A successful year

Xintela had a very eventful year with success regarding both projects and financing. The following presentation summarises the status of Xintela’s various activities and overall plans for the coming year. Through a directed issue of approximately MSEK 50 to the German orthopaedic company Bauerfeind AG, we achieved financial stability and a long-term owner with a major commitment to Xintela’s future R&D activities. This will enable us to apply a strategy whereby some projects can be further developed in order to increase the value of projects and thereby advance our positions prior to commercialisation.

Clinical trial in Australia

In the stem cell project, we are fully focused on preparing clinical trials in humans where the main objective is to demonstrate that our stem cells are safe, but also to study efficacy on damaged articular cartilage of osteoarthritis patients. We have advanced plans to conduct our first clinical trial in Australia in order to save time and to keep costs down. Several companies in Australia have conducted clinical trials with stem cells, which means that regulatory authorities in Australia now have extensive experience in development of stem cell-based products. This has resulted in a more simple regulatory framework for approval of clinical trials with stem cells, which can also be used as a basis for further clinical development in the EU and the US. In addition, the Australian authorities have introduced considerable tax rebates for companies engaged in R&D in the country, which is also in Xintela’s interest because this will significantly reduce the company’s costs for the trial. Xintela’s goal is to be ready to commence clinical trials by the end of 2019.

Partnership discussions with CO.DON

The discussions with CO.DON will continue in the coming year. From Xintela’s point of view, it is important that Xintela continues to develop value-enhancing steps in the stem cell project and we are investigating the suitable time point for starting up a joint venture with CO.DON. Xintela’s plans to commence clinical trials in Australia are not dependent on the continuing discussions with CO.DON.

GMP facility for stem cell manufacturing

The GMP facility is a key component in Xintela’s path to clinical trials, which is why so much has focused on getting the facility ready and approved for stem cell manufacturing. The GMP facility and related equipment will be qualified and ready for use before the end of the year as planned. An application for a manufacturing licence is planned for submission during the spring, with the aim of commencing clinical trials by the end of 2019 as planned.

Neural stem cells – a new cell therapy area with major business potential

As previously announced, Xintela has developed new methods for identifying and isolating neural stem cells from the brain. The new methods have opened up a completely new field for the company – the treatment of traumatic injuries and diseases affecting the central nervous system (CNS).

Last year, Xintela filed a patent application to protect these interesting findings. We can now announce that an International Preliminary Report on Patentability (IPRP) has been issued for our international patent application WO 2018/033596, in which the European Patent Office (EPO) concludes that all patent claims are novel and innovative, which is a highly significant milestone in our efforts to obtain approved national patents in key strategic markets.

Xintela is now working on a strategy for our continued R&D activities. The company has already entered into discussions with possible partners who can contribute complementary research competencies within the CNS area as well as financial resources.

New horse study

Xintela had previously planned to start a new horse study in collaboration with Cornell University in the US during the autumn with the aim of studying the mechanisms of action of our stem cells in more detail. Since these results are not needed in the preclinical documentation that Xintela is compiling for its clinical trial application in Australia, we have chosen to postpone the start-up of this study until early 2019.

The results from the first horse study received considerable attention and we are expecting further dissemination of the positive results when the manuscript, which has now been submitted, is published. We have also submitted another manuscript for publication describing how our marker technology can be used in a unique way to purify and quality assure stem cells from horses for the treatment of osteoarthritis.

Partnership discussions with veterinary companies

Xintela’s veterinary medicine strategy is to conduct clinical trials in horses together with a partner that can co-finance the development costs. Our participation in international partnering conferences during the year has given us contact with several leading veterinary companies and a number of interesting discussions are ongoing.

XACT partnerships

During the year, Xintela partnered with the Japanese company CellSeed regarding Xintela’s analytical test XACT (Xintela Assay for Cell Therapy), which is used to quality assure cartilage cells. Although the studies generated positive results, we have different expectations with regard to our continued collaboration and have therefore reached a mutual decision to discontinue our partnership. Xintela will continue to evaluate other potential partnerships and by filing a new patent application we have broadened and extended the protection for the use of this marker technology for cartilage cells.

Positive development for the oncology business

The highly positive trend for the oncology project has continued. The collaboration with the US company Catalent is already ongoing, and the first analyses of new antibodies produced by Catalent will begin in January. The glioblastoma project has expanded with new results and we expect the results to be published in a prestigious scientific journal in the first half of 2019. Efforts to broaden the oncology project to other therapeutic indications in oncology have also been highly successful during the year and we are expecting to file a new patent application in the beginning of the year. When this has been done, we will provide information about Targinta’s expanded focus.

Spin-out to Targinta AB

Efforts to spin-out the oncology business to Targinta are in progress. We have now completed the necessary preparations for transferring projects and relevant patents to Targinta and the company is now ready to be registered as a public company. Targinta will initially have the same management and Board as Xintela.

The process of transferring a business operation from one company to another requires careful planning and for various reasons, including fiscal issues, the spin-out will not be completed until early 2019. Xintela’s auditors and legal advisors have been actively involved in the process of evaluating the various transactions to ensure compliance with both the Swedish Companies Act and various tax rules. In January, our efforts to achieve financing for Targinta will intensify. We are already evaluating various financing options, including an IPO.

Archive

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

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.
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
The following presentation summarises the status of Xintela’s various activities and overall plans for the coming year.
January 14, 2019
Xintela has worked intensively to connect the company with potential partners and international investors.
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
April 5, 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 3, 2019
3-6 June: Bio International Convention, Philadelphia
3-6 June: Bio International Convention, Philadelphia
April 23, 2019
23-25 April: Cell&Gene on the Mediterranean, Barcelona
23-25 April: Cell&Gene on the Mediterranean, Barcelona
April 9, 2019
9-11 April: Animal Health Investment USA Conference, Boston
9-11 April: Animal Health Investment USA Conference, Boston
April 4, 2019
4 April: ATMP Sweden Annual Conference, Gothenburg
4 April: ATMP Sweden Annual Conference, Gothenburg
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 16, 2016

Investor presentation from Lund - Jan 27

March 15, 2016

Interview with Xintelas CEO

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
April 12, 2018
Read the full analysis here
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