Interim Report Second Quarter 2023

Regulatory press release 2023-08-02

April-June 2023, Group

  • Net sales amounted to SEK 0 thousand (0)
  • Loss before tax amounted to SEK -51,402 thousand (-28,865)
  • Earnings per share before dilution amounted to SEK -2.27 (-1.40)
  • Cash flow from operating activities amounted to SEK -56,503 thousand (-24,472)
  • Cash flow from investing activities amounted to SEK -16,027 thousand (-29,197)

January-June 2023, Group

  • Net sales amounted to SEK 0 thousand (0)
  • Loss before tax amounted to SEK -86,229 thousand (-47,799)
  • Earnings per share before dilution amounted to SEK -3.80 (-2.31)
  • Cash flow from operating activities amounted to SEK -102,038 thousand (-52,085)
  • Cash flow from investing activities amounted to SEK -30,677 thousand (-76,738)

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

Significant events during the quarter

  • The US court has rejected Xspray Pharma’s motion to dismiss in the ongoing patent dispute concerning XS004. The lawsuit will thus proceed further with evidence including expert statements, where the counterparty BMS is to demonstrate that XS004 does contain crystalline substances.
  • Xspray Pharma announced the outcome of a preferential rights issue of units including two shares and two warrant series. The preferential rights issue was subscribed to 83 percent, thereby raising a total of approximately SEK 251 million in proceeds before transaction expenses for Xspray Pharma. The proceeds were raised after the end of the period. The two warrant series include TO5, which matures on November 30, 2023, and TO6, which matures on May 2, 2024. Together, these could raise approximately a further SEK 251 million upon full subscription.

Significant events after the end of the reporting period

  • Xspray Pharma received a complete response letter (CRL) in which the FDA requested that supplementary information be provided to physicians and patients regarding the dosage of Dasynoc, as well as information regarding a third-party manufacturing facility. At the same time, the FDA accepted important aspects of the application by not identifying any deficiencies in stability or the clinical data that has been submitted to date.

“Xspray Pharma continues to work towards commercialization of the company’s leading product candidate, XS004, with the working name of Dasynoc. Dasynoc is an amorphous version of dasatinib for the treatment of the blood cancer diseases chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). After the end of the period, we received a Complete Response Letter (CRL) from the FDA requesting more information about our application for market approval of Dasynoc. During the quarter, we also announced the preferential rights issues that successfully raised approximately SEK 251 million after the end of the period. We have now secured the necessary financing for the launch of Dasynoc in the US. We are continuing to make preparations ahead of launch in collaboration with our partner EVERSANA.” – Per Andersson CEO, Xspray Pharma

For further information, please contact:

Kerstin Hasselgren
Chief Financial Officer
Xspray Pharma AB
Mob: +46 (0) 70 311 16 83
E-mail: kerstin.hasselgren@xspray.com

About Xspray Pharma

Xspray Pharma AB (publ) is a pharmaceutical company with numerous product candidates in clinical development, utilizing its innovative, patented HyNap-technology to create improved versions of marketed protein kinase inhibitors (PKI), the largest oncology segment often with high drug prices. The company’s goal is to become a market leader of enhanced PKIs for cancer treatment. Xspray Pharma’s primary drug candidate, Dasynoc (XS004-dasatinib), is currently undergoing FDA review. It is an amorphous form of dasatinib, demonstrating bioequivalence at a 30% lower dose because of better solubility profile. Its compatibility with proton pump inhibitors (PPIs), commonly co-prescribed to chronic myeloid leukemia patients, provides a significant advantage. Xspray Pharma is building a robust product portfolio, including XS003-nilotinib (an optimized version of Tasigna®) and XS008-axitinib (an optimized version of Inlyta®).

Xspray Pharma’s shares are traded at Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY).
www.xspraypharma.com

This information is information that Xspray Pharma AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2023-08-02 08:00 CEST.

Attachments

Xspray Q2 Rapport ENG