July-September 2026, Group
- Net sales amounted to SEK 0 thousand (0)
- Earnings before tax amounted to SEK -39,323 thousand (-47,332)
- Earnings per share before dilution amounted to SEK?-0.83 (-1.25)
- Cash flow from operating activities amounted to?SEK -33,374 thousand (-41,354)
- Cash flow from investing activities amounted to SEK -5,616 thousand (-6,865)
January-September 2026, Group
- Net sales amounted to SEK 0 thousand (0)
- Earnings before tax amounted to SEK -114,497 thousand (-134,537)
- Earnings per share before dilution amounted to SEK -2.54 (-3.60)
- Cash flow from operating activities amounted to SEK -100,996 thousand (-151,793)
- Cash flow from investing activities amounted to SEK?-16,990 thousand (-27,698)
Amounts in parentheses refer to the year-earlier period.
Significant events during the quarter
- In August, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding Xspray Pharma's New Drug Application (NDA) for Dasynoc®. The CRL relates to the previously communicated GMP observations at the third-party manufacturer NerPharMa, as well as a request for additional commercial scale consecutive batch data following already implemented corrective actions. The FDA did not raise questions regarding the clinical data, bioequivalence or stability of Dasynoc®, and the risk of medication error raised in previous CRLs has been resolved. Xspray Pharma intends to resubmit the application during Q4 2026 after which a new PDUFA date will be issued.
- In September, Xspray Pharma announced that data for Dasynoc® and Nilopki® had been accepted for poster presentation at the ESH-iCMLf 28th Annual John Goldman Conference on Chronic Myeloid Leukemia in Gothenburg on October 2-4, 2026. The data show significantly more consistent drug exposure with Dasynoc® and a significantly lower food effect with Nilopki® strengthening their clinical differentiation.
Significant events after the quarter
- In October, Xspray Pharma announced that the FDA has confirmed that the NDA for Dasynoc® can be resubmitted independently of NerPharMa's cGMP status, as was previously confirmed for Nilopki®. The company maintains its plan to resubmit both applications during Q4 2026, and manufacturing of the required additional commercial batches has commenced. Final regulatory clearance of the facility is still required before approval.
- On 5 November, Xspray was informed that the FDA had initiated an unannounced follow-up inspection at NerPharMa's manufacturing facility, relating to previously identified cGMP-observations.
- After the period, the company announced that the Board had decided to carry out a rights issue of shares of approximately SEK 90 million, with preferential rights for the company's existing owners. The rights issue can be increased by up to SEK 72 million through an over-allotment option. The company has also entered into an agreement with the lender to extend the maturity of its existing loan to 15 August 2028 and, following a contractual repayment, reduce the loan facility to SEK 50 million. The warrants held by the lender, which were issued in spring 2026, will be cancelled and replaced with newly issued warrants in connection with the loan extension.
A message from the CEO
The third quarter was an important period for Xspray Pharma, marked by continued regulatory clarity, disciplined financial management and further strengthening of the clinical and commercial rationale for our two lead product candidates, Dasynoc® and Nilopki®. While the quarter included a further regulatory delay for Dasynoc®, our overall position has continued to develop in a constructive way. We have clarified the remaining regulatory path for both Dasynoc® and Nilopki®, continued to advance the activities required for resubmission of both NDAs, maintained our commercial readiness. After the end of the period, we were informed that the FDA had initiated a follow-up inspection at NerPharMa's manufacturing facility, relating to previously identified cGMP-observations. The inspection is an important step in the ongoing regulatory processes for Dasynoc® and Nilopki®. We have also presented financing solutions aimed at securing funding through to the expected approvals of our two lead candidates.
Our strategic objective remains unchanged: to bring improved formulations of well-established and widely used oncology medicines to patients and to build Xspray into a commercial-stage oncology company. Dasynoc® and Nilopki® are the first two products in this strategy, each addressing distinct treatment needs within chronic myeloid leukemia, CML, where there is an established treatment market, a concentrated specialist prescriber base and clear clinical needs related to tolerability, exposure predictability, drug interactions, practical use over long treatment durations and better quality of life aspects for the patients.
Regulatory progress and path to resubmission
Dasynoc® remains our near-term priority. During the quarter, Xspray received a Complete Response Letter from the FDA for Dasynoc®. The FDA did not raise questions regarding the clinical data, bioequivalence or stability, and the risk of medication error raised in previous review cycles has thus been resolved. We have addressed this question over several review cycles through adjusted tablet strengths and labeling comprehension work, and we are pleased to have it closed. The remaining issues concern supporting batch data and the cGMP status of NerPharMa.
We have continued to work systematically to address the remaining requirements. For both Dasynoc® and Nilopki®, the required work to manufacture additional consecutive commercial-scale batch data and the related analytical work is underway. For Nilopki®, we are also preparing the documentation required to establish dose correspondence with Tasigna® at the relevant dose level for a defined patient sub-population.
Following dialogue with the FDA, we have confirmed that resubmission of the NDAs for Dasynoc® and Nilopki® may occur independently of the cGMP status of NerPharMa. It means that the timing of our resubmissions is in our own hands. At the same time, final FDA clearance of the manufacturing facility remains necessary before either product can be approved.
Our current assessment is that the Xspray-controlled activities required for resubmission of both NDAs can be completed in time to support resubmission during the fourth quarter of 2026. We therefore reiterate our plan to resubmit both applications in Q4 2026.
The NerPharMa situation remains outside Xspray's direct control, but we are encouraged by the progress reported by the facility. NerPharMa has previously informed the FDA that it considers its facility ready for inspection. On 5 November, we were informed that the FDA had initiated an unannounced follow-up inspection at the facility. Subject to successful resubmission, FDA review and resolution of the remaining manufacturing facility matters, our plan is to be in a position to launch both Dasynoc® and Nilopki® in the quarter immediately following approval.
Increasing KOL Endorsement Further Supports the Long-Term Value Proposition of Xspray's Differentiated Platform
After the end of the quarter, we held an Investor Update in Gothenburg in connection with the ESH-iCMLf John Goldman Conference on Chronic Myeloid Leukemia. The event provided an important opportunity to place our regulatory, clinical and commercial strategy in a broader scientific context with leading CML prescribers world-wide.
At the Goldman Conference, Xspray presented two scientific posters relating to Dasynoc® and Nilopki®. The data support our view that HyNap-formulated products can address clinically relevant limitations of established TKI therapies. For Dasynoc®, the new data further support the potential importance of lower exposure variability and the future opportunity to evaluate a lower-dose dasatinib strategy. For Nilopki®, the data support the potential relevance of reducing food-related exposure effects and thereby improving predictability in everyday use.
Equally important is the work of preparing the ground for our products ahead of launch. At the Goldman Conference, our two posters generated substantial discussion and feedback from physicians treating CML. That dialogue is consistent with what our earlier U.S. market research has indicated: that physicians and patients see real value in our TKI formulations offering more predictable exposure and simpler everyday use.
The Investor Update also featured Professor Michael J. Mauro and Professor Jorge Cortes, two internationally recognized CML experts and co-authors of the poster abstracts, who joined our Chief Scientific Officer Per Andersson in a moderated expert discussion. Their participation underlined the clinical relevance of the questions addressed by our science: dose, exposure variability, pleural effusion risk, food effect, cardiovascular safety considerations and patient quality of life, through our improved formulations for long-term CML treatment.
This matters because the Xspray case is not only about reaching the next regulatory milestone. Approval remains the most important near-term value driver, but the long-term opportunity is broader. The new data strengthen our belief that Dasynoc® and Nilopki® may offer clinically meaningful differentiation in CML and that our HyNap technology can serve as a platform for developing improved versions of established oncology medicines.
Financing and shareholder support
In connection with this report, we have announced a financing package consisting of a rights issue and an over-allotment issue. The financing has received strong support from existing shareholders and new well-reputed investors, with subscription commitments and indications corresponding to approximately 116 percent of the rights issue. The existing loan conditions have been renegotiated into a loan facility of SEK 50 million and extended to 15 August 2028.
The purpose of the financing is aligned with our previously communicated priorities: to focus resources on value-creating milestones to support the ongoing regulatory, manufacturing and pre-commercialization of Dasynoc® and Nilopki®, as well as to advance the company's development pipeline and enhance its future manufacturing capacity.
We are grateful for the continued confidence shown by our shareholders and by new investors. Their support is important as we move through the final regulatory steps and prepare the company for commercial launch.
Financial discipline and efficient execution
We continue to manage Xspray's resources with a clear focus on value creation, launch readiness and financial discipline. During the first nine months of 2026, operating expenses decreased by 15 percent compared with the corresponding period last year. In the third quarter, cash flow from operating and investing activities improved to SEK -39.0 million, compared with SEK -47.3 million in the second quarter 2026, corresponding to a 17 percent reduction in negative cash flow.
During the quarter, we also completed a contractual repayment of SEK 50.4 million of our outstanding debt financing, reducing the Company's outstanding debt.
These measures reflect our continued commitment to responsible financial management. We are maintaining a lean and efficient organization, while preserving the capabilities required to complete the remaining regulatory work, sustain launch readiness and continue building the scientific and commercial foundation for Dasynoc®, Nilopki® and the broader HyNap platform.
Positioned for the next phase
Xspray is approaching a decisive phase. The regulatory process has taken longer than expected, and we recognize the patience required from shareholders and other stakeholders. At the same time, the market potential remains unchanged. CML remains a long-duration treatment setting, physicians continue to need effective and practical therapies, and the case for improved formulations of established TKIs has continued to strengthen.
Our priorities are clear: complete the remaining work required for resubmission of Dasynoc® and Nilopki® in the fourth quarter, closely monitoring the resolution of the NerPharMa facility matter, maintain launch readiness, secure the financing required for execution and continue building the scientific evidence behind our differentiated product profiles.
We remain focused, realistic and forward-looking. With two lead product candidates in CML, a proprietary formulation platform, a growing body of scientific evidence and continued support from shareholders and investors, we believe Xspray is well positioned to move from late-stage regulatory execution toward commercial oncology launch.
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.
