Xspray Pharma publishes Interim report Q1, January – March 2020

Press release 2020-05-14

“This year is an important year for Xspray. I expect that the amorphous material provided by our unique production facility will provide positive clinical data, which is a prerequisite for us to apply for market approval for HyNap-Dasa in the U.S. This means that we together with a partner who either buys or licenses the HyNap-Dasa product, will gain access to a multibillion market.” Per Andersson, CEO Xspray Pharma AB (publ)

Significant events during January – March 2020

In February, stability studies for the final HyNap-Dasa tablets were initiated and will be a part of the company’s ANDA application.
In February, four new patents for the pharmaceutical composition of the company’s primary product candidate, HyNap-Dasa, were granted in the US.
In March, Xspray’s production partner, Nerpharma, received approval from Italian Medicines Agency (AIFA) for the full-scale production facility
In March, Nasdaq Stockholm's listing committee approved Xspray's application to be listed on Nasdaq Stockholm main market. The first trading day on Nasdaq Stockholm was March 27.

Significant events after the end of the reporting period

In mid-April, Xspray announced that the start of pivotal clinical bioequivalence studies with HyNap-Dasa will be delayed by two to three months due to the Covid-19 pandemic.

January – March 2020, Group

Net sales amounted to SEK 0 thousand (0)
Earnings before tax amounted to SEK -10,532 thousand ( -7,753)
Earnings per share before dilution amounted to SEK -0.63 (-0.51)
Cash flow from operating activities amounted to SEK -13,490 thousand (-12,926)
Cash flow from investing activities amounted to SEK -23,918 thousand (-15,473)

January – March 2020, Parent Company

Net sales amounted to SEK 0 thousand (0)
Earnings before tax amounted to SEK -10,513 thousand (-7,792)
Earnings per share before dilution amounted to SEK -0.63 (-0.52)
Cash flow from operating activities amounted to SEK -13,245 thousand (-12,943)

Amounts in brackets refer to the corresponding period for the previous year

The report is available on the company’s website: https://xspraypharma.com/en/investors/financial-reports/

About Xspray Pharma

Xspray Pharma AB (publ) is a product development company with multiple product candidates in clinical development. Xspray 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 54 in December 2019. The company’s leading product candidates, HyNap-Dasa, HyNap-Sora and HyNap-Nilo, are stable amorphous versions of the three blockbuster cancer drugs Sprycel® (dasatinib), Nexavar® (sorafenib) and Tasigna® (nilotinib), respectively. The launch of the first product candidate, HyNap-Dasa, is planned to take place in 2021. The substance patent for the original drug Sprycel® (dasatinib) expires at the end of 2020, and the secondary patents in 2026, which offers Xspray’s HyNap-Dasa a period of five years of semi-exclusivity before other competitors gain access to the market.

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