January-March 2026, Group
- Net sales amounted to SEK 0 thousand (0)
- Earnings before tax amounted to SEK -35,380 thousand (-42,321)
- Earnings per share before dilution amounted to SEK -0.85 (-1.14)
- Cash flow from operating activities amounted to SEK -30,676 thousand (-66,329)
- Cash flow from investing activities amounted to SEK -1,067 thousand (-14,701)
Amounts in parentheses refer to the year-earlier period.
Significant events during the quarter
- In February, Blake Leitch was appointed Chief Executive Officer, effective no later than June 1, 2026. He succeeds Per Andersson, who continues in the role of Chief Scientific Officer.
- In February, Xspray Pharma announced that it had re-submitted its application for market approval for Dasynoc® to the US Food and Drug Administration (FDA). The resubmission includes the additional information requested by the FDA.
- In March, the FDA announced that it had accepted the resubmitted application for market approval of Dasynoc® for review and set a PDUFA date of August 25, 2026, which is the date when the agency is expected to announce a decision on the application.
- In March, the company announced that the Board had resolved to carry out a new issue of shares for approximately SEK 83 million, with preferential rights for the company's existing shareholders, as well as an over-allotment issue. In light of the oversubscription, the company resolved to increase the over-allotment issue from SEK 20 million to SEK 30 million.
Significant events after the reporting period
- In April, Xspray Pharma announced that the FDA had accepted the proprietary name Nilopki® for the company's drug candidate XS003 (nilotinib), ahead of a planned launch in the US in the second half of 2026, subject to FDA approval.
- In April, Xspray Pharma announced the outcome of the Company's rights issue, which was significantly oversubscribed with subscriptions corresponding to approximately 258 percent of the offered shares. In light of the strong investor interest, the Board of Directors resolved to fully exercise the over-allotment issue. Through the rights issue and the over-allotment issue, the Company will receive total issue proceeds of approximately SEK 113 million before transaction costs.
A message from the CEO
Dear shareholders,
We took several important steps in the first quarter of 2026 toward our ultimate goal of obtaining market approval for our products and making them available for all of the patients who truly need them.
Physicians confirm that there is a real need in the market
During and after the quarter, we held in-depth conversations with hematologists in the US - both through Advisory Boards and at conferences such as NCODA Global Congress 2026. These conversations provided me with more than just crucial strategic input. They have further strengthened my conviction that what we have achieved during our nearly 20 years fulfills a highly significant clinical need in the market.
In our analysis of real clinical patient data - corresponding to more than 35,000 patient-years - we are seeing a clear pattern that physicians can understand but rarely see quantified. Patients often switch treatments at an early stage - in most cases due to side effects. One widespread and underestimated problem is co-medication with proton-pump inhibitors (PPIs). A large proportion of all CML patients treat stomach problems with PPIs while taking dasatinib - which drastically impairs the uptake of the crystalline drug. This is an everyday clinical problem that currently lacks a good solution. The reaction from physicians when we presented this data and demonstrated how Dasynoc® addresses this problem was clear and straightforward - not politely interested, but genuinely engaged. Having persuasive clinical data in an application is one thing. Hearing the physicians who will soon be prescribing the product say that their patients actually need this, is another.
Regulatory status - we are close
We enter the second quarter with optimism. Two products are very close to approval. The PDUFA date for Dasynoc® is set to August 25, 2026, and for Nilopki® (XS003 nilotinib) to June 18, 2026. Our manufacturing partner in Italy is expected to be inspection-ready during the first half of the year. If the FDA is able to complete the inspection before the PDUFA date, approval could come as early as June 18. If the inspection instead takes place after the PDUFA date, the FDA is likely to issue a CRL (Complete Response Letter) that relates solely to the inspection and not to the product itself.
As soon as the inspection is approved, Xspray will inform the FDA that no remaining obstacles to approval exist. Both paths are consistent with Xspray's plan to launch in the U.S. during the second half of 2026.
We are following the situation closely and are well prepared for a dual launch of Dasynoc® and Nilopki® in the autumn of 2026.
The HyNap platform is stronger than ever
Having two NDA applications under review at the same time, for two separate products based on the same technology platform, is something quite unique - especially for a company of our size. With every regulatory response we formulated, and every CMC question we answered, we have built up a knowledge base that is now clearing a shorter - and less costly - path for the next product candidates.
Financing
The completed preferential rights issue will secure the capital requirement up through launch and give us the resources needed to genuinely start up commercial operations with full force. Additional financing - for example, in the form of loan financing - may be needed to complete a successful double launch and achieve cash-flow positivity. Our cost structure is suitably adapted to keep running costs down, with launch-related investments being capitalized in line with future approvals.
Looking ahead
Now that the company is entering an eagerly awaited commercial phase, I would like to welcome Blake Leitch as our new CEO - the right person, at the right time. I, myself, am looking forward to focusing on the technology and the science, and to developing the next generation of improved PKI drugs in my role as Chief Scientific Officer.
In conclusion, I would like to say that leading an organization with so many competent and committed people has been a glorious journey. There is no doubt in my mind that, scientifically and technically, we have essentially done everything correctly. What we sometimes underestimated was the methodology. In breaking new ground, it is easy to assume that the business environment is keeping pace, that partners understand the implications of what we are doing, and that government authorities are sending the right expertise to audit us. This has not always been the case, and it has cost us time and money. We have every reason to believe that this phase is now behind us. The dialogue with the FDA has matured, the technology has been established and documented, and our take-aways from this journey will shorten the path to market for the next products. Now, it is a matter of transforming all this into successful commercialization and a strong pipeline, and I am genuinely looking forward to the next phase.
Thank you all for your confidence.
Per Andersson
CEO
For further information, please contact:
Jacob Nyberg, IRO
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, patent protected 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 lead drug candidate, Dasynoc® and Nilopki® (an optimized version of Tasigna®) are currently undergoing FDA review. Dasynoc 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 Nilopki 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.
