Advancements for Anxiety, Sleep Apnea, Brain Injury, Lung Inflammation, Rheumatoid Arthritis & Inflammatory Bowel Disease: Incannex Healthcare Limited (NASDAQ: IXHL)

• Developing Multiple Unique Cannabinoid & Psychedelic Medicine Therapies Targeted for U.S. FDA Approval and Registration.
• Completed Loyalty Option Program to Raise A$23.6M Primarily Allocated to Clinical R&D Program. 
• Plans Underway to Acquire APIRx Pharmaceuticals USA, LLC. 
• Substantial Reduction in AHI in Preliminary Results of Clinical Trial Assessing IHL-42X in Patients with OSA

Incannex Healthcare Limited (NASDAQ: IXHL), is an Australian based clinical stage pharmaceutical company that is developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for the treatment of anxiety disorders, obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. 

U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each IXHL drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public. IXHL has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners.

• IXHL Completes Loyalty Option Program to Raise A$23.6M; Current Cash  is Approximately A$40.0M

On April 28^th IXHL announced that it has finalized its loyalty option offer to shareholders to raise A$23.6M. 

IXHL Loyalty options expired on April 22, 2022, and a total of 67.3M new shares are to be issued shortly as a result of the entitlement program. For every two (2) new shares that will be issued, one (1) piggy-back option will be granted to participants.

Piggy-back options will be issued shortly and have an exercise price of A$1.00 (equivalent to approx. US$18.25 per ADS on Nasdaq), expiring April 28, 2023. A total of 33.7M piggy-back options will be issued and Incannex does not intend to seek approval to list the piggy-back options on ASX or NASDAQ.

The Directors of IXHL collectively hold 175.9M shares in the Company and permitted their entitlement of approximately 11.7M shares, representing A$4.1M in investment capital, to be allocated to a strategic investor group that intend to enhance liquidity via the company’s ADS program on the NASDAQ exchange.

The additional capital will primarily be allocated to IXHL clinical research and development activities that are significantly ramping up in 2022 and 2023.

• IXHL to Acquire APIRx Pharmaceuticals USA, LLC

Highlights:

• APIRx has twenty-two (22) active clinical and pre-clinical research and development projects
• therapeutic candidates are targeted at treating pain, dementia, Parkinson’s disease, restless leg syndrome, gastrointestinal diseases, periodontitis, addiction disorders, skin conditions and ophthalmic conditions
• therapeutic candidates are underpinned by an extensive intellectual property portfolio that includes 19 granted patents and 23 pending patents
• proposed acquisition price of US$93.3M in all scrip transaction
• the transaction affirms IXHL position as a global leader in the fields of cannabinoid, psychedelic, and combination pharmaceuticals.

On March 24^th IXHL announced that it has executed a term sheet with binding commercial terms to wholly acquire APIRx Pharmaceutical USA, LLC (‘APIRx’), subject to shareholder approval under ASX listing Rule 7.1.

About APIRx – First Mover in Pharmaceutical Medicinal Product Development

APIRx is an innovative biotechnology company focused on research, development, and production of prescription pharmaceutical cannabinoid medicines. It has twenty-two (22) active clinical and pre-clinical research and development projects utilizing proprietary technologies. The acquisition of APIRx brings to IXHL a diverse portfolio of promising therapeutic candidates targeted at treating an extensive range of conditions including pain, dementia, Parkinson’s Disease, restless leg syndrome, gastrointestinal diseases, periodontitis, addiction disorders, skin conditions and ophthalmic conditions. 

APIRx was established as a corporate entity in the Netherlands to amalgamate the intellectual property assets of medicinal cannabis pioneers, and APIRx co-founders, Dr George Anastassov and Mr Lekhram Changoer. Dr Anastassov and Mr Changoer have collaborated since 2003 to develop the largest privately held patent portfolio pertaining to pharmaceutical cannabinoid inventions globally. They previously licensed their technology to AXIM Biotechnologies Inc., where they were part of the lead management team, overseeing a peak market capitalization of approximately US$1.2B in 2017 prior to the assets being privatized by APIRx.

Numerous pre-clinical studies and clinical trials over the APIRx therapeutic candidates have been undertaken to justify the intellectual property portfolio, which includes 19 granted patents and 23 pending patents. Key patents relate to sustained oral mucosal delivery of cannabinoids and cannabinoid combinations through chewing gum, oral care cannabinoid compositions, cannabinoid ophthalmic solutions, topical compositions containing cannabinoids and cannabinoid extraction technologies.

Medicated chewing gum (‘MCG’) is a novel drug delivery system growing in favor amongst the medical community due to widespread potential applications as an extended-release dosage form that provides a continuous release of the medicine contained. MCGs are fast acting as they release the active ingredients into the oral mucosa, reducing the potential for gastric intolerance amongst patients. These qualities, amongst others, make MCGs an excellent delivery system for medicinal combinations designed to treat sustaining pain and addiction disorders.

Strategic Rationale

The acquisition of APIRx will significantly strengthen the IXHL position as a market leader at the forefront of treatment development. It will:

• Add a large portfolio of intellectual property with granted and pending patents
• Expand the IXHL addressable markets globally and addressable market sizes by over US$400bn per annum
• Further enhance the IXHL technical and drug development capability by adding some of the industry’s longest standing and best-known scientists to the IXHL team.
• Expand the IXHL drug delivery capability to include APIRx’s patented delivery technologies.

For more information on Incannex Healthcare Limited (NASDAQ: IXHL) visit: www.incannex.com.au

DISCLAIMER: The products mentioned are THC-free and/or compliant with the 2018 Farm Bill.

This article is purely for informational purposes and is not a recommendation in any way for buying or selling stocks

Media Contact
Company Name: INCANNEX HEALTHCARE LIMITED
Contact Person: Michael Miller
Email: Send Email
Phone: 1-917-633-6086
Country: United States
Website: https://www.incannex.com.au/