Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 13

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 13
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 a reduction from the dosing in the first cohort
based on the significant pharmacodynamic effect seen with the first cohort and anticipated optimal Decoy20 safety profile for both multi-dosing
and combination approaches. In May 2024, we successfully dosed the first patient in the multi-dose portion
of the Phase I clinical trial with Decoy20. The primary goal of this stage of the trial was to evaluate the safety of Decoy20 when administered
multiple times to the same patient. We intend to progress Decoy20 into combination studies with a checkpoint inhibitor. In August 2024,
the Safety Review Committee convened to review the safety data at the higher Decoy20 dose with single dose administration and the safety
data at the lower Decoy20 dose with weekly administration. The data led to the decision to continue dosing additional patients at the
lower Decoy20 dose on a weekly schedule and initiate dosing patients at the higher Decoy20 dose on a weekly schedule. In October 2024,
the Safety Review Committee examined weekly administration data at the lower Decoy20 dose and cleared unrestricted enrollment of patients
at this dose. As of March 12, 2025, we have enrolled more than 20 patients in the weekly dosing among the two Decoy20 dose levels
and we have observed early signs of potential benefits emerging with some patients with stable disease. We are working to increase the
number of trial sites to accelerate patient enrollment and data collection.

In
February 2025, we announced that we received clinical trial authorization from Health Canada to initiate a clinical trial for Decoy20
which allows us to expand our ongoing U.S. clinical trial to Canadian sites. The trial will enroll patients in Canada under the current
protocol, which involves weekly dosing of Decoy20. We also plan to submit an amendment to Health Canada to initiate the Combination Study
in Canada.

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.

Our
business strategy includes:

    ●
    adding operational, financial
    and management information systems and personnel, including personnel to support our planned product development and commercialization
    efforts, as well as to support our reporting and other compliance obligations as a public reporting company;

    ●
    advancing to the expansion
    portion of the Phase 1 clinical trial for Decoy20;