Theriva Biologics — Third Quarter 2026 Earnings Summary

Financial Performance:

• General and administrative expenses decreased 51% to $923,000 for the three months ended September 30, 2026, from $1.9 million in the same period in 2025, primarily driven by an $841,000 decrease in the fair value of contingent consideration compared to a $633,000 increase in 2025.
• Research and development expenses decreased 76% to $612,000 for the three months ended September 30, 2026, from approximately $2.6 million in the same period in 2025, due to lower direct expenses from the completion of the VCN-01 Phase 2b PDAC trial, reduced manufacturing costs, and paused SYN-004 trial expenses.
• Net loss for the nine months ended September 30, 2026, was $6.7 million, compared to a net loss of $21.7 million for the same period in 2025.
• Net loss per share for the three months ended September 30, 2026, was $0.03, compared to $0.45 in the same period in 2025.
• Cash and cash equivalents totaled $8.5 million as of September 30, 2026, a decrease of $4.6 million from December 31, 2025.
• Total operating costs and expenses were $1.5 million for the three months ended September 30, 2026, compared to $4.4 million in the same period in 2025.
• Other income was $64,000 for the three months ended September 30, 2026, compared to $79,000 in the same period in 2025.
• Total assets were $31.6 million as of September 30, 2026, down from $38.2 million as of December 31, 2025.
• Total liabilities were $20.8 million as of September 30, 2026, down from $22.9 million as of December 31, 2025.
• Stockholders' equity was $10.8 million as of September 30, 2026, down from $15.4 million as of December 31, 2025.

Guidance and Future Outlook:

• VIRAGE2 trial enrollment is expected to complete in the fourth quarter of 2026.
• Initial pharmacodynamic and safety/tolerability data from the VIRAGE2 trial are anticipated by the third quarter of 2027.
• Results from the VIRAGE2 trial are expected to inform the VCN-01 dosing regimen for future clinical trials, including a potential pivotal Phase 3 clinical trial in metastatic PDAC.
• The Company has a cash runway extending into the first quarter of 2027.
• Additional interactions with the FDA regarding the retinoblastoma clinical trial design are anticipated in the first quarter of 2027.
• The Company is evaluating strategic alternatives intended to maximize value for stockholders.

Business Segments and Product Lines:

• VCN-01 (Metastatic PDAC): Two-thirds of the target number of patients (4) have been dosed in the VIRAGE2 Phase 2a trial evaluating more frequent repeated dosing of VCN-01 in combination with standard-of-care chemotherapy.
• VCN-01 (Metastatic PDAC): Detailed analyses of the VIRAGE Phase 2b trial results were published in Nature Medicine, showing improved overall survival, progression-free survival, and duration of response with repeated dosing compared to chemotherapy alone.
• VCN-01 (Retinoblastoma): Discussions with key opinion leaders and the FDA are ongoing regarding a proposed Phase 2/3 clinical trial of intravitreal VCN-01 combined with intravitreal topotecan for children with refractory/resistant vitreous seeds.
• VCN-01 (Retinoblastoma): VCN-01 holds Orphan Drug Designation from the FDA, Orphan Medicinal Product Designation from the EMA, and Rare Pediatric Disease Designation from the FDA for retinoblastoma.
• VCN-01 (Retinoblastoma): If a Biologics License Application (BLA) for VCN-01 for retinoblastoma is approved by the FDA by September 30, 2029, the Company may be eligible for a Priority Review Voucher.
• SYN-004: The Company completed the sale of SYN-004 (ribaxamase) and related antibiotic-degrading enzyme portfolio to Biossil Labs Inc. in October 2026.
• SYN-004: The sale included a $350,000 upfront payment and eligibility for up to $91 million in aggregate milestones ($3 million regulatory, $88 million sales) plus single-digit royalties on net product sales (capped at $250 million).
• SYN-004: Concurrent with the sale, Theriva amended its Asset Purchase Agreement with PREV ABR LLC, requiring a $140,000 payment to PREV ABR and obligating Theriva to pay 50% of future regulatory/sales milestones, 33 1/3% of royalties, and 50% of other consideration up to an aggregated total of $13 million.

Market and Competitive Landscape:

• The VIRAGE2 trial builds on FDA and EMA recognition of improved survival outcomes in metastatic PDAC patients receiving two doses of VCN-01 administered three months apart.
• The published data supports an immune-mediated mechanism of action for VCN-01 that may enhance anti-tumor effects of coadministered pancreatic cancer therapies.
• The proposed retinoblastoma trial targets an ultra-rare pediatric population with no current treatment options.

Risks and Challenges:

• Actual results may differ materially from expectations due to the ability to finalize protocols for future clinical trials, obtain development funding, and receive milestone or royalty payments from Biossil.
• Risks include the ability to raise capital, enter into strategic alternatives (including mergers), and commence planned clinical trials subject to sufficient financing.
• Potential delays in reaching clinical milestones, patient enrollment challenges, and regulatory approval for commercialization are cited as factors that could impact results.
• Competitor developments could render products obsolete or non-competitive, and the Company faces risks related to maintaining license agreements and patent estate growth.

Management Commentary and Tone:

• CEO Steven A. Shallcross expressed pleasure with clinical progress, noting that VIRAGE2 enrollment and dosing are progressing well.
• Management described the publication of VIRAGE data in Nature Medicine as a "gratifying validation" of VCN-01's novel mode of action and therapeutic potential.
• The asset sale of SYN-004 was characterized as a demonstration of the Company's commitment to deriving value from legacy microbiome programs while focusing on the lead program VCN-01.

Other Key Points:

• The VIRAGE2 trial is designed to evaluate the safety and feasibility of administering at least three doses of VCN-01 given approximately two months apart in combination with standard-of-care chemotherapy, with a target enrollment of 6 evaluable patients.
• A Type C meeting with the FDA on August 31, 2026, provided guidance on endpoints and statistical considerations for the proposed retinoblastoma trial.
• Stock-based compensation expense was $119,000 for the three months ended September 30, 2026, compared to $118,000 in the same period in 2025.
• The Company reported a net loss of $23.7 million for the year ended December 31, 2025.
• Weighted average shares outstanding for the three months ended September 30, 2026, were 45,892,668, compared to 9,676,521 in the same period in 2025.