Presentation

Company Profile
Xspray Pharma is a pharmaceutical company focused on developing improved and generic versions of marketed drugs. The company’s initial focus is on the orally administered drugs of the protein kinase inhibitor (PKI) class within precision oncology. Xspray’s products are based on the patented RightSize technology. The technology comprises of a uniquely up-scalable supercritical CO2 fluid extraction method that allows for the generation of amorphous forms out of crystalline drugs, such as the aforementioned PKIs. The amorphous form improves the drug product through primarily better absorption kinetics, which leads to multiple secondary benefits such as lower required dose, higher dose accuracy, no issues with proton pump inhibitors, ulcers and other drugs/conditions affecting the stomach’s pH. The leading product candidates, HyNap-Dasa, HyNap-Sora and HyNap-Nilo, are stable amorphous and improved versions of the three blockbuster cancer drugs Sprycel® (dasatinib), Nexavar® (sorafenib) and Tasigna® (nilotinib), respectively.

Recent highlights
After some struggles with the lead asset HyNapDasa with regards to reaching bioequivalence for the generic (ANDA) pathway, the company has generated all the data needed to submit through the FDA’s improved product’s 505(b)(2) pathway. Throughout this process the company improved its dissolution model and manufacturing processes which should allow for faster development of the follow-on products.

Outlook
We expect the regulatory submission to the FDA within the coming months and market approval likely before October 2022.