Xspray Pharma

October-December 2023, Group

• Net sales amounted to SEK 0 thousand (0)
• Loss before tax amounted to SEK -54,513 thousand (-55,220)
• Earnings per share before dilution amounted to SEK -1.85 (-2.48)
• Cash flow from operating activities amounted to SEK -32,626 thousand (-35,003)
• Cash flow from investing activities amounted to SEK -20,729 thousand (-29,481)

January-December 2023, Group

• Net sales amounted to SEK 0 thousand (0)
• Loss before tax amounted to SEK -179,684 thousand (-131,670)
• Earnings per share before dilution amounted to SEK -6.76 (-6.25)
• Cash flow from operating activities amounted to SEK -203,275 thousand (-110,179)
• Cash flow from investing activities amounted to SEK -65,876 thousand (-135,345)

Amounts in parentheses refer to the same period the previous year.

Significant events during the quarter

• Xspray Pharma published a registry study in the European Journal of Haematology demonstrating that nearly half of CML patients treated with tyrosine kinase inhibitors (TKIs) take proton pump inhibitors (PPIs) concurrently. The study also indicated a higher risk of patient mortality during treatment in this group compared to a group not receiving concurrent PPI treatment. This can be mitigated with Xspray's enhanced amorphous dasatinib formulation, Dasynoc®, which has demonstrated in a clinical trial that its concentration in the blood was not affected by co-administration of the PPI.
• Xspray Pharma has demonstrated that the uptake of Dasynoc® in the blood is unchanged when omeprazole, a PPI, is taken, whereas the uptake of Sprycel® is significantly lower than previously shown.
• Xspray Pharma published the results of a study with product candidate XS003, Xspray's amorphous non-crystalline version of nilotinib. The results show bioavailability within the 80-125% range in relation to Tasigna® following oral administration with significantly lower dose.
• Xspray Pharma announced the outcome of the TO5 series of warrants. In total, 2,307,242 warrants of series TO5 were exercised for subscription of an equal number of new shares. Xspray Pharma thereby received issue proceeds of SEK 92.3 million.

Significant events after the end of the reporting period

• Xspray Pharma appointed Michael af Winklerfelt as acting CFO, started on February 8th.
• Xspray Pharma was assigned a PDUFA date, July 31, 2024, by the FDA, which refers to the FDA's deadline for completing the approval process of Dasynoc®.

“We continue to make significant progress on our journey towards the commercialization of our groundbreaking product – Dasynoc®. Dasynoc® may offer potential benefits beyond the currently only available dasatinib-product on the market, Sprycel®. Including increased precision of dosage and allowing cancer patients to simultaneously take medications that elevate stomach pH, such as omeprazol. We have commissioned market research, which reported promising results, together with our commercialization partner EVERSANA, signaling positive prospects for patients, providers, payors, and ultimately, Xspray’s shareholders. Sprycel® reported sales of USD 1.45 billion in 2023. If approved, our planned launch is in September 2024. We recently responded to the FDA´s Complete Response Letter and received a PDUFA date of July 31, 2024. We look forward with confidence to the regulatory approval of Dasynoc®. Our primary focus is now on continuing the efforts to prepare for a successful US launch on September 1, 2024.
I am also pleased to report progress with our second product candidate, XS003 nilotinib, where study results demonstrate comparable bioavailability to Tasigna®, but achieved with a significantly lower dose using our amorphous formula. We continue to conduct the remaining studies with the goal of submitting a marketing approval application to the FDA for XS003 upon completion of the studies.” - Per Andersson, CEO, Xspray Pharma