The European Patent Office intends to grant a Patent for Selection Algorithm

May 31, 2022

NextCell Pharma AB ("NextCell" or the"Company") today announces that the European Patent Office (EPO) hasissued an Intention to Grant notice relating to the patent entitled "Allogeneic Composition" (publication number EP3752598). The patent describes the method of manufacturing the drug candidate ProTrans, where the selection algorithm is key for selecting optimal cells and donors. Patent protection is valid until 2039.

The selection algorithm consists of a method for selecting cells with a suitable immunomodulatory effect that are assessed by a panel of different analyses. The algorithm makes an overall assessment of several functional analyses to identify optimal donors and cells for the manufacture of cell therapies. NextCell's accurate and advanced selection method has a scalable capability and guarantees high reproducibility and efficacy compared to other applications in cell therapy. The careful selection method results in consistently high-quality cells and hence a strong safety profile with few side effects.

"It is reassuring for NextCell that we have received positive notification from the EPO and can protect our most valuable asset," says CEO Mathias Svahn.

ProTrans is NextCell's first drug candidate based on the selection algorithm. It is an allogeneic celltherapy which means that donated cells, not the patient's own, are used. The cells are extracted from donated umbilical cord tissue and the cells are then multiplied to generate large amounts of cells.

Clinical trials intype-1 diabetes have shown promising results for ProTrans to stop the course of the disease for 1 year in adult patients, potentially longer. Ongoing trials are now evaluating efficacy in adolescents and children newly diagnosed withtype-1 diabetes. In addition, clinical trials are ongoing with patients with severe pneumonia due to COVID-19 infection, in Sweden and Canada.

This information is the information that NextCell Pharma AB is required to disclose under the EU Market Abuse Regulation. The information was provided by the below contact person for publication on 31st of May at 08.30 CET.^‍

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For more information about NextCell Pharma AB, please contact:

Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8-735 5595
E-mail: info@nextcellpharma.com

Webpage: www.nextcellpharma.com
LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma

Certified Adviser:

‍FNCA Sweden AB is assigned as Certified Adviser, 08-528 00 399, info@fnca.se.

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‍About NextCell Pharma AB

NextCell is a phase II cell therapy company with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to take ProTrans to market approval via a Phase III study. ProTrans is in addition to diabetes, used in two clinical trials for Covid-19, in Örebro and Montreal (Canada). The company is in the processes of establishing its own GMP facility for production of ProTrans. The GMP facility is expected to be ready for production of smaller quantities of ProTrans in 2023. NextCell furthermore owns 8,5% in FamicordTX, a CAR-T start-up in oncology and 100 % of Cellaviva, Scandinavia's largest stem cell bank for family saving stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).

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2018-07-09

Publication of scientific article regarding the clinical trial with ProTrans

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2018-07-03

NextCell applies for prediction methodology patent

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2018-06-29

The Data and Safety Monitoring Board approves the usage of high-dose ProTrans in the ongoing clinical trial

Stem cell company NextCell Pharma AB ("NXTCL") announces today that the Data and Safety Monitoring Board for the clinical trial using ProTrans has given its approval for the principal investigator professor Per-Ola Carlsson and NextCell to proceed and treat 3 patients in the high-dose cohort. The treatment of all three patients in the medium-dose cohort with ProTrans has been assessed as safe using a one-month follow-up period. Now NXTCL is now able to recruit patients for the last dose cohort, which is the high-dose cohort. The recruitment of the last dose cohort is expected to take one

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2018-06-28

Extended tissue establishment authorization

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2018-05-18

Six patients now treated with NextCells ProTrans stem cells

NextCell Pharma AB ("NXTCL") announces that an additional three patients have been treated with ProTrans in the ongoing clinical phase I/II trial. In total 6 patients with type 1 diabetes in the low- and medium-dose-cohort have now undergone treatment. The trial performed with NXTCL's drug candidate ProTrans, is divided into two parts, the first part being a dose-escalation phase with 3 + 3 + 3 patients being treated with either a; low, medium or high dose of ProTrans. Now all patients in the low-dose-cohort and the medium-dose-cohort have been treated. After the 1-month follow-up of the

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2018-04-30

Today NextCell Publishes its half-year report

NextCell Pharma AB ("NEXTCL", "NextCell") today released its half-year report (September 1, 2017 - February 28, 2018) By "NextCell" or "Company" is meant NextCell Pharma AB with organization number 556965-8361. Amount in brackets in the report refers to the corresponding period in the previous year. Note that the Company's fiscal year is September 1 - August 31. First half (2017-09-01 till 2018-02-28) · Net sales amounted to SEK 391 204 (120 594). · Operating result amounted to SEK -7 524 256 (-4 863 506). · Cash and bank amounted to SEK 9 444 381 (4 124 396). ·

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2018-04-27

NextCell enters into Memorandum of Agreement with China General Consulting & Investment Co., Ltd.

NextCell Pharma AB ("NextCell") hereby announces that the company has entered a Memorandum of Agreement with China General Consulting & Investment Co., Ltd. (”CGCI”). The purpose of the agreement is to create a base for future co-operation. The agreement includes that the parties should prioritize working together when it comes to stem cell development and China, but is otherwise without claims or obligations and does not affect NextCell financially. NextCell has developed a patented applied for selection algorithm to ensure the selection and production of potent mesenchymal stem cells in

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2018-03-27

The Data and Safety Monitoring Board approves the usage of medium-dose ProTrans in the ongoing clinical trial.

Stem cell company NextCell Pharma AB ("NXTCL") announces today that the Data and Safety Monitoring Board for the clinical trial using ProTrans has given its approval for the principal investigator professor Per-Ola Carlsson and NextCell to proceed and treat 3 patients in the medium-dose cohort. The Data and Safety Monitoring Boards consists of; Ulf Smith MD, PhD, Professor and Director, Lundberg Laboratory for Diabetes Research, Sahlgrenska Academy and Sahlgrenska University Hospital, Gothenburg; Anders Fasth MD, PhD, Professor of Pediatric Immunology, Sahlgrenska Academy and Chief Physician

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