1TM Mithra Pharmaceuticals SA

• Mithra to hold joint symposium with partner Gedeon Richter on 11 October
• Four leading experts will outline why estrogens are critical in contraception and postmenopausal symptoms
• Data show promising safety and efficacy features of E4, key ingredient in ESTELLE® and DONESTA®

Liege, Belgium, 10 October 2023 – 18:00 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, will hold four presentations on the role of estrogens - including its Estetrol (E4) - in a symposium at the International Federation of Gynecology and Obstetrics (FIGO) World Congress, which will take place 9-12 October in Paris.

The 11 October symposium, which Mithra is holding jointly with its partner Gedeon Richter Plc., will highlight why estrogens are critical in contraception and for postmenopausal women. Estrogen plays an important role across organs and tissues and is pivotal in governing the female reproductive system and secondary sex characteristics. It is at the heart of women’s health, due to its intricate role, and regulation of multiple functions.

E4 is a key active pharmaceutical ingredient in both Mithra’s first E4-based combined oral contraceptive (COC) ESTELLE®, which is already marketed, and its next generation hormone therapy candidate for postmenopausal symptoms, DONESTA®. Robust data from preclinical and clinical studies underscoring E4's compelling safety and efficacy profile.

Dr. Graham Dixon, Chief Scientific Officer of Mithra, said: “The symposium at the FIGO congress will provide an opportunity to present the vital role of estrogen in women’s health, and the potential groundbreaking characteristics of our E4 product to support healthcare professionals and women’s confidence in hormone therapy. While ongoing research promises deeper understanding, current data strongly suggests that E4's unique molecular mode of action and metabolism contribute notably to its selective pharmacological profile, suggesting its favorable benefit–risk ratio in transforming women's health. In particular, the exclusive and innovative profile of E4 shows its possible ability to significantly improve contraception and treatment of postmenopausal women, with a strong safety profile. We are grateful to our presenters, who are all leading experts in the field, and look forward to this opportunity to discuss the role of estrogens with the scientific community at FIGO.”

Pre-clinical and clinical data have shown its proapoptotic effect on breast cancer tissue, indicating therapeutic promise. In postmenopausal patients with breast cancer, E4 shows objective antitumor effects, promising a valuable addition to breast cancer interventions. As a component in a COC with drospirenone and under development for menopausal hormone therapy, E4 demonstrates therapeutic efficacy beyond contraception. It elicits estrogenic activity in uterovaginal tissues, contributing to bone turnover, and shows positive effects on cardiovascular functions. E4's profile shows a low estrogenic impact on the liver and hemostasis balance, suggesting a diminished thrombotic risk.

Details of the presentations at the FIGO World Congress are as follows:

• Exploring how estrogens are essential for a woman’s health, throughout her life

            Presenter: Professor Mitchell Creinin, USA

            Time: 13:00-13:15 CET

• Discovering the exclusive and innovative profile of E4

            Presenter: Professor Jean-Michel Foidart, Belgium

            Time: 13:15-13:30 CET

• Highlighting an effective contraceptive, with neutral liver and kidney impact

            Presenter: Professor Mitchell Creinin, USA

            Time: 13:30-13:45 CET

• Discussing how we can meet expectations in menopause

            Presenter: Professor Amanda Black, Canada

            Time: 13:45-14:05 CET

For more information, please contact:

About Mithra

Mithra Pharmaceuticals SA (Euronext: MITRA) is a Belgian biopharmaceutical company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Mithra explores the potential of the unique native estrogen estetrol in a wide range of applications in women health and beyond. After having successfully launched the first estetrol-based product in 2021, the contraceptive pill ESTELLE®, Mithra is now focusing on its second product DONESTA®, the next-generation hormone therapy. Mithra also offers partners a complete spectrum of solutions from early drug development, clinical batches and commercial manufacturing of complex polymeric products (vaginal ring, implants) and complex liquid injectables and biologicals (vials, pre-filled syringes or cartridges) at its technological platform Mithra CDMO. Active in more than 100 countries around the world, is headquartered in Liège, Belgium. www.mithra.com

ESTELLE® and DONESTA® are registered trademarks of Mithra Pharmaceuticals or one of its affiliates.

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 the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such 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 forward-looking statements, except as may be required by law.

Attachments

• French MDN_2023-10-11_Mithra FIGO_FR (002)
• English MDN_2023-10-11_Mithra FIGO_EN Correction

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