January-March 2023, Group
- Net sales amounted to SEK 0 thousand (0)
- Loss before tax amounted to SEK -34,827 thousand (-18,934)
- Earnings per share before dilution amounted to SEK -1.54 (-0.92)
- Cash flow from operating activities amounted to SEK -45,535 thousand (-27,613)
- Cash flow from investing activities amounted to SEK -14,650 thousand (-47,541)
Significant events during the quarter
- Xspray Pharma has entered into a partnership agreement with EVERSANA for the launch and commercialization of the company's product candidate XS004 in the US. Xspray Pharma retains financial and strategic control while granting EVERSANA exclusive rights to commercialize XS004. The goal is to be prepared to launch the product in the second half of 2023.
- Xspray Pharma announced a new product candidate: XS008, which is based on the original substance axitinib, used in the treatment of kidney cancer.
- Xspray's production partner NerPharMa obtained approval from AIFA, the Italian Medicines Agency, for commercial production of amorphous material for XS004.
Significant events after the end of the reporting period
- The US court has rejected Xspray Pharma's motion to dismiss in the ongoing patent dispute involving XS004. The lawsuit will thus continue with a review of the technical details of the case, which provides Xspray Pharma the opportunity to demonstrate that XS004 does not contain any patented crystalline substances.
- The Board of Xspray Pharma announced a planned rights issue of units of approximately SEK 300 million, with two warrant series totaling an additional approximately SEK 300 million upon full exercise. An extraordinary general meeting is proposed to authorize the Board of Directors to resolve on the rights issue. Approximately 83 percent of the rights issue is secured by subscription commitments and intentions, as well as guarantee commitments.
- The shareholders of Xspray Pharma were summoned to an extraordinary general meeting on Thursday, 25 May 2023 at 13.00 CEST at Advokatfirman Vinge's office on Smålandsgatan 20 in Stockholm.
"We have started the year with important preparations for the launch of Xspray Pharma's first commercial product: XS004, with the working name Dasynoc. Dasynoc, which is intended to treat the blood cancer diseases chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), may provide clinical benefits by reducing the variability in uptake and enabling co-medication with proton-pump inhibitors. During the quarter, we entered into a partnership agreement with EVERSANA and continued to make preparations for launch of Dasynoc in the US, which is expected by July 2024, but with potential for launch as early as the second half of 2023. In addition, we have obtained approval from AIFA, the Italian Medicines Agency, for the production of commercial volumes of amorphous material for Dasynoc at NerPharMa's manufacturing facility in Italy." - 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
