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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2019-11-07

Correction: Notice to attend the Annual General Meeting

NextCell Pharma AB ("NextCell") announces that a notice of the Annual General Meeting for the 2018-2019 financial year has been published. Compared to the press release published this morning, corrections have been made regarding the Market Abuse Regulation label. The information is not subject to the Market Abuse Regulation. The annual general meeting will be held on December 5, 2019 at 10.00 at Novum, Hälsovägen 7, Huddinge. The notice has been published in Svenska Dagbladet and Post and Inrikes Tidningar as well as on the company's website, www.nextcellpharma.com. The Annual Report and

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2019-11-07

Notice to attend the Annual General Meeting

NextCell Pharma AB ("NextCell") announces that a notice of the Annual General Meeting for the 2018-2019 financial year has been published. The annual general meeting will be held on December 5, 2019 at 10.00 at Novum, Hälsovägen 7, Huddinge. The notice has been published in Svenska Dagbladet and Post and Inrikes Tidningar as well as on the company's website, www.nextcellpharma.com. The Annual Report and Audit Report will be available three weeks before the Meeting, November 14, on the Company's website, www.nextcellpharma.com. This information is the information that NextCell Pharma AB

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2019-10-31

Year-end report 2018-09-01 - 2019-08-31

Nextcell Pharma AB ("NXTCL") today announces the year-end report for the 2018/2019 fiscal year (2018-08-31 2019-08-31) Twelve months (2018-09-01 until 2019-08-31) · Operating income amounted to SEK 1 964 132 (655 413). · Operating result amounted to SEK -21 450 784 (-14 032 294). · Earnings per share* amounted to SEK -1.36 (-0.61). · Cash and bank amounted to SEK 20 128 185 (3 115 876). · Solidity** amounted to 85.9 (59.2) %. Fourth quarter (2019-06-01 until 2019-08-31) · Operating income amounted to SEK 551 708 (127 868). · Operating result

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2019-10-25

NextCell invests in the Danish Cellaviva operations with a new Copenhagen office

NextCell Pharma AB ("NextCell") today announces they are investing for growth in Cellaviva's Danish operations with the opening of a new Copenhagen office. In October, Cellaviva's new office was opened in Copenhagen, located in Kløvebyen. The Copenhagen office is primarily intended to be a hub for the Danish Cellaviva business with the opportunity to host customers, hold training sessions etc. The purpose is also to enable increased exposure and presence for NextCell in the Öresund region. [image] [image]

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2019-10-01

All patients in ProTrans-Repeat are now treated

NextCell Pharma AB ("NextCell") announces that another significant milestone has been reached when the last patient, as part of the ProTrans-Repeat active treatment group, today has received their treatment. This implies that all treatments, related to the two ongoing ProTrans studies, have been completed. NextCell is conducting two parallel clinical trials with the drug candidate ProTrans, with the aim to treat diabetes type-1. ProTrans-Repeat, which was initiated in May 2019, is a continuation trial of ProTrans-1 dose escalation part with the aim of maximizing data collection on repeated

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2019-09-24

Last patient, last visit completed in the dose escalation part

NextCell Pharma AB (NextCell) is today announcing that the last patient in the dose escalation part of the clinical trial ProTrans-1 for diabetes is completed. The last patient was today at the last visit and has now left the trial. ProTrans-1 is a two-part phase I / II clinical trial where the phase I part evaluates safety for three doses. All nine patients have now been followed up for 12 months and have left the study. As previously communicated, all 15 patients in the phase II part of ProTrans-1 have been treated and will be followed for 12 months. The second part is randomized,

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2019-09-12

Update on the ongoing clinical trials

NextCell Pharma AB (NextCell) is today providing a status update regarding its two ongoing clinical trials, presented at the Nordic Life Science days in Malmö. All patients in ProTrans-1 were treated by June 2019 and 8 out of 9 patients in the dose escalation part have already left the trial after 12 months follow-up. The ProTrans-Repeat has included 5 out of 18 patients. NextCell is conducting two parallel clinical trials with the drug candidate ProTrans, with the aim to treat type-1 diabetes. A single dose of ProTrans is given and the patients own ability to produce insulin is compared

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2019-08-16

NextCell Pharma files another patent application

NextCell Pharma AB ("NextCell") today announces that they have filed a new patent application to the Swedish Patent and Registration Office. The patent relates to the Company's proprietary selection algorithm, now with extended and tailored analyses for diseases and conditions affecting the central nervous system. The application was submitted to the Swedish Patent and Registration Agency on August 15 and is formulated to cover the general production of all types of mesenchymal stem cell products derived from multiple donors and cells selected by the selection algorithm. Furthermore, the

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