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Notice of annual general meeting of Xspray Pharma AB (publ)

The shareholders of Xspray Pharma AB (publ), Reg. No. 556649-3671, are summoned to the annual general meeting on Thursday 14 May 2020 at 11.00 CEST at Advokatfirman Vinge’s office on Stureplan 8 in Stockholm. Registration starts at 10.30 CEST. Due to the current pandemic (covid-19), Xspray has taken a number of precautionary measures ahead of the annual general meeting aimed at keeping the meeting short and efficient and reduce the risk of spreading the virus. No food or drinks will be served before or after the annual general meeting. The CEO will not hold any address in the meeting

Trading in Xspray Pharma’s shares commences today on Nasdaq Stockholm

STOCKHOLM – March 27, 2020. Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) announces today the commencement of trading in the company’s shares on Nasdaq Stockholm's main market.“We are very excited about the move to the main market. This is a natural step as we approach a new phase in the company's development and move towards commercialization of our first product. Being listed on a regulated market increases our chances to become an interesting investment for more institutional owners and international specialist investors in biotech”, said Per Andersson, CEO of Xspray. Xspray Pharma’s

Bulletin from the extraordinary general meeting of Xspray Pharma AB (publ)

Press release, Solna on 26 March 2020   The following resolution was passed at the extraordinary general meeting in Xspray Pharma AB (publ) today, on 26 March 2020.Adoption of incentive programme  The extraordinary general meeting resolved, in accordance with the board’s proposal, to adopt a long-term incentive programme for a number of employees of Xspray. According to the incentive programme, the participants will be offered to acquire warrants which after three years will entitle the holder to subscribe for shares in the company to a pre-determined price, corresponding to 170

The conditions for Xspray Pharma’s listing on Nasdaq Stockholm have been fulfilled

STOCKHOLM – March 26, 2020. Xspray Pharma AB (Nasdaq First North Growth Market: XSPRAY) announced on March 18, 2020, that the company had received clearance for a listing on Nasdaq Stockholm, following the fulfilment of customary conditions. Xspray Pharma has today received information that the conditions have been fulfilled and accordingly, Xspray Pharma’s first day of trading on Nasdaq Stockholm’s main market is March 27, 2020. The last day of trading on Nasdaq First North Growth Market is March 26, 2020.For further information, please contact: Per Andersson, CEO, Xspray Pharma AB

Xspray Pharma publishes prospectus in connection with its listing on Nasdaq Stockholm

STOCKHOLM – March 23, 2020. Xspray Pharma AB (Nasdaq First North Growth Market: XSPRAY) announced on March 18, 2020 that Nasdaq Stockholm’s listing committee had approved that the company’s shares are admitted to trading on Nasdaq Stockholm’s main market. Today, on 23 March, the prospectus that has been prepared by the company in connection with the listing was approved and registered by the Swedish Financial Supervisory Authority (“SFSA”) and is now available on Xspray Pharma’s website, www.xspraypharma.com, and on SFSA’s website, www.fi.se.The first day of trading on Nasdaq Stockholm’s

Xspray Pharma approved for listing on Nasdaq Stockholm

STOCKHOLM – March 18, 2020. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that Nasdaq Stockholm’s listing committee has approved the company’s application to be listed on Nasdaq Stockholm’s main market. The approval is conditional upon the fulfilment of customary conditions, among others that a prospectus is approved and registered by the Swedish Financial Supervisory Authority (“SFSA”). The trading of the company’s shares on Nasdaq Stockholm’s main market is expected to commence on Friday 27 March 2020, and the last day of trading on Nasdaq First North Growth Market is

Xspray receives notification of manufacturing approval and provides update on clinical studies

STOCKHOLM – March 17, 2020. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces today that its production partner, Nerpharma, has received approval from Italian Medicines Agency (AIFA) for the full-scale production facility in Milan, Italy. The approval applies to clinical trial use ofamorphous material based on the company’s HyNap technology. The company also announces that the Covid-19 pandemic may affect the start of the pivotal clinical bioequivalence studies.“We are very pleased to receive this notification from AIFA that allows us to continue our development work. It

Xspray Pharma publishes Interim report Q4, January – December 2019

PRESS RELEASE  February 28, 2020 “One important milestone was reached in June when our production facility in Italy was completed and was able to do a test run. We have now proven that our technology is possible to scale up - and we are the first in the world to manufacture amorphous material in the form of hybrid nanoparticles on a commercial scale. With our technology, we can now develop improved versions of already marketed cancer drugs, especially in the protein kinase inhibitor class, which is a pharmaceutical group with a very high price level.” Per Andersson, CEO Xspray Pharma AB

Notice of extraordinary general meeting of Xspray Pharma AB (publ)

The shareholders of Xspray Pharma AB (publ), Reg. No. 556649-3671, are summoned to an extraordinary general meeting on Thursday 26 March 2020 at 16.00 CET at Advokatfirman Vinge’s office on Stureplan 8 in Stockholm. Registration starts at 15.30 CET.Right to attend the general meeting Shareholders who wish to attend the general meeting must: · be registered in the share register maintained by Euroclear Sweden AB on Friday 20 March 2020, and must also · notify the company of their intention to attend the meeting, no later than on Friday 20 March 2020. The notification must be

Three additional product patents in the US for HyNap-Dasa

STOCKHOLM – February 18, 2020. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that the United States Patent and Trademark Office (USPTO) has granted Xspray three new US patent for HyNap-Dasa. The new patents, US10,561,643; US 10,561,644; and US10,561,645, are valid until January 2033. This means that Xspray now has seven product patents for the pharmaceutical composition of the company's primary product candidate, HyNap-Dasa, in the company's main market USA.“With a total of seven patents for HyNap-Dasa in our most important market, we can justifiably state that it will

Additional product patent in the US for HyNap-Dasa

STOCKHOLM – February 12, 2020. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that the United States Patent and Trademark Office (USPTO) has granted Xspray a new US patent for HyNap-Dasa. The new patent, US 10,555,937, covers the pharmaceutical composition of the company's primary product candidate, HyNap-Dasa. This is Xspray's fourth product patent in the United States, which is the company's main market. The patent is valid until January 11, 2033.“This new patent on our most important market is yet another confirmation of our innovative development work. The formal

Stability studies initiated with Xspray’s HyNap-Dasa tablets

STOCKHOLM – February 11, 2020. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that the stability studies with the company’s commercially manufactured HyNap-Dasa tablets began today, February 11. The readout of the study results after six months will be a part of the company’s ANDA application (Abbreviated New Drug Application) for market approval in the US for the HyNap-Dasa product. The application is planned to be submitted to the FDA in the third quarter of 2020. This means that the development of the company's first product candidate HyNap-Dasa, an amorphous version of

First batch of HyNap-Dasa tablets manufactured on commercial scale according to GMP

STOCKHOLM – December 19, 2019. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that the first batch of HyNap-Dasa tablets has now been manufactured on commercial scale. The tablets are intended for the regulatory stability studies that are necessary for an ANDA application. The development of the company's first product candidate HyNap-Dasa, an amorphous version of Sprycel® (dasatinib), continues according to plan.Xspray Pharma's CMO (Contract Manufacturing Organization) in the US, for the manufacturing of final tablets, has now produced the first batch of commercial-

Xspray Pharma has carried out a directed share issue raising gross proceeds of approximately SEK 122 million

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL PURSUANT TO APPLICABLE RULES OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. Solna, 5 December 2019 Xspray Pharma AB (publ) (“Xspray” or the “Company”) has, based on the authorisation given by Xspray’s annual general meeting on 23 May 2019, and in accordance with what the Company indicated in a press release on 5 December 2019, successfully carried out a

Xspray Pharma contemplates a directed share issue

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL PURSUANT TO APPLICABLE RULES OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. Solna, 5 December 2019 Xspray Pharma AB (publ) (“Xspray” or the “Company”) has mandated Carnegie Investment Bank and Zonda Partners to evaluate the conditions for a directed share issue of approximately 1.5 million new shares (the “Issue”) to institutional investors through an

Xspray Pharma publishes Interim Report Q3, January – September 2019

November 14, 2019  ”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-

Xspray receives FDA clearance of IND for HyNap-Dasa

2019.10.31 STOCKHOLM – October 31, 2019. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that the US Food and Drug Administration (FDA) has cleared the company's IND application for the product candidate HyNap-Dasa.Xspray Pharma's Investigational New Drug (IND) application, for permission to produce materials for and conduct clinical trials with the product candidate HyNap-Dasa, was accepted for review on September 30, 2019 by the US FDA. The application has now been given clearance by the FDA's Division of Hematology Products (DHP). “We are very pleased that the

Xspray – Successful submission of IND application to FDA

STOCKHOLM – October 4, 2019. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that FDA has accepted the company’s submission of IND application for HyNap-Dasa.Xspray Pharma announces a successful submission of its Investigational New Drug (IND) application to the Food and Drug Administration (FDA), with acceptance date September 30th 2019, in order to obtain permission to produce material for and perform clinical studies with the product candidate HyNap-Dasa.The Division of Hematology Products issued an IND Acknowledgment letter indicating that the application will be

Xspray aims for up-listing first half of 2020

STOCKHOLM – September 10, 2019. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) revises the schedule for its planned list change from Nasdaq First North Growth Market to Nasdaq Stockholm, with the goal to complete the up-listing in the first half of 2020.On October 25, 2018, Xspray announced the Board of directors’ decision to apply for listing of the company’s share on Nasdaq Stockholm’s main list, and that the up-listing was expected to take place within 12 months. Due to the resource-demanding work that is currently in progress, primarily production, clinical and business

Xspray Pharma publishes Interim Report Q2, January – June 2019

August 29, 2019 ”We have previously shown that it is possible to manufacture small pilot quantities of amorphous material for clinical studies but now we have shown that the process works at commercial scale. We have ”cracked the code”, so to speak, and have taken a great step toward a finished product.” Per Andersson, CEO Xspray Pharma AB (publ)    Significant events during the second quarter 2019 · In June, Xspray announced the successful start of HyNap-Dasa production in the Company’s unique full-scale manufacturing facility in Italy · In June, Xspray was granted

Successful production start for HyNap-Dasa in Xspray's unique full-scale production line

STOCKHOLM – June 27, 2019. Xspray Pharma (Nasdaq First North: XSPRAY) today announced that the first of two full-scale production lines, producing the company's amorphous formulation on a commercial scale, is now installed and tested in Milan, Italy. This means that the development of the company's first product candidate HyNap-Dasa, an amorphous version of Sprycel® (dasatinib), is proceeding according to plan.Xspray Pharma's production process at NerPharma in Milan, Italy, is developed for commercial production of drugs formulated with the company’s HyNap technology. The production

Xspray granted additional product patents in the United States for HyNap-Sora and HyNap-Nilo

STOCKHOLM – June 11, 2019. Xspray Pharma (Nasdaq First North: XSPRAY) announces that the United States Patent and Trademark Office (USPTO) has granted Xspray two new patents in the United States for its product candidates HyNap-Sora and HyNap-Nilo. The new patents are Xspray’s sixth and seventh product patents, respectively, in the United States, which is Xspray’s main market. The new patents will expire January 11, 2033.“The new patents for HyNap-Sora and HyNap-Nilo make it significantly more difficult for our competitors to copy upcoming products from our unique platform technology. The

Bulletin from the annual general meeting of Xspray Pharma AB (publ)

Press releaseSolna, 23 May 2019 The following resolutions were passed at the annual general meeting (the “AGM”) of Xspray Pharma AB (publ) (“Xspray”) on May 23 2019, in Stockholm.Adoption of income statement and balance sheet for the financial year 2018 and discharge from liability The AGM resolved to adopt the income statement for the financial year 2018 as well as the balance sheet and consolidated balance sheet as of 31 December 2018. The members of the board of directors and the managing director were discharged from liability for the financial year 2018. Allocation of profit

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