NextCell publishes its Interim Report 3 2023/2024

July 25, 2024

NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 3 for the period September 1, 2023 – May 31, 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.

Third quarter (2024-03-01 until 2024-05-31)

Operating income amounted to 2,482 (4,189) TSEK,
    of which Cellaviva amounted to 2,442 (3,040) TSEK.

Net Income amounted to 2,442 (3,040) SEK

Operating result amounted to -8,821 (-10,916) TSEK.

Earnings per share* amounted to -0.26 (-0.32) SEK.

Cash and Bank amounted to 20,798 (63,230) TSEK.

Solidity** amounted to 76.9 (88.1) percent.



First nine months (2023-09-01 until 2024-05-31)

Operating income amounted to 9,582 (9,937) TSEK,
    of which Cellaviva amounted to 9,023 (7,284) TSEK.

Net Income amounted to 9,022 (7,284) SEK

Operating result amounted to -28,710 (-31,243) TSEK.

Earnings per share* amounted to -0.84 (-0.91) SEK.

Earnings per share: Profit for the period divided by average number of shares. Average number of shares for the third quarter 2023/2024: 34,379,523 (34,379,523) shares. Number of shares in NextCell as of May 31, 2024: 34,379,523 (34,379,523) shares.
**Solidity: Equity to total balance sheet.

Significant events in the third quarter

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.

At the end of May, NextCell announced that the Extraor­dinary General Meeting had resolved that the number of Board members had been changed from a minimum of four (4) to a minimum of 3 (three), and that the remuneration to the Board members should be unpaid. Furthermore, it was resolved to re-elect Hans-Peter Ekre, Camilla Myhre Sandberg and Edvard Smith for the period until the end of the next Annual General Meeting. Hans-Peter Ekre was elected as new Chairman of the Board- The AGM further resolved, in accordance with the Board of Directors' proposal, to approve the Board of Directors' resolution on 24 April 2024 on a new share issue, with preferential rights for existing shareholders, of a maximum of 37,817,475 shares and a maximum of 37,817,475 warrants of series TO2, entitling to subscrip­tion of a total of 37,817,475 shares in the company. The issues are carried out with the issuance of so-called units. One (1) unit consists of one (1) share and one (1) warrant of series TO2.

At the end of May, the company announced that pa­tients who were treated with a single dose of ProTrans five years ago in the randomized, placebo-controlled phase II trial ProTrans-2 have significantly maintained higher endogenous insulin production than patients who received placebo. The results are in line with previously reported 3-year data and demonstrates a disease-modifying treatment with long-lasting efficacy.


Significant events after the reporting period

● At the beginning of June, NextCell announced that the Company had agreed on a so-called top guarantee of a total of approximately SEK 8.0 million, corresponding to approximately 20.0 percent of the issue volume. Through the additional top guarantee, the Rights Issue is covered up to approximately 100 percent by subscrip­tion and guarantee commitments.

● At the beginning of June, the company published a supplementary prospectus due to the fact that it had entered into an agreement on a so-called top guarantee of a total of approximately SEK 8.0 million in the ongo­ing rights issue.

● At the beginning of June, NextCell announced that 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, 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.

● The company announced in mid-June that the Data Safety Monitoring Board for the ProTrans-Young study had 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 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.

● In mid-June, NextCell announced the outcome of the rights issue. The outcome showed that 34,747,218 units, corresponding to approximately 91.9 percent of the Rights Issue, were subscribed for with unit rights, and that 22,636,886 units were applied for subscription without the support of unit rights, corresponding to ap­proximately 59.9 percent of the Rights Issue. Together, subscriptions of units with the support of unit rights and subscription applications of units without the support of unit rights corresponded to approximately 151.7 percent of the Rights Issue. The Rights Issue was thus oversubscribed and NextCell will receive approximately SEK 40.1 million before deduction of issue costs.

● At the beginning of July, NextCell announced that it is carrying out a directed share issue to guarantors in connection with the completed rights issue, corre­sponding to 894,232 units, which reduces the guarantee compensation by approximately SEK 1.34 million.

● 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.


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 25-07-2024 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)
2020-10-29
Study design and plan for the recently approved COVID-19 study with ProTrans
NextCell Pharma AB (“NextCell” or “the Company”) announced last week that a clinical trial with the stem cell therapy product ProTrans for the treatment of patients with COVID-19 has been approved. A total of nine patients will be treated within this phase 1b study, called "ProTrans 19+". The company provides an update prior to the initiation of the study. · ProTrans 19+ will treat COVID-19 patients with NextCell's lead candidate ProTrans. The study will be performed at the University Hospital in Örebro in collaboration with the Department of Clinical Trials and Karolinska Trial Alliance.
NextCell Pharma AB (“NextCell” or “the Company”) announced last week that a clinical trial with the stem cell therapy product ProTrans for the treatment of patients with COVID-19 has been approved. A total of nine patients will be treated within this phase 1b study, called "ProTrans 19+". The com...
Read moreRead more
2020-10-21
ProTrans stem cells approved for clinical trials in COVID-19 patients
NextCell Pharma AB ("NextCell") today announces that the application for clinical trial of COVID-19 patients with the drug candidate ProTrans has been approved by both the Ethics Committy and the Swedish Medical Product Agency. The study will be conducted at the University Hospital in Örebro in collaboration with the Department of Clinical Trials and Karolinska Trial Alliance. ProTrans is developed as an immunomodulatory stem cell therapy presently evaluated in clinical trials treating patients with type-1 diabetes. However, the mechanism of immunomodulation is expected to be applicable in
NextCell Pharma AB ("NextCell") today announces that the application for clinical trial of COVID-19 patients with the drug candidate ProTrans has been approved by both the Ethics Committy and the Swedish Medical Product Agency. The study will be conducted at the University Hospital in Örebro in c...
Read moreRead more
2020-10-14
NextCell presents at “Investerarjakten”
NextCell Pharma AB (“NextCell”) will today at 15:00 present at Investerarjakten. Viewers have the possibility to ask questions directly to CEO Mathias Svahn. The event is broadcast live on Studio Direct's youtube channel, the facebook group Aktier and on Investerarbrevet.se between 13:00-17:00. In September, NextCell published positive data for its Phase II study, ProTrans-2. The patients with type 1 diabetes treated with a dose of the stem cell drug ProTrans had maintained a statistically significantly higher insulin production after 12 months compared with the patients treated with placebo
NextCell Pharma AB (“NextCell”) will today at 15:00 present at Investerarjakten. Viewers have the possibility to ask questions directly to CEO Mathias Svahn. The event is broadcast live on Studio Direct's youtube channel, the facebook group Aktier and on Investerarbrevet.se between 13:00-17:00. ...
Read moreRead more
2020-09-10
Presentation of the positive results from ProTrans-2
NextCell Pharma AB ("NextCell") announced earlier this week that the clinical diabetes trial ProTrans-2 had met the primary endpoints. On the occation of that, the principal investigator Professor Per-Ola Carlsson together with NextCell will hold a webcast presentation today, Thursday 10 September at 16.00. The result from the clinical trial ProTrans-2 said that patients treated with a single dose ProTrans show a statistically significant improved preservation of insulin production over 12 months, compared to patients treated with placebo (p-value < 0.05). Today, on Thursday the 10th of
NextCell Pharma AB ("NextCell") announced earlier this week that the clinical diabetes trial ProTrans-2 had met the primary endpoints. On the occation of that, the principal investigator Professor Per-Ola Carlsson together with NextCell will hold a webcast presentation today, Thursday 10 Septembe...
Read moreRead more
2020-09-08
ProTrans shows significant effect in Diabetes
NextCell Pharma AB ("NextCell") today announces that the ProTrans-2 clinical trial met the primary endpoint. Patients treated with a single dose ProTrans show a statistically significant improved preservation of insulin production over 12 months, compared to patients treated with placebo (p-value < 0.05). A total of 15 patients were included in the ProTrans-2 trial. They were randomized to receive either ProTrans (n=10), NextCell’s proprietary stem cell therapy, or placebo (n=5). Treatment was blinded, ensuring that neither patients or their physicians knew whether they had received active
NextCell Pharma AB ("NextCell") today announces that the ProTrans-2 clinical trial met the primary endpoint. Patients treated with a single dose ProTrans show a statistically significant improved preservation of insulin production over 12 months, compared to patients treated with placebo (p-value...
Read moreRead more
2020-08-03
NextCell announces Eurostars grant for developing an innovative cell therapy production platform
NextCell Pharma AB (“NextCell” or the “Company”) announces today that the Company together with 3 partner organizations have been awarded a €1.6M Eurostars grant of which NextCell’s share is €470,000. The aim of the project entitled Bioscale, is to optimise automated bioreactors to manufacture the drug candidate ProTrans. The SCINUS expansion system presents cost-efficient cell culturing, designed for standardised cell therapy production, leading to improved quality consistency and reduced cost. · NextCell has been granted €470,000 of a Eurostar grant totalling €1.6M. The total budget of the
NextCell Pharma AB (“NextCell” or the “Company”) announces today that the Company together with 3 partner organizations have been awarded a €1.6M Eurostars grant of which NextCell’s share is €470,000. The aim of the project entitled Bioscale, is to optimise automated bioreactors to manufacture th...
Read moreRead more
2020-07-31
NextCell Pharma AB publishes its interim report for September 2019 - May 2020
NextCell Pharma AB (publ) (NXTCL) today announces that its Interim report for the period September 1, 2019 - May 31, 2020 now is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report Nine months (2019-09-01 until 2020-05-31) · Operating income amounted to SEK 3 191 314 (1 273 201). · Operating result amounted to SEK -12 803 349 (-13 477 202). · Earnings per share* amounted to SEK -1,11 (-1,17). · Cash and bank amounted to SEK 5 612 952 (2 249 092). In addition, after the end of the period, in June 2020, the Company received an
NextCell Pharma AB (publ) (NXTCL) today announces that its Interim report for the period September 1, 2019 - May 31, 2020 now is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report Nine months (2019-09-01 until 2020-05-31) · Operating income amounted...
Read moreRead more
2020-07-06
NextCell approved for trading on Nasdaq First North
NextCell Pharma AB (publ) (“NextCell” or “the Company”) announces that Nasdaq Stockholm AB today has approved their application for trading on Nasdaq Stockholm First North. The last day for trading on Spotlight is Tuesday, July 21, 2020 and the first day for trading on Nasdaq First North is Wednesday, July 22, 2020. The shares in NextCell will be traded with unchanged ticker (NXTCL) and ISIN code (SE0009723125) and shareholders in NextCell need not take any action in connection with the list change. "The list change is a natural step in our development and is expected to attract a broader
NextCell Pharma AB (publ) (“NextCell” or “the Company”) announces that Nasdaq Stockholm AB today has approved their application for trading on Nasdaq Stockholm First North. The last day for trading on Spotlight is Tuesday, July 21, 2020 and the first day for trading on Nasdaq First North is Wedne...
Read moreRead more