Theriva Biologics Inc
F:SFY
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Theriva Biologics Inc
Theriva Biologics, Inc. is a clinical stage company, which engages in the development of therapeutics to preserve the microbiome to protect and restore the health of patients. The company is headquartered in Rockville, Maryland and currently employs 21 full-time employees. The firm is advancing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patients immune system. The Company’s lead candidates are: VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier; SYN-004 (ribaxamase) which is designed to degrade used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, and SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases.
Theriva Biologics, Inc. is a clinical stage company, which engages in the development of therapeutics to preserve the microbiome to protect and restore the health of patients. The company is headquartered in Rockville, Maryland and currently employs 21 full-time employees. The firm is advancing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patients immune system. The Company’s lead candidates are: VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier; SYN-004 (ribaxamase) which is designed to degrade used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, and SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases.
VIRAGE Trial Progress: Enrollment in the Phase IIb VIRAGE trial for pancreatic cancer (PDAC) is on track to complete in the first half of 2024, with final primary endpoint data (overall survival) expected in mid to late 2025.
Encouraging Clinical Data: Early clinical results from VCN-01, including high response rates and improved survival in difficult-to-treat cancers, are generating optimism and potential for regulatory engagement.
Financials: General and administrative expenses dropped 91% to $212,000 this quarter, but this was an accounting anomaly and future quarters are expected to return to around $2 million.
Cash Position: Cash and cash equivalents stood at $31.2 million as of September 30, 2023, providing runway into the first quarter of 2025.
Regulatory Updates: A meeting with the FDA is scheduled in December to discuss the retinoblastoma program pathway; additional IND filings and next-generation pipeline progress are expected in the first half of 2024.
