Incannex Healthcare Ltd Stock Price, News & Analysis

Incannex Healthcare Limited (NASDAQ: IXHL) has successfully completed a pre-IND meeting with the FDA regarding its drug IHL-42X, aimed at treating obstructive sleep apnoea (OSA). The FDA expressed constructive feedback and supported the proposed development program, allowing the company to bypass animal studies. This marks a significant advancement toward opening an IND application and conducting clinical trials in the U.S. Preliminary results from a phase 2 trial showed 60% of participants had over 55% AHI reduction. A complete report is expected in June 2022.

Incannex Healthcare Limited (Nasdaq: IXHL) has entered a Share Sale and Purchase Agreement to acquire 100% of APIRx Pharmaceuticals USA, LLC. The acquisition involves issuing 218,169,506 new shares valued at $0.573 each. Subject to shareholder approval and customary conditions, completion is anticipated in June 2022. The Sellers provide warranties and indemnities typical for such transactions. CEO Joel Latham expressed confidence in the acquisition, highlighting significant growth opportunities and a robust cash position to pursue diverse product developments.

Incannex Healthcare Limited (Nasdaq: IXHL) announced positive results for its drug IHL-216A, demonstrating a strong neuroprotective effect in a rodent model of sports concussion. In studies conducted with the NFL, IHL-216A notably restored spatial memory within 24 hours post-injury, outperforming both CBD and isoflurane treatments. The company plans to meet with the FDA in Q3 2022 to discuss expedited clinical trials for IHL-216A's potential application in treating traumatic brain injuries. This development follows earlier successful animal studies conducted in 2020.

Incannex Healthcare Limited (IXHL) reported promising phase 2a clinical trial results for IHL-42X, with 60% of participants showing over a 55% reduction in Apnoea Hypopnea Index (AHI), and 20% achieving reductions exceeding 80%. The company is advancing several initiatives, including a second clinical psychedelic therapy program and an acquisition of APIRx Pharmaceuticals for US$93.3M, which supports 22 cannabinoid R&D projects. With cash reserves of A$40.0M, Incannex aims to enhance its product pipeline in cannabinoid and psychedelic medicine.

On April 28, 2022, Incannex Healthcare Limited (Nasdaq: IXHL) announced the completion of its loyalty option offer, successfully raising A$23.6M. The options expired on April 22, allowing for the issuance of 67.3M new shares; for every two new shares, one piggy-back option will be granted with an exercise price of A$1.00. The additional funding will support clinical research and development activities ramping up in 2022 and 2023. Incannex's directors allocated their shares of approximately A$4.1M to a strategic investor group to enhance liquidity on NASDAQ.

Incannex Healthcare Limited (Nasdaq: IXHL) plans to acquire APIRx Pharmaceutical USA for US$93.3 million in an all-scrip transaction. This acquisition will enhance Incannex's standing as a leader in cannabinoid and psychedelic pharmaceuticals. APIRx has 22 active clinical and pre-clinical projects targeting various conditions including pain, dementia, and addiction disorders. The transaction is subject to shareholder approval under ASX listing Rule 7.1, and is expected to reinforce Incannex's intellectual property with 19 granted and 23 pending patents.

Incannex Healthcare Limited (Nasdaq: IXHL) has reported promising preliminary results from its phase 2 clinical trial of IHL-42X, a cannabinoid treatment for obstructive sleep apnea (OSA). Key findings include a 44.4% average reduction in the apnoea hypopnoea index (AHI) across all doses, with 60% of participants achieving a reduction greater than 50% and 20% exceeding 80%. IHL-42X was well tolerated, paving the way for a pre-IND meeting with the FDA on May 11, 2022, and plans for pivotal trials following IND submission. The trial signifies a critical step towards addressing unmet medical needs in OSA treatment.

Incannex Healthcare Limited (Nasdaq: IXHL) has signed a global license agreement with Monash University to develop a novel treatment combining Virtual Reality (VR) and psychedelics aimed at anxiety disorders. This initiative marks the start of a new clinical psychedelic therapy program. The agreement involves three license fees totaling A$800,000, which Incannex will pay at various stages, along with a 7.5% royalty on net sales post-commercialization. Funded by Incannex, the project will be led by esteemed Monash researchers to explore treatment effectiveness and safety.

Incannex Healthcare Limited (Nasdaq: IXHL) has commenced trading its American Depositary Shares (ADS) on the Nasdaq Global Market. Each IXHL ADS represents 25 ordinary shares of the Company. The listing follows the SEC's declaration of effectiveness for its registration statement, allowing broader access to investors interested in medicinal cannabis and psychedelic therapies. Incannex retains its listing on the ASX and completed the Nasdaq listing without a capital raise. The listing aims to enhance visibility and facilitate U.S. FDA approval for its therapeutic pipeline.