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NextCell Pharma publishes Interim Report 2 2020/2021

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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.

Second quarter (2020-12-01 until 2021-02-28)

  • Operating income amounted to SEK 1 007 846 (1 364 645).
  • Operating result amounted to SEK -8 148 299 (-4 228 449).
  • Earnings per share* amounted to SEK -0,27 (-0,22).
  • Cash and bank amounted to SEK 148 936 293 (10 700 725).
  • Solidity** amounted to 96,8 (80,2) %.

First six month (2020-09-01 until 2021-02-28)

  • Operating income amounted to SEK 2 140 858 (2 586 733).
  • Operating result amounted to SEK -13 621 085 (-7 970 016).
  • Earnings per share* amounted to SEK -0,51 (-0,42).

Significant events during the second quarter of 2020/2021

  • A prospectus was published at the beginning of December and a subscription period began following the fully guaranteed rights issue of SEK 150 million, decided by the Board on November 26. 2020 with the support of authorization from the Annual General Meeting on 24 November 2020.
  • In early December, NextCell published results from the clinical trial ProTrans-Repeat. The primary endpoint, safety, has been 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 announced in mid-December 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 announced the outcome in the rights issue. The issue was oversubscribed and thus, NextCell has been 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.

Significant events after the reporting period

  • NextCell announced in the beginning of March, the decision to build a production facility in order to optimize and further scale up for a 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 and clean room 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 or additional contract manufacturer in addition to the PBKM FamiCord Group.
  • The Board of NextCell decided, with the support of the authorization by Annual General Meeting's 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, and the Company received 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 Chief Examiner 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 part is performed to evaluate the treatment effect.
 

CEO comments

During the second quarter of our fiscal year, NextCell has made progress on several fronts.

In the financial area:

An oversubscribed rights issue of SEK 150 million; a directed issue of approximately SEK 4 million to NextCell's most important partner, PBKM; and most recently after the end of the period, a directed issue of SEK 10 million to Consensus Sverige Select, granted with the award Best Sweden Fund 2020. The money will primarily be used to bring ProTrans to market via a Phase 3 study, conduct other trials of ProTrans in diabetes and other indications, and build our own production facility.

In the Diabetes area:

During the past quarter data from ProTrans-Repeat, a study where patients with type 1 diabetes are treated with a second dose of ProTrans, were presented. It is a small study but of great importance with safety as primary endpoint after receiving a repeated treatment of ProTrans. No serious side effects or other problematic effects were found. Thus, ProTrans can be given at more than one occasion while maintaining safety, a finding that opens the opportunity to develop treatment strategies over time. The trend is clear as two out of three patients had increased insulin production after 24 months compared with before the first treatment with ProTrans.

After the period ended, we also announced that Uppsala University has received approval from both the Medical Products Agency and the Swedish Ethical Review Authority to treat 66 young people and children who recently have developed diabetes. I am proud and grateful that Per-Ola Carlsson, together with Johnny Ludvigsson and Helena Elding Larsson, will run this important study and NextCell is pleased to contribute with ProTrans and Placebo.  

Our main focus right now is to get the Phase-3 study started. Market approval for ProTrans for the treatment of type-1 diabetes can be achieved most quickly by conducting a phase-3 study similar to the ProTrans-2 study. This Phase-3 study will align with the Protrans-2 study in terms of treatment regimen and patient population i.e., treating patients between 18-40 years with a dose of ProTrans. We are now in discussions with the European Medicines Agency, EMA regarding the Phase-3 study.

In the Covid-19 area:

ProTrans is an immunomodulatory therapy, a platform technology with the potential to treat autoimmune diseases and inflammatory conditions. Mesenchymal stem cells are balancing the body's immune system between inflammation and allowing regeneration. On some occasions, the balance is disturbed due to genetics, infections or other external factors that require a large dose of mesenchymal stem cells to restore balance. A current example is in severe pneumonia due to SARS-CoV-2 infection. Covid-19 is an acute viral disease, and in the worst cases, can lead to a stage where the body's immune system becomes hyperactivated and destroys itself. The aim is to investigate whether a dose of ProTrans can protect the patient from ending up on a respirator and require long rehabilitation. At best, this therapy could be lifesaving. It is also a valuable opportunity for NextCell to gain experience in the treatment of diseases other than diabetes in order to broaden our knowledge.

McGill University in Montreal has been granted an accelerated approval from Health Canada to conduct a phase-2 study with ProTrans for the treatment of hyperinflammation of the lungs caused by the coronavirus. The regulatory process has been shortened to meet an urgent need. NextCell has established a close collaboration with doctors and researchers, something we can benefit from in the future.

In parallel with the Canadian study, a dose-escalation trial with Covid patients is underway in Örebro. We see value in conducting another dose escalation study as there are great fundamental differences between diabetes and Covid. ProTrans is given intravenously into the armpit and a large part of the cells are expected to get caught in the small blood vessels in the lung, which is optimal as the virus specifically causes hyperinflammation in the lungs.

In the Cellaviva area:

In March, family savings of stem cells from umbilical cord and cord blood for possible future use have, following a period of stagnant sales, reached previous sales records. This has happened despite complicated circumstances with visitation restrictions at the hospitals and uncertainty in customer household finances. Increased evidence for family savings of stem cells, in combination with enhanced exposure, is reflected in sales statistics and will also, with a certain delay, be seen in the company's future results.

The second quarter of NextCell's fiscal year has shown strength and growth on several fronts. I would like to thank all loyal employees and shareholders and, at the same time, welcome all new ones. We work passionately to drive the company forward and hope to show continued progress during this current third quarter.                                                                                                                             

Mathias Svahn, Ph.D., CEO NextCell Pharma AB

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 April 29, 2021.


 

Stay up to date with the latest development in NextCell Pharma

LinkedIn: https://www.linkedin.com/company/15255207/

Twitter: https://twitter.com/NextCellPharma

 

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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