October-December 2025, Group
- Net sales amounted to SEK 0 thousand (0)
- Earnings before tax amounted to SEK -37,009 thousand (-82,002)
- Earnings per share before dilution amounted to SEK -0.89 (-2.36)
- Cash flow from operating activities amounted to SEK -41,370 thousand (-61,601)
- Cash flow from investing activities amounted to SEK -1,488 thousand (-19,202)
January-December 2025, Group
- Net sales amounted to SEK 0 thousand (0)
- Earnings before tax amounted to SEK -171,546 thousand (-285,674)
- Earnings per share before dilution amounted to SEK -4.46 (-8.62)
- Cash flow from operating activities amounted to SEK -193,163 thousand (-222,367)
- Cash flow from investing activities amounted to SEK -29,186 thousand (-42,142)
Amounts in parentheses refer to the year-earlier period.
Significant events during the quarter
- In October, the FDA issued a Complete Response Letter (CRL) regarding Xspray's application for market approval of Dasynoc®.
- In October, Xspray Pharma published the Nomination Committee's composition for the Annual General Meeting on May 12, 2026. The Nomination Committee consists of: Thomas Eldered, appointed by Flerie Invest, Chairman of the Nomination Committee; Johan Gyllenswärd, appointed by Ribbskottet AB; Mattias Klintemar, appointed by the Foundation for Baltic and East European Studies; Johan Wadell, appointed by AP2; and Anders Ekblom, Chairman of the Board of Directors of Xspray Pharma AB.
- In October, the FDA announced that it had accepted Xspray Pharma's NDA application for XS003 for review. At the same time, the FDA set the PDUFA date to June 18, 2026.
Significant events after the reporting period
- No significant events have occurred after the end of the reporting period.
A message from the CEO
Dear shareholders,
Our intensive efforts at transforming Xspray Pharma from a research company into a commercial pharmaceutical company continued during the fourth quarter. We are doing this in a growing market with significant medical need, with our product candidates addressing widely acknowledged limits in today's treatments, where we are seeing clear opportunities for creating long-term value. At the same time, the quarter was marked by further regulatory challenges. In October, we received a Complete Response Letter (CRL) for Dasynoc from the FDA. The primary reason was observations linked to deficiencies in quality at our contract manufacturer. These deficiencies relate to parts of the plant that are not used for Xspray's production, but the deficiencies need to be addressed in order to obtain an approval. The contract manufacturer is working to address the identified deficiencies in dialogue with the FDA. According to information from the contract manufacturer, a re-inspection of the plant is expected in the first half of the year, which - given the current assessment - is not expected to affect our overall launch preparations.
Regulatory situation and ongoing dialogue with the FDA
In parallel, we have been working to respond to the FDA's questions that are under our control. On the one hand, this includes providing documentation that shows the effect of previously implemented production measures; on the other, showing that the product information on the package leaflet is appropriate and facilitates safe use. We chose to address the latter issue through a survey of authorized prescribers that is now nearing completion. Once the compilation is finished, which we believe will be in the first quarter of 2026, our formal response will be submitted to the FDA, which subsequently will have up to six months to make a decision.
Preparations ahead of launch, and market potential
For XS003 nilotinib, the PDUFA date has been set for June 18, 2026, and we expect a new PDUFA date for Dasynoc in the third quarter. In light of these circumstances, we are continuing our preparations ahead of a potential launch of two differentiated drugs for chronic myeloid leukemia in the US market during the second half of 2026. This marks an important step in our evolution toward becoming a fully integrated commercial company.
Positive response for our technology among key opinion leaders
In parallel with the regulatory agenda, we continued to build confidence among leading clinics and key opinion leaders. Their response confirms both the clinical need for and the relevance of our technology as a solution to widely acknowledged problems with current treatments. The clinical results for XS003 were presented at the ASH Congress in December, which met with great interest and provided valuable dialogue on future clinical use.
Strong underlying CML market
The US market for chronic myeloid leukemia (CML) continues to perform strongly, growing approximately 12 percent to total sales of USD 6.6 billion in 2025. Dasatinib and nilotinib continue to comprise nearly half of total sales, with price levels remaining high despite generic sales. This is creating good conditions for differentiated products with clear clinical benefits.
Financial position, and focus going forward
Cash on hand at the end of the quarter amounted to SEK 154 million, which is believed will finance operations through the autumn of 2026 under the current plan. This gives us scope for completing the regulatory processes and continuing the preparations for commercialization. To ensure optimal readiness for two FDA approvals and future market launches, the company may further strengthen its financial position through additional capital in order to fully support a successful commercialization.
We are going into 2026 with a clear strategy, two products close to market launch and a technology that addresses real clinical needs. Our focus remains unchanged: fully transitioning to a commercial pharmaceutical company and creating value for patients, healthcare and our shareholders.
Per Andersson, CEO
Xspray Pharma
For further information, please contact:
Jacob Nyberg, IR
Xspray Pharma AB (publ)
Tel: + 46 (0) 70 767 08 83
E-mail: ir@xspray.com
About Xspray Pharma
Xspray Pharma AB (publ) is a pharmaceutical company with several product candidates in clinical development utilizing its innovative, patented HyNap technology platform to create improved versions of marketed protein kinase inhibitors (PKI), the largest oncology market segment, often with high drug prices. The company's goal is to become the market leader in improved PKI's for cancer treatment. Xspray Pharma's drug candidates, Dasynoc®, and XS003-nilotinib, is currently undergoing FDA review. It is an amorphous form of dasatinib, demonstrating bioequivalence at a 30% lower dose due to a better solubility profile. Its compatibility with proton pump inhibitors (PPIs), which are often co-prescribed to patients with CML and ALL, is 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®) and XS025-cabozantinib (an optimized version of Cabometyx®).
The Xspray Pharma AB-share is trading at Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY).
www.xspraypharma.com.
