Xspray Pharma publishes Interim report Q4, January – December 2020

Regulatory press release 2021-02-25

“Our business model is different from traditional drug development. Instead of developing a new drug candidate that will have to undergo Phase I, Phase II and Phase III studies, our technology platform produces amorphous PKI versions that need to demonstrate bioequivalence with already marketed drugs. Several of the marketed PKI:s are highly variable and have low solubility, several studies may be required to achieve bioequivalence, which we see with HyNap-Dasa. Repeated studies are a common procedure in generic drug development. Our development process is now established, and we will be able to work with several drug candidates in parallel to maximize the number of approved products.” Per Andersson, CEO Xspray Pharma (publ)

Significant events during the fourth quarter, 2020

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.
In December, Xspray Pharma received HyNap-Nilo orphan drug status from the FDA for the treatment of chronic myeloid leukemia.
In December, Xspray Pharma received positive results from a study with HyNap-Dasa during treatment with omeprazole.

Significant events after the end of the reporting period

As of January 4, 2021, the company's shares were moved from Nasdaq Small Cap to the Mid Cap segment after a significant increase in share price during 2020.
In January, Xspray Pharma announced results from the ex-tra fasting bioequivalence study conducted with HyNap-Dasa, the results were in line with previous bioequivalence studies.
In January, it was announced that CEO Per Andersson and other warrant holders subscribed for shares in Xspray Pharma through their respective exercise of the full num-ber of warrants available in the warrant program LTIP 2015/2021.
In February, the Nomination Committee of Xspray Pharma proposed to elect Anders Ekblom as new Chairman. The Nomination Committee further proposed to reelect the former Board members and elect Anders Bladh as a new Board member. Resolutions will take place at the Annual General Meeting on May 20, 2021.

October – December 2020, Group

Net sales amounted to SEK 0 thousand (0)
Earnings before tax amounted to SEK -14,972 thousand (-18,738)
Earnings per share before dilution amounted to SEK -0.81 (-1.20)
Cash flow from operating activities amounted to SEK -11,717 thousand (-11,546)
Cash flow from investing activities amounted to SEK -27,926 thousand (-24,147)

January – December 2020, Group

Net sales amounted to SEK 0 thousand (0)
Earnings before tax amounted to SEK -52,410 thousand (-45,771)
Earnings per share before dilution amounted to SEK -3.05 thousand (-3.01)
Cash flow from operating activities amounted to SEK -47,792 thousand (-34,237)
Cash flow from investing activities amounted to SEK -96,828 thousand (-91,994)
Cash and cash equivalents and current investments at the end of the period totalled SEK 325,598 thousand (209,872)

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