ResolutionRx

Drug development

Program transferred from the US

Obstructive Sleep Apnoea (OSA)

Initial use case obstructive sleep apnoea followed by anorexia

Investment Highlights

• Australian Contract Research Organization contracted
• Australian manufacturer contracted
• Term sheet from source of debt funding to finance 80% of R&D tax credit 
• Plans to become listed for public trading
• Auditor engaged
• Accountants engaged
• Lawyers engaged
• First equity finance term sheet in place on same terms as offering for US$3.125M (~AUD4.687M)

De-risked drug commercialisation for millions of sleep apnoea sufferers

ResolutionRx Ltd is focused on developing and repurposing an FDA-approved drug Dronabinol in helping Obstructive Sleep Apnoea (“OSA”) sufferers to better manage their condition.

Dronabinol is a cannabinoid drug with FDA approval for the treatment of AIDS-related anorexia and chemotherapy-induced nausea and vomiting.

Two statistically significant Phase 2 clinical trials completed. New improved formulation created in preparation for Phase 3. This repurposing strategy should only require approval by the U.S. FDA of a 505(b)(2) new drug application (“NDA”), an efficient regulatory pathway to further approval for OSA treatment that allows the use of publicly available data. Similarly efficient regulatory pathways are available elsewhere in the world.

Dronabinol, a synthetic version of ∆-9-THC, a naturally occurring substance in the cannabis plant, has already demonstrated significant improvement in the symptoms of OSA in two Phase 2 clinical trials in the United States.

A serious respiratory disorder that affects millions of people globally

OSA is a serious respiratory disorder that impacts more than 90 million in Australia, the United States, Germany and the United Kingdom. There are an estimated 1 billion cases worldwide

Corporate Structure

ResolutionRx Ltd was formed in Australia in January 2023 by RespireRx as an unlisted public company. RespireRx Pharmaceuticals Inc. (US OTC: RSPI) has contributed via sublicense and license with ResolutionRx, its cannabinoid drug development program subject to certain liabilities.

ResolutionRx is engaging in the R&D associated with that program, initially for the development of a new formulation of dronabinol for use in Phase 3 clinical trial and the filing of regulatory approval for the treatment of obstructive sleep apnoea (“OSA”).

The current total budget for that program over the next several years is approximately A$24.8M, most, but not all of which is expected to be eligible for the R&D tax refund expected to be 43.5%.

Raising an additional A$18M (to achieve A$22.7M of which A$4.7M is the subject of an existing term sheet with a single investor) on a pre-money valuation of A$33.75M by way of series A preference shares that will convert into ordinary shares.

Funds will be used for Research and Development and General and Administrative Purposes.

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