Emplicure's application of a clinical PK study of Empli03 has been approved

The UK authorities have approved Emplicure's application to conduct a clinical pharmacokinetic study of Empli03, a drug candidate for chronic pain.

The purpose of the study is to document the safety profile and pharmacokinetic properties of Empli03 in humans. Empli03 is an oral bucGcal tablet containing the opioid buprenorphine. The tablet can be placed under the upper lip to achieve stable pain relief using a controlled release of buprenorphine. The risk of serious side effects if the user swallows the tablet is low due to buprenorphine being broken down and inactivated in the upper part of the intestine. Empli03 also has properties that make abuse more difficult.

Chronic pain is a growing health problem globally and in the United States, as many as 20 percent of the population is estimated to suffer from chronic pain and be in need of long-term pain relief. Widespread chronic pain is a problem associated with high costs for society and individual patients. Opioids are, and will continue to be, an important class of treatments for moderate to severe chronic pain.

The results from this first clinical study will provide valuable information for the next step in the development of Empli03 and are also important for Emplior as a platform. The company's CRO Quotient Sciences, is now starting recruitment and screening of the subjects to be included in the study, a total of twelve healthy volunteers.  The subjects are dosed with one tablet and the concentration in blood of the active substance will be measured.  Initial results will be available towards the end of the year.

"With this positive news, Emplicure is driving the clinical development of Empli03 further.  It is an important milestone on our journey forward and I am proud of the focused and hard work that has made this possible." says CEO Torbjörn Walker Larsson.

This information is information that Emplicure AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The informationen was submitted for publication, through the agency of the contact persons above, on September 6, 2022 at 08:30 CET.

For more information, please contact:

Torbjörn W. Larsson
Phone: +46 (0)70 747 65 99
Email: [email protected]

Erik Magnusson
CFO, Investor Relations
Phone: +46 (0)708 565 245
Email: [email protected]

Emplicure AB (publ) is listed on the Nasdaq First North Growth Market. Certified Adviser is Mangold Fondkommission AB, +46 8 503 015 50, or via [email protected]

Emplicure develops new and innovative products by combining existing and approved active substances with advanced materials science within ceramic biomaterials. The product portfolio is focused on chronic pain and on abuse-deterrent formulations. Wholly owned subsidiary Amplicon AB develops consumer products with oral nicotine as the first product. The share is listed on Nasdaq First North Growth Market (EMPLI). Read more at www.emplicure.com

Emplicure anlitar Erik Penser Bank som likviditetsgarant

Emplicure AB (publ) har utsett Erik Penser Bank AB ("Penser") till likviditetsgarant för Bolagets aktie. Syftet är att förbättra aktiens likviditet och Pensers uppdrag inleds den 24 november 2022.

Emplicure engages Erik Penser Bank as liquidity provider

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Kommuniké från extra bolagsstämma i Emplicure AB (publ)

Extra bolagsstämma i Emplicure AB (publ) ("Bolaget") ägde rum kl. 11.00 måndagen den 14 november 2022 i Bolagets lokaler, Virdings allé 32B, Uppsala.

Communiqué from extraordinary general meeting in Emplicure AB (publ)

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Emplicure upptar lån om 9,0 MSEK

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Emplicure takes up a loan in the amount of 9.0 MSEK

Emplicure AB (publ) has today entered into a loan agreement with a loan consortium through which the Company has taken up a loan in the amount of 9.0 MSEK. The loan consortium includes certain existing shareholders, including the board member Johan Wieslander. The purpose of the loan is to strengthen the Company's short-term working capital and to meet the requirement of going concern for the next twelve months.

Emplicure utser valberedning

Emplicure AB meddelar idag att valberedningen har utsetts inför stämman i maj 2023. Valberedningen består av representanter för de tre största aktieägarna per den sista bankdagen i tredje kvartalet, jämte styrelsens ordförande. Bolagets tre största aktieägare, tillika grundare, har enats om att rösta som en genom Thomas Lundqvist, för att ge företräde till oberoende aktieägare.

Emplicure has formed Nomination Comittee

Emplicure AB announces today that the Nomination Committee for the annual general shareholders meeting (AGM) in May 2023 is formed. The Nomination Committee  consists of representatives nominated by the three largest shareholders per the last bank-day in the third quarter, as well as the Chairman of the Board. Emplicure's three largest shareholders, also the founders, have agreed to vote as one, in order to give preference for more shareholders.

Dosering i fas I PK-studie för EMPLI03 slutförd

Emplicure AB rapporterar genomförd dosering i den första fas I farmakokinetikstudien med EMPLI03, avsedd för behandling av medelsvår till svår smärta

Dosing in Phase I PK study for EMPLI03 completed

Emplicure AB today reported dosing in the first Phase I pharmacokinetic study for EMPLI03, intended for the treatment of moderate to severe pain

Emplicure byter Certified Adviser till Erik Penser Bank AB

Uppsala 2022-10-03 Emplicure AB (publ) meddelade idag att bolaget byter Certified Adviser

Emplicure changes Certified Adviser to Erik Penser Bank AB

Uppsala, 2022-10-03 Emplicure AB (publ) today announced that the company changes Certified Adviser

Emplicure genomför holdingbolagsstruktur

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Emplicure adopts a holding company structure

Uppsala 2022-09-19 Emplicure AB (publ) announces today that the Company's Board of Directors has resolved to implement a holding company structure with operational subsidiaries. The purpose of the restructuring is to increase visibility and reinforce the Group's ability to focus on business and product development across various product areas, including nicotine and pharmaceuticals as well as other consumer product areas. As a direct consequence of the above, the Board of Directors has appointed Tomas Hammargren as CEO of the subsidiary Amplicon.

Håkan Engqvist ny VD på Emplicure

Uppsala 2022-09-19 Emplicure AB (publ) meddelar idag att bolagets styrelse beslutat att utse styrelsemedlemmen och medgrundaren Håkan Engqvist till ny vd och koncernchef.

Håkan Engqvist new CEO of Emplicure

Uppsala 2022-09-19 Emplicure AB (publ) announces today that the Company's Board of Directors has resolved to appoint member of the board and co-founder Håkan Engqvist as new CEO and President. 

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