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]

Summary of Zenas BioPharma FY Conference Call Company Overview - **Company**: Zenas BioPharma (NasdaqGS: ZBIO) - **Date of Conference**: December 03, 2025 Key Accomplishments in 2025 - Completion of patient enrollment in the Phase III trial for obexelimab targeting IgG4-related disease, with last patient out in November [2][5] - Successful enrollment in a lupus study, with results expected in Q3 of the following year [3][5] - Significant results from the MOONSTONE Global Phase II study in relapsing multiple sclerosis (RMS), showing a 95% reduction in new T1 GAD-enhancing lesions compared to placebo [4][5] - Expansion of the pipeline with the acquisition of orelabrutinib, now in Phase III trials for progressive MS [4][5] - Partnership with Royalty Pharma for a potential $300 million financing related to obexelimab [5] Clinical Trials and Data Insights - The MOONSTONE study involved 116 patients and demonstrated a new benchmark for B-cell targeting agents in RMS [3][4] - Upcoming 24-week data from the MOONSTONE study will provide insights into various parameters, including T1 GAD-enhancing lesions and biomarkers [10][11] - Discussion on regulatory pathways for RMS trials, emphasizing the need for evolving endpoints beyond annualized relapse rates [14] Market Opportunities - Estimated 20,000 to 40,000 diagnosed patients in the U.S. for IgG4-related disease, with a potential market size based on competitive drug pricing exceeding $250,000 annually [23][24] - Observations on the competitive landscape, noting the successful launch of a competing drug with sales growth from mid-$20 million to over $40 million in the first two quarters [25] Future Expectations - Anticipation of Phase II SUNSTONE results for lupus, aiming for a significant difference from placebo [26][27] - Plans to integrate findings from the lupus study into the broader rheumatology franchise [27] Differentiation of Products - Obexelimab is positioned as a more flexible treatment option compared to continuous B-cell depleting therapies, with at-home auto-injector capabilities [20][21] - Orelabrutinib is highlighted as a best-in-class BTK inhibitor, with superior brain penetration and potency compared to competitors [28][29] Conclusion - Zenas BioPharma has made significant strides in 2025, with promising clinical trial results and strategic partnerships that position the company for future growth in the biopharmaceutical market. The focus on innovative treatment options and market opportunities in IgG4-related disease and lupus reflects a strong potential for success in upcoming years.

Meridian Funds, managed by ArrowMark Partners, released its third-quarter 2025 investor letter for the “Meridian Small Cap Growth Fund.” A copy of the letter can be downloaded here. Driven by continued gains in technology and falling bond yields, equities reached record highs in the quarter. U.S. small caps outperformed in the quarter, gaining 12.4%, while large caps returned 5.3%. Among small caps, value stocks slightly surpassed growth stocks, returning 12.6% and 12.2%, respectively, according to Russell ...

Core Viewpoint - Purcell & Lefkowitz LLP is investigating Zenas BioPharma, Inc. to determine if the company's directors breached their fiduciary duties related to recent corporate actions [1]. Group 1: Investigation Details - The investigation is on behalf of Zenas BioPharma's shareholders [1]. - Shareholders interested in more information about their rights and options can contact Purcell & Lefkowitz LLP [2]. Group 2: Firm Background - Purcell & Lefkowitz LLP specializes in representing shareholders who are victims of securities fraud and breaches of fiduciary duty [3].

Summary of Zenas BioPharma Conference Call Company Overview - **Company**: Zenas BioPharma (NasdaqGS: ZBIO) - **Event**: Jefferies London Healthcare Conference 2025 - **Date**: November 18, 2025 Key Points Industry and Pipeline Developments - Zenas BioPharma has expanded its pipeline significantly with new molecules, including obexelimab and rilzabrutinib [2][3] - Obexelimab is concluding a phase three trial in IgG4-related disease, with top-line results expected by the end of the year [3][7] - The company is also advancing a lupus program with 70% enrollment and plans to report a 24-week top-line endpoint in 2026 [3][4] Obexelimab Details - Obexelimab is a novel B cell inhibitor that co-engages CD19 and Fc gamma R2b (CD32b), leading to profound B cell inhibition [4][5] - The phase three trial for IgG4-related disease has shown a dramatic improvement in the IgG4-RI responder index, with a low flare rate of approximately 10% expected compared to a placebo flare rate of 60% [5][7][31] - The trial design is validated by the successful launch of Amgen's OPLISNA, which had a strong market performance [6][7] Market Opportunity - The U.S. market opportunity for IgG4-related disease is estimated at over $3 billion, targeting approximately 30,000-40,000 patients [9][10] - A recent market study indicated a 45% share for obexelimab compared to competitors OPLISNA and rituximab, suggesting strong market potential [10] Rilzabrutinib Insights - Rilzabrutinib is positioned as a best-in-class BTK inhibitor, with a focus on progressive multiple sclerosis (PPMS and SPMS) [11][12] - The drug has shown a 90% reduction in lesions in early studies, with a phase three program already initiated for PPMS [15][24] - The pharmacological profile of rilzabrutinib is highlighted as superior, with a CNS concentration IC90 ratio significantly higher than competitors [14][36] Clinical Trial Design and Strategy - The phase two study for obexelimab in relapsing multiple sclerosis (RMS) demonstrated a 95% risk reduction, setting a new benchmark for B cell targeting [11][19] - The company is optimistic about the transition from RMS to IgG4-related disease, leveraging insights from previous trials to optimize dosing regimens [18][19] - The phase three trial for IgG4-RD is considered overpowered with 194 patients enrolled, compared to 135 in the successful MITIGATE trial [26][31] Future Outlook - Zenas BioPharma anticipates significant milestones in 2026, including results from the IgG4-RD trial and further developments in the lupus program [16][38] - The company is confident in its ability to execute trial designs agreed upon with regulatory agencies, enhancing its position in the competitive landscape of MS treatments [37][36] Additional Considerations - The company is focused on patient preferences for at-home subcutaneous administration, which may lead to better patient compliance and lower costs compared to IV infusions [9][10] - The competitive landscape for BTK inhibitors is evolving, with several companies advancing their products in the MS space, indicating a growing market [35][36] This summary encapsulates the critical insights and developments discussed during the conference call, highlighting Zenas BioPharma's strategic direction and market positioning.

Financial Performance - Total revenue for the nine months ended September 30, 2025, was $10 million, compared to $0 for the same period in 2024[20] - The net loss attributable to common stockholders for the nine months ended September 30, 2025, was $137.3 million, compared to a loss of $104.4 million for the same period in 2024[20] - The company reported a comprehensive loss of $137.6 million for the nine months ended September 30, 2025, compared to a loss of $104.4 million in 2024[20] - For the nine months ended September 30, 2025, the company reported a net loss of $137.3 million, compared to a net loss of $104.4 million for the same period in 2024, representing a 31.5% increase in losses year-over-year[33] - The company experienced a net loss of $52,223,000 for the quarter ending June 30, 2025, compared to a net loss of $33,573,000 for the previous quarter, indicating a 56% increase in losses[22] - The Company reported a segment net loss of $51.499 million for the three months ended September 30, 2025, compared to a net loss of $38.606 million for the same period in 2024[106] Expenses - Research and development expenses for the three months ended September 30, 2025, were $34.4 million, an increase from $33.5 million in the same period in 2024[20] - General and administrative expenses for the nine months ended September 30, 2025, were $37.7 million, up from $18.3 million in 2024, reflecting a 106% increase[20] - The company incurred acquired in-process research and development expenses of $5 million during the three months ended September 30, 2025[20] - The company incurred stock-based compensation expenses of $18.8 million for the nine months ended September 30, 2025, compared to $5.3 million for the same period in 2024, representing a significant increase[33] - The company reported a stock-based compensation expense of $7,336,000 for the quarter ending June 30, 2025, compared to $6,045,000 for the previous quarter, reflecting an increase of approximately 21%[22] - Total stock-based compensation expense for the three months ended September 30, 2025, was $7.336 million, compared to $2.843 million for the same period in 2024, representing an increase of 158%[92] - For the nine months ended September 30, 2025, total stock-based compensation expense was $18.767 million, up from $5.326 million in 2024, reflecting a 253% increase[92] Cash and Liquidity - Cash and cash equivalents decreased to $115.6 million as of September 30, 2025, from $319.7 million at the end of 2024[18] - As of September 30, 2025, the company had cash, cash equivalents, and restricted cash totaling $115.6 million, down from $360.1 million at the end of the same period in 2024, reflecting a decrease of 67.8%[34] - The company expects its existing cash and investments of $301.6 million, along with $120.0 million from a Private Investment in Public Equity (PIPE) received in October 2025, to fund operations into the fourth quarter of 2026[35] - As of September 30, 2025, the Company reported a total stockholders' equity of $196,428,000, down from $312,458,000 as of December 31, 2024, reflecting a decrease of approximately 37%[22] - The Company recorded total assets of $301.6 million as of September 30, 2025, compared to $350.8 million as of December 31, 2024[50] Liabilities - Total liabilities increased significantly to $125.6 million as of September 30, 2025, compared to $57.5 million at the end of 2024[18] - The Company has accrued expenses totaling $45.4 million as of September 30, 2025, an increase from $39.4 million as of December 31, 2024[55] - The Company has non-cancellable clinical manufacturing contract payment obligations totaling $18.7 million, all payable within 12 months[98] Financing and Capital - The company anticipates requiring substantial additional financing to achieve its goals, which may cause dilution to stockholders[13] - The Company completed its initial public offering (IPO) on September 16, 2024, raising net proceeds of $234.3 million from the sale of 15,220,588 shares at a public offering price of $17.00 per share[31] - The Company sold 6,262,112 shares of common stock at $19.00 per share, generating gross proceeds of approximately $120 million in October 2025[115] Agreements and Milestones - The Company entered into a license agreement with Bristol-Myers Squibb, receiving a one-time upfront payment of $50 million and potential milestone payments of up to $149.5 million[59] - The Company recognized a one-time upfront cash payment of $5 million from Tenacia Biotechnology under a novation agreement, with potential milestone payments of up to $86 million[64] - The Company received a one-time upfront cash payment of $10 million from Zai Lab under a license agreement, with potential milestone payments of up to $117 million[66] - The 2021 Xencor Agreement includes regulatory milestone payments up to $75.0 million and one-time sales milestone payments up to $385.0 million based on net sales thresholds[72] - The Company entered into a Royalty Purchase Agreement in September 2025, receiving a $75.0 million upfront payment and agreeing to pay 5.5% of net sales of obexelimab products[78] - An additional $225.0 million in payments is contingent upon achieving specific milestones related to obexelimab's clinical trials and FDA approvals[79] - The Company has committed to make a one-time non-refundable upfront cash payment of $35 million under the InnoCare License Agreement, with $5 million paid as of September 30, 2025[110] - Future regulatory and commercial milestones related to orelabrutinib could total up to $723 million, with additional development milestones for preclinical compounds up to $656 million[112] Stock Options and Equity - The weighted-average common stock outstanding for the nine months ended September 30, 2025, was 41,943,160 shares, compared to 3,621,276 shares in 2024[20] - As of September 30, 2025, the Company had 10,507,497 stock options outstanding with a weighted average exercise price of $12.86[89] - The Company granted 538,550 restricted stock units (RSUs) with a weighted average grant date fair value of $12.15, with 525,350 unvested as of September 30, 2025[90] - There was $81.2 million of unrecognized stock-based compensation related to unvested stock options and RSUs expected to be recognized over a weighted-average period of 3.0 years[91] - The Company has reserved 12,313,103 shares of common stock for potential conversion of outstanding stock options and other equity awards[84] - As of September 30, 2025, the Company had 773,122 shares available for future issuance under the Employee Stock Purchase Plan (ESPP) after an automatic increase of 417,934 shares on January 1, 2025[93] Risks and Future Outlook - The company anticipates continued operating losses and negative cash flows for the foreseeable future, necessitating additional capital to fund operations[35] - The company is subject to substantial risks and uncertainties typical of clinical-stage biopharmaceutical companies, including the need for significant research and development efforts[30] - Inflation has generally increased labor and clinical trial costs, but it has not had a material effect on the business[210] Currency and Foreign Transactions - The reporting currency for the company is the U.S. dollar (USD), with functional currencies for subsidiaries being the Chinese Yuan and Swiss Franc[208] - Realized foreign currency transaction gains (losses) were immaterial for the three and nine months ended September 30, 2025[208] - The company does not currently engage in currency hedging activities but may consider it in the future[209] - A hypothetical 10% increase or decrease in exchange rates would not have had a material impact on the financial statements[209]

Core Insights - Zenas BioPharma reported significant advancements in its clinical trials, particularly with obexelimab, which showed promising results in treating autoimmune diseases [1][2][3] - The company has secured substantial funding to support its clinical development and commercialization efforts, including a $300 million agreement with Royalty Pharma [1][6] - Zenas is expanding its product pipeline with the acquisition of three new autoimmune product candidates, including orelabrutinib, which is in Phase 3 development for multiple sclerosis [1][3][10] Clinical Trial Updates - The Phase 3 INDIGO trial for obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD) is set to report topline results around year-end 2025, marking it as the largest clinical trial for this condition to date [1][3] - The Phase 2 MoonStone trial for obexelimab in Relapsing Multiple Sclerosis (RMS) demonstrated a 95% relative reduction in new gadolinium-enhancing lesions compared to placebo, with a p-value of 0.0009 [3][4] - Zenas expects to report 24-week data from the MoonStone trial in the first quarter of 2026 [3] Financial Highlights - As of September 30, 2025, Zenas had cash, cash equivalents, and investments totaling $301.6 million, which, along with recent financing, is expected to fund operations into the fourth quarter of 2026 [7][18] - The company reported a net loss of $51.5 million for the third quarter of 2025, compared to a net loss of $38.6 million for the same period in 2024 [13][17] - Research and development expenses for the quarter were $34.4 million, while general and administrative expenses increased to $13.2 million from $7.5 million year-over-year [7][17] Pipeline Expansion - Zenas has entered into a license agreement for orelabrutinib, a BTK inhibitor, granting global development and commercialization rights outside Greater China and Southeast Asia [3][10] - The company is also advancing two additional product candidates, ZB021 and ZB022, both of which are expected to enter Phase 1 clinical development in 2026 [4][10] Company Overview - Zenas BioPharma is focused on developing transformative therapies for autoimmune diseases, with a strategy that includes acquiring and developing product candidates that offer superior clinical benefits [11] - The company aims to become a leader in the biopharmaceutical industry, leveraging its experienced leadership and disciplined approach to product development [11]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Click Holdings Limited (CLIK) is up 81% at $11.17 [3] - Avidity Biosciences, Inc. (RNA) is up 43% at $70.72 [3] - Dyne Therapeutics, Inc. (DYN) is up 37% at $23.58 [3] - Zenas BioPharma, Inc. (ZBIO) is up 21% at $29.00 [3] - ProPetro Holding Corp. (PUMP) is up 18% at $7.47 [3] - PepGen Inc. (PEPG) is up 17% at $5.35 [3] - Unusual Machines, Inc. (UMAC) is up 15% at $14.85 [3] - Semler Scientific, Inc. (SMLR) is up 14% at $27.32 [3] - ETHZilla Corporation (ETHZ) is up 13% at $20.51 [3] - Relmada Therapeutics, Inc. (RLMD) is up 13% at $2.38 [3] Premarket Losers - Smart Logistics Global Limited (SLGB) is down 37% at $3.21 [4] - MaxsMaking Inc. (MAMK) is down 22% at $4.08 [4] - Prenetics Global Limited (PRE) is down 14% at $14.40 [4] - United States Antimony Corporation (UAMY) is down 14% at $10.22 [4] - NeurAxis, Inc. (NRXS) is down 12% at $3.01 [4] - Obook Holdings Inc. (OWLS) is down 9% at $11.39 [4] - Qualigen Therapeutics, Inc. (QLGN) is down 9% at $3.30 [4] - Critical Metals Corp. (CRML) is down 8% at $13.70 [4] - Neuphoria Therapeutics Inc. (NEUP) is down 8% at $5.73 [4] - Beam Therapeutics Inc. (BEAM) is down 7% at $25.86 [4]

Core Insights - Zenas BioPharma announced positive results from the Phase 2 MoonStone trial of obexelimab in Relapsing Multiple Sclerosis (RMS), achieving a 95% relative reduction in new gadolinium-enhancing T1 lesions compared to placebo [1][2][3] Company Overview - Zenas BioPharma 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 [12] Clinical Trial Results - The MoonStone trial enrolled 116 patients and demonstrated a near-complete suppression of new GdE T1 hyperintense lesions by 8 weeks, sustained through week 12 [3][9] - The adjusted mean number of new GdE T1 lesions per scan in the obexelimab group was 0.01 compared to 0.23 in the placebo group [3] - Obexelimab also significantly reduced the cumulative number of new and/or enlarging T2 weighted hyperintense lesions, indicating a reduction in disease burden [3] Future Developments - Zenas plans to report 24-week data from the MoonStone trial in Q1 2026, which will include additional secondary and exploratory endpoints [4] - The company expects to report topline results from the Phase 3 INDIGO trial in IgG4-RD by the end of 2025 and from the Phase 2 SunStone trial in Systemic Lupus Erythematosus by mid-2026 [4] Mechanism of Action - Obexelimab is a bifunctional monoclonal antibody designed to inhibit B cell activity without depleting them, targeting both CD19 and FcγRIIb [10][12] - This unique mechanism may effectively address the pathogenic role of B cells in chronic autoimmune diseases [10][12] Disease Context - Multiple Sclerosis (MS) is a chronic autoimmune disorder affecting approximately 2.9 million people globally, with RMS being the most common subtype [5][8] - Early intervention with effective therapies is crucial to manage the disease and prevent disability progression [7][8]