Summary of Climb Bio's Conference Call Company Overview - **Company**: Climb Bio - **Focus**: Autoimmune diseases with two antibodies in clinical development Key Points Upcoming Milestones - Climb Bio has five clinical data readouts scheduled for this year - Monoclonal antibody targeting CD19: - Data on subcutaneous (subQ) formulation in healthy volunteers expected in the first half of the year - Initial data from Phase 1b studies in Immune Thrombocytopenic Purpura (ITP) and Systemic Lupus Erythematosus (SLE) in the second half - Initial data from Phase 2 study in Primary Membranous Nephropathy (PMN) also expected in the second half - Second antibody, an APRIL-only antibody for IgA nephropathy, will have data available mid-year [2][3][4] Competitive Landscape - UPLIZNA is currently the only approved CD19 antibody, focusing on rare neuro diseases - Climb Bio's CD19 antibody is believed to have greater affinity and a subQ formulation option, which UPLIZNA lacks [5][7][11] PMN Indication - No approved therapies currently exist for PMN; standard care includes off-label use of rituximab - Rituximab achieves complete renal remission in only 10% of patients after one year and 35% after two years - Climb Bio's Phase 1b study showed a 60% complete remission rate and 100% serological remission in PLA2R antibody-positive patients [14][15][32] Market Opportunity - Approximately 70,000 patients in the U.S. have PMN, with two-thirds requiring therapeutic intervention - Regulatory strategy involves one Phase 3 study with around 150 patients, focusing on proteinuria as the primary endpoint [32][34] ITP and SLE Indications - ITP has a strong rationale for CD19 targeting, with only 20% of refractory patients achieving a durable platelet response - SLE is viewed as a more complex indication, requiring larger pivotal trials; Climb Bio is conducting a parallel study in China for lupus nephritis patients [39][40][41] APRIL Antibody Development - Climb Bio's APRIL-only antibody (CLYM116) features a unique sweeper mechanism, allowing for high-affinity binding and potential for longer half-life - Early studies indicate a two- to threefold longer half-life compared to existing therapies, with better activity in IgA suppression [48][56][60] Financial Position - Climb Bio reported $176 million in cash at the end of Q3, with a runway extending into 2028, covering all planned readouts for the year [93][95] Future Indications - Climb Bio is exploring additional indications for the APRIL antibody, including Sjögren's syndrome, to maximize asset potential [90][91] Conclusion - Climb Bio is positioned to address significant unmet needs in autoimmune diseases with promising clinical data and a strong financial foundation, paving the way for potential market success in the coming years [2][93][95]

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 Viewpoint - ImmunityBio Inc. has experienced a stock surge of over 100% year-to-date, driven by positive preliminary fourth-quarter results and promising trial data [1] Group 1: Anktiva Trial Update - Enrollment in the QUILT-2.005 trial for BCG-naïve non-muscle-invasive bladder cancer (NMIBC) has exceeded expectations, with over 85% completion anticipated by Q2 2026 [2] - A biologics license application (BLA) is expected to be submitted to the FDA by the end of 2026, following an interim analysis requested by the FDA to evaluate Anktiva's efficacy [3] - The interim analysis showed that Anktiva significantly prolonged the duration of complete response when combined with BCG, with 85% of patients maintaining a complete response at six months compared to 57% for BCG alone [4] Group 2: QUILT-106 Study Update - The ongoing QUILT-106 study of CAR-NK therapy combined with rituximab for Waldenström Non-Hodgkin lymphoma has shown sustained complete responses lasting up to 15 months, with 100% disease control observed [6] - Four patients have been enrolled in the study, all of whom remain in clinical disease control, with two patients demonstrating durable complete remission at seven and 15 months, respectively [7] - Notably, one patient with extensive disease at baseline achieved a complete response after just four doses of CAR-NK + rituximab, maintaining remission for 15 months without further treatment [9]

Core Insights - Incyte (INCY) has received approval from the European Commission (EC) for a label expansion of Minjuvi (tafasitamab) to treat adult patients with relapsed or refractory follicular lymphoma (FL) in combination with Revlimid (lenalidomide) and rituximab [1][9] Approval Details - This marks the second indication for Minjuvi in the EU, as it was previously approved for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) [2] - The latest approval is based on the inMIND study, which demonstrated significantly improved progression-free survival for patients with relapsed or refractory FL when treated with Minjuvi, Revlimid, and rituximab [3][9] - Minjuvi was generally well-tolerated, with a safety profile comparable to the combination of Revlimid and rituximab [4] Market Context - Follicular lymphoma is the most common indolent form of B-cell non-Hodgkin lymphoma, accounting for approximately 30% of NHL cases globally, with a significant unmet need for new treatment options [5] - The approval of Minjuvi introduces the first dual-targeted CD19 and CD20 immunotherapy for eligible FL patients in Europe, showing a meaningful reduction in disease progression risk [6] Company Strategy - Incyte is diversifying its portfolio beyond its lead drug Jakafi, which is a JAK1/JAK2 inhibitor, by gaining new approvals for Minjuvi and other drugs [7][10] - The company has seen strong uptake of recently approved drugs, including Pemazyre, Monjuvi, and Tabrecta, which will further enhance its revenue base [10] Financial Performance - Incyte has performed well in 2025, with shares surging 45.6% over the year, significantly outperforming the industry growth of 16.9% [11] - The company has also entered a global collaboration with Qiagen to develop a diagnostic panel for myeloproliferative neoplasms, which is expected to support its pipeline of investigational treatments [12][13]

Core Insights - BI-1206 shows potential to overcome resistance mechanisms to rituximab in treating non-Hodgkin's lymphoma [1] - 47% of patients achieved complete responses (CR), with an overall response rate of 80% [1] - The safety profile is favorable, with 87% of adverse events being mild or moderate, and no treatment-related discontinuations [1] - The safety run-in portion of the study is complete, showing no significant differences in safety or efficacy between the two dose levels [1] - The signal-seeking expansion phase of the study is currently ongoing [1] Company Overview - BioInvent International AB is focused on discovering and developing novel and first-in-class immune-modulatory antibodies for cancer immunotherapy [1] - The company presented new data from its ongoing trial of BI-1206 at the 2025 American Society of Hematology Annual Meeting [1] Industry Context - Anti-CD20 antibodies, such as rituximab, are critical for the treatment of non-Hodgkin's lymphoma [1]

Core Insights - The combination of evorpacept, rituximab, and lenalidomide achieved a complete response (CR) rate of 92% in patients with untreated indolent non-Hodgkin lymphoma (iNHL), significantly higher than the historical CR rate of approximately 50% for rituximab alone [1][2] - The treatment regimen was well-tolerated and demonstrated impressive anti-tumor activity in the frontline setting, with a one-year progression-free survival (PFS) rate of 91% and a one-year overall survival (OS) rate of 100% [2] Study Details - The Phase 2 investigator-sponsored trial enrolled 24 patients, including 14 with follicular lymphoma and 10 with marginal zone lymphoma, and met the primary objective of achieving a CR rate above 80% [2] - The trial was led by Dr. Paolo Strati from The University of Texas MD Anderson Cancer Center, and the results were presented at the American Society of Hematology (ASH) Annual Meeting 2025 [3] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with evorpacept as its lead candidate [4] - The company is also advancing a second pipeline candidate, ALX2004, which is an EGFR-targeted antibody-drug conjugate currently in Phase 1 trials [5]

Core Insights - Genmab A/S announced positive results from the Phase 3 EPCORE® FL-1 study, demonstrating that the combination of EPKINLY® (epcoritamab) with rituximab and lenalidomide significantly reduces the risk of disease progression or death by 79% compared to standard care [2][3] - The overall response rate (ORR) for patients treated with EPKINLY + R2 was 95%, compared to 79% for those receiving R2 alone, indicating a substantial improvement in treatment efficacy [2][3] - The U.S. FDA has approved the EPKINLY + R2 combination for patients with relapsed or refractory follicular lymphoma after one or more lines of systemic therapy, marking a significant advancement in treatment options [4][5] Study Results - The EPCORE FL-1 study included patients with relapsed or refractory follicular lymphoma, showing that 83% of patients achieved a complete response (CR) with EPKINLY + R2, compared to 50% with R2 alone [3][5] - The duration of response (DOR) at 12 months was 89% for EPKINLY + R2 versus 49% for R2, highlighting the long-term benefits of the new treatment [3][5] - The safety profile of EPKINLY + R2 was consistent with known safety profiles, with 90.1% of patients experiencing Grade 3 or 4 treatment-emergent adverse events (TEAEs) [3][4] Industry Context - Follicular lymphoma is a common form of non-Hodgkin lymphoma, accounting for 20-30% of all NHL cases, with approximately 15,000 new diagnoses in the U.S. annually [7] - Current standard treatments are often ineffective over time, leading to relapses and shorter remission periods, which underscores the need for innovative therapies like EPKINLY [7] - Epcoritamab, developed using Genmab's DuoBody technology, is designed to target both T cells and B cells, enhancing the immune response against cancer cells [8][9] Future Developments - Genmab and AbbVie are continuing to explore the use of epcoritamab in various hematologic malignancies, with multiple ongoing Phase 3 trials assessing its efficacy as a monotherapy and in combination with other treatments [9] - The companies aim to expand regulatory approvals for epcoritamab in additional indications, including relapsed/refractory diffuse large B-cell lymphoma (DLBCL) [8][9] - Genmab's vision is to transform cancer treatment through innovative antibody medicines, with a focus on improving patient outcomes [10]

Summary of ADC Therapeutics SA Lotus 7 Update Conference Call Company and Industry Overview - **Company**: ADC Therapeutics SA - **Industry**: Oncology, specifically focusing on therapies for Diffuse Large B-Cell Lymphoma (DLBCL) Key Points and Arguments 1. **Clinical Trial Update**: ADC Therapeutics announced updated results from the LOTIS-7 clinical trial, focusing on the combination of Zynlonta and glofitamab for treating DLBCL [2][10] 2. **Zynlonta's Profile**: Zynlonta is positioned as a single-agent therapy for third-line plus DLBCL, with rapid, deep, and durable efficacy, and manageable safety [4][20] 3. **Market Opportunity**: The potential peak revenue for Zynlonta in DLBCL is estimated to be between $500 million and $800 million, with a broader potential reaching $600 million to $1 billion as it expands into earlier lines of therapy and indolent lymphomas [20][21] 4. **Efficacy Data**: The best overall response rate (ORR) in the LOTIS-7 trial was reported at 89.8%, with a complete response (CR) rate of 77.6% among 49 efficacy-available patients [11][12] 5. **Patient Demographics**: The median age of patients in the study was 70 years, with a range from 26 to 85 years, and a median of one prior line of therapy [12][14] 6. **Safety Profile**: Neutropenia was the most common treatment-emergent adverse event, occurring in 32.7% of patients, consistent with known profiles of the individual drugs [11][14][39] 7. **Combination Therapy Rationale**: The combination of Zynlonta and glofitamab is expected to provide additive or synergistic efficacy due to their complementary mechanisms of action [8][10] 8. **Regulatory Strategy**: ADC Therapeutics plans to submit for regulatory approval and compendia listing following positive results from ongoing trials, with updates expected in 2026 [22][23] Additional Important Information 1. **Treatment Landscape**: The DLBCL treatment landscape is evolving, with a current 60/40 split between complex therapies (e.g., CAR-T, bispecifics) and broadly accessible therapies (e.g., ADCs, monoclonal antibodies) [5][6] 2. **Future Catalysts**: Multiple data catalysts are expected in 2026, including updates from LOTIS-5 and LOTIS-7 trials, which could significantly impact Zynlonta's market potential [21][22] 3. **Durability of Responses**: Among patients achieving CR, 33 out of 38 maintained their response as of the data cutoff, indicating promising durability [11][19] 4. **Comparative Efficacy**: The trial showed strong efficacy in both relapsed (100% ORR, 91.6% CR) and primary refractory (80% ORR, 64% CR) patient populations [18][30] 5. **Enrollment Trajectory**: The company is on track to complete enrollment of 100 patients in the LOTIS-7 trial by the first half of 2026, with a focus on maintaining a balanced patient population [43] This summary encapsulates the critical insights from the ADC Therapeutics conference call, highlighting the company's strategic direction, clinical trial outcomes, and market potential in the oncology sector.

LOTIS-7 Clinical Trial Results and Strategy - The LOTIS-7 trial (ZYNLONTA + glofitamab) showed an overall response rate (ORR) of 89.8% (44/49 patients) in 2L+ LBCL patients[37] - The complete response (CR) rate in the LOTIS-7 trial was 77.6% (38/49 patients)[41] - In the LOTIS-7 trial, 6 out of 8 patients previously treated with CAR-T achieved a CR[41] - Grade 3 or higher treatment emergent adverse events (TEAEs) occurred in >5% of patients, including neutropenia (32.7%), GGT increased (16.3%), and anemia (10.2%)[40] - Grade 5 AEs occurred in 4.1% (2/49) of patients in the LOTIS-7 trial[40] - Cytokine release syndrome (CRS) of any grade was observed in 36.7% (18/49) of patients in the LOTIS-7 trial[47] Market Opportunity and Revenue Potential - ZYNLONTA has a U S peak revenue potential of $600 million to $1 billion in DLBCL and indolent lymphomas[56] - The company believes LOTIS-7 has the potential to be the leading bispecific combination regimen for patients with access to complex therapies[17] - The company believes LOTIS-5 has the potential to be the leading regimen for patients who will not receive complex therapies[17] Upcoming Milestones - The company expects full enrollment of 100 patients at selected dose for LOTIS-7 in 1H2026[59] - The company expects to share topline results for LOTIS-5[59]

Summary of Nurix Therapeutics Conference Call Company Overview - **Company**: Nurix Therapeutics (NasdaqGM:NRIX) - **Event**: Jefferies London Healthcare Conference 2025 - **Date**: November 19, 2025 Key Points Industry and Product Focus - Nurix Therapeutics is focused on developing therapies for Chronic Lymphocytic Leukemia (CLL) and other indications using their BTK degrader platform, specifically Bexobrutideg and NX-5948 [3][4][5] Upcoming Events and Data Releases - The company will present data at the upcoming ASH conference, including follow-up data from Phase 1A and Phase 1B trials for Bexobrutideg and NX-5948 [3][4] - Key metrics to be reported include duration of therapy and duration of response, with patients having been on therapy for over two years [3][4] Pivotal Trial Design - The pivotal trial for Bexobrutideg will focus on a triple-exposed patient population in CLL, with a selected dose of 600 mg once daily based on Phase 1B data [4][6] - The trial aims for accelerated approval, allowing early market access, while full approval will follow a randomized control study [10][11] Competitive Landscape - The company anticipates competition from pirtobrutinib, a non-covalent BTK inhibitor from Eli Lilly, which is expected to gain full approval [8][10] - Nurix is positioning Bexobrutideg as a potential standard of care in the U.S. market for CLL [10] Combination Therapies - Nurix is planning combination studies with Bexobrutideg and other therapies, including venetoclax and anti-CD20 antibodies [22][23] - The company is also exploring the potential of combining with T-cell engagers [23] Autoimmune Indications - The company is developing Bexobrutideg for autoimmune diseases, leveraging its ability to degrade BTK, which may provide advantages over traditional inhibitors [26][27] - A new formulation for Bexobrutideg is in development, with plans for IND submission in 2026 [27] Partnerships and Pipeline - Nurix has partnerships with Gilead for an IRAK4 degrader and with Sanofi for a STAT6 degrader, both of which are in various stages of development [35][36] - The IRAK4 program is in Phase 1, while the STAT6 program is in IND enabling studies [35][36] Financial Position - Nurix recently raised $250 million, bringing total cash reserves to over $650 million, providing a strong financial runway through early 2028 [41][42] Future Considerations - The company is preparing for multiple decisions regarding its partnerships and potential opt-ins based on upcoming clinical data [38][41] Conclusion - Nurix Therapeutics is strategically positioned in the biotech space with a focus on innovative therapies for CLL and autoimmune diseases, backed by a strong financial position and promising clinical data on the horizon [41][42]