Year-end Report 2018

#Regulatory

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The aim is set for clinical studies

The final quarter of the year was very eventful, and successful in terms of both projects and financing.

We conducted a directed share issue of MSEK 50 to the German orthopaedic company Bauerfeind AG.

In the companies stem-cell project, our aim is to commence clinical trials in Australia.

In the oncology project, the collaboration with Catalent is in full swing and an evaluation of antibodies has now commenced.

We continued to prepare for the spin-out of the oncology business to the newly formed company Targinta and we are now evaluating various financing solutions. For more information, read the CEO-statement below.

- Evy Lundgren Åkerlund, CEO


Summary of the year-end repor
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The “company” or “Xintela” refers to Xintela AB (publ), corporate registration number 556780-3480.


Twelve months (1 Jan 2018-31 Dec 2018)

• Income amounted to TSEK 1,628 (2).

• Loss before tax totalled TSEK 26,274 (loss: 21,945)

• Loss per share* was SEK 0.67 (loss: 0,72).

• At 31 December 2018, the equity/assets ratio** was 90% (64).

Fourth quarter (1 Oct 2018-31 Dec 2018)

• Income amounted to TSEK 616 (0).

• Loss before tax totalled TSEK 8,693 (loss: 6,636).

• Loss per share* was SEK 0.22 (loss: 0.22).

* Earnings/loss per share: Profit/loss for the period divided by 39,470,708 shares, which was the registered number of shares at 31 Dec 2018. In the year-earlier period, the company had 30,367,904 registered shares.

** Equity/assets ratio: Equity divided by total capital.

Amounts in parentheses: Comparative period of the preceding year.


Significant events in the fourth quarter of 2018

Xintela held an Extraordinary General Meeting on 15 October 2018. The Meeting resolved to adopt the Board’s decision to annul the rights issue decision of 5 September, and to adopt the Board’s proposal of a directed share issue. The directed share issue decision means that the share capital will be increased by a maximum of SEK 249,609.99 by issuing no more than 8,320,333 shares at a subscription price of SEK 6. The directed share issue will generate a maximum amount of MSEK 50 for the company.

On 25 October, Xintela announced that the company had signed a collaboration agreement with US company Redwood BioScience Inc., a wholly owned subsidiary of Catalent, Inc., a global leader in the development of antibody-drug conjugate (ADC) technology for cancer therapy. The parties intend to co-develop an ADC-based therapeutic product, initially focusing on the glioblastoma brain tumour.

Significant events after the end of the period

On 8 January 2019, Xintela announced that the company’s international patent application (PCT application) for quality-assured chondrocytes, isolated using the company’s integrin markers, had been published.

On 15 February 2019, Xintela announced that results from the characterisation of stem cells derived from horses and selected with Xintela’s marker technology had now been published in the international scientific journal Annals of Stem Cell Research. The functional benefits of Xintela’s selected stem cells are demonstrated and discussed in the publication.

Statement from the CEO, Evy Lundgren-Åkerlund

The final quarter of the year was very eventful, and successful in terms of both projects and financing. One important event was that we conducted a directed share issue to the German orthopaedic company Bauerfeind AG of MSEK 50, thereby achieving a stable cash position and a long-term owner with a major commitment to Xintela’s future R&D activities.

Another significant event during the quarter was that we entered into a collaboration agreement with US company Catalent, a leader in ADC technology, regarding the joint financing and development of an ADC therapy for brain tumours. Collaboration with Catalent is in full swing and an evaluation of antibodies developed by Catalent has now commenced. This collaboration is building an excellent foundation for a continued and broader focus in oncology.

We continued to prepare for the spin-out of the oncology business to the newly formed company Targinta. We expect that registration and other formalities will soon be in place. After that, the plan is to complete the spin-out in conjunction with obtaining financing for Targinta and we are now evaluating various financing solutions.

In the stem-cell project, our aim is to commence clinical trials in Australia by the end of the year. The primary endpoint is to demonstrate that our stem cells are safe, but also to study efficacy on the articular cartilage of osteoarthritis patients. 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. Our partnership discussions with CO.DON regarding the possible joint development of a stem-cell therapy for osteoarthritis are continued, and we extended our previous “Letter of Intent” until 30 June 2019. During this period, CO.DON will not hold exclusive rights.

We take an active role in international partnering meetings, which has led to a major interest in Xintela’s marker technology and projects in both regenerative medicine and oncology. We have also forged connections with several veterinary companies with a major interest in cell therapy for osteoarthritis, especially for dogs.

2019 also began on a high note. We announced the publication of a patent application that protects chondrocyte preparations of high quality and purity and the method for culturing them, which is a further development of the XACT analytical test. We also published results from a characterisation of stem cells in an international scientific journal, which demonstrates and discusses the functional benefits of Xintela’s selected stem cells.

With a successful 2018 behind us, we are now looking forward to a new and exciting year and I would like to welcome our shareholders to Xintela’s Annual General Meeting on 27 May to hear more about our development plans.

Sincerely,
Evy Lundgren-Åkerlund
CEO, Xintela AB


Xintela AB

Xintela develops medical products in the fields of regenerative medicine and oncology based on the company’s patented marker technology, XINMARK®. Xintela uses the technology to produce and assure the quality of stem cells for the treatment of osteoarthritis, a degenerative joint disease. Equine studies have shown that the stem cells are safe, and have a therapeutic effect on articular cartilage and the underlying bone following injury. Xintela has recently established its own GMP facility for the manufacture of stem cells for clinical trials. In the oncology project, XINMARK® is used to manufacture an antibody drug conjugate (ADC) for the treatment of tumours, initially focusing on the aggressive glioblastoma brain tumour. Positive preclinical data from cell studies and an animal model have shown that ADC treatment has a targeting and killing effect on specific tumour cells, which has laid the foundation for continued development of the company’s oncology operations.

Performance figures

Income

The company reported net sales of TSEK 1,628 (2) for the 2018 financial year. The sales are derived from income from the Japanese company CellSeed, and an exclusivity fee from CO.DON in relation to the ongoing discussions to co-develop a stem cell product for the treatment of articular cartilage damage, including osteoarthritis, for European and North American markets. For the fourth quarter, the company reported net sales of TSEK 616 (0).

Earnings

The company’s operating loss for the year totalled TSEK 24,204 (loss: 21,933). The corresponding figures for the fourth quarter were a loss of TSEK 8,104 (loss: 6,625)

Research and development costs, which account for the highest portion of the company’s costs, amounted to TSEK 17,637 (16,216) for the January-December period. The corresponding figures for the fourth quarter were TSEK 6,376 (5,142).

Marketing and sales costs for the year amounted to TSEK 4,730 (3,401). The corresponding figures for the fourth quarter were TSEK 1,350 (837).

Administrative expenses for the year amounted to TSEK 3,465 (2,318). The corresponding expenses for the fourth quarter amounted to TSEK 994 (645).

For the January-December period of 2018, loss before tax was TSEK 26,274 (loss: 21,945)

Financial position

On 31 December 2018, Xintela’s equity/assets ratio was 90% (64) and equity amounted to TSEK 44,945 (18,415). The company’s cash and cash equivalents amounted to TSEK 31,397 (21,910). On the same date, the company’s total assets amounted to TSEK 49,714 (28,585).

Cash flow and investments

Xintela’s cash flow for the January-December period of 2018 was TSEK 9,487 (2,931). Investments amounted to TSEK 12,112 (2,074), of which tangible assets accounted for TSEK 12,246 (511). The investments are linked to the establishment of Xintela’s own GMP facility for the manufacture of stem cells for clinical trials.

The share

Xintela AB (publ) was listed on Nasdaq First North in Stockholm on 22 March 2016 under the ticker symbol “XINT.” First North is an alternative marketplace, operated by an exchange within the NASDAQ OMX Group. Companies on First North are not subject to the same rules as companies on the regulated main market. They are subject to a less regulated framework, adapted for small growth companies. A company listed on First North may therefore entail a higher investment risk than a company listed on the main market. All companies listed on First North have a Certified Adviser to oversee their compliance with the rules. The exchange assesses applications for admission to trading. Xintela’s Certified Adviser on Nasdaq First North is Erik Penser Bank AB, +46 (0)8-463 80 00, certifiedadviser@penser.se.

At 31 December 2018, the number of shares was 39,470,708. The company has only one class of shares. Each share carries identical rights to the company’s assets and earnings, and one vote at General Meetings.

Financial statements in accordance with RFR2 (IFRS)

Xintela prepares its financial statements in accordance with RFR2 (IFRS). Historical financial information has been restated from 1 January 2014, which was the date of transition to IFRS.

Review by auditors

This year-end report has not been reviewed by the company’s auditor.

Financial calendar

Interim report Jan-Mar 2019 23 May 2019

Six-monthly report Jan-Jun 2019 30 August 2019

Interim report Jan-Sep 2019 29 November 2019

Proposed allocation of Xintela’s profits

The Board of Directors and CEO recommend that no dividend be paid for the 2018 financial year, 1 January 2018-31 December 2018.

Annual General Meeting and publication of Annual Report

The Annual General Meeting (AGM) will be held in Lund on 27 May 2019. The Annual Report will be available for download on the company’s website (www.xintela.se) by the date on which the notice of the Annual General Meeting is published.

Risks and uncertainties

Limited resources

Xintela AB is a small company with limited resources in terms of management, administration and capital. The implementation of any major strategies requires optimisation of the company’s resource appropriation. There is a risk that the company’s resources could be insufficient, and lead to financial and operational problems. The Board works continuously to secure financing for the company’s needs based on various scenarios, including revenue from licensing and partnerships to external funding.

Dependence on key individuals and employees

Xintela AB’s success is based on the knowledge, experience and creativity of a few specific individuals. The company’s future is dependent on being able to recruit qualified employees. The company works hard to reduce this dependency by maintaining proper documentation of procedures and working methods.

Earning capacity and capital requirements

Drug development is both expensive and time-consuming. It may take longer than expected before the company can generate a positive cash flow. To cover these costs, Xintela AB may need to raise new capital. There is no guarantee that such capital can be obtained on terms that are favourable to shareholders. Failure to generate sufficient profits may impact the company’s market value.

Sales risk

There is no certainty that the products developed by the company will gain the market acceptance reflected in this interim report. The quantity of products sold may be lower, and the period required for market establishment may be longer, than the company currently has reason to believe.

Underwriting commission claim

The Extraordinary General Meeting (EGM) on 21 September approved a rights issue of approximately MSEK 24. When the rights issue was announced on 5 September, 60% of the issue had been underwritten in an underwriting agreement between the company and the following underwriters; Formue Nord Markedsneutral A/S, Modelio Equity AB, Oliver Molse and Råsunda Förvaltning AB. Shortly after the EGM, however, the Board decided not to go ahead with the rights issue because the company had received a very attractive financing option deemed considerably more advantageous for the company and its shareholders. This was communicated to the market on 24 September and on 15 October, and EGM approved the Board’s decision. Although the rights issue was never implemented, the underwriters consider themselves entitled to a total underwriting commission of MSEK 1.5. Xintela disputes the payment of any underwriting commission and discussions are currently taking place between the parties.

Lund, 27 February 2019

Greg Batcheller
Chairman of the Board

Sven Kili
Board member

Claes Post
Board Member

Karin Wingstrand
Board Member

Evy Lundgren-Åkerlund
Chief Executive Officer

For more information, contact:
Evy Lundgren-Åkerlund, CEO
Telephone: +46 (0)703 291 871
E-mail: evy@xintela.se
Website: www.xintela.se
Address: Medicon Village, SE-223 81 Lund, Sweden

Xintela has been listed on Nasdaq First North since 22 March 2016. Xintela’s Certified Adviser on Nasdaq First North is Erik Penser AB:

Certified Adviser: Erik Penser Bank AB
Tel: +46 8-463 83 00
E-mail: certifiedadviser@penser.se

This information is such information that Xintela AB is required to publish under the EU Market Abuse Regulation. The information was issued for publication through the agency of the above contact person on 27 February 2018 at 16:00 CET.

Archive

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

Nov 30, 2023
Dec 2, 2023
3rd Regenerative Orthopaedic Summit by the Regenerative Medicine Orthopaedic Society (RMOS), Istanbul
Nov 21, 2023
Nov 23, 2023
43rd Orthopaedic World Congres by the International Society of Orthopaedic Surgery and Traumatology (SICOT), Cairo
Oct 10, 2023
Oct 12, 2023
2023 Cell & Gene Meeting on the Mesa, Carlsbad, October 10-12
Sep 9, 2023
Sep 12, 2023
- 17th world congress by the International Cartilage Regeneration & Joint Preservation Society (ICRS), Sitges/Barcelona
Jun 5, 2023
Jun 8, 2023
BIO International Convention, Boston
May 31, 2023
Jun 3, 2023
23rd European Congress of Rheumatology, by European Alliance of Associations for Rheumatology (EULAR), Milan
May 11, 2023
May 13, 2023
2nd Regenerative Orthopaedic Summit, Naples
May 12, 2023
May 13, 2023
10. Berliner Knorpelsymposium, Berlin
Apr 27, 2023
Apr 29, 2023
ICRS Focus Meeting on Allografts and synthetics on the frontstage, Nice
Apr 12, 2023
Apr 14, 2023
Cell & Gene Meeting on the Med 2023 Barcelona
Mar 17, 2023
Mar 20, 2023
OARSI world congress on osteoarthritis, Denver
Mar 16, 2023
BioStock Investor Meeting (broadcast online)
Mar 1, 2023
Mar 2, 2023
European Life Sciences CEO Forum (ELSF 2023) in Zürich, March 1-2, 2023
Feb 22, 2023
Redeye Theme: Regenerative Medicine / Cell Therapy, February 22, 2023
Jan 9, 2023
JPM Annual Healthcare Meeting 2023, San Francisco, January 9-12
Dec 1, 2022
1st Regenerative Orthopaedic Summit, Athens, December 1-3, 2022
Nov 29, 2022
BioStock Life Science Summit, Lund, November 29-30 2022
Nov 14, 2022
Investival Showcase, London, November 14, 2022
Nov 2, 2022
BioEurope (Digitalt), November 2-4, 2022
Oct 11, 2022
2022 Cell & Gene Meeting on the Mesa, Carlsbad, October 11-13
Oct 6, 2022
ICRS Focus Meeting, Bologna, October 6-7
Sep 28, 2022
Nordic Life Science Days, Malmö, September 28-29, 2022
Aug 30, 2022
2nd Integrin-Targeted Drug Development Summit, Boston, August 30 - September 1
Jun 13, 2022
Bio International Convention, San Diego, June 13-16
Jun 13, 2022
Småbolagsdagarna, Stockholm, June 13-15
March 30, 2023

Chairman Gregory Batcheller visited BioStock’s studio to tell us more about the company’s journey and business development.

March 16, 2023

CEO Evy Lundgren-Åkerlund presents the company at BioStock Investor Meeting on March 16, 2023.

November 30, 2022

CEO Evy Lundgren-Åkerlund presents the company at BioStock Life Science Fall Summit 2022 on November 30.

June 14, 2022

CEO Evy Lundgren-Åkerlund presents the company at Aktiespararnas Småbolagsdagarna 2022 (in Swedish).

June 14, 2022

Targinta's CEO Per Norlén presents the company at Aktiespararnas Småbolagsdagarna 2022 (in Swedish).

June 9, 2022

CEO Evy Lundgren-Åkerlund presents the company at BioStock Life Science Spring Summit 2022.

June 1, 2022

Watch the video interview with CEO Evy Lundgren-Åkerlund (in Swedish).

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

January 22, 2024
BioStock: Targinta’s CEO “Strong interest in ADCs in 2023”
June 1, 2023
DIs #InvestTalks - Xintela develops new generation stem cell products
May 30, 2023
BioStock: Xintela highlights the unique properties of XSTEM
May 2, 2023
BioStock: Xintela initiates last dose level in knee osteoarthritis study
March 22, 2023
BioStock: Targinta positions itself in the ADC field
July 6, 2022
BioStock: Xintela in clinical development
June 1, 2022
BioStock Studio: Xintela's CEO comments on the upcoming share issue
April 12, 2022
BioStock: Xintela's CEO on the potential in difficult-to-heal wounds
March 4, 2022
BioStock: Xintela presents plans for 2022 in its Q4 report
January 27, 2022
BioStock Studio: Targinta provides business update prior to spin-off
January 19, 2022
BioStock: Xintela advances to clinical phase in osteoarthritis and difficult-to-heal wounds 2022
October 12, 2021
BioStock: Professor Folke Sjöberg about XSTEM for treatment of venous leg ulcers.
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
March 13, 2024
Västra Hamnen Corporate Finance has published a research update for Q4 2023.
December 1, 2023
Västra Hamnen Corporate Finance has published an initial analysis of Xintela.
December 10, 2021
Edison Group has published a research update on Xintela.
July 14, 2021
Xintela, backed by its integrin biomarker technology platform XINMARK, is a potential disrupter
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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