Press Release

Interim Report 1 January to 30 September 2021

October 29, 2021 08:31 (CEST)
Regulatory

Financial Summary for the group

KSEK 2021-07-01 2020-07-01 2021-01-01 2020-01-01
2021-09-30 2020-09-30 2021-09-30 2020-09-30
Profit/loss before tax -10 974 -12 620 -31 043 -37 014
Total assets 58 567 61 797 58 567 61 797
Earnings per share before and after dilution (SEK) -0,17 -0,26 -0,51 -0,75
Cash and cash equivalents as per period end 42 963 45 562 42 963 45 562
Equity ratio as per period end 90,8% 91,0% 90,8% 91,0%
Significant events during the third quarter of 2021
  • Cyxone and Medical University of Vienna announced collaboration to study broader T20K use in MS
  • Cyxone recruited Chief Medical Officer and key members to the development team
  • Cyxone announced Rabeximod in Covid-19 Phase 2 trial closed
  • Cyxone to leverage IND and use FDA pre-review for Covid-19 phase 2 trial
Significant events after the end of the period
  • No significant events
CEO Tara Heitner comments Preparing a Phase 2b study in rheumatoid arthritis

As Scandinavia emerged from pandemic-related lockdowns, we continued to ramp up our activities toward the initiation of a Phase 2b study of Rabeximod in a well-defined subgroup of rheumatoid arthritis patients. As we strive to reach our goal to enrol patients in the study in early 2022, the company has allocated more resources to study preparations. An important part of these activities has been the expansion of our development team. I am happy that we recently could announce the recruitment of a Chief Medical Officer as well as of two new clinical trial managers. Together they command vast knowledge in clinical development including experience in clinical rheumatoid arthritis trials. Further, having held key positions in global clinical trial management, all three bring important insights and experience into running global multisite clinical trials, giving us the best possible starting position to conduct a successful clinical study with Rabeximod in rheumatoid arthritis.

Due to recent warnings from the FDA that limit the prescription of JAK inhibitors to rheumatoid arthritis patients, the need for new safe and effective long-term disease-modifying therapies has become more acute. Since Rabeximod has been proven safe and well-tolerated in a previous clinical Phase 2a study, we see an increased market void for our lead drug candidate, which we hope to be a potential treatment option with high impact.

Cyxone plans for the next steps for Rabeximod in Covid-19

While the world is slowly but steadily coming to enjoy the benefits of the newly developed vaccines toward Covid-19, the need for effective therapies limiting the severe effects from an infection remain a defined need in many parts of the world, including Europe and the U.S. Cyxone recently concluded a clinical Phase 2 study of Rabeximod in Covid-19 patients. The study included around 90 patients who were enrolled into three treatment arms; two where the patients received either a low dose or a high dose of Rabeximod, and one placebo arm.

Provided positive results from the recently concluded Phase 2 study, we will engage with the relevant regulatory authorities in order to outline the most effective pathway toward a potential market approval. In order to fund the continued development for Rabeximod in Covid-19, Cyxone intends to seek a commercial partnership, or external funding via development grants.

Taking the next step with T20K as a treatment of multiple sclerosis

In July, a collaboration with the Medical University of Vienna was initiated. The aim of the partnership is to explore the drug candidate’s mode of action, as well as to expand the potential medical use of T20K in multiple sclerosis. T20K has previously shown positive properties in preclinical studies, pointing toward decreased levels of inflammatory cytokines and ameliorating effects on disease onset and severity. Based on these important insights we are now honing in on a more optimal drug formulation and administrative route for T20K – a challenging feat where drug efficacy, patient convenience, and manufacturing optimization, among other parameters, are balanced. The results from these formulation studies will serve as foundation for the next step ahead, which include non-clinical and clinical studies.

All in all, we are facing an eventful time period in the near future, with each step taking us closer to reaching our goal of providing millions of patients suffering from debilitating diseases with better therapies.

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

11 February 2022                    Year-end report 2021

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
October 29, 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

The information was submitted for publication, through the agency of the contact person set out above, at 08.30 a.m. CEST on 29th of October 2021.

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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