04.

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Here, you can find the latest news and press releases about NextCell.

From August 2024, children aged 7-11 years, newly diagnosed with type 1 diabetes will be able to participate in a study with ProTrans.

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Q&A with NextCell's CEO Mathias Svahn

NextCellPharma has many active owners. Questions come in regularly. NextCell's CEO Mathias Svahn answers a number of these questions in this Q&A section.

The information below has previously been communicated by NextCell. This information has been compiled to make it easier for NextCell's stakeholders to obtain an overall picture. This English version is a translation of the Swedish version. The Swedish version is at all times to be deemed as the correct version.

How is the "Child Study" progressing and when will it be completed?

– The paediatric study, or ProTrans-Young which is the formal name of the ongoing Phase 2 study, consists of two parts. The first part includes a group of 30 young people aged 12-21 years, and the second part includes a group of 30 children aged 7-11. Before recruitment of the 30 younger children begins, a statement from our safety committee regarding the 6 children who have recently developed diabetes and been treated with ProTrans is expected during the spring.

The study is progressing well and according to plan. For both groups, treatment regarding safety has been carried out and, as in other studies with ProTrans, no serious side effects were found.

The Phase 2 study has continued in the older group and hopefully the last patient in this group will be treated this year, which means that results may be available around the end of next year. As for the younger children, that part of the study will start in mid-2024 and will be evaluated 12 months after the last patient has been treated. Uppsala University is the sponsor of the study. The principal investigator is Professor Per-Ola Carlsson, and he decides when the data will be analysed. According to the study protocol, an analysis of the effect will be carried out when all patients have had a one-year follow-up.

Read an interview (in Swedish) with Mathias Svahn about the ProTrans-Young paediatric study

Is it enough that the safety part of the paediatric study is completed for NextCell to apply for a Phase 3 study with ProTrans?

– After scientific consultation with EMA, we understand that the pending paediatric safety data and approved PIP (see below) allows us to design a pivotal Phase 3 study that includes both paediatric and adult patients. This limits the need for separate paediatric studies and offers the opportunity to apply for market approval to, in principle, all patients newly diagnosed with type 1 diabetes.

NextCell has submitted a Paediatric Investigational Plan (PIP), which is an EMA requirement for drug development. We have received a very good response and the main criticism, which is not really a criticism, was that EMA believes that all children should have access to treatment, regardless of age. In addition to demonstrated safety, the paediatric plan must be approved before a Phase 3 application can be submitted.

Why haven't you already applied for a Phase 3 study with ProTrans?

– First and foremost, we want to ensure that a Phase 3 study includes as wide an age range as possible to avoid having to conduct additional Phase 3 studies in other age groups. This is why the ongoing ProTrans-Young study is so important. This study will provide us with incredibly valuable data from a total of 66 patients, compared to the previous ProTrans 1 & 2 studies which together included 24 patients.

Thus, we will build up a significant database of clinical data that will be valuable when we submit the application for a Phase 3 study. The total number of patients who have undergone treatment is of great importance for both regulatory authorities and potential licensees. In addition, we continue to collect long-term data from, for example, the ProTrans-Repeat study (a follow-up study aimed at verifying whether a second treatment with ProTrans can extend or maintain any effect over a longer period of time). The results indicate that a single treatment changes the course of the disease and that two treatments are probably even better.

We estimate that the cost of the ProTrans-Young study amounts to 60-80 million SEK, funds that are sponsored by Uppsala University in exchange for us providing the drug. In addition, we obtain access to study data that can be used in the application for market authorisation. A win-win-win for our shareholders, the healthcare system, and all patients.

Before it was clear that Uppsala would actually carry out ProTrans-Young, the strategy was to go straight in with a Phase 3 application. When ProTrans-Young became a reality, the company chose to lower the risk of the operation and we have never regretted that decision.

When will you submit the Phase 3 study application?

– We believe that we create the best possible shareholder value if we can apply for a Phase 3 study together with a future licensee, who will cover the development costs. Alternatively, we await results from ProTrans-Young to optimise the study design and apply ourselves. It is possible that the process could be accelerated with the right financial partner.

Why do you think it is positive for NextCell that the first drug for type 1 diabetes has been approved in the US? Is it not competitor of yours?

– Tzield has set a new standard for diabetes treatment. The drug is administered intravenously, one injection a day during what is currently a 14-day hospital stay. Tzield also requires premedication to reduce side effects. The total cost of treatment with Tzield in the US has been estimated at 194,000 USD plus hospital costs per patient, while ProTrans is estimated to be priced significantly lower. In addition, ProTrans causes no known serious side effects and we expect comparable efficacy. In addition, Tzield is currently only approved to treat patients with Stage 2 type 1 diabetes, i.e. individuals who have two antibodies against insulin-producing beta cells, but where the disease has not yet progressed to Stage 3 insulin-dependent type 1 diabetes. I think the results indicate that an infusion of ProTrans is more attractive than 14 injections of Tzield when compared to previous studies.

NextCell has invested in FamiCordTx. How is the company developing?

– FamiCordTx is a joint venture between, among others, NextCell and PBKM in Poland, with whom we have collaborated for a long time. FamiCordTx, which is also a cell therapy company, develops CAR-T treatments to cure cancer. Simply put, CAR-T treatments involve reprogramming the immune system's T-cells (white bloodcells) to effectively identify and kill tumour cells. CAR-T treatments are important in cancer care and are likely to play an even more important role in the future as research progresses.

FamiCordTx has shown good results and has established a manufacturing process. The Polish Medicines Agency has approved their application for a Phase 1B study, i.e. a study focusing on safety. The study has treated four out of six and is expected to conclude in the first half of 2024.

Press releases and news

2024-07-03

NextCell carries out a directed issue of units to guarantors in connection with the completed rights issue

Regulatory
THIS PRESS RELEASE MAY NOT BE RELEASED, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND, CANADA, HONG KONG, BELARUS, RUSSIA OR IN ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLISHING OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTATION OR OTHER MEASURES IN ADDITION TO THOSE REQUIRED BY SWEDISH LAW. SEE SECTION "IMPORTANT INFORMATION" AT THE END OF THIS PRESS RELEASE. The Board of Directors of NextCell Pharma AB (publ) (“NextCell” or the “Company”) has today, based on the authorisation from the Annual General Meeting on 30 November 2023, resolved on a directed issue of 894,329 units to guarantors who provided guarantee commitments in the rights issue of units resolved upon by the Board of Directors on 24 April 2024 (the “Right Issue”), in accordance with guarantee agreements entered into (the “Remuneration Issue”). Each (1) unit consists of one (1) newly issued share and one (1) warrant of series TO2. The subscription price in the Remuneration Issue is SEK 1.50 per unit and payment is made by offsetting the guarantors’ claims on the Company.
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2024-06-17

NextCell’s rights issue oversubscribed

Regulatory
THIS PRESS RELEASE MAY NOT BE RELEASED, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND, CANADA, HONG KONG, BELARUS, RUSSIA OR IN ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLISHING OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTATION OR OTHER MEASURES IN ADDITION TO THOSE REQUIRED BY SWEDISH LAW. SEE SECTION ”IMPORTANT INFORMATION” AT THE END OF THIS PRESS RELEASE. NextCell Pharma AB (publ) (”NextCell” or the “Company”) hereby announces the outcome of the Company’s rights issue of units, consisting of shares and warrants of series TO2, with preferential rights for the Company’s existing shareholders, which was announced through a press release on 24 April 2024 (the “Rights Issue”). The outcome of the Rights Issue shows that 34,747,218 units, corresponding to approximately 91.9 percent of the Rights Issue, were subscribed for with the support of unit rights. In addition, applications for subscription of 22,636,886 units without the support of unit rights have been submitted, corresponding to approximately 59.9 percent of the Rights Issue. Together, subscriptions of units with the support of unit rights and applications for subscription of units without the support of unit rights correspond to approximately 151.7 percent of the Rights Issue. The Rights Issue is therefore oversubscribed and NextCell will from the Rights Issue receive approximately SEK 40.1 million before deduction of issue costs.
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2024-06-12

The paediatric diabetes study gets the green light to treat the age group 7 – 11 years

Regulatory
NextCell Pharma AB (publ) ("NextCell") announces that the Data Safety Monitoring Board for the ProTrans-Young study has recommended the principal investigator, Professor Per-Ola Carlsson, to continue with treatment of children in the younger age group 7 – 11 years. This decision is based on a review of all available safety data from the 36 children and adolescents who have participated in the study so far. The recruitment of the 30 children aged 7-11 will begin in August 2024.
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2024-06-11

The Board of Directors and management sign in addition to subscription commitments

Regulatory
NextCell Pharma AB (publ) ("NextCell" or the "Company") carries out a rights issue of units of up to approximately SEK 40.1 million, which is covered to approximately 100 percent by subscription and guarantee commitments. The company's Board of Directors, management and key employees, who have previously entered into subscription commitments of up to a total of approximately SEK 1.5 million, have now announced that they will register their interest in subscribing for units for a total of approximately SEK 3.3 million, corresponding to 8.2 percent of the rights issue.
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