Announcement • Aug 05
Molecure Receives Positive IDMC Recommendation To Continue The KITE Clinical Trial Without Changes To The Study Protocol Molecure S.A. has received a positive recommendation from the IDMC to continue the Phase II KITE clinical trial without protocol changes. The trial evaluates the efficacy and safety of OATD-01, a first-in-class CHIT1 inhibitor, in active pulmonary sarcoidosis patients. The IDMC reviewed data collected following the 12-week treatment period for the first 30 patients receiving either OATD-01 or a placebo, recommending that the trial continue in its current form. The Independent Data Monitoring Committee (IDMC) recommended continuation of the global Phase II PoC study in patients with active pulmonary sarcoidosis without changes to the current protocol. The recommendation followed the IDMC’s review of the complete safety and efficacy dataset for an interim analysis in 30 patients. Based on unblinded data, a futility analysis indicated sufficient probability of achieving the primary endpoint—based on differences in PET/CT imaging—and selected secondary endpoints. Preliminary biomarker analysis of blinded data showed inflammatory biomarker trends consistent with OATD-01's expected biological response. Molecure is currently randomizing 20 additional patients for the second and final interim analysis, which will involve a statistical re-evaluation of the required trial size. Biomarker analysis is an important component of this early trial stage. The Company analyzed blinded data from 23 patients, focusing on inflammatory biomarkers. The observed trends suggest anti-inflammatory activity, though definitive conclusions cannot be drawn until the study is unblinded. The KITE study is a double-blind, placebo-controlled Phase II trial conducted at nearly 30 sites across the US, EU, Norway, and the UK, evaluating a fixed 25 mg dose of OATD-01 over 12 weeks. OATD-01 has therapeutic potential in interstitial lung diseases, including sarcoidosis and idiopathic pulmonary fibrosis, as well as MASH. Announcement • Jun 04
Molecure S.A., Annual General Meeting, Jun 29, 2026 Molecure S.A., Annual General Meeting, Jun 29, 2026, at 10:00 Central European Standard Time. New Risk • Jan 29
New major risk - Revenue and earnings growth Earnings have declined by 50% 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 Less than 1 year of cash runway based on free cash flow trend (-zł69m free cash flow). Earnings have declined by 50% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (8.5% average weekly change). Shareholders have been diluted in the past year (22% increase in shares outstanding). Revenue is less than US$5m (zł5.9m revenue, or US$1.7m). Market cap is less than US$100m (zł178.8m market cap, or US$50.8m). New Risk • Dec 03
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 Polish stocks, typically moving 6.6% 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 Risk Less than 1 year of cash runway based on free cash flow trend (-zł69m free cash flow). Minor Risks Currently unprofitable and not forecast to become profitable next year (zł20m net loss next year). Share price has been volatile over the past 3 months (6.6% average weekly change). Shareholders have been diluted in the past year (22% increase in shares outstanding). Revenue is less than US$5m (zł5.9m revenue, or US$1.6m). Market cap is less than US$100m (zł141.3m market cap, or US$39.0m). Reported Earnings • Oct 01
Second quarter 2025 earnings released: zł0.17 loss per share (vs zł0.46 loss in 2Q 2024) Second quarter 2025 results: zł0.17 loss per share (improved from zł0.46 loss in 2Q 2024). Net loss: zł3.51m (loss narrowed 55% from 2Q 2024). Revenue is forecast to grow 96% p.a. on average during the next 2 years, compared to a 5.3% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has fallen by 19% per year, which means it is significantly lagging earnings. New Risk • Jul 09
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 Polish stocks, typically moving 7.3% 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 Less than 1 year of cash runway based on free cash flow trend (-zł47m free cash flow). Revenue is less than US$1m (zł3.5m revenue, or US$962k). Minor Risks Currently unprofitable and not forecast to become profitable next year (zł42m net loss next year). Share price has been volatile over the past 3 months (7.3% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (zł117.0m market cap, or US$32.3m). Reported Earnings • May 05
First quarter 2025 earnings released: zł0.26 loss per share (vs zł0.41 loss in 1Q 2024) First quarter 2025 results: zł0.26 loss per share (improved from zł0.41 loss in 1Q 2024). Net loss: zł5.18m (loss narrowed 24% from 1Q 2024). Revenue is forecast to grow 93% p.a. on average during the next 2 years, compared to a 5.9% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, earnings per share has fallen by 1% per year but the company’s share price has fallen by 31% per year, which means it is performing significantly worse than earnings. New Risk • May 02
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: zł34m 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 (-zł81m free cash flow). Revenue is less than US$1m (zł2.9m revenue, or US$770k). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (zł34m net loss in 3 years). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (zł171.7m market cap, or US$45.3m). Breakeven Date Change • Apr 29
Forecast to breakeven in 2025 The 2 analysts covering Molecure expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of zł1.80m in 2025. New Risk • Apr 08
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 20% 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 Risks Less than 1 year of cash runway based on free cash flow trend (-zł81m free cash flow). Revenue is less than US$1m (zł2.9m revenue, or US$748k). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (zł34m net loss in 3 years). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (zł170.9m market cap, or US$43.8m). New Risk • Nov 19
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 Polish stocks, typically moving 6.1% 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 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$372k). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (zł28m net loss in 3 years). Share price has been volatile over the past 3 months (6.1% average weekly change). Market cap is less than US$100m (zł164.7m market cap, or US$40.2m). 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$373k). 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 (zł166.5m market cap, or US$40.8m). Price Target Changed • Nov 13
Price target decreased by 22% to zł23.25 Down from zł29.80, the current price target is an average from 2 analysts. New target price is 135% above last closing price of zł9.89. Stock is down 45% over the past year. The company is forecast to post a net loss per share of zł1.60 next year compared to a net loss per share of zł1.69 last year. 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 7.6% growth forecast for the Pharmaceuticals industry in Europe. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 49 percentage points per year, which is a significant difference in performance. 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 (zł232.7m 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 (zł246.5m 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. Announcement • 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. Announcement • 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 (zł247.5m market cap, or US$62.9m). Announcement • 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. New Risk • Jan 17
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 6.3% 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 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$340k). Minor Risks Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (zł303.0m market cap, or US$75.0m). Announcement • 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 02
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). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 86 percentage points per year, which is a significant difference in performance. Reported Earnings • Oct 01
Second quarter 2023 earnings released Second quarter 2023 results: Net loss: zł4.12m (loss widened 8.5% from 2Q 2022). New Risk • Aug 22
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 Polish stocks, typically moving 7.1% 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 Risk Revenue is less than US$1m (zł1.6m revenue, or US$390k). Minor Risks Share price has been volatile over the past 3 months (7.1% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (zł403.2m market cap, or US$97.9m). New Risk • Aug 20
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 20% 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 Revenue is less than US$1m (zł1.6m revenue, or US$392k). Minor Risks Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (zł340.1m market cap, or US$82.9m). Announcement • 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. Announcement • 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. Announcement • 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. Announcement • 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. Reported Earnings • Nov 02
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). Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has increased by 10% per year, which means it is well ahead of earnings. Reported Earnings • Sep 30
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). Over the last 3 years on average, earnings per share has increased by 21% per year but the company’s share price has only increased by 5% per year, which means it is significantly lagging earnings growth. Valuation Update With 7 Day Price Move • Mar 15
Investor sentiment improved over the past week After last week's 18% share price gain to zł31.20, the stock trades at a trailing P/E ratio of 7.4x. Average trailing P/E is 20x in the Pharmaceuticals industry in Europe. Total returns to shareholders of 65% over the past three years. Valuation Update With 7 Day Price Move • Feb 24
Investor sentiment deteriorated over the past week After last week's 16% share price decline to zł29.00, the stock trades at a trailing P/E ratio of 6.8x. Average trailing P/E is 23x in the Pharmaceuticals industry in Europe. Total returns to shareholders of 86% over the past three years. 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). Over the last 3 years on average, earnings per share has increased by 125% per year but the company’s share price has only increased by 31% per year, which means it is significantly lagging earnings growth. Recent Insider Transactions • Aug 27
CEO & President of Management Board recently bought zł178k worth of stock On the 23rd of August, Marcin Szumowski bought around 4k shares on-market at roughly zł44.38 per share. This was the largest purchase by an insider in the last 3 months. This was Marcin's only on-market trade for the last 12 months. Is New 90 Day High Low • Nov 07
New 90-day high: zł57.80 The company is up 195% from its price of zł19.60 on 07 August 2020. The Polish market is down 9.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 1.0% over the same period. Announcement • Nov 06
OncoArendi Therapeutics SA and Galapagos Enter into Exclusive Collaboration on Chitinase Inhibitors in Fibrosis Galapagos NV announced that they have signed an exclusive collaboration and license agreement for the global development and commercialization of OncoArendi’s OATD-01. OATD-01 is a Phase 2-ready chitotriosidase/acidic mammalian chitinase (CHIT1/AMCase) inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF) and other diseases with a fibrotic component. OncoArendi has developed a portfolio of CHIT1/AMCase inhibitors, of which OATD-01 is the first-in-class frontrunner. OATD-01 is a novel, small molecule CHIT1/AMCase inhibitor targeting a key pathway in tissue remodeling. It has shown compelling translational data, a favorable profile in animal studies at expected therapeutic doses and it has successfully completed Phase 1 studies in healthy volunteers. Galapagos aims to bring OATD-01 to a Phase 2 clinical trial for the treatment of IPF and possibly other diseases with a fibrotic component. In exchange for global research, development and commercialization rights, OncoArendi will receive an upfront payment of €25 million and will be eligible to receive development, regulatory and commercial milestones on licensed products, for a total potential deal value of €320 million. OncoArendi is also eligible to receive tiered royalties ranging up to low double-digits, based on future net sales. Additionally, under the terms of the agreement, Galapagos will pay OncoArendi €2 million for the right of first negotiation on all other earlier stage programs on its chitinase platform. OncoArendi remains responsible for all research activity until preclinical candidate selection, after which Galapagos can exercise the option to initiate negotiations to obtain development or commercialization rights for the selected molecules. Any such transaction will be subject to a separate set of payments. Reported Earnings • Nov 02
Third quarter 2020 earnings released: zł0.06 loss per share Third quarter 2020 results: Net loss: zł750.5k (loss narrowed 13% from 3Q 2019). Reported Earnings • Sep 27
First half earnings released Over the last 12 months the company has reported total losses of zł3.49m, with losses narrowing by 23% from the prior year.