Cilcare and Shionogi Announce Exclusive Option Agreement for Innovative Hearing Disorder Treatments

Cilcare, a leading biotech company specializing in auditory sciences, is pleased to announce a landmark agreement with Shionogi, an impact-driven pharmaceutical company. This exclusive option agreement grants Shionogi the right to license global rights to CIL001 and/or CIL003, two promising drug candidates aimed at treating hearing disorders, with a particular focus on addressing the increasing prevalence of hidden hearing loss and tinnitus.

Under the terms of the agreement:

• Shionogi will receive an exclusive option to license global rights to CIL001 and/or CIL003.
• Cilcare will receive an upfront payment of €15 million.
• Cilcare is eligible to receive up to €400 million in milestone payments upon successful
  development and commercialization of the drug candidates.
• Shionogi will decide whether to exercise the option right based on the results of the Phase 2a studies of CIL001 and preclinical study data of CIL003, both to be conducted by Cilcare.

Driven by its pioneering approaches from preclinical research to drug development, which harness AI-driven auditory markers known as Digital Auditory Signatures, Cilcare is dedicated to advancing therapies for auditory-related diseases. The agreement with Shionogi underscores Cilcare’s commitment to external innovation and collaboration to address critical unmet needs in hearing disorders.

CIL001, a disease-modifying small molecule, holds promise for treating cochlear synaptopathy and associated disorders through a single and painless transtympanic administration. Supported by robust preclinical and clinical safety data, CIL001 is poised to enter Phase 2a trials in 2025 in Europe and United States of America. Additionally, preclinical studies for CIL003 are currently underway. Celia Belline, CEO of Cilcare, expressed her pride in the recognition of Cilcare’s expertise by a global pharmaceutical leader. She emphasized the partnership’s potential to expand the pipeline and drive innovation in hearing disease therapeutics.

Shionogi echoed Cilcare’s enthusiasm for the partnership, citing the alignment with their strategic focus on improving global health and well-being. Hearing loss affects approximately 1.5 billion people worldwide, with hidden hearing loss, or cochlear synaptopathy, emerging as a significant challenge despite normal hearing tests. This
condition, affecting about 15% of the population, underscores the urgent need for innovative therapies to address speech comprehension difficulties and other associated symptoms.

The collaboration between Cilcare and Shionogi represents a pivotal step in addressing the urgent global health crisis posed by hearing disorders, offering hope for millions of individuals worldwide. For this option agreement, Cilcare was advised by Agile Capital Markets and McDermott Will & Emery.

For media inquiries, please contact:
Marie Peytavy, Marketing & Communication Director: marie.peytavy@cilcare.com

For investor relations, please contact: investors@cilcare.com

Compliments of Cilcare – a member of the EACCNY.