News – Molecure

Invitation to investor meeting 3rd October 2023, 2:00 pm (CET)

Posted on: September 20, 2023

We are pleased to invite you to a meeting focused on a comprehensive review of the Company’s operational and financial performance during H1 2023, also including presentations on the progress of our research programs and forthcoming development plans.

The meeting will be conducted mainly in Polish and partly in English. Simultaneous interpretation will be provided. The anticipated duration of the meeting is approximately 90 minutes.

Presenting team:

Dr. Marcin Szumowski – Chief Executive Officer, President of the Board
Dr. Samson Fung – Chief Medical Officer, Member of the Board
Dr. Zbigniew Zasłona – Chief Scientific Officer, Member of the Board
Sławomir Broniarek – Chief Financial Officer, Member of the Board

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date: 3 October 2023 (Tuesday)
time: 2:00 p.m. (CEST) Warsaw

Registration link (with the option to ask questions in writing): https://livingmedia.com.pl/live/molecure/2Q2023-en

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Technical requirements

To participate in the video broadcast you need:

Current version of browser with javascript enabled
Open Internet ports: 1935, 80, 443, 53
An internet connection with a minimum actual bandwidth of 4Mbps

Please report technical problems to: support@livingmedia.pl or k.tadeusiak@molecure.com

Molecure submits application to the European Medicines Agency (EMA) to initiate a phase II clinical trial in the European Union and Norway to investigate OATD-01 for the treatment of pulmonary sarcoidosis

Posted on: September 9, 2023

OATD-01 is a first-in-class inhibitor of chitotriosidase 1 (CHIT1) with disease-modifying potential in sarcoidosis and other interstitial lung diseases
EMA approval will enable clinical trials to be conducted in centers in the European Union, including several sites in Poland, and in Norway
In July 2023, Molecure received approval from the U.S. Food and Drug Administration (FDA) to conduct a phase II clinical trial for OATD-01 in the U.S., expected to start in the fourth quarter 2023
In September, the Central Institutional Review Board approved the Company’s application, which enables the qualification of sites conducting clinical trials in the USA

Warsaw, September 8, 2023 – Molecure S.A. (“Molecure”, GPW ticker: MOC), clinical stage biotechnology company developing first-in-class small molecule drug candidates that directly modulate unexplored protein and RNA targets to treat multiple incurable diseases, has applied to the European Medicines Agency (EMA) for permission to initiate a phase II study for OATD-01, a first-in-class and potentially disease-modifying chitotriosidase 1 (CHIT1) inhibitor. EMA approval will enable Molecure to start a phase II clinical trial in the European Union and in Norway to evaluate the safety and efficacy of OATD-01 for the treatment of pulmonary sarcoidosis.

“This is an important step for Molecure, bringing us closer to the start of a phase II clinical trial for OATD-01 in Europe. The European Union – after the USA – is the largest regulated market where we intend to conduct a clinical trial for our innovative CHIT1 inhibitor. said Marcin Szumowski, President of the Management Board of Molecure S.A.

“Administration of the drug to the first patient with pulmonary sarcoidosis is scheduled for the fourth quarter 2023. We will start the study in the USA at the same time, having received FDA approval in July, and where we have the approval of the American bioethics committee to qualify medical centers where the study will be carried out.

“The clinical development of our leading program is entering a very important clinical proof-of-concept stage and the protocol of this study has gained wide approval among eminent specialists in the field of lung diseases. We expect the completion of the US study together with the final report in 2025. I am convinced that OATD-01, which has been shown to modify the course of the disease in preclinical studies, has the potential to become the new standard of care for pulmonary sarcoidosis. This is another step forward in the implementation of our mission – to improve the health and quality of life of patients struggling with incurable diseases. We believe that our drug, if trials are successful, could change the fate of patients with pulmonary sarcoidosis” – added Mr. Szumowski.

The phase II clinical trial for OATD-01 is designed as a multicenter, randomized, double-blind, placebo-controlled trial to evaluate safety and efficacy in approximately 90 patients with active pulmonary sarcoidosis.

For the efficacy study, an innovative primary endpoint was established with the FDA, i.e. response to 12-week administration measured by the degree of reduction of granulomatous inflammation in the lung parenchyma, assessed by PET/CT imaging. In the middle of the study, i.e. for about 50 patients, an intermediate checkpoint is planned in order to assess it statistically and decide on the further course of the study in terms of the number of patients – this should take place 2024. The disclosure of the final trial results is anticipated in 2025.

About OATD-01

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 represents a promising molecular target due to its role in converting local anti-inflammatory macrophages into pro-inflammatory and pro-fibrotic types. Blocking CHIT1 activity by OATD-01 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 a variety of inflammatory and fibrotic diseases that represent an unmet medical need, such as sarcoidosis, as well as idiopathic pulmonary fibrosis (IPF) and non-alcoholic steatohepatitis (NASH).

Molecure has obtained an FDA designation of ODD (orphan drug designation) for OATD-01 in indications of sarcoidosis and idiopathic pulmonary fibrosis.

About sarcoidosis

Sarcoidosis is a multi-organ disease of unknown etiology, which is characterized by the formation of granulomatous structures in various organs, mainly in the lungs and lymphatic system.

Sarcoidosis is a globally occurring disease, affecting both men and women with an estimated incidence of 5-50 cases per 100,000 inhabitants, with 70% of patients between the ages of 25-45.

The most serious and common complication of sarcoidosis is pulmonary fibrosis. This is usually associated with significant impairment of lung function. Pulmonary fibrosis is the cause of most sarcoidosis-related deaths in Western countries.

For further information, please contact:

Molecure S.A. (PR & IR)

Marta Borkowska

Email: m.borkowska@molecure.com

(+48) 728 728 143

MEDiSTRAVA Consulting

Frazer Hall, Sandi Greenwood

+44 (0)203 928 6900

Email: molecure@medistrava.com

About Molecure S.A.

Molecure S.A. is a biotechnology company discovering and developing drugs to the clinical stage, which uses its own unique competences in the field of medicinal chemistry and biology to search for and develop first-in-class small-molecule drugs that, through direct modulation of previously unexplored protein and RNA targets, can be the therapy of many incurable diseases.

Molecure has generated a diverse portfolio of seven distinct programs with the support of leading academic scientific institutions around the world, including Yale University, Rutgers University, the Flemish Institute for Biotechnology (VIB) in Ghent, the University of Michigan, and the International Institute of Molecular and Cell Biology in Warsaw (MIBMiK).

The most advanced drug candidate developed by Molecure is OATD-01, a first-in-class CHIT1 inhibitor for use in the treatment of interstitial lung diseases such as sarcoidosis and idiopathic pulmonary fibrosis, which is ready to enter phase II clinical trials. The start of a phase 2 trial in sarcoidosis patients is expected in early Q4 2023.

The second drug candidate is OATD-02, an oral, selective, first-in-class, dual arginase inhibitor (ARG1 and ARG2) for use in cancer treatment, whose phase I clinical trial began with its first administration to a patient in Q1 2023.

Molecure’s headquarters and laboratories are located in Warsaw and Łódź. The company is listed on the Warsaw Stock Exchange (ticker: MOC).

Detailed information can be found at: https://molecure.com/pl/

LinkedIn: Molecure | Twitter: @molecure_sa | YouTube: Molecure SA

The U.S. Food and Drug Administration Gives the Green Light to Molecure’s Flagship Program – Phase II Clinical Testing of OATD-01 is Ready for Launch

Posted on: July 22, 2023

Molecure can proceed with clinical trials in the U.S.A – Phase II proof-of-concept study will be the first to treat patients suffering from pulmonary sarcoidosis with OATD-01
In the coming weeks Molecure will also seek the European Medicine Agency’s approval to conduct phase II clinical testing of OATD-01 in the European Union
OATD-01 is the first-ever chitotriosidase 1 (CHIT1) inhibitor with disease modifying potential in sarcoidosis and other interstitial lung diseases

22 July 2023, Warsaw – Molecure S.A. (“Molecure”: WSE: MOC) a clinical stage biotechnology company developing first-in-class small molecule drug candidates that directly modulate unexplored protein and RNA targets to treat multiple incurable diseases, announces that, has received of its Investigational New Drug (IND) Application from the U.S. Food and Drug Administration (FDA). This IND will allow the company 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 Q4 2O23.

“We are extremely excited to share this great news – not only for us, but for every patient looking for a better and more effective way of treating sarcoidosis. This marks the beginning of a new chapter in the development of our flagship project, as we enter human proof-of-concept and begin treating pulmonary sarcoidosis patients with OATD-01. As we have confirmed in a range of preclinical studies, OATD-01 has the ability to modulate macrophage activity meaning it has the potential to treat various inflammatory and fibrotic diseases which develop based on a similar molecular mechanism. In the coming weeks we are also planning to file for approval of phase II clinical trials with the European Medicines Agency (EMA). That would make it possible for us to begin testing OATD-01 in the European Union – including Poland. We expect to conclude these Phase II clinical studies in mid-2025 with the publication of a report containing analyzing the headline data.” – says Marcin Szumowski, CEO of Molecure S.A.

In recent months we’ve put a lot of effort into raising the profile of our clinical research plans with OATD-01 internationally – a process designed to build relationships with renowned clinical experts who specialize in lung diseases (including sarcoidosis), as well as foundations and other organizations which build communities to support patients suffering from a range of difficult diseases that have a significant and negative impact on the quality of their lives. The Molecure team has also participated in numerous seminars and conferences such as the World Association for Sarcoidosis and Other Granulomatous Disorders (WASOG) 2023 – the largest international meeting place focused on the future of sarcoidosis and other granulomatous disorders. At WASOG we presented the disease modifying potential of OATD-01 to global industry opinion leaders and we are confident that that this will help us get more U.S. and EU research faculties involved in our trials, resulting in faster patient recruitment.” – adds Marcin Szumowski.

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.

About OATD-01

OATD-01, is an oral, once-daily, first-in-class highly selective CHIT1 inhibitor for the treatment of sarcoidosis. CHIT1 is a promising molecular target through its role in transforming resident, anti-inflammatory macrophages into pro-inflammatory and pro-fibrotic types. The inhibition of CHIT1 by OATD‑01 has been shown to reduce inflammation & fibrosis.

OATD-01 has demonstrated potent anti-inflammatory and antifibrotic effects in various disease models and has high therapeutic potential in diverse inflammatory and fibrotic diseases with high unmet medical needs such as sarcoidosis, as well as idiopathic pulmonary fibrosis (IPF) and NASH.

Molecure has received orphan drug designation (ODD) from the FDA for OATD-01 in the indications of sarcoidosis and idiopathic pulmonary fibrosis.

About Sarcoidosis

Sarcoidosis is a systemic disease of unknown cause that is characterized by the formation of immune granulomas in various organs, mainly the lungs and the lymphatic system. Sarcoidosis is a global disease, affecting both men and women with a prevalence of about 5–50 in 100,000 with 70% of patients aged between 25 and 45 years.

The most severe and frequent complication of sarcoidosis is the occurrence of pulmonary fibrosis. This is usually associated with significant impairment of pulmonary function. Pulmonary fibrosis results in the majority of deaths related to sarcoidosis in western countries.

About Molecure

Molecure is a clinical stage biotechnology company that uses its world leading medicinal chemistry and biology capabilities to discover and develop first-in-class small molecule drug candidates that directly modulate the function of underexplored protein and RNA targets to treat multiple incurable diseases.

Molecure has generated a diverse pipeline of seven distinct programs with the support of leading academic life science institutions.

Molecure’s most advanced in-house drug candidate is OATD-01, a first in class dual chitinase inhibitor for the treatment of interstitial lung diseases, such as sarcoidosis and idiopathic pulmonary fibrosis, that is Phase II ready. A Phase II trial in patients with sarcoidosis is expected to start in 2023.

Molecure’s headquarters and laboratories are located in Warsaw, Poland with an additional laboratory facility in Łódź. The company is listed on the Warsaw Stock Exchange (ticker: MOC).

For more information, please visit molecure.com/en/

Molecure completes successful Secondary Public Offering of approximately USD 12 million with proceeds to be used to fund and build a first in class, sustainable pipeline of breakthrough therapies

Posted on: July 19, 2023

Closing of equity offering of 2,776,000 series H shares by private placement, offered within the authorised capital, at an issue price of PLN 18 per share
Series H shares were subscribed for by 35 investors, new and existing institutional investors participated in the placement
Investor interest was very high and the offer was oversubscribed
The Company will leverage the recently completed capital raise to co-finance the implementation of Molecure’s strategic plans for 2023-2025

Warsaw, 18 July 2023. – Molecure S.A. (“Molecure”, WSE ticker: MOC), a biotechnology company discovering and developing drugs to the clinical stage, which leverages its globally unique expertise in medicinal chemistry and biology to explore and develop first-in-class small-molecule drugs that directly modulate protein activity and mRNA function to treat a wide range of incurable diseases, announced that it has successfully closed the SPO and entered into subscription agreements for all 2,776,000 H shares offered by way of private placement, within the authorized capital. The issue price was set at PLN 18, bringing the gross value of the offering to approximately USD 12 milion (PLN 50 million).

“We have successfully closed the H-share offering, which garnered significant interest from investors, including those who previously were not part of our shareholder base. We would like to thank all investors for participating in the offering and for the trust they have placed in Molecure. During the discussions with investors throughout the offering, we encountered a very good reception to our Strategy and a positive evaluation of the Company’s growth potential, which translated into investors’ interest several times higher than the number of shares offered. Considering the current market conditions, we view the execution of the share issue as a remarkable achievement. The proceeds from the offering will be utilized to finance the advancement of Molecure’s research programmes, aimed at developing effective therapies to address numerous incurable diseases afflicting patients” – says Marcin Szumowski, CEO and shareholder of Molecure S.A.

The proceeds raised through the offering will co-finance the implementation of the Company’s strategic plans for 2023-2025, including, in particular, significant progress in the clinical development of two flagship programmes, namely OATD-01 (a first-in-class chitotriosidase 1 inhibitor, CHIT1) and OATD-02 (a first-in-class dual arginase inhibitor). Additionally, efforts will be intensified in a portfolio of early-stage programmes, including breakthrough small-molecule drug technology that modulates mRNA translation and therapeutics targeting previously unexplored protein targets. These initiatives are bolstered by advanced machine learning and generative artificial intelligence (GenAI) methods. Molecure estimates that the capital expenditure associated with the strategy from mid-2023 to the end of 2025 will amount to approximately PLN 250 million.

Molecure is the exclusive owner – as the only biotech company in Poland – two first-in-class compounds at the clinical trial stage and is consistently building the value of these programmes, aiming to secure at least one high-value partnership agreement between 2023 and 2025, which could translate into tangible benefits for Shareholders.

“The primary business objective of our strategy is to transform the intellectual value we have created into commercial success. We anticipate concluding a partnering agreement for at least one of our clinical assets before 2025, while also establishing commercial collaborations for programmes currently at an earlier stage of development. We are pleased that investors participating in the share offering have recognised our progress thus far and our Strategy for future growth. The funds raised from the share issue, combined with other sources of funding, will provide vital support for the successful and on-track progress of our programme development and further strengthen our negotiating position with partners” – adds Marcin Szumowski.

LEGAL DISCLAIMER

This material is for information purposes only. It is published by the Company solely for the purpose of providing relevant information regarding the terms and conditions of the offer of H Shares. This material is in no way intended to promote, directly or indirectly, the offer, subscription or purchase of H Shares, nor does it constitute any advertisement or promotional material prepared or published by the Company for the purpose of promoting the H Shares, their subscription, purchase or offer or for the purpose of encouraging investors, directly or indirectly, to purchase or subscribe for H Shares. The Company has not published to date and does not intend to publish after the date of this current report any material for the purpose of promoting the Series H Shares, their subscription or purchase.

This material does not identify or suggest, and is not intended to identify or suggest, any risks [direct or indirect] that may be associated with an investment in the H Shares. Any investment decision to subscribe for or purchase H Shares pursuant to an offer, subscription or sale of such shares must be made solely on the basis of publicly available information.

This material does not constitute an invitation to underwrite, subscribe for or otherwise acquire or dispose of any securities in any jurisdiction. This material does not constitute a recommendation regarding an investor’s decision to offer, subscribe for or purchase H Shares. Each investor or potential investor should conduct its own investigation, analysis and evaluation of the business and data described in this material and publicly available information. The price and value of securities can go up as well as down. Past performance is not a guide to future performance.

For further information, please contact:

media and retail investors:
Michał Wierzchowski, cc group
mob. +48 531 613 067
e-mail: michal.wierzchowski@ccgroup.pl

institutional investors and sell-side analysts:
Katarzyna Mucha, cc group
mob. +48 697 613 712
e-mail: katarzyna.mucha@ccgroup.pl

About Molecure

Molecure has generated a diverse pipeline of seven distinct programs with the support of leading academic life science institutions.

Molecure’s headquarters and laboratories are located in Warsaw, Poland with an additional laboratory facility in Łódź. The company is listed on the Warsaw Stock Exchange (ticker: MOC).

For more information, please visit https://molecure.com/

LinkedIn: Molecure | Twitter: @molecure_sa | YouTube: Molecure SA

Molecure has signed an agreement to conduct a Phase II clinical trial for its lead molecule OATD-01, taking another important step in the development of this program.

Posted on: July 3, 2023

The agreement with Simbec-Orion includes organizing and fully executing a proof-of-concept Phase II clinical trial in patients with pulmonary sarcoidosis.
The Phase II proof-of-concept study of OATD-01 will be conducted as multi-center and international clinical trial in the United States and the European Union and is expected to start in Q4 2023.
OATD-01 is a first-in-class chitotriosidase 1 (CHIT1) inhibitor that modulates macrophage function and has broad therapeutic potential for the treatment of inflammatory and fibrotic diseases.
Molecure has filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for a Phase II study in the United States.
Molecure has received Orphan Drug Designation (ODD) from the FDA for OATD-01 in sarcoidosis and idiopathic pulmonary fibrosis.

Warsaw, 3rd July 2023 – Molecure S.A. (“Molecure”: WSE: MOC) a clinical stage biotechnology company that uses its world leading medicinal chemistry and biology capabilities to discover and develop first in class small molecule drug candidates that directly modulate unexplored protein and RNA targets to treat multiple incurable diseases, announced that it has entered into an agreement with Orion Sante Sarl (Simbec-Orion), based in France, to organize and conduct a comprehensive Phase II clinical trial for OATD-01.

The OATD-01 Phase II trial will be conducted in the US and several European Union countries. Phase II is planned as a double-blind, placebo-controlled, clinical trial with a fixed dose of compound OATD-01 administered once daily for 12 weeks. The study is designed to evaluate the clinical efficacy, pharmacokinetics, pharmacodynamics, and safety of OATD-01 in patients with active pulmonary sarcoidosis. The value of the agreement with Simbec-Orion is approximately €10.1 million (PLN 45 million – according to the average exchange rate of the National Bank of Poland published on 3rd July 2023, i.e., PLN 4.43).

“The signing of an agreement with Simbec-Orion, an experienced international CRO, marks another important step in recent days towards the initiation of a Phase II trial of OATD-01 in sarcoidosis patients. We recently announced the submission of an IND application to the US Food and Drug Administration (FDA) for this trial, which was preceded by a meeting with the regulator to discuss the dossier and the design of the clinical trial, including its innovative endpoints. We have provided the FDA with more than 20,000 pages of documentation from preclinical studies conducted to date and from the completed Phase I study in 2020. In the near future, we will submit a similar clinical trial application to the EMA under the European Centralised Procedure. We expect to enroll the first patient in the trial in early Q4 2023. The trial will enroll approximately 90 patients with active pulmonary sarcoidosis in the US and Europe, including Poland. This phase of the trial, known as “proof-of-concept in humans”, is critical to the validation of the chitinase platform as it is the first time a chitinase inhibitor has been administered to patients worldwide. Positive results from this phase could pave the way for many other indications with significant unmet medical needs worldwide, such as other interstitial lung diseases or non-alcoholic steatohepatitis (NASH), where similar molecular mechanisms lead to disease development,” – said Marcin Szumowski, CEO of Molecure S.A.

“Sarcoidosis is a rare but highly debilitating disease that significantly reduces the quality of life and, in some cases, leads to death of patients. It remains an unmet clinical need, and the needs of patients are often overlooked. We are, therefore, committed to initiating this trial as soon as possible as we believe that OATD-01 can play an important role in helping patients, not only by alleviating their symptoms but also by improving their quality of life and potentially halting the progression of the disease. Our innovative compound OATD-01, by blocking chitotriosidase 1, is the first-in-class potential drug using this mechanism to modify macrophage function. Our planned study includes an innovative primary efficacy endpoint, consulted with the FDA in a pre-IND meeting. This is the response to 12-week administration of OATD-01, verified by PET/CT imaging, reduction in size and number of granulomas in patients’ lungs. We prepared the study design, including the recruitment criteria and its endpoints, in collaboration with key opinion leaders in fibrotic and pulmonary diseases. We hope that with our most advanced molecule, we will soon be able to bring help to patients with sarcoidosis, fulfilling our mission,” – said Dr. Samson Fung, MD, Chief Medical Officer, and Board Member of Molecure S.A.

Simbec-Orion was selected following a competitive tender organized by Molecure.

About OATD-01

Molecure has received orphan drug designation (ODD) from the FDA for OATD-01 in the indications of sarcoidosis and idiopathic pulmonary fibrosis.

About Sarcoidosis

Sarcoidosis is a systemic disease of unknown cause that is characterized by the formation of immune granulomas in various organs, mainly the lungs and the lymphatic system.

Sarcoidosis is a global disease, affecting both men and women with a prevalence of about 5–50 in 100,000 with 70% of patients aged between 25 and 45 years.

About Molecure

Molecure has generated a diverse pipeline of seven distinct programs with the support of leading academic life science institutions.

Molecure’s headquarters and laboratories are located in Warsaw, Poland with an additional laboratory facility in Łódź. The company is listed on the Warsaw Stock Exchange (ticker: MOC).

For more information, please visit molecure.com/en/

About Simbec-Orion

Simbec-Orion is an experienced, full-service Contract Research Organisation (CRO), with offices across the UK, Europe, and the United States. Established for over 45 years, providing clinical trial expertise to a wide range of small to mid-sized biotech and pharmaceutical partners across Europe, North America and beyond.

Across the organisation, scientific teams leverage both a wide therapeutic experience in clinical pharmacology, as well as more specialist expertise in Phase I-IV oncology and rare disease. Simbec-Orion’s adaptable, highly experienced teams continuously take a quality-first approach, whilst maintaining the short communication lines and Senior Leadership Team oversight only achievable with a lean management structure. Learn more at www.simbecorion.com

Molecure Files an Investigational New Drug (IND) application for lead clinical candidate OATD-01 with U.S. FDA ahead of a planned Phase 2 pulmonary sarcoidosis study

Posted on: June 22, 2023

OATD-01 is a first in class chitotriosidase 1 (CHIT1) inhibitor with disease modifying potential in sarcoidosis and other interstitial lung diseases
Clearance of the IND application will pave the way for Molecure to initiate the study in the United States becoming only the second Polish biotech company from Poland ever to do so

Warsaw, Poland 22 June 2023 – Molecure S.A. (“Molecure”: WSE: MOC) a clinical stage biotechnology company developing first-in-class small molecule drug candidates that directly modulate unexplored protein and RNA targets to treat multiple incurable diseases, announces that it has filed an Investigational New Drug (IND) application with the U.S. FDA for OATD-01, a first in class and potentially disease modifying Chitotriosidase (CHIT1) inhibitor. Clearance of the IND would allow Molecure to begin an international Phase 2 proof of concept study to evaluate OATD-01 for the treatment of pulmonary sarcoidosis.

“Today’s IND filing is another landmark milestone for Molecure and its lead product OATD-01” said Molecure CEO Marcin Szumowski. “There are currently no approved therapies for sarcoidosis, and while steroids are often used, they have serious side effects and deliver only short-term benefits with little evidence of extended therapeutic efficacy. As a result, there is a significant unmet need for better treatments that can prevent disease progression. We believe that OATD-01, which has demonstrated efficacy in several pre-clinical models, could alter the fate of sarcoidosis patients by becoming the new standard of care for sarcoidosis. Clearance of our IND would allow Molecure to become only the second, Polish biotech company in history to initiate in the United States a multicenter Phase 2 study for an innovative drug, a major accomplishment for everyone involved in this programme.”

Samson Fung, Molecure CMO and Member of the Management Board added, “This IND application brings us a step closer to a new treatment option for underserved sarcoidosis patients. We are excited about our plans to advance OATD-01 into a Phase 2 trial as we believe this highly promising new agent could play a key role in the treatment of this rare disease, improving symptoms as well as quality of life and potentially stopping disease progression. We anticipate beginning our Phase 2 trial in patients in the US and EU in the fourth quarter of this year.

This Phase 2 trial is expected to be a global, multi-center, randomized, double blind and placebo-controlled study to evaluate the safety and efficacy of OATD-01 in approximately 90 patients with active pulmonary sarcoidosis. The results of this double-blinded study will be available once the study is complete, expected in H1 2025. The innovative primary endpoint, already discussed and cleared by the FDA during the pre-IND meeting procedure is the response to a 12-week treatment with OATD-01 measured by the reduction of granulomatous inflammation in pulmonary parenchyma evaluated by PET/CT imaging.”

Molecure has received orphan drug designation (ODD) from the FDA for OATD-01 in the indications of sarcoidosis and idiopathic pulmonary fibrosis.

About OATD-01

About Sarcoidosis

Sarcoidosis is a systemic disease of unknown cause that is characterized by the formation of immune granulomas in various organs, mainly the lungs and the lymphatic system.

Sarcoidosis is a global disease, affecting both men and women with a prevalence of about 5–50 in 100,000 with 70% of patients aged between 25 and 45 years.

ENDS

For further information, please contact:

Molecure S.A. (PR & IR)

Marta Borkowska

Email: m.borkowska@molecure.com

(+48) 728 728 143

MEDiSTRAVA Consulting (Financial PR)

Frazer Hall, Sandi Greenwood, Eleanor Perkin

molecure@medistrava.com

+44 (0)203 928 6900

About Molecure

Molecure has generated a diverse pipeline of seven distinct programs with the support of leading academic life science institutions.

Molecure’s headquarters and laboratories are located in Warsaw, Poland with an additional laboratory facility in Łódź. The company is listed on the Warsaw Stock Exchange (ticker: MOC).

For more information, please visit molecure.com/en/

LinkedIn: Molecure| Twitter: @molecure_sa | YouTube: Molecure SA

Molecure Announces Full Year Financial 2022 Results – A Year of Significant Progress

Posted on: March 30, 2023

Entering 2023 with strong momentum and a robust pipeline of proprietary, first-in-class compounds
First patient dosed in Phase I trial with OATD-02, a novel, first in class dual arginase inhibitor for the treatment of cancer
Lead proprietary candidate, OATD-01, a novel chitinase inhibitor in sarcoidosis, expected to advance into a Phase II study with first patient dosed in second half of 2023
Chief Medical Officer Samson Fung, MD, appointed to the Molecure Management Board to lead global clinical development, translational science and regulatory strategies
Zbigniew Zasłona, Director of Biology, promoted to Chief Scientific Officer

Warsaw, Poland – 30 March 2023 – Molecure S.A. (“Molecure”: WSE: MOC) a clinical stage biotechnology company that uses its world leading medicinal chemistry and biology capabilities to discover and develop first-in-class small molecule drug candidates that directly modulate unexplored protein and RNA targets to treat multiple incurable diseases, announces full year results for the period ended 31 December 2022. The full report in Polish can be found here https://molecure.com/pl/informacje-dla-inwestorow/

“Molecure has made significant progress over 2022, becoming a clinical stage biotechnology company preparing our two most advanced assets to start multi-center phase I and phase II studies respectively” said Marcin Szumowski, CEO and President of the Management Board of Molecure. “The decision to change our name to Molecure reflects our mission, vision and confidence in the clinical and market potential of our pipeline which we believe has the potential to make an important difference to patients with cancer and interstitial lung diseases. In recent weeks, we achieved an important milestone dosing the first cancer patient in a Phase I study with OATD-02, the first and only dual arginase inhibitor. This novel small molecule has been designed to treat a broad range of solid tumors as well as leukemia, particularly in combination with other anti-cancer therapeutics, such as immune checkpoint inhibitors.

OATD-01, a novel chitotriosidase 1 (CHIT1) inhibitor with disease modifying potential in patients with pulmonary sarcoidosis, is nearing start of Phase II, with the first patient expected to be dosed in the second half of 2023. Positive results of this clinical proof-of-concept study in Sarcoidosis may open doors to treatment of other Interstitial Lung Diseases (ILDs), including idiopathic pulmonary fibrosis (IPF) as well as nonalcoholic steatohepatitis (NASH) which represent significantly larger global patient populations. I am looking forward to data from this study which we hope will confirm the key role of CHIT1 inhibition as a new treatment pathway for diseases where chronic inflammation leads to tissue remodeling and fibrosis.

We believe that a successful outcome to this study may mark an important value inflection milestone that will further enhance Molecure’s profile with both potential pharma partners and investors.”

Investor Presentation

The Company’s full year presentation to investors will be held on April 5, 2023 at 2:00 PM (CET) in an online meeting format, available at the link: https://us06web.zoom.us/webinar/register/WN_dKmDwNAUTdiu72mZ0lVitw

The meeting will be conducted in Polish and English with simultaneous translation. It is expected to last approximately 90 minutes. Selection of the meeting language will be available after joining the event.

Commercial & Operational Highlights

In 2022, Molecure announced a new name and brand identiy. This change reflects the Company’s “DNA” as well as its growth and maturity, with ongoing commitment to discover and develop novel small molecule therapies for millions of people suffering from serious and incurable diseases worldwide.

Molecure regained all rights to its novel, chitinase inhibitor OATD-01
Data generated to date demonstrate an attractive pharmacological profile for OATD-01 and scientific advice received from EMA and FDA is highly supportive of progressing OATD-01 into Phase II clinical development. The first patient in the planned Phase II trial is expected to be dosed in the second half of 2023
Multiple discussions with leading pulmonologists & KOLs in interstitial lung diseases have taken place throughout 2022 to help shape the planned clinical development program of this novel drug candidate
OATD-01 could be the first drug targeting sarcoidosis that is disease modifying and moreover it has potential in several other respiratory indications including IPF as well as nonalcoholic steatohepatitis (NASH),which addressing much larger patient populations

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 in November 2022
Following the CTA approval, Molecure has recently initiated a Phase I clinical trial with the first patient dosed in March 2023. The study will assess safety, tolerability and preliminary efficacy of OATD-02 in patients with advanced and/or metastatic solid tumors
OATD-02 is an oral, potent and selective first-in-class, dual arginase inhibitor (ARG1 and ARG2) with the potential to treat a broad range of cancers in combination with other anti-cancer agents
A Publication* entitled “OATD-02 Validates the Benefits of Pharmacological Inhibition of Arginase 1 and 2 in Cancer” was published in August 2022
- This paper covered the first study validating the potential benefits of pharmacological inhibition of ARG2 in cancer and demonstrates that OATD-02 is a potent dual ARG1/ARG2 inhibitor with intracellular activity (necessary for targeting ARG2) and exhibiting immunomodulatory and direct antitumor efficacy in pre-clinical models

* Link to publication: https://www.mdpi.com/2072-6694/14/16/3967

Significant progress in deubiquitinase inhibitors programs
USP7 inhibitor program is progressing to the advanced lead optimization stage
- The lead molecule OATD–4828 has shown encouraging dose-dependent inhibition of tumor growth in preclinical models of various cancer types
A promising selective and potent compound has recently been discovered with high affinity for USP21, a novel and biologically validated therapeutic target for cancer treatment

Further development and expansion of the mRNA targeting small molecule discovery platform
Continued development of this novel platform, with a broad range of analytical techniques being applied to confirm the secondary structure of 6 most promising target regions
Expansion of both cellular and molecular screening capabilities
Ongoing collaborations with leading international RNA centers to expand and leverage the company’s expertise and alternative approach to identify compounds interacting with selected mRNA regions
A profit-sharing based service offering is being developed to provide potential industry partners interested in discovery and development of small molecules that interact with mRNA an option to pursue targets and any NCE leads discovered under the collaboration in exchange for revenue sharing with Molecure in the form of development milestones & royalties

Key organizational changes to drive the Company through its next phase of growth and clinical development

Appointment of Samson Fung, M.D., as Chief Medical Officer to lead global clinical development, translational science and regulatory strategies. Dr Fung will lead the advancement of 0ATD-01 and OATD-02 into Phase II and Phase I clinical trials respectively
Zbigniew Zasłona, former VP research biology promoted to Chief Scientific Officer
Supervisory board expanded to include Dr. Paul van der Horst, Dr. Nancy Van Osselaer and Paweł Trawkowski as its new members

Important Post-period Highlights

Significant progress made on OATD-02, an oral, potent and selective first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer
First patient dosed in March 2023 in Phase I clinical trial to assess safety, tolerability and preliminary efficacy of OATD-02 in patients with advanced and/or metastatic solid tumors
- lnitial clinical data expected at the end of 2023
Publication in Molecular Cancer Therapeutics, a journal of the American Association of Cancer Research, entitled “Arginase 1/2 inhibitor OATD-02: from discovery to first-in-man setup in cancer immunotherapy”

Arginase 1/2 inhibitor OATD-02: from discovery to first-in-man setup in cancer immunotherapy | Molecular Cancer Therapeutics | American Association for Cancer Research (aacrjournals.org)

Samson Fung, Chief Medical Officer appointed to the Company’s Management Board to support the successful clinical development of OATD-01 and OATD-02
Zbigniew Zasłona, promoted to Chief Scientific Officer from his former position as VP Research Biology. Dr. Zasłona, remains on Molecure’s Management Board

Partnering events and investor conferences
Post period end, CEO, Marcin Szumowski and business development director, Nicolas Beuzen attended partnering conference Bio-Europe in Basel Switzerland in March. The event brought together thousands of outstanding biopharma companies enabling meaningful partner discussions
The company will also attend and present pipeline progress at the LSX Congress in London, 3-4^th The LSX Congress is one of the largest healthcare conferences and partnering events held in Europe.

Full Year Financial Highlights

Operating income of PLN1.64 million, a slight increase from 2021 due to grants received during the year
Operating expenses totaled PLN18.63 million, an increase of PLN3.41 million. This was mainly due to higher wages as the company’s pipeline advances together with increasing costs of external services
Net loss for the year ended 31 December 2022 totaled PLN15.26 million vs net loss of PLN13.64 million in 2021 due to higher costs
As of December 31, 2022, Molecure had cash of PLN66 million (US$15 million)
Current cash balances are expected to fund the company’s operating expenses and capital expenditure requirements for at least another 12 months.
US$/PLN exchange rate 4.38 as of 31 December 2022

ENDS

For further information, please contact:

Molecure S.A. (PR & IR)

Marta Borkowska

Email: m.borkowska@molecure.com

+(48) 728 728 143

MEDiSTRAVA Consulting (Financial PR)

Frazer Hall, David Dible, Sandi Greenwood, Eleanor Perkin

molecure@medistrava.com

+44 (0)203 928 6900

About Molecure

Molecure has generated a diverse pipeline of seven distinct programs with the support of leading academic life science institutions globally, including Yale University, Rutgers University, the Flemish Institute for Biotechnology (VIB) in Ghent, the University of Michigan and the International Institute of Molecular and Cell Biology in Warsaw (IIMCB).

Molecure’s most advanced in-house drug candidate is OATD-01, a first-in-class inhibitor of CHIT1 for the treatment of interstitial lung diseases, such as sarcoidosis and idiopathic pulmonary fibrosis, that is Phase II ready. A Phase II trial in patients with sarcoidosis is expected to start in the second half of 2023.

Our second proprietary candidate is OATD-02, an oral, potent and selective first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer, which has advanced to Phase I clinical development in March 2023.

Molecure’s headquarters and laboratories are located in Warsaw, Poland with an additional laboratory facility in Łódź. The company is listed on the Warsaw Stock Exchange (ticker: MOC).

For more information, please visit https://molecure.com

LinkedIn: Molecure| Twitter: @molecure_sa | YouTube: Molecure SA

Invitation to investor meeting 5th April 2023, 2:00 pm (CET)

Posted on: March 28, 2023

We would like to invite you to Company’s quarterly online meeting. During the webcast, management will discuss the company’s financial results for the year 2022 and provide an update of its clinical and preclinical pipeline, as well as development plans for the coming quarters.

The meeting will largely be conducted in Polish, and partly in English, and is expected to last approximately 90 minutes. Simultaneous English translation of the meeting will be provided.

Molecure S.A. Presenters:

Dr Marcin Szumowski – CEO, President of the Board
Dr Samson Fung – Chief Medical Officer, Board Member
Dr Zbigniew Zasłona – Chief Scientific Officer, Board Member
Sławomir Broniarek – CFO, Board Member

The webinar will take place on Wednesday, 5^th April 2023 at 2:00 PM (CET).

Link to registration (with the possibility to ask questions in writing):
https://us06web.zoom.us/webinar/register/WN_dKmDwNAUTdiu72mZ0lVitw

Selection of the meeting language will be available after joining the event.

Technical problems:

When there is a break or transmission suspension, it is recommended to turn it off and rejoin the meeting through the link in the invitation.

In case of any technical problems, kindly contact: k.tadeusiak@molecure.com

Molecure announces first patient dosed in Phase I trial with novel, first-in-class dual arginase inhibitor OATD-02 for the treatment of cancer

Posted on: March 8, 2023

OATD-02 is an oral, potent and selective dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer
Phase I clinical trial to assess safety, tolerability and preliminary efficacy of OATD-02 in patients with advanced and/or metastatic solid tumors – initial clinical data expected at the end of 2023
Second new drug candidate from Molecure’s proprietary pipeline in clinical development

Warsaw, Poland 8 March 2023 – Molecure S.A. (“Molecure”: WSE: MOC) a clinical stage biotechnology company that uses its world leading medicinal chemistry and biology capabilities to discover and develop first in class small molecule drug candidates that directly modulate unexplored protein and RNA targets to treat multiple incurable diseases, announces today that the first patient has been dosed in a Phase I trial evaluating OATD-02 as a monotherapy in cancer patients with advanced solid tumors.

The Phase I trial is an open-label, multi-center, first in human, dose escalation study to evaluate safety, tolerability, anti-cancer activity and to establish the maximum tolerated dose of OATD-02. The study is being conducted at three sites 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.

Marcin Szumowski, Chief Executive Officer of Molecure, said, “We are very excited to start this first in human clinical trial with OATD-02, the second candidate from Molecure’s proprietary pipeline to enter clinical development. This is another important milestone for the company and underpins our commitment to deliver novel medicines that can provide significant benefit to people suffering from advanced and/or metastatic solid tumors. We believe OATD-02 has shown a very promising pre-clinical profile, and we look forward to seeing the initial data from this first in human study in the latter part of 2023.”

Dr Samson Fung, Chief Medical Officer added: “OATD-02 is the first and only dual acting arginase inhibitor in development globally to treat solid tumors. This novel drug candidate has been designed to improve treatment outcomes, including in more advanced disease, helping to restore the patient’s antitumor immune response by overcoming the immunosuppressive tumor environment. The important data emerging from this trial will help to guide future clinical development for OATD-02, which we hope will bring treatment benefits to patients with a broad range of tumors.”

For further information, please contact:

Molecure S.A. (PR & IR)

Marta Borkowska

Email: m.borkowska@molecure.com

(+48) 728 728 143

MEDiSTRAVA Consulting (Financial PR)

Frazer Hall, Sandi Greenwood, Eleanor Perkin

molecure@medistrava.com

+44 (0)203 928 6900

About OATD-02

OATD-02 is being developed by Molecure 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.

About Molecure

Molecure has generated a diverse pipeline of seven distinct programs with the support of leading academic life science institutions.

Our second proprietary candidate is OATD-02, an oral, potent and selective first in class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer, which advanced to Phase I clinical development in Q1 2023.Molecure’s headquarters and laboratories are located in Warsaw, Poland with an additional laboratory facility in Łódź. The company is listed on the Warsaw Stock Exchange (ticker: MOC).

For more information, please visit molecure.com/en/

LinkedIn: Molecure| Twitter: @molecure_sa | YouTube: Molecure SA