Form 8-K - Current report
10 August 2023 - 10:45PM
Edgar (US Regulatory)
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2023-08-10
2023-08-10
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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) August 10,
2023
INDAPTUS
THERAPEUTICS, 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, New York |
|
10019 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(646)
427-2727
(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 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
8.01. Other Events.
On
August 10, 2023, Indaptus Therapeutics, Inc. (the “Company”) announced completion of the first cohort of patients who received
a single dose in Part 1 of its INDP-D101 trial of Decoy20 and the initiation of a new cohort following review of data by the Safety Review
Committee as prescribed by the clinical trial protocol.
As
of August 10, 2023, three of the patients in the first cohort have completed the 28-day safety review period with two of the patients
having also completed post-study tumor re-staging. One clinically relevant dose limiting toxicity of grade 3 bradycardia occurred and
was reversible in under 30 minutes following a bolus of normal saline; grade 3 malaise in the same patient resolved overnight. Two patients
experienced a grade 3 AST increase which resolved within 1 day. Other Adverse Events including chills, fatigue, vomiting, and fever were
of grade 1-2 severity and resolved quickly. Evidence of immune activation was observed, based on transient expression of multiple plasma
cytokines and chemokines associated with activation of innate and adaptive immune pathways, including several not expected with lipopolysaccharide
exposure.
Forward-Looking
Statements
This
Current Report on Form 8-K (the “Form 8-K”) contains forward-looking statements with the meaning of the Private Securities
Litigation Reform Act. These include statements regarding management’s expectations, beliefs and intentions regarding, among other
things: our expectations and plans regarding the timing and design of Phase 1 clinical trial of Decoy20, including the timing of the
enrollment of the second cohort of patients and the anticipated effects of our product candidates, including Decoy20. Forward-looking
statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”,
“plan”, “may”, “should”, “could”, “might”, “seek”, “target”,
“will”, “project”, “forecast”, “continue” or “anticipate” or their negatives
or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters.
Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and
uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking
statements. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in
forward-looking statements, including, but not limited to the following: our limited operating history; conditions and events that raise
substantial doubt regarding our ability to continue as going concern; the need for, and our ability to raise, additional capital given
our lack of current cash flow; our clinical and preclinical development, which involves a lengthy and expensive process with an uncertain
outcome; our incurrence of significant research and development expenses and other operating expenses, which may make it difficult for
us to attain profitability; our pursuit of a limited number of research programs, product candidates and specific indications and failure
to capitalize on product candidates or indications that may be more profitable or have a greater likelihood of success; our ability to
obtain and maintain regulatory approval of any product candidate; the market acceptance of our product candidates; our reliance on third
parties to conduct our preclinical studies and clinical trials and perform other tasks; our reliance on third parties for the manufacture
of our product candidates during clinical development; our ability to successfully commercialize Decoy20 or any future product candidates;
our ability to obtain or maintain coverage and adequate reimbursement for our products; the impact of legislation and healthcare reform
measures on our ability to obtain marketing approval for and commercialize Decoy20 and any future product candidates; product candidates
of our competitors that may be approved faster, marketed more effectively, and better tolerated than our product candidates; our ability
to adequately protect our proprietary or licensed technology in the marketplace; the impact of, and costs of complying with healthcare
laws and regulations, and our failure to comply with such laws and regulations; information technology system failures, cyberattacks
or deficiencies in our cybersecurity; and unfavorable global economic conditions. These and other important factors discussed under the
caption “Risk Factors” included in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 filed with the
SEC on May 11, 2023, our most recent Annual Report on Form 10-K filed with the SEC on March 17, 2023, and our other filings with the
SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this Form 8-K. All
forward-looking statements speak only as of the date of this Form 8-K and are expressly qualified in their entirety by the cautionary
statements included in this Form 8-K. We undertake no obligation to update or revise forward-looking statements to reflect events or
circumstances that arise after the date made or to reflect the occurrence of unanticipated events, except as required by applicable law.
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:
August 10, 2023
|
INDAPTUS
THERAPEUTICS, INC. |
|
|
|
|
By: |
/s/
Nir Sassi |
|
Name:
|
Nir
Sassi |
|
Title: |
Chief
Financial Officer |
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