Xspray Pharma publishes Q4 Year-End report 2021

Regulatory press release 2022-02-18

”When looking back at Xspray Pharma’s fourth quarter 2021, I see it marked by hope for the future. After the end of the quarter, we reached a significant milestone when the US Food and Drug Administration (FDA) announced that it had agreed to review Xspray Pharma’s first product candidate: Dasynoc, an improved version of dasatinib. The development processes that we have created with Dasynoc can now be used in the development of our other product candidates, and the process with HyNap-Nilo is progressing according to plan. Today, we can take a new product candidate through the development in a much shorter period of time, and the new product line now being constructed in Malta will be extremely valuable for the production of future products”, says Per Andersson, CEO Xspray Pharma.

Significant events during the fourth quarter

October – December 2021
• In October, Xspray Pharma announced that it had chosen to focus solely on its improved product HyNap-Dasa 505(b)(2), or Dasynoc™ (“Dasynoc”), since bioequivalence had not been achieved for the generic version, HyNap-Dasa ANDA. The earnings effect of the disposal of the capitalized development expenses totaled SEK 31 million.

• In October, the composition of the Nomination Committee for the 2022 Annual General Meeting was announced.

• In October, the company announced that the report for the third quarter had been brought forward from 4 November to 26 October.

• A private placement of new shares was issued to Flerie Invest AB in November, with a subscription price of SEK 62.00 per share. The issue generated SEK 100 million before transaction costs and increased the number of shares by 1,612,904, from 19,067,504 to 20,680,408.

• In November, it was announced that Christina Malmberg Hägerstrand had been appointed Vice President Investor Relations and Communications. Christina joined on January 10, 2022 and is member of the company's management team.

• In November, the company submitted its application to the FDA for US market approval of the company’s product candidate Dasynoc (dasatinib) under the 505(b)(2) NDA process.

Significant events after the end of the reporting period
• In January, the FDA announced that the application for market approval of Dasynoc had been accepted for a full review.

• In February, the company announced that Anna-Karin Ekberg has been appointed Global Head of Marketing and Sales. Anna-Karin will take office on March 15, 2022 and will become member of the company’s management team.

October – December 2021, Group
• Net sales amounted to SEK 0 thousand (0)

• Loss before tax amounted to SEK -51,944 thousand (-14,972)

• Earnings per share before dilution amounted to SEK -2.62 (-0.81)

• Cash flow from operating activities amounted to SEK -10,280 thousand (-11,717)

• Cash flow from investing activities amounted to SEK -33,691 thousand (-27,926)

January – December 2021, Group
• Net sales amounted to SEK 0 thousand (0)

• Loss before tax amounted to SEK -96,698 thousand (-52,410)

• Earnings per share before dilution amounted to SEK -5.03 (-3.05)

• Cash flow from operating activities amounted to SEK -51,607 thousand (-47,792)

• Cash flow from investing activities amounted to SEK -105,818 thousand (-96,828)

• Cash and cash equivalents at the end of the period amounted to SEK 271,881 thousand (325,598)

Amounts in parentheses refer to the year earlier period.

About Xspray Pharma

Xspray Pharma AB (publ) is a pharmaceutical company with several product candidates in clinical development. Xspray Pharma uses its innovative, patented RightSize™ technology to develop improved versions of marketed drugs, primarily protein kinase inhibitors (PKIs) for the treatment of cancer. The segment is the second largest in oncology, and drug prices are very high.

The company´s innovative technology allows Xspray Pharma to gain entry as the first competitor to today’s original drugs before the secondary patents expire. Xspray’s goal is to become the leader in the development of improved drugs or generic versions of PKIs already marketed for the treatment of cancer, which numbered to 72 in the end of 2021. The company’s leading product candidates, Dasynoc (former HyNap-Dasa), HyNap-Nilo, and HyNap-Sora, are stable amorphous versions of the three blockbuster cancer drugs Sprycel® (dasatinib), Tasigna® (nilotinib) and Nexavar® (sorafenib). HyNap-Dasa is being developed as an improved version of Sprycel. HyNap-Nilo is being developed as an improved version of Tasigna and has has received orphan drug status from the US FDA. HyNap-Sora is being developed as an improved version of Nexavar®.

The company has patented manufacturing technology, equipment, and the resulting products. The shares in Xspray Pharma are traded on Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY).
www.xspraypharma.com