Financial Data and Key Metrics Changes - The company ended the quarter with a cash balance of $3.2 million, with cash used in operations for the three months ended March 31, 2025, at $1.3 million, reduced from $2.5 million for the same period in 2024 [21] - The net loss for the first quarter of 2025 was $2.8 million or $0.70 per share, compared to a net loss of $3.8 million or $1.10 per share for the first quarter of 2024 [21] Business Line Data and Key Metrics Changes - The company made significant progress in clinical trials, particularly in solid tumors, with new data presented at the AACR IO conference showing immune activation and early clinical activity in patients with second-line gastric cancer [6][10] - The company is advancing its INKT cell therapies in multiple areas, including solid tumors and immune-related diseases, with a focus on acute respiratory distress syndrome (ARDS) and graft versus host disease (GVHD) [15][18] Market Data and Key Metrics Changes - The company is engaging in confidential discussions for proposals that could extend its runway and accelerate its impact in oncology and immunology [7][9] - The company has observed promising survival rates exceeding 70% in critically ill ventilated patients with ARDS, indicating a potential shift in treatment paradigms [16] Company Strategy and Development Direction - The company is focused on advancing its INKT platform in oncology and immunology, with plans to initiate a phase one trial for GVHD and continue developing its CAR NKT and TCR NKT therapies [8][18] - The company aims to diversify capital and reduce dilution through strategic partnerships, which are essential for unlocking the full potential of its technology [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the regulatory path forward, particularly with the FDA's increased receptivity to novel immune-based approaches [17] - The company is committed to advancing its programs rapidly, guided by scientific conviction and a mandate to bring transformative immune-based therapies to patients in need [19] Other Important Information - The company has been selected for probable funding by the National Institute of Allergy and Infectious Diseases, which is expected to provide critical non-dilutive funding [19] - The company is working to make its therapies accessible through well-designed clinical trials and compassionate use programs [17] Q&A Session Summary Question: Duration until complete response observed in testicular cancer patient - Management indicated that the complete response was formally designated at month 24 after the initial treatment, with disease stabilization observed during the 12-month follow-up period [25][26] Question: Status of phase two gastric trial and expected data release - Management confirmed that they are on track for initial efficacy data in the second half of the year, with updates expected by early next year at the latest [29][30] Question: Updates on government funding and potential delays - Management reassured that while there were delays expected, they received formal notification from NIAID regarding probable funding, which remains a high priority for the agency [31][33] Question: Details on GVHD trial and patient enrollment - Management outlined plans to study GVHD in both steroid refractory acute patients and prophylaxis settings, with discussions with regulators imminent [37][39]

Financial Data and Key Metrics Changes - The company ended the quarter with a cash balance of $3.2 million, with cash used in operations for the three months ended March 31, 2025, at $1.3 million, reduced from $2.5 million for the same period in 2024 [22] - The net loss for the first quarter of 2025 was $2.8 million or $0.70 per share, compared to a net loss of $3.8 million or $1.10 per share for the first quarter of 2024 [22] Business Line Data and Key Metrics Changes - The company made significant progress in clinical trials, particularly in solid tumors, with new data presented at the AACR IO conference showing immune activation and early clinical activity in patients with second-line gastric cancer [6][11] - The company is advancing its INKT cell therapies in multiple areas, including solid tumors and immune-related diseases, with a focus on acute respiratory distress syndrome (ARDS) and graft versus host disease (GVHD) [16][19] Market Data and Key Metrics Changes - The company is engaging in confidential discussions for proposals that could extend its runway and accelerate its impact in oncology and immunology [10] - The company has observed promising survival rates exceeding 70% in critically ill ventilated patients with ARDS, indicating the potential to change treatment paradigms [16] Company Strategy and Development Direction - The company is focused on advancing its INKT platform in oncology and immunology, with plans to initiate a phase one trial for GVHD and continue developing its CAR NKT and TCR NKT therapies [19][20] - The company aims to diversify capital, reduce dilution, and accelerate development through external partnerships, reflecting strong external conviction in the value of its INKT platform [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the regulatory path forward, particularly with the FDA's increased receptivity to novel immune-based approaches [17] - The company is committed to advancing its programs rapidly, guided by scientific conviction and a mandate to bring transformative immune-based therapies to patients in need [20] Other Important Information - The company has been able to reduce its operating cash burn by about 47% year on year, preserving its ability to invest in core programs [6] - The company expects to receive formal funding from the National Institute of Allergy and Infectious Diseases (NIAID) by June, which would provide critical non-dilutive funding [20] Q&A Session Summary Question: Regarding the testicular cancer patient, how long after treatment was the complete response observed? - The complete response was formally designated at month 24 after the initial treatment of AGENT-797, with disease stabilization observed during the 12-month follow-up period [25][27] Question: Is the company still on track for initial efficacy data in the phase two gastric trial in the second half of this year? - The company is on target to present initial efficacy data by the end of this year, with ongoing enrollment in the trial [30][31] Question: Any updates on government funding from NIAID? - The company has received reassurance from NIAID regarding probable funding and expects to hear conclusively in June, indicating that NIAID has not been heavily impacted by recent delays [32][33] Question: Can the company provide details on the GVHD trial and patient enrollment? - The company plans to study GVHD in both steroid refractory acute patients and in prophylaxis settings, with discussions with regulators imminent [37][39]