Core Insights - Theriva Biologics has made significant progress in its oncology pipeline, particularly with VCN-01 for metastatic pancreatic ductal adenocarcinoma (PDAC) and VCN-12, a next-generation oncolytic virus [2][3] Financial Overview - As of September 30, 2025, cash and cash equivalents were $7.5 million, which increased to $15.5 million following recent capital raises, extending the cash runway into Q1 2027 [8] - General and administrative expenses decreased by 18% to $1.9 million for Q3 2025 compared to $2.3 million in Q3 2024, primarily due to reduced compensation costs [5] - Research and development expenses decreased by 7% to $2.6 million for Q3 2025 from approximately $2.7 million in Q3 2024, attributed to lower clinical trial expenses [6] Clinical Development - Expanded data from the VIRAGE Phase 2b trial showed that VCN-01 combined with standard-of-care chemotherapy improved overall survival (OS) and progression-free survival (PFS) in metastatic PDAC patients [3][12] - The company is pursuing regulatory interactions with the European Medicines Agency and the US FDA for a proposed Phase 3 study of VCN-01 plus gemcitabine/nab-paclitaxel as first-line treatment for metastatic PDAC [2] - VCN-12 demonstrated increased cell killing in preclinical studies compared to VCN-01 and showed a similar toxicity profile in animal studies [9] Pipeline and Future Plans - The company is designing a potential Phase 2/3 clinical trial for retinoblastoma, with discussions with regulators anticipated in the first half of 2026 [2] - Ongoing preclinical studies for VCN-12 are expected to confirm its efficacy and safety profile [9]

Financial Data and Key Metrics Changes - As of December 31, 2024, the company reported cash and cash equivalents of $15.9 million [38] - Net cash used in operating activities for 2024 totaled $27 million, a decrease from $28.4 million in 2023 [39] - The net loss for Q4 2024 was $8 million, compared to a net loss of $3.9 million in Q4 2023 [41] - For the full year 2024, net loss totaled $31.7 million, up from $27.8 million in 2023 [41] Business Line Data and Key Metrics Changes - The BRACELET-1 study in breast cancer exceeded expectations, showing a clinically meaningful benefit for patients treated with PELA-based combination therapy compared to chemotherapy alone [11][21] - In the goblet study, a 33% objective response rate was reported in relapsed anal cancer patients [15] Market Data and Key Metrics Changes - The company estimates that approximately 55,000 breast cancer patients in the U.S. could benefit from pelareorep [13][29] - The potential market for pelareorep in breast cancer is projected to reach $2.4 billion in annual sales across the U.S. and major European markets by 2033 [29] Company Strategy and Development Direction - The company is focused on advancing pelareorep for cancer patients, particularly in HR-positive HER2-negative metastatic breast cancer [11] - Plans are in place to initiate a large Phase 2 study of approximately 180 patients to support an accelerated approval submission [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of pelareorep to improve patient outcomes, particularly in difficult-to-treat cancers [42] - The company is actively seeking a new CEO to lead the advancement of pelareorep [10] Other Important Information - The company is collaborating with GCAR and PanCAN for ongoing studies in gastrointestinal cancers, with a $5 million grant from PanCAN for the goblet cohort [33][35] Q&A Session Questions and Answers Question: What are the total costs and timing for the registration-enabling study in metastatic breast cancer? - The company is finalizing the protocol and expects to begin enrollment in the latter half of the year, with an 18-month enrollment period and a six-month data maturity for PFS readout [50] Question: Is there a renaissance in the oncolytic virus space? - Management noted increased interest from pharma and investors in the oncolytic virus space, which is beneficial for the company [56][60] Question: What is the commercial positioning of PELA given the success of ADCs? - The company aims to target patients who progress on ADC therapy, which represents a significant population that will need alternative treatment options [72]

Core Viewpoint - Mustang Bio, Inc. has exited its lease for a manufacturing facility in Worcester, Massachusetts, and divested certain fixed assets to AbbVie for $1.0 million, while relocating its corporate headquarters to Waltham, Massachusetts [1][2]. Group 1: Financial Implications - The termination of the lease is expected to result in approximately $2.0 million in cash expense savings over the next 24 months [2]. - The divestment of fixed assets to AbbVie Bioresearch Center Inc. was completed for a total of $1.0 million [1]. Group 2: Strategic Focus - The company remains committed to advancing its existing portfolio and plans to initiate a novel clinical trial with MB-109, targeting recurrent glioblastoma and high-grade astrocytomas in the second half of 2025 [3]. - MB-109 is a combination therapy that includes MB-101 (IL13Rα2-targeted CAR-T cell therapy) and MB-108 (HSV-1 oncolytic virus), aimed at enhancing the efficacy of CAR-T cell therapy by modifying the tumor microenvironment [4]. Group 3: Company Overview - Mustang Bio is a clinical-stage biopharmaceutical company focused on developing cell therapies for difficult-to-treat cancers, partnering with leading medical institutions to advance CAR-T therapies [5].