Indaptus Therapeutics, Inc. (Nasdaq: INDP) ("Indaptus" or the
"Company”), today announces financial results for the second
quarter ended June 30, 2022 and provides a corporate update.
“We made substantial progress throughout the
second quarter, highlighted by the FDA clearance of our IND
application for systemically administered Decoy20. This important
regulatory milestone keeps us on track to initiate our first in
human clinical trial this year,” said Jeffrey Meckler, Chief
Executive Officer of Indaptus. “Despite advances in the
immuno-oncology field, there still remains a great unmet need in
the treatment of solid tumor cancers. We believe Decoy20 has
the potential to effectively tackle these hard-to-treat tumors with
its ability to activate both the innate and adaptive immune
systems.”
Recent Corporate Highlights
Investigational New Drug Application
Clearance
In May, Indaptus announced that the FDA cleared
the Company’s IND application for a Phase 1, open-label dose
escalation and expansion, clinical trial in patients with advanced
solid tumors where currently approved therapies have failed. The
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. Decoy20
has the potential to treat a wide range of solid tumors including
hepatocellular, colorectal and pancreatic carcinomas.
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. Decoy20 has also produced significant single
agent activity in murine models of both metastatic pancreatic
carcinoma and orthotopic, colorectal carcinoma.
Financial Highlights for Second Quarter
Ended June 30, 2022
Research and development expenses, for the
three-month period ended June 30, 2022, were approximately $1.5
million, an increase of approximately $1.1 million compared with
approximately $390,000 in the three-month period ended June 30,
2021. Research and development expenses for the six-month period
ended June 30, 2022, were approximately $2.8 million, an increase
of approximately $1.9 million compared with approximately $900,000
in the six-month period ended June 30, 2021. The increase for the
three and six-month periods was primarily due to payroll and
related expenses including stock-based compensation, and the
preparation of the Phase 1 clinical trial and IND submission.
General and administrative expenses, for the
three-month period ended June 30, 2022, were approximately $2.4
million, an increase of approximately $2.2 million compared with
approximately $138,000 in the three-month period ended June 30,
2021. General and administrative expenses for the six-month period
ended June 30, 2022, were approximately $4.5 million, an increase
of approximately $4.2 million compared with approximately $260,000
in the six-month period ended June 30, 2021. The increase for the
three and six-month periods was primarily due to payroll and
related expenses, including stock-based compensation, resulting
from increased headcount of our executive team following the Merger
and increase in directors’ and officers’ insurance policy,
professional fees and other expenses associated with being a public
company following the Merger.
Loss per share for the three-month period ended
June 30, 2022, was approximately $0.46 compared with approximately
$0.27 for the three-month period ended June 30, 2021. Loss per
share for the six-month period ended June 30, 2022, was
approximately $0.87 compared with approximately $0.58 for the
six-month period ended June 30, 2021.
As of June 30, 2022, the Company had cash, cash
equivalents and short-term investments of approximately $33.0
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 $6.3 million for the six-month period ended June 30,
2022, compared with net cash used in operating activities of
approximately $2.1 million for the six-month period ended June 30,
2021. This increase resulted primarily from an increase in our
research and development expenses and general and administrative
expenses.
Net cash used in investing activities was
approximately $18.6 million for the six-month period ended June 30,
2022 which was primarily due to the purchase of marketable
securities investments during that period. There was an immaterial
amount in net cash used in investing activities in the six months
ended June 30, 2021.
There was no net cash provided by financing
activities in the six months ended June 30, 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. Decoy20 represents an
antigen-agnostic technology that has produced significant single
agent activity against metastatic pancreatic and orthotopic
colorectal carcinomas, single agent eradication of established,
antigen-expressing breast carcinoma, as well as
combination-mediated eradication of established hepatocellular
carcinomas and non-Hodgkin’s lymphomas in standard pre-clinical
models, including syngeneic mouse tumors and human tumor
xenografts. Tumor eradication has been observed with Decoy products
in combination with anti-PD-1 checkpoint therapy, low-dose
chemotherapy or an approved targeted antibody. Combination-based
tumor eradication produces innate and adaptive immunological
memory, involves activation of both innate and adaptive immune
cells and is associated with induction of innate and adaptive
immune pathways in tumors after only one i.v. dose of Decoy
product, with associated “cold” to “hot” tumor inflammation
signature transition. IND-enabling toxicology studies have
demonstrated safe i.v. administration, with no sustained induction
of hallmarks of cytokine release syndromes, possibly due to passive
targeting to liver, spleen and tumor, followed by rapid elimination
of the product. Indaptus products have also produced significant
single agent activity against chronic hepatitis B virus (HBV) and
chronic human immunodeficiency virus (HIV) infections in
pre-clinical models.
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
|
|
June 30,2022 |
|
|
December 31,2021 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
14,258,812 |
|
|
$ |
39,132,165 |
|
Marketable securities |
|
|
18,753,081 |
|
|
|
- |
|
Assets held for sale |
|
|
- |
|
|
|
148,400 |
|
Prepaid expenses and other
current assets |
|
|
260,884 |
|
|
|
1,106,653 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
33,272,777 |
|
|
|
40,387,218 |
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
2,732 |
|
|
|
3,800 |
|
Right-of-use asset |
|
|
124,853 |
|
|
|
169,088 |
|
Other assets |
|
|
659,049 |
|
|
|
16,477 |
|
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
|
786,634 |
|
|
|
189,365 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
34,059,411 |
|
|
$ |
40,576,583 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and other
current liabilities |
|
$ |
3,526,034 |
|
|
$ |
4,507,676 |
|
Operating lease liability,
current portion |
|
|
97,905 |
|
|
|
96,465 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
3,623,939 |
|
|
|
4,604,141 |
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Operating lease liability, net
of current portion |
|
|
27,907 |
|
|
|
72,862 |
|
|
|
|
|
|
|
|
|
|
Total non-current liabilities |
|
|
27,907 |
|
|
|
72,862 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
3,651,846 |
|
|
|
4,677,003 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingent
liabilities (Note 8) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock: $0.01 par value,
200,000,000 shares authorized as of June 30, 2022 and December 31,
2021; 8,258,597 shares issued and outstanding as of June 30, 2022
and December 31, 2021 |
|
|
82,586 |
|
|
|
82,586 |
|
Additional paid in
capital |
|
|
53,223,459 |
|
|
|
51,487,881 |
|
Accumulated deficit |
|
|
(22,871,543 |
) |
|
|
(15,670,887 |
) |
Accumulated other
comprehensive loss |
|
|
(26,937 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
|
30,407,565 |
|
|
|
35,899,580 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
34,059,411 |
|
|
$ |
40,576,583 |
|
Unaudited Condensed
Consolidated Statements of Operations and Other
Comprehensive Loss
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,506,165 |
|
|
$ |
391,118 |
|
|
$ |
2,803,263 |
|
|
$ |
880,839 |
|
General and administrative |
|
|
2,363,095 |
|
|
|
137,527 |
|
|
|
4,468,070 |
|
|
|
261,782 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
3,869,260 |
|
|
|
528,645 |
|
|
|
7,271,333 |
|
|
|
1,142,621 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(3,869,260 |
) |
|
|
(528,645 |
) |
|
|
(7,271,333 |
) |
|
|
(1,142,621 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
33,758 |
|
|
|
13,166 |
|
|
|
70,677 |
|
|
|
14,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,835,502 |
) |
|
$ |
(515,479 |
) |
|
$ |
(7,200,656 |
) |
|
$ |
(1,127,900 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common
stockholders per share of common stock, basic and diluted |
|
$ |
(0.46 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.87 |
) |
|
$ |
(0.58 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares used in calculating net loss per share, basic and
diluted |
|
|
8,258,597 |
|
|
|
1,944,672 |
|
|
|
8,258,597 |
|
|
|
1,944,672 |
|
Net loss |
|
$ |
(3,835,502 |
) |
|
$ |
(515,479 |
) |
|
$ |
(7,200,656 |
) |
|
$ |
(1,127,900 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on available-for-sale securities |
|
|
(17,716 |
) |
|
|
- |
|
|
|
(26,937 |
) |
|
|
- |
|
Comprehensive loss |
|
$ |
(3,853,218 |
) |
|
$ |
(515,479 |
) |
|
$ |
(7,227,593 |
) |
|
$ |
(1,127,900 |
) |
Unaudited Condensed
Consolidated Statements of Cash Flows
|
|
For the six months ended |
|
|
|
June 30, |
|
|
|
2022 |
|
|
2021 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(7,200,656 |
) |
|
$ |
(1,127,900 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
1,068 |
|
|
|
426 |
|
Stock-based compensation |
|
|
1,735,578 |
|
|
|
41,118 |
|
Realized gain on assets held for sale |
|
|
(24,155 |
) |
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
845,769 |
|
|
|
(31,355 |
) |
Accounts payable and other current liabilities |
|
|
(981,642 |
) |
|
|
(169,219 |
) |
Deferred transaction costs |
|
|
- |
|
|
|
(873,836 |
) |
Other assets |
|
|
(642,572 |
) |
|
|
40,445 |
|
Operating lease right-of-use asset and liability, net |
|
|
720 |
|
|
|
- |
|
Net cash used in operating activities |
|
|
(6,265,890 |
) |
|
|
(2,120,321 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from investing
activities: |
|
|
|
|
|
|
|
|
Proceeds received for assets held for sale |
|
|
172,555 |
|
|
|
- |
|
Purchases of property and equipment |
|
|
- |
|
|
|
(2,200 |
) |
Purchase of marketable securities |
|
|
(18,780,018 |
) |
|
|
- |
|
Net cash used in investing activities |
|
|
(18,607,463 |
) |
|
|
(2,200 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from financing
activities: |
|
|
|
|
|
|
|
|
Advances received from potential merger counterparty |
|
|
- |
|
|
|
450,000 |
|
Proceeds from SAFEs, net |
|
|
- |
|
|
|
5,000,000 |
|
Net cash provided by financing activities |
|
|
- |
|
|
|
5,450,000 |
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in
cash and cash equivalents |
|
|
(24,873,353 |
) |
|
|
3,327,479 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
beginning of period |
|
|
39,132,165 |
|
|
|
1,637,499 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
end of period |
|
$ |
14,258,812 |
|
|
$ |
4,964,978 |
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow
disclosures |
|
|
|
|
|
|
|
|
Cash paid for income taxes |
|
$ |
2,400 |
|
|
$ |
800 |
|
Cash received for interest earned on deposits |
|
$ |
- |
|
|
$ |
2,362 |
|
Indaptus Therapeutics (NASDAQ:INDP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Indaptus Therapeutics (NASDAQ:INDP)
Historical Stock Chart
From Jul 2023 to Jul 2024