Fourth quarter October 1 – December 31, 2021
Income amounted to TSEK 0 (0).
Loss before tax totalled TSEK 26,643 (loss: 25,335).
Loss per share* was SEK 0.30 (loss: 0.34).
At December 31, 2021, the equity/assets ratio** was 16% (57).


The period January 1 – December 31, 2021
Income amounted to TSEK 0 (0).
Loss before tax totalled TSEK 58,394 (loss: 50,257).
Loss per share* was SEK 0.65 (loss: 0.68).


* Earnings/loss per share: Profit/loss for the period divided by 89,134,021 shares, which was the number of registered shares at December 31, 2021. In the year-earlier period, the Company had 73,966,564 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 2021

• Targinta selects lead drug candidate for triple-negative breast cancer. (October 15, 2021)

• Xintela taking EQSTEM, a stem cell product for horses, towards the market. (October 27, 2021)

• New board of directors appointed in Targinta AB. (October 29, 2021)

• Update on status and strategi for Xintela and Targinta. (November 4, 2021)

• Xintela receives a loan of SEK 9 million. (November 18, 2021)

• Xintela AB Interim report January - September 2021. (November 19, 2021)

• Xintela and ScanVet Animal Health A/S sign Letter of Intent. (December 13, 2021)

• Notice of extraordinary general meeting in Xintela AB (publ). (December 28, 2021)

 
Significant events after the end of the period

• Bulletin from the extraordinary general meeting in Xintela. (January 17, 2022)

• Xintela granted 4.8 million SEK from Vinnova. (January 18, 2022)

 
CEO comments
In Focus: Clinical studies and Targinta spin-out
Our oncology pipeline and Targinta subsidiary have evolved from scientific concept to a full-blown drug development company with a unique proprietary oncology target, with function-blocking and toxin-armed antibodies that show effect in preclinical models for aggressive cancer, and with a patent portfolio that protects both the target and the pipeline. At the Extraordinary General Meeting on January 17, it was decided that Targinta will be spun out before Xintela's Annual General Meeting and that the Targinta shares will be made available for trading shortly afterward. In the spin-out, Xintela's shareholders will receive shares in Targinta in proportion to their shareholding in Xintela and will thus have the opportunity to participate in Targinta's exciting onward journey. We now look forward to Targinta´s venture as an independent drug development company, developing novel therapeutic options for patients affected by aggressive and deadly cancers which today lack effective treatment.

Targinta has recently designated the function-blocking antibody TARG10 as candidate drug for the treatment of triple-negative breast cancer, which is one of the company's focus indications. Targinta thus takes the step from preclinical research into preclinical development to prepare TARG10 for future clinical trials.

Targinta is also developing antibodies armed with a powerful toxin, known as Antibody Drug Conjugates (ADC), and plans to select the first ADC drug candidate this quarter for the treatment of aggressive cancers including glioblastoma.

Xintela will now focus entirely on the development of stem cell-based therapies. The stem cell product XSTEM will enter clinical testing for the first time in humans in two different phase I/IIa clinical studies, one for knee osteoarthritis and the other for difficult-to-heal leg ulcers. The main goal of the studies is to show that XSTEM is safe but also to obtain preliminary efficacy results.

The osteoarthritis study is awaiting its final approval from the regulatory authority in Australia, which is expected within the next few weeks. Patients with knee osteoarthritis will receive a single injection of XSTEM into the knee joint and will then be followed for 18 months, with safety and efficacy evaluations every six months. We expect to have initial safety data before the end of the year and efficacy readout during 2023. Our preclinical studies have shown that XSTEM has a regenerative effect and therefore has the potential to be a breakthrough treatment for osteoarthritis.

The second study, evaluating XSTEM for the treatment of difficult-to-heal (chronic) leg ulcers, is scheduled to start mid this year. In January, we were pleased to receive a grant from Vinnova of SEK 4.8 million, to carry out the clinical study in collaboration with Professor Folke Sjöberg and his colleagues at Linköping University Hospital. We are now working to complete the clinical documentation for an application to the Medical Products Agency, which we plan to submit in March. In the study, XSTEM will be applied to the wound to assess safety and wound-healing effect over 10 weeks, and we expect results already this year. Upon positive results, we plan to broaden XSTEM's use for the treatment of burns and other skin defects. 

We also plan a clinical study in horses with the stem cell product EQSTEM for the treatment of joint disease. In December, we signed a Letter of Intent with the Danish veterinary company ScanVet Animal Health and have ongoing activities in the joint clinical and commercial development of EQSTEM. One major advantage of a veterinary stem cell product is its shorter development time, meaning it can reach the market and generate revenue significantly sooner than the equivalent for humans.

Our stem cell patent portfolio, which protects the development and commercialization of our stem cell products for all therapeutic uses, continues to broaden its geographic reach. It has previously been approved in Europe, and is now approved also in Israel, Mexico, and South Africa, and we expect several approvals from other countries in 2022. 

Xintela’s focus on clinical studies for stem cell therapies and Targinta’s focus on preclinical development of therapeutic antibodies for aggressive cancers, mean a continued need to find the resources required to perform the value increasing development before partnership and outlicensing and thus generate value for our shareholders. We focus on securing our financing needs and are currently evaluating several financing possibilities, including development collaborations, project financing, equity capital raisies, grants and loans.

Evy Lundgren-Åkerlund
CEO, Xintela AB (publ)
 
The complete report is attached as pdf and is available on the company’s website https://www.xintela.se/en/investors#reports.