Interim Report 1 January to 30 September 2020

Summary of the interim report

• Operating revenue KSEK 0 (0)
• Income after financial items KSEK -36 978 (-26 122)
• Earnings per share -0,75 (-0,70)
• Cash and cash equivalents as of September 30th KSEK 44 587 (12 307)
• Equity ratio as of September 30th 64,1 (83,0) %

• Operating revenue KSEK 0 (0)
• Income after financial items KSEK -12 608 (-12 710)
• Earnings per share -0,25 (-0,34)

• Cyxone signed agreement with Dr Maarten Kraan as Senior Scientific Advisor
• Cyxone signed agreement with Professor Rikard Holmdahl as Senior Scientific Advisor
• Cyxone raised SEK 0.9 million in a first directed share issue under the agreement with Dr Kask to jointly develop a new treatment of Covid-19
• Cyxone plans to initiate a Phase 2 clinical trial with Rabeximod in Covid-19 patients
• Cyxone raises SEK 1 million in a second directed share issue under the agreement with Dr Kask to jointly develop a new treatment of Covid-19
• Cyxone revises the development plan for Rabeximod

• Fully exercised option agreement with Dr. Kalev Kask brings in a total of SEK 21.8 million before transaction costs, of which SEK 1.8 million was obtained through previous exercises.
• Cyxone filed patent application to extend exclusivity of Rabeximod.
• The board of directors of Cyxone decided to carry out a directed issue of units of approximately SEK 19 million and an issue of warrants to current shareholders. The directed issue was carried out through an accelerated book-building procedure.

During the past quarter, we have been delighted to report continued progress in our efforts to build further value based on our two unique, clinical stage drug candidates, Rabeximod and T20K. Most important is the addition of yet another project to our pipeline. This exciting opportunity is based on preclinical results indicating the potential of Rabeximod to control the overactivation of the immune system in patients infected with life threatening viruses. Rabeximod will be evaluated as a Covid-19 treatment in patients exhibiting a moderate disease status with symptoms that may also appear in other virally induced respiratory diseases. Further, Rabeximod has shown an excellent safety profile in human studies. In a very short time span, we have been able to plan, finance and initiate a Phase 2 trial in this indication, with expected read-out in the third quarter of 2021. In parallel, we are continuing our efforts to bring Rabeximod forward as a treatment for rheumatoid arthritis. Supported by our senior medical advisors, we are in the process of more precisely defining the patient population which is expected to benefit most from Rabeximod treatment (RA). The outcome of this exercise will be of immense value for optimizing the design of the next clinical study, which is expected to commence in the latter part of 2021. The favorable safety and tolerability profile of our drug candidate is further supported by the positive top-line results from a six-month toxicological study in two species, which became available a few weeks ago. 

Our drug candidate T20K, a potential new treatment of multiple sclerosis, has previously undergone a limited Phase 1 study as an infusion. As we aspire to improve the convenience for patients and caregivers, we are currently assessing a more convenient administration in complementary preclinical studies including oral administration.  

Over the last few months, we have been able to attract and engage a range of competent colleagues and advisors. The most recent addition to the team, Sally Abdel Moaty, will be a valuable contributor to bring preclinical projects into the clinical Phase. Sally has long experience in research on rheumatology and inflammation as well as from project management in academia and the pharmaceutical industry. Most recently, she was employed by the Swedish biotech company Kancera, with responsibility for projects within rheumatoid arthritis and multiple sclerosis. Sally was also involved in the preparations of a clinical trial in Covid-19 patients.

Cyxone’s financial position has been strengthened through a series of directed share issues that have been executed within the frames of an option agreement with the US-based scientist and entrepreneur, Dr Kalev Kask. In total, the issues resulted in a gross proceed of SEK 21.8 million, which will cover most of the costs for the Covid-19 trial. Based on the significant interest in Cyxone from investors, we were able to secure an additional gross amount of approximately SEK 19 million through a time- and cost-effective directed share issue that was announced on November 10. The simultaneous issue of free warrants to our existing shareholders is an important component of this financing solution, as it provides an opportunity to partly compensate the dilution effect that the directed issue entails.

We have also put great efforts into our outreach activities, primarily intended to raise the awareness of our key assets among potential commercial partners within the global pharma industry, but also to create stronger ties with existing and potential new investors. During the quarter, I have had the opportunity to present Cyxone at a number of investor meetings and partnering events, most recently at BioEurope’s digital conference that hosted close to 3,000 participants from over 50 countries. 

To summarize, in a very short time frame we have managed to expand our project portfolio, filed new patent applications for our most mature asset Rabeximod to potentially prolong its market exclusivity, secured additional financing and expanded our team. This provides us with a considerably strengthened platform for the ongoing efforts to combat disease and create value for our shareholders. We are now eagerly looking forward to progressing the Covid-19 trial, optimizing the development plan for Rabeximod in rheumatoid arthritis and optimizing T20K’s development towards clinical Phase.

Follow our news and information about our presence at investment events via Nasdaq First North Growth Market and the company's website: www.cyxone.com

Tara Heitner
CEO, Cyxone

12 February 2021                   Year-end report 2020

Malmö
November 13, 2020

The Board of Directors
Cyxone AB

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.

Tara Heitner, CEO
Tel: +46 70 781 88 08
Email: tara.heitner@cyxone.com
Adelgatan 21
211 22 Malmö, Sweden

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 Tara Heitner for publication on November 13, 2020.

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 (publ) (Nasdaq First North Growth Market: CYXO) develops disease modifying therapies for diseases such as rheumatoid arthritis and multiple sclerosis as well as treatments for virally induced acute respiratory disorders. Rabeximod is a Phase 2 candidate drug being evaluated for the management of rheumatoid arthritis and moderate Covid-19 infections. T20K is a Phase 1 candidate drug for treatment of multiple sclerosis. Certified Adviser is Mangold Fondkommission AB, +46 (0)8 503 015 50, ca@mangold.se. For more information, please visit www.cyxone.com