July-September 2025, Group
- Net sales amounted to SEK 0 thousand (0)
- Earnings before tax amounted to SEK -47,332 thousand (-82,272)
- Earnings per share before dilution amounted to SEK -1.25 (-2.44)
- Cash flow from operating activities amounted to SEK -41,354 thousand (-41,275)
- Cash flow from investing activities amounted to SEK -6,865 thousand (-9,053)
January-September 2025, Group
- Net sales amounted to SEK 0 thousand (0)
- Earnings before tax amounted to SEK -134,537 thousand (-203,672)
- Earnings per share before dilution amounted to SEK -3.60 (-6.24)
- Cash flow from operating activities amounted to SEK -151,793 thousand (-160,767)
- Cash flow from investing activities amounted to SEK -27,698 thousand (-22,940)
Amounts in parentheses refer to the year-earlier period.
Significant events during the quarter
- In July, Xspray Pharma announced that the company had completed the population pharmacokinetic (PopPK) modeling that confirmed bioequivalence between XS003 and the reference drug Tasigna®. Bioequivalence with XS003 was achieved at less than half the dose compared with Tasigna®. Accordingly, all regulatory documentation has been completed for submitting a 505(b)(2) NDA for the XS003 product candidate.
- In August, Xspray Pharma entered into a license agreement with Handa Therapeutics ("Handa"), granting Handa a non-exclusive license to certain Xspray patents. The license covers commercialization of a dasatinib product in the US market and, at a later stage, selected Asian markets. Under the agreement, Xspray will receive up to a double-digit royalty on Handa's net proceeds.
- In August, the Board of Directors resolved on a new issue of shares of approximately SEK 130 million as well as an over-allotment issue. The issue was heavily oversubscribed, and in light of the high subscription rate the over-allotment issue was increased from SEK 20 million to approximately SEK 31 million. Through the preferential rights issue and the over-allotment issue, Xspray received a total of approximately SEK 161 million before transaction costs. Furthermore, the Board resolved to refinance an existing loan. The maturity was extended by 18 months, and the loan amount was increased by SEK 25 million.
- In August, Xspray Pharma submitted a New Drug Application (NDA) for its product candidate XS003 nilotinib for the treatment of chronic myeloid leukemia to the U.S. Food and Drug Administration. The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna®. Due to XS003's improved food interaction profile, the warning about three hours of fasting - currently included in the reference product's "boxed warning" - is not expected to apply to XS003. This may simplify treatment and improve adherence.
- In September, Xspray Pharma announced that new shares had been issued as a result of the rights issue and over-allotment issue. Overall, the number of outstanding shares and votes increased by 4,603,849 shares to a total of 41,742,340 shares, and the share capital had increased by SEK 4,603,849 to SEK 41,742,340.
Significant events after the reporting period
- 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, 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.
A message from the CEO
Dear shareholders
The third quarter involved a gathering of forces ahead of the completion of the regulatory process and preparations for the launch of our first product candidate, Dasynoc®. We are convinced that we were extremely close to approval when the FDA, after the expiration of the review period, issued a Complete Response Letter (CRL) with three main points: The first observation concerns overarching GMP issues at our Italian contract manufacturer. The company has assured us that it has taken immediate corrective actions and is doing everything in its power to address the deficiencies identified by the FDA. The second observation requires us to submit additional documentation to ensure that the product information, which was discussed with the FDA up until the PDUFA date, is appropriate. The third relates to a request for information confirming the effectiveness of previously implemented manufacturing measures. We have promptly initiated efforts to respond to the FDA's questions and are doing everything we can to minimize the delay.
During the quarter, we strengthened our cash position thanks to broad support from our existing shareholders as well as several new investors. Our improved financial position now leaves us well equipped to manage the current situation.
One important event that was slightly overshadowed by the challenges with Dasynoc® was the submission during the quarter of our application for market approval for our second product candidate, XS003 nilotinib, which after the end of the period was accepted by the FDA with a PDUFA date of June 18, 2026.
Dasynoc® update
Naturally, the further delay to Dasynoc® is unexpected and unfortunate. It is important to note that, in the current situation for the contract manufacturer, the FDA pauses approvals of new products while corrective actions are being implemented at the facility. The manufacturer has confirmed that a remediation plan is already in place, and that a meeting with the FDA is scheduled for December. After that, we anticipate increased clarity concerning the timeline for continuing the regulatory process. The supplementary information that we are to submit ourselves is clearly specified, and we are working intensively on completing our response for submission to the FDA. Even though we do not have full clarity regarding all circumstances, we believe that resubmission can take place during the first quarter of 2026.
I would like to emphasize that the clinical and commercial conditions for Dasynoc® remain good. Pricing remains high despite more dasatinib products now being available in the market. Dasynoc®'s improvement profile - stable uptake, lower doses and less impact from co-medication with acid reducing agents - satisfies significant needs among AML and CML patients, which no other existing product can manage to the same extent.
XS003 nilotinib - PDUFA date and regulatory progress
One positive piece of news was received after the period from the FDA: it had accepted the company's New Drug Application (NDA) for XS003 nilotinib for review. This is the second product that the company has applied for market approval for that is based on the HyNap technology. This demonstrates the broad applicability of our technology. The FDA has set a PDUFA date of June 18, 2026, which is the FDA's deadline for announcing its decision on the company's application.
XS003 is an improved amorphous version of nilotinib (Tasigna®) for the treatment of chronic myeloid leukemia (CML), developed using Xspray's patented HyNap technology. The data demonstrates bioequivalence with the reference drug at less than half the dose, as well as sharply reduced food interaction (29 percent compared with 82 percent for Tasigna). The food interaction linked to the reference drug makes it more difficult for patients to take the drug as intended, since it must be taken while fasting. This requirement is stated in the "boxed warning", which pertains to the risk of QTc prolongation and sudden death. The sharply reduced food interaction in XS003 means it is expected that it can be taken with or without food, thereby avoiding the warning text regarding food interaction. The final product information and any warning texts will be decided on by the FDA during the review period.
With two product candidates under FDA review, we can show that the HyNap platform has broad applicability and the potential to deliver more improved PKI drugs to the market. Together, the product candidates XS003 and Dasynoc® address a US market of approximately USD 2.7 billion.
XS003 is manufactured at the same external facility that is used for Dasynoc®. Since the FDA now has a good understanding of our manufacturing process, I am convinced that the upcoming PAI inspection will be conducted without any observations. In our assessment, the production challenges that have been identified at the contract manufacturer will be resolved before the FDA returns with its decision regarding XS003.
Rights issue heavily oversubscribed
During the quarter, we successfully carried out a rights issue that was heavily oversubscribed, which demonstrates continued strong confidence among our shareholders. In total, the rights issue together with the over-allotment issue raised approximately SEK 161 million before transaction costs. During the quarter we also refinanced an existing loan of SEK 100 million, with the maturity extended by 18 months and the loan increased by SEK 25 million.
All together, this means that we have secured crucial financing for pursuing the regulatory FDA process for both Dasynoc® and XS003, as well as conducting necessary market preparations ahead of a launch.
Outlook
Our financial position is solid, and we have sufficient financing to take us up to the forthcoming PDUFA date. We are continuing to work in a cost-efficient manner, prioritizing investments that directly strengthen our potential for successful regulatory outcomes.
We are continuing to work purposefully toward market approval of our products, and we will provide an updated timeline for future product launches.
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.