Single treatment with ProTrans demonstrates long-term therapeutic effect over 5 years

May 28, 2024

NextCell Pharma AB ("NextCell" or the "Company") today announces that patients who were treated with a single dose of ProTrans five years ago in the randomized, placebo-controlled phase II study ProTrans-2 have retained significantly higher endogenous insulin production than patients who received placebo. ProTrans treated patients maintained 57% of their endogenous insulin production compared to 15% in the placebo group. The results are in line with NextCell’s previously reported three year data and demonstrates that ProTrans offers a disease-modifying treatment with long-lasting clinically relevant effect.

	ProTrans	Placebo
1 year	89% (± 10%)	53% (± 34%)
2 years	71% (± 21%)	33% (± 26%)
3 years	63% (± 33%)	23% (± 19%)
4 years	66% (± 41%)	14% (± 12%)
5 years	57% (± 29%)	14% (± 13%)

Table 1: Maintenance of endogenous insulin production per year after a single infusion of ProTrans, mean value for each treatment arm + standard deviation.

NextCell's Chief Scientific Officer, Dr. Lindsay Davies, will present the data and explain how a single dose of ProTrans can provide such a long-lasting effect. The presentation will be available at https://www.redeye.se/events/1012070/nextcell-pharma from Wednesday 29 May at 09:00 CET.

In 2018, the randomized double-blinded phase II study ProTrans-2 started at Karolinska University Hospital. A total of 15 patients were randomized 2:1 for treatment with one infusion of ProTrans or placebo control. The primary endpoint was the percentage of retained endogenous insulin production capacity one year after treatment, with patients treated with ProTrans maintaining an average of 89% compared to placebo controls which maintained 53%.

The 14 patients who completed ProTrans-2 were invited, after completion of the study, to participate in a non-interventional follow-up study where they would be followed for an additional 5 years, ProTrans-Obs. In total 6 patients treated with ProTrans and 5 patients who received placebo completed the study. In ProTrans-Obs, the patients' endogenous insulin production capability was measured. ProTrans treatment demonstrated a statistically significant effect (p<0.05) compared to placebo.

No serious adverse reactions related to treatment have been reported. The company continues to analyses the data and will present more detailed results in the coming weeks.

This disclosure contains information that NextCell Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 28-05-2024 14:15 CET.

For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 5595
E-mail: info@nextcellpharma.com

Websites:
NextCell Pharma AB: www.nextcellpharma.com
Cellaviva Sverige: www.cellaviva.se
Cellaviva Danmark: www.cellaviva.dk

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

Certified Adviser
FNCA Sweden AB is assigned as Certified Adviser.

About NextCell Pharma AB

NextCell is a cell therapy company that is in phase 2 studies with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to obtain market approval of ProTrans via a phase 3 study. ProTrans is manufactured utilizing the patented platform technology for selection of optimal cells with potency to treat inflammatory disorders including autoimmune diseases. NextCell owns Cellaviva, the largest stem cell bank in the Nordics and QVance, a quality analysis CRO company in start up.

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2018-09-11

Last day of trading in series TO 1 warrants

Today, 11th September 2018, is the last day of trading in warrants of series TO 1 issued as part of NextCell Pharma AB's ("NXTCL") listing in the spring of 2017. Last day to subscribe for shares on the basis of warrants of series TO 1 is 13th September 2018. The teaser and subscription form are available on the following websites: NXTCL (www.nextcellpharma.com (http://file///C:/Users/ErikBerggren/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/TLO3KWR6/www.nextcellpharma.com)); Sedermera Fondkommission (www.sedermera.se (http://file///C:/Users/ErikBerggren/AppData/Local/Microsoft/

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2018-09-05

Reminder to exercise your series TO 1 warrants

The subscription period for the series TO 1 warrants issued as part of NextCell Pharma AB’s ("NXTCL") issue of units during the spring of 2017 will continue until 13th September 2018. The last day for trading with the series TO 1 warrants is 11th September 2018. Holders of the series TO 1 warrants are entitled to subscribe for a new share for each warrant at a price of SEK 5.00 per share. If all of the series TO 1 warrants are exercised, 2 860 940 new shares will be issued and NXTCL is receives approximately MSEK 14.3 before issue costs. The subscription of series TO 1 warrants to be

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2018-08-28

Upcoming events and conferences for NXTCL

Stem cell company NextCell Pharma AB ("NXTCL") announces today, that CEO Mathias Svahn has been invited to speak at the annual BiotechBuilders event held today, 28th of September 2018. Mathias Svahn will also give a presentation at the Nordic Life Science Days, which will be held 10th-12th of September 2018. The BiotechBuilders event which is held today, 28th of September 2018, has invited CEO Mathias Svahn to speak about NXTCL and how the company has developed over time. The title of his presentation is: “Turning opportunity into productivity, starting a stem cell clinical trial in record

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2018-08-27

Summary of exercised warrants by Board members and senior executives in NXTCL

Stem cell company NextCell Pharma AB ("NXTCL") announces today, that members of the Board Anders Essen-Möller, Edvard Smith, Hans-Peter Ekre, Niclas Löwgren, CEO Mathias Svahn and CFO Leo Groenewegen have exercised all of their respective series TO 1 warrants. In total this means that 173 430 warrants are to be converted, corresponding to a total investment of SEK 867 150. In total, investments from the Board and Management correspond to approximately 6 percent of the total outstanding warrants. Below, each person’s amount of to be exercised series TO 1 warrants is presented: · Mathias

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2018-08-23

NextCell's largest shareholder Diamyd Medical exercise all of its warrants

Stem cell company NextCell Pharma AB ("NXTCL") announces today, that its largest shareholder, Diamyd Medical AB, will exercise all its 296 800 series TO1 warrants. Diamyd will exercise the warrants during the subscription period which runs during the period 23rd August – 13th September 2018. This represents an investment total of SEK 1 484 000, corresponding to approximately 10 % of the outstanding warrants. The diabetes Company Diamyd Medical is one of the main owners of NextCell Pharma, with a shareholding of approximately 14 %. In addition to its current shares, Diamyd Medical also has

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2018-08-23

The subscription period of the series TO 1 warrants starts today

Stem cell company NextCell Pharma AB ("NXTCL") announces that today, 23rd of August 2018, marks the start of the subscription period of the series of TO 1 series warrants which were issued as part of the company's issue of units during the spring of 2017. The subscription period will end on the 13th of September 2018. Holders of the series TO 1 warrants are entitled to subscribe for a new share for each warrant at a price of SEK 5.00 per share. If all of the series TO 1 warrants are exercised, 2 860 940 new shares will be issued and NXTCL is receives approximately MSEK 14.3 before issue costs.

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2018-08-17

NextCell’s partner PBKM exercises its TO 1 warrants

Stem cell company NextCell Pharma AB ("NXTCL") announces today that its shareholder and partner Polski Bank Komorek Macierzystych S.A. ("PBKM") is exercising all of its 320,000 warrants. This represents an investment of MSEK 1.6, corresponding to approximately 11 % of the outstanding series TO 1 warrants. The subscription period of the series TO 1 warrants runs from 23rd of August – 13th of September 2018. PBKM is one of Europe's leading players in the field of stem cells and is also contracted for the manufacturing of NXTCL's drug candidate ProTrans. PBKM is thus an important partner of

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2018-08-13

An additional batch of ProTrans is released prior to use in NextCell Pharma’s ongoing clinical trial.

Stem cell company NextCell Pharma AB ("NextCell") hereby announces that it has received another batch of ProTrans for clinical use. ProTrans is manufactured according to GMP (Good Manufacturing Practices) and the stem cells are selected with the company's selection algorithm to ensure quality. The selection is carried out by NextCell and the large-scale production is then produced by supplier and shareholder Polski Bank Komorek Macierzystych S.A. ("PBKM"). The delivery is intended for use in the second part of the company's ongoing Phase I/II trial with ProTrans, which includes a total of 15

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