Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the
“Company”), today announced financial results for the fourth
quarter and fiscal year ended December 31, 2022 and provided a
corporate update.
“With the initiation of our INDP-D101 trial at
the end of December 2022 and the subsequent dosing of our first
patient in the first cohort, we are well underway in our Phase 1
trial of Decoy20 for the treatment of solid tumors,” said Jeffrey
Meckler, chief executive officer of Indaptus. “Following the
initial dosing we were encouraged to learn that the subject
experienced manageable and expected adverse events related to the
immune response we anticipated. We are looking forward to analyzing
the data generated from that first patient and finishing the first
arm of the trial per the protocol. As we continue to bring new
centers online and enroll patients, we will continue to prudently
manage our cash position, and update stakeholders on our progress
as it develops.”
Key highlights from Q4 2022 to
date:
- The Company reported the first
dosing of a study subject in the INDP-D101 trial in March 2023.
After Decoy20 dosing, the subject experienced expected and
manageable adverse events believed to be related to the immune
system activating components known to be in the product. A second
subject in the first three-subject cohort is expected to be
enrolled following final assessment of the safety and tolerability
associated with dosing of the first subject, per the study
protocol.
- In February 2023, Indaptus
activated Morristown Medical Center as the second trial site in the
INDP-D101 trial. The third site, Emory Winship Cancer Institute in
Atlanta, GA, was activated in March 2023.
- Robert Martell, M.D., Ph.D. was
elected to the Indaptus Therapeutics Board of Directors in February
2023.
- In December 2022, the Company
initiated its first-in-human, Phase 1, open-label dose escalation
and expansion clinical trial of Decoy20 in patients with advanced
solid tumors where currently approved therapies have failed. The
study’s objectives are to assess the safety and tolerability of
Decoy20, to determine the maximum tolerated dose (MTD) and
recommended phase 2 dose (RP2D), as well as to assess Decoy20
pharmacokinetics (PK), pharmacodynamics and clinical activity. The
Phase 1 study has begun with a single dose escalation followed by
an expansion with continuous administration of Decoy20. The initial
trial site was the USC Norris Cancer Center in Los Angeles, CA.
More information can be found at www.clinicaltrials.gov.
Financial Highlights for
Fourth Quarter and Fiscal
Year Ended December
31, 2022
Research and development expenses for the
three-month period ended December 31, 2022, were approximately $1.9
million, an increase of approximately $0.9 million, or
approximately 90%, compared with approximately $1.0 million in the
three-month period ended December 31, 2021. Research and
development expenses for the twelve-month period ended December 31,
2022, were approximately $6.3 million, an increase of approximately
$3.8 million, or approximately 150%, compared with approximately
$2.5 million in the twelve-month period ended December 31, 2021.
The increase in each of the three and twelve-month periods was
primarily due to increased payroll and related expenses,
share-based compensation, Phase 1 clinical trial activities
including the IND preparation and submission, and costs associated
with the manufacturing processes of our lead clinical
candidate.
General and administrative expenses for the
three-month period ended December 31, 2022, were approximately $2.2
million, a decrease of approximately $0.1 million, or approximately
4%, compared with approximately $2.3 million in the three-month
period ended December 31, 2021. General and administrative expenses
for the twelve-month period ended December 31, 2022, were
approximately $8.6 million, an increase of approximately $3.4
million, or approximately 65%, compared to approximately $5.2
million for the twelve-month period ended December 31, 2021. The
increase in the twelve-month period was primarily due to increased
payroll and related expenses, stock-based compensation expense
resulting from increased headcount of our executive team,
directors’ and officers’ insurance expenses, professional fees and
other expenses associated with being a public company following the
merger.
Loss per share for the twelve-month period ended
December 31, 2022, was approximately $1.73 compared with
approximately $1.89 for the twelve-month period ended December 31,
2021.
As of December 31, 2022, the Company had cash
and cash equivalents and marketable securities of approximately
$26.4 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
would support its corporate strategy.
Net cash used in operating activities was
approximately $13.1 million for the twelve-month period ended
December 31, 2022, compared with net cash used in operating
activities of approximately $11.3 million for the twelve-month
period ended December 31, 2021. The approximately $1.8 million
increase in net cash used was primarily attributable to expenses
related to research and development activities in connection with
the Phase 1 clinical trial and general and administrative expenses
associated with being a public company following the merger.
There was no net cash provided by financing
activities for the twelve-month period ended December 31, 2022. Net
cash provided by financing activities was approximately $48.3
million for the year ended December 31, 2021 which was primarily
due to the merger and the private placement that closed in August
2021 as well as a series of SAFEs (Simple Agreements for Future
Equity) that was issued to accredited investors at the effective
time of the merger.
About Indaptus Therapeutics
Indaptus Therapeutics has evolved from more than
a century of immunotherapy advances. The Company’s novel approach
is based on the hypothesis that efficient activation of both innate
and adaptive immune cells and pathways 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 (i.v.). Indaptus’ patented
technology is composed of single strains of attenuated and killed,
non-pathogenic, Gram-negative bacteria producing a multiple
Toll-like receptor (TLR) agonist Decoy platform. The products are
designed to have reduced i.v. toxicity, but largely uncompromised
ability to prime or activate many of the cells and pathways of
innate and adaptive immunity. Decoy products represent an
antigen-agnostic technology that have produced 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. In pre-clinical studies tumor eradication was observed
with Decoy products in combination with anti-PD-1 checkpoint
therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory
drug, or an approved, targeted antibody. Combination-based tumor
eradication in pre-clinical models produced innate and adaptive
immunological memory, involved activation of both innate and
adaptive immune cells, and was 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, nonclinical toxicology studies
demonstrated safe i.v. administration without sustained induction
of hallmark biomarkers of cytokine release syndromes, possibly due
to passive targeting to liver, spleen, and tumor, followed by rapid
elimination of the product. Indaptus’ Decoy 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 expectations and plans regarding the Phase 1 clinical trial of
Decoy20, including the timing and design thereof; the plans and
objectives of management for future operations; our research and
development activities and costs; the sufficiency of our cash, cash
equivalents and marketable securities to fund our ongoing
activities; and our assessment of financing options to support our
corporate strategy. 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. 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 limited operating
history; the need for, and our ability to raise, additional capital
given our lack of current cash flow; our clinical and preclinical
development, which involves a lengthy and expensive process with an
uncertain outcome; our incurrence of significant research and
development expenses and other operating expenses, which may make
it difficult for us to attain profitability; our pursuit of a
limited number of research programs, product candidates and
specific indications and failure to capitalize on product
candidates or indications that may be more profitable or have a
greater likelihood of success; our ability to obtain and maintain
regulatory approval of any product candidate; the market acceptance
of our product candidates; our reliance on third parties to conduct
our preclinical studies and clinical trials and perform other
tasks; our reliance on third parties for the manufacture of our
product candidates during clinical development; our ability to
successfully commercialize Decoy20 or any future product
candidates; our ability to obtain or maintain coverage and adequate
reimbursement for our products; the impact of legislation and
healthcare reform measures on our ability to obtain marketing
approval for and commercialize Decoy20 and any future product
candidates; product candidates of our competitors that may be
approved faster, marketed more effectively, and better tolerated
than our product candidates; our ability to adequately protect our
proprietary or licensed technology in the marketplace; the impact
of, and costs of complying with healthcare laws and regulations,
and our failure to comply with such laws and regulations;
information technology system failures, cyberattacks or
deficiencies in our cybersecurity; and unfavorable global economic
conditions. These and other important factors discussed under the
caption “Risk Factors” included in our most recent Annual Report on
Form 10-K filed with the SEC on March 17, 2023, and our other
filings with the SEC, could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this press release. 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.
Contact: investors@indaptusrx.com
Investor Relations Contact:CORE IRLouie
Tomalouie@coreir.com
Media Contact:CORE IRJules
Abrahamjulesa@coreir.com917-885-7378
INDAPTUS THERAPEUTICS, INC.
Consolidated Balance Sheets
|
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
9,626,800 |
|
|
$ |
39,132,165 |
|
Marketable securities |
|
|
16,806,009 |
|
|
|
- |
|
Assets held for sale |
|
|
- |
|
|
|
148,400 |
|
Prepaid expenses and other
current assets |
|
|
811,433 |
|
|
|
1,106,653 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
27,244,242 |
|
|
|
40,387,218 |
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
2,019 |
|
|
|
3,800 |
|
Right-of-use asset |
|
|
79,294 |
|
|
|
169,088 |
|
Other assets |
|
|
738,251 |
|
|
|
16,477 |
|
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
|
819,564 |
|
|
|
189,365 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
28,063,806 |
|
|
$ |
40,576,583 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and other
current liabilities |
|
$ |
3,352,847 |
|
|
$ |
4,507,676 |
|
Operating lease liability,
current portion |
|
|
80,494 |
|
|
|
96,465 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
3,433,341 |
|
|
|
4,604,141 |
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Operating lease liability, net
of current portion |
|
|
- |
|
|
|
72,862 |
|
|
|
|
|
|
|
|
|
|
Total non-current liabilities |
|
|
- |
|
|
|
72,862 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
3,433,341 |
|
|
|
4,677,003 |
|
|
|
|
|
|
|
|
|
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock: $0.01 par value,
200,000,000 shares authorized as of December 31, 2022 and 2021;
8,401,047 and 8,258,597 shares issued and outstanding as of
December 31, 2022 and 2021, respectively |
|
|
84,011 |
|
|
|
82,586 |
|
Additional paid in
capital |
|
|
54,443,705 |
|
|
|
51,487,881 |
|
Accumulated deficit |
|
|
(29,993,685 |
) |
|
|
(15,670,887 |
) |
Accumulated other
comprehensive income |
|
|
96,434 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
|
24,630,465 |
|
|
|
35,899,580 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
28,063,806 |
|
|
$ |
40,576,583 |
|
|
|
|
|
|
|
|
|
|
Consolidated Statements of Operations and
Comprehensive Loss
|
|
|
For the year ended December 31, |
|
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
6,324,657 |
|
|
$ |
2,523,153 |
|
General and administrative |
|
|
8,586,249 |
|
|
|
5,205,955 |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
14,910,906 |
|
|
|
7,729,108 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(14,910,906 |
) |
|
|
(7,729,108 |
) |
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
588,108 |
|
|
|
17,722 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(14,322,798 |
) |
|
$ |
(7,711,386 |
) |
|
|
|
|
|
|
|
|
|
Net loss available to common
stockholders per share of common stock, basic and diluted |
|
$ |
(1.73 |
) |
|
$ |
(1.89 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of
shares used in calculating net loss per share, basic and
diluted |
|
|
8,262,119 |
|
|
|
4,090,599 |
|
Net loss |
|
$ |
(14,322,798 |
) |
|
$ |
(7,711,386 |
) |
Other comprehensive
income: |
|
|
|
|
|
|
|
|
Reclassification adjustment for realized gain on marketable
securities included in net loss |
|
|
(110,002 |
) |
|
|
- |
|
Unrealized gain on marketable securities |
|
|
206,436 |
|
|
|
- |
|
Comprehensive loss |
|
$ |
(14,226,364 |
) |
|
$ |
(7,711,386 |
) |
|
|
|
|
|
|
|
|
|
Consolidated Statements of Cash
Flows
|
|
|
For the year ended December 31, |
|
|
|
2022 |
|
|
2021 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(14,322,798 |
) |
|
$ |
(7,711,386 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
1,781 |
|
|
|
1,403 |
|
Stock-based compensation |
|
|
2,957,249 |
|
|
|
1,510,258 |
|
Realized gain on assets held for sale |
|
|
(24,155 |
) |
|
|
- |
|
Realized gain on marketable securities |
|
|
(110,002 |
) |
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
295,220 |
|
|
|
(837,917 |
) |
Accounts payable and other current liabilities |
|
|
(1,154,829 |
) |
|
|
(4,236,656 |
) |
Other assets |
|
|
(721,774 |
) |
|
|
(16,477 |
) |
Operating lease right-of-use asset and liability, net |
|
|
961 |
|
|
|
240 |
|
Net cash used in operating activities |
|
|
(13,078,347 |
) |
|
|
(11,290,535 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from investing
activities: |
|
|
|
|
|
|
|
|
Proceeds received for assets held for sale |
|
|
172,555 |
|
|
|
451,600 |
|
Purchases of property and equipment |
|
|
- |
|
|
|
(3,854 |
) |
Purchase of marketable securities |
|
|
(29,599,573 |
) |
|
|
- |
|
Maturity of marketable securities |
|
|
13,000,000 |
|
|
|
- |
|
Net cash (used in) provided by investing activities |
|
|
(16,427,018 |
) |
|
|
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 pre-funded warrants |
|
|
- |
|
|
|
27,273 |
|
Proceeds from SAFEs, net |
|
|
- |
|
|
|
5,000,000 |
|
Exercise of stock options |
|
|
- |
|
|
|
363,058 |
|
Net cash provided by financing activities |
|
|
- |
|
|
|
48,337,455 |
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in
cash and cash equivalents |
|
|
(29,505,365 |
) |
|
|
37,494,666 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
beginning of year |
|
|
39,132,165 |
|
|
|
1,637,499 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
end of year |
|
$ |
9,626,800 |
|
|
$ |
39,132,165 |
|
|
|
|
|
|
|
|
|
|
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 |
|
Issuance of initial commitment shares |
|
$ |
1,425 |
|
|
$ |
- |
|
Change in unrealized gain on marketable securities |
|
$ |
96,434 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow
disclosures |
|
|
|
|
|
|
|
|
Cash paid for income taxes |
|
$ |
2,400 |
|
|
$ |
800 |
|
Cash received for interest earned on deposits |
|
$ |
111,018 |
|
|
$ |
5,141 |
|
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