Company: INDP
Filing Date: 2025-05-14
Form Type: 10-Q
Source: 0001641172-25-010099
Chunk: 58

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-05-14
Form: 10-Q
Item: Part I, Item 2
Chunk 58
---
 potential benefits
emerging with some participants with stable disease. As
expected with the mechanism of action of Decoy20, we have seen adverse events of cytokine release syndrome (CRS) in 4 participants
that have resolved within 24 hours.

In
October 2024, we entered into a clinical supply agreement, or the Supply Agreement, with BeOne Medicines (formerly known as BeiGene Switzerland GmbH), to advance
clinical evaluation of Decoy20 in combination with BeOne’s anti-PD-1 antibody, Tislelizumab, or the BeOne Product, for the
treatment of participants with advanced solid tumors, or the Combination Study. This Combination Study builds on preclinical results where
Decoy20, combined with a PD-1 inhibitor, demonstrated tumor eradication. In March 2025,
we announced the initiation of the Phase 1 Combination Study of Decoy20 with Tislelizumab.

Under
the terms of the Supply Agreement, we will pay for all costs associated with the Combination Study (other than the cost of the BeOne
Product), BeOne will supply the BeOne 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
BeOne 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.

Impact
of Macroeconomic Conditions on our Operations

Economic
developments such as inflation, interest rates and tariffs have negatively affected the global financial markets and may reduce our
ability to access capital, which could negatively impact our short-term and long-term liquidity. The ultimate impact of current
economic conditions is highly uncertain and subject to change. While it is unknown how long these conditions will last and what the
complete financial effect will be to us, capital raise efforts and additional development of our technologies may be negatively
affected. In addition, our business operations expose us to risks associated with public health crises and
epidemics/pandemics.

Components
of Operating Results

Research
and Development Expenses

Research
and development expenses account for a significant portion of our operating expenses. Research and development expenses consist primarily
of fees paid to contract research organizations, or CROs, and contract manufacturing organizations, or CMOs, as well as compensation
expenses for certain employees involved