NextCell publishes its Interim Report 2 2023/2024

April 25, 2024

NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period September 1, 2023 – Februari 29, 2024. 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 (2023-12-01 until 2024-02-29)

Operating Income amounted to 2,405 (2,734) TSEK, of which
    Cellaviva amounted to 2,334 (2,107) TSEK.

Net Income amounted to 2,334 (2,106) TSEK.
Operating result amounted to -10,093 (-11,408) TSEK.
Earnings per share* amounted to -0.29 (-0.33) SEK.
Cash and bank amounted to 30,393 (77,617) TSEK.
Solidity** amounted to 79.2 (89,3)

First half year (2023-09-01 until 2024-02-29)

Operating Income amounted to 7,099 (5,746) TSEK, of which
    Cellaviva amounted to 6,580 (4,244) TSEK.

Net Income amounted to 6,580 (4,244) TSEK.
Operating result amounted to -19,889 (-20,327) TSEK.
Earnings per share* amounted to -0.58 (-0.59) SEK.

Earnings per share: Profit for the period divided by average number of shares. Average number of shares for the second quarter 2023/2024: 34,379,523 (34,379,523) shares. Number of shares in NextCell as of February 29, 2024: 34,379,523 (34,379,523) shares.
**Solidity: Equity to total balance sheet.

Significant events in the second quarter

At the end of January, NextCell published an update on the ongoing clinical trials. The largest ongoing study – ProTrans Young, which includes 66 patients – is progressing well.

At the end of February, NextCell Pharma announced that it had decided on a new strategic direction. The strategic changes means that Cellaviva will become a wholly owned subsidiary and also cost savings as a result of staff reductions.


Significant events after the reporting period

NextCell announced in early March that it was establishing the subsidiary QVance to meet a Nordic demand for quality analyses. The launch is a strategic addition to NextCell to increase the company's sales and presence in the market for advanced therapy drugs.

At the end of March, the company announced that the Swedish Medical Products Agency had approved the application to conduct a subgroup analysis of the treatment effect of ProTrans in 30 adolescents in the age group 12-21 years treated in the ProTrans-Young study. The approval for the subgroup analysis by the Swedish Medical Products Agency means that the primary efficacy endpoint readout is available after 12 months. Results from the subgroup analysis are planned to be presented in the second quarter of 2025.

In mid-April, Nextcell Pharma announced that its longtime Chairman of the Board, Anders Essen-Möller, after ten years of dedicated leadership, will step down from his role on May 20, 2024 due to health reasons.

NextCell announced in mid-April that the Health and Social Care Inspectorate (IVO) has granted their tissue facility Cellaviva permission to handle the amniotic tissue.

On April 24th the company announced that the Board of Directors resolves on a rights issue of units of approximately SEK 40.1 million, subject to approval by an Extraordinary General Meeting.

On April 24th NextCell gave notice of an Extraordinary General Meeting to be held May 27th.


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 25-04-2024 07:30 CET.

For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 55 95
E-mail: info@nextcellpharma.com
Website:www.nextcellpharma.com

Linkedin: https://www.linkedin.com/NextCell-Pharma
Twitter: https://twitter.com/NextCellPharma


For more information about Cellaviva, please contact
Sofie Falk Jansson, Head of Cellaviva
Tel: +46 8 735 20 10
E-mail: info@cellaviva.se
Website:www.cellaviva.se


Facebook: https://www.facebook.com/cellavivasverige
Instagram: https://www,instagram.com/cellaviva

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.

Download attachmentRead full press release on Cision (external link)
2019-06-05
Selected to participate in the EIT Health Start.Smart.Global (SSG) programme.
NextCell Pharma AB (publ) ("NextCell") has been chosen as one of a select group of companies to participate in the EIT Health Start.Smart.Global (SSG) programme. The programme focusses on helping European life science SMEs successful entries into Japan and South Korea. EIT Health is a Knowledge and Innovation Community established by the European Institute for Innovation & Technology (EIT) (https://eit.europa.eu/), an independent EU body set up to promote innovation and entrepreneurship across Europe. The EIT Health Start.Smart.Global (SSG) programme, helps European life science SMEs
NextCell Pharma AB (publ) ("NextCell") has been chosen as one of a select group of companies to participate in the EIT Health Start.Smart.Global (SSG) programme. The programme focusses on helping European life science SMEs successful entries into Japan and South Korea. EIT Health is a Knowledge a...
Read moreRead more
2019-05-17
NextCell now has two parallel running clinical trials, ProTrans-1 and ProTrans-Repeat which was initiated today
NextCell Pharma AB (NextCell) announces that the initiation meeting for ProTrans-Repeat was held today at Karolinska University Hospital in Huddinge. ProTrans-Repeat is a completely independent trial and has no effect on the ProTrans-1 study. NextCell now has two ongoing clinical trials that run parallel and according to plan. ProTrans-Repeat's Principal investigator Professor Per-Ola Carlsson and the study team from Karolinska Trial Alliance, together with NextCell, went through the last practical details, which means that the new study has now been formally initiated. ProTrans-Repeat means
NextCell Pharma AB (NextCell) announces that the initiation meeting for ProTrans-Repeat was held today at Karolinska University Hospital in Huddinge. ProTrans-Repeat is a completely independent trial and has no effect on the ProTrans-1 study. NextCell now has two ongoing clinical trials that run ...
Read moreRead more
2019-05-17
Rectification: Six out of nine patients in the first part of the phase I/II trial, ProTrans-1 have completed treatment
NextCell Pharma AB (NextCell) announces that six out of the nine patients included in the dose escalation part of ProTrans-1, the trial with the drug candidate ProTrans, now have completed treatment and left the study. Earlier this week, the last of the three patients in the so-called medium-dose-cohort visited for their 12-month follow-up, the final part of the trial, which means that all three now have completed their part of the trial. In early March, the three patients in the low-dose cohort had already completed the trial. This means that six out of nine patients in the phase I part
NextCell Pharma AB (NextCell) announces that six out of the nine patients included in the dose escalation part of ProTrans-1, the trial with the drug candidate ProTrans, now have completed treatment and left the study. Earlier this week, the last of the three patients in the so-called medium-dose...
Read moreRead more
2019-05-17
Six out of nine patients in the phase-II part of the ProTrans-1 study have completed treatment
NextCell Pharma AB (NextCell) announces that six out of the nine patients included in ProTrans-1, the trial with the drug candidate ProTrans, now have completed treatment and left the study. Earlier this week, the last of the three patients in the so-called medium-dose-cohort visited for their 12-month follow-up, the final part of the trial, which means that all three now have completed their part of the trial. In early March, the three patients in the low-dose cohort had already completed the trial. This means that six out of nine patients in the phase II part have now successfully
NextCell Pharma AB (NextCell) announces that six out of the nine patients included in ProTrans-1, the trial with the drug candidate ProTrans, now have completed treatment and left the study. Earlier this week, the last of the three patients in the so-called medium-dose-cohort visited for their 12...
Read moreRead more
2019-05-15
NextCell Pharma invited speaker at the World Advanced Therapies & Regenerative Medicine Congress
NextCell Pharma AB ("NextCell") and Cellaviva have been invited to attend and speak at the 14th annual World Advanced Therapies & Regenerative Medicine Congress, which is held at the Business Design Centre, London 15 - 17 May. On 16 May, CEO Dr. Mathias Svahn will be chairing the Roundtable Discussion Session regarding hospital exemption procedures. For the duration of the conference NextCell/Cellaviva delegates will be participating in workshops, attending lectures and engaging in a variety of networking activities.  The World Advanced Therapies & Regenerative Medicine Congress is an
NextCell Pharma AB ("NextCell") and Cellaviva have been invited to attend and speak at the 14th annual World Advanced Therapies & Regenerative Medicine Congress, which is held at the Business Design Centre, London 15 - 17 May. On 16 May, CEO Dr. Mathias Svahn will be chairing the Roundtable Discu...
Read moreRead more
2019-05-09
ProTrans-Repeat, an approved clinical trial for repeated treatment of patients with diabetes
The Medical Products Agency has granted NextCell Pharma AB ("NextCell") permission to conduct the new study, ProTrans-Repeat. The study is a continuation of ProTrans-1 where patients with type-1 diabetes who participated in the dose escalation part will be asked to participate in ProTrans-Repeat. The purpose is to investigate whether repeated treatment is safe and gives increased effect on the patient's ability to produce insulin. ProTrans-Repeat is a Phase IIa clinical trial that aims to evaluate whether repeated treatment can increase or maintain the effect of ProTrans over a longer period
The Medical Products Agency has granted NextCell Pharma AB ("NextCell") permission to conduct the new study, ProTrans-Repeat. The study is a continuation of ProTrans-1 where patients with type-1 diabetes who participated in the dose escalation part will be asked to participate in ProTrans-Repeat....
Read moreRead more
2019-05-08
The Medical Products Agency grants NextCell permission to initiate the ProTrans-Repeat trial
NextCell Pharma AB ("NextCell") today received a permit from the Medical Products Agency granting permission to initiate a new clinical trial, called ProTrans-Repeat. The trials is a continuation of the ongoing ProTrans-1 trial and of great importance to the further development of ProTrans. The goal for this study is to include those patients with type 1 diabetes who participated in the dose escalation part of the ongoing ProTrans-1 study and the study purpose is to demonstrate that ProTrans also has a positive effect when using a repeated treatment approach. ProTrans-Repeat is a Phase IIa
NextCell Pharma AB ("NextCell") today received a permit from the Medical Products Agency granting permission to initiate a new clinical trial, called ProTrans-Repeat. The trials is a continuation of the ongoing ProTrans-1 trial and of great importance to the further development of ProTrans. The g...
Read moreRead more
2019-05-08
The NextCell Pharma AB board of directors proposes an Rights Issue of MSEK 24.9 and calls for an extraordinary general meeting
The Board of NextCell Pharma AB (publ) ("NextCell" or "the Company") has decided to propose an extraordinary general meeting on May 24, 2019 to decide on a rights issue of shares ("Rights Issue") totaling SEK 24.9 million. The rights issue is secured through subscription commitments and letter of intent of approximately 21 per cent and guarantee commitments of approximately 59 per cent, which corresponds to approximately 80 per cent of the total issue volume. The reason for the rights issue is to obtain working capital to expand the clinical trial program with the company's first drug
The Board of NextCell Pharma AB (publ) ("NextCell" or "the Company") has decided to propose an extraordinary general meeting on May 24, 2019 to decide on a rights issue of shares ("Rights Issue") totaling SEK 24.9 million. The rights issue is secured through subscription commitments and letter of...
Read moreRead more