Annuncio • Nov 15
Celon Pharma S.A. to Report Q3, 2025 Results on Nov 19, 2025 Celon Pharma S.A. announced that they will report Q3, 2025 results on Nov 19, 2025 Annuncio • Oct 10
FDA Clears Celon Pharma's Schizophrenia Drug for Phase 3 Trial Celon Pharma S.A. announced it has secured a key regulatory milestone for its lead neuroscience program. The U.S. Food and Drug Administration (FDA) provided positive feedback clearing the path for Phase 3 testing of CPL'36, the company's novel second-generation PDE10A inhibitor for schizophrenia. The FDA confirmed that Celon Pharma's existing preclinical data are sufficient to begin pivotal studies and approved the proposed Phase 3 program, which includes two 28-day randomized, double-blind trials in patients with acute schizophrenia episodes and a 12-month open-label extension to establish long-term safety. The FDA also agreed that "treatment of schizophrenia" is the appropriate indication for CPL'36, confirming the compound's potential for broad labeling at registration. The Agency supported Celon Pharma's plan to conduct required supportive studies--including drug-drug interaction (DDI), QTc, and mass balance--concurrently with the pivotal trials, provided key safety measures are in place. This parallel development plan is expected to streamline timelines and maintain strategic flexibility. Strong Efficacy in Phase 2 Sets the Stage: CPL'36 previously demonstrated robust and clinically meaningful efficacy in a 189-patient Phase 2 trial, with both the 20 mg and 40 mg doses producing statistically significant improvements versus placebo across positive and total PANSS scores. The 40 mg dose also showed early signs of cognitive benefit. At Week 4, the positive PANSS subscale improved by 3.7 points for the 20 mg dose. Annuncio • Aug 21
Celon Pharma S.A. to Report First Half, 2025 Results on Sep 17, 2025 Celon Pharma S.A. announced that they will report first half, 2025 results on Sep 17, 2025 Annuncio • Mar 05
Celon Pharma S.A. Announces Strong Proof-of-Concept Data from Phase 2 Trial of PDE10A Inhibitor (CPL’36), a Novel Once-Daily Treatment of Levodopa-Induced Dyskinesia in Parkinson’s Disease Celon Pharma S.A. announced robust and positive Phase 2 clinical trial results for its PDE10A inhibitor (CPL’36), a novel, oral, once-daily medication for the treatment of Levodopa-Induced Dyskinesia (LID) in Parkinson’s disease. The study met its primary endpoint and many of its secondary endpoints. CPL’36 demonstrated robust and consistent efficacy across all utilized scales measuring improvement in treatment of LID in Parkinson’s disease. The effect size was large and clinically meaningful. CPL’36 was previously investigated as a potential treatment for schizophrenia and demonstrated positive Phase 2 results that were reported in July 2024. Trial description The CPL’36 Phase 2 study was multinational, multicenter, randomized, placebo-controlled trial conducted in a group 105 adult patients with LID dyskinesia in Parkinson’s disease. CPL’36 was administered orally in one of two doses of 20 mg or 40 mg, once daily and placebo controlled at a ratio (1:1:1) for a period of 4 weeks. Patient baseline severity was moderate-severe to severe, as characterized by a UDysRS (Unified Dyskinesia Rating Scale) total score of approximately 45. At Week 4, the improvement in UDysRS total score (primary endpoint) for the 20 mg dose was 12.30 units (LS Mean difference from placebo, p<0.001, Cohen’s d: 0.90) and improvement for the 40 mg dose was 13.58 units (LS Mean difference from placebo, p<0.001, Cohen’s d: 1.00). CPL’36 treatment was associated with improvement in most secondary endpoints, including the UDysRS objective subscale, in which the improvement in both active groups was statistically significant from Day 7 of the treatment phase. Drug tolerability was favorable with most severe adverse events occurring in the placebo-treated patients (8.8% in placebo group, 0% in 20 mg dose and 5.7% in 40 mg dose). Treatment related emergent adverse events leading to discontinuation of study medication were recorded in 2.9% of the placebo group, 11.1% of the 20 mg dosing arm, and 8.6% in the 40 mg dosing arm. The most common adverse event reported in both active groups was somnolence with mild to moderate intensity. No deaths were reported in the trial, and one Serious Adverse Event of atrial fibrillation with moderate intensity was reported in the 40 mg dosing arm. Annuncio • Jan 15
Celon Pharma S.A. to Report Fiscal Year 2024 Results on Apr 16, 2025 Celon Pharma S.A. announced that they will report fiscal year 2024 results at 8:30 AM, Central European Standard Time on Apr 16, 2025 Reported Earnings • Sep 20
Second quarter 2024 earnings released: zł0.15 loss per share (vs zł0.18 profit in 2Q 2023) Second quarter 2024 results: zł0.15 loss per share (down from zł0.18 profit in 2Q 2023). Revenue: zł65.6m (down 3.5% from 2Q 2023). Net loss: zł8.03m (down 188% from profit in 2Q 2023). Revenue is forecast to grow 7.3% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 39% per year but the company’s share price has only fallen by 11% per year, which means it has not declined as severely as earnings. New Risk • Aug 12
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 5.3% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (16% average weekly change). Minor Risk Shareholders have been diluted in the past year (5.3% increase in shares outstanding). Annuncio • Jul 09
Celon Pharma S.A. Announces Strong Proof-Of-Concept Data from Phase 2 Trial of PDE10A Inhibitor (CPL'36), a Novel Oral Antipsychotic Celon Pharma S.A. announces robust and positive Phase 2 clinical trial results for its PDE10A inhibitor (CPL’36), a novel, oral, once-daily antipsychotic. Statistically significant and clinically meaningful improvements in the primary endpoint of positive subscale of the PANSS were seen in both tested doses of CPL’36, with a dose-response effect. Management plans to discuss these highly encouraging results with regulatory agencies to advance CPL’36 towards registrational trials and global marketing approvals. Additionally, CPL’36 is being investigated as a potential treatment for levodopa-induced dyskinesia in Parkinson’s disease, with Phase 2 results expected to be reported in Fourth Quarter 2024. The CPL’36 Phase 2 study was an international, multicenter, randomized, placebo-controlled clinical trial conducted on a group of 189 adult patients hospitalized due to acute schizophrenia. CPL’36 was administered for 4 weeks in two doses of 20 and 40 mg once daily and was placebo-controlled at a ratio of 1:1:1. Patient baseline severity was moderate-severe to severe, as characterized by a PANSS total score of approximately 106. Patients were screened for up to 10 days and then randomized and treated over a four-week period, at which time the primary endpoint assessment was conducted at Day 28. At Week 4 of treatment, the reduction in positive PANSS subscale score which was the primary endpoint in the trial was 3.7 units from baseline in the 20 mg dose (LS mean difference from placebo, p<0.001, Cohen’s d: 0.73), and 6.3 units in the 40 mg dose (LS Mean difference from placebo, p<0.001, Cohen’s d: 1.38). For total PANSS score at week 4 of treatment (a key secondary endpoint), the 20 mg dose of CPL’36 demonstrated a 9.7 unit reduction from baseline compared to placebo (LS mean difference from placebo, p<0.001, Cohen’s d: 0.77), and 16.4 units in the 40 mg dose (LS mean difference from placebo, p<0.001, Cohen’s d: 1.47). Other secondary endpoints in the trial included the effects of CPL’36 on overall clinical improvement cognitive performance and functioning such as Clinical Global Impression Scale Improvement (CGI-I), Brief Assessment of Cognition in Schizophrenia (BACS), and number of participants who withdraw due to adverse events (AEs). Results across all of these endpoints were also positive. Drug tolerability was favorable with most treatment emergent adverse events characterized as mild. Exacerbations of schizophrenia represented the most common severe adverse events that were potentially related to the drug (1.5% in the placebo group, 1.8% in the 20 mg group and 3.1% in the 40 mg group). Treatment discontinuation due to adverse events likely related to the drug occurred in 3.1% patients in the placebo group, 0% patients in the 20 mg group and 7.7% patients in the 40 mg group. Upcoming Dividend • Jun 20
Upcoming dividend of zł0.08 per share Eligible shareholders must have bought the stock before 27 June 2024. Payment date: 04 July 2024. The company is not currently making a profit and is not cash flow positive. Trailing yield: 0.5%. Lower than top quartile of German dividend payers (4.8%). Lower than average of industry peers (2.2%). Annuncio • Jun 18
Celon Pharma Announces Results of Phase Ii Clinical Trial for Cpl’ 116, A Jak/Rock Dual Inhibitor in the Treatment of Rheumatoid Arthritis (Ra) Celon Pharma S.A. announced the successful completion of a Phase 2 trial a JAK/ROCK dual inhibitor in the treatment of Rheumatoid Arthritis (RA). The primary endpoint results are statistically significant, the primary endpoint is met. The study was a multicentre, randomised, double-blind clinical trial conducted on over 100 patients who have had inadequate therapeutic response to methotrexate. The compound was administered over the course of 12 weeks in 3 doses of 60, 120 and 240 mg BID as an add-on to methotrexate therapy. The trial was placebo-controlled. The objective of the trial was to determine the dose-dependent response to treatment. The primary endpoint was efficacy determined based on the change (compared to baseline) at week 12, measured as the Disease Activity Score-28 for RA with CRP. (DAS 28-CRP). Other, secondary endpoints included efficacy assessment measured using other scales, remission and safety of use. Findings: CPL’116 improved the patients’ condition measured with DAS28-CRP in a dose-dependent manner. Change in the DAS28-CRP score in week 12 compared to baseline was 1.702; 2.032; 2.361 and 1.668 for doses of 60, 120, 240 mg and placebo, respectively. Change in the DAS28-CRP score 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. Hence the primary endpoint results are statistically significant, the primary endpoint is met. The response to treatment in the 240 mg dose was fast – a statistically significant benefit over placebo with regard to the DAS28-CRP score was already observed at week 4 of treatment. The difference of the 240 mg dose compared to placebo was statistically significant in most of the secondary endpoints. The high remission rate observed at this dose throughout the trial (defined as DAS28-CRP<2.6) – which exceeded 45% – is particularly noteworthy. The 120 mg dose was partially efficacious. Statistically significant differences compared to placebo were observed is some measurements and scales. The overall tolerability of the compound was good and no unexpected adverse effects previously unknown for these drug classes have been observed. In the upcoming weeks, the Company will present results of pharmacokinetic and pharmacodynamic analyses for this trial, as well as detailed safety parameter analyses. The positive outcomes of this trial validate clinical development of CPL’116 as the world's first dual JAK/ROCK inhibitor in a broad spectrum of autoimmune diseases, in particular conditions with an inflammatory and fibrotic component, such as idiopathic pulmonary fibrosis (IPF) or rheumatoid arthritis-associated interstitial lung disease (RA-ILD). Reported Earnings • Apr 26
Full year 2023 earnings released: zł0.55 loss per share (vs zł0.77 loss in FY 2022) Full year 2023 results: zł0.55 loss per share (improved from zł0.77 loss in FY 2022). Revenue: zł216.6m (up 12% from FY 2022). Net loss: zł28.1m (loss narrowed 28% from FY 2022). Revenue is forecast to grow 6.4% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 59% per year but the company’s share price has only fallen by 32% per year, which means it has not declined as severely as earnings. Reported Earnings • Nov 25
Third quarter 2023 earnings released Third quarter 2023 results: Revenue: zł48.8m (up 8.8% from 3Q 2022). Net loss: zł6.82m (loss narrowed 42% from 3Q 2022). Revenue is forecast to grow 5.5% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. New Risk • Sep 22
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 13% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Minor Risk Share price has been volatile over the past 3 months (6.5% average weekly change). Reported Earnings • Sep 21
Second quarter 2023 earnings released Second quarter 2023 results: Revenue: zł69.0m (up 31% from 2Q 2022). Net income: zł9.14m (up zł17.3m from 2Q 2022). Profit margin: 13% (up from net loss in 2Q 2022). The move to profitability was primarily driven by higher revenue. Revenue is forecast to grow 6.1% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Upcoming Dividend • Jun 22
Upcoming dividend of zł0.09 per share at 0.6% yield Eligible shareholders must have bought the stock before 29 June 2023. Payment date: 06 July 2023. The company is not currently making a profit and is not cash flow positive. Trailing yield: 0.6%. Lower than top quartile of German dividend payers (4.7%). Lower than average of industry peers (2.6%). Reported Earnings • May 01
Full year 2022 earnings released Full year 2022 results: Revenue: zł194.6m (flat on FY 2021). Net loss: zł39.3m (loss widened 238% from FY 2021). Revenue is forecast to grow 6.0% p.a. on average during the next 3 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany. Reported Earnings • Nov 25
Third quarter 2022 earnings released Third quarter 2022 results: Revenue: zł45.0m (up 13% from 3Q 2021). Net loss: zł11.7m (loss widened 49% from 3Q 2021). Revenue is forecast to grow 5.2% p.a. on average during the next 3 years, compared to a 3.8% growth forecast for the Pharmaceuticals industry in Germany. Reported Earnings • Sep 30
Second quarter 2022 earnings released Second quarter 2022 results: Revenue: zł52.8m (down 8.2% from 2Q 2021). Net loss: zł8.11m (down zł10.1m from profit in 2Q 2021). Revenue is forecast to grow 5.4% p.a. on average during the next 3 years, compared to a 4.2% growth forecast for the Pharmaceuticals industry in Germany. Upcoming Dividend • Jun 23
Upcoming dividend of zł0.29 per share Eligible shareholders must have bought the stock before 30 June 2022. Payment date: 11 July 2022. The company is not currently making a profit and is not cash flow positive. Trailing yield: 1.9%. Lower than top quartile of German dividend payers (4.6%). Lower than average of industry peers (2.7%). Annuncio • May 31
Celon Pharma S.A., Annual General Meeting, Jun 22, 2022 Celon Pharma S.A., Annual General Meeting, Jun 22, 2022, at 10:00 Central European Standard Time. Reported Earnings • Dec 03
Third quarter 2021 earnings: EPS in line with analyst expectations despite revenue beat Third quarter 2021 results: zł0.17 loss per share (down from zł0.04 profit in 3Q 2020). Revenue: zł39.9m (up 4.8% from 3Q 2020). Net loss: zł7.83m (down zł9.64m from profit in 3Q 2020). Revenue exceeded analyst estimates by 9.5%. Over the next year, revenue is forecast to grow 39%, compared to a 6.9% growth forecast for the industry in Germany. Reported Earnings • Oct 03
Second quarter 2021 earnings released: EPS zł0.01 (vs zł0.25 in 2Q 2020) The company reported a mediocre second quarter result with weaker earnings and profit margins, although revenues improved. Second quarter 2021 results: Revenue: zł57.7m (up 48% from 2Q 2020). Net income: zł2.02m (down 82% from 2Q 2020). Profit margin: 3.5% (down from 29% in 2Q 2020). Reported Earnings • Oct 03
Second quarter 2021 earnings released: EPS zł0.01 (vs zł0.25 in 2Q 2020) The company reported a mediocre second quarter result with weaker earnings and profit margins, although revenues improved. Second quarter 2021 results: Revenue: zł57.7m (up 48% from 2Q 2020). Net income: zł2.02m (down 82% from 2Q 2020). Profit margin: 3.5% (down from 29% in 2Q 2020). Annuncio • Jun 23
Celon Pharma Files for Approval of Phase II Trial of CPL’280, a Second Generation GPR40 Agonist, in Type 2 Diabetes Celon Pharma announced filing for approval to start a Phase II clinical study of CPL’280, its second generation GPR40 agonist in type 2 diabetes. This double-blind, randomized, placebo-controlled, multiple dose Phase II study will evaluate the ability of orally administered CPL’280 to control blood glucose in patients with diagnosed type 2 diabetes. Both naive and metformin-inadequate responders will be administered once-daily CPL’280 for two weeks. Safety and pharmacokinetics will be secondary endpoints. The trial plans to include 80 patients. Celon Pharma expects to dose the first patient in Fourth Quarter 2021 and top-line results are anticipated in first half of 2022. CPL’280 was designed to improve on the drawbacks of the first generation GPR40 agonists. The molecule, which is structurally different from the first generation agonists, is free from known risk factors associated with liver injury, i.e. bile acid transporter inhibition and the formation of reactive metabolites. The molecule showed strong evidence of safety both in preclinical and Phase I clinical studies including liver safety. Liver injury was a known risk factor identified for fasiglifam, which was the most advanced first generation GPR40 agonist which was terminated in late-stage clinical development.