Company intends to file an IND in Q4 2026 for its first RedTail lead candidate, CLD-401, a systemically delivered and targeted genetic medicine engineered to deliver high concentrations of IL-15 superagonist to the tumor microenvironment in patients with metastatic disease.Calidi expects to present proof of concept data demonstrating the versatility of the RedTail platform and expanding its oncology platform with new payloads including the simultaneous delivery of tumor-localized BiTEs alongside T-cell ampl ...

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].

As filed with the Securities and Exchange Commission on July 19, 2024. Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Mustang Bio, Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 47-3828760 (I.R.S. Employer Identification Number) 377 Plantation ...

As filed with the Securities and Exchange Commission on April 29, 2024. Registration Statement No. 333-275997 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Mustang Bio, Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 2834 47-3828760 (Primary Standard Industrial Classification Code Number) Identification Number) 377 P ...