Core Insights - Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency (EMA) for an indication extension of TECVAYLI® (teclistamab) in combination with DARZALEX® (daratumumab SC) for treating adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy [1][2] Group 1: Clinical Study and Results - The application is supported by data from the Phase 3 MajesTEC-3 study, which showed a statistically significant improvement in progression-free survival (PFS) and overall survival (OS) compared to standard treatment [1][2] - The MajesTEC-3 study enrolled 587 patients and demonstrated an 83.4% reduction in the risk of disease progression or death compared to standard regimens at nearly three years follow-up (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.12-0.23; P<0.0001) [2][4] - More than 90% of patients who remained progression-free at six months continued to be progression-free at three years [2] Group 2: Treatment Efficacy and Safety - Teclistamab and daratumumab SC work in a complementary manner by targeting both BCMA and CD38, enhancing immune-mediated responses earlier in treatment [2] - The combination regimen showed similar rates of Grade 3/4 treatment-emergent adverse events (TEAE) compared to standard care (95.1% vs. 96.6%) [2] - The most common Grade 3/4 events were cytopenia and infection, with infections observed in 96.5% of patients receiving teclistamab and daratumumab SC [2] Group 3: Regulatory and Market Position - The FDA has granted Breakthrough Therapy Designation for the teclistamab and daratumumab SC combination, expediting its development and regulatory review [2] - Johnson & Johnson aims to redefine treatment possibilities in multiple myeloma by using the right medicines early and combining them for optimal outcomes [3] Group 4: Background on Multiple Myeloma - Multiple myeloma is an incurable blood cancer affecting plasma cells, with over 35,000 new diagnoses in the EU in 2022 [8] - Patients experience frequent relapses, and remissions become progressively shorter with each line of therapy [8]

Financial Data and Key Metrics Changes - As of June 30, 2025, the company ended the quarter with $158.1 million in cash, cash equivalents, and investments, compared to $79.9 million at the end of 2024 [16] - Total revenue for the quarter was $18.7 million, down from $25.1 million in 2024, primarily due to the completion of performance obligations in collaborations with BMS and Amgen, as well as decreased activity with Moderna [16] - Operating expenses decreased to $19.9 million from $33.6 million in 2024, with R&D expenses at $13.3 million, a decrease of $11.9 million compared to 2024 [16][17] Business Line Data and Key Metrics Changes - The company is focused on the CX-2051 program, which targets colorectal cancer (CRC) and has shown a 28% confirmed overall response rate in initial Phase I data [8][9] - CX-801, a masked interferon alpha-2B program, is being developed in combination with Keytruda for metastatic melanoma, with initial data expected in 2026 [11][12] Market Data and Key Metrics Changes - CRC is a significant unmet need in oncology, with approximately 1.9 million patients diagnosed globally each year, expected to rise to over 3 million in the coming decades [5] - The five-year survival rate for metastatic CRC is currently about 13%, highlighting the urgent need for new treatments [5] Company Strategy and Development Direction - The company aims to advance CX-2051 as a first-in-class treatment for late-line CRC, with plans for combination studies in earlier lines of therapy [10][18] - The strategy includes exploring partnerships for broader applications of EpCAM beyond CRC, as it is expressed in many solid tumors [30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of CX-2051 in addressing the high unmet need in CRC and plans to execute against this opportunity as a top priority [18] - The company is also focused on generating proof of concept for CX-801 in combination with Keytruda, which could reestablish interferon as a key component of immunotherapy [18] Other Important Information - The company completed a $100 million follow-on offering, strengthening its financial position with a projected cash runway into 2027 [14] - Management emphasized a disciplined, data-driven capital allocation approach to advance promising opportunities in the pipeline [17] Q&A Session Summary Question: Potential to move into earlier lines of colorectal therapy - Management indicated a focus on late-line opportunities first, with plans to explore earlier lines through combination studies in the future [21][22] Question: Rationale for value creation of EpCAM beyond CRC - Management acknowledged the potential for EpCAM in various solid tumors and indicated that partnerships could be explored when the time is right [28][30] Question: Bar for accelerated approval in CRC - Management noted that while there is no precedent for accelerated approval based on overall response rate (ORR) in CRC, they are considering strategies to expedite approval due to the high unmet need [34][36] Question: Confidence in combination potential of CX-801 with KEYTRUDA - Management highlighted the strong mechanistic precedent for the combination and the ongoing study of tumor biopsies to assess the immune microenvironment [42][44] Question: Size of the dataset for CX-2051 and durability data - Management expects to have a larger dataset by Q1 2026, with plans to integrate this data into their strategy for Phase II [52][54]