Zenas Biopharma, Inc. and Innocare Pharma Limited have announced a significant license agreement that grants Zenas global development and commercialization rights to Orelabrutinib for multiple sclerosis (MS) and across all therapeutic areas other than oncology. Orelabrutinib, a highly selective central nervous system (CNS)-penetrant, oral small molecule Bruton’s tyrosine kinase (BTK) inhibitor, is now in phase 3 development for progressive forms of MS.
In the previously completed global phase 2 clinical trial for relapsing-remitting MS (RRMS), Orelabrutinib demonstrated significant reductions in new lesions versus placebo at weeks 12 and 24, with sustained reductions in inflammatory activity through week 96. The safety and tolerability profile of Orelabrutinib is consistent with other BTK inhibitors in development for MS.
The license agreement includes 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. In addition, Innocare is entitled to receive tiered royalties of up to high teens percentages on annual net sales of the licensed products.
Zenas also announced a $120.0 million private placement financing, which is expected to result in gross proceeds to Zenas of approximately $120.0 million. This financing is expected to fund Zenas' operating expenses and capital expenditure requirements into the fourth quarter of 2026, and assuming receipt of the potential $75 million milestone from Royalty Pharma into the first quarter of 2027.
The company's pipeline includes Obexelimab, a CD19 and FcγRIIB inhibitor of B cell function, and additional potential blockbuster molecules, including a novel oral IL-17AA/AF inhibitor and an oral, brain-penetrant, TYK2 inhibitor. Zenas plans to advance each of these programs to human clinical trials in 2026 and expects to have initial patient data from the oral IL-17AA/AF clinical program in 2027.
Zenas Biopharma will host a conference call and webcast to discuss the transformational license agreement and provide an update on the company’s business and strategy. Innocare will host a conference call in Chinese to discuss the partnership.
The press release does not constitute an offer to sell or the solicitation of an offer to buy the securities. Any offering of the shares under the resale registration statement will only be by means of a prospectus. Today the company's shares have moved -9.47% to a price of $20.85. For the full picture, make sure to review Zenas BioPharma's 8-K report.
