Core Viewpoint - Zenas BioPharma Inc. stock is experiencing a decline despite positive results from the Phase 3 INDIGO trial of obexelimab for Immunoglobulin G4-Related Disease (IgG4-RD) [1][4]. Group 1: Trial Results - Obexelimab achieved the primary endpoint with a statistically significant 56% reduction in the risk of IgG4-RD flare compared to placebo over a 52-week period [2]. - The drug also met all four key secondary endpoints, showing significant activity in reducing investigator-assessed IgG4-RD flare, the number of flares requiring rescue therapy, the proportion of patients achieving complete remission, and the cumulative use of rescue therapy [3]. Group 2: Safety and Future Plans - Rates of infections, including Grade 3, were lower in the obexelimab group compared to placebo, with similar incidence of injection site reactions across both groups [4]. - Zenas plans to submit a Biologics License Application (BLA) for obexelimab to the FDA in Q2 2026 and a Marketing Authorization Application (MAA) to the EMA in the second half of 2026 [7]. - The company expects to report topline results from the Phase 2 SunStone trial in SLE in Q4 2026 [8]. Group 3: Competitive Landscape - Amgen's Uplizna, the first approved treatment for IgG4-RD, demonstrated an 87% reduction in flare risk compared to placebo, with 10.3% of participants experiencing a flare versus 59.7% in the placebo group [5]. - Amgen acquired Uplizna through a $27.8 billion acquisition of Horizon Therapeutics [6].

Market Overview - U.S. stocks traded higher, with the Dow Jones index gaining over 250 points, up 0.54% to 48,641.58, NASDAQ up 0.65% to 23,386.57, and S&P 500 up 0.63% to 6,901.52 [1] - Energy shares increased by 2.9% on Monday [1] Sector Performance - Consumer staples stocks dipped by 0.4% [2] Commodity Prices - Oil traded up 1.4% to $58.12, gold up 2.4% to $4,433.50, silver up 7.5% to $76.320, and copper rose 4.1% to $5.9260 [5] European Market Performance - Eurozone's STOXX 600 gained 0.5%, Spain's IBEX 35 Index rose 0.3%, London's FTSE 100 up 0.4%, Germany's DAX gained 0.2%, and France's CAC 40 climbed 0.1% [6] Asian Market Performance - Asian markets closed mostly higher, with Japan's Nikkei 225 gaining 2.97%, Hong Kong's Hang Seng Index up 0.03%, China's Shanghai Composite surging 1.38%, while India's BSE Sensex fell 0.38% [7] Company News - The FDA lifted the clinical hold on GH Research Plc's Investigational New Drug Application for GH001 [3] - Momentus Inc shares surged 94% to $11.14 after announcing the development of an additive-manufactured fuel tank [9] - TMD Energy Ltd shares increased by 76% to $0.78 [9] - VerifyMe Inc shares rose 40% to $0.94 following a strategic merger announcement [9] - Zenas Biopharma Inc shares dropped 55% to $15.54 after Phase 3 trial results [9] - Signing Day Sports Inc shares fell 37% to $0.60, and Lavoro Ltd shares decreased by 26% to $0.82 [9]

Summary of Zenas BioPharma Conference Call Company Overview - **Company**: Zenas BioPharma (NasdaqGS: ZBIO) - **Focus**: Development of obexelimab for the treatment of immunoglobulin G4-related disease (IgG4-RD) Key Industry Insights - **Disease Prevalence**: Estimated diagnosed prevalence of IgG4-RD in the U.S. is around 20,000 patients, with total prevalence (including undiagnosed) potentially reaching 40,000. Similar global prevalence is suggested [doc id='9'] - **Market Opportunity**: The market opportunity for IgG4-RD treatment is approximately $3 billion in the U.S. and $2 billion in Europe, with over half of diagnosed patients experiencing frequent flares [doc id='17'] Core Findings from INDIGO Trial - **Trial Results**: The INDIGO trial met its primary endpoint, showing a 56% reduction in the risk of IgG4-RD flare compared to placebo, with a hazard ratio of 0.443 and a p-value of 0.0005 [doc id='12'] - **Secondary Endpoints**: All four key secondary endpoints were met, including time to first flare and the proportion of patients achieving complete remission [doc id='13'] - **Safety Profile**: Obexelimab demonstrated a compelling safety and tolerability profile, with lower incidences of serious adverse events and infections compared to placebo [doc id='15] Treatment Advantages - **Mechanism of Action**: Obexelimab's unique inhibitory mechanism targets B-cells without depleting them, which may provide advantages over existing therapies like Uplizna [doc id='16'] - **Administration**: The drug is administered subcutaneously at home, aligning with patient preferences and reducing the need for infusion center visits [doc id='16'] - **Cost-Effectiveness**: The at-home administration model may lead to lower out-of-pocket costs for patients compared to high-priced infused therapies [doc id='17'] Future Plans - **Regulatory Submissions**: Plans to submit a Biologics License Application (BLA) to the U.S. FDA in Q2 and a marketing authorization application to the European Medicines Agency in the second half of the year [doc id='6'] - **Pipeline Expansion**: Zenas is advancing multiple candidates, including orelabrutinib and ZBO21, into clinical trials, aiming to establish a strong portfolio in autoimmune diseases [doc id='19'] Market Dynamics - **Underdiagnosis**: IgG4-RD is currently underdiagnosed, and the approval of obexelimab could enhance disease recognition and treatment [doc id='18'] - **Competitive Landscape**: The efficacy and safety profile of obexelimab positions it as a potential first-line therapy, especially for older patients who may not tolerate B-cell depletion [doc id='24'] Additional Insights - **KOL Feedback**: Key opinion leaders expressed enthusiasm for obexelimab's efficacy and safety, viewing it as a strong candidate for first-line treatment [doc id='23'] - **Payer Discussions**: Preliminary conversations with payers indicate a favorable view of obexelimab's risk-benefit profile, especially in comparison to existing therapies [doc id='49'] Conclusion - **Transformational Year**: 2025 was highlighted as a transformational year for Zenas, with the INDIGO results expected to drive momentum into 2026 and beyond [doc id='18']

Zenas BioPharma said on Monday its experimental drug cut the risk of disease flare-ups in a late-stage study of patients with a rare immune system-related condition that can damage organs over time. ...

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): January 5, 2026 ZENAS BIOPHARMA, INC. 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 un ...

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]

Group 1: Palvella Therapeutics Inc. (PVLA) - Palvella is a clinical-stage biopharmaceutical company focused on developing therapies for rare diseases with no FDA-approved treatments [2] - Its lead product, QTORIN rapamycin, targets microcystic lymphatic malformations and has a multi-billion-dollar market opportunity if approved [2] - The stock rose from $25 on March 10, 2025, to a 52-week high of $114.69 on December 22, 2025, before pulling back to $99.88 [3] Group 2: Cidara Therapeutics Inc. (CDTX) - Cidara is developing a preventive therapy for influenza and has agreed to be acquired by Merck for $221.50 per share, totaling approximately $9.2 billion [4] - The stock was trading at $18.98 when profiled on November 21, 2024 [4] Group 3: Celcuity Inc. (CELC) - Celcuity is focused on targeted therapies for oncology, with its lead drug candidate Gedatolisib aimed at breast and prostate cancers [5] - The stock increased from $12.60 on December 4, 2024, to an all-time high of $112.64 on December 12, 2025, before retreating to $99.16 [6] Group 4: Nanobiotix (NBTX) - Nanobiotix is a late-stage clinical biotechnology company developing physics-based therapies for cancer [7] - Its lead candidate, NBTXR3, is undergoing a phase III study for head and neck squamous cell carcinoma, with interim data expected in the first half of 2027 [8] - The stock rose from $12.23 on September 19, 2025, to a high of $30.35 on October 13, 2025, before trading around $21 [10] Group 5: Terns Pharmaceuticals Inc. (TERN) - Terns Pharma is developing small-molecule candidates for serious diseases, with TERN-701 targeting chronic myeloid leukemia [12] - Recent data showed a 75% major molecular response rate among patients receiving higher doses [13] - The stock increased from $5.98 on August 6, 2025, to an all-time high of $48.26 on December 10, 2025, before pulling back to around $40 [14] Group 6: DBV Technologies S.A. (DBVT) - DBV Technologies is developing an epicutaneous immunotherapy for food allergies, with its lead product, the VIASKIN Peanut patch, showing positive results in a phase 3 study [15] - The company aims to submit a Biologics License Application in the first half of 2026, with potential sales of $1.5 billion by 2030 if approved [15] - The stock rose from $10.64 on October 2, 2025, to a high of $26.18 on December 17, 2025, before trading around $19 [16] Group 7: Nutex Health Inc. (NUTX) - Nutex Health reported a significant turnaround from a $424 million net loss in 2022 to a $59 million net income for the nine months ended September 30, 2025 [17] - Revenue increased from $219 million in 2022 to $723.6 million in the first nine months of 2025 [17] - The stock rose from $33.56 on November 25, 2024, to a 52-week high of $193.07 before closing at $182.23 [18] Group 8: Inhibrx Biosciences Inc. (INBX) - Inhibrx is developing biologic therapies for cancer, with Ozekibart showing significant improvement in progression-free survival in chondrosarcoma [19] - The company plans to submit a biologics license application for Ozekibart in the second quarter of 2026 [20] - The stock rose from $18.35 on July 8, 2025, to an all-time high of $94.57 on December 22, 2025, before trading around $77 [21] Group 9: GRAIL Inc. (GRAL) - GRAIL focuses on early cancer detection with its Galleri test, which is not yet FDA-approved [23] - The company expects to submit a PMA for the Galleri test in Q1 2026 [23] - The stock increased from $48.50 on September 26, 2025, to a high of $115.76 on November 25, 2025, before trading around $88 [24] Group 10: Cogent Biosciences Inc. (COGT) - Cogent is developing precision therapies for genetically defined diseases, with Bezuclastinib being its lead candidate [25] - The company submitted its first NDA to the FDA for Non-AdvSM, with additional submissions planned for GIST and advanced systemic mastocytosis [26] - The stock rose from $7.25 on July 2, 2025, to a 52-week high of $43.73 on December 8, 2025, before easing back to around $35 [26] Group 11: Sol-Gel Technologies Ltd. (SLGL) - Sol-Gel has two FDA-approved products for dermatological conditions and is developing investigational products [27] - A phase III trial for SGT-610 is ongoing, with results expected in Q4 2026 [28] - The stock rose from $7.26 on May 7, 2025, to a high of $52.26 on October 6, 2025, before trading around $43 [28] Group 12: Zenas BioPharma Inc. (ZBIO) - Zenas is focused on therapies for autoimmune diseases, with Obexelimab in phase 3 trials for IgG4-RD [29] - Positive data from a phase 2 trial in multiple sclerosis showed a 95% reduction in new lesions [30] - The stock rose from $8.79 on December 17, 2024, to a high of $44.60 on December 24, 2025, before pulling back to around $35 [31]

Core Insights - Zenas BioPharma, Inc. (NASDAQ: ZBIO) is a clinical-stage global biopharmaceutical company focused on developing innovative therapies for patients with unmet medical needs [1] - Citigroup maintains a "Buy" rating for ZBIO, indicating confidence in the company's future performance [1][5] Stock Options and Employee Incentives - Zenas BioPharma granted non-qualified stock options covering 300,000 shares to two new employees, with an exercise price of $32.59 per share [2] - The stock options have a ten-year term and will vest over four years, with 25% vesting after one year [3] - This strategy aims to retain talent and align employee interests with company performance [3] Stock Performance and Market Activity - ZBIO's stock price has increased by 3.08%, reaching $36.15, reflecting positive market sentiment [3][5] - The stock has shown significant volatility, with a daily trading range between $35.25 and $37.97 [4] - Over the past year, the stock fluctuated from a low of $5.83 to a high of $41.50, with a current market capitalization of approximately $1.51 billion [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]

Core Insights - Zenas BioPharma (ZBIO) stock has experienced significant positive momentum, increasing by 395% year-to-date and outperforming the S&P index [1] Company Overview - Zenas BioPharma has two late-stage assets, specifically obexelimab, which are critical to its growth strategy [1] Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, which informs their investment analysis in the biotech sector [1] - The analyst has been active in the investing space for five years, focusing on identifying promising biotechnology companies with innovative approaches [1] Investment Focus - The investment strategy emphasizes evaluating the science behind drug candidates, the competitive landscape, clinical trial design, and potential market opportunities [1] - The goal is to provide insights that help investors understand both opportunities and risks in the biotech sector, which is characterized by breakthrough science and potential for high returns [1]