Form 8-K

8-K — Celldex Therapeutics, Inc.

Accession: 0001104659-26-109465

Filed: 2026-09-22

Period: 2026-09-22

CIK: 0000744218

SIC: 2835 (IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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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): September 22, 2026

Celldex

Therapeutics, Inc.

(Exact name of registrant as specified in its

charter)

Delaware

000-15006

13-3191702

(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 class

Trading

Symbol(s)

Name

of each exchange on which registered

Common

Stock, par value $.001

CLDX

Nasdaq

Capital Market

Indicate by check mark whether the registrant 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 ¨

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 8.01. Other Events.

On September 22, 2026, Celldex Therapeutics, Inc. issued a press release

announcing results from its two Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials of Barzolvolimab in chronic spontaneous urticaria (CSU). A

copy of this press release is attached hereto as Exhibit 99.1 hereto and is incorporated by reference herein.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

99.1

Press Release of Celldex Therapeutics, Inc., dated September 22, 2026.

104

Cover 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: September 22, 2026

By:

/s/ Sam Martin

Sam Martin

Senior Vice President and Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2625892d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Celldex Announces Positive Results from Phase

3 EMBARQ-CSU1 and EMBARQ-CSU2

Studies of Barzolvolimab Which Met Primary and All Key Secondary Endpoints

· Best-in-disease results showed rapid, profound, sustained efficacy, supporting

barzolvolimab’s potential to be a transformational therapy in CSU

· EMBARQ-CSU1 and -CSU2 met primary and all key secondary endpoints at 12

weeks across both studies and both dose groups

· Clinically meaningful and statistically significant benefit demonstrated

in omalizumab refractory CSU and patients with severe disease or severe angioedema

· Efficacy sustained or deepened from weeks 12 to 24

· Well tolerated with a favorable safety profile through 24 weeks; consistent

with prior studies

· Treatment will continue in both trials to 52 weeks; BLA submission anticipated

in 2027

· Company to host webcast today at 8:00 am ET

HAMPTON, N.J., September 22, 2026 -- Celldex (NASDAQ:CLDX) today

reported positive topline results from the Company’s Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials evaluating two doses of barzolvolimab

in patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines. The EMBARQ-CSU1

and EMBARQ-CSU2 studies are the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory

CSU. Both Phase 3 trials met the primary endpoint of mean change from baseline in weekly urticaria activity score (UAS7) at Week 12, and

all key secondary endpoints, demonstrating clinically meaningful and statistically significant improvements in disease activity. Barzolvolimab

was well-tolerated through the 24 week placebo controlled treatment period with a favorable safety profile consistent with prior Phase

2 experience. The EMBARQ-CSU trials are ongoing, with treatment continuing through 52 weeks. The Company intends to present the EMBARQ-CSU

data at an upcoming medical meeting and plans to submit a Biologics License Application (BLA) to the FDA in 2027.

“We are proud of the results shared today and believe that barzolvolimab

has the potential to address the enormous unmet need in CSU,” said Diane Young, MD, Senior Vice President and Chief Medical Officer

of Celldex. “Barzolvolimab continued to show unprecedented complete response rates across the overall studies and demonstrated strong

differentiation in patient populations underserved by existing therapies, including those with severe disease or angioedema, and those

whose disease is refractory to omalizumab. We believe that barzolvolimab can be a transformational therapy for people living with CSU

and thank the CSU community, trial participants, and investigators around the world for their support of the EMBARQ-CSU trials and the

entire barzolvolimab clinical program.”

"The results from our two Phase 3 EMBARQ-CSU trials showed efficacy

that is best-in-disease in CSU,” said Anthony Marucci, Co-Founder, President, and Chief Executive Officer at Celldex. “We

believe barzolvolimab is well-positioned to address large CSU populations of high unmet need—as a first-line therapy for patients

with severe CSU or angioedema, and as the second-line advanced therapy of choice. We look forward to continuing to grow our leadership

in mast cell biology as we advance to our next stage of development—establishing a commercial-stage organization committed to delivering

barzolvolimab to patients and physicians in need as quickly as possible.”

Summary of Key Findings

Data cutoff: September 9, 2026

The Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 studies demonstrated rapid,

profound, sustained efficacy consistent with Phase 2 and unparalleled in CSU. Efficacy was sustained or deepened from weeks 12 to 24 across

primary and all key secondary endpoints

Primary Endpoint: Mean Change from Baseline in UAS7 at Week 12:

EMBARQ-CSU1

EMBARQ-CSU2

Baseline UAS7

LS Mean Change (SE) at Week 12

Baseline UAS7

LS Mean Change (SE) at Week 12

Placebo

30.9

-10.7 (0.65)

29.3

-11.4 (0.64)

150 mg Q4W

30.6

-20.2 (0.64) (p<.00001)

29.7

-20.2 (0.63) (p<.00001)

300 mg Q8W

30.3

-20.5 (0.65) (p<.00001)

29.6

-19.7 (0.64) (p<.00001)

P-values are for LS Mean treatment difference versus placebo.

· The primary endpoint showed clinically meaningful and highly statistically

significant improvement.

Key Secondary Endpoints: All key secondary endpoints in both

EMBARQ-CSU trials were met at Week 12 with high statistical significance and were clinically meaningful.

Given the importance of Complete Response (complete absence of itch

and hives) to patients and physicians, and barzolvolimab’s unique ability to drive sustained Complete Response, the Company is presenting

UAS7=0 data observed at both 12 and 24 weeks.

Proportion of Patients with Complete Response (UAS7=0) at Weeks 12 and 24

EMBARQ-CSU1

EMBARQ-CSU2

12 Weeks

Placebo

9.3%

12.6%

150 mg Q4W

42.4% (p<.00001)

45.7% (p<.00001)

300 mg Q8W

42.1% (p<.00001)

44.0% (p<.00001)

24 Weeks

Placebo

15.4%

17.6%

150 mg Q4W

49.0% (p<.00001)

54.0% (p<.00001)

300 mg Q8W

45.1% (p<.00001)

48.4% (p<.00001)

P-values are based on adjusted odds ratio of logistic regression

models.

· Significantly more patients achieved Complete Response (UAS7=0) with both

barzolvolimab doses vs. placebo at Weeks 12 and 24.

Proportion of Patients with Complete Response (UAS7=0) at Week 12

in Omalizumab-Refractory CSU

EMBARQ-CSU1

EMBARQ-CSU2

Placebo

9.3%

15.1%

150 mg Q4W

55.3% (p<.00001)

41.7% (p=.0089)

300 mg Q8W

44.3% (p=.00017)

46.4% (p=.0036)

P-values are based on adjusted odds ratio of logistic regression

models.

· A higher proportion of patients achieved Complete Response (UAS7=0) vs placebo

at Week 12 in the sub-population of patients with CSU refractory to omalizumab.

Proportion of Patients with AAS7=0 at Week 12 in Patients with Baseline AAS7>0

EMBARQ-CSU1

EMBARQ-CSU2

Placebo

33.8%

33.7%

150 mg Q4W

62.7% (p<.00001)

74.3% (p<.00001)

300 mg Q8W

66.3% (p<.00001)

66.2% (p<.00001)

P-values are based on adjusted odds ratio of logistic regression

models.

· A statistically higher proportion of patients achieved complete resolution

of angioedema (AAS7=0) at Week 12 vs. placebo in patients with baseline AAS7>0.

Barzolvolimab was well-tolerated and demonstrated a favorable safety

profile consistent with prior experience through the end of the placebo controlled period at Week 24.

The Phase 3 EMBARQ-CSU1 and CSU2 studies are ongoing. A BLA submission

is planned for 2027.

The Phase 3 Program is designed to establish the efficacy and safety

of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. Both Phase 3 trials are randomized,

double-blind, placebo-controlled, parallel group, global studies. 1,939 patients were randomized (n=963 EMBARQ-CSU1; n=976 EMBARQ-CSU2)

evenly to barzolvolimab 150 mg every 4 weeks (following 300 mg loading dose), barzolvolimab 300 mg every 8 weeks (following 450 mg loading

dose) for 52 weeks or placebo for 24 weeks. At 24 weeks, patients on placebo were re-randomized to active treatment across both dosing

groups. The primary endpoint of the study evaluated the clinical effect of barzolvolimab in reducing urticaria activity (weekly urticaria

activity score; UAS7) at Week 12. The studies were designed to detect a clinically meaningful difference between each of the active

arms vs placebo in the overall population as well as in the subpopulation of omalizumab refractory participants. The primary endpoint

analysis was performed when all patients completed the placebo controlled portion of the study at 24 weeks. A global Phase 3b long term

extension study (LTE) has been established and is ongoing, which patients can enter following completion of the EMBARQ-CSU Phase 3 trials.

Please visit clinicaltrials.gov for additional information

on EMBARQ-CSU1; NCT06445023 and EMBARQ-CSU2; NCT06455202.

Webcast and Conference Call

The Company will host a conference call/webcast today to discuss the

results at 8:00am ET. To access the live and archived webcast, please visit the Events section on the Investor Relations page of Celldex’s

website. Parties interested in participating via telephone may register here to receive the dial-in numbers and unique

PIN to seamlessly access the call. Otherwise, please access the listen-only webcast link. The archived webcast will be available for

a limited time on the Company’s website.

About Barzolvolimab

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. Based on data from

robust, randomized, placebo controlled Phase 2 studies, barzolvolimab has significant potential as a first-in-class and best-in-disease

treatment option for patients with chronic spontaneous urticaria (CSU), cold urticaria (ColdU) and symptomatic dermographism (SD). Barzolvolimab

is currently being studied in Phase 3 studies in CSU and ColdU/SD and a Phase 2 study in atopic dermatitis (AD), with additional indications

planned for the future.

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, including the Company’s plan

to submit a BLA in 2027; 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

scavanaugh@celldex.com

Elizabeth Higgins

Executive Director, Investor Relations & Corporate Communications

(857) 404-2088

ehiggins@celldex.com

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