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 amounted to SEK -7 973 582 (-3 422 828) SEK which includes issue costs of SEK 3.7 million.
- Earnings per share* amounted to SEK -0.51 (-0.40).
*Operating income per share: operating results divided by the average number of shares. Average number of shares for the fourth quarter of 2018/2019: 15 717 641 shares (8 505 425). Number of shares in NextCell as per August 31, 2019, 19 144 092 shares
(8 505 425).
** Solidity/Equity ratio: shareholders' equity of the balance sheet total.
Significant events during the fourth quarter 2018/2019
- Subscription period regarding the rights issue begins and an information memorandum is published. NXTCL receives guarantee commitments from an external guarantee consortium of about SEK 14.7 million and subscription commitments and letter of intent for about SEK 5.2 million, which means that the rights issue is secured at approximately 80 %. The company's two largest shareholders, Anders Essen-Möller and Diamyd Medical AB, both fully subscribe to their respective shares.
- The first patient in the ProTrans-Repeat Study, gets their treatment in mid-June.
- Via its biobanking business, Cellaviva, NXTCL is partnering with Bonzun Health Information AB to provide digital services, primarily apps, for expectant parents before and during pregnancy. The purpose is to increase the digital presence.
- The outcome of the rights issue is published. The issue was subscribed to 368 percent and NXTCL is thus given the full issue amount of approximately SEK 24.9 million before issue costs. The oversubscription means that no issue guarantees have been used.
- The last diabetic patient in the Phase II part of the ProTrans-1 trial is treated. This means that all patients included in the study have now been treated and are undergoing a 12-month follow-up period before efficacy and safety data will be available.
- In mid-August, NXTCL files 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 analyzes for diseases and conditions affecting the central nervous system. The current patent application is the third in order. Already, there are two existing patent applications, filed in February and July 2018.
Significant events after the reporting period
- For ProTrans-1, the dose escalating phase I-part, the last patient visit is completed at the end of September and the Phase 1 part of the study is thus completed.
- The last patient in ProTrans-Repeat's active treatment group will receive their treatment at the beginning of October. This means that all ProTrans treatments for the two ongoing studies now are completed. Regarding the patients included in the control group, four out of nine are included. The remaining five patients are expected to be included before year-end 2019.
- In October, Cellaviva's new office was opened in Copenhagen. 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.
CEO Mathias Svahn's comments
We have now completed our second year as a publicly traded company. We can look back on a productive year where we treated all the patients in our phase II-part of ProTrans-1 trial and filed the application, received approval, and subsequently started the ProTrans-Repeat phase-II clinical trial. Shortly after closing our fiscal-year all patients in ProTrans-Repeat were also treated.
ProTrans is our proprietary drug candidate. The starting materials is umbilical cord derived mesenchymal stem cells selected using the company's patent pending selection algorithm. The algorithm is specifically designed to select the most suitable stem cells and donors to counteract an overactive immune system, which is generally considered to be the cause of autoimmune diseases. Cell therapy treatment using ProTrans means that we boost the patient’s body own potential for regeneration and self-healing, by adding a large number of specific stem cells. Every step of the development of cell therapies focuses on how to bring efficous treamtents all the way to patients. The production of ProTrans is robust, scalable and ensures that only potent stem cells are used. ProTrans is an allogeneic treatment that can be easily stored, shipped and administered. All in all, this means that we can offer cost-effective treatment, which is absolutely crucial to successful commercialization and treating as many patients as possible.
Our first two trials using ProTrans are focused on type-1 diabetes patients, under the guidance and supervision of principal investigator, Professor Per Ola Carlsson, based at Uppsala University Hospital and Uppsala University. Both trials are further supervised by a Data Safety Monitoring Board, consisting of Professors Anders Fasth, Åke Lernmark and Ulf Schmidt. Furthermore, are very excited see the results from our ProTrans-1 phase I/II trial which we expect to have available in the summer of 2020. Due to the excellent study team and our fantastic staff with their medical & scientific expertise our clinical trials have progressed according to plan. We have now also completed treatment of patients in the ProTrans-Repeat trial and only the inclusion of some control patients remains. Results for the ProTrans-Repeat trial can be expected by the end of 2020.
As a company we have increased our cost compared to the previous fiscal year, this mainly due to the fact that NextCell now is a thriving biotech company with a drug candidate in two phase II clinical trials. In Q4 of this fiscal year we also incurred additional costs related to our share issue which was oversubscribed by more than 300%. Most of the cost relating to our clinical trials have already been taken and our run-rate based on current activities is below SEK 1.5 million per month, which I believe is cost-efficient for a company with two ongoing phase II clinical trials. Cellaviva's operations, i.e. the family saving of stem cells, have steadily increased during the fiscal year. Cellaviva has exceeded its sales on a month-by-month basis compared to last year. Already after five months into the fiscal year, we passed last year's total annual sales of Cellaviva boxes and the positive trend seems to be continuing.
The increased number of customers, wanting to save stem cells, puts increased pressure on Cellaviva's organization. In order to meet demand, Cellaviva now has collection staff in our three Swedish metropolitan regions and throughout Denmark. Furthermore, in October 2019 we inaugurated a new office in Copenhagen which will primarily be used to receive Cellaviva customers and hold training courses. The Öresund region is an important cluster for the life sciences and I also see the opportunity to increase NextCell's presence and exposure in the region now that we have offices in both Stockholm and Copenhagen.
We at NextCell / Cellaviva look forward to our coming fiscal year and hope to remain of interest and joy to our shareholders, customers and patients. Thank you all for joining us on this journey!
Mathias Svahn, Ph.D.
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For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Sofia Fredrikson, CFO
Phone: 08-735 5595
E-mail: info@nextcellpharma.com
About NextCell Pharma AB:
Stem cells are expected to change the way how many of today's life-threatening diseases are treated. NextCell
Pharma AB develops ProTrans, a drug candidate consisting of stem cells for the primary treatment of autoimmune and inflammatory diseases as well as for use in kidney transplants. ProTrans consists of selected stem cells derived from the umbilical cord tissue with NextCell's patent pending selection algorithm. NextCell operates the stem cell bank Cellaviva, which is Sweden's first and only IVO-approved biobank for family-saving of stem cells from umbilical cord blood and umbilical cord tissue.