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