NextCell Pharma publishes Interim Report 1 2020/2021

NextCell Pharma AB (publ) (NXTCL) publishes its Interim Report 1 for the period September 1, 2020 - November 30, 2020 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.

First quarter (2020-09-01 until 2020-11-30)

  • Operating income amounted to SEK 1 148 187 (1 222 087)
  • Operating result amounted to SEK -17 680 697 (-17 997 787)..
  • Earnings per share amounted to SEK -0,23 (-0,20).
  • Cash and bank amounted to SEK 16 810 206 (15 715 418). After the end of the period, in December 2020, the Company received an additional SEK 150 million (approximately SEK 135 million after deductions for transaction costs) as a result of a rights issue.
  • Solidity amounted to 84,9 (84,6) %.
 

Significant events during the first quarter of 2020/2021

  • NextCell announces, in early September, a significant effect in the phase II study ProTrans-2. The patients treated with one dose of the stem cell product ProTrans™ (ProTrans) did maintained a statistically significantly higher insulin production after a 12-months period compared with patients treated with placebo (p-value <0.05).

  • NextCell announces in late October that the application for clinical trial of COVID-19 patients with ProTrans has been approved by both the Ethics Committy and the Swedish Medical Product Agency. The study will be conducted at the University Hospital in Örebro in collaboration with the Department of Clinical Trials and Karolinska Trial Alliance.

  • NXTCL publishes a notice to attend the Annual General Meeting. Notice with suggested resolutions is available on the Company´s website (www.nextcellpharma.com).

  • NextCell announces that it, in collaboration with other project members, including SCINUS Cell Expansion, now officially has started the previously communicated Eurostars project, Bioscale, with the aim of developing a cost-effective expansion technology in cell culture. NextCell's stem cell product ProTrans will be used to test and validate the capacity of the SCINUS bioreactor to provide an optimized method for cost-effective cell production. NextCell has been granted a Eurostar grant of SEK 5 million and will contribute the same amount in own work. The total budget for the project is SEK 28 million.

  • NextCell has entered into an agreement with Professor Per-Ola Carlsson, at Uppsala University Hospital and Uppsala University, with the aim of contributing ProTrans for the treatment of children and adolescents with type 1 diabetes, within the framework of clinical drug trials. The study, which is in the planning stage, is part of NextCell's strategy to support academic groups with drugs to be able to evaluate ProTrans for a wider use.

  • The Board of Directors of NextCell announces its intention to resolve on a fully guaranteed rights issue of up to approximately SEK 150 million for the Company’s existing shareholders. The Board of Directors’ intent to resolve on the Rights Issue requires that the shareholders at the Annual General Meeting authorizes the Board of Directors to resolve on share issues. In the notice convening the Annual General Meeting, which

  • The Board of NextCell announces its intention to resolve on a fully guaranteed rights issue of approximately SEK 150 million, provided that the Annual General Meeting authorizes the Board to decide on a new rights issue. The Company's largest shareholder, Diamyd Medical AB, has undertaken to subscribe for its pro rata share, amounting to a total of approximately SEK 19 million. Furthermore, parts of the Company's Board and senior executives have entered into subscription undertakings amounting to approximately SEK 5,3 million. In total, the rights issue is covered by subscription undertakings to 45 percent and by issue guarantees to 55 percent.

  • NXTCL holds its Annual General Meeting. Communique with a summary of decided resolutions is available on the Company´s website (www.nextcellpharma.com).

  • The Board decides, based on the authorization from the Annual General Meeting, to carry out the previously proposed rights issue of SEK 150 million.

Significant events after the reporting period

  • Due to the decided rights issue, a prospectus is published at the beginning of December and a subscription period begins.

  • NextCell publishes, in early December, results from the clinical trial ProTrans-Repeat. The primary endpoint, safety, is met. There were no severe adverse events recorded during the 12-month follow-up period after a second dose of ProTrans Furthermore, a strong tendency of sustained efficacy was observed in the three patients receiving high dose ProTrans.

  • NextCell announces that an observational study, ProTrans-OBS, has been approved by the Swedish Ethical Review Board for long-term follow-up of patients previously participating in the ProTrans-2 clinical trial. The study is conducted by professor Per-Ola Carlsson, at Uppsala University.

  • NextCell announces the outcome in the rights issue. The issue was oversubscribed and, thus, NextCell is provided with the full issue amount of SEK 150 million before issue costs. The oversubscription means that no issue guarantees have been used.

  • The Board of Directors of NextCell resolves, based on the authorization from the Annual General Meeting, on a directed issue of 286 666 new shares to Polski Bank Komórek Macierzystych SA (“ PBKM ”), Europe's largest stem cell bank and an important partner to the Company. The subscription price in the share issue amounts to SEK 15 per new share, giving the Company approximately SEK 4,3 million in issue proceeds.

CEO comments

For a start, I want to thank all the shareholders who participated in the recently completed rights issue. SEK 135 million - after deductions for issue related costs - means that NextCell now can fully focus on developing treatments for diseases with great medical need, and thus build value for our shareholders. Also, the completion of an oversubscribed share issue of this size under prevailing market conditions is a major milestone. A strength that may take ProTrans™ (ProTrans) all the way to the market.

Your trust makes it possible for NextCell to conduct a phase III study with ProTrans. There are only a few clinical trials with mesenchymal stem cells that have reached phase III. Together with our study teams, we have managed to demonstrate ProTrans' efficacy and safety in ProTrans-1, ProTrans-2 and ProTrans-Repeat. Importantly, these studies were completed on schedule and within budget.

Preparations for Phase III are proceeding according to plan. There is feverish activity in the Company right now and we have strengthened the organisation with additional employees and contracted an international CRO to run the study. It is a giant operation that means gradually increased costs. These changes have been absolutely crucial, ensuring that the study is optimally designed and therefore we must allow the process to take some time. Although my hope is that we will get the study both approved and started within 2021.

The study design of ProTrans-3 will be very similar to ProTrans-2. Patients aged 18-40, diagnosed within the last two years will be able to participate and the therapeutic effect will be evaluated one year after treatment. For this particular group of patients, we feel confident that ProTrans has an effect up to 12 months post treatment. However, questions remain regarding the longevity of the therapeutic effect and the feasibility of treating children and adolescents. To get answers to these questions, further studies are planned. We are following the participants in ProTrans-2 for a total of five years in an observational study, ProTrans OBS, and in ProTrans-Repeat we will the same for the participants who completed ProTrans 1. Furthermore, Professor Per-Ola Carlsson is planning a study similar to ProTrans1/2 for treatment of children and adolescents where NextCell will contribute with ProTrans drugs.The first quarter of our financial year coincides with the second wave of COVID-19. Unfortunately, the pandemic during the autumn has affected the possibility of carrying out stem cell collections, which has led to a lack of the usual increase in Cellaviva's sales. Despite the circumstances, the influx of customers has been relatively good but, unfortunately due to increasingly strict restrictions on the maternity wards, many collections have not been practically feasible.COVID-19 has also led to NextCell accelerating the clinical trial program for the treatment of hyper inflammation of the lungs. We know that a large part of ProTrans stem cells get stuck in the small blood vessels in the lungs, which makes the lung an excellent target for treatment. Hyper inflammation of the lungs can be caused by various traumas and infections, such as corona virus. A lung study is within our area of ​​interest and the large and acute medical need for this type of treatment has pushed us to accelerate this development. ProTrans19 +, a Phase Ib study, has been approved by the Medical Products Agency and we hope to be able to start treatment of patients with severe COVID-19 during the current quarter. In addition to the scientific rationale and the extensive medical need, the choice to start a clinical trial in hyperinflammation of the lungs caused by corona virus infection is also a strategic decision to show the breadth of ProTrans potential for immunomodulatory treatment. Diabetes is a severe chronic autoimmune disease, but as long as the patients have good control of their diabetes, they often feel relatively well for several years. COVID-19 is an acute viral infection that in severe cases can lead to hyperinflammation, intensive care and in the worst cases, death. Two completely different conditions due to an immune system that has become unbalanced, and thus potentially benefiting from the immunomodulatory therapeutic effects of ProTrans.Finally, I would like to thank all the patients who participated in our clinical trials. It has been three years since the first patient with type 1 diabetes, a young man, received the world's first dose of ProTrans. Since that time, I have received calls and e-mails from people who would like to be part of a study with ProTrans. I hope for your continued confidence during the implementation of ProTrans-3.

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: info@fnca.se.

The information was submitted for publication, through the agency of the contact person set out below, at 08.30 CET on January 29, 2021.

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For more information about NextCell Pharma AB, please contact:

Mathias Svahn, CEO

Sofia Fredrikson, CFO

Phone: 08-735 5595

E-mail: info@nextcellpharma.com

 

Website:

www.nextcellpharma.com, www.cellaviva.se

www.cellaviva.se

www.cellaviva.dk

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, info@fnca.se.

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