Xintela's GMP facility approved for manufacturing of cell therapy products

Xintela announces today that the company has received permission from the Medical Products Agency to produce cell therapy products, so-called advanced therapy drugs (ATMPs), in its own GMP facility.

- It is a key achievement from the team that the manufacturing permit is now in place. This means we can now start to manufacture our stem cell product, XSTEM®, for clinical studies. We will initiate clinical studies on knee osteoarthritis patients during the year and plan for other indications going forward. To have full control and flexibility in the manufacturing of our own cell therapy products also brings financial and business advantages, says Xintela's CEO Evy Lundgren-Åkerlund.

Liselotte Theorell, Quality Management Director at Xintela, who played a key role in building the GMP facility and its associated production processes and quality system, says:

- This has been a major project and substantial investment for Xintela and I am really proud of what we have achieved through the fantastic effort of our team. That a company as small as Xintela chooses to produce its own cell therapy products is very unusual, but is clearly a winning strategy. Most cell therapy peer companies rely on contracting-out production of their products and have far less control over cost and scheduling. There is a recognized worldwide shortage of contract manufacturing for cell therapies, which is creating development bottlenecks for many companies. With our own production facility, Xintela has none of these worries. We are now really looking forward to starting XSTEM production for the coming clinical trials.



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

About Xintela
Xintela develops innovative and patent protected cell therapies and targeted cancer therapies based on the 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 (XSTEM) to develop stem cell therapies for diseases that today lack efficient treatment options, including the joint disease osteoarthritis (OA). Xintela has built 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.

Xintela tecknar avtal med australiensisk CRO för klinisk studie

Xintela meddelar idag att företaget har tecknat ett avtal med GreenLight Clinical, en australiensisk CRO (Contract Research Organization) för att genomföra Xintelas första kliniska studie i människa med stamcellsprodukten XSTEM.


Xintela signs with Australian CRO for clinical study

Xintela announces today that the company has signed a contract with GreenLight Clinical, an Australian Contract Research Organisation (CRO) to conduct Xintela's First-in-Human study using the stem cell product XSTEM.


Kommuniké från extra bolagsstämma i Xintela

Xintela 5 juli 2021 - Idag hölls en extra bolagsstämma i Xintela AB. Nedan följer en sammanfattning av de beslut som fattades. Samtliga beslut fattades med erforderlig majoritet.


Xintela bildar dotterbolag i Australien

Xintela har bildat ett helägt dotterbolag, Xindu Pty Ltd, i Australien som ska administrera bolagets kommande kliniska studie på artrospatienter.


Xintela incorporates subsidiary in Australia

Xintela has formed a wholly owned subsidiary, Xindu Pty Ltd, in Australia, which will administer the company's upcoming clinical study on osteoarthritis patients.


Kallelse till extra bolagsstämma i Xintela AB

Aktieägarna i Xintela AB, org.nr 556780-3480, ("Bolaget") kallas härmed till extra bolagsstämma måndag den 5 juli 2021.


Xintela har genomfört en riktad nyemission av aktier och tillförs därigenom cirka 28 MSEK

Lund, 2021-06-17

EJ FÖR PUBLICERING, DISTRIBUTION ELLER OFFENTLIGGÖRANDE, DIREKT ELLER INDIREKT, HELT ELLER DELVIS, INOM ELLER TILL USA, AUSTRALIEN, HONGKONG, JAPAN, KANADA, NYA ZEELAND, SCHWEIZ, SINGAPORE, SYDAFRIKA ELLER NÅGON ANNAN JURISDIKTION DÄR SÅDAN PUBLICERING, DISTRIBUTION ELLER OFFENTLIGGÖRANDE SKULLE VARA I STRID MED GÄLLANDE REGLER ELLER KRÄVA YTTERLIGARE REGISTRERING ELLER ANDRA ÅTGÄRDER.

INSIDERINFORMATION: Xintela AB (publ) ("Xintela" eller "Bolaget") har, i enlighet med vad som offentliggjordes i Bolagets pressmeddelande igår, framgångsrikt genomfört en riktad kontant nyemission om 11 965 812 aktier till en teckningskurs om 2,34 SEK per aktie (den "Riktade Emissionen"). Genom den Riktade Emissionen tillförs Bolaget cirka 28 MSEK före avdrag för kostnader relaterade till den Riktade Emissionen. Teckningskursen i den Riktade Emissionen fastställdes genom ett accelererat bookbuilding-förfarande som genomförts av Vator Securities. Investerarna i den Riktade Emissionen utgörs av ett antal svenska och internationella professionella investerare. Därutöver har Maarten de Chateau, styrelseledamot i Xintela, tecknat aktier motsvarandes cirka 3 MSEK i den Riktade Emissionen.


Xintela has completed a directed new share issue raising proceeds of approximately SEK 28 million

Lund, 2021-06-17

NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, FULLY OR PARTLY, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES OF AMERICA, AUSTRALIA, HONG KONG, CANADA, JAPAN, NEW ZEALAND, SWITZERLAND, SOUTH AFRICA, SOUTH KOREA, OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR ANY OTHER MEASURE IN ACCORDANCE WITH APPLICABLE LAW.

INSIDE INFORMATION: Xintela AB (publ) ("Xintela" or the "Company") has, in accordance with the Company's press release yesterday, resolved to issue 11,965,812 new shares at a subscription price of SEK 2.34 (the "Directed Issue"). The Company will receive approximately SEK 28 million through the Directed Issue before deductions for costs related to the Directed Issue. The subscription price in the Directed Issue was determined through an accelerated bookbuilding procedure conducted by Vator Securities. The investors in the Directed Issue consist of a number of Swedish and international professional investors. In addition, Maarten de Chateau, a board member of Xintela, has subscribed for shares corresponding to approximately SEK 3 million in the Directed Issue.


Xintela intends to carry out a directed share issue through an accelerated book building procedure

Lund, 2021-06-16

NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, FULLY OR PARTLY, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES OF AMERICA, AUSTRALIA, HONG KONG, CANADA, JAPAN, NEW ZEALAND, SWITZERLAND, SOUTH AFRICA, SOUTH KOREA, OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR ANY OTHER MEASURE IN ACCORDANCE WITH APPLICABLE LAW.

INSIDE INFORMATION: Xintela AB (publ) ("Xintela" or the "Company") hereby announces the Company's intention to carry out a new share issue, with deviation from the shareholders' preferential rights of approximately SEK 25 million, with an option to upsize the new share issue, through an accelerated bookbuilding procedure (the "Directed Issue"). The purpose of the Directed Issue is to finance the start of a clinical phase I/IIa study for stem cell treatment of knee osteoarthritis and within Oncology continue preclinical studies of the Company's targeted antibodies for the treatment of glioblastoma and triple negative breast cancer. The Directed Issue is intended to be carried out based on the authorization from the Annual General Meeting on 7 May 2021. The Directed Issue will be offered to professional investors. The Company has mandated Vator Securities to investigate the conditions for carrying out the Directed Issue.


Xintela avser att genomföra en riktad nyemission av aktier genom ett accelererat bookbuilding-förfarande

Lund, 2021-06-16

EJ FÖR PUBLICERING, DISTRIBUTION ELLER OFFENTLIGGÖRANDE, DIREKT ELLER INDIREKT, HELT ELLER DELVIS, INOM ELLER TILL USA, AUSTRALIEN, HONGKONG, JAPAN, KANADA, NYA ZEELAND, SCHWEIZ, SINGAPORE, SYDAFRIKA ELLER NÅGON ANNAN JURISDIKTION DÄR SÅDAN PUBLICERING, DISTRIBUTION ELLER OFFENTLIGGÖRANDE SKULLE VARA I STRID MED GÄLLANDE REGLER ELLER KRÄVA YTTERLIGARE REGISTRERING ELLER ANDRA ÅTGÄRDER.

INSIDERINFORMATION: Xintela AB (publ) ("Xintela" eller "Bolaget") offentliggör härmed Bolagets avsikt att genomföra en nyemission, med avvikelse från aktieägarnas företrädesrätt, om cirka 25 MSEK, med möjlighet att utöka nyemissionen, genom ett accelererat bookbuilding-förfarande (den "Riktade Emissionen"). Syftet med den Riktade Emissionen är att finansiera start av en klinisk fas I/IIa studie för stamcellsbehandling av knäartros och inom Onkologi fortsätta prekliniska studier av Bolagets riktade antikroppar för behandling av glioblastom och trippelnegativ bröstcancer. Den Riktade Emissionen avses att genomföras med stöd av bemyndigande från årsstämman den 7 maj 2021. Den Riktade Emissionen kommer att erbjudas till professionella investerare. Bolaget har uppdragit åt Vator Securities att utreda förutsättningarna för att genomföra den Riktade Emissionen.


Xintela offentliggör delårsrapport för första kvartalet 2021

Sammanfattning av kvartalsrapporten


Xintelas GMP-anläggning erhåller tillstånd att producera cellterapiprodukter

Xintela meddelar idag att bolaget har erhållit tillstånd från Läkemedelsverket att producera cellterapiprodukter, så kallade avancerade terapiläkemedel (ATMPs), i den egna GMP-anläggningen.


Xintela's GMP facility approved for manufacturing of cell therapy products

Xintela announces today that the company has received permission from the Medical Products Agency to produce cell therapy products, so-called advanced therapy drugs (ATMPs), in its own GMP facility.


Xintela utvecklar stamcellsbehandling för svårläkta sår

Xintela tillkännager idag att bolaget ska utveckla sin stamcellsprodukt XSTEM® för behandling av svårläkta (kroniska) sår. I samarbete med Brännskadecentrum vid Universitetssjukhuset i Linköping har Xintela i en preklinisk sårmodell visat utmärkt sårläkningsförmåga med XSTEM och planerar nu för en klinisk studie på patienter med svårläkta sår.


Xintela to develop stem cell therapy for difficult-to-heal wounds

Xintela announces today that the company will develop its stem cell product XSTEM® for the treatment of difficult-to-heal (chronic) wounds. In collaboration with The Burn Center at Linköping University Hospital, Xintela has found that XSTEM has excellent wound healing capability in a preclinical model and is now planning for a clinical trial on patients with difficult-to-heal wounds.


Följ oss

Om beQuoted

beQuoted publicerar nyheter, analyser och pressmeddelanden för investerare och journalister. Viktiga företagshändelser bevakas av vår egen nyhetsredaktion och vidaredistribueras i ledande finansiella medier.

Vi uppdaterar även nyhetsrum, Investor Relations och IR-webbplatser för företag som vill utveckla sina relationer med finansmarknaden.

Kontakta oss

beQuoted AB
Nybrogatan 34
Box 5216
SE-102 45 Stockholm, Sweden

08-692 21 90

Om beQuoted