Indaptus Therapeutics, Inc. (Nasdaq: INDP) ("Indaptus" or the
"Company”), today announces financial results for the third quarter
ended September 30, 2021 and provides a corporate update.
“The third quarter was transformative for
Indaptus as we successfully closed the merger with Decoy
Biosystems, Inc. ("Decoy") and completed a $30 million private
placement to support our exciting new clinical programs,” said
Jeffrey Meckler, Chief Executive Officer of Indaptus. “We are
executing to our strategy of advancing Decoy20 as a potential new
treatment modality for a variety of cancer indications with unmet
medical need. Our goal to enter the clinic with Decoy20 in 2022
remains on track, however, we now plan to file the IND next year as
we are in the process of recruiting a Chief Medical Officer to lead
our clinical trials. We believe we have a unique opportunity to
shape the course of cancer treatment by activating both the innate
and adaptive immune systems with our therapeutics and look forward
to making our vision a reality.”
Recent Corporate Highlights
Received Notice of Allowance for
Strategic Patent in Virology
In September, Indaptus announced that the United
States Patent and Trademark Office issued a notice of allowance for
claims related to the Company’s platform technology in the field of
virology. The patent, titled, “Methods of Treatment of Infections
Using Bacteria,” (Application No.16/584,644) provides broad
protection for the application of the Company’s platform technology
alone and in combination with standards of care for the treatment
and inhibition of hepatitis B virus (HBV) and human
immunodeficiency virus (HIV) infections.
Closed Merger with Decoy Biosystems and
Completed $30 Million Private Placement
In August, Indaptus closed its previously
announced merger with Decoy and the completion of a $30 million
private placement. In addition, the Company announced a corporate
name change to Indaptus Therapeutics, as it better reflects the
Company's therapeutic focus.
Financial Highlights for Third Quarter
Ended September 30, 2021
Research and development expenses, for the
three-month period ended September 30, 2021, were approximately
$0.7 million, a decrease of approximately $0.7 million, or
approximately 48%, compared with approximately $1.4 million in the
three-month period ended September 30, 2020. Research and
development expenses for the nine-month period ended September 30,
2021, were approximately $1.6 million, a decrease of approximately
$0.7 million, or approximately 31%, compared with approximately
$2.3 million in the nine-month period ended September 30, 2020. The
decrease for the three and nine-month periods was primarily due to
the manufacturing and characterization of Decoy20 during the three
and nine months ended September 30, 2020.
General and administrative expenses for the
three-month period ended September 30, 2021, were approximately
$2.7 million, an increase of approximately $2.5 million, or
approximately 1,260%, compared with approximately $0.2 million in
the three-month period ended September 30, 2020. General and
administrative expenses for the nine-month period ended September
30, 2021, amounted to approximately $2.9 million, an increase of
approximately $2.4 million, or approximately 456%, compared to
approximately $0.5 million for the nine-month period ended
September 30, 2020. The increase for the three and nine-month
periods was primarily related to the payroll and related expenses,
stock-based compensation expense for stock options issued in August
2021 and professional fees associated with being a public company
following the merger.
Loss per share for the three-month period ended
September 30, 2021, was approximately $0.81 compared with
approximately $0.79 for the three-month period ended September 30,
2020. Loss per share for the nine-month period ended September 30,
2021, was approximately $1.67 compared with approximately $1.45 for
the nine-month period ended September 30, 2020.
As of September 30, 2021, the Company had cash
and cash equivalents of approximately $41.9 million. As of December
31, 2020, the Company had cash and cash equivalents of
approximately $1.6 million.
Net cash used in operating activities was
approximately $7.8 million for the nine-month period ended
September 30, 2021, compared with net cash used in operating
activities of approximately $2.4 million for the nine-month period
ended September 30, 2020. This increase resulted primarily from an
increase in general and administrative expenses and effects of the
merger and changes in operating assets and liabilities.
Net cash provided by financing activities for
the nine-month period ended September 30, 2021, was approximately
$48.0 million, which was provided by the proceeds from the
Company's private placement offering in August 2021 that resulted
in net proceeds of approximately $27.3 million, net proceeds from
the merger in the amount of approximately $15.7 million and the
sale of additional Simple Agreements for Future Equity (SAFEs) in
the amount of approximately $5.0 million. Net cash provided by
financing activities for the nine-month period ended September 30,
2020, was approximately $1.2 million, which was provided by the
sale of SAFEs.
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 demonstrated activation of
both innate and adaptive immunological memory and, importantly,
does not require provision of or targeting a tumor antigen in
pre-clinical models. Indaptus has carried out successful GMP
manufacturing of its lead clinical oncology candidate, Decoy20, and
is currently completing 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: Indaptus' plans to develop and potentially commercialize
its technology, the timing and cost of Indaptus' 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, Indaptus' ability to protect and maintain its
intellectual property and licensing arrangements, Indaptus' 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 Indaptus' estimates regarding future revenue,
expenses capital requirements and the need for additional financing
following the merger. These risks, as well as other risks are
discussed in the proxy statement/prospectus that was included in
the registration statement on Form S-4 filed with the SEC in
connection with the merger. 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
|
|
September 30, 2021 |
|
|
December 31, 2020 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
41,857,222 |
|
|
$ |
1,637,499 |
|
Assets held for sale |
|
|
600,000 |
|
|
|
- |
|
Prepaid expenses and other
current assets |
|
|
1,397,669 |
|
|
|
94,500 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
43,854,891 |
|
|
|
1,731,999 |
|
|
|
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
4,335 |
|
|
|
1,349 |
|
Other assets |
|
|
- |
|
|
|
44,445 |
|
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
|
4,335 |
|
|
|
45,794 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
43,859,226 |
|
|
$ |
1,777,793 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable and other
current liabilities |
|
$ |
5,780,184 |
|
|
$ |
598,365 |
|
SAFE agreements |
|
|
- |
|
|
|
1,417,129 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
5,780,184 |
|
|
|
2,015,494 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingent
liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity
(deficit) |
|
|
|
|
|
|
|
|
Preferred stock; Series Seed;
$0.01 par value; 5,000,000 and 972,335 shares authorized as of
September 30, 2021 and December 31, 2020, respectively, 0 and
835,928 shares issued and outstanding as of September 30, 2021 and
December 31, 2020, respectively |
|
|
- |
|
|
|
8,359 |
|
Common stock; $0.01 par value,
200,000,000 and 3,185,224 shares authorized as of September 30,
2021 and December 31, 2020, respectively; 8,133,243 and 1,944,672
shares issued and outstanding as of September 30, 2021 and December
31, 2020, respectively |
|
|
81,332 |
|
|
|
19,447 |
|
Additional paid in
capital |
|
|
50,452,275 |
|
|
|
7,693,994 |
|
Accumulated deficit |
|
|
(12,454,565 |
) |
|
|
(7,959,501 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders’ equity (deficit) |
|
|
38,079,042 |
|
|
|
(237,701 |
) |
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity (deficit) |
|
$ |
43,859,226 |
|
|
$ |
1,777,793 |
|
|
|
Unaudited Condensed Consolidated
Statements of Operations
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
697,674 |
|
|
$ |
1,349,835 |
|
|
$ |
1,578,512 |
|
|
$ |
2,302,883 |
|
General and administrative |
|
|
2,670,317 |
|
|
|
196,578 |
|
|
|
2,932,100 |
|
|
|
527,830 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
3,367,991 |
|
|
|
1,546,413 |
|
|
|
4,510,612 |
|
|
|
2,830,713 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(3,367,991 |
) |
|
|
(1,546,413 |
) |
|
|
(4,510,612 |
) |
|
|
(2,830,713 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
827 |
|
|
|
3,680 |
|
|
|
15,548 |
|
|
|
16,781 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,367,164 |
) |
|
$ |
(1,542,733 |
) |
|
$ |
(4,495,064 |
) |
|
$ |
(2,813,932 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common
stockholders per share of common stock, basic and diluted |
|
$ |
(0.81 |
) |
|
$ |
(0.79 |
) |
|
$ |
(1.67 |
) |
|
$ |
(1.45 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares used in calculating net loss per share, basic and
diluted |
|
|
4,180,744 |
|
|
|
1,944,672 |
|
|
|
2,692,770 |
|
|
|
1,944,672 |
|
|
|
Unaudited Condensed Consolidated
Statements of Cash Flows
|
|
|
Nine months ended |
|
|
|
September |
|
|
|
2021 |
|
|
2020 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,495,064 |
) |
|
$ |
(2,813,932 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
868 |
|
|
|
639 |
|
Stock-based compensation |
|
|
836,456 |
|
|
|
116,872 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
(1,128,933 |
) |
|
|
(19,418 |
) |
Accounts payable and other current liabilities |
|
|
(2,964,147 |
) |
|
|
348,241 |
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(7,750,820 |
) |
|
|
(2,367,598 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from investing
activities: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(3,854 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net cash used in investing
activities |
|
|
(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 |
|
|
5,000,000 |
|
|
|
1,167,129 |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
47,974,397 |
|
|
|
1,167,129 |
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in
cash and cash equivalents |
|
|
40,219,723 |
|
|
|
(1,200,469 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
beginning of period |
|
|
1,637,499 |
|
|
|
3,798,955 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
end of period |
|
$ |
41,857,222 |
|
|
$ |
2,598,486 |
|
|
|
|
|
|
|
|
|
|
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 |
|
$ |
800 |
|
|
$ |
800 |
|
Cash received for interest earned on deposits |
|
$ |
2,362 |
|
|
$ |
12,365 |
|
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