Core Insights - The Meridian Small Cap Growth Fund reported a 0.90% net return in Q4 2025, underperforming the Russell 2000 Growth Index, which returned 1.22% [1] - Small caps achieved an annual return of 12.8% with a 2.2% gain in Q4 2025, indicating a positive overall market performance despite some cooling in sentiment [1] Company Highlights - Zenas BioPharma, Inc. (NASDAQ:ZBIO) is a clinical-stage biopharmaceutical company focused on autoimmune diseases, with its lead drug Obexelimab in Phase 3 trials, potentially launching in 2027 [3] - Zenas BioPharma's stock saw a one-month return of 30.78% and a remarkable 241.61% increase over the past 52 weeks, closing at $26.68 per share with a market cap of $1.432 billion on February 18, 2026 [2][3] - The company has the potential for annual revenues exceeding $1 billion, contingent on successful drug development and regulatory approval [3] Investment Sentiment - Zenas BioPharma is not among the top 30 most popular stocks among hedge funds, with 13 hedge fund portfolios holding its shares at the end of Q3 2025, unchanged from the previous quarter [4] - While Zenas BioPharma is recognized for its potential, the company is viewed as having less upside compared to certain AI stocks, which are considered to carry less downside risk [4]

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]

Market Overview - U.S. stock futures showed mixed results, with Dow futures declining by 0.2% [1] Company-Specific Movements - Jefferson Capital Inc (NASDAQ:JCAP) experienced a significant drop of 4.4%, trading at $22.00, following the announcement of a secondary offering of 10 million shares [1] - MOBIX LABS, INC. (NASDAQ:MOBX) fell sharply by 25.4% to $0.24 due to plans for a common stock offering [2] - Datavault AI Inc (NASDAQ:DVLT) shares decreased by 12.4% to $1.26 after a previous surge of 43% on Monday, linked to a nationwide deployment announcement [2] - BitVentures Ltd – ADR (NASDAQ:BVC) saw a decline of 9.7% to $13.33 after a 5% gain on Monday [2] - Zenas Biopharma Inc (NASDAQ:ZBIO) tumbled by 6.6% to $15.50 following a 52% drop on Monday due to Phase 3 trial results [2] - Theravance Biopharma Inc (NASDAQ:TBPH) dipped 6% to $17.07 after a 3% decline on Friday [2] - Graphic Packaging Holding Co (NYSE:GPK) fell 4.9% to $14.70 ahead of its fourth quarter financial results announcement [2] - ATRenew Inc (NYSE:RERE) declined by 4.1% to $5.65 after a 9% gain on Monday [2] - Rezolve AI PLC (NASDAQ:RZLV) fell 3.7% to $3.07 in pre-market trading [2] - NovaBay Pharmaceuticals Inc (NYSE:NBY) slipped 3.4% to $6.52 after a 15% jump on Monday [2] - Starfighters Space Inc (NYSE:FJET) decreased by 3.3% to $9.08 after a 10% dip on Monday [2]