Indaptus Therapeutics, Inc. (Nasdaq: INDP) ("Indaptus" or the
"Company”), today announces financial results for the fourth
quarter and year ended December 31, 2021 and provides a corporate
update.
“We enter 2022 excited about the future for
Indaptus as we continue to advance our clinical readiness with site
selection, toxicology studies and other tasks necessary for the
successful clearance of our Investigational New Drug application,”
said Jeffrey Meckler, Chief Executive Officer of Indaptus. “With
Dr. Litchev at the clinical helm, we look forward to his final
evaluation of the study design and clinical strategy. We remain on
track to initiate this important Phase 1 study of Decoy20 this year
and look forward to bringing this novel, multi-targeted therapy to
the fight against cancer.”
Recent Corporate Highlights
Appointed Boyan Litchev, M.D., as Chief
Medical Officer
In January, Indaptus announced the appointment
of Boyan Litchev, M.D., as Chief Medical Officer. Dr. Litchev will
oversee clinical strategy, clinical development and the conduct of
all clinical programs. Dr. Litchev brings significant experience
across a multitude of medical leadership roles that are
specifically relevant for Indaptus.
Appointed Mark Gilbert, M.D., to Board
of Directors
In December, Indaptus announced the appointment
of Mark Gilbert, M.D., to its Board of Directors. Dr. Gilbert
served as Chief Medical Officer of Juno Therapeutics prior to its
acquisition by Celgene Corporation and currently serves as
Executive Vice President of Research and Development at
Acepodia.
Financial Highlights for Fourth Quarter
and Full Year Ended December 31, 2021
Research and development expenses, for the
three-month period ended December 31, 2021, were approximately $1
million, an increase of approximately $0.6 million, or
approximately 150%, compared with approximately $0.4 million in the
three-month period ended December 31, 2020. Research and
development expenses for the twelve-month period ended December 31,
2021, were approximately $2.5 million, a decrease of approximately
$0.1 million, or approximately 4%, compared with approximately $2.6
million in the twelve-month period ended December 31, 2020. The
increase for the three-month period was primarily due to salaries
and share-based compensation. The change in the twelve-month period
was a result of the manufacturing and characterization costs of
Decoy20 in 2020 that was offset by the increase of salaries and
share-based compensation in 2021.
General and administrative expenses for the
three-month period ended December 31, 2021, were approximately $2.3
million, an increase of approximately $1.9 million, or
approximately 475%, compared with approximately $0.4 million in the
three-month period ended December 31, 2020. General and
administrative expenses for the twelve-month period ended December
31, 2021, amounted to approximately $5.2 million, an increase of
approximately $4.2 million, or approximately 420%, compared to
approximately $1.0 million for the twelve-month period ended
December 31, 2020. The increase for the three and twelve-month
periods was primarily as a result of increased 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 Decoy merger.
Loss per share for the twelve-month period ended
December 31, 2021, was approximately $1.89 compared with
approximately $1.84 for the twelve-month period ended December 31,
2020.
As of December 31, 2021, the Company had cash
and cash equivalents of approximately $39.1 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 $11.3 million for the twelve-month period ended
December 31, 2021, compared with net cash used in operating
activities of approximately $3.3 million for the twelve-month
period ended December 31, 2020. 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 provided by financing activities for
the twelve-month period ended December 31, 2021, was approximately
$48.3 million, which was primarily 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 Decoy 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 twelve-month period
ended December 31, 2020, was approximately $1.2 million, which was
provided by the sale of SAFEs.
More detailed information can be found in the
Company’s Annual Report, a copy of which has been filed with the
Securities and Exchange Commission and posted on the Company’s
website at www.indaptusrx.com. You may request a copy of the
Company’s Form 10-K, at no cost to you, by writing to the Chief
Financial Officer of the Company at 3 Columbus Circle, 15th Floor,
New York, NY 10019 or by calling the Company at (347) 480 9760.
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 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. Consolidated Balance SheetsAs of
December 31, 2021 and 2020
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
39,132,165 |
|
|
$ |
1,637,499 |
|
Assets held for sale |
|
|
148,400 |
|
|
|
- |
|
Prepaid expenses and other
current assets |
|
|
1,106,653 |
|
|
|
94,500 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
40,387,218 |
|
|
|
1,731,999 |
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
3,800 |
|
|
|
1,349 |
|
Operating lease right-of-use
asset |
|
|
169,088 |
|
|
|
- |
|
Other assets |
|
|
16,477 |
|
|
|
44,445 |
|
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
|
189,365 |
|
|
|
45,794 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
40,576,583 |
|
|
$ |
1,777,793 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and other
current liabilities |
|
$ |
4,507,676 |
|
|
$ |
598,365 |
|
Operating lease liability,
current portion |
|
|
96,465 |
|
|
|
- |
|
SAFE agreements |
|
|
- |
|
|
|
1,417,129 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
4,604,141 |
|
|
|
2,015,494 |
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Operating lease liability, net
of current portion |
|
|
72,862 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total non-current
liabilities |
|
|
72,862 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
4,677,003 |
|
|
|
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
December 31, 2021 and 2020, respectively, 0 and 835,928 shares
issued and outstanding as of December 31, 2021 and 2020,
respectively |
|
|
- |
|
|
|
8,359 |
|
Common stock; $0.01 par value,
200,000,000 and 3,185,224 shares authorized as of December 31, 2021
and 2020, respectively; 8,258,597 and 1,944,672 shares issued and
outstanding as of December 31, 2021 and 2020, respectively |
|
|
82,586 |
|
|
|
19,447 |
|
Additional paid in
capital |
|
|
51,487,881 |
|
|
|
7,693,994 |
|
Accumulated deficit |
|
|
(15,670,887 |
) |
|
|
(7,959,501 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders’ equity (deficit) |
|
|
35,899,580 |
|
|
|
(237,701 |
) |
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity (deficit) |
|
$ |
40,576,583 |
|
|
$ |
1,777,793 |
|
INDAPTUS THERAPEUTICS, INC.
Consolidated Statements of
OperationsFor the Years Ended December 31, 2021
and 2020
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
2,523,153 |
|
|
$ |
2,655,017 |
|
General and administrative |
|
|
5,205,955 |
|
|
|
944,248 |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
7,729,108 |
|
|
|
3,599,265 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(7,729,108 |
) |
|
|
(3,599,265 |
) |
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
17,722 |
|
|
|
15,114 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(7,711,386 |
) |
|
$ |
(3,584,151 |
) |
|
|
|
|
|
|
|
|
|
Net loss available to common
stockholders per share of common stock, basic and diluted |
|
$ |
(1.89 |
) |
|
$ |
(1.84 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of
shares used in calculating net loss per share, basic and
diluted |
|
|
4,090,599 |
|
|
|
1,944,672 |
|
INDAPTUS THERAPEUTICS, INC.
Consolidated Statements of Cash
FlowsFor the Years Ended December 31, 2021 and
2020
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
Cash flows from operating
activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(7,711,386 |
) |
|
$ |
(3,584,151 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
1,403 |
|
|
|
852 |
|
Stock-based compensation |
|
|
1,510,258 |
|
|
|
139,960 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
(837,917 |
) |
|
|
2,811 |
|
Accounts payable and other current liabilities |
|
|
(4,236,656 |
) |
|
|
113,900 |
|
Operating lease right-of-use asset and liability, net |
|
|
240 |
|
|
|
- |
|
Other assets |
|
|
(16,477 |
) |
|
|
2,000 |
|
Net cash used in operating activities |
|
|
(11,290,535 |
) |
|
|
(3,324,628 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from investing
activities: |
|
|
|
|
|
|
|
|
Proceeds received for assets held for sale |
|
|
451,600 |
|
|
|
- |
|
Purchases of property and equipment |
|
|
(3,854 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities |
|
|
447,746 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
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 prepaid warrants |
|
|
27,273 |
|
|
|
- |
|
Proceeds from SAFEs, net |
|
|
5,000,000 |
|
|
|
1,163,172 |
|
Exercise of stock options |
|
|
363,058 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
48,337,455 |
|
|
|
1,163,172 |
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in
cash and cash equivalents |
|
|
37,494,666 |
|
|
|
(2,161,456 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
beginning of year |
|
|
1,637,499 |
|
|
|
3,798,955 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
end of year |
|
$ |
39,132,165 |
|
|
$ |
1,637,499 |
|
|
|
|
|
|
|
|
|
|
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 |
|
|
$ |
- |
|
Initial recognition of operating right-of-use asset and lease
liability upon lease commencement |
|
$ |
183,480 |
|
|
$ |
- |
|
Reclass from non-current assets to current assets |
|
$ |
44,445 |
|
|
$ |
- |
|
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 |
|
$ |
5,141 |
|
|
$ |
14,260 |
|
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