Xspray Pharma publishes Interim Report Q3, January – September 2020

Regulatory press release 2020-11-20

”Xspray Pharma is in an eventful phase with several crucial milestones within reach. After completing bioequivalence studies, intensive work is being done on the preparations for the Company's first ANDA application and finding the right partner for HyNap-Dasa”. Per Andersson, CEO Xspray Pharma AB (publ)

Significant events during the third quarter, 2020

  • In August, a term sheet for a new manufacturing facility in Malta, with Pharmacare Premium Ltd, was signed.
  • In August, the preliminary results of the first study for HyNap-Dasa were announced. The study did not fulfil statistical bioequivalence requirements due to high variability in pharmacokinetic parameters for the reference product Sprycel®. A few subjects had very low absorption from Sprycel® which was not observed for HyNap-Dasa.
  • In August, the company strengthened its IP rights by receiving a Notice of Allowance from the US Patent Office regarding its patent application for tablets containing dasatinib propylene glycol solvate (dasatinib PG).
  • In August, it was announced that the CEO Per Andersson and other warrant holders have chosen to make full use of the opportunity to subscribe for shares in Xspray by fully exercising their respective number of warrants in the warrant program LTIP 2017/2020.
  • In August, six months data from the company's stability study with commercially manufactured HyNap-Dasa tablets were published. Data from the study demonstrates that the tablets comply with the specifications and that they can be used in an upcoming ANDA filing.
  • In September, the Chairman of the Board, Michael Wolff Jensen, announced that he will not be available for re-election at the 2021 Annual General Meeting.
  • In September, the preliminary results from the second out of two bioequivalence studies in healthy volunteers with HyNap-Dasa, were announced. The study fulfilled statistical and formal bioequivalence requirements for HyNap-Dasa compared to the reference product Sprycel®. The study was conducted in healthy volunteers under fed conditions.

Significant events after the end of the reporting period

  • In October, a directed new issue of shares was made at a subscription price of SEK 142.50 per share. The issue raised approximately SEK 265 million before transaction costs and increased the number of shares by 1,861,291, from 17,031,213 to 18,892,504.
  • In October, the composition of the Nomination Committee for the 2021 Annual General Meeting was announced.

Group, July – September 2020

  • Net sales amounted to SEK 0 thousand (0)
  • Earnings before tax amounted to SEK -11,560 thousand (-9,921)
  • Earnings per share before dilution amounted to SEK 0.69 (-0.62)
  • Cash flow from operating activities amounted to SEK -12,764 thousand (-8,747)
  • Cash flow from investing activities amounted to SEK -19,868 thousand (-22,898)

Group, January – September 2020

  • Net sales amounted to SEK 0 thousand (0)
  • Earnings before tax amounted to SEK -37,438 thousand (-27,033)
  • Earnings per share before dilution amounted to SEK -2.23 thousand (-1.79)
  • Cash flow from operating activities amounted to SEK -36,076 thousand (-22,692)
  • Cash flow from investing activities amounted to SEK -68,901 thousand (-67,846)
  • Cash and cash equivalents and current investments at the end of the period totalled SEK 116,622 thousand (130,657)

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/

For further information, please contact:

Per Andersson, CEO, Xspray Pharma AB
Phone: +46 (0) 706 88 23 48
E-mail: per.andersson@xspray.com

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

Attachments

Interim report Q3 2020