Theriva Biologics, Inc. · AMEX:TOVX
Theriva Biologics — Technical Presentation (May 2025)
32 slides from Theriva Biologics's technical presentation, May 7, 2025
Slide 1: VIRAGE Phase 2b Clinical Trial of VCN-01 in Pancreatic Cancer
VIRAGE Phase 2b Clinical Trial of VCN - 01 in Pancreatic Cancer 07 May 2025
Slide 2: Forward Looking Statements
2 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,” “
Slide 3: VIRAGE Phase 2 Data Update – Agenda and Speakers
3 VIRAGE PHASE 2 DATA UPDATE – AGENDA AND SPEAKERS Introduction to Theriva and VCN - 01 Steven Shallcross - CEO, CFO, Theriva Biologics, Inc. Pancreatic cancer treatment landscape Manuel Hidalgo Medina, MD, PhD – Chief of Hematology and Medical Oncology, Weill Cornell Medicine/New York - Presbyteria
Slide 4: Theriva Biologics develops unique oncolytic virus therapeutics targeting solid tumors
4 Theriva Biologics develops unique oncolytic virus therapeutics targeting solid tumors VCN - 01 (zabilugene almadenorepvec)
Slide 5: Overview: Financial Snapshot
5 OVERVIEW Financial Snapshot NYSE American Exchange TOVX Ticker $11.6M Cash (12/31/2024) Q3 2025 Projected cash runway 55.8k¹ Average Daily Volume (3M) Rockville, MD / Barcelona, Spain Locations CRC colorectal cancer. HNSCC head and neck squamous cell carcinoma. Rb retinoblastoma. SoC standard of c
Slide 6: Theriva Pipeline
6 THERIVA PIPELINE *Based on Management’s current beliefs and expectations. aGVHD acute graft - vs - host disease; allo - HCT allogeneic hematopoietic ce ll transplant. CSR clinical study report. HNSCC head and neck squamous cell carcinoma. IV intravenous. IVit intravitreal. ¹Final Phase 1b/2a study
Slide 7: VCN-01 Is a Uniquely Engineered Human Adenovirus
7 VCN - 01 IS A UNIQUELY ENGINEERED HUMAN ADENOVIRUS 5 High dose, highly replicating virus designed to destroys cancer cells Replication enhanced by significantly increased E2F binding. E1a - δ24 gene deletion means replication only in cells with a defective Rb - E2F pathway. Fiber shaft RGDK modifi
Slide 8: VCN-01 Is a Uniquely Engineered Human Adenovirus
8 VCN - 01 IS A UNIQUELY ENGINEERED HUMAN ADENOVIRUS 5 Cancer Associated Fibroblast Stroma Tumor Surrounded by STROMA VCN - 01 1 SYSTEMIC delivers VCN - 01 to the primary tumor and metastases and detargets the liver SELECTIVE replication at very high levels lyses tumor cells directly without harming
Slide 9: Designed to Have Multiple Anti-Tumor Actions
9 VCN - 01 DESIGNED TO HAVE MULTIPLE ANTI - TUMOR ACTIONS PH20 PH20 PH20 PH20 PH20 PH20 PH20 PH20 Neoantigen Cancer Associated Fibroblast Stroma STROMA degradation by PH20 facilitates solid tumor access and destruction by coadministered cancer therapies 3 4 IMMUNOGENIC actions of VCN - 01 turn “cold
Slide 10: Extensive Clinical Program
10 VCN - 01 EXTENSIVE CLINICAL PROGRAM 142 patients treated with VCN - 01 to date in multiple indications and combinations HEAD & NECK – IV + Durvalumab (20) PANCREATIC - IV + Gemcitabine / Abraxane ® Phase 1 (26) and Phase 2b (53)* COLORECTAL – IV Alone (15) PANCREATIC - IT + Gemcitabine / Abraxane
Slide 11: Pancreatic Cancer Treatment Landscape
PANCREATIC CANCER TREATMENT LANDSCAP E
Slide 12: Pancreatic Cancer Current Treatments
12 (m)FOLFIRINOX, NALIRIFOX (ECOG 0 - 1) Gemcitabine + nab - Paclitaxel (ECOG 0 - 2) S ingle agent gemcitabine, capecitabine, 5 - FU (ECOG 3 - 4) PANCREATIC CANCER CURRENT TREATMENTS ¹Bengtsson (2020) Sci Rep 10: 16425. ²Used in <20% of PDAC cases. ³Identical to first - line chemotherapy. CPI checkp
Slide 13: VCN-01 in Metastatic Pancreatic Cancer
VCN - 01 IN METASTATIC PANCREATIC CANCER
Slide 14: Lead Indication Pancreatic Cancer
14 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 6,440 new cases and 51,750 deaths in 2024 3 • Hyaluronic acid in stroma i
Slide 15: Preferred Dosing Regimen Established in Phase 1
15 PREFERRED VCN - 01 DOSING REGIMEN ESTABLISHED IN PHASE 1 Dose escalation in patients with metastatic pancreatic cancer ¹Single dose of VCN - 01 administered by 10 min IV infusion. ²nab - Paclitaxel (Abraxane®; 30 min infusion) administered at least 4 hours after VCN - 01. ³Gemcitabine (30 min inf
Slide 16: VIRAGE Pancreatic Cancer Phase 2b Clinical Trial
16 V IR AGE PANCREATIC CANCER PHASE 2B CLINICAL TRIAL Multicenter, open - label, randomized, controlled trial (NCT05673811) • Patients with newly - diagnosed metastatic pancreatic ductal adenocarcinoma ( first line ) • Direct comparison of up to two doses of VCN - 01 with gemcitabine/nab - paclitaxe
Slide 17: VIRAGE Enrollment
17 V IR AGE ENROLLMENT Total USA Spain Parameter 17 7 10 Sites Open 171 40 131 Screened 59 (35%) 17 (43%) 42 (32%) Screen Failure 112 23 89 Randomized 55 11 44 SoC 57 12 45 VCN - 01 + SoC Treated* 48 7 41 SoC 48 9 39 VCN - 01 + SoC Standard of care (SoC) is gemcitabine / nab - paclitaxel chemotherap
Slide 18: VIRAGE Baseline Demographics
18 V IR AGE BASELINE DEMOGRAPHICS Patients who received at least one dose of SoC in each Arm (FAS) Full analysis set (FAS) for ARM I includes patients who received at least one dose of gemcitabine/nab paclitaxel SoC chemotherapy; FAS for ARM II includes patients who received VCN - 01 followed 1 week
Slide 19: Adverse Events by Preferred Term
19 Grade 3 - 4 All Grades Preferred Term – No. Patients (%) a,b Second Dose (n=36) First Dose (n=53) Second Dose (n=36) First Dose (n=53) - 1 (1.9%) 19 (52.7%) 31 (58.5%) Pyrexia - - 6 (16.6%) 16 (30.2%) Nausea 1 (2.8%) 1 (1.9%) 4 (11.1%) 15 (28.3%) Asthenia - - 9 (25.0%) 14 (26.4%) Vomiting - 5 (9.
Slide 20: VIRAGE Safety Review by Independent DMC
20 • 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 illness, vomiting, nausea, and el
Slide 21: Increased Progression-Free Survival in VCN-01 + SoC Arm
21 INCREASED PROGRESSION - FREE SURVIVAL IN VCN - 01+SOC ARM Adj HR (95% CI) Median (95% CI) Events / Total Treatment Arm Ref. 4.6 (3.5 - 6.5) 41 / 48 SoC 0.55 (0.34 - 0.88) 7.0 (4.8 - 11.2) 33 / 48 VCN - 01 + SoC Logrank P - value: 0.0105 + Censor Based on CT scan evaluation by sites. Data are for
Slide 22: Increased Overall Survival in VCN-01 + SoC Arm
22 INCREASED OVERALL SURVIVAL IN VCN - 01+SOC ARM Data are for the Full Analysis Set (FAS) which comprises patients who received at least 1 dose of gemcitabine/nab - paclitaxel (SoC) chemotherapy in each arm. 70.8% of patients in the VCN - 01+SoC arm received 2 doses of VCN - 01. SoC VCN - 01 + SoC
Slide 23: Duration of Response Doubled in VCN-01 + SoC Arm
23 DURATION OF RESPONSE DOUBLED IN VCN - 01+SOC ARM Based on CT scan evaluation by sites. Data are for the Full Analysis Set (FAS) which comprises patients who received at least 1 dose of gemcitabine/nab - paclitaxel (SoC) chemotherapy in each arm. SoC VCN - 01 + SoC Adj HR (95% CI) Median (95% CI)
Slide 24: VIRAGE Analysis of Patients Receiving Two Doses
24 V IR AGE ANALYSIS OF PTS RECEVING TWO VCN - 01 DOSES Evaluate the impact of the second VCN - 01 dose • Measure OS and PFS in patients who initiate the 4 th treatment cycle • ARM I: Cycle 4 of gemcitabine/nab - paclitaxel SoC • ARM II: Second dose of VCN - 01 followed by Cycle 4 of gemcitabine/nab
Slide 25: VIRAGE Demographics Patients Receiving Two Doses
25 V IR AGE DEMOGRAPHICS PTS RECEIVING TWO VCN - 01 DOSES Comparison of patients who started the 4 th treatment cycle Analysis compares patients in ARM II who received a second dose of VCN - 01 followed 1 - week later by the 4 th treatment cycle of gemcitabine/nab - paclitaxel SoC to patients in ARM
Slide 26: Improved PFS in Patients Receiving Two Doses
26 IMPROVED PFS IN PTS RECEIVING TWO VCN - 01 DOSES PFS progression free survival. Based on CT scan evaluation by sites. Analysis compares patients in ARM II who received a second dose of VCN - 01 followed 1 - week later by the 4 th treatment cycle of gemcitabine/nab - paclitaxel SoC to patients in
Slide 27: Improved OS in Patients Receiving Two Doses
27 IMPROVED OS IN PTS RECEIVING TWO VCN - 01 DOSES OS overall survival. Analysis compares patients in ARM II who received a second dose of VCN - 01 followed 1 - week later by the 4 th treatment cycle of gemcitabine/nab - paclitaxel SoC to patients in ARM I who started the 4 th treatment cycle of gem
Slide 28: VIRAGE Results Support Phase 3 Trial in PDAC
28 • Enrolled a “real world” population of older and more fragile patients • Acceptable AE profile consistent with prior VCN - 01 clinical trials • Increased OS, PFS, and DoR in VCN - 01 plus gemcitabine/nab - paclitaxel SoC treatment group compared to SoC alone • Hazard ratios for OS (0.57), PFS (0
Slide 29: Questions and Answers
29 QUESTIONS AND ANSWERS Steven Shallcross CEO, CFO, Theriva Biologics, Inc. Manuel Hidalgo Medina, MD, PhD Chief of Hematology and Medical Oncology, Weill Cornell Medicine/New York - Presbyterian Hospital Mike Pishvaian , MD, PhD Associate Professor of Oncology and Director of Gastrointestinal, Dev
Slide 30: Appendix
APPENDIX © Theriva
Slide 31: References
31 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 disrupts pancreatic cancer stroma an
Slide 32: References: Description, Classification, Staging, Stroma
32 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 with advanced pancreatic
Theriva Biologics — Technical Presentation (May 2025) on 6ix