Theriva Biologics, Inc. · AMEX:TOVX

Theriva Biologics — Investor Presentation (January 2026)

54 slides from Theriva Biologics's investor presentation, January 2026

  1. Slide 1: Unique Oncolytic Virus Therapies for Multiple Solid Tumors

    Unique Oncolytic Virus Therapies for Multiple Solid Tumors January 2026

  2. Slide 2: Forward Looking Statements

    FORWARD LOOKING STATEMENTS This presentation contains forward -looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 . In some cases forward - looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “ant

  3. Slide 3: Overview

    OVERVIEW • VCN -01 lead candidate undergoing Financial Snapshot Phase 3 clinical trial preparation¹ Exchange NYSE American • First -line metastatic pancreatic cancer • Retinoblastoma (rare pediatric disease) Ticker TOVX • VCN -01 Phase 1 clinical data support Cash (10Nov2025) $15.5M potential in add

  4. Slide 4: VCN-01 Is a Uniquely Engineered Human Adenovirus

    VCN -01 IS A UNIQUELY ENGINEERED HUMAN ADENOVIRUS 5 Designed to have multiple anti -tumor actions VCN -01 targets both primary and Systemic metastatic lesions Virus replicates only in tumor cells Selective Liver detargeted Replicating virus expresses PH20 hyaluronidase -- RGDK Stroma Degrading Expos

  5. Slide 5: Theriva Pipeline

    THERIVA PIPELINE Candidate Target Pre-IND Phase 1 Phase 2 Phase 3 Sites Status* Preparing Phase 3 Pancreatic Cancer (IV) with Multicenter Orphan Drug Designation US, EU gemcitabine/nab-paclitaxel Spain, USA Fast Track Designation US Planning Phase 2/3 Retinoblastoma (IVit) Orphan Drug Designation US

  6. Slide 6: VCN-01 Lead Indication Pancreatic Cancer

    VCN -01 LEAD INDICATION PANCREATIC CANCER Highly fatal cancer protected by dense tumor stroma • Orphan disease, highest mortality of all solid tum ors • Median survival 8 -11 months for metastatic disease 1,2 • USA est. 6 7,440 new cases and 51,980 deaths in 2025 3 • Hyaluronic acid in stroma is ass

  7. Slide 7: VIRAGE Pancreatic Cancer Phase 2b Clinical Trial

    VIR AGE PANCREATIC CANCER PHASE 2B CLINICAL TRIAL Multicenter, open -label, randomized, controlled trial (NCT05673811) • Patients with newly -diagnosed metastatic pancreatic ductal adenocarcinoma ( first line ) • Primary endpoints overall survival , VCN -01 AE profile and tolerability • Secondary en

  8. Slide 8: VIRAGE Phase 2b Trial Key Findings

    VIR AGE PHASE 2B TRIAL KEY FINDINGS Data provide strong support for Phase 3 trial • Enrolled a “real world” population of older and more fragile patients • Increased overall and progression free survival (OS, PFS) and duration of response (DoR) observed in VCN -01 plus gemcitabine/nab -paclitaxel So

  9. Slide 9: VIRAGE Demographics

    VIRAGE DEMOGRAPHICS Parameter Statistics Main Analysis (FAS)¹ Subgroup Analysis (Two Doses VCN-01)² SoC VCN-01 + SoC SoC C4+ 2*VCN-01 + SoC No. Patients (% of cohort) n (%) 48 48 29 (60.4) 34 (70.8) Age (years) Mean (SD) 69.5 (8.25) 66.0 (8.97) 68.1 (8.31) 65.8 (9.71) Median 68.5 66.0 66.0 66.0 <65

  10. Slide 10: Increased Overall Survival in VCN-01+SoC Arm

    INCREASED OVERALL SURVIVAL IN VCN -01+SOC ARM Greater OS improvement with two VCN -01 doses Main Analysis Population¹ Two doses of VCN -01² Median (95% CI) HR (95% CI) Median (95% CI) HR (95% CI) SoC 8.6 (6.9-11.6) Ref. SoC 11.6 (8.6-12.8) Ref. VCN-01+SoC 10.8 (7.4-15.8) 0.57 (0.34-0.96) VCN-01+SoC

  11. Slide 11: Increased Progression-Free Survival in VCN-01+SoC Arm

    INCREASED PROGRESSION -FREE SURVIVAL IN VCN -01+SOC ARM Greater PFS improvement with two VCN -01 doses Main Analysis Population¹ Two doses of VCN -01² Median (95% CI) HR (95% CI) Median (95% CI) HR (95% CI) SoC 4.6 (3.5-6.5) Ref. SoC 7.4 (5.7-8.4) Ref. VCN-01+SoC 7.0 (4.8-11.2) 0.55 (0.34-0.88) VCN-

  12. Slide 12: Duration of Response Doubled in VCN-01+SoC Arm

    DURATION OF RESPONSE DOUBLED IN VCN -01+SOC ARM Increased response rate with two VCN -01 doses Patients who had a Partial or Complete Response¹ Median (95% CI) HR (95% CI) SoC 5.4 (2.0-6.8) Ref. VCN-01+SoC 11.2 (7.4-NE) 0.22 (0.08-0.62) Objective Response Rates (ORR)¹ Logrank P-value: 0.0035 + Censo

  13. Slide 13: VIRAGE Biological Data Support Repeat Dosing

    V IR AGE BIOLOGICAL DATA SUPPORT REPEAT DOSING Circulating viral genomes and NAbs VIRAGE similar after both VCN -01 doses All patients 10 9 262,144 NAbs 10 8 VCN-01 genomes 65,536 Nabs titer (1/X) VG/mL blood 10 7 16,384 10 6 4,096 10 5 10 4 1,024 10 3 0 100 200 300 400 500 600 Days (theoretical) VC

  14. Slide 14: Proposed Phase 3 Trial in Pancreatic Cancer

    PROPOSED PHASE 3 TRIAL IN PANCREATIC CANCER Repeated VCN -01 dosing intended to improve outcomes • Patients with newly -diagnosed metastatic pancreatic ductal adenocarcinoma ( first line ) • Multicenter, double -blinded , placebo -controlled, randomized (1:1), controlled trial • Repeated 3 -month “m

  15. Slide 15: Pursuing Regulatory Agreement on Phase 3 Design

    PURSUING REGULATORY AGREEMENT ON PHASE 3 DESIGN • Positive Scientific Advice from European Medicines Agency (EMA) • Agreed on proposed inclusion/exclusion criteria, primary endpoint (OS), and secondary endpoints (including PFS, DoR, and patient reported outcomes) • Agreed on proposed sample size and

  16. Slide 16: VCN-01 Additional Clinical Activities

    VCN -01 ADDITIONAL CLINICAL ACTIVITIES • Potential Phase 1b study in PDAC to explore more frequent VCN -01 dosing (q2 months) to potentially improve outcomes • Builds on EMA suggestion and recognition of the benefit of multiple VCN -01 doses • VCN -01 dosing q2 months means at least two doses could

  17. Slide 17: Theriva OV Pipeline Discovery and Development

    THERIVA OV PIPELINE DISCOVERY AND DEVELOPMENT Advancing founders’ decades of world leading OV innovation Common Features Product Specific Features Clinically -tested Adenovirus Expressing PH20 Hyaluronidase to Degrade Tumor Stroma VCN -01 Hyaluronidase alone + Additional Transgene Payloads to Enhanc

  18. Slide 18: 2026 Projected Milestones

    2026 PROJECTED MILESTONES VCN -01 FDA EOP2 VIRAGE AACR Presentation VCN -01 PDAC Phase 1 VCN -01 PDAC Phase 3 Phase 3 study design Abstract submitted More frequent dosing, PK/PD If funding obtained VCN -01 Rb FDA Meeting Review Ph 2 -3 study design Potential Out -license VCN -12 candidate VCN -01 CM

  19. Slide 19: Appendix

    APPENDIX © Theriva BIOLOGICS

  20. Slide 20: Seasoned Leadership Team

    SEASONED LEADERSHIP TEAM Steven Shallcross Manel Cascalló PhD Vince Wacher PhD Chief Executive Officer, Chief General Director, EU Subsidiary Head Corporate Development Financial Officer Expertise in oncolytic adenovirus Nearly 30 years leading corporate Served as the Company’s CEO since clinical de

  21. Slide 21: VCN-01 Is a Uniquely Engineered Human Adenovirus

    VCN -01 IS A UNIQUELY ENGINEERED HUMAN ADENOVIRUS 5 SYSTEMIC delivers VCN -01 to the primary tumor and SELECTIVE replication at very high levels lyses tumor 1 metastases and detargets the liver 2 cells directly without harming healthy tissues VCN -01 Tumor Surrounded by STROMA Cancer Associated Stro

  22. Slide 22: VCN-01 Designed to Have Multiple Anti-Tumor Actions

    VCN -01 DESIGNED TO HAVE MULTIPLE ANTI -TUMOR ACTIONS STROMA degradation by PH20 facilitates solid tumor IMMUNOGENIC actions of VCN -01 turn “cold” tumors 3 access and destruction by coadministered cancer therapies 4 “hot” and elicit an anti -tumor immune response PH20 nab -paclitaxel PH20 PH20 PH20

  23. Slide 23: VCN-01 Extensive Clinical Experience

    VCN -01 EXTENSIVE CLINICAL EXPERIENCE 142 patients treated with VCN -01 in multiple indications and combinations Preparing Rb – IVit BRAIN TUMORS – IV (1)* for Phase 3 alone (9) COLORECTAL – IV Alone (15) HEAD & NECK – IV alone (1) HEAD & NECK – IV PANCREATIC - IV ® + Durvalumab (20) + Gemcitabine /

  24. Slide 24: VCN-01 Compared to Other Oncolytic Viruses in Development

    VCN -01 COMPARED TO OTHER ONCOLYTIC VIRUSES IN DEVELOPMENT THERIVA ONCOLYTICS COMPANY CG ONCOLOGY GENELUX REPLIMMUNE BIOLOGICS BIOTECH Ticker NYSE MKT: TOVX NASDAQ: CGON NASDAQ: GNLX NASDAQ:ONCY NASDAQ: REPL Market Cap¹ $3.7M $2.07B $102.3M $48.5M $753.9M Cretostimogene Product VCN-01 Olvi-Vec Pelar

  25. Slide 25: Theriva OV Portfolio Highlights

    THERIVA OV PORTFOLIO HIGHLIGHTS Multiple modes of action, indications and combinations • Highly differentiated OVs designed to have multiple antitumor effects • Systemic administration, selective tumor replication, stroma degradation • Multiple potential value opportunities for lead asset VCN -01 •

  26. Slide 26: VCN-01 in Pancreatic Cancer

    VCN-01 IN PANCREATIC CANCER @ Theriva

  27. Slide 27: Pancreatic Cancer Staging

    PANCREATIC CANCER STAGING PDAC >90% pancreatic cancer¹; median age 67-68 yr; 51% male² Male (per 100,000)³ N. America 9.3; W. Europe 9.9; E. Asia 7.0 Pancreatic Cancer 1-year (5-year) overall survival 24% (9%)³; median 4-6 months² Female (per 100,000)³ N. America 6.9; W. Europe 7.4; E. Asia 4.8 Bord

  28. Slide 28: Pancreatic Cancer Current Treatments

    PANCREATIC CANCER CURRENT TREATMENTS Borderline Locally Advanced Metastatic / Recurrent Status Resectable Resectable (unresectable) (unresectable) Staging¹ Stage I (5%) Stage II (28%) Stage III (11%) Stage IV (56%) Radiotherapy if increases resection margins² First -Line Treatments (m)FOLFIRINOX, NA

  29. Slide 29: Preferred VCN-01 Dosing Regimen Established in Phase 1

    PREFERRED VCN -01 DOSING REGIMEN ESTABLISHED IN PHASE 1 Dose escalation in patients with metastatic pancreatic cancer VCN -01 (1x10 13 vp)¹ SEQUENTIAL nab -Paclitaxel ² Repeat SoC chemotherapy 28-day cycles starting Day 36 Gemcitabine ³ | | | | | | Cycle 1 Day 1 8 15 22 29 36 Encouraging clinical pr

  30. Slide 30: Clinical Data Support VCN-01 Mode-of-Action

    CLINICAL DATA SUPPORT VCN -01 MODE -OF -ACTION Overcomes Neutralizing Antibodies and remodels the tumor matrix and turns “cold” tumors “hot” Persistent replication*: PH20 levels in patient sera Immune markers upregulated in indicate sustained VCN -01 activity in tumors biopsies of hepatic metastases

  31. Slide 31: VIRAGE Enrollment

    VIRAGE ENROLLMENT Parameter Spain USA Total Sites Open 10 7 17 Screened 131 40 171 Screen Failure 42 (32%) 17 (43%) 59 (35%) Randomized 89 23 112 SoC 44 11 55 VCN-01 + SoC 45 12 57 Treated* SoC 41 7 48 VCN-01 + SoC 39 9 48 Standard of care (SoC) is gemcitabine / nab -paclitaxel chemotherapy in repea

  32. Slide 32: VIRAGE Treatment Emergent Adverse Events

    V IR AGE TREATMENT EMERGENT ADVERSE EVENTS VCN -01 related events occurring in ≥5% of patients Preferred Term – No. Patients (%)a,b All Grades Grade 3-4 First Dose Second Dose First Dose Second Dose (n=53) (n=36) (n=53) (n=36) Pyrexia 31 (58.5%) 19 (52.7%) 1 (1.9%) - Nausea 16 (30.2%) 6 (16.6%) - -

  33. Slide 33: VIRAGE Safety Review by Independent DMC

    VIRAGE SAFETY REVIEW BY INDEPENDENT DMC • VIRAGE clinical data was reviewed on two occasions by an independent Data Monitoring Committee (DMC) who noted the following: • Intravenous VCN -01 was well tolerated in patients treated in this study • The most common VCN -01 related AEs (pyrexia, flu -like

  34. Slide 34: VIRAGE Compared to NALIRIFOX NAPOLI 3

    VIRAGE COMPARED TO NALIFIROX NAPOLI 3 Statistics VIRAGE NAPOLI 3¹ Treatment Arm VCN-01+Gem/Nab Gem/Nab NALIRIFOX Gem/Nab Age (years) n 48 48 383 387 Median (range) 66.0 (41-86) 68.5 (52-85) 64 (20-85) 65 (36-82) Sex Female n (%) 25 (52.1) 26 (54.2) 179 (46.7) 157 (40.6) Male n (%) 23 (47.9) 22 (45.8

  35. Slide 35: VCN-01 in Head & Neck Cancer

    @ Theriva VCN-01 IN HEAD & NECK CANCER

  36. Slide 36: VCN-01 IV + Anti-PD-L1 Phase 1 Trial in HNSCC

    VCN -01 IV + ANTI -PD -L1 PHASE 1 TRIAL in HNSCC Multicenter, open -label, dose escalation study (NCT03799744) ✓ Single IV doses of VCN -01 combined with anti -PD -L1 ✓ Patients with metastatic squamous cell carcinoma of the head & neck previously REFRACTORY to anti -PD(L)1 treatment (R/M HNSCC) ✓ E

  37. Slide 37: Extended Survival with VCN-01+Durvalumab

    EXTENDED SURVIVAL with VCN -01+DURVALUMAB Survival correlated with PD -L1 upregulation after VCN -01 treatment • Higher than expected survival (OS) Overall Survival vs CPS in Biopsies at Day 8 despite previous anti -PD(L)1 failure Spearman r = 0.7676 P (2-tailed) = 0.0050 Regimen Median OS (95% CI),

  38. Slide 38: VCN-01 May Sensitize Patients to Subsequent Therapy

    VCN -01 MAY SENSITIZE PATIENTS TO SUBSEQUENT THERAPY Patients responded to subsequent chemotherapy after progressing with VCN -01 + durvalumab ICI Treatment 1st Line after 2nd Line after Current Trial Progression (Pre -trial ) Current Trial Current Trial ARM Median OS post -1st ICI ORR Median PFS Me

  39. Slide 39: AE Profile for the Combination of VCN-01 and Durvalumab

    AE PROFILE FOR THE COMBINATION OF VCN -01 AND DURVALUMAB Most common AEs related to IV VCN -01 [ NCT03799744] Arm I - Concomitant Arm II - Sequential Arm II - Sequential Adverse Reactions (Dose 3,3E12 , n=6)² (Dose 3,3E12 , n=6)³ (Dose 1E13 , n=8)³ CTCAE Grade Grade 1-2 Grade ≥3 Grade 1-2 Grade ≥3 G

  40. Slide 40: VCN-01 Induces Transcriptomic Changes in Tumor Microenvironment

    VCN -01 INDUCES TRANSCRIPTOMIC CHANGES in TUMOR MICROENVIRONMENT RNAseq Analysis in Clinical Samples from HNSCC Patients [NCT03799744] Principal Component Analysis1 Most significant Reactome and KEGG pathways in GSEA (Gene Set Enrichment Analysis) 1 including all the Pre- and Post-treatment samples

  41. Slide 41: VCN-01 Findings in R/M HNSCC

    VCN -01 FINDINGS in R/M HNSCC Data support VCN -01 MOA and immune enhancing effects • VCN -01 has an acceptable adverse event profile when administered prior to durvalumab (Imfinzi ®) • VCN -01 reaches tumors, has sustained replication and PH20 expression • VCN -01 treatment led to downregulation of

  42. Slide 42: VCN-01 in Retinoblastoma

    @ Theriva VCN-01 IN RETINOBLASTOMA

  43. Slide 43: Retinoblastoma, a Rare Pediatric Malignancy

    RETINOBLASTOMA, A RARE PEDIATRIC MALIGNANCY • Retinoblastoma (Rb) is an orphan indication that accounts for ~2 -3% of all childhood cancers¹ • 200 -300 cases each year in the USA, EU² -⁴ • VCN -01 selectivity enables development as an intravitreal treatment for Rb patients • VCN -01 could be used in

  44. Slide 44: VCN-01 in Retinoblastoma

    VCN -01 IN RETINOBLASTOMA • Single center, open -label, dose escalation study of intravitreal (IVit) VCN -01¹ -³ Promising Results in Patients Treated with High Dose VCN -01 • Children aged 1 -12 years (n=9) • Retinoblastoma that is recurrent or refractory to chemotherapy Reduced number and size of

  45. Slide 45: Adverse Event Data for Intravitreal VCN-01

    ADVERSE EVENT DATA FOR INTRAVITREAL VCN -01 Two Intravitreal VCN -01 Doses of 2.0x10 ⁹ or 2.0x10 10 vp per eye¹ Adverse Reaction Pts All Grades Grade ≥3 Selective expression of viral proteins CTCAE grade N n % n % Uveitis 6 2 33% 2 33% Conserved retina Eye oedema 6 1 17% 0 0% Conjunctival hyperemia

  46. Slide 46: VCN-01 Development in Retinoblastoma

    VCN -01 DEVELOPMENT IN RETINOBLASTOMA • Phase 1 ISS Completed H1 2024 • Initial data demonstrate acceptable adverse event profile and one durable complete response • Developing a clinical protocol for an open -label, multinational study • Refractory retinoblastoma patients with vitreous seeds • IVit

  47. Slide 47: VCN-X Next Generation OV Discovery Platform

    VCN -X NEXT GENERATION OV DISCOVERY PLATFORM

  48. Slide 48: Albumin Shield to Enhance OV Systemic Delivery

    ALBUMIN SHIELD to ENHANCE OV SYSTEMIC DELIVERY • Albumin Shield technology protects OVs as they OV Parent oncolytic virus ,² (OV) susceptible to travel to tumors after systemic administration¹ neutralizing antibodies • Albumin Shield modified OVs bind albumin in the patient’s blood to form a protect

  49. Slide 49: Bibliography

    BIBLIOGRAPHY

  50. Slide 50: Theriva Oncolytic Viruses Key Publications

    THERIVA ONCOLYTIC VIRUSES KEY PUBLICATIONS Bayo -Puxan N et al. (2006) Role of the putative heparan sulfate glycosaminoglycan -binding site of the adenovirus type 5 fiber sh aft on liver detargeting and knob - mediated retargeting. J Gen Virol 87:2487 –2495 Bazan -Peregrino M et al. (2021) VCN -01 d

  51. Slide 51: Pancreatic Cancer References

    PANCREATIC CANCER REFERENCES DESCRIPTION, CLASSIFICATION, STAGING, STROMA Balachandran VP et al. (2019) Broadening the impact of immunotherapy to pancreatic cancer: challenges and opportunities. Gast roe nterology 156:2056 -72 Christenson ES et al. (2020) Current and emerging therapies for patients

  52. Slide 52: Retinoblastoma (Rb) References

    RETINOBLASTOMA (Rb) REFERENCES DESCRIPTION, CLASSIFICATION, STAGING American Academy of Ophthalmology. EyeWiki ®. Retinoblastoma. https://eyewiki.org/Retinoblastoma American Cancer Society. Key statistics for retinoblastoma. https://www.cancer.org/cancer/retinoblastoma/about/key -statistics.html Can

  53. Slide 53: OV Company References

    OV COMPANY REFERENCES CG Oncology CG0070 ( cretostimogene grenadenorepvec ) https://cgoncology.com Ramesh N et al. (2006) CG0070, a conditionally replicating granulocyte macrophage colony -stimulating factor -armed oncolytic adenovirus for the treatment of bladder cancer. Clin Cancer Res 12:305 Svat

  54. Slide 54: OV Company References

    OV COMPANY REFERENCES Oncolytics Biotech: Pelareorep (formerly Reolysin ®) https://oncolyticsbiotech.com Arnold D et al. Pelareorep (pela) + atezolizumab ( atezo ) and chemotherapy in first -line (1L) advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients – Results from the GOBLET s

Theriva Biologics — Investor Presentation (January 2026) on 6ix