July – September 2024, Group

• Net sales amounted to SEK 0 thousand (0)
• Loss before tax amounted to SEK -82,272 thousand (-38,942)
• Earnings per share before dilution amounted to SEK -2.44 (-1.59)
• Cash flow from operating activities amounted to SEK -41,275 thousand (-68,611)
• Cash flow from investing activities amounted to SEK -9,053 thousand (-14,470)

January – September 2024, Group

• Net sales amounted to SEK 0 thousand (0)
• Loss before tax amounted to SEK -203,672 thousand (-125,171)
• Earnings per share before dilution amounted to SEK -6.24 (-5.11)
• Cash flow from operating activities amounted to SEK -160,767 thousand (-170,649)
• Cash flow from investing activities amounted to SEK -22,940 thousand (-45,147)

Amounts in parentheses refer to the year-earlier period.

Significant events during the quarter

• In early July, Xspray Pharma announced new clinical data from its registration study program for its product candidate XS003, which is an amorphous, non-crystalline formulation of nilotinib. The data shows matching bioavailability of XS003 to Tasigna® with a 50% reduced dose.
• In late July, 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®. All of the questions in the previous CRL were answered on January 31, 2024, but the FDA was now requesting additional information as a result of the pre-approval inspection at the third party's manufacturing site, which was conducted on June 10-19, 2024, as well as information pertaining to labeling comprehension. Importantly, the FDA did not request any additional clinical studies, nor did it question or remark on any deficiencies in the stability or clinical data.
• In late August, Xspray Pharma released an update concerning Dasynoc® after a meeting with the FDA. The company plans to resubmit its New Drug Application (NDA) in Q4 2024. A decision on whether the company's application will be approved by the FDA is anticipated within two or six months of the resubmission.

Significant events after the end of the reporting period

• In mid-October, Xspray Pharma announced the composition of its Nomination Committee for the Annual General Meeting on May 13, 2025. The Nomination Committee, which has been appointed in accordance with the principles adopted by the Annual General Meeting on May 21, 2024, consists of: Thomas Eldered, appointed by Flerie AB, 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.
• The Board resolved, with authorization from the annual general meeting on May 21, 2024, to carry out a new share issue of approximately SEK 135 million, with preferential rights for the company's existing shareholders. Furthermore, the Board decided to issue a loan of a total of SEK 100 million and issue warrants to the lenders. The financing is carried out with the primary purpose of financing preparatory activities for the planned launch of Dasynoc® on the American market, as well as the implementation of registration-based studies for XS003 nilotinib and continued development of the company's other product portfolio. The rights issue is covered by subscription commitments, declarations of intent regarding the subscription of shares and guarantee commitments of 100% of the rights issue, corresponding to SEK 135 million.

Outtake from CEO-letter

“During the quarter, Xspray focused on completing the work to bring our first product, Dasynoc®, to market approval and launch in the US. In July, we received a complete response letter (CRL) from the FDA, and we plan to resubmit our New Drug Application (NDA) in the fourth quarter of 2024.

Preparations for launch
As part of this resubmission, we had a positive meeting with the FDA, which provided increased clarity regarding the information that is being requested in order to get Dasynoc® approved. If the FDA designates our resubmission as a “class 1”, we can expect a review period of two months, which means that Dasynoc® could be launched as early as the first quarter of 2025. If the resubmission is instead deemed to be a “class 2”, the process could take six months, with a potential launch at the end of the second quarter of 2025.

There are a number of reasons for why we believe that FDA will be satisfied with our resubmission. The reason for the CRL is related to the inspection, concerning the third-party manufacturing facility in Italy. Even though the previous production results were good, we have implemented improvements that have raised the quality further.

• The previous solvent levels in Dasynoc® were low, but we have now managed to lower them further and thereby achieve results that are 30 times lower than the FDA’s safety limit, which we expect will satisfy their requirements.
• The FDA has accepted the responses related to the inspection concerning the manufacturing facility in Italy, and is now only requesting a follow-up to verify that these improvements function as intended. We have results that lead us to believe this follow-up will confirm that these measures are sufficient for approval.
• At a positive and constructive meeting with the FDA during the period, we agreed on minor adjustments to three out of six of the dosage strengths in order to reduce the risk of medication errors, compared with other dasatinib products that require higher dosage strengths to achieve the same uptake. According to the agreement with FDA we will manufacture new product batches for the adjusted dosage strengths, and this process is progressing according to plan. Along with further labeling discussions we believe this will resolve any remaining questions pertaining to prescribing and product safely.

As we prepare for commercialization along with EVERSANA, our flexible model has demonstrated value allowing us to temporarily pause costly launch activities related to Dasynoc®. Nevertheless, we have continued to build relationships with both physicians and insurance companies to raise awareness of the clear patient benefits that Dasynoc® offers as well as its potential health economic savings. To date, we have received very positive feedback regarding the medical benefits of Dasynoc® that other dasatinib products lack.” – Per Andersson, CEO, Xspray Pharma