Interim Report 1 January to 30 June 2021

Financial Summary for the group

Significant events during the second quarter of 2021

• World leading rheumatology authority Professor Costantino Pitzalis collaborates with Cyxone on Rabeximod Phase 2b study.
• Cyxone AB (publ) receives approximately SEK 18.2 million through exercised warrants of series TO4.
• Cyxone appointed new COO and CFO.

Significant events after the end of the period

• Cyxone and Medical University of Vienna announce collaboration to study broader T20K use in MS.
• Cyxone announces Rabeximod in Covid-19 Phase 2 trial closed, data to be reported in Q3.

CEO Tara Heitner comments

Developing a treatment for Covid-19 is an even more challenging task than other drug development processes. It is therefore with extra pride I note that Cyxone successfully has met several challenges and that we expect to present data from a phase 2 trial during the third quarter.

Phase 2 trial with Rabeximod in patients with Covid-19 closed

In January 2021 we initiated a clinical phase 2 trial in eastern Europe with the aim to enroll 300 patients. After reevaluation of the study design by two independent biostatisticians, we concluded that the number of patients recruited at that time was sufficient to provide statistically significant readout. We therefore decided to close the trial, with the implications that we met our timelines under budget while not taking on further risk by opening more sites in other regions. The recurring waves of the pandemic led to slower enrollment rates than expected. During the most intense periods there was good access to patients – but the health care system and the professions working in it were overloaded. In contrast, when the intensity of the pandemic eased, it also meant that the number of patients relevant for the clinical trial decreased and patient recruitment slowed down. 

When vaccinations and the spring season resulted in falling infection rates, we had to adapt. A thorough analysis was conducted where we looked at different opportunities to open research sites in other areas of the world where the pandemic is still in an intense phase. In parallel, we let two independent biostatisticians reevaluate the statistical requirements based on what the industry has learned over the past year of running Covid trials. Both concluded that the initial trial design was overpowered and that the 90 patients already enrolled would be sufficient to power an analysis of effect of Rabeximod over placebo.  

We therefore decided to close recruitment to the phase 2 trial of Rabeximod in Covid-19 patients in July. Importantly, the clinical trial study results that will be reported in Q3 2021 are expected to yield valuable information also for the further development of Rabeximod as a treatment to prevent Covid-19 mediated Acute Respiratory Distress Syndrome (ARDS) – the severe complication in the lungs seen in Covid-19 patients and other viral infections of the lung.

Intensified preclinical activities for T20K in multiple sclerosis

During the second quarter we ramped up the preclinical activities for our drug candidate T20K – a potential new treatment of multiple sclerosis (MS). The drug candidate has already shown to be well tolerated in humans in a Phase 1a study when administrated as an infusion. As we pursue development activities for T20K, we strongly believe in developing an administration form that is convenient for the patients. As we now work to entering IND enabling studies for T20K in 2022, we are evaluating both an oral and a subcutaneous form in order to continue the clinical development with the most appropriate form. 

The research collaboration with Prof. Christian Gruber and Prof. Gernot Schabbauer from the Medical University of Vienna that we announced in the summer is an important contributor to the preclinical program with T20K. The aim of the collaboration is to expand the therapeutic application of T20K in MS, gain more in-depth knowledge of the Mode of Action and deepen our scientific understanding of how T20K works in the body. Prof. Christian Gruber is the inventor of T20K and has a thorough understanding of the drug candidate, and together with Prof. Gernot Schabbauer’s state of the art in vivo model for MS, the collaboration creates new opportunities to further develop T20K. Results are expected in Q2 2022, and a successful outcome can expand the therapeutic scope of T20K in MS and potentially in other indications as well.

Preparations for the start of a Rabeximod Phase 2 trial in RA

The preparations for a phase 2b trial of Rabeximod in Rheumatoid arthritis (RA) are ongoing and we are currently putting the final touches on the trial synopsis with input from our advisors and CROs. CROs for the trial are being screened and we have engaged new team members to support the trial. Our collaboration with Prof. Constantino Pitzalis that we established earlier this year will generate more detailed information about the Mode of Action of Rabeximod which will help us to better define the patient group in RA as well as alternative indications for Rabeximod beyond RA.

Operations adapted to the future

To ensure that Cyxone can successfully deliver on all our activities, including the uplisting to the Nasdaq main market, the company has taken time to improve and expand the team. Carl-Magnus Högerkorp, who joined as COO in May, brings long and broad experience from pharma and biotech companies, both internationally and nationally. On August 1, Henrik Hang started as CFO and his many years of experience as CFO and multiple finance positions in international enterprises and listed companies in Sweden will be a great contribution to the management team. The preclinical and clinical development teams have also been expanded and further new employees will be joining the company during the autumn.

We also welcome Peter Heinrich and Alejandra Mørk as new board members, both bringing valuable experience and network to the company. Peter Heinrich has more than 20 years of experience in the pharma and biotech industry and is a serial entrepreneur that has started a number of biotech companies. He brings to the team an extensive network in Europe and experience with fundraising. Alejandra Mørk is CEO and part owner of KLIFO A/S. Previously she worked for Nycomed Pharma for 18 years, in various management positions in latestage drug development, and lifecycle management.

Step by step we aim to become a company that is equipped to run and manage multiple drug development programs in parallel which can deliver unique solutions for patients. Together with research collaborators and strategic partners around the world, we are confident to fully deliver on the potential in our innovative pipeline.

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

12 November 2021                 Q3 report

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
August 27, 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 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 27 August 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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