October-December 2024, Group
- Net sales amounted to SEK 0 thousand (0)
- Loss before tax amounted to SEK -82,002 thousand (-54,513)
- Earnings per share before dilution amounted to SEK -2.36 (-1.85)
- Cash flow from operating activities amounted to SEK -61,601 thousand (-32,626)
- Cash flow from investing activities amounted to SEK -19,202 thousand (-20,729)
Amounts in parentheses refer to the year-earlier period.
January - December 2024, Group
- Net sales amounted to SEK 0 thousand (0)
- Loss before tax amounted to SEK -285,523 thousand (-179,684)
- Earnings per share before dilution amounted to SEK -8.62 (-6.76)
- Cash flow from operating activities amounted to SEK -222,367 thousand (-203,275)
- Cash flow from investing activities amounted to SEK -42,142 thousand (-65,876)
Amounts in parentheses refer to the year-earlier period.
Significant events during the quarter
- In October, Xspray Pharma published the composition of its Nomination Committee for the Annual General Meeting on May 13, 2025. The Nomination Committee, which has been appointed in accordance with the principles adopted by the Annual General Meeting on May 21, 2024, consists of: Thomas Eldered, appointed by Flerie AB, 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, Xspray Pharma AB.
- In November, the Board of Directors, by virtue of the authorization from the Annual General Meeting on May 21, 2024, resolved to carry out a new issue of shares of approximately SEK 135 million, with preferential rights for the company's existing shareholders. The final outcome, which was announced in December, showed that the rights issue was oversubscribed and that the total number of shares increased by 3,376,226 to a total of 37,138,491. Furthermore, the Board resolved to take a loan of SEK 100 million and issue warrants to the lenders. The primary purpose of the loan is to finance the preparatory activities ahead of the contemplated launch of Dasynoc® in the US market, conduct registration-based studies for XS003 nilotinib, and continue development of the rest of the company's product portfolio.
Significant events after the end of the reporting period
- In January, Xspray Pharma provided an update regarding the process for submitting an updated application to the US Food and Drug Administration (FDA) for Dasynoc®, the company's lead product candidate. The timeline has been adjusted as the result of one batch of tablets being identified as aberrant. The cause of the aberration has been identified, the batch has been remade to safeguard the stringent quality requirements and production has resumed. As a result of the turnaround times in production, the company intends to submit the updated application in the March/April timeframe.
- In January, interim data from a food interaction study with product candidate XS003 nilotinib was presented. The study shows that bioavailability remains stable and consistent regardless of food intake. These results confirm the benefits of the company's patented HyNap technology platform and its ability to deliver significant benefits for patients compared with existing PKI drugs.
CEO Statement
Dear shareholders,
Significant advances and preparations
Intensive efforts with our application for market approval of Dasynoc® during the quarter have brought us closer to our goal despite the delay that arose in the final stages. We have produced batches of tablets of Dasynoc® with adjusted dosage strengths in accordance with the FDA's requests in order to reduce the risk of medication error. Unfortunately, an aberration in one batch of tablets was noticed very late. The turnaround times for producing and analyzing a new batch of tablets means a delay that is of course unwelcome but fully manageable. We are now producing the adjusted dosage strengths and intend to submit our revised application in the March/April timeframe.
If our application receives a Class 1 designation, we can expect a review period of two months, which will enable a launch as soon as the second quarter of 2025. If it receives a Class 2 designation, the FDA's processing time is six months from the date we submit our updated application, which will enable a launch during the autumn of 2025.
Focus on launch and future growth
Our work on building relationships with physicians and payors in the US continued during the quarter. Outside of this, the launch efforts and related costs are on hold.
We do not believe that our market positioning of Dasynoc® will be impacted by the new timeline. Our product candidate has important advantages, with the potential of being best in class compared with competing products. Dasynoc® has lower variability, the same effect at a lower dosage strength, and solves the complex problem of co-medication with all types of acid reducing agents. This is possible because of our patented HyNap technology. With Dasynoc®, we have laid the foundation for future product candidates that are developed using the same technology platform.
Financing
Despite these challenges, we have strong support from our investors, both large and small, which we are grateful for. During the period, financing that encompassed a new share issue of SEK 135 million and a loan of SEK 100 million was successfully completed. Our cost profile is flexible, and largely connected with the launch itself. We believe that we have the financing we need to cover the company's capital requirements until Dasynoc® is approved, regardless of which response period the FDA uses, and to complete the remaining studies for XS003 nilotinib.
Earnings for the quarter are lower compared to the year-earlier period. One reason is a higher share of research and development costs now being expensed directly instead of being capitalized, and another is previous investments for production capacity in Malta being written off due to new timelines and changed patent situation.
The technology platform: advantages and outlook
After the quarter, we presented interim data from a food interaction study for our product candidate XS003 nilotinib. The data confirms the ability of the company's HyNap technology platform to deliver significant benefits for patients compared with existing PKI drugs. Our amorphous formulation of nilotinib eliminates the problems with food interaction, thus demonstrating a markedly improved profile compared with all currently approved nilotinib products. This would improve patient quality of life and reduce the risk of serious side effects. The findings of the current study, together with the product candidate's robust patent protection, provide unique competitive advantages that would enable XS003 nilotinib to capture significant market shares.
There are exciting times ahead, and I look forward to leading Xspray Pharma through the next stage of the journey toward becoming a commercial-stage, profitable pharmaceutical company and beginning to build a position as a leading player in improved protein kinase inhibitors.
Per Andersson, CEO, Xspray Pharma
For further information, please contact:
Per Andersson, CEO
Xspray Pharma AB (publ)
Tel: + 46 (0)8 730 37 00
E-mail: per.andersson@xspray.com
About Xspray Pharma
Xspray Pharma AB (publ) is a pharmaceutical company focused on the development of improved PKIs for cancer treatment, leveraging its proprietary HyNap technology platform. The company aims to enhance clinical outcomes for cancer patients by improving the efficacy, safety, and patient experience of existing cancer therapies. Xspray Pharma's shares are traded at Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY). For more information about Xspray Pharma AB and its innovative approach to cancer treatment, please visit www.xspraypharma.com.
