Year-end report 1 Jan - 31 Dec 2020
Summary of the year-end report
The "Company" or "Xintela" refers to Xintela AB (publ), corporate registration number 556780-3480.
Twelve months (1 Jan 2020-31 Dec 2020)
Net sales amounted to TSEK 0 (38).
Loss before tax totalled TSEK 50,257 (loss: 43,530).
Loss per share* was SEK 0.68 (loss: 1.10).
At 31 December 2020, the equity/assets ratio** was 57% (55).
Fourth quarter (1 Oct 2020-31 Dec 2020)
Net sales amounted to TSEK 0 (35).
Loss before tax totalled TSEK 25,335 (loss: 15,449).
Loss per share* was TSEK 0.34 (loss: 0.39).
* Earnings/loss per share: Profit/loss for the period divided by 73,966,564 shares, which was the registered number of shares at 31 Dec 2020. In the year-earlier period, the Company had 39,470,708 registered shares.
** Equity/assets ratio: Equity divided by total capital.
Amounts in parentheses: Comparative period of the preceding year.
Significant events in the first quarter of 2020
On 3 February, Xintela announced that the findings from the company's stem cell study on horses had now been published in the prestigious The American Journal of Sports Medicine. The publication shows that the stem cell treatment is safe and has a significant positive effect on cartilage and bone in a joint with osteoarthritis.
On 27 March, Xintela announced that the company had been granted MSEK 2 from Vinnova as part of the "Innovationsproject i små och medelstora företag" (Innovation project in small and medium-sized businesses) call for proposals. The grant pertains to one of the company's cancer projects for developing targeting therapies against aggressive forms of cancer with ADCs that bind to integrin 10.
Significant events in the second quarter of 2020
On 1 May, Xintela announced that its AGM has been postponed until 9 June.
On 8 May, Xintela announced that the company had been granted MSEK 1 from Vinnova in the call for "Innovations in the wake of the crisis - Restructuring of society, operations and production in the wake of the corona epidemic." The grant concerns the funding of a preclinical study to evaluate Xintela's stem cells for the treatment of COVID-19 patients with the fatal disease condition ARDS (Acute Respiratory Distress Syndrome).
On 22 May, Xintela announced that it had signed an agreement with Gerhard Dal pertaining to raising bridge loans totalling MSEK 18.9. The loans were paid in two tranches whereby the first portion of MSEK 8 was paid when the loan agreement was signed (Tranche 1) and the second portion of MSEK 10.9 was paid not later than 20 June 2020 (Tranche 2). The Tranche 1 loan carries interest at a monthly interest of 1.50% and Tranche 2 carries monthly interest of 1.40%. The lender has the right to request that the loan is converted into shares in the Company.
On 26 May, Xintela published its Annual Report for the 2019 financial year
On 29 May, Xintela published its interim report for Q1 2020.
On 9 June, the company held its AGM
On 12 June, Xintela announced that the Board of Directors had resolved to conduct a new issue of shares and warrants (units) with pre-emptive rights for the Company's existing shareholders, backed by the general meeting of shareholders' authorisation on 9 June 2020.
On 17 June, Xintela announced its decision that the next focus in its oncology programme will be triple-negative breast cancer, which is an aggressive form of breast cancer that often metastasizes and has a poor prognosis. This decision was made based on the accumulated positive preclinical results using the company's proprietary function blocking antibodies in cell experiments and in a validated tumour model.
On 23 June, the Board of Directors announced that it had received an additional subscription undertaking as part of the right issue for approximately MSEK 3 from the Company's largest shareholder, Bauerfeind Group.
On 23 June, Xintela announced that the European Patent Office (EPO) has issued a preliminary approval (Intention to grant) for the company's patent application related to antibody treatment of Glioblastoma and other tumours of the brain using the company's target molecule integrin 101.
On 23 June, Xintela published a prospectus concerning the fully underwritten rights issue of units amounting to approximately MSEK 37.
Significant events in the third quarter of 2020
On 13 July, Xintela announced that the fully underwritten rights issue of units was heavily oversubscribed and the company was exercising the overallotment option.
On 29 July, Xintela announced that the US Patent and Trademark Office (USPTO) had issued a Notice of Allowance for the company's patent application covering quality assurance of chondrocytes (XACT), which is important for the development of chondrocyte-based cell therapy products. This Notice of Allowance means that the USPTO intends to grant the patent after certain formal steps have been completed. Once granted, the patent will be valid until 2038.
On 19 August, Xintela announced that it is expanding and strengthening its management team with Peter Ekolind as COO (Chief Operating Officer) and Thomas Areschoug as CBO (Chief Business Officer). Sven Kili, who has had a combined role as COO and CMO (Chief Medical Officer), will focus on his role as CMO.
On 28 August, Xintela published its interim report for Q2 2020.
Significant events in the fourth quarter of 2020
Xintela announced on 26 October that the company's selected human stem cells XSTEM® show a therapeutic effect in ARDS (Acute Respiratory Distress Syndrome) in an ongoing preclinical study in pigs. ARDS is a life-threatening lung complication that may affect severely ill COVID-19 patients.
Xintela announced on 28 October that the Company had submitted an application to the Medical Products Agency for a tissue establishment license for handling tissues and cells for manufacturing of medicinal products.
Xintela announced on 29 October that the European Patent Office (EPO) had issued an "Intention to grant" decision for the patent application covering the company's stem cell product XSTEM®, consisting of integrin 10-selected mesenchymal stem cells.
On 2 November, Xintela announced that the exercise price for the Company's TO 2 warrant had been set at SEK 2.28, and the subscription period would begin on 4 November. Warrants not sold by 11 November or alternatively exercised by 18 November will expire worthless.
On 12 November, Xintela announced that Lars Hedbys had accepted an invitation to join the company's Board of Directors. The Xintela Board will recommend that shareholders formally appoint Lars at the next shareholders' meeting. In the meantime, Lars will be co-opted to attend future Board meetings.
On 23 November, Xintela announced the outcome of the utilisation of TO 2 warrants. A total of 16,423,708 warrants were exercised to subscribe for 16,423,708 new shares in the Company, corresponding to approximately 98% of the total number of warrants.
On 27 November, Xintela published its interim report for Q3 2020.
On 3 December, Xintela announced that Maarten de Château had accepted an invitation to join the company's Board of Directors. The Xintela Board will recommend that shareholders formally appoint Maarten at the next shareholders' meeting. In the meantime, Maarten will be co-opted to attend future Board meetings.
On 4 December, Xintela announced that the arbitral tribunal had rendered an arbitral award in the dispute between Xintela and four former underwriters. The arbitration established that Xintela was not to pay any remuneration to the underwriters.
On 14 December, it was announced that Jeffrey Abbey had been recruited as Senior Management Advisor to support further development of the wholly owned subsidiary Targinta. Jeffrey 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.
On 21 December, Xintela announced that the company had 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.
Significant events after the end of the period
On 7 July, Xintela announced that the US Patent and Trademark Office (USPTO) had issued a Notice of Allowance for the company's patent application covering targeted antibody treatment of tumours of the central nervous system (CNS).
On 12 January, it was announced that Xintela's Board of Directors had resolved on an offset issue, pursuant to the authorisation granted by the AGM on 9 June 2020.
On 19 January, Xintela publishes a correction pertaining to the Board decision for an offset issue with a higher number of shares than permitted within the authorisation granted by the AGM on 9 June 2020, due to incorrect advice from external advisors. Accordingly, the Board decision from 12 January was withdrawn and a new Board decision taken. The number of shares issued for subscription amounts to 3,201,645 (3,538,175 in the previous decision), which means the bridge loan of MSEK 8.6 (previously MSEK 9.5) is being set off against new shares in Xintela.
Statement from the CEO, Evy Lundgren-Åkerlund Q4 2020
Several important pieces of the puzzle are now falling into place in our stem cell project, ensuring the long-term successful development and commercialisation of stem cell products from our stem cell platform, XSTEM.
On 28 October, we announced we have applied for a license from the Swedish Medical Products Agency to operate a tissue establishment, which concerns the processing of tissues and cells to be used in the manufacture of our stem cell products. We recently had an inspection by the Agency and are awaiting their report.
Then, on 21 December, we announced that we have - 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 Practice) facility. The inspection by the Agency, which was planned for March, will now take place in early April so as not to conflict with other activities at our GMP facility. At that time, the Agency will determine whether the facility, the production process and the XSTEM product all meet existing regulatory requirements.
Once 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.
On 29 October, we had the privilege of announcing we have obtained preliminary approval from the European Patent Office for our XSTEM stem cell product, which protects the use of XSTEM for various treatments including osteoarthritis and other degenerative joint diseases, through 2038. We expect to obtain final approval shortly. Previously, we patented our method of selecting stem cells using our marker technology.
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 can affect, for example, patients who are severely ill with COVID-19. In an ongoing preclinical trial we are conducting in partnership with the cardiothoracic surgery clinic in Lund, Sweden, we are evaluating XSTEM in an animal model of ARDS and can see that animals treated using XSTEM experience a distinct improvement in lung function.
The pieces are falling into place in our oncology project as well. We have successfully evaluated our antibodies directed against our target molecule, integrin 101, and demonstrated that they significantly reduce tumour growth of both glioblastoma and triple negative breast cancer (TNBC) in animal models. In the next step, we will produce selected antibody candidates and conduct bioanalyses and toxicological trials to prepare for clinical trials.
The European Patent Office (EPO) has now granted our brain cancer patent through 2036, thereby protecting the treatment of glioblastoma and other brain tumours with antibodies that are directed against our target molecule. Moreover, on 7 January, we announced we have obtained preliminary approval from the US Patent Office for a similar application in the US. The successes in our patentportfolio ensure the development and commercialisation of our targeted therapeutic antibodies for cancer treatments, and pave the way for continued development towards clinical trials and partnership dialogues.
The work to make our subsidiary, Targinta, which is pursuing our oncology project, an independent, self-financing company in 2021 is proceeding as planned. In December, we recruited Jeffrey Abbey as Senior Management Advisor to have a central role in the work of developing and financing Targinta. Jeffrey Abbey has more than 20 years' experience of biologics and has spent much of his career focused 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 at the next Annual General Meeting and until that time will be adjoined 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 ahead of clinical trials, partnerships and commercialisation.
On 23 November, we announced the results of subscriptions for warrants received in conjunction with the company's new share issue in July 2020. Of the total number of warrants outstanding, approximately 98 percent were subscribed, which netted Xintela approximately MSEK 37.4 in proceeds before issuance costs.
In January, we conducted an offset issue directed to Gerhard Dal, which involved a debt of MSEK 8.6 being set off against new shares in Xintela in accordance with his convertible loan agreement.
On 4 December, we also announced that the arbitration between Xintela and four underwriters, pertaining to the dispute that arose in conjunction with a rights issue that was planned for September 2018 but not executed, was resolved in Xintela's favour. The arbitration established that Xintela was not liable to pay any remuneration to the underwriters and that they must pay certain costs of the arbitration process.
Evy Lundgren-Åkerlund, CEO
Xintela develops innovative patented stem cell therapies and targeted cell therapies based on the marker technology platform XINMARK®.
Xintela's technology platform XINMARK is based on specific cell-surface proteins (integrins) and antibodies that bind to these integrins. Xintela uses the marker technology to select and assure the quality of stem cells for the development of stem cell products (XSTEM®) for diseases that currently lack effective treatment alternatives, such as the degenerative joint disease osteoarthritis. Studies on horses with osteoarthritis have demonstrated that the stem cells are safe and have a positive effect on cartilage and bone. Xintela has established its own GMP facility for stem cell manufacturing and is preparing a first-in-human trial on patients with osteoarthritis of the knee. At the same time, Xintela is preparing for the development of an animal stem cell product and also evaluating other indications including Acute Respiratory Distress Syndrome (ARDS), a lung condition that affects seriously ill COVID-19 patients.
In the company's oncology program, Xintela is developing antibody-based therapies for the treatment of aggressive forms of cancer. Positive preclinical findings have shown that the company's antibodies targeted on integrin 101 have a killing effect on cancer cells and inhibit the growth of glioblastoma and triple-negative breast cancer in animal models.
The Company reported net sales of TSEK 0 (38) for the 2020 financial year. For the fourth quarter, the Company reported net sales of TSEK 0 (35). Other income for the year amounted to TSEK 14,947 and pertains to costs invoiced onward to the wholly owned subsidiary Targinta of TSEK 12,868 (5,640) and research grants from Vinnova of TSEK 2,079 (0)
The Company's operating loss for the year totalled TSEK 33,897 (loss: 38,047). The corresponding figures for the fourth quarter were a loss of TSEK 11,178 (loss: 9,968)
Research and development costs, which account for the highest portion of the Company's costs, amounted to TSEK 38,170 (34,714) for the January-December period. The corresponding figures for the fourth quarter were TSEK 12,658 (13,181).
Marketing and sales costs for the year amounted to TSEK 3,757 (4,741). The corresponding figures for the fourth quarter were TSEK 1,052 (1,090). Due to the pandemic, travel costs have fallen dramatically, which led to lower costs this year compared to last.
Administrative expenses for the year amounted to TSEK 6,917 (4,270). The corresponding expenses for the fourth quarter amounted to TSEK 2,333 (1,372).
Loss before appropriations and tax for the January-December period of 2020 was TSEK 36,564 (loss: 38,065) The corresponding figures for the fourth quarter were TSEK 11,642 (9,984).
The year-end report for 2020 includes a Group contribution to the Targinta AB subsidiary of SEK 13,693 (5,465).
On 31 December 2020, Xintela's equity/assets ratio was 57% (55) and equity amounted to TSEK 27,607 (9,323). The Company's cash and cash equivalents amounted to TSEK 33,601 (412). On the same date, the Company's total assets amounted to TSEK 48,513 (17,093).
Cash flow and investments
Xintela's cash flow for the January-December period of 2020 was a positive TSEK 33,189 (neg: 30,985). Investments amounted to TSEK 383 (1,744), of which tangible assets accounted for TSEK 383 (1,619). The investments are linked to the establishment of Xintela's own GMP facility for the manufacture of stem cells for clinical trials.
Xintela AB (publ) was listed on Nasdaq First North Growth Market in Stockholm on 22 March 2016 under the ticker symbol "XINT." First North Growth Market is an alternative marketplace, operated by an exchange within the NASDAQ OMX Group. Companies on First North Growth Market 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 Growth Market may therefore entail a higher investment risk than a company listed on the main market. All companies listed on First North Growth Market 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 Growth Market is Erik Penser Bank AB, +46 (0)8 463 80 00, firstname.lastname@example.org.
At 31 December 2020, the number of shares was 73,966,564. 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 K3
Xintela has previously prepared its financial statements in accordance with RFR2 (IFRS). In accordance with the exception rules set out in Chapter 7 of the Swedish Annual Accounts Act, Xintela has chosen not to prepare consolidated accounts. As no consolidated accounts have been prepared in accordance with IFRS, on account of the abovementioned exception rules, Xintela has decided to transition to accounting and financial reporting in accordance with the Swedish Accounting Standards Board BFNAR 2012:1 Annual Accounts and Consolidated Financial Statements (K3) as of the year-end report for 2020. The transition to K3 did not have any impact on Xintela AB's financial statements.
Review by auditors
This year-end report has not been reviewed by the Company's auditor.
Annual Report for the 2020 financial year
16 April 2021
Interim report Jan-Mar 2021
21 May 2021
Six-monthly report Jan-Jun 2021
27 August 2021
Interim report Jan-Sep 2021
19 November 2021
For the January-December 2020 period, the average number of employees at Xintela was 17 (15), of whom 2 (2) were men.
Proposed allocation of Xintela's profits
The Board of Directors and CEO recommend that no dividend be paid for the 2020 financial year.
Annual General Meeting and publication of Annual Report
The Annual General Meeting (AGM) will be held in Lund on 7 May 2021. The Annual Report will be available for download on the company's website (www.xintela.se) in accordance with provisions in the Swedish Companies Act.
Risks and uncertainties
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.
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.
Lund February 2021
Chairman of the Board
Evy Lundgren Åkerlund
Chief Executive Officer
Xintela's financial reports are available at www.xintela.se/en/investors#reports
For more information, contact:
Evy Lundgren-Åkerlund, CEO
Telephone: +46 (0)46 275 65 00
Address: Medicon Village, SE-223 81 Lund, Sweden
Xintela has been listed on Nasdaq First North Growth Market since 22 March 2016. Xintela's Certified Adviser on Nasdaq First North Growth Market is Erik Penser AB:
Certified Adviser: Erik Penser Bank AB
Tel: +46 (0)8 463 83 00
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 26 February 2021 at 8:55 a.m. CET.
Lund, Sverige, 7 maj 2021 - Idag hölls årsstämma i Xintela AB (publ). Nedan följer en sammanfattning av de beslut som fattades. Samtliga beslut fattades med erforderlig majoritet.
Lund, Sverige, den 4 maj 2021 - Xintela meddelar idag att Per Norlén har rekryterats som VD för Xintelas helägda dotterbolag Targinta inom onkologi. Han tillträder 1 september 2021. Per Norlén kommer även ha rollen som Xintelas Chief Medical Officer (CMO/Medicinsk Chef) från 1 juli 2021. Rekryteringen är ett viktigt steg i processen med att knoppa av Targinta som ett fristående bolag.
Lund, Sweden, May 4, 2021 - Xintela announces today that Per Norlén has been recruited as CEO of Xintela's wholly owned oncology subsidiary Targinta. He will start on 1 September 2021. Per Norlén will also have the role of Xintela's Chief Medical Officer (CMO) from 1 July 2021. The recruitment is an important step in the process of spinning out Targinta as an independent company.
Lund, Sverige, 16 april 2021 - Xintela AB (publ) meddelar idag att bolaget publicerar årsredovisningen för 2020. Årsredovisningen finns tillgänglig på bolagets hemsida www.xintela.se samt via bifogad PDF.
Lund, Sverige, den 12 april 2021 - Xintela meddelar idag att Läkemedelsverket har genomfört en inspektion för tillstånd att producera cellterapiprodukter, så kallade avancerade terapiläkemedel (ATMPs), för kliniska studier.
Lund, Sweden, 12 April 2021 - Xintela announces today completion of the inspection by the Swedish Medical Products Agency for a license to produce cell therapy products, also known as Advanced Therapy Medicinal Products (ATMPs), for clinical studies.
Aktieägarna i Xintela AB (publ), org. nr. 556780-3480, kallas härmed till årsstämma den 7 maj 2021 kl. 09.00 i Medicon Village, Scheeletorget 1, hus 601, i Lund.
Xintela rapporterar positiva resultat från preklinisk ARDS studie och erhåller nytt anslag om 2,3 miljoner kronor
Lund, Sverige, 6 april, 2021 - Xintela meddelar idag positiva resultat från den prekliniska ARDS (Acute Respiratory Distress Syndrome) studien som delfinansierats av Vinnova. Resultaten från studien visar potentialen av bolagets stamcellsprodukt XSTEM® för behandling av ARDS, en livshotande lungkomplikation som bl.a. kan drabba svårt sjuka covid-19 patienter. Xintela meddelar också att bolaget har erhållit ett nytt bidrag från Swelife/Vinnova för att fortsätta undersöka verkningsmekanismer av XSTEM i ARDS modellen och förbereda XSTEM för kliniska studier.
Lund, Sweden, 6 April 2021 - Xintela today announces the positive outcome of the preclinical ARDS (Acute Respiratory Distress Syndrome) study partly financed by Vinnova. The results of the study demonstrate the potential of the company's stem cell product XSTEM® in the treatment of ARDS, a life-threatening lung complication that can affect severely ill COVID-19 patients. Xintela also announces a new grant from Swelife/Vinnova to further investigate the mechanism of action of XSTEM in the preclinical ARDS model and to prepare XSTEM for clinical studies.
Lund, Sverige, 19 mars 2021 - Xintela meddelar idag att bolaget har erhållit tillstånd för vävnadsinrättning från Läkemedelsverket för hantering av humana vävnader och celler avsedda för framställning av läkemedel.
Lund, Sweden, 19 March 2021 - Xintela announces today that the company has received a tissue establishment license from the Swedish Medical Products Agency for handling human tissues and cells for manufacturing medicinal products.
Lund, Sverige, 17 mars 2021 - Xintela meddelar att Europapatentverket (EPO) idag har godkänt patentansökan avseende bolagets stamcellsprodukt XSTEM® bestående av integrin α10β1-selekterade mesenkymala stamceller.
Lund, Sweden, 17 March 2021 - Xintela announces that the European Patent Office (EPO) has today approved the patent application for the company's stem cell product XSTEM® consisting of integrin 10-selected mesenchymal stem cells.
Lund, Sverige, 12 mars 2021 - Xintela meddelar att resultaten från bolagets prekliniska glioblastomstudie med funktionsblockerande antikroppar idag har publicerats i den välrenomerade internationella vetenskapliga tidskriften Cancers. Publikationen visar bland annat att antikroppar riktade mot bolagets målmolekyl integrin 101 signifikant minskar tillväxt av den mycket aggressiva hjärntumören glioblastom i en djurmodell.
Lund, Sweden, March 12, 2021 - Xintela announces that the results of the company's preclinical glioblastoma study with function-blocking antibodies have today been published in the renowned international scientific journal Cancers. The publication shows, among other things, that antibodies directed to the company's target molecule integrin 101 significantly reduce the growth of the aggressive and deadly brain tumor glioblastoma in an animal model.
Sammanfattning av bokslutskommuniké
Summary of the year-end report