Xspray Pharma publishes interim report Q3, January – September 2021

Regulatory press release 2021-10-26

"Since the company's start, the business's focus and communication has been on generic and improved versions of PKIs. Going forward we have, after the end of the reporting period, decided to focus entirely on improved PKIs. In recent years, the value of generics in our models has gradually decreased, while the value of improved drugs has instead increased. This is a very important decision that will significantly simplify and streamline the development of new product candidates and lead to increased focus for the entire organization,” says Per Andersson, CEO Xspray Pharma.

Significant events during the third quarter

July – September 2021

In July, Xspray Pharma announced that bioequivalence had been achieved compared with the reference product in the bioequivalence study with the company’s improved version of dasatinib, HyNap-Dasa 505(b)(2), which now goes under the name Dasynoc™.
In August, bioequivalence studies were conducted with the company’s generic version of dasatinib, HyNap-Dasa ANDA C. The studies were conducted in two groups of healthy volunteers under fed and fasting conditions.

Significant events after the end of the reporting period

In October, it was announced that bioequivalence had not been achieved for HyNap-Dasa ANDA, and that the company chooses that further development of the generic version will be terminated and instead focusing on the improved product HyNap-Dasa 505(b)(2), Dasynoc™, which demonstrated bioequivalence in previous studies. The disposals of the capitalized development expenses attributable to the generic version will impact earnings in the fourth quarter. The estimated total of the effect is 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 November 4, 2021, to October 26, 2021.

July – September 2021, Group

Net sales amounted to SEK 0 thousand (0)
Loss before tax amounted to SEK -13,890 thousand (-11,560)
Earnings per share before dilution amounted to SEK -0.73 (-0.69)
Cash flow from operating activities amounted to SEK -16,524 thousand (-12,764)
Cash flow from investing activities amounted to SEK -20,086 thousand (-19,868)

January – September 2021, Group

Net sales amounted to SEK 0 thousand (0)
Loss before tax amounted to SEK -44,754 thousand (-37,438)
Earnings per share before dilution amounted to SEK -2.35 (-2.23)
Cash flow from operating activities amounted to SEK -41,327 thousand (-36,076)
Cash flow from investing activities amounted to SEK -72,127 thousand (-68,901)
Cash and cash equivalents at the end of the period amounted to SEK 216,543 thousand (116,622)

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 and generic 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 68 in the beginning of 2021. The company’s leading product candidates, 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