Mithra Announces Estelle® Launch in Belgium

Liege, Belgium, 21 October 2021 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, is very pleased to announce that its novel combined oral contraceptive Estelle® is now available in Belgium. The product is marketed in Belgium by Richter under the brand name Drovelis® and by Ceres Pharma under the brand name Lydisilka®.

The Board of Directors confirms Leon Van Rompay as Mithra’s CEO

Liege, Belgium, 15 October 2021 – 17:45 CEST – The Board of Directors of Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, has confirmed the appointment of Mr. Leon Van Rompay as Chief Executive Officer of the company, a position he held ad interim since February 04, 2021.

Mithra Provides FDA Update on Myring®

Liege, Belgium, 6 October 2021 – 17:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that its US commercial partner Mayne Pharma (ASX:MYX) has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) in relation to the abbreviated new drug application (ANDA) for Myring®, the vaginal contraceptive ring made of ethylene vinyl acetate copolymers (EVA).

In the letter, Mayne Pharma has been requested to provide additional data on compatibility. All other topics, in particular the manufacturing process by the Mithra CDMO, did not raise any supplementary questions. Mayne Pharma is working closely with Mithra and the FDA to address the few remaining questions raised in the CRL before year-end.

Mithra Announces the Appointment of its Representative to Mayne Pharma’s Board of Directors

Liege, Belgium, 4 October 2021 – 17:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, is pleased to announce that it has joined the Board of Mayne Pharma Group Limited, in accordance with the license and supply agreement to commercialize Nextstellis® (E4/DRSP) oral contraceptive in the United States. As Mayne Pharma’s largest shareholder (9.6% stake), Mithra has appointed Dr. Carolyn Myers as Director on the Board, as well as on the joint steering committee related to the commercialization and continued development of Nextstellis®.

Mithra Announces Topline Results for COVID-19 Phase II Study

Liege, Belgium, 24 September 2021 – 7:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces topline results of the Coronesta Phase II study, which aimed to assess the safety and efficacy of estetrol (E4) for the treatment of patients who were hospitalized with moderate COVID-19. E4 is a native occurring estrogen produced by the human fetus during pregnancy.

Mithra Announces 2021 Half Year Results

Liege, Belgium, 24 September 2021 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces its financial results for the six-month period ending on 30 June 2021, prepared in accordance with IFRS. The full interim report is available on the Investors section of the website.

Mithra Announces an Update on PeriNesta®

Liege, Belgium, 21 September 2021 –17:50 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces an update on its Research & Development strategy regarding the PeriNesta® product candidate.

At inception, the PeriNesta® product candidate was intended to specifically target relief of hot flushes, and/or vasomotor symptoms (VMS), while providing effective contraception for women who are starting to exit the reproductive stage and are transitioning into postmenopause, a period called perimenopause. To do so, Mithra intended to conduct a safety study with a comparable formulation to E4 15 mg/DRSP 3 mg in women aged around 50 years of age affected by VMS.

Donesta® Phase III: Recruitment Completion of American Study and Additional Recruitment in the European Study

LIEGE (Belgium, 21 September 2021 – 17:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the completion of recruitment of 1015 menopausal women in the “E4 Comfort” pivotal study1 of Donesta® in the United States and Canada. Donesta® is a next generation orally-administrated estetrol-based hormone therapy product candidate for the relief of menopausal vasomotor symptoms (VMS).

Mithra Announces Estelle® Approval in Russia

Liege, Belgium, 16 September 2021 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, is pleased to announce that the Russian Medicines Agency (Roszdravnadzor) has approved the registration application for the novel combined oral contraceptive Estelle® containing 15mg estetrol (E4) and 3 mg drospirenone (DRSP).

Developed by Mithra, Estelle® is the first and only pill containing estetrol (E4), a naturally occurring native estrogen produced in the human body during pregnancy.

Mithra and Searchlight Pharma Announce Availability of Nextstellis® in Pharmacies Across Canada

LIEGE (Belgium – 7:30 AM CEST) and MONTREAL (Canada – 7:00 AM EST), September 15, 2021 – Mithra and Searchlight Pharma are pleased to announce that women across Canada looking for the latest advancement in combined oral contraception (COC) now have access to Nextstellis® , a first-of-its-kind COC that includes the unique natural estrogen estetrol (E4), featuring strong efficacy, safety and tolerability with excellent cycle control. E4 is the first new estrogen in a COC in the Canadian market in more than half a century. E4 is naturally produced in the human body during pregnancy and, in Nextstellis, it is synthesized from plant sources.