Financial Data and Key Metrics Changes - Research and development (R&D) expenses decreased to $12.4 million for Q1 2025 from $18.9 million in Q1 2024, a reduction of $6.5 million primarily due to lower clinical development expenses [12] - General and administrative (G&A) expenses were $5.3 million for Q1 2025, down from $5.6 million in Q1 2024, reflecting a decrease of $300,000 [13] - Net loss for Q1 2025 was $15.3 million compared to a net loss of $23.2 million in Q1 2024, indicating improved financial performance [13] - Cash and cash equivalents as of March 31, 2025, were $32.4 million, down from $49 million as of December 31, 2024 [13] Business Line Data and Key Metrics Changes - The Phase one dose escalation study for the dual conditionally binding EpCAM and CD3 T cell engager is progressing well, with multiple patients achieving tumor reduction [6] - The MACV ADC demonstrated a two-year landmark survival of 59% in MKRAS non-small cell lung cancer patients, significantly higher than the less than 20% reported for standard care [7] - The OSV ADC showed a 100% disease control rate and a 45% overall response rate in treatment-refractory HPV positive head and neck cancer patients [9] Market Data and Key Metrics Changes - The company is focusing on the HPV positive head and neck cancer segment, which is currently underserved by existing treatments [9] - The overall survival data for MACV across different solid tumor types, including soft tissue sarcomas, indicates a strong market potential for the product [8] Company Strategy and Development Direction - The company is committed to advancing its CAD platform and is focusing on two internal priority programs while seeking partnerships for others [14][42] - Ongoing discussions with potential collaborators aim to maximize the value of the company's assets, particularly in the context of pivotal trials and accelerated approval opportunities [26][44] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the progress of clinical programs and the potential impact of their therapies on patients with challenging solid tumors [15] - The company anticipates that cost reductions from recent restructuring will provide sufficient runway to fund operations and achieve key clinical readouts in the first half of 2026 [14] Other Important Information - The company has received Fast Track designation from the FDA for its OSV program, facilitating discussions regarding treatment options for metastatic HPV positive squamous cell carcinoma [10] - Management highlighted the importance of overall survival as a key metric in evaluating the effectiveness of their therapies compared to standard care [38] Q&A Session Summary Question: Will the poster presentation for the ROAR-two program at ASCO contain an updated data cut? - Yes, there will be an updated data cut including additional safety data and long-term outcomes [20] Question: Any thoughts on a pivotal design for the actual program and options for accelerated approval? - The pivotal trial would likely be randomized against docetaxel in second and third line patients, with FDA guidance supportive of this approach [25][26] Question: Can you provide details on tumor regressions and patient therapy duration for the EpCAM program? - Two patients with colorectal adenocarcinoma have shown extended progression-free intervals, with ongoing dose escalation and no concerning safety issues reported [33][34] Question: What is the ideal partnership structure for the company? - The company seeks multiple partnerships, aiming to maintain substantial value in North America while generating cash value through upfront and near-term milestones [41][44]