Mithra and Searchlight Pharma Announce Donesta® Licensing Agreement for Canada

Mithra and Searchlight Pharma Announce Donesta^® Licensing Agreement for Canada

• Mithra to receive up to €17.05 million in licensing fees and regulatory and sales milestones, along with tiered royalties on annual net sales
• Promising topline safety results from the Donesta^® Phase 3 trial in North America
• Searchlight Pharma anticipates filing of Canadian regulatory submission in H1 2024

Liege, Belgium and Montreal, Canada, 31 July 2023 – 07:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health and Searchlight Pharma Inc. (“Searchlight”), a private Canadian-specialty pharmaceutical company, today announced the signing of a binding term sheet for a licensing agreement for the Canadian rights to Donesta^®, an investigational medicine for the treatment of the symptoms of menopause.

Under the binding terms, Searchlight will have the exclusive sales and marketing rights for Donesta^® in Canada. Mithra is eligible to receive up to €17.05 million in licensing fees and regulatory and sales-related milestone payments, plus tiered double-digit royalties on total Canadian annual net sales. Searchlight will be responsible for obtaining and maintaining any regulatory approvals required to market and sell Donesta^® in Canada.

Donesta^® is the next generation orally administered Estetrol (E4)-based hormone therapy product candidate. E4 is a unique natural estrogen, produced only during fetal development; E4 displays a differentiated biological mechanism compared to other estrogens suggesting that E4 may offer women an improved benefit/risk profile for the treatment of the symptoms of menopause.

David Horn Solomon, Chief Executive Officer of Mithra, commented: “We are very pleased to reach this agreement with Searchlight Pharma for the licensing of Donesta^® in Canada. As a Canadian company with extensive experience in women’s health, Searchlight is ideally positioned to ensure optimized launch to provide rapid access to this differentiated-therapeutic candidate and generate maximum value for our shareholders. We continue to have active discussions with multiple parties, as we seek an optimal partner for U.S. marketing rights for Donesta^®.”

Searchlight has repeatedly ranked among the top-growth companies in Canada, with one of the largest portfolios of women’s health products and associated sales team in the Canadian market. Mithra and Searchlight have a continuing partnership for NEXTSTELLIS^®, a combined oral contraceptive product based on Estetrol and HALOETTE^®, a vaginal contraceptive ring in Canada. NEXTSTELLIS^® was launched in Canada in Q3 2021, while HALOETTE^® was launched in Q1 2022.

“Donesta^® is the third licensing arrangement we have completed with Mithra,” said Mark Nawacki, Searchlight’s President and Chief Executive Officer. “We are very proud of the relationship that we have developed with Mithra, but also about what this says about partnering with Searchlight more broadly. Strong relationships built on trust and backed by results are integral to our strategic focus of bringing innovative products, such as this novel Estetrol-based hormone therapy, to the Canadian market. As a leader in women’s health in Canada, we’re excited to be able to deliver another option to help Canadian women address their unmet needs in managing the symptoms of menopause.”

In 2022, Mithra announced topline efficacy results of the Donesta^® Phase 3 clinical program, which demonstrated a meaningful reduction in vasomotor symptoms from baseline and compared to placebo, with all co-primary efficacy endpoints met with statistical significance. The two ongoing trials are being carried out in 2,550 postmenopausal women (40-65 years): one in North America (“C302”) and a second at centers in 14 countries in Europe and Latin America (“C301”). Both trials are randomized, multicentre and double-blind.

In March 2023, Mithra announced promising topline safety results from the Donesta^® Phase 3 trial in North America (C302). The results will support marketing authorization filings scheduled in the U.S. in H2 2023 and in Canada in 2024. Primary safety data are anticipated for Europe in H1 2024.

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.

NEXTSTELLIS^®, HALOETTE^® and DONESTA^® are registered trademarks of Mithra Pharmaceuticals or one of its affiliates.

About Searchlight Pharma Inc.

Searchlight Pharma Inc., headquartered in Montreal, is a leading Canadian-based specialty healthcare company that executes best-in-class search, acquisition, commercialization, and focused development of innovative and unique specialty healthcare products. Following its acquisition of Miravo Healthcare in March 2023, Searchlight’s core promoted products now focus on women’s health, dermatology, allergy, pain management and hospital specialty markets, and its team is committed to improving people’s lives by bringing the right products to market. Follow Searchlight, learn more about what it does, and get to know its product portfolio at www.searchlightpharma.com.

Mithra 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.

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• 2023-07-31_Mithra Donesta Canada_Final_FR