Full Press Release Details
BioPharma and InnoCare Pharma Announce License Agreement Granting Zenas Rights for Three Autoimmune Product Candidates, Including
Orelabrutinib, a BTK Inhibitor in Phase 3 Development for Multiple Sclerosis
- Orelabrutinib, a highly selective CNS-penetrant,
oral small molecule Bruton's Tyrosine Kinase (BTK) inhibitor with best-in-class potential now in Phase 3 development for progressive
forms of Multiple Sclerosis (MS) -
Pivotal Phase 3 clinical trial evaluating orelabrutinib in patients with Primary Progressive MS (PPMS) initiated; Pivotal Phase 3 clinical
trial in patients with Secondary Progressive MS (SPMS) expected to initiate in 1Q 2026 -
A novel oral IL-17AA/AF inhibitor, and an oral, brain-penetrant, TYK2 inhibitor, expected to begin Phase 1 clinical trials in 2026 -
- Zenas also announces $120.0 million private
placement financing -
to host a conference call today, October 8, 2025, at 8:00 a.m. ET -
to host a conference call on October 9, 2025, at 8:30 a.m. Beijing time -
and Beijing, October 8, 2025 (GLOBE NEWSWIRE) - Zenas BioPharma, Inc. ("Zenas," "Zenas BioPharma"
or the "Company") (Nasdaq: ZBIO) and InnoCare Pharma Limited ("InnoCare" or "InnoCare Pharma") (HKEX:
09969; SSE: 688428) today announced a transformational license agreement granting Zenas global development and commercialization
rights to orelabrutinib for Multiple Sclerosis (MS) and across all therapeutic areas other than oncology. Zenas also secured rights to
a novel, oral, IL-17AA/AF inhibitor, and an oral, brain-penetrant, TYK2 inhibitor.
is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule BTK inhibitor with the potential to address compartmentalized
inflammation and disease progression in MS. A global, Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial
evaluating the safety and efficacy of orelabrutinib dosed 80 mg once daily (QD) in patients with Primary Progressive MS (PPMS) has been
initiated. Zenas plans to initiate a second global, Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial
evaluating orelabrutinib in patients with Secondary Progressive MS (SPMS) in the first quarter of 2026.
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
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 MS and is well characterized across multiple prior autoimmune disease and hematologic
"InnoCare is a globally recognized company with a successful
track record of drug discovery, development and commercialization. This transformative collaboration with InnoCare further positions Zenas
to execute on its vision to become a global, fully integrated development and commercial-stage autoimmune-focused biopharmaceutical company.
With global rights to orelabrutinib, we are advancing a potential blockbuster franchise for progressive MS. Orelabrutinib, with its best-in-class
potential, is strongly positioned to address disease progression independent of relapse activity, the highest unmet medical need in MS,
and to improve the lives of patients living with progressive MS. We are also excited to add two potentially best-in-class molecules, a
novel, oral, IL-17AA/AF inhibitor and an oral, brain-penetrant, TYK2 inhibitor, to our pipeline. We plan to advance each of these
programs to human clinical trials in 2026 and expect to have initial patient data from the oral IL-17AA/AF clinical program in 2027,"
said Lonnie Moulder, Founder and Chief Executive Officer (CEO) of Zenas.
are delighted to partner with Zenas BioPharma. The partnership with Zenas BioPharma represents a significant milestone in our journey,
and we will continue to enhance and advance our globalization efforts in the future," said Dr. Jasmine Cui, Co-Founder, Chairwoman
and CEO of InnoCare Pharma. "Orelabrutinib has a differentiated mechanism of action and strong clinical data underscoring its promising
potential as a treatment for patients with progressive forms of MS. We are confident in Zenas' management team given their exceptional
track record of successful drug development, global regulatory approvals and commercial launches, and their commitment to driving innovation
for autoimmune diseases."
Mr. Moulder continued, "With this transaction, we have established
a balanced portfolio of complementary mechanisms and modalities with best-in-class blockbuster potential across multiple therapeutic areas.
With our two franchise programs, obexelimab concluding Phase 3 development for IgG4-RD, and now orelabrutinib for progressive forms of
MS, Zenas is well positioned to meaningfully impact the lives of patients living with autoimmune diseases. We are prioritizing the tremendous
opportunity ahead with orelabrutinib in PPMS and SPMS. We expect to report obexelimab topline 12-week primary endpoint results from the
Phase 2 MoonStone trial in patients with RMS early in the fourth quarter of 2025 and 24-week data in the first quarter of 2026. We anticipate
making a program decision based on these data and the evolving landscape for the development of new therapies for RMS in early 2026."
"This strategic collaboration will leverage our shared focus
to accelerate the development of orelabrutinib and help maximize its clinical and commercial potential on a global scale, particularly
in MS," added Dr. Cui, "Given the statistically significant and clinically meaningful data from the Phase 2 trial, and
promising blood-brain barrier penetration capability, orelabrutinib has the potential to transform the treatment paradigm for this devastating
disease. In addition to orelabrutinib, we have fortified our powerful discovery engine to focus on cutting-edge targets for the development
of autoimmune therapeutics through B-cell and T-cell pathways, with the aim of delivering first-in-class and/or best-in-class treatments
to address the massive unmet medical needs and strong market potential in China and worldwide."
inhibition is a validated mechanism for the treatment of progressive forms of MS, and there is immense scientific interest in its potential
to impact inflammation compartmentalized in the CNS and thereby potentially impact disability progression independent of relapse activity.
We believe the differentiated, potentially best-in-class profile of orelabrutinib could make a meaningful difference for patients with
PPMS and SPMS, which have few treatment options. With our late-stage development capabilities and expertise in MS, we are well positioned
to execute on the pivotal, global, Phase 3 development of orelabrutinib, as well as advance two early candidates into clinical
development," said Lisa von Moltke, M.D., Head of Research and Development and Chief Medical Officer of Zenas.
Obexelimab, a CD19 and Fc RIIb inhibitor of B cell function
a highly selective CNS-penetrant, oral, small molecule BTK inhibitor
Oral, IL-17AA/AF inhibitor that blocks IL-17 AA homodimer and
IL-17AF heterodimer signaling
Oral, brain-penetrant, TYK2 inhibitor
license agreement, 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 7,000,000 shares of Zenas common stock, including shares issuable upon a milestone expected to
be achieved in early 2026. The total of the upfront payment, near term milestone and potential development and regulatory milestone payments,
along with potential commercial sales achievement milestone payments for all three programs, exceeds $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.
have the exclusive right to develop, manufacture and commercialize orelabrutinib in the field of MS globally, and non-oncology fields
in all territories outside Greater China and Southeast Asia, while InnoCare retains full global rights in the field of 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 has entered into a securities purchase agreement for a private
placement financing of shares of its common stock (the "Private Placement"). The Private Placement is expected to result in
gross proceeds to Zenas of approximately $120.0 million, before deducting placement agent fees and other Private Placement expenses payable
Pursuant to the terms of the securities purchase agreement, at the
closing of the Private Placement, Zenas will issue approximately 6.3 million shares of its common stock to (i) certain institutional
and accredited investors at a price of $19.00 per share and (ii) certain directors and officers of the Company at a price of $20.85
per share. The closing of the Private Placement is expected to occur on or about October 9, 2025, subject to the satisfaction of
customary closing conditions.
Jefferies and Evercore ISI served as exclusive placement agents for
the Private Placement.
The Private Placement included participation from a syndicate of new
and existing investors, including mutual funds and healthcare dedicated funds.
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, and 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.
The sale and issuance of the foregoing shares are being made in a transaction
not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act").
The shares being issued in the Private Placement may not be offered or sold in the United States absent registration or pursuant to an
exemption from the registration requirements of the Securities Act and applicable state securities laws. Zenas has agreed to file a registration
statement with the Securities and Exchange Commission covering the resale of the shares acquired by the investors in the Private Placement.
This press release does not constitute an offer to sell or the solicitation
of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer or sale would be unlawful
prior to the registration or qualification under the securities laws of such state. Any offering of the shares under the resale registration