Molecure has published its financial report for the first quarter of 2024. The company is progressing, as anticipated, the next steps in the development of its clinical and pre-clinical programmes

  • In March this year, the Edinburgh (UK) clinic saw the first patient dosing of the drug or placebo in the Phase II clinical trial of OATD-01 (the KITE trial), a first-in-class chitinase inhibitor for potential use in inflammatory and fibrotic diseases 
  • Two patients are currently dosed in the UK, and more are in the pipeline (screening) for inclusion in the Phase II clinical trial of OATD-01 for the treatment of pulmonary sarcoidosis 
  • In the USA, the process of enrolling additional sites to conduct the OATD-01 clinical trial is at an advanced stage, with a total of three sites active there, which have started the recruitment process  
  • In April, an application was submitted to the US NIH (National Health Institute) for US$2.2 million for funding for the US portion of the OATD-01 clinical trial and a grant of US$0.3 million was awarded by the NIH for the development of inhibitors of key signalling pathways responsible for the fibrosis process – a programme licensed from University of Michigan  
  • Progress in the Phase I clinical trial of OATD-02, the first-in-class dual arginase inhibitor being developed for the treatment of cancer – commencement of drug administration to the 4th cohort of patients (20 mg dose). The aim of the study is to determine the maximum tolerated dose and the recommended dose for the next phase of trials 
  • Consistent support of preclinical programme development processes with artificial intelligence (AI) tools, including for the designation of an official preclinical development candidate in the USP7 immuno-oncology programme for use in anti-cancer therapies 
  • As at 31 March 2024, the Company had cash resources of PLN 52.4m  

Warsaw, May 17, 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 explore and develop first-in-class small-molecule drugs that directly modulate protein activity and mRNA function to treat a range of incurable diseases, has released its Q1 2024 report. The report is available at: 


Marcin Szumowski’s Comment, CEO of Molecure S.A. 

„In the first quarter, we focused on advancing the development of the OATD-01 and OATD-02 clinical programs, which are the most important elements of our pipeline, building Molecure’s value from a partnering perspective. OATD-01 is a drug candidate for the potential treatment of pulmonary sarcoidosis, a globally prevalent disease for which there are currently no effective therapies. In the second phase of the OATD-01 study, we plan to demonstrate that blocking chitinases in patients has a therapeutic effect and inhibits inflammatory processes. We have already commenced Phase II trials in the United Kingdom and are ready to enroll patients in several centers in the USA. A positive decision from regulatory authorities in European countries, which we anticipate, will also give us the “green light” to conduct Phase II OATD-01 trials in Denmark, France, Greece, Germany, and Norway. We plan to have the first readings of therapeutic efficacy signals in patients with sarcoidosis at the beginning of 2025. However, due to the requirement for a double-blind study, the final results will be published upon its completion and are expected at the earliest by the end of 2025. 

In our second clinical program, currently in Phase I, OATD-02, we are gathering data and gaining more knowledge from successive cohorts of patients. In April of this year, we began administering a 20mg dose of OATD-02 to the first patient and are now preparing to administer it to the second patient in the 4th cohort. We expect to have analyzed data from the fourth cohort by September of this year, and based on the recommendation of the Safety Review Committee, we will decide on the next dose level. The primary goal of our Phase I oncology study is to determine the safety profile of OATD-02, which is essential for determining the dose for the next phase. So far, we see that the data indicate a safe profile for the drug at the doses used and no significant adverse effects. As we obtain data from subsequent cohorts, we will also gain more indirect information about the antitumor activity of our compound. 

In the longer term, a key element of our pipeline is our small molecule drug discovery platform targeting mRNA. The first milestones we have achieved in this area validate the effectiveness of our methodology, generating the first molecules that successfully and selectively bind to and modify RNA function. This represents a true breakthrough and enhances Molecure’s development potential and long-term value. The breakthrough nature of this technology is evidenced by the fact that major partnering transactions are being concluded at the development stage we are currently entering. We are experiencing significant interest in our mRNA platform at leading global industry conferences and are actively building a service offering that meets the expectations of potential partners.” 


Business Development Activities 

  • In the first quarter of 2024, company representatives participated in industry conferences, including BIO Europe Spring in Barcelona, where they held 38 meetings with representatives from the biotechnology and pharmaceutical industries, primarily potential partners, investors, and global pharmaceutical companies. The key discussion topics were OATD-01 (over 50% of the meetings), OATD-02, and the RNA platform. 
  • The company will participate in further industry conferences this year, including major global events such as Bio International in San Diego and Bio Europe in Stockholm, as well as WASOG, AASOG, likely ESMO, and the RNA Assay Development & Screening Summit. 


Scientific publications 

  • In March 2024, a scientific publication authored by the Molecure team (Zbigniew Zasłona, Katarzyna Drzewiecka) on the role of CHIT1 in cellular metabolism, titled “Metabolism-driven glycosylation represents therapeutic opportunities in interstitial lung diseases,” was published. Targeting enzymes that regulate protein glycosylation processes (including CHIT1) can effectively block immunometabolic changes leading to inflammation and fibrosis. This peer-reviewed review article was published in the prestigious journal Frontiers in Immunology.

    The publication is available at this link: 

The Molecure team is working on another (mechanistic) publication in collaboration with Professor Luke O’Neill, a world expert in innate immunity and inflammatory diseases, who joined the Molecure Scientific Advisory Board in 2023. 


Summary of financial data in Q1 2024 

  • Operating revenues amounted to 0.03 million PLN, compared to 1.75 million PLN in Q1 2023*. 
  • Operating expenses were 7.29 million PLN, compared to 8.65 million PLN in Q1 2023*. In Q1 2024, there was a decrease in operating expenses by 1.36 million PLN compared to the first quarter of 2023. The main factor for this change was a 1.02 million PLN reduction in expenditures on programs that, according to the new accounting policy, can no longer be capitalized under unfinished development work. Additionally, costs for external services not directly related to projects decreased by approximately 0.57 million PLN in 2024 compared to 2023. 
  • Net loss amounted to 6.84 million PLN, compared to 5.89 million PLN in the same period of 2023*. 
  • As of March 31, 2023, Molecure had cash resources of over 52 million PLN. Additionally, contracted grant funding for the coming years amounts to 32.5 million PLN. The company plans to secure further grants for projects within its developing pipeline of clinical and preclinical projects. 

*Data for the first quarter of 2023 has been restated for comparability due to changes 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 unique expertise in medicinal chemistry and biology to identify and develop first-in-class small molecule drugs. These drugs target previously unexplored protein and RNA targets, offering potential therapies for many incurable diseases. 

Molecure has generated a diverse 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, 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 cancer treatment, with its Phase I clinical trial having begun with the first patient dosing 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). 

For more detailed information, please visit websites: 

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