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Zenas BioPharma Secures Global Rights to Orelabrutinib

Zenas Biopharma (NASDAQ: ZBIO) and Innocare Pharma Limited (HKEX: 09969; SSE: 688428) have announced a significant license agreement granting Zenas global development and commercialization rights to Orelabrutinib for multiple sclerosis (MS) and other therapeutic areas outside of oncology. This transformational collaboration also includes rights to a novel oral IL-17AA/AF inhibitor and an oral, brain-penetrant, TYK2 inhibitor. As part of this agreement, Zenas has secured a private placement financing of $120.0 million.

Orelabrutinib, a highly selective CNS-penetrant, oral, small molecule Bruton’s tyrosine kinase (BTK) inhibitor, is now in Phase 3 development for progressive forms of MS. Zenas plans to initiate a global Phase 3 clinical trial evaluating Orelabrutinib in patients with secondary progressive MS (SPMS) in the first quarter of 2026. In a previously completed global Phase 2 clinical trial in patients with relapsing-remitting MS (RRMS), Orelabrutinib demonstrated significant reductions in new GD+ T1 lesions versus placebo at weeks 12 and 24, with sustained reductions in inflammatory activity through week 96.

The license agreement includes substantial upfront and near-term milestone payments of up to $100 million in cash, including milestone achievements expected in 2026, and up to 7,000,000 shares of Zenas common stock, with the total potential payments exceeding $2 billion. Additionally, Innocare is entitled to receive tiered royalties of up to high teens percentages on annual net sales of the licensed products.

Zenas has entered into a private placement financing of shares of its common stock, expected to result in gross proceeds of approximately $120.0 million. The financing is anticipated to provide adequate funding for the company's operating expenses and capital expenditure requirements into the fourth quarter of 2026, with potential additional funding from milestone payments.

Upon closing of the private placement, Zenas expects to have sufficient funds to support its operational needs and advancements into early 2027, subject to the receipt of potential milestone payments.

The strategic collaboration with Innocare positions Zenas to accelerate the development of Orelabrutinib, with the potential to impact inflammation compartmentalized in the CNS and potentially impact disability progression independent of relapse activity. This collaboration also enhances Zenas' pipeline with two additional potentially best-in-class molecules, reinforcing the company's commitment to addressing unmet medical needs in autoimmune diseases.

Zenas will host a conference call and webcast to discuss the license agreement and provide an update on the company’s business and strategy, while Innocare will host a conference call in Chinese to discuss the collaboration.

This collaboration represents a significant milestone for both companies and underscores their commitment to advancing innovative treatments for autoimmune diseases on a global scale. Today the company's shares have moved -9.47% to a price of $20.85. Check out the company's full 8-K submission here.

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