Form 8-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________

FORM 8-K

_________________

CURRENT REPORT

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

Date of Report (Date of earliest event reported):  August 6, 2026

_______________________________

Celldex Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

_______________________________

Delaware000-1500613-3191702
(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification No.)

Perryville III Building, 53 Frontage Road, Suite 220

Hampton, New Jersey 08827

(Address of Principal Executive Offices) (Zip Code)

(908) 200-7500

(Registrant's telephone number, including area code)

 

(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))

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

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

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. ☐

 
 
Item 2.02. Results of Operations and Financial Condition.

 

On August 6, 2026, Celldex Therapeutics, Inc. (the "Company") issued a press release announcing its financial results for the second quarter of 2026. 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 August 6, 2026.
104Cover Page Interactive Data File (embedded within the Inline XBRL document)
  

 

 
 

 

SIGNATURE

 

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: August 6, 2026By: /s/ Sam Martin        
  Sam Martin
  Senior Vice President and
Chief Financial Officer
  

 

EXHIBIT 99.1

Celldex Reports Second Quarter Financial Results and Provides Corporate Update

HAMPTON, N.J., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported financial results for the second quarter ended June 30, 2026 and provided a corporate update.

“We are leaders in mast cell science with a pipeline of programs that have the potential to dramatically shift treatment paradigms for patients,” said Anthony Marucci, Co-founder, President and Chief Executive Officer at Celldex. “Barzolvolimab, followed by our first bispecific candidate CDX-622, are a powerful portfolio combination targeting inflammatory diseases where mast cells are implicated, with the goal of ultimately bringing our leading science to additional patient populations that could benefit from our medicines. We are looking forward to sharing the topline results from our two Phase 3 trials of barzolvolimab in the early fall and are actively driving towards potential commercialization.”

Recent Program Highlights

Barzolvolimab - KIT Inhibitor Program

Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activation plays a central role in the onset and progression of the disease.

Chronic Urticarias

Atopic Dermatitis and Prurigo Nodularis

Novel Bispecific Antibody Platform

CDX-622 – Bispecific SCF & TSLP

CDX-622 is a uniquely engineered novel bispecific antibody that targets soluble SCF and the alarmin thymic stromal lymphopoietin (TSLP), two critical pathways that may contribute to the pathology of several allergic and inflammatory disorders with significant unmet medical need. Combined neutralization of SCF and TSLP with CDX-622 is expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses, allowing for a complementary dual mechanism approach that may overcome the heterogeneity inherent in the pathophysiology of many inflammatory disorders. CDX-622 has been engineered to disable effector function (AQQ) and enhance half-life (YTE).

Second Quarter 2026 Financial Highlights and 2026 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2026 were $717.6 million compared to $451.5 million as of March 31, 2026. The increase was primarily driven by net proceeds of $323.8 million from our April 2026 underwritten public offering, partially offset by second quarter cash used in operating activities of $57.4 million. At June 30, 2026, Celldex had 78.5 million shares outstanding.

Revenues: No material revenue was recognized in the second quarter of 2026 or the six months ended June 30, 2026, compared to $0.7 million and $1.4 million for the comparable periods in 2025, respectively. The decrease in revenue was primarily due to a decrease in services performed under our manufacturing and research and development agreements with Rockefeller University.

R&D Expenses: Research and development (R&D) expenses were $67.5 million in the second quarter of 2026 and $140.5 million for the six months ended June 30, 2026, compared to $54.2 million and $106.8 million for the comparable periods in 2025. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial and contract manufacturing expenses and an increase in employee headcount.

G&A Expenses: General and administrative (G&A) expenses were $13.1 million in the second quarter of 2026 and $24.6 million for the six months ended June 30, 2026, compared to $10.4 million and $21.2 million for the comparable periods in 2025. The increase in G&A expenses was primarily due to an increase in barzolvolimab commercial planning expenses.

Net Loss: Net loss was $73.5 million, or ($0.94) per share, for the second quarter of 2026, and $152.2 million, or ($2.11) per share, for the six months ended June 30, 2026, compared to a net loss of $56.6 million, or ($0.85) per share, for the second quarter of 2025, and $110.4 million, or ($1.66) per share, for the six months ended June 30, 2025.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at June 30, 2026 are sufficient to meet estimated working capital requirements and fund current planned operations through 2028.

About Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. 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, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; 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 Contacts
Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
[email protected]

Elizabeth Higgins
Executive Director, Investor Relations & Corporate Communications
(857) 404-2088
[email protected]

 
CELLDEX THERAPEUTICS, INC.
(In thousands, except per share amounts)
         
         
  Three Months Six Months
Consolidated Statements of Operations Data Ended June 30, Ended June 30,
   2026   2025   2026   2025 
  (Unaudited) (Unaudited)
Revenues:        
Product development and licensing agreements $7  $7  $7  $57 
Contracts and grants  15   723   30   1,367 
         
Total revenues  22   730   37   1,424 
         
Operating expenses:        
Research and development  67,542   54,196   140,543   106,810 
General and administrative  13,103   10,391   24,552   21,211 
         
Total operating expenses  80,645   64,587   165,095   128,021 
         
Operating loss  (80,623)  (63,857)  (165,058)  (126,597)
         
Investment and other income, net  7,120   7,257   12,870   16,201 
         
Net loss $(73,503) $(56,600) $(152,188) $(110,396)
         
Basic and diluted net loss per common share $(0.94) $(0.85) $(2.11) $(1.66)
         
Shares used in calculating basic and diluted net loss per share  77,840   66,392   72,234   66,388 
                 


Condensed Consolidated Balance Sheet Data June 30
 December 31
   2026   2025 
  (Unaudited)
   
Assets      
Cash, cash equivalents and marketable securities $717,587  $518,573 
Other current assets  7,344   16,091 
Property and equipment, net  9,756   5,334 
Intangible and other assets, net  47,662   42,985 
Total assets $782,349  $582,983 
       
Liabilities and stockholders' equity      
Current liabilities $61,325  $50,991 
Long-term liabilities  6,460   4,827 
Stockholders' equity  714,564   527,165 
Total liabilities and stockholders' equity $782,349  $582,983