Zenas BioPharma Inc. (NASDAQ:ZBIO) and InnoCare Pharma Ltd. on Wednesday announced a license agreement granting Zenas global development and commercialization rights to orelabrutinib for multiple sclerosis and across all therapeutic areas other than oncology.
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Zenas also secured rights to a novel, oral, IL-17AA/AF inhibitor and an oral, brain-penetrant, TYK2 inhibitor.
A global, Phase 3 trial has been initiated to evaluate the safety and efficacy of orelabrutinib dosed at 80 mg once daily (QD) in patients with primary progressive multiple sclerosis.
Zenas plans to initiate a second global Phase 3 trial evaluating orelabrutinib in patients with secondary progressive multiple sclerosis in the first quarter of 2026.
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In a previously completed global Phase 2 clinical trial in patients with relapsing-remitting multiple sclerosis, 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 as demonstrated by meaningful impact on endpoints indicative of disease progression.
The safety and tolerability profile of orelabrutinib is consistent with other BTK inhibitors in development for multiple sclerosis and is well characterized across multiple prior autoimmune disease and hematologic cancer trials.
Zenas will pay InnoCare upfront and near-term milestone payments of up to $100 million in cash, including milestone achievements expected in 2026, and up to seven million Zenas shares upon a milestone expected to be achieved in early 2026.
The upfront payment and milestone payments for all three programs exceed $2 billion.
In addition, InnoCare is entitled to receive tiered royalties of up to high teens percentages on annual net sales of the licensed products.
Zenas will have the exclusive right to develop, manufacture, and commercialize orelabrutinib for multiple sclerosis and non-oncology fields in all territories outside Greater China and Southeast Asia, while InnoCare retains full global rights for oncology.
Zenas will also have the exclusive right to develop, manufacture and commercialize the oral, IL-17AA/AF inhibitor in all territories outside Greater China and Southeast Asia, and the oral, brain-penetrant, TYK2 inhibitor globally.
Private Placement Financing
Zenas also announced a private placement of approximately $120 million.
Upon closing of the Private Placement, Zenas expects that its cash, cash equivalents and investments will be sufficient to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026, assuming receipt of the potential $75 million milestone from Royalty Pharma for the defined success criteria in the Phase 3 INDIGO trial, into the first quarter of 2027.
ZBIO Price Action: Zenas stock is up 16.35% at $24.26 at publication on Wednesday.
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