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

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

 

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

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

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

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

Investor Presentation

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

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

Commercial & Operational Highlights

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

 

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

 

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

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

 

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

 

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

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

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

 

Important Post-period Highlights

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

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

 

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

 

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

Full Year Financial Highlights

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

 

ENDS

 

For further information, please contact:

Molecure S.A. (PR & IR)

Marta Borkowska                                  

Email: m.borkowska@molecure.com

+(48) 728 728 143

 

MEDiSTRAVA Consulting (Financial PR)                           

Frazer Hall, David Dible, Sandi Greenwood, Eleanor Perkin

molecure@medistrava.com

+44 (0)203 928 6900

 

About Molecure

 

Molecure 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 globally, including Yale University, Rutgers University, the Flemish Institute for Biotechnology (VIB) in Ghent, the University of Michigan and the International Institute of Molecular and Cell Biology in Warsaw (IIMCB).

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

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

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

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

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

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

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

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

Molecure S.A. Presenters: 

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

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

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

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

Technical problems:

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

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

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

  • 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 Announces Details for Virtual R&D Day Webcast to be held on Wednesday 7th December 2022

Warsaw, Poland – 5 December 2022 – 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 agenda topics and participating key opinion leaders for its virtual R&D Day.

The webcast event will be hosted by Molecure on the 7th December 2022 at 13.30 – 16.30 CET / 12.30 – 15.30 BST/ 7.30 – 10.30 ET.

The meeting is available here:
https://us06web.zoom.us/j/84261604213?pwd=QTlVZytQTWFUd3Y1N080R2hwWGZydz09

The presentations by Key Opinion Leaders and Molecure management will showcase the scientific insights and clear clinical needs that underpin Molecure’s pipeline programs.


Agenda topics:

13.30-15.30

  • Molecure’s Vision, Strategy and Pipeline
  • OATD-01, Molecure’s first in class chitinase inhibitor:
    • Clinical evaluation in sarcoidosis and potential patient impact (Prof. Krenke)
    • Landscape and therapy opportunity in sarcoidosis
    • Clinical development plan
    • Other opportunities in interstitial lung disease
  • OATD-02, Molecure’s novel dual arginase inhibitor:
    • Pre-clinical activity in a broad range of cancers
    • State of oncology in Poland (Prof. Szczylik)
    • Clinical development plan

15.30-15.40 Break

15.40-16.30

  • Early-stage pipeline
    • Deubiquitinating enzymes (DUBs) program including USP7 in oncology
    • YKL40 in oncology
    • University of Michigan collaboration in fibrosis
    • mRNA platform

Key Opinion Leader Presenters:

  • Rafal Krenke, Pulmonologist, Head of Department of Internal Medicine, Pulmonary Diseases & Allergy, Medical University of Warsaw
  • Cezary Szczylik, Oncologist, Head of the Department of Clinical Oncology and Chemotherapy Europejskie Centrum Zdrowia (European Health Center) Otwock

Molecure S.A. Presenters:

  • Dr Marcin Szumowski – CEO, President of the Board
  • Dr Zbigniew Zasłona – VP Research Biology, Member of the Board
  • Dr Samson Fung – Chief Medical Officer
  • Dr Nicolas Beuzen – Director of Business Development and Licensing


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 Third Quarter 2022 Pipeline Highlights and Financial Results

Molecure Third Quarter 2022 Pipeline Highlights and Financial Results

  • Proprietary pipeline progressing in-line with our strategic objectives for 2022-2025
  • Lead proprietary candidate, OATD-01 a novel chitinase inhibitor in sarcoidosis expected to advance into a Phase II study in mid-2023
  • Second proprietary candidate, OATD-02, a first in class arginase inhibitor for cancer on track to enter Phase I clinical trials in late 2022, following CTA approval

Warsaw, Poland – 31 October 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 third quarter results for the period ended 30 September 2022. The full report in Polish can be found here.

“We are delighted with the progress we are making on our strategic objectives, accomplished year to date,” said Marcin Szumowski, CEO and President of the Management Board of Molecure. “Our confidence in OATD-01’s potential to be a best and first in class disease modifying therapy for sarcoidosis has been enhanced over the period as a result of our discussions with a group of leading global experts and clinicians in sarcoidosis. Their input has also been important to ensure the successful planning and execution of this high priority clinical program. We are equally excited about the opportunity for OATD-02 in cancer, given this novel molecule’s clearly differentiated mode of action, and remain on track to start a Phase I study in late 2022.”

Molecure R&D Day

Molecure will host an R&D Day in the first half of December 2022. During this event, management and scientific leaders will provide a comprehensive review of the company’s pipeline. The event will provide updates on our development plans and related near-term catalysts, with a focus on OATD-01 and OATD-02 for sarcoidosis and cancer respectively.

Commercial & Operational Highlights

  • Preparations for a multi-centre Phase II trial for OATD-01 in sarcoidosis
  • Multiple discussions with leading pulmonologists & opinion leaders have taken place to help shape the planned clinical development program in sarcoidosis
  • 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
  • This novel drug candidate has 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 2022 to assess safety of OATD-02 in patients with advanced and/or metastatic solid tumors. The planned trial has already received a positive opinion from the bioethics committee in Poland
  • Publication* (August) entitled, “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 that OATD-02 is a potent dual ARG1/ARG2 inhibitor with cellular activity (necessary for targeting ARG2) and exhibiting immunomodulatory and direct antitumor efficacy in animal models

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

  • 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 target regions
  • Ongoing collaborations with global leading RNA centres to further leverage the company’s expertise and alternative approach to identify compounds interacting with selected mRNA regions
  • Partnering events and investor conferences
  • Post period end, CEO, Marcin Szumowski and business development director, Nicolas Beuzen attended partnering conference Bio-Europe in Leipzig, Germany in October. The event brought together thousands of outstanding biopharma companies enabling meaningful partner discussions
  • The company will attend a number of partnering and investor events before the end of 2022 including the Jefferies Healthcare conference in London in November, the largest healthcare conference held in Europe each year

Third Quarter Financial Highlights

  • Operating income totaled PLN0.24 million, a slight decrease yoy due to lower subsidies booked from public grants compared to the same period in 2021.
  • Operating expenses totaled PLN3.49 million, an increase of PLN1.26 million. 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 3 months ended 30 September 2022 totaled PLN2.46 million.
  • As of September 30, 2022, Molecure had cash of PLN80 million (US$16 million).
  • Current funds are expected to fund the company’s operating expenses and capital expenditure requirements for the next 18-20 months.
  • US$/PLN exchange rate 5.0 as of 30 September 2022

ENDS

 

For further information, please contact:

Molecure S.A. (PR & IR)
Marta Borkowska
Email: m.borkowska@molecure.com
+(48) 728 728 143

MEDiSTRAVA Consulting (Financial PR)        
Frazer Hall, David Dible, Sandi Greenwood, Eleanor Perkin
molecure@medistrava.com
+44 (0)203 928 6900

About Molecure

Molecure 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 molecure.com/en/

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

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