Correction: Interim Report January 1st to September 30th, 2019
Report enclosed Summary of the interim reportFirst nine months (January 1st to September 30th, 2019)
- Operating revenue KSEK 0 (0)
- Income after financial items KSEK -14 894 (-10 893)
- Earnings per share -0,40 (-0,55)
- Cash and cash equivalents as of 30 September KSEK 12 307 (10 478)
- Equity ratio as of 30 September 92,7 (90,7) %
- Operating revenue KSEK 0 (0)
- Income after financial items KSEK -5 765 (-4 390)
- Earnings per share -0,15 (-0,22)
- In July, an application was submitted to the Central Ethics Committee (CEC) in Poland for permission to initiate a phase 2b clinical trial with the drug candidate Rabeximod for rheumatoid arthritis (RA). Applications in up to eight additional European countries will follow in the next six months, with recruitment planned to start during H1 2020.
- In July, it was announced that the first healthy male volunteer received the first dose of the drug candidate T20K as part of the First-in-Human, phase 1 study.
- In July, it was announced that Cyxone signed an agreement with EGeen Inc., a clinical research organization (CRO), to conduct the upcoming phase 2b clinical trial with Rabeximod for RA in selected Eastern European countries.
- In early August, it was confirmed that the phase 1 clinical trial with drug candidate T20K successfully achieved its aim of confirming T20K's safety and tolerability in humans and the study showed no reports of serious adverse events.
- In August, it was announced that Cyxone strengthens the team with Malin Berthold as project manager for the company's development programs.
- In September, Cyxone's board of directors decided to explore the possibilities of an orphan drug designation (ODD) of the drug candidate Rabeximod.
- At the end of September, it could be determined that the exercise rate of the warrants TO3 corresponded to 66%, which means a capital injection of approximately 62.4 MSEK before issue costs.
- In November, the company's Board of Directors announced the decision to find a new CEO. Ola Skanung, CFO, acts as interim CEO effective immediately while the recruitment process to meet new CEO is ongoing.
Earlier this week, the Board of Cyxone resolved to appoint a new CEO. The company has in a relatively short time developed from an early stage research company to the promising clinical development company it is today. Combined with the recently completed capital increase, we are well positioned toward our bigger ambitions and the next phase for the company. With the team we have in place, our planned activities and projects will progress at the same time as the recruitment process to find a new CEO. If we regress to a summary of this year’s third quarter, we see the milestones that we have achieved with our two drug candidates in focus; successful clinical study results with T20K, submitted applications for phase 2b study with Rabeximod and a positive outcome of TO3 that points to a high level of commitment and trust from our shareholders. It has been an intense year, but we also see the results that the company’s efforts lead to in the steps taken towards the goal of being able to offer new effective and safe drugs that can improve the quality of life for those affected by autoimmune diseases.
Positive outcome of TO3
Once the outcome of the series 3 warrants was completed, it was revealed that 66% of the warrants had been exercised bringing in 62.4 million SEK to the company. These will come in good use for driving Rabeximod through both toxicology studies and into phase 2b studies as well as taking T20K further in the oral development program. We are grateful for the confidence shown in us and the opportunity to continue to push Cyxone’s two candidates toward the next stage of development.
Plans for T20K
In July, we announced that the clinical phase 1 trial with drug candidate T20K successfully achieved its goal of confirming T20K's safety and tolerability in humans. There were also no reports of serious adverse events. In other words, this is now a closed chapter and the next step working to develop an oral formulation for T20K has already started. Discussions with experts and potential partners have been conducted to identify the best way to formulate T20K into a tablet or capsule form. Once T20K has been prepared in an oral formulation, a further phase 1 clinical trial is planned to confirm the safety and tolerability in humans with the new substance.
Development of the phase 2b study with Rabeximod
We were able to announce in July that we have reached so far in the work that we were able to submit the first of up to nine applications for permits to initiate a clinical phase 2b trial with Rabeximod. The plan is to conduct a multicenter study in a number of Eastern and Western European countries, which requires coordinated work with good partners since each country has its own application process. Mutual for the different countries is, however, that the assessment is carried out by a national ethics committee as well as approval by the respective competent authority. At the time of writing, we have received positive responses from ethical committees in two countries and are either preparing supplementary material or awaiting response to move the process forward. The documentation for the respective competent authority is called an IMPD, Investigational Medicinal Product Dossier, and must contain all the details of the study and is now in the final stages to be completed. It is thanks to our dedicated and committed team that these processes have been able to run as expected in recent months.
The two bigger nearest milestones in the project, in addition to the permit process, is the execution of a six-month toxicology study in two animal species that the authorities require, and the capsulation of the GMP quality Rabeximod substance that was included in the acquisition of the project from OxyPharma.
Orphan Drug Designation exploration of Rabeximod
A parallel track that is being evaluated is the possibility of an Orphan Drug Designation (ODD) for Rabeximod. We have seen a big trend for a while, where the interest in orphan drugs and all its benefits has increased. Therefore, the decision to explore an Orphan Drug Designation for Rabeximod is very interesting.
Presence in Switzerland
With our wholly owned subsidiary in Basel, Switzerland, a major step was taken towards increasing the company's exposure to pharmaceutical companies as well as long term investors this summer. Another initiative in Switzerland during the quarter was the company’s participation in the 'Biotech in Europe Forum' organized by the industry-renowned Sachs Associates. A very interesting conference focusing on investments and partnering where business developers from pharmaceutical companies and representatives from investment funds make up the majority of participants. We received attention from international parties that we might not otherwise have come in contact with, which meant that it was time well spent.
Thank you for the support and the commitment you show Cyxone.
Follow our news and information about our presence at investment events via Nasdaq First North and the company's website: www.cyxone.com
Chairman of the Board, Cyxone AB
Upcoming financial reports
February 14th, 2020 Year-end Report, 2019
Submission of interim report
November 15, 2019
The Board of Directors
This is a translation of the original Swedish version of the interim report. In case of any discrepancy between this translation and the Swedish original, the latter shall prevail.
Bert Junno, Chairman of the Board
Ola Skanung, CFO and interim CEO
Phone: +46 (0) 705 121 040
Cyxone AB (publ)
211 22 Malmö
This report contains such information that Cyxone AB is required to make public under the EU’s Market Abuse Regulation. This Information was submitted by CEO Kjell Stenberg for publication on November 15, 2019 at 08.55 CET.
This press release contains forward-looking statements that constitute subjective estimates and forecasts about the future. Assessments about the future are only valid on the date they are made and are, by their nature, similar to research and development work in the biotech field, associated with risk and uncertainty. In light of this, actual outcomes may differ substantially from what is described in this press release.
Cyxone AB is a clinical stage biotech company with a portfolio of immunomodulating drugs for the treatment of autoimmune diseases such as multiple sclerosis (MS) and rheumatoid arthritis (RA). The company’s drug portfolio is based on two technological pillars in the form of oral molecules and cyclotide-based drugs that inhibit key processes in the body’s cells that are typically associated with various immune-related disorders. Cyxone’s technologies have the potential to address an unmet need and provide new effective and safe medicines that can improve the quality of life for patients affected by autoimmune diseases. The company has two drug candidates, T20K for MS in a clinical phase I-program and Rabeximod for RA in clinical phase II-program. Cyxone’s Certified Adviser on the Nasdaq First North Growth Market is Mangold Fondkommission AB, telephone +46 (0)8-503 015 50 and e-mail email@example.com. www.cyxone.com