Recent 8-K filings for TOVX
Highest-materiality recent filing
VIRAGE Phase 2b trial meets primary OS endpoint; VCN-01+SoC mOS 10.8 vs 8.6 months
- VCN-01 + gem/nab-paclitaxel met primary OS endpoint in FAS: median 10.8 vs 8.6 months, HR 0.57 (p=0.034).
- PFS improved: 7.0 vs 4.6 months (HR 0.55, p=0.012) and duration of response doubled (11.2 vs 5.4 months).
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AEMPS authorized VIRAGE2, a Phase 2a trial evaluating at least 3 doses of VCN-01 given 2 months apart with gemcitabine/nab-paclitaxel in first-line metastatic PDAC.
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Theriva Biologics announces VCN-01 Phase 1 HNSCC data showing median OS up to 17.3 months
Median OS 10.3-17.3 months across three arms in heavily pre-treated, immunotherapy-refractory HNSCC patients.
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Theriva Biologics reports Q1 2026 net loss $2.0M, FDA agrees to Phase 3 design for VCN-01 in PDAC
Cash and cash equivalents $14.4M as of March 31, 2026; cash runway into Q1 2027.
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Theriva reports positive VIRAGE Phase 2b data for VCN-01 in pancreatic cancer at AACR 2026
VCN-01 + gemcitabine/nab-paclitaxel improved OS and PFS vs GnP alone in metastatic pancreatic cancer patients.
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Theriva Biologics fails to convene special meeting due to lack of quorum; will call new meeting
Special Meeting on April 9, 2026 lacked quorum; meeting could not convene.
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Theriva Biologics obtains FDA agreement on Phase 3 trial design for VCN-01 in metastatic PDAC
FDA provided general agreement on proposed Phase 3 trial design for VCN-01 plus gemcitabine/nab-paclitaxel.
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Theriva Biologics FY2025 cash $13.1M; licensing deal, EMA guidance on VCN-01 Phase 3
G&A expense rose 109% to $15.4M on $9.0M contingent consideration from VCN-01 trial success.
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Theriva Biologics licenses SYN-020 to Rasayana for $300K upfront, up to $38M milestones
Upfront payment of $300,000 received; eligible for $16M development/regulatory and $22M sales milestones.
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EMA CHMP agreed on Phase 3 design for VCN-01 + gem/nab-paclitaxel vs SoC; primary endpoint overall survival.
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Theriva Biologics Q3 2025 cash $7.5M; raises $8M post-quarter, extends runway into Q1 2027
Cash and equivalents $7.5M at Sep 30; subsequent raises bring to $15.5M at Nov 10, funding ops into Q1 2027.
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VIRAGE Phase 2b trial meets primary OS endpoint; VCN-01+SoC mOS 10.8 vs 8.6 months
VCN-01 + gem/nab-paclitaxel met primary OS endpoint in FAS: median 10.8 vs 8.6 months, HR 0.57 (p=0.034).
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Theriva (TOVX) raises ~$4.4M via warrant exercise at $0.54/share; grants 16.2M new warrants
Entered warrant inducement with existing holders exercising 8,092,280 shares at $0.54 for ~$4.4M gross proceeds.
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Theriva VIRAGE Phase 2b: VCN-01+GA OS 10.8mo (HR0.57, p=0.055), PFS 7.0mo (HR0.55, p=0.011)
In FAS population, VCN-01 + GA improved median OS to 10.8 mo vs 8.6 mo (HR 0.57, p=0.055) and PFS to 7.0 vs 4.6 mo (HR 0.55, p=0.011).
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Board approved restructuring plan to focus on business development and VCN-01 clinical trials for PDAC and retinoblastoma.
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Theriva Biologics reports Q2 2025: VCN-01 Phase 2b success, cash $12.1M, runway into Q1 2026
Positive topline from VIRAGE Phase 2b: VCN-01 plus chemo improved OS, PFS, DOR vs chemo alone in metastatic pancreatic cancer.
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VCN-01 intravitreal injection at 2E+10 vp/eye was well-tolerated; no retinal toxicity or DLTs; main AE Grade 1-2 uveitis.
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Theriva Biologics Q1 2025: VCN-01 Ph2b meets endpoints; cash runway extended into Q1 2026
VCN-01 plus gemcitabine/nab-paclitaxel increased OS, PFS, DOR in mPDAC vs SoC alone in Phase 2b.
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Theriva Biologics closes $7.5M public offering of common stock and warrants
Gross proceeds of ~$7.5M from offering of 6.8M shares (or pre-funded warrants) and common warrants at $1.10/unit.
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Median OS 10.8 vs 8.6 months for VCN-01+SoC vs SoC alone (HR=0.57, p=0.0546).
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Theriva Biologics FY2024 cash $11.6M; VCN-01 Phase 2b data due Q2 2025
Cash and cash equivalents $11.6M as of Dec 31, 2024; expected runway into Q3 2025.
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Theriva Biologics receives FDA guidance for Phase 3 study of VCN-01 in metastatic pancreatic cancer
FDA advised stand-alone Phase 3 study of VCN-01 with gemcitabine/nab-paclitaxel; VIRAGE Phase 2b should not be expanded into Phase 3.
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Theriva Biologics Q3 2024: completes VIRAGE enrollment, cash $16.4M, impairment charges
Completed enrollment of 92 evaluable patients in VIRAGE Phase 2b trial of VCN-01 in metastatic pancreatic ductal adenocarcinoma.
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Theriva shareholders approve 8.9x stock plan share increase and 25x authorized share increase.
Stockholders approved Amendment No. 2 to the 2020 Stock Incentive Plan, increasing the share reserve from 280,000 to 2,500,000 shares.
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European Commission grants orphan designation to VCN-01 for retinoblastoma
Orphan medicinal product designation granted by European Commission for VCN-01 oncolytic adenovirus to treat retinoblastoma.
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DSMC reviewed safety and PK data from Cohort 2 (19 patients) and recommended study proceed to Cohort 3 using cefepime.
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Theriva Biologics closes $2.5M public offering of shares and warrants
Aggregate gross proceeds of approximately $2.5 million from offering of common shares and warrants.
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Target enrollment of 92 evaluable patients (46 per arm) achieved across 15 sites in Spain and USA within 21 months.
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Theriva Biologics awarded €2.28M Spanish government funding for THERICEL cell platform
€1.33M unsecured loan lump sum in Q4 2024; interest 4.015%; repayable over 7 yrs after 3-yr grace.
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Theriva Biologics announces 1-for-25 reverse stock split effective Aug 26, 2024
Reverse split at 1-for-25 ratio; outstanding shares reduce from ~25.1M to ~1.0M.
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Theriva Biologics Q2 2024 cash $16.6M, VIRAGE trial to complete enrollment in Q3
Cash $16.6M as of June 30, 2024 vs $23.2M at Dec 31, 2023; runway into Q2 2025.
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Theriva Biologics receives FDA Rare Pediatric Drug Designation for VCN-01 in retinoblastoma
FDA grants Rare Pediatric Drug Designation for VCN-01, a stroma-degrading oncolytic adenovirus, to treat retinoblastoma.
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Theriva Biologics receives FDA Fast Track Designation for VCN-01 in metastatic pancreatic cancer
FDA granted Fast Track Designation for VCN-01 combined with gemcitabine/nab-paclitaxel for metastatic pancreatic adenocarcinoma.
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Phase 1 trial of intravitreal VCN-01 in 9 evaluable patients with refractory retinoblastoma determined positive by Monitoring Committee.
Earnings & guidance
Materiality & sentiment trend
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