Interim Report First Quarter 2024

Regulatory press release 2024-05-08

January–March 2024, Group

  • Net sales amounted to SEK 0 thousand (0)
  • Loss before tax amounted to SEK -67,781 thousand (-34,827)
  • Earnings per share before dilution amounted to SEK -2.17 (-1.54)
  • Cash flow from operating activities amounted to SEK -55,311 thousand (-45,535)
  • Cash flow from investing activities amounted to SEK -5,149 thousand (-14,650)

Significant events during the quarter

  • Xspray Pharma appointed Michael af Winklerfelt as acting CFO, starting on February 8.
  • In January 2024, Xspray Pharma submitted additional information for its New Drug Application for Dasynoc® following a Complete Response Letter from the FDA. 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®.

Significant events after the end of the reporting period

  • Xspray Pharma received declarations of intent whereby owners of approximately 62 percent of shares in the company stated their intent to subscribe for newly issued shares with their outstanding TO6 warrants.
  • Xspray Pharma announced its fourth product candidate, XS025 (previously designated XS015) for clinical study. XS025 will be based on the active substance cabozantinib, which is used in renal cell carcinoma and other cancers. This initiative targets the US market for cabozantinib, which is projects to reach approximately USD 2.3 billion by 2026.
  • Xspray Pharma announced the outcome of exercised warrants of series TO6. In total, 2,508,723 series TO6-warrants were exercised to subscribe for the same number of new shares. Xspray Pharma thereby received proceeds of SEK 100.3 million before transaction costs. Proceeds will be used for the US launch of the company’s first product, Dasynoc®, as well as for continued development of other product candidates in the company’s portfolio.
  • The shareholders of Xspray Pharma AB are summoned to the annual general meeting on Tuesday 21 May 2024 at 10.00 CET at Advokatfirman Vinge’s office on Smålandsgatan 20 in Stockholm

“We are continuing to make important preparations for the launch of our first product – Dasynoc®. This is an improved version of a well-established drug for the treatment of leukemia (CML and ALL). Dasynoc® has shown distinct clinical benefits through lower dosage requirements and lower variability in absorption, and the ability to be co-medicated with commonly used gastric acid suppressants. Existing treatments have major problems with co-medication for gastric ulcers, making Dasynoc® poised to offer vital patient benefits. Alongside the clinical arguments, during the period we produced compelling health economic data showing how Dasynoc® can lower the overall healthcare costs for patients – an extremely strong message to the US insurance companies concerned.

Together with our commercial partner, EVERSANA, we are creating a basis for a rapid and robust launch of Dasynoc®. In parallel, we are building the infrastructure for bringing forthcoming products that are based on our platform technology to market.

During the quarter, we submitted additional information for our New Drug Application (NDA) for Dasynoc® to the FDA. Subsequently, the FDA issued a PDUFA date: July 31, 2024, which is the FDA’s own deadline for a decision on the marketing approval process for Dasynoc®. After the end of the period, we announced that we are ready to advance our fourth product candidate, XS025 (previously designated XS015) cabozantinib, into clinical study – our additional product candidate for the treatment of renal cancer. We also strengthened our cash holdings ahead of the final phase of our planned launch through the TO6 program, which has been subscribed at a rate of 80 percent and raised SEK 100 million before issue expenses.” – Per Andersson CEO, Xspray Pharma