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

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

~~FORM 10-Q~~

For the Quarterly Period Ended ~~June 30, 2019~~March 31, 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

ASSETS

Current Assets:

Cash and Cash Equivalents

$
19,744

$
24,310

Marketable Securities

61,598

69,712

Accounts and Other Receivables

1,170

3,162

Prepaid and Other Current Assets

1,853

1,895

Total Current Assets

84,365

99,079

Property and Equipment, Net

5,086

6,111

Operating Lease Right-of-Use Assets, Net

3,974

—

Intangible Assets, Net

48,690

48,690

Other Assets

129

1,929

Total Assets

$
142,244

$
155,809

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current Liabilities:

Accounts Payable

$
1,016

$
1,069

Accrued Expenses

5,410

7,007

Current Portion of Operating Lease Liabilities

2,538

—

Current Portion of Other Long-Term Liabilities

2,545

4,526

Total Current Liabilities

11,509

12,602

Long-Term Portion of Operating Lease Liabilities

1,867

—

Other Long-Term Liabilities

19,242

19,147

Total Liabilities

32,618

31,749

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

Additional Paid-In Capital

1,098,429

1,083,903

Accumulated Other Comprehensive Income

2,638

2,583

Accumulated Deficit

(991,456
)
(962,438
)
Total Stockholders’ Equity

109,626

124,060

Total Liabilities and Stockholders’ Equity

$
142,244

$
155,809

March 31,
2020 December 31,
2019
ASSETS
Current Assets:
Cash and Cash Equivalents $ 22,724 $ 11,232
Marketable Securities 30,998 53,151
Accounts and Other Receivables 1,108 1,015
Prepaid and Other Current Assets 1,088 1,300
Total Current Assets 55,918 66,698
Property and Equipment, Net 4,116 4,031
Operating Lease Right-of-Use Assets, Net 3,739 3,473
Intangible Assets, Net 48,690 48,690
Other Assets 41 41
Total Assets $ 112,504 $ 122,933
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts Payable $ 1,609 $ 1,174
Accrued Expenses 5,648 6,499
Current Portion of Operating Lease Liabilities 1,682 1,944
Current Portion of Other Long-Term Liabilities 1,993 2,026
Total Current Liabilities 10,932 11,643
Long-Term Portion of Operating Lease Liabilities 2,106 1,713
Other Long-Term Liabilities 15,763 15,551
Total Liabilities 28,801 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 March 31, 2020 and December 31, 2019 — —
Common Stock, $.001 Par Value; 297,000,000 Shares Authorized; 17,730,802 and 16,972,077 Shares Issued and Outstanding at March 31, 2020 and December 31, 2019, Respectively 18 17
Additional Paid-In Capital 1,107,029 1,104,706
Accumulated Other Comprehensive Income 2,597 2,619
Accumulated Deficit (1,025,941 ) (1,013,316 )
Total Stockholders’ Equity 83,703 94,026
Total Liabilities and Stockholders’ Equity $ 112,504 $ 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

REVENUES:

Product Development and Licensing Agreements

$
195

$
1,667

$
325

$
2,662

Contracts and Grants

520

1,096

1,815

4,172

Total Revenues

715

2,763

2,140

6,834

OPERATING EXPENSES:

Research and Development

10,081

21,448

21,232

43,323

General and Administrative

3,908

5,621

8,804

11,215

Goodwill Impairment

—

—

—

90,976

Intangible Asset Impairment

—

—

—

18,677

Other Asset Impairment

—

—

1,800

—

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

(1,017
)
(7,433
)
502

(21,033
)
Amortization of Acquired Intangible Assets

—

—

—

224

Total Operating Expenses

12,972

19,636

32,338

143,382

Operating Loss

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

478

466

1,180

1,245

Net Loss Before Income Tax Benefit

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

—

—

—

765

Net Loss

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

Basic and Diluted Net Loss Per Common Share

$
(0.84
)
$
(1.67
)
$
(2.21
)
$
(14.01
)

Shares Used in Calculating Basic and Diluted Net Loss Per Share

13,952

9,829

13,129

9,600

COMPREHENSIVE LOSS:

Net Loss

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

Unrealized Gain on Marketable Securities

36

31

55

26

Comprehensive Loss

$
(11,743
)
$
(16,376
)
$
(28,963
)
$
(134,512
)
Three Months
Ended
March 31, 2020 Three Months
Ended
March 31, 2019
REVENUES:
Product Development and Licensing Agreements $ 2,286 $ 129
Contracts and Grants 442 1,296
Total Revenues 2,728 1,425

OPERATING EXPENSES:
Research and Development 11,695 11,151
General and Administrative 3,666 4,896
Other Asset Impairment — 1,800
Loss on Fair Value Remeasurement of Contingent Consideration 234 1,519
Total Operating Expenses 15,595 19,366

Operating Loss (12,867 ) (17,941 )
Investment and Other Income, Net 242 702
Net Loss $ (12,625 ) $ (17,239 )

Basic and Diluted Net Loss Per Common Share $ (0.73 ) $ (1.40 )

Shares Used in Calculating Basic and Diluted Net Loss Per Share 17,406 12,297

COMPREHENSIVE LOSS:
Net Loss $ (12,625 ) $ (17,239 )
Other Comprehensive Income (Loss):
Unrealized Gain (Loss) on Marketable Securities (22 ) 19
Comprehensive Loss $ (12,647 ) $ (17,220 )

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

Cash Flows From Operating Activities:

Net Loss

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

Depreciation and Amortization

2,505

2,021

Amortization of Intangible Assets

—

224

Amortization and Premium of Marketable Securities, Net

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

7

1,069

Goodwill Impairment

—

90,976

Intangible Asset Impairment

—

18,677

Other Asset Impairment

1,800

—

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

502

(21,033
)
Non-Cash Income Tax Benefit

—

(765
)
Stock-Based Compensation Expense

3,157

4,536

Changes in Operating Assets and Liabilities:

Accounts and Other Receivables

1,992

(713
)
Prepaid and Other Current Assets

(137
)
801

Accounts Payable and Accrued Expenses

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

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

(24,275
)
(45,417
)

Cash Flows From Investing Activities:

Sales and Maturities of Marketable Securities

67,386

106,182

Purchases of Marketable Securities

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

(484
)
(591
)
Net Cash Provided by Investing Activities

8,337

28,689

Cash Flows From Financing Activities:

Net Proceeds from Stock Issuances

11,363

19,960

Proceeds from Issuance of Stock from Employee Benefit Plans

9

374

Net Cash Provided by Financing Activities

11,372

20,334

Net Increase/(Decrease) in Cash and Cash Equivalents

(4,566
)
3,606

Cash and Cash Equivalents at Beginning of Period

24,310

40,288

Cash and Cash Equivalents at End of Period

$
19,744

$
43,894

Non-cash Investing Activities

Accrued construction in progress

$
55

$
—

Non-cash Supplemental Disclosure

Shares issued to former Kolltan executive for settlement of severance

$
—

$
57

Three Months
Ended
March 31, 2020 Three Months
Ended
March 31, 2019
Cash Flows From Operating Activities:
Net Loss $ (12,625 ) $ (17,239 )
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities:
Depreciation and Amortization 1,165 1,352
Amortization and Premium of Marketable Securities, Net (63 ) (345 )
Loss on Sale or Disposal of Assets — 25
Other Asset Impairment — 1,800
Loss on Fair Value Remeasurement of Contingent Consideration 234 1,519
Stock-Based Compensation Expense 687 1,693
Changes in Operating Assets and Liabilities:
Accounts and Other Receivables (93 ) 855
Prepaid and Other Current Assets 206 299
Accounts Payable and Accrued Expenses (853 ) (1,455 )
Other Liabilities (768 ) (1,737 )
Net Cash Used in Operating Activities (12,110 ) (13,233 )

Cash Flows From Investing Activities:
Sales and Maturities of Marketable Securities 22,200 37,886
Purchases of Marketable Securities — (21,404 )
Acquisition of Property and Equipment (235 ) (186 )
Net Cash Provided by Investing Activities 21,965 16,296

Cash Flows From Financing Activities:
Net Proceeds from Stock Issuances 1,613 4,151
Proceeds from Issuance of Stock from Employee Benefit Plans 24 9
Net Cash Provided by Financing Activities 1,637 4,160

Net Increase in Cash and Cash Equivalents 11,492 7,223
Cash and Cash Equivalents at Beginning of Period 11,232 24,310
Cash and Cash Equivalents at End of Period $ 22,724 $ 31,533

Non-cash Investing Activities
Accrued construction in progress $ 462 $ 65

See accompanying notes to unaudited condensed consolidated financial statements
5
CELLDEX THERAPEUTICS, INC.
Notes to Unaudited Condensed Consolidated Financial Statements
~~June 30, 2019~~March 31, 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.

Under U.S. GAAP, the Company has the responsibility to evaluate whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date that the financial statements are issued. This evaluation shall initially not take into consideration the potential mitigating effects of plans that have not been fully implemented as of the date the financial statements are issued. The Company’s financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. At ~~June 30, 2019,~~March 31, 2020, the Company had cash, cash equivalents and marketable securities of ~~$81.3~~$53.7 million. The Company has had recurring losses and incurred a loss of ~~$29.0~~$12.6 million for the ~~six~~three months ended ~~June 30, 2019.~~March 31, 2020. Net cash used in operations for the ~~six~~three months ended ~~June 30, 2019~~March 31, 2020 was ~~$24.3~~$12.1 million. ~~The~~As of May 6, 2020, the date of issuance of the consolidated financial statements, the Company ~~believes~~expects that ~~the~~its cash, cash equivalents and marketable securities ~~at August 7, 2019~~of $53.7 million as of March 31, 2020 will be sufficient to ~~meet estimated working~~fund its operating expenses and capital expenditure requirements ~~and fund planned operations for at least~~into the ~~next twelve months from the date~~second quarter of ~~issuance of these financial statements.~~
2021. The ~~Board of Directors~~future viability of the Company ~~approved a one for fifteen reverse stock split of~~beyond that point is dependent on the Company’s ~~outstanding common stock, which was effected on February 8, 2019. All share~~ability to raise additional capital to finance its operations. The Company has generated no product revenue to date and ~~per share amounts in~~cannot predict when and if it will generate product revenue. The Company has had recurring losses and anticipate operating losses to continue for the foreseeable future due to, among other things, costs related to research, development of product candidates, conducting preclinical studies and clinical trials, facilities and general and administrative expenses. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for one year after the date that 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.are issued.

During the next twelve months and beyond, the Company will take further steps to raise additional capital to meet its 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 the Company is unable to raise the funds necessary to meet its liquidity needs, it may have to delay or discontinue the development of one or more programs, discontinue or delay ongoing or anticipated clinical trials, license out programs earlier than expected, raise funds at a significant discount or on other unfavorable terms, if at all, or sell all or a part of the Company. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

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 over 200 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. COVID-19 has had a more severe impact in New Jersey, Massachusetts and Connecticut, where the Company has office, research and manufacturing facilities, than in other parts of the United States. In an effort to halt the outbreak of COVID-19, various states, including New Jersey, Massachusetts and Connecticut, have placed significant restrictions on travel and many businesses have announced extended closures which could adversely impact our operations. To date, the Company has not experienced significant delays or disruptions in planned and ongoing preclinical and clinical trials, manufacturing or shipping. Potential impacts to our business include delays in planned and ongoing preclinical and clinical trials including enrollment of patients, disruptions in time and resources provided by independent clinical investigators, contract research organizations, 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 which amounted to $48.7 million at March 31, 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~~March 31, 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~~three 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.

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.
7

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
March 31, 2020 Level 1 Level 2 Level 3

(In thousands)

(In thousands)
Assets:

Money market funds and cash equivalents

$
15,755

—

$
15,755

—

$ 15,396 — $ 15,396 —
Marketable securities

69,712

—

69,712

—

30,998 — 30,998 —

$
85,467

—

$
85,467

—

$ 46,394 — $ 46,394 —
Liabilities:

Kolltan acquisition contingent consideration

$
13,779

—

—

$
13,779

$ 12,719 — — $ 12,719

$
13,779

—

—

$
13,779

$ 12,719 — — $ 12,719
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~~three months ended ~~June 30, 2019~~March 31, 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 234
Balance at March 31, 2020 $ 12,719

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 March 31, 2020, the weighted average discount rate used in calculating the fair value of contingent consideration was 16.5% (with a range of 16.3% to 18.9%) and the weighted average amount of time until the conditions of the milestone payments are met was 3 years.

During the three ~~and six~~ months ended ~~June 30, 2019,~~March 31, 2020, the Company recorded a ~~$1.0 million gain and $0.5~~$0.2 million loss on fair value remeasurement of contingent consideration, respectively,primarily due to the passage of time. During the three months ended March 31, 2019, the Company recorded a $1.5 million loss on fair value remeasurement of contingent consideration, 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~~three months ended ~~June 30, 2019.~~March 31, 2020.
8
(4) Marketable Securities

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

Gross Unrealized

Amortized
Cost

Gains

Losses

Fair
Value

(In thousands)

June 30, 2019

U.S. government and municipal obligations (maturing in one year or less)

$
27,622

$
25

$
—

$
27,647

Corporate debt securities (maturing in one year or less)

33,934

17

—

33,951

Total Marketable Securities

$
61,556

$
42

$
—

$
61,598

December 31, 2018

U.S. government and municipal obligations (maturing in one year or less)

$
27,355

$
—

$
(4
)
$
27,351

Corporate debt securities (maturing in one year or less)

42,370

—

(9
)
42,361

Total Marketable Securities

$
69,725

$
—

$
(13
)
$
69,712

Gross Unrealized
Amortized
Cost Gains Losses Fair
Value
(In thousands)
March 31, 2020
U.S. government and municipal obligations (maturing in one year or less) $ 10,538 $ 16 $ — $ 10,554
Corporate debt securities (maturing in one year or less) 20,459 — (15 ) 20,444
Total Marketable Securities $ 30,997 $ 16 $ (15 ) $ 30,998

December 31, 2019
U.S. government and municipal obligations (maturing in one year or less) $ 18,509 $ 13 $ — $ 18,522
Corporate debt securities (maturing in one year or less) 34,619 13 (3 ) 34,629
Total Marketable Securities $ 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~~March 31, 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~~March 31, 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,~~March 31, 2020 and 2019, ~~and 2018,~~ the Company recorded indefinite-lived intangible assets of $48.7 million. 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. CDX-3379 is in Phase 2 ~~development. The anti-KIT~~development, CDX-0159 is in Phase 1 development, and the TAM ~~programs are~~program is in preclinical development. As of ~~June 30, 2019,~~March 31, 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.

~~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.

~~(8)~~
9
(7) Other Long-Term Liabilities

Other long-term liabilities include the following:

June 30, 2019

December 31, 2018

March 31,
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) $ 3,007 $ 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

12,719 12,485
Deferred Revenue (Note 12)

485

1,586

Deferred Revenue (Note 11) 199 254
Total

21,787

23,673

17,756 17,577
Less Current Portion

(2,545
)
(4,526
)
(1,993 ) (2,026 )
Long-Term Portion

$
19,242

$
19,147

$ 15,763 $ 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,~~March 31, 2020 and 2019, ~~respectively, and $0.0 million and $0.4 million during the three and six months ended June 30, 2018,~~ respectively.
~~(9)~~
(8) Stockholders’ Equity

In May 2016, the Company entered into ana controlled equity offering sales agreement 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,~~March 2020, the Company filed a prospectus supplement ~~registering~~for the amount of shares that the Company is eligible to sell pursuant to the Cantor Agreement. Under the March 2020 prospectus supplement, the Company may offer and ~~sale of~~sell shares of common stock having an aggregate offering price of up to ~~an additional $75.0 million under the agreement with Cantor.~~$18,000,000. During the ~~six~~three months ended ~~June 30, 2019,~~March 31, 2020, the Company issued ~~2,856,194~~0.7 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~~$1.6 million after deducting commission and offering expenses. At ~~June 30, 2019,~~March 31, 2020, the Company had ~~$25.8~~$17.9 million remaining in aggregate gross offering price available under the ~~Cantor agreement.~~March 2020 prospectus supplement. In ~~July 2019,~~April 2020, the Company issued ~~201,687~~1.2 million shares of its common stock resulting in net proceeds to the Company of ~~$0.5~~$2.9 million.

The changes in Stockholders’ Equity during the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019 ~~and 2018~~ 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

Shares Issued in Connection with Cantor Agreement

884,068

1

8,270

—

—

8,271

Shares Issued in Connection with Kolltan Severance

1,071

—

19

—

—

19

Share-Based Compensation

—

—

2,048

—

—

2,048

Unrealized Gain on Marketable Securities

—

—

—

31

—

31

Net Loss

—

—

—

—

(16,407
)
(16,407
)
Consolidated Balance at June 30, 2018

10,443,058

10

1,071,239

2,590

(945,792
)
128,047

Consolidated Balance at March 31, 2020 17,730,802 $ 18 $ 1,107,029 $ 2,597 $ (1,025,941 ) $ 83,703

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

A summary of stock option activity for the ~~six~~three months ended ~~June 30, 2019~~March 31, 2020 is as follows:

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

Granted

863,290

2.78

Exercised

—

—

Canceled

(39,348
)
131.86

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

Shares Available for Grant Under the 2008 Plan

433,391

Shares Weighted
Average
Exercise
Price
Per Share Weighted
Average
Remaining
Contractual
Term (In Years)
Options Outstanding at December 31, 2019 1,699,202 $ 44.87 8.0
Granted 2,750 $ 1.66
Exercised — —
Canceled (43,811 ) $ 50.59
Options Outstanding at March 31, 2020 1,658,141 $ 44.65 7.8
Options Vested and Expected to Vest at March 31, 2020 1,585,639 $ 46.50 7.8
Options Exercisable at March 31, 2020 576,042 $ 118.98 5.6
Shares Available for Grant Under the 2008 Plan 465,324

The weighted average grant-date fair value of stock options granted during the three ~~and six~~ month ~~periods~~period ended ~~June 30, 2019~~March 31, 2020 was ~~$2.09.~~$1.23. Stock-based compensation expense for the three months ended March 31, 2020 and ~~six month periods ended June 30,~~ 2019 ~~and 2018~~ 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 March 31,
2020 2019
(In thousands)
Research and development $ 310 $ 756
General and administrative 377 937
Total stock-based compensation expense $ 687 $ 1,693
The fair values of employee and director stock options granted during the three months ended March 31, 2020 and ~~six month periods ended June 30,~~ 2019 ~~and 2018~~ were valued using the Black-Scholes option pricing model with the following assumptions:

Three months ended June 30,

Six months ended June 30,

2019

2018

2019

2018

Expected stock price volatility

91%

85%

91%

73 - 85%

Expected option term

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%

Expected dividend yield

None

None

None

None

Three months ended March 31,
2020 2019
Expected stock price volatility 91% 91%
Expected option term 6.0 Years
6.0 Years

Risk-free interest rate 0.6% 2.5%
Expected dividend yield None None

~~(11)~~
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~~three months ended ~~June 30, 2019~~March 31, 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 (22 ) — (22 )
Balance at March 31, 2020 $ 1 $ 2,596 $ 2,597

No amounts were reclassified out of accumulated other comprehensive income during the ~~six~~three months ended ~~June 30, 2019.~~March 31, 2020.

~~(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~~Company entered into an agreement with Rockefeller University in ~~2014~~September 2013, as amended, (the “Rockefeller Agreement”) pursuant to ~~evaluate~~which the ~~safety, tolerability~~Company performs manufacturing and ~~preliminary efficacy~~development services for Rockefeller University for their portfolio of ~~varlilumab and Opdivo~~®~~, BMS’s PD-1 immune checkpoint inhibitor,~~antibodies against HIV. This portfolio was licensed to Gilead Sciences in ~~a Phase 1/2 study. Under this agreement, BMS made~~January 2020 from Rockefeller University (“Rockefeller Transaction”). Pursuant to the Rockefeller Agreement, the Company received an upfront payment ~~to Celldex~~ of ~~$5.0~~$1.8 million ~~and provides funding for 50%~~as a result of the ~~external costs incurred by the Company in connection with the clinical trial. The Company~~Rockefeller Transaction which was recorded ~~$0.1 million and $0.2 million in~~to revenue ~~related to this agreement~~ during the three ~~and six~~ months ended ~~June 30, 2019, respectively,~~March 31, 2020. The Company is eligible to receive additional payments from Rockefeller University if this portfolio progresses through clinical and ~~$1.7 million and $2.6 million during the three and six months ended June 30, 2018, respectively.~~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. The Company recognized $0.4 million and ~~$1.5~~$1.2 million in revenue for labor hours and direct costs incurred under these agreements during the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 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 million in revenue under these agreements during the three and six months ended June 30, 2019, respectively, and $0.4 million and $2.7 million during the three and six months ended June 30, 2018, respectively.
Contract Assets and Liabilities

At December 31, ~~2018~~2019 and ~~June 30, 2019,~~March 31, 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,~~March 31, 2020, the Company had ~~$1.6~~$0.3 million and ~~$0.5~~$0.2 million in contract liabilities recorded, respectively. Revenue recognized from contract liabilities as of December 31, ~~2018~~2019 during the three ~~and six~~ months ended ~~June 30, 2019~~March 31, 2020 was ~~$0.4 million and $1.2 million, respectively.~~$0.1 million.

~~(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~~March 31, 2020 and December 31, ~~2018.~~2019.
The net deferred tax liability of $3.0 million at ~~June 30, 2019~~March 31, 2020 and December 31, ~~2018~~2019 relates to the temporary differences associated with the IPR&D intangible assets acquired in previous business combinations and is not deductible for tax purposes. ~~As a result of the discontinuation of the Glemba program, the Company recorded~~ ~~a $0.8 million non-cash income tax benefit during the first quarter of 2018.~~

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.

~~(14)~~
12
(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

Three Months Ended March 31,
2020 2019
Stock Options 1,658,141 836,104
Restricted Stock 1,110 3,552
1,659,251 839,656
(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 March 31, 2020, the Company believes that the adjusted amount we may be required to pay for future consideration is up to $127.5 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 discussing 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.
13
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 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 continue as a going concern;
· 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 (“COVID-19”) 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 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;
14
· 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;
· 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 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 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.

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-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 recently 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). The Company is exploring additional combination cohorts with mechanisms that we believe could be complementary or synergistic with CDX-1140.

·                  ~~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-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^®;

·
CDX-0159, a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity, which recently completed enrollment and ~~is expected~~treatment of healthy subjects in a Phase 1a study. We plan to ~~enter~~study CDX-0159 in mast cell driven diseases, including, initially, chronic spontaneous urticaria (CSU) and chronic inducible urticarias (CINDUs); and,
CDX-527, a bispecific antibody that uses our proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway, for which we are planning a Phase 1 study in ~~healthy subjects by year end.~~advanced solid tumors.
15

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

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.

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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~~three months ended ~~June 30, 2019~~March 31, 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

Three Months Ended
March 31, 2020 Three Months Ended
March 31, 2019
(In thousands)
CDX-1140 $ 3,136 $ 1,573
CDX-3379 813 1,161
CDX-0159/Anti-KIT Program 1,246 1,143
CDX-527 2,924 1,082
TAM Program 811 1,336
Other Programs 2,765 4,856
Total R&D Expense $ 11,695 $ 11,151

Clinical Development Programs

CDX-1140

CDX-1140 is a fully human agonist monoclonal antibody targeted to CD40, a key activator of immune response, which is found on dendritic cells, macrophages and B cells and is also expressed on many cancer cells. Potent CD40 agonist antibodies have shown encouraging results in early clinical studies; however, systemic toxicity associated with broad CD40 activation has limited their dosing. 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.

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.
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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~~HNSCC. In addition, we have amended 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. The 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 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 with CDX-1140 in NHL models. We plan to present updated data from the Phase 1 study atto evaluate CDX-1140 in combination with KEYTRUDA^® (pembrolizumab), Merck’s anti-PD-1 therapy, under a ~~future medical meeting~~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 ~~2019.~~combination with pembrolizumab in patients refractory to PD1/PDL1 treatment. Enrollment is ongoing. The Company is exploring additional combination cohorts with mechanisms that we believe could be complementary or synergistic with CDX-1140.

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 being evaluated in a Phase 2 ~~study in combination with Erbitux in Erbitux-resistant, advanced head and neck squamous cell carcinoma (HNSSC).~~study.

~~A Phase 1a/1b study of CDX-3379 was conducted~~Enrollment opened 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 addedNovember 2017 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 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 is objective response rate (ORR). Secondary endpoints include 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 and interim data from the study were presented at the 2019 ASCO Annual Meeting in June that support the continued development of CDX-3379.
18
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. A durable confirmed complete response (11+ months) was ~~observed; this response remains ongoing and the patient continues to receive treatment.~~observed. An unconfirmed partial response (uPR) in a patient that had not received cetuximab was also 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 the Phase 2 study and earlier studies of CDX-3379 suggest that antitumor activity may 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 NOTCH1-3 mutations.
·
FAT1 and NOTCH 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 study has been expanded (n= ~45 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 the receptor tyrosine kinase KIT ~~receptor~~ and potently inhibits its activity. ~~The~~ KIT ~~receptor tyrosine kinase~~ 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 ~~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~~Celldex believes that by targeting KIT, CDX-0159 may be able to inhibit mast cell activity and ~~decreased~~decrease mast cell numbers ~~supporting the concept that targeting KIT can modulate mast cell activity and potentially~~to provide potential 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~~recently completed enrollment and ~~initiate a~~treatment of healthy subjects in the Phase 1a study of ~~CDX-0159 by year end 2019.~~CDX-0159. The study, which was initiated in November 2019, 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,~~CDX-0159. Based on positive results to date, we plan to ~~further study~~initiate studies of CDX-0159 in ~~CIU, a~~CSU and CINDU, both mast cell-related ~~disease. CIU~~diseases, by year-end 2020. 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 ~~CIU~~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 more effective later line therapies. CINDUs are forms of urticaria that have an attributable cause or trigger associated with them, typically resulting in hives or wheals. We are exploring cold-induced and dermographism-induced (scratching of the skin-induced) urticarias.
19
We plan to present data from the Phase 1a study mid-year 2020.

~~Varlilumab~~CDX-527

~~Varlilumab~~CDX-527 is the first candidate from Celldex’s bispecific antibody platform. Bispecifics provide opportunities to engage two independent pathways involved in controlling immune responses to tumors. CDX-527 uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway to help prime and activate anti-tumor T cell responses through CD27 costimulation, while preventing PD-1 inhibitory signals that subvert the immune response.
Celldex’s prior clinical experience with combining CD27 activation and PD-1 blockade provide the rationale for linking these two pathways into one molecule. Preclinical data presented at the SITC 34th Annual Meeting in November 2019 demonstrated that CDX-527 is more potent at T cell activation and anti-tumor immunity than the combination of parental monoclonal antibodies.
Celldex plans to initiate a ~~fully human agonist monoclonal antibody~~Phase 1 dose-escalation study in up to 90 patients with advanced or metastatic solid tumors that ~~binds to and activates CD27, a critical co-stimulatory molecule~~have progressed during or after standard of care therapy in the ~~immune activation cascade. We believe varlilumab works primarily~~second half of 2020, followed by ~~stimulating T cells, an important component~~tumor-specific expansion cohorts to further evaluate the tolerability, biologic and anti-tumor effects of ~~a person’s immune system, to attack cancer cells. Restricted expression and regulation~~selected dose level(s) of ~~CD27 enables varlilumab specifically to activate T cells, resulting~~CDX-527 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 clinical activity in~~
~~patients with cancer, but we believe the greatest opportunity for varlilumab is as an immune activator in combination with other agents.~~specific tumor types.

~~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 activity of the combination in disease specific cohorts. Enrollment to the Phase 2 portion of the study was completed 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.
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 alsoNote 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~~March 31, 2020 Compared with Three Months Ended ~~June 30, 2018~~March 31, 2019

Three Months Ended
June 30,

Increase/
(Decrease)

Increase/
(Decrease)

2019

2018

$

%

(In thousands)

Revenues:

Product Development and Licensing Agreements

$
195

$
1,667

$
(1,472
)
(88
)%
Contracts and Grants

520

1,096

(576
)
(53
)%
Total Revenue

$
715

$
2,763

$
(2,048
)
(74
)%
Operating Expenses:

Research and Development

10,081

21,448

(11,367
)
(53
)%
General and Administrative

3,908

5,621

(1,713
)
(30
)%
Gain on Fair Value Remeasurement of Contingent Consideration

(1,017
)
(7,433
)
(6,416
)
(86
)%
Total Operating Expense

12,972

19,636

(6,664
)
(34
)%
Operating Loss

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

478

466

12

3
%
Net Loss

$
(11,779
)
$
(16,407
)
$
(4,628
)
(28
)%
Three Months Ended
March 31, Increase/
(Decrease) Increase/
(Decrease)
2020 2019 $ %
(In thousands)
Revenues:
Product Development and Licensing Agreements $ 2,286 $ 129 $ 2,157 1,672 %
Contracts and Grants 442 1,296 (854 ) (66 )%
Total Revenue $ 2,728 $ 1,425 $ 1,303 91 %
Operating Expenses:
Research and Development 11,695 11,151 544 5 %
General and Administrative 3,666 4,896 (1,230 ) (25 )%
Other Asset Impairment — 1,800 (1,800 ) (100 )%
Loss on Fair Value Remeasurement of Contingent Consideration 234 1,519 (1,285 ) (85 )%
Total Operating Expense 15,595 19,366 (3,771 ) (19 )%
Operating Loss (12,867 ) (17,941 ) (5,074 ) (28 )%
Investment and Other Income, Net 242 702 (460 ) (66 )%
Net Loss $ (12,625 ) $ (17,239 ) $ (4,614 ) (27 )%

Net Loss

The $4.6 million decrease in net loss for the three months ended ~~June 30, 2019,~~March 31, 2020, as compared to the three months ended ~~June 30, 2018,~~March 31, 2019, was primarily the result of an increase in revenue from product development and licensing agreements and a decrease in ~~research and development expenses, partially offset by the decrease in gain on fair value remeasurement of contingent consideration.~~non-cash other asset impairment expense.

20
Revenue

The ~~$1.5~~$2.2 million ~~decrease~~increase in product development and licensing agreements revenue for the three months ended ~~June 30, 2019,~~March 31, 2020, as compared to the three months ended ~~June 30, 2018,~~March 31, 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 ~~$0.6~~$0.9 million decrease in contracts and grants revenue for the three months ended ~~June 30, 2019,~~March 31, 2020, as compared to the three months ended ~~June 30, 2018,~~March 31, 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 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)

2019

2018

$

%

(In thousands)

Personnel

$
5,408

$
7,719

$
(2,311
)
(30
)%
Laboratory Supplies

1,257

1,212

45

4
%
Facility

1,558

2,019

(461
)
(23
)%
Product Development

827

7,576

(6,749
)
(89
)%
Three Months Ended
March 31 Increase/
(Decrease)
2020 2019 $ %
(In thousands)
Personnel $ 5,616 $ 5,753 $ (137 ) (2 )%
Laboratory Supplies 1,460 796 664 83 %
Facility 1,730 1,897 (167 ) (9 )%
Product Development 1,806 1,695 111 7 %

Personnel expenses primarily include salary, benefits, stock-based compensation and payroll taxes. The ~~$2.3~~$0.1 million decrease in personnel expenses for the three months ended~~June 30, 2019,~~March 31, 2020, as compared to the three months ended ~~June 30, 2018,~~March 31, 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 $0.7 million increase in laboratory supply expenses for the three months ended ~~June 30, 2019 were consistent with~~March 31, 2020, as compared to the three months ended ~~June 30, 2018.~~March 31, 2019, was primarily due to higher 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 in facility expenses for the three months ended March 31~~June 30, 2019,~~, 2020, as compared to the three months ended ~~June 30, 2018,~~March 31, 2019, was primarily due to lower depreciation expense. 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~~decision to consolidate our Massachusetts lab and manufacturing ~~facilities to further preserve our financial resources and direct them towards reaching meaningful development milestones across our pipeline.~~facilities. 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 induring the second ~~half~~quarter of 2020.

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~~$0.1 million ~~decrease~~increase in product development expenses for the three months ended March 31~~June 30, 2019,~~, 2020, as compared to the three months ended ~~June 30, 2018,~~March 31, 2019, was primarily due to ~~a decrease~~an increase in clinical trial expenses of ~~$3.9~~$0.5 million, ~~and~~partially offset by a decrease in contract ~~manufacturing~~research expenses of ~~$2.2~~$0.4 million. We expect product development expenses to ~~increase~~remain relatively consistent 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~~$1.2 million decrease in general and administrative expenses for the three months ended March 31~~June 30, 2019,~~, 2020, as compared to the three months ended ~~June 30, 2018,~~March 31, 2019, was primarily due to ~~a decrease in headcount,~~ lower ~~commercial planning costs~~stock-based compensation expense and lower ~~lease restructuring expense.~~professional service expenses. We expect general and administrative expenses to remain relatively consistent over the next twelve months, although there may be fluctuations on a quarterly basis.

~~Gain on Fair Value Remeasurement of Contingent Consideration~~
~~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 and other income, net for the three months ended~~ ~~June 30, 2019 was consistent with the three months ended June 30, 2018. We anticipate investment income to decrease over the next twelve months due to lower levels of cash and investment balances.~~
~~Six Months Ended June 30, 2019 Compared with Six Months Ended June 30, 2018~~

Six Months Ended
June 30,

Increase/
(Decrease)

Increase/
(Decrease)

2019

2018

$

%

(In thousands)

Revenues:

Product Development and Licensing Agreements

$
325

$
2,662

$
(2,337
)
(88
)%
Contracts and Grants

1,815

4,172

(2,357
)
(56
)%
Total Revenue

$
2,140

$
6,834

$
(4,694
)
(69
)%
Operating Expenses:

Research and Development

21,232

43,323

(22,091
)
(51
)%
General and Administrative

8,804

11,215

(2,411
)
(21
)%
Goodwill Impairment

—

90,976

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

—

18,677

(18,677
)
(100
)%
Other Asset Impairment

1,800

—

1,800

n/a

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

502

(21,033
)
21,535

102
%
Amortization of Acquired Intangible Assets

—

224

(224
)
(100
)%
Total Operating Expense

32,338

143,382

(111,044
)
(77
)%
Operating Loss

(30,198
)
(136,548
)
(106,350
)
(78
)%
Investment and Other Income, Net

1,180

1,245

(65
)
(5
)%
Net Loss Before Income Tax Benefit

(29,018
)
(135,303
)
(106,285
)
(79
)%
Income Tax Benefit

—

765

(765
)
(100
)%
Net Loss

$
(29,018
)
$
(134,538
)
$
(105,520
)
(78
)%
~~Net Loss~~
The $105.5 million decrease in net loss for the six months ended June 30, 2019, as compared to the six months ended June 30, 2018, 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 increase in loss on fair value remeasurement of contingent consideration.
~~Revenue~~
The $2.3 million decrease in product development and licensing agreements revenue for the six months ended June 30, 2019, as compared to the six months ended June 30, 2018, was primarily due to a decrease in revenue related to our BMS agreement as a result of the completion of our combination clinical study. The $2.4 million decrease in contracts and grants revenue for the six months ended June 30, 2019, as compared to the six months ended June 30, 2018, 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)

2019

2018

$

%

(In thousands)

Personnel

$
11,162

$
16,776

$
(5,614
)
(33
)%
Laboratory Supplies

2,053

2,469

(416
)
(17
)%
Facility

3,454

4,082

(628
)
(15
)%
Product Development

2,522

14,925

(12,403
)
(83
)%
Personnel expenses primarily include salary, benefits, stock-based compensation and payroll taxes. The $5.6 million decrease in personnel expenses for the six months ended June 30, 2019, as compared to the six months ended June 30, 2018, 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.
Laboratory supplies expenses include laboratory materials and supplies, services, and other related expenses incurred in the development of our technology. The $0.4 million decrease in laboratory supply expenses for the six months ended June 30, 2019, as compared to the six months ended June 30, 2018, was primarily due to lower 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 expenses for the six months ended June 30, 2019, as compared to the six months ended June 30, 2018, was primarily due to lower depreciation expense.
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 million decrease in product development expenses for the six months ended June 30, 2019, as compared to the six months ended June 30, 2018, was primarily due to a decrease in clinical trial expenses of $7.2 million and a decrease in contract manufacturing expenses of $4.2 million.
~~General and Administrative Expense~~
~~The $2.4 million decrease in general and administrative expenses for the six months ended June 30, 2019, as compared to the six months ended June 30, 2018,~~ ~~was primarily due to a decrease in headcount, lower commercial planning costs and lower lease restructuring expense.~~
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.
21

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

The $0.2 million loss~~$0.5~~ on fair value remeasurement of contingent consideration for the three months ended March 31, 2020 was primarily due to the passage of time. The $1.5 million loss on fair value remeasurement of contingent consideration for the ~~six~~three months ended ~~June 30,~~March 31, 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~~$0.5 million decrease in investment and other income, net for the ~~six~~three months ended ~~June 30, 2019,~~March 31, 2020, as compared to the ~~six~~three months ended ~~June 30, 2018,~~March 31, 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. We anticipate investment income to decrease over the next twelve months due to lower levels of cash and investment balances.

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.~~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,~~March 31, 2020, our principal sources of liquidity consisted of cash, cash equivalents and marketable securities of ~~$81.3~~$53.7 million. We have had recurring losses and incurred a loss of ~~$29.0~~$12.6 million for the ~~six~~three months ended ~~June 30, 2019. Net cash used in operations for the six months ended June 30, 2019 was $24.3 million.~~March 31, 2020. We believe that ~~the~~our existing cash, cash equivalents and marketable securities ~~at June 30, 2019, combined~~will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2021. In accordance with U.S. GAAP, we have determined that there is substantial doubt about our ability to continue as a going concern. The financial statements do not include any adjustments that might result from the ~~anticipated proceeds from future sales~~outcome of this uncertainty. See Note 1 to the unaudited consolidated financial statements for further discussion of our ~~common stock under~~liquidity and the ~~Cantor agreement, are sufficient~~conditions and events that raise substantial doubt regarding our ability 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. This could be impacted if we elected to pay Kolltan contingent milestones, if any, in cash.continue as a going concern.

During the next twelve months, we will take further steps to raise additional capital to meet our 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 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 $$12.1~~24.3~~ million for the ~~six~~three months ended ~~June 30, 2019~~March 31, 2020 as compared to ~~$45.4~~$13.2 million for the ~~six~~three months ended ~~June 30, 2018.~~March 31, 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.
22

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 investing activities was $~~8.3~~$22.0 million for the ~~six~~three months ended ~~June 30, 2019~~March 31, 2020 as compared to ~~$28.7~~$16.3 million for the ~~six~~three months ended ~~June 30, 2018.~~March 31, 2019. The ~~decrease~~increase in net cash provided by investing activities was primarily due to net sales and maturities of marketable securities for the ~~six~~three months ended ~~June 30, 2019~~March 31, 2020 of ~~$8.8~~$22.2 million as compared to ~~$29.3~~$16.5 million for the ~~six~~three months ended ~~June 30, 2018.~~March 31, 2019.

Financing Activities

Net cash provided by financing activities was $$1.6~~11.4~~ million for the ~~six~~three months ended ~~June 30, 2019~~March 31, 2020 as compared to ~~$20.3~~$4.2 million for the ~~six~~three months ended ~~June 30, 2018.~~March 31, 2019. Net proceeds from stock issuances pursuant to employee benefit plans were $0.0 million during the ~~six~~three months ended ~~June 30, 2019 as compared to $0.4 million for the six months ended June 30, 2018.~~March 31, 2020 and March 31, 2019.

In ~~May 2016,~~March 2020, we ~~entered into an agreement with~~filed a prospectus supplement for the amount of shares that we are eligible to sell pursuant to the Cantor ~~Fitzgerald & Co. (“Cantor”) to allow us to issue~~Agreement.. Under the March 2020 prospectus supplement, we may offer 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.$18,000,000. During the ~~six~~three months ended~~June 30, 2019,~~March 31, 2020, we issued ~~2,856,194~~0.7 million shares of common stock under ~~this controlled equity offering sales~~our Cantor agreement ~~with Cantor~~ resulting in net proceeds of ~~$11.4~~$1.6 million after deducting commission and offering expenses. At ~~June 30, 2019,~~March 31, 2020, we had ~~$25.8~~$17.9 million remaining in aggregate gross offering price available under the ~~Cantor agreement.~~March 2020 prospectus supplement. In ~~July 2019,~~April 2020, we issued ~~201,687~~1.2 million shares of its common stock resulting in net proceeds to us of ~~$0.5~~$2.9 million.

Aggregate Contractual Obligations

~~Except as set forth below,~~ T~~the~~he 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~~March 31, 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,~~March 31, 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.~~March 31, 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.

23
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~~March 31, 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 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~~
*31.1
Celldex Therapeutics, Inc. Amended and Restated 2008 Stock Option and Incentive Plan (as amended, effective 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.
~~10.2~~
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.
24
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~~
May 6, 2020
Anthony S. Marucci
President and Chief Executive Officer
(Principal Executive Officer)
/s/ SAM MARTIN
Dated: ~~August 7, 2019~~
May 6, 2020
Sam Martin
Senior Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)
30
25

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~~March 31, 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,~~March 31, 2020 and 2019 ~~and 2018~~	3	4

Condensed Consolidated Statements of Cash Flows for the ~~Six~~Three Months Ended ~~June 30,~~March 31, 2020 and 2019 ~~and 2018~~	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	14

Item 3. Quantitative and Qualitative Disclosures About Market Risk	27	23

Item 4. Controls and Procedures	28	23

Part II — Other Information

Item 1A. Risk Factors	28	24

Item 6. Exhibits	28	24

Exhibit Index	29	24

Signatures	30	25

	June 30, 2019			December 31, 2018
ASSETS
Current Assets:
Cash and Cash Equivalents	$	19,744		$	24,310
Marketable Securities	61,598			69,712
Accounts and Other Receivables	1,170			3,162
Prepaid and Other Current Assets	1,853			1,895
Total Current Assets	84,365			99,079
Property and Equipment, Net	5,086			6,111
Operating Lease Right-of-Use Assets, Net	3,974			—
Intangible Assets, Net	48,690			48,690
Other Assets	129			1,929
Total Assets	$	142,244		$	155,809
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts Payable	$	1,016		$	1,069
Accrued Expenses	5,410			7,007
Current Portion of Operating Lease Liabilities	2,538			—
Current Portion of Other Long-Term Liabilities	2,545			4,526
Total Current Liabilities	11,509			12,602
Long-Term Portion of Operating Lease Liabilities	1,867			—
Other Long-Term Liabilities	19,242			19,147
Total Liabilities	32,618			31,749
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
Additional Paid-In Capital	1,098,429			1,083,903
Accumulated Other Comprehensive Income	2,638			2,583
Accumulated Deficit	(991,456		)	(962,438		)
Total Stockholders’ Equity	109,626			124,060
Total Liabilities and Stockholders’ Equity	$	142,244		$	155,809

	March 31, 2020			December 31, 2019
ASSETS
Current Assets:
Cash and Cash Equivalents	$	22,724		$	11,232
Marketable Securities		30,998			53,151
Accounts and Other Receivables		1,108			1,015
Prepaid and Other Current Assets		1,088			1,300
Total Current Assets		55,918			66,698
Property and Equipment, Net		4,116			4,031
Operating Lease Right-of-Use Assets, Net		3,739			3,473
Intangible Assets, Net		48,690			48,690
Other Assets		41			41
Total Assets	$	112,504		$	122,933
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts Payable	$	1,609		$	1,174
Accrued Expenses		5,648			6,499
Current Portion of Operating Lease Liabilities		1,682			1,944
Current Portion of Other Long-Term Liabilities		1,993			2,026
Total Current Liabilities		10,932			11,643
Long-Term Portion of Operating Lease Liabilities		2,106			1,713
Other Long-Term Liabilities		15,763			15,551
Total Liabilities		28,801			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 March 31, 2020 and December 31, 2019		—			—
Common Stock, $.001 Par Value; 297,000,000 Shares Authorized; 17,730,802 and 16,972,077 Shares Issued and Outstanding at March 31, 2020 and December 31, 2019, Respectively		18			17
Additional Paid-In Capital		1,107,029			1,104,706
Accumulated Other Comprehensive Income		2,597			2,619
Accumulated Deficit		(1,025,941	)		(1,013,316	)
Total Stockholders’ Equity		83,703			94,026
Total Liabilities and Stockholders’ Equity	$	112,504		$	122,933

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

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

Operating Loss	(12,257		)	(16,873		)	(30,198		)	(136,548		)
Investment and Other Income, Net	478			466			1,180			1,245
Net Loss Before Income Tax Benefit	(11,779		)	(16,407		)	(29,018		)	(135,303		)
Income Tax Benefit	—			—			—			765
Net Loss	$	(11,779	)	$	(16,407	)	$	(29,018	)	$	(134,538	)

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

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

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

	Three Months Ended March 31, 2020			Three Months Ended March 31, 2019
REVENUES:
Product Development and Licensing Agreements	$	2,286		$	129
Contracts and Grants		442			1,296
Total Revenues		2,728			1,425

OPERATING EXPENSES:
Research and Development		11,695			11,151
General and Administrative		3,666			4,896
Other Asset Impairment		—			1,800
Loss on Fair Value Remeasurement of Contingent Consideration		234			1,519
Total Operating Expenses		15,595			19,366

Operating Loss		(12,867	)		(17,941	)
Investment and Other Income, Net		242			702
Net Loss	$	(12,625	)	$	(17,239	)

Basic and Diluted Net Loss Per Common Share	$	(0.73	)	$	(1.40	)

Shares Used in Calculating Basic and Diluted Net Loss Per Share		17,406			12,297

COMPREHENSIVE LOSS:
Net Loss	$	(12,625	)	$	(17,239	)
Other Comprehensive Income (Loss):
Unrealized Gain (Loss) on Marketable Securities		(22	)		19
Comprehensive Loss	$	(12,647	)	$	(17,220	)

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

Cash Flows From Investing Activities:
Sales and Maturities of Marketable Securities	67,386			106,182
Purchases of Marketable Securities	(58,565		)	(76,902		)
Acquisition of Property and Equipment	(484		)	(591		)
Net Cash Provided by Investing Activities	8,337			28,689

Cash Flows From Financing Activities:
Net Proceeds from Stock Issuances	11,363			19,960
Proceeds from Issuance of Stock from Employee Benefit Plans	9			374
Net Cash Provided by Financing Activities	11,372			20,334

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

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

	Three Months Ended March 31, 2020			Three Months Ended March 31, 2019
Cash Flows From Operating Activities:
Net Loss	$	(12,625	)	$	(17,239	)
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities:
Depreciation and Amortization		1,165			1,352
Amortization and Premium of Marketable Securities, Net		(63	)		(345	)
Loss on Sale or Disposal of Assets		—			25
Other Asset Impairment		—			1,800
Loss on Fair Value Remeasurement of Contingent Consideration		234			1,519
Stock-Based Compensation Expense		687			1,693
Changes in Operating Assets and Liabilities:
Accounts and Other Receivables		(93	)		855
Prepaid and Other Current Assets		206			299
Accounts Payable and Accrued Expenses		(853	)		(1,455	)
Other Liabilities		(768	)		(1,737	)
Net Cash Used in Operating Activities		(12,110	)		(13,233	)

Cash Flows From Investing Activities:
Sales and Maturities of Marketable Securities		22,200			37,886
Purchases of Marketable Securities		—			(21,404	)
Acquisition of Property and Equipment		(235	)		(186	)
Net Cash Provided by Investing Activities		21,965			16,296

Cash Flows From Financing Activities:
Net Proceeds from Stock Issuances		1,613			4,151
Proceeds from Issuance of Stock from Employee Benefit Plans		24			9
Net Cash Provided by Financing Activities		1,637			4,160

Net Increase in Cash and Cash Equivalents		11,492			7,223
Cash and Cash Equivalents at Beginning of Period		11,232			24,310
Cash and Cash Equivalents at End of Period	$	22,724		$	31,533

Non-cash Investing Activities
Accrued construction in progress	$	462		$	65

	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 March 31, 2020		Level 1		Level 2		Level 3
	(In thousands)							(In thousands)
Assets:
Money market funds and cash equivalents	$	15,755	—	$	15,755	—		$	15,396		—	$	15,396		—
Marketable securities	69,712		—	69,712		—			30,998		—		30,998		—
	$	85,467	—	$	85,467	—		$	46,394		—	$	46,394		—
Liabilities:
Kolltan acquisition contingent consideration	$	13,779	—	—		$	13,779	$	12,719		—		—	$	12,719
	$	13,779	—	—		$	13,779	$	12,719		—		—	$	12,719

	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		234
Balance at March 31, 2020	$	12,719

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

December 31, 2018
U.S. government and municipal obligations (maturing in one year or less)	$	27,355	$	—	$	(4	)	$	27,351
Corporate debt securities (maturing in one year or less)	42,370		—		(9		)	42,361
Total Marketable Securities	$	69,725	$	—	$	(13	)	$	69,712

	Gross Unrealized
	Amortized Cost		Gains		Losses			Fair Value
	(In thousands)
March 31, 2020
U.S. government and municipal obligations (maturing in one year or less)	$	10,538	$	16	$	—		$	10,554
Corporate debt securities (maturing in one year or less)		20,459		—		(15	)		20,444
Total Marketable Securities	$	30,997	$	16	$	(15	)	$	30,998

December 31, 2019
U.S. government and municipal obligations (maturing in one year or less)	$	18,509	$	13	$	—		$	18,522
Corporate debt securities (maturing in one year or less)		34,619		13		(3	)		34,629
Total Marketable Securities	$	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)
Options Outstanding at December 31, 2018	866,132		$	93.70	7.1
Granted	863,290		2.78
Exercised	—		—
Canceled	(39,348	)	131.86
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
Shares Available for Grant Under the 2008 Plan	433,391

	Shares			Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (In Years)
Options Outstanding at December 31, 2019		1,699,202		$	44.87		8.0
Granted		2,750		$	1.66
Exercised		—			—
Canceled		(43,811	)	$	50.59
Options Outstanding at March 31, 2020		1,658,141		$	44.65		7.8
Options Vested and Expected to Vest at March 31, 2020		1,585,639		$	46.50		7.8
Options Exercisable at March 31, 2020		576,042		$	118.98		5.6
Shares Available for Grant Under the 2008 Plan		465,324

	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 March 31,
	2020		2019
	(In thousands)
Research and development	$	310	$	756
General and administrative		377		937
Total stock-based compensation expense	$	687	$	1,693

	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		(22	)		—		(22	)
Balance at March 31, 2020	$	1		$	2,596	$	2,597

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

	Three Months Ended March 31, 2020		Three Months Ended March 31, 2019
		(In thousands)
CDX-1140	$	3,136	$	1,573
CDX-3379		813		1,161
CDX-0159/Anti-KIT Program		1,246		1,143
CDX-527		2,924		1,082
TAM Program		811		1,336
Other Programs		2,765		4,856
Total R&D Expense	$	11,695	$	11,151

	Three Months Ended June 30,						Increase/ (Decrease)			Increase/ (Decrease)
	2019			2018			$			%
	(In thousands)
Revenues:
Product Development and Licensing Agreements	$	195		$	1,667		$	(1,472	)	(88	)%
Contracts and Grants	520			1,096			(576		)	(53	)%
Total Revenue	$	715		$	2,763		$	(2,048	)	(74	)%
Operating Expenses:
Research and Development	10,081			21,448			(11,367		)	(53	)%
General and Administrative	3,908			5,621			(1,713		)	(30	)%
Gain on Fair Value Remeasurement of Contingent Consideration	(1,017		)	(7,433		)	(6,416		)	(86	)%
Total Operating Expense	12,972			19,636			(6,664		)	(34	)%
Operating Loss	(12,257		)	(16,873		)	(4,616		)	(27	)%
Investment and Other Income, Net	478			466			12			3	%
Net Loss	$	(11,779	)	$	(16,407	)	$	(4,628	)	(28	)%

	Three Months Ended March 31,						Increase/ (Decrease)			Increase/ (Decrease)
	2020			2019			$			%
	(In thousands)
Revenues:
Product Development and Licensing Agreements	$	2,286		$	129		$	2,157			1,672	%
Contracts and Grants		442			1,296			(854	)		(66	)%
Total Revenue	$	2,728		$	1,425		$	1,303			91	%
Operating Expenses:
Research and Development		11,695			11,151			544			5	%
General and Administrative		3,666			4,896			(1,230	)		(25	)%
Other Asset Impairment		—			1,800			(1,800	)		(100	)%
Loss on Fair Value Remeasurement of Contingent Consideration		234			1,519			(1,285	)		(85	)%
Total Operating Expense		15,595			19,366			(3,771	)		(19	)%
Operating Loss		(12,867	)		(17,941	)		(5,074	)		(28	)%
Investment and Other Income, Net		242			702			(460	)		(66	)%
Net Loss	$	(12,625	)	$	(17,239	)	$	(4,614	)		(27	)%

	Three Months Ended June 30				Increase/ (Decrease)
	2019		2018		$			%
	(In thousands)
Personnel	$	5,408	$	7,719	$	(2,311	)	(30	)%
Laboratory Supplies	1,257		1,212		45			4	%
Facility	1,558		2,019		(461		)	(23	)%
Product Development	827		7,576		(6,749		)	(89	)%

	Three Months Ended March 31				Increase/ (Decrease)
	2020		2019		$			%
	(In thousands)
Personnel	$	5,616	$	5,753	$	(137	)		(2	)%
Laboratory Supplies		1,460		796		664			83	%
Facility		1,730		1,897		(167	)		(9	)%
Product Development		1,806		1,695		111			7	%

	Six Months Ended June 30,						Increase/ (Decrease)			Increase/ (Decrease)
	2019			2018			$			%
	(In thousands)
Revenues:
Product Development and Licensing Agreements	$	325		$	2,662		$	(2,337	)	(88	)%
Contracts and Grants	1,815			4,172			(2,357		)	(56	)%
Total Revenue	$	2,140		$	6,834		$	(4,694	)	(69	)%
Operating Expenses:
Research and Development	21,232			43,323			(22,091		)	(51	)%
General and Administrative	8,804			11,215			(2,411		)	(21	)%
Goodwill Impairment	—			90,976			(90,976		)	(100	)%
Intangible Asset Impairment	—			18,677			(18,677		)	(100	)%
Other Asset Impairment	1,800			—			1,800			n/a
Loss/(Gain) on Fair Value Remeasurement of Contingent Consideration	502			(21,033		)	21,535			102	%
Amortization of Acquired Intangible Assets	—			224			(224		)	(100	)%
Total Operating Expense	32,338			143,382			(111,044		)	(77	)%
Operating Loss	(30,198		)	(136,548		)	(106,350		)	(78	)%
Investment and Other Income, Net	1,180			1,245			(65		)	(5	)%
Net Loss Before Income Tax Benefit	(29,018		)	(135,303		)	(106,285		)	(79	)%
Income Tax Benefit	—			765			(765		)	(100	)%
Net Loss	$	(29,018	)	$	(134,538	)	$	(105,520	)	(78	)%

Exhibit No.		Description
~~10.1~~ *31.1		Celldex Therapeutics, Inc. Amended and Restated 2008 Stock Option and Incentive Plan (as amended, effective 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.

~~10.2~~		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.