New Risk • Nov 13
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: zł31m Forecast net loss in 3 years: zł28m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-zł61m free cash flow). Revenue is less than US$1m (zł1.5m revenue, or US$370k). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (zł28m net loss in 3 years). Market cap is less than US$100m (€37.2m market cap, or US$39.3m). Reported Earnings • Oct 02
Second quarter 2024 earnings released: zł0.46 loss per share (vs zł0.29 loss in 2Q 2023) Second quarter 2024 results: zł0.46 loss per share (further deteriorated from zł0.29 loss in 2Q 2023). Net loss: zł7.73m (loss widened 87% from 2Q 2023). Revenue is forecast to grow 99% p.a. on average during the next 3 years, compared to a 3.6% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 51 percentage points per year, which is a significant difference in performance. New Risk • Aug 08
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 6.8% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 37% per year over the past 5 years. Revenue is less than US$1m (zł1.9m revenue, or US$488k). Minor Risks Less than 1 year of cash runway based on current free cash flow (-zł55m). Share price has been volatile over the past 3 months (6.8% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (€57.6m market cap, or US$62.9m). New Risk • Jul 15
New major risk - Revenue and earnings growth Earnings have declined by 37% per year over the past 5 years. 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 declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. 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 Risks Earnings have declined by 37% per year over the past 5 years. Revenue is less than US$1m (zł1.9m revenue, or US$496k). Minor Risks Less than 1 year of cash runway based on current free cash flow (-zł55m). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (€54.7m market cap, or US$59.7m). New Risk • Jun 07
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -zł55m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (zł1.9m revenue, or US$491k). Minor Risks Less than 1 year of cash runway based on current free cash flow (-zł55m). Currently unprofitable and not forecast to become profitable next year (zł5.9m net loss next year). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (€57.4m market cap, or US$62.6m). Breakeven Date Change • May 27
No longer forecast to breakeven The analyst covering Molecure no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of zł14.0m in 2025. New forecast suggests the company will make a loss of zł23.8m in 2025. Aankondiging • May 23
Molecure S.A. Receives Approval to Initiate A Phase II Clinical Trial (KITE) for OATD-01 for the Treatment of Pulmonary Sarcoidosis in Selected Countries of the European Union and Norway Molecure S.A. announced that it has received national regulatory approvals from Denmark, France, Greece, Germany and Norway to conduct a Phase II clinical trial for OATD-01, a first-in-class chitotriosidase 1 (CHIT1) inhibitor with disease-modifying potential in pulmonary sarcoidosis. The Phase II clinical trial for OATD-01 is a randomized, double-blinded, placebo-controlled, multicenter study to evaluate the safety and efficacy of OATD-01 in approximately 100 patients with active pulmonary sarcoidosis, including patients previously receiving other therapies with no clinical improvement and patients previously untreated. Due to the requirement for double blinding in the study, the final unblinded results publication will occur after its completion and is scheduled for the end of 2025. To measure efficacy of OATD-01 in the study, an innovative primary endpoint has been agreed upon with the regulatory authorities, which is the response to 12-week administration of OATD-01, measured by the degree of granulomatous inflammation reduction in the lung parenchyma, assessed by PET/CT imaging. Following the completion of full dosing along with a monitoring period involving approximately 50 patients, an interim analysis (intermediate checkpoint) is planned to evaluate the statistical results by an independent committee and make decisions regarding the study's continuation in terms of patient numbers in early First Quarter of 2025. The study will involve approximately 20-30 centers in the USA, European Union, Norway, and the United Kingdom. The renowned Contract Research Organization (CRO) responsible for organizing and conducting the comprehensive study is Simbec Orion. OATD-01 is an oral, once-daily, first-in-class, and highly selective CHIT1 inhibitor for potential use in the treatment of sarcoidosis. The CHIT1 enzyme is a promising molecular target due to its role in transforming local anti-inflammatory macrophages into pro-inflammatory and pro-fibrotic types. Blocking CHIT1 activity by OATD-01 has resulted in documented anti-inflammatory and anti-fibrotic effects. The OATD-01 molecule has shown strong anti-inflammatory and anti-fibrotic effects in various disease models and has high therapeutic potential in diverse inflammatory and fibrotic diseases with unmet medical needs, such as sarcoidosis, as well as idiopathic pulmonary fibrosis (IPF) and non-alcoholic steatohepatitis (NASH), recently relabeled as Metabolic Dysfunction-Associated Steatohepatitis (MASH). Molecure has obtained orphan drug designation (ODD) from the FDA for OATD-01 in the indications of sarcoidosis and idiopathic pulmonary fibrosis and has received approval to initiate a Phase II clinical trial for the treatment of pulmonary sarcoidosis in the US, UK, selected countries of the European Union, and Norway. Sarcoidosis is a multi-organ disease of unknown etiology characterized by the formation of granulomatous structures in various organs, primarily in the lungs and lymphatic system. It is a globally occurring disease affecting both men and women with an estimated incidence of 5-50 cases per 100,000 population, with 70% of patients being between 25-45 years old. The most serious and common complication of sarcoidosis is pulmonary fibrosis, usually associated with significant impairment of lung function. Pulmonary fibrosis is the cause of most sarcoidosis-related deaths in Western countries. Aankondiging • May 21
Molecure S.A., Annual General Meeting, Jun 13, 2024 Molecure S.A., Annual General Meeting, Jun 13, 2024. New Risk • May 17
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended September 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 6.3% per year for the foreseeable future. Revenue is less than US$1m (zł1.4m revenue, or US$349k). Minor Risks Latest financial reports are more than 6 months old (reported September 2023 fiscal period end). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (€58.0m market cap, or US$62.9m). Aankondiging • Mar 22
Molecure S.A. Announces First Patient in the OATD-01 Phase 2 KITE Study in Pulmonary Sarcoidosis Molecure S.A. has started the clinical trial where OATD-01 is being administered to patients with active pulmonary sarcoidosis as part of a Phase II clinical trial (proof-of-concept in human). The world's first administration of the chitotriosidase 1 (CHIT1) inhibitor (or placebo) to patient took place at the Royal Infirmary in Edinburgh. As part of the trial, patients will take a daily fixed dose of 25 mg OATD-01 or placebo tablets for 12 weeks. Patient safety will be monitored regularly through laboratory tests, neurological examinations and ECG and spirometry. The Phase II clinical trial for OATD-01 is designed as a randomised, double-blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of the oral CHIT1 inhibitor (OATD-01) in approximately 100 patients with active pulmonary sarcoidosis, including patients both previously receiving other therapies and previously untreated. The study will involve approximately 20-30 centres in the US, the European Union, Norway and the UK. The renowned CRO (Contract Research Organisation) Simbec Orion is responsible for the organization and comprehensive conduct of the study. Due to the double-blinding requirement of the study, publication of the final unblinded results will follow completion of the study and is anticipated by the end of 2025. For the efficacy trial, an innovative primary endpoint has been agreed with the FDA, namely the response to 12-week administration of OATD-01 as measured by the degree of reduction in granulomatous inflammation in the lung parenchyma, as assessed by PET/CT imaging. After approximately 50 patients have completed their participation in the study, a sub-analysis (intermediate checkpoint) will be scheduled to statistically evaluate the results by an independent committee and decide how to proceed with the study in terms of the number of patients. Aankondiging • Jan 17
Molecure S.A Announces No Grant of Permission to Conduct Phase II Clinical Trials for the OATD-01 Molecule I Molecure has not been granted permission to conduct phase II clinical trials for the OATD-01 molecule in patients with active pulmonary sarcoidosis in the European Union and Norway. The company is analysing ways to reapply for authorisation as soon as possible. As stated, one of the reasons for the refusal of the clinical trial authorisation was, in relation to Poland, an additional stringent condition concerning the limitation of the radiation exposure of patients participating in the clinical trial (i.e. the effective dose of radiation) in the course of medical procedures performed during the clinical trial, in particular PET/CT imaging (which is the diagnostic method for the assumed endpoint of efficacy assessment of the studied drug). Reported Earnings • Nov 01
Third quarter 2023 earnings released: zł0.25 loss per share (vs zł0.16 loss in 3Q 2022) Third quarter 2023 results: zł0.25 loss per share (further deteriorated from zł0.16 loss in 3Q 2022). Net loss: zł4.15m (loss widened 81% from 3Q 2022). Reported Earnings • Oct 01
Second quarter 2023 earnings released Second quarter 2023 results: Net loss: zł4.12m (loss widened 8.5% from 2Q 2022). Aankondiging • Jul 25
Molecure S.A. Receives Clearance from the U.S. Food and Drug Administration on its Investigational New Drug Application to Conduct Phase II Clinical Testing of OATD-01 Molecure S.A. announced that it has received clearance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) Application to conduct Phase II clinical testing of OATD-01, the first-ever chitotriosidase 1 (CHIT1) inhibitor with disease-modifying potential. The first pulmonary sarcoidosis patients in this Phase II study are scheduled to begin receiving treatment in Fourth Quarter 2O23. OATD-01 has displayed disease modifying abilities in preclinical trials and has the potential to become the new standard of care for treating pulmonary sarcoidosis. The phase II clinical trial of OATD-01 is expected to be a multi-center, randomized, double-blind, placebo-controlled study assessing the drug’s safety and effectiveness in treating approximately 90 pulmonary sarcoidosis patients. As result of the double-blind requirement the study’s final unblinded results will be published after its conclusion which is scheduled for the first half of 2025. The study has an innovative primary efficacy end point – the level to which OATD-01 is able to reduce granulomatous inflammation in the pulmonary parenchyma over a 12-week period based on PET/CT scan results. This endpoint was agreed with the FDA following a pre-IND meeting. Aankondiging • Jul 23
Molecure S.A. announced that it has received PLN 49.968 million in funding Molecure S.A. entered into subscription agreements for 2,776,000 H common shares at the price of PLN 18 per share for gross proceeds of PLN 49,968,000 on July 21, 2023. The transaction will include participation from new and existing institutional investors. The transaction was over-subscribed. Aankondiging • May 09
Molecure S.A., Annual General Meeting, May 31, 2023 Molecure S.A., Annual General Meeting, May 31, 2023, at 12:00 Central European Standard Time. Aankondiging • Jan 04
Molecure S.A. Announces Management Changes Molecure S.A. announced that Dr. Samson Fung, Chief Medical officer has been appointed to the Company's management board. Dr. Adam Golebiowski has stepped down from the management board to take on the role of Senior Research Fellow at Molecure. In parallel, Dr. Zbigniew Zaslona, has been promoted to Chief Scientific Officer from his current position as VP Research Biology. Dr. Zaslona, will remain on Molecure's management board. These changes are designed to better position the company to rapidly progress its clinical stage assets towards meaningful endpoints and partnering transactions, while simultaneously developing its early stage programs, including its innovative RNA discovery platform, to create a balanced pipeline of first-in-class assets with breakthrough therapy potential. Dr. Samson Fung graduated from the University of Freiburg, Germany and obtained his board certification in internal medicine with sub-specialization in oncology and hematology. Dr. Fung brings more than three decades of global industry and senior leadership experience across the life science sector. He has significant biotech experience with senior leadership roles (Head of Clinical Development, interim CMO) at several of Europe's most successful biotech companies including Micromet, later acquired by AMGEN, Morphosys and Argenx. Before that Dr. Fung has held senior roles in clinical development, medical affairs, business development and strategic marketing at leading global pharmaceutical companies including Roche, Novartis, Pharmacia/Pfizer, Novo Nordisk and AstraZeneca. Dr. Zbigniew Zaslona has been with Molecure for 2.5 years. He obtained his PhD in 2010 at the University of Giessen and the Marburg Lung Center in Germany, followed by a postdoctoral fellowship at the University of Michigan, USA. From 2015 to October 2020, he was a research fellow at Trinity College Dublin (Ireland) in the Department of Biochemistry and Immunology, as well as a Senior Investigator at the UK biotechnology company Sitryx (which in March 2020 entered into a $1bln collaboration and license agreement with Eli Lilly), where he was responsible for anti-inflammatory drug development programs. Dr. Zaslona has a publishing track record with h-index 26 and over 3000 citations. He is a recognized international expert in the field of inflammatory processes and lung diseases being repeatedly invited to lecture at leading international scientific conferences. Dr. Adam Golebiowski, who is a co-founder of Molecure has over 30 years of experience in leading research and development and drug discovery programs. In 1987 he completed his doctorate at the Institute of Organic Chemistry of the Polish Academy of Sciences, followed by a postdoctoral fellowship at Wayne State University, Michigan, USA. From 1989 to 2006, he led teams of medicinal chemists and research programs at Procter & Gamble Pharmaceuticals. From 2006 to 2012, he led research programs at the Institutes for Pharmaceutical Discovery (IPD) in Connecticut, USA. He is author of over 30 patents, 100 original publications, review articles and books. Aankondiging • Nov 29
Molecure S.A. to Begin Clinical Development of Novel Dual Arginase Inhibitor Oatd-02 for the Treatment of Cancer After Gaining Permission to Conduct First Clinical Trial in Poland Molecure S.A. announced that the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products granted permission to conduct the first clinical trial of OATD-02. The planned Phase I trial will be an open-label, multi-center, dose escalation study to evaluate safety, tolerability, anti-cancer activity and to establish the maximum tolerated dose of OATD-02. The study will be conducted in Poland and will enroll a maximum of 40 patients with selected advanced and/or metastatic solid tumors including colorectal cancer, ovarian cancer, pancreatic cancer or renal cell carcinoma. The study is expected to start before the end of 2022. The clinical trial will be co-financed by the European Union within the framework of the European Funds Smart Growth and European Regional Development Fund. OATD-02 is being developed as a potential new therapeutic for a range of solid tumors. It is the first and only dual acting, highly potent arginase inhibitor in development for the treatment of cancer, involved in both tumor immunity and metabolism. Arginase 1 (ARG1) and Arginase 2 (ARG2) are validated targets that have been found on a variety of tumor types where their increased activity correlates with more advanced disease and worse clinical prognosis due to diminished arginine levels. Reported Earnings • Nov 03
Third quarter 2022 earnings released: zł0.16 loss per share (vs zł0.13 loss in 3Q 2021) Third quarter 2022 results: zł0.16 loss per share (further deteriorated from zł0.13 loss in 3Q 2021). Net loss: zł2.30m (loss widened 22% from 3Q 2021). Reported Earnings • Oct 01
Second quarter 2022 earnings released: zł0.27 loss per share (vs zł0.20 loss in 2Q 2021) Second quarter 2022 results: zł0.27 loss per share (further deteriorated from zł0.20 loss in 2Q 2021). Net loss: zł3.80m (loss widened 35% from 2Q 2021). Aankondiging • Jun 07
Molecure S.A., Annual General Meeting, Jun 30, 2022 Molecure S.A., Annual General Meeting, Jun 30, 2022, at 12:00 Central European Standard Time. Valuation Update With 7 Day Price Move • Mar 15
Investor sentiment improved over the past week After last week's 26% share price gain to €6.74, the stock trades at a trailing P/E ratio of 7.2x. Average trailing P/E is 20x in the Pharmaceuticals industry in Europe. Total loss to shareholders of 41% over the past year. Valuation Update With 7 Day Price Move • Feb 25
Investor sentiment deteriorated over the past week After last week's 15% share price decline to €6.51, the stock trades at a trailing P/E ratio of 6.8x. Average trailing P/E is 23x in the Pharmaceuticals industry in Europe. Aankondiging • Feb 01
OncoArendi Therapeutics S.A. Announces Board Appointments OncoArendi Therapeutics S.A. announced the appointments of Dr. Adam Golebiowski, Dr. Zbigniew Zaslona and Agnieszka Rajczuk–Szczepanska to its Management Board. These appointments bring further scientific expertise as well as enhanced organizational and development capabilities to the Management Board. Dr. Adam Golebiowski, who is a co-founder of OncoArendi brings over 20 years of experience in leading research and development and drug discovery programs. In 1987 he completed his doctorate at the Institute of Organic Chemistry of the Polish Academy of Sciences, followed by a postdoctoral fellowship at Wayne State University, Michigan, USA. From 1989 to 2006, he led teams of medicinal chemists and research programs at Procter & Gamble Pharmaceuticals. From 2006 to 2012, he led research at the Institutes for Pharmaceutical Discovery (IPD) in Connecticut, USA. He is author of over 30 patents, 100 original publications, review articles and books. Dr. Zbigniew Zaslona currently serves as Director of Biology at OncoArendi. He obtained his PhD in 2010 at the University of Giessen and the Marburg Lung Center in Germany, studying the mechanisms that modulate innate immunity in the context of pneumonia. He then undertook a postdoctoral fellowship at the University of Michigan in the USA, where he focused on pharmacological studies of GPCR receptors, in particular lipid mediators of inflammation. From 2015 to October 2020, he was a research fellow at Trinity College Dublin (Ireland) in the Department of Biochemistry and Immunology, as well as a Senior Investigator at the UK biotechnology company Sitryx (which in March 2020 entered into a $1 billion collaboration and license agreementwith Eli Lilly), where he was responsible for anti-inflammatory drug development programs. Dr. Zaslona is a recognized international expert in the field of inflammatory processes and lung diseases and is repeatedly invited to lecture at leading international scientific conferences. Agnieszka Rajczuk-Szczepanska currently serves as the Human Resources (HR) Director at OncoArendi. She has over 25 years of experience in HR, including over 10 years in managerial positions. As HR Director, she is responsible for recruitment, on-boarding, motivation, training and employee development, competence assessment and talent development management, work efficiency management and building employee engagement. She is a graduate of the University of Wroclaw in the field of psychology with a specialization in organization and management. She also completed post-graduate studies in human resources management and labor law at the Kozminski University in Warsaw. She is a co-founder of the Polish HR Association in Poland. Reported Earnings • Sep 28
Second quarter 2021 earnings released: zł0.21 loss per share (vs zł0.034 loss in 2Q 2020) The company reported a poor second quarter result with increased losses, weaker revenues and weaker control over costs. Second quarter 2021 results: Revenue: zł361.2k (down 35% from 2Q 2020). Net loss: zł2.81m (loss widened zł2.34m from 2Q 2020). 
