• Civorebrutinib is an investigational oral, covalent reversible BTK inhibitor designed to provide differentiated efficacy, safety and convenience in immune-mediated kidney diseases
• Civorebrutinib adds pipeline-in-a-product potential across multiple rare kidney diseases, expanding and diversifying Travere's pipeline

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that it has entered into an exclusive licensing and collaboration agreement with Travere Therapeutics, Inc. (NASDAQ: TVTX) for the development and commercialization of civorebrutinib (also known as EVER001), a potential best-in-class oral, covalent reversible Bruton's tyrosine kinase (BTK) inhibitor in all markets outside China and certain countries in East and Southeast Asia.

"This collaboration with Travere brings together deep expertise in kidney disease development and commercialization and we look forward to advancing civorebrutinib in primary membranous nephropathy, immune-mediated FSGS, and minimal change disease, delivering transformative therapies for patients with serious kidney diseases worldwide," said Mr. Yifang Wu, Chairman of the Board of Everest Medicines. "As a differentiated, potential best-in-class therapy, civorebrutinib has demonstrated encouraging efficacy in primary membranous nephropathy. With its highly selective and reversible covalent mechanism of action, it is well positioned to advance in development across multiple immune-mediated kidney indications. Everest remains committed to our dual-engine strategy of business development partnerships and in-house R&D. This collaboration will accelerate the global development and potential commercialization of civorebrutinib, expanding its clinical and future commercial value in autoimmune kidney diseases and the ability to deliver more innovative treatment options to patients."

"Civorebrutinib represents a strategic and complementary addition to our rare kidney disease portfolio, with the potential to become a best-in-class therapy across multiple immune-mediated rare kidney diseases," said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. "Patients living with rare kidney diseases still face significant unmet need, and we believe the progress made to date in IgAN and FSGS is only the beginning of what is possible for these communities. Travere has helped to deliver important firsts in these diseases, and we believe our expertise, infrastructure and deep commitment to the rare kidney community position us well to continue advancing innovation for patients. With proof-of-concept data in primary membranous nephropathy, a differentiated profile as an oral, reversible BTK inhibitor, and expected broad mechanistic applicability across diseases such as immune-mediated FSGS, minimal change disease and beyond, we believe civorebrutinib has the potential to meaningfully advance the treatment paradigm for rare kidney disease patients."

Civorebrutinib is an investigational oral, covalent reversible BTK inhibitor designed to provide differentiated efficacy, safety and convenience for patients with rare, immune-mediated kidney diseases, including primary membranous nephropathy (PMN), with planned evaluation in focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD) and potentially additional indications. BTK is a key mediator of B-cell receptor signaling and plays an important role in B-cell activation, maturation, proliferation, and differentiation into antibody-producing cells.

In immune-mediated kidney diseases, B-cell activation and autoantibody production are believed to contribute directly to kidney injury. Civorebrutinib has demonstrated proof of concept in a Phase 1/2 clinical trial of patients with PMN. The previously reported Phase 1/2 data demonstrated rapid and sustained reductions in anti-PLA2R autoantibodies and proteinuria, with high rates of immunologic and clinical remission and stable kidney function through 52 weeks of follow-up. Civorebrutinib has been generally well tolerated throughout the development program to date.

As innovation in rare kidney diseases continues to accelerate, patients still face significant unmet need and limited treatment options across many serious conditions. Civorebrutinib has the potential to serve as a pipeline-in-a-product across multiple immune-mediated kidney diseases. Travere plans to investigate civorebrutinib in PMN, immune-mediated FSGS and MCD, with the potential for additional indications. These diseases share immune-mediated mechanisms that can lead to glomerular damage, resulting in proteinuria and impaired kidney function that may ultimately require dialysis or transplant. Civorebrutinib may also broaden future treatment approaches in FSGS, where both nephroprotective and targeted immune control approaches may play important roles.

Under the terms of the agreement, Everest will receive an upfront payment of $112.5 million in exchange for granting Travere exclusive development and commercialization rights for civorebrutinib in all markets outside of China and certain countries in East and Southeast Asia. Everest is also eligible to receive up to approximately $1.03 billion in additional cash payments tied to specified clinical development, regulatory and commercial milestones across up to five indications. Travere will also pay tiered royalties on future sales in its licensed territories, ranging from high single-digit to double-digit percentages based on annual net sales thresholds. The license agreement will become effective upon satisfaction of customary conditions, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.