Current Report Filing (8-k)
May 19 2022 - 7:52AM
Edgar (US Regulatory)
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2022-05-19
2022-05-19
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 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)
May
19, 2022
INDAPTUS
THERAPEUTICS, INC.
(formerly
Intec Parent, Inc.)
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-40652 |
|
86-3158720 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
3
Columbus Circle
15th
Floor |
|
|
New
York |
|
10019 |
(Address of principal executive
offices) |
|
(Zip Code) |
(347)
480 - 9760
(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 (see General Instruction A.2. below):
☐ |
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 |
|
Name
of each exchange on which registered |
Common Stock, $0.01 par
value |
|
INDP |
|
Nasdaq Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in 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
7.01 Results of Operation and Financial Condition.
On
May 19, 2022, Indaptus Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration
(“FDA”) has cleared the Company’s Investigational New Drug (“IND”) application to initiate a Phase 1 clinical
trial of Decoy20 in patients with advanced solid tumors where currently approved therapies have failed. The press release is attached
hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein in its entirety.
The
information included in this Item 7.01 of Current Report on Form 8-K, including the attached Exhibit 99.1, 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, and shall not be deemed to be incorporated by reference in any filing under the Securities Act of
1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report, regardless of any general incorporation
language in any such filing, except as expressly set forth by specific reference in such filing.
Item
8.01 Other Events
On
May 19, 2022, the Company issued a press release announcing that the FDA has cleared the Company’s IND application to initiate
a Phase 1 clinical trial of Decoy20 in patients with advanced solid tumors where currently approved therapies have failed. The Company
plans to initiate the clinical trial in the second half of 2022.
The
Phase 1 study is designed to evaluate the safety, tolerability, and preliminary efficacy of Decoy 20 and will follow a 3+3 design of
dose-escalation cohorts. The study protocol allows for exploration of additional dosing regimens, including continuous weekly administration
after initial safety has been established.
Item
9.01. Financial Statement and Exhibits.
(d)
Exhibits.
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 hereunto duly authorized.
Date:
May 19, 2022
|
INDAPTUS THERAPEUTICS, INC. |
|
|
|
By: |
/s/
Nir Sassi |
|
|
Nir Sassi |
|
|
Chief Financial Officer |
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