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.

ExeVir and Mithra announce manufacturing collaboration for innovative Covid-19 treatments

15 July 2021, 07:30 CEST, Belgium: ExeVir, which is developing single domain antibody therapies providing broad protection against viral infections, and Mithra Pharmaceuticals (Euronext Brussels: MITRA) announce a new collaboration to utilize the fill and finish capabilities for ExeVir’s innovative therapies at Mithra’s integrated R&D and manufacturing platform, Mithra CDMO.

 

Mithra Issues a Put Option Notice Under Capital Agreement with LDA Capital

Liege, Belgium, 02 July 2021 – 17:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the issuance of a put option notice, according to the terms of the capital commitment agreement signed with LDA Capital Limited on April 24, 20201 . Under the terms of this agreement, LDA Capital commits an amount of up to EUR 50 million in cash within a maximum of three years in exchange for new ordinary shares in Mithra. This is the second put option notice related to this agreement, after the first issued on May 29, 2020.

Mithra successfully renegotiates the earnouts relating to its Complex Therapeutics and acquires full licensing and distribution rights for Zoreline®

Liege, Belgium, 24 June 2021 – 17:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, is pleased to announce today the successful renegotiation of the earnouts linked to two products of its Complex Therapeutic portfolio: the Zoreline® implant and the Myring® contraceptive hormonal ring

Estelle® Oral Contraceptive Now Available In The United States

21 June 2021, 07:30 CEST – Adelaide, Australia and Liege, Belgium: Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are very pleased to announce the US commercial launch of Estelle® under the trademark Nextstellis® (3 mg drospirenone and 14.2 mg estetrol (E4) tablets), a new oral contraceptive with a novel estrogen having a unique mechanism of action.

Mithra Completes Recruitment of Covid-19 Phase II Study

Liege, Belgium, 17 June 2021 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has completed recruitment of the Coronesta Phase II, aiming to assess the protective role of Estetrol in Covid-19 infection. Estetrol is a naturally occurring estrogen produced by the human fetus during pregnancy.

Nextstellis® Receives FDA Marketing Exclusivity And Phase III Data Published

27 May 2021, 07:30 CEST – Adelaide, Australia and Liege, Belgium – Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are very pleased to announce that the novel oral contraceptive Estelle® – under the trademark Nextstellis® (3 mg drospirenone and 14.2 mg estetrol (E4) tablets) – has been granted marketing exclusivity as a new chemical entity (NCE) from the US Food and Drug Administration (FDA). The exclusivity runs for five years from FDA approval of the New Drug Application for Nextstellis.