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Molecure - Q323 report highlights clinical progress

Molecure has released its Q323 report, providing an update on its clinical development activities, particularly around its oral, first-in-class inhibitor, OATD-01. Following the acceptance of the Investigational New Drug (IND) application in July 2023, the Phase II proof-of-concept study (KITE) for OATD-01 in pulmonary sarcoidosis remains on track with the first US patient expected to receive dosing in Q423. Additionally, we anticipate the company to obtain approval to commence recruitment for the KITE study in Europe in Q124, as the application was submitted to the EMA and MHRA in September 2023. Recruitment for Molecure’s second clinical-stage asset, OATD-02, in patients with advanced and/or metastatic solid tumours, is ongoing, and we now anticipate initial data in early 2024 (previously expected in Q423). As of 30 September 2023, Molecure had a gross cash position of PLN85m, which includes the PLN50m (c $12m) from the Q323 public offering. However, to support its strategic plans for 2023–25, the company will need to seek additional funding to fully cover its estimated capital expenditure requirement of PLN250m.