Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the
“Company”), today announces financial results for the third quarter
ended September 30, 2022 and provides a corporate update.
“We continue to diligently prepare for the
launch of our Phase 1 trial of Decoy20 for the treatment of solid
tumors, while carefully managing our expenses,” said Jeffrey
Meckler, chief executive officer of Indaptus. “Once we have
finalized the initiation process with our trial sites we will be
prepared to speak more openly about progress, including trial
locations and first patient dosed, and we remain on track to
initiate the trial in Q4 2022.”
Phase 1 trial for the treatment of solid
tumors
In May, Indaptus announced that the U.S. Food
and Drug Administration cleared the Company’s Investigational New
Drug 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.
Financial Highlights for
Third Quarter Ended
September 30, 2022
Research and development expenses, for the
three-month period ended September 30, 2022, were approximately
$1.6 million, an increase of approximately $900,000 compared with
approximately $700,000 in the three-month period ended September
30, 2021. Research and development expenses for the nine-month
period ended September 30, 2022, were approximately $4.4 million,
an increase of approximately $2.8 million compared with
approximately $1.6 million in the nine-month period ended September
30, 2021. The increase for the three and nine-month periods was
primarily due to payroll and related expenses including stock-based
compensation, and for the preparation of our Phase 1 clinical trial
and costs associated with the manufacturing processes of our lead
clinical candidate.
General and administrative expenses, for the
three-month period ended September 30, 2022, were approximately
$2.0 million, a decrease of approximately $700,000 compared with
approximately $2.7 million in the three-month period ended
September 30, 2021. The decrease was primarily due to payroll and
stock-based compensation, and to professional fees that were
associated with the merger in 2021. This decrease was offset by
various expenses associated with being a public company. General
and administrative expenses for the nine-month period ended
September 30, 2022, were approximately $6.4 million, an increase of
approximately $3.5 million compared with approximately $2.9 million
in the nine-month period ended September 30, 2021. The increase was
primarily due to payroll and related expenses, including
stock-based compensation, resulting from increased headcount of our
executive team 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
September 30, 2022, was approximately $0.42 compared with
approximately $0.81 for the three-month period ended September 30,
2021. Loss per share for the nine-month period ended September 30,
2022, was approximately $1.29 compared with approximately $1.67
loss per share for the nine-month period ended September 30,
2021.
As of September 30, 2022, the Company had cash,
cash equivalents and marketable securities of approximately $28.5
million. As of December 31, 2021, the Company had cash and cash
equivalents of approximately $39.1 million. The Company expects
that its current cash, cash equivalents and marketable securities
will support its ongoing operating activities into the second
quarter of 2024. This cash runaway guidance is based on the
Company’s current operational plans and excludes any additional
funding and any business development activities that may be
undertaken. Indaptus continues to assess all financing options that
support its corporate strategy.
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 Relations
Contact:CORE IRScott Birkbyir@indaptusrx.com
Media Contact:CORE IRJules
Abrahamjulesa@coreir.com917-885-7378
INDAPTUS THERAPEUTICS, INC.
Unaudited Condensed Consolidated Balance
Sheets
|
September 30, 2022 |
|
|
December 31, 2021 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
6,718,213 |
|
|
$ |
39,132,165 |
|
Marketable securities |
|
21,742,040 |
|
|
|
- |
|
Assets held for sale |
|
- |
|
|
|
148,400 |
|
Prepaid expenses and other
current assets |
|
1,133,392 |
|
|
|
1,106,653 |
|
|
|
|
|
|
|
|
|
Total current assets |
|
29,593,645 |
|
|
|
40,387,218 |
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
Property and equipment,
net |
|
2,340 |
|
|
|
3,800 |
|
Right-of-use asset |
|
102,254 |
|
|
|
169,088 |
|
Other assets |
|
754,728 |
|
|
|
16,477 |
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
859,322 |
|
|
|
189,365 |
|
|
|
|
|
|
|
|
|
Total assets |
$ |
30,452,967 |
|
|
$ |
40,576,583 |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable and other
current liabilities |
$ |
2,782,084 |
|
|
$ |
4,507,676 |
|
Operating lease liability,
current portion |
|
98,625 |
|
|
|
96,465 |
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
2,880,709 |
|
|
|
4,604,141 |
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
Operating lease liability, net
of current portion |
|
4,949 |
|
|
|
72,862 |
|
|
|
|
|
|
|
|
|
Total non-current liabilities |
|
4,949 |
|
|
|
72,862 |
|
|
|
|
|
|
|
|
|
Total liabilities |
|
2,885,658 |
|
|
|
4,677,003 |
|
|
|
|
|
|
|
|
|
Commitments and contingent
liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Common stock: $0.01 par value,
200,000,000 shares authorized as of September 30, 2022 and December
31, 2021; 8,258,597 shares issued and outstanding as of September
30, 2022 and December 31, 2021 |
|
82,586 |
|
|
|
82,586 |
|
Additional paid in
capital |
|
53,807,500 |
|
|
|
51,487,881 |
|
Accumulated deficit |
|
(26,337,908 |
) |
|
|
(15,670,887 |
) |
Accumulated other
comprehensive income |
|
15,131 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
27,567,309 |
|
|
|
35,899,580 |
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
$ |
30,452,967 |
|
|
$ |
40,576,583 |
|
Unaudited Condensed
Consolidated Statements of Operations and Comprehensive
Loss
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
1,609,554 |
|
|
$ |
697,674 |
|
|
$ |
4,412,817 |
|
|
$ |
1,578,512 |
|
General and administrative |
|
1,942,995 |
|
|
|
2,670,317 |
|
|
|
6,411,066 |
|
|
|
2,932,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
3,552,549 |
|
|
|
3,367,991 |
|
|
|
10,823,883 |
|
|
|
4,510,612 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(3,552,549 |
) |
|
|
(3,367,991 |
) |
|
|
(10,823,883 |
) |
|
|
(4,510,612 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
86,184 |
|
|
|
827 |
|
|
|
156,862 |
|
|
|
15,548 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(3,466,365 |
) |
|
$ |
(3,367,164 |
) |
|
$ |
(10,667,021 |
) |
|
$ |
(4,495,064 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common
stockholders per share of common stock, basic and diluted |
$ |
(0.42 |
) |
|
$ |
(0.81 |
) |
|
$ |
(1.29 |
) |
|
$ |
(1.67 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares used in calculating net loss per share, basic and
diluted |
|
8,258,597 |
|
|
|
4,180,744 |
|
|
|
8,258,597 |
|
|
|
2,692,770 |
|
Net loss |
$ |
(3,466,365 |
) |
|
$ |
(3,367,164 |
) |
|
$ |
(10,667,021 |
) |
|
$ |
(4,495,064 |
) |
Other comprehensive
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification adjustment for realized gain on available for sale
securities included in net loss |
|
(7,836 |
) |
|
|
|
|
|
|
(7,836 |
) |
|
|
|
|
Unrealized gain on available-for-sale securities |
|
49,904 |
|
|
|
- |
|
|
|
22,967 |
|
|
|
- |
|
Comprehensive loss |
$ |
(3,424,297 |
) |
|
$ |
(3,367,164 |
) |
|
$ |
(10,651,890 |
) |
|
$ |
(4,495,064 |
) |
Unaudited Condensed
Consolidated Statements of Cash Flows
|
|
|
|
|
|
|
For the nine months ended |
|
|
September 30, |
|
|
2022 |
|
|
2021 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
Net loss |
$ |
(10,667,021 |
) |
|
$ |
(4,495,064 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
Depreciation |
|
1,460 |
|
|
|
868 |
|
Stock-based compensation |
|
2,319,619 |
|
|
|
836,456 |
|
Realized gain on assets held for sale |
|
(24,155 |
) |
|
|
- |
|
Realized gain on marketable securities |
|
(7,836 |
) |
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
(26,739 |
) |
|
|
(1,128,933 |
) |
Accounts payable and other current liabilities |
|
(1,725,592 |
) |
|
|
(2,964,147 |
) |
Other assets |
|
(738,251 |
) |
|
|
- |
|
Operating lease right-of-use asset and liability, net |
|
1,081 |
|
|
|
- |
|
Net cash used in operating activities |
|
(10,867,434 |
) |
|
|
(7,750,820 |
) |
|
|
|
|
|
|
|
|
Cash flows from investing
activities: |
|
|
|
|
|
|
|
Proceeds received for assets held for sale |
|
172,555 |
|
|
|
- |
|
Purchases of property and equipment |
|
- |
|
|
|
(3,854 |
) |
Purchase of marketable securities |
|
(23,719,073 |
) |
|
|
- |
|
Maturity of short-term investments |
|
2,000,000 |
|
|
|
- |
|
Net cash used in investing activities |
|
(21,546,518 |
) |
|
|
(3,854 |
) |
|
|
|
|
|
|
|
|
Cash flows from financing
activities: |
|
|
|
|
|
|
|
Proceeds from merger |
|
- |
|
|
|
16,346,622 |
|
Decoy’s transaction costs |
|
- |
|
|
|
(665,627 |
) |
Issuance of pre-funded warrants and warrants |
|
- |
|
|
|
29,972,727 |
|
Issuance costs of Private Placement |
|
- |
|
|
|
(2,706,598 |
) |
Exercise of pre-funded warrants |
|
- |
|
|
|
27,273 |
|
Proceeds from SAFEs, net |
|
- |
|
|
|
5,000,000 |
|
Net cash provided by financing activities |
|
- |
|
|
|
47,974,397 |
|
|
|
|
|
|
|
|
|
Net (decrease) increase in
cash and cash equivalents |
|
(32,413,952 |
) |
|
|
40,219,723 |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
beginning of period |
|
39,132,165 |
|
|
|
1,637,499 |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
end of period |
$ |
6,718,213 |
|
|
$ |
41,857,222 |
|
|
|
|
|
|
|
|
|
Noncash investing and
financing activities |
|
|
|
|
|
|
|
Conversion of preferred stock |
$ |
- |
|
|
$ |
8,359 |
|
Conversion of SAFEs |
$ |
- |
|
|
$ |
6,417,129 |
|
Liabilities assumed, net of non-cash assets received in reverse
merger |
$ |
- |
|
|
$ |
7,616,175 |
|
Release of deposit upon closing of merger |
$ |
- |
|
|
$ |
200,000 |
|
|
|
|
|
|
|
|
|
Supplemental cash flow
disclosures |
|
|
|
|
|
|
|
Cash paid for income taxes |
$ |
2,400 |
|
|
$ |
800 |
|
Cash received for interest earned on deposits |
$ |
70,353 |
|
|
$ |
2,362 |
|
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