Xspray Pharma publishes Interim Report Q1, January – March 2021

Regulatory press release 2021-05-06

"We are working on a technology platform with potential for many PKI products. The results of the latest studies have set us back, but in a greater perspective it is an unwelcome but minor obstacle. What makes the product platform possible is the unique technology behind the HyNap formulations that can be scaled up. This is the single most important factor for Xspray Pharma over the long term. Previously, I said that it was not a question of if a HyNap-Dasa product could be released, but when. This is still the case, and as this year continues, I’m convinced that we will demonstrate positive results from the study and submit an application for market approval," says Per Andersson, CEO Xspray Pharma (publ).

Significant events during the first quarter

In January, Xspray Pharma announced the results of an extra bioequivalence (BE) study on fed and fasting healthy volunteers that was conducted with the company’s leading product candidate, HyNap-Dasa. The results are in line with previous bioequivalence studies in which formal bioequivalence was not achieved in the fasting group.
In January, BE studies were initiated with a new version of HyNap-Dasa, formulation B, a slightly altered formulation.
In January, Xspray Pharma announced that CEO Per Andersson and other warrant holders had chosen to fully utilize the option to subscribe for shares in Xspray Pharma through their respective exercise of the number of warrants in the LTIP 2015/2021 warrant program.
In February, Xspray Pharma announced that the Nomination Committee had proposed Anders Ekblom for election as the new Chairman of the Board of Xspray Pharma at the coming Annual General Meeting on May 20, 2021. The Committee further proposed 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.
In March, Xspray Pharma provided an update of the planned registrational studies with the improved version of Sprycel® (dasatinib), based on the company’s HyNap-Dasa formulation. The work on the study has commenced, and the dosing for the bioequivalence study will begin in the second quarter.

Significant events after the end of the reporting period

In April, Xspray Pharma announced the results of bioequivalence studies in fed and fasting healthy volunteers with a slightly modified tablet formulation of the generic product candidate HyNap-Dasa, formulation B. Bioequivalence with Sprycel® was achieved in the study in fed condition. The study in fasting condition demonstrated a lowered level of absorption of HyNap-Dasa, but the effect was not sufficient to achieve bioequivalence.
In April, Xspray Pharma announced that the company’s improved version of Sprycel® (dasatinib), HyNap-Dasa 505(b)(2), was expected to have a significantly improved product profile with more efficient absorption, which would lead to medically relevant 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.

January – March 2021, Group

Net sales amounted to SEK 0 thousand (0)
Loss before tax amounted to SEK -13,912 thousand (-10,532)
Earnings per share before dilution amounted to SEK -0.73 (-0.63)
Cash flow from operating activities amounted to SEK -11,971 thousand (-13,490)
Cash flow from investing activities amounted to SEK -25,188 thousand (-23,918)

About Xspray Pharma

Xspray Pharma AB (publ) is a pharma company with several product candidates in clinical development. Xspray Pharma 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 55 in December 2020. The company’s leading product candidates, HyNap-Dasa, HyNap-Nilo, and HyNap-Sora, are stable amorphous versions of the three blockbuster cancer drugs Sprycel® (dasatinib), Tasigna® (nilotinib) and Nexavar® (sorafenib). HyNap-Dasa is being developed in two versions, a generic and an improved version of Sprycel. HyNap-Nilo is being developed as an improved version of Tasigna and has has received orphan drug status from the US FDA. HyNap-Sora is being developed as an improved version of Nexavar®.

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