Molecure 3rd Quarter 2022 Pipeline Highlights and Financial Results.

WARSAW, Poland: 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...