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Theriva Biologics (TOVX) investor relations material

Theriva Biologics Q3 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 2025 earnings summary12 Nov, 2025

Executive summary

  • Focus shifted to oncology, with VCN-01 as lead candidate for pancreatic cancer and retinoblastoma, following the acquisition of VCN Biosciences.

  • Expanded clinical data for VCN-01 in metastatic PDAC from the VIRAGE Phase 2b trial presented at ESMO 2025, showing improved overall survival and progression-free survival with VCN-01 plus standard chemotherapy compared to chemotherapy alone.

  • Preclinical data for next-generation oncolytic virus VCN-12 presented at ESGCT, demonstrating enhanced cell killing and immune response in animal models.

  • Workforce reduced by 32% to prioritize business development, licensing, and pivotal trial preparation.

  • Cash position increased to $15.5M as of November 2025, expected to fund operations into Q1 2027 following recent capital raises.

Financial highlights

  • Net loss for Q3 2025 was $4.4M ($0.45/share), down from $7.7M ($6.81/share) in Q3 2024.

  • Net loss for the nine months ended September 30, 2025 was $21.7M ($3.38/share), compared to $21.2M ($24.47/share) in the prior year period.

  • General and administrative expenses for Q3 2025 decreased 18% year-over-year to $1.9M, mainly due to lower compensation costs.

  • R&D expenses for Q3 2025 decreased 7% year-over-year to $2.6M, reflecting lower clinical trial costs after completion of the VIRAGE Phase 2b trial.

  • Cash and cash equivalents were $7.5M at September 30, 2025, increasing to $15.5M in early November 2025 due to equity and warrant proceeds.

Outlook and guidance

  • Current cash expected to fund operations into Q1 2027, supporting regulatory, clinical, and preclinical activities, including close-out of VIRAGE trial and VCN-01 manufacturing scale-up.

  • Additional funding required for future Phase 3 trials and further development of SYN-004 and SYN-020; no committed sources of financing for these at present.

  • Strategic focus on advancing VCN-01, with out-licensing or partnering planned for SYN-004 and SYN-020.

  • Plans to discuss Phase 3 VCN-01 trial protocol with US and European regulators and design a Phase 2/3 trial in retinoblastoma for 2026.

  • General and administrative and R&D expenses anticipated to decrease further due to workforce reduction and completion of the VIRAGE trial.

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Frequently asked questions

Theriva Biologics Inc. is a clinical-stage biotechnology company developing novel therapies for cancer and other serious diseases. The company focuses on oncolytic viruses and microbiome-based therapies designed to enhance the effectiveness of existing treatments and improve patient outcomes. Theriva’s pipeline includes investigational products targeting solid tumors, gastrointestinal diseases, and other conditions. The company is headquartered in Rockville, Maryland, and its shares are listed on the NYSE.

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