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[8-K] Zenas BioPharma, Inc. Reports Material Event

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8-K

Zenas BioPharma, Inc. (ZBIO) reported a material event announcing licensing and financing documents executed in early October 2025. The company obtained exclusive rights for three clinical-stage programs: orelabrutinib (a BTK inhibitor) in the multiple sclerosis field worldwide and in non-oncology indications outside Greater China and specified Southeast Asia countries; ZB021 (an IL-17AA/AF inhibitor) in all fields worldwide excluding Greater China and Southeast Asia; and ZB022 (a TYK2 inhibitor) in all fields worldwide. The filing lists a Subscription Agreement, Registration Rights Agreement and related securities purchase forms dated October 7, 2025, plus a press release and investor presentation dated October 8, 2025.

The disclosure identifies geographic carve-outs for two programs and confirms executed commercial and investor agreements, but it does not state any monetary terms, milestone schedules, or expected timelines for development or commercialization.

Zenas BioPharma, Inc. (ZBIO) ha comunicato un evento materiale annunciando documenti di licenza e finanziamento stipulati all'inizio di ottobre 2025. L'azienda ha ottenuto diritti esclusivi per tre programmi in fase clinica: orelabrutinib (un inibitore BTK) nel campo della sclerosi multipla in tutto il mondo e per indicazioni non oncologiche al di fuori della Grande Cina e paesi specifici del Sud-Est asiatico; ZB021 (un inibitore IL-17AA/AF) in tutti i campi a livello mondiale esclusa la Grande Cina e il Sud-Est asiatico; e ZB022 (un inibitore TYK2) in tutti i campi a livello mondiale. La comunicazione elenca un Accordo di Sottoscrizione, un Accordo sui Diritti di Registrazione e moduli di acquisto di titoli correlati datati 7 ottobre 2025, oltre a un comunicato stampa e una presentazione agli investitori datati 8 ottobre 2025.

La divulgazione identifica eccezioni geografiche per due programmi e conferma accordi commerciali e con gli investitori già stipulati, ma non indica termini monetari, scadenze delle milestone o tempistiche attese per lo sviluppo o la commercializzazione.

Zenas BioPharma, Inc. (ZBIO) informó un evento material anunciando documentos de licencia y financiación ejecutados a principios de octubre de 2025. la empresa obtuvo derechos exclusivos para tres programas en fase clínica: orelabrutinib (un inhibidor BTK) en el campo de esclerosis múltiple a nivel mundial y para indicaciones no oncológicas fuera de Gran China y países específicos del sudeste asiático; ZB021 (un inhibidor IL-17AA/AF) en todos los campos a nivel mundial excepto Gran China y Sudeste Asiático; y ZB022 (un inhibidor TYK2) en todos los campos a nivel mundial. El registro enumera un Acuerdo de Suscripción, un Acuerdo de Derechos de Registro y formularios de compra de valores relacionados con fecha 7 de octubre de 2025, además de un comunicado de prensa y una presentación para inversionistas con fecha 8 de octubre de 2025.

La divulgación identifica exclusiones geográficas para dos programas y confirma acuerdos comerciales y con inversores ya ejecutados, pero no indica términos monetarios, cronogramas de hitos o plazos esperados para el desarrollo o la comercialización.

Zenas BioPharma, Inc. (ZBIO)는 2025년 10월 초에 체결된 라이선스 및 자금 조달 문서를 발표하는 중요한 사건을 보고했습니다. 회사는 세 가지 임상 단계 프로그램에 대해 독점권을 얻었습니다: orelabrutinib (BTK 억제제) 전 세계 다발성 경화증 분야 및 그레이터 차이나 외의 비암 연구 지표에 한정; ZB021 (IL-17AA/AF 억제제) 전 세계 모든 분야에서 그레이터 차이나 및 동남아시아를 제외한 지역; 그리고 ZB022 (TYK2 억제제) 전 세계 모든 분야에서. 공시는 Subscription Agreement, Registration Rights Agreement 및 관련 증권 매매 양식을 2025년 10월 7일로 명시하고, 또한 2025년 10월 8일로 기재된 보도자료 및 투자자 프리젠테이션을 포함합니다.

공시는 두 프로그램에 대한 지리적 예외를 식별하고 상업 및 투자자 계약이 체결되었음을 확인하지만, 금전적 조건, 마일스톤 일정 또는 개발 또는 상용화에 대한 예상 일정은 명시하지 않습니다.

Zenas BioPharma, Inc. (ZBIO) a signalé un événement important annonçant des documents de licence et de financement signés au début octobre 2025. L'entreprise a obtenu des droits exclusifs sur trois programmes en phase clinique: orelabrutinib (un inhibiteur BTK) dans le domaine de la sclérose en plaques au niveau mondial et pour des indications non oncologiques en dehors de Grande Chine et de certains pays du sud-est asiatique; ZB021 (un inhibiteur IL-17AA/AF) dans tous les domaines au niveau mondial sauf Grande Chine et Sud-Est asiatique; et ZB022 (un inhibiteur TYK2) dans tous les domaines au niveau mondial. Le dossier mentionne un Accord de Souscription, un Accord sur les Droits d’Inscription et des formulaires d’achat de titres associés datés du 7 octobre 2025, ainsi qu’un communiqué de presse et une présentation investisseurs datés du 8 octobre 2025.

La divulgation identifie des exclusions géographiques pour deux programmes et confirme des accords commerciaux et avec des investisseurs déjà conclus, mais elle ne précise aucun terme monétaire, calendrier des jalons ou délais prévus pour le développement ou la commercialisation.

Zenas BioPharma, Inc. (ZBIO) meldete eine wesentliche Angelegenheit und kündigte Lizenz- und Finanzierungsdokumente an, die Anfang Oktober 2025 abgeschlossen wurden. Das Unternehmen erhielt exklusive Rechte für drei klinische Programme: orelabrutinib (ein BTK-Inhibitor) im Bereich Multiplen Sklerose weltweit und in nicht-onkologischen Indikationen außerhalb von Greater China und bestimmten Südostasiatischen Ländern; ZB021 (ein IL-17AA/AF-Inhibitor) in allen Bereichen weltweit mit Ausnahme von Greater China und Südostasien; und ZB022 (ein TYK2-Inhibitor) in allen Bereichen weltweit. Die Einreichung führt ein Subscription Agreement, ein Registration Rights Agreement und damit verbundene Wertpapierkauf-Formulare datiert auf 7. Oktober 2025 sowie eine Pressemitteilung und eine Investorenpräsentation datiert auf 8. Oktober 2025 auf.

Die Offenlegung identifiziert geografische Ausnahmen für zwei Programme und bestätigt abgeschlossene kommerzielle und Investorvereinbarungen, nennt jedoch keine monetären Bedingungen, Milestones oder erwartete Zeitpläne für Entwicklung oder Vermarktung.

Zenas BioPharma, Inc. (ZBIO) أبلغت عن حدث مادي يعلن عن وثائق الترخيص والتمويل التي تم تنفيذها في أوائل أكتوبر 2025. حصلت الشركة على حقوق حصرية لثلاثة برامج في مرحلتها الإكلينيكية: orelabrutinib (مثبط BTK) في مجال التصلب المتعدد عالميًا وفي مؤشرات غير علاجية خارج أكبر الصين والبلدان المعينة في جنوب شرق آسيا؛ ZB021 (مثبط IL-17AA/AF) في جميع المجالات عالميًا باستثناء أكبر الصين وجنوب شرق آسيا؛ وZB022 (مثبط TYK2) في جميع المجالات عالميًا. تتضمن الأوراق المودعة اتفاقية الاشتراك، واتفاقية حقوق التسجيل ونماذج شراء الأوراق المالية المرتبطة المؤرخة في 7 أكتوبر 2025، بالإضافة إلى بيان صحفي وعرض للمستثمرين مؤرَّخ في 8 أكتوبر 2025.

تحدد الافصاح استثناءات جغرافية لبرنامجين وتؤكد اتفاقيات تجارية واتفاقيات مع المستثمرين تم تنفيذها، لكنها لا تذكر أي شروط مالية أو جداول milestones أو الجداول الزمنية المتوقعة للتطوير أو التسويق.

Zenas BioPharma, Inc. (ZBIO) 报告了一项重大事件,宣布在2025年10月初执行的许可与融资文件。 公司获得了三个临床阶段项目的独家权利:orelabrutinib(BTK抑制剂)在全球范围内的 多发性硬化症领域以及在 大中华区 以外的非肿瘤适应症;ZB021(IL-17AA/AF 抑制剂)在全球所有领域,排除大中华区和东南亚;以及 ZB022(TYK2 抑制剂)在全球所有领域。 filing 列出一个 Subscription Agreement、一个 Registration Rights Agreement 及相关证券购买表格,日期为 2025年10月7日,以及一份日期为 2025年10月8日 的新闻稿和投资者介绍。

披露为两个程序标识了地理排除,并确认已执行的商业和投资者协议,但未说明货币条件、里程碑时间表或开发或商业化的预期时间线。

Positive
  • Exclusive global rights for ZB022 (TYK2 inhibitor) enable unified development strategy
  • Orelabrutinib rights secured for MS worldwide, expanding the company’s neurology portfolio
  • Executed legal agreements (Subscription and Registration Rights Agreements) dated October 7, 2025 confirm completed transactions
Negative
  • Geographic exclusions for orelabrutinib and ZB021 in Greater China and parts of Southeast Asia limit direct market access
  • No financial terms disclosed in the filing—payment amounts, milestones, and royalties are absent
  • Potential investor dilution implied by securities purchase and subscription agreements without stated size or pricing

Insights

Material licensing expands program control but includes regional carve-outs.

The company acquired exclusive rights for three assets, including global rights for ZB022 and MS-focused rights for orelabrutinib, which centralizes development decision-making for those programs. Holding broad rights can simplify partner coordination and downstream partnering or monetization.

These deals exclude Greater China and specified Southeast Asian territories for two assets, which limits direct commercial upside in those markets. Watch for disclosed financial terms, milestone schedules, or partner obligations in forthcoming filings or the referenced press release and presentation over the next weeks.

Agreements executed but key commercial terms are not disclosed in the filing.

The 8-K lists executed documents dated October 7, 2025 including subscription and registration rights agreements and securities purchase documents, which suggests concurrent financing and licensing steps. Formal execution of these agreements is a necessary legal step to transfer or secure rights.

Because the filing omits payment amounts, royalty structures, and milestone triggers, investors should consult the press release and any exhibit copies for contract exhibits to assess financial commitments and dilution impact; expect those exhibits or a later amended filing to clarify material economic terms.

Zenas BioPharma, Inc. (ZBIO) ha comunicato un evento materiale annunciando documenti di licenza e finanziamento stipulati all'inizio di ottobre 2025. L'azienda ha ottenuto diritti esclusivi per tre programmi in fase clinica: orelabrutinib (un inibitore BTK) nel campo della sclerosi multipla in tutto il mondo e per indicazioni non oncologiche al di fuori della Grande Cina e paesi specifici del Sud-Est asiatico; ZB021 (un inibitore IL-17AA/AF) in tutti i campi a livello mondiale esclusa la Grande Cina e il Sud-Est asiatico; e ZB022 (un inibitore TYK2) in tutti i campi a livello mondiale. La comunicazione elenca un Accordo di Sottoscrizione, un Accordo sui Diritti di Registrazione e moduli di acquisto di titoli correlati datati 7 ottobre 2025, oltre a un comunicato stampa e una presentazione agli investitori datati 8 ottobre 2025.

La divulgazione identifica eccezioni geografiche per due programmi e conferma accordi commerciali e con gli investitori già stipulati, ma non indica termini monetari, scadenze delle milestone o tempistiche attese per lo sviluppo o la commercializzazione.

Zenas BioPharma, Inc. (ZBIO) informó un evento material anunciando documentos de licencia y financiación ejecutados a principios de octubre de 2025. la empresa obtuvo derechos exclusivos para tres programas en fase clínica: orelabrutinib (un inhibidor BTK) en el campo de esclerosis múltiple a nivel mundial y para indicaciones no oncológicas fuera de Gran China y países específicos del sudeste asiático; ZB021 (un inhibidor IL-17AA/AF) en todos los campos a nivel mundial excepto Gran China y Sudeste Asiático; y ZB022 (un inhibidor TYK2) en todos los campos a nivel mundial. El registro enumera un Acuerdo de Suscripción, un Acuerdo de Derechos de Registro y formularios de compra de valores relacionados con fecha 7 de octubre de 2025, además de un comunicado de prensa y una presentación para inversionistas con fecha 8 de octubre de 2025.

La divulgación identifica exclusiones geográficas para dos programas y confirma acuerdos comerciales y con inversores ya ejecutados, pero no indica términos monetarios, cronogramas de hitos o plazos esperados para el desarrollo o la comercialización.

Zenas BioPharma, Inc. (ZBIO)는 2025년 10월 초에 체결된 라이선스 및 자금 조달 문서를 발표하는 중요한 사건을 보고했습니다. 회사는 세 가지 임상 단계 프로그램에 대해 독점권을 얻었습니다: orelabrutinib (BTK 억제제) 전 세계 다발성 경화증 분야 및 그레이터 차이나 외의 비암 연구 지표에 한정; ZB021 (IL-17AA/AF 억제제) 전 세계 모든 분야에서 그레이터 차이나 및 동남아시아를 제외한 지역; 그리고 ZB022 (TYK2 억제제) 전 세계 모든 분야에서. 공시는 Subscription Agreement, Registration Rights Agreement 및 관련 증권 매매 양식을 2025년 10월 7일로 명시하고, 또한 2025년 10월 8일로 기재된 보도자료 및 투자자 프리젠테이션을 포함합니다.

공시는 두 프로그램에 대한 지리적 예외를 식별하고 상업 및 투자자 계약이 체결되었음을 확인하지만, 금전적 조건, 마일스톤 일정 또는 개발 또는 상용화에 대한 예상 일정은 명시하지 않습니다.

Zenas BioPharma, Inc. (ZBIO) a signalé un événement important annonçant des documents de licence et de financement signés au début octobre 2025. L'entreprise a obtenu des droits exclusifs sur trois programmes en phase clinique: orelabrutinib (un inhibiteur BTK) dans le domaine de la sclérose en plaques au niveau mondial et pour des indications non oncologiques en dehors de Grande Chine et de certains pays du sud-est asiatique; ZB021 (un inhibiteur IL-17AA/AF) dans tous les domaines au niveau mondial sauf Grande Chine et Sud-Est asiatique; et ZB022 (un inhibiteur TYK2) dans tous les domaines au niveau mondial. Le dossier mentionne un Accord de Souscription, un Accord sur les Droits d’Inscription et des formulaires d’achat de titres associés datés du 7 octobre 2025, ainsi qu’un communiqué de presse et une présentation investisseurs datés du 8 octobre 2025.

La divulgation identifie des exclusions géographiques pour deux programmes et confirme des accords commerciaux et avec des investisseurs déjà conclus, mais elle ne précise aucun terme monétaire, calendrier des jalons ou délais prévus pour le développement ou la commercialisation.

Zenas BioPharma, Inc. (ZBIO) meldete eine wesentliche Angelegenheit und kündigte Lizenz- und Finanzierungsdokumente an, die Anfang Oktober 2025 abgeschlossen wurden. Das Unternehmen erhielt exklusive Rechte für drei klinische Programme: orelabrutinib (ein BTK-Inhibitor) im Bereich Multiplen Sklerose weltweit und in nicht-onkologischen Indikationen außerhalb von Greater China und bestimmten Südostasiatischen Ländern; ZB021 (ein IL-17AA/AF-Inhibitor) in allen Bereichen weltweit mit Ausnahme von Greater China und Südostasien; und ZB022 (ein TYK2-Inhibitor) in allen Bereichen weltweit. Die Einreichung führt ein Subscription Agreement, ein Registration Rights Agreement und damit verbundene Wertpapierkauf-Formulare datiert auf 7. Oktober 2025 sowie eine Pressemitteilung und eine Investorenpräsentation datiert auf 8. Oktober 2025 auf.

Die Offenlegung identifiziert geografische Ausnahmen für zwei Programme und bestätigt abgeschlossene kommerzielle und Investorvereinbarungen, nennt jedoch keine monetären Bedingungen, Milestones oder erwartete Zeitpläne für Entwicklung oder Vermarktung.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): October 7, 2025

 

 

ZENAS BIOPHARMA, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware   001-42270   93-2749244

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

   

852 Winter Street, Suite 250

Waltham, MA

  02451
(Address of principal executive offices)   (Zip Code)

 

(Registrant’s telephone number, including area code): (857) 271-2954

 

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) 

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) 

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class  

Trading
Symbol(s)

 

Name of each exchange
on which registered

Common Stock, par value $0.0001 per share   ZBIO   The Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

Item 1.01 Entry into a Material Definitive Agreement

 

License Agreement with InnoCare Pharma Inc.

 

On October 7, 2025, Zenas BioPharma, Inc. (“Zenas” or the “Company”) entered into a License Agreement (the “InnoCare License Agreement”) with InnoCare Pharma Inc. (“InnoCare”). Under the InnoCare License Agreement, InnoCare granted Zenas exclusive rights to develop, manufacture, and commercialize certain small molecule compounds and related products in specified fields and territories, as further described below.

 

License Grants

 

1.Orelabrutinib (a BTK inhibitor): Zenas obtained exclusive rights in the multiple sclerosis (“MS”) field worldwide, and in all non-oncology indications outside mainland China, Hong Kong, Macau and Taiwan (“Greater China”) and Brunei, Burma, Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, Philippines, Singapore, Thailand and Vietnam (“Southeast Asia”).
2.ZB021 (an IL-17AA/AF inhibitor): Zenas obtained exclusive rights in all fields of use worldwide, excluding Greater China and Southeast Asia.
3.ZB022 (a TYK2 inhibitor): Zenas obtained exclusive rights in all fields of use worldwide.

 

Zenas also obtained certain non-exclusive rights to perform development and manufacturing activities in Greater China and Southeast Asia to support each program in its respective licensed territories.

 

Consideration

 

Zenas has agreed to pay InnoCare an upfront cash payment of $35 million and also issued to InnoCare 5,000,000 shares (the “InnoCare Upfront Shares”) of its common stock, par value $0.0001 per share (“Common Stock”), representing approximately 10.6% of Zenas’s issued and outstanding Common Stock as of October 7, 2025, after giving effect to the issuance to InnoCare, and approximately 9.3% of Zenas’s issued and outstanding Common Stock after giving effect to the further issuance of the PIPE Shares (as defined below).

 

Zenas has agreed to make a one-time, cash payment of $25 million and issue 2,000,000 shares of Common Stock (the “InnoCare Near-Term Milestone Shares” and, together with the InnoCare Upfront Shares, the “InnoCare Shares”) upon the earlier of (i) Zenas’ initiation of a Phase 3 clinical trial for orelabrutinib in any indication other than primary progressive MS, and (ii) March 31, 2026, upon the occurrence of certain specified events (the “Orelabrutinib Near-Term Milestone”). Additionally, Zenas has agreed to make one-time, potential near-term milestone payments of $20 million each, upon the achievement of certain regulatory milestones for ZB021 and ZB022.

 

Zenas is obligated to pay up to approximately $723 million in additional cash payments upon the achievement of certain regulatory and commercial sales milestones for orelabrutinib. For the ZB021 and ZB022 early-development product candidates, Zenas is obligated to pay up to approximately $656 million each, upon the achievement of certain development, regulatory and commercial sales milestones. Zenas will also pay tiered royalties on net sales at rates ranging from high-single digits to high-teens for orelabrutinib, and mid-single digits to mid-teens for ZB021 and ZB022.

 

Governance and Development

 

Zenas will assume responsibility for development and commercialization of orelabrutinib in its licensed fields and territories, including the transition of ongoing Phase 3 global trials for orelabrutinib in MS. A joint steering committee will oversee development and regulatory activities related to orelabrutinib.

 

 

 

 

Term and Termination

 

The InnoCare License Agreement will remain in effect on a product-by-product and country-by-country basis until expiration of the applicable royalty term, unless earlier terminated. Each party has customary termination rights, including for uncured material breach, insolvency, patent challenge, or, in the case of Zenas, for convenience.

 

The foregoing description of the InnoCare License Agreement does not purport to be complete and is qualified in its entirety by reference to the InnoCare License Agreement, a copy of which the Company will file as an exhibit to its Annual Report on Form 10-K for the year ending December 31, 2025.

 

InnoCare Subscription Agreement and Registration Rights Agreement

 

On October 7, 2025, in connection with the InnoCare License Agreement described in Item 1.01 above, Zenas issued the InnoCare Upfront Shares (the “InnoCare Private Placement”), pursuant to the terms of a Subscription Agreement between InnoCare and Zenas (the “InnoCare Subscription Agreement”) in a private placement transaction. The InnoCare Subscription Agreement also provides that the Company will issue the Near-Term Milestone Shares upon the occurrence of the Orelabrutinib Near-Term Milestone. The InnoCare Subscription Agreement provides that InnoCare may not transfer any of the InnoCare Shares until October 7, 2026, and thereafter may not transfer InnoCare Shares during any one month in an amount the exceeds the greater of (i) one percent of the outstanding Common Stock as most recently reported by Zenas publicly and (ii) the average weekly reported volume of trading in the Common Stock during the four preceding calendar weeks. The foregoing restrictions will not apply to transfers to an affiliate of InnoCare, to Zenas or in connection with a change of control of Zenas approved by board of directors of Zenas.

 

In connection with the InnoCare Private Placement, the Company and InnoCare also entered into a Registration Rights Agreement on October 7, 2025 (the “InnoCare Registration Rights Agreement”). Pursuant to the terms of the InnoCare Registration Rights Agreement, the Company is obligated (i) to prepare and file with the Securities and Exchange Commission (the “SEC”) prior to October 7, 2026 a registration statement (the “InnoCare Registration Statement”) to register for resale the InnoCare Shares, and (ii) to use its reasonable best efforts to cause the Registration Statement to be declared effective by the SEC as soon as practicable thereafter.

 

The InnoCare Subscription Agreement contains customary representations, warranties and covenants that were made solely for the benefit of the parties to the InnoCare Subscription Agreement. Such representations, warranties and covenants (i) are intended as a way of allocating risk between the parties to the InnoCare Subscription Agreement and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Accordingly, the InnoCare Subscription Agreement is included with this Current Report on Form 8-K only to provide investors with information regarding the terms of transaction and not to provide investors with any other factual information regarding the Company. Investors should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the InnoCare Subscription Agreement, which subsequent information may or may not be fully reflected in public disclosures.

 

The foregoing descriptions of the InnoCare Subscription Agreement and the InnoCare Registration Rights Agreement do not purport to be complete and are qualified in their entirety by reference to the Subscription Agreement and the Registration Rights Agreement, which are filed as Exhibit 10.1 and Exhibit 10.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

 

 

 

 

Securities Purchase Agreement

 

On October 7, 2025, the Company entered into a Securities Purchase Agreement (the "Securities Purchase Agreement") with (i) certain institutional and accredited investors (the "Institutional Investors") and (ii) certain directors and officers of the Company (the "Director and Officer Investors" and, together with the Institutional Investors, each, an "Investor" and, together, the "Investors"), pursuant to which the Company agreed to sell to (i) the Institutional Investors an aggregate of 6,261,893 shares of Common Stock (the "Institutional Investor PIPE Shares"), at a price of $19.00 per share, and (ii) the Director and Officer Investors an aggregate of 48,918 shares of Common Stock (the "Director and Officer Investor PIPE Shares" and, together with the Institutional Investor PIPE Shares, the "PIPE Shares") at a price of $20.85 per share, in each case in a private placement transaction (the "Investor Private Placement" and, together with the InnoCare Private Placement, the "Private Placements") for gross proceeds to the Company of approximately $120.0 million, before deducting placement agent fees and other expenses. The Closing of the Investor Private Placement is anticipated to occur on or about October 9, 2025 (the "PIPE Closing").

 

The Securities Purchase Agreement contains customary representations, warranties and covenants that were made solely for the benefit of the parties to the Securities Purchase Agreement. Such representations, warranties and covenants (i) are intended as a way of allocating risk between the parties to the Securities Purchase Agreement and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Accordingly, the Securities Purchase Agreement is included with this Current Report on Form 8-K only to provide investors with information regarding the terms of transaction and not to provide investors with any other factual information regarding the Company. Investors should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Securities Purchase Agreement, which subsequent information may or may not be fully reflected in public disclosures.

 

PIPE Registration Rights Agreement

 

In connection with the Investor Private Placement, on October 7, 2025, the Company entered into a Registration Rights Agreement (the “PIPE Registration Rights Agreement”) with the Investors, pursuant to which the Company will prepare and file, within 15 days of the PIPE Closing and subject to certain allowable delays, an initial registration statement (the “PIPE Registration Statement”) with the SEC to register for resale the PIPE Shares. The Company has granted the Investors customary indemnification rights in connection with the PIPE Registration Rights Agreement. The Investors have also granted the Company customary indemnification rights in connection with the PIPE Registration Rights Agreement.

 

The foregoing descriptions of the Securities Purchase Agreement and the PIPE Registration Rights Agreement do not purport to be complete and are qualified in their entirety by reference to the complete text of the form of the Securities Purchase Agreement and the PIPE Registration Rights Agreement, forms of which are filed as Exhibits 10.3 and 10.4, respectively, to this Current Report on Form 8-K and are incorporated by reference herein.

 

Item 2.02 Results of Operations and Financial Condition

 

The disclosure regarding the Company’s existing cash, cash equivalents and investments as of September 30, 2025 set forth under Item 8.01 of this Current Report on Form 8-K is incorporated by reference under this Item 2.02.

 

 

 

 

Item 3.02 Unregistered Sales of Equity Securities

 

The disclosure regarding the securities to be sold and issued pursuant to the InnoCare Subscription Agreement and the Securities Purchase Agreement set forth under Item 1.01 of this Current Report on Form 8-K is incorporated by reference under this Item 3.02.

 

None of the securities described above under Item 1.01 has been registered under the Securities Act or any state securities laws. The Company is relying on exemptions from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof.

 

Neither this Current Report on Form 8-K nor any exhibit attached hereto is an offer to sell or the solicitation of an offer to buy shares of Common Stock or other securities of the Company.

 

Item 7.01. Regulation FD Disclosure

 

On October 8, 2025, the Company issued a press release announcing the Agreement and the Private Placement. The Company is also hosting a conference call and webcast at 8 a.m. Eastern Time, on October 8, 2025.

 

A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and the presentation the Company intends to present on the conference call and webcast is furnished as Exhibit 99.2 to this Current Report on Form 8-K, and both are incorporated by reference herein. The exhibits furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act, regardless of any general incorporation language in such filing.

 

Item 8.01 Other Events

 

Recent Developments

 

Following entry into the InnoCare License Agreement, the Company’s pipeline currently comprises four programs it is developing initially for the treatment of immunology and inflammation diseases: (1) obexelimab, a bifunctional monoclonal antibody designed to bind both CD19 and  FcγRIIb, which are broadly present across the B cell lineage, in order to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them, (2) orelabrutinib, a highly selective and central nervous system-penetrant, oral small molecule Bruton’s Tyrosine Kinase inhibitor, (3) ZB021, an IL-17 AA/AF inhibitor and (4) ZB022, a brain-penetrant TYK2 inhibitor.

 

Additional information about the Company’s current pipeline can be found in Exhibit 99.3 to this Current Report on Form 8-K, which is incorporated by reference herein.

 

Company Cash Update

 

The Company estimates that, as of September 30, 2025, it had approximately $302 million in existing cash, cash equivalents and investments. During the three months ended September 30, 2025, a $5 million deposit was paid towards the $35 million upfront cash payment due to InnoCare. This estimated amount of cash, cash equivalents and investments as of September 30, 2025 is preliminary and is subject to completion of the Company’s financial closing procedures and has not been reviewed or audited by our independent auditors. Consequently, this amount may differ materially from the amount that will be reflected in the Company’s unaudited condensed consolidated balance sheet as of September 30, 2025.

 

As of the date of this Current Report on Form 8-K, after giving effect to the upfront cash consideration paid to InnoCare pursuant to the InnoCare License Agreement and the anticipated proceeds from the PIPE Transaction, the Company 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 from Royalty Pharma Investments 2019 ICAV (“Royalty Pharma”) of the potential $75 million milestone for the defined success criteria in the Phase 3 INDIGO trial of obexelimab pursuant to the Revenue Participation Right Purchase and Sale Agreement between the Company and Royalty Pharma, into the first quarter of 2027.

 

 

 

 

Forward Looking Statements

 

This Current Report on Form 8-K 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 Current Report on Form 8-K 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 the Company’s milestones, expectations and intentions, including timing of the initiation of, results and data from clinical trials, including timing of reporting topline results from the INDIGO trial, and if successful, the timing of BLA submission, potential approval and commercial launch, 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, and if successful, the timing of initiating the Phase 3 trial in SLE, 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 ZB021 and ZB022, the timing of initial patient data in ZB021; the potential benefits, development and commercialization of orelabrutinib and obexelimab and orelabrutinib’s potential as a franchise for progressive MS; the expansion of the Company’s pipeline; the expected PIPE Closing; the achievement of payment-triggering milestones pursuant to the InnoCare License Agreement and the Company’s cash guidance. The forward-looking statements in this Current Report on Form 8-K speak only as of the date of this Current Report on Form 8-K 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; 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 the Company files with the Securities and Exchange Commission. The forward-looking statements in this Current Report on Form 8-K are inherently uncertain, speak only as of the date of this Current Report on Form 8-K and may prove incorrect. These statements are based upon information available to the Company as of the date of this Current Report on Form 8-K 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.

 

 

 

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit
No.
  Description
10.1   Subscription Agreement, dated October 7, 2025, by and between the Company and InnoCare Pharma Inc.
10.2   Registration Rights Agreement, dated October 7, 2025, by and between the Company and InnoCare Pharma Inc.
10.3   Form of Securities Purchase Agreement, dated October 7, 2025, by and among the Company and the investors party thereto.
10.4   Form of Registration Rights Agreement, dated October 7, 2025, by and among the Company and the investors party thereto.
99.1   Press Release, dated October 8, 2025
99.2   Zenas BioPharma, Inc. Presentation, dated October 8, 2025
99.3   Zenas BioPharma, Inc. Business Updates
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  ZENAS BIOPHARMA, INC.
     
  By: /s/ Jennifer Fox
    Name: Jennifer Fox
    Title: Chief Business Officer and Chief Financial Officer

 

Date: October 8, 2025

 

 

 

FAQ

What rights did Zenas BioPharma (ZBIO) obtain for orelabrutinib?

Zenas obtained exclusive rights for orelabrutinib in the multiple sclerosis field worldwide and for all non-oncology indications outside Greater China and specified Southeast Asian countries.

Does ZBIO hold worldwide rights for ZB022?

Yes. The company obtained exclusive rights for ZB022 (a TYK2 inhibitor) in all fields of use worldwide.

Were financial terms of the licensing disclosed in the 8-K?

No. The filing lists executed agreements dated October 7, 2025 but does not disclose any monetary amounts, milestone payments, or royalty rates.

What agreements were filed with the SEC on October 7, 2025?

The filing references a Subscription Agreement, a Registration Rights Agreement, a Form of Securities Purchase Agreement, and a Form of Registration Rights Agreement, all dated October 7, 2025.

Is there supporting investor material for this announcement?

Yes. The 8-K lists a press release and a presentation dated October 8, 2025, along with business updates.
Zenas BioPharma Inc.

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