Financial Data and Key Metrics Changes - The company ended the second quarter of 2025 with $77 million in cash and cash equivalents, with a net cash used in operating activities of $22.6 million, which included $2.4 million in severance payments [14] - Collaboration revenue for 2025 was $3.1 million, an increase from $2.3 million in the same period in 2024, primarily due to increased revenue from collaborations with J&J and Merck KGAA [15] - Research and development expenses for 2025 were $16.2 million, down from $17.2 million in 2024, attributed to lower headcount and related compensation costs [16] - General and administrative expenses decreased to $7.4 million from $10.5 million in 2024, mainly due to lower headcount and reduced consulting fees [17] - The net loss for the second quarter of both 2025 and 2024 was $24.3 million [18] Business Line Data and Key Metrics Changes - The company reported strong enrollment progress in the EMILY phase one trial, particularly in expansion cohorts targeting triple negative breast cancer (TNBC) [4][10] - Among evaluable patients with high B7-H4 tumor expression, the confirmed objective response rate (ORR) was 31% [5] - In patients with adenoid cystic carcinoma type one (ACC1), the ORR was 56% [6] Market Data and Key Metrics Changes - The market for topo one ADCs in TNBC is expected to grow significantly, with Trodelvy projected to generate about $1 billion in global revenues in 2025 [11] - The company believes the post-topo one TNBC opportunity is sizable and could expand as more agents move into earlier lines of therapy [11] Company Strategy and Development Direction - The company is focusing on addressing unmet needs in TNBC, particularly for patients previously treated with topo one ADCs [6][12] - The company is exploring the potential of EMILY as a second-line therapy for patients who have received prior topo one ADCs [12] - The company is also developing XMT-2056, an Immunosynthen ADC targeting HER2, with GSK holding an exclusive global license option [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for EMILY to meet significant unmet needs in the TNBC market [10][12] - The management highlighted the importance of the evolving treatment landscape and the potential for EMILY to address the needs of topo-experienced patients if approved [11] Other Important Information - The company incurred $3.9 million in restructuring charges primarily related to severance and benefit payments [17] - The company expects its capital resources to support its operating plan commitments into mid-2026 [14] Q&A Session Summary Question: Expectations for upcoming data in the second half - Management indicated that the data will be based on over 45 enrolled patients, with both dose A and B included, but cautioned about committing to an exact number due to treatment and scan requirements [21][22] Question: Good benchmark for efficacy - Management stated that a response rate in the 20s and a median PFS of 16 weeks would be a good benchmark, considering the standard of care has a 5% response rate and 6-7 weeks PFS [23] Question: Implementation of proteinuria mitigation strategies - Management confirmed that Amendment five was implemented to minimize proteinuria development, allowing patients to continue treatment despite isolated albuminuria [28] Question: Enrollment progress and potential next steps - Management reported that enrollment is going well, with no need for additional sites for the expansion, and they are focused on TNBC for the pivotal study [50][67] Question: Milestone payment details - The $15 million milestone payment is development-based, but further details remain confidential [58]

Financial Data and Key Metrics Changes - At the end of 2024, the company reported cash, cash equivalents, and marketable securities totaling $134.6 million, which is expected to support operations into 2026 [16] - Net cash used in operating activities for Q4 2024 was $19.3 million, a significant decrease from $32 million in the same quarter of 2023 [16] - Collaboration revenue for Q4 2024 was $16.4 million, up from $10.7 million in Q4 2023, primarily due to increased revenue from collaborations with J&J, Merck, and GSK [17] - Research and development expenses for Q4 2024 were $22.3 million, slightly up from $21.5 million in Q4 2023, with $1.7 million attributed to non-cash stock-based compensation [18] - General and administrative expenses decreased to $8.9 million in Q4 2024 from $10.1 million in Q4 2023, reflecting reduced employee compensation and consulting fees [18] - The net loss for Q4 2024 was $14.1 million, compared to a net loss of $19.5 million in Q4 2023 [18] Business Line Data and Key Metrics Changes - The lead ADC, Emily, reported a confirmed objective response rate (ORR) of 23% across all tumor types with high B7H4 expression, defined as an IHC score of 70% or more [7][9] - The expansion portion of the trial for Emily was initiated for patients with triple-negative breast cancer (TNBC) who have previously been treated with at least one TOPO1 ADC [8] - The company is exploring doses up to 95 mg/m² for Emily, with the top dose of 67.4 mg/m² being well tolerated in the expansion cohort [14][51] Market Data and Key Metrics Changes - The competitive landscape for B7H4 ADCs has shifted favorably for Emily, as a primary competitor, Pfizer, discontinued its B7H4 ADC candidate [12][40] - The company believes it is well-positioned in the B7H4 ADC space, being the most advanced in clinical development with positive efficacy data in the post-TOPO breast cancer setting [40] Company Strategy and Development Direction - The company is focused on advancing its lead candidates, Emily and XMT-2056, with ongoing clinical trials and collaborations [15] - There is an emphasis on the potential for Emily to be used in combination with standard care treatments, such as platinum chemotherapy, due to its favorable safety profile [41] - The company is also exploring additional indications for Emily beyond TNBC, given the clinical activity observed across various tumor types [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical activity of Emily, particularly in a high unmet need population of TNBC patients [8] - The company is optimistic about its cash runway and operational plans, expecting to support its commitments into 2026 without relying on future milestone payments [16] - Management highlighted the importance of ongoing investigator interest and engagement in their clinical studies [13] Other Important Information - The company has made progress in its collaborations with J&J and Merck KGa, which are expected to contribute to its research and development efforts [15] - The company has amended its clinical trial protocol to mitigate proteinuria issues observed at higher doses of Emily [14][22] Q&A Session Summary Question: Progress on mitigating AST elevation and proteinuria related to Emily - Management indicated that AST elevation does not lead to meaningful dose delays and is a transient, reversible phenomenon [21] - For proteinuria, mitigation strategies such as ACE inhibitors are being implemented, allowing for dose reductions instead of delays [23] Question: Distribution of patients with prior lines of therapy in the expansion cohort - Management stated it is too early to determine the distribution of patients with fewer prior lines of therapy, but confirmed that patients with more than four prior lines are excluded [29] Question: Establishing the final biomarker cutoff for B7H4 high - Management expects the TPS score to capture roughly 40% to 50% of the TNBC population [34] Question: Competitive landscape and Pfizer's discontinuation - Management noted that the discontinuation of Pfizer's program has led to increased interest in their study, positioning Emily favorably in the market [54]