Year-end Report 1 January to 31 December 2022
Financial Summary for the group
|Profit/loss before tax
|Earnings per share before and after dilution (SEK)
|Cash and cash equivalents as per period end
|Equity ratio as per period end
Significant events during the fourth quarter of 2022
- Nomination committee appointed for Cyxone Annual General Meeting 2023
- Cyxone receive ethical and regulatory approval from Hungary to start clinical Phase 2b study in RA
- Cyxone appoints Carl-Magnus Högerkorp as permanent CEO
Significant events after the end of the period
- Cyxone advances the patent portfolio for Rabeximod
- Cyxone receive ethical and regulatory approval from Georgia to conduct clinical Phase 2b study in RA
Capitalization of developmental expenses and adjustment of Q3
During Q3 2022 Cyxone received regulatory approval to conduct the clinical phase 2b study in Rheumatoid Arthritis. After obtaining the approval, the board and management made the assessment that the criteria for capitalizing developmental expenditures according to IAS 38 have been met. During the second half of 2022, the development costs for RA that met the activation criteria amounted to 6 399 KSEK. In the report for Q4, the Q3 period is therefore adjusted as a result of 4 428 KSEK being capitalized. The change results in the group's profit after tax for the third quarter of 2022 changing from -11 274 KSEK to -6 846 KSEK. See report for more details.
CEO Carl-Magnus Högerkorp comments
The recent advances during Q4 include additional ethical and regulatory approval for our upcoming Phase 2b APPRAIS study in moderate to severe rheumatoid arthritis, now covering Poland, Hungary and Georgia.
The Phase 2b study APPRAIS continues on a positive track
The preparations for the planned Phase 2b study APPRAIS in moderate to severe patients with rheumatoid arthritis continues with new ethical and regulatory approvals, strengthening our confidence in the protocol and the study design. In December regulatory approvals from the Hungarian Medical Product Agency (National Institute of Pharmacy and Nutrition - OGYEI) were obtained, and in February ethical and regulatory approvals were obtained from the Georgian Medical Product Agency (LEPL Regulation Agency for Medical and Pharmaceutical Activities). In addition to Georgia and Hungary, the study is approved by the Polish Medical Product Agency (Office for Registration of Medicinal Products, Medical devices and Biocides) and central ethics committee.
During the autumn we have also engaged in conducting a follow-up non-clinical study which was recommended by the American Medical Product Agency (Food and Drug Administration - FDA) following a pre-IND meeting held in June 2022. The study is a GLP-study to complement a previous investigation as part of our drug safety assessment program for Rabeximod.
GLP denotes a certain quality level – Good Laboratory Practice – that assures the highest data quality. Due to the high demand, GLP studies typically require long term planning in order to acquire appropriate time slots at a very limited number of specialist research service providers. The experienced Cyxone team did a stellar job in engaging a top service provider to conduct this important study during the winter of 2022-23. Having settled to start this GLP study in the near term, the original study plan has during the course of the experiments gone through some revisions which have resulted in a slightly prolonged study duration.
During the initiation phase of Cyxone’s Phase 2 study in Covid-19, in 2021, the interactions with FDA were very instructive. The feedback we received from the agency was highly influential on important parameters of the study protocol, which resulted in the implementation of changes that impacted the study and the ongoing patient recruitment process. We have therefore learnt that securing FDA’s feedback will be important also for the APPRAIS study.
Key activities in optimizing cost effectiveness in manufacturing
As part of the continued development of both Rabeximod and T20K, we are conducting a range of activities to establish more cost-effective manufacturing procedures. This work is carried out in collaboration with leading contract development and manufacturing organizations. For T20K we have currently been able to establish a process that enables the production of substance for the upcoming non-clinical and clinical development activities. For Rabeximod the work will be more extensive since the objective is to establish a value adding scalable process for the late-stage development and commercialization.
The Patent portfolio is maturing
One of the more important value building activities for the company is the continued expansion and maturation of the patent portfolio. Cyxone is working with different patent law firms and experts, each experts in their respective fields, in order to advance the patent portfolio in an international setting. Recently we could communicate about the national phase conversions of four of our PCT (Patent Convention Treaty) applications. Cyxone’s patent applications are being submitted to a range of different countries representing important future markets, such as USA and European countries. The national phase conversion is an important milestone in the patent process strengthening company value.
The macroeconomic effects of world events have great implication on the life science innovation industry. The willingness to take risks in the investor collective has been greatly impacted by the economic slowdown. This affects our industry with the significantly decreased valuations and opportunities for funding. In Cyxone we are working broadly, exploring various avenues for fundraising. We have committed to a range of non-dilutive funding opportunities to seek support for some of our R&D activities. We are also very busy with several business-to-business interactions to establish fruitful collaborations for future deals. We see that there is great interest in our projects and the planned R&D activities, and I am confident that we will be able to build on this in a positive way. We are also looking onwards with great optimism on the stock market trends and the ongoing recovery. The recent signals from both US and Swedish biotech indexes indicate positive sentiments on the market.
Please follow the company's development and our participation in investor meetings via Nasdaq First North Growth Market and on the company's website, www.cyxone.com
Upcoming financial reports and Annual General Meeting
27 April Annual Report 2022
12 May Interim Report Q1
30 May Annual General Meeting
30 August Half Year Report
27 October Interim Report Q3, 2023
23 February Year-end Report 2023
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 17, 2023
The Board of Directors
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, CEO
Tel: +46 (0)70 781 88 12
The information was submitted for publication, through the agency of the contact person set out above, at 08.30 a.m. CET on 17th of February 2023.
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