Theriva Biologics TOVX

Theriva Biologics Inc is a diversified clinical stage company developing therapeutics to treat cancer and related diseases. The company shifted its strategic focus to oncology after acquiring Theriva Biologics S L formerly known as VCN Biosciences S L in March 2022. Through this acquisition Theriva Biologics gained access to an oncolytic adenovirus platform designed for intravenous and intravitreal delivery. The lead candidate from this platform is an oncolytic human adenovirus modified to express the enzyme PH20 hyaluronidase which helps the virus and co administered therapies penetrate tumors. Prior to the acquisition the company pursued gastrointestinal disease programs including SYN 004 a ribaxamase formulation intended to degrade intravenous beta lactam antibiotics in the gut and SYN 020 a recombinant oral intestinal alkaline phosphatase aimed at treating local gastrointestinal and systemic conditions. These programs are now being out licensed or partnered to allow Theriva Biologics to concentrate resources on its oncology assets.

Theriva Biologics generates revenue primarily through licensing agreements and milestone payments from partners. In February 2026 the company entered into the Rasayana License Agreement granting Rasayana an exclusive worldwide license to develop manufacture and commercialize SYN 020. Under this agreement Theriva Biologics received an upfront payment of three hundred thousand dollars and is eligible to receive development milestone payments totaling up to sixteen million dollars and sales milestone payments totaling up to twenty two million dollars. Additionally the company is entitled to tiered royalties ranging from low to mid single digits on net sales of SYN 020. The company also pursues value creation options for its SYN 004 asset including out licensing or partnering which may produce future revenue streams. No product sales have been recorded to date as all programs remain in clinical or pre clinical stages.

The company operates through the following segments:

• The oncology segment focuses on the development of oncolytic adenovirus therapies designed for intravenous or intravitreal administration to treat solid tumors. The lead program evaluates an oncolytic human adenovirus engineered to express PH20 hyaluronidase for use in pancreatic cancer head and neck squamous cell carcinoma ovarian cancer colorectal cancer and retinoblastoma. Activities include conducting Phase 1 and Phase 2 clinical trials assessing safety tolerability and biological activity in combination with standard chemotherapies such as gemcitabine and nab paclitaxel. The segment also explores next generation oncolytic viruses incorporating albumin shield technology to evade neutralizing antibodies and enhance tumor penetration.

• The gastrointestinal and microbiome segment develops oral therapies aimed at preserving gut flora and preventing antibiotic related complications. SYN 004 is a ribaxamase formulation designed to degrade intravenous beta lactam antibiotics in the gastrointestinal tract to reduce the risk of Clostridioides difficile infection vancomycin resistant enterococci and acute graft versus host disease in hematopoietic cell transplant recipients. SYN 020 is a recombinant oral intestinal alkaline phosphatase intended to mitigate gastrointestinal inflammation tighten the gut barrier and promote a healthy microbiome. The segment has completed Phase 1 and Phase 2 studies demonstrating safety and proof of concept for both candidates and is pursuing out licensing or partnership opportunities to generate value from these assets.

Theriva Biologics occupies a niche in the biotechnology sector where it combines oncolytic virus engineering with enzyme delivery to overcome tumor stromal barriers. Its focus on intravenous administration distinguishes it from many rivals that rely on direct tumor injection. The company’s proprietary albumin shield technology aims to extend viral circulation in the presence of neutralizing antibodies a capability not universally present among peers. Additionally the orphan drug and fast track designations received for its lead candidate in pancreatic cancer and retinoblastoma provide potential regulatory and market exclusivity advantages. These factors position Theriva Biologics as a specialized developer of systemic oncolytic therapies targeting solid tumors with high unmet need.

Theriva Biologics serves patients with solid tumors such as pancreatic cancer and retinoblastoma as well as individuals undergoing hematopoietic cell transplant who are at risk of gastrointestinal infections. The company’s therapeutic candidates are intended for use by healthcare providers in hospital and outpatient settings. While the filing does not name specific end user customers the target market includes oncology clinics transplant centers and gastrointestinal care facilities.