Synthetic Biologics, Inc., a clinical-stage company, develops therapeutics to treat diseases in areas of high unmet need. The company's lead product candidates include SYN-004 designed to degrade various commonly used intravenous beta-lactam antibiotics in gastrointestinal (GI) tract for the prevention of microbiome damage, clostridium difficile infection (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR), and acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant recipients; and SYN-020, a recombinant oral formulation for the enzyme intestinal alkaline phosphatase to treat both local GI and systemic diseases. It also develops VCN-01 for the treatment of patients with pancreatic cancer, head and neck squamous cell carcinoma, colorectal cancer, and retinoblastoma. In addition, the company develops clinical stage products, such as SYN-006 to prevent aGVHD and infection by carbapenem resistant enterococci; SYN-007 for preventing antibiotic associated diarrhea with oral ß-lactam antibiotics; SYN-005 for the prevention and treatment of pertussis; and VCN-11 to treat cancer. It has collaborations with Intrexon Corporation, The University of Texas at Austin, and Cedars-Sinai Medical Center; and a clinical trial agreement with Washington University School of Medicine in St. Louis to conduct a Phase 1b/2a clinical trial of SYN-004. Synthetic Biologics, Inc. is headquartered in Rockville, Maryland.
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Here are 1-3 brief analogies for Theriva Biologics (TOVX):
- A smaller, earlier-stage Genentech, but specifically focused on engineering viruses to fight cancer.
- Like an early Gilead Sciences, but instead of focusing on infectious diseases, they're developing engineered viruses to destroy cancer cells.
- A specialized version of Bristol Myers Squibb (BMS) or Merck, aiming to pioneer new cancer immunotherapies using engineered viruses.
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- RP-323 (formerly TAVO™/tavokinogene): An investigational intratumoral gene therapy designed to stimulate anti-tumor immune responses, currently being evaluated for various cancers.
- RP-L323 (formerly TAVO-HPV-DNA): A next-generation gene therapy platform under development, aimed at treating infectious diseases.
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Theriva Biologics (TOVX) - Major Customers
Theriva Biologics (symbol: TOVX) is a clinical-stage oncology company focused on developing viral-based immunotherapies. As a clinical-stage company, it does not currently have commercialized products approved for sale to individuals or other companies. Therefore, it does not have "major customers" in the traditional sense of entities purchasing its products.
Instead, the company's primary revenue sources come from grants and collaboration agreements that fund its research and development activities. Its major funding sources and partners can be considered its "customers" or key collaborators in the context of its business model.
A significant source of funding and collaboration for Theriva Biologics is:
* **California Institute for Regenerative Medicine (CIRM)**: CIRM is a California state agency that funds stem cell research and development with the goal of accelerating treatments for patients. Theriva Biologics has received significant grants from CIRM to support the development of its investigational therapies, particularly for its VCN-01 program. CIRM is a public agency, not a public company, and therefore does not have a stock symbol.
In the future, should Theriva Biologics successfully develop and gain approval for its product candidates, its "customers" would likely transition to larger pharmaceutical companies that would license or acquire its products for commercialization, or healthcare providers and systems that would administer the therapies to patients. However, at its current stage, grants and strategic development collaborations are its primary financial drivers.
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Steven A. Shallcross, Chief Executive Officer, Chief Financial Officer, Director
Steven A. Shallcross has served as Theriva's CEO and Director since 2018, and as CFO since joining the company in 2015. He brings extensive operational, financial, and international biotechnology industry experience, with a proven track record in leading the financial development and strategy for several publicly traded biotech companies. His past appointments include Executive Vice President and CFO of Nuo Therapeutics, Inc., Acting CFO of Senseonics, and CFO and Treasurer of Vanda Pharmaceuticals, Inc. Mr. Shallcross led Vanda Pharmaceuticals through a successful IPO and follow-on offering. He also served as the Chief Financial Officer of Bering Truck Corporation and Executive Vice President and Chief Financial Officer of Innocoll AG. With over 25 years of experience in public and private companies across various sectors, including life sciences, he has been involved in equity and debt transactions that raised over $700 million in capital, including two initial public offerings. He possesses extensive expertise in mergers and acquisitions. Mr. Shallcross holds an MBA from the University of Chicago, Booth School of Business, and a Bachelor of Science degree in Accounting from the University of Illinois, and is a Certified Public Accountant.
Manel Cascallo, PhD, General Director, EU Subsidiary
Manel Cascallo serves as the General Director for Theriva Biologics' EU Subsidiary.
Vince Wacher, PhD, Head of Corporate & Product Development
Vince Wacher is the Head of Corporate & Product Development at Theriva Biologics.
Michael Kaleko, Senior Vice President of Research & Development
Michael Kaleko holds the position of Senior Vice President of Research & Development at Theriva Biologics.
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Theriva Biologics (TOVX) is a clinical-stage company with several product candidates in development. The addressable markets for their main products or services are as follows:
VCN-01 (Oncolytic Adenovirus Platform)
VCN-01 is an oncolytic adenovirus designed to treat cancer, with clinical studies in pancreatic cancer (PDAC), retinoblastoma, and head and neck squamous cell carcinoma.
- Oncolytic Virotherapy Market: The global oncolytic virotherapy market size was valued at USD 26.08 million in 2024 and is projected to reach approximately USD 216.37 million by 2034, demonstrating a Compound Annual Growth Rate (CAGR) of 26.50% from 2025 to 2034.
- Pancreatic Ductal Adenocarcinoma (PDAC): VCN-01 is in a Phase 2 clinical study for the treatment of metastatic pancreatic cancer.
- Retinoblastoma: VCN-01 has received Rare Pediatric Disease Designation from the FDA for the treatment of retinoblastoma.
- Head and Neck Squamous Cell Carcinoma: VCN-01 is also in a Phase 1 clinical study for the treatment of head and neck squamous cell carcinoma. There were an estimated 170,000 incident cases of head and neck cancer across the 7MM (United States, EU4 countries, United Kingdom, and Japan) in 2024, including nearly 150,000 cases of Head and Neck Squamous Cell Carcinoma (HNSCC). The United States accounted for the highest oropharyngeal cancer treatment market size in 7MM in 2024.
SYN-004 (ribaxamase)
SYN-004 (ribaxamase) is an oral therapy intended to degrade certain intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent Clostridioides difficile infection (CDI), antibiotic-associated diarrhea (AAD), the emergence of antimicrobial resistance (AMR), and acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients.
- Clostridioides difficile infection (CDI) Prevention: In the U.S., more than 453,000 patients are diagnosed with CDI annually.
- Acute Graft-Versus-Host-Disease (aGVHD): Approximately 55,000 cases of GvHD occurred in the 7MM in 2024, and these numbers are projected to grow.
SYN-020
SYN-020 is a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) designed to treat both local GI and systemic diseases.
- Digestive Health Market: The global digestive health market size was valued at USD 38.8 billion in 2021 and is projected to reach USD 90.2 billion by 2031, with a CAGR of 8.8% from 2022 to 2031. Other estimates indicate the global digestive health market size was approximately USD 48.4 billion in 2022 and is expected to reach around USD 104 billion by 2032, growing at a CAGR of 8.2% from 2023 to 2032. Additionally, the global digestive health products market size is calculated at USD 51.46 billion in 2024 and is expected to reach around USD 105.48 billion by 2033, growing at a CAGR of 8% from 2024 to 2033. The global digestive health supplements market size was estimated at USD 13.17 billion in 2023 and is projected to reach USD 25.17 billion by 2030, growing at a CAGR of 9.6% from 2024 to 2030.
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Theriva Biologics (TOVX) is a clinical-stage immuno-oncology company focused on developing novel therapeutics for cancer and related diseases. While analysts currently forecast no revenue for the company in 2025, 2026, or 2027, the expected drivers of future revenue growth over the next 2-3 years are centered on the successful advancement and potential commercialization of its pipeline candidates beyond this immediate period, and the establishment of strategic partnerships.
Here are 3-5 expected drivers of Theriva Biologics' future revenue growth:
- Progression and potential commercialization of VCN-01 in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): Theriva Biologics' lead candidate, VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus, has shown promising results in the Phase 2b VIRAGE trial for metastatic PDAC when combined with standard-of-care chemotherapy. Positive topline results announced in May 2025 indicated increased overall survival, progression-free survival, and duration of response. The company has initiated discussions for a Phase 3 trial, and the FDA granted Fast Track designation in May 2024. Successful advancement through Phase 3 and subsequent regulatory approval within the coming years would be a significant driver of future revenue.
- Advancement of VCN-01 for the treatment of Retinoblastoma: VCN-01 has received both Rare Pediatric Disease Designation from the FDA (July 2024) and Orphan Medicinal Product Designation from the European Commission (October 2024) for retinoblastoma. These designations can facilitate accelerated development and review pathways. The completion of a Phase 1 study and ongoing discussions for a potential pivotal trial protocol are critical steps in setting the stage for future revenue generation in this area of high unmet medical need.
- Successful clinical development of SYN-004 (ribaxamase) for the prevention of acute Graft-versus-Host Disease (aGVHD): SYN-004 is an oral beta-lactamase designed to protect the gut microbiome during antibiotic treatment in allogeneic hematopoietic cell transplant (HCT) recipients, aiming to prevent complications like aGVHD. The ongoing Phase 1b/2a clinical trial, with a recommendation to expand to Cohort 3 from the Data and Safety Monitoring Committee, represents continued progress. Positive outcomes and further advancement in clinical development would be crucial for its eventual commercial potential.
- Strategic Partnerships and Collaborations: Theriva Biologics has indicated it is actively seeking strategic partners for the late-stage clinical development of VCN-01. Such partnerships could provide significant non-dilutive funding through upfront payments and milestone payments, which would contribute to the company's financial resources and potentially accelerate the development and commercialization timelines for its pipeline products, leading to future revenue sharing or royalty streams.
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Share Issuance
- In May 2025, Theriva Biologics completed a public offering, generating approximately $7.5 million in gross proceeds through the sale of common stock and accompanying warrants.
- In October 2025, the company executed a warrant inducement agreement, resulting in approximately $4.0 million in gross proceeds from the immediate exercise of existing warrants.
- Through an at-the-market (ATM) offering, Theriva Biologics raised approximately $6.1 million in net proceeds by December 31, 2024, and initiated a new ATM offering of up to $4,019,597 in October 2025.
Inbound Investments
- On January 17, 2025, Theriva Biologics received a loan of approximately $1.48 million from the Spanish government, as part of a larger €2.28 million manufacturing funding award from the National Knowledge Transfer Program.
Capital Expenditures
- Research and development expenses were $12.0 million for the year ended December 31, 2024, decreasing from $14.3 million in 2023. For the second quarter of 2025, R&D expenses were $2.0 million, a decrease from approximately $3.0 million in the same period of 2024.
- The company anticipates an increase in research and development expenditures for completing its VIRAGE Phase 2b and potential Phase 3 clinical trials of VCN-01 in pancreatic cancer, advancing the VCN-01 program in retinoblastoma, and expanding GMP scale-up manufacturing activities for VCN-01.
- Proceeds from a May 2025 public offering and an October 2025 warrant inducement transaction, totaling approximately $7.5 million and $4.0 million respectively, are intended, in part, for working capital, general corporate purposes, research and development, and manufacturing scale-up.
