Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the
“Company”) today announced financial results for the second quarter
ended June 30, 2023 and provided a corporate update.
“We have recently announced the completion of
the first cohort of patients in our INDP-D101 trial evaluating
Decoy20 for the treatment of solid tumors and receipt of
authorization from the Safety Review Committee to advance into the
second cohort. As previously announced, we are pleased to observe
evidence of immune activation, along with short-lived adverse
events consistent with Decoy20's mechanism of action,” said Jeffrey
Meckler, Chief Executive Officer of Indaptus. “We continue to
analyze the data generated and anticipate that the data from the
dose finding studies will guide the selection for the recommended
Phase 2 dose for subsequent multi-dosing and combination studies,
which are planned for 2024. An additional recent accomplishment is
the appointment of industry veteran, Roger Waltzman, M.D., as our
Chief Medical Officer. We anticipate benefiting from his expertise
as we continue our Phase 1 trial and further develop the Decoy
platform. In the meantime, we are prudently managing our cash
position.”
Recent Corporate Highlights:
- The Company announced the completion of the first cohort of its
INDP-D101 trial and receipt of authorization from its Safety Review
Committee to proceed into the second cohort of the Phase 1
trial.
- A compound from the Company’s Decoy platform was presented in a
poster titled, “A systemically administered killed bacteria-based
multiple immune receptor agonist for pulsed anti-tumor
immunotherapy,” at the American Association for Cancer Research
Conference 2023. The poster highlighted that Decoy10
demonstrated 90% reduction of LPS-endotoxin activity and use of
100% killed, non-pathogenic bacteria.
- The Company’s Chief Scientific Officer, Michael Newman, Ph.D.,
was named Chair for two of the three days of the 4th STING &
TLR-Targeting Therapies Summit held in Boston from May 9 to 11,
where he was also a featured speaker.
- The Company received patent allowances for its Decoy
immunotherapy platform in Brazil and India. The Indian patent
allowance brought the number of countries in which the Company
holds patent protection to 32.
- Roger Waltzman, M.D. was appointed the Chief Medical Officer of
Indaptus, effective August 7, 2023.
Financial Highlights for the Second
Quarter Ended June 30, 2023
Research and development expenses for the three
months ended June 30, 2023 and 2022 were approximately $1.5
million. Research and development expenses for the six months ended
June 30, 2023 were approximately $3.4 million, an increase of
approximately $0.6 million compared with approximately $2.8 million
in the six months ended June 30, 2022. The increase for the
six-month period was primarily due to expenses for our Phase 1
clinical trial that was initiated in December 2022 and payroll and
related expenses.
General and administrative expenses for the
three months ended June 30, 2023 were approximately $2.0 million, a
decrease of approximately $0.4 million compared with approximately
$2.4 million in the three months ended June 30, 2022. The decrease
was primarily due to a decrease in stock-based compensation and a
decrease in directors’ and officers’ insurance expenses. General
and administrative expenses for the six months ended June 30, 2023
were approximately $4.6 million, an increase of approximately $0.1
million compared with approximately $4.5 million in the six months
ended June 30, 2022.
Loss per share for the three months ended June
30, 2023 was approximately $0.39 compared with approximately $0.46
for the three months ended June 30, 2022. Loss per share for the
six months ended June 30, 2023 was approximately $0.89 compared
with approximately $0.87 per share for the six months ended June
30, 2022.
As of June 30, 2023, the Company had cash, cash
equivalents and marketable securities of approximately $19.7
million as compared to $26.4 million as of December 31, 2022. 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 runway 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 $7.1 million for the six months ended June 30, 2023,
compared with net cash used in operating activities of
approximately $6.3 million for the six months ended June 30, 2022.
The increase of approximately $0.8 million in net cash used was
primarily attributable to an increase in our spending related to
research and development activities in connection with the Phase 1
clinical trial and for general and administrative expenses.
Net cash provided by investing activities was
approximately $10.1 million for the six months ended June 30, 2023,
which was a result of the maturity of $17.0 million in marketable
securities, offset by net investment of approximately $6.9 million
in marketable securities. Net cash used in investing activities was
approximately $18.6 million for the six months ended June 30, 2022,
which was primarily related to net investment in marketable
securities in the amount of approximately $18.8 million, offset by
approximately $0.2 million from the proceeds received for assets
held for sale.
There was no net cash provided by or used in
financing activities in the six months ended June 30, 2023 and
2022.
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), Nucleotide oligomerization domain
(Nod)-like receptor (NLR) and Stimulator of interferon genes
(STING) 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 Phase 1 clinical trial of
Decoy20, including the timing and design thereof, the timing of the
enrollment of the second cohort of patients in the Phase 1 trial,
and our expectations regarding the recommended Phase 2 doses for
subsequent multi-dosing and combination studies and related timing;
the anticipated effects of our product candidates, including
Decoy20; 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 going activities and our cash management strategy; 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; conditions and events that raise substantial doubt
regarding our ability to continue as going concern; 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 Quarterly Report on Form
10-Q for the quarter ended June 30, 2023 to be filed with the SEC,
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 IR Louie Toma
louie@coreir.com
Media Contact:CORE IRJules
Abrahamjulesa@coreir.com917-885-7378
INDAPTUS THERAPEUTICS, INC.
Unaudited Condensed Consolidated Balance
Sheets
|
|
June 30, 2023 |
|
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
12,698,387 |
|
|
$ |
9,626,800 |
|
Marketable securities |
|
|
6,993,588 |
|
|
|
16,806,009 |
|
Prepaid expenses and other
current assets |
|
|
180,784 |
|
|
|
811,433 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
19,872,759 |
|
|
|
27,244,242 |
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
1,376 |
|
|
|
2,019 |
|
Right-of-use asset |
|
|
215,846 |
|
|
|
79,294 |
|
Other assets |
|
|
754,728 |
|
|
|
738,251 |
|
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
|
971,950 |
|
|
|
819,564 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
20,844,709 |
|
|
$ |
28,063,806 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and other
current liabilities |
|
$ |
2,002,625 |
|
|
$ |
3,352,847 |
|
Operating lease liability,
current portion |
|
|
100,421 |
|
|
|
80,494 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
2,103,046 |
|
|
|
3,433,341 |
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Operating lease liability, net
of current portion |
|
|
116,170 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total non-current liabilities |
|
|
116,170 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
2,219,216 |
|
|
|
3,433,341 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingent
liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock: $0.01 par value,
200,000,000 shares authorized as of June 30, 2023 and December 31,
2022; 8,401,047 shares issued and outstanding as of June 30, 2023
and December 31, 2022 |
|
|
84,011 |
|
|
|
84,011 |
|
Additional paid in
capital |
|
|
55,899,315 |
|
|
|
54,443,705 |
|
Accumulated deficit |
|
|
(37,491,988 |
) |
|
|
(29,993,685 |
) |
Accumulated other
comprehensive income |
|
|
134,155 |
|
|
|
96,434 |
|
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
|
18,625,493 |
|
|
|
24,630,465 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
20,844,709 |
|
|
$ |
28,063,806 |
|
|
|
|
|
|
|
|
|
|
Unaudited Condensed Consolidated
Statements of Operations and Comprehensive Loss
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,480,485 |
|
|
$ |
1,506,165 |
|
|
$ |
3,360,385 |
|
|
$ |
2,803,263 |
|
General and administrative |
|
|
2,014,777 |
|
|
|
2,363,095 |
|
|
|
4,590,043 |
|
|
|
4,468,070 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
3,495,262 |
|
|
|
3,869,260 |
|
|
|
7,950,428 |
|
|
|
7,271,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(3,495,262 |
) |
|
|
(3,869,260 |
) |
|
|
(7,950,428 |
) |
|
|
(7,271,333 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
250,197 |
|
|
|
33,758 |
|
|
|
452,125 |
|
|
|
70,677 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,245,065 |
) |
|
$ |
(3,835,502 |
) |
|
$ |
(7,498,303 |
) |
|
$ |
(7,200,656 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common
stockholders per share of common stock, basic and diluted |
|
$ |
(0.39 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.89 |
) |
|
$ |
(0.87 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares used in calculating net loss per share, basic and
diluted |
|
|
8,401,047 |
|
|
|
8,258,597 |
|
|
|
8,401,047 |
|
|
|
8,258,597 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,245,065 |
) |
|
$ |
(3,835,502 |
) |
|
$ |
(7,498,303 |
) |
|
$ |
(7,200,656 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification adjustment for interest earned on marketable
securities included in net loss |
|
|
(161,197 |
) |
|
|
- |
|
|
|
(290,426 |
) |
|
|
- |
|
Unrealized gain (loss) on marketable securities |
|
|
117,895 |
|
|
|
(17,716 |
) |
|
|
328,147 |
|
|
|
(26,937 |
) |
Comprehensive loss |
|
$ |
(3,288,367 |
) |
|
$ |
(3,853,218 |
) |
|
$ |
(7,460,582 |
) |
|
$ |
(7,227,593 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unaudited Condensed Consolidated
Statements of Cash Flows
|
|
For the Six months ended |
|
|
|
June 30, |
|
|
|
2023 |
|
|
2022 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(7,498,303 |
) |
|
$ |
(7,200,656 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
643 |
|
|
|
1,068 |
|
Stock-based compensation |
|
|
1,455,610 |
|
|
|
1,735,578 |
|
Interest earned on marketable securities |
|
|
(290,426 |
) |
|
|
- |
|
Realized gain on assets held for sale |
|
|
- |
|
|
|
(24,155 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
614,172 |
|
|
|
845,769 |
|
Accounts payable and other current liabilities |
|
|
(1,350,222 |
) |
|
|
(981,642 |
) |
Other assets |
|
|
- |
|
|
|
(642,572 |
) |
Operating lease right-of-use asset and liability, net |
|
|
(455 |
) |
|
|
720 |
|
Net cash used in operating activities |
|
|
(7,068,981 |
) |
|
|
(6,265,890 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from investing
activities: |
|
|
|
|
|
|
|
|
Proceeds received for assets held for sale |
|
|
- |
|
|
|
172,555 |
|
Maturity of marketable securities |
|
|
17,000,000 |
|
|
|
- |
|
Purchase of marketable securities |
|
|
(6,859,432 |
) |
|
|
(18,780,018 |
) |
Net cash provided by (used in) investing activities |
|
|
10,140,568 |
|
|
|
(18,607,463 |
) |
|
|
|
|
|
|
|
|
|
Net increase (decrease) in
cash and cash equivalents |
|
|
3,071,587 |
|
|
|
(24,873,353 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
beginning of period |
|
|
9,626,800 |
|
|
|
39,132,165 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
end of period |
|
$ |
12,698,387 |
|
|
$ |
14,258,812 |
|
|
|
|
|
|
|
|
|
|
Noncash investing and
financing activities |
|
|
|
|
|
|
|
|
Change in unrealized gain/loss on marketable securities |
|
$ |
37,721 |
|
|
$ |
- |
|
ASC 842 lease renewal option exercise |
|
$ |
236,506 |
|
|
$ |
- |
|
Reclassification of security deposit |
|
$ |
16,477 |
|
|
$ |
- |
|
Supplemental
Disclosures |
|
|
|
|
|
|
|
|
Cash paid for income taxes |
|
$ |
1,600 |
|
|
$ |
2,400 |
|
Cash received for interest earned on deposits |
|
$ |
127,013 |
|
|
$ |
- |
|
Indaptus Therapeutics (NASDAQ:INDP)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Indaptus Therapeutics (NASDAQ:INDP)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024