Iro organization

Mithra Announces Improved First Consolidated Results from Donesta Phase 3 Studies and Start of Recruitment for European Study Extension

Liege, BelgiumMithras (Euronext Brussels: MITRA), a company dedicated to women’s health announces the first positive consolidated results of phase 3 of the Donesta program. Donesta is Mithra’s next-generation orally administered estetrol (E4) hormone therapy product candidate, offering a potential long-term solution to treat different menopausal symptoms, simultaneously or sequentially, caused by the loss of menopause. estrogen.

All four co-primary endpoints were met

On January 14, 2022, Mithra announced the first efficacy data from the Donesta Phase 3 program, which demonstrated a significant reduction in vasomotor symptoms (VSM) from baseline and compared to placebo1. After further analysis of all research data consolidated by the contract research organization managing the Donesta studies, Mithra is particularly pleased to report that the efficacy results are even better than previously announced.

Leon Van RompayCEO Mithra Women’s Health, commented, “These excellent efficacy results demonstrate that Donesta is expected to offer the most comprehensive symptom relief profile of any existing or developing therapy for the treatment of menopausal symptoms. By the end of the year, we will be able to once again demonstrate the unique safety profile of E4, further building on the fantastic potential of this molecule. From the start of the geopolitical crisis, our teams immediately activated a mitigation plan allowing us to launch the recruitment of the complementary European study just after the green light from the DSMB. Despite the current economic and geopolitical context, we do not foresee any delay in obtaining marketing authorizations, which demonstrates that Mithra’s teams remain fully focused on our achievements and strongly committed to converting the potential of our products into hit.

Benoit Mathieu (IRO): +32 473 35 80 18 – [email protected]

About Mithras

Mithras (Euronext: MITRA) is a Belgian biotechnology company dedicated to the transformation women’s health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products with improved efficacy, safety and convenience, meeting the needs of women throughout their lives. Mithra explores the potential of the unique native estrogen, estetrol, in a wide range of applications in women’s health and beyond. After successfully launching the first estetrol product in 2021, the birth control pill Is she , Mithra is now focusing on its second product Donesta, the next generation hormone therapy. Mithra also develops and manufactures complex therapies in the fields of contraception, menopause and hormone-dependent cancers. It offers its partners a full range of research, development and specialized manufacturing on its Mithra CDMO technology platform. Active in more than 100 countries around the world, Mithra employs approximately 300 people and is headquartered in Liege, Belgium.

Important Information

The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the words “believes”, “estimates”, “anticipates”, “expects”, “intends”, “may”. , ‘will’, ‘plans’, ‘continue’, ‘ongoing’, ‘potential’, ‘predict’, ‘project’, ‘target’, ‘seek’ or ‘should’, and include statements made by the Company regarding the expected results of its strategy. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that these forward-looking statements are not guarantees of future performance. The Company’s actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.