Mithra Announces Launch of Warrant Exercise Period

Liège, Belgium, 30 October 2017 – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces the launch of an exercise period of its warrant plan initiated on 2 March 2015.

Mithra Completes Recruitment for Estelle® Phase III Study in US and Canada

  • Estelle® Phase III study in US/Canada remains on track to report top line data in Q1 2019
  • Study recruited 2148 women in total; 57% of subjects already completed over half the 13 treatment cycles
  • First subject completed the 13 cycle treatment as well as the end of study visit in October

Liège, Belgium, 30 October 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces the completion of recruitment in the E4 Freedom Phase III study of Estelle® in the US and Canada. Estelle® is Mithra’s combined oral contraceptive (COC) candidate composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP). Top-line data, based on 13 cycles of treatment, remain on track to be reported in the first quarter of 2019.

Mithra Announces Completion of Recruitment in Donesta® Phase II Study

  • Donesta® Phase II study remains on track to report top line data late Q1 2018
  • 260 women recruited in total, of which 86 have already completed at least 12 weeks of treatment as part of the Phase II study

Liège, Belgium, 13 October 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces the completion of recruitment in the E4 Relief Phase II study of Donesta®, Mithra’s next-generation hormone therapy (HT) candidate with oral administration of Estetrol (E4) for Vasomotor Menopausal Symptoms (VMS) relief. Top-line data, based on 12-weeks of treatment, remain on track to be reported late in the first quarter of 2018.

Mithra’s Marketing Authorization Application for Tibelia® Accepted by Health Canada

  • Tibelia® would be the first tibolone-based Hormone Therapy product available in Canada
  • Marketing Authorization (MA) decision in Canada expected as of Q4 2018
  • Mithra’s Canadian partner preparing for potential launch shortly thereafter

Liège, Belgium, 10 October 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces that Health Canada has accepted the Marketing Authorization Application for its complex therapeutic Tibelia®, the company’s tibelone-based product for use in Hormone Therapy (HT).