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Xspray Pharma (XSPRAY) investor relations material
Xspray Pharma Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary5 Nov, 2025
Executive summary
No net sales were recorded in Q3 or the first nine months of 2025, as product launches are pending regulatory approval.
The period was marked by regulatory progress for two lead product candidates, DasynocⓇ and XS003 nilotinib, both based on HyNap™ technology.
A heavily oversubscribed rights issue and loan refinancing strengthened the financial position, raising SEK 161 million before costs.
The FDA issued a Complete Response Letter (CRL) for DasynocⓇ, citing GMP issues at a contract manufacturer and requesting additional documentation.
The FDA accepted the NDA for XS003 nilotinib, setting a PDUFA date of June 18, 2026.
Financial highlights
Net sales were SEK 0 thousand for Q3 and Jan–Sep 2025 (unchanged year-over-year).
Loss before tax improved to SEK -47,332 thousand in Q3 2025 from SEK -82,272 thousand in Q3 2024.
Loss before tax for Jan–Sep 2025 was SEK -134,537 thousand, compared to SEK -203,672 thousand year-over-year.
Earnings per share before dilution were SEK -1.25 in Q3 2025 (Q3 2024: -2.44) and SEK -3.60 for Jan–Sep 2025 (Jan–Sep 2024: -6.24).
Cash and cash equivalents at September 30, 2025, were SEK 197,984 thousand (Sep 30, 2024: 74,759).
Equity/assets ratio was 78.2% at September 30, 2025 (Sep 30, 2024: 87.7%).
Outlook and guidance
Financial position is considered solid, with sufficient funds to reach the PDUFA date for XS003.
Resubmission for DasynocⓇ is targeted for Q1 2026, pending resolution of manufacturing issues.
Updated launch timelines for both products will be provided after regulatory clarity.
Impact of Dasynoc CRL on XS003 approval timeline?
Detail the going concern risk mitigation plan
What are Dasynoc's key commercial advantages?
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Next Xspray Pharma earnings date
Q4 202512 Feb, 2026
Next Xspray Pharma earnings date
Q4 202512 Feb, 2026
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Frequently asked questions
Xspray Pharma AB is a pharmaceutical company, which engages in the development of protein kinase inhibitors for targeted cancer treatments. Its product candidates include HyNap-Nilo and HyNap-DS. The company was founded by Lars Holmkvist, Ola Winqvist and Magnus Persson on April 3, 2003 and is headquartered in Solna, Sweden.
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