Zenas BioPharma (NasdaqGS:ZBIO) FY Conference September 10, 2025 07:45 AM ET Company ParticipantsLonnie Moulder - Founder and CEOConference Call ParticipantsJudah Frommer - AnalystJudah FrommerWelcome to this session of the Morgan Stanley Global Healthcare Conference. Let me read a quick disclosure before welcoming Zenas BioPharma to the stage. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please ...

Summary of Zenas BioPharma (ZBIO) 2025 Conference Call Company Overview - Zenas BioPharma is a development stage oncology company focused on autoimmune diseases, particularly with its molecule obexelimab, which is completing a global Phase 3 trial for IgG4-related disease (IgG4RD) with top-line results expected by year-end [2][22] - The company is also conducting two global Phase 2 programs: one for relapsing multiple sclerosis, with results expected in early Q4, and another for systemic lupus erythematosus (SLE), with results anticipated mid-next year [2][3] Financial Position - As of June 30, Zenas had approximately $275 million in cash, bolstered by a $300 million deal with Royalty Pharma, which extends the company's financial runway beyond the Phase 3 readout for IgG4RD [4][6] - The deal allocates $225 million specifically for the obexelimab program and IgG4RD, with additional milestones possible after Phase 3 data [4][6] Market Opportunity - The current diagnosed patient population for IgG4RD is about 20,000, with expectations that it could grow to 35,000-40,000 with a new drug on the market [8] - The company believes that the market opportunity for IgG4RD is larger than consensus estimates, which could lead to higher returns for investors [6][8] Product Differentiation - Obexelimab is engineered to target B cells differently than existing therapies, such as anti-CD20 antibodies, by removing certain aspects of the antibody that lead to B cell depletion [9][10] - The drug is designed for chronic administration, allowing for continuous inhibition of B cells, which may prevent disease flares more effectively than current therapies [15][16] - The administration method is subcutaneous and self-contained, which is expected to be more convenient for patients compared to intravenous infusions [31][32] Clinical Data and Efficacy - The Phase 3 INDIGO study for IgG4RD is the largest ever conducted for this indication, with over 190 patients enrolled [26] - The primary endpoint is the disease flare rate, with expectations based on Phase 2 data indicating a flare rate of about 10% for obexelimab compared to over 50% for the control [27][28] - The company aims to demonstrate a significant reduction in corticosteroid use and overall toxicity through its treatment regimen [28] Competitive Landscape - The anti-CD20 antibody market is substantial, accounting for nearly 60% of the market with over $10 billion in sales [37] - Zenas aims to differentiate obexelimab by addressing the ongoing disability progression in multiple sclerosis, which is not adequately managed by current therapies [44] Future Milestones - Upcoming data from the Phase 2 study for relapsing multiple sclerosis is expected soon, which will inform future development strategies [39] - The company is also exploring the potential for obexelimab in SLE, leveraging previous clinical data to support its efficacy [48] Conclusion - Zenas BioPharma is positioned to capitalize on significant market opportunities with its innovative product obexelimab, backed by strong financial support and a clear clinical development strategy aimed at addressing unmet needs in autoimmune diseases [2][4][6]

Summary of Zenas BioPharma (ZBIO) Conference Call Company Overview - **Company**: Zenas BioPharma (Ticker: ZBIO) - **Focus**: Autoimmune diseases, with a lead program on obexelimab, a novel monoclonal antibody targeting CD19 and CD32B [4][5] Key Programs and Developments - **Obexelimab**: - In-licensed from Xencor, designed to inhibit B-cell lineage cells, impacting antibody production and cytokine production [4][5] - Completed five clinical trials prior to Zenas acquiring it, including studies in rheumatoid arthritis and systemic lupus erythematosus [5] - Phase three results for IgG4-related disease expected by the end of 2025 [6][18] - Ongoing phase two global program for relapsing multiple sclerosis (RMS) with results expected early in Q4 2025 [6][42] Financial Position - **Cash Position**: Approximately $275 million as of June 30, 2025 [6] - **Strategic Collaboration**: Announced a $300 million funding deal with Royalty Pharma, with $225 million allocated for the IgG4-related disease program [6][10] Market Opportunity - **IgG4-Related Disease**: - Estimated diagnosed population of 20,000 in the U.S., with a potential market opportunity of around $3 billion [20][21] - Current treatment options are limited to corticosteroids, which are not well tolerated [14][15] - Obexelimab offers a subcutaneous self-administration option, reducing economic burden for patients [20] Clinical Trial Design and Expectations - **IgG4RD Study Design**: - Primary endpoint is time to disease flare, with a focus on reducing flare rates compared to placebo [15][16] - Previous studies showed a 60% flare rate for placebo and a single-digit flare rate for obexelimab [16][17] - **RMS Study Design**: - Phase two trial with MRI readout as the primary endpoint, focusing on cumulative new GAD-enhancing lesions [44][45] - Aims to assess neurodegeneration and disability progression, with a potential for a pivotal registration program [46] Competitive Differentiation - **Mechanism of Action**: - Obexelimab inhibits B cells rather than depleting them, allowing for a more controlled treatment approach [18][31] - Subcutaneous administration is more convenient compared to infusion therapies [19][20] - **Safety Profile**: - Well-tolerated with a potential for pausing treatment to allow for vaccination, addressing concerns raised during the pandemic [31][32] Future Plans - **Lupus Program**: - Phase two data expected mid-2026, with a focus on proper study design and patient selection to ensure robust results [56][60] - Potential to incorporate biomarker analysis into future studies [61][70] - **BLA Process**: - Initiated for IgG4-related disease, with a smaller scale compared to larger registration programs [78][79] Conclusion - Zenas BioPharma is positioned to make significant advancements in the treatment of autoimmune diseases with its lead program, obexelimab, backed by a strong financial position and strategic collaborations. The upcoming clinical trial results will be critical in validating its efficacy and market potential.

Core Insights - Royalty Pharma plc will provide up to $300 million in funding to Zenas BioPharma, in exchange for a royalty on sales of obexelimab, targeting autoimmune diseases such as IgG4-RD [1][2][3] Company Overview - Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation in the biopharmaceutical industry, collaborating with various innovators [8] - Zenas BioPharma is a clinical-stage biopharmaceutical company focused on developing transformative therapies for autoimmune diseases, with obexelimab as its lead product candidate [9] Product Development - Obexelimab is an investigational bifunctional monoclonal antibody designed to inhibit B cell function, currently in Phase 3 development for IgG4-RD and Phase 2 for Relapsing Multiple Sclerosis and Systemic Lupus Erythematosus [2][5][7] - The funding will support the development of obexelimab and a potential commercial launch for IgG4-RD in the first half of 2027, pending FDA approval [2][3][6] Financial Terms - The agreement includes an upfront payment of $75 million, with three additional payments of $75 million each contingent on specific milestones related to clinical trials and FDA approvals [3][6] - Royalty Pharma will receive a 5.5% royalty on worldwide net sales of obexelimab by Zenas and its affiliates [3]

Core Insights - Zenas BioPharma and Royalty Pharma have entered into a partnership where Royalty Pharma will provide up to $300 million in funding for the development and potential commercialization of obexelimab, a treatment for IgG4-Related Disease [1][2][3] Funding and Financial Terms - The agreement includes an initial payment of $75 million, with three additional payments of $75 million each contingent upon specific milestones: success in the Phase 3 INDIGO trial, FDA approval for IgG4-RD, and FDA approval for Systemic Lupus Erythematosus [3] - Royalty Pharma will receive a 5.5% royalty on worldwide net sales of obexelimab by Zenas and its affiliates [3] Product Development and Clinical Trials - Obexelimab is currently in Phase 3 development for IgG4-RD and Phase 2 development for Relapsing Multiple Sclerosis and Systemic Lupus Erythematosus [2][5][7] - The topline results from the pivotal Phase 3 trial for IgG4-RD are expected around the end of 2025, with a potential commercial launch in the first half of 2027, pending FDA approval [2][6] Mechanism of Action - Obexelimab is a bifunctional monoclonal antibody designed to inhibit B cell function by binding to CD19 and FcγRIIb, which are present across B cell lineage, without depleting them [5][8] Company Background - Zenas BioPharma is a clinical-stage biopharmaceutical company focused on developing therapies for autoimmune diseases, with obexelimab as its lead product candidate [8] - Royalty Pharma is a leading funder of innovation in the biopharmaceutical industry, known for acquiring royalties and co-funding late-stage clinical trials [9]

Company Overview - Zenas BioPharma, Inc. is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [2] - The company's lead product candidate, obexelimab, is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb to inhibit the activity of B cells involved in autoimmune diseases without depleting them [2] - Zenas aims to leverage its experienced leadership and disciplined product acquisition strategy to identify and develop candidates that provide superior clinical benefits for patients [2] Upcoming Events - Zenas will present at the Citi's 2025 Biopharma Back to School Conference on September 2, 2025, at 1:00 p.m. ET [3] - The company will also participate in the Cantor Global Healthcare Conference 2025 on September 3, 2025, at 8:35 a.m. ET [3] - Additionally, Zenas is scheduled to present at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 10, 2025, at 7:45 a.m. ET [3]

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 June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES Zenas BioPharma, Inc. (Exact name of registrant as specified in its charter) Delaware 93-2749244 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification N ...

Exhibit 99.1 Zenas BioPharma Reports Second Quarter 2025 Financial Results and Provides Corporate Updates - Topline results from pivotal Phase 3 INDIGO trial in Immunoglobulin G4-Related Disease expected around year-end 2025 - - Completed enrollment of Phase 2 MoonStone trial in Relapsing Multiple Sclerosis; results expected early in the fourth quarter 2025 - - Enrollment of Phase 2 SunStone trial in Systemic Lupus Erythematosus expected to be completed by year-end 2025; topline results expected mid-2026 - ...

Core Insights - Zenas BioPharma is advancing its obexelimab development program, with key clinical trials ongoing for autoimmune diseases, including the Phase 3 INDIGO trial for Immunoglobulin G4-Related Disease (IgG4-RD) and the Phase 2 MoonStone trial for Relapsing Multiple Sclerosis (RMS) [1][2][4] Clinical Trials - The Phase 3 INDIGO trial for IgG4-RD is the largest clinical trial conducted for this condition, with topline results expected around year-end 2025 [1][4] - Enrollment for the Phase 2 MoonStone trial in RMS has been completed, with results anticipated in early Q4 2025 [1][4] - The Phase 2 SunStone trial for Systemic Lupus Erythematosus (SLE) is expected to complete enrollment by year-end 2025, with topline results projected for mid-2026 [1][4] Financial Overview - As of June 30, 2025, Zenas BioPharma reported cash, cash equivalents, and investments totaling $274.9 million, which is expected to fund operations into Q4 2026 [1][4][16] - Research and development (R&D) expenses for Q2 2025 were $43.0 million, an increase from $33.8 million in Q2 2024, primarily due to higher clinical development costs for obexelimab [4][9] - General and administrative (G&A) expenses rose to $12.1 million in Q2 2025 from $5.9 million in Q2 2024, attributed to increased personnel costs and pre-commercialization activities [9][14] Product Information - Obexelimab is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, designed to inhibit B cell function without depleting them, potentially addressing chronic autoimmune diseases effectively [5][7] - The drug has shown pharmacologic activity in five completed clinical trials involving 198 subjects, indicating its potential as a potent B cell inhibitor [6]

If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries, and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth ?This is my first time covering Zenas BioPharma, Inc. (NASDAQ: ZBIO ), a Waltham, Massachusetts based biotech that completed its initial public offering ("IPO") in September last year, raising $225m via the issuance ...