Theriva Biologics, Inc. · AMEX:TOVX
Theriva Biologics — Investor Presentation (May 2026)
53 slides from Theriva Biologics's investor presentation, May 2026
Slide 1: Unique Oncolytic Virus Therapies for Multiple Solid Tumors
Unique Oncolytic Virus Therapies for Multiple Solid Tumors May 2026
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
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 (31Mar2026) $14.4M potential in add
Slide 4: Theriva Current Pipeline
THERIVA CURRENT 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 VCN-01 Planning Phase 2/3 Selective, Stroma Retinoblastoma
Slide 5: 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
Slide 6: 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
Slide 7: 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
Slide 8: VCN-01 Extensive Clinical Experience
VCN -01 EXTENSIVE CLINICAL EXPERIENCE 144 patients treated with VCN -01 in multiple indications and combinations • Successful pancreatic Phase 2b • EMA & FDA agreement Phase 3 Rb – IVit BRAIN TUMORS – IV (1)* • On -going partnering efforts alone (11) COLORECTAL – IV Alone (15) HEAD & NECK – IV alone
Slide 9: 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
Slide 10: 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
Slide 11: 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 <
Slide 12: 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%) -
Slide 13: 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
Slide 14: 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-
Slide 15: 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
Slide 16: OS Benefits Consistent Across Different Subgroups
OS BENEFITS CONSISTENT ACROSS DIFFERENT SUBGROUPS OS benefit regardless of hepatic metastases or age group Subgroup GnP VCN-01 + GnP Hazard Ratio for Death (95% Confidence Interval) HR p-value Age nºevents / nº patients < 70 years 17/26 18/33 0.75 (0.39-1.45) 0.391 ≥ 70 years 18/22 9/15 0.39 (0.16-0
Slide 17: 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
Slide 18: VIRAGE Phase 2b Trial Key Findings
V IR 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 S
Slide 19: 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 “macrocycle
Slide 20: Regulatory Alignment on Phase 3 Trial Design
REGULATORY ALIGNMENT ON PHASE 3 TRIAL DESIGN FDA and EMA agreement on critical protocol elements • Agreed on proposed inclusion/exclusion criteria, study arms, primary endpoint (OS) and secondary endpoints (including PFS, ORR) • Agreed on proposed sample size and adaptive trial design with two inter
Slide 21: VCN-01 Additional PDAC Clinical Activities
VCN -01 ADDITIONAL PDAC CLINICAL ACTIVITIES • Phase 2a study to explore feasibility of more frequent VCN -01 dosing to potentially improve outcomes in a Phase 3 trial • Small (n=6 evaluable), single -arm, open -label study at a single center in Spain • VCN -01 administered every 2 months (up to 3 do
Slide 22: Retinoblastoma, a Rare Pediatric Malignancy
RETINOBLASTOMA, A RARE PEDIATRIC MALIGNANCY Potentially lower -cost pathway to market • Retinoblastoma ( Rb ) is an ultrarare orphan indication that accounts for 2 -3% of all childhood cancers¹ • 200 -300 cases each year in the USA, EU • >1,000 cases each year in India, China 2-4 • VCN -01 designed
Slide 23: VCN-01 Development in Retinoblastoma
VCN -01 DEVELOPMENT IN RETINOBLASTOMA Leverage Rare Pediatric Disease Designation • Phase 1 Investigator Sponsored Study Completed H1 2024 • Data in last line/rescue patients demonstrated acceptable AE profile and 3 complete responses • Finalizing a Phase 2 -3 Protocol for Discussion with the FDA •
Slide 24: VCN-01 Phase 1 ISS Last-Line/Rescue Therapy
VCN -01 PHASE 1 ISS Last -Line/Rescue Therapy Promising antitumor activity • Nine children ages 2 -7 with refractory RB ID Dose (vp/eye) x Day Response Follow -Up Day 42 facing imminent enucleation 1 2E09 x D1, 15 SD Enucleation (D44) • Anticipated eye survival 37 -43 days 2 2E10 x D1, 15 PR Enuclea
Slide 25: Safety Data Phase 1 Trial of VCN-01 in Rb
SAFETY DATA PHASE1 TRIAL OF VCN -01 in RB Adverse reactions (events associated with VCN -01, monotherapy) Description/Nature of the event All Grades Grade 3 MedDRA System Organ Class (SOC) (MedDRA PT) n % n % Eye disorders Uveitis 7 78% 4 44% Eye disorders Palpebral edema 1 11% 0 0% Eye disorders Co
Slide 26: VIRAGE-Rb: Proposed Phase 2/3 Trial Design
VIRAGE -RB: PROPOSED PHASE 2/3 TRIAL DESIGN Intravitreal (IVit) VCN -01 plus topotecan (VTOP) in refractory Rb Regression (90%) Recurrence (20%) TARGET POPULATION Children with refractory retinoblastoma and vitreous seeds that have not responded to Refractory First Line IVit TOP treatment with intra
Slide 27: VIRAGE-Rb Proposes Phase 2/3 Trial Timing
VIRAGE -RB PROPOSES PHASE 2/3 TRIAL TIMING • Anticipate a single arm study with estimated N=25 -30 patients¹ • Global patient recruitment with treatment at 3 -4 reference sites (US, Spain, India) • Budget ~$12M (including manufacturing) • Targeting potential approval before 30 Sep 2029 • FDA, EMA su
Slide 28: 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
Slide 29: Milestone Summary
MILESTONE SUMMARY VIRAGE AACR Poster VCN -01 PDAC Phase 2a 20Apr2026 Initiate 3 -dose PK PD VCN -01 CMC Scale -up VCN -01 Rb Phase 2 -3 FDA Meetings, Rb & CMC Contingent on financing If regulatory agreement, financing VCN -12 candidate SYN -004 in allo -HCT Next generation OV* Initiate final Phase1b
Slide 30: Appendix
APPENDIX @ Theriva
Slide 31: Seasoned Leadership Team
SEASONED LEADERSHIP TEAM Steven Shallcross Manel Cascalló PhD Vince Wacher PhD Chief Executive Officer, Chief General Director, EU Subsidiary SVP Corporate & Product Financial Officer Expertise in oncolytic adenovirus Development Served as the Company’s CEO since clinical development, received Over
Slide 32: VCN-01 in Pancreatic Cancer
VCN-01 IN PANCREATIC CANCER © Theriva BIOLOGICS
Slide 33: 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
Slide 34: 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
Slide 35: 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
Slide 36: Phase 1 Data Support VCN-01 Mode-of-Action
PHASE 1 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*
Slide 37: VIRAGE Data Support Immune Mechanism-of-Action
VCN-01+GnP Ov 20 20 Progres GnP 10 10 GnP 0 0 0 3 6 9 12 15 18 21 24 27 0 3 6 9 12 15 18 21 24 27 Time (months) Time (months) VIR AGE DATA SUPPORT IMMUNE MECHANISM -OF -ACTION At risk: At risk: 48 41 32 18 10 3 2 1 1 0 48 34 19 6 4 1 1 0 48 43 36 25 13 10 4 1 1 0 48 37 26 18 9 6 3 1 1 0 FAS Long dur
Slide 38: 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 *Patients received at least one dose of SoC in each arm and comprise the Full
Slide 39: 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
Slide 40: 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
Slide 41: VCN-01 in Retinoblastoma
© Theriva BIOLOGICS VCN-01 IN RETINOBLASTOMA
Slide 42: Retinoblastoma Cases Per Year
Retinoblastoma Cases Per Year (One Retinoblastoma World Map) 120 48 24 46 50 30 26 249 1,037 84 59 147 39 1,611 446 315 189 19 47 70 4 42
Slide 43: Ph1 Trial Design VCN-01 in Rb (HSJD-2015-RB Trial)
PH1 TRIAL DESIGN VCN -01 IN RB (HSJD -2015 -RB TRIAL) • Children (2 -6 years) • Intraocular retinoblastoma who failed conservative therapy and were facing imminent enucleation. Investigator Sponsored Trial • Two intravitreal administrations 2 weeks apart PIs: Jaume Catalá , Guillermo Chantada • Endp
Slide 44: Phase 1 Trial of Intravitreal VCN-01 Demographics
PHASE 1 TRIAL OF INTRAVITREAL VCN -01 DEMOGRAPHICS Low dose High dose 2E+9 vp /eye 2E+10 vp /eye (n=1) (n=8) Age, years Median (Range) 2 3.2 (2 -7) Sex (Male / Female) 0/1 5/3 Weight, Kg Median (Range) 12 16.35 (9.4 -31.0) Height, cm Median 98 103.5 (87 -126) RB1 gene mutation, n Somatic 1 3 Germina
Slide 45: Safety Data Ph1 Trial VCN-01 in Rb
SAFETY DATA Ph1 TRIAL VCN -01 in RB: Staining of VCN -01 viral proteins in healthy retina Patient #1 Patient #8 (germline mutation) Conserved retina Calcified tumor area Conserved retina Tumor area Patient #2 Patient #9 (germline mutation) (germline mutation) Conserved retina Calcified tumor area Co
Slide 46: Preliminary Evidence of Enhanced Activity VCN-01 + Topo-1 Inhibitor
PRELIMINARY EVIDENCE OF ENHANCED ACTIVITY VCN -01 + TOPO -1 INH Patient #3 • 3-years old • Bilateral retinoblastoma (with germline Rb1 mutation), with 1st eye already enucleated. • Previous treatments: - Systemic chemotherapy CBP/VP-16/VCR (followed by intraarterial dosing of topotecan/melphalan). -
Slide 47: Topo-1 Inhibitors Enhance VCN-01 Antitumor Activity
TOPO -1 INHIBITORS ENHANCE VCN -01 ANTITUMOR ACTIVITY Improved ocular survival after intravitreal VCN -01 and Topotecan in intraocular RB Y79 RBT-7 Ocular Survival model model Control 35 days 35 days VCN-01 + TPT 67 days 80 days Two intratumoral (intravitreal) injections of VCN-01 in the left eye in
Slide 48: Bibliography
BIBLIOGRAPHY @ Theriva
Slide 49: Theriva Oncolytic Viruses Key Publications
THERIVA ONCOLYTIC VIRUSES KEY PUBLICATIONS CLINICAL TRIALS Bazan -Peregrino M et al. (2021) VCN -01 disrupts pancreatic cancer stroma and exerts antitumor effects. J ImmunoTher Cancer 9:e003254. Català -Mora J et al. (2025). Poster 161: A Phase I dose -escalation study to assess the oncolytic virus
Slide 50: Theriva Oncolytic Viruses Key Publications
THERIVA ONCOLYTIC VIRUSES KEY PUBLICATIONS PRECLINICAL and MECHANISM OF ACTION Bayo -Puxan N et al. (2006) Role of the putative heparan sulfate glycosaminoglycan -binding site of the adenovirus type 5 fiber shaft on liv er detargeting and knob - mediated retargeting. J Gen Virol 87:2487 –2495 Guedan
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
Slide 52: Pancreatic Cancer References
PANCREATIC CANCER REFERENCES TREATMENT Dotan E et al. (2025) Effect of baseline geriatric and quality of life assessments on treatment outcomes in ECOG -ACRIN EA2186 (G IANT): A randomized phase II study of gemcitabine and nab -paclitaxel compared with 5 -fluorouracil, leucovorin, and liposomal irin
Slide 53: 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