Financial Data and Key Metrics Changes - The company ended Q3 2025 with a cash position of approximately $238.56 million [36] - Total GAAP operating expenses for Q3 2025 were $234.2 million, a decrease from $568.4 million in Q2 2025, primarily due to a higher stock-based compensation expense recorded in the previous quarter [36][37] - Non-GAAP operating expenses for Q3 2025 were $103.4 million, an increase from $89.6 million in the previous quarter, mainly due to increased R&D expenses related to ongoing trials [37] Business Line Data and Key Metrics Changes - The Harmony Three study is enrolling ahead of goals, with over 80% of the planned 600 squamous patients cohort expected to complete enrollment in Q1 2026 [35] - The Harmony GI3 study, evaluating ivonescimab in colorectal cancer, is set to begin activating clinical trial sites in the U.S. by the end of 2025, with an expected enrollment of 600 patients [30][22] Market Data and Key Metrics Changes - The Harmony Six study demonstrated a median progression-free survival (PFS) of 11.14 months for ivonescimab plus chemotherapy compared to 6.90 months for the control group, indicating a significant clinical benefit [10][17] - The study showed consistent benefits across various PD-L1 expression levels, with hazard ratios of 0.55 for negative, 0.63 for low, and 0.71 for high PD-L1 expression [11][17] Company Strategy and Development Direction - The company plans to submit a Biologics License Application (BLA) for ivonescimab based on the Harmony study results, aiming to establish it as a new standard of care for advanced squamous non-small cell lung cancer [24][19] - The clinical development program has expanded to include multiple phase three trials across various solid tumors, indicating a strategic focus on broadening the application of ivonescimab [22][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the results from Harmony Six and its implications for future studies, emphasizing the potential of ivonescimab to improve outcomes for patients with limited treatment options [21][19] - The company is actively engaging with the FDA and is confident in the safety and efficacy data supporting the BLA submission [52][51] Other Important Information - The Harmony Six study was conducted in China and sponsored by Akeso Inc., with all relevant data managed and analyzed by them [2][6] - The company highlighted the importance of the safety profile of ivonescimab, noting low rates of adverse events leading to discontinuation [12][17] Q&A Session Summary Question: When could the first overall survival (OS) cut from Harmony Six be expected? - Management indicated that a review in 2026 is likely, but specific timelines are difficult to disclose [41][43] Question: What options are being evaluated to extend the runway for funding? - The company has an ATM with approximately $350 million and has received inbound interest for additional capital [47][48] Question: Can you provide insights on the BLA submission and interactions with the FDA? - Continuous interactions with the FDA have been positive, and the company is preparing to submit the BLA based on the Harmony data [51][52] Question: What prompted the protocol amendments to Harmony Three? - The amendments were made to accelerate the front-line lung cancer opportunity and reduce regulatory risks by separating analyses for squamous and non-squamous histologies [70][71]

Core Insights - Johnson & Johnson announced significant findings from two Phase 3 studies demonstrating that DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) based regimens lead to deep and sustained minimal residual disease (MRD) negativity and improved long-term progression-free survival (PFS) in newly diagnosed multiple myeloma patients, regardless of transplant eligibility [1][2][3] Group 1: Study Findings - In the Phase 3 PERSEUS study, over half of the patients maintained MRD negativity for 24 months or longer with the DARZALEX FASPRO® regimen [1][2] - The addition of DARZALEX FASPRO® to the standard treatment regimen (bortezomib, lenalidomide, and dexamethasone) resulted in a 55.8% sustained MRD negativity rate at the 10⁻⁵ threshold compared to 22.6% with the standard regimen alone [2][4] - The Phase 3 CEPHEUS study showed a 60% overall MRD negativity rate at the 10⁻⁵ threshold in transplant-ineligible patients, indicating significant treatment benefits across different patient populations [1][3] Group 2: Long-term Outcomes - At a median follow-up of 47.5 months, the PFS rate was 95.3% at 48 months for patients receiving the DARZALEX FASPRO® regimen, highlighting its effectiveness in delaying disease progression [2] - The study results indicated that 69% of patients treated with the DARZALEX FASPRO® regimen remained progression-free at 54 months, compared to 48% with the standard regimen [4][5] - The overall survival (OS) favored the DARZALEX FASPRO® group, with a hazard ratio of 0.66, suggesting a potential survival benefit [4] Group 3: Safety and Efficacy - The safety profiles of DARZALEX FASPRO® in the PERSEUS and CEPHEUS studies were consistent with previously known safety data, indicating a manageable safety profile [5] - The studies included diverse patient populations, including those considered high-risk for cytogenetic abnormalities, reinforcing the broad applicability of DARZALEX FASPRO® in treating multiple myeloma [3][5] - The consistent results across different studies support the role of DARZALEX FASPRO® as a cornerstone of frontline therapy for multiple myeloma [5]