Company: IXHL
Filing Date: 2025-02-14
Form Type: 10-Q
Source: 0001213900-25-013783
Chunk: 80

Company: Incannex Healthcare Inc.
Filing Date: 2025-02-14
Form: 10-Q
Item: Part I, Item 8
Chunk 80
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 ended June 30, 2024, as filed with the Securities and Exchange
Commission (the “SEC”) on September 30, 2024 (the “2024 Annual Report”) and this Quarterly Report. We caution
the reader not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date
of this Quarterly Report. We undertake no obligation to update forward-looking statements, which reflect events or circumstances occurring
after the date of this Quarterly Report. 

Our accounting policies under U.S. GAAP are referred
to in Note 1 of the unaudited condensed consolidated financial statements in this Quarterly Report. All amounts are in United States dollars,
unless otherwise indicated.

Overview

We are a clinical-stage biopharmaceutical development
company dedicated to developing combination medicines that target the underlying biological pathways associated with chronic conditions,
including obstructive sleep apnea (“OSA”), rheumatoid arthritis and generalized anxiety disorder. We are advancing novel oral
fix-dosed treatments and therapeutic regimens based on evidence-based innovation. Our lead Phase 2/3 and Phase 2 clinical programs include
IHL-42X for the treatment of OSA; IHL-675A for the treatment of inflammatory conditions, including rheumatoid arthritis, and PSX-001,
our oral synthetic psilocybin treatment, in combination with psychotherapy, for the treatment of generalized anxiety disorder. Our programs
target disorders that have limited, inadequate, or no approved pharmaceutical treatment options.

Recent Developments

Topline Results from Pharmacokinetics
(“PK”) Study of IHL-42X

In January 2024, we released positive topline results from a completed
PK and safety study of IHL-42X, a novel, oral fixed-dose combination of acetazolamide and dronabinol for the treatment of OSA. The study
confirmed bioavailability 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