Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces its financial results for the six-month period ending 30 June 2018, prepared in accordance with IFRS. The full interim report is available on the Investors sections of the website (https://investors.mithra.com/en/).
Operational Highlights (including post-period end)
Licensing and supply agreements
Financial Highlights (including post-period end)
François Fornieri, CEO of Mithra Women’s Health commented: “Mithra made good progress in the first half of 2018 as we continue to focus on bringing our innovative E4-based oral contraceptive and hormone therapy products to market. The unique profile of Estelle® as a new generation oral contraceptive was underlined by a number of studies, including positive top-line results from the Europe/Russia Phase III. Its uniqueness was further recognised by the broad commercialization agreement recently signed with Gedeon Richter for Estelle in Europe and Russia. We look forward to the results from the North American Phase III trial early next year.
“Positive Phase IIb results were announced for our hormone therapy candidate, Donesta®, which demonstrated a statistically significant reduction in the frequency of hot flushes. Preparations for Phase III initiation are well under way. Myring™ saw its first launches in Europe and is on track for launch in the US in 2019 following acceptance of the regulatory filing by the FDA.
“We further strengthened our financial position with a private placement and raised EUR 77,5 million. This strengthening will continue in the second half through the signed divestment of our Belux commercial portfolio to Ceres Pharma for up to EUR 40 million; and with significant upfront, milestone and sales-related royalty payments from the signed Gedeon Richter agreement for Estelle®. With a robust financial position, new partnering deals in key territories around the world and continued further progress on our key programs, we remain confident in our vision to transform women’s health through innovation.”
 MyringTM will be marketed under a different trademark name in Russia
 MyringTM will be marketed under a different trademark name in Denmark
 Tibelia® will be marketed under a different trademark name in Taiwan
 Tibelia® will be marketed under a different trademark name in Hungary
Mithra (Euronext: MITRA) is dedicated to providing innovation and choice in women's health, with a particular focus on fertility, contraception and menopause. Mithra's goal is to develop new and improved products that meet women's needs for better safety and convenience. Its two lead development candidates - a fifth generation oral contraceptive, Estelle®, and a next generation hormone therapy, Donesta®- are built on Mithra's unique native estrogen platform, E4 (Estetrol). Mithra also develops, manufactures and markets complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its Mithra CDMO. Mithra was founded in 1999 as a spin-off of the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart and is headquartered in Liège, Belgium. Further information can be found at: www.mithra.com