Vaxart, Inc. · OTC:VXRT
Vaxart — Aviragen Therapeutics — Investor Presentation (January 2017)
36 slides from Vaxart's investor presentation, Jan 9, 2017
Slide 1: Developing Next Generation Direct-Acting Antivirals
AVIRAGEN THERAPEUTICS Developing Next Generation Direct-Acting Antivirals January 2017
Slide 2: Safe Harbor
Safe Harbor This presentation contains forward-looking statements about Aviragen Therapeutics, Inc. and its business, business prospects, strategy and plans, including but not limited to statements regarding anticipated preclinical and clinical drug development activities and timelines and market op
Slide 3: Aviragen Therapeutics Overview
Aviragen Therapeutics Overview = Two Phase 2 clinical trial data readouts in next several weeks > BTA5S85 Phase 2a RSV challenge trial >» Vapendavir Phase 2b SPIRITUS trial for rhinovirus in moderate and severe asthmatics = Additional Phase 2 clinical programs in RV and HPV f = Strong IP portfolio =
Slide 4: Advanced Pipeline of Direct-Acting Antivirals
Advanced Pipeline of Direct-Acting Antivirals Preclinical © Phase? © Phaso2 © Phase _—- Marketed HUMAN RHINOVIRUS, \Vapendavir SPIRITUS: Moderate and severe asthmatics _ TKZZD omtnt CT apt ICES RESPIRATORY SYNCYTIAL VIRUS. BTAS85 - Challenge Study in healthy volunteers Non-Fusion Inhibitor => HUMAN
Slide 5: Vapendavir Development Programs
Vapendavir Development Programs
Slide 6: Vapendavir is Most Advanced Antiviral in Development for Rhinovirus (RV)
Vapendavir is Most Advanced Antiviral in Development for Rhinovirus (RV) = Potent, broad spectrum, orally bioavailable picornavirus capsid binder >» RV, EV-68, EV-71, and polio virus = Indevelopment to treat RV upper and lower respiratory infections = Clinical utility in multiple patient populations
Slide 7: Antiviral Activity Through Capsid Binding
Antiviral Activity Through Capsid Binding Interference with receptor binding ceptor Binding ‘ Release ‘Assembly @ Packaging Inhibit /ranslation Entry/Uncoating e noel Replication —* iy *Receptor= ICAM-1 (Major Group; RV-A & B) LDLR (Minor Group; RV-A) ‘CDHR3 (RV-C) Jacobs 2013 Clin, Microbiol. Rev.,
Slide 8: Positive Proof-of-Concept Antiviral Data - Phase 2a RV Challenge Trial
Positive Proof-of-Concept Antiviral Data - Phase 2a RV Challenge Trial Dose-Dependent Decrease 7 of RV39 Viral Load = Double-blind, in Nasal Washings placebo-controlled, randomized study in 41 healthy volunteers challenged intranasally with RV Slog drop p=0.01 AUC (Days 1-6) PCR Log;oTCIDgq days/mL
Slide 9: RV Infections are Major Factor in the Loss of Asthma Control
RV Infections are Major Factor in the Loss of Asthma Control = Asthma is a major cause of morbidity Asthma and mortality in the U.S. 16 a ae - 239|millionworldwide = 45-80% of asthma exacerbations are 24 million U.S.2 : dj i : associated with respiratory viral 40% infections, 60% are caused by RV 25
Slide 10: Phase 2 Randomized, Double-Blind, Placebo Controlled Study in Asthmatic Adults
Phase 2 Randomized, Double-Blind, Placebo Controlled Study in Asthmatic Adults with Symptomatic RV Infection . 4 Day 1 Day 6 Randomized RV(+) first dose: last dos Day 14 n=155 n=42 (aera n=145 n=51 (Ree) rhino study Jppe 7 {10
Slide 11: WURSS-21 Measures Cold Severity
WURSS-21* Measures Cold Severity Wisconsin Upper Respiratory Symptom Survey 21 Dally Symptom Report = An illness-specific eae wes may bo quality-of-life instrument, oft 2 3 4 6 6 7 Howsekdoyouteeloday? 0 | 0 0 0 0 0 0 © used to measure the Peace atte average severity of your cold symptoms ovr the la
Slide 12: Statistically Significant Reduction in the Severity of Cold Related Symptoms
Statistically Significant Reduction in the ™ Placebo Severity of Cold Related Symptoms 60 50 * 40 > * * 30 * ey 20 * +s ° bb o/s SI A A 12 3 4 5 6 7 8 9 10 11 12 13 14 Day +p <0.05 Mean WURSS-21 Severity Score
Slide 13: Favorable Results on the Primary and Secondary Endpoints
Favorable Results on the Primary and Secondary Endpoints = Statistically significant reduction in the severity of cold related symptoms >» Days 2-4 (p=0.02)* primary endpoint » Days 2-14 (p=0.001) = Strong trends on secondary endpoints © Change in the ACQ-5 © Smaller decrease in FEV1 e Reduced daily
Slide 14: Phase 2b SPIRITUS Trial Design
Phase 2b SPIRITUS Trial Design Multi-center, randomized, double-blind, placebo-controlled dose-ranging study in moderate-to-severe adult asthmatics with symptomatic RV infection anda history of asthma worsening or exacerbation with a cold/upper respiratory infection RV(H) [Oral desing | 264 mg vapen
Slide 15: Asthma Control Questionnaire (ACQ-6)
Asthma Control Questionnaire 6 (ACQ-6) (On average, during the past week, how often ‘were you woken by your asthma during the night? . On average, during the past weak, how bad were your asthma symptoms when you woke upin the moming? . In general, during the past week, how limited ‘ware you in your
Slide 16: Severity of Asthma Symptoms is Correlated with Asthma Control
Severity of Asthma Symptoms is Correlated with Asthma Control fe} i=] > 100 2 0 ° -£ —_— $ s $ > se ‘e Z 104 50° oe . $8 7 090 £2 60 ° O 2° a a . =< * be eee = 20 ‘00 « z5 . Bs 00) —— a 8 : as 3 ra Sm 80 O50 se . 2 B® 6 Oo) 52 40 . = 0° i¢ - 20 = 40 078 076-149 1.8 <075 — 0.76.1.49 8 Aca Aca
Slide 17: Primary and Secondary Endpoints
Primary and Secondary Endpoints m= Primary endpoint — Asthma Control Questionnaire (ACQ-6) >» Least square mean change from study day 1 to study day 14 in ACQ-6 total score > Primary efficacy analysis population is the intent-to-treat infected population >» 80% power to detect a clinically meaningfu
Slide 18: RV is a Common Cause of Exacerbations in COPD
RV is a Common Cause of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) = COPD is a major cause of chronic morbidity and mortality’ >» 10% of the U.S. population has COPD > Fourth leading cause of death = Viruses account for 25-60% of exacerbations either alone or as co- pathogens2+ =
Slide 19: Treatment of RV Infections Represents a $1.5B+ Market Opportunity in the U.S.
U.S, Revenue billions ($) Treatment of RV Infections Represents a $1.5B+ Market Opportunity in the U.S. Adult Moderate - Severe Asthma 1.60 7 1.40 4 1.20 4 1.00 + 0.80 + 0.60 5 0.40 + 0.20 + 0.00 = Pediatric Moderate - Severe Asthma ™Moderate - Severe COPD. Forecast Assumptions’ = US. only ™ Treatme
Slide 20: Rhinovirus (RV) Infections in Hematopoietic Stem Cell Transplant (HSCT) Patients
Rhinovirus (RV) Infections in Hematopoietic Stem Cell Transplant (HSCT) Patients
Slide 21: Hematopoietic Stem Cell Transplant Patients
Hematopoietic Stem Cell Transplant Patients = Post transplantleaves patient susceptible to opportunistic infection > Lack of functional immunity > Infections are a common cause of death in HSCT patients ® 72,000 HSCT’s performed per year in major markets > 25-30% and growing in the U.S. = RV is most
Slide 22: RV is the Most Common Respiratory Viral Infection Among HSCT Patients
RV is the Most Common Respiratory Viral Infection Among HSCT Patients Probability of infection Days after transplantation
Slide 23: Phase 2 Trial: Treatment of RV Infections in HSCT Patients
Phase 2 Trial: Treatment of RV Infections in Hematopoietic Stem Cell Transplant Patients Asymptomatic, non-shedding DeKI@E 528 mg vapendavir bid LEatag Placebo bid Phone visit day 56 B60 72 Visit ilinic visits days 56 and 72) Symptomatic, shedding
Slide 24: Phase 2 Trial: Vapendavir Treatment of RV Infections in HSCT Patients
Phase 2 Trial: Vapendavir Treatment of RV Infections in HSCT Patients = Allogeneic or autologous transplant within last 6 months or HSCT patients at any timepoint post transplant with chronic graft vs host disease requiring systemic treatment m= Primary endpoint > Time-weighted average change from b
Slide 25: Respiratory Development Programs: BTA585
Respirato Developmen Programs BTA585
Slide 26: BTA585 Overview
BTA585 Overview @ Indevelopment to treat potentially life-threatening RSV infections in children >» RSV is the most common cause of acute lower respiratory tract infection >» RSV infection in early childhoodis associated with wheezing later in life > Current standard of care for RSV infected childre
Slide 27: Positive Phase 1a and 1b Safety and PK Results of BTA585
Positive Phase 1a and 1b Safety and PK Results of BTA585 m= Phase 1a - Single ascending oral doses (50, 100, 200, 400, 500, 800 mg; 100 mg food effect) > 10 subjects per cohort (7 active, 3 placebo) m= Phase 1b - Multiple ascending oral doses (100, 400, and 600 mg bid) for seven consecutive days > 1
Slide 28: Phase 2a RSV Challenge Study
Phase 2a RSV Challenge Study ® Randomized, double-blind, placebo controlled trial to evaluate safety, PK, and antiviral activity of BTA585 in healthy adult volunteers challenged intranasally with RSV » 400 or 600 mg BTAS85 twice daily (n = 20/cohort) for seven days » Placebo twice daily for seven da
Slide 29: Treatment of Condyloma Caused by Human Papilloma Virus Types 6 & 11: BTA074
Treatment of Cond ze caused by Human Papilloma Types 6 & 11 © BTAD4 eit
Slide 30: BTA074: First-in-Class Direct-Acting Antiviral Treatment for Condyloma
BTA074: First-in-Class Direct-Acting Antiviral Treatment for Condyloma = HPV infection = Most frequent sexually transmitted viral disease worldwide m= Anogenital warts are the most common clinical manifestation of HPV infection = Highly infectious and transmitted to partner approximately 65% of the
Slide 31: Current Topical Treatments for Condyloma are Suboptimal
Current Topical Treatments for Condyloma are Suboptimal Excessive Local Skin Reactions Veregen® Zyclara® Aldara® o 10 20 30 40 50 60 70 80 Percent Subjects mm Erythema mm Edema lm Erasion/Ulceration * FDA Label (dosing up to 16 weeks) Limited Efficacy * Veregen® Zyleara® Aldara® 0 10 20 3 40 50 6 70
Slide 32: Phase 2 CT4 Trial
Phase 2 CT4 Trial Multi-center, randomized, double-blind, placebo-controlled trial in adult condyloma (anogenital warts) patients a Primary Objective: Pharmacokinetics, safety and tolerability with special focus on local skin reactions = Secondary Objective (efficacy): Complete clearance of baseline
Slide 33: Exciting Year of Clinical Progress
Exciting Year of Clinical Progress 1Q2017 2Q2017 392017 4Q2017 Vapendavir (RV) Phase 2b SPIRITUS trial top-line data Emm@ Initiate Phase 2 trial in HSCT patients Hmmm@ End of Phase 2 meeting with FDA Initiate Phase 3 tial in moderate to severe asthnaticS BTA585 (RSV) FA Fast Track Designation Phase
Slide 34: Financial Strength for Effective Execution
Financial Strength for Effective Execution September 30, 2016 NASDAQ Symbol AVIR Commons Shares Outstanding (primary) 38.6M Cash and short-term investments $58.3 M
Slide 35: Aviragen Therapeutics Overview
Aviragen Therapeutics Overview = TwoPhase 2 clinical trial data readouts in next several weeks >» BTAS85 Phase 2a RSV challenge trial » Vapendavir Phase 2b SPIRITUS trial for rhinovirus in moderate and severe asthmatics = Additional Phase 2 clinical programs in RV and HPV = Strong IP portfolio = Wel
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