Xspray Pharma (XSPRAY) Q3 2025 earnings summary

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.