Xintela submits manufacturing license application

Lund, Sweden, 21 December 2020 - Xintela announces today that the company has submitted its application to the Swedish Medical Products Agency for a license to produce cell therapy products, also known as Advanced Therapy Medicinal Products (ATMPs), for clinical studies.

Xintela has developed and patented the stem cell product platform XSTEM® and built its own GMP (Good Manufacturing Practice) compliant facility for the production of ATMPs. The company is now applying for a license to produce ATMPs for human clinical studies. This approval is issued by the Swedish Medical Products Agency, which is responsible for the inspection and approval of GMP facilities in Sweden. The inspection is performed to ensure that the GMP facility, the production process and the cell therapy product meet the requirements for Good Manufacturing Practise and safety and that the documentation requirements for an ATMP are followed.

"This is a huge and very important step forward for Xintela following a fantastic effort from our team. Once we have the license in place, we can start manufacturing for our clinical programmes. We plan to start our first study with XSTEM-OA in osteoarthritis patients in 2021 and then to test XSTEM in other indications as we move forward," says Xintela's CEO Evy Lundgren-Åkerlund.

This information is such information that Xintela AB (publ) is obligated to publish in compliance with the EU market abuse regulation. The information was provided, through the below contact, for publication at 08:30 CET on the 21st of December, 2020.

Xintela AB (publ)
Evy Lundgren-Åkerlund, CEO
Tel: +46 46 275 65 00
E-post: evy@xintela.se
Medicon Village
223 81 Lund, Sweden
www.xintela.se

About Xintela
Xintela is an Advanced Therapy company developing regenerative stem cell therapies and targeted cancer therapies based on the patented marker technology platform XINMARK®. The platform is built on specific cell surface proteins (integrins) and more than 25 years of research and development. Xintela uses the marker technology to select and quality assure stem cells to develop stem cell therapies for diseases that today lack efficient treatment options, including osteoarthritis (OA). Studies on horses with OA have demonstrated that the stem cells are safe and that they have a positive effect on cartilage and bone. Xintela has established an in-house GMP-facility for manufacturing of stem cell products and is preparing a First in Human clinical study on patients with knee OA. In the oncology program, Xintela develops antibody-based therapies for treatment of aggressive tumors including glioblastoma and triple-negative breast cancer. Xintela is listed on Nasdaq First North Growth Market Stockholm since 22 March 2016. Xintela's Certified Adviser at Nasdaq First North Growth Market is Erik Penser Bank AB, +46 8-463 80 00, certifiedadviser@penser.se.

Rättelse: Uppdatering tidigare pressmeddelande "Xintela AB har genomfört en kvittningsemission av aktier om 9,5 MSEK"

Rättelsen avser att styrelsen beslutade om en kvittningsemission med ett högre antal aktier än vad som rymdes inom bemyndigandet från årsstämman den 9 juni 2020, detta på grund av felaktig rådgivning från externa rådgivare. Således har styrelsebeslutet per den 12 januari annullerats och ett nytt styrelsebeslut har tagits idag. Antalet aktier som emitteras och tecknas uppgår till 3 201 645 aktier (tidigare beslut 3 538 175), vilket innebär att fordran om 8,6 MSEK (tidigare 9,5 MSEK) kvittas mot nya aktier i Xintela. Nedan följer pressmeddelandet i sin helhet med uppdaterade uppgifter som markerats med fet och kursiv text.


Xintela AB har genomfört en kvittningsemission av aktier om 9,5 MSEK

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Xintela submits manufacturing license application

Lund, Sweden, 21 December 2020 - Xintela announces today that the company has submitted its application to the Swedish Medical Products Agency for a license to produce cell therapy products, also known as Advanced Therapy Medicinal Products (ATMPs), for clinical studies.


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Lund, Sverige den 14 december 2020 -Xintela AB (publ) meddelar att Jeffrey Abbey har rekryterats som Senior Management Advisor för utveckling av det helägda dotterbolaget Targinta. Jeffrey Abbey har mer än 20 års erfarenhet från den biologiska läkemedelsindustrin och har ägnat en stor del av sin karriär åt utveckling av innovativa cancerbehandlingar.


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Lund, Sweden, 14 December 2020 -Xintela AB (publ) announces that Jeffrey Abbey has been recruited as a Senior Management Advisor to support further development of the wholly owned subsidiary Targinta. Mr. Abbey has more than 20 years of experience in the biopharmaceutical industry and has spent much of his career focused on the development of innovative oncology therapies.


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Lund, Sweden, 3 December 2020 -Xintela AB (publ) announces that Maarten de Château has accepted an invitation to join the Xintela Board of Directors. The Xintela Board will recommend that shareholders formally appoint Maarten at the next shareholders meeting. In the meantime, Maarten will be adjoined to future Board meetings.





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Lund, Sverige, 12 november 2020 -Xintela AB (publ) meddelar att Lars Hedbys har accepterat rollen som styrelseledamot i bolaget. Xintelas styrelse kommer föreslå att bolagets ägare formellt utser Lars till styrelseledamot vid nästa bolagsstämma. Under tiden kommer Lars att adjungeras till kommande styrelsemöten.


Xintela Board recommends Lars Hedbys as new Board member

Lund, Sweden, 12 November 2020 -Xintela AB (publ) announces that Lars Hedbys has accepted an invitation to join the Xintela Board of Directors.  The Xintela Board will recommend that shareholders formally appoint Lars at the next shareholders meeting. In the meantime, Lars will be adjoined to future Board meetings.


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