Nurix Therapeutics (NasdaqGM:NRIX) 2025 Conference November 19, 2025 06:00 AM ET Company ParticipantsArthur Sands - President and CEOConference Call ParticipantsRoger Song - Senior AnalystRoger SongAll right. Welcome, everyone, to Jefferies London Healthcare Conference 2025. My name is Roger Song, one of the senior analysts covering medical biotech in the U.S. It is my pleasure to have the fireside chat with our next company, Nurix Therapeutics' CEO, Arthur Sands.Arthur SandsThanks for having us, Roger.Roge ...

-Â Â EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) Â is now the first and only bispecific antibody combination therapy available for patients with relapsed or refractory follicular lymphoma after at least one line of systemic therapy -Â Â In the Phase 3 EPCORE® FL-1 trial, EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2 with approximately 3 out of 4 patients achieving a complete response -Â Â Approval marks third ...

Company Announcement EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is the first and only bispecific-based therapy approved by the FDA for follicular lymphoma in the second-line settingIn the Phase 3 EPCORE® FL-1 trial, fixed duration EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2, with approximately three out of four patients achieving a complete responseThis approval marks the third indication for EPKINLY and th ...

Summary of Artiva Biotherapeutics Conference Call Company Overview - **Company**: Artiva Biotherapeutics (NasdaqGM:ARTV) - **Lead Product**: AlloNK, a non-genetically modified NK cell therapy targeting autoimmune diseases - **Financial Position**: As of Q3, the company reported $123 million in cash, providing a runway into Q2 2027 [1][2] Industry Context - **Targeted Therapies**: The company aims to position AlloNK within the deep B-cell depletion space, similar to existing therapies like TNF inhibitors and JAK inhibitors, which are significant in treating autoimmune diseases [3] - **Market Opportunity**: The refractory rheumatoid arthritis (RA) market is highlighted as a key focus, with over 150,000 patients in the U.S. alone, indicating a substantial unmet need for effective treatments [31][36] Core Points and Arguments - **Clinical Development**: Over 100 patients have been dosed with AlloNK across oncology and autoimmune diseases, with initial safety data from 32 patients treated in autoimmune studies showing no significant toxicities [1][15] - **Mechanism of Action**: AlloNK utilizes monoclonal antibodies to target B-cells, leveraging ADCC via the CD16 receptor, which is expected to provide higher efficacy with favorable safety compared to traditional biologics [5][6] - **Treatment Regimen**: The regimen involves low doses of cyclophosphamide and fludarabine as conditioning agents, followed by AlloNK and rituximab, designed for outpatient administration [10][11] - **Safety Profile**: Initial safety data indicates no severe treatment-emergent adverse events, with a low rate of infections and no cases of cytokine release syndrome (CRS) or neurotoxicity [16][17] Key Data Points - **Efficacy in Oncology**: In a study of 14 patients with aggressive non-Hodgkin lymphoma, a 64% complete response rate was achieved, with a minimum duration of response of 19.4 months [7] - **B-cell Depletion**: AlloNK plus anti-CD20 monoclonal antibody demonstrated complete B-cell depletion in all patients by day 13, with reconstitution observed around six months [24][25] - **Durability of Response**: The company aims for a median duration of response of 12-24 months, with the potential for patients to be weaned off immunomodulatory drugs post-treatment [12][45] Additional Insights - **Regulatory Strategy**: Artiva plans to engage with the FDA regarding pivotal trial design for refractory RA in the first half of 2026, with a focus on demonstrating significant clinical responses [38][58] - **Market Landscape**: The company identifies a gap in late-stage development for therapies targeting refractory RA, positioning AlloNK as a potential first deep B-cell depleting agent in this space [37][58] - **Patient Demographics**: The treatment has been well-tolerated in older patients, with no specific concerns raised regarding safety in this demographic [51][52] Conclusion Artiva Biotherapeutics is advancing its AlloNK therapy with promising initial safety and efficacy data in autoimmune diseases, particularly in refractory RA. The company is strategically positioned to address significant unmet needs in the market, with plans for further clinical development and regulatory engagement in the near future.

Financial Data and Key Metrics Changes - Net product revenues for the second quarter were $18.1 million, and for the first half, they were $35.5 million, both slightly higher compared to the same periods in the prior year [4][28] - The company reported a net loss of $56.6 million for the second quarter, compared to a net loss of $36.5 million in the same period of 2024, primarily due to one-time restructuring and impairment costs [29] - Total operating expenses for the quarter were $47.8 million on a non-GAAP basis, representing an 8% increase over the prior year, driven by higher R&D costs [28][29] Business Line Data and Key Metrics Changes - The company is focusing on the commercialization of ZENLANTA, which has shown promising data in clinical trials, particularly in combination with glufetamab [5][10] - The LOTUS-seven trial data presented at conferences indicated a complete response rate of 86.7% across 30 efficacy evaluable LBCL patients [5][27] - The company plans to expand enrollment to 100 patients at the selected dose to support regulatory discussions [6][9] Market Data and Key Metrics Changes - The company estimates that ZENLANTA could reach peak sales of $600 million to $1 billion in the U.S. market, with significant opportunities in both DLBCL and indolent lymphomas [11][12] - The DLBCL treatment landscape is divided into complex therapies and broadly accessible therapies, with the latter expected to grow as ZENLANTA is positioned as a preferred option [12][13] Company Strategy and Development Direction - The company is strategically focusing resources on ZENLANTA commercialization and has discontinued early development efforts for other preclinical programs in solid tumors [8][9] - The company aims to position itself for long-term growth by reducing operating expenses and extending its cash runway into 2028 through a recent private placement [9][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the unmet medical need in the second line plus DLBCL landscape and the potential of LOTUS trials to address this need [38] - The company anticipates multiple data catalysts in the remainder of 2025 and 2026, with potential regulatory submissions and approvals expected [31][32] Other Important Information - The company incurred $13.1 million in restructuring and impairment costs related to the closure of its UK facility [29] - The company plans to engage with regulatory authorities regarding the LOTUS trials and explore potential pathways for approval [56][58] Q&A Session Summary Question: Impact of Roche's complete response letter on DLBCL market - Management noted that while details of the CRL are unknown, they remain confident in the unmet medical need in the second line plus DLBCL landscape and the positioning of LOTUS trials to address this need [38][39] Question: Status of LOTUS V overall survival analysis - Management indicated that it is difficult to speculate on the maturity of overall survival data by year-end, but they will provide updates once the pre-specified number of PFS events is reached [42][44] Question: Durability of responses in LOTUS trials - Management highlighted the unprecedented complete response rates observed in LOTUS trials and expressed confidence in the durability of these responses, with plans to share more data as it matures [48][50] Question: Communication of LOTUS-seven data - Management stated that they are considering the best way to communicate LOTUS-seven data, whether through a company update or at a medical congress, depending on data maturity [59][60] Question: Indolent lymphomas and NCCN inclusion - Management expressed confidence in the ongoing Phase II IIT for MZL and noted that a CR rate of 40% or above would be significant for NCCN inclusion [64][65]

Core Insights - Genmab A/S has released results from the Phase 3 EPCORE FL-1 trial, showing that subcutaneous epcoritamab in combination with rituximab and lenalidomide (R2) significantly improves outcomes for adult patients with relapsed or refractory follicular lymphoma [1][2] Study Results - The trial met its dual primary endpoints of overall response rate (ORR) and progression-free survival (PFS), demonstrating a 79% reduction in the risk of disease progression or death [2] - Results will be presented at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) and will support global regulatory submissions [3] Regulatory Developments - The U.S. FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for epcoritamab plus R2, based on significant ORR and PFS improvements from interim analysis [4] - The FDA has set a target action date of November 30, 2025, for the sBLA [5] Market Performance - Genmab reported revenue of $1.64 billion for the first half of 2025, up from $1.38 billion year-over-year, with second-quarter sales of $925 million exceeding consensus estimates [6] - The 19% revenue increase was driven by higher royalties from collaborations and increased sales of Epkinly [7] - The company raised its fiscal year 2025 sales guidance to between $3.5 billion and $3.7 billion, surpassing consensus expectations [7]

Core Insights - Genmab A/S announced positive results from the Phase 3 EPCORE FL-1 trial for subcutaneous epcoritamab in combination with rituximab and lenalidomide, showing significant improvements in overall response rate (ORR) and progression-free survival (PFS) for patients with relapsed or refractory follicular lymphoma [2][6][4] - The U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for epcoritamab plus rituximab, with a target action date of November 30, 2025, which could make it the first bispecific antibody combination available in the U.S. for second-line treatment of this condition [3][6] - Epcoritamab is designed to target CD3 on T cells and CD20 on B cells, facilitating T-cell-mediated killing of malignant B cells, and has received regulatory approval in various lymphoma indications [8][9] Trial Results - The EPCORE FL-1 trial met its dual primary endpoints, achieving an ORR of 95.7% (p-value < 0.0001) and a PFS hazard ratio of 0.21 (p-value < 0.0001), indicating a 79% reduction in the risk of disease progression or death [2][6][4] - The safety profile of epcoritamab in combination with rituximab was consistent with known safety profiles, with no new safety signals observed [4][6] Industry Context - Follicular lymphoma (FL) is a slow-growing form of non-Hodgkin's lymphoma, accounting for 20-30% of all NHL cases, with approximately 15,000 new cases annually in the U.S. [5] - Current treatment options for R/R FL often lead to declining response rates and shorter remission periods, with over 25% of patients potentially transforming to aggressive large-cell lymphoma [5][4] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics, with a vision to transform cancer treatment by 2030 [11][12] - The company is co-developing epcoritamab with AbbVie, sharing commercial responsibilities in the U.S. and Japan, while pursuing additional international regulatory approvals [9][10]

Summary of ADC Therapeutics Conference Call - June 12, 2025 Company Overview - **Company**: ADC Therapeutics (ADCT) - **Focus**: Development of therapies for hematological malignancies, particularly diffuse large B-cell lymphoma (DLBCL) Key Industry Insights - **LOTUS-seven Trial**: A Phase 1b study focusing on relapsed or refractory B-cell non-Hodgkin lymphoma, with updated results presented at the European Hematology Association Congress (EHA) [3][7] - **ZULANTA Franchise**: The company is expanding its ZULANTA therapy into earlier lines of treatment for DLBCL and indolent lymphomas, aiming to increase patient reach and commercial opportunity [6][10] Core Points and Arguments - **Efficacy of ZENLANTA**: - ZENLANTA shows rapid, deep, and durable efficacy with a 50% complete response rate in the LOTUS-five trial, which is double that of monotherapy data in line plus DLBCL [9] - The LOTUS-seven trial reported an overall response rate of approximately 93% and a complete response rate of about 87% [16][25] - The combination of ZENLANTA and glufetamab is expected to provide additive or synergistic efficacy due to their complementary mechanisms of action targeting different B-cell surface antigens [11][44] - **Safety Profile**: - The combination therapy has a manageable safety profile, with neutropenia being the most common treatment-emergent adverse event at 24%, consistent with individual drug profiles [21][14] - Lower rates of cytokine release syndrome (CRS) were observed with the 150 microgram per kg dose compared to the 120 microgram per kg dose, indicating a favorable safety profile [84][85] - **Market Potential**: - The company estimates peak sales for ZENLANTA in the range of $600 million to $1 billion across various indications, including DLBCL and indolent lymphomas [30] - The potential to double the addressable patient population and extend the duration of therapy is expected to significantly enhance market share [10][29] Additional Important Insights - **Regulatory Strategy**: - ADC Therapeutics plans to engage with regulatory authorities later in the year, with the aim of submitting for approval based on the expanded cohort data [31][60] - The company is also considering a potential compendia strategy to support the therapy's adoption in clinical practice [32] - **Patient Demographics**: - The median age of patients in the LOTUS-seven trial was 71, with a significant proportion having received prior CAR T therapy [19][20] - The study included patients with complex disease characteristics, such as double or triple hit lymphomas, indicating a challenging patient population [20] - **Future Data Catalysts**: - Multiple data catalysts are expected in 2025 and 2026, with potential approval or compendia listing anticipated in the first half of 2027 [31] - **Community Adoption**: - The combination therapy is expected to be adopted in community centers due to its manageable safety profile and the increasing comfort of physicians with bispecific therapies [41] This summary encapsulates the key points discussed during the ADC Therapeutics conference call, highlighting the company's strategic direction, clinical trial updates, market potential, and regulatory plans.

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $23 million, including net product revenues of $17.4 million, which is consistent with Q1 2024 and an increase from $16.4 million in Q4 2024 [5][16] - Net loss for Q1 2025 was $38.6 million, an improvement from a net loss of $46.6 million in Q1 2024, primarily due to higher license revenues and lower expenses [17] - Cash and cash equivalents as of March 31, 2025, were $194.7 million, down from $250.9 million at December 31, 2024, mainly due to net loss from operations and timing of cash receipts [17] Business Line Data and Key Metrics Changes - Milestone and royalty payments contributed an additional $5.6 million to total revenue for the quarter [6] - The LOTUS-seven study showed a 95.5% overall response rate and a 90.9% complete response rate in 22 efficacy evaluable patients [14] Market Data and Key Metrics Changes - The company is focusing on maintaining its position as a treatment option for third-line plus DLBCL patients, with ongoing trials showing promising data [5][9] - The competitive landscape is highlighted by the potential of ZYNLATA plus glufitamab to be a best-in-class combination in a highly competitive market [6][10] Company Strategy and Development Direction - The company aims to expand the use of ZYNLATA into earlier lines of therapy in DLBCL and indolent lymphomas, believing in the potential for significant patient reach and commercial opportunity [9][10] - Regulatory discussions are planned based on data from 100 patients, aligning with recent examples of bispecific combination therapies [10][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the cash runway extending into the second half of 2026, positioning the company to deliver on upcoming catalysts [20] - The management is encouraged by the promising data from ongoing trials and believes in multiple pathways to achieve peak revenue goals [22] Other Important Information - The LOTUS-five trial is on track to reach the pre-specified number of progression-free survival events by the end of 2025, with top-line data expected thereafter [7][19] - The company is engaged in discussions for potential research collaborations to advance its preclinical assets [8][19] Q&A Session Summary Question: Follow-up time for patients and CR conversion times - Management indicated that follow-up assessments are ongoing, with encouraging complete response rates serving as strong biomarkers for durability [24][27] Question: Competitive strategy and regulatory engagement - Management plans to engage with regulatory authorities after gathering data from approximately 100 patients, assessing the best path forward [29][47] Question: Expected patient numbers at upcoming conferences - Management confirmed that 40 patients have been enrolled, with additional patients expected to be presented at the EHA conference [33][34] Question: LOTUS-five trial data expectations - Management reiterated that the timing for top-line data from the LOTUS-five trial could be late 2025 or early 2026, depending on the number of PFS events [42][43] Question: Discontinuation of the ADCT-602 program - Management clarified that the discontinuation of the ADCT-602 program has minimal financial impact, allowing focus on other research programs [49][50]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $23 million, including net product revenues of $17.4 million, consistent with Q1 2024 and an increase from $16.4 million in Q4 2024 [5][17] - Net loss for Q1 2025 was $38.6 million, an improvement from a net loss of $46.6 million in Q1 2024, attributed to higher license revenues and lower expenses [18] - Cash and cash equivalents as of March 31, 2025, were $194.7 million, down from $250.9 million at December 31, 2024, primarily due to net loss from operations [18] Business Line Data and Key Metrics Changes - The company reported $5.6 million in milestone and royalty payments included in total revenue for the quarter [6] - The LOTUS-seven study showed an overall response rate of 95.5% and a complete response rate of 90.9% in 22 efficacy evaluable patients [14] Market Data and Key Metrics Changes - The company is focusing on maintaining its position as a treatment option for third-line plus DLBCL patients, with promising data from the LOTUS-seven study [5][10] - The competitive landscape is highlighted by the potential of ZYNLATA plus glufitamab to be a best-in-class combination in a highly competitive market [6][11] Company Strategy and Development Direction - The company aims to expand the use of ZYNLATA into earlier lines of therapy in DLBCL and indolent lymphomas, believing in the potential for significant revenue growth [10][22] - The strategy includes pursuing regulatory discussions and compendia strategies based on the data from ongoing trials [8][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming catalysts and the company's cash runway expected to fund operations into the second half of 2026 [10][21] - The management is optimistic about the promising data from ongoing trials and the potential to change treatment paradigms for patients with aggressive lymphoma [15][22] Other Important Information - The LOTUS-five trial is on track to reach the pre-specified number of progression-free survival events by the end of 2025, with top-line data expected thereafter [8][20] - The company is engaged in discussions for potential research collaborations to advance its programs [9][20] Q&A Session Summary Question: Follow-up time for patients and CR conversion times - Management indicated that follow-up assessments are ongoing, with high complete response rates being a strong biomarker for durability [27][28] Question: Competitive strategy and regulatory engagement - The company plans to engage with regulatory authorities once sufficient data from approximately 100 patients is available [30] Question: Expected patient numbers at upcoming conferences - Management confirmed that more patients than the 22 already discussed will be presented at the EHA and ICML conferences, but exact numbers cannot be disclosed [34] Question: Timing for LOTUS-five data readout - The company expects to reach the pre-specified number of PFS events this year, with data readout potentially at the end of this year or early next year [42] Question: Discontinuation of the ADCT-602 program - The discontinuation of the ADCT-602 program has minimal capital implications, allowing focus on advancing other research programs [50][51]