Interim Report 1 January to 30 June 2022

Financial Summary for the group  

• Tara Heitner steps down as CEO of Cyxone AB
• Carl-Magnus Högerkorp is appointed as interim CEO
• The board has decided to employ Bert Junno as working chairman to assist in investor relations, legal and contractual technical areas
• Cyxone files regulatory submission to start clinical phase 2b study with Rabeximod 

• Cyxone files submission to start clinical Phase 2b study in Poland and Georgia

At the beginning of the quarter, we finalized the report on our program with Rabeximod in Covid-19 and confirmed the previously demonstrated favorable safety and tolerability profile of the drug candidate Rabeximod in this indication. However, it was concluded that no statistically significant advantage between the treatment and placebo arms was observed. The data from this study will be added to data we have collected previously in patients with rheumatoid arthritis (RA), which is the main indication for Rabeximod. The main focus on Rabeximod is now to perform a phase 2b study in RA.

During second quarter we intensified our work with our CRO. The focus has been on the preparations for the study and applications to regulatory authorities. To ensure the recruitment of all patients to the study, extensive work has been made to identify and engage study centers and investigators in a number of countries in Europe. This work has been completed and all study centers in Europe are now confirmed. The process has been facilitated by the great interest and commitment seen among participating doctors.

Before the study can start, regulatory approvals from the various countries where we intend to conduct the study will be required. Hence, during the summer, applications were sent to authorities and ethics committees in Hungary, Poland and Georgia. These are the three countries we have chosen to prioritize because they will contribute with a substantial part of the enrolled patients, as well as being able to quickly start patient recruitment. We are now looking forward to receiving responses from these authorities and start the study as soon as possible.

Another important activity during the period was the preparations for an advisory dialogue with the US Food and Drug Administration (FDA). In the form of a pre-IND Type B interaction, the company was given the opportunity to ask the authority questions about the planned study, the preclinical documentation that supports the study; about the manufacturing process of the drug substance and the final formulation, as well as to ask questions about future development activities.

Since the FDA is an agency that provides advice on many projects from both small and large pharmaceutical companies, there is an enormous amount of knowledge to gain from them. During July, Cyxone received feedback on the questions and concerns that were presented to the FDA. As expected, they provided very valuable advice on both the preclinical and the clinical development activities. Their advice will also facilitate the further development of the project and the future cooperation with them and other authorities. From this interaction we see that we have all the components in place for a continued path forward for Rabeximod in RA.

The work with T20K continues in both preclinical studies and initial investigation activities for more efficient manufacturing. T20K has during the winter and spring been explored in a series of preclinical studies where we reported promising data with T20K and a kappa opioid receptor agonist. Furthermore, T20K has been studied with respect to different routes of administration, which open up for more possibilities with the substance.

An important aspect before we can start new clinical studies with T20K is to optimize the manufacturing process. Together with our partner, we are currently conducting a pilot study to optimize the manufacturing process and achieve a better quality and cost profile for the T20K substance.

In the beginning of the year, a rights issue was carried out, totaling SEK 61 million before issuing costs. To ensure a more cost-effective operation and a sustainable budget, a savings program was launched during the summer. Among other things, reduction of staff and consultants has been implemented. Several other costs are under review to be able to focus on the upcoming clinical study.

As a part of this strategic refocusing of projects, the board decided to let go of CEO Tara Heitner in June 2022 and appointed COO Carl-Magnus Högerkorp as interim CEO. Tara Heitner was hired as CEO in 2020 and led the company during a challenging period. During her tenure, Tara made several important value creation initiatives for the company. For example, the patent portfolio has been expanded with several new patent applications. Furthermore, Tara worked diligently with business development and in that process established many valuable contacts for the company. Tara also organized the company to take on more advanced development activities. Cyxone is grateful for what Tara contributed with during her time.

We are now looking forward to an intense autumn with an optimized plan for both our pipelines, especially our phase 2b study with Rabeximod. Please follow the company's development and receive information about our participation in investor meetings via Nasdaq First North Growth Market and on the company's website, www.cyxone.com

Carl-Magnus Högerkorp
Acting CEO
Cyxone AB

27 October 2022              Interim reportQ3, 2022

17 February 2023             Year-end report 2022

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

Malmö
August 24, 2022
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.

Carl-Magnus Högerkorp, Acting CEO
Tel: +46 (0)70 781 88 12
Email: carl.hogerkorp@cyxone.com

The information was submitted for publication, through the agency of the contact person set out above, at 08.30 a.m. CEST on 24th of August 2022.

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. Rabeximod is a Phase 2 candidate drug being evaluated for the management of rheumatoid arthritis. T20K is a Phase 1 candidate drug for treatment of multiple sclerosis. Certified Adviser is FNCA Sweden AB.
Please visit www.cyxone.com