Year-end Report 1 January to 31 December 2021

Financial Summary for the group

Significant events during the fourth quarter of 2021

• Cyxone presented top-line results from a phase 2 study of Rabeximod in Covid-19 patients.
• Cyxone filed a patent application for the drug candidate Rabeximod to enable patent protection and exclusivity until 2043, with potential extension.
• Cyxone initiated early operations with a global contract research organization to conduct Phase 2b trial in rheumatoid arthritis.
• Cyxone announced the execution of a rights issue of SEK 66.9 million to finance the planned Phase 2b study in RA through 2022 and part of 2023.

Significant events after the end of the period

• Cyxone engaged a Contract Development & Manufacturing Organization for production of T20K.
• Cyxone completed a rights issue and received approximately SEK 61 million before deduction of issue costs.

CEO Tara Heitner comments

Influx of funds paves way for phase 2b trial of Rabeximod in rheumatoid arthritis

Cyxone has concluded a rights issue that brought the company SEK 61 million, before issue costs. The goal is now to progress our unique drug projects and prepare for partnerships with larger biotech and pharma companies. With a strengthened financial situation and good progress in both our drug programs, it enables us to continue our exciting journey. 

The phase 2b study of Rabeximod in RA

Preparations were initiated during the period to allow for patient recruitment in the phase 2b study of Rabeximod in rheumatoid arthritis (RA). We have signed an Early Operations Agreement and a Letter of Agreement with an internationally renowned clinical research organization (CRO). The CRO will support Cyxone in preparatory activities and in finalizing the trial protocol and selecting the countries and trial centers that meet the study design criteria. Further, we have secured the support of Professor Constantino Pitzalis, a world-leading expert in translational research as well as other rheumatology thought leaders. Input from Professor Pitzalis and our other scientific advisors has been incorporated into the new study design for the phase 2b trial.

Outcome of Rabeximod in Covid-19

Already during the early stages of the Covid-19 pandemic, Cyxone, along with several other biotech companies, realized we had an asset that might lead to potential treatment. We knew from previous studies that the mode of action (MoA) of Rabeximod is extremely relevant for Acute Respiratory Disease Syndrome (ARDS) caused by viral lung infections such as Covid-19.

Although at that time not much was known about Covid-19 clinical trials or how to treat patients, we chose to follow the FDA guidelines and advice on how to conduct a Phase II study where Rabeximod was compared to and tested on top of standard treatment dexamethasone (placebo).

RA remains our focus

Nevertheless, and a very important aspect, is that we can conclude that Rabeximod is safe and well tolerated in patients with Covid infection and does not increase the risk of developing severe disease. Further the trial was a good first step in assessing trial design required to evaluate Rabeximod as a treatment for Covid-19 and we believe further exploration is warranted. However, our aim is to retain our focus on Rabeximod in RA and other autoimmune diseases since this is the main long-term commercial value driving activity in the company with the most interest from potential partners. 

These positive yet inconclusive results were disappointing, but I would like to repeat our strong belief in Rabeximod as a new and exciting therapy for RA patients. This sentiment is shared by our partners and advisors. Rabeximod in RA always has been and continues to be the lead value driver for the company.

Promising preclinical results for a combination therapy with T20K in multiple sclerosis

During the fourth quarter, together with our academic partners Professors Christian Gruber and Gernot Schabbauer from the Medical University of Vienna, we were able to demonstrate promising preclinical results for a treatment in multiple sclerosis using our drug candidate T20K in combination with a kappaopioid receptor agonist. The combination shows therapeutic effects and disease-modifying properties that go beyond T20K alone and may support regenerative effects. While T20K monotherapy is the current focus, the company will continue to explore the combination therapy since we find it an interesting opportunity to treat a more advanced segment of MS patients and potentially develop a regenerative therapy. We are particularly pleased that the new data supports the company's patent application for the combination therapy filed in March 2020, which is a good example of our ability to strategically broaden our drug development programs while protecting our intellectual property rights.

In early 2022 we were also happy to announce that we have signed an initial agreement with one of the world’s top peptide manufacturers as well as leading innovators of peptide manufacturing. This is an important step signaling the start of non-clinical studies and necessary to position ourselves to generate sufficient peptide for our non-clinical and clinical studies.

As we announced earlier in the year, we have strengthened the organization, onboarding new staff in clinical trials, finance and operations, while adding two new members to the Board. This, together with the stronger financial situation and continued progress of our two lead drug projects Rabeximod and T20K, means that we can put a productive quarter and year behind us and that we are well equipped to take on new challenges in 2022.

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

13 April 2022                                Annual report 2021

12 May 2022                                Q1 report

16 May 2022                                Annual General Meeting

24 August 2022                           Q2 report

27 October 2022                         Q3 report

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

Submission of Year-end Report

Malmö February 22, 2022

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

The information was submitted for publication, through the agency of the contact person set out above, at 08.30 a.m. CET on 22nd of February 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.

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 FNCA Sweden AB, +46(0)8-528 00 399, info@fnca.se. For more information, please visit www.cyxone.com

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