Here are 1-2 brief analogies for Theriva Biologics (TOVX):

1. Like Moderna or BioNTech, but instead of vaccines, they're developing a pipeline of innovative drugs for conditions like microbiome damage, GI diseases, and cancer.
2. A clinical-stage Gilead Sciences or Amgen, focused on discovering and developing novel therapeutics for unmet medical needs.

• SYN-004: A therapeutic designed to degrade various intravenous beta-lactam antibiotics in the GI tract to prevent microbiome damage, C. difficile infection, pathogenic overgrowth, antimicrobial resistance, and acute graft-versus-host-disease.
• SYN-020: A recombinant oral formulation of intestinal alkaline phosphatase for treating both local GI and systemic diseases.
• VCN-01: A product for the treatment of patients with pancreatic cancer, head and neck squamous cell carcinoma, colorectal cancer, and retinoblastoma.
• SYN-006: Developed to prevent acute graft-versus-host-disease and infection by carbapenem resistant enterococci.
• SYN-007: Aimed at preventing antibiotic associated diarrhea specifically with oral ß-lactam antibiotics.
• SYN-005: Focused on the prevention and treatment of pertussis.
• VCN-11: A clinical stage product developed for treating various types of cancer.

Based on the provided company description, Theriva Biologics (TOVX) is a clinical-stage biopharmaceutical company focused on the research and development of therapeutic product candidates. The company's products are currently in various stages of clinical trials and have not yet been commercialized.

Therefore, Theriva Biologics (TOVX) does not currently have major customers in the traditional sense of selling commercial products to other companies or individuals.

Steven A. Shallcross, Chief Executive Officer, Chief Financial Officer, Director

Steven Shallcross has served as Theriva Biologics' CEO and Director since 2018, and as CFO since joining the company in 2015. He possesses extensive operational, financial, and international biotechnology industry experience, with a track record of leading the financial development and strategy for several publicly traded biotech companies. Previously, Mr. Shallcross was the Executive Vice President and CFO of Nuo Therapeutics, Inc., Acting CFO of Senseonics, and CFO and Treasurer of Vanda Pharmaceuticals, Inc. At Vanda Pharmaceuticals, Inc., he led the company through its initial public offering (IPO) and subsequent follow-on offerings, demonstrating significant public-company finance expertise. He also gained restructuring experience when Nuo Therapeutics, Inc. filed for Chapter 11 in 2016. His career includes CFO roles at Middlebrook Pharmaceuticals (Advancis), Innocoll AG, Empire Petroleum Partners, LLC, and Bering Truck Corporation. Mr. Shallcross holds an MBA from the University of Chicago Booth and a B.S. in Accounting from the University of Illinois, Chicago, and is a CPA.

Manel Cascalló, PhD, General Director, EU Subsidiary

Manel Cascalló serves as the General Director of Theriva Biologics' EU Subsidiary.

Vince Wacher, PhD, Head of Corporate & Product Development

Vince Wacher is the Head of Corporate & Product Development at Theriva Biologics.

The key risks for Theriva Biologics (TOVX) primarily stem from its status as a clinical-stage biopharmaceutical company with no approved products or significant revenue generation.

1. Clinical Trial Failure and Regulatory Approval Risk: Theriva Biologics' business success hinges on the successful outcome of its ongoing and future clinical trials for its product candidates, such as VCN-01 for pancreatic cancer and retinoblastoma, and SYN-004 for preventing acute graft-versus-host-disease (aGVHD). As a clinical-stage company, there is no guarantee that these candidates will demonstrate sufficient safety and efficacy in human trials or ultimately receive regulatory approval from bodies like the FDA or EMA. Failure at any stage of development, or delays in the regulatory process, could significantly impact the company's prospects and financial viability.

2. Funding and Liquidity Risk (Going Concern): The company has a limited operating history in oncology and currently generates no significant product revenue. It has a substantial accumulated deficit and a history of operational losses. Theriva Biologics is reliant on future capital raises to fund its operations, with current cash reserves projected to fund operations only into the first quarter of 2027. This continuous need for additional financing creates a risk of shareholder dilution through equity offerings or the inability to secure sufficient capital, which could impede the advancement of its pipeline and threaten its ability to continue as a going concern.

3. Competition and Market Adoption Risk: Theriva Biologics operates in highly competitive therapeutic areas, including various cancers and gastrointestinal diseases, where established treatments and other pipeline candidates from larger pharmaceutical companies exist. For example, VCN-01's potential benefit in pancreatic cancer Phase 3 trials will be compared against existing standard of care chemotherapies. Even if a product candidate receives regulatory approval, there is no assurance of widespread market acceptance or successful commercialization due to intense competition and the evolving landscape of medical treatments.

The rapid advancement and clinical progression of next-generation oncolytic viruses from competitors, such as Replimune (RPGN), pose a clear emerging threat. Replimune is specifically focused on engineering oncolytic immunotherapies with enhanced anti-tumor immune responses and has lead candidates in late-stage clinical trials. Should these more advanced oncolytic platforms prove broadly superior in efficacy, safety, or applicability across various solid tumors, including those targeted by Theriva Biologics' VCN-01 and VCN-11 programs, they could diminish the market opportunity and competitive positioning for Theriva's oncolytic virus pipeline.

Theriva Biologics (TOVX) develops therapeutics for diseases with high unmet needs. The addressable markets for its main product candidates are detailed below:

SYN-004

• Clostridium difficile infection (CDI) treatment: The global market for Clostridium difficile infection treatment was estimated at approximately USD 2.906 billion in 2024 and is projected to reach USD 5.776 billion by 2035, with a compound annual growth rate (CAGR) of 6.44% during this period. Another estimate places the global market at USD 1,325.1 million in 2025, anticipated to grow to USD 2,059.2 million by 2032 with a CAGR of 6.5%.
• Acute Graft-versus-Host-Disease (aGVHD) treatment: The global Acute Graft-versus-Host Disease market is estimated to be valued at USD 4.07 billion in 2025 and is expected to reach USD 5.46 billion by 2032, growing at a CAGR of 4.3% from 2025 to 2032. The overall Graft Versus Host Disease treatment market in the 7 major markets (7MM) was approximately USD 1,626 million in 2025, with projections to reach USD 3,304 million in 2034.

SYN-020

• Intestinal alkaline phosphatase for local GI and systemic diseases: A specific addressable market size for therapeutic intestinal alkaline phosphatase could not be precisely identified. However, the broader global digestive enzymes market was valued at USD 699.40 million in 2021 and is estimated to reach USD 1.64 billion by 2031, growing at a CAGR of 8.7% from 2022 to 2031. The global phosphatases market, which includes alkaline phosphatase applications beyond therapeutics, was valued at USD 90.13 million in 2025 and is expected to reach USD 194.62 million by 2033, at a CAGR of 10.10%.

VCN-01

• Pancreatic cancer treatment: The global pancreatic cancer treatment market size was valued at approximately USD 3.54 billion in 2024 and is expected to reach around USD 13.93 billion by 2034, growing at a CAGR of roughly 14.68% between 2025 and 2034. Other estimates include a market size of USD 2.92 billion in 2024, projected to reach USD 5.84 billion by 2030, growing at a CAGR of 12.3%.
• Head and neck squamous cell carcinoma (HNSCC) treatment: The global head and neck cancer therapeutics market size was estimated at USD 2.53 billion in 2025 and is projected to reach USD 6.25 billion by 2033, growing at a CAGR of 12.00%. Another source reported the global head and neck squamous cell carcinoma market size was worth around USD 2.35 billion in 2025 and is set to exceed USD 5.46 billion by 2035, registering over 8.8% CAGR.
• Colorectal cancer treatment: The global colorectal cancer therapeutics market size was valued at USD 12.79 billion in 2024 and is expected to be worth around USD 19.95 billion by 2034, at a CAGR of 4.55% from 2025 to 2034. Another valuation for the global market was USD 12.4 billion in 2023, poised to expand at over 4.6% CAGR from 2024 to 2032.
• Retinoblastoma treatment: The global retinoblastoma treatment market size was valued at USD 2.95 billion in 2024 and is estimated to reach USD 4.09 billion by 2033, exhibiting a CAGR of 3.52% from 2025-2033. Another estimate indicates the global market size was around USD 1.6 billion in 2024 and is estimated to grow at 5% CAGR from 2025 to 2034, reaching USD 2.6 billion by 2034.

1. Milestone Payments from SYN-020 Licensing Agreement: Theriva Biologics recently licensed its SYN-020 asset to Rasayana Therapeutics in February 2026. This agreement included an upfront payment (already received) and provides for potential development and regulatory milestones of up to $16 million, along with up to $22 million in sales milestones, and tiered single-digit royalties on net product sales. As Rasayana Therapeutics advances SYN-020 through its clinical development (currently poised to enter Phase 2 testing), the achievement of these milestones could generate significant revenue for Theriva Biologics within the next 2-3 years.
2. Advancement of VCN-01 in Pancreatic Ductal Adenocarcinoma (PDAC) towards Pivotal Phase 3 and Potential Partnerships: VCN-01, Theriva’s lead oncolytic virus candidate, is progressing towards pivotal clinical development for metastatic PDAC. Following positive scientific advice from the European Medicines Agency (EMA) and an End-of-Phase 2 meeting with the FDA planned for the first half of 2026 to finalize the design of a multinational pivotal Phase 3 trial, the advancement of this program is a key value driver. While direct product sales from VCN-01 in PDAC are likely beyond the 2-3 year horizon, the successful progression into a pivotal Phase 3 study significantly enhances the asset's attractiveness for substantial partnering or licensing agreements. Such agreements could include significant upfront and/or milestone payments, thereby driving future revenue growth within the specified timeframe.
3. Advancement of VCN-01 in Retinoblastoma towards Pivotal Phase 2/3 and Potential Partnerships: VCN-01 has received Orphan Drug and Rare Pediatric Disease designations for retinoblastoma. Theriva Biologics plans further interactions with the FDA and EMA in 2026 to refine the design of a potential Phase 2/3 trial for this challenging childhood cancer. Similar to the PDAC program, the successful advancement of VCN-01 into these later-stage clinical trials for retinoblastoma would increase its value and potential for strategic partnerships or licensing deals that could yield milestone payments and contribute to revenue growth over the next 2-3 years.

Share Issuance

• In October 2025, Theriva Biologics issued common stock purchase warrants to institutional investors, with stockholders being asked to approve the issuance of up to 16,184,560 shares upon exercise. If fully exercised for cash at $0.54 per share, these warrants could generate approximately $8.7 million in gross proceeds.
• In September 2024, the company priced a public offering for up to 1,428,600 shares of common stock (or pre-funded warrants) and warrants to purchase an equal number of shares. This offering was expected to generate approximately $2.5 million in gross proceeds, assuming no exercise of the accompanying warrants which had an exercise price of $2.00 per share.
• As of November 2025, the company reported capital raises from a warrant inducement and sales made pursuant to its at-the-market (ATM) facility, contributing to its cash position.

Inbound Investments

• Theriva Biologics licensed its Phase 2-ready asset SYN-020 to Rasayana Therapeutics. This strategic deal includes up to $38 million in potential milestones plus royalties, with Rasayana assuming future development costs for the program.
• A private placement with institutional investors in October 2025 involved the issuance of warrants, which if fully exercised, could bring in approximately $8.7 million in gross proceeds.

Capital Expenditures

• Research and development (R&D) expenses were $8.6 million in 2025, a 28% decrease from the previous year, with a focus on regulatory interactions for potential pivotal clinical trials of VCN-01 in pancreatic ductal adenocarcinoma (PDAC) and retinoblastoma, and planning for VCN-01 manufacturing scale-up activities.
• R&D expenses are anticipated to decrease further in 2026 due to workforce reductions and the completion of the VIRAGE Phase 2b clinical trial of VCN-01.
• In the third quarter of 2025, R&D expenses decreased to $2.6 million from approximately $2.7 million in the prior year, primarily due to lower clinical trial expenses for VCN-01 and SYN-004, offset by higher patent expenses for SYN-020.