Cyxone : Annual Report from Cyxone AB for the period 1 January 2022 to 31 December 2022

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: [phone]

E-mail: [e-mail]

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