April-June 2026, Group
- Net sales amounted to SEK 0 thousand (0)
- Earnings before tax amounted to SEK -39,794 thousand (-44,885)
- Earnings per share before dilution amounted to SEK -0.87 (-1.21)
- Cash flow from operating activities amounted to SEK -36,946 thousand (-44,111)
- Cash flow from investing activities amounted to SEK -10,307 thousand (-6,132)
Amounts in parentheses refer to the year-earlier period.
January-June 2026, Group
- Net sales amounted to SEK 0 thousand (0)
- Earnings before tax amounted to SEK -75,174 thousand (-87,206)
- Earnings per share before dilution amounted to SEK -1.72 (-2.35)
- Cash flow from operating activities amounted to SEK -67,622 thousand (-110,440)
- Cash flow from investing activities amounted to SEK -11,374 thousand (-20,833)
Significant events during the quarter
- 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. As a result, the number of outstanding shares and votes increased by 5,674,234 shares to a total of 47,416,574 shares and the share capital has increased by SEK 5,674,234 to SEK 47,416,574.
- In June, Xspray Pharma's two newly implemented long-term incentive programs for employees, LTIP 2025/2028 and LTIP 2026/2029, reached full participation. The programs mature from May 2028 onwards with subscription prices of SEK 49.30 and SEK 48.80 per share.
- In June, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding Xspray Pharma's New Drug Application (NDA) for Nilopki®. The FDA requested additional information relating to dose level, product labelling and manufacturing.
- In June, Xspray Pharma provided a regulatory update on its product candidates. For Nilopki®, Xspray has defined an approach to address the items raised in the Complete Response Letter (CRL) and has requested a Type A meeting with the FDA. For Dasynoc®, the FDA is conducting labelling review ahead of the PDUFA date of 25 August 2026. Separately, the FDA has accepted Xspray's request for a Type C meeting to discuss a potential labelling enhancement for Dasynoc®.
A message from the CEO
Dear shareholders,
The second quarter marked continued progress in Xspray Pharma's transformation into a commercial-stage oncology-focused company. We remain firmly focused on our key strategic priorities: advancing Dasynoc toward a U.S. commercial launch, implementing a path forward for Nilopki with the FDA, maintaining a disciplined approach to financial management, and further strengthening our organization and commercial capabilities.
During the quarter, we continued to build the operational and organizational foundations necessary to support future growth and execute effectively on our commercialization strategy. Our commitment to delivering improved alternatives to well established oncology treatments for patients remains strong, and we are encouraged by the progress achieved across our development and commercial readiness initiatives.
As we move forward, we remain focused on creating long-term value for patients, shareholders, and other stakeholders while positioning Xspray Pharma for its next phase of growth.
Dasynoc: Advanced application stage and positioned for launch
Dasynoc remains our foremost priority. The regulatory process for our New Drug Application is now at an advanced stage. We have responded to all FDA information requests and addressed all outstanding dossier-related matters, including those concerning product labelling. The most recent phase of the dialogue has included detailed work on the presentation of the product, including carton design and color schemes, reflecting the level of detail normally associated with a mature application review process. To the best of our knowledge, there are no remaining matters related to the Dasynoc application itself that are within Xspray Pharma's control.
Nevertheless, approval of Dasynoc remains contingent on the regulatory status of our third-party manufacturing facility, NerPharMa. The timing of the remaining actions and reviews is not within Xspray Pharma's control, and we will not speculate about the decisions by the FDA.
However, it is our understanding that the implementation of the corrective actions at the facility is progressing according to plan. We view Benta Group's ambition to establish a long-term manufacturing partnership with Xspray Pharma positively. In July, I visited the manufacturing facility and met with the Benta Group team to review the progress of the facility and the manufacturing setup. The visit strengthened my confidence in Benta Group's commitment to supporting Xspray Pharma's HyNap-technology platform and serving as a manufacturing partner for our future commercial products.
Our current planning continues to support a Dasynoc launch in the US before the end of 2026, provided that the remaining regulatory requirements are resolved in a timely manner. This remains a conditional objective, but an important one. A regulatory clearance for NerPharMa during the autumn would still be consistent with a launch within the year, even if it were to happen after the PDUFA-date set for Dasynoc. We are therefore maintaining the operational and commercial readiness needed to act quickly once the remaining conditions for approval have been met. The FDA may issue a Complete Response Letter (CRL), as the Agency has not yet completed its inspection of the third-party manufacturing site or finalized the corresponding inspection report. While the previously announced PDUFA date is August 25, the FDA may communicate its decision earlier, as was the case with Nilopki.
Beyond the path to approval, we are focused on realizing the full potential of Dasynoc. Drawing on feedback from key opinion leaders, we have begun regulatory discussions aimed at evaluating future opportunities for label development aligned with clinical treatment guidelines together with the FDA. While we are not in a position to provide further details at this stage, these efforts reflect our long-term vision for the product and our belief that Dasynoc may offer value extending beyond its initial commercial launch.
Nilopki: Revised regulatory pathway toward Q4 2026 resubmission
During the period, we also advanced the regulatory work for Nilopki. The Company has completed a Type A meeting with the FDA within July as expected. The dialogue provided further clarity regarding the Agency's expectations and represents an important step in defining the most efficient path forward for the product. Based on the feedback from FDA, we are adjusting the regulatory plan. We are working towards a resubmission during the fourth quarter 2026. If the FDA assigns a review period of six months a PDUFA-date could be expected six months after resubmission. Therefore a launch of Nilopki in 2026 remains unlikely. Although the development timeline has shifted, we continue to see a significant opportunity to bring Nilopki to the U.S. market and remain committed to executing the most efficient path toward approval.
Dasynoc and Nilopki share a common commercial infrastructure and address meaningful limitations in current chronic myeloid leukemia treatments. This creates the potential for synergistic commercialization as the portfolio expands.
Financial discipline and execution capability
We continue to manage the Company's resources with a clear focus on value creation and launch readiness. During the quarter, we maintained a disciplined approach to cost management while preserving the capabilities required to support the anticipated commercial launch of Dasynoc. The year-to-date reduction in operating expenses and the improved operating result demonstrate that the measures implemented over the past year are delivering tangible results. We have successfully streamlined our cost base without compromising the quality or commercial preparations.
In July, we also made a contractual repayment of SEK 50.4 million of debt financing, reducing the Company's financial leverage and providing for financial flexibility ahead.
Maintaining the right balance between financial discipline and execution readiness remains a key priority. Our objective is to ensure that the Company is well financed and positioned to transition efficiently into the commercial phase and capture the full value of Dasynoc and Nilopki as soon as the remaining regulatory conditions have been satisfied.
Positioned for the next phase
Xspray Pharma has made impressive progress in recent years: From technology development and clinical work to late-stage regulatory execution and commercial preparation.
I have been impressed by the quality, commitment and execution capability of the Xspray team and our partners. The work required to bring improved oncology products to market is demanding, particularly when important steps depend on external regulatory processes. Nevertheless, we remain focused, realistic and forward-looking to the significant potential that will be soon unlocked. Dasynoc has a differentiated, improved clinical profile and the potential to address a clear need among patients treated with dasatinib. It is Xspray Pharma's first planned commercial product and an important foundation for the broader HyNapbased portfolio.
We will continue to communicate transparently as confirmed information becomes available. Our focus remains on completing the remaining regulatory steps, maintaining launch readiness including securing the necessary financing, and creating the foundation for long-term value for patients and shareholders.
Blake Leitch
CEO, Xspray Pharma
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.
This information is information that Xspray Pharma AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-08-05 08:00 CEST.
