en
svXspray Pharma publishes Interim Report Q3, January – September 2019
Press release 2019-11-14
”It is with a high pace, dedication and broad expertise that Xspray's team continued to drive the development of our furthest progressed product candidate, HyNap-Dasa, towards our first ANDA application. HyNap-Dasa is an amorphous version of Sprycel® (dasatinib). The target of submitting an application to the US FDA during the summer of next year remains firm, as is the planned market launch in the US of HyNap-Dasa in 2021”
Per Andersson, CEO Xspray Pharma AB (publ)
Significant events during the third quarter 2019
• Xspray announced that the company aims to up-list to Nasdaq Stockholm in the first half of 2020
• The commercial manufacturing process of amorphous material on a commercial scale with Xspray's patented technology has been validated and tested for robustness by the company's Italian manufacturing partner
Significant events after the interim reporting period
• Xspray announced in October that the US Food and Drug Administration (FDA) has cleared the company’s IND application for the product candidate HyNap-Dasa
July – September 2019, Group
Because no Group existed during the same period in the previous year, there are no comparative figures
• Net sales amounted to SEK 0 thousand
• Earnings before tax amounted to SEK –10,583 thousand
• Earnings per share before dilution amounted to SEK -0.70
• Cash flow from operating activities totaled SEK –8,747 thousand
January – September 2019, Group
Because no Group existed during the same period in the previous year, there are no comparative figures
• Net sales amounted to SEK 0 thousand
• Earnings before tax amounted to SEK –30,138 thousand
• Earnings per share before dilution amounted to SEK –2.00
• Cash flow from operating activities totaled SEK –22,692 thousand
• Cash and cash equivalents and current investments at the end of the period totaled SEK 130,657 thousand
July – September 2019, Parent Company
Amounts in brackets refer to the corresponding period for the previous year
• Net sales amounted to SEK 0 thousand (0)
• Earnings before tax amounted to SEK –10,587 thousand (–4,116)
• Earnings per share before dilution amounted to SEK –0.70 (–0.30)
• Cash flow from operating activities totaled SEK –8,281 thousand (–4,253)
January – September 2019, Parent Company
Amounts in brackets refer to the corresponding period for the previous year
• Net sales amounted to SEK 0 thousand (71)
• Earnings before tax totaled SEK –30,171 thousand (–12,501)
• Earnings per share before dilution amounted to SEK –2.00 (–0.93)
• Cash flow from operating activities totaled SEK –22,018 thousand (–11,859)
• Cash and cash equivalents and current investments at the end of the period totaled SEK 130,607 thousand (157,922)
For further information, please contact:
Per Andersson, CEO, Xspray Pharma AB (publ)
Telephone: +46 (0)8 730 37 00
Email: per.andersson@xspray.com
The report is available on the company’s website: https://xspraypharma.com/en/investors/financial-reports/
The information was submitted for publication, through the agency of the contact person set out above, at 8:00 a.m. CET on November 14, 2019.
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 47 in 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