Xintela Newsletter December 2020

Dear shareholders,

It has been an unusual year that was dominated by COVID-19 and we have had to adapt our business to the prevailing pandemic. Thanks to the fantastic effort by our team and strict procedures, we have nonetheless been able continue our operations safely and can now say that 2020 was a very successful year for Xintela. Below, I will describe some key events that occurred towards the end of the year and which will be of major significance for our development projects going forward.

In mid-December, we announced that we had – according to plan – submitted our application to the Swedish Medical Products Agency for a license to produce cell therapy products, also known as Advanced Therapy Medicinal Products (ATMPs), at our own GMP (Good Manufacturing Practise) facility. The GMP facility itself has been complete and in use for our development work for some time now. Recently, we have been focusing on the validation and quality program to select, produce, formulate and store our XSTEM® stem cell product. We are now well prepared for an inspection by the Medical Products Agency, that will ensure that Xintela’s GMP facility, production process and cell therapy product meet the requirements for Good Manufacturing Practise and that there is compliance with the documentation requirements for the development of an ATMP. This is a large and very important step forward for Xintela and a fantastic effort by our team. When we have the permit in place, we can begin producing stem cells for our clinical trials. We plan to start our first trial with the XSTEM-OA product on osteoarthritis patients in 2021 and to test our stem cells for the treatment of other diseases going forward.

A new potential indication for XSTEM is Acute Respiratory Distress Syndrome (ARDS), a life-threatening lung complication for which there is no effective treatment today and that could affect, for example, patients who are severely ill with COVID-19. In an ongoing preclinical study that we are conducting together with the cardiothoracic surgery clinic in Lund, Sweden, we are evaluating XSTEM in an animal model for ARDS and can see that animals treated using XSTEM have a distinct improvement in lung function.  

Another very important step is that the patent application that protects our XSTEM stem cell product has received preliminary approval (“Intention to grant”) from the European Patent Office (EPO) and we expect to receive formal approval shortly. Accordingly, Xintela will have patent protection in Europe for its stem cell product XSTEM and for the broad application of the product, including for the prevention and treatment of degenerative joint diseases such as osteoarthritis and degenerative disc disease (DDD), as well as traumatic cartilage and bone injuries. The patent protection of XSTEM, combined with our own GMP classified production facility, will ensure the development and commercialisation of treatments from our stem cell platform for many years to come.

We also announced important progress regarding patents in our oncology program, in which we are developing targeted antibodies for various cancer therapies. The EPO has now granted one of our patents, which protects the treatment of the highly aggressive brain tumour glioblastoma and other CNS tumours with antibodies that are directed against our target molecule integrin α10β1. During the year, we communicated that our antibodies significantly reduce tumour growth of both glioblastoma and triple-negative breast cancer in animal models and that we are also evaluating our antibodies for other aggressive forms of cancer. The successes in our oncology project ensure the development and commercialisation of our antibodies for cancer treatments and bring us closer to clinical trials and potential partnerships.

The work to prepare a spin-out of the subsidiary Targinta, which is pursuing our oncology project, proceeded as planned, with the objective that Targinta will become an independent, self-financing company in 2021. In December, we recruited Jeffrey Abbey as Senior Management Advisor to have a central role in the work to develop and finance Targinta. Jeffrey Abbey has more than 20 years’ experience of biologics and has spent much of his career focusing on the development of innovative cancer therapies, and we are delighted to have recruited Jeffrey to Targinta.  

Recently, we also announced two valuable new recruitments to our Board of Directors. Lars Hedbys and Maarten de Château will be proposed as new Board members of Xintela at the next Annual General Meeting and will, in the meantime, be co-opted to upcoming Board meetings. We very much look forward to having Lars and Maarten on our Board. Their knowledge and experience of the life science industry will be of great value as we approach clinical trials, partnerships and commercialisation.

Finally, I want to thank you, our shareholders, for your confidence and your contribution to Xintela’s exciting journey. We conducted two successful financing rounds during the year, partly in the form of a new share issue in July, which generated MSEK 40.5 before issuance costs and a subscription ratio of 291%. In the subsequent round, approximately 98% of the warrants were exercised, which generated a further MSEK 37.4 for Xintela. With the help of these proceeds, we were able to implement our plans and take key steps forward.

From us at Xintela to all of you, enjoy the remainder of the Christmas holiday and have a very happy new year!

Evy Lundgren-Åkerlund, CEO

Archive

Below you will find the collected information on Xintela’s press releases, newsletters, diary events, films, media coverage and analyses.

April 12, 2021
Xintela GMP inspection for manufacturing license completed
April 6, 2021
Xintela reports positive results from preclinical ARDS study and new grant of 2.3 million SEK
March 19, 2021
Xintela gets tissue establishment license
March 17, 2021
Xintela gets patent grant in Europe for XSTEM stem cell product
March 12, 2021
Xintela publishes results from glioblastoma antibody study
February 26, 2021
Year-end report 1 Jan 2020 – 31 Dec 2020
January 7, 2021
Xintela receives Notice of Allowance from USPTO for the treatment of brain tumors
December 21, 2020
Xintela submits manufacturing license application
December 14, 2020
Xintela recruits Jeffrey Abbey to Targinta
December 4, 2020
Arbitral award rendered in favour of Xintela in dispute with former underwriters
December 3, 2020
Xintela Board recommends Maarten de Château as new Board member
November 27, 2020
Xintela publishes interim report for the third quarter of 2020
November 12, 2020
Xintela Board recommends Lars Hedbys as new Board member
October 30, 2020
Status report of Xintela published by BioStock
October 29, 2020
Xintela receives ‘intention to grant’ decision from European Patent Office for stem cell product XSTEM
October 28, 2020
Xintela applies for tissue establishment license
October 26, 2020
Xintela's stem cells show promising results in preclinical ARDS study
August 19, 2020
Xintela strengthens management team
July 29, 2020
Xintela receives Notice of Allowance from USPTO
June 23, 2020
Granted preliminary approval from the European Patent Office for the treatment of brain tumors
June 17, 2020
Xintela develops treatment for aggressive breast cancer
May 8, 2020
Xintela granted 1 million SEK from Vinnova
March 27, 2020
Xintela has been granted 2 million SEK from Vinnova in the call for "Innovation projects in small and medium-sized companies"
February 3, 2020
Positive preclinical results from equine study
December 11, 2019
Positive preclinical results in Xintela’s glioblastoma project
November 29, 2019
Interim report 1 JAN 2019-30 SEP 2019
April 26, 2019
The Board of Xintela AB (publ) announces that Peter Edman has been nominated for election to the Board at the annual general meeting
April 26, 2019
The results of the company's glioblastoma study have now been published in the renowned international scientific journal Cancers.
April 16, 2019
Xintela appoints Sven Kili as Chief Operating Officer
February 27, 2019
Xintela publishes its Year-end Report for 2018
February 15, 2019
Xintela publishes results from stem cell study
January 8, 2019
Xintela broadens and extends patent protection for chondrocyte products and chondrocyte markers
October 25, 2018
The parties intend to jointly develop an ADC therapeutic product with a first focus on glioblastoma
August 29, 2018
Xintela has made the decision to spin out its oncology business to a newly formed subsidiary company, Targinta AB.
August 29, 2018
Sven Kili extends his commitment to Xintela as Chief Medical Officer
August 21, 2018
Xintela announces an update on the company's development programs
August 9, 2018
Xintela today announced that the company's international patent application has been published
July 9, 2018
Xintela signs Letter of Intent with CO.DON
June 28, 2018
Xintela receives MUMS-status for the treatment of osteoarthritis in horses
April 26, 2018
Xintela's GMP facility is completed and being prepared for production and clinical trials
April 17, 2018
Xintela develops unique methods in stem cell therapy for the brain and broadens patent portfolio
March 20, 2018
Xintela prepares for a possible spin-out of its oncology business into a separate company
February 22, 2018
Xintela publishes the Year-end Report for 2017-01-01 - 2017-12-31
December 29, 2017
Xintela licenses human antibody technology for cancer therapy
December 19, 2017
Xintela to collaborate with Japanese CellSeed Inc.
November 13, 2017
Xintela raises 17 million SEK in debt and equity
October 17, 2017
Keld Søndergaard has resigned from the company’s Board of Directors, citing personal reasons.
September 11, 2017
Xintela building own GMP-facility for stem cell production
July 17, 2017
Xintela recruits Liselotte Theorell as Director Product Development and Quality Management
June 22, 2017
Xintela participates in multi-million, government funded initiative to form a cell and gene therapy research center
May 22, 2017
Xintela signs Memorandum of Understanding with the leading European cell therapy company, CO.DON
May 9, 2017
Xintela: Keld Sondergaard nominated as new board member
March 21, 2017
Xintela announces today that Thomas Areschoug has been recruited to the business development team......
February 8, 2017
(In Swedish) Xintela: Insynspersoner och huvudägare avser nyttja teckningsoptioner av serie TO1
January 20, 2017
Xintela reports positive preclinical results in cancer project
January 4, 2017
Xintela´s stem cells show positive treatment effects on cartilage damage in horse study
December 22, 2016
Xintela reports positive results from completed horse study
September 12, 2016
Xintela announces that Rickard Mosell has been recruited as Head of Business Development from October 1, 2016.
August 22, 2016
Xintela today announces that it has settled a dispute and will receive 1,500,000 Swedish Crowns in compensation.
June 23, 2016
Xintela announces that Christer Betsholtz has been engaged as a scientific and strategic advisor
June 1, 2016
Xintela strengthens its organisation wih the appointment of Caroline Ehrencrona as Director Clincial Development and Regulatory Affairs
April 25, 2016
Xintela initiates a study on the treatment of cartilage damage in horses in the USA.
March 16, 2016
Xintela's press releases are currently only published in Swedish. Please contact us if you have further questions.
January 26, 2021
Xintela Newsletter December 2020
November 9, 2020
Xintela is targeting several important milestones in the remainder of 2020 and 2021
January 13, 2020
Newsletter December 2019
July 30, 2019
Newsletter July 2019
May 8, 2019
Projects in both regenerative medicine and oncology are making progress and developing very positively.
January 14, 2019
Xintela has worked intensively to connect the company with potential partners and international investors.
January 14, 2019
The following presentation summarises the status of Xintela’s various activities and overall plans for the coming year.
July 17, 2018
Strong first six months for Xintela
March 27, 2018
Large-scale stem cell production paves the way for GMP-certified production
January 5, 2018
Pre-Christmas breakthrough promises an exciting 2018
September 28, 2017
‍Strategic decisions that builds significant value
July 19, 2017
Focusing on Stem Cell Production and Preparations for Clinical Trials
May 16, 2017
On the 21st March 2017, Xintela reported that it was strengthening its Business Development team...
April 5, 2017
A word from the CEO
February 15, 2017
The subscription period for shares supported by warrants has started
December 29, 2016
A Year of Significant Progress
December 14, 2016
Glioblastoma—Xintela's Focus in the Cancer Arena
November 8, 2016
Starting the Autumn with an increased focus on Xintela’s commercial development
October 19, 2016
Since our listing in the Spring, the company has developed in a very positive way and we are on track with the milestones we have set.
August 11, 2016
Confidence in the future with a strong organisation
August 11, 2016
Welcome to Xintela's newsletter
June 10, 2021
10-11 & 14-18 June: BIO Digital
BIO Digital 10-11 & 14-18 June
May 17, 2021
17-20 May: Biotechgate Digital Partnering
Biotechgate Digital Partnering 17-20 May
April 6, 2021
6-9 April: Cell&Gene on the Med
Cell&Gene on the Med 6-9 April
March 25, 2021
23-25 March: Bio Europe Spring Digital
Bio Europe Spring Digital 23-25 March
March 2, 2021
2-5 March: Oncology Virtual Partnering
Oncology Virtual Partnering 2-5 March
February 27, 2020

BioStock interview with Xintela's CMO and board member Sven Kili.

August 30, 2018

BioStock was given the opportunity to interview Sven Kili in connection with his visit to Sweden for board and strategy work in Xintela.

February 9, 2017

Dr. Marcus Keep comments on Xintelas glioblastoma project.

January 31, 2017

Xintelas Chairman of the board and strategic advisor Greg Batcheller, tells us more about Xintelas potential and prospects.

January 30, 2017

Dr. Lisa Fortier at Cornell University, New York is interviewed by BioStock about Xintelas positive results in horse study.

December 28, 2016

In the following video interview, Karin explains her role at Xintela and what she considers to be Xintela’s primary strengths.

December 13, 2016

See the interview with Claes Post, member of the board in Xintela. The interview is in swedish with english subtitles.

March 24, 2016

See the interview with Sven Kili, member of the board in Xintela. The interview is in English (introduction is in Swedish).

March 22, 2016

See an interview with Xintela's CEO Evy Lundgren-Åkerlund, after the listing ceremony at Nasdaq First North.

March 15, 2016

Investor presentation from Lund - Jan 27

January 14, 2016

Interview with Xintelas CEO

November 9, 2020
BioStock: Xintela’s CEO comments on the positive patent notice
June 22, 2017
Xintela covered in GEN regarding its participation in multi-million, government funded initiative to form a...
March 2, 2017
Xintela covered in Horsetalk.co.nz regarding that its stem cells are safe for use in horses
March 23, 2016
(Article in Swedish) Xintela tar behandling av ledskador och cancer till First North.
March 23, 2016
(Article in Swedish) Grundare av Xintela ser notering som viktig milstolpe
March 23, 2016
(Article in Swedish) Xintela covered in Life Science Sweden
February 24, 2016
(Article in Swedish) Rapidus: Xintela på väg till First North
November 9, 2020
A status report of the Xintela has been published by Biostock
April 12, 2018
Read the full analysis here
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