Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the
“Company”), today announced financial results for the first quarter
ended March 31, 2023 and provided a corporate update.
“Following the dosing and completion of our
first patient in the first cohort of our INDP-D101 trial of Decoy20
for the treatment of solid tumors, we continue the screening and
enrollment process to complete our first cohort,” said Jeffrey
Meckler, chief executive officer of Indaptus. “In the interim, we
have presented significant data at the American Association for
Cancer Research scientific conference and received additional
recognition within the scientific community. We have also received
important additions to our intellectual property portfolio, now
having patent protections for our Decoy immunotherapy platform in
all 32 countries for which we applied. As we continue to screen and
enroll patients for our trial, we will continue to prudently manage
our cash position.”
Key highlights from Q1
2023 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. 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.
- 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.
- A compound from the Company’s Decoy
platform was featured in a poster presentation at the American
Association for Cancer Research. The poster, titled, “A
systemically administered killed bacteria-based multiple immune
receptor agonist for pulsed anti-tumor immunotherapy,” 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 on May 9-11, where he was also a featured
speaker.
- Robert Martell, M.D., Ph.D. was
elected to the Indaptus Therapeutics Board of Directors in February
2023.
- Indaptus received patent allowances
for its immunotherapy platform in Brazil and India. The Indian
patent allowance brought the number of countries in which the
Company holds IP protection to 32.
Financial Highlights for
the First Quarter
Ended March
31, 2023
Research and development expenses, for the
three-month period ended March 31, 2023, were approximately $1.9
million, an increase of approximately $600,000 compared with
approximately $1.3 million in the three-month period ended March
31, 2022. The increase was primarily for payroll and related
expenses and for our phase 1 clinical trial that was initiated in
December 2022.
General and administrative expenses, for the
three-month period ended March 31, 2023, were approximately $2.6
million, an increase of approximately $500,000 compared with
approximately $2.1 million in the three-month period ended March
31, 2022. The increase was primarily for legal fees, recruitment
costs and other professional fees and was primarily offset by a
decrease in directors’ and officers’ insurance expenses and in
payroll and related expenses.
Loss per share for the three-month period ended
March 31, 2023 was approximately $0.51 compared with approximately
$0.41 for the three-month period ended March 31, 2022.
As of March 31, 2023, the Company had cash and
cash equivalents and marketable securities of approximately $21.7
million. As of December 31, 2022, the Company had cash and cash
equivalents and marketable securities of approximately $26.4
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
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 $5.0 million for the three-month period ended March
31, 2023, compared with net cash used in operating activities of
approximately $3.1 million for the three-month period ended March
31, 2022. The increase of approximately $1.9 million in net cash
used was primarily attributable to expenses related to research and
development activities in connection with the Phase 1 clinical
trial and an increase in general and administrative expenses.
Net cash provided by investing activities was
approximately $2.1 million for the three months ended March 31,
2023 which was related to the maturity of $9.0 million in
marketable securities, offset by net investment of approximately
$6.9 million in marketable securities. Net cash used in investing
activities was approximately $2.8 million for the three months
ended March 31, 2022 which was primarily related to net investment
in marketable securities in the amount
of approximately $3.0 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 three months ended March 31, 2023 and
in the three months ended March 31, 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) 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 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; 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 March 31, 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 IRLouie
Tomalouie@coreir.com
Media Contact:CORE IRJules
Abrahamjulesa@coreir.com 917-885-7378
INDAPTUS
THERAPEUTICS, INC. |
|
|
|
|
|
|
|
|
|
|
Unaudited
Condensed Consolidated Balance
Sheets |
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
6,805,146 |
|
|
$ |
9,626,800 |
|
Marketable
securities |
|
|
14,875,693 |
|
|
|
16,806,009 |
|
Prepaid
expenses and other current assets |
|
|
470,751 |
|
|
|
811,433 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
22,151,590 |
|
|
|
27,244,242 |
|
|
|
|
|
|
|
|
|
|
Non-current
assets: |
|
|
|
|
|
|
|
|
Property and
equipment, net |
|
|
1,698 |
|
|
|
2,019 |
|
Right-of-use
asset |
|
|
236,506 |
|
|
|
79,294 |
|
Other
assets |
|
|
754,728 |
|
|
|
738,251 |
|
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
|
992,932 |
|
|
|
819,564 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
23,144,522 |
|
|
$ |
28,063,806 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and other current liabilities |
|
$ |
1,722,622 |
|
|
$ |
3,352,847 |
|
Operating
lease liability, current portion |
|
|
99,837 |
|
|
|
80,494 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
1,822,459 |
|
|
|
3,433,341 |
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities: |
|
|
|
|
|
|
|
|
Operating
lease liability, net of current portion |
|
|
136,669 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total non-current liabilities |
|
|
136,669 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
1,959,128 |
|
|
|
3,433,341 |
|
|
|
|
|
|
|
|
|
|
Commitments
and contingent liabilities |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common
stock: $0.01 par value, 200,000,000 shares authorized as of March
31, 2023 and December 31, 2022; 8,401,047 shares issued and
outstanding as of March 31, 2023 and December 31, 2022 |
|
|
84,011 |
|
|
|
84,011 |
|
Additional
paid in capital |
|
|
55,170,849 |
|
|
|
54,443,705 |
|
Accumulated
deficit |
|
|
(34,246,923 |
) |
|
|
(29,993,685 |
) |
Accumulated
other comprehensive income |
|
|
177,457 |
|
|
|
96,434 |
|
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
|
21,185,394 |
|
|
|
24,630,465 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
23,144,522 |
|
|
$ |
28,063,806 |
|
|
|
|
|
|
|
|
|
|
Unaudited
Condensed Consolidated Statements of
Operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
2022 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,879,900 |
|
|
$ |
1,297,098 |
|
General and administrative |
|
|
2,575,266 |
|
|
|
2,104,975 |
|
|
|
|
|
|
|
|
|
|
Total
operating expenses |
|
|
4,455,166 |
|
|
|
3,402,073 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(4,455,166 |
) |
|
|
(3,402,073 |
) |
|
|
|
|
|
|
|
|
|
Other
income, net |
|
|
201,928 |
|
|
|
36,919 |
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(4,253,238 |
) |
|
$ |
(3,365,154 |
) |
|
|
|
|
|
|
|
|
|
Net loss
available to common stockholders per share of common stock, basic
and diluted |
|
$ |
(0.51 |
) |
|
$ |
(0.41 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average number of shares used in calculating net loss per share,
basic and diluted |
|
|
8,401,047 |
|
|
|
8,258,597 |
|
Net
loss |
|
$ |
(4,253,238 |
) |
|
$ |
(3,365,154 |
) |
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
Reclassification adjustment for realized gain on marketable
securities included in net loss |
|
|
(129,229 |
) |
|
|
- |
|
Unrealized gain (loss) on marketable securities |
|
|
210,252 |
|
|
|
(9,221 |
) |
Comprehensive loss |
|
$ |
(4,172,215 |
) |
|
$ |
(3,374,375 |
) |
|
|
|
|
|
|
|
|
|
Unaudited
Condensed Consolidated Statements of Cash
Flows |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months
ended |
|
|
|
March 31, |
|
|
|
2023 |
|
|
2022 |
|
Cash flows
from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,253,238 |
) |
|
$ |
(3,365,154 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
321 |
|
|
|
534 |
|
Stock-based compensation |
|
|
727,144 |
|
|
|
831,183 |
|
Realized gain on marketable securities |
|
|
(129,229 |
) |
|
|
- |
|
Realized gain on assets held for sale |
|
|
- |
|
|
|
(24,155 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
324,205 |
|
|
|
364,708 |
|
Accounts payable and other current liabilities |
|
|
(1,630,225 |
) |
|
|
(925,204 |
) |
Operating lease right-of-use asset and liability, net |
|
|
(1,200 |
) |
|
|
360 |
|
Net cash used in operating activities |
|
|
(4,962,222 |
) |
|
|
(3,117,728 |
) |
|
|
|
|
|
|
|
|
|
Cash flows
from investing activities: |
|
|
|
|
|
|
|
|
Proceeds received for assets held for sale |
|
|
- |
|
|
|
172,555 |
|
Maturity of marketable securities |
|
|
9,000,000 |
|
|
|
- |
|
Purchase of marketable securities |
|
|
(6,859,432 |
) |
|
|
(2,970,681 |
) |
Net cash provided by (used in) investing activities |
|
|
2,140,568 |
|
|
|
(2,798,126 |
) |
|
|
|
|
|
|
|
|
|
Net decrease
in cash and cash equivalents |
|
|
(2,821,654 |
) |
|
|
(5,915,854 |
) |
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents at beginning of period |
|
|
9,626,800 |
|
|
|
39,132,165 |
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents at end of period |
|
$ |
6,805,146 |
|
|
$ |
33,216,311 |
|
|
|
|
|
|
|
|
|
|
Noncash investing and financing activities |
|
|
|
|
|
|
|
|
Change in unrealized gain/loss on marketable securities |
|
$ |
81,023 |
|
|
$ |
- |
|
ASC 842 lease renewal option exercise |
|
$ |
236,506 |
|
|
$ |
- |
|
Reclassification of security deposit |
|
$ |
16,477 |
|
|
$ |
- |
|
Supplemental Disclosures |
|
|
|
|
|
|
|
|
Cash received for interest earned on deposits |
|
$ |
36,123 |
|
|
$ |
1,318 |
|
|
|
|
|
|
|
|
|
|
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