• XS003, an amorphous non-crystalline nilotinib, designed to overcome therapeutic limitations of the currently available crystalline formulation of nilotinib (TASIGNA?), is the second protein kinase inhibitor (PKI) product candidate developed with Xspray’s HyNap? technology

• TASIGNA is an import treatment for chronic myeloid leukemia (CML), with worldwide sales in 2022 approaching $2.0 billion, despite a labeled warning for food interactions and a boxed warning in the US

• New Drug Application (NDA) is expected to be submitted to the US Food and Drug Administration (FDA) in the second half of 2024.

STOCKHOLM, November 21, 2023--(BUSINESS WIRE)--Xspray Pharma AB (Stockholm/Nasdaq: XSPRAY) a biotechnology company developing improved PKIs for cancer treatment, through its proprietary HyNap? technology, today announced that XS003, its amorphous, non-crystalline formulation of nilotinib, has demonstrated bioavailability within the 80-125% range to TASIGNA? following oral administration with significantly lower dose. This is the second of three announced amorphous PKIs under development by Xspray using the HyNap platform to address critical limitations with currently marketed crystalline formulations.

"Our goal is to submit the NDA to the FDA in the second half of 2024 once all required studies are finalized; such as e.g. food effect and proton pump inhibitor interaction," says Xspray Pharma Chief Executive Officer, Per Andersson, PhD. "XS003 is designed to reduce food interactions, inherent with TASIGNA, that may increase the risk of sudden death caused by prolongation of the QTc interval, and for which TASIGNA carries a boxed warning. We have now demonstrated that XS003 exhibits improved absorption, matching TASIGNA at lower dose."

About XS003

XS003 demonstrated the results in a comparative bioavailability study involving healthy volunteers. It is Xspray's second product candidate developed using the HyNap technology. XS003 is being developed under the regulatory 505(b)(2) NDA process, which streamlines the approval process, and XS003 is expected to be submitted to the FDA for approval in the second half of 2024. In 2020, XS003 received orphan drug status by the FDA for the treatment of CML. Worldwide sales for TASIGNA approached $2.0 billion in 2022.

Forward Looking Statement

This press release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although Xspray’s management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as; "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding Xspray’s beliefs relating to the technologies in Xspray’s current pipeline. These forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in Xspray’s lack of profitability and need for additional capital to grow Xspray’s business; Xspray’s dependence on partners to further the development of Xspray’s product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory approvals or authorization for patient use for the product candidate and launch of any new pharmaceutical product; the outcome of pending or future litigation.