Company: IXHL
Filing Date: 2025-02-14
Form Type: 10-Q
Source: 0001213900-25-013783
Chunk: 27

Company: Incannex Healthcare Inc.
Filing Date: 2025-02-14
Form: 10-Q
Item: Part I, Item 1
Chunk 27
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availability of IHL-42X, demonstrating delivery of both dronabinol and acetazolamide. The PK profile of IHL-42X was observed
to be similar to those established for the respective reference listed drugs (“RLDs”), including equivalent total exposure
levels observed for the drug molecules. Furthermore, administration of IHL-42X with food, in contrast to fasted conditions, indicated
no substantial food effect on overall exposure to acetazolamide. Consistent with what is known for the RLD, an increase in overall exposure
to delta-9-tetrahydrocannabinol was observed when IHL-42X was administered with food, compared to fasted state. No serious adverse events
were reported during the study. All but one Treatment-Emergent Adverse Event (“TEAE”) was reported to be mild or moderate.
The proportion of subjects reporting at least one TEAE on the IHL-42X fasted period (57.4%) was similar to the dronabinol fasted period
(52.1%). Fewer subjects reported TEAEs during the acetazolamide fasted treatment period (37.8%). Food did not have a substantial effect
on the number of subjects reporting TEAEs for IHL-42X, with 57.4% fasted vs 58.8% fed. We believe this data establishes a scientific bridge
to the RLD, potentially enabling us to leverage existing safety and toxicology data in an FDA 505(b)(2) new drug application for IHL-42X,
and assist in the analysis of the global Phase 2/3 RePOSA trial.  

Update on Australian IHL-675A clinical trial in patients with
rheumatoid arthritis

In November 2024, we decided to pause the Australian Phase 2 clinical
trial investigating IHL-675A in rheumatoid arthritis patients with pain and reduced function regardless of current treatment due to slower
than anticipated patient recruitment. The Company intends to re-allocate use of resources to a larger U.S. Phase 2 IHL-675A clinical study.
Adaptations to the study design will be implemented in the U.S. Phase 2 study, investigating safety and efficacy of IHL-675A in patients
with rheumatoid arthritis. 

16

Equity-Line of Credit Purchase
Agreement

On September 6, 2024, we entered into an equity
line of credit Purchase Agreement