INDP US Equity☆

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

10-K

(Mark

One)

☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For

the fiscal year ended December 31, 2021

OR

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR

THE TRANSITION PERIOD FROM TO

Commission

File Number 001-37521

INDAPTUS

THERAPEUTICS, INC.

(Exact

name of Registrant as specified in its Charter)

3 Columbus Circle 15th Floor New York, NY 10019

(Address of principal executive offices) (Zip Code)

Registrant’s

telephone number, including area code: +(347)480-9760

Securities

registered pursuant to Section 12(b) of the Act:

Common stock, par value $0.01 INDP Nasdaq Capital Market

Securities

registered pursuant to Section 12(g) of the Act:

None

Indicate

by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ☐ NO ☒

Indicate

by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES ☐ NO ☒

Indicate

by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange

Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2)

has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐

Indicate

by check mark whether the Registrant has submitted electronically, every Interactive Data File required to be submitted and posted pursuant

to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant

was required to submit and post such files). YES ☒ NO ☐

Indicate

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company,

or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller

reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer ☒ Smaller reporting company ☒

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. ☐

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered

public accounting firm that prepared or issued its audit report. ☐

Indicate

by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒

The

aggregate market value of the common stock held by non-affiliates of Intec Pharma Ltd. (the “Predecessor”), the Registrant’s

predecessor, based on the closing price of the ordinary shares of the Predecessor on the Nasdaq Capital Market on June 30, 2021, was

$25,712,232.

The

number of shares of Registrant’s common stock outstanding as of March 16, 2022: 8,258,597

DOCUMENTS

INCORPORATED BY REFERENCE

None.

Table

of Contents

Page

PART I

Item 1. Business 6

Item 1A. Risk Factors 18

Item 1B. Unresolved Staff Comments 43

Item 2. Properties 43

Item 3. Legal Proceedings 43

Item 4. Mine Safety Disclosures 43

PART II

Item 6. [Reserved] 44

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 50

Item 8. Financial Statements and Supplementary Data 50

Item 9A. Controls and Procedures 51

Item 9B. Other Information 52

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 52

PART III

Item 10. Directors, Executive Officers and Corporate Governance 52

Item 11. Executive Compensation 58

Item 14. Principal Accounting Fees and Services 66

PART IV

Item 15. Exhibits, Financial Statement Schedules 67

ABOUT

THIS ANNUAL REPORT

All

references to “we,” “us,” “our,” “Indaptus Therapeutics”, “Indaptus”, “the

Company” and “our company”, in this Annual Report on Form 10-K, or our Annual Report, are to Indaptus Therapeutics,

Inc. (formerly Intec Parent, Inc.) and, where appropriate, its consolidated subsidiaries Intec Pharma Ltd. and Decoy Biosystems, Inc.

References to “Intec Parent” refer to Intec Parent, Inc., the successor of Intec Pharma Ltd. following the Domestication

Merger, references to “Intec Israel” refer to Intec Pharma Ltd., the predecessor of Indaptus prior to the Domestication Merger,

and references to “Decoy” refer to Decoy Biosystems, Inc., the entity acquired by Indaptus in connection with the Merger

described below in “Item 1. Business—Historical Background and Corporate Structure”.

All references to “common stock” and “share capital” refer to common stock and share capital of Indaptus.

Our historical results do not necessarily indicate our expected results for any future periods. Any discrepancies in any table between

totals and sums of the amounts listed are due to rounding. Unless otherwise indicated, or the context otherwise requires, references

in this Annual Report to financial and operational data for a particular year refer to the fiscal year of our Company ended December

31 of that year.

CAUTIONARY

NOTE REGARDING FORWARD-LOOKING STATEMENTS

This

Annual Report contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our product

development efforts, business, financial condition, results of operations, strategies, plans and prospects. In addition, from time to

time, we or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can

be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,”

“may,” “should,” “anticipate,” “could,” “might,” “seek,” “target,”

“will,” “project,” “forecast,” “continue” 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. These forward-looking statements

may be included in, among other things, various filings made by us with the Securities and Exchange Commission, or the SEC, press releases

or oral statements made by or with the approval of one of our authorized executive officers. Forward-looking statements relate to anticipated

or expected events, activities, trends or results as of the date they are made. 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 our actual

activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but

not limited to, the factors summarized below:

● our plans to develop and potentially commercialize our technology;

● the completion and receipt of favorable results in any clinical trials;

● Our ability to develop, manufacture and commercialize our product candidates;

We

believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known

and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance

or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in

this Annual Report in greater detail under the heading “Risk Factors” and elsewhere in this Annual Report. Given these uncertainties,

you should not rely upon forward-looking statements as predictions of future events.

All

forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified

in their entirety by the cautionary statements included in this Annual Report. We undertake no obligations 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 law. In evaluating forward-looking statements, you should consider these risks and uncertainties and not place undue reliance

on our forward-looking statements.

EXPLANATORY

NOTE

Market

data and certain industry data and forecasts used throughout this Annual Report were obtained from market research databases, consultant

surveys commissioned by us, publicly available information, reports of governmental agencies and industry publications and surveys. Industry

surveys, publications, consultant surveys commissioned by us and forecasts generally state that the information contained therein has

been obtained from sources believed to be reliable. We have relied on certain data from third-party sources, including internal surveys,

industry forecasts and market research, which we believe to be reliable based on our management’s knowledge of the industry. Statements

as to our market position are based on the most currently available data. While we are not aware of any misstatements regarding the industry

data presented in this Annual Report, our estimates involve risks and uncertainties and are subject to change based on various factors,

including those discussed under the heading “Risk Factors” in this Annual Report. Notwithstanding the foregoing, we remain

responsible for the accuracy and completeness of the historical information presented in this Annual Report, as of the date on the front

cover of this Annual Report.

PART

I

Item

1. Business.

Overview

We

are a pre-clinical biotechnology company developing a novel and patented systemically-administered anti-cancer and anti-viral immunotherapy.

We have evolved from more than a century of immunotherapy advances. Our approach is based on the hypothesis that efficient activation

of both innate and adaptive immune cells 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. Our patented technology is composed of single strains

of attenuated and killed, non-pathogenic, Gram-negative bacteria, with reduced i.v. toxicity, but largely uncompromised ability to prime

or activate many of the cellular components of innate and adaptive immunity. This approach has led to broad anti-tumor and anti-viral

activity, including safe, durable anti-tumor response synergy with each of five different classes of existing agents, including checkpoint

therapy, targeted antibody therapy and low-dose chemotherapy in pre-clinical models. Tumor eradication by our technology has demonstrated

activation of both innate and adaptive immunological memory and, importantly, does not require provision of or targeting a tumor antigen

in pre-clinical models. We have carried out successful GMP manufacturing of our lead clinical candidate, Decoy20, and completed other

IND-enabling studies.

Unlike

many competitor products, our technology does not depend on targeting with or to a specific antigen, providing broad applicability across

multiple indications. Our products are designed to have a much shorter half-life and produce less systemic exposure than small molecule,

antibody or human cell-based therapies, potentially reducing the risk of non-specific auto-immune reactions. Our technology produces

single agent activity and/or combination therapy-based durable responses of lymphoma, hepatocellular, colorectal and pancreatic tumors

and is also active against hepatitis B virus (HBV) and HIV infection in standard pre-clinical models. We have carried out a Pre-IND meeting

with the US FDA, plans to file an IND in the first half of 2022 and then initiate in 2022 a Phase 1 clinical trial targeting tumors that

exhibit low durable response rates to current immunotherapy. Target indications include, but not limited to, colorectal, hepatocellular

(± HBV), bladder, cervical and pancreatic carcinoma, which according to GLOBOCAN 2020, account in the aggregate

for 23% of yearly cancer cases and over 28% of yearly cancer deaths world-wide.

Historically,

we have operated virtually with a team of highly experienced consultants and advisors, carrying out research and development at contract

research organizations. We have a broad patent portfolio with 33

granted patents and 16 pending patent applications. Since our inception, we have funded our operations

primarily through public and private offerings of our equity securities.

We

are a smaller reporting company, and we will remain a smaller reporting company until the fiscal year following the determination that

our common stock held by non-affiliates is more than $250 million measured on the last business day of our second fiscal quarter, or

our annual revenues are more than $100 million during the most recently completed fiscal year and our common stock held by non-affiliates

is more than $700 million measured on the last business day of our second fiscal quarter. Similar to emerging growth companies, smaller

reporting companies are able to provide simplified executive compensation disclosure, are exempt from the auditor attestation requirements

of Section 404 of the Sarbanes-Oxley Act, and have certain other reduced disclosure obligations, including, among other things,

being required to provide only two years of audited financial statements and not being required to provide selected financial data, supplemental

financial information or risk factors.

Our

principal executive offices are located at 3 Columbus Circle, 15th Floor, New York, NY 10019 and our telephone number is (347)

480-9760. Our website address is http://www.indaptusrx.com. The information contained on, or that can be accessed through, our website

is neither a part of nor incorporated into this Annual Report. We have included our website address in this Annual Report solely as an

inactive textual reference.

We

use our investor relations website (https://indaptusrx.com/investors/) as a channel of distribution of Company information. The information

we post through this channel may be deemed material. Accordingly, investors should monitor our website, in addition to following our

press releases, SEC filings and public conference calls and webcasts. The contents of our website are not, however, a part of this Annual

Report.

Background

Approved

immunotherapies, such as Interluekin-2, Interferon-alpha and the more recently approved “checkpoint” and CAR-T therapies

produce durable responses in a few percent to about fifty percent of patients across about a dozen out of over one hundred different

types of cancer. Although checkpoint therapies are able to effectively cure many previously incurable patients, only about 15% of patients

receiving this type of therapy respond. The main limitation of existing immunotherapies is that they each activate only one or a small

number of key steps in either the innate or adaptive immune system, but there is general agreement that highly efficient cancer immunotherapy

will require activation of both innate and adaptive immunity. The human body’s innate and adaptive immune systems are each capable

of cell-mediated destruction of tumors if the tumor cells are recognized as foreign or damaged. Activation of innate and adaptive responses

is also dependent on immune cells sensing the presence of “danger.” The most potent immune cell activating danger signals

are released by bacteria and viruses in the setting of infection, and include agonists of immune cell receptors, such as Toll-Like (TLR),

NOD and STING. Bacterial danger signals, including TLR agonists are called pathogen-associated molecular patterns (PAMPs) and can activate

both innate and adaptive immune cells, including antigen-presenting cells, promoting innate (NK, macrophage) and adaptive (T cell-mediated)

destruction of tumors.

The

oldest form of cancer immunotherapy involves the provision of decoy danger signals from bacteria. It was based on the long-standing observation

of tumor regression in the setting of bacterial infection. Treatment of cancer patients with heat-killed bacteria (“Coley’s

toxins”) was established in 1891 and used for 70 years with significant success. For example, ≥5-year survival was reported

for 45% of 432 inoperable sarcoma, lymphoma, melanoma, and carcinoma patients. Despite this success, several limitations led to the abandonment

of this approach by the pharmaceutical industry. Although there was an indication that Coley’s toxins worked best when administered

intravenously (i.v.), it was too toxic when given by this route, limiting the approach to local administration, which produced highly

variable results. Another limitation was lack of knowledge about the mechanism of action, preventing optimization and standardization

of manufacturing, leading to another source of variability in clinical response. Due to this high variability, Coley’s toxins was

not grandfathered-in as an approved drug by the FDA in 1963 and was supplanted by radiation and chemotherapy, despite the fact that these

more modern approaches rarely produce durable responses in advanced cancer patients.

Scientists

now understand the mechanism of action of Coley’s toxins. Gram-negative bacteria contain multiple immune-stimulating danger signals,

including TLR agonists such as lipopolysaccharide (LPS). Bacteria and purified or mono-specific TLR agonists, including LPS derivatives,

have been validated and approved for prevention and treatment of early stage cancer. However, a safe and effective TLR agonist-based

approach for advanced cancer has been elusive, possibly due to limitations in the ability of intratumorally administered, mono-specific

TLR agonists to induce potent, systemic anti-tumor immune responses. In addition, the intratumoral approach is not feasible with all

tumor types or patients. Our hypothesis is that an effective TLR agonist-based immunotherapy for advanced cancer will require invention

of a packaged, multi-TLR agonist or multi-danger signal product that is modified or attenuated to allow safe i.v. administration.

Our

Approach

Our

patented approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and associated anti-tumor

immune responses can be achieved by using intact bacteria, containing multiple PAMPs, which have been attenuated so that they can be

administered safely intravenously. Because LPS appears to be the most important contributor to both toxicity and efficacy, our patented

products are single strains of killed, non-pathogenic Gram-negative bacteria that have been treated to kill the bacteria and significantly

reduce, but not completely eliminate, the cell surface lipopolysaccharide (LPS)-endotoxin activity. Our products are designed to have

enhanced i.v. safety and sufficient residual LPS to synergize with other PAMPs in the bacteria to efficiently prime innate and adaptive

immune pathways. This leads to broad anti-tumor responses, including safe, synergistic regressions and durable responses with five different

classes of existing anti-tumor agents, including checkpoint therapy, targeted antibody therapy and low-dose chemotherapy. Tumor eradication

by our technology produces both innate and adaptive immunological memory and, importantly, does not require provision of an exogenous

tumor antigen, probably due to the ability of LPS and other PAMPS to activate dendritic cells that have already captured a tumor antigen.

All

immune cells can participate in killing of tumors and viruses. As illustrated below, current therapies activate only one or a small subset

of both pathways and cure only a small percentage of patients.

Our

bacteria, however, are engineered to synergize with existing therapies to activate both innate and adaptive immune cells, inducing efficient

anti-tumor immune responses with a wide safety margin. Induction of adaptive anti-tumor immune responses and immunological memory by

our bacteria does not require an exogenous tumor antigen.

Innate

and adaptive immune responses require identification of a tumor as foreign or not self. However, most steps required for migration and

activation of immune cells are unrelated to the tumor or are tumor non-specific. All innate and adaptive non-specific steps are induced

or promoted by immune system “danger signal” molecules, such as those found in our bacteria. Bacteria-derived danger signals

are also able to enhance the processing and recognition of tumor antigens, which are frequently present, but not “seen” by

the immune system.

Results

We

have developed patented treatment methods (and associated patented compositions) for attenuation and killing of non-pathogenic, Gram-negative

bacteria (33 issued or granted patents). Indaptus treated bacteria induce significantly less systemic toxicity than untreated

bacteria but are still able to activate innate and adaptive immune responses. Despite exhibiting reduced in vivo pyrogenicity and toxicity,

our bacteria are able to induce cytokine and chemokine secretion from mouse and human immune cells at levels comparable to those seen

with untreated bacteria. Our bacteria are also able to synergize with human immune cells to kill human tumor cells in vitro.

We

have observed significant single agent anti-tumor activity and/or combination therapy-mediated regression with durable response of established

non-Hodgkin’s lymphoma, as well as colorectal, hepatocellular and pancreatic carcinoma in pre-clinical syngeneic and human tumor

xenograft models. Our bacteria safely synergize with each of five different classes of approved agents, including checkpoint therapy,

targeted antibodies, low-dose chemotherapy, non-steroidal anti-inflammatory drugs (NSAIDs) and cytokines to induce tumor regression,

providing significant flexibility for targeting of diverse types of cancer. Our technology eradicates tumors via activation of both innate

(NK cell) and adaptive (CD4+ and CD8+ T cell) mechanisms, producing both innate and adaptive immunological memory. Tumor eradication

occurs at non-toxic doses of our bacteria, with a very wide (10 to ≥33-fold) therapeutic index. Significant mechanism of action information

has also been obtained, via gene expression analysis with treated tumors and plasma cytokine analysis, demonstrating that our combination

technology turns “cold” tumors into “hot” tumors and induces, activates or recruits innate and adaptive genes,

cells and pathways. Immune cell pre-depletion studies have demonstrated that both innate (NK) and adaptive (CD4 T and CD8 T) immune cells

are involved in tumor eradication. We have also demonstrated significant single agent activity against chronic Hepatitis B virus (HBV)

and human immunodeficiency virus (HIV) infection in standard pre-clinical models.

We

have carried out successful GMP manufacturing and stability studies with our lead product, Decoy20. In addition, IND-enabling multi-dose

toxicology studies have completed and have not produced sustained induction of factors that are associated with cytokine release syndrome.

We plan to file an IND in the first half of 2022 and then initiate in 2022 a Phase 1 clinical trial with solid tumor patients.

The

chart above demonstrates that our bacteria synergize with Anti-PD-1 Checkpoint therapy to regress established mouse hepatocellular carcinoma

(HCC) Tumors. All mice (all groups) received a low-dose, non-steroidal anti-inflammatory drug (NSAID/Indomethacin), which increases the

number of regressions in the combination setting. Most regressions were durable, with 5/6 combination regressions stable through termination

at Day 91 and in a repeat experiment through termination at Day 143 (see next Figure below) (CR = complete response or complete regression).

The repeat experiment also produced safe, 5/6 or 6/6 durable regressions per group over a 33-fold Indaptus concentration range, demonstrating

a very wide therapeutic index. Similar tumor eradication results have been obtained by combining our bacteria with low-dose chemotherapy

in a mouse non-Hodgkin’s lymphoma model. Eradication of established non-Hodgkin’s lymphoma tumors by our technology has also

been observed with human tumor xenografts, via activation of the innate immune system. Development and preclinical efficacy characterization

of a systemically administered multiple Toll-like receptor (TLR) agonist for antitumor immunotherapy [abstract]. In: Proceedings of the

Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival; Sept 30-Oct 3, 2018; New

York, NY. Philadelphia (PA): AACR; Cancer Immunol Res 2019;7(2 Suppl):Abstract nr B178.

The

chart above illustrates that the synergistic tumor eradication by our and Anti-PD-1 produces immunological memory. Established tumors

were regressed in 11 mice by combination treatment as in the Figure above and then the mice were re-challenged with fresh HCC tumor cells,

without further treatment. All of the new tumors were rejected. Similar results have been obtained by combining our bacteria with low-dose

chemotherapy in a non-Hodgkin’s lymphoma model.

Business

Strategy

Our

mission is to enhance and expand curative cancer immunotherapy for patients with unresectable or metastatic solid tumors and lymphomas,

which are responsible for approximately 90% of all cancer deaths. We intend to initiate a Phase 1 clinical trial in 2022 with advanced

solid tumor patients. The trial will include a dose escalation to determine the side-effect profile and recommended Phase 2 dose, an

expansion with tumor types that may be responsive, and a Phase 1b combination trial with Checkpoint Therapy, targeted antibodies and/or

low-dose chemotherapy. Its business strategy includes:

● Maintaining, expanding and protecting our intellectual property portfolio; and

Competitive

Advantages

Our

bacteria contain multiple constituents, capable of priming or activating many of the cellular components of both innate and adaptive

immunity, but have been attenuated by a patented process to reduce the potential for over-stimulation of the immune system and consequential

induction of undesirable autoimmune reactions. Our bacteria are also likely to be cleared very quickly by the liver and spleen, which

may further reduce the risk of non-specific autoimmune side effects, relative to other types of immunotherapy that are designed for continuous

exposure. We believe a short Indaptus exposure is sufficient to act alone and as a “primer” to enhance other products. Additionally,

Our products can be manufactured by a highly cost-efficient process, potentially providing accelerated patient access in both developed

and developing geographical regions.

Governmental

Regulation

We

operate in a highly regulated industry that is subject to significant federal, state, local and foreign regulation. Its present and future

business strategy has been, and will continue to be, subject to a variety of laws including, the FDCA, subject to a variety of laws including,

the FDCA and the Public Health Service Act (PHSA), among others.

The

FDCA, PHSA, and other federal and state statutes and regulations govern the testing, manufacturing, safety, effectiveness, labeling,

storage, record keeping, approval, advertising and promotion of our products. As a result of these laws and regulations, product development

and product approval processes are very expensive and time-consuming.

FDA

Approval Process

In

the United States, pharmaceutical products, including biologics, are subject to extensive regulation by the FDA. The FDCA and other federal

and state statutes and regulations, govern, among other things, the research, development, testing, manufacturing, storage, record keeping,

approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of

pharmaceutical products. Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or

judicial sanctions, such as FDA refusal to approve pending NDAs or BLAs, warning letters, product recalls, product seizures, total or

partial suspension of production or distribution, injunctions, fines, civil penalties, and criminal prosecution.

Pharmaceutical

product development in the United States typically involves preclinical laboratory and animal tests, the submission to the FDA of an

IND, which must become effective before clinical testing may commence, and adequate and well-controlled clinical trials to establish

the safety and effectiveness of the drug or biologic for each indication for which FDA approval is sought. Satisfaction of FDA pre-market

approval requirements typically takes many years and the actual time required may vary substantially based upon the type, complexity

and novelty of the product or disease.

Pre-clinical

tests include laboratory evaluation as well as animal trials to assess the characteristics and potential pharmacology and toxicity of

the product. The conduct of the pre-clinical tests must comply with federal regulations and requirements including good laboratory practices.

The results of pre-clinical testing are submitted to the FDA as part of an IND along with other information, including information about

product chemistry, manufacturing and controls, and a proposed clinical trial protocol. Long term pre-clinical tests, such as animal tests

of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.

A

30-day waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA

has not objected to the IND within this 30-day period, the clinical trial proposed in the IND may begin.

Clinical

trials involve the administration of the investigational drug to healthy volunteers or patients under the supervision of a qualified

investigator. Clinical trials must be conducted in compliance with federal regulations and good clinical practices, or GCP, as

well as under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness

criteria to be evaluated. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to

the FDA as part of the IND.

The

FDA may order the temporary or permanent discontinuation of a clinical trial at any time or impose other sanctions if it believes that

the clinical trial is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial

patients. The clinical trial protocol and informed consent information for patients in clinical trials must also be submitted to an institutional

review board (“IRB”) for approval. An IRB may also require the clinical trial at the site to be halted, either temporarily

or permanently, for failure to comply with the IRB’s requirements, or may impose other conditions.

Clinical

trials to support NDAs or BLAs, which are applications for marketing approval, are typically conducted in three sequential Phases, but

the Phases may overlap. In oncology Phase 1 trials, the investigational drug candidate is typically given to cancer patients who have

failed all approved products in order to assess metabolism, pharmacokinetics, pharmacological actions, side effects associated with increasing

doses and, if possible, early evidence on effectiveness. Phase 2 usually involves trials in a limited patient population, to determine

the effectiveness of the investigational drug for a particular indication or indications, dosage tolerance and optimum dosage, and identify

common adverse effects and safety risks.

If

an investigational cancer drug demonstrates significant evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations,

it may be considered for accelerated approval, although more often, Phase 3 clinical trials are undertaken to obtain additional information

about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit

the FDA to evaluate the overall benefit-risk relationship of the investigational drug and to provide adequate information for its labeling.

After

completion of the required clinical testing, an NDA or, in the case of a biologic, a BLA, is prepared and submitted to the FDA. FDA approval

of the marketing application is required before marketing of the product may begin in the United States. The marketing application must

include the results of all preclinical, clinical and other testing and a compilation of data relating to the product’s pharmacology,

chemistry, manufacture, and controls.

The

FDA has 60 days from its receipt of an NDA or BLA to determine whether the application will be accepted for filing based on the agency’s

threshold determination that it is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the

FDA begins an in-depth review. The FDA has agreed to certain performance goals in the review of marketing applications. Most such applications

for non-priority drug products are reviewed within ten months. The review process may be extended by the FDA for three additional months

to consider new information submitted during the review or clarification regarding information already provided in the submission. The

FDA may also refer applications for novel drug products or drug products that present difficult questions of safety or efficacy to an

advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether

the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such

recommendations. Before approving a marketing application, the FDA will typically inspect one or more clinical sites to assure compliance

with GCP.

Additionally,

the FDA will inspect the facility or the facilities at which the drug product is manufactured. The FDA will not approve the NDA or, in

the case of a biologic, the BLA unless compliance with GMP is satisfactory and the marketing application contains data that provide substantial

evidence that the product is safe and effective in the indication studied. Manufacturers of biologics also must comply with FDA’s

general biological product standards.

After

the FDA evaluates the NDA or BLA and the manufacturing facilities, it issues an approval letter or a complete response letter. A complete

response letter outlines the deficiencies in the submission and may require substantial additional testing or information in order for

the FDA to reconsider the application. If and when those deficiencies have been addressed in a resubmission of the marketing application,

the FDA will re-initiate their review. If the FDA is satisfied that the deficiencies have been addressed, the agency will issue an approval

letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type of information included. It

is not unusual for the FDA to issue a complete response letter because it believes that the drug product is not safe enough or effective

enough or because it does not believe that the data submitted are reliable or conclusive.

An

approval letter authorizes commercial marketing of the drug product with specific prescribing information for specific indications. As

a condition of approval of the marketing application, the FDA may require substantial post-approval testing and surveillance to monitor

the drug product’s safety or efficacy and may impose other conditions, including labeling restrictions, which can materially affect

the product’s potential market and profitability. Once granted, product approvals may be withdrawn if compliance with regulatory

standards is not maintained or problems are identified following initial marketing.

Other

Regulatory Requirements

FDA

Post-Approval Requirements

Once

an NDA or BLA is approved, a product will be subject to certain post-approval requirements. For instance, the FDA closely regulates the

post-approval marketing and promotion of therapeutic products, including standards and regulations for direct-to-consumer advertising,

off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the internet.

Biologics

may be marketed only for the approved indications and in accordance with the provisions of the approved labeling. Changes to some of

the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities,

require submission and FDA approval of a new BLA or BLA supplement, before the change can be implemented. A BLA supplement for a new

indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions

in reviewing BLA supplements as it does in reviewing BLAs. We cannot be certain that the FDA or any other regulatory agency will grant

approval for our product candidate for any other indications or any other product candidate for any indication on a timely basis, if

at all.

Adverse

event reporting and submission of periodic reports is required following FDA approval of a BLA. The FDA also may require post-marketing

testing, known as Phase IV testing, risk evaluation and mitigation strategies, and surveillance to monitor the effects of an approved

product or place conditions on an approval that could restrict the distribution or use of the product. In addition, quality control as

well as product manufacturing, packaging, and labeling procedures must continue to conform with cGMP after approval. Manufacturers and

certain of their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject

to periodic unannounced inspections by the FDA during which the agency inspects manufacturing facilities to assess compliance with GMP.

Accordingly, manufacturers must continue to expend time, money and effort in the areas of production and quality control to maintain

compliance with GMP. Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with

regulatory standards, if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently

discovered.

Competition

The

pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis

on proprietary products. While we believe that our technology, knowledge and scientific resources provide us with certain competitive

advantages, we face competition from many sources including pharmaceutical and biotechnology companies, academic institutions, governmental

agencies and public and private research institutions. Many of these competitors may have access to greater capital and resources than

us. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel. Any product candidates

that we successfully develop and commercialize will compete with new immunotherapies that may become available in the future. Our competitors

include larger and better funded biopharmaceutical, biotechnology and therapeutics companies, specifically companies focused on cancer

immunotherapies, such as Amgen, Inc., AstraZeneca plc, BMS, Genentech, Inc., GlaxoSmithKline PLC, Merck & Co., Inc., Novartis AG,

Pfizer Inc., Roche Holding Ltd and Sanofi S.A. In contrast, many of these companies are developing immunotherapeutics which may have

potential to be used in concert with Decoy20 and in this regard, we view them as potentially complimentary.

With

respect to our lead candidate Decoy20, there are a number of companies that are developing possible treatments for cancer, however, we

believe we are the only company using systemic administration of killed, non-pathogenic Gram-negative bacteria with reduced lipopolysaccharide-endotoxin

to stimulate innate and adaptive immune system pathways.

Our

success will be based in part upon our ability to successfully commercialize Decoy20 and to identify, develop and manage a portfolio

of therapeutics that are safer and more effective than competing products in our target indications. Our market opportunity has the potential

to be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer side effects,

are more convenient or are less expensive than any therapeutics we may develop. Our competitive position will also be dependent upon

our ability to attract and retain qualified personnel, to obtain patent protection or otherwise develop proprietary products or processes,

and protect our intellectual property, and to secure sufficient capital resources for the period between technological conception and

commercial sales. The availability of reimbursement from government and other third-party payors will also significantly affect the pricing

and competitiveness of our products. Our competitors may also obtain FDA or other regulatory approval for their products more rapidly

than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able

to enter the market.

Intellectual

Property

Our

success depends, at least in part, on our ability to protect our proprietary technology and intellectual property, and to operate without

infringing or violating the proprietary rights of others. We rely on a combination of patent, trademark, trade secret and copyright laws,

know-how, intellectual property licenses and other contractual rights (including confidentiality and invention assignment agreements)

to protect our proprietary technology and intellectual property, including related intellectual property rights.

Patents

As

of March 1, 2022, we own 33 granted patents and 16 pending patent applications to use within our field of business. Our patents and patent

applications generally relate to compositions and methods for treating cancer and infectious diseases, and our patents and any patents

that issue from our pending patent applications are expected to expire at various dates between 2033 and 2039.

We

intend to submit patent applications for each new product and technology that we develop. The patent outlook for companies like ours

is generally uncertain and may involve complex legal and factual questions. Our ability to maintain and consolidate our proprietary position

for our technology will depend on our success in obtaining effective claims and enforcing those claims once granted. We do not know whether

any of our patent applications or any patent applications that we may license will result in the issuance of any patents. Our issued

patents and those that may be issued in the future, or patents that we may exclusively license, may be challenged, narrowed, circumvented

or found to be invalid or unenforceable, which could limit our ability to stop competitors from marketing related products or the length

of term of patent protection that we may have for our products. We cannot be certain that we were the first to invent the inventions

claimed in our owned patents or patent applications. In addition, our competitors may independently develop similar technologies or duplicate

any technology developed by us, and the rights granted under any issued patents may not provide us with any meaningful competitive advantages

against these competitors. Furthermore, because of the extensive time required for development, testing and regulatory review of a potential

product, it is possible that, before any of our products can be commercialized, any related patent may expire or remain in force for

only a short period following commercialization, thereby reducing any advantage of the patent.

Trade

Secrets and Confidential Information

In

addition to patents, we rely on trade secrets and know-how to develop and maintain our competitive position. Trade secrets and know-how

can be difficult to protect. We rely on, among other things, confidentiality and invention assignment agreements to protect our proprietary

know-how and other intellectual property that may not be patentable, or that we believe is best protected by means that do not require

public disclosure. For example, we require our employees to execute confidentiality agreements in connection with their employment relationships

with us, and to disclose and assign to us inventions conceived in connection with their services to us. However, there can be no assurance

that these agreements will be enforceable or that they will provide us with adequate protection. We also seek to preserve the integrity

and confidentiality of our data, trade secrets and know-how by maintaining physical security of our premises and physical and electronic

security of our information technology systems.

We

may be unable to obtain, maintain and protect the intellectual property rights necessary to conduct our business, and may be subject

to claims that we infringe or otherwise violate the intellectual property rights of others, which could materially harm our business.

For a more comprehensive summary of the risks related to our intellectual property, see “Item 1A. Risk Factors — Risks Related

to Our Intellectual Property.”

Environmental

Matters

We

are subject to various environmental, health and safety laws and regulations, including those governing air emissions, water and wastewater

discharges, noise emissions, the use, management and disposal of hazardous materials and wastes and the cleanup of contaminated sites.

In addition, all of our laboratory personnel participate in instruction on the proper handling of chemicals, including hazardous substances

before commencing employment, and during the course of their employment with us. In addition, all information with respect to any chemical

substance that we use is filed and stored as a Material Safety Data Sheet, as required by applicable environmental regulations. Based

on information currently available to us, we do not expect environmental costs and contingencies to have a material adverse effect on

us. The operation of our facilities, however, entails risks in these areas. Significant expenditures could be required in the future

if we are required to comply with new or more stringent environmental or health and safety laws, regulations or requirements.

We

believe that our business, operations and facilities are being operated in compliance in all material respects with applicable environmental

and health and safety laws and regulations.

Human

Capital Management

As

of December 31, 2021, we have five full-time employees. None of our employees are

represented by labor unions or covered by collective bargaining agreements.

We

believe that our future success will depend, in part, on our continued ability to attract, hire and retain qualified personnel. In particular,

we depend on the skills, experience and performance of our senior management and research personnel. We compete for qualified personnel

with other biotechnology, medical device, pharmaceutical and healthcare companies, as well as universities and

non-profit research institutions.

We

provide competitive compensation and benefits programs to help meet the needs of our employees. In addition to salaries, these programs

(which vary by country/region and employment classification) include incentive compensation plan, pension, healthcare and insurance benefits,

paid time off, and family leave, among others. We also use targeted equity-based grants with vesting conditions

to facilitate retention of personnel, particularly for our key employees.

The

success of our business is fundamentally connected to the well-being of our people. Accordingly, we are committed to the health and safety

of our employees including safety measures that are required for the COVID-19 pandemic and that comply with government regulations.

We

consider our relations with our employees to be good.

Historical

Background and Corporate Structure

Intec

Israel was established and incorporated in Israel on October 23, 2000 as a private Israeli company under the name Orly Guy Ltd. In February

2001, Intec Israel’s name was changed to Intec Pharmaceuticals (2000) Ltd. Intec Israel’s research and development activities

began originally through a private partnership, Intec Pharmaceutical Partnership I.P.P, a general Israeli partnership, formed on September

21, 2000. Its operations were transferred in full to Intec Israel at the beginning of 2002 in return for the allocation of shares

in Intec Israel to the partners in the partnership, pro rata with their ownership in the partnership. In March 2004, Intec Israel

changed its corporate name to Intec Pharma, Ltd. In February 2010, Intec Israel successfully completed an initial public offering in

Israel on the Tel Aviv Stock Exchange, or TASE and in August 2015 Intec Israel completed an initial public offering in the U.S.

Indaptus

(formerly Intec Parent) was established and incorporated in Delaware on February 24, 2021 as a private Delaware corporation and wholly

owned subsidiary of Intec Israel.

On

March 15, 2021, Indaptus, Domestication Merger Sub Ltd., an Israeli company and a wholly owned subsidiary of Indaptus, or Domestication

Merger Sub, Dillon Merger Subsidiary, Inc., or Merger Sub, and Decoy Biosystems, Inc., a Delaware corporation, or Decoy, entered into

an Agreement and Plan of Merger Agreement, or the Merger Agreement, whereby upon satisfaction of certain closing conditions set forth

in the Merger Agreement, including consummation of the Domestication Merger (as defined herein), Merger Sub was to merge with and into

Decoy, with Decoy being the surviving entity and a wholly owned subsidiary of Indaptus, or the Merger.

On

April 27, 2021, Indaptus, Intec Israel and Domestication Merger Sub entered into an Agreement and Plan of Merger, or the Domestication

Merger Agreement, pursuant to which Intec Israel was to domesticate as a wholly owned subsidiary

of a Delaware corporation by Domestication Merger Sub merging with and into Intec Israel, with Intec Israel being the surviving

entity and a wholly owned subsidiary of Indaptus, or the Domestication Merger.

On

June 21, 2021, Intec Israel held a special meeting of shareholders, or the Special Meeting, to consider certain proposals related to

the Domestication Merger and the Merger. Each of Intec Israel’s proposals was approved at the Special Meeting by the requisite

vote of Intec Israel shareholders.

On

July 27, 2021, Intec Israel, Indaptus and Domestication Merger Sub completed the Domestication Merger pursuant to the terms and

conditions of the Domestication Merger Agreement, whereby Domestication Merger Sub merged with and into Intec Israel, with Intec

Israel being the surviving entity and a wholly-owned subsidiary of Indaptus. To effect the Domestication Merger, Intec Israel

ordinary shares, having no par value per share, or Intec Israel Shares, outstanding immediately prior to the Domestication Merger

converted, on a one-for-one basis, into shares of Indaptus’ common stock, $0.01 par value per share, and all options and

warrants to purchase Intec Israel Shares outstanding immediately prior to the Domestication Merger were exchanged for equivalent

securities of Indaptus. As a result of the Domestication Merger, Intec Israel continued to possess all of its assets, rights, powers

and property as constituted immediately prior to the Domestication Merger and continued to be subject to all of its debts,

liabilities and obligations as constituted immediately prior to the Domestication Merger.

On

August 3, 2021, Indaptus changed its name from Intec Parent, Inc. to Indaptus Therapeutics, Inc. and completed the Merger following

the satisfaction or waiver of the conditions set forth in the Merger Agreement.

At

the effective time of the Merger, each share of Decoy common stock (including shares issuable upon the conversion of Decoy SAFEs (Simple

Agreements for Future Equity) and Decoy preferred stock, par value $0.001 per share, into Decoy common stock) converted into 2.654353395

shares of our common stock, par value $0.01 per share. In addition, at the effective time of the Merger, each outstanding and unexercised

Decoy stock option converted into a stock option exercisable for that number of shares of our common stock subject to such option and

the exercise price being appropriately adjusted to reflect the exchange ratio. Immediately following closing of the Merger there were

5,405,970 shares of our common stock outstanding, with pre-merger Decoy stockholders owning approximately 65.6% and pre-merger Intec

Israel shareholders owning approximately 34.4% of our common stock. The figures above do not give effect to shares issuable upon the

exercise of our outstanding warrants or options. Assuming the exercise in full of the pre-funded warrants sold in the August 2021 Private

Placement (as defined below), there would have been 8,133,243 shares of our common stock outstanding.

Following

completion of the Merger, shares of our common stock commenced trading at market open on August 4, 2021 on the Nasdaq Capital Market

under the name “Indaptus Therapeutics, Inc.” and ticker symbol “INDP”.

In