intestinal alkaline phosphatase delayed release (SYN-020) / Theriva Bio - LARVOL DELTA

Theriva Biologics Reports First Quarter 2025 Operational Highlights and Financial Results (GlobeNewswire) - "Research and development expenses decreased to $3.0 million for the three months ended March 31, 2025, from approximately $3.5 million for the three months ended March 31, 2024. This decrease of 14% is primarily the result of lower indirect cost related to decreased VCN-01 manufacturing costs and lower clinical trial expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, offset by slightly higher clinical trial expenses related to our VIRAGE Phase 2b clinical trial of VCN-01 in PDAC and higher patent expenses related to SYN-020. We anticipate research and development expense to increase as we complete our VIRAGE Phase 2b clinical trial of VCN-01 and plan for our Phase 3 clinical trial of VCN-01 in PDAC, advance our VCN-01 program in retinoblastoma, expand GMP scale-up manufacturing activities for VCN-01, and continue supporting our other preclinical and discovery initiatives."

Commercial • Gastrointestinal Disorder • Immunology • Pancreatic Ductal Adenocarcinoma • Retinoblastoma

Theriva Biologics Reports Third Quarter 2023 Operational Highlights and Financial Results (GlobeNewswire) - "Research and development expenses increased to $4.0 million for the three months ended September 30, 2023, from approximately $2.6 million for the three months ended September 30, 2022. This increase of 56% is primarily the result of higher clinical trial expenses related to our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, offset by decreased expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, Phase 1a clinical trial of SYN-020, and decreased manufacturing expenses related to our Phase 1a clinical trial of SYN-020.We anticipate research and development expenses to increase as we continue enrollment in our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC and our ongoing Phase 1 clinical trial in retinoblastoma, expand GMP manufacturing activities for VCN-01, and continue supporting our VCN-11 and other preclinical and discovery initiatives."

Commercial • Trial status • Eye Cancer • Gastrointestinal Cancer • Immunology • Inflammation • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Retinoblastoma • Solid Tumor

Multiple Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN 020 (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Synthetic Biologics Inc. | Recruiting ➔ Completed | Trial completion date: Jun 2022 ➔ Mar 2022

Trial completion • Trial completion date • Gastrointestinal Disorder

Multiple Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN 020 (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Synthetic Biologics Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Gastrointestinal Disorder

Pharmacokinetics, Safety, and Tolerability of SYN-020 (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: Synthetic Biologics Inc.; Recruiting ➔ Completed; N=36 ➔ 24

Clinical • Enrollment change • Trial completion • Gastrointestinal Disorder

Multiple Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN 020 (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Synthetic Biologics Inc.

Clinical • New P1 trial • Gastrointestinal Disorder