Zenas 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
Zenas BioPharma (Nasdaq: ZBIO) announced a license agreement with InnoCare granting Zenas global MS and non-oncology rights to orelabrutinib plus rights to an oral IL-17AA/AF inhibitor and an oral, brain-penetrant TYK2 inhibitor. A global Phase 3 trial in PPMS has been initiated and a SPMS Phase 3 is expected to start in 1Q 2026. The two early candidates aim for IND/Phase 1 starts in 2026. Financial terms include up to $100M in upfront/near-term cash, up to 7.0M Zenas shares, total deal value exceeding $2B, and tiered royalties up to high‑teens. Zenas also announced a $120M private placement expected to close ~October 9, 2025, which it says funds operations into Q4 2026 (into Q1 2027 assuming a $75M milestone).
Zenas BioPharma (Nasdaq: ZBIO) ha annunciato un accordo di licenza con InnoCare che concede a Zenas diritti globali sul MS e non oncologici per orelabrutinib oltre a diritti su un inibitore orale IL-17AA/AF e un inibitore TYK2 orale in grado di penetrare nel cervello. È stato avviato uno studio globale di fase 3 in PPMS e ci si aspetta che una fase 3 in SPMS inizi nel 1Q 2026. I due candidati iniziali mirano ad avviare IND/Fase 1 nel 2026. Le condizioni finanziarie includono fino a $100M in contanti upfront/near-term, fino a 7.0M azioni Zenas, un valore totale dell’accordo superiore a $2B e royalties a livelli a scalare fino agli alti decimali. Zenas ha inoltre annunciato una $120M private placement che dovrebbe chiudersi intorno al 9 ottobre 2025, che secondo quanto detto finanzia le operazioni fino al Q4 2026 (fino al Q1 2027 presumendo un milestone di $75M).<
Zenas BioPharma (Nasdaq: ZBIO) anunció un acuerdo de licencia con InnoCare que concede a Zenas derechos globales de MS y no oncológicos para orelabrutinib además de derechos sobre un inhibidor oral IL-17AA/AF y un inhibidor TYK2 oral que penetra el cerebro. Se ha iniciado un ensayo global de Fase 3 en PPMS y se espera que una Fase 3 en SPMS comience en 1Q 2026. Los dos candidatos iniciales apuntan a iniciar IND/Fase 1 en 2026. Los términos financieros incluyen hasta $100M en efectivo inicial/near-term, hasta 7.0M de acciones de Zenas, un valor total del acuerdo que supera $2B y regalías escalonadas hasta niveles altos. Zenas también anunció una $120M private placement que se espera cierre alrededor del 9 de octubre de 2025, y afirma que financia las operaciones hasta el Q4 2026 (hasta el Q1 2027 asumiendo un hito de $75M).
Zenas BioPharma (Nasdaq: ZBIO)는 InnoCare와의 라이선스 계약을 발표하여 Zenas에 글로벌 MS 및 비종양 영역에 대한 권리와 함께 orelabrutinib, 경구 IL-17AA/AF 억제제 및 뇌 침투 TYK2 억제제의 권리를 부여했습니다. PPMS에서 글로벌 3상 임상시험이 시작되었고 SPMS의 3상은 2026년 1분기에 시작될 예정입니다. 두 초기 후보는 2026년에 IND/1상 시작을 목표로 합니다. 재무 조건은 선지급 현금 최대 $100M, 최대 7.0M주 Zenas 주식, 총 거래가 $2B를 초과하고 계단식 로열티가 높은 구간까지 포함됩니다. 또한 Zenas는 $120M 사모 배정을 발표하였으며 2025년 10월 9일경 마감될 예정이며, 이는 Q4 2026까지(If milestone $75M 가정 시 Q1 2027까지) 운영 자금을 조달합니다.
Zenas BioPharma (Nasdaq : ZBIO) a annoncé un accord de licence avec InnoCare accordant à Zenas des droits mondiaux sur la SEP et non oncologiques pour orelabrutinib ainsi que des droits sur un inhibiteur oral IL-17AA/AF et un inhibiteur TYK2 oral capable de traverser le cerveau. Un essai mondial de phase 3 dans le PPMS a été lancé et une phase 3 SPMS devrait commencer au 1Q 2026. Les deux premiers candidats visent des démarrages IND/Phase 1 en 2026. Les conditions financières comprennent jusqu'à $100M en cash upfront/near-term, jusqu'à 7.0M d'actions Zenas, une valeur totale de l'accord dépassant $2B, et des royalties échelonnées jusqu'à des niveaux élevés. Zenas a également annoncé une $120M private placement qui devrait se clôturer vers le 9 octobre 2025, et indique que cela finance les opérations jusqu'au Q4 2026 (jusqu'au Q1 2027 en supposant une étape (milestone) de $75M).
Zenas BioPharma (Nasdaq: ZBIO) gab eine Lizenzvereinbarung mit InnoCare bekannt, die Zenas globale MS- und nicht-onkologische Rechte an orelabrutinib sowie Rechte an einem oralen IL-17AA/AF-Inhibitor und einem oralen, gehirn-durchdringenden TYK2-Inhibitor gewährt. Eine globale Phase-3-Studie bei PPMS wurde initiiert und eine SPMS-Phase-3-Studie soll im 1Q 2026 beginnen. Die beiden frühen Kandidaten zielen auf IND/Phase-1-Starts im 2026. Finanzielle Bedingungen umfassen bis zu $100M upfront/near-term Cash, bis zu 7.0M Zenas-Aktien, einen Gesamtwert des Deals von über $2B und gestaffelte Royalties bis in hohe einstellige Bereiche. Zenas kündigte außerdem eine $120M private placement an, die voraussichtlich Ende Oktober 2025 abgeschlossen wird und die die Operationen bis ins Q4 2026 finanzieren soll (bis Q1 2027 bei einem Milestone von $75M).
Zenas BioPharma (Nasdaq: ZBIO) أعلنت عن اتفاقية ترخيص مع InnoCare تمنح Zenas حقوقاً عالمية في MS وغير مرضية للأورام لـ orelabrutinib إضافة إلى حقوق في مثبط فموي IL-17AA/AF ومثبط TYK2 فموي قادر على اختراق الدماغ. تم تشغيل تجربة عالمية من المرحلة الثالثة في PPMS ومن المتوقع أن تبدأ تجربة SPMS في 1Q 2026. الهدفان الأوليان يسعيان لبدء IND/المرحلة 1 في 2026. تشمل الشروط المالية حتى $100M من النقد مقدم/قريب، حتى 7.0M من أسهم زيناس، قيمة إجمالية للصفقة تتجاوز $2B وروابط ملكية مع ترويجات متدرجة حتى المستويات العالية. كما أعلنت زيناس عن $120M private placement من المتوقع أن يغلق حوالي 9 أكتوبر 2025، وتقول إنها ستغطي العمليات حتى Q4 2026 (حتى الربع الأول من 2027 بافتراض Milestone بقيمة $75M).
Zenas BioPharma (纳斯达克: ZBIO) 宣布与 InnoCare 达成许可协议,授予 Zenas 全球的 MS 及非肿瘤领域权利,涉及 orelabrutinib 以及一个 口服 IL-17AA/AF 抑制剂 和一个 口服、可穿透大脑的 TYK2 抑制剂。 已启动在 PPMS 的全球 III 期试验,SPMS 的 III 期预计将于 2026 年第一季度 开始。 两个早期候选药物目标在 2026 启动 IND/一级临床研究。 财务条款包括最高 $100M 的 upfront/近期现金、最高 7.0M 股 Zenas 股票、总交易额超过 $2B,并提供分层的特许权使用费直至高位十几的水平。 Zenas 还宣布了一笔 $120M 私募配售,预计在大约 2025 年 10 月 9 日 收盘,称其资金将支持运营至 2026 年第四季度(若以 milestone 为 7500 万美元则可至 2027 年第一季度)。
- PPMS Phase 3 trial initiated in Q3 2025
- SPMS Phase 3 trial expected to start in 1Q 2026
- $120.0M private placement expected to close ~Oct 9, 2025
- License deal total consideration exceeds $2B
- Rights to two preclinical programs targeting IND/Phase 1 in 2026
- Issuance of ~6.3M shares in private placement (dilution)
- Up to 7.0M Zenas shares payable to InnoCare (additional dilution)
- Near‑term cash and stock payments up to $100M
- Cash runway only into Q4 2026 absent a $75M milestone
Insights
License grants Zenas global MS rights to orelabrutinib, adds two early oral programs, and secures
Zenas acquires exclusive rights for orelabrutinib in MS and non‑oncology fields outside Greater China and Southeast Asia, plus two early candidates. A global Phase 3 in PPMS has been initiated and an SPMS Phase 3 is expected to start in
The transaction pairs clear clinical progression with immediate funding: a
- 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
- Zenas to host a conference call today, October 8, 2025, at 8:00 a.m. ET -
- InnoCare to host a conference call on October 9, 2025, at 8:30 a.m. Beijing time -
WALTHAM, Mass. and BEIJING, Oct. 08, 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.
Orelabrutinib 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.
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 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 cancer trials.
“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.
“We 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.”
“BTK 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.
Pipeline Overview
Obexelimab, a CD19 and FcγRIIb inhibitor of B cell function
- Immunoglobulin G4-Related Disease (IgG4-RD) Phase 3 INDIGO trial, a global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with IgG4-RD. INDIGO is the largest clinical trial conducted in patients living with IgG4-RD to date. Target enrollment of the INDIGO trial concluded in November 2024, and Zenas expects to report topline results around year-end 2025.
- Relapsing Multiple Sclerosis (RMS) Phase 2 MoonStone trial, a multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with RMS. Zenas expects to report results from this trial, including the 12-week primary endpoint results, early in the fourth quarter of 2025.
- Systemic Lupus Erythematosus (SLE) Phase 2 SunStone trial, a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of obexelimab in patients with SLE. Zenas expects to complete enrollment of the Phase 2 SunStone trial around year-end 2025 and report topline results in mid-2026.
Orelabrutinib, a highly selective CNS-penetrant, oral, small molecule BTK inhibitor
- PPMS Phase 3 trial, a global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of orelabrutinib for patients with PPMS initiated in the third quarter of 2025.
- SPMS Phase 3 trial, a global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of orelabrutinib for patients with SPMS is expected to initiate in the first quarter of 2026.
Oral, IL-17AA/AF inhibitor that blocks IL-17 AA homodimer and IL-17AF heterodimer signaling
- Currently in Investigational New Drug (IND) enabling studies. Zenas expects to submit an IND and initiate Phase 1 clinical development in 2026.
Oral, brain-penetrant, TYK2 inhibitor
- Currently in IND enabling studies. Zenas expects to submit an IND and initiate Phase 1 clinical development in 2026.
License Agreement
Under the license agreement, Zenas will pay InnoCare upfront and near-term milestone payments of up to
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 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
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
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.
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, and assuming receipt of the potential
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 statement will only be by means of a prospectus.
Conference Call Information
Zenas BioPharma will host a conference call and webcast today, October 8, 2025, at 8:00 a.m. ET to discuss the transformational license agreement and to provide an update on the Company’s business and strategy. To access the live webcast of the call, please visit the “Events and Presentations” page in the Investor & Media Relations section of the Zenas BioPharma website. A replay of the webcast will be available following the call.
InnoCare will host a conference call at 8:30 a.m. Beijing time on October 9, 2025, in Chinese. To access the conference call, please register in advance through the link: https://s.comein.cn/fufgvbun.
About Orelabrutinib
Orelabrutinib is a late-stage, potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor. In Multiple Sclerosis (MS), InnoCare initiated a Phase 3 trial for Primary Progressive MS (PPMS) in the third quarter of 2025. A Phase 3 trial for Secondary Progressive MS (SPMS) is expected to initiate in the first quarter of 2026. The Phase 3 PPMS and SPMS trials have obtained U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) alignment. Orelabrutinib is approved for B cell malignancies in mainland China and Singapore.
About Obexelimab
Obexelimab is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of the B cell lineage in chronic autoimmune disease.
Obexelimab has been evaluated in six clinical trials in a total of 208 patients who received obexelimab either as an intravenous infusion or as a subcutaneous injection. Obexelimab was well tolerated and demonstrated clinical activity across these clinical trials, providing the Company with an initial clinical proof of concept for obexelimab as a potent B cell inhibitor for the treatment of patients living with certain autoimmune diseases. Zenas is conducting a fully enrolled Phase 3 trial in Immunoglobulin G4-Related Disease and Phase 2 trials for Relapsing Multiple Sclerosis and Systemic Lupus Erythematosus.
About Zenas BioPharma, Inc.
Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas’ earlier stage programs include a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
About InnoCare Pharma
InnoCare (SSE: 688428; HKEX: 09969) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
InnoCare has established a comprehensive platform with strong in-house innovation capabilities focused on liquid and solid cancers as well as autoimmune diseases. To date, the company has developed a robust product pipeline comprising two approved drugs, more than ten innovative drug candidates in clinical development, and multiple programs in preclinical and IND-enabling stages. For more information about InnoCare, please visit https://www.innocarepharma.com/en and follow us on LinkedIn.
Zenas BioPharma Forward-Looking Statements
This press release contains “forward-looking statements” which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning Zenas’s milestones, expectations and intentions, including milestones under the license agreement, timing of the initiation of, results and data from clinical trials, including timing of reporting topline results from the INDIGO trial, the timing of reporting the 12-week and 24-week topline results from the MoonStone trial, the timing of the completion of enrollment and reporting the topline results from the SunStone trial, the timing of initiation of the Phase 3 clinical trial of orelabrutinib in patients with SPMS, the timing to submit an IND, and subject to IND clearance, the initiation of Phase 1 clinical studies of two preclinical assets, the timing of initial patient data from the first preclinical asset; the potential benefits, development and commercialization of orelabrutinib and obexelimab and orelabrutinib’s potential as a blockbuster franchise for progressive MS; expansion of the Zenas pipeline; the Company’s cash runway; and the expected closing of the Private Placement. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company’s current indications; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; significant political, trade, regulatory developments, including changes in relations between the U.S. and China; risks related to the operations of the Company’s suppliers, many of which are located outside of the United States, including the Company’s current sole contract manufacturing organization for drug substance and drug product, WuXi Biologics (Hong Kong) Limited, which is located in China; the risk that the conditions to closing of the Private Placement are not satisfied; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as well as other information we file with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain, speak only as of the date of this press release and may prove incorrect. These statements are based upon information available to the Company as of the date of this press release and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that the Company has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, these forward-looking statements should not be relied upon as guarantees of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
The Zenas BioPharma word mark, logo mark, and the “lightning bolt” design are trademarks of Zenas BioPharma, Inc. or its affiliated companies.
InnoCare Pharma Forward-Looking Statements
This release contains certain forward-looking statements. All statements, other than statements of fact, could be considered forward-looking statements, meaning statements regarding actions, events, or developments that we or our management intend, expect, project, believe, or anticipate will or may occur in the future. These statements are based on assumptions and estimates made by our management in light of their experience and perception of historical trends, current conditions, expected future developments, and other relevant factors. Forward-looking statements are not guarantees of future performance, and actual results, developments, and business decisions may differ materially from those contemplated by these forward-looking statements. Our forward-looking statements are subject to a number of risks and uncertainties that could affect our near- and long-term performance.
Zenas BioPharma Investor and Media Contact:
Argot Partners
Zenas@argotpartners.com
InnoCare Investor Contact:
Bonnie Yuan
86-10-66609999
IR@innocarepharma.com
InnoCare Media Contact:
Chunhua Lu
86-10-66609879
chunhua.lu@innocarepharma.com
