Financial Data and Key Metrics Changes - As of September 30, 2025, cash and cash equivalents were $5.3 million, with a net loss for Q3 2025 of $3.4 million, or $1.16 per share, compared to $4.8 million, or $3.76 per share in Q3 2024 [25][26] - R&D expenses were $1.9 million for Q3 2025, down from $3.3 million in the same period last year, primarily due to the completion of the OVATION 2 study [25][26] - G&A expenses were $1.6 million in Q3 2025, down from $1.7 million in the same period last year [26] Business Line Data and Key Metrics Changes - The OVATION 3 trial is actively recruiting, with strong investigator enthusiasm and enrollment surpassing internal targets [9][12] - The MRD study has seen 25 patients randomized to date, with plans to cap enrollment at 30 patients [19][20] Market Data and Key Metrics Changes - The company is addressing a significant unmet need in ovarian cancer, with 300,000 new cases globally each year and 13,000 deaths annually in the U.S. alone [5][6] - The OVATION 3 trial is designed to meet regulatory expectations for approval in Europe, focusing on overall survival as a primary endpoint [10][50] Company Strategy and Development Direction - The company is focused on advancing its proprietary IL-12 immunotherapy, IMNN-001, through the OVATION 3 pivotal phase III trial [4][5] - The strategy includes a multi-pronged approach to navigate the biotech capital markets, combining non-dilutive partnerships with prudent equity raises [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum of the OVATION 3 trial and the transformative potential of IMNN-001 for ovarian cancer treatment [5][12] - The company is well-positioned to extend its runway through value-enhancing non-dilutive transactions, with cash projected to last through mid-Q1 2026 [23] Other Important Information - The NASDAQ compliance matter is closed, with shareholder equity confirmed above the required threshold [24] - The company has received positive reactions regarding potential partnerships, although no imminent agreements are in place [22] Q&A Session Summary Question: Clarification on interim analysis and approval - Management clarified that positive results in interim analyses could lead to full approval for the group being tested, with the trial continuing for broader indications [32][34] Question: P-value requirements for interim analysis - Management explained that the determination of stopping the trial for efficacy is complex and involves various operating characteristics rather than a fixed P-value [35][36] Question: Pain management protocol for IMNN-001 administration - It was confirmed that a prophylactic pain management protocol is mandated for all patients to ensure comfort during drug administration [38][40] Question: Durability of response and mechanism of action - Management discussed the durability of IL-12 expression and its effects on the immune system, emphasizing the localized delivery of the drug to minimize systemic adverse events [43][46] Question: Update on OVATION 2 trial and site overlap with OVATION 3 - Management indicated that an update on the OVATION 2 trial is expected by the end of the year, and there will be significant overlap in sites between OVATION 2 and OVATION 3 [58][63]