New projects will focus on the same indications as Dasynoc® and XS003 nilotinib as well as on other cancer indications. The development processes created with Dasynoc® and XS003 nilotinib will be applicable to the new projects allowing to significantly reduce development timelines.

Dasynoc® (dasatinib)
Dasynoc® is an improved version of Sprycel® for treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), and has been granted orphan drug status by the FDA in the US for both CML and ALL. Studies confirm:

•Dasynoc® is unaffected by the pH value of the stomach and can thus be used together with omeprazole and other antacids without impacting the absorption of the drug. This facilitates concurrent treatment of common diseases in the stomach such as peptic ulcers and gastritis with, for example, proton-pump inhibitors (PPIs) and antacids while the patient is being treated for cancer.
• Dasynoc® yields a more even uptake of the drug in the body compared with the variations seen for the original product in previous studies.
• Dasynoc® can be administered at a 30-percent lower dosage than the original product.

The FDA’s review of the company’s application for market approval of Dasynoc® is in progress.
Dasynoc’s confirmed profile benefits, which were supported by both patient representatives and clients in market surveys that were conducted, facilitates a favorable position for launch in a well-established,
stable and valuable market. In 2024, the global market for Sprycel® – whose secondary patent expires in 2026 – amounted to approximately USD 1.93 billion, of which the US market accounted for approximately USD 1.45 billion. The market value for Dasynoc® is high both during and after the end of the patent window.

XS003 nilotinib
Xspray Pharma’s product candidate XS003 is amorphous non-crystalline nilotinib for the treatment of chronic myeloid leukemia (CML). The FDA has granted orphan drug status to XS003 for the treatment of CML, in view of the fact that XS003 nilotinib addresses the food interaction that is included in the warning text for Tasigna® in the US. XS003 is being developed as an improved version of the crystalline original drug Tasigna.

In studies, XS003 has demonstrated matching bioavailability with Tasigna® with a more than 50-percent
reduced dose. This means that a lower dose of XS003 compared with Tasigna® yields comparable  plasma concentrations of nilotinib. Since Tasigna® is a highly variable product with pH-dependent  solubility, optimizing the lower dosage of XS003 to achieve comparable bioavailability has been a  challenge. Xspray Pharma is now completing the remaining studies for XS003 and plans to submit an application in the first half of 2025 to the FDA for market approval in the US under the abbreviated 505(b)(2) NDA pathway.

Global sales of Tasigna® totaled USD 1,85 billion in 2023, of which the US market accounted for USD 0.88 billion. Tasignas drug substance patent expired in January 2024, and the secondary patent in October 2032.

XS008 axitinib
Xspray Pharma’s product candidate XS008 is amorphous non-crystalline axitinib for the treatment of kidney cancer. The currently marketed product, which is based on axitinib, is Inlyta® and the expiration of its patents creates an attractive patent window between April 2025 and December 2030 in the US. The PKI market for kidney cancer had sales of approximately USD 3 billion in the US in 2023. Sales of
Inlyta in 2023 amounted to USD 0.64 billion in the US and USD 1.04 billion globally.

XS025 cabozantinib
Xspray Pharma’s product candidate XS025 is amorphous non-crystalline cabozantinib used in conjunction with renal cell carcinoma and other cancers. The currently marketed product based on cabozantinib is Cabometyx®, whose drug substance patent expires in August 2026 and whose secondary patents expire in July 2033. Cabozantinib achieved USD 1.81 billion in net sales
in the US for fiscal year 2024.