April–June 2024, Group

• Net sales amounted to SEK 0 thousand (0)
• Loss before tax amounted to SEK -53,620 thousand (-51,402)
• Earnings per share before dilution amounted to SEK -1.64 (-2.27)
• Cash flow from operating activities amounted to SEK -64,181 thousand (-56,503)
• Cash flow from investing activities amounted to SEK -8,738 thousand (-16,027)

Amounts in parentheses refer to the year-earlier period.

January – June 2024, Group

• Net sales amounted to SEK 0 thousand (0)
• Loss before tax amounted to SEK -121,401 thousand (-86,229)
• Earnings per share before dilution amounted to SEK -3.79 (-3.80)
• Cash flow from operating activities amounted to SEK -119,492 thousand (-102,038)
• Cash flow from investing activities amounted to SEK -13,887 thousand (-30,677)

Amounts in parentheses refer to the year-earlier period.

Significant events during the quarter

• Xspray Pharma received declarations of intent whereby owners of approximately 62 percent of shares in the company stated their interest to subscribe for newly issued shares with their outstanding TO6 warrants.
• Xspray Pharma announced its fourth product candidate, XS025 for clinical study. XS025 will be based on the active substance cabozantinib, which is used in renal cell carcinoma and other cancers. The value in the US market for cabozantinib is projected to reach approximately USD 2.3 billion by 2026.
• Xspray Pharma announced the outcome of the exercised warrants of series TO6. In total, 2,508,723 warrants of series TO6, corresponding to approximately 80 percent, were exercised to subscribe for the same number of new shares. Xspray Pharma thereby received issue proceeds of SEK 100.3 million before transaction costs. Proceeds will be used for the US launch of the company's first product, Dasynoc®, as well as for continued development of other product candidates in the company's portfolio. The number of shares increased by 2,508,723 to 33,762,265 and the share capital increased by SEK 2,508,723 to SEK 33,762,265.
• Xspray Pharma appointed Niklas Adenborg as the company’s Chief Financial Officer (CFO) and Linda Glimberg as the company’s Chief Operating Officer (COO), a newly established role. Both already work at Xspray Pharma with Niklas Adenborg as Finance Director and Linda Glimberg as consulting Senior Vice President Legal. Both are included in Xspray Pharma’s executive management team.
• Xspray presented data at the American Society of Clinical Oncology (ASCO) demonstrating that co-medication with PPIs and TKIs occurs frequently among CML patients. Further, this co-medication has a substantial impact on the bioavailability of crystalline dasatinib, the type of dasatinib currently available in the market. i) 54% of TKI-treated CML-patients received a PPI. ii) 66% of concomitant prescribing was by a different healthcare provider. iii) Crystalline dasatinib Cmax and AUC24 reduced by 96% and 88% respectively. Xspray’s dasatinib candidate, Dasynoc®, is not crystalline but amorphous, which drastically reduces the problems with the co-medication of PPIs and results in significantly improved absorption.

Significant events after the end of the reporting period

• Xspray Pharma announced new clinical data from its registration study program for the XS003 product candidate, which is an amorphous, non-crystalline formulation of nilotinib. The data shows the matching bioavailability of XS003 to Tasigna® at a 50% reduced dose.
• Xspray Pharma received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company's New Drug Application (NDA) for Dasynoc®. The updated NDA was sent to the FDA on January 31, 2024. In the CRL, the FDA requests additional information pertaining to the labeling comprehension and the pre-approval inspection at the third party's manufacturing site, which was conducted 10 to 19 of June, 2024. All issues from the previous CRL were addressed and the responses were accepted by the FDA. The new CRL therefore includes a number of new supplementary requests. Importantly, the CRL does not request any additional clinical studies, nor does it question or remark on any deficiencies in the stability or clinical data.

“Despite recent challenges, Xspray Pharma is in better shape than ever. Our strong pre-launch shows that both physicians and pharmacists understand the problem with crystalline dasatinib, and that Dasynoc® offers a solution. We have also observed excellent results for nilotinib, and our product platform is truly gaining momentum.

After the period, we received a Complete Response Letter (CRL) from the FDA outlining that we will need to supplement our application for market approval of Dasynoc®. It is unfortunate that we received this notification, which came after a reinspection of our manufacturing site just six weeks before our expected approval date. The site submitted its responses to the first inspection in October 2023, so it is unfortunate that the unexpected reinspection occurred at such a late date. We have received requests for additional information which we will address as soon as possible and we have requested and anticipate a meeting with the FDA within 30 days.

The launch of Dasynoc® will not be possible in September, but rather we will need to wait for an additional time period. Together with our commercial partner EVERSANA, which provides a dedicated commercial organization, we have decided to temporarily pause our launch preparations for Dasynoc®. This also means that the related costs for the launch will be deferred. However, we will continue to build relationships with both physicians and insurance companies to continue to raise awareness of the clear patient benefits that Dasynoc® offers as well as the health economic savings that the product enables. These savings are a strong argument for Dasynoc® in with insurance companies, which also greatly contributes to the competitiveness of our offering.

We also presented an important study at the American Society of Clinical Oncology (ASCO) demonstrating that chronic myeloid leukemia (CML) patients often need to be treated for peptic ulcers while they undergo treatment for their leukemia. 54% of CML patients co-medicate dasatinib with a proton-pump inhibitor (PPI), which is problematic because the bioavailability of crystalline dasatinib is significantly reduced when co-medicated with a PPI. The study demonstrated that the effects of a PPI are considerably greater than previously reported, reducing Cmax and AUC24 by 96% and 88% respectively.

Dasynoc® can offer these patients significant advantages through its amorphous formulation. To successfully treat the disease, consistent absorption and bioavailability of dasatinib are critical. Dasynoc® demonstrates clear clinical benefits through lower dosage requirements, reduced variability in absorption and plasma concentrations, and the ability to be co-medicated with PPIs.

We also strengthened our cash holdings through the TO6 program, which was approximately 80 percent subscribed, raising approximately SEK 100 million in proceeds before issue expenses for the company. The proceeds will primarily be used for the US launch of Dasynoc® and to continue the development of the company’s pipeline. We believe that existing working capital is sufficient to cover the company’s capital requirements for the next six to 12 months as we defer costs while awaiting for the delayed FDA approval. However, we are currently unable to forecast exactly how long the delay in the regulatory process will be. As previously expected ahead of planned September launch, which is now delayed, additional external financing will be necessary to ensure a successful launch of Dasynoc® when approval is received from the FDA. However, we believe that this will be possible in the form of non-dilutive financing. Any potential further need for equity will be determined by the pace of development of the rest of our product portfolio, and is therefore a decision that is in the company’s hands.” – Per Andersson CEO, Xspray Pharma

For further information, please contact:
Kerstin Hasselgren
Senior Advisor & Investor Relations
Xspray Pharma AB
Mob: +46 (0) 70 311 16 83
E-mail: kerstin.hasselgren@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.