Company: INDP
Filing Date: 2025-03-13
Form Type: POS AM
Source: 0001493152-25-010137
Chunk: 8

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: POS AM
Chunk 8
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 the 3 x 10^7 Decoy20 dose and following the review of the safety data by the Safety Review Committee we received the authorization to initiate unrestricted enrollment of patients at the 3 x 10^7 Decoy20 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 October 2024, we entered into a clinical supply agreement (the “Supply Agreement”) with BeiGene Switzerland GmbH, or BeiGene, to advance clinical evaluation of Decoy20 in combination with BeiGene’s anti-PD-1 antibody, tislelizumab, or the BeiGene Product, for the treatment of patients with advanced solid tumors, or the Combination Study. This Combination Study builds on preclinical results where Decoy20, combined with a PD-1 inhibitor, demonstrated high tumor eradication rates and established immunological memory. We intend to seek approval from the FDA to initiate the Combination Study, which is anticipated to begin in 2025.

Under the terms of the Supply Agreement, we will pay for all costs associated with the Combination Study (other than the cost of the BeiGene Product), BeiGene will supply the BeiGene Product to us for the purposes of the study, and we will supply Decoy20 for the purposes of the Combination Study. The Supply Agreement will terminate upon the earlier of (i) the one-year anniversary of the date that we provide BeiGene with the Combination Study’s final clinical study report or (ii) the date of termination of the Combination Study, subject to early termination in certain circumstances.

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.

August 2024 Financing

On August 8, 2024, we completed a registered direct offering, pursuant to which we sold and issued to certain investors, including an officer and director of the Company, 1,643,837 shares of our common stock. In addition, in a concurrent private placement, we