Washington, D.C. 20549

Form 8-K


Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): March 29, 2021  

Celldex Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)

(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification Number)


Perryville III Building, 53 Frontage Road, Suite 220, Hampton, New Jersey 08827
(Address of Principal Executive Offices) (Zip Code)

(908) 200-7500
(Registrant's telephone number, including area code)

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 [   ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 [   ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 [   ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 [   ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [   ]


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [   ]


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


Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $.001CLDXNasdaq Capital Market

Item 2.02. Results of Operations and Financial Condition.

On March 29, 2021, Celldex Therapeutics, Inc. (the "Company") issued a press release announcing its financial results for the fourth quarter and year ended 2020. The full text of the press release is furnished as Exhibit 99.1 hereto and is incorporated by reference herein.

The information in this Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits
99.1 Press Release of Celldex Therapeutics, Inc., dated March 29, 2021.


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 hereunto duly authorized.

 Celldex Therapeutics, Inc.
Date: March 29, 2021By: /s/ Sam Martin        
  Sam Martin
  Senior Vice President and
Chief Financial Officer



Celldex Provides Corporate Update and Reports Fourth Quarter and Year End 2020 Results

HAMPTON, N.J., March 29, 2021 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business and financial highlights for the fourth quarter and year ended December 31, 2020.

“Celldex made significant progress across our pipeline in 2020 and today continued this momentum with the announcement of compelling interim results from our ongoing Phase 1b study of CDX-0159 in chronic inducible urticaria where we have observed an 80% complete response rate and a well-tolerated safety profile to date,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “These data support the novel mechanism of CDX-0159 and the potential broad applicability of this compound in mast cell driven diseases. Based on these results, we are expanding the study to also include patients with cholinergic urticaria and look forward to presenting updated results from the cold induced and symptomatic dermographism cohorts this summer. We also anticipate results from the ongoing Phase 1b study in chronic spontaneous urticaria by the end of the year and are on track to initiate a third study in prurigo nodularis in the fourth quarter.”

“In 2020, we also continued to advance our oncology programs, presenting data from our CDX-1140 program supporting this candidate as a best in class CD40 agonist and initiating a Phase 1 study of CDX-527, the first candidate from our bispecific platform, into the clinic. We anticipate data updates from both of these programs later this year and look forward to what promises to be a busy and exciting time for the Company.”

Recent Pipeline Highlights

While Celldex’s clinical development programs have not been significantly, negatively impacted by COVID-19 to date, the Company continues to carefully monitor the evolving situation closely across all development programs and work to minimize potential impact/disruptions.

CDX-0159—a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells. Results from a Phase 1a dose escalation study of CDX-0159 were featured in a late breaking presentation in June at the EAACI Annual Congress 2020. CDX-0159 demonstrated a favorable safety profile as well as profound and durable reductions of plasma tryptase, indicative of systemic mast cell ablation.

CDX-1140—a potent CD40 human agonist antibody developed by Celldex that the Company believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile.

Updated data from this program are expected to be presented later this year.

CDX-527—the first candidate developed by Celldex from its bispecific platform which utilizes the Company’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.

Fourth Quarter and Twelve Months 2020 Financial Highlights and 2021 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2020 were $194.4 million compared to $199.6 million as of September 30, 2020. The decrease was primarily driven by fourth quarter cash used in operating activities of $5.2 million. At December 31, 2020, Celldex had 39.6 million shares outstanding.

Revenues: Total revenue was $3.8 million in the fourth quarter of 2020 and $7.4 million for the year ended December 31, 2020, compared to $0.9 million and $3.6 million for the comparable periods in 2019. The increase in revenue was primarily due to the $1.8 million milestone payment from Rockefeller University related to our manufacturing and development services agreement and an increase in services performed under our manufacturing and research and development agreements with Rockefeller University and Gilead Sciences, partially offset by a decrease in services performed under our manufacturing and research and development agreement with Duke University.

R&D Expenses: Research and development (R&D) expenses were $10.4 million in the fourth quarter of 2020 and $42.5 million for the year ended December 31, 2020, compared to $10.3 million and $42.7 million for the comparable periods in 2019. The decrease in R&D expenses was primarily due to a decrease in contract research and facility expenses, partially offset by an increase in clinical trials and contract manufacturing expenses.

G&A Expenses: General and administrative (G&A) expenses were $3.6 million in the fourth quarter of 2020 and $14.5 million for the year ended December 31, 2020, compared to $3.2 million and $15.4 million for the comparable periods in 2019. The decrease in G&A expenses was primarily due to a decrease in stock-based compensation and facility expenses.

Intangible Asset Impairment: The Company recorded a non-cash partial impairment charge of $14.5 million related to the TAM program IPR&D asset in the fourth quarter of 2020 as a result of changes in the projected development and regulatory timelines for the program. The Company recorded a non-cash impairment charge of $3.5 million related to the CDX-3379 IPR&D asset in the second quarter of 2020 as a result of the discontinuation of the CDX-3379 program.

Changes in Fair Value Remeasurement of Contingent Consideration: During the year ended December 31, 2020, the Company recorded a $4.2 million gain on the fair value remeasurement of contingent consideration primarily due to updated assumptions for CDX-3379 related milestones due to the discontinuation of the CDX-3379 program partially offset by changes in discount rates and the passage of time.

Net Loss: Net loss was $21.9 million, or ($0.55) per share, for the fourth quarter of 2020 and $59.8 million, or ($2.02) per share, for the year ended December 31, 2020, compared to a net loss of $10.4 million, or ($0.64) per share, for the fourth quarter of 2019 and $50.9 million, or ($3.51) per share, for the year ended December 31, 2019.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2020 are sufficient to meet estimated working capital requirements and fund planned operations through 2023.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA.

About Celldex Therapeutics, Inc.
Celldex is a clinical stage biotechnology company dedicated to developing monoclonal and bispecific antibodies that address devastating diseases for which available treatments are inadequate. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with inflammatory diseases and many forms of cancer. Visit www.celldex.com.

Forward Looking Statement
This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates; the effects of the outbreak of COVID-19 on our business and results of operations; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q.

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 release. 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.

Company Contact
Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
Celldex Therapeutics, Inc.
(508) 864-8337

(In thousands, except per share amounts)
OF OPERATIONS DATA Ended December 31, Ended December 31,
    2020   2019   2020   2019 
Product Development and        
 Licensing Agreements $3  $94  $2,301  $473 
Contracts and Grants  3,783   793   5,117   3,100 
Total Revenue  3,786   887   7,418   3,573 
Research and Development  10,425   10,339   42,534   42,672 
General and Administrative  3,623   3,219   14,456   15,426 
Intangible Asset Impairment  14,500   -   18,000   - 
Other Asset Impairment  -   -   -   1,800 
Loss (Gain) on Fair Value Remeasurement        
 of Contingent Consideration  18   318   (4,218)  (1,294)
Total Operating Expense  28,566   13,876   70,772   58,604 
Operating Loss  (24,780)  (12,989)  (63,354)  (55,031)
Investment and Other Income, Net  1,941   2,542   2,407   4,153 
Net Loss Before Income Tax Benefit  (22,839)  (10,447)  (60,947)  (50,878)
Income Tax Benefit  939   -   1,167   - 
Net Loss $(21,900) $(10,447) $(59,780) $(50,878)
Basic and Diluted Net Loss per        
 Common Share $(0.55) $(0.64) $(2.02) $(3.51)
Shares Used in Calculating Basic        
 and Diluted Net Loss per Share  39,577   16,442   29,640   14,507 
BALANCE SHEETS DATA     December 31, December 31,
        2020   2019 
Cash, Cash Equivalents and Marketable Securities     $194,422  $64,383 
Other Current Assets      3,421   2,315 
Property and Equipment, net      3,815   4,031 
Intangible and Other Assets, net      34,180   52,204 
 Total Assets     $235,838  $122,933 
Current Liabilities     $14,206  $11,643 
Long-Term Liabilities      12,275   17,264 
Stockholders' Equity      209,357   94,026 
 Total Liabilities and Stockholders' Equity     $235,838  $122,933