NextCell Pharma publishes Interim Report 3 2020/2021
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period September 1, 2020 - February 28, 2021 The report is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report
NextCells share is traded on Nasdaq First North Growth Market under the ticker "NXTCL". The amount in brackets refers to the corresponding period in the previous year.
Third quarter (2020-03-01 until 2021-05-31)
- Operating income amounted to SEK 905 750 (750 512).
- Operating result amounted to SEK -6 457 514 (-4 833 332).
- Earnings per share* amounted to SEK -0,19 (-0,42).
- Cash and bank amounted to SEK 150 753 843 (5 612 952).
- Solidity** amounted to 96,6 (74,5) %.
First nine month (2020-09-01 until 2021-05-31)
- Operating income amounted to SEK 3 074 446 (3 191 314).
- Operating result amounted to SEK -20 078 599 (-12 803 349).
- Earnings per share* amounted to SEK -0,69 (-1,11).
Significant events during the third quarter of 2020/2021
- NextCell announced in the beginning of March, the decision to establish a production facility in order to optimize and further scale up production for future market approval. NextCell has an agreement with the landlord Hemsö and the clean room supplier QleanAir to build a production facility in direct connection to the Company's existing office in the Novum building at Karolinska University Hospital in Huddinge. The construction will take place during the spring 2021 and the premises are expected to be completed in the third quarter of 2021. The expansion of the existing NextCell production capacity with an internal GMP facility is a further development of the ProTrans manufacturing process, from 2-dimensional cell culture to 3-dimensional bioreactor, in accordance with the awarded Eurostars Horizon 2020 grant of SEK 5 million. The primary purpose of NextCell's GMP facility is to prepare technology transfer to a potential partner and additional contract manufacturers.
- The Board of NextCell decided, with authorization at the Annual General Meeting on November 24, 2020, on a directed issue of 666,666 shares to Consensus Sverige Select at the end of March. The subscription price was set at SEK 15 per new share, with the Company receiving approximately SEK 10 million. The purpose of the issue of shares, and the reason for the deviation from the shareholders' preferential rights, is to broaden the shareholder base and to finance the Company’s investment in its own production facility as communicated by a press release on 2 March 2021.
- NextCell announced in mid-April that the Academic Hospital and Principal Investigator Professor Per-Ola Carlsson have been granted approval from the Medical Products Agency and the Swedish Ethical Review Authority to conduct a pediatric clinical drug trial with ProTrans to treat children and adolescents with type 1 diabetes. The study is a phase I / II study with a total of 66 patients. The first six patients, three adolescents (12-18 years) and then three children (7-11 years), will be evaluated for safety. Thereafter, a randomized, placebo-controlled phase is performed to evaluate the treatment effect.
Significant events after the reporting period
- NextCell announces that at the beginning of June the first patient with severe pneumonia, as a result of COVID-19 infection, has been treated with ProTrans. The patient was hospitalized at Örebro University Hospital, where the Phase 1b study ProTrans19+SE is in progress led by Principal Investigator Associate Professor Josefin Sundh.
- NextCell announces in mid-June that an advisory meeting with the European Medicines Agency (EMA) has been held regarding ProTrans and the path forward to a possible market approval. The focus was the design of the phase III study ProTrans-3, which NextCell intends to submit an application for later this year.
- NextCell announces in late June that they have invested in a joint venture together with their long-term collaborator and contract manufacturing organisation, Polski Bank Komórek Macierzystych (PBKM, FamiCord Group). NextCell has acquired approximately 10 % of shares in the newly started company FamiCordTx through a directed equity issue, raising the capital with 0,5 MEuro in cash. FamiCordTx has exclusively licensed a patent pending CAR-T technology. Tech transfer is completed, and the production of CAR-T cell therapy is awaiting ATMP manufacturing approval before clinical trial use can be started.
Now the third quarter of 2021 is filed. At the time of writing, it is in the middle of summer and exactly one year since NextCell was listed on Nasdaq First North and four years since the company's shares entered a marketplace. It is a relatively short time for a pharmaceutical company, where the lead times can be long with no income at all along the way. I think though, we have succeeded quite well in building financial value for long-term shareholders, as well as adding benefit in the medical field. In our clinical diabetes studies, patients receiving treatment with our drug candidate, ProTrans have improved their ability to produce insulin. We are a passionate team and we believe that ProTrans will make a big difference in several indications.
Clinical trials with the lead candidate ProTrans have shown both safety and efficacy in Phases 1 and 2 as well as in repeated treatments (ProTrans-1, ProTrans-2 and ProTrans-Repeat) for the treatment of adults with type-1 diabetes. The evaluation of primary endpoints has been made after 1 and 2 years, respectively, and the patients are followed up further, up to five years, to evaluate the long-term effect of the cell therapy treatment. (ProTrans-Repeat and ProTrans-OBS).
NextCell focuses on entering the market with ProTrans for the treatment of type 1 diabetes and has far-reaching plans for a phase 3 study (ProTrans-3). The study will be a multicenter study with hospitals in several countries in the EMA region. The plan is to submit the application in 2021 and start the study during the first half of 2022.
ProTrans-Young is an important investigator-initiated study to broaden the treatment of type-1 diabetes with ProTrans. The study has been granted with approval to include a total of 66 children and adolescents who will be recruited at three study centers. The principal investigator is prof. Per-Ola Carlsson at Uppsala University Hospital together with the co-investigators prof. Johnny Ludvigsson at Linköping University Hospital and prof. Helena Larsson at Skåne University Hospital.
Mesenchymal stromal cell therapies have shown promise for the treatment of severely affected COVID-19 patients. ProTrans has been shown to be a potentially effective mesenchymal stromal cell therapy and therefore, in these challenging times, been requested for use in two clinical COVID-19 studies; a phase 1b in Sweden and a phase 2 study in Canada. These studies are now recruiting patients.
ProTrans mesenchymal stromal cells are given as an infusion into the armpit. The stem cells pass, and a large part of the stem cells linger in the small blood vessels in the lungs. There, most of the cells will temporarily stay and will affect the inflammation. This makes the lung the most optimal target organ for ProTrans treatment. Patients who get life-threatening symptoms related to COVID-19 usually get it because the body overreacts to the viral infection. The immune system causes hyperinflammation in the lungs. In this hyperinflammatory state, ProTrans is given to control a local immunomodulatory effect in the lungs. We have a strong believe that ProTrans will be a particularly potent treatment for inflammatory conditions in the lungs.Since start, NextCell has generated income via the stem cell bank Cellaviva. An important core business that demonstrates the company's business skills and ability to performing sales. The pandemic has been a challenge and has had a negative impact on Cellaviva's sales statistics. However, now the curves have turned up and this has also started to be reflected in the result, a development that we think will intensify during the second half of 2021.
Great things are happening in NextCell and the development of ProTrans. Together we build value and I want to thank all shareholders for being a part of the journey. Finally, I want to point out that the NextCell team is passionate about making a difference by developing the next generation of cell therapies. We do it for the patients, together with researchers and patients and we do it with the aim that we all shall be winners.
Huddinge, July 2021
Matgias Svahn, VD
Read the full report at: https://www.nextcellpharma.com/en/investors#financial-report
FNCA Sweden AB is the Company’s Certified Adviser; phone: +46 8-528 00 399, e-mail: firstname.lastname@example.org.
The information was submitted for publication, through the agency of the contact person set out below, at 08.15 CET on July 30, 2021.
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For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Sofia Fredrikson, CFO
Phone: 08-735 5595
About NextCell Pharma AB
NextCell is a Phase II cell therapy company with the lead candidate ProTrans™, for the treatment of type-1 diabetes. Focus is to take ProTrans™ to market approval via a phase III study. Furthermore, NextCell operates Cellaviva, Scandinavia's largest stem cell bank for family-saving of stem cells from umbilical cord blood and umbilical cord tissue with permission from IVO.
FNCA Sweden AB is assigned as Certified Adviser, 08-528 00 399, email@example.com.