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10-K2026-03-12· grok-4-1-fast-non-reasoning

TOVX · Theriva Biologics, Inc.

0001104659-26-026767

SEC filing

Summary

Theriva Biologics, Inc. (TOVX), a clinical-stage oncology-focused biotech, reported a FY 2025 net loss of $23.7M, improved from $25.7M in FY 2024, driven by lower R&D expenses of $8.6M versus $12.0M prior year, offset by higher G&A costs of $15.4M from $7.4M. Total operating expenses declined to $24.1M from $26.3M, yielding a $24.1M operating loss. No revenue was generated as the company advances its lead asset VCN-01 through clinical stages without commercialization. Cash used in operations was $16.7M, funded by $18.2M in financing activities including $6.8M ATM offerings, $6.7M stock/warrant proceeds, and $3.9M warrant inducements, resulting in year-end cash of $13.1M and total assets of $38.2M. Stockholders' equity stood at $15.4M after impairments and financings. Balance sheet shows $22.9M liabilities, including $10.0M non-current contingent consideration. With cash runway into Q1 2027, focus remains on VCN-01 Phase 3 planning for PDAC and retinoblastoma amid going concern risks and need for further funding.

Key takeaways

Full analysis

Performance Summary

Theriva Biologics reported FY2025 net loss of $23.7M, an improvement from $25.7M in FY2024, primarily due to R&D expense reduction to $8.6M from $12.0M, though G&A rose to $15.4M from $7.4M. Operating loss narrowed to $24.1M from $26.3M. No revenue generated. Comprehensive loss was $21.8M after $1.9M foreign currency translation gain. Basic/diluted EPS improved to -$2 from -$19 on 12.1M weighted shares. Cash balance $13.1M supports operations to Q1 2027. Total assets $38.2M, equity $15.4M. Auditor notes going concern doubt due to recurring losses and capital needs.

Revenue Analysis

No revenue reported in FY2025 or FY2024 as Theriva remains pre-commercial, focused on clinical-stage assets like VCN-01. Development funded by equity raises: $6.8M ATM, $6.7M stock/warrants, $3.9M inducements. No segment revenue breakdown disclosed; single oncology-focused segment.

Margins & Profitability

N/A - No revenue, thus no gross margins. Operating margin effectively -100% on zero revenue. Expenses: G&A $15.4M (64% of opex), R&D $8.6M (36%). Prior year impairments ($1.3M IPR&D, $5.6M goodwill) absent in 2025. Net loss per share -$2 vs -$19 YoY, reflecting dilution from 12.1M shares vs 1.3M.

Cash Flow & Balance Sheet

Operating cash use $16.7M (net loss $23.7M adjusted for $9.0M contingent consideration change, $5.6M prior goodwill impairment non-cash). Investing outflow $35K (PPE). Financing inflow $18.2M drove $1.4M cash increase to $13.1M + $46K restricted. Total current assets $17.5M; liabilities $22.9M (10% current). Contingent consideration $10.0M (up $3.0M FV change). Loans $1.7M non-current. Equity $15.4M after $373.6M APIC, -$358.7M deficit.

Outlook

Management targets VCN-01 Phase 3 in PDAC/retinoblastoma post-VIRAGE Phase 2b success (OS 10.8 vs 8.6 months). Plans FDA/EMA End-of-Phase 2 meetings H1 2026. Cash funds VIRAGE closeout, manufacturing scale-up, preclinical VCN-12. Seeking partnerships for SYN-004/SYN-020 out-licensing. Risks: funding needs beyond Q1 2027, $5.0M deferred Grifols milestone, going concern. No revenue guidance; profitability post-approval.