Interim Report Third Quarter 2023

July-September 2023, Group

• Net sales amounted to SEK 0 thousand (0) 
• Loss before tax amounted to SEK -38,942 thousand (-28,651)
• Earnings per share before dilution amounted to SEK -1.59 (-1.39)
• Cash flow from operating activities amounted to SEK -68,611 thousand (-23,091)
• Cash flow from investing activities amounted to SEK -14,470 thousand (-29,126)

January-September 2023, Group 

• Net sales amounted to SEK 0 thousand (0)
• Loss before tax amounted to SEK -125,171 thousand (-76,450)
• Earnings per share before dilution amounted to SEK -5.11 (-3.70)
• Cash flow from operating activities amounted to SEK -170,649 thousand (-75,176)
• Cash flow from investing activities amounted to SEK -45,147 thousand (-105,864)

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

Significant events during the quarter 

• Xspray Pharma received a complete response letter (CRL) in which the FDA requested supplementary information concerning how physicians and users are to dose Dasynoc™, as well as supplementary information regarding a third-party manufacturing facility. At the same time, the FDA accepted critical aspects of the application by not identifying any deficiencies in stability or the clinical data that has been submitted to date.
• Through the preferential rights issue that was completed in July 2023, the number of shares and votes increased 6,265,892, from 22,680,408 to 28,946,300. The share capital increased SEK 6,265,892, from SEK 22,680,408 to SEK 28,946,300. The company received SEK 250,636 thousand before transaction costs.
• Xspray Pharma reached a settlement with Bristol Myers Squibb (BMS) regarding the patent dispute concerning Dasynoc. The settlement removes all claims from BMS regarding patent infringement, including the possibility of an appeal, and makes it possible for Xspray to launch Dasynoc in the US market on September 1, 2024, conditional on final approval from the FDA.
• Xspray Pharma recruited Edward P. Jordan to the position of Chief Commercial Officer. Edward Jordan will lead the launch and commercialization of Dasynoc in the US.

Significant events after the end of the reporting period 

• 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 which increases the risk of patient mortality. This can be mitigated with Xspray´s enhanced amorphous dasatinib formulation, Dasynoc.

“With a favorable settlement in the patent dispute regarding our lead product candidate, Dasynoc, we took a significant step closer during the quarter to the commercialization of our first product. Dasynoc is an amorphous version of dasatinib that has the potential to enhance the treatment of patients with the blood cancers chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), who often take dasatinib concurrently with PPIs for the treatment of peptic ulcers. We now have an updated timetable for the ongoing FDA application process for Dasynoc, and continue to progress towards a US launch on September 1 next year. Ahead of the launch, we have recruited the highly experienced and accomplished Edward P. Jordan to the key role as the company’s Chief Commercial Officer. The development of our second product candidate, XS003 nilotinib, is making important advances and I hope to present our way forward already in Q4. During the period, we also published a study in the European Journal of Haematology that once again demonstrates the need for a product such as Dasynoc to enable co-medication of dasatinib with PPIs.” – Per Andersson CEO, Xspray Pharma