Core Viewpoint - Zenas BioPharma, a clinical-stage biopharmaceutical company, has announced the pricing of a $200 million public offering of convertible senior notes and a $100 million equity offering, aiming to raise approximately $287.5 million in net proceeds to support its product development and commercialization efforts [1][2]. Group 1: Offerings Details - The company is offering $200 million in 2.50% convertible senior notes due 2032 and 5 million shares of common stock at $20.00 per share [1]. - The net proceeds from both offerings are estimated to be around $287.5 million after deducting underwriting discounts and expenses [2]. - The offerings are expected to close on March 31, 2026, subject to customary closing conditions [3]. Group 2: Convertible Notes Characteristics - The convertible notes will be unsecured senior obligations, accruing interest at 2.50% per year, with a maturity date of April 1, 2032 [4]. - Noteholders can convert their notes under certain conditions, with an initial conversion rate of 37.7358 shares per $1,000 principal amount, equating to a conversion price of approximately $26.50 per share [5]. - The notes are redeemable at the company's option after April 8, 2030, under specific conditions related to the stock price [6]. Group 3: Use of Proceeds - The company intends to use the proceeds to support the U.S. commercial launch of obexelimab for IgG4-RD treatment, advance its development pipeline, and for general corporate purposes [8]. Group 4: Company Overview - Zenas BioPharma focuses on developing transformative therapies for autoimmune diseases, with key products including obexelimab and orelabrutinib [13]. - Obexelimab is designed to inhibit pathogenic B cells without depleting them, while orelabrutinib targets B cells in both peripheral and central nervous systems [13].

Core Viewpoint - Zenas BioPharma, a clinical-stage biopharmaceutical company, has initiated underwritten public offerings for convertible senior notes due 2032 and shares of its common stock to support its commercial launch and development pipeline for autoimmune disease therapies [1][5]. Offering Details - The company is offering convertible senior notes with a maturity date of April 1, 2032, and will pay interest semi-annually [4]. - Underwriters will have a 30-day option to purchase an additional 15% of the convertible notes and shares of common stock to cover over-allotments [2]. Use of Proceeds - The net proceeds from the offerings are intended to support the U.S. commercial launch of obexelimab for IgG4-RD treatment, advance the development pipeline, and cover working capital and general corporate purposes [5]. Company Overview - Zenas BioPharma focuses on developing transformative therapies for autoimmune diseases, with lead candidates including obexelimab and orelabrutinib [10]. - Obexelimab is designed to inhibit pathogenic B cells without depleting them, while orelabrutinib targets B cells in both peripheral and central nervous systems [10].

Core Insights - Zenas BioPharma is preparing to submit marketing applications for obexelimab for IgG4-RD to the FDA in Q2 2026 and to the EMA in H2 2026, following positive Phase 3 INDIGO trial results [1][4] - The company anticipates topline results from the Phase 2 SunStone trial for systemic lupus erythematosus (SLE) in Q4 2026 [1][4] - Zenas has secured up to $250 million in non-dilutive debt financing from Pharmakon, enhancing its financial flexibility for commercialization and pipeline investments [1][6] Corporate Highlights - Obexelimab is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, showing a 56% reduction in IgG4-RD flare risk compared to placebo in the INDIGO trial [4][12] - The company is advancing multiple pipeline programs, including orelabrutinib for multiple sclerosis (MS) and ZB021, an oral IL-17AA/AF inhibitor, with Phase 1 trials expected to start in Q2 2026 [2][3][7] - ZB014, a new half-life extended anti-CD-19 and FcγRIIb antibody, is also progressing toward clinical development [3][4] Financial Results - For the year ended December 31, 2025, Zenas reported revenue of $10 million, primarily from a license agreement, compared to $5 million in 2024 [10][11] - Research and development expenses increased to $168.1 million in 2025 from $139.1 million in 2024, driven by higher personnel and clinical trial costs [13][21] - The net loss for the year was $377.7 million, compared to a net loss of $157.0 million in 2024 [13][21] Balance Sheet - As of December 31, 2025, the company had cash, cash equivalents, and investments totaling $360.5 million, up from $350.8 million in 2024 [22] - Total liabilities increased to $141.5 million from $57.5 million in 2024, reflecting the new debt facility [22] - The accumulated deficit reached $765.1 million as of December 31, 2025, compared to $387.4 million in 2024 [22]

Core Insights - Zenas BioPharma, Inc. is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [3] - The company will present at the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 11, 2026 [1] Company Overview - Zenas aims to lead in the development and commercialization of therapies for autoimmune diseases, leveraging an experienced leadership team and a disciplined product candidate acquisition strategy [3] - The company is advancing two late-stage product candidates: obexelimab and orelabrutinib [3] - Obexelimab is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, designed to inhibit pathogenic B cells without depleting them [3] - Orelabrutinib is a selective CNS-penetrant oral small molecule BTK inhibitor that targets pathogenic B cells in both peripheral and central nervous systems [3] - Zenas also has earlier stage programs, including ZB021, an oral IL-17AA/AF inhibitor, and ZB022, a brain-penetrant TYK2 inhibitor [3]

Core Insights - Zenas BioPharma announced positive results from the Phase 3 INDIGO trial of obexelimab, showing a 56% reduction in the risk of IgG4-RD flare compared to placebo, with a Hazard Ratio of 0.44 and p=0.0005 [1][2] - Obexelimab demonstrated statistically significant activity on all four key secondary efficacy endpoints, including reduction in flares requiring rescue therapy and the proportion of patients achieving complete remission [1][2] - The company plans to submit a Biologics License Application (BLA) to the FDA in Q2 2026 and a Marketing Authorization Application (MAA) to the EMA in H2 2026 [1][2] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing therapies for autoimmune diseases [15] - The company is advancing two late-stage product candidates: obexelimab and orelabrutinib, with obexelimab being the lead candidate targeting IgG4-RD [15] - Zenas aims to address the unmet medical needs of patients with autoimmune diseases through innovative therapies [15] Clinical Trial Details - The Phase 3 INDIGO trial enrolled 194 patients and was designed to evaluate the safety and efficacy of obexelimab over a 52-week period [10] - The primary endpoint was the time to first IgG4-RD flare requiring rescue therapy, with key secondary endpoints including the number of flares and the cumulative use of rescue therapy [11][12] - Obexelimab was well tolerated, with lower rates of infections and similar incidence of injection site reactions compared to placebo [1][2] Future Developments - Zenas expects to report topline results from the Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE) in Q4 2026 [4] - The company is also studying orelabrutinib in a global Phase 3 trial for Primary Progressive Multiple Sclerosis (PPMS) and plans to initiate a trial for non-active Secondary Progressive Multiple Sclerosis (naSPMS) in Q1 2026 [4] - Zenas is preparing to initiate Phase 1 clinical development for two additional product candidates, ZB021 and ZB022, in 2026 [4]

Core Insights - Orelabrutinib is the first BTK inhibitor to show significant clinical activity in a Phase 2 clinical trial for Systemic Lupus Erythematosus (SLE) [1] - Zenas BioPharma has acquired exclusive rights to develop, manufacture, and commercialize orelabrutinib for Multiple Sclerosis (MS) globally, and for non-oncology fields outside Greater China and Southeast Asia [1][5] Clinical Trial Results - In the Phase 2b study, 187 patients were randomized into three groups: orelabrutinib 75 mg once-daily, orelabrutinib 50 mg once-daily, and placebo [2] - The primary endpoint, SLE Response Index-4 (SRI-4) response rate at week 48, was met with the 75 mg group showing a response rate of 57.1% compared to 34.4% for placebo (p < 0.05) [2] - Secondary endpoints, including SRI-6 and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rates, were also significantly higher in the 75 mg group compared to placebo (p < 0.05) [3] Safety and Tolerability - Orelabrutinib was well tolerated, exhibiting a safety profile consistent with BTK inhibition and the disease biology of SLE [3] Development Pipeline - Zenas is advancing orelabrutinib into a Phase 3 trial for Primary Progressive MS (PPMS) and plans to initiate a Phase 3 trial for Secondary Progressive MS (SPMS) in Q1 2026 [6] - Orelabrutinib is already approved for B cell malignancies in mainland China and Singapore, marketed by InnoCare [6] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [7] - The company is advancing two late-stage molecules: obexelimab and orelabrutinib, with obexelimab being a bifunctional monoclonal antibody targeting CD19 and FcγRIIb [7][8]

Summary of Zenas BioPharma Conference Call - October 08, 2025 Company Overview - **Company**: Zenas BioPharma (NasdaqGS: ZBIO) - **Industry**: Biopharmaceuticals, focusing on autoimmune diseases and multiple sclerosis Key Points Collaboration with Innocare Pharma - Zenas BioPharma announced a transformational global collaboration with Innocare Pharma, a fully integrated biopharmaceutical company [6][8] - The collaboration includes an upfront payment of $35 million in cash and 5 million shares of Zenas common stock [6] - Additional payments of $25 million and 2 million shares will be made upon the first patient treated in the Phase III study for secondary progressive multiple sclerosis (SPMS) [7] Pipeline and Product Candidates - Zenas has a differentiated pipeline with potential best-in-class molecules targeting autoimmune diseases, including relabrutinib for multiple sclerosis [6][8] - The company aims to launch three best-in-class franchise molecules across five indications in three therapeutic areas by 2031 [55] - The pipeline includes: - **Arelobrutinib**: A BTK inhibitor in Phase III trials for primary progressive multiple sclerosis (PPMS) and SPMS [10][25] - **Abexolumab**: Focused on IgG4-related disease, with Phase III results expected by year-end [33][55] - **ZB021**: An oral IL-17 targeting small molecule expected to enter clinical trials in 2026 [31] - **ZB022**: A brain-penetrant TYK2 inhibitor also anticipated to enter clinical trials in 2026 [31] Market Opportunity - The market for progressive multiple sclerosis is estimated at approximately $12 billion in potential peak sales in the U.S. alone [27][29] - The global multiple sclerosis market is projected to exceed $30 billion by 2030, with progressive forms representing over 40% of that market [29] Clinical Data and Efficacy - Arelobrutinib has shown promise in addressing disability progression in progressive MS patients, with a unique mechanism of action targeting both peripheral and central nervous system inflammation [12][28] - The Phase II trial for arelobrutinib demonstrated a greater than 90% reduction in new lesions compared to placebo [21] - The safety profile of arelobrutinib is consistent with other BTK inhibitors, with treatment emergent adverse events observed in 53% of the population [23] Regulatory Path and Future Trials - Phase III protocols for both PPMS and SPMS have been cleared by the FDA and EMA, with the first site for the PPMS study initiated in the U.S. [25][29] - The company is focused on regulatory alignment and is prepared to adapt to evolving regulatory endpoints for relapsing MS [90] Financial Position and Strategy - Zenas BioPharma has completed major financings and significantly advanced its pipeline, positioning itself as a fully integrated commercial-stage biopharmaceutical company [55] - The company emphasizes its strong financial position and global development capabilities to execute its vision [55] Conclusion - Zenas BioPharma is poised for significant growth with its strategic collaboration, robust pipeline, and focus on addressing unmet needs in autoimmune diseases, particularly in multiple sclerosis [55]

InnoCare Collaboration - Zenas BioPharma has a collaboration agreement with InnoCare Pharma, a biopharmaceutical company with a market cap exceeding $4.5 billion USD, two marketed products, and over 10 candidates in clinical development[9] - InnoCare will receive global rights to Orelabrutinib and ZB022, and global rights to ZB021 excluding China and Southeast Asia, while retaining global rights to Orelabrutinib in oncology indications[11] - Zenas will receive $35 million USD in cash and 5 million shares of Zenas common stock upfront from InnoCare[11] - Zenas is eligible for up to an additional 2 million shares of Zenas stock and up to $240 million USD in development and regulatory milestone payments for Orelabrutinib, as well as commercial sales milestone payments and tiered royalties on net sales[11] Orelabrutinib (BTKi) Program - A Phase 3 PPMS registration-directed trial has been initiated in the U S for Orelabrutinib, with a Phase 3 SPMS registration-directed trial expected to initiate in Q1 2026[11] - Orelabrutinib treatment in a Phase 2 RRMS trial resulted in a significant reduction in new GdE+ T1 lesions, with a >90% reduction observed at the 80mg QD dose at week 12 (P=0 0018)[48] - The global MS market is expected to exceed $30 billion USD, with SPMS and PPMS representing >$12 billion USD[61] Pipeline Programs - IND clearance and enrollment of the first patient for ZB021, an oral IL-17AA/AF inhibitor, and ZB022, a brain penetrant TYK2 inhibitor, are expected in 2026[11] - The anti-IL-17 biologics market is currently a $10 billion USD global market with ~50% average annual growth since first approval[74] Obexelimab Program - Phase 3 INDIGO trial for IgG4-RD is fully enrolled with topline results expected around year-end 2025[83] - Phase 2 MoonStone trial for RMS is fully enrolled with (12-week) data expected early Q4 2025[83] - Phase 2 SunStone trial for SLE is enrolling with (24-week) data expected mid-2026[83] - Obexelimab represents a compelling $1 billion+ USD commercial revenue opportunity in the U S alone for IgG4-RD[120]