Summary of Zenas BioPharma Conference Call Company Overview - **Company**: Zenas BioPharma (NasdaqGS: ZBIO) - **Event**: Guggenheim Emerging Outlook Biotech Summit 2026 - **Date**: February 11, 2026 Key Points on IgG4-RD and Obexelimab - **Pipeline Focus**: The primary focus is on obexelimab and its application in IgG4-related disease (IgG4-RD) [2][3] - **INDIGO Phase 3 Study Results**: - Reported a **56% risk reduction** in time to disease flare with a hazard ratio of **0.4** [3] - Approximately **75% of patients** were free from flares, indicating strong efficacy [3] - In the open-label extension, **92% of evaluable patients** remained flare-free at six months [4] - **Safety Profile**: - Serious adverse events were comparable to placebo, with no significant increase in infections [4][5] - The subcutaneous administration showed similar injection site reactions to placebo, enhancing its safety profile [5] Market Research Insights - **Market Research Study**: Conducted with **80 participants**, primarily rheumatologists and gastroenterologists [6] - **Prescribing Likelihood**: - **64%** of physicians indicated they would likely prescribe obexelimab [8] - Expected market share allocation: **47%** for obexelimab, with the remainder split between Uplizna and rituximab [8] - **Patient Population Insights**: - Physicians reported treating an average of **18 patients** per year with IgG4-RD [6] - The drug is seen as suitable for older patients or those with concurrent illnesses [9] Commercialization Strategy - **Market Opportunity**: Estimated market size for IgG4-RD treatment in the U.S. is between **$3-$4 billion**, with expectations for obexelimab to exceed **$1 billion** in sales [41][42] - **Patient Population**: Approximately **20,000 diagnosed patients** in the U.S. currently, with potential for growth through increased education and diagnosis [40] - **Launch Timeline**: - BLA filing expected in **Q2 2026** for the U.S. and in the second half of the year for Europe [56] - Initial launch will feature prefilled syringes, followed by an autoinjector within a year [56] Lupus Program Insights - **Sunstone Study**: - Results expected in **Q4 2026**, focusing on the **BICLA primary endpoint** [62] - Emphasis on strict screening criteria to ensure a pure patient population for accurate results [65] - **Biomarker Program**: A gene pattern identified in **30% of lupus patients** may indicate higher responsiveness to treatment [80] BTK Inhibitor Insights - **Orelibrutinib**: Positioned as a potent option for progressive MS, with ongoing trials to demonstrate its efficacy [90] - **Comparison with Competitors**: Fenebrutinib showed promising results compared to Ocrevus, indicating a competitive landscape for BTK inhibitors [88] Future Developments - **New Molecules**: - TYK2 and IL-17 oral molecules are set to enter clinical trials soon, with promising characteristics noted [95][97] - **Rapid Development**: The IL-17 molecule is expected to move quickly through clinical phases, with outcomes anticipated by the end of the year [97] Conclusion - Zenas BioPharma is positioned to capitalize on its robust pipeline, particularly with obexelimab for IgG4-RD, and is preparing for significant market entry and expansion in the coming years. The company is also actively pursuing additional indications, including lupus and progressive MS, with a focus on safety and efficacy in patient populations.

Core Insights - Obexelimab demonstrated a 95% relative reduction in new gadolinium-enhancing T1 lesions compared to placebo in the Phase 2 MoonStone trial, indicating significant efficacy in treating Relapsing Multiple Sclerosis (RMS) [1][2] - The 24-week data further confirmed the drug's robust and durable activity, maintaining significant reductions in lesions and improving biomarkers associated with disease activity [3][4] - The safety profile of obexelimab was consistent with previous trials, showing good tolerability without new safety signals [2][3] Company Overview - Zenas BioPharma, Inc. is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [12] - The company is advancing two late-stage product candidates: obexelimab and orelabrutinib, with obexelimab being the lead candidate targeting B cell activity [12] - Zenas plans to submit a Biologics License Application (BLA) for obexelimab in the second quarter of 2026 and a Marketing Authorization Application (MAA) in the second half of 2026 for Immunoglobulin G4-Related Disease [11][12] Clinical Trial Details - The Phase 2 MoonStone trial enrolled 116 patients and was designed to evaluate the efficacy and safety of obexelimab in RMS, using MRI endpoints to measure treatment outcomes [9] - The trial's primary endpoint was the cumulative number of new gad-enhancing T1 lesions over weeks 8 and 12, with secondary endpoints assessing disease progression through various biomarkers [9] - Following the double-blind phase, patients transitioned to an open-label period to continue treatment and assess long-term outcomes [9] Mechanism of Action - Obexelimab is a bifunctional monoclonal antibody that binds to CD19 and FcγRIIb, inhibiting B cell activity without depleting them, which is crucial for addressing autoimmune diseases [10][12] - The drug's unique mechanism and self-administered subcutaneous injection regimen may effectively target the pathogenic role of B cells in chronic autoimmune conditions [10][12]

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 Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Zenas BioPharma, Inc. and its officers or directors, following disappointing results from a clinical trial that negatively impacted the company's stock price [1][3]. Group 1: Company Overview - Zenas BioPharma, Inc. is a publicly traded company on NASDAQ under the ticker ZBIO [1]. - The company recently announced results from the Phase 3 INDIGO trial of its drug obexelimab for Immunoglobulin G4-Related Disease (IgG4-RD) [3]. Group 2: Trial Results and Market Reaction - The trial results were characterized as "positive" by Zenas; however, analysts indicated that the drug's efficacy did not meet the necessary threshold for commercial viability [3]. - Following the announcement, Zenas's stock price dropped by $17.89 per share, or 51.86%, closing at $16.61 on January 5, 2026 [3]. - On a subsequent conference call, the CEO expressed disappointment regarding the drug's hazard ratio, which did not meet expectations, leading to an additional stock price decline of $1.41 per share, or 8.49%, closing at $15.20 on January 6, 2026 [4].

Core Viewpoint - Zenas BioPharma, Inc. is under investigation for potential securities fraud following disappointing results from a clinical trial, which led to significant stock price declines [1][2][3]. Group 1: Company Overview - Zenas BioPharma, Inc. trades on NASDAQ under the ticker ZBIO [1]. - The company recently announced results from the Phase 3 INDIGO trial of obexelimab for Immunoglobulin G4-Related Disease (IgG4-RD) [2]. Group 2: Trial Results and Market Reaction - The trial results were characterized as "positive" by Zenas, but analysts indicated that the drug's efficacy did not meet the necessary threshold for commercial viability [2]. - Following the announcement, Zenas's stock price dropped by $17.89 per share, or 51.86%, closing at $16.61 on January 5, 2026 [2]. - On a subsequent conference call, the CEO expressed disappointment regarding the hazard ratio, which did not meet expectations, resulting in an additional stock price decline of $1.41 per share, or 8.49%, closing at $15.20 on January 6, 2026 [3].

Core Viewpoint - The conference call discusses the top line results of the Phase III INDIGO trial for obexelimab, aimed at treating immunoglobulin G4-related disease (IgG4-RD) [2]. Group 1: Company Overview - Zenas Biopharma is conducting a registrational Phase III trial for obexelimab, which targets IgG4-RD [2]. - The call is being recorded and will be available for replay on the company's website [1]. Group 2: Forward-Looking Statements - The presentation includes forward-looking statements regarding expectations or predictions of future events and performance [3]. - These statements are subject to risks and uncertainties that may lead to actual results differing from those anticipated [3].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Zenas BioPharma, Inc. following a significant drop in stock price after the announcement of Phase 3 trial results for obexelimab [1][3]. Group 1: Company Overview - Zenas BioPharma, Inc. (NASDAQ: ZBIO) is currently under investigation for possible securities fraud [1]. - The company recently announced results from the Phase 3 INDIGO trial of obexelimab for Immunoglobulin G4-Related Disease (IgG4-RD) [3]. Group 2: Financial Impact - Following the announcement of the trial results, Zenas's stock price decreased by $17.89 per share, representing a decline of 51.86%, closing at $16.61 per share on January 5, 2026 [3]. Group 3: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [4].

Core Insights - Zenas BioPharma's phase III INDIGO study for obexelimab in treating IgG4-related disease has met its primary endpoint, showing a significant reduction in flare risk [1][2][7] Study Results - Obexelimab demonstrated a 56% reduction in the risk of IgG4-RD flare compared to placebo over a 52-week period, achieving the primary endpoint of the INDIGO study [2][7] - The treatment also showed significant efficacy across four key secondary endpoints, including reductions in investigator-assessed flares and the number of flares requiring rescue therapy [3][7] Market Reaction - Despite the positive study results, Zenas BioPharma's shares fell by 51.9% on January 5, indicating that the efficacy data may not have met investor expectations [4][7] Future Plans - The company plans to submit a biologics license application to the FDA for obexelimab in Q2 2026 and a marketing authorization application to the European Medicines Agency in the second half of 2026 [5][7] Ongoing Development - Zenas BioPharma is also exploring obexelimab for other autoimmune diseases, with ongoing studies for systemic lupus erythematosus and multiple sclerosis [8][9] - The company is focused on the successful development of obexelimab and other pipeline candidates, as it currently lacks a marketed product [10] Stock Performance - Over the past six months, Zenas BioPharma's shares have increased by 69.7%, outperforming the industry average rise of 21.5% [6]

Core Viewpoint - Zenas BioPharma's shares dropped over 50% following the Phase 3 results for obexelimab in patients with immunoglobulin G4-related disease, as efficacy metrics did not meet market expectations, leading to a significant stock repricing [1][2]. Group 1: Trial Results and Market Reaction - The Phase 3 trial showed a meaningful reduction in flare risk, but the overall efficacy metrics fell short of what the market anticipated, resulting in a sharp decline in stock price [1][2]. - The stock's cyclical positioning indicated elevated risk prior to the trial results, which explains the aggressive selloff [2]. Group 2: Adhishthana Framework Analysis - Zenas BioPharma is currently in Phase 2 of its 18-phase Adhishthana cycle, which is characterized by two segments: the Sankhya period (consolidation and volatility) and the Buddhi period (sustained upside moves) [3]. - The stock's initial rally during the Sankhya period was atypical, as premature rallies in this phase are often unstable and corrected quickly [4][6]. Group 3: Future Outlook and Investment Strategy - Despite the significant decline, caution is advised as Zenas remains in the Sankhya period, with high volatility expected until a transition to the Buddhi phase occurs [7][12]. - Deviations during Phase 2 can impair the quality of any subsequent Buddhi move, suggesting that anticipated rallies may not materialize, supporting a wait-and-watch approach [8][9]. - The recent downgrade from Morgan Stanley aligns with the deteriorating risk profile of the stock, indicating latent structural risks not immediately visible through fundamentals [9][10].

Core Insights - The analysis highlights significant price declines among three companies, emphasizing the volatility in the biotech and technology sectors [1][4][5] Company Summaries Zenas BioPharma Inc. (NASDAQ:ZBIO) - Experienced a -57.30% drop in stock price, falling to $14.73, following the Phase 3 INDIGO trial results for obexelimab despite positive outcomes [1][5] - The market's negative reaction indicates the unpredictable nature of biotech investments [5] Signing Day Sports, Inc. (SGN) - Stock price decreased to $0.51, reflecting a -46.30% change [2] - The company announced an opportunity in AI and HPC infrastructure with BlockchAIn Digital Infrastructure, but competitive pressures and operational challenges may have contributed to the decline [2] Shineco, Inc. (SISI) - Experienced a -37.16% drop, with stock price falling to $0.18 [3] - The company saw a 6.8% decline during mid-day trading, despite a 99% reduction in trading volume, suggesting market competition and regulatory challenges in China's sectors may be impacting its performance [3] Market Trends - The significant price movements among these companies underscore the stock market's volatility, particularly in the biotech and technology sectors [4] - Investors must consider clinical trial outcomes, regulatory decisions, and competitive pressures when making informed decisions in this rapidly changing landscape [4]