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Theriva Biologics (TOVX) investor relations material

Theriva Biologics Q2 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q2 2025 earnings summary11 Aug, 2025

Executive summary

  • Achieved positive topline results in the VIRAGE Phase 2b trial for VCN-01 in metastatic pancreatic cancer, meeting primary survival and safety endpoints and supporting advancement to Phase 3 planning.

  • VCN-01 showed promising results in a Phase 1 study for refractory retinoblastoma, with favorable safety and antitumor activity, leading to Rare Pediatric Disease and Orphan Drug designations.

  • Strategic focus remains on oncology, with ongoing efforts to out-license or partner legacy GI assets (SYN-004, SYN-020).

  • Initiated strategic outreach for potential partners and began preparing for a Phase 3 clinical trial of VCN-01.

Financial highlights

  • Net loss of $13.1 million for Q2 2025, compared to $8.3 million in Q2 2024; net loss per share: $(1.93) for Q2 2025.

  • General and administrative expenses rose to $11.2 million in Q2 2025, mainly due to a $9.2 million increase in fair value of contingent consideration tied to clinical milestones.

  • Research and development expenses decreased 34% year-over-year to $2.0 million in Q2 2025, reflecting lower clinical trial and manufacturing costs.

  • Cash and cash equivalents were $12.1 million as of June 30, 2025, with an expected cash runway into Q1 2026.

  • Raised $6.9 million net from a May 2025 public offering and received $1.7 million from a Spanish R&D rebate program.

Outlook and guidance

  • Current cash is expected to fund operations into the first quarter of 2026, covering overhead, manufacturing for near-term clinical supply, and limited research.

  • Additional funding is required to initiate Phase 3 trials for VCN-01 and further development of SYN-004 and SYN-020; no committed sources of future financing.

  • Actively pursuing equity or debt financing, partnerships, and licensing arrangements; failure to secure funding may delay or halt development programs.

  • Anticipates increased R&D expenses as VCN-01 advances to Phase 3 and manufacturing scale-up continues.

  • Expanded VIRAGE trial data to be presented at ESMO 2025 Congress in October.

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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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