Xspray Pharma publishes interim report Q2 , January – June 2021

Regulatory press release 2021-08-06

"We have now shown that our unique technology platform makes it possible to develop amorphous versions of protein kinase inhibitors, or PKIs. With HyNap-Dasa 505(b)(2) and previous studies, we have demonstrated that we can scale up the process and modify formulations to change the uptake of the drug and achieve bioequivalence. This will be of crucial value for Xspray Pharma over the long term, since our platform was developed to create improved products of many of today’s PKI drugs," says Per Andersson, CEO Xspray Pharma (publ).

Significant events during the second quarter

  • In April, Xspray Pharma announced the findings of two bioequivalence studies on fed and fasting healthy volunteers with formulation B of the generic product candidate HyNap-Dasa ANDA. Bioequivalence with Sprycel® was achieved in the study in fed condition. The study in fasting condition demonstrated, as expected, a lowered level of absorption of HyNap-Dasa compared to formulation A, but the effect was not sufficient to achieve bioequivalence.
  • In April, Xspray Pharma announced that the company’s improved version of dasatinib, HyNap-Dasa 505(b)(2), was expected to have a significantly improved product profile with more efficient absorption, which could lead to clinical advantages for patients. This version is based on the thoroughly tested formulation A, and will be tested in a registrational bioequivalence study in the second quarter.
  • In May, the Annual General Meeting resolved, in accordance with the Nomination Committee’s proposal, on the re-election of Board members Gunnar Gårdemyr, Maris Hartmanis, Torbjörn Koivisto, Christine Lind and Carl-Johan Spak as well as the election of new Board members Anders Ekblom and Anders Bladh. Anders Ekblom replaces Michael Wolff Jensen as Chairman of the Board.
  • In June, it was announced that the company’s two new long-term incentive programs had been fully subscribed. The first program, LTIP 2021–2024, was offered to all employees including senior executives. The second program, LTIP 2021–2026, was offered to and subscribed by the company’s new Chairman of the Board.
  • In June, the bioequivalence study announced in April with the improved version of dasatinib, HyNap-Dasa 505(b)(2) commenced, and all participants received a dose. The objective of the study is to demonstrate that a lower dose strength of Xspray Pharma’s improved version of dasatinib is bioequivalent to a higher dose strength of the original drug Sprycel®.

Significant events after the end of the reporting period

  • In July, Xspray Pharma announced, that the pivotal study with the improved version of dasatinib, HyNap-Dasa 505(b)(2), that started in June, showed that bioequivalence was achieved with healthy margins compared with the reference product.

April – June 2021, Group

  • Net sales amounted to SEK 0 thousand (0)
  •  Loss before tax amounted to SEK -16,952 thousand (-15,346)
  • Earnings per share before dilution amounted to SEK -0.89 (-0.92)
  • Cash flow from operating activities amounted to SEK -12,831 thousand (-9,822)
  • Cash flow from investing activities amounted to SEK -26,854 thousand (-25,115)

January – June 2021, Group

  • Net sales amounted to SEK 0 thousand (0)
  • Loss before tax amounted to SEK -30,863 thousand (-25,878)
  • Earnings per share before dilution amounted to SEK -1.62 (-1.54)
  • Cash flow from operating activities amounted to SEK -24,802 thousand (-23,311)
  •  Cash flow from investing activities amounted to SEK -52,042 thousand (-49,033)
  • Cash and cash equivalents at the end of the period amounted to SEK 253,737 thou-sand (137,766)

Amounts in parentheses refer to the year-earlier period.

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