Form 8-K - Current report
November 06 2023 - 9:00AM
Edgar (US Regulatory)
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0000744218
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2023-11-05
2023-11-05
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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):
November 5, 2023
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) |
|
(IRS
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)
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 (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. ¨
Item 8.01. Other Events.
On November 6, 2023, Celldex Therapeutics, Inc.
(the “Company”) announced topline data from the Company’s ongoing Phase 2 study of barzolvolimab in patients with chronic
spontaneous urticaria (“CSU”) refractory to antihistamines, including patients who received prior biologics, which data supports
further development of barzolvolimab in Phase 3 CSU studies. Treatment options for patients with CSU are limited and there are no approved
therapies for patients who do not respond to omalizumab.
Data from the 208 patients randomized in the study
showed that barzolvolimab achieved the primary efficacy endpoint across multiple dose groups, with a statistically significant mean change
from baseline to week 12 of UAS7 (urticaria activity score) compared to placebo. Barzolvolimab demonstrated rapid, durable and clinically
meaningful responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment.
Demographics and baseline disease characteristics were well balanced across treatment groups.
Summary of Clinical Activity Assessments at Week 12 |
| |
300 mg q8w (n=51) | |
150 mg q4w (n=52) | |
75 mg q4w (n=53) | |
Placebo (n=51) | |
UAS7 Changes | |
| |
| |
| |
| |
Baseline UAS7 (mean) | |
| 31.33 | |
| 30.75 | |
| 30.30 | |
| 30.09 | |
LS Mean change at Week 12 | |
| -23.87 | |
| -23.02 | |
| -17.06 | |
| -10.47 | |
LS Mean difference from placebo (Confidence Interval, p value) | |
| -13.41 (CI: -17.47, -9.34) p<0.0001 | |
| -12.55 (CI:-16.56, -8.55) p<0.0001 | |
| -6.60 (CI:-10.71, -2.49) p=0.0017 | |
| | |
Clinical Responses | |
| | |
| | |
| | |
| | |
UAS7=0 (Complete Control) | |
| 37.5% | |
| 51.1% | |
| 22.9% | |
| 6.4% | |
UAS7≤6 (Well-controlled) | |
| 62.5% | |
| 59.6% | |
| 41.7% | |
| 12.8% | |
Approximately 20% of enrolled patients received
prior treatment with omalizumab. These patients experienced a similar clinical benefit as the overall treated population within their
individual dosing groups.
Barzolvolimab was generally well tolerated with
a favorable safety profile. Most adverse events were mild to moderate in severity; through 12 weeks, the most common treatment emergent
adverse events in barzolvolimab treated patients were hair color changes (9%), urticaria (9%) and neutropenia (8%). The rate of infections
was similar between barzolvolimab-treated patients and placebo with no apparent association between neutropenia and infections. Treatment
will continue to 52 weeks. The Company expects to advance CSU into registrational studies in 2024.
In addition, as previously disclosed, the Company
entered a Confidential Settlement Agreement and Mutual Release (the “Settlement Agreement”) with Shareholder Representatives
Services LLC (“SRS”) relating to the previously disclosed litigation brought by the Company (the “Litigation”)
arising under the Agreement and Plan of Merger, dated November 1, 2016 (the “Merger Agreement”), by and among Kolltan Pharmaceuticals,
Inc., the Company, Connemara Merger Sub 1 Inc., Connemara Merger Sub 2 LLC and SRS, solely in its capacity as the Stockholders Representative.
The Company has determined that the positive topline results from the Company’s Phase 2 clinical trial of barzolvolimab in patients
with moderate to severe CSU satisfies the requirement of “successful completion” such that the Company is obligated to make
the applicable milestone payment under the Settlement Agreement in the amount of $12,500,000, which the Company intends to pay in cash.
On November 5, 2023, the Company also
presented positive data from its Phase 1B study of barzolvolimab in prurigo nodularis. The data demonstrated a meaningful reduction
in itch (≥4-point decrease in Worst Itch-Numerical Rating Scale) and clear or almost clear skin (Investigator Global
Assessment 0/1 of skin lesions) with single dose 3.0 mg/kg barzolvolimab.
The Company also disclosed that data from its Phase
2 study in patients with chronic inducible urticaria who remain symptomatic despite antihistamine therapy is expected in the second half
of 2024.
Forward-Looking Statements
This current report on Form 8-K contains "forward-looking"
statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical
fact are statements that could be forward-looking statements. You can identify these forward-looking statements through the Company’s
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. These forward-looking statements are subject to risks and uncertainties that may cause actual future experience and results to
differ materially from those discussed in these forward-looking statements. Important factors that might cause such a difference include,
but are not limited to, whether results from preclinical studies and early stage clinical trials will be predictive of the results of
later preclinical studies and clinical trials; the timing, cost and uncertainty of obtaining regulatory approvals for product candidates;
changes in the Company’s expected uses of cash and other expenditures, the Company’s ability to develop and commercialize
products before competitors that are superior to the alternatives developed by such competitors; the validity of the Company’s patents
and the Company’s ability to avoid intellectual property litigation, which can be costly and divert management time and attention;
and the other factors listed under “Risk Factors” in the Company’s filings with the Securities and Exchange Commission,
including Forms 10-K, 10-Q and 8-K. The Company does not undertake any obligation to release publicly any revisions to any such forward-looking
statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
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. |
|
|
Dated: November 6, 2023 |
By: |
/s/ Sam Martin |
|
Name: |
Sam Martin |
|
Title: |
Senior Vice President and Chief Financial Officer |
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Nov. 05, 2023 |
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Entity File Number |
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|
Entity Registrant Name |
Celldex
Therapeutics, Inc.
|
Entity Central Index Key |
0000744218
|
Entity Tax Identification Number |
13-3191702
|
Entity Incorporation, State or Country Code |
DE
|
Entity Address, Address Line One |
Perryville III Building, 53 Frontage Road, Suite 220
|
Entity Address, City or Town |
Hampton
|
Entity Address, State or Province |
NJ
|
Entity Address, Postal Zip Code |
08827
|
City Area Code |
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|
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|
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|
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