Mithra Receives Positive DSMB Opinion on DONESTA European Phase 3 Trial - Seite 2

E4 is the first native and selective estrogen, present in developing human fetuses and is manufactured from a plant-based source. It acts differently from classical estrogens and its unique metabolism results in a low impact on haemostasis and breast tissue with an expected improvement in the benefit-to-risk profile.

In early 2022, Mithra announced positive top-line efficacy results of the DONESTA phase 3 program, which demonstrated a meaningful reduction in vasomotor symptoms of menopause (VMS) from baseline and compared to placebo with all co-primary efficacy endpoints statistically met. Data also showed improved quality of life and reduction of genito-urinary symptoms of menopause, as secondary efficacy endpoints. Promising top-line safety results from the phase 3 trial in North America (C302) were announced in 2023, and primary safety data from the European trial are expected in H1 2024.

Mithra has agreed with the US Food and Drug Administration (FDA) that it will conduct additional endometrial data analyses, due to a variation observed by Mithra in the endometrial biopsy diagnoses, which could have resulted in a limited addressable market for DONESTA. The US new drug application (NDA), including the complementary data, is expected in Q4 2024. This additional safety data is foreseen to be included in the European Medicines Agency (EMA) and FDA submissions, planned within the same time frame.

For more information, please contact:

Mithra Pharmaceuticals SA Alex Sokolowski, PhD Head of IR & Communications [e-mail] [phone]

Frédérique Depraetere Communications Director [e-mail] [phone]

About Mithra

Mithra Pharmaceuticals SA (Euronext: MITRA) is a Belgian biopharmaceutical company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Mithra explores the potential of the unique native estrogen estetrol in a wide range of applications in women health and beyond. After having successfully launched the first estetrol-based product in 2021, the contraceptive pill ESTELLE, Mithra is now focusing on its second product DONESTA, the next-generation hormone therapy. Mithra also offers partners a complete spectrum of solutions from early drug development, clinical batches and commercial manufacturing of complex polymeric products (vaginal ring, implants) and complex liquid injectables and biologicals (vials, pre-filled syringes or cartridges) at its technological platform Mithra CDMO. Active in more than 100 countries around the world, is headquartered in Liège, Belgium. www.mithra.com