Interim Report 1 January to 31 March 2021

Financial Summary for the group

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

• World leading rheumatology authority Professor Costantino Pitzalis collaborates with Cyxone on Rabeximod Phase 2b study

A new year marks new beginnings. However, in 2021 we are still navigating a global pandemic that challenges us. At the same time we’ve never felt a stronger incentive to do what we do in Cyxone.

It is almost an understatement to say that last year was a challenging one - both on an individual and a societal level. In 2020, the pandemic also led Cyxone to pivot focus when we discovered that our drug candidate Rabeximod, otherwise tested as a treatment for rheumatoid arthritis, could have a positive effect on patients with moderate Covid-19. We decided to roll out clinical trials in Eastern Europe, with phase 2 set out to start January 2021. 

I’m pleased to say that the Covid-19 trial has now been successfully started. The challenge of running clinical trials with Covid-19 patients during the peak of the pandemic tested our capabilities as a company with new waves of the pandemic putting countries, health care systems and personnel under immense pressure at times. The recruitment of patients into our trial has been successful despite overloaded and understaffed hospitals and due to the dedication of the Cyxone team. We have been successful in recruiting patients to the trial by opening more sites and gaining approvals in more countries than planned. We have established a good interaction with principal investigators on the sites, who are very interested in enrolling patients for our phase 2 trial. The high pressure on the hospitals has underscored the need for a drug like Rabeximod to ease the burden on health care systems.  

A read out of our preliminary results of Rabeximod as treatment for Covid-19 is expected by the end of Q3 2021, as originally planned. We continue discussions with potential partners to support further drug development steps and commercialization of Rabeximod.

As recently announced, we are very happy to have initiated a collaboration with Professor Costantino Pitzalis, a world leading expert in translational research and biopsy driven RA clinical trials. As part of the collaboration with Cyxone, Professor Pitzalis along with a team of world-class international rheumatologists will continue to work with Cyxone on running the Phase 2b trial. The advisors have fine-tuned and optimized the design of Cyxone’s next clinical phase 2b study of Rabeximod, building on the encouraging results of the phase 2a trial. Within the scope of the collaboration Cyxone will seek to include ex vivo studies to deepen the understanding of the mode of action and potentially expand applicability to other disease indications. Input from Professor Pitzalis and our team of advisors has been included in the new Phase 2b clinical trial design. 

We are running the next trial in collaboration with Professor Pitzalis and this provides Cyxone the opportunity to include biopsy driven endpoints, highlighting the action of Rabeximod on immune cells in the joint and providing key biomarkers as early predictors of therapeutic efficacy.

We’re very excited about the collaboration with Professor Pitzalis on the Rabeximod clinical trial and the opportunity to dive deeper into the mode of action of Rabeximod. Cyxone recently met with its rheumatology scientific advisors including Professor Pitzsalis. During the discussion on the Phase 2b clinical trial Rabeximod was highlighted as a potential ideal alternative to methotrexate as a first line therapy and the novelty of its mode of action was considered a unique selling point. Furthermore, the relevance of Rabeximod’s mode of action in other indications was also discussed and this was viewed as an additional value driver. We are currently in an ongoing dialogue with potential partners on co-development or license agreement for the RA program.

In the past quarter, we have progressed as planned with T20K, our drug candidate for patients with multiple sclerosis, and we continue to progress with our nonclinical studies. Work to validate the manufacturing processes with top tier CMOs, validation of biomarkers to simplify clinical development and studies for evaluating the most convenient and effective administration forms are progressing. These nonclinical studies are key components for IND submission and to ensure the greatest possibility for successful T20K clinical studies in the future.

In other news, we are also growing and strengthening the company even further including the management and development team. Cyxone is currently recruiting a head of clinical trials, ensuring continuous quality in current and future clinical trial studies.

In preparation for uplisting to the main market we have allocated resources to meet regulatory compliance in all aspects of the company for the application process.

We look forward to a productive Q2 on all our current projects, onboarding of new team members and the Covid-19 trial progression. 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

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

Malmö

May 12, 2021

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 (0)70 781 88 08
Email: tara.heitner@cyxone.com
Adelgatan 21
211 22 Malmö, Sweden

This information is such information as Cyxone AB (publ) is obliged to make public pursuant to the Swedish Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 a.m. CET on 12 May 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.

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