~~Table of Contents~~CELLDEX THERAPEUTICS, INC.

~~CELLDEX THERAPEUTICS, INC.~~FORM 10-Q

~~FORM 10-Q~~

For the Quarterly Period Ended June 30, ~~2019~~2020

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)

	June 30, 2019			December 31, 2018			June 30, 2020			December 31, 2019
ASSETS
Current Assets:
Cash and Cash Equivalents	$	19,744		$	24,310		$	68,027		$	11,232
Marketable Securities	61,598			69,712				138,888			53,151
Accounts and Other Receivables	1,170			3,162				329			1,015
Prepaid and Other Current Assets	1,853			1,895				1,748			1,300
Total Current Assets	84,365			99,079				208,992			66,698
Property and Equipment, Net	5,086			6,111				4,044			4,031
Operating Lease Right-of-Use Assets, Net	3,974			—				3,134			3,473
Intangible Assets, Net	48,690			48,690				45,190			48,690
Other Assets	129			1,929				41			41
Total Assets	$	142,244		$	155,809		$	261,401		$	122,933
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts Payable	$	1,016		$	1,069		$	950		$	1,174
Accrued Expenses	5,410			7,007				6,467			6,499
Current Portion of Operating Lease Liabilities	2,538			—				1,320			1,944
Current Portion of Other Long-Term Liabilities	2,545			4,526				2,104			2,026
Total Current Liabilities	11,509			12,602				10,841			11,643
Long-Term Portion of Operating Lease Liabilities	1,867			—				1,720			1,713
Other Long-Term Liabilities	19,242			19,147				10,396			15,551
Total Liabilities	32,618			31,749				22,957			28,907
Commitments and Contingent Liabilities
Stockholders’ Equity:
Convertible Preferred Stock, $.01 Par Value; 3,000,000 Shares Authorized; No Shares Issued and Outstanding at June 30, 2019 and December 31, 2018	—			—
Common Stock, $.001 Par Value; 297,000,000 Shares Authorized; 14,816,917 and 11,957,635 Shares Issued and Outstanding at June 30, 2019 and December 31, 2018, Respectively	15			12
Convertible Preferred Stock, $.01 Par Value; 3,000,000 Shares Authorized; No Shares Issued and Outstanding at June 30, 2020 and December 31, 2019								—			—
Common Stock, $.001 Par Value; 297,000,000 Shares Authorized; 39,093,868 and 16,972,077 Shares Issued and Outstanding at June 30, 2020 and December 31, 2019, Respectively								39			17
Additional Paid-In Capital	1,098,429			1,083,903				1,272,783			1,104,706
Accumulated Other Comprehensive Income	2,638			2,583				2,594			2,619
Accumulated Deficit	(991,456		)	(962,438		)		(1,036,972	)		(1,013,316	)
Total Stockholders’ Equity	109,626			124,060				238,444			94,026
Total Liabilities and Stockholders’ Equity	$	142,244		$	155,809		$	261,401		$	122,933

See accompanying notes to unaudited condensed consolidated financial statements

3
CELLDEX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)

(In thousands, except per share amounts)

Three Months
Ended
June 30, 2019

Three Months
Ended
June 30, 2018

Six Months
Ended
June 30, 2019

Six Months
Ended
June 30, 2018

Three Months
Ended
June 30, 2020 Three Months
Ended
June 30, 2019 Six Months
Ended
June 30, 2020 Six Months
Ended
June 30, 2019
REVENUES:

Product Development and Licensing Agreements

$
195

$
1,667

$
325

$
2,662

$ — $ 195 $ 2,285 $ 325
Contracts and Grants

520

1,096

1,815

4,172

236 520 680 1,815
Total Revenues

715

2,763

2,140

6,834

236 715 2,965 2,140

OPERATING EXPENSES:

Research and Development

10,081

21,448

21,232

43,323

9,705 10,081 21,400 21,232
General and Administrative

3,908

5,621

8,804

11,215

3,528 3,908 7,194 8,804
Goodwill Impairment

—

—

—

90,976

Intangible Asset Impairment

—

—

—

18,677

3,500 — 3,500 —
Other Asset Impairment

—

—

1,800

—

— — — 1,800
(Gain)/Loss on Fair Value Remeasurement of Contingent Consideration

(1,017
)
(7,433
)
502

(21,033
)
Amortization of Acquired Intangible Assets

—

—

—

224

(Gain) Loss on Fair Value Remeasurement of Contingent Consideration (5,132 ) (1,017 ) (4,898 ) 502
Total Operating Expenses

12,972

19,636

32,338

143,382

11,601 12,972 27,196 32,338

Operating Loss

(12,257
)
(16,873
)
(30,198
)
(136,548
)
(11,365 ) (12,257 ) (24,231 ) (30,198 )
Investment and Other Income, Net

478

466

1,180

1,245

106 478 347 1,180
Net Loss Before Income Tax Benefit

(11,779
)
(16,407
)
(29,018
)
(135,303
)
(11,259 ) (11,779 ) (23,884 ) (29,018 )
Income Tax Benefit

—

—

—

765

228 — 228 —
Net Loss

$
(11,779
)
$
(16,407
)
$
(29,018
)
$
(134,538
)
$ (11,031 ) $ (11,779 ) $ (23,656 ) $ (29,018 )

Basic and Diluted Net Loss Per Common Share

$
(0.84
)
$
(1.67
)
$
(2.21
)
$
(14.01
)
$ (0.50 ) $ (0.84 ) $ (1.20 ) $ (2.21 )

Shares Used in Calculating Basic and Diluted Net Loss Per Share

13,952

9,829

13,129

9,600

22,082 13,952 19,744 13,129

COMPREHENSIVE LOSS:

Net Loss

$
(11,779
)
$
(16,407
)
$
(29,018
)
$
(134,538
)
$ (11,031 ) $ (11,779 ) $ (23,656 ) $ (29,018 )
Other Comprehensive Income (Loss):

Unrealized Gain on Marketable Securities

36

31

55

26

Unrealized (Loss) Gain on Marketable Securities (3 ) 36 (25 ) 55
Comprehensive Loss

$
(11,743
)
$
(16,376
)
$
(28,963
)
$
(134,512
)
$ (11,034 ) $ (11,743 ) $ (23,681 ) $ (28,963 )

See accompanying notes to unaudited condensed consolidated financial statements
4
CELLDEX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
(Unaudited)

(In thousands)

Six Months Ended
June 30, 2019

Six Months Ended
June 30, 2018

Six Months
Ended
June 30, 2020 Six Months
Ended
June 30, 2019
Cash Flows From Operating Activities:

Net Loss

$
(29,018
)
$
(134,538
)
$ (23,656 ) $ (29,018 )
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities:

Depreciation and Amortization

2,505

2,021

2,313 2,505
Amortization of Intangible Assets

—

224

Amortization and Premium of Marketable Securities, Net

(652
)
(380
)
(335 ) (652 )
Loss on Sale or Disposal of Assets

7

1,069

Goodwill Impairment

—

90,976

(Gain) Loss on Sale or Disposal of Assets (20 ) 7
Intangible Asset Impairment

—

18,677

3,500 —
Other Asset Impairment

1,800

—

— 1,800
Loss/(Gain) on Fair Value Remeasurement of Contingent Consideration

502

(21,033
)
(Gain) Loss on Fair Value Remeasurement of Contingent Consideration (4,898 ) 502
Non-Cash Income Tax Benefit

—

(765
)
(228 ) —
Stock-Based Compensation Expense

3,157

4,536

1,408 3,157
Changes in Operating Assets and Liabilities:

Accounts and Other Receivables

1,992

(713
)
686 1,992
Prepaid and Other Current Assets

(137
)
801

(436 ) (137 )
Accounts Payable and Accrued Expenses

(1,598
)
(5,895
)
(254 ) (1,598 )
Other Liabilities

(2,833
)
(397
)
(1,412 ) (2,833 )
Net Cash Used in Operating Activities

(24,275
)
(45,417
)
(23,332 ) (24,275 )

Cash Flows From Investing Activities:

Sales and Maturities of Marketable Securities

67,386

106,182

47,000 67,386
Purchases of Marketable Securities

(58,565
)
(76,902
)
(132,439 ) (58,565 )
Acquisition of Property and Equipment

(484
)
(591
)
(1,145 ) (484 )
Net Cash Provided by Investing Activities

8,337

28,689

Proceeds from Sale or Disposal of Assets 20 —
Net Cash (Used in) Provided by Investing Activities (86,564 ) 8,337

Cash Flows From Financing Activities:

Net Proceeds from Stock Issuances

11,363

19,960

166,667 11,363
Proceeds from Issuance of Stock from Employee Benefit Plans

9

374

24 9
Issuance of Term Loan 2,962 —
Payment of Term Loan (2,962 ) —
Net Cash Provided by Financing Activities

11,372

20,334

166,691 11,372

Net Increase/(Decrease) in Cash and Cash Equivalents

(4,566
)
3,606

Net Increase (Decrease) in Cash and Cash Equivalents 56,795 (4,566 )
Cash and Cash Equivalents at Beginning of Period

24,310

40,288

11,232 24,310
Cash and Cash Equivalents at End of Period

$
19,744

$
43,894

$ 68,027 $ 19,744

Non-cash Investing Activities

Accrued construction in progress

$
55

$
—

$ 22 $ 55
Non-cash Supplemental Disclosure

Shares issued to former Kolltan executive for settlement of severance

$
—

$
57

See accompanying notes to unaudited condensed consolidated financial statements
5
CELLDEX THERAPEUTICS, INC.
Notes to Unaudited Condensed Consolidated Financial Statements
June 30, ~~2019~~2020

(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 ~~subsidiaries.~~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, ~~2018,~~2019, which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March ~~7, 2019.~~26, 2020. 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, ~~2019.~~2020.

At June 30, ~~2019,~~2020, the Company had cash, cash equivalents and marketable securities of ~~$81.3~~$206.9 million. The Company has had recurring losses and incurred a loss of ~~$29.0~~$23.7 million for the six months ended June 30, ~~2019.~~2020. Net cash used in operations for the six months ended June 30, ~~2019~~2020 was ~~$24.3~~$23.3 million. The Company believes that the cash, cash equivalents and marketable securities at August ~~7, 2019~~6, 2020 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.

The Board of Directors of the Company approved a one for fifteen reverse stock split of the Company’s outstanding common stock, which was effected on February 8, 2019. All share and per share amounts in the financial statements have been retroactively adjusted for all periods presented to give effect to the reverse stock split, including reclassifying an amount equal to the reduction in par value to additional paid-in capital.
During the next twelve months and beyond, the Company ~~will~~may take further steps to raise additional capital to meet its long-term liquidity ~~needs. These capital raising activities may include,~~needs including, but may not be 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. ~~While~~Although the Company ~~may seek~~has been successful in raising capital ~~through a number of means,~~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 into and beyond twelve months from the issuance date is also dependent on the timing and manner of payment of ~~future~~ contingent milestones from the Kolltan acquisition, 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
6
In December 2019, a novel strain of coronavirus, now referred to as COVID-19, surfaced in Wuhan, China. The virus continues to spread globally, has been declared a pandemic by the World Health Organization and has spread to hundreds of countries, including the United States. The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world. In an effort to halt the outbreak of COVID-19, various states, including New Jersey, Massachusetts and Connecticut, where the Company ~~is unable to raise~~has office, research and manufacturing facilities, have placed significant restrictions on travel and many businesses have announced extended closures which could adversely impact our operations. To date, the ~~funds necessary to meet its liquidity needs, it may have to delay~~Company has not experienced significant delays or ~~discontinue the development of one or more programs, discontinue or delay~~disruptions in planned and ongoing ~~or anticipated~~preclinical and clinical trials, ~~license out programs earlier than expected, raise funds~~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, 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 (IPR&D) assets with a carrying value of $45.2 million at ~~a significant discount or on other unfavorable terms, if at all, or sell all or a part of the Company.~~June 30, 2020.

(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 six months ended June 30, ~~2019~~2020 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, ~~2018,~~2019, except as it relates to the adoption of new accounting standards during the first six months of ~~2019~~2020 as discussed below.
Newly Adopted Accounting Pronouncements

On January 1, ~~2019,~~2020, the Company adopted a new ~~U.S. GAAP~~ accounting standard ~~which requires~~ that modifies certain disclosure requirements for fair value measurements. For instance, the Company is required to disclose weighted average information for significant unobservable inputs for all ~~lessees recognize the assets and liabilities that arise from leases~~Level 3 fair value measurements. The adoption of this new guidance did not have a material impact on the ~~balance sheet~~Company’s consolidated financial statements and ~~disclose qualitative and quantitative information about its leasing arrangements. The new standard was adopted using~~related disclosures. Refer to Note 3 for the ~~modified retrospective transition method, which requires~~disclosures related to the Company’s level 3 fair value measurements.
On January 1, 2020, the Company ~~to apply~~adopted a new accounting standard that clarifies the ~~standard~~interaction between the accounting guidance for collaborative arrangements and revenue from contracts with customers. The amendments clarify that certain transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606, when the collaborative arrangement participant is a customer in the context of ~~the effective date and does not require restatement~~a unit of ~~prior periods.~~account. The Company elected to apply the package of practical expedients, which allowed the Company to not reassess: (i) whether expired or existing contracts contain leases; (ii) lease classification for any expired or existing leases; and (iii) initial direct costs for any existing leases. Adoptionadoption of this standard did not have a material impact on our consolidated financial statements, as we have no arrangements within the ~~Company’s Consolidated Statement~~scope of Operations and Comprehensive Loss or Statement of Cash Flow, however, upon adoption, the Company recorded right-of-use assets of $3.8 million and lease liabilities of $4.7 million on its Consolidated Balance Sheet related to the Company’s operating leases. The difference between the right-of-use assets and lease liabilities recorded upon adoption is due to certain adjustments required to the right-of-use assets for prepaid rent and accrued termination expenses. Refer to Note 5 “Leases” for the Company’s updated lease accounting policy and disclosures.ASC 808.

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, ~~2020. The adoption of~~2023. We are currently evaluating the potential impact that this standard ~~is not expected to~~may have ~~a material impact~~ on the Company’s consolidated financial statements and related disclosures.

7
In August 2018, the FASB issued amendments that modify certain disclosure requirements for fair value measurements. The amendments become effective, including interim periods, beginning January 1, 2020. Early adoption, of all the amendments or only the provisions that eliminate or modify the requirements, is permitted. The adoption of this new guidance is not expected to have a material impact on the Company’s consolidated financial statements and related disclosures.

In November 2018, the FASB issued guidance to clarify the interaction between the accounting guidance for collaborative arrangements and revenue from contracts with customers. The amendments become effective, including interim periods, beginning January 1, 2020. Early adoption, including adoption in an interim period, is permitted. This guidance is required to be applied retrospectively as of the date of our adoption of the new revenue standard on January 1, 2018. We are currently evaluating the timing of our adoption and the expected impact this guidance could have on our consolidated financial statements and related disclosures.
(3) Fair Value Measurements

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

As of
June 30, 2019

Level 1

Level 2

Level 3

(In thousands)

Assets:

Money market funds and cash equivalents

$
13,867

—

$
13,867

—

Marketable securities

61,598

—

61,598

—

$
75,465

—

$
75,465

—

Liabilities:

Kolltan acquisition contingent consideration

$
14,281

—

—

$
14,281

$
14,281

—

—

$
14,281

As of
December 31, 2018

Level 1

Level 2

Level 3

As of
June 30, 2020 Level 1 Level 2 Level 3

(In thousands)

(In thousands)
Assets:

Money market funds and cash equivalents

$
15,755

—

$
15,755

—

$ 54,597     — $ 54,597 —
Marketable securities

69,712

—

69,712

—

138,888 — 138,888 —

$
85,467

—

$
85,467

—

$ 193,485 — $ 193,485 —
Liabilities:

Kolltan acquisition contingent consideration

$
13,779

—

—

$
13,779

$ 7,587 — — $ 7,587

$
13,779

—

—

$
13,779

$ 7,587 — — $ 7,587
As of
December 31, 2019 Level 1 Level 2 Level 3
(In thousands)
Assets:
Money market funds and cash equivalents $ 4,024 — $ 4,024     —
Marketable securities 53,151 — 53,151 —
$ 57,175 — $ 57,175 —
Liabilities:
Kolltan acquisition contingent consideration $ 12,485 — — $ 12,485
$ 12,485 — — $ 12,485

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.

The following table reflects the activity for the Company’s contingent consideration liabilities measured at fair value using Level 3 inputs for the six months ended June 30, ~~2019~~2020 (in thousands):

Other Liabilities:
Contingent
Consideration

Balance at December 31, 2018

$
13,779

Fair value adjustments included in operating expenses

502

Balance at June 30, 2019

$
14,281

Other Liabilities:
Contingent
Consideration
Balance at December 31, 2019 $ 12,485
Fair value adjustments included in operating expenses (4,898 )
Balance at June 30, 2020 $ 7,587

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 in 2016, was primarily an income approach. The ~~Company may be required to pay future consideration of up to $127.5 million that is contingent upon the achievement of specified development, regulatory approvals or sales-based milestone events. 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 June 30, 2020, the weighted average discount rate used in calculating the fair value of contingent consideration was 11.6% (with a range of 11.5% to 12.2%) and the weighted average amount of time until the conditions of the milestone payments are met was 3 years.
8

During the three and six months ended June 30, 2020, the Company recorded a $5.1 million and $4.9 million gain on fair value remeasurement of contingent consideration, respectively, primarily due to updated assumptions for CDX-3379 related milestones due to the discontinuation of the CDX-3379 program and the passage of time. During the three and six months ended June 30, 2019, the Company recorded a $1.0 million gain and $0.5 million loss on fair value remeasurement of contingent consideration, respectively, primarily due to changes in discount rates and the passage of time. ~~During~~The assumptions related to determining the ~~three and six months ended June 30, 2018, the Company recorded a $7.4 million and $21.0 million gain on~~ fair value ~~remeasurement~~ of contingent consideration ~~respectively, primarily due to discontinuation~~include a significant amount of judgment, and any changes in the ~~glembatumumab vedotin (“Glemba”) and CDX-014 programs and updated assumptions for~~underlying estimates could have a material impact on the ~~varlilumab program.~~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 ~~between the fair value measurement classifications~~ during the six months ended June 30, ~~2019.~~2020.
(4) Marketable Securities

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

Gross Unrealized

Gross Unrealized

Amortized
Cost

Gains

Losses

Fair
Value

Amortized
Cost Gains Losses Fair
Value

(In thousands)

(In thousands)
June 30, 2019

June 30, 2020
U.S. government and municipal obligations (maturing in one year or less)

$
27,622

$
25

$
—

$
27,647

$ 79,937 $ — $ — $ 79,937
Corporate debt securities (maturing in one year or less)

33,934

17

—

33,951

58,954 10 (13 ) 58,951
Total Marketable Securities

$
61,556

$
42

$
—

$
61,598

$ 138,891 $ 10 $ (13 ) $ 138,888

December 31, 2018

December 31, 2019
U.S. government and municipal obligations (maturing in one year or less)

$
27,355

$
—

$
(4
)
$
27,351

$ 18,509 $ 13 $ — $ 18,522
Corporate debt securities (maturing in one year or less)

42,370

—

(9
)
42,361

34,619 13 (3 ) 34,629
Total Marketable Securities

$
69,725

$
—

$
(13
)
$
69,712

$ 53,128 $ 26 $ (3 ) $ 53,151

The Company holds investment-grade marketable securities, and none were in a continuous unrealized loss position for more than twelve months as of June 30, ~~2019~~2020 and December 31, ~~2018.~~2019. 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 ~~$0.1~~$0.2 million in accrued interest at June 30, ~~2019~~2020 and December 31, ~~2018, respectively.~~2019.

(5) ~~Leases~~
~~The Company has operating leases of office, manufacturing and laboratory space, which have remaining lease terms of one to six years and may include one or more options to renew or terminate early.~~
~~The~~ Company determines if an arrangement contains a lease at inception. Operating lease right-of-use assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. Certain adjustments to the right-of-use asset may be required for items such as prepaid or accrued lease payments, initial direct costs paid or incentives received. The Company’s leases do not contain an implicit rate, and therefore the Company uses an estimated incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. Options to extend or terminate the lease are reflected in the calculation when it is reasonably certain that the option will be exercised. The Company has elected to account for lease and non-lease components as a single lease component, however non-lease components that are variable, such as common area maintenance and utilities, are generally paid separately from rent based on actual costs incurred and therefore are not included in the right-of-use asset and operating lease liability and are reflected as an expense in the period incurred. Leases with an initial term of 12 months or less are not recorded on the balance sheet.
During the first quarter of 2019, the Company amended its Hampton, New Jersey lease to eliminate 16,200 square feet of space and extend the remaining 33,400 square feet of space for an additional five-year term with an early termination option after three years. The Company recorded an additional right-of-use asset and lease liability of $1.4 million during the first quarter of 2019 for the initial 3 years related to the amendment.
Operating lease expense was $0.5 million and $1.2 million for the three and six months ended June 30, 2019, respectively. Variable lease expense was $0.3 million and $0.7 million for the three and six months ended June 30, 2019, respectively. Operating cash flows used for operating leases during the six months ended June 30, 2019 was $0.9 million. As of June 30, 2019, the weighted-average remaining lease term was 2 years and the weighted-average discount rate was 11.3%.
~~Future minimum lease payments under non-cancellable leases as of June 30, 2019 were as follows:~~
Remainder of 2019

$
1,313

2020

2,171

2021

508

2022

747

2023

311

Total lease payments

5,050

Less imputed interest

(645
)
Present value of operating lease liabilities

$
4,405

~~Under the prior lease accounting guidance, operating lease obligations, including estimated variable lease obligations, as of December 31, 2018 were as follows:~~
2019

$
4,648

2020

3,140

Thereafter

—

Total lease payments

$
7,788

~~(6)~~ Intangible Assets ~~and Goodwill~~
~~Intangible Assets, Net~~
As a result of the discontinuation of the Glemba program, the Company concluded that the finite-lived intangible asset related to its Amgen Fremont license rights to develop and commercialize Glemba and the indefinite-lived Glemba IPR&D asset were fully impaired and a non-cash impairment charge of $18.7 million was recorded in the first quarter of 2018. Amortization expense related to the finite-lived intangible asset was $0.0 million for the three and six months ended June 30, 2019, and $0.0 million and $0.2 million for the three and six months ended June 30, 2018, respectively.

At June 30, ~~2019~~2020 and ~~2018,~~December 31, 2019, the Company recorded indefinite-lived intangible assets of $45.2 million and $48.7 ~~million.~~million, respectively. Indefinite-lived intangible assets consist of acquired in-process research and development (“IPR&D”) related to the development of CDX-3379, the anti-KIT program (including CDX-0159) and the TAM program. The Company evaluated the CDX-3379 IPR&D asset for potential impairment as a result of the discontinuation of the CDX-3379 program. 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 for the three months ended June 30, 2020. CDX-0159 is in Phase ~~2 development. The anti-KIT~~1 development and the TAM ~~programs are~~program is in preclinical development. As of June 30, ~~2019,~~2020, none of the Company’s IPR&D assets had reached technological feasibility nor did any 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. 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.

9
~~Goodwill~~

The Company evaluated goodwill for potential impairment due to the discontinuation of the Glemba program in the first quarter of 2018. The carrying amount of the Company was compared to the Company’s fair value. The Company’s fair value assessment reflected a number of significant management assumptions and estimates including the Company’s probability forecasts for pipeline assets, income taxes, capital expenditures, market premium and changes in working capital requirements. Changes in these assumptions and/or discount rates could materially impact the Company’s conclusions. Through this assessment, it was determined that the carrying amount of the Company exceeded its fair value by over $91.0 million. As such, the full goodwill asset was considered impaired and a charge of $91.0 million was recorded during the first quarter of 2018.
~~(7)~~(6) Other Assets

In 2016, the Company entered into a research and collaboration agreement with an undisclosed private company to access novel technologies and paid $3.5 million to support research activities and make an investment in the private company. The Company recorded $1.8 million to other assets related to this investment and $1.7 million was recorded to research and development expense over the term of the research activities. The stock of the private company does not have a readily determinable fair value, and therefore it is measured at cost less impairment, if any. Based on information received in April 2019, it was determined that there was a deterioration of the private company’s financial condition due to a working capital deficiency and an inability to secure additional funding as of March 31, 2019. Therefore, the Company concluded that the investment was impaired, and a non-cash impairment charge of $1.8 million was recorded during the first quarter of 2019. The Company assesses the private company’s financial condition on a quarterly basis. There was no change in the value of the investment during the six months ended June 30, 2020.

~~(8)~~(7) Other Long-Term Liabilities

Other long-term liabilities include the following:

June 30, 2019

December 31, 2018

June 30,
2020 December 31,
2019

(In thousands)

(In thousands)
Net Deferred Tax Liabilities Related to IPR&D (Note 13)

$
3,007

$
3,007

Net Deferred Tax Liabilities Related to IPR&D (Note 12) $ 2,779 $ 3,007
Deferred Income From Sale of Tax Benefits

4,014

4,218

1,831 1,831
Other

—

1,083

Contingent Milestones (Note 3)

14,281

13,779

7,587 12,485
Deferred Revenue (Note 12)

485

1,586

Deferred Revenue (Note 11) 303 254
Total

21,787

23,673

12,500 17,577
Less Current Portion

(2,545
)
(4,526
)
(2,104 ) (2,026 )
Long-Term Portion

$
19,242

$
19,147

$ 10,396 $ 15,551

In November 2015, ~~and December 2014,~~ the Company received approval from the New Jersey Economic Development Authority and agreed to sell New Jersey tax benefits of $9.8 million ~~and $1.9 million~~ to an independent third party for $9.2 ~~million and $1.8 million, respectively.~~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. The Company recognized $0.0 ~~million and $0.2~~ million in other income related to the sale of these tax benefits during the three and six months ended June 30, ~~2019, respectively,~~2020 and $0.0 million and ~~$0.4~~$0.2 million during the three and six months ended June 30, ~~2018,~~2019, respectively.
~~(9)~~
(8) Stockholders’ Equity

In May 2016, the Company entered into ana 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 ~~having an aggregate offering price of up to $60.0 million~~ from time to time through Cantor, acting as agent. ~~In November 2017, the Company filed a prospectus supplement registering the offer and sale of shares of common stock of up to an additional $75.0 million under the agreement with Cantor.~~ During the six months ended June 30, ~~2019,~~2020, the Company issued ~~2,856,194~~6.7 million shares of common stock ~~under this controlled equity offering sales agreement with~~pursuant to the Cantor Agreement resulting in net proceeds of ~~$11.4~~$25.3 million after deducting commission and offering expenses. At June 30, ~~2019,~~2020, the Company had ~~$25.8~~$18.3 million remaining in aggregate gross offering price available under a prospectus supplement filed pursuant to the ~~Cantor~~ agreement. ~~In July 2019,~~
During the three months ended June 30, 2020, the Company issued ~~201,687~~15,384,614 shares of its common stock in an underwritten public offering resulting in net proceeds to the Company of ~~$0.5 million.~~$141.4 million, after deducting underwriting fees and offering expenses.
10

The changes in Stockholders’ Equity during the three and six months ended June 30, ~~2019~~2020 and ~~2018~~2019 are summarized below:

Common
Stock
Shares

Common
Stock Par
Value

Additional
Paid-In
Capital

Accumulated
Other
Comprehensive
Income

Accumulated
Deficit

Total
Stockholders’
Equity

(In thousands, except share amounts)

Consolidated Balance at December 31, 2018

11,957,635

12

1,083,903

2,583

(962,438
)
124,060

Shares Issued under Stock Option and Employee Stock Purchase Plans

3,507

—

9

—

—

9

Shares Issued in Connection with Cantor Agreement

883,569

1

4,150

—

—

4,151

Share-Based Compensation

—

—

1,693

—

—

1,693

Unrealized Gain on Marketable Securities

—

—

—

19

—

19

Net Loss

—

—

—

—

(17,239
)
(17,239
)
Consolidated Balance at March 31, 2019

12,844,711

13

1,089,755

2,602

(979,677
)
112,693

Shares Cancelled under Stock Option and Employee Stock Purchase Plans

(222
)
—

—

—

—

—

Shares Issued in Connection with Cantor Agreement

1,972,428

2

7,210

—

—

7,212

Share-Based Compensation

—

—

1,464

—

—

1,464

Unrealized Gain on Marketable Securities

—

—

—

36

—

36

Net Loss

—

—

—

—

(11,779
)
(11,779
)
Consolidated Balance at June 30, 2019

14,816,917

15

1,098,429

2,638

(991,456
)
109,626

Common
Stock
Shares

Common
Stock Par
Value

Additional
Paid-In
Capital

Accumulated
Other
Comprehensive
Income

Accumulated
Deficit

Total
Stockholders’
Equity

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

(In thousands, except share amounts)

(In thousands, except share amounts)
Consolidated Balance at December 31, 2017

9,234,693

9

1,046,313

2,564

(812,517
)
236,369

Consolidated Balance at December 31, 2019 16,972,077 $ 17 $ 1,104,706 $ 2,619 $ (1,013,316 ) $ 94,026
Shares Issued under Stock Option and Employee Stock Purchase Plans

9,453

—

374

—

—

374

12,573 — 24 — — 24
Shares Issued in Connection with Cantor Agreement

312,802

—

11,689

—

—

11,689

746,152 1 1,613 — — 1,614
Shares Issued in Connection with Kolltan Severance

971

—

38

—

—

38

Share-Based Compensation

—

—

2,488

—

—

2,488

— — 686 — — 686
Unrealized Loss on Marketable Securities

—

—

—

(5
)
—

(5
)
— — — (22 ) — (22 )
Adoption of ASC 606

—

—

—

—

1,263

1,263

Net Loss

—

—

—

—

(118,131
)
(118,131
)
— — — — (12,625 ) (12,625 )
Consolidated Balance at March 31, 2018

9,557,919

9

1,060,902

2,559

(929,385
)
134,085

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 Cantor Agreement

884,068

1

8,270

—

—

8,271

5,978,452 6 23,686 — — 23,692
Shares Issued in Connection with Kolltan Severance

1,071

—

19

—

—

19

Shares Issued in Underwritten Offering 15,384,614 15 141,346 — — 141,361
Share-Based Compensation

—

—

2,048

—

—

2,048

— — 722 — — 722
Unrealized Gain on Marketable Securities

—

—

—

31

—

31

Unrealized Loss on Marketable Securities — — — (3 ) — (3 )
Net Loss

—

—

—

—

(16,407
)
(16,407
)
— — — — (11,031 ) (11,031 )
Consolidated Balance at June 30, 2018

10,443,058

10

1,071,239

2,590

(945,792
)
128,047

Consolidated Balance at June 30, 2020 39,093,868 $ 39 $ 1,272,783 $ 2,594 $ (1,036,972 ) $ 238,444
Common
Stock
Shares Common
Stock Par
Value Additional
Paid-In
Capital Accumulated
Other
Comprehensive
Income Accumulated
Deficit Total
Stockholders’
Equity
(In thousands, except share amounts)
Consolidated Balance at December 31, 2018 11,957,635 $ 12 $ 1,083,903 $ 2,583 $ (962,438 ) $ 124,060
Shares Issued under Stock Option and Employee Stock Purchase Plans 3,507 — 9 — — 9
Shares Issued in Connection with Cantor Agreement 883,569 1 4,150 — — 4,151
Share-Based Compensation — — 1,693 — — 1,693
Unrealized Gain on Marketable Securities — — — 19 — 19
Net Loss — — — — (17,239 ) (17,239 )
Consolidated Balance at March 31, 2019 12,844,711 $ 13 $ 1,089,755 $ 2,602 $ (979,677 ) $ 112,693
Shares Cancelled under Stock Option and Employee Stock Purchase Plans (222 ) — — — — —
Shares Issued in Connection with Cantor Agreement 1,972,428 2 7,210 — — 7,212
Share-Based Compensation — — 1,464 — — 1,464
Unrealized Gain on Marketable Securities — — — 36 — 36
Net Loss — — — — (11,779 ) (11,779 )
Consolidated Balance at June 30, 2019 14,816,917 $ 15 $ 1,098,429 $ 2,638 $ (991,456 ) $ 109,626
11

~~(10)~~
(9) Stock-Based Compensation

A summary of stock option activity for the six months ended June 30, ~~2019~~2020 is as follows:

Shares

Weighted
Average
Exercise
Price
Per Share

Weighted
Average
Remaining
Contractual
Term (In Years)

Shares Weighted
Average
Exercise
Price
Per Share Weighted
Average
Remaining
Contractual
Term (In Years)
Options Outstanding at December 31, 2018

866,132

$
93.70

7.1

Options Outstanding at December 31, 2019 1,699,202 $ 44.87 8.0
Granted

863,290

2.78

1,439,175 $ 10.36
Exercised

—

—

— —
Canceled

(39,348
)
131.86

(53,090 ) $ 46.03
Options Outstanding at June 30, 2019

1,690,074

46.37

8.4

Options Vested and Expected to Vest at June 30, 2019

1,538,046

50.45

8.3

Options Exercisable at June 30, 2019

529,136

132.85

5.7

Options Outstanding at June 30, 2020 3,085,287 $ 28.76 8.69
Options Vested and Expected to Vest at June 30, 2020 2,875,684 $ 30.23 8.62
Options Exercisable at June 30, 2020 821,537 $ 84.93 6.39
Shares Available for Grant Under the 2008 Plan

433,391

938,178

The weighted average grant-date fair value of stock options granted during the three and six month ~~periods~~period ended June 30, ~~2019~~2020 was ~~$2.09.~~$7.96 and $7.95, respectively. Stock-based compensation expense for the three and six ~~month periods~~months ended June 30, ~~2019~~2020 and ~~2018~~2019 was recorded as follows:

Three months ended June 30,

Six months ended June 30,

2019

2018

2019

2018

(In thousands)

(In thousands)

Research and development

$
654

$
978

$
1,410

$
2,289

General and administrative

810

1,070

1,747

2,247

Total stock-based compensation expense

$
1,464

$
2,048

$
3,157

$
4,536

Three months ended June 30, Six months ended June 30,
2020 2019 2020 2019
(In thousands) (In thousands)
Research and development $ 342 $ 654 $ 652 $ 1,410
General and administrative 380 810 756 1,747
Total stock-based compensation expense $ 722 $ 1,464 $ 1,408 $ 3,157
The fair values of employee and director stock options granted during the three and six ~~month periods~~months ended June 30, ~~2019~~2020 and ~~2018~~2019 were valued using the Black-Scholes option pricing model with the following assumptions:

Three months ended June 30,

Six months ended June 30,

Three months ended June 30, Six months ended June 30,

2019

2018

2019

2018

2020 2019 2020 2019
Expected stock price volatility

91%

85%

91%

73 - 85%

97% 91% 91 – 97% 91%
Expected option term

6.0 Years

6.0 Years

6.0 Years

6.0 Years

6.0 Years 6.0 Years 6.0 Years 6.0 Years
Risk-free interest rate

1.9 – 2.4%

2.9%

1.9 – 2.5%

2.8 – 3.0%

0.5% 1.9 – 2.4% 0.5 – 0.6% 1.9 – 2.5%
Expected dividend yield

None

None

None

None

None None None None

~~(11)~~(10) Accumulated Other Comprehensive Income

The changes in accumulated other comprehensive income, which is reported as a component of stockholders’ equity, for the six months ended June 30, ~~2019~~2020 are summarized below:

Unrealized
Gain/(Loss) on
Marketable
Securities

Foreign
Currency Items

Total

(In thousands)

Balance at December 31, 2018

$
(13
)
$
2,596

$
2,583

Other comprehensive gain

55

—

55

Balance at June 30, 2019

$
42

$
2,596

$
2,638

Unrealized
Gain/(Loss) on
Marketable
Securities Foreign
Currency Items Total
(In thousands)
Balance at December 31, 2019 $ 23 $ 2,596 $ 2,619
Other comprehensive loss (25 ) — (25 )
Balance at June 30, 2020 $ (2 ) $ 2,596 $ 2,594

No amounts were reclassified out of accumulated other comprehensive income during the six months ended June 30, ~~2019.~~2020.

~~(12)~~
12
(11) Revenue

Product Development and Licensing Revenue
~~The Company’s primary product development and licensing revenue is associated with a clinical collaboration agreement~~ ~~with BMS entered into in 2014 to evaluate the safety, tolerability and preliminary efficacy of varlilumab and Opdivo~~®, BMS’s PD-1 immune checkpoint inhibitor, in a Phase 1/2 study. Under this agreement, BMS made an upfront payment to Celldex of $5.0 million and provides funding for 50% of the external costs incurred by the Company in connection with the clinical trial. The Company recorded $0.1 million and $0.2 million in revenue related to this agreement during the three and six months ended June 30, 2019, respectively, and $1.7 million and $2.6 million during the three and six months ended June 30, 2018, respectively.
~~Contract and Grants Revenue~~

The Company entered into an agreement with Rockefeller University in September 2013, as amended, (the “Rockefeller Agreement”) pursuant to which the Company performs 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 ~~agreements~~the Rockefeller Agreement and an agreement with ~~Rockefeller University and~~ Duke University pursuant to which the Company performs manufacturing and research and development services on a time-and-materials ~~basis.~~basis or at a negotiated fixed-price. The Company recognized ~~$0.4~~$0.2 million and $1.5 million in revenue for labor hours and direct costs incurred under these agreements during the three and six months ended June 30, 2019, respectively, and $0.7 million and $1.4 million during the three and six months ended June 30, 2018, respectively.
The Company has entered into fixed-fee manufacturing and research and development arrangements with the International AIDS Vaccine Initiative and Frontier Biotechnologies, Inc. The Company recognized $0.1 million and $0.2$0.5 million in revenue under these agreements during the three and six months ended June 30, ~~2019,~~2020, respectively, and $0.4 million and ~~$2.7~~$1.5 million during the three and six months ended June 30, ~~2018,~~2019, respectively.

Contract Assets and Liabilities

At December 31, ~~2018~~2019 and June 30, ~~2019,~~2020, the Company’s right to consideration under all contracts was considered unconditional, and as such, there were no recorded contract assets. At December 31, ~~2018~~2019 and June 30, ~~2019,~~2020, the Company had ~~$1.6 million and $0.5~~$0.3 million in contract liabilities ~~recorded, respectively.~~recorded. Revenue recognized from contract liabilities as of December 31, ~~2018~~2019 during the three and six months ended June 30, ~~2019~~2020 was ~~$0.4~~$0.0 million and ~~$1.2~~$0.1 million, respectively.

~~(13)~~(12) 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 June 30, ~~2019~~2020 and December 31, ~~2018.~~2019.
The net deferred tax liability of $2.8 million and $3.0 million at June 30, ~~2019~~2020 and December 31, ~~2018~~2019, respectively, relates to the temporary differences associated with the IPR&D intangible assets acquired in previous business combinations and is not deductible for tax purposes. AsDuring the quarter ended June 30, 2020, a ~~result of the discontinuation of the Glemba program, the Company recorded~~ ~~a $0.8~~$0.2 million non-cash income tax benefit ~~during~~was recorded related to the ~~first quarter~~impairment of ~~2018.~~the CDX-3379 IPR&D asset.

Massachusetts, New Jersey, ~~Connecticut~~New York and ~~Australia~~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.

13
~~(14)~~
(13) 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:

Six Months Ended June 30,

2019

2018

Stock Options

1,690,074

931,080

Restricted Stock

1,110

4,000

1,691,184

935,080

Six Months Ended June 30,
2020 2019
Stock Options 3,085,287 1,690,074
Restricted Stock — 1,110
3,085,287 1,691,184
(14) Kolltan Acquisition
On November 29, 2016, the Company acquired all of the share and debt interests of Kolltan Pharmaceuticals, Inc. (“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 Kolltan Milestone payments, if any, may be made, at Celldex’s sole election, in cash, in shares of Celldex’s common stock or a combination of both, subject to provisions of the Merger Agreement. Certain Kolltan Milestones have been abandoned consistent with the provisions of the Merger Agreement and, because of this, as of June 30, 2020, 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 the representative of Kolltan’s former stockholders notifying the Company that it objected to the Company’s abandonment of certain Kolltan Milestones relating to development, regulatory approval and sales-based milestones. The Company disagrees with their objection and believes their objection to be without merit. The Company is continuting to discuss with the representative of Kolltan’s former stockholders potential amendments to the Merger Agreement with respect to the Kolltan Milestones. There can be no assurances that an amendment to the Merger Agreement will be completed on terms acceptable to the Company or at all. At this time, the Company is unable to reasonably assess the ultimate outcome of the Company’s disagreement with the representative of Kolltan’s former stockholders over its objection to the Company’s abandonment of certain Kolltan Milestones or determine an estimate of potential losses, if any.
14
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 dependence on product candidates, which are still in an early development stage;~~
· our ability to successfully complete research and further development, including animal, 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 recent outbreak of a novel strain of coronavirus on our business or on the economy generally;
· Whether the recent coronavirus outbreak 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;
15
· 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 immunotherapeutics;
· the cost of paying development, regulatory approval and sales-based milestones under the merger agreement by which we acquired Kolltan, including under any future amendment to that agreement;
· our ability to realize the anticipated benefits from the acquisition of Kolltan;
· our ability to raise sufficient capital to fund our animal, preclinical and clinical studies and to meet our liquidity needs, on terms acceptable to us, or at all. If we are unable to raise the funds necessary to meet our 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 annual report on Form 10-K for the year ended December 31, 2019 and other reports that we file with the Securities and Exchange Commission.

·                  our ability to successfully complete research and further development, including animal, 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 ability to raise sufficient capital to fund our animal, preclinical and clinical studies and to meet our liquidity needs, on terms acceptable to us, or at all. If we are unable to raise the funds necessary to meet our 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 anticipated timing for preclinical development, regulatory submissions, commencement and completion of clinical trials and product approvals;~~
·                  ~~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;~~
·                  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 immunotherapeutics;
·                  ~~our ability to realize the anticipated benefits from the acquisition of Kolltan;~~
·                  our ability to protect our intellectual property rights, including the ability to successfully defend patent oppositions filed against a European patent related to technology we use in varlilumab, 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 annual report on Form 10-K for the year ended December 31, 2018 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 focused on the development and commercialization of immunotherapies and other targeted biologics. Our drug candidates are derived from a broad set of ~~complementary technologies~~human and bispecific antibodies which have the ability to engage the human immune system and/or directly inhibit tumors to treat specific types of cancer or other diseases. They are aimed at addressing market opportunities for which we believe current therapies are inadequate or non-existent.

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

·                  CDX-1140, an agonist monoclonal antibody targeted to CD40, a key activator of immune response, currently being studied as a single-agent and in combination with CDX-301, a dendritic cell growth factor, in a Phase 1 dose-escalation study in multiple types of solid tumors and B cell lymphomas. In addition, we are evaluating the potential combination of CDX-1140 with varlilumab, an immune modulating antibody designed to target CD27 and enhance a patient’s immune response, especially in lymphomas which co-express CD40 and CD27 receptors;
·                  ~~CDX-3379, a monoclonal antibody designed to block the activity of ErbB3 (HER3), currently in an early Phase 2 study in advanced head and neck squamous cell cancer in combination with Erbitux®; and,~~
·
CDX-0159, a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity, which recently completed a Phase 1a study in healthy subjects. We plan to study CDX-0159 in mast cell driven diseases, including, initially, initiating Phase 1b studies in chronic spontaneous urticaria (CSU) and ~~is expected~~chronic inducible urticarias (CIndUs) this fall; and,
• CDX-1140, an agonist monoclonal antibody targeted to CD40, a key activator of immune response, currently being studied as a single-agent and in combination with CDX-301, a dendritic cell growth factor. Dose escalation was completed in a Phase 1 study in solid tumors and lymphoma and the recommended dose for further study was determined to be 1.5 mg/kg for both CDX-1140 monotherapy and in combination with CDX-301. Celldex has initiated multiple expansion cohorts within the study, including a combination cohort with KEYTRUDA^® (pembrolizumab) in patients refractory to PD1/PDL1 treatment and plans to initiate a combination cohort with standard of care chemotherapy in patients with untreated metastatic pancreatic cancer later this year. The Company is exploring additional combination cohorts with mechanisms that we believe could be complementary or synergistic with CDX-1140;
CDX-527, a bispecific antibody that uses our proprietary highly active anti-PD-L1 and CD27 human antibodies to ~~enter~~couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway, for which we plan to initiate a Phase 1 study in ~~healthy subjects by year end.~~advanced solid tumors later this year.
We are discontinuing development of CDX-3379, an ErbB3 inhibitor, and directing the resources allocated to this program to expanded development of CDX-0159 and other assets in our pipeline. CDX-3379 was in an exploratory study designed to evaluate of the utility of biomarkers for patient selection in the treatment of cetuximab-refractory head and neck squamous cell carcinoma.

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.

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:
Clinical Phase
Estimated
Completion
Period
Phase 1
1 - 2 Years
Phase 2
1 - 5 Years
Phase 3
1 - 5 Years
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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 number of patients that ultimately participate in the trial;

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

·                  ~~the number of clinical sites included in the trials;~~
· the number of clinical sites included in the trials;

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

·                  ~~the efficacy and safety profile of the drug candidate.~~
· 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.

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 agency 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.

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, ~~2018,~~2019, we incurred an aggregate of ~~$469.9~~$408.2 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 six months ended June 30, ~~2019~~2020 and ~~2018.~~2019. 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.

Six Months Ended
June 30, 2019

Six Months Ended
June 30, 2018

(In thousands)

CDX-1140

$
3,195

$
2,325

CDX-3379

2,180

1,672

Anti-KIT Program (including CDX-0159)

1,974

3,967

Varlilumab

1,947

5,660

CDX-301

635

1,164

CDX-527

3,412

208

TAM Program

2,571

3,056

Other Programs

5,318

25,271

Total R&D Expense

$
21,232

$
43,323

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Six Months Ended
June 30, 2020 Six Months Ended
June 30, 2019
(In thousands)
CDX-0159/Anti-KIT Program $ 2,896 $ 1,974
CDX-1140 5,069 3,195
CDX-527 5,891 3,412
TAM Program 1,192 2,571
Other Programs 6,352 10,080
Total R&D Expense $ 21,400 $ 21,232

Clinical Development Programs

CDX-0159
CDX-0159 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 urticarias (CIndUs), mast cell degranulation plays a central role in the onset and progression of the disease.
CDX-0159 is designed to block KIT activation by disrupting both SCF binding and KIT dimerization. Celldex believes that by targeting KIT, CDX-0159 may be able to inhibit mast cell activity and decrease mast cell numbers to provide potential clinical benefit in mast cell related diseases.

We recently completed a randomized, double-blind, placebo-controlled, single ascending dose escalation Phase 1a study of CDX-0159 in healthy subjects (n=32; 8 subjects per cohort, 6 CDX-0159; 2 placebo). Subjects received a single intravenous infusion of CDX-0159 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 demonstrated a favorable safety profile as well as profound and durable reductions of plasma tryptase, consistent with systemic mast cell suppression.
· Most common adverse events were mild infusion-related reactions, all of which spontaneously resolved without intervention. Mild and asymptomatic decreases in neutrophil and white blood cell count were observed in laboratory testing.
· A single dose of CDX-0159 suppressed plasma tryptase levels in a dose-dependent manner, indicative of systemic mast cell suppression. Tryptase suppression below the level of detection was observed after a single 1.0 mg/kg dose and was maintained for more than 2 months at single doses of both 3.0 and 9.0 mg/kg of CDX-0159. A subset of subjects from the 3mg/kg and 9 mg/kg cohorts agreed to continued follow up for tryptase suppression which remained below the level of detection for over 3 months (14 weeks) in 50% of subjects and over 4 months (18 weeks) in all subjects, respectively.
· Dose dependent increases in plasma stem cell factor mirror decreases in tryptase, consistent with allosteric blockade of stem cell factor to KIT and demonstrate complete target engagement in vivo.
· Long serum half-life and non-immunogenic profile support a convenient dosing schedule.
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· Enhanced PK profile and durable tryptase suppression at low doses support re-formulation for sub-cutaneous administration.
These data support expansion of the CDX-0159 program into mast cell driven diseases, including initially studies in forms of chronic urticaria (CU) given the central role mast cells are known to play in the etiology of CU. Celldex plans to initiate Phase 1b studies of CDX-0159 this fall in patients with chronic spontaneous urticaria (CSU) and chronic inducible urticaria (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 exploring cold-induced and dermographism (scratch-induced) urticarias. Celldex is also exploring additional mast cell driven diseases for future development.
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. 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 Phase 1 study to identify the dose for characterizing single-agent and combination activity.

We initiated a Phase 1 study of CDX-1140 in November 2017. This study is expected to enroll up to approximately ~~180~~220 patients with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas. The study is designed to determine the maximum tolerated dose, or 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. The expansion is designed to further evaluate the tolerability and biologic effects of selected dose(s) of CDX-1140 in specific tumor types. 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.

In support of this, the Phase 1 study protocol also allows for the exploration of CDX-1140 in combination with CDX-301 at a fixed dose of CDX-301 and escalating doses of CDX-1140. Dendritic cells, which express CD40, are often rare or missing from the tumor microenvironment and are critical for initiating anti-tumor immunity. CDX-301, a recombinant FMS-like tyrosine kinase 3 ligand, or Flt3L, is a hematopoietic cytokine that uniquely expands dendritic cells and hematopoietic stem cells, and in combination with other agents may potentiate anti-tumor responses. CDX-301 is being utilized as a priming agent in this study to increase the number of dendritic cells in blood and tissue available for CDX-1140 activation. CDX-1140 should, in turn, activate and mature the dendritic cells, an important step for enhancing anti-tumor immune responses.

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Interim data from ~~the Phase 1~~this ongoing study were presented ~~in April 2019~~ at the ~~American Association~~Society for ~~Cancer Research (AACR)~~Immunotherapy of Cancer’s (SITC) 34th Annual ~~Meeting. 30 patients were enrolled~~Meeting in November 2019. CDX-1140 monotherapy dose escalation in the study is complete and the maximum tolerated dose and recommended Phase 2 dose was defined as 1.5 mg/kg every four weeks. CDX-1140 monotherapy and combination with CDX-301 was generally well tolerated, with mostly grade 1 or grade 2 drug related adverse events reported. Two patients out of six experienced pneumonitis as dose limiting toxicities (DLTs) in the CDX-1140 3.0 mg/kg monotherapy cohort. There were no DLTs observed in the CDX-301 combination cohorts up to 0.72 mg/kg CDX-1140. A cohort of CDX-1140 at 1.5 mg/kg plus CDX-301, which was ongoing at the time of data ~~analysis (n=22 monotherapy; n=8 combination). Six monotherapy dosing cohorts~~release, has subsequently completed dose escalation with no DLTs observed; therefore, the recommended dose of CDX-1140 in ~~both~~combination with CDX-301 is 1.5mg/kg.
As of the cut-off date for data reporting for SITC, 62 patients with advanced refractory solid tumors or lymphoma were enrolled and ~~non-Hodgkin lymphoma (NHL) (0.01, 0.03, 0.09, 0.18, 0.36~~38 patients had pre- and post-treatment scans available. Patients were heavily pretreated (median of 4 prior therapies) and per protocol were required to have received all standard of care treatments prior to study entry. CDX-1140 demonstrated clinical and biological activity in the study.
Two of five patients with head and neck squamous cell carcinoma (HNSCC) treated with CDX-1140 doses of 0.72 mg/~~kg) and~~kg or higher experienced clinical activity. The first patient experienced dramatic shrinkage of a large, protruding neck mass on physical exam after two ~~combination cohorts in solid tumors (0.09 and 0.18 mg/kg) with CDX-301 were completed. Enrollment to the seventh monotherapy cohort~~doses of CDX-1140 at 1.5 mg/kg ~~and to the third CDX-301 combination cohort at~~with documented evidence of tumor necrosis/cavitation on CT scan. This patient also reported decreased tumor pain. A second patient experienced cavitation of greater than 50% of lung metastases on CT scan after one dose of CDX-1140 3 mg/kg.
A patient with gastroesophageal carcinoma experienced a RECIST response after two cycles of CDX-1140 0.36 mg/kg ~~were ongoing. In general, patients had advanced disease~~plus CDX-301 that included 41% shrinkage of liver and ~~were heavily pretreated (median number~~lymph node target lesions, with near complete resolution of ~~prior therapies: 4 monotherapy arm; 3.5 combination arm). CDX-1140~~the liver lesion. This response was ~~generally well tolerated. An MTD had not been reached. Three~~durable for four months.
Six patients experienced ~~serious~~stable disease (n=4 CDX-1140 monotherapy; n=2 CDX-1140/CDX-301 combination) with a duration of 1.8 months to 5.4 months.
One patient experienced immune unconfirmed progressive disease on their first scan and continued on treatment ~~related adverse events (pneumonitis and hypoxia; possible cytokine release, fatigue and fever; and, fatigue and nausea). Across both arms~~for 10+ months without confirmation of ~~the study, there were no high grade (Grade 3 or above) drug-related changes observed in liver function tests or platelets, including~~progressive disease at CDX-1140 ~~dose levels which exceed the MTDs or recommended Phase 2 dose reported~~0.09 mg/kg plus CDX-301.
Potent pharmacological effects associated with ~~other CD40 agonists. The addition of CDX-301 did not affect the tolerability of CDX-1140 at the dose levels tested. Dose dependent biological effects consistent with CD40-mediated~~ immune activation were ~~reported. Higher dose levels achieved circulating antibody concentrations in the range of 20 to 30 micrograms~~
~~CDX-1140 per milliliter. Transient dose-dependent pharmacodynamic effects were~~also observed, including transient induction of inflammatory cytokines and chemokines associated with dendritic cell and T cell activation at higher dose levels. Similar activation was observed with each cycle of therapy. Peripheral blood immune cells had upregulated immune activation markers and CDX-301 markedly increased the number of dendritic cells and ~~B cells,~~was associated with higher IL-12p40 induction, a key molecule for inducing anti-tumor T cell responses.
CDX-1140 monotherapy expansion cohorts in HNSCC, renal cell carcinoma and gastroesophageal adenocarcinoma have been added to the study, along with ~~increases~~a combination cohort of CDX-1140 and CDX-301 in pro-inflammatory cytokines and chemokines in the blood, all of which are consistent with CD40-mediated immune activation and the hypothesis that CDX-1140 is achieving dose levels optimal for systemic exposure. TheHNSCC. In addition, ~~of CDX-301 further enhanced cytokine responses. While not anticipated at low CDX-1140 dose levels, stable disease was observed in this heavily pretreated population.~~
~~Continued enrollment is ongoing~~we have prioritized a cohort to define the MTD and select a dose for disease-specific expansion cohorts that will be monitored for clinical activity. Future combination opportunities are also being considered, including with PD-1 or PD-L1 inhibitors, chemotherapy, radiation therapy and Celldex’s potent CD27 agonist monoclonal antibody varlilumab. Several B cell lymphomas, including diffuse large B-cell lymphoma and follicular lymphoma, also express both CD40 and CD27. Celldex’s varlilumab is a potent CD27 agonist and has been shown to synergize withevaluate CDX-1140 in ~~NHL models.~~combination with KEYTRUDA^® (pembrolizumab), Merck’s anti-PD-1 therapy, under a clinical trial collaboration agreement with Merck (known as MSD outside of the U.S. and Canada). The cohort is designed to characterize the safety, pharmacodynamics and activity of CDX-1140 in combination with pembrolizumab in patients refractory to PD1/PDL1 treatment. Enrollment is ongoing. We also plan to ~~present updated data from the Phase 1 study at~~initiate a ~~future medical meeting~~cohort in ~~2019.~~combination with standard of care chemotherapy in patients with previously untreated metastatic pancreatic cancer later this year. The Company is exploring additional combination cohorts with mechanisms that we believe could be complementary or synergistic with CDX-1140.

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.
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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.
Later this year, Celldex plans to initiate a Phase 1 dose-escalation study in up to ~90 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, biologic and anti-tumor effects of selected dose level(s) of CDX-527 in specific tumor types.
CDX-3379

CDX-3379 is a human monoclonal antibody with half-life extension designed to block the activity of ErbB3 (HER3). We believe ErbB3 may be an important receptor regulating cancer cell growth and survival as well as resistance to targeted ~~therapies and~~therapies. ErbB3 is expressed in many cancers, including head and neck, thyroid, breast, lung and gastric cancers, as well as melanoma. ~~We believe the proposed mechanism of action for~~ CDX-3379 sets it apart from other drugs in development in this class due to its ability to block both ligand-independent and ligand-dependent ErbB3 signaling by binding to a unique epitope. It has a favorable pharmacologic profile, including a longer half-life and slower clearance relative to other drug candidates in this class. We believe CDX-3379 also has potential to enhance anti-tumor activity and/or overcome resistance in combination with other targeted and cytotoxic therapies to directly kill tumor cells. Tumor cell death and the ensuing release of new tumor antigens has the potential to serve as a focus for combination therapy with immuno-oncology approaches, even in refractory patients. CDX-3379 has been evaluated in three Phase 1 studies for the treatment of multiple solid tumors that express ErbB3 and is currently beingwas recently evaluated in a Phase 2 ~~study in combination with Erbitux in Erbitux-resistant, advanced head and neck squamous cell carcinoma (HNSSC).~~
A Phase 1a/1b study of CDX-3379 was conducted in solid tumors. The study included a single-agent, dose-escalation portion and combination expansion cohorts. The single-agent, dose-escalation portion of the study did not identify an MTD, and there were no dose limiting toxicities. Four combination arms across multiple tumor types were added to evaluate CDX-3379 with several drugs that target EGFR, HER2 or BRAF. They include combinations with Erbitux® ~~(n=16), Tarceva~~® ~~(n=8), Zelboraf~~® ~~(n=9) and Herceptin~~® (n=10). Patients had advanced disease and were generally heavily pretreated. Across the combination arms, the most frequent adverse events were diarrhea, nausea, rash and fatigue. Objective responses were observed in the Erbitux and Zelboraf combination arms. In the Erbitux arm, there was one durable complete response in a patient with head and neck cancer, who had been previously treated with Erbitux and was refractory. In the Zelboraf arm, there were two partial responses in patients who had lung cancer, one of whom had been previously treated with Tafinlar® and was considered refractory, as well as an unconfirmed partial response in a patient with thyroid cancer. Initial data were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting.
In April 2018, results from a window-of-opportunity study evaluating the effect of CDX-3379 on potential biomarkers in patients with HNSCC were presented at the American Association for Cancer Research (AACR) Annual Meeting. The study enrolled 12 patients with newly diagnosed HNSCC who received two doses of CDX-3379, at a two-week interval prior to tumor resection. CDX-3379 reduced phosphorylated ErbB3 (pErbB3) levels in 83% (10/12) of patient samples, with greater than or equal to 50% decreases in 58% of patients (7/12), which met the primary study objective. Stable disease was observed in 92% (11/12) of patients prior to surgery, and a patient with HPV-negative disease experienced an exceptional response (greater than 92% tumor shrinkage). CDX-3379 was well-tolerated, and no treatment-related adverse events were observed.
Preclinical data from the combination of CDX-3379 and Erbitux in xenograft models of HNSCC were also presented at the AACR Annual Meeting in April 2018. Combining CDX-3379 and Erbitux inhibited tumor growth more potently than Erbitux alone. Mechanistic studies demonstrated a reduction of PD-L1 expression from the combination.
~~We initiated an~~ open-label ~~Phase 2~~exploratory study in combination with Erbitux in patients with human papillomavirus (HPV) negative, Erbitux-resistant, advanced HNSCC who have previously been treated with an anti-PD1 checkpoint inhibitor, a population with limited options and a particularly poor prognosis. ~~We opened the study to enrollment in November 2017.~~
The study was initially designed as a Simon two-stage design with an interim futility analysis following enrollment of the first 13 patients. According to the study design, if at least one patient achieved an objective response in the first stage, enrollment could progress to the second stage. The primary endpoint of the study iswas objective response rate (ORR). Secondary endpoints ~~include~~included assessments of clinical benefit response (CBR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety and pharmacokinetics associated with the combination. Enrollment to the first stage of the Phase 2 study (n=15) ~~is complete~~was completed and interim data ~~from the study~~ were presented at the 2019 ASCO Annual Meeting in ~~June that support the continued development of CDX-3379.~~
Patients had a median of 3 (range of 2-6) prior cancer therapy treatments. All patients had received prior checkpoint inhibitor treatment and 14 of 15 patients were cetuximab refractory. Notable clinical activity was observed in this refractory patient population.June. A durable confirmed complete response (11+ months) ~~was observed; this response remains ongoing~~ and ~~the patient continues to receive treatment. An~~an unconfirmed partial response (uPR) in a patient that had not received cetuximab ~~was also observed.~~were observed; 7 patients experienced stable disease (47%; includes uPR)~~. A clinical benefit rate of 29% was achieved (objective response or stable disease greater than or equal to 12 weeks)~~. CDX-3379 in combination with cetuximab was generally associated with ~~the expected~~ target-mediated adverse events of diarrhea and ~~rash.~~
~~Emerging data from~~rash and dose reductions and/or delays to the combination therapy in the majority of patients were contemplated to have potentially impacted the magnitude of anti-tumor activity in the study. The analysis presented at ASCO also suggested that observed antitumor activity with CDX-3379 across the Phase 1 and Phase 2 ~~study and earlier~~ studies ~~of CDX-3379 suggest that antitumor activity may~~might be associated with somatic mutations in certain genes. Based on these observations, next-generation sequencing was performed on tumor samples from 18 patients with HNSCC treated with CDX-3379 across three clinical studies of CDX-3379 that have enrolled patients with HNSCC. This data set included four patients with clinical responses, eight patients with stable disease and/or tumor shrinkage, and six patients with progressive disease. Key findings are outlined below.
·                  ~~All four clinical responses occurred in patients with mutations in~~ the FAT1 ~~gene.~~
·                  ~~All four clinical responses occurred in patients with a primary tumor site of oral cavity.~~
·                  ~~Three of the four clinical responses occurred in patients who also had mutations in NOTCH1, NOTCH2 or NOTCH3 genes.~~
·                  ~~Also, of note, all patients (n=7 of 18) who experienced clinical benefit (objective response or stable disease greater than or equal to 12 weeks) had FAT1 and/or~~and NOTCH1-3 ~~mutations.~~
·                  ~~FAT1 and NOTCH~~ genes—genes ~~are~~ associated with tumor suppression. Inactivating mutations in the FAT1 and NOTCH genes occur in sizeable subsets of HPV negative HNSCC tumors, having been identified in 32% (FAT1) and 26% (NOTCH) of these tumors, respectively. Preclinical studies investigating the association of CDX-3379 sensitivity and inactivating mutations of FAT1 and other genes are ongoing.

Based on these biomarker observations and the ~~notable~~ clinical activity observed in ~~this refractory patient population,~~the Phase 2 study, the study ~~has been~~was amended and expanded ~~(n= ~45~~to add an additional 30 patients ~~including at least 15 patients with FAT1 mutations)~~ to allow for an evaluation of the utility of biomarkers for ~~future~~ patient selection. Enrollment ~~is ongoing.~~
~~CDX-0159~~
~~CDX-0159 is a humanized monoclonal antibody that specifically binds~~of the ~~KIT receptor~~first 15 patients in this expansion cohort was recently completed. One patient experienced an ongoing objective response (7%) and ~~potently inhibits its activity. The KIT receptor tyrosine kinase is expressed~~5 (33%) patients experienced stable disease on at least one tumor assessment. Consistent with the first cohort, the combination of CDX-3379 and cetuximab appears to result in ~~a variety~~synergistic toxicity with target mediated adverse events of ~~cells, including mast cells,~~diarrhea and ~~its activation by its ligand SCF regulates mast cell growth, differentiation, survival, chemotaxis~~rash. While diarrhea prophylaxis implemented in second cohort appeared to have been effective in ameliorating severity of symptoms it did not decrease the frequency and ~~degranulation. In certain inflammatory diseases, such as chronic idiopathic urticaria (CIU), mast cell degranulation plays a central role~~the incidence of severe rash increased, resulting in dose reductions and/or delays to the combination therapy in the ~~onset and progression~~majority of patients. When considered together, the ~~disease.~~
CDX-0159 is a re-engineered variant of CDX-0158, which was specifically designed to block KIT activation by disrupting both SCF binding and KIT dimerization. Preclinical and clinical data with CDX-0158 demonstrated robust inhibition of mast cell activity and decreased mast cell numbers, supporting the concept that targeting KIT can modulate mast cell activity and potentially provide clinical benefit in mast cell related diseases. CDX-0159 was re-designed to ablate Fc receptor interactions and effector function and improve its safety profile, while preserving full KIT inhibitory activity. In addition, CDX-0159 was modified to provide extended half-life following administration.
~~We plan to submit an Investigational New Drug (IND) Application and initiate a Phase 1a study of CDX-0159 by year end 2019. The study is designed to~~ evaluate the safety profile, pharmacokinetics and pharmacodynamics of single ascending doses of CDX-0159 in healthy subjects. Following completion of this study, we plan to further study CDX-0159 in CIU, a mast cell-related disease. CIU 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 CIU 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 more effective later line therapies.
~~Varlilumab~~
Varlilumab is a fully human agonist monoclonal antibody that binds to and activates CD27, a critical co-stimulatory molecule in the immune activation cascade. We believe varlilumab works primarily by stimulating T cells, an important component of a person’s immune system, to attack cancer cells. Restricted expression and regulation of CD27 enables varlilumab specifically to activate T cells, resulting in an enhanced immune response with the potential for a favorable safety profile. In preclinical studies, varlilumab has been shown to directly kill or inhibit the growth of CD27 expressing lymphomas and leukemias in ~~in vitro~~ ~~and~~ ~~in vivo~~ ~~models. Varlilumab was initially studied as a single-agent to establish a safety profile and assess immunologic and~~emerging clinical activity in
~~patients with cancer, but we believe~~data is not adequate to justify the ~~greatest opportunity for varlilumab is as an immune activator in combination with other agents.~~
~~Single-Agent Phase 1 Study:~~ In an open-label Phase 1 study of varlilumab in patients with selected malignant solid tumors or hematologic cancers, varlilumab demonstrated an acceptable safety profile and induced immunologic activity in patients that is consistent with both its proposed mechanism of action and data in preclinical models. A total of 90 patients received varlilumab in the study at multiple clinical sites in the U.S. In both the solid tumor and hematologic dose escalations, the pre-specified maximum dose level (10 mg/kg) was reached without identification of an MTD. The majority of adverse events, or AEs, related to treatment were mild to moderate (Grade 1/2) in severity, and no significant immune-mediated adverse events typically associated with checkpoint blockade were observed. Durable, multi-year clinical benefit was demonstrated in select patients without additional anti-cancer therapy. Final results from the study in patients with solid tumors were published in the ~~Journal of Clinical Oncology~~ ~~in April 2017.~~
~~Phase 1/2 Varlilumab/Opdivo Combination Study:~~ In 2014, we entered into a clinical trial collaboration with Bristol-Myers Squibb, or BMS, to evaluate the safety, tolerability and preliminary efficacy of varlilumab and Opdivo, BMS’s PD-1 immune checkpoint inhibitor, in a Phase 1/2 study. The Phase 1 portion of the study was initiated in January 2015 and conducted in adult patients with multiple solid tumors to assess the safety and tolerability of varlilumab at varying doses when administered with Opdivo. It was followed by a Phase 2 expansion to evaluate the activitytoxicity of the combination ~~in disease specific cohorts. Enrollment to~~and the ~~Phase 2 portion~~results do not support continued development of the ~~study was completed~~combination, regardless of pending biomarker data. As a result, Celldex is discontinuing development of CDX-3379 and the resources allocated to this program will be focused on expanded development of CDX-0159 and additional assets in January 2018 with cohorts in colorectal cancer (n=21), ovarian cancer (n=58), head and neck squamous cell carcinoma (HNSCC) (n=24), renal cell carcinoma (RCC) (n=14) and glioblastoma (GBM) (n=22). The primary objective of the Phase 2 cohorts was objective response rate, or ORR, except glioblastoma, where the primary objective was the rate of 12-month OS.our pipeline.

CRITICAL ACCOUNTING POLICIES

The combination of varlilumab and nivolumab was generally well tolerated across indications at all varlilumab dose levels/schedules tested. Clinical data from patients with “cold” tumors with low expectation of response to checkpoint inhibition monotherapy suggested potential benefit from the combination. Uniquely in the ovarian cancer cohort, increased PD-L1 and CD8 TIL were observed in ~ 60% of patients with paired biopsy samples. Patients with increase in PD-L1 and CD8 TIL had good clinical outcome and higher doses of varlilumab trended towards better activity then lower/less frequent dosing. In recurrent GBM, results in the subgroup (n=16) with unmethylated MGMT appeared promising with 2 (14%) partial responses noted and a median overall survival of 12.5 months. Among colorectal cancer patients, durable clinical responses were observed in a patient with MSI-high tumor and one with a high mutational burden. In HNSCC, in the subgroup (n=9) with PD-L1 negative disease, one partial response was observed (13%) and a median OS of 11 months was reported. Given the changing treatment paradigm in RCC, only fourteen patients were treated in the study; 39% of these patients experienced stable disease.
Future development of varlilumab is focused on inclusion in internal combination studies, including potentially in the ongoing Phase 1 trial of CDX-1140, and several external investigator-initiated studies.
~~CDX-301~~
CDX-301, a recombinant FMS-like tyrosine kinase 3 ligand, or Flt3L, is a hematopoietic cytokine that uniquely expands dendritic cells and hematopoietic stem cells, and in combination with other agents may potentiate anti-tumor responses. Depending on the setting, cells expanded by CDX-301 promote either enhanced or permissive immunity. We believe CDX-301 may hold significant opportunity for synergistic development in combination with other proprietary molecules in our portfolio, as well as with approved or investigational therapies for the treatment of cancer.
A Phase 1 study of CDX-301 evaluated seven different dosing regimens of CDX-301 to determine the appropriate dose for further development based on safety, tolerability and biological activity. The data from the study were consistent with previous clinical experience and demonstrated that CDX-301 has an acceptable safety profile to date and can mobilize dendritic cell and hematopoietic stem cell populations in healthy volunteers. The study was published in the journal Bone Marrow Transplantation in 2015.
CDX-301 is being used as a priming agent to potentially increase the number of cells available to respond to CDX-1140 in the ongoing Phase 1 trial of CDX-1140. CDX-301 is also in clinical development for multiple cancers in ongoing investigator-sponsored and collaborative studies, including in combination with treatments that release tumor antigens, such as radiation therapy.
~~CRITICAL ACCOUNTING POLICIES~~
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, ~~2018~~2019 for a discussion of our critical accounting policies. There have been no material changes to such critical accounting ~~policies except for the adoption of the updated lease accounting standard on January 1, 2019.~~policies. We believe our most critical accounting policies include accounting for ~~business combinations,~~contingent consideration, revenue recognition, intangible and long-lived assets, research and development expenses and stock-based compensation expense.

RESULTS OF OPERATIONS

Three Months Ended June 30, ~~2019~~2020 Compared with Three Months Ended June 30, ~~2018~~2019

Three Months Ended
June 30,

Increase/
(Decrease)

Increase/
(Decrease)

Three Months Ended
June 30, Increase/
(Decrease) Increase/
(Decrease)

2019

2018

$

%

2020 2019 $ %

(In thousands)

(In thousands)
Revenues:

Product Development and Licensing Agreements

$
195

$
1,667

$
(1,472
)
(88
)%
$ — $ 195 $ (195 ) (100 )%
Contracts and Grants

520

1,096

(576
)
(53
)%
236 520 (284 ) (55 )%
Total Revenue

$
715

$
2,763

$
(2,048
)
(74
)%
$ 236 $ 715 $ (479 ) (67 )%
Operating Expenses:

Research and Development

10,081

21,448

(11,367
)
(53
)%
9,705 10,081 (376 ) (4 )%
General and Administrative

3,908

5,621

(1,713
)
(30
)%
3,528 3,908 (380 ) (10 )%
Intangible Asset Impairment 3,500 — 3,500 n/a
Gain on Fair Value Remeasurement of Contingent Consideration

(1,017
)
(7,433
)
(6,416
)
(86
)%
(5,132 ) (1,017 ) 4,115 405 %
Total Operating Expense

12,972

19,636

(6,664
)
(34
)%
11,601 12,972 (1,371 ) (11 )%
Operating Loss

(12,257
)
(16,873
)
(4,616
)
(27
)%
(11,365 ) (12,257 ) (892 ) (7 )%
Investment and Other Income, Net

478

466

12

3
%
106 478 (372 ) (78 )%
Net Loss Before Income Tax Benefit (11,259 ) (11,779 ) (520 ) (4 )%
Income Tax Benefit 228 — 228 n/a
Net Loss

$
(11,779
)
$
(16,407
)
$
(4,628
)
(28
)%
$ (11,031 ) $ (11,779 ) $ (748 ) (6 )%

Net Loss

The ~~$4.6~~$0.7 million decrease in net loss for the three months ended June 30, ~~2019,~~2020, as compared to the three months ended June 30, ~~2018,~~2019, was primarily the result of ~~a decrease~~an increase in ~~research and development expenses, partially offset by~~ the ~~decrease in~~ gain on fair value remeasurement of contingent ~~consideration.~~
consideration, partially offset by the increase in non-cash intangible asset impairment expense.
Revenue

The ~~$1.5~~$0.2 million decrease in product development and licensing agreements revenue for the three months ended June 30, ~~2019,~~2020, as compared to the three months ended June 30, ~~2018,~~2019, was primarily due to a decrease in revenue ~~related to our BMS agreement as a result of~~under the ~~completion of our combination clinical study.~~Rockefeller Agreement. The ~~$0.6~~$0.3 million decrease in contracts and grants revenue for the three months ended June 30, ~~2019,~~2020, as compared to the three months ended June 30, ~~2018,~~2019, was primarily related to a decrease in services performed under our ~~contract~~ manufacturing and research and development ~~agreements~~agreement with ~~Rockefeller University and the International AIDS Vaccine Initiative.~~Duke University. We expect revenue to ~~decrease~~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
June 30

Increase/
(Decrease)

Three Months Ended
June 30 Increase/
(Decrease)

2019

2018

$

%

2020 2019 $ %

(In thousands)

(In thousands)
Personnel

$
5,408

$
7,719

$
(2,311
)
(30
)%
$ 5,216 $ 5,408 $ (192 ) (4 )%
Laboratory Supplies

1,257

1,212

45

4
%
775 1,257 (482 ) (38 )%
Facility

1,558

2,019

(461
)
(23
)%
1,758 1,558 200 13 %
Product Development

827

7,576

(6,749
)
(89
)%
1,023 827 196 24 %

Personnel expenses primarily include salary, benefits, stock-based compensation and payroll taxes. The ~~$2.3~~$0.2 million decrease in personnel expenses for the three months ended June 30, ~~2019,~~2020, as compared to the three months ended June 30, ~~2018,~~2019, was primarily due to ~~a decrease in headcount and~~ lower ~~severance expense related to the workforce reduction that occurred in the second quarter of 2018 as a result of the discontinuation of the Glemba program.~~stock-based compensation expense. We expect personnel expenses to remain relatively consistent over the next twelve months, although there may be fluctuations on a quarterly basis.

Laboratory supplies expenses include laboratory materials and supplies, services, and other related expenses incurred in the development of our technology. ~~Laboratory~~The $0.5 million decrease in laboratory supply expenses for the three months ended June 30, ~~2019 were consistent with~~2020, as compared to the three months ended June 30, ~~2018.~~2019, was primarily due to 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~~$0.2 million ~~decrease~~increase in facility expenses for the three months ended June 30, ~~2019,~~2020, as compared to the three months ended June 30, ~~2018,~~2019, was primarily due to ~~lower depreciation expense.~~higher variable lease expense, including common area maintenance and utilities, in the second quarter of 2020. We expect facility expenses to decrease over the next twelve months as a result of the ~~reduction in leased space in our Hampton, New Jersey facility. In addition, in June 2019, we decided to consolidate~~consolidation our Massachusetts lab and manufacturing facilities to further preserve our financial resources and direct them towards reaching meaningful development milestones across our pipeline. The lease in Needham, MA will not be renewed and most functions and employees will be integrated into our Fall River, MA facility in 2020. We estimate that this consolidation along with the reduction in square footage at our Hampton, NJ facility earlier this year will decrease our facility footprint by over 35% and will save the Company over $3.5 million annually starting in the second ~~half~~quarter of 2020. In July 2020, we extended the term of its Fall River lease through July 2023.

Product development expenses include clinical investigator site fees, external trial monitoring costs, data accumulation costs, contracted research and outside clinical drug product manufacturing. The ~~$6.7~~$0.2 million ~~decrease~~increase in product development expenses for the three months ended June 30, ~~2019,~~2020, as compared to the three months ended June 30, ~~2018,~~2019, was primarily due to ~~a decrease~~an increase in contract manufacturing and clinical trial expenses of ~~$3.9~~$0.4 million, ~~and~~partially offset by a decrease in contract ~~manufacturing~~research expenses of ~~$2.2~~$0.2 million. We expect product development expenses to increase over the next twelve months, asalthough there may be fluctuations on a ~~result of increased clinical trial expenses.~~quarterly basis.

General and Administrative Expense

The ~~$1.7~~$0.4 million decrease in general and administrative expenses for the three months ended June 30, ~~2019,~~2020, as compared to the three months ended June 30, ~~2018,~~2019, was primarily due to ~~a decrease in headcount,~~ lower ~~commercial planning costs and lower lease restructuring~~stock-based compensation expense. We expect general and administrative expenses to remain relatively consistent over the next twelve months, although there may be fluctuations on a quarterly basis.

Intangible Asset Impairment
We evaluated the CDX-3379 IPR&D asset for potential impairment as a result of the discontinuation of the CDX-3379 program. We concluded that the CDX-3379 IPR&D asset was fully impaired, and a non-cash impairment charge of $3.5 million was recorded for the three months ended June 30, 2020.

Gain on Fair Value Remeasurement of Contingent Consideration
The ~~$1.0~~$5.1 million gain on fair value remeasurement of contingent consideration for the three months ended June 30, 2020 was primarily due to updated assumptions for CDX-3379 related milestones due to the discontinuation of the CDX-3379 program. The $1.0 million gain on fair value remeasurement of contingent consideration for the three months ended June 30, 2019 was primarily due to changes in discount rates and the passage of time. The $7.4 million gain on fair value remeasurement of contingent consideration for the three months ended June 30, 2018 was due to a reduction in fair value as a result of discontinuation of the CDX-014 program and updated assumptions for the varlilumab program.
Investment and Other Income, Net

~~Investment~~The $0.4 million decrease in investment and other income, net for the three months ended June 30, ~~2019 was consistent with~~2020, as compared to the three months ended June 30, ~~2018. We anticipate investment income to decrease over the next twelve months~~2019, was primarily due to lower levels of cash and investment balances. We anticipate investment income to increase over the next twelve months due to higher levels of cash and investment balances and higher other income related to our sale of New Jersey tax benefits.
Income Tax Benefit
During the quarter ended June 30, 2020, a $0.2 million non-cash income tax benefit was recorded related to the impairment of the CDX-3379 IPR&D asset.

Six Months Ended June 30, ~~2019~~2020 Compared with Six Months Ended June 30, ~~2018~~2019

Six Months Ended
June 30,

Increase/
(Decrease)

Increase/
(Decrease)

Six Months Ended
June 30, Increase/
(Decrease) Increase/
(Decrease)

2019

2018

$

%

2020 2019 $ %

(In thousands)

(In thousands)
Revenues:

Product Development and Licensing Agreements

$
325

$
2,662

$
(2,337
)
(88
)%
$ 2,285 $ 325 $ 1,960 603 %
Contracts and Grants

1,815

4,172

(2,357
)
(56
)%
680 1,815 (1,135 ) (63 )%
Total Revenue

$
2,140

$
6,834

$
(4,694
)
(69
)%
$ 2,965 $ 2,140 $ 825 39 %
Operating Expenses:

Research and Development

21,232

43,323

(22,091
)
(51
)%
21,400 21,232 168 1 %
General and Administrative

8,804

11,215

(2,411
)
(21
)%
7,194 8,804 (1,610 ) (18 )%
Goodwill Impairment

—

90,976

(90,976
)
(100
)%
Intangible Asset Impairment

—

18,677

(18,677
)
(100
)%
3,500 — 3,500 n/a
Other Asset Impairment

1,800

—

1,800

n/a

— 1,800 (1,800 ) (100 )%
Loss/(Gain) on Fair Value Remeasurement of Contingent Consideration

502

(21,033
)
21,535

102
%
Amortization of Acquired Intangible Assets

—

224

(224
)
(100
)%
(Gain) Loss on Fair Value Remeasurement of Contingent Consideration (4,898 ) 502 5,400 1,076 %
Total Operating Expense

32,338

143,382

(111,044
)
(77
)%
27,196 32,338 (5,142 ) (16 )%
Operating Loss

(30,198
)
(136,548
)
(106,350
)
(78
)%
(24,231 ) (30,198 ) (5,967 ) (20 )%
Investment and Other Income, Net

1,180

1,245

(65
)
(5
)%
347 1,180 (833 ) (71 )%
Net Loss Before Income Tax Benefit

(29,018
)
(135,303
)
(106,285
)
(79
)%
(23,884 ) (29,018 ) (5,134 ) (18 )%
Income Tax Benefit

—

765

(765
)
(100
)%
228 — 228 n/a
Net Loss

$
(29,018
)
$
(134,538
)
$
(105,520
)
(78
)%
$ (23,656 ) $ (29,018 ) $ (5,362 ) (18 )%

Net Loss

The ~~$105.5~~$5.4 million decrease in net loss for the six months ended June 30, ~~2019,~~2020, as compared to the six months ended June 30, ~~2018,~~2019, was primarily the result of ~~a decrease in non-cash goodwill and intangible asset impairment expense and a decrease in research and development expenses, partially offset by the~~an increase in ~~loss~~the gain on fair value remeasurement of contingent ~~consideration.~~consideration and a decrease in non-cash other asset impairment expense, partially offset by an increase in intangible asset impairment expense.

Revenue

The ~~$2.3~~$2.0 million ~~decrease~~increase in product development and licensing agreements revenue for the six months ended June 30, ~~2019,~~2020, as compared to the six months ended June 30, ~~2018,~~2019, was primarily due to ~~a decrease in revenue related to our BMS agreement as a result of~~ the ~~completion of our combination clinical study.~~$1.8 million received from the Rockefeller Transaction. The ~~$2.4~~$1.1 million decrease in contracts and grants revenue for the six months ended June 30, ~~2019,~~2020, as compared to the six months ended June 30, ~~2018,~~2019, was primarily related to a decrease ~~in services performed under our~~ ~~contract manufacturing and research and development agreements with Rockefeller University and the International AIDS Vaccine Initiative, partially offset by an increase~~ in services performed under our manufacturing and research and development agreement with Duke University.
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:

Six Months Ended
June 30,

Increase/
(Decrease)

Six Months Ended
June 30, Increase/
(Decrease)

2019

2018

$

%

2020 2019 $ %

(In thousands)

(In thousands)
Personnel

$
11,162

$
16,776

$
(5,614
)
(33
)%
$ 10,832 $ 11,162 $ (330 ) (3 )%
Laboratory Supplies

2,053

2,469

(416
)
(17
)%
2,235 2,053 182 9 %
Facility

3,454

4,082

(628
)
(15
)%
3,487 3,454 33 1 %
Product Development

2,522

14,925

(12,403
)
(83
)%
2,829 2,522 307 12 %

Personnel expenses primarily include salary, benefits, stock-based compensation and payroll taxes. The ~~$5.6~~$0.3 million decrease in personnel expenses for the six months ended June 30, ~~2019,~~2020, as compared to the six months ended June 30, ~~2018,~~2019, was primarily due to ~~a decrease in headcount,~~ lower stock-based compensation ~~expense and lower severance expense related to the workforce reduction that occurred in the second quarter of 2018 as a result of the discontinuation of the Glemba program.~~expense.

Laboratory supplies expenses include laboratory materials and supplies, services, and other related expenses incurred in the development of our technology. The ~~$0.4~~$0.2 million ~~decrease~~increase in laboratory supply expenses for the six months ended June 30, ~~2019,~~2020, as compared to the six months ended June 30, ~~2018,~~2019, was primarily due to ~~lower~~higher laboratory materials and supplies purchases.

Facility expenses include depreciation, amortization, utilities, rent, maintenance and other related expenses incurred at our facilities. ~~The $0.6 million decrease in facility~~Facility expenses for the six months ended June 30, ~~2019, as compared to~~2020 were consistent with the six months ended June 30, ~~2018, was primarily due to lower depreciation expense.~~2019.

Product development expenses include clinical investigator site fees, external trial monitoring costs, data accumulation costs, contracted research and outside clinical drug product manufacturing. The ~~$12.4~~$0.3 million ~~decrease~~increase in product development expenses for the six months ended June 30, ~~2019,~~2020, as compared to the six months ended June 30, ~~2018,~~2019, was primarily due to ~~a decrease~~an increase in clinical trial and contract manufacturing expenses of ~~$7.2~~$0.9 million, ~~and~~partially offset by a decrease in contract ~~manufacturing~~research expenses of ~~$4.2 million~~.$0.6 million.

General and Administrative Expense

The ~~$2.4~~$1.6 million decrease in general and administrative expenses for the six months ended June 30, ~~2019,~~2020, as compared to the six months ended June 30, ~~2018,~~ 2019, was primarily due to ~~a decrease in headcount,~~ lower ~~commercial planning costs and lower lease restructuring~~stock-based compensation expense.

Intangible Asset Impairment
We evaluated the CDX-3379 IPR&D asset for potential impairment as a result of the discontinuation of the CDX-3379 program. We concluded that the CDX-3379 IPR&D asset was fully impaired, and a non-cash impairment charge of $3.5 million was recorded for the three months ended June 30, 2020.

Other Asset Impairment

We concluded that the Company’s investment in an undisclosed private company was impaired as a result of a deterioration in the private company’s financial condition and recorded a non-cash impairment charge of $1.8 million during the first quarter of 2019.

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

The ~~$0.5~~$4.9 million gain on fair value remeasurement of contingent consideration for the six months ended June 30, 2020 was primarily due to updated assumptions for CDX-3379 related milestones due to the discontinuation of the CDX-3379 program and the passage of time. The $0.5 million loss on fair value remeasurement of contingent consideration for the six months ended June 30, 2019 was primarily due to changes in discount rates and the passage of time. The $21.0 million gain on fair value remeasurement of contingent consideration for the six months ended June 30, 2018 was due to discontinuation of the Glemba and CDX-014 programs and updated assumptions for the varlilumab program.

~~Amortization Expense~~
The decrease in amortization expense for the six months ended June 30, 2019, as compared to the six months ended June 30, 2018, was the result of impairing the remaining balance of our intangible assets subject to amortization during the first quarter of 2018 ~~due to the discontinuation of the Glemba program.~~
Investment and Other Income, Net

The ~~$0.1~~$0.8 million decrease in investment and other income, net for the six months ended June 30, ~~2019,~~2020, as compared to the six months ended June 30, ~~2018,~~2019, was primarily due to lower levels of cash and investment balances and lower other income related to our sale of New Jersey tax benefits.

Income Tax Benefit
During the quarter ended June 30, 2020, a $0.2 million non-cash income tax benefit was recorded related to the impairment of the CDX-3379 IPR&D asset.
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. 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 June 30, ~~2019,~~2020, our principal sources of liquidity consisted of cash, cash equivalents and marketable securities of ~~$81.3~~$206.9 million. We have had recurring losses and incurred a loss of ~~$29.0~~$23.7 million for the six months ended June 30, ~~2019.~~2020. Net cash used in operations for the six months ended June 30, ~~2019~~2020 was ~~$24.3~~$23.3 million. We believe that the cash, cash equivalents and marketable securities at June 30, ~~2019, combined with the anticipated proceeds from future sales of our common stock under the Cantor agreement,~~2020 are sufficient to meet estimated working capital requirements and fund planned operations through ~~2020, although there is no assurance that future sales under the Cantor agreement will occur.~~2023. This could be impacted if we elected to pay Kolltan contingent milestones, if any, in cash.

During the next twelve months, we ~~will~~may take further steps to raise additional capital to meet our long-term liquidity ~~needs. Our capital raising activities may include,~~needs including, but may not be 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. ~~While~~Although we ~~may seek~~have been successful in raising capital ~~through a number of means,~~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~~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 future contingent milestones from the Kolltan acquisition, 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 $~~24.3~~$23.3 million for the six months ended June 30, ~~2019~~2020 as compared to ~~$45.4~~$24.3 million for the six months ended June 30, ~~2018.~~2019. The decrease in net cash used in operating activities was primarily due to ~~decreases~~a decrease in ~~both~~ general and administrative expenses and ~~research~~an increase in cash received related to product development and ~~development expenses.~~licensing agreements. We expect that cash used in operating activities will remain relatively consistent over the next twelve months, although there may be fluctuations on a quarterly basis.

We have incurred and will continue to incur significant costs in the area of research and development, including preclinical studies and clinical trials, as our drug candidates are developed. We plan to spend significant amounts to progress our current drug candidates through the clinical trial and commercialization 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.
Investing Activities

Net cash ~~provided by~~used in investing activities was $~~8.3~~$86.6 million for the six months ended June 30, ~~2019~~2020 as compared to ~~$28.7~~net cash provided by investing activities of $8.3 million for the six months ended June 30, ~~2018.~~2019. The ~~decrease~~increase in net cash ~~provided by~~used in investing activities was primarily due to net ~~sales and maturities~~purchases of marketable securities for the six months ended June 30, ~~2019~~2020 of ~~$8.8~~$85.4 million as compared to ~~$29.3~~net sales and maturities of marketable securities of $8.8 million for the six months ended June 30, ~~2018.~~2019.

Financing Activities

Net cash provided by financing activities was $~~11.4~~$166.7 million for the six months ended June 30, ~~2019~~2020 as compared to ~~$20.3~~$11.4 million for the six months ended June 30, ~~2018. Net proceeds from stock issuances pursuant to employee benefit plans were $0.0 million during~~2019.
During the six months ended June 30, ~~2019 as compared to $0.4 million for the six months ended June 30, 2018.~~
In May 2016, we entered into an agreement with Cantor Fitzgerald & Co. (“Cantor”) to allow us to issue and sell shares of our common stock having an aggregate offering price of up to $60.0 million from time to time through Cantor, acting as agent. In November 2017, we filed a prospectus supplement registering the offer and sale of shares of common stock of up to an additional $75.0 million under the agreement with Cantor. During the six months ended ~~June 30, 2019,~~2020, we issued ~~2,856,194~~6.7 million shares of common stock under ~~this controlled equity offering sales agreement with~~our Cantor Agreement resulting in net proceeds of ~~$11.4~~$25.3 million after deducting commission and offering expenses. At June 30, ~~2019,~~2020, we had ~~$25.8~~$18.3 million remaining in aggregate gross offering price available under the ~~Cantor~~ agreement. ~~In July 2019, we~~
During the three months ended June 30, 2020, the Company issued ~~201,687~~15,384,614 shares of its common stock in an underwritten public offering resulting in net proceeds to usthe Company of ~~$0.5 million.~~$141.4 million, after deducting underwriting fees and offering expenses.

Aggregate Contractual Obligations

~~Except as set forth below,~~ ~~the~~The disclosures relating to our contractual obligations reported in our Annual Report on Form 10-K for the year ended December 31, ~~2018~~2019 which was filed with the SEC on March ~~7, 2019~~26, 2020 have not materially changed since we filed that report.

In March 2019, the Company amended its Hampton, New Jersey lease to eliminate 16,200 square feet of space and extend the remaining 33,400 square feet of space for an additional five-year term with an early termination option after three years.
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~~
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 June 30, ~~2019~~2020 due to the short-term maturities of these instruments.
~~Item 4.~~~~Controls and Procedures~~
Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures.

As of June 30, ~~2019,~~2020, 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 June 30, ~~2019.~~2020. 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 June 30, ~~2019~~2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II — OTHER INFORMATION

~~Item 1A.~~~~Risk Factors~~
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, ~~2018,~~2019, 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. Additional risks and uncertainties not currently known to the Company or that the Company currently deems to be immaterial also may materially adversely affect the Company’s 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 ~~7, 2019.~~26, 2020.
Item 5. Other Information
On August 4, 2020, we determined that a non-cash impairment charge of $3.5 million should be recorded for the three months ended June 30, 2020 related to our CDX-3379 program. The CDX-3379 program was acquired as part of our acquisition of Kolltan Pharmaceuticals, Inc. in the fourth quarter of 2016. We determined that the discontinuation of development of CDX-3379 constituted a triggering event that required us to evaluate the intangible asset for impairment. See Note 5 to the consolidated financial statements included elsewhere in this quarterly report on Form 10-Q for further discussion of this impairment charge.
~~Item 6.~~~~Exhibits~~
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
*10.1
~~Celldex Therapeutics, Inc. Amended~~Extension of Lease Agreement between the Company and ~~Restated 2008 Stock Option and Incentive Plan (as amended, effective~~University of Massachusetts Dartmouth dated as of ~~June 19, 2019), incorporated by reference to Exhibit 10.1 to the Company’s current report on Form 8-K, filed on June 20, 2019 with the Securities and Exchange Commission.~~July 1, 2020
~~10.2~~
*31.1
Celldex Therapeutics, Inc. Amended and Restated 2004 Employee Stock Purchase Plan (effective as of June 19, 2019), incorporated by reference to Exhibit 10.2 to the Company’s current report on Form 8-K, filed on June 20, 2019 with the Securities and Exchange Commission.
~~10.3~~
Employment Agreement, dated July 8, 2019, by and between Diane Young and Celldex Therapeutics., Inc., incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed on June 24, 2019 with the Securities and Exchange Commission.
*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
XBRL Instance Document.
*101
XBRL Taxonomy Extension Schema Document.
*101
XBRL Taxonomy Extension Calculation Linkbase Document.
*101
XBRL Taxonomy Extension Definition Linkbase Document.
*101
XBRL Taxonomy Extension Label Linkbase Document.
*101
XBRL Taxonomy Extension Presentation Linkbase Document.

*       Filed herewith.
**       Furnished herewith.

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: August ~~7, 2019~~
6, 2020
Anthony S. Marucci
President and Chief Executive Officer
(Principal Executive Officer)
/s/ SAM MARTIN
Dated: August ~~7, 2019~~
6, 2020
Sam Martin
Senior Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)

30

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

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $.001		CLDX		Nasdaq Capital Market

Large accelerated filer o¨		Accelerated filer x¨

Non-accelerated filer ox		Smaller reporting company x

	Emerging growth company o¨

		Page
Part I — Financial Information

Item 1. Unaudited Financial Statements	2	3

Condensed Consolidated Balance Sheets at June 30, ~~2019~~2020 and December 31, ~~2018~~2019	2	3

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, ~~2019~~2020 and ~~2018~~2019	3	4

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, ~~2019~~2020 and ~~2018~~2019	4	5

Notes to Unaudited Condensed Consolidated Financial Statements	5	6

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations		15

Item 3. Quantitative and Qualitative Disclosures About Market Risk	27	29

Item 4. Controls and Procedures	28	29

Part II — Other Information

Item 1A. Risk Factors	28	30

Item 5. Other Information		30

Item 6. Exhibits	28	30

Exhibit Index	29	30

Signatures	30	31

	Three Months Ended June 30, 2019			Three Months Ended June 30, 2018			Six Months Ended June 30, 2019			Six Months Ended June 30, 2018				Three Months Ended June 30, 2020			Three Months Ended June 30, 2019			Six Months Ended June 30, 2020			Six Months Ended June 30, 2019
REVENUES:
Product Development and Licensing Agreements	$	195		$	1,667		$	325		$	2,662		$	—		$	195		$	2,285		$	325
Contracts and Grants	520			1,096			1,815			4,172				236			520			680			1,815
Total Revenues	715			2,763			2,140			6,834				236			715			2,965			2,140

OPERATING EXPENSES:
Research and Development	10,081			21,448			21,232			43,323				9,705			10,081			21,400			21,232
General and Administrative	3,908			5,621			8,804			11,215				3,528			3,908			7,194			8,804
Goodwill Impairment	—			—			—			90,976
Intangible Asset Impairment	—			—			—			18,677				3,500			—			3,500			—
Other Asset Impairment	—			—			1,800			—				—			—			—			1,800
(Gain)/Loss on Fair Value Remeasurement of Contingent Consideration	(1,017		)	(7,433		)	502			(21,033		)
Amortization of Acquired Intangible Assets	—			—			—			224
(Gain) Loss on Fair Value Remeasurement of Contingent Consideration														(5,132	)		(1,017	)		(4,898	)		502
Total Operating Expenses	12,972			19,636			32,338			143,382				11,601			12,972			27,196			32,338

Operating Loss	(12,257		)	(16,873		)	(30,198		)	(136,548		)		(11,365	)		(12,257	)		(24,231	)		(30,198	)
Investment and Other Income, Net	478			466			1,180			1,245				106			478			347			1,180
Net Loss Before Income Tax Benefit	(11,779		)	(16,407		)	(29,018		)	(135,303		)		(11,259	)		(11,779	)		(23,884	)		(29,018	)
Income Tax Benefit	—			—			—			765				228			—			228			—
Net Loss	$	(11,779	)	$	(16,407	)	$	(29,018	)	$	(134,538	)	$	(11,031	)	$	(11,779	)	$	(23,656	)	$	(29,018	)

Basic and Diluted Net Loss Per Common Share	$	(0.84	)	$	(1.67	)	$	(2.21	)	$	(14.01	)	$	(0.50	)	$	(0.84	)	$	(1.20	)	$	(2.21	)

Shares Used in Calculating Basic and Diluted Net Loss Per Share	13,952			9,829			13,129			9,600				22,082			13,952			19,744			13,129

COMPREHENSIVE LOSS:
Net Loss	$	(11,779	)	$	(16,407	)	$	(29,018	)	$	(134,538	)	$	(11,031	)	$	(11,779	)	$	(23,656	)	$	(29,018	)
Other Comprehensive Income (Loss):
Unrealized Gain on Marketable Securities	36			31			55			26
Unrealized (Loss) Gain on Marketable Securities														(3	)		36			(25	)		55
Comprehensive Loss	$	(11,743	)	$	(16,376	)	$	(28,963	)	$	(134,512	)	$	(11,034	)	$	(11,743	)	$	(23,681	)	$	(28,963	)

	Six Months Ended June 30, 2019			Six Months Ended June 30, 2018			Six Months Ended June 30, 2020			Six Months Ended June 30, 2019
Cash Flows From Operating Activities:
Net Loss	$	(29,018	)	$	(134,538	)	$	(23,656	)	$	(29,018	)
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities:
Depreciation and Amortization	2,505			2,021				2,313			2,505
Amortization of Intangible Assets	—			224
Amortization and Premium of Marketable Securities, Net	(652		)	(380		)		(335	)		(652	)
Loss on Sale or Disposal of Assets	7			1,069
Goodwill Impairment	—			90,976
(Gain) Loss on Sale or Disposal of Assets								(20	)		7
Intangible Asset Impairment	—			18,677				3,500			—
Other Asset Impairment	1,800			—				—			1,800
Loss/(Gain) on Fair Value Remeasurement of Contingent Consideration	502			(21,033		)
(Gain) Loss on Fair Value Remeasurement of Contingent Consideration								(4,898	)		502
Non-Cash Income Tax Benefit	—			(765		)		(228	)		—
Stock-Based Compensation Expense	3,157			4,536				1,408			3,157
Changes in Operating Assets and Liabilities:
Accounts and Other Receivables	1,992			(713		)		686			1,992
Prepaid and Other Current Assets	(137		)	801				(436	)		(137	)
Accounts Payable and Accrued Expenses	(1,598		)	(5,895		)		(254	)		(1,598	)
Other Liabilities	(2,833		)	(397		)		(1,412	)		(2,833	)
Net Cash Used in Operating Activities	(24,275		)	(45,417		)		(23,332	)		(24,275	)

Cash Flows From Investing Activities:
Sales and Maturities of Marketable Securities	67,386			106,182				47,000			67,386
Purchases of Marketable Securities	(58,565		)	(76,902		)		(132,439	)		(58,565	)
Acquisition of Property and Equipment	(484		)	(591		)		(1,145	)		(484	)
Net Cash Provided by Investing Activities	8,337			28,689
Proceeds from Sale or Disposal of Assets								20			—
Net Cash (Used in) Provided by Investing Activities								(86,564	)		8,337

Cash Flows From Financing Activities:
Net Proceeds from Stock Issuances	11,363			19,960				166,667			11,363
Proceeds from Issuance of Stock from Employee Benefit Plans	9			374				24			9
Issuance of Term Loan								2,962			—
Payment of Term Loan								(2,962	)		—
Net Cash Provided by Financing Activities	11,372			20,334				166,691			11,372

Net Increase/(Decrease) in Cash and Cash Equivalents	(4,566		)	3,606
Net Increase (Decrease) in Cash and Cash Equivalents								56,795			(4,566	)
Cash and Cash Equivalents at Beginning of Period	24,310			40,288				11,232			24,310
Cash and Cash Equivalents at End of Period	$	19,744		$	43,894		$	68,027		$	19,744

Non-cash Investing Activities
Accrued construction in progress	$	55		$	—		$	22		$	55
Non-cash Supplemental Disclosure
Shares issued to former Kolltan executive for settlement of severance	$	—		$	57

	As of June 30, 2019		Level 1	Level 2		Level 3
	(In thousands)
Assets:
Money market funds and cash equivalents	$	13,867	—	$	13,867	—
Marketable securities	61,598		—	61,598		—
	$	75,465	—	$	75,465	—
Liabilities:
Kolltan acquisition contingent consideration	$	14,281	—	—		$	14,281
	$	14,281	—	—		$	14,281

	As of December 31, 2018		Level 1	Level 2		Level 3		As of June 30, 2020		Level 1		Level 2		Level 3
	(In thousands)							(In thousands)
Assets:
Money market funds and cash equivalents	$	15,755	—	$	15,755	—		$	54,597		—	$	54,597		—
Marketable securities	69,712		—	69,712		—			138,888		—		138,888		—
	$	85,467	—	$	85,467	—		$	193,485		—	$	193,485		—
Liabilities:
Kolltan acquisition contingent consideration	$	13,779	—	—		$	13,779	$	7,587		—		—	$	7,587
	$	13,779	—	—		$	13,779	$	7,587		—		—	$	7,587

	As of December 31, 2019		Level 1		Level 2		Level 3
	(In thousands)
Assets:
Money market funds and cash equivalents	$	4,024		—	$	4,024		—
Marketable securities		53,151		—		53,151		—
	$	57,175		—	$	57,175		—
Liabilities:
Kolltan acquisition contingent consideration	$	12,485		—		—	$	12,485
	$	12,485		—		—	$	12,485

	Other Liabilities: Contingent Consideration
Balance at December 31, 2018	$	13,779
Fair value adjustments included in operating expenses	502
Balance at June 30, 2019	$	14,281

	Other Liabilities: Contingent Consideration
Balance at December 31, 2019	$	12,485
Fair value adjustments included in operating expenses		(4,898	)
Balance at June 30, 2020	$	7,587

	Gross Unrealized									Gross Unrealized
	Amortized Cost		Gains		Losses			Fair Value		Amortized Cost		Gains		Losses			Fair Value
	(In thousands)									(In thousands)
June 30, 2019
June 30, 2020
U.S. government and municipal obligations (maturing in one year or less)	$	27,622	$	25	$	—		$	27,647	$	79,937	$	—	$	—		$	79,937
Corporate debt securities (maturing in one year or less)	33,934		17		—			33,951			58,954		10		(13	)		58,951
Total Marketable Securities	$	61,556	$	42	$	—		$	61,598	$	138,891	$	10	$	(13	)	$	138,888

December 31, 2018
December 31, 2019
U.S. government and municipal obligations (maturing in one year or less)	$	27,355	$	—	$	(4	)	$	27,351	$	18,509	$	13	$	—		$	18,522
Corporate debt securities (maturing in one year or less)	42,370		—		(9		)	42,361			34,619		13		(3	)		34,629
Total Marketable Securities	$	69,725	$	—	$	(13	)	$	69,712	$	53,128	$	26	$	(3	)	$	53,151

Remainder of 2019	$	1,313
2020	2,171
2021	508
2022	747
2023	311
Total lease payments	5,050
Less imputed interest	(645		)
Present value of operating lease liabilities	$	4,405

	Common Stock Shares		Common Stock Par Value	Additional Paid-In Capital	Accumulated Other Comprehensive Income	Accumulated Deficit		Total Stockholders’ Equity
	(In thousands, except share amounts)
Consolidated Balance at December 31, 2018	11,957,635		12	1,083,903	2,583	(962,438	)	124,060
Shares Issued under Stock Option and Employee Stock Purchase Plans	3,507		—	9	—	—		9
Shares Issued in Connection with Cantor Agreement	883,569		1	4,150	—	—		4,151
Share-Based Compensation	—		—	1,693	—	—		1,693
Unrealized Gain on Marketable Securities	—		—	—	19	—		19
Net Loss	—		—	—	—	(17,239	)	(17,239	)
Consolidated Balance at March 31, 2019	12,844,711		13	1,089,755	2,602	(979,677	)	112,693
Shares Cancelled under Stock Option and Employee Stock Purchase Plans	(222	)	—	—	—	—		—
Shares Issued in Connection with Cantor Agreement	1,972,428		2	7,210	—	—		7,212
Share-Based Compensation	—		—	1,464	—	—		1,464
Unrealized Gain on Marketable Securities	—		—	—	36	—		36
Net Loss	—		—	—	—	(11,779	)	(11,779	)
Consolidated Balance at June 30, 2019	14,816,917		15	1,098,429	2,638	(991,456	)	109,626

	Shares		Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (In Years)	Shares			Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (In Years)
Options Outstanding at December 31, 2018	866,132		$	93.70	7.1
Options Outstanding at December 31, 2019							1,699,202		$	44.87		8.0
Granted	863,290		2.78				1,439,175		$	10.36
Exercised	—		—				—			—
Canceled	(39,348	)	131.86				(53,090	)	$	46.03
Options Outstanding at June 30, 2019	1,690,074		46.37		8.4
Options Vested and Expected to Vest at June 30, 2019	1,538,046		50.45		8.3
Options Exercisable at June 30, 2019	529,136		132.85		5.7
Options Outstanding at June 30, 2020							3,085,287		$	28.76		8.69
Options Vested and Expected to Vest at June 30, 2020							2,875,684		$	30.23		8.62
Options Exercisable at June 30, 2020							821,537		$	84.93		6.39
Shares Available for Grant Under the 2008 Plan	433,391						938,178

	Three months ended June 30,				Six months ended June 30,
	2019		2018		2019		2018
	(In thousands)				(In thousands)
Research and development	$	654	$	978	$	1,410	$	2,289
General and administrative	810		1,070		1,747		2,247
Total stock-based compensation expense	$	1,464	$	2,048	$	3,157	$	4,536

	Three months ended June 30,				Six months ended June 30,
	2020		2019		2020		2019
	(In thousands)				(In thousands)
Research and development	$	342	$	654	$	652	$	1,410
General and administrative		380		810		756		1,747
Total stock-based compensation expense	$	722	$	1,464	$	1,408	$	3,157

	Unrealized Gain/(Loss) on Marketable Securities			Foreign Currency Items		Total
	(In thousands)
Balance at December 31, 2018	$	(13	)	$	2,596	$	2,583
Other comprehensive gain	55			—		55
Balance at June 30, 2019	$	42		$	2,596	$	2,638

	Unrealized Gain/(Loss) on Marketable Securities			Foreign Currency Items		Total
	(In thousands)
Balance at December 31, 2019	$	23		$	2,596	$	2,619
Other comprehensive loss		(25	)		—		(25	)
Balance at June 30, 2020	$	(2	)	$	2,596	$	2,594

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

	Six Months Ended June 30, 2020		Six Months Ended June 30, 2019
	(In thousands)
CDX-0159/Anti-KIT Program	$	2,896	$	1,974
CDX-1140		5,069		3,195
CDX-527		5,891		3,412
TAM Program		1,192		2,571
Other Programs		6,352		10,080
Total R&D Expense	$	21,400	$	21,232

	Three Months Ended June 30,						Increase/ (Decrease)			Increase/ (Decrease)		Three Months Ended June 30,						Increase/ (Decrease)			Increase/ (Decrease)
	2019			2018			$			%		2020			2019			$			%
	(In thousands)											(In thousands)
Revenues:
Product Development and Licensing Agreements	$	195		$	1,667		$	(1,472	)	(88	)%	$	—		$	195		$	(195	)		(100	)%
Contracts and Grants	520			1,096			(576		)	(53	)%		236			520			(284	)		(55	)%
Total Revenue	$	715		$	2,763		$	(2,048	)	(74	)%	$	236		$	715		$	(479	)		(67	)%
Operating Expenses:
Research and Development	10,081			21,448			(11,367		)	(53	)%		9,705			10,081			(376	)		(4	)%
General and Administrative	3,908			5,621			(1,713		)	(30	)%		3,528			3,908			(380	)		(10	)%
Intangible Asset Impairment													3,500			—			3,500			n/a
Gain on Fair Value Remeasurement of Contingent Consideration	(1,017		)	(7,433		)	(6,416		)	(86	)%		(5,132	)		(1,017	)		4,115			405	%
Total Operating Expense	12,972			19,636			(6,664		)	(34	)%		11,601			12,972			(1,371	)		(11	)%
Operating Loss	(12,257		)	(16,873		)	(4,616		)	(27	)%		(11,365	)		(12,257	)		(892	)		(7	)%
Investment and Other Income, Net	478			466			12			3	%		106			478			(372	)		(78	)%
Net Loss Before Income Tax Benefit													(11,259	)		(11,779	)		(520	)		(4	)%
Income Tax Benefit													228			—			228			n/a
Net Loss	$	(11,779	)	$	(16,407	)	$	(4,628	)	(28	)%	$	(11,031	)	$	(11,779	)	$	(748	)		(6	)%

	Three Months Ended June 30				Increase/ (Decrease)					Three Months Ended June 30				Increase/ (Decrease)
	2019		2018		$			%		2020		2019		$			%
	(In thousands)									(In thousands)
Personnel	$	5,408	$	7,719	$	(2,311	)	(30	)%	$	5,216	$	5,408	$	(192	)		(4	)%
Laboratory Supplies	1,257		1,212		45			4	%		775		1,257		(482	)		(38	)%
Facility	1,558		2,019		(461		)	(23	)%		1,758		1,558		200			13	%
Product Development	827		7,576		(6,749		)	(89	)%		1,023		827		196			24	%

	Six Months Ended June 30,						Increase/ (Decrease)			Increase/ (Decrease)		Six Months Ended June 30,						Increase/ (Decrease)			Increase/ (Decrease)
	2019			2018			$			%		2020			2019			$			%
	(In thousands)														(In thousands)
Revenues:
Product Development and Licensing Agreements	$	325		$	2,662		$	(2,337	)	(88	)%	$	2,285		$	325		$	1,960			603	%
Contracts and Grants	1,815			4,172			(2,357		)	(56	)%		680			1,815			(1,135	)		(63	)%
Total Revenue	$	2,140		$	6,834		$	(4,694	)	(69	)%	$	2,965		$	2,140		$	825			39	%
Operating Expenses:
Research and Development	21,232			43,323			(22,091		)	(51	)%		21,400			21,232			168			1	%
General and Administrative	8,804			11,215			(2,411		)	(21	)%		7,194			8,804			(1,610	)		(18	)%
Goodwill Impairment	—			90,976			(90,976		)	(100	)%
Intangible Asset Impairment	—			18,677			(18,677		)	(100	)%		3,500			—			3,500			n/a
Other Asset Impairment	1,800			—			1,800			n/a			—			1,800			(1,800	)		(100	)%
Loss/(Gain) on Fair Value Remeasurement of Contingent Consideration	502			(21,033		)	21,535			102	%
Amortization of Acquired Intangible Assets	—			224			(224		)	(100	)%
(Gain) Loss on Fair Value Remeasurement of Contingent Consideration													(4,898	)		502			5,400			1,076	%
Total Operating Expense	32,338			143,382			(111,044		)	(77	)%		27,196			32,338			(5,142	)		(16	)%
Operating Loss	(30,198		)	(136,548		)	(106,350		)	(78	)%		(24,231	)		(30,198	)		(5,967	)		(20	)%
Investment and Other Income, Net	1,180			1,245			(65		)	(5	)%		347			1,180			(833	)		(71	)%
Net Loss Before Income Tax Benefit	(29,018		)	(135,303		)	(106,285		)	(79	)%		(23,884	)		(29,018	)		(5,134	)		(18	)%
Income Tax Benefit	—			765			(765		)	(100	)%		228			—			228			n/a
Net Loss	$	(29,018	)	$	(134,538	)	$	(105,520	)	(78	)%	$	(23,656	)	$	(29,018	)	$	(5,362	)		(18	)%

Exhibit No.		Description
*10.1		~~Celldex Therapeutics, Inc. Amended~~Extension of Lease Agreement between the Company and ~~Restated 2008 Stock Option and Incentive Plan (as amended, effective~~University of Massachusetts Dartmouth dated as of ~~June 19, 2019), incorporated by reference to Exhibit 10.1 to the Company’s current report on Form 8-K, filed on June 20, 2019 with the Securities and Exchange Commission.~~July 1, 2020

~~10.2~~ *31.1		Celldex Therapeutics, Inc. Amended and Restated 2004 Employee Stock Purchase Plan (effective as of June 19, 2019), incorporated by reference to Exhibit 10.2 to the Company’s current report on Form 8-K, filed on June 20, 2019 with the Securities and Exchange Commission.

~~10.3~~		Employment Agreement, dated July 8, 2019, by and between Diane Young and Celldex Therapeutics., Inc., incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K, filed on June 24, 2019 with the Securities and Exchange Commission.

*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		XBRL Instance Document.

*101		XBRL Taxonomy Extension Schema Document.

*101		XBRL Taxonomy Extension Calculation Linkbase Document.

*101		XBRL Taxonomy Extension Definition Linkbase Document.

*101		XBRL Taxonomy Extension Label Linkbase Document.

*101		XBRL Taxonomy Extension Presentation Linkbase Document.

		CELLDEX THERAPEUTICS, INC.

		BY:

		/s/ ANTHONY S. MARUCCI
Dated: August ~~7, 2019~~ 6, 2020		Anthony S. Marucci
		President and Chief Executive Officer
		(Principal Executive Officer)

		/s/ SAM MARTIN
Dated: August ~~7, 2019~~ 6, 2020		Sam Martin
		Senior Vice President and Chief Financial Officer
		(Principal Financial and Accounting Officer)