In reference to current reports 36/2021 on the successful completion ofphase I clinical trial and 47/2021 on submission of an application forconsent to commence a phase II trial of an innovative JAK/ROCK inhibitor- CPL 409116 - in the treatment of Rheumatoid Arthritis (RA), theCompany's Management Board hereby informs that on June 17, 2024 theCompany has concluded an analysis of the phase II trial findings.

It was a multicentre, randomised, double-blind clinical trial conductedon over 100 patients who have had inadequate therapeutic response tomethotrexate. The compound was administered over the course of 12 weeksin 3 doses of 60, 120 and 240 mg BID as an add-on to methotrexatetherapy. The trial was placebo-controlled. The objective of the trialwas to determine the dose-dependent response to treatment. The primaryendpoint was efficacy determined based on the change (compared tobaseline) at week 12, measured as the Disease Activity Score-28 for RAwith CRP. (DAS 28-CRP). Other, secondary endpoints included efficacyassessment measured using other scales, remission and safety of use.

Findings: CPL'116 improved the patients' condition measured withDAS28-CRP in a dose-dependent manner. Change in the DAS28-CRP score inweek 12 compared to baseline was 1.702; 2.032; 2.361 and 1.668 for dosesof 60, 120, 240 mg and placebo, respectively. Change in the DAS28-CRPscore compared to placebo (LS MD) was 0.145 (p=0.67); 0.564 (p=0.10),and 0.887 (p=0.01) for doses of 60, 120 and 240 mg, respectively. Hencethe primary endpoint results are statistically significant, the primaryendpoint is met.

The response to treatment in the 240 mg dose was fast - a statisticallysignificant benefit over placebo with regard to the DAS28-CRP score wasalready observed at week 4 of treatment.

The difference of the 240 mg dose compared to placebo was statisticallysignificant in most of the secondary endpoints. The high remission rateobserved at this dose throughout the trial (defined as DAS28-CRP_lt;2.6) -which exceeded 45% - is particularly noteworthy.

The 120 mg dose was partially efficacious. Statistically significantdifferences compared to placebo were observed is some measurements andscales.

The overall tolerability of the compound was good and no unexpectedadverse effects previously unknown for these drug classes have beenobserved.

In the upcoming weeks, the Company will present results ofpharmacokinetic and pharmacodynamic analyses for this trial, as well asdetailed safety parameter analyses.

The positive outcomes of this trial validate clinical development ofCPL'116 as the world's first dual JAK/ROCK inhibitor in a broad spectrumof autoimmune diseases, in particular conditions with an inflammatoryand fibrotic component, such as idiopathic pulmonary fibrosis (IPF) orrheumatoid arthritis-associated interstitial lung disease (RA-ILD).