Interim Report 1 October to 31 December 2020

Financial Summary for the group

* Comparative figures for the group consist of the period after the group was established 2019-07-30 to 2019-12-31.

Significant events during the fourth quarter of 2020

• Fully exercised option agreement with Dr. Kalev Kask brought in a total of SEK 21.8 million before transaction costs, of which SEK 1.8 million was obtained through previous exercises.
• Cyxone announced positive results from regulatory toxicology studies of Rabeximod.
• Cyxone filed patent application to extend exclusivity of Rabeximod.
• A directed issue of units of approximately SEK 19 million and an issue of warrants to current shareholders were carried out. The directed issue was carried out through an accelerated book-building procedure.
• Cyxone received regulatory approval to initiate a clinical Phase 2 study with Rabeximod in Covid-19 patients.
• Cyxone decided to apply for a listing of its shares on Nasdaq Stockholm Main Market.
• Because of the potential change of listing, Cyxone as of Q4 2020, adjusted the accounting principles and will report group according to IFRS.
• Cyxone has filed an IND in the US with Rabeximod following positive feed-back from pre-IND meeting with the FDA.

Significant events after the end of the period

• Cyxone reported first Covid-19 patient screened in Phase 2 clinical trial of Rabeximod.

CEO Tara Heitner comments

After 6 months at the helm of Cyxone AB I am pleased with the significant advancements Cyxone AB made in 2020 to bring forward drug candidates that can revolutionize the treatment of diseases with substantial unmet medical needs. We have been able to attract several new competent and experienced colleagues and advisors and our team is now stronger than ever. Further, we have identified a new and compelling opportunity for our most advanced drug candidate, Rabeximod, as a potential treatment of Covid-19. We have filed a new medical use patent as well as 4 additional patents on Rabeximod. This expanded patent estate increases the value and scope for Rabeximod immensely and offers Cyxone time to position Rabeximod more competitively in the market. We are currently finalizing the optimized development plan for Rabeximod to increase its value in treating rheumatoid arthritis, and the trial is expected to commence in the latter part of 2021. The outcome of this effort is an increased value for Rabeximod and for Cyxone. 

In the fourth quarter, we were granted regulatory approval to initiate a Phase 2 study of Rabeximod in Covid-19 patients and the enrollment of patients is now ongoing. The trial will include 300 patients at clinical centers in Poland, Slovakia and in additional countries. Rabeximod is being evaluated in patients suffering from moderate Covid-19 in need of oxygen treatment but not ventilator support. It’s novel mode of action in controlling hyperactivated immune cells that cause a cytokine storm in the lung – a potentially lethal overreaction to the virus that is responsible for the high number of Covid-19 deaths. It holds hope that moderate to severe patients can quickly recover and progression to acute disease and death can be prevented for Covid-19 as well for other viral infections of the lung. Preliminary results are expected in the third quarter of 2021. A positive study outcome would be a considerable breakthrough for the pandemic making us eligible to apply for emergency use authorization. To this end we will seek a strategic partner to assist with commercialization and distribution, to fund further development, and to prepare for future trials which will also be required.  

An important stamp of quality was received after we filed an IND (Investigational New Drug) application for Rabeximod with the US Food & Drug Administration in December. The IND is a key step towards being able to perform studies and eventually apply for market authorization in the US – the world’s largest pharmaceutical market. During the review process, the FDA has provided valuable feedback on the protocol for the Covid-19 study, which we have adapted accordingly. The IND submission passed the review process without any comments from the expert committee, which underpins the quality of the scientific data that has already been obtained for Rabeximod. Should we so wish, we are now able to apply for ethical approvals to include study sites in the US. Another important aspect of the IND registration status is that it opens up for seeking patent term extension in the US on all 5 new patents filed in 2020.

In the past quarter, we have also made further progress in our T20K program, which aims at developing a new treatment for multiple sclerosis. Cyxone has previously tested a microdose of T20K in an intravenous formulation in human volunteers with no adverse effects. However, since T20K has shown efficacy in vivo with more convenient administration forms, our aim is now to bring forward a convenient administration such as an oral formulation to optimize the administration and safety of a future treatment for patients and caregivers. This is the focus of our current IND-enabling preclinical investigations. Together with our external scientific advisors, we are continuously gaining a better understanding of the unmet medical needs and the optimal positioning for T20K in this debilitating disease.

The funding received from the directed share issue announced in November has provided us with additional resources needed to drive our unique drug projects forward. We were happy to see a strong interest from investors, leading to a net proceed from the issue of SEK 18 million. At the same time, the Board of Directors decided to issue warrants that will to some extent compensate our shareholders for the dilution in the directed issue. If all the warrants are exercised for the subscription of new shares, Cyxone can receive, at most, an additional SEK 42 million already in May. 

We look forward to a productive year with accelerated progress. We are working intensively with the study centers in the Covid-19 trial to ensure a swift inclusion process and successful trial completion. We will soon finalize development plans for Rabeximod in rheumatoid arthritis and initiate start-up activities for the trial. In parallel we have started scouting for partners and we will intensify business development activities in 2021.  We will continue to prepare T20K for convenient administration in multiple sclerosis and develop biomarkers needed for further development. We will continue to expand our team and increase our internal core competencies. I have set lofty goals for Cyxone and will do my utmost to realize the potential of our assets and our team. Our exciting journey continues where our focus is to ensure that Cyxone takes further leaps forward in the coming year, all in the interest developing cutting edge treatments that can make a meaningful difference in the lives of patients while enhancing company and shareholder value.

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

Upcoming financial reports and Annual General Meeting

9 April 2021                              Annual report 2020

12 May 2021                             Q1 report

3 June 2021                              Annual General Meeting

27 August 2021                        Q2 report

12 November 2021                   Q3 report

11 February 2022                     Q4 report

The report is enclosed in full here, and all reports will be available from these dates at www.cyxone.com

Submission of interim report

Malmö

February 12, 2021

The Board of Directors
Cyxone AB

Disclaimer

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.

Contact

Tara Heitner, CEO
Tel: +46 (0)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 February 12th, 2021 at 08.30 a.m. 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.

About Cyxone

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

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