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

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

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

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

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

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

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

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

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

Investor presentation

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

Commercial & Operational Highlights

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

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

• Internal team members appointed to the Management Board: Dr. Adam Gołębiowski, Dr. Zbigniew Zasłona and Agnieszka Rajczuk-Szczepańska
• Appointment of Samson Fung, M.D., PhD, as Chief Medical Officer to lead global clinical development, translational science and regulatory strategies. Dr Fung will lead the advancement of 0ATD-01 and OATD-02 into Phase II and Phase I clinical trials respectively
• Supervisory board expanded to include Nancy Van Osselaer, Paul van der Horst and Paweł Trawkowski as its new members

Important Post-period Highlights

• Significant progress made on OATD-02, an oral, potent and selective first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer expected to enter the clinic in late 2022.
• Publication* (17th August) titled, "OATD-02 Validates the Benefits of Pharmacological Inhibition of Arginase 1 and 2 in Cancer". This is the first study validating the benefits of pharmacological inhibition of ARG2 in cancer and demonstrates OATD-02 as a potent dual ARG1/ARG2 inhibitor with a cellular activity (necessary for targeting ARG2) exhibiting immunomodulatory and direct antitumor efficacy in animal models

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

First Half Financial Highlights

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

For further information, please contact:

Molecure S.A. (PR & IR) 
Marta Borkowska 
Email: [email protected]
+(48) 728 728 143

MEDiSTRAVA Consulting (Financial PR)
Frazer Hall, David Dible, Sandi Greenwood, Eleanor Perkin
[email protected]
+44 (0)203 928 6900

About Molecure

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

Molecure has generated a diverse pipeline of eight distinct programs with the support of leading academic life science institutions globally, including 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

SOURCE Molecure