en
svXspray Pharma publishes Interim report Q4, January – December 2019
Press release 2020-02-28
“One important milestone was reached in June when our production facility in Italy was completed and was able to do a test run. We have now proven that our technology is possible to scale up – and we are the first in the world to manufacture amorphous material in the form of hybrid nanoparticles on a commercial scale. With our technology, we can now develop improved versions of already marketed cancer drugs, especially in the protein kinase inhibitor class, which is a pharmaceutical group with a very high price level.”
Per Andersson, CEO Xspray Pharma AB (publ)
Significant events during October – December 2019
• In October, Xspray announced change of listing to Nasdaq Stockholm during the first half year 2020.
• In October, IND application for HyNap-Dasa was approved by the FDA.
• Xspray Pharma completed in December a directed new share issue of 1,675,162 shares of SEK 122 m before transaction costs. The new share issue was made to finance the company's continued development of ongoing projects as well as to expand and strengthen the company's shareholder base in a cost-effective way.
• In December, the first GMP batch of HyNap-Dasa tablet was manufactured on a commercial scale.
Significant events after the end of the reporting period
• In February 2020, stability studies for the final HyNap-Dasa tablets were initiated and will be a part of the company’s ANDA application.
• In February 2020, four new patents for the pharmaceutical composition of the company’s primary product candidate, HyNap-Dasa, were granted in the US.
• In February 2020, Xspray issued a notice of Extraordinary General Meeting on March 26, 2020, regarding decisions on long-term incentive program2020 (LTI 2020) and issue of warrants.
October – December 2019, Group
Because no Group existed during the same period in the previous year, there are no comparative figures
• Net sales amounted to SEK – thousand
• Earnings before tax amounted to SEK –18,738 thousand
• Earnings per share before dilution amounted to SEK –1.20
• Cash flow from operating activities totaled SEK –11,546 thousand
• Cash flow from investing activities amounted to SEK –24,147 thousand
October – December 2019, Parent Company
Amounts in brackets refer to the corresponding period for the previous year
• Net sales amounted to SEK – thousand (206)
• Earnings before tax amounted to SEK –18,729 thousand (–8,913)
• Earnings per share before dilution amounted to SEK –1.20 (–0.63)
• Cash flow from operating activities totaled SEK –11,319 thousand (–5,888)
For further information, please contact:
Per Andersson, CEO, Xspray Pharma AB
Phone: +46 (0) 706 88 23 48
E-mail: per.andersson@xspray.com
The report is available on the company’s website: https://xspraypharma.com/wp-content/uploads/2020/02/Xspray-Q4-2019_ENG.pdf
The information was submitted for publication, through the agency of the contact person set out above, at 8:00 a.m. CET on February 28, 2020.
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 First North Growth Market Stockholm.
Xspray Pharma AB (publ)
Råsundavägen 12
169 67 Solna
info@xspray.com
Redeye AB is Xspray Pharma’s Certified Adviser
Telephone +46 (0)8 121 576 90