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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d)
of
the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported) August 14, 2023
INDAPTUS
THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-40652 |
|
86-3158720 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
3
Columbus Circle 15th Floor |
|
|
New
York, New York |
|
10019 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(646)
427-2727
(Registrant’s
telephone number, including area code)
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section
12(b) of the Act: |
Title
of each class |
|
Trading
Symbol |
|
Name
of each exchange on which registered |
Common
Stock, $0.01 par value |
|
INDP |
|
Nasdaq
Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
2.02. |
Results
of Operations and Financial Condition. |
On
August 14, 2023, Indaptus Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for
the quarter ended June 30, 2023. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and
is incorporated herein by reference.
The
information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section
18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that
Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended,
or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item
9.01. |
Financial
Statements and Exhibits. |
(d)
Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Date:
August 14, 2023
|
INDAPTUS
THERAPEUTICS, INC. |
|
|
|
|
By:
|
/s/
Nir Sassi |
|
Name:
|
Nir
Sassi |
|
Title:
|
Chief
Financial Officer |
Exhibit
99.1
Indaptus
Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update
NEW
YORK (August 14, 2023) - 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
IR
Jules
Abraham
julesa@coreir.com
917-885-7378
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 | | |
$ | - | |
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