19
%
Operating expenses:

Research and development

38,633

32,109

6,524

20
%
General and administrative

14,247

10,833

3,414

32
%
Intangible asset impairment

3,500

3,500

—

—
%
Gain on fair value remeasurement of contingent consideration

(1,160)

(4,236)

(3,076)

(73)
%
Total operating expense

55,220

42,206

13,014

31
%
Operating loss

(50,903)

(38,573)

12,330

32
%
Investment and other income, net

313

465

(152)

(33)
%
Net loss before income tax benefit

(50,590)

(38,108)

12,482

33
%
Income tax benefit

227

228

(1)

—
%
Net loss

$
(50,363)

$
(37,880)

$
12,483

33
%


	Nine Months Ended				Increase/		Increase/
	September 30,				(Decrease)		(Decrease)
	2022		2021		$		%

	(In thousands)
Revenues:
Product development and licensing agreements	$	30	$	29	$	1	3	%
Contracts and grants		714		4,288		(3,574)	(83)	%
Total revenues	$	744	$	4,317	$	(3,573)	(83)	%
Operating expenses:
Research and development		59,359		38,633		20,726	54	%
General and administrative		20,596		14,247		6,349	45	%
Intangible asset impairment		—		3,500		(3,500)	(100)	%
Gain on fair value remeasurement of contingent consideration		(6,862)		(1,160)		5,702	492	%
Litigation settlement related loss		15,000		—		15,000	n/a
Total operating expenses		88,093		55,220		32,873	60	%
Operating loss		(87,349)		(50,903)		36,446	72	%
Investment and other income, net		1,511		313		1,198	383	%
Net loss before income tax benefit		(85,838)		(50,590)		35,248	70	%
Income tax benefit		—		227		(227)	(100)	%
Net loss	$	(85,838)	$	(50,363)	$	35,475	70	%

Net Loss

The ~~$12.5~~$35.5 million increase in net loss for the nine months ended September 30, ~~2021,~~2022, as compared to the nine months ended September 30, ~~2020,~~2021, was primarily due to the ~~result~~$15.0 million litigation settlement related loss recorded in the second quarter of ~~an increase~~2022 and increases in research and development and general and administrative expenses, ~~and a decrease~~partially offset by an increase in the gain on fair value remeasurement of contingent consideration.

Revenue

The Company’s agreement with Rockefeller University, as amended, (the “Rockefeller Agreement”) provides for the Company to perform manufacturing and development services for Rockefeller University for their portfolio of antibodies against HIV. This portfolio was licensed to Gilead Sciences in January 2020

Revenue from ~~Rockefeller University (“Rockefeller Transaction”). The $2.3 million decrease in~~ product development and licensing agreements ~~revenue~~ for the nine months ended September 30, ~~2021, as compared to~~2022, was relatively consistent with the nine months ended September 30, ~~2020, was primarily due to the $1.8~~2021. The $3.6 million ~~received from the Rockefeller Transaction in the first quarter of 2020. The $3.0 million increase~~decrease in contracts and grants revenue for the nine months ended September 30, ~~2021,~~2022, as compared to the nine months ended September 30, ~~2020,~~2021, was primarily related to ~~an increase~~a decrease in services performed under our manufacturing and research and development agreements with Rockefeller University and Gilead Sciences.

Research and Development Expense

Nine Months Ended

Increase/

September 30,

(Decrease)


2021

2020

$

%


(In thousands)

Personnel

$
19,037

$
16,513

$
2,524

15
%
Laboratory supplies

4,370

2,998

1,372

46
%
Facility

3,601

5,093

(1,492)

(29)
%
Product development

8,835

4,681

4,154

89
%


	Nine Months Ended				Increase/
	September 30,				(Decrease)
	2022		2021		$		%

	(In thousands)
Personnel	$	24,116	$	19,037	$	5,079	27	%
Laboratory supplies		4,821		4,370		451	10	%
Facility		3,566		3,601		(35)	(1)	%
Product development		22,374		8,835		13,539	153	%

~~Table of Contents~~

Personnel expenses primarily include salary, benefits, stock-based compensation and payroll taxes. The ~~$2.5~~$5.1 million increase in personnel expenses for the nine months ended September 30, ~~2021,~~2022, as compared to the nine months ended September 30, ~~2020,~~2021, was primarily due to higher stock-based compensation expense and an increase in employee headcount.

Table of Contents

Laboratory supplies expenses include laboratory materials and supplies, services, and other related expenses incurred in the development of our technology. The ~~$1.4~~$0.5 million increase in laboratory supply expenses for the nine months ended September 30, ~~2021,~~2022, as compared to the nine months ended September 30, ~~2020,~~2021, was primarily due to higher laboratory materials and supplies purchases.

Facility expenses include depreciation, amortization, utilities, rent, maintenance and other related expenses incurred at our facilities. ~~The $1.5 million decrease in facility~~Facility expenses for the nine months ended September 30, ~~2021, as compared to~~2022 was relatively consistent with the nine months ended September 30, ~~2020, was primarily due to lower rent as a result of the consolidation of our Massachusetts lab and manufacturing facilities in the second quarter of 2020 and lower depreciation expenses.~~2021.

General and Administrative Expense

The ~~$3.4~~$6.3 million increase in general and administrative expenses for the nine months ended September 30, ~~2021,~~2022, as compared to the nine months ended September 30, ~~2020,~~2021, was primarily due to higher ~~personnel~~stock-based compensation, legal and ~~legal~~barzolvolimab commercial planning expenses.

Intangible Asset Impairment

During the third quarter of 2021, we evaluated the TAM program IPR&D asset for potential impairment as a result of a lack of interest in the program from third parties. We concluded that the TAM program IPR&D asset was fully impaired, and a non-cash impairment charge of $3.5 million was recorded in the third quarter of 2021.We evaluated the CDX-3379 IPR&D asset for potential impairment as a result of the discontinuation of the CDX-3379 program in the second quarter of 2020. We concluded that the CDX-3379 IPR&D asset was fully impaired, and a non-cash impairment charge of $3.5 million was recorded in the second quarter of 2020.2021.

~~Gain~~(Gain) Loss on Fair Value Remeasurement of Contingent Consideration

The $6.9 million gain on fair value remeasurement of contingent consideration for the nine months ended September 30, 2022 was primarily due to our decision to deprioritize the CDX-1140 program. The $1.2 million gain on fair value remeasurement of contingent consideration for the nine months ended September 30, 2021 was primarily due to updated assumptions for the TAM program, changes in discount rates and the passage of time. ~~The $4.2~~

Litigation Settlement Related Loss

We recorded a loss of $15.0 million ~~gain on fair value remeasurement~~in the second quarter of ~~contingent consideration for the nine months ended September 30, 2020 was primarily due to updated assumptions for CDX-3379~~2022 related ~~milestones due~~ to the ~~discontinuation of~~Initial Payment due under the ~~CDX-3379 program, changes in discount rates and the passage of time.~~binding settlement term sheet (the “Term Sheet”) entered with SRS.

Investment and Other Income, Net

The ~~$0.2~~$1.2 million ~~decrease~~increase in investment and other income, net for the nine months ended September 30, ~~2021,~~2022, as compared to the nine months ended September 30, ~~2020,~~2021, was primarily due to ~~lower~~higher interest rates on fixed income investments.

Income Tax Benefit

A $0.2 million non-cash income tax benefit was recorded related to the impairment of the TAM program IPR&D asset in the third quarter of ~~2021 and a $0.2 million non-cash income tax benefit was recorded related to the impairment of the CDX-3379 IPR&D asset in the second quarter of 2020.~~2021.

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LIQUIDITY AND CAPITAL RESOURCES

Our cash equivalents are highly liquid investments with a maturity of three months or less at the date of purchase and consist primarily of investments in money market mutual funds with commercial banks and financial institutions. We maintain cash balances with financial institutions in excess of insured limits. We do not anticipate any losses with respect to such cash balances. We invest our excess cash balances in marketable securities, including municipal bond securities, U.S. government agency securities and high-grade corporate bonds that meet high credit quality standards, as specified in our investment policy. Our investment policy seeks to manage these assets to achieve our goals of preserving principal and maintaining adequate liquidity.

The use of our cash flows for operations has primarily consisted of salaries and wages for our employees; facility and facility-related costs for our offices, laboratories and manufacturing facility; fees paid in connection with preclinical studies, clinical studies, contract manufacturing, laboratory supplies and services; and consulting, legal and other professional fees. We anticipate that our cash flows from operations will continue to be focused in these areas as we progress our current drug candidates through the clinical trial process and develop additional drug candidates. To date, the primary sources of cash flows from operations have been payments received from our collaborative partners and from government entities and payments received for contract manufacturing and research and development services provided by us. The timing of any new contract manufacturing and research and development agreements, collaboration agreements, government contracts or grants and any payments under these agreements, contracts or grants cannot be easily predicted and may vary significantly from quarter to quarter.

At September 30, ~~2021,~~2022, our principal sources of liquidity consisted of cash, cash equivalents and marketable securities of ~~$423.1~~$323.5 million. We have had recurring losses and incurred a loss of ~~$50.4~~$85.8 million for the nine months ended September 30, ~~2021.~~2022. Net cash used in operations for the nine months ended September 30, ~~2021~~2022 was ~~$46.4~~$82.0 million. We believe that the cash, cash equivalents and marketable securities at September 30, ~~2021~~2022 are sufficient to meet estimated working capital requirements and fund planned operations through 2025. This could be impacted if we elect to pay ~~Kolltan contingent~~the future milestones under the Settlement Agreement with SRS, if any, in cash.

During the next twelve months, we may take further steps to raise additional capital to meet our long-term liquidity needs including, but not limited to, one or more of the following: the licensing of drug candidates with existing or new collaborative partners, possible business combinations, issuance of debt, or the issuance of common stock or other securities via private placements or public offerings. Although we have been successful in raising capital in the past, there can be no assurance that additional financing will be available on acceptable terms, if at all, and our negotiating position in capital raising efforts may worsen as existing resources are used. There is also no assurance that we will be able to enter into further collaborative relationships. Additional equity financings may be dilutive to our stockholders; debt financing, if available, may involve significant cash payment obligations and covenants that restrict our ability to operate as a business; and licensing or strategic collaborations may result in royalties or other terms which reduce our economic potential from products under development. Our ability to continue funding our planned operations into and beyond twelve months from the issuance date is also dependent on the timing and manner of payment of the future ~~contingent~~ milestones ~~from~~under the ~~Kolltan acquisition,~~Settlement Agreement with SRS, in the event that we achieve the ~~drug candidate~~ milestones related to those payments. We may decide to pay those milestone payments in cash, shares of our common stock or a combination thereof. If we are unable to raise the funds necessary to meet our long-term liquidity needs, we may have to delay or discontinue the development of one or more programs, discontinue or delay ongoing or anticipated clinical trials, license out programs earlier than expected, raise funds at a significant discount or on other unfavorable terms, if at all, or sell all or a part of our business.

Operating Activities

Net cash used in operating activities was $82.0 million for the nine months ended September 30, 2022 as compared to $46.4 million for the nine months ended September 30, ~~2021 as compared to $35.2 million for the nine months ended September 30, 2020.~~2021. The increase in net cash used in operating activities was primarily due to an increase in research and development and general and administrative ~~expenses.~~expenses and the $15.0 million Initial Payment made to SRS under the Settlement Agreement. We expect that cash used in operating activities (not including the $15.0 million Initial Payment made to SRS) will increase over the next twelve months as a result of the expanded development of ~~CDX-0159, although there may be fluctuations on a quarterly basis.~~barzolvolimab.

We have incurred and will continue to incur significant costs in the area of research and development, including preclinical and clinical trials and clinical drug product manufacturing as our drug candidates are developed. We plan to spend significant amounts to progress our current drug candidates through the clinical trial process as well as to develop additional drug candidates. As our drug candidates progress through the clinical trial process, we may be obligated to make significant milestone ~~payments.~~payments, pursuant to our existing arrangements and arrangements we may enter in the future.

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Investing Activities

Net cash provided by investing activities was $58.7 million for the nine months ended September 30, 2022 as compared to net cash used in investing activities ~~was~~of $197.2 million for the nine months ended September 30, ~~2021 as compared~~2021. The increase in net cash provided by investing activities was primarily due to ~~$129.1~~net sales and maturities of marketable securities of $60.3 million for the nine months ended September 30, ~~2020. The increase in net cash used in investing activities was primarily due~~2022 as compared to net purchases ~~of marketable securities~~ of $196.3 million for the nine months ended September 30, ~~2021 as compared to $127.8~~2021.

Financing Activities

Net cash provided by financing activities was $2.7 million for the nine months ended September 30, ~~2020.~~

~~Financing Activities~~

~~Net cash provided by financing activities was~~2022 as compared to $271.9 million for the nine months ended September 30, ~~2021 as compared to $171.2 million for the nine months ended September 30, 2020.~~2021. The ~~increase~~decrease in net cash provided by financing activities was primarily due to ~~an increase~~a decrease in net proceeds from stock issuances.

During the nine months ended September 30, 2020, we issued 7.1 million shares of common stock under our Cantor Agreement resulting in net proceeds of $29.6 million after deducting commission and offering expenses. No shares of common stock were sold under the Cantor Agreement during the nine months ended September 30, 2021.

During the second quarter of 2020, we issued 15,384,614 shares of common stock in an underwritten public offering resulting in net proceeds of $141.4 million, after deducting underwriting fees and offering expenses.

During the third quarter of 2021, we issued 6,845,238 shares of common stock in an underwritten public offering resulting in net proceeds of $269.9 million, after deducting underwriting fees and offering expenses.

~~Aggregate Contractual Obligations~~

The disclosures relating to our contractual obligations reported in our Annual Report on Form 10-K for the year ended December 31, 2020 which was filed with the SEC on March 29, 2021 have not materially changed since we filed that report.

~~OFF-BALANCE SHEET ARRANGEMENTS~~

~~We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.~~

Item 3. Quantitative and Qualitative Disclosures about Market Risk

We own financial instruments that are sensitive to market risk as part of our investment portfolio. Our investment portfolio is used to preserve our capital until it is used to fund operations, including our research and development activities. None of these market-risk sensitive instruments are held for trading purposes. We invest our cash primarily in money market mutual funds. These investments are evaluated quarterly to determine the fair value of the portfolio. From time to time, we invest our excess cash balances in marketable securities including municipal bond securities, U.S. government agency securities and high-grade corporate bonds that meet high credit quality standards, as specified in our investment policy. Our investment policy seeks to manage these assets to achieve our goals of preserving principal and maintaining adequate liquidity. Because of the short-term nature of these investments, we do not believe we have material exposure due to market risk. The impact to our financial position and results of operations from likely changes in interest rates is not material.

We do not utilize derivative financial instruments. The carrying amounts reflected in the consolidated balance sheet of cash and cash equivalents, accounts receivables and accounts payable approximate fair value at September 30, ~~2021~~2022 due to the short-term maturities of these instruments.

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Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures.

As of September 30, ~~2021,~~2022, we evaluated, with the participation of our Chief Executive Officer and Chief Financial Officer, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)). Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of September 30, ~~2021.~~2022. Our disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within time periods specified by the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting.

There were no changes in our internal control over financial reporting during the quarter ended September 30, ~~2021~~2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II — OTHER INFORMATION

~~Item 1.~~~~Legal Proceedings~~

Shareholder Representative Services LLC (SRS) is the hired representative of the former stockholders of Kolltan Pharmaceuticals, Inc. (Kolltan) in connection with the Agreement and Plan of Merger, dated November 1, 2016, by and among Kolltan, Connemara Merger Sub 1, Inc., Connemara Merger Sub 2 LLC, and SRS (Merger Agreement). On August 18, 2020, Celldex filed a Verified Complaint in the Court of Chancery of the State of Delaware against SRS (acting in its capacity as the representative of the former stockholders of Kolltan pursuant to the Merger Agreement) seeking declaratory relief with respect to the rights and obligations of the parties relating to certain contingent milestone payments under the Merger Agreement. Specifically, Celldex sought the entry of an order declaring that:

~~(i)~~

~~Celldex’s determination to discontinue the development of CDX-0158 (formerly known as KTN0158) was proper and valid under the Merger Agreement;~~

~~(ii)~~

~~(iii)~~

~~under the Merger Agreement, the CDX-0159 program is not a program that results in milestone payments under the Merger Agreement.~~

In SRS’ responsive Answer and Verified Counterclaim, SRS made claims of breach of contract with respect to the Merger Agreement, breach of implied covenant of good faith and fair dealing, declaratory relief, and unjust enrichment regarding abandonment of the CDX-0158 milestones, based in part on SRS’ assertion that the CDX-0159 program is in essence an extension of the CDX-0158 (formerly KTN0158) program. The parties entered into non-binding mediation in May 2021 following SRS’s approach to Celldex about its interest in settlement or mediation discussions, but those discussions did not result in a resolution of the dispute.~~The case remains ongoing and we are currently unable to predict or estimate the outcome of this matter. The case is currently scheduled for trial in June 2022.~~

Item 1A. Risk Factors

In addition to the other information set forth in this report, you should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, ~~2020,~~2021, which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K may not be the only risks facing ~~the Company.~~us. Additional risks and uncertainties not currently known to ~~the Company~~us or that ~~the Company~~we currently ~~deems~~deem to be immaterial also may materially adversely affect ~~the Company’s~~our business, financial condition and/or operating results.

There were no material changes to the risk factors previously disclosed in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on ~~March 29, 2021.~~February 28, 2022.

Item 5.Other Information

On November 3, ~~2021, we determined that a non-cash impairment charge~~2022, our Board of ~~$3.5 million should~~Directors, upon the recommendation of the Board’s Nominating and Corporate Governance Committee, voted to amend and restate our Amended and Restated By-Laws, as amended (the “Old Bylaws”) and approve the Second Amended and Restated By-Laws of Celldex Therapeutics, Inc. (the “New Bylaws), effective immediately. The New Bylaws include the following amendments:

●

Generally provide that for all matters (other than the election of directors, which is governed by a standard contained in a separate section of the New Bylaws and is unchanged from the standard in the Old Bylaws, and those where a different vote is required by applicable law, the Company’s Certificate of Incorporation, the New Bylaws or the rules of any stock exchange upon which the Company’s securities are listed) shall be determined by a majority of the votes cast on such matter. Prior to effectiveness of the New Bylaws, all matters other than the election of directors, and except as otherwise required by law, were authorized by the affirmative vote of the majority of the voting power of the shares present at the meeting and entitled to vote on the subject matter;

●

Amend the existing advance notice bylaw provisions by adopting certain technical and administrative clarifications and by supplementing additional stockholder proponent requirements, which, among other changes, now require: (i) disclosure of derivative ownership by the stockholder and the underlying beneficial owners, (ii) stockholders (including, if the stockholder is an entity, the control persons of that entity) to include a representation as to whether the stockholder intends to solicit proxies from other stockholders, (iii) disclosure of any significant equity interest held by the stockholder in any principal competitor of the Company, (iv) attendance by either the stockholder or a qualified representative to appear at the meeting, and (v) when a stockholder has submitted a nominee to stand for election to the Board of Directors, (a) a representation that the director nominee currently intends to serve for a full term if elected, (b) submission of a completed questionnaire by the director nominee (which form shall be provided by the Company), (c) a representation from the director nominee that they are not and will not become a party to any agreement, arrangement or understanding as to how he or she will vote if elected or relating to compensation for service as a director or nominee (in each case, that has not been disclosed to the Company) or that would limit or interfere with such person’s ability to comply with his or her fiduciary duties and (d) a representation from the director nominee that he or she agrees to comply with all of the Company’s policies and guidelines applicable to directors of the Company;

●

In cases where the “universal proxy” rules apply, the New Bylaws include a provision that disqualifies a director nominee if the stockholder proponent fails to comply with such rules;

●

For stockholder proposals submitted in compliance with Rule 14a-8 of the Exchange Act of 1934, as amended, the New Bylaws require attendance at the meeting by either the stockholder proponent or a qualified representative;

●

Provide that the Board of Directors, the President, the Chair of the Board or the chair of the meeting may adjourn any meeting of stockholders for any reason, whether or not a quorum is present;

●

Empowers the chair of the meeting to set the rules of procedure for the meeting and make administrative decisions thereat, including, among others, requirements related to attendance and procedures related to questions and answers at the meeting;

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●

Designates, unless otherwise selected or consented to by the Company, the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have, or declines to accept, jurisdiction, another state court or a federal court located within the State of Delaware) as the sole and exclusive forum for any complaint asserting any internal corporate claims. Such claims include claims in the right of the Company that are based upon a violation of a duty by a current or former director, officer, employee or stockholder in such capacity, or as to which the Delaware General Corporation Law (the “DGCL”) confers jurisdiction upon the Court of Chancery;

●

Designates, unless otherwise selected or consented to by the Company, the federal district courts of the United States of America as the sole and exclusive forum for any complaint asserting a cause of action arising under the Securities Act of 1933, as amended;

●

Amend the Company’s indemnification bylaw to clarify that (i) indemnification will not be provided to employees and agents of the Company, other than directors and officers as described in the New By-Laws and (ii) the Company will not be required to provide indemnification for any individual in connection with any action initiated by such individual unless such initiation was approved by the Board of Directors or the initiation was in connection with successfully establishing the individual’s right to indemnification or advancement of expenses;

●

Add provisions that, for the duration of an emergency as contemplated by Section 110 of the DGCL, grant flexibility for the Company and the Board of Directors to act during times where normal Board procedures would be impractical, as expressly authorized by the DGCL;

●

Adds a bylaw specifying that, unless otherwise directed by the Board of Directors, the President or any officer of the Company authorized by the President, has the power to vote and act on behalf of the Company with respect to any other entity in which the Company may hold securities;

●

Includes a provision which provides, among other things, greater flexibility with respect to the authority of committees of the Board in accordance with the DGCL; and

●

Make certain administrative, modernizing, clarifying and confirming changes.

The foregoing summary does not purport to be ~~recorded for the three months ended September 30, 2021 related to our TAM program. The TAM program was acquired as part of our acquisition of Kolltan Pharmaceuticals, Inc.~~complete and is qualified in ~~the fourth quarter of 2016. During the fourth quarter of 2020, the Company decided that although it had developed promising data for the AxL target within the TAM program, it will focus~~ its efforts on out-licensing opportunities for its TAM program. During the third quarter of 2021, the Company evaluated its out-licensing progress since December 31, 2020 and the status and expectation for the TAM program. We determined that the lack of interest in the program from third parties constituted a triggering event that required us to evaluate the intangible asset for impairment. See Note 5entirety by reference to the ~~unaudited condensed consolidated financial statements included in~~Second Amended and Restated By-Laws of Celldex Therapeutics, Inc., filed as Exhibit 3.1 to this ~~quarterly report~~Quarterly Report on Form 10-Q ~~for further discussion of this impairment charge.~~and incorporated by reference herein.

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Item 6. Exhibits

The exhibits filed as part of this quarterly report on Form 10-Q are listed in the exhibit index included herewith and are incorporated by reference herein.

EXHIBIT INDEX


Exhibit No.		Description
**3.1		Second Amended and Restated By-Laws of Celldex Therapeutics, Inc., dated November 3, 2022
**10.1		Amended and Restated License Agreement by and between the Company and Yale University dated as of July 26, 2022*
**10.2		Tenth Amendment to Lease by and between the Company and University of Massachusetts Dartmouth dated as of August 1, 2022
**31.1		Certification of President and Chief Executive Officer
**31.2		Certification of Senior Vice President and Chief Financial Officer
***32.1		Section 1350 Certifications
**101.INS		InlineXBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
**101.SCH		Inline XBRL Taxonomy Extension Schema Document.
**101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document.
**101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document.
**101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document.
**101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibits 101).

* ~~Filed herewith.~~

Certain confidential portions of this exhibit were redacted. Celldex Therapeutics, Inc. agrees to furnish supplementally to the U.S. Securities and Exchange Commission a copy of any omitted schedule and/or exhibit upon request. The confidential portions of this exhibit were omitted by means of marking such portions with asterisks because the identified confidential portions (i) are not material, (ii) would be competitively harmful if publicly disclosed and (iii) contain information that Celldex Therapeutics, Inc, customarily and actually treats as private or confidential.

** ~~Furnished herewith.~~

~~† Indicates a management contract or compensation plan, contract or arrangement.~~

Filed herewith.

***	Furnished herewith.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


		CELLDEX THERAPEUTICS, INC.

		BY:

		/s/ ANTHONY S. MARUCCI
Dated: November 9, ~~2021~~	2022	Anthony S. Marucci
		President and Chief Executive Officer
		(Principal Executive Officer)

		/s/ SAM MARTIN
Dated: November 9, ~~2021~~	2022	Sam Martin
		Senior Vice President and Chief Financial Officer
		(Principal Financial and Accounting Officer)


	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
Revenues:
Product development and licensing agreements	$	—	$	12	$	29	$	2,297
Contracts and grants		153		656		4,288		1,336
Total revenues		153		668		4,317		3,633

Operating expenses:
Research and development		13,557		10,708		38,633		32,109
General and administrative		5,821		3,640		14,247		10,833
Intangible asset impairment		3,500		—		3,500		3,500
(Gain) loss on fair value remeasurement of contingent consideration		(1,901)		662		(1,160)		(4,236)
Total operating expenses		20,977		15,010		55,220		42,206

Operating loss		(20,824)		(14,342)		(50,903)		(38,573)
Investment and other income, net		145		118		313		465
Net loss before income tax benefit		(20,679)		(14,224)		(50,590)		(38,108)
Income tax benefit		227		—		227		228
Net loss	$	(20,452)	$	(14,224)	$	(50,363)	$	(37,880)

Basic and diluted net loss per common share	$	(0.45)	$	(0.36)	$	(1.21)	$	(1.44)

Shares used in calculating basic and diluted net loss per share		45,453		39,278		41,582		26,303

Comprehensive loss:
Net loss	$	(20,452)	$	(14,224)	$	(50,363)	$	(37,880)
Other comprehensive income (loss):
Unrealized (loss) gain on marketable securities		(44)		14		(41)		(11)
Comprehensive loss	$	(20,496)	$	(14,210)	$	(50,404)	$	(37,891)