Valion Bio, Inc. · NASDAQ:VBIO
Valion Bio — Tivic Health Systems — Q1 2025 Earnings Presentation
16 slides from Valion Bio's earnings presentation, May 15, 2025
Slide 1: A diversified immunotherapeutics company
® Nasdaq: TIVC A diversified immunotherapeutics company 1 ir@tivichealth.com – May 2025 – Jennifer Ernst, CEO, Tivic Health
Slide 2: Safe Harbor
Safe Harbor This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation may be forward-looking statements. Statements regarding our future results of operations and financial position, economic performance, business s
Slide 3: Tivic Transformation 2025
Tivic Transformation 2025 February 12, 2025: Newly licensed Phase III immunotherapy program (TLR5 agonist) - $140MM previously invested in program - Licensing program includes two molecules - Supported by numerous animal and human trials, 60+ patents and patents pending - Phase III for acute radiati
Slide 4: Immunotherapy Market Valued at $182.5B 2023, 10.4% CAGR
Looking forward, a reinvented company Immunotherapy Market Valued at $182.5B 2023, 10.4%CAGR Bioelectronic Immunomodulation via neurologic pathways Biologic Immunomodulation via molecular pathways (1) Immunotherapy Drugs Market Size, https://www.gminsights.com/industry-analysis/immunotherapy-drugs-m
Slide 5: Diverse modalities, scalable portfolio
Looking forward, a reinvented company Diverse modalities, scalable portfolio Subject of licensing program with Statera Biopharma, Inc. Discovery Proof of Concept Phase I Phase II Phase III Commercial * Tivic rights subject to exercise of exclusive Acute Radiation Syndrome license options and additio
Slide 6: TLR5 Program: In-licensing Agreement
Biologic TLR5 Program: In-licensing Agreement • Entolimod and Entolasta are biologic drugs engineered to activate the immune system via toll-like receptor 5 (TLR5) • Over $140MM previously invested in TLR5 program, including funding from DARPA, BARDA, DoD and NASA • Entolimod and Entolasta have unde
Slide 7: 3x Increase in Survival w/one dose, no signs of toxicity
3x Increase in Survival w/one dose, no signs of toxicity 100 100 P < .0 0 0 1 P = .0 0 2 1 P < .0 0 0 1 90 90 6 0 - D a y S u r v iv a l, % 9 5 % C I 80 80 70 E m a x P r e d ic t i o n 70 S u r v iv a l, % 60 60 50 ~3-fold 1 2 0 (N = 2 0 ) survival 50 40 4 0 (N = 2 0 ) 1 0 (N = 2 0 ) increase 40
Slide 8: Key Milestones: Entolimod for Acute Radiation Syndrome
Key Milestones: Entolimod for Acute Radiation Syndrome April 2025 White House & FDA Briefings May 2025 Emergency Use FDA Pre-BLA Emergency Use Stockpile Orders GMP Manufacturing Application(s), Meeting Granted (if (OUS or US) Kick-off US and OUS approved) Stockpile Orders Feb 2025 GMP First GMP Lot
Slide 9: TLR5 Program: Additional Indications
Biologic TLR5 Program: Additional Indications In addition to ARS, Tivic’s licensing agreement comprehends multiple additional indications; provides flexibility in timing of investment. • Neutropenia (acute & chronic) - $20.8B Market by 2032* A condition characterized by an abnormally low number of n
Slide 10: Broad mechanism may offer new protection for cancer patients
Biologic TLR5 Science: Broad mechanism may offer new protection for cancer patients Approved Drugs Currently Approved drugs G-CSF (Neupogen, TLR5 (Entolimod) Neulasta, biosimilars) Bone Marrow Only Bone Marrow & GI Tract Treat After Exposure Treatment & Prevention Additional supportive No Adjunct Ca
Slide 11: Broad mechanism may offer new protection for cancer patients
Biologic TLR5 Science: Broad mechanism may offer new protection for cancer patients Currently Approved drugs New Class G-CSF (Neupogen, TLR5 (Entolimod) Neulasta, biosimilars) Bone Marrow Only Bone Marrow & GI Tract Treat After Exposure Treatment & Prevention Additional supportive No adjunctive care
Slide 12: Vagus Nerve: High-value Medical Target
Bioelectronic Vagus Nerve: High-value Medical Target Vagus Nerve Current VNS Tivic creating approaches are non-invasive surgically VNS option implanted Concept Illustration • Vagus nerve regulates autonomic • Current vagus nerve stimulators • Tivic has demonstrated medical grade, NON-INVASIVE VNS ne
Slide 13: Vagus Nerve Stimulation Market
Bioelectronic Vagus Nerve Stimulation Market Dominant Approach: Tivic Target: Surgically Implanted VNS Medical-grade, Non-Invasive VNS • Rigorous clinical testing • Rigorous clinical testing • FDA regulated and approved • FDA regulated and approved • Prescribed for medical indications • Prescribed f
Slide 14: Cap Table Proforma
Cap Table Proforma As of June 30, 2025 Current Common Stock Equivalents(1) 516M shares Common Stock 878,341 Common Stock Warrants (WAP: $18.44)(2) 430,175 70MM shares 35M shares Common Stock Options (WAP: $219.12) 8,868 Restricted Stock Units Outstanding (insiders) 79,415 Convertible Preferred Share
Slide 15: Diverse modalities, scalable portfolio
Looking forward, a reinvented company Diverse modalities, scalable portfolio Subject of licensing program with Statera Biopharma, Inc. Discovery Proof of Concept Phase I Phase II Phase III Commercial * Tivic rights subject to exercise of exclusive Acute Radiation Syndrome license options and additio
Slide 16: A diversified immunotherapeutics company
® Nasdaq: TIVC A diversified immunotherapeutics company 16 ir@tivichealth.com – May 2025 – Jennifer Ernst, CEO, Tivic Health