January - March 2025, Group
• Net sales amounted to SEK 0 thousand (0)
• Earnings before tax amounted to SEK -42,321 thousand (-67,781)
• Earnings per share before dilution amounted to SEK -1.14 (-2.17)
• Cash flow from operating activities amounted to SEK -66,329 thousand (-55,311)
• Cash flow from investing activities amounted to SEK -14,701 thousand (-5,149)
Amounts in parentheses refer to the year-earlier period.
Significant events during the quarter
• In January, Xspray Pharma issued an update regarding the process for submitting its updated application to the US Food and Drug Administration (FDA) for Dasynoc®, the company's lead product candidate. The timeline was adjusted as the result of one batch of tablets being identified as aberrant. A new batch of tablets was produced to safeguard the stringent quality requirements and production was resumed.
• In January, interim data from a food interaction study with product candidate XS003 nilotinib was presented. The study showed that bioavailability remains stable regardless of food intake. These results confirmed the benefits of the company's patented HyNap technology platform and its ability to deliver significant benefits for patients compared with existing PKI drugs.
Significant events after the reporting period
• In April, Xspray Pharma announced that it had re-submitted its application for market approval for Dasynoc® to the US Food and Drug Administration (FDA). Within 2 to 4 weeks after the re-submission of the application, the FDA is expected to announce a new PDUFA date, i.e. the date they intend to reach a decision on market approval.
• Shareholders in Xspray Pharma were called to attend the Annual General Meeting, which has been arranged for Tuesday, May 13, 2025, at 10:00 am CEST. The meeting will be held on the premises of Advokatfirman Vinge at Smålandsgatan 20, Stockholm, Sweden.
A message from the CEO
Dear shareholders,
Our updated application regarding market approval for Dasynoc® was submitted to the FDA shortly after the end of the first quarter. The FDA has not yet communicated a new PDUFA date for the decision regarding our marketing authorization application. We expect this date to be determined in the near future. The PDUFA date brings us a step closer to a market-approved product that will be best-in-class, and we are well prepared for a launch in the autumn of 2025.
One step closer to launch of Dasynoc®
In parallel with the regulatory approval process, we have continued to build up relationships with US physicians and insurance companies for the purpose of supporting a future launch of Dasynoc®. In parallel, we are focused on limiting day-to-day expenses and have therefore placed other launch activities on hold. While generic competitors to Sprycel are available in the US market, we believe market conditions for Dasynoc® remain favorable due to its clear patient benefits and strong patent protection.
In conjunction with a market launch of Dasynoc®, US physicians will gain access to a significantly improved treatment for CML and ALL patients. Dasynoc® delivers lower variability and the same efficacy at a lower dosage strength, and solves the complex problem of co-medication with all types of drugs that inhibit stomach acids. This is possible because of our patented HyNap technology. Dasynoc® is positioned to be a best-in-class product, and serves as the cornerstone for future product candidates that are developed on the same technology platform.
There are a number of reasons why I feel confident regarding the continued regulatory process for Dasynoc®. The inspection related questions that formed the basis for the delayed CRL are specific, limited and have been addressed. While the production process was already solid at an earlier stage, we have since implemented improvements that have further elevated the quality.
• The FDA has requested that it be allowed to evaluate the improvements that have been implemented in the manufacturing facility in Italy, and we have results that lead us to believe this follow-up will confirm that these measures are sufficient for approval.
• The previous solvent levels in Dasynoc® were low, but we have now reduced them to a level 30 times below the FDA's safety limit.
• We previously had a positive and constructive meeting with the FDA, where we agreed on a minor adjustment to three out of six of the dosage strengths in order to reduce the risk of medication errors. Moreover, we have had constructive labeling discussions, and we have answered outstanding questions.
While we take nothing for granted, we are optimistic about the prospect of having our first market-approved product ready for launch in 2025.
Continued progress for product candidate XS003
During the quarter, we presented interim data from a food interaction study for our product candidate XS003 nilotinib, which - like Dasynoc® is intended to be used to treat leukemia. The data confirms that our amorphous formulation of nilotinib eliminates the problems with food interaction and can thus offer unique patient benefits. This would improve patient quality of life and reduce the risk of serious side effects. Once again, we see that the HyNap technology platform has the ability to deliver significant benefits for patients compared with existing PKI drugs. Our ambition is to complete the final sub-studies during the current quarter and submit our application for market approval for XS003 nilotinib during the summer of 2025.
Positive outlook
Despite these challenges, we have strong support from our owners. 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, and to complete the remaining studies for XS003 nilotinib. At the same time, we are working towards securing debt financing for the upcoming launch of Dasynoc®.
We have an exciting period before us, and I look forward to Xspray Pharma embarking on its commercial journey.
Per Andersson, CEO
Xspray Pharma AB
For further information, please contact:
Jacob Nyberg, IR
Xspray Pharma AB (publ)
Tel: + 46 (0)8 730 37 00
E-mail: ir@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.
