Molecure at the threshold of a breakthrough in the treatment of inflammatory and fibrotic diseases. The focus on the most breakthrough therapy and the OATD-01 and OATD-02 clinical trials results in a reduction of programs in the discovery phase from five to three

  • Molecure has reduced the number of active projects from seven to five, focusing resources on the most promising assets;
  • Key areas for further development and value building for Molecure are: OATD-01 as a potential breakthrough therapy for the treatment of sarcoidosis and MASH, and OATD-02 in trials in patients with solid tumors. Development of projects in the discovery phase powered by machine learning and generative artificial intelligence (GenAI) methods includes a small-molecule drug discovery platform that modulates mRNA translational function and the USP7 program;
  • Molecure’s strategic goal is to conclude a partnership agreement in the OATD-01 program, enabling it to initiate a Phase II clinical trial in its next indication, MASH (ang. metabolic dysfunction-associated steatohepatitis), with its partner as soon as possible;
  • Molecure’s OATD-02 clinical trial is nearing the determination of a maximum tolerable dose (MTD) or potentially therapeutic dose (Ph2RD), which should increase interest from potential oncology partners;
  • In active programs at an earlier stage of development, in early 2025 Molecure plans to identify a candidate for preclinical development in the USP7 project (a deubiquitinase inhibitor in immuno-oncology), followed by intensified partnering discussions in this program, and to identify lead compounds for two mRNA targets for which the Company has previously obtained proof-of-concept in vitro and to sign a collaboration or partnership agreement in the mRNA platform;
  • Molecure’s expenditures to complete both clinical trials and continue development of the most promising early-stage projects between Q4 2024 and the end of 2025 are estimated at about PLN 95 million;
  • Molecure intends to use four possible sources of financing: transaction proceeds such as up-front payment(s) on one or more partnering agreements, grants and subsidies, and equity issuances with possible use of debt instruments.

Warsaw, 15 October 2024 – Molecure S.A. (“Molecure”, WSE ticker: MOC), a clinical-stage biotechnology company that 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 translational function to treat incurable diseases, has updated its portfolio of research programs, focusing on its most promising clinical projects: OATD-01 and OATD-02, and the preclinical USP7 project and mRNA platform.

Reducing the number of projects that are in the early stages is intended to manage resources more efficiently and focus on clinical programs that have the greatest commercial potential. At the same time, Molecure is continuing promising preclinical projects such as USP7 and early-stage projects in its mRNA platform, in which the Company uses artificial intelligence (AI) to virtually screen and optimize drugs targeting mRNA.

„We have decided to update our research pipeline, focusing resources and efforts on the development and commercialization of projects that will bring the greatest increase in the Company’s value, contributing to our mission. We are getting closer to reaching a milestone in the development of OATD-01 in Phase II clinical trials, while aiming to determine the maximum tolerable drug dose (MTD) and/or recommended Phase II dose (Ph2RD) for OATD-02. Both molecules are being administered to pulmonary sarcoidosis patients and oncology patients in Phase II and Phase I clinical trials, respectively. Progress in both trials should reinforce interest from strategic partners in the coming year.

We see tremendous potential for value especially in the OATD-01 project, which, thanks to its unique and pioneering mechanism of action – blocking chitinase activity – has the potential to become a therapy in the area of unmet medical needs and diseases that affect a growing proportion of the population. The huge body of compelling preclinical data we have accumulated – ours and those of our partners – as well as literature data confirm that elevated chitinase expression leads to excessive macrophage activity, which in turn is responsible for the induction of many serious diseases, including sarcoidosis and MASH. Molecure is a clear leader and pioneer in the development of chitinase inhibitors, and we are the only company in the world to bring such a compound into clinical trials, currently at the proof of concept stage in humans, being tested in patients with active pulmonary sarcoidosis. We want to see preliminary confirmation of the efficacy of our compound through data from an interim analysis, which we plan for Q3 2025.

MASH disease, or steatohepatitis associated with metabolic disorders, in particular, is an extremely attractive therapeutic and commercial area. Over the past decade or so alone, the incidence rate of the disease has increased several to a dozen times, and the global market is projected to be worth more than $25 billion in 2032. Positive data confirming efficacy in part of the mechanisms responsible for the disease processes of MASH and the approval this year of the first drug in this indication, developed by Madrigal, have contributed to a more than 4-fold increase in the market value of this company and resulted in a significant increase in interest in MASH among big pharma and large biotech companies. We are determined to capitalize on the potential of our molecule and our strong data for development in precisely this indication, so we want to attract a partner who will support our research from the financial side, as well as further strengthen our expertise in the area of metabolic diseases. We are confident that success in Phase II clinical trials in one, and even more so in both indications (MASH and sarcoidosis) will lead to a multiplication of the value of our flagship molecule, and thus the Molecure” – says Marcin Szumowski, CEO, co-founder and shareholder of Molecure S.A.

Molecure is also advancing its most promising preclinical programs. In the USP7 project, among other collaborations with Avicenna Biosciences, the Company has overcome challenges in optimizing drug-like parameters for lead compounds (drug-like properties), and is developing a revised formulation of the drug. As a result of this work, a candidate is planned for official preclinical development in early 2025, followed by intensified partnering talks. It is worth recalling that in 2023, Exelixis acquired an exclusive global license from Insilico Medicine for the development and commercialization of the USP1 inhibitor (identified through its AI platform), a molecular target in the mechanisms of synthetic lethality. The up-front payment in this transaction was $80 million.

In the mRNA program, on the other hand, the Company is well on its way to selecting lead compounds for two mRNA targets for which it has reached proof-of-concept stage in vitro over the past 12 months, confirming the ability of small molecules to bind to mRNA fragments and efficacy in inhibiting translation of pathogenic proteins. The Company’s priorities in this area, having already achieved initial validation of the methodology’s efficacy and generation of functional in vitro molecules, are to identify lead compounds and enter into commercial service or partnering agreements.

Molecure’s ability to commercialize early-stage projects has been demonstrated through a deal with U.S. biotechnology company Ocean Biomedical, Inc. (NASDAQ: OCEA) in the YKL-40 program. On October 15, 2024, the Company entered into an exclusive license agreement with its U.S. partner covering the sale of rights to molecules from the YKL-40 program, including the lead compound OAT-3912, previously developed by Molecure at the early discovery stage, and a second patent for a molecular screening assay, allowing Molecure to continue its research program. The revenue potential for Molecure assuming the achievement of milestones in program development by Ocean Biomedical and the launch of the drug, according to the “bio-dollar value” formula, was set at approximately $32 million.

Recognizing the greatest commercial potential in clinical programs, Molecure has reduced the number of active programs in the discovery phase, closing the least promising program conducted under a know-how licensing agreement with the University of Michigan and Michigan State University (the Company plans to terminate this agreement, which will be done at no cost to the Company). In addition, development activities in the USP21 project have been temporarily suspended.

Molecure’s outlays for completing both clinical trials and continuing the development of the most promising early-stage projects in the period from Q4 2024 to the end of 2025 will amount to about PLN 95 million, including:

  • Clinical phase programs – approx. PLN 40 million
  • Discovery and preclinical development programs (including AI tools) – approx. PLN 16 million
  • mRNA platform (including AI tools) – approx. PLN 23 million
  • General and administrative expenses, including business development and IR – approx. PLN 16 million.

In parallel with the reduction of the Molecure pipeline, there was also a reduction in the workforce in the area of the three early programs, which translated into savings of more than PLN 3 million by the end of September this year, while by the end of 2025 the total planned savings from this will amount to about PLN 13 million.

Taking into account Molecure’s cash holdings (PLN 28.6 million as of the end of September this year) in order to complete the two clinical trials and continue the development of the most promising early-stage projects, the Company estimates a funding requirement of about PLN 70 million. To raise funds, Molecure intends to use four possible sources of financing: transaction proceeds such as up-front payment(s) from one or more partnering agreements, grants and subsidies, and issuance of equity and/or debt instruments.

Summary of financial data in 1-3Q 2024.*

  • Operating income of PLN 1.1 million (including a grant from the NIH and income from the Innovative Workers Credit), compared to PLN 3.3 million for 1-3Q 2023.
  • Operating expenses amounted to PLN 22.8 million, compared to PLN 25.2 million for 1-3Q 2023.
  • Operating expenses for 9Q 2024 were lower y-o-y by PLN 2.4 million, driven by lower expenses for programs in early stages of development (by PLN 1.3 million), as well as lower expenses for consulting services, including legal services (by PLN 1.0 million).
  • Net loss amounted to PLN 20.8 million, compared to PLN 18.4 million for the same period in 2023.
  • As of September 30, 2024, Molecure had cash and cash equivalents of PLN 28.6 million. In addition, contracted grant funding for future years is more than PLN 32 million. The company plans to attract further grants for projects within its developing pipeline of clinical and preclinical programs.

* Comparative figures for Q1-Q3 2023 have been restated for comparability due to a change in accounting policy.

***

About Molecure S.A.

Molecure S.A. is a biotechnology company that discovers and develops drugs to the clinical stage, leveraging its own unique expertise in medicinal chemistry and biology to explore and develop first-in-class small-molecule drugs that, through direct modulation of previously unexplored protein and RNA targets, could provide therapies for many incurable diseases.

Molecure has generated a diverse portfolio of seven distinct programs with the support of leading academic research institutions around the world, including Yale University, Rutgers University, the Flemish Institute for Biotechnology (VIB) in Ghent, the University of Michigan, Trinity College Dublin (TCD) 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 the treatment of interstitial lung diseases such as sarcoidosis and idiopathic pulmonary fibrosis, and MASH, which is in phase II clinical trials.

The second drug candidate is OATD-02, an oral, selective, first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer, whose Phase I clinical trial has begun with first patient administration in Q1 2023.

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

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

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

Molecure (WSE: MOC) and Nasdaq-listed biotechnology company Ocean Biomedical (NASDAQ: OCEA) sign an exclusive licensing agreement for the development and commercialization of selective YKL-40 inhibitors

This license covers first-in-class small molecule YKL-40 inhibitors, including the lead molecule OAT-3912, which has shown potential therapeutic benefits in preclinical models in various cancers as well as inflammatory and fibrotic diseases, offering a novel approach to treating these conditions. In addition, the license covers a patent pending for a molecular screening test for further the continuation of the program and the development of new YKL-40 inhibitors.

The Bio-dollar value of the agreement is approximately $32 million

Warsaw, 15 October 2024 – Molecure S.A., a clinical stage biotechnology company, leveraging unique competencies in medical chemistry and biology to discover and develop first-in-class small molecule drugs that directly modulate protein activity and mRNA function to treat incurable diseases, has signed an exclusive licensing agreement with Ocean Biomedical Inc. (NASDAQ: OCEA) based in Providence, Rhode Island, USA. The agreement concerns the development and commercialization of the selective YKL-40 inhibitor program, including the lead molecule OAT-3912, which Molecure has developed to early preclinical stage, as well as a second patent for a primary screening test enabling continuation of a continued discovery and development of novel YKL-40 modulators.

Under the agreement, Ocean Biomedical gains the exclusive rights to further research, develop, manufacture and commercialize Molecure’s OAT-3912 and other selective YKL-40 inhibitors worldwide and for all indications.

We are pleased to have completed this transaction, which will enable further continued development of the YKL-40 inhibitor program and our lead molecule OAT-3912, which has shown potential therapeutic benefits in preclinical models in various cancers as well as inflammatory and fibrotic diseases, offering a novel approach to treating these conditions. This transaction at early stage of the program confirms the attractiveness of our early pipeline both from business and scientific perspective. The potential financial benefits for Molecure, assuming the achievement of milestones in the program’s development by Ocean Biomedical and the drug’s market launch according to the “bio-dollar value” formula, are estimated at approximately USD 32 million. This amount excludes potential royalties and sublicensing fees.said Marcin Szumowski, CEO, Co-Founder, and shareholder of Molecure S.A.

As part of the collaboration, Molecure and Ocean Biomedical teams will continue development efforts through a joint steering committee overseeing research progress and commercialization processes.

We are excited to sign this agreement with Molecure as we see great potential in the biological target and its selective small molecule modulator,” said Ocean Biomedical Chairman and Co-Founder, Dr. Chirinjeev Kathuria,In our view, OAT-3912 has the potential to become a new therapeutic option for patients suffering from various types of cancers and fibrotic diseases, fitting perfectly into our strategy of pursuing innovative therapies in areas of unmet medical need. We are licensing the rights to further develop OAT-3912 and other selective YKL-40 modulators developed by Molecure, enriching our pipeline of programs modulating the activity of the very promising biological target – protein CHI3L1.

Under the agreement, Molecure will receive initial compensation of $600,000 in cash and stock.  Molecure will receive further milestone payments upon achievement of preclinical & clinical development, regulatory & commercial milestones. The maximum bio-dollar value of the agreement amounts to approximately $32 million. Additionally, Molecure is also guaranteed additional revenues from the development and commercialization of other products containing selective YKL-40 inhibitors covered by the agreement, which Ocean Biomedical may choose to pursue.

This deal is based on a discovery program carried out by Molecure, focused on the development of selective YKL-40 modulators, which may play a key role in various cancers and fibrotic diseases. This program led to the discovery of the lead compound OAT-3912, which strongly and selectively binds to YKL-40. In preclinical in vivo studies OAT-3912 demonstrated efficacy in cancer, as well as inflammatory and fibrotic diseases.

 

About Ocean Biomedical Inc.

Ocean Biomedical Inc. (NASDAQ ticker: OCEA) is a U.S.-based global biotechnology company that licenses promising research and develops them through preclinical and clinical stages. Ocean Biomedical’s R&D portfolio includes five research projects in indications such as lung fibrosis, cancers, and malaria, including a monoclonal antibody targeting YKL-40. One of the company’s co-founders and Chairman of its Scientific Advisory Board is Prof. Jack A. Elias, a renowned researcher and physician in the field of respiratory diseases, particularly known for his work on the translational use of YKL-40 as a therapeutic target in various lung diseases, including cancer and fibrosis.

 

About Molecure S.A.

Molecure S.A. is a clinical stage biotechnology company. The company uses its unique competencies in medical chemistry and biology to discover and develop first-in-class small molecule drugs that directly modulate previously unexploited protein and RNA targets, offering treatments for many incurable diseases.

Molecure has generated a diversified portfolio of seven distinct programs with the support of leading academic research institutions worldwide, including Yale University, Rutgers University, the Flemish Institute for Biotechnology (VIB) in Ghent, the University of Michigan, Trinity College Dublin (TCD) and the International Institute of Molecular and Cell Biology in Warsaw (IIMCB).

The most advanced drug candidate developed by Molecure is OATD-01, the first-in-class CHIT1 inhibitor for the treatment of interstitial lung diseases such as sarcoidosis, idiopathic pulmonary fibrosis, and MASH, currently in Phase II clinical trials. The second drug candidate is OATD-02, an oral selective first-in-class dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer, whose Phase I clinical trial began with the first patient dose 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).

More information is available at: molecure.com

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

 

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

molecure@medistrava.com

+44 (0)203 928 6900

Invitation to investor meeting 16th October 2024, 10:00 am (CET)

Molecure S.A. is pleased to invite you to a meeting to discuss the Company’s operational and financial situation following the publication of its Q3 2024 report, in particular the progress of ongoing clinical and preclinical stage research programs and further plans.

The expected time of the meeting is about 90 minutes. The meeting will be held in Polish. The recording in English will be available on October 21st on the Molecure’s YouTube channel.

The meeting will be attended by:

– Dr Marcin Szumowski – Chief Executive Officer, President of the Management Board

– Dr Piotr Iwanowski – Chief Medical Officer, Member of the Management  Board

– Dr Zbigniew Zasłona – Chief Scientific Officer, Member of the Management Board

– Sławomir Broniarek – Chief Financial Officer, Member of the Management Board

 

_______

date: October 16, 2024 (Wednesday)

time: 10:00 am (CET)

registration link: https://ccgroup.clickmeeting.com/molecure-omowienie-sytuacji-operacyjno-finansowej-spolki-po-publikacji-raportu-3q-2024/register

 *Registration for the meeting is required – you will receive an email with an individual access link

_______

 

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Molecure has released its financial report for the first half of 2024. The company continues to develop innovative therapies in the fight against oncological and inflammatory-fibrotic diseases

  • In H1 2024, Molecure focused on the development of two key molecules: OATD-01 and OATD-02, as well as expanding research activities based on, among other things, advanced artificial intelligence technologies
  • In May, Molecure received approval to initiate a Phase II clinical trial (KITE) for clinical candidate OATD-01 for the treatment of pulmonary sarcoidosis in the European Union and Norway. Earlier, Molecure received approval from the U.S. FDA and the U.K. MHRA
  • In the OATD-01 clinical trial, the Company currently has 13 sites activated in the US, the European Union, the UK and Norway. More will be activated by mid-November this year.
  • Progress in the Phase I clinical trial of OATD-02, the first-in-class dual arginase inhibitor being developed for the treatment of cancer. Following analysis of clinical and pharmacokinetic data and Safety Review Committee (SRC) recommendations, recruitment continues with the addition of 3 additional patients in the fourth cohort at the 20 mg dose level, with the goal of expanding the amount and scope of data to inform decisions on further dose escalation
  • Molecure has confirmed in in vitro tests the ability of the second molecule already being developed within the mRNA platform to effectively bind to the presumed mRNA fragment and block the translation process of the pathogenic protein. Reaching the PoC (in vitro proof-of-concept) stage for yet another molecule being developed in the mRNA platform is evidence of the effectiveness of Molecure’s strategy to identify mRNA-binding compounds with therapeutic potential.
  • In July, Molecure and Avicenna Biosciences entered into a strategic research collaboration agreement to optimize USP7’s small-molecule drug discovery and development processes. The collaboration will combine Molecure’s extensive drug discovery and USP7 biology expertise with Avicenna’s machine learning-based medicinal chemistry platform to identify new drug candidates with superior pharmaceutical properties.
  • In August, Dr Piotr Iwanowski, M.D., was appointed Chief Medical Officer (CMO) and Member of the Management Board of Molecure S.A., he will assume the above functions on September 30th this year.

 

Warsaw, 27 September 2024 – Molecure S.A. (“Molecure”, WSE ticker: MOC), a biotechnology company that discovers and develops drugs to the clinical stage and 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, has released its report for the first half of 2024. The report is available at: https://molecure.com/pl/informacje-dla-inwestorow/

 

Marcin Szumowski, CEO Molecure S.A.

„In the past six months, our main focus has been on the continued clinical development of OATD-01 and OATD-02. We continued to recruit to clinical trial of OATD-01, a first-in-class chitotriosidase 1 (CHIT1) inhibitor, in patients with pulmonary sarcoidosis on both continents. A positive decision by regulatory authorities from European countries, following earlier approval in the US and UK, has given us the “green light” to conduct Phase II trials of OATD-01 also in Denmark, France, Greece, Germany and Norway. We still hope that we will be able to involve Polish centers and Polish patients in this study. We are planning the first readouts of intermediate signals of therapeutic efficacy and safety in patients with sarcoidosis at the first half of 2025. However, due to the double-blinding requirement of the study, the publication of the final results will occur after the completion of the study and is scheduled for 2026. Our attention in the OATD-01 program is increasingly focused on the area of metabolic diseases, particularly MASH (metabolic dysfunction-associated steatohepatitis). We have very good preclinical results and there are a growing number of scientific publications from genetic studies and based on samples from MASH patients highlighting the key role of CHIT1 in disease escalation. The MASH market is projected to grow at more than 40% CAGR annually to a size of more than $25 billion in 2032. Molecure aims to play a significant role in treatment in MASH in partnership with a major company in the area of progressive metabolic liver disease. Scientific data and market projections support our assumptions about the therapeutic potential of blocking chitinases in multi-organ diseases.

In the Phase I clinical trial of OATD-02, an innovative arginase inhibitor, we are continuing to recruit and add 3 more patients to this cohort after analyzing data from the fourth cohort at the 20 mg daily dose level and the Safety Review Committee’s recommendation. As recommended by the SRC, we want to collect more extensive pharmacokinetics and pharmacodynamics data at this stage in order to decide whether to further increase the dose. We are confident that this next phase will bring us significantly closer to bringing breakthrough therapies to market that can change the lives of patients around the world.

We see great potential for a platform of small-molecule drug discovery that modulates mRNA function. In December 2023, we obtained positive in vitro results for the first of our molecules, and just a few months later we confirmed translation inhibition for another molecule targeting a different mRNA target. At the BIO International Convention in San Diego in early June, we had many meetings with representatives of Big Pharma companies interested in collaborating on the mRNA platform. In small molecule technology targeting mRNA, we are at the European and even global forefront, so we assume that establishing a commercially attractive collaboration with a large industry partner is likely within the next year.

Also noteworthy is the establishment of a strategic collaboration with Avicenna Biosciences to support the discovery and development of new small-molecule drugs targeting ubiquitin-specific protease 7 (USP7), a deubiquitinating enzyme that promotes oncogenesis and whose high expression is observed in a number of cancers. By combining Molecure’s expertise on this attractive, in vivo validated target with Avicenna’s machine learning-driven medicinal chemistry platform, we intend to generate better drug candidates with optimal pharmacological profiles for further preclinical and clinical development.”

 

Webinar with Molecure’s Management Board

A meeting will be held on October 1, 2024 at 2:00 pm to discuss the Company’s operational and financial situation for 1H 2024, including the presentation of progress in ongoing research programs, as well as development plans for the coming quarters. The meeting will be held in online format, at the link:

 

Business Development activities

  • In the first half of 2024, representatives of the Company participated in two important industry conferences:
    • BIO Europe Spring in Barcelona, where they held 38 meetings with biotech and pharmaceutical industry representatives, mainly potential partners, investors and global pharmaceutical companies. The key topics of discussion were OATD-01 (more than 50% of the meetings), OATD-02 and the RNA platform,
    • BIO International Convention in San Diego, where they held a total of a record 42 meetings, of which as many as 28 were related to OATD-01, demonstrating the growing and increasingly concrete interest in the results of preclinical and clinical research in lung diseases and also in metabolic diseases such as MASH.
  • In addition, representatives of the Company participated in conferences: “Immunometabolism in Health and Disease” organized by Gordon Research Conferences at the American Bryant University in Smithfield, congress The European Congress of Life Sciences EUROBIOTECH in Krakow, Poland, International Conference on Medicinal Chemistry in Bordeaux, France, PHASE2024 in Warsaw, Americas Association of Sarcoidosis and Other Granulomatous Disorders (AASOG) in Baltimore, USA, IPF Summit in Boston, USA, and many others..
  • The company will participate in more industry conferences this year, including but not limited to major global events i.e. Bio Europe in Stockholm, as well as WASOG in India.

 

Summary of financial data in 1H 2024*

  • Operating income of PLN 0.4 million, up from PLN 1.8 million in 1H 2023.
  • Operating expenses amounted to PLN 15.6 million, compared to PLN 17.2 million in 1Q 2023. 1H 2024 saw a decrease of PLN 1.6 million in operating expenses compared to 1H 2023. The main factor for the change was a decrease of PLN 0.5 million in program expenses, which, in accordance with the new accounting policy, are no longer capitalized under uncompleted development work. In addition, costs of legal and consulting services decreased by about PLN 0.9 million in 2024 compared to 2023.
  • Net loss amounted to PLN 14.6 million compared to PLN 12.9 million in the same period in 2023.
  • As of June 30, 2024, Molecure had cash of more than PLN 38 million, and the end of September this year. PLN 27 million. In addition, contracted grant funding for the coming years amounts to PLN 32.5 million. The company plans to raise further project grants as part of its expanding pipeline of clinical and preclinical projects.

* Comparative figures for the first half of 2024 have been restated for comparability due to a change in accounting policy.

 

***

About Molecure S.A.

Molecure S.A. is a biotechnology company that discovers and develops drugs to the clinical stage, leveraging its own unique expertise in medicinal chemistry and biology to explore and develop first-in-class small-molecule drugs that, through direct modulation of previously unexplored protein and RNA targets, could provide therapies for many incurable diseases.

Molecure has generated a diverse portfolio of seven distinct programs with the support of leading academic research 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, Poland (MIBMiK).

The most advanced drug candidate developed by Molecure is OATD-01, a first-in-class CHIT1 inhibitor for the treatment of interstitial lung diseases such as sarcoidosis and idiopathic pulmonary fibrosis, and MASH, which is in phase II clinical trials.

The second drug candidate is OATD-02, an oral, selective, first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer, whose Phase I clinical trial has begun with first patient administration in Q1 2023.

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

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

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

Invitation to investor meeting 1st October 2024, 2:00 pm (CET)

Molecure S.A. is pleased to invite you to a meeting dedicated to discussing the Company’s operational and financial situation for 1H 2024, including the presentation of progress in ongoing research programs, as well as development plans for the coming quarters.

The expected time of the meeting is about 90 minutes.

 

The meeting will be attended by:

– Dr Marcin Szumowski – Chief Executive Officer, President of the Management Board

– Dr Zbigniew Zasłona – Chief Scientific Officer, Member of the Management Board

– Sławomir Broniarek – Chief Financial Officer, Member of the Management Board

– Dr Piotr Iwanowski – Chief Medical Officer, Member of the Board as of September 30, 2024

 

_____

date: October 1, 2024 (Tuesday)

time: 14:00

 

Link to the broadcast in English (with the possibility to ask questions in writing): https://livingmedia.com.pl/live/molecure/1H2024-en

 

Link to the original track:

https://livingmedia.com.pl/live/molecure/1H2024-pl

 

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

Dr Piotr Iwanowski appointed as Chief Medical Officer and Board Member of Molecure

Warsaw, 1 August 2024 r. – Molecure S.A. (‘Molecure’, WSE ticker: MOC), a biotechnology company that discovers and develops drugs to the clinical stage and 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, announces the appointment of Piotr Iwanowski, M.D., Ph.D., as Chief Medical Officer (CMO) and Board Member of Molecure S.A., effective as of 30 September 2024.

 

„We are delighted that Piotr is joining the Molecure team. He is a high-level professional with many years of experience in the management, design, medical monitoring, oversight, and reporting of international clinical trials, with multiple interactions with regulators, including EMA and FDA. Piotr has been involved in the planning and execution of dozens of international clinical trials on all continents, both early and late stage. Several drugs from clinical trials in which Piotr had a significant impact at the operational level have already reached the market’’ says Marcin Szumowski, CEO of Molecure. ,,Piotr has already been co-operating with Molecure as a consultant in our clinical programs, scientific advise and other regulatory procedures. His expert knowledge and familiarity with Molecure’s research programs are key assets and will allow him to quickly establish himself in the effective management of Molecure’s clinical team, crucial in accelerating their progress and building Molecure’s value” – adds Marcin Szumowski.

 

„I am honored to have the opportunity to join such an innovative Polish biotechnology company. Having worked for more than 20 years in international teams involved in the clinical development of drugs and medical devices, I am delighted that I can now apply my experience in a domestic biotech company. I assume that my knowledge of clinical trials, both early and late phases, will be crucial to the development of the company’s promising portfolio. I am enthusiastic about the upcoming collaboration with the talented Molecure team. Together, we will accelerate innovations under development to deliver new, effective and safe therapies for patients in Poland and around the world” – says Dr Piotr Iwanowski.

 

Piotr Iwanowski is a doctor of medicine and an expert with extensive international experience in the clinical development of medicinal products and medical devices, which he acquired in various roles including senior medical positions. His responsibilities have included management of the clinical teams, interactions with principal investigators at clinical sites involved in ongoing clinical trials, study design, shaping the clinical development strategy, medical and regulatory supervision of clinical trial progress, scientific procedures with regulators, scientific publications, as well as support of business development processes from the clinical end.

Previously, Piotr served as associate vice president of clinical research in Europe at Wockhardt Bio and associate director of clinical operations in CEE and Turkey at Bristol-Myers Squibb. He also has several years of experience as a manager, monitor and auditor of clinical trials at Servier Poland. Since 2017, he has been a consultant physician at the Centre for Rare Diseases at the Children’s Memorial Health Intitute in Warsaw.

Piotr Iwanowski graduated in medicine and obtained his thesis in medical sciences at the Medical University of Białystok and specialized in clinical genetics. He completed postgraduate studies in medical law, bioethics and sociology of medicine at the University of Warsaw. He is fluent in Polish, English, French, German and Russian.

He has authored numerous scientific publications in the field of clinical drug development, including a co-authored publication with the Molecure team on arginase inhibitors.

He plays an active role in various scientific and educational organizations, including as a lecturer and faculty member for public grant application evaluation. He has also held positions in the Polish Association for Good Clinical Practice, including vice-president and board member.

 

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About Molecure S.A.

Molecure S.A. is a biotechnology company that discovers and develops drugs to the clinical stage, leveraging its own unique expertise in 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, may provide therapies for many incurable diseases.

Molecure has generated a diverse portfolio of seven distinct programs with the support of leading academic research 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 the treatment of interstitial lung diseases such as sarcoidosis and idiopathic pulmonary fibrosis and MASH, which is in Phase II clinical trials.

The second drug candidate is OATD-02, an oral, selective, first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer, whose Phase I clinical trial has begun with first patient administration in Q1 2023.

Molecure’s headquarters and laboratories are located in Warsaw and Lodz. 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

Avicenna Biosciences and Molecure S.A. Sign Strategic Research Collaboration Agreement to Accelerate Discovery and Development of Small Molecule Drugs

Warsaw, Poland and Durham, North Carolina, USA, July 31, 2024 – Molecure S.A. (‘Molecure’, SWE Ticker: MOC) and Avicenna Biosciences, Inc. announced today that they have entered into a strategic research collaboration to facilitate the discovery and development of novel small molecule drugs targeting ubiquitin-specific protease 7 (USP7), a deubiquitinase relevant in a number of tumors.  The collaboration will combine the extensive expertise of Molecure related to drug discovery and biology of USP7 with Avicenna’s machine learning-driven medicinal chemistry platform to identify novel drug candidates with superior pharmaceutical properties.

 

USP7 is an attractive target in cancer which regulates the stability of crucial proteins involved in pathways relevant for tumor suppression and immune response. Under the terms of the agreement, Avicenna will design algorithms to identify new chemical entities which inhibit USP7, and meet pre-specified pharmacological criteria. Molecure will be responsible for synthesizing and evaluating these new chemical entities and selecting one or more for further development. Molecure retains the right to develop and commercialize novel drug candidates resulting from the collaboration.

Avicenna, under the risk-sharing model, will receive an upfront fee and research funding, which will be contingent upon the generated compounds meeting the established success criteria. Additionally, if Molecure exercises the option to license the generated molecules, Avicenna will be eligible for license fees and will retain a specified share in the future revenues derived from drug candidates developed by Molecure.

 

Marcin Szumowski, Molecure’s CEO said:By combining Molecure’s in-depth knowledge of this attractive, validated in vivo target with Avicenna’s ML-driven medicinal chemistry platform,  we intend to generate superior drug candidates with optimal pharmacological profiles for further preclinical and clinical development.

Chris Meldrum, President & CEO of Avicenna, stated:We have been very impressed with the Molecure team, their deep expertise in targeting USP7, and their efforts to deliver new treatment options to patients with difficult-to-treat cancers. Avicenna welcomes the challenge to transform chemical potential to biological and clinical reality for this important target.

 

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About Molecure S.A.

Molecure S.A. is a biotechnology company that discovers and develops drugs to the clinical stage, leveraging its own unique expertise in 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, may provide therapies for many incurable diseases.

Molecure has generated a diverse portfolio of seven distinct programs with support from leading academic research 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, Poland (MIBMiK).

The most advanced drug candidate developed by Molecure is OATD-01, a first-in-class CHIT1 inhibitor for the treatment of interstitial lung diseases such as sarcoidosis, idiopathic pulmonary fibrosis and MASH. The second drug candidate is OATD-02, an oral, selective, first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer, whose Phase I clinical trial has begun with first patient administration in Q1 2023.

Molecure’s headquarters and laboratories are located in Warsaw and Lodz. 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

 

 

About Avicenna Biosciences

Avicenna was founded in 2020 by Drs. Thomas Kaiser and Pieter Burger out of the Liotta Research Group at Emory University.  The company is on a mission to solve the intractable drug design challenges that previously stopped drug candidates in their tracks.  Its machine learning-driven medicinal chemistry platform makes lead-to-drug optimization faster, cheaper and more successful – transforming sub-optimal clinical candidates into life-saving drugs.  Avicenna is backed by DCVC Bio. The company’s peer-reviewed research has been published in outlets such as Journal of Chemical Information and Modeling.  For more information, visit www.avicenna-bio.com and follow the company on LinkedIn.

 

Avicenna Media Contact

Kerry Walker

kerry@walkercomms.com

Molecure has confirmed the in vitro activity of another molecule binding to a new mRNA target within the mRNA discovery platform

– In December 2023, Molecure confirmed the inhibition of protein translation with compounds targeting the mRNA in an in vitro proof-of-concept (PoC) using a cell-based assay 

– This month, Molecure confirmed inhibition of the protein translation function for another mRNA target. Another small molecule discovered and synthesized by Molecure showed efficacy in an in vitro assay, expanding the number of selective binders in its mRNA discovery platform. 

– The achievement of the PoC stage for another molecule and a second target in the mRNA platform provides evidence of the effectiveness of Molecure’s strategy to identify mRNA-binding compounds with therapeutic potential 

– Strong biopharmaceutical industry interest in Molecure’s mRNA targeting technology increases the  commercial potential of Molecure’s mRNA discovery platform and the likelihood of signing a collaboration or partnership agreement. 

 

Warsaw, 12th June 2024 – Molecure S.A. (‘Molecure’, WSE ticker: MOC), a biotechnology company discovering and developing drugs to the clinical stage that leverages its globally unique expertise in medicinal chemistry and biology to search for and develop first-in-class small-molecule drugs that directly modulate protein activity and mRNA translation for the treatment of multiple incurable diseases, has confirmed in vitro the ability to bind to another mRNA target and demonstrated efficacy of a second molecule in inhibiting the translation mechanism of a pathological protein using compounds that target the mRNA encoding that protein. This is another success in the development of the mRNA discovery platform and one of the Company’s strategic goals for 2023-2025. 

 

„The discovery of another class of molecules binding to a second mRNA biological target, confirmed in in vitro assays, is the result of our team’s tremendous commitment and innovative approach to finding new molecules that modulate the translational function of mRNA. In December 2023, we obtained positive in vitro results for the first class of our molecules, and just a few months later we confirmed translational inhibition for another molecule targeting a different mRNA target. This attests to the broad scientific competence of our team and the high quality of our drug design processes, which we are improving through the use of advanced AI tools and computational methods. In the mRNA-targeting small molecule technology, we are in the European and even global vanguard and see great commercial potential for our mRNA discovery platform.  At the June BIO International Convention in San Diego, we had many meetings with representatives of companies interested in collaborating on discovering and developing small molecules targeting mRNA. Most of them were BigPharma representatives. We see many large partnership deals in this space signed at very early stages of drug development. In line with our strategy, this should allow us to intensify our partnering discussions and increase the likelihood of establishing a commercially attractive collaboration with a large industry partner. We are very pleased with multiple discussions we had during the recent BIO in the US with potential partners regarding our research program pipeline” – said dr Zbigniew Zasłona, CSO Molecure S.A. 

 

Molecure in the area of the mRNA platform is considering several commercialisation models, including a service model based on generating revenue from collaborating on the development of mRNA targets selected by the partner, which, through the use of a platform supported by AI tools, the Company can validate and then design and optimise molecules that interact with these targets. Another model is the classic licensing to a partner of Molecure’s newly discovered molecules that directly model mRNA function. Molecure is one of the few biotech companies in the world that develops small-molecule drugs that directly interact with mRNA targets.  

 

About Molecure S.A. 

Molecure S.A. is a biotechnology company that discovers and develops drugs to the clinical stage, leveraging its own unique expertise in 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, may provide therapies for many incurable diseases. 

Molecure has generated a diverse portfolio of seven distinct programmes with support from leading academic research 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, Poland (MIBMiK). 

The most advanced drug candidate developed by Molecure is OATD-01, a first-in-class CHIT1 inhibitor for the treatment of interstitial lung diseases such as sarcoidosis and idiopathic pulmonary fibrosis.  

The second drug candidate is OATD-02, an oral, selective, first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer, whose Phase I clinical trial has begun with first patient administration in Q1 2023. 

Molecure’s headquarters and laboratories are located in Warsaw and Lodz. 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    

Molecure receives approval to initiate a Phase II clinical trial (KITE) for OATD-01 for the treatment of pulmonary sarcoidosis in selected countries of the European Union and Norway

  • OATD-01 is a first-in-class chitotriosidase 1 (CHIT1) inhibitor with the potential to modify the course of disease in sarcoidosis and other interstitial lung diseases.
  • Obtaining regulatory approvals in Denmark, France, Greece, Germany, and Norway enables the conduct of the Phase II clinical trial of OATD-01 in these countries.
  • First administration of OATD-01 in the European Union and Norway is planned for the third quarter of this year.
  • Previously, Molecure received clinical trial approvals from the US FDA and the UK MHRA, with first patients dosed in March 2024 in the UK.
  • First-ever administration of a chitotriosidase 1 (CHIT1) inhibitor is a significant milestone in the clinical development of Molecure’s leading program.

 

Warsaw, 21st May 2024 – Molecure S.A. (‘Molecure’, WSE ticker: MOC), a biotechnology company that discovers and develops drugs to the clinical stage, leveraging 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 for the treatment of multiple incurable diseases, announces today that it has received national regulatory approvals from Denmark, France, Greece, Germany and Norway to conduct a Phase II clinical trial for OATD-01, a first-in-class chitotriosidase 1 (CHIT1) inhibitor with disease-modifying potential in pulmonary sarcoidosis.

 

Marcin Szumowski, Molecure’s CEO said: “An important milestone has been reached in the Phase II clinical trial of OATD-01 with the first patient administration in March this year at the Royal Infirmary in Edinburgh. We are pleased to receive further regulatory approvals from selected EU countries and Norway to conduct this breakthrough clinical study. The first dose is expected to be administered to patients in the selected countries in the third quarter of this year. The Phase II clinical trials to be conducted in both the USA and Europe, the two most commercially important markets, will enable us to collect the necessary data that, if positive, will confirm clinical proof of concept in a pulmonary sarcoidosis patient population that currently has few treatment options with limited efficacy in disease modification. OATD-01 has demonstrated remarkable potential in preclinical studies, suggesting it could redefine the standard of care for pulmonary sarcoidosis. The results of these studies will be crucial for further development and commercialization of OATD-01 in this and other potential indications such as NASH/MASH, IPF or inflammatory bowel disease (IBD). We look forward to presenting the unblinded results of this study in late 2025.”

 

The Phase II clinical trial for OATD-01 is a randomized, double-blinded, placebo-controlled, multicenter study to evaluate the safety and efficacy of OATD-01 in approximately 100 patients with active pulmonary sarcoidosis, including patients previously receiving other therapies with no clinical improvement and patients previously untreated.

Due to the requirement for double blinding in the study, the final unblinded results publication will occur after its completion and is scheduled for the end of 2025. To measure efficacy of OATD-01 in the study, an innovative primary endpoint has been agreed upon with the regulatory authorities, which is the response to 12-week administration of OATD-01, measured by the degree of granulomatous inflammation reduction in the lung parenchyma, assessed by PET/CT imaging. Following the completion of full dosing along with a monitoring period involving approximately 50 patients, an interim analysis (intermediate checkpoint) is planned to evaluate the statistical results by an independent committee and make decisions regarding the study’s continuation in terms of patient numbers in early Q1 of 2025.

The study will involve approximately 20-30 centers in the USA, European Union, Norway, and the United Kingdom. The renowned Contract Research Organization (CRO) responsible for organizing and conducting the comprehensive study is Simbec Orion.

 

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 is a promising molecular target due to its role in transforming local anti-inflammatory macrophages into pro-inflammatory and pro-fibrotic types. Blocking CHIT1 activity by OATD-01 has resulted in documented anti-inflammatory and anti-fibrotic effects.

The OATD-01 molecule has shown strong anti-inflammatory and anti-fibrotic effects in various disease models and has high therapeutic potential in diverse inflammatory and fibrotic diseases with unmet medical needs, such as sarcoidosis, as well as idiopathic pulmonary fibrosis (IPF) and non-alcoholic steatohepatitis (NASH), recently relabeled as Metabolic Dysfunction-Associated Steatohepatitis (MASH).

Molecure has obtained orphan drug designation (ODD) from the FDA for OATD-01 in the indications of sarcoidosis and idiopathic pulmonary fibrosis and has received approval to initiate a Phase II clinical trial for the treatment of pulmonary sarcoidosis in the US, UK, selected countries of the European Union, and Norway.

 

About sarcoidosis

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

It is a globally occurring disease affecting both men and women with an estimated incidence of 5-50 cases per 100,000 population, with 70% of patients being between 25-45 years old.

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

 

About Molecure S.A.

Molecure S.A. is a biotechnology company discovering and developing drugs to the clinical stage, leveraging its unique expertise in 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 provide therapy for many incurable diseases.

Molecure has generated a diversified portfolio of seven distinct programs with the support of leading academic institutions worldwide, 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 the treatment of interstitial lung diseases such as sarcoidosis and idiopathic pulmonary fibrosis.

The second drug candidate is OATD-02, an oral, selective, first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancers, with Phase I clinical trials commencing with the first patient administration in the first quarter of 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 on: https://molecure.com/pl/

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