Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) is well positioned to fund its operations into the 2024 financial year, underpinned by its cash balance of $33.4 million at the end of the September quarter, Edison Investment Research Ltd said.
As well, the clinical-stage pharmaceutical company’s recent inclusion in Standard and Poor’s ASX 300 Index should further enhance its visibility, the research firm said, maintaining its valuation of Incannex at US$714.7 million or US$11.74 per ADR.
Moreover, with the addition of 22 drug development projects to its portfolio from the acquisition of APIRx Pharmaceuticals USA, LLC, the company now boasts a broad pipeline of activities.
The following is an extract from Edison’s research update:
Incannex Healthcare’s Q123 cash flow report highlighted two key developments in the company’s drug pipeline.
Following approval from the Bellberry Human Research Ethics Committee for the Phase I study of its anti-inflammatory drug IHL675A, the company reported encouraging preliminary safety data (healthy volunteers; n=36) from the trial and has commenced preparation for Phase II clinical trials, which will initially target patients with rheumatoid arthritis, followed by inflammatory bowel disease and lung inflammation. Final data from the Phase I study will be released in Q1 CY23.
In addition, Incannex reported a constructive pre-investigational new drug (IND) meeting with the US FDA for its proprietary inhaled drug product IHL-216A for the treatment of concussion and TBI, with the FDA providing detailed feedback and guidance on the most efficient clinical trial development plan to effect successful commercialisation, in particular related to developing an inhaled drug.
As the next step, Incannex is preparing a follow-up request seeking additional information on the FDA’s recommendations.
The company also partnered with Curia Global, a US-based contract research and manufacturing organisation in August 2022 to develop and manufacture GMPgrade IHL-216A.
Moreover, IHL-42X, Incannex’s most advanced program for the treatment of obstructive sleep apnoea, has completed a Phase II study and is preparing for an IND to initiate FDA regulated trials, which management expects in CY23 (update expected in December 2022).
In a separate development, we see the appointment of Robert B Clark, a regulatory affairs expert, to the board of directors as a positive step as the company gears up for regulatory trials in the near future.