Company: INDP
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001641172-25-023333
Chunk: 18

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 8
Chunk 18
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 (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 June 2025 we
announced the dosing of the first participant in the Combination Study and by August 2025 we had enrolled 6 participants, and we
have seen one related serious adverse event of CRS in 1 participant that has resolved within 72 hours. The Combination Study will
assess safety, dose optimization, and early signs of anti-tumor activity in participants with advanced solid tumors, previously
treated with a checkpoint inhibitor or with tumors typically unresponsive to checkpoint inhibitors.

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 in the planning,