Recent Updates
Recently added Catalysts
INDP Positive Sentiment Score: 70/100

Indaptus Therapeutics Reports Fourth Quarter and Year-End 2022 Financial Results and Provides Corporate Update Enrollment Underway in Phase 1 Clinical Trial of Decoy20 for Treatment of Solid Tumors with First Patient Dos

Key Takeaway: Indaptus Therapeutics announced its financial results for Q4 and the fiscal year ended December 31, 2022, while providing a corporate update on its clinical activities. The company has successfully dosed the first patient in its Phase 1 trial of Decoy20 for solid tumors, with further enrollment expected as trial sites expand. Although operational costs have increased significantly, Indaptus expects its financial resources to sustain ongoing activities through mid-2024.

Market Sentiment Analysis

POSITIVE FACTORS

  • First patient dosed in Phase 1 clinical trial of Decoy20.
  • Company's cash position is expected to support operations into Q2 2024.
  • Two trial sites activated, indicating progress in patient enrollment.

CONCERNS & RISKS

  • Increasing research and development expenses could strain finances.
  • Need for additional funding not guaranteed, creating uncertainty.

Full Press Release Details

Therapeutics Reports Fourth Quarter and Year-End 2022 Financial Results and Provides Corporate Update
Underway in Phase 1 Clinical Trial of Decoy20 for Treatment of Solid Tumors with First Patient Dosed In March 2023
YORK (March 17, 2023) - 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.
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."
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 .
Highlights for Fourth Quarter and Fiscal Year Ended December 31, 2022
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.
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.
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.
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.
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.
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.
Indaptus Therapeutics
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.
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
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
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 )
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

Frequently Asked Questions

What is the status of Indaptus' Phase 1 Clinical Trial?

Indaptus is currently progressing in its Phase 1 trial of Decoy20, with the first patient dosed in March 2023.

What adverse events occurred during the trial?

The first patient experienced manageable adverse events believed to relate to the immune system's response.

How much cash did Indaptus have by the end of 2022?

As of December 31, 2022, Indaptus had approximately $26.4 million in cash and marketable securities.

What are the objectives of the Decoy20 study?

The study aims to assess safety, tolerability, MTD, RP2D, and pharmacokinetics of Decoy20.

What was the net cash used in operating activities in 2022?

Indaptus used approximately $13.1 million in net cash for operating activities in 2022.

Last updated: Mar 17, 2023