Mithra Signs LSA for Commercialization of Estelle® in North Africa

  • Mithra grants exclusive license to GyneBio Pharma for commercialization of its combined oral contraceptive Estelle® in Algeria, Morocco and Tunisia
  • Deal worth up to EUR 25 million for Mithra over the contract period
  • Agreement follows licensing deals for Estelle® with market leaders in key regions such as U.S., Europe, Australia, South America, ASEAN and Middle East

Liege, Belgium, 19 October 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that it has entered into an exclusive license and supply agreement with Gynebio Pharma for the commercialization of Estelle® in North Africa. Estelle® is a novel, next generation oral contraceptive product candidate containing Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg, with a unique benefit/risk profile.

Mithra Announces FDA update

  • Mithra’s US partner Mayne Pharma receives complete response letter from FDA for Myring™ requesting additional data that is not normally requested for generic products
  • Based on the information available to date, Mithra expects to have the necessary data in hand to respond to FDA before year-end
  • No questions or comments have been raised by FDA with regard to Mithra CDMO, which provides comfort regarding robustness of manufacturing process
  • Mid-cycle review with FDA regarding the New Drug Application (NDA) for Estelle (Nextstellis) raised no substantive issues
  • Solid cash position and funding facilities to cover working capital needs

Liege, Belgium, 6 October 2020 – 07:30 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 from the US Food & Drug Administration (FDA) related to the abbreviated new drug application (ANDA) for Myring™, the vaginal ring made of ethylene vinyl acetate copolymers (EVA).

Mithra Announces 2020 Half Year Results

  • Substantial funding transactions of EUR 135 million that should secure Mithra for all future working capital needs, and more so if Estelle® receives marketing authorization
  • Total revenues from licensing milestones for Estelle® of EUR 487 million, with EUR 349 million cash to still be collected (EUR 322 million under IFRS15) with a payment horizon dependent on the commercial success of Estelle®
  • Revenues of EUR 5 million, to be bolstered by licensing and supply agreements for Estelle® in major territories such as Latam, sales of Myring, and CDMO revenues
  • Net loss significantly improved (-62%) thanks to substantial reduction on the impact of the fair value of the earnouts (-94%)
  • Regulatory submission for Estelle® accepted for review by the FDA, Health Canada, and the EMA with approval anticipated in H1 2021
  • Business development strategy of Donesta® progressed, targeting major global partners

Liege, Belgium, 24 September 2020 – 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 30 June 2020, prepared in accordance with IFRS. The full interim report is available on the Investors section of the website.

Webcast

Mithra will host a live webcast on Thursday, 24 September 2020 at 15:00 CEST/ 09:00 EDT to announce its 2020 Half Year financial and operating results. The live webcast can be accessed on the Mithra website or by clicking here. To participate in the questions and answers session, please register on this link, five to ten minutes prior to the scheduled start of the call.

A replay of the webcast will be available on the Mithra investor’s website shortly after the close of the call.

Mithra to Host Webcast for Half Year Financial Results on 24 September 2020

Liege, Belgium, 21 September 2020 – 18:00  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that it will host a live webcast on Thursday, 24 September 2020 at 15:00 CEST/ 09:00 EDT to announce its 2020 Half Year financial and operating results.

The live webcast can be accessed on the Mithra website or by clicking here.

To participate in the questions and answers session, please register on this link, five to ten minutes prior to the scheduled start of the call.

A replay of the webcast will be available on the Mithra investor’s website shortly after the close of the call.

 

Mithra’s EGM Approves Warrant Plan for Share Lending Shareholders

Liege, Belgium, 07 July 2020 – 17:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that the Company’s Extraordinary General Meeting (EGM) held on 7 September 2020 approved the issuance of 300,000 warrants for the benefit of François Fornieri, Alychlo NV, and Noshaq SA (together the share lending shareholders), in relation to the LDA Capital Ltd. transaction announced on April 24 2020 .

 

Publication of a Transparency Notification Received from Alychlo NV

Liege, Belgium, 20 August 2020 – 17:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces, in accordance with Article 14 of the Belgian Law of 2 May 2007 regarding the publication of major shareholdings in issuers whose securities are admitted to trading on a regulated market (the “Transparency Law”), that it received a notification of transparency from Alychlo NV, having its registered seat located at Lembergsesteenweg 19, 9820 Merelbeke, on 17th August 2020.

Mithra Announces Commercial Launch of Myring™ in the Netherlands

Liege, Belgium, 19 August 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the commercial launch of its vaginal contraceptive ring Myring™ in the Netherlands.

Notice of Extraordinary Shareholders’ Meeting on 7th September 2020 Regarding Proposed Warrant Plans

Liège, Belgium, 7 August 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the publication of the invitation to its Extraordinary General Shareholders’ Meeting (EGM) that will be held on Monday September 7 2020 at 2:00 PM (CET) in Flémalle 57 rue de l’Expansion (Belgium).

 

Information on the Total Number of Voting Rights (Denominator) Following the Completion of the LDA Capital Increase

Liege, Belgium, 05 August 2020 – 17:45 CEST –In accordance with article 15 of the Belgian Act of 2 May 2007 on the disclosure of major participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions, Mithra Pharmaceuticals SA (the “Company” or “Mithra”) announces the below information, following the issuance of 159,800 new shares today for a total amount of EUR 3,104,869 following the First Put Option Notice issued on May 29 2020 in the framework of the formal completion of the Company’s capital increase approved by the Board on May 22, 2020 according to the terms of the LDA capital commitment agreement.

Mithra Announces Shelf Life Extension for Myring™ to 36 Months

  • Shelf life extended from 24 to 36 months in Europe
  • Competitive advantage in terms of optimizing the supply chain costs and convenience for distributors, pharmacists and patients

Liege, Belgium, 4 August 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that the European Authorities have approved the extension in the shelf life of its vaginal contraceptive ring Myring™ from 24 to 36 months, allowing distributors to optimize their supply chain management.