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

  • 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.

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/

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

  • 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 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 early Q4 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 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 https://molecure.com/

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

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

  • 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 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.

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

Molecure Appoints Dr. Samson Fung, Chief Medical Officer to its Management Board as it Continues to Focus on Successfully Progressing its Expanded Clinical Portfolio Copy

  • Dr Zbigniew Zasłona, PhD promoted to Chief Scientific Officer – Dr Zasłona remains a member of Molecure’s Management Board
  • Dr Adam Gołębiowski transitioning from management board position to take on role of Senior Research Fellow

 

Warsaw, Poland – 03.01.2023 – Molecure S.A. (“Molecure”: WSE: MOC) a clinical stage biotechnology company using its world leading medicinal chemistry capabilities to discover first-in-class small molecule drug candidates that directly modulate unexplored protein and RNA targets to treat multiple incurable diseases, announces that Dr. Samson Fung, Chief Medical officer has been appointed to the Company’s management board. Dr. Adam Gołębiowski has stepped down from the management board to take on the role of Senior Research Fellow at Molecure. In parallel, Dr. Zbigniew Zasłona, has been promoted to Chief Scientific Officer from his current position as VP Research Biology. Dr. Zasłona, 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.

Marcin Szumowski, Co-founder & CEO commented, “The new roles among our leadership team are tailored to support the successful development of our exciting clinical portfolio, which comprises 0ATD-01, which is targeting inflammatory lung diseases, starting with sarcoidosis, and OATD-02, which is being developed to treat a broad range of cancers. I would like to congratulate Samson as he becomes a new member of the management board where his significant pharmaceutical and biotech industry experience will be an important asset. I am also delighted to announce the promotion of Zbigniew to Chief Scientific Officer, which reflects the significant contribution he has made since joining Molecure. Dr. Adam Gołębiowski has initiated the discovery of both of our clinical stage assets enabling Molecure to become a clinical stage company. He has been instrumental in launching our early stage pipeline since co-founding Molecure and we look forward to having his continued engagement in a more science focused role in Molecure’s early-stage programs. The experience within the senior leadership team combines deep scientific knowledge and clinical development expertise that will be important in helping us advance and broaden our pipeline.”

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 Zasłona 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. Zasłona 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 Gołębiowski, 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.

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 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 eight 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 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.

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.

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 www.molecure.com

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

 

Molecure 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

  • OATD-02 is an oral, potent and selective first in class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer.
  • Phase I clinical trial to begin later in 2022 to assess safety, tolerability and efficacy of OATD-02 in patients with advanced and/or metastatic solid tumors.

Warsaw, Poland  28th of November 2022 – Molecure S.A. (“Molecure”: WSE: MOC) a clinical stage biotechnology company that uses its world leading medicinal 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 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.

Dr Samson Fung, Chief Medical Officer, said “We are delighted to receive approval to advance OATD-02 into its first clinical study which is a major milestone for Molecure. OATD-02 is the only dual acting arginase inhibitor in development globally for the treatment of cancer and it has demonstrated significant anti-cancer activity in pre-clinical studies, by impacting both tumor immunity and tumor metabolism.

OATD-02 is the second candidate from Molecure’s pipeline to enter the clinic and we look forward to seeing the first data from patients with solid tumors where despite the availability of new treatments there is still a significant unmet need.”

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.

About OATD-02

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.

 

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 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 eight 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.

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 is expected to advance to Phase I clinical development before the end of 2022.

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 to Host Virtual R&D Day on 7th December 2022

Warsaw, Poland – 14 November 2022 – Molecure S.A. (“Molecure”: WSE: MOC) a clinical stage biotechnology company that uses its world leading medicinal chemistry capabilities to discover first-in-class small molecule drug candidates that directly modulate unexplored protein and RNA targets to treat multiple incurable diseases, will host a virtual R&D Day on the 7th December 2022 at 13.30 CET / 12.30 BST / 6.30 ET.

During this event, management and scientific leaders will provide a comprehensive review of Molecure’s the company’s pipeline.

The event will provide updates on Molecure’s clinical development plans and related near-term catalysts, with a focus on its two novel drug candidates, OATD-01, a first in class chitinase inhibitor for sarcoidosis and OATD-02, a dual acting, highly potent arginase inhibitor for a broad range of cancers.

Date: 7th December 2022

Time: 13.30 – 16.30 CET

The agenda and details of how to join the meeting will be available in an invitation and on the Company’s website (www.molecure.com) which will be issued closer to the time of the event.

 

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 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 eight 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 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.

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 is expected to advance to Phase I clinical development in the second half of 2022.

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/pl/

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

Molecure reports continued pipeline momentum for 6 months ended 30th June 2022

  • Our new name “Molecure” reflects expansion of scope of small molecule targets from novel proteins to mRNA in discovery & development of breakthrough therapies for multiple diseases
  • Worldwide rights regained to novel, dual chitinase inhibitor OATD-01 following a strategic review by Galapagos enabling first administration to sarcoidosis patients in a Phase II PoC study in mid-2023
  • Dr Samson Fung appointed as Chief Medical Officer to lead global clinical development, translational science and regulatory strategies
  • Strong progress across proprietary pipeline with two key clinical trials planned with OATD-01 and OATD-02 respectively
  • First administration of OATD-02 to oncology patients expected at end of 2022

 

Warsaw, Poland – 29 September 2022 – Molecure S.A. (“Molecure”: WSE: MOC) a clinical stage biotechnology company that uses its world leading medicinal capabilities to discover and develop first-in-class small molecule drug candidates that directly modulate RNA and unexplored protein targets to treat multiple incurable diseases, announces interim results for the six months ending 30 June 2022. The full report in Polish can be found here https://molecure.com/pl/informacje-dla-inwestorow/

Marcin Szumowski, CEO and President of the Management Board of Molecure commented: The last 6 months has been a period of significant transformation for Molecure. We unveiled our new identity in April as Molecure (formerly OncoArendi Therapeutics). This significant change reflects and highlights our growing ambition, passion and ongoing commitment to discover and develop novel small molecule therapies for millions of people with serious and incurable diseases.

I am pleased with the progress that the team has made to advance and expand our portfolio of products including establishment of a new mRNA discovery platform. We intend to build on our balanced pipeline and accelerate its progress in the remainder of 2022 and beyond.

Molecure is entering a very exciting stage in its development with a number of potential near-term value creating milestones set to be achieved from its pipeline portfolio. These include regulatory clearance and launch of a Phase II proof-of-concept study for OATD-01 in sarcoidosis patients in mid-2023. We believe that OATD‑01, a novel chitinase inhibitor with first-in-class potential has a key role to play in multiple inflammatory and fibrotic diseases. It is also a front-runner in creating future value for our shareholders and the start of the Phase II trial will be a significant corporate milestone. Following the strategic review by Galapagos, Molecure now retains all global commercial rights to this molecule.

We have also made excellent progress with OATD-02, a first-in-class dual arginase inhibitor for the treatment of cancer that has recently successfully completed preclinical development. A CTA was filed for OATD-02 with the Polish regulator on August 11 with a decision expected in late October, paving the way for us to start Phase I clinical trials in December 2022.

We are also continuing to explore and optimize our mRNA platform that aims to generate small molecule RNA-binding drugs that can address a range of difficult to drug targets.

Our value generating strategy is based on a diverse set of growth opportunities and I am confident that our expertise in medicinal chemistry and the biology of low-grade inflammation leading to tissue remodeling, and cancer will enable us to generate disease modifying treatments to improve the lives of many people.

Investor presentation

The Molecure leadership team will host a live online/in-person presentation relating to the interim results via a live webcast on 29 September 2022 at 2:30pm CET. The presentation and recording will be available on the Company’s YouTube channel: Molecure SA.

Commercial & Operational Highlights

  • Rights regained to 0ATD-01, following Galapagos strategic pipeline review
  • Data generated to date shows attractive benefit-risk profile and together with the scientific advice received from the EMA are highly supportive of further progressing OATD-01 into Phase II clinical trials expected to start in mid-2023
  • Sarcoidosis has been chosen as the initial indication for the Phase II study
  • Further potential in several other respiratory indications, other ILDs and NASH
  • CTA for OATD-02 filed with Polish regulator in August, following successful completion of preclinical studies
  • OATD-02 is an oral, potent and selective first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer
  • Following CTA approval, Molecure plans to initiate a Phase I clinical trial at the end of end 2022 to assess safety of OATD-02 in patients with advanced and/or metastatic solid tumors.
  • Rapid development of USP-7 inhibitors program
  • Continued development of program, selected lead molecule with high in vitro activity confirms its in-vivo effectiveness in the syngeneic colorectal cancer model showing a dose-dependent inhibition of tumor growth
  • Further development of mRNA platform
  • Continued development of platform, as Molecure applies a range of analytical techniques to confirm the secondary structure of 6 most promising regions
  • Currently, work is being carried out on modeling the tertiary structure of these identified mRNA fragments, which in the next stage will allow for the launch of work aimed at discovering compounds that bind these targeted regions

Key organizational changes to drive the Company through its next phase of evolution

  • Internal team members appointed to the Management Board: Dr. Adam Gołębiowski, Dr. Zbigniew Zasłona and Agnieszka Rajczuk-Szczepańska
  • Appointment of Samson Fung, M.D., PhD, 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
  • Supervisory board expanded to include Nancy Van Osselaer, Paul van der Horst 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 expected to enter the clinic in late 2022.
  • Publication* (17th August) titled, “OATD-02 Validates the Benefits of Pharmacological Inhibition of Arginase 1 and 2 in Cancer”. This is the first study validating the benefits of pharmacological inhibition of ARG2 in cancer and demonstrates OATD-02 as a potent dual ARG1/ARG2 inhibitor with a cellular activity (necessary for targeting ARG2) exhibiting immunomodulatory and direct antitumor efficacy in animal models

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

First Half Financial Highlights

  • Operating income totaled PLN1.25 million (US$275,000), an increase of PLN0.69 million (US$129,400) due to subsidies received from public grants
  • Operating expenses totaled PLN8.66 million (US$1.91 million), an increase of PLN3.07 million (US$451,800). This was mainly due to higher R&D costs as the company’s pipeline advances, the cost of external services, wages and rebranding activities
  • Net loss for the 6 months ended 30 June 2022 totaled PLN7.06 million (US$1.55 million). This was due to higher operating expenses as above
  • As of June 30, 2022 Molecure had cash of PLN82.78 million (US$18.2 million)
  • Current funds are expected to fund the company’s operating expenses and capital expenditure requirements into mid-2024.
  • US$/PLN exchange rate 4.54 as 30 June 2022
  • US$/PLN exchange rate 3.84 as 30 June 2021

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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

 

Molecure announces filing of Clinical Trial Application with Polish regulator for OATD-02, a novel dual arginase inhibitor being developed for the treatment of cancer

  • OATD-02 is an oral, potent and selective first in class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer.
  • Following CTA approval, Molecure plans to initiate a Phase I clinical trial in late 2022 to assess safety and efficacy of OATD-02 in patients with advanced and/or metastatic solid tumors.

 

Warsaw, Poland  11 August 2022 – Molecure S.A. (“Molecure”: WSE: MOC) a clinical stage biotechnology company that uses its world leading medicinal capabilities to discover and develop first in class small molecule drug candidates that directly modulate RNA and unexplored protein targets to treat multiple incurable diseases, announces today it has filed a Clinical Trial Application (CTA) for OATD-02 with the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The Company plans to conduct a Phase I clinical trial with OATD-02 in patients with selected advanced and/or metastatic solid tumors including colorectal cancer, ovarian cancer, pancreatic cancer or renal cell carcinoma.

The Phase I trial is expected to 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 is expected to start in the fourth quarter of 2022, subject to regulatory approval.

Marcin Szumowski, Molecure CEO commented, “Today’s CTA filing represents a significant milestone in the development of OATD-02, potentially the first dual arginase inhibitor to enter the clinic. We have already seen promising pre-clinical data that shows OATD-02 has significant anti-cancer activity with potential to improve treatment outcomes in a broad range of solid tumors. Subject to regulatory approval we look forward to advancing OATD-02 into clinical development later this year.”

The clinical part of the development of the OATD-02 compound is carried out within the framework of the project: pre-clinical and clinical development of arginase inhibitor for application in anti-cancer immunotherapy (POIR.01.01.01-00-0415/17), cofinanced by the European Union in the framework of European Funds Smart Growth and European Regional Development Fund.

About OATD-02 (oncology)

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.

 

For further information, please contact:

Molecure S.A. (PR & IR)                                      

Magdalena Licka

Email: m.licka@molecure.com

(+48) 512 777 001

 

MEDiSTRAVA Consulting (Financial PR)                           

Frazer Hall, David Dible, Sandi Greenwood, Eleanor Perkin

molecure@medistrava.com

+44 (0)203 928 6900

 

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 RNA and underexplored protein targets to treat multiple incurable diseases.

Molecure has generated a diverse pipeline of eight distinct programs with the support of leading academic life science institutions globally, including the International Institute of Molecular and Cell Biology in Warsaw (IIMCB), which has significant expertise in RNA science.

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.

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 is expected to advance to Phase I clinical development in the second half of 2022.

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/

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