Theriva Biologics, Inc.

For the year ended December 31, 2023, general and administrative expenses decreased to $7.1 million from $9.9 million in 2022, a 28% decline. Research and development expenses increased to $14.3 million from $11.7 million in 2022, a 22% increase. Other income was $1.442 million in 2023 versus $471,000 in 2022, and cash and cash equivalents were $23.2 million at December 31, 2023 compared with $41.8 million a year earlier. The company did not provide revenue or EPS figures on the call. Forward guidance: VIRAGE enrollment is expected to complete in the first half of 2024; retinoblastoma follow-up is expected to complete in the first half of 2024 and mid-2024, respectively, with an IND discussion likely in 2025; SYN-004 cohort 2 enrollment is expected to complete in the second quarter of 2024; and primary endpoint survival data for VIRAGE is expected next year, with a potential interim analysis later in 2024.

Steven Shallcross emphasized that the company is concentrated on oncology programs with VCN-01 at the center, and he repeatedly framed the opportunity around difficult-to-treat cancers. He said the company is trying to be a good steward of cash while stretching resources to generate as much clinical data as possible, and he expressed confidence that upcoming catalysts can support value creation. His tone was cautiously upbeat, with more emphasis on execution and data generation than on near-term commercial outcomes.

Shallcross, acting as both CEO and CFO on the call, highlighted cost control and the balance between spending and pipeline progress. He said G&A fell to $7.1 million from $9.9 million, while R&D rose to $14.3 million from $11.7 million because of higher VIRAGE clinical trial spending and ongoing work on retinoblastoma, VCN-01 manufacturing, and preclinical discovery. He noted cash and equivalents of $23.2 million at year-end and said that supports a runway into the first quarter of 2025.

Analysts focused on which investigator-sponsored studies looked most promising, when retinoblastoma might reach the next regulatory step, when VIRAGE could produce top-line data, and what the plan is for SYN-004. Management said the head and neck study had the most complete data so far, with signals of safety, biomarker changes, and some long survivals, while retinoblastoma data were still maturing. For VIRAGE, management said enrollment should finish in the first half of 2024, survival readout is not expected until next year, and a possible interim analysis could come later in 2024 if supported by the data. On SYN-004, they said the cohort at Wash U should finish in the near term, after which they will decide whether to advance to a third cohort or whether current data are sufficient for the FDA’s questions.