Acquisition of APIRx slide image

Acquisition of APIRx

For personal use only MedChew™ Dronabinol Nausea and vomiting in Chemotherapy Problem According to the WHO, cancer is one of the leading causes for death. Chemotherapy is utilized by 10 million cancer patients each year. This number will grow by 53% by 2040. Nausea and vomiting are two of the most dreaded cancer treatment-related side effects. Solution MedChewTM Dronabinol treatment for Chemotherapy-related nausea and vomiting. Dronabinol Approved for treatment of chemotherapy associated nausea and vomiting as well as anorexia associated with HIV/AIDS. Clinical Trial Results 1) All subjects showed a release of dronabinol starting at 10 minutes, providing evidence of oro-mucosal absorption. Incannex 2) In most of the study's subjects, the dronabinol Pharmacokinetic (PK) profile reflected a sustained released effect for four to eight hours after administration. 3) No serious side effects reported. Competitive Advantage Product fully formulated. Completed IND with the FDA. Completed Pharmacokinetic (PK)/ Pharmacodynamic (PD) studies. Oral dronabinol is taken up slowly, 1-2.5 h to reach peak plasma concentration, and subject to first pass metabolism, which means that only 10-20% of the dose reaches the circulation. Global dronabinol market was US$ 147.2M in 2020. CAGR of 4.5% during 2021-2026 leading to projected market of US$ 191.9M by 2026. Addressable Market (a) US$ 3.1B Chemotherapy Induced Nausea and Vomiting Drugs (Global) by '24 MedChew™ Dronabinol Absorption through the oral mucosa bypasses first pass metabolism, increasing bioavailability. The formulation has been developed and is patented by APIRX. In a phase 1A study THC appears in circulation within 10 min and sustained release profile was observed in most study subjects so that the product is more useful in the time in which it is required. IND open with FDA. Lead Assets 7.5% CAGR from 2018 - 2024 a) Brisk Insights, "Chemotherapy Induced Nausea And Vomiting Treatment Market, 2018-2026", Sept. 8, 2021 Next Steps: Step 1 - Conduct Bioavailability/Bioequivalence clinical study to support application for approval by bridging to publicly available data on Marinol. Step 2 - Additional late stage (phase 3 and 4) clinical trials to support additional indications where THC is reported to have a therapeutic benefit. Shareholder Presentation 18
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