Cyxone AB (publ.) | Corp. reg. no. 559020-5471
2022
Annual Report
2022-01-01 - 2022-12-31
Transformative
Therapies for
Autoimmune
Diseases
This is a translation of the original Swedish version of the annual report. In case of any discrepancy between this translation and the Swedish original, the latter shall prevail.
Our vision is to develop better therapies
for autoimmune diseases such as rheumatoid arthritis (RA) and multiple sclerosis (MS) where patients do not have to compromise between disease progression and quality of life.
Financial summary
Profit after | Balance sheet | Cash and cash equivalents |
financial items | total | at the end of the year |
-42 468 | 52 527 | 29 246 |
SEK | SEK | SEK |
(2021: -45 028) | (2021: 46 128) | (2021: 29 357) |
Net sales | Earnings per share | Solidity |
0 | -0.44 | 89.4 |
SEK | SEK | % |
(2021: 0) | (2021: -0.73) | (2021: 85.0) |
Address
Cyxone AB
Hyllie Boulevard 34
215 32 Malmö, Sweden
Contact
Phone: +46 708 882 172
E-mail: info@cyxone.com
Corp.reg.no. 559020-5471
Table of Contents
Company | Cyxone in Brief | 4 | ||
Comments from the CEO | 5 | |||
Business Model, Aims and Strategy | 7 | |||
Scientific Advisory Board | 9 | |||
Projects | Rabeximod for rheumatoid arthritis (RA) | 11 | ||
T20K for multiple sclerosis (MS) | 12 | |||
Intellectual Property | 14 | |||
From CDO's point of view | 15 | |||
Management | The Share | 17 | ||
Management | 19 | |||
Board of Directors | 20 | |||
Director's Report | 24 | |||
Financial information | 26 | |||
Statement of Profit or Loss for the Group | 29 | |||
Statement of Profit or Loss and other | 30 | |||
Comprehensive Income for the Group | ||||
Statement of Financial Position for the Group | 31 | |||
Statement of Changes in Equity for the | ||||
Information | Group | 32 | ||
Consolidated Statement of Cash for the | ||||
Group | 34 | |||
Income Statement for the Parent Company | 35 | |||
Financial | Statement of Profit or Loss and other | |||
Comprehensive Income for the Parent | ||||
Company | 35 | |||
Balance Sheet for the Parent Company | 36 | |||
Statement of Changes in Equity for the | ||||
Parent Company | 38 | |||
Cash flow Analysis for the Parent Company | 39 | |||
Notes | 41 | |||
The Board of Director's Certificate | 67 | |||
Auditor's Report | 68 | |||
COMPANY
About Cyxone
Cyxone AB is a clinical stage biotech company specializing in the development of transformative therapies against auto- immune and autoinflammatory diseases. Our pipeline includes Rabeximod, currently in Phase 2 clinical development for the treatment of rheumatoid arthritis and T20K, currently in early clinical development for the treatment of multiple sclerosis.
Cyxone is listed on Nasdaq First North Growth Market since 2016 under the ticker CYXO.
Current treatment options for rheumatoid arthritis and multiple sclerosis have come a long way but still have several shortcomings. These include side effects, administration forms that often require visits to the hospital, and lack of response in many patients
Rabeximod directly addresses the gap in the medical need for RA treatment. Combined with the convenience of oral administration and a beneficial safety and tolerability profile, Rabeximod can be available for treatment in both early and later stages of the disease. It is cost-effective and will be positioned as a treatment option for a patient group who demonstrated inadequate response to the first-line treatment methotrexate.
T20K is a plant derived cyclotide that have demonstrated compelling immunomodulating properties impacting on T cell responses. In a preclinical model of multiple sclerosis (EAE model), T20K has been shown to significantly delay onset as well as severity of clinical symptoms by modulating T cells. This is a potentially disease preventing mechanism and T20K could thus be effective in slowing down the disease progression and even preventing disease flares and postponing the need of second-line treatments.
Rabeximod
Preclinical
Phase 1
Phase 2
Phase 3
T20K
Cyxone AB | Annual Report 2022 | 4 |
COMPANY
Comments from the CEO
Cyxone is concluding a year that in the light of the post pandemic world events have managed to continue its important development tasks for our projects Rabeximod and T20K in a diligent and stringent manner.
Rabeximod advances in many directions
The main highlights are of course that much of the preparatory work for the clinical Phase 2b trial in patients with moderate to severe rheumatoid arthritis - APPRAIS, has been completed. APPRAIS is a 24-week multicentre, ran- domized, double-blind, placebo controlled, parallel group trial to evaluate the efficacy, safety and tolerability of orally administered Rabeximod in patients with active, moderate to severe rheumatoid arthritis with inadequate response to the current first line treatment methotrexate.
Clinical trial applications were filed with Polish Medical Product Agency (Office for Registration of Medicinal Prod- ucts, Medical devices and Biocides), Hungarian Medical Product Agency (National Institute of Pharmacy and Nutrition - OGYEI), and the Georgian Medical Product Agency (LEPL Regulation Agency for Medical and Pharmaceutical Activities), for which approvals now have been obtained.
The APPRAIS trial is a cornerstone in the upcoming commercialization activities for Rabeximod. We are therefore positioning Rabeximod with its favorable safety and tolerability profile as a second line oral therapeutic, following methotrexate failure, to delay the need for patients to move to more invasive and complex biologics and other inject- ables.
The study preparation and the additional non-clinicalde-risking activities have significant impact on the value building of the Rabeximod project and the company.
The continued building of a knowledge base around Rabeximod as a molecule and its pharmacological proper- ties, is also important for the understanding of the broader potential of the molecule. Cyxone's research collaboration with the William Harvey Research Institute in London, has the objective to get a more detailed insight into the molecular regulation of Rabeximod in rheumatoid arthritis. This activity is coordinated by Professor Costantino Pitzalis, who is a well-renowned rheumatologist and researcher in this field, with a special interest in exploring new treatment alternatives. Our collaboration has so far led to several very useful new learnings about the molecule, its selectivity and its mode of action, again demonstrating profound regulation of proinflammatory myeloid cells.
Our patent protection efforts for Rabeximod are also of outmost importance for future commercialization. During the
therefore positioning with its favorable tolerability profile
as a second line oral therapeutic, following methotrexate failure, to delay the need for patients to move to more invasive and complex biologics and other injectables."
year, four of five recent PCT applications were transitioned to national phase, which is an important step towards eventually being granted. Cyxone also recently shared that the United States Patent and Trademark Office issued a Notice of Allowance for our fifth patent application, indicating a pending granting of the patent. This is of course is a very important milestone for the company as granted patent secures substantial value for us.Cyxone's strategy is to achieve a multilayered protection covering various aspects of Rabeximod, its use and its manufacturing.
During the year, we entered a program aiming to optimize the manufacturing of Rabeximod in collaboration with our contract development and manufacturing organization (CDMO) partner. The objective is to prepare for large scale commercial manufacturing for the late-stage development activities. These activities are ongoing and will continue over the next 18-24 months. In the initial phases, we have made some significant progress and could report that a very time-consuming process step has successfully been streamlined from requiring many days to complete, to now just needing a few hours.
Progress within preclinical activities and manufacturing lead to a more consolidated T20K program
During the year T20K has been further investigated with respect to pharmacological, pharmacodynamic and other functional aspects. Before advancing into more costly non-clinical and clinical development activities, important aspects of the molecule need to be established. Alongside this, it is important to secure a well-functioning manufacturing process that can provide the required amount of the pharmaceutical product.
Cyxone AB | Annual Report 2022 | 5 |
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Cyxone AB published this content on 27 April 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 May 2023 11:50:08 UTC.