Indaptus Therapeutics, Inc. (Nasdaq: INDP) ("Indaptus" or the
"Company”), today announces financial results for the first quarter
ended March 31, 2022 and provides a corporate update.
“We are delighted to report the submission of
our Investigational New Drug (IND) application for systemically
administered Decoy20. The timing of this submission keeps us on
track to initiate our first in human clinical trial this year and
we look forward to working with the FDA as we move through the IND
submission process,” said Jeffrey Meckler, Chief Executive Officer
of Indaptus. “Decoy20, with its ability to activate both the innate
and adaptive immune systems as a multiple Toll-like receptor (TLR)
agonist, holds the promise to effectively combat solid tumor
cancers, an area where even many of the new immuno-oncology
approaches have failed.”
“This is a significant milestone for Indaptus as
it advances our approach to induce multiple immune system
components as a mechanism to combat solid tumors. We look forward
to dosing our first patient later this year and to gathering data
in support of Decoy20’s fight against cancer,” continued Mr.
Meckler.
Recent Corporate Highlights
Submission of Investigational New Drug
Application
Today, Indaptus announces the submission of its
Investigational New Drug Application (IND) for Decoy20. The Company
continues to expect to initiate a Phase 1 clinical trial for
Decoy20 targeting solid tumors in 2022. Importantly, the
Company has successfully completed GMP manufacturing and
IND-enabling multi-dose toxicology studies that have not produced
sustained induction of factors associated with cytokine release
syndromes.
Earlier pre-clinical data have demonstrated
Decoy20’s ability to eradicate established tumors in a murine model
of hepatocellular carcinoma in combination with either a
non-steroidal anti-inflammatory drug (NSAID) or an anti-PD-1 agent,
and more efficiently with both. Tumor eradication has occurred with
a wide therapeutic index and has led to induction of 100%
immunological memory. Mechanism of actions studies have
demonstrated activation of innate and adaptive immune pathways and
immunologically cold to hot transition in subcutaneous tumors after
only one intravenous (IV) administration of Decoy product in the
tumor eradicating, combination setting.
In combination with low-dose chemotherapy, Decoy
candidates have also produced highly efficient eradication of
established tumors in a mouse model of non-Hodgkin’s lymphoma
(NHL), also with induction of immunological memory.
Combination-mediated tumor eradication has also been observed with
a human tumor xenograft NHL model with inclusion of a targeted
antibody. Mechanism of action studies have demonstrated involvement
of activation of both innate and adaptive immune pathways in this
anti-tumor activity. Decoy candidates have also produced
significant single agent activity in murine models of both
metastatic pancreatic carcinoma and orthotopic, colorectal
carcinoma.
Financial Highlights for First Quarter
Ended March 31, 2022
Research and development expenses, for the
three-month period ended March 31, 2022, were approximately $1.3
million, an increase of approximately $0.8 million compared with
approximately $0.5 million in the three-month period ended March
31, 2021. The increase was primarily as a result of payroll and
related expenses, stock-based compensation and expenses for the
phase 1 clinical trial preparation and the preparation of the IND
that was recently filed.
General and administrative expenses, for the
three-month period ended March 31, 2022, were approximately $2.1
million, an increase of approximately $2.0 million compared with
approximately $0.1 million in the three-month period ended March
31, 2021. The increase was primarily as a result of payroll and
related expenses, stock-based compensation, directors' and
officers’ insurance expenses and professional fees associated with
being a public company.
Loss per share for the three-month period ended
March 31, 2022, was approximately $0.41 compared with approximately
$0.31 for the three-month period ended March 31, 2021.
As of March 31, 2022, the Company had cash, cash
equivalents and marketable securities of approximately $36.2
million. As of December 31, 2021, the Company had cash and cash
equivalents of approximately $39.1 million.
Net cash used in operating activities was
approximately $3.1 million for the three-month period ended March
31, 2022, compared with net cash used in operating activities of
approximately $0.8 million for the three-month period ended March
31, 2021. This increase resulted primarily from an increase in
general and administrative expenses and effects of the Decoy merger
and changes in operating assets and liabilities.
Net cash used in investing activities was
approximately $2.8 million for the three-month period ended March
31, 2022 which was primarily due to the purchase of marketable
securities during that period. There was no net cash provided by or
used in investing activities in the three months ended March 31,
2021.
There was no net cash provided by financing
activities in the three months ended March 31, 2022.
About Indaptus Therapeutics
Indaptus Therapeutics has evolved from more than
a century of immunotherapy advances. The Company’s approach is
based on the hypothesis that efficient activation of both innate
and adaptive immune cells and associated anti-tumor and anti-viral
immune responses will require a multi-targeted package of immune
system activating signals that can be administered safely
intravenously. Indaptus’ patented technology is composed of single
strains of attenuated and killed, non-pathogenic, Gram-negative
bacteria, with reduced i.v. toxicity, but largely uncompromised
ability to prime or activate many of the cellular components of
innate and adaptive immunity. This approach has led to broad
anti-tumor and anti-viral activity, including safe, durable
anti-tumor response synergy with each of five different classes of
existing agents, including checkpoint therapy, targeted antibody
therapy and low-dose chemotherapy in preclinical models. Tumor
eradication by Indaptus technology has been demonstrated to produce
both innate and adaptive immunological memory and, importantly,
does not require provision of or targeting a specific tumor antigen
in pre-clinical models. Indaptus technology has also produced
significant single agent activity against chronic hepatitis B virus
(HBV) and chronic human immunodeficiency virus (HIV) infections in
pre-clinical models. Indaptus has carried out successful GMP
manufacturing of its lead clinical oncology candidate, Decoy20, and
has completed other IND enabling studies.
Forward-Looking Statements
This press release 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 product development efforts, business, financial condition,
results of operations, strategies, plans and prospects.
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. Forward-looking statements relate to
anticipated or expected events, activities, trends or results as of
the date they are made. 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 plans to develop and potentially commercialize its
technology, the timing and cost of our planned investigational new
drug application and any clinical trials, the completion and
receiving favorable results in any clinical trials, Indaptus'
ability to obtain and maintain regulatory approval of any product
candidate, our ability to protect and maintain its intellectual
property and licensing arrangements, our ability to develop,
manufacture and commercialize its product candidates, the risk of
product liability claims, the availability of reimbursement, the
influence of extensive and costly government regulation, and our
estimates regarding future revenue, expenses capital requirements
and the need for additional financing. More detailed information
about the risks and uncertainties affecting us is contained under
the heading “Risk Factors” included in our most recent Annual
Report on Form 10-K filed with the SEC on March 21, 2022, and in
other filings that we have made and may make with the Securities
and Exchange Commission in the future. All forward-looking
statements speak only as of the date of this press release and are
expressly qualified in their entirety by the cautionary statements
included in this press release. 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.
Investor Contact:Will O'Connor Stern
IR +1 212-362-1200 will@sternir.com
INDAPTUS THERAPEUTICS, INC.
Unaudited Condensed Consolidated Balance
Sheets
|
March 31, 2022 |
|
|
December 31, 2021 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
33,216,311 |
|
|
$ |
39,132,165 |
|
Marketable securities |
|
2,961,460 |
|
|
|
- |
|
Assets held for sale |
|
- |
|
|
|
148,400 |
|
Prepaid expenses and other
current assets |
|
741,945 |
|
|
|
1,106,653 |
|
|
|
|
|
|
|
|
|
Total current assets |
|
36,919,716 |
|
|
|
40,387,218 |
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
Property and equipment,
net |
|
3,266 |
|
|
|
3,800 |
|
Right-of-use asset |
|
147,102 |
|
|
|
169,088 |
|
Other assets |
|
16,477 |
|
|
|
16,477 |
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
166,845 |
|
|
|
189,365 |
|
|
|
|
|
|
|
|
|
Total assets |
$ |
37,086,561 |
|
|
$ |
40,576,583 |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable and other
current liabilities |
$ |
3,582,472 |
|
|
$ |
4,507,676 |
|
Operating lease liability,
current portion |
|
97,185 |
|
|
|
96,465 |
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
3,679,657 |
|
|
|
4,604,141 |
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
Operating lease liability, net
of current portion |
|
50,516 |
|
|
|
72,862 |
|
|
|
|
|
|
|
|
|
Total non-current liabilities |
|
50,516 |
|
|
|
72,862 |
|
|
|
|
|
|
|
|
|
Total liabilities |
|
3,730,173 |
|
|
|
4,677,003 |
|
|
|
|
|
|
|
|
|
Commitments and contingent
liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Common stock: $0.01 par value,
200,000,000 shares authorized as of March 31, 2022 and December 31,
2021; 8,258,597 shares issued and outstanding as of March 31, 2022
and December 31, 2021 |
|
82,586 |
|
|
|
82,586 |
|
Additional paid in
capital |
|
52,319,064 |
|
|
|
51,487,881 |
|
Accumulated deficit |
|
(19,036,041 |
) |
|
|
(15,670,887 |
) |
Accumulated other
comprehensive loss |
|
(9,221 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
33,356,388 |
|
|
|
35,899,580 |
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
$ |
37,086,561 |
|
|
$ |
40,576,583 |
|
|
|
|
|
|
|
|
|
Unaudited Condensed
Consolidated Statements of Operations
|
|
|
|
|
|
Three Months Ended March 31, |
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
$ |
1,297,098 |
|
|
$ |
489,721 |
|
General and administrative |
|
2,104,975 |
|
|
|
124,254 |
|
|
|
|
|
|
|
|
Total operating expenses |
|
3,402,073 |
|
|
|
613,975 |
|
|
|
|
|
|
|
|
Loss from operations |
|
(3,402,073 |
) |
|
|
(613,975 |
) |
|
|
|
|
|
|
|
Other income, net |
|
36,919 |
|
|
|
1,554 |
|
|
|
|
|
|
|
|
Net loss |
$ |
(3,365,154 |
) |
|
$ |
(612,421 |
) |
|
|
|
|
|
|
|
Net loss available to common
stockholders per share of common stock, basic and diluted |
$ |
(0.41 |
) |
|
$ |
(0.31 |
) |
|
|
|
|
|
|
|
Weighted average number of
shares used in calculating net loss per share, basic and
diluted |
|
8,258,597 |
|
|
|
1,944,672 |
|
Net loss |
$ |
(3,365,154 |
) |
|
$ |
(612,421 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
Unrealized loss on available-for-sale securities |
|
(9,221 |
) |
|
|
- |
|
Comprehensive loss |
$ |
(3,374,375 |
) |
|
$ |
(612,421 |
) |
|
|
|
|
|
|
|
|
Unaudited Condensed
Consolidated Statements of Stockholders’ Equity
(Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series Seed Preferred |
|
|
Common stock |
|
|
Additional paid in |
|
|
Accumulated |
|
|
Accumulated Other Comprehensive |
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
capital |
|
|
deficit |
|
|
Loss |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, January 1, 2021 |
|
835,928 |
|
|
$ |
8,359 |
|
|
|
1,944,672 |
|
|
$ |
19,447 |
|
|
$ |
7,693,994 |
|
|
$ |
(7,959,501 |
) |
|
$ |
- |
|
|
$ |
(237,701 |
) |
Stock-based compensation |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
20,445 |
|
|
|
- |
|
|
|
- |
|
|
|
20,445 |
|
Net loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(612,421 |
) |
|
|
|
|
|
|
(612,421 |
) |
Balance, March 31, 2021 |
|
835,928 |
|
|
|
8,359 |
|
|
|
1,944,672 |
|
|
|
19,447 |
|
|
|
7,714,439 |
|
|
|
(8,571,922 |
) |
|
|
- |
|
|
|
(829,677 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, January 1, 2022 |
|
- |
|
|
|
- |
|
|
|
8,258,597 |
|
|
$ |
82,586 |
|
|
$ |
51,487,881 |
|
|
$ |
(15,670,887 |
) |
|
|
- |
|
|
$ |
35,899,580 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
831,183 |
|
|
|
- |
|
|
|
- |
|
|
|
831,183 |
|
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,221 |
) |
|
|
(9,221 |
) |
Net loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(3,365,154 |
) |
|
|
- |
|
|
|
(3,365,154 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31, 2022 |
|
- |
|
|
$ |
- |
|
|
|
8,258,597 |
|
|
$ |
82,586 |
|
|
$ |
52,319,064 |
|
|
$ |
(19,036,041 |
) |
|
$ |
(9,221 |
) |
|
$ |
33,356,388 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unaudited Condensed
Consolidated Statements of Cash Flows
|
|
|
|
|
|
|
For the three months ended |
|
|
March 31, |
|
|
2022 |
|
|
2021 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
Net loss |
$ |
(3,365,154 |
) |
|
$ |
(612,421 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
Depreciation |
|
534 |
|
|
|
213 |
|
Stock-based compensation |
|
831,183 |
|
|
|
20,445 |
|
Realized gain on assets held for sale |
|
(24,155 |
) |
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
364,708 |
|
|
|
(109,883 |
) |
Accounts payable and other current liabilities |
|
(925,204 |
) |
|
|
481,050 |
|
Deferred transaction costs |
|
- |
|
|
|
(604,988 |
) |
Operating lease right-of-use asset and liability, net |
|
360 |
|
|
|
- |
|
Net cash used in operating activities |
|
(3,117,728 |
) |
|
|
(825,584 |
) |
|
|
|
|
|
|
|
|
Cash flows from investing
activities: |
|
|
|
|
|
|
|
Proceeds received for assets held for sale |
|
172,555 |
|
|
|
- |
|
Purchase of marketable securities |
|
(2,970,681 |
) |
|
|
- |
|
Net cash used in investing activities |
|
(2,798,126 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
Cash flows from financing
activities: |
|
|
|
|
|
|
|
Proceeds from SAFEs, net |
|
- |
|
|
|
3,675,000 |
|
Net cash provided by financing activities |
|
- |
|
|
|
3,675,000 |
|
|
|
|
|
|
|
|
|
Net (decrease) increase in
cash and cash equivalents |
|
(5,915,854 |
) |
|
|
2,849,416 |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
beginning of period |
|
39,132,165 |
|
|
|
1,637,499 |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
end of period |
$ |
33,216,311 |
|
|
$ |
4,486,915 |
|
|
|
|
|
|
|
|
|
Supplemental cash flow
disclosures |
|
|
|
|
|
|
|
Cash paid for income taxes |
$ |
- |
|
|
$ |
800 |
|
Cash received for interest earned on deposits |
$ |
1,318 |
|
|
$ |
506 |
|
|
|
|
|
|
|
|
|
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