WASHINGTON, May 15, 2025 (GLOBE NEWSWIRE) -- Cohen Milstein Sellers & Toll PLLC alerts investors that they have until June 16, 2025 to seek appointment as lead plaintiff in a securities class action lawsuit against Zenas BioPharma, Inc. (NASDAQ: ZBIO). The lawsuit, filed in the U.S. District Court for the District of Massachusetts, concerns alleged material misstatements in the company’s September 2024 IPO offering documents. [Click here for information about joining the class action] If you’d like to discu ...

Obexelimab: A Differentiated B Cell Therapy - Obexelimab is a potentially highly differentiated I&I franchise molecule targeting autoimmune diseases [5] - It is the first bifunctional B cell targeting (CD19 x FcγRIIb) antibody in Phase 3 trial for IgG4-Related Disease and Phase 2 trials for RMS and SLE [6] - The company estimates a potential multi-billion-dollar commercial opportunity for Obexelimab [6, 45, 120] - Zenas BioPharma had approximately $314 million in cash as of Q1 2025, funding operations into Q4 2026 [6, 121] Clinical Development and Trial Readouts - Phase 3 topline results for the INDIGO trial in IgG4-RD are expected around year-end 2025 [46] - Phase 2 primary endpoint (12-week) data for the MoonStone trial in RMS is expected in early Q4 2025 [46] - Phase 2 primary endpoint (24-week) data for the SunStone trial in SLE is expected in mid-2026 [46] - The Phase 3 INDIGO trial in IgG4-RD has completed enrollment with approximately 190 patients [67] Market Opportunity and Strategic Collaboration - The estimated prevalence of IgG4-RD patients in the U S is approximately 20,000 to 40,000, and approximately 20,000 to 40,000 collectively in the UK, Germany, France, Italy, and Spain alone [52] - The company estimates that Obexelimab represents a compelling $1 billion+ commercial revenue opportunity in the U S alone for IgG4-RD [75] - Bristol Myers Squibb (BMS) has rights to develop and commercialize obexelimab in Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia [47, 110]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-42270 Zenas BioPharma, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdicti ...

Zenas BioPharma Q1 2025 Corporate and Financial Update [Corporate Updates and Pipeline Progress](index=1&type=section&id=Corporate_Updates_and_Pipeline_Progress) Zenas BioPharma advanced its obexelimab clinical programs with key trial enrollments and data readouts, while also strengthening its leadership and securing a regional licensing agreement [Obexelimab Program Updates](index=1&type=section&id=Obexelimab_Program_Updates) Key clinical trials for obexelimab, including Phase 3 INDIGO and Phase 2 MoonStone and SunStone, are progressing with anticipated data readouts - The pivotal Phase 3 INDIGO trial for Immunoglobulin G4-Related Disease (IgG4-RD) has completed enrollment, with topline results expected around year-end 2025[1](index=1&type=chunk)[3](index=3&type=chunk) - Enrollment for the Phase 2 MoonStone trial in Relapsing Multiple Sclerosis (RMS) is concluding, and topline results are anticipated in the early fourth quarter of 2025[1](index=1&type=chunk)[5](index=5&type=chunk) - The Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE) is expected to complete enrollment by year-end 2025, with topline results projected for mid-2026[1](index=1&type=chunk)[5](index=5&type=chunk) [Other Corporate Highlights](index=2&type=section&id=Other_Corporate_Highlights) Zenas BioPharma strengthened its leadership team with key appointments and secured a regional licensing deal for its thyroid eye disease program - Strengthened the leadership team with the appointments of Lisa von Moltke, M.D., as Head of Research and Development and Chief Medical Officer, and Haley Laken, Ph.D., as Chief Scientific Officer[1](index=1&type=chunk)[5](index=5&type=chunk) - Out-licensed regional rights in Greater China for its thyroid eye disease program (ZB001) to Zai Lab. Zenas received an upfront payment and is eligible for future milestone payments and royalties[5](index=5&type=chunk) [First Quarter 2025 Financial Results](index=1&type=section&id=First_Quarter_2025_Financial_Results) For Q1 2025, Zenas BioPharma reported $10.0 million in licensing revenue, an increased net loss of $33.6 million due to higher operating expenses, and maintained a strong cash position of $314.2 million, providing a financial runway into Q4 2026 - As of March 31, 2025, cash, cash equivalents, and investments totaled **$314.2 million**[1](index=1&type=chunk)[5](index=5&type=chunk) - The current cash position is expected to fund operating expenses and capital expenditure requirements into the fourth quarter of 2026[1](index=1&type=chunk)[5](index=5&type=chunk) Q1 2025 vs Q1 2024 Financial Performance (in millions) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | License and collaboration revenue | $10.0 | $0.0 | +$10.0 | | Research and development (R&D) expenses | $34.9 | $22.6 | +$12.3 | | General and administrative (G&A) expenses | $12.4 | $4.9 | +$7.5 | | Net loss | $33.6 | $27.8 | +$5.8 | | Net loss per share | ($0.80) | ($17.89) | N/A | [Detailed Financial Statements](index=6&type=section&id=Detailed_Financial_Statements) This section presents the unaudited condensed consolidated statements of operations for the three months ended March 31, 2025, and selected consolidated balance sheet data as of March 31, 2025 [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed_Consolidated_Statements_of_Operations) This table provides the unaudited condensed consolidated statements of operations for the three months ended March 31, 2025 and 2024 Condensed Consolidated Statements of Operations (Unaudited, in thousands) | | Three Months Ended March 31, | | | :--- | :--- | :--- | | | **2025** | **2024** | | **Revenue:** | | | | License and collaboration revenue | $10,000 | $— | | **Total revenue** | **$10,000** | **$—** | | **Operating expenses:** | | | | Research and development | $34,915 | $22,645 | | General and administrative | $12,415 | $4,933 | | **Total operating expenses** | **$47,330** | **$27,578** | | **Loss from operations** | **($37,330)** | **($27,578)** | | Other income (expense), net | $3,552 | ($222) | | Income tax benefit | $205 | $— | | **Net loss to common stockholders** | **($33,573)** | **($27,800)** | | **Net loss per share - basic and diluted** | **($0.80)** | **($17.89)** | | Weighted-average common stock outstanding | 41,800,802 | 1,554,087 | [Selected Consolidated Balance Sheet Data](index=6&type=section&id=Selected_Consolidated_Balance_Sheet_Data) This table presents selected unaudited consolidated balance sheet data as of March 31, 2025 Selected Consolidated Balance Sheet Data (Unaudited, in thousands) | | March 31, 2025 | | :--- | :--- | | Cash, cash equivalents and investments | $314,214 | | Working capital | $268,675 | | Total assets | $333,766 | | Accumulated deficit | ($420,964) | | Total stockholders' equity | $284,317 | [Company and Product Information](index=3&type=section&id=Company_and_Product_Information) Zenas BioPharma is a clinical-stage biopharmaceutical company focused on developing therapies for autoimmune diseases, with its lead product obexelimab designed as a bifunctional antibody to inhibit B cell activity without depletion [About Obexelimab](index=3&type=section&id=About_Obexelimab) Obexelimab is a bifunctional monoclonal antibody designed to inhibit B cell activity without depletion, showing promising clinical activity and tolerability - Obexelimab is a bifunctional monoclonal antibody that binds to both CD19 and FcγRIIb on B cells to inhibit their activity without depleting them[6](index=6&type=chunk) - The drug has been evaluated in five completed clinical trials involving 198 patients, where it was well tolerated and showed clinical activity, providing initial proof of concept[7](index=7&type=chunk) [About Zenas BioPharma, Inc.](index=3&type=section&id=About_Zenas_BioPharma_Inc) Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on acquiring and developing product candidates for autoimmune diseases - Zenas is a clinical-stage global biopharmaceutical company focused on developing and commercializing therapies for autoimmune diseases[8](index=8&type=chunk) - The company's core strategy involves acquiring and developing product candidates with the potential to offer superior clinical benefits to patients with autoimmune diseases[8](index=8&type=chunk)

Core Insights - Zenas BioPharma is advancing its obexelimab program through multiple clinical trials, with topline results expected in late 2025 for Immunoglobulin G4-Related Disease and early Q4 2025 for Relapsing Multiple Sclerosis [1][2][4] Clinical Trials - The Phase 3 INDIGO trial for Immunoglobulin G4-Related Disease is the largest clinical trial conducted for this condition, with topline results anticipated around year-end 2025 [1][4] - The Phase 2 MoonStone trial for Relapsing Multiple Sclerosis is concluding enrollment, with topline results expected early in Q4 2025 [1][4] - The Phase 2 SunStone trial for Systemic Lupus Erythematosus is expected to complete enrollment by year-end 2025, with topline results anticipated in mid-2026 [1][4] Leadership Changes - The company has strengthened its leadership team with the appointments of Lisa von Moltke, M.D., as Head of Research and Development and Chief Medical Officer, and Haley Laken, Ph.D., as Chief Scientific Officer [1][4] Financial Position - As of March 31, 2025, Zenas BioPharma reported cash, cash equivalents, and investments totaling $314.2 million, which is expected to fund operations into Q4 2026 [1][11] - License and collaboration revenue for Q1 2025 was $10 million, attributed to a sublicense agreement with Zai Lab [11] - Research and development expenses increased to $34.9 million in Q1 2025 from $22.6 million in Q1 2024, primarily due to clinical development costs for obexelimab [11] - General and administrative expenses rose to $12.4 million in Q1 2025 from $4.9 million in Q1 2024, driven by increased personnel costs and pre-commercialization activities [11] Product Overview - Obexelimab is a bifunctional monoclonal antibody designed to inhibit B cell function without depleting them, targeting autoimmune diseases [3][7][9] - The drug has shown clinical activity in five completed trials involving 198 patients, providing initial proof of concept for its efficacy [8]

NEW YORK, May 15, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Zenas BioPharma, Inc. (NASDAQ: ZBIO).Shareholders who purchased shares of ZBIO during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/zenas-biopharma-inc-loss-submission-form/?id=148435&from=4CLASS PERIOD: This lawsuit ...

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Zenas BioPharma, Inc. due to allegations of violations of federal securities laws, specifically regarding misleading statements about the company's financial status and operational funding [3][5]. Group 1: Legal Investigation - The law firm is encouraging investors who suffered losses exceeding $75,000 in Zenas to contact them for discussing legal options [1]. - A federal securities class action has been filed against Zenas, with a deadline of June 16, 2025, for investors to seek the role of lead plaintiff [3]. - The complaint alleges that Zenas materially overstated its ability to fund operations with existing cash and expected IPO proceeds, leading to misleading public statements [5]. Group 2: Class Action Details - The lead plaintiff in the class action will be the investor with the largest financial interest who is also typical of class members [6]. - Any member of the putative class can move the court to serve as lead plaintiff or remain an absent class member without affecting their ability to share in any recovery [6]. Group 3: Additional Information - Faruqi & Faruqi encourages anyone with information regarding Zenas' conduct, including whistleblowers and former employees, to contact the firm [7]. - For more information about the class action, interested parties can visit the firm's website or contact partner Josh Wilson directly [8].

WASHINGTON, D.C., May 13, 2025 (GLOBE NEWSWIRE) -- Cohen Milstein Sellers & Toll PLLC issues the following update to investors in Zenas BioPharma, Inc. (NASDAQ: ZBIO) regarding the securities class action lawsuit filed in the U.S. District Court for the District of Massachusetts. Investors who purchased Zenas BioPharma shares pursuant and/or traceable to the company’s September 2024 initial public offering (IPO) have until June 16, 2025 to file a motion with the court to serve as lead plaintiff. [Click here ...

Core Viewpoint - A class action securities lawsuit has been filed against Zenas BioPharma, Inc. due to alleged securities fraud related to its September 2024 initial public offering [1][2]. Group 1: Lawsuit Details - The lawsuit aims to recover losses for investors who purchased Zenas BioPharma securities linked to the company's IPO [2]. - The complaint alleges that Zenas BioPharma materially overstated its ability to fund operations with existing cash and expected IPO proceeds, leading to misleading public statements [3]. Group 2: Next Steps for Investors - Investors who suffered losses in Zenas BioPharma have until June 16, 2025, to request to be appointed as lead plaintiff, although participation in any recovery does not require this [4]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [4]. Group 3: Legal Representation - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions for shareholders over the past 20 years [5].

NEW YORK, May 13, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Zenas BioPharma, Inc. ("Zenas BioPharma, Inc." or the "Company") (NASDAQ: ZBIO) of a class action securities lawsuit.CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Zenas BioPharma, Inc. investors who were adversely affected by alleged securities fraud. This lawsuit is on behalf of persons who purchased or otherwise acquired Zenas BioPharma securities pursuant and/or traceable to the registration statement ...