Xspray Pharma (XSPRAY) Investor Update summary

Regulatory update and FDA feedback

• Received a Complete Response Letter from the FDA for Dasynoc's New Drug Application, requesting more information on labeling comprehension and pre-approval inspection at the third-party manufacturing site.

• No additional clinical studies or new stability/clinical data were requested by the FDA.

• Xspray will collaborate with its manufacturer to address inspection-related requests and engage in dialogue with the FDA to adapt labeling strategy.

• The anticipated September launch is delayed, impacting patients needing alternatives to dasatinib when co-medicating with acid reducing agents.

• An updated timeline for resubmission will be provided in the coming weeks.

Product highlights and patient impact

• Dasynoc is designed for CML and ALL, offering bioequivalence at 30% lower doses using HyNap Technology.

• Enables more precise and predictable bioavailability, allowing flexible co-prescription with acid reducing agents.

• Co-medication with Tyrosine Kinase Inhibitors and acid reducing agents is common, but can reduce survival rates if not managed properly.

• Dasynoc aims to address a significant unmet need for patients requiring both therapies.

Company background and strategy

• Xspray Pharma focuses on developing improved protein kinase inhibitors for cancer using its proprietary HyNap technology.

• The company is committed to enhancing efficacy, safety, and patient experience in cancer therapies.

• Shares are listed on Nasdaq Stockholm.