Financial Data and Key Metrics Changes - The company ended Q1 2025 with a consolidated cash balance of $18.5 million, down from $40.4 million at the end of 2024 [24] - Cash used in operations for Q1 2025 was $25.6 million, reduced from $38.2 million for the same period in 2024 [24] - Revenue for Q1 2025 was $24.1 million, compared to $28 million in Q1 2024, with a net loss of $26.4 million or $1.03 per share, down from a net loss of $63.5 million or $3.04 per share in Q1 2024 [24] Business Line Data and Key Metrics Changes - The company is focusing on operational efficiencies to cut annualized cash burn to below $50 million in the second half of 2025 [21] - Four formal near-term transaction proposals have been received, including a facility sale and significant equity investment, aimed at strengthening the balance sheet [22] Market Data and Key Metrics Changes - Colorectal cancer incidences have doubled in U.S. adults aged 55 from 1995 to 2019, with projections indicating it will become the leading cause of cancer-related death in men by 2030 [8][9] - The company is addressing the urgent need for alternative treatments for colorectal cancer, particularly for younger patients [9][10] Company Strategy and Development Direction - The company is pursuing a regulatory path for its immunotherapy agents, particularly focusing on colorectal cancer and other difficult-to-treat solid tumors [11][19] - The new leadership is committed to accelerating the development of transformative therapies in response to the changing regulatory environment [10][19] - The company is exploring both global and geography-specific licensing agreements to support its development strategy [61] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the new regulatory environment at the FDA, which may favor rapid approval of innovative therapies [10] - The company is confident in the curative potential of its therapies and is focused on delivering breakthrough treatments to patients [27][28] Other Important Information - The company has received proposals that could inject substantial new capital, which would help in monetizing its Emeryville facility [22] - A Type B meeting with the FDA has been formally requested to discuss the potential accelerated approval of its therapies [27] Q&A Session Summary Question: What is the long-term follow-up data from the phase two study? - The median follow-up for the phase one study is 18 months, while the phase two trial has over 12 months of median follow-up, which will be significant for the FDA review [32][33] Question: Are there any updates on the development plan in light of recent data? - The focus remains on colorectal cancer, particularly in refractory disease and the neoadjuvant setting, with plans to expand indications based on emerging data [48][49] Question: What is the status of interactions with the new FDA? - The company has not yet engaged with the new FDA leadership but views the upcoming Type B meeting as an opportunity to present comprehensive data [68][69] Question: How much focus will be on metastatic CRC versus other tumor types? - The primary focus will be on colorectal cancer due to the significant unmet need, but there is also potential in the neoadjuvant setting for other tumor types [70][72] Question: What is the strategy for sharing phase two data with the market? - The company plans to share phase two data in conjunction with the FDA meeting, highlighting the acceptable safety profile observed in recent studies [74]