Company: INDP
Filing Date: 2025-02-12
Form Type: S-1
Source: 0001493152-25-006068
Chunk: 89

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-02-12
Form: S-1
Chunk 89
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, advanced into the multi-dosing cohort of the Phase 1 clinical trial. The second cohort dose was 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.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.

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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;                                             |
| ● | expanding                                                                                                       
 our bacterial product platform to target additional types of cancer, as well as additional infectious diseases; |
| ● | maintaining,                                                                                                    
 expanding and protecting our intellectual property portfolio; and                                               |
| ● | seeking                                                                                                         
 regulatory approvals for any product