Company: INDP
Filing Date: 2025-11-12
Form Type: 10-Q
Source: 0001493152-25-021759
Chunk: 58

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-11-12
Form: 10-Q
Item: Part I, Item 8
Chunk 58
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 enrolled six evaluable participants in the Combination Study, and we have seen one related serious adverse event of CRS in one
participant that has resolved within 72 hours. Following efficacy evaluations, we had three participants who experienced disease
progression and had to discontinue from the study, and we had evidence of stable disease at the first re-staging assessment in three
subjects. Of the three stable disease participants, one subject developed disease progression at the next restaging assessment
and has discontinued from the study; one subject continues dosing with Decoy20 alone with stable disease - this subject
developed an immune-related adverse event and has not been receiving tislelizumab since the emergence of that adverse
event; and the third subject continues dosing with both Decoy20 and tislelizumab with stable disease and is scheduled for further
re-staging assessments. The Safety Review Committee has reviewed all available safety data from this cohort and determined that
the Decoy20 and tislelizumab combination appears to be tolerable at the current dose and schedule. 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. Currently, we have paused enrollment
pending additional efficacy evaluations of the remaining participants and to further assess our next development options.

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.

2

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