October–December 2022, Group

• Net sales amounted to SEK 0 thousand (0)
• Loss before tax amounted to SEK -55,220 thousand (-51,944)
• Earnings per share before dilution amounted to -2.48 SEK (-2.62)
• Cash flow from operating activities amounted to SEK -35,003 thousand (-10,280)
• Cash flow from investing activities amounted to SEK -29,481 thousand (-33,691)

January–December 2022, Group

• Net sales amounted to SEK 0 thousand (0)
• Loss before tax amounted to SEK -131,670 thousand (-96,698)
• Earnings per share before dilution amounted to -6.31 SEK (-5.03)
• Cash flow from operating activities amounted to SEK -110,179 thousand (-51,607)
• Cash flow from investing activities amounted to SEK -135,345 thousand (-105,818)
• Cash and cash equivalents at the end of the period amounted to SEK 120,166 thousand (271,881)

Significant events during the quarter

• In October, a directed issue of shares was conducted to a number of Swedish institutional investors, including Third Swedish National Pension Fund, Flerie Invest and the Foundation for Baltic And East European Studies. The subscription price was set at SEK 50,00 per share and, the issue raised proceeds of SEK 100 million before transaction costs. The number of shares increased by 2,000,000 shares, from 20,680,408 to 22,680,408.
• In November, Xspray received an approval from FDA on Orphan Drug Status in the US for XS004 dasatinib for treatment of acute lymfatic leukemia (ALL).
• In December, Xspray presented new data for XS004 at the annual international American Society of Hematology Congress (ASH) in the US.

Significant events after the end of the reporting period

• Xspray Pharma decided upon a commercialization strategy for future product launches and is negotiating with a partner to market and sell the product candidate XS004 in the entire US.
• Xspray Pharma announces a new product candidate: XS008. The product candidate is based on the original substance axitinib which is used for treatment of kidney cancer.
• Xspray’s production partner NerPharma received approval by AIFA, Italy’s medical product agency, for commercial production of XS004.

“We concluded 2022 with an eventful quarter for Xspray Pharma. One of the more important events was that we could present new data related to the product candidate XS004. These clearly demonstrate the advantages of our amorphous version of Dasatinib for the treatment of chronic myeloid leukemia, CML. Preparations ahead of a commercial launch in the latter part of 2023 progress, and we began producing the first quantities of XS004 for commercial use. We have also decided upon a commercialization strategy for our first product, based upon which we will establish collaboration with a specialized commercialization partner, which provides access to a cost efficient and ready to go sales organization in the US. Following an extensive evaluation, we have concluded that this is the most efficient and economically advantageous model to initially establish our product portfolio on the US market without limiting our right to future profits from our products.” – Per Andersson CEO, Xspray Pharma.