Enanta Pharmaceuticals, Inc. · NASDAQ:ENTA
Enanta Pharmaceuticals — Investor Presentation (June 2023)
44 slides from Enanta Pharmaceuticals's investor presentation, Jun 7, 2023
Slide 1: Corporate Presentation June 7, 2023
Company Logo Corporate Presentation June 7, 2023
Slide 2: Forward Looking Statements Disclaimer
Company Logo Forward Looking Statements Disclaimer This presentation contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our research and development programs, our business and the indu
Slide 3: A Proven Approach to Drug Discovery
Company Logo A Proven Approach to Drug Discovery Using a proven, chemistry-driven approach to develop best-in-class small molecule drugs for viral infections Robust Clinical Stage Pipeline RSV: Phase 2 in pediatric patients (RSVPEDs) Phase 2b in adult stem cell transplant patients (RSVTx) Phase 2b i
Slide 4: Our Therapeutic Focus
RSV hMPV COVID-19 HCV HBV Our Therapeutic Focus Leveraging our core strength in Hepatitis C to become a leader in oral treatments for viral infections Several therapeutic areas with goal of building multiple approaches in each
Slide 5: Enanta Pipeline
Company Logo Enanta Pipeline PRODUCT CANDIDATE DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 MARKET Virology: Liver HCV Protease Inhibitor HBV Core Inhibitor Glecaprevir* EDP-514 Company logo EDP-938 RSVPEDs N-Protein Inhibitor EDP-938 RSVTx RSV EDP-938 RSVHR Virology: Respiratory L-Protein Inhibito
Slide 6: Our Therapeutic Focus
Our Therapeutic Focus RSV hMPV COVID-19 HCV HBV Leveraging our core strength in Hepatitis C to become a leader in oral treatments for viral infections Several therapeutic areas with goal of building multiple approaches in each
Slide 7: Respiratory Syncytial Virus (RSV)
Company Logo Respiratory Syncytial Virus (RSV) Causes severe lung infections, including bronchiolitis (infection of small airways in the lungs) and pneumonia (an infection of the lungs). No safe and effective treatments. Higher risk populations for severe illness: Young infants and children Prematur
Slide 8: EDP-938: N-Protein Inhibitor for RSV
Company Logo EDP-938: N-Protein Inhibitor for RSV EDP-938 is the only N-inhibitor in later stage clinical development Non-fusion approach directly targets viral replication vs. entry Granted Fast Track Designation by the FDA Strong preclinical virologic profile Nanomolar inhibitor of both RSV-A and
Slide 9: EDP-938 Robust Antiviral Effect in Human Challenge Model
Company Logo EDP-938 Robust Antiviral Effect in Human Challenge ModelRapid and Sustained Reduction in Viral Load in Both Active Arms Compared to Placebo (71%, 74% ↓AUC; P<0.001) Viral Load (Log10 copies/ml) Mean 0123456 (+-SE) EDP-938 600mg QD (N=25) EDP-938 500mg LD/300mg BID (N=31) Placebo (N=30)
Slide 10: EDP-938 Robust Symptom Reduction in Human Challenge Model
Company Logo EDP-938 Robust Symptom Reduction in Human Challenge ModelRapid and Sustained Attenuation of RSV Symptoms in Both Active Arms Compared to Placebo (68%, 74% ↓AUC; P<0.001) Total Symptom Score Mean (+-SE) EDP-938 600mg QD (N=25) EDP-938 500mg LD/300mg BID (N=31) Placebo (N=30) 012345 01234
Slide 11: EDP-938: Summary of Data Across Completed Clinical Studies
Company Logo EDP-938: Summary of DataAcross Completed Clinical Studies Safety and Pharmacokinetic Summary Generally safe and well-tolerated; AEs infrequent, generally mild, and resolved in follow-up No serious or severe AEs Consistent safety profile observed in approximately 500 subjects exposed to
Slide 12: EDP-938: Potential to be the Leading Antiviral Treatment for RSV
Company Logo EDP-938: Potential to be the Leading Antiviral Treatment for RSV Company logo Company logo Company logo Properties EDP-938 Ziresovir/ AK0529 Sisunatovir/ PF-079235681 Mechanism N inhibitor Fusion inhibitor Fusion inhibitor Pre-clinical Effectiveness After Infection Yes No No Clinical Ef
Slide 13: EDP-938 Development Plans: Treatment for Patients at High-Risk
Company Logo EDP-938 Development Plans: Treatment for Patients at High-Risk for Severe RSV Infection Enanta Pharmaceuticals High-risk populations have reduced RSV immunity, resulting in a higher and Goal: Treat patients at high-risk for developing severe infection leading to hospitalization or death
Slide 14: Ongoing Phase 2 Clinical Trials: RSVPEDs and RSVTx
Company Logo Ongoing Phase 2 Clinical Trials: RSVPEDs and RSVTX RSVPEDS ~90 patients Age 28 days - 36 months Dosed in 2 age cohorts Double-Blinded Treatment Phase 5 days Part 1: MAD in 2 age cohorts Part 2: Selected dose from Part 1 across 2 age cohorts 23 Day Follow-up Enanta Pharmaceuticals Primar
Slide 15: Newest Phase 2b Study: RSVHR (High Risk Populations)
Company Logo Newest Phase 2 Study: RSVHR (High Risk Populations) Enanta Pharmaceuticals RSVHR ~180 adults with at least one of the following: Double-Blinded Treatment Phase 5 days Placebo (QD) COPD Congestive heart 28 Day Follow-up failure 800mg (QD) Asthma* • Age ≥ 65* Day 1 Day 5 Day 33 *The total
Slide 16: EDP-323: RSV L-Protein Inhibitor
Company Logo EDP-323: RSV L-Protein Inhibitor Novel, oral, selective direct-acting antiviral targeting the RSV L-protein Granted Fast Track Designation by the FDA Potential to be used alone or in combination with other classes of RSV inhibitors, such as EDP-938 - Additive to synergistic with F-, N-,
Slide 17: EDP-323 is a Potent Inhibitor of RSV Replication In Vitro
Company Logo EDP-323 is a Potent Inhibitor of RSV Replication In Vitro With Excellent Preclinical Pharmacokinetics Sub-nanomolar inhibition of RSV replication in a range of cell types Enanta Pharmaceuticals ― Active against both major RSV subtypes Virus Cell Type EC90 (nM) RSV-A Long PHAEC ALI 0.27
Slide 18: Human Metapneumovirus (hMPV)
Company Logo Human Metapneumovirus (hMPV) Important cause of respiratory tract infections (RTIs), particularly in children, the elderly and immunocompromised individuals. No approved vaccine or therapeutics available. Enanta Pharmaceuticals Paramyxovirus closely related to RSV ― hMPV replication dep
Slide 19: hMPV/RSV Dual Inhibitor Discovery Program
Company Logo hMPV/RSV Dual Inhibitor Discovery Program Enanta is developing novel, oral, directacting antivirals specifically designed to target both hMPV and RSV Potential for a broader spectrum antiviral – Respiratory infections diagnosed as either hMPV or RSV treated with a single agent Enanta ha
Slide 20: Prototype Dual Inhibitor Blocks Both hMPV and RSV Replication
Company Logo Prototype Dual Inhibitor Blocks Both hMPV and RSV Replication Prototype inhibitor Dual-001 potently blocks replication of both hMPV and RSV, in a dose-dependent manner, in respective mouse models Dual-001 Dosing Period* N = 5-12/ cohort -1 0 1 2 3 4 5 Infect w/virus Endpoint hMPV (A1 GS
Slide 21: Our Therapeutic Focus
RSV hMPV COVID-19 HCV HBV Our Therapeutic Focus Leveraging our core strength in Hepatitis C to become a leader in oral treatments for viral infections Several therapeutic areas with goal of building multiple approaches in each
Slide 22: EDP-235: Oral Protease Inhibitor Designed for COVID-19
Company Logo EDP-235: Oral Protease Inhibitor Designed for COVID-19 • Novel, oral, direct-acting antiviral specifically designed to target the SARS-CoV-2 3CL protease • Potent and selective inhibition of SARS-CoV-2 3CLpro enzyme – Potent inhibition in multiple cellular models • Potent against SARS-C
Slide 23: EDP-235: Highly Potent 3CLpro Inhibitor Retains Activity Against Variants
Company Logo EDP-235: Highly Potent 3CLpro Inhibitor and Retains Activity Against SARS-CoV-2 Variants Assay Variant / Lineage (mutation) Potency (EC90, nM) Biochemical Activity 3CLpro FRET (IC50) Omicron (P132H) [B.1.1.529, BA.2, BA.5, BA.2.75, BQ.1, BQ1.1, XBB.1] Alpha [Original] / Delta* [B.1.617.
Slide 24: EDP-235 is Efficacious in a Ferret Model of COVID-19
Company Logo EDP-235 is Efficacious in a Ferret Model of COVID-19 Antiviral Treatment Effect • EDP-235 treatment of SARS-CoV-2 infected animals resulted in a rapid and robust decline in viral replication Infection N=6 cohort EDP-235 Dosing Period Co-house Monitor contact animals 0 1 2 3 4 5 6 7 8 Da
Slide 25: EDP-235: Phase 1 Safety, Tolerability and Pharmacokinetics
Company Logo Randomized, double-blind, placebo-controlled Phase 1 study in healthy volunteers (n=72) – Single and multiple ascending doses (SAD: 50 – 800mg and MAD: 200 – 800mg once-daily) • Generally safe and well-tolerated up to 400mg for up to 7 days – Majority of AEs were mild, with the most fre
Slide 26: SPRINT: Phase 2 Study for EDP-235 in Non-hospitalized Standard Risk Patients
Company Logo SPRINT: SARS-CoV-2 PRotease INhibitor Treatment Phase 2 Study for EDP-235 in Non-hospitalized Standard Risk Patients 26 Day 1 Day 5 Day 33 28 Day Follow-up Placebo (QD) EDP-235 200mg (QD) EDP-235 400mg (QD) Screening ~200 patients* 1:1:1 Randomization (~66 per group) Double Blinded Trea
Slide 27: SPRINT Phase 2 Results: Conclusions
Company Logo SPRINT Phase 2 Results: Conclusions 27 Safety • EDP-235 was generally safe and well tolerated • Low frequency of adverse events; most were mild in severity – 1.3%, 6.4%, and 2.6% in the EDP-235 200mg, 400mg and placebo arms • No serious adverse events or discontinuations due to adverse
Slide 28: Subtotal Symptom Score: Change from Baseline
Company Logo line chart Subtotal Symptom Score: Change from Baseline (ITT-c population within 3 days of symptom onset; 6 selected symptoms1) 28 1COVID-19 Selected Symptoms: Respiratory: Shortness of Breath, Sore Throat, Stuffy or Runny Nose Systemic: Chills or Shivering, Feeling Hot or Feverish, Hea
Slide 29: Subtotal Symptom Score: Change from Baseline
Company logo Subtotal Symptom Score: Change from Baseline (ITT-c population within 3 days of symptom onset; 6 selected symptoms1) 29 1COVID-19 Selected Symptoms: Respiratory: Shortness of Breath, Sore Throat, Stuffy or Runny Nose Systemic: Chills or Shivering, Feeling Hot or Feverish, Headache • EDP
Slide 30: SPRINT: Symptom Summary
Company Logo SPRINT: Symptom Summary 30 • Improvement in 14 symptom TSS for 400mg EDP-235 compared to placebo: – Statistical significance achieved at multiple timepoints in full ITT-c population – Statistical significance at all time points in a prespecified population enrolled within 3 days of symp
Slide 31: SPRINT: Viral RNA Change from Baseline
Company Logo SPRINT: Viral RNA Change from Baseline ITT-c population within 3 days of symptom onset and nucleocapsid negative • Seropositive: presence of antibodies to COVID, generated by prior natural infection and/or vaccination (≥1) – Natural infection produces antibodies to both nucleocapsid and
Slide 32: COVID Trial Placebo Arms: Change in Viral RNA from Baseline
Company Logo COVID Trial Placebo Arms: Change in Viral RNA from Baseline company logo Rapid decline in viral RNA from nasal swabs in placebo arm of SPRINT was more robust than in placebo arms from other trials of antivirals published to date, indicating this highly immune population rapidly cleared
Slide 33: SPRINT: Virology Summary
Company Logo SPRINT: Virology Summary High degree of nucleocapsid positivity and rapid decline in viral RNA from nasal swabs in placebo arm indicate a highly immune population that quickly cleared virus from the nose • No difference between treatment arms and placebo for viral RNA decline (ITTc) • A
Slide 34: EDP-235 Profile Suggests Potential for Best-in-Class Antiviral
Company Logo EDP-235 Profile Suggests Potential for Best-in-Class Antiviral Treatment for SARS-CoV-2 Infection Preclinical Properties EDP-2351 Nirmatrelvir2 Pomotrelvir3 Ensitrelvir4 Molnupiravir5 Bemnifosbuvir6 Mechanism Protease Protease Protease Protease Polymerase Polymerase Potency (nM)* Enzyme
Slide 35: New Program Developing SARS-CoV-2 PLpro Inhibitors
Company Logo New Program Developing SARS-CoV-2 PLpro Inhibitors Enanta is developing novel, oral, directacting antivirals specifically designed to target the SARS-CoV-2 PLpro – SARS-CoV-2 protease required for viral replication (distinct from 3CLpro) – Acts to suppress the innate immune response • I
Slide 36: Our Therapeutic Focus
Our Therapeutic Focus Leveraging our core strength in Hepatitis C to become a leader in oral treatments for viral infections Several therapeutic areas with goal of building multiple approaches in each RSV hMPV COVID-19 HCV HBV.
Slide 37: Hepatitis B Virus (HBV)
Company Logo Hepatitis B Virus (HBV) Potentially life-threatening liver infection In 2019, hepatitis B resulted in an estimated 820,000 deaths, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer)1 Current treatments rarely give true cures Interferon is ~10% effective, but with
Slide 38: EDP-514: HBV Core Inhibitor
Company Logo EDP-514: HBV Core Inhibitor A novel core inhibitor that displays potent anti-HBV activity at multiple points in the HBV lifecycle Granted Fast Track Designation by the FDA In vitro Potent anti-HBV activity in HBV expressing stable cell lines Capable of preventing the establishment of cc
Slide 39: EDP-514: Two Positive Phase 1b Studies in HBV Patients
Company Logo EDP-514: Two Positive Phase 1b Studies in HBV Patients Randomized, double-blind studies in NUC-suppressed (n=24) or viremic (n=24) HBV patients Patients dosed for 28 days with 200mg, 400mg or 800mg of EDP-514 or placebo EDP-514 was safe and well-tolerated in both patient populations at
Slide 40: Our Therapeutic Focus
Our Therapeutic Focus Leveraging our core strength in Hepatitis C to become a leader in oral treatments for viralinfections Several therapeutic areas with goal of building multiple approaches in each RSVhMPV COVID-19 HCV HBV
Slide 41: Glecaprevir: Our Licensed Protease Inhibitor for Hepatitis C Virus
Company Logo Glecaprevir: Our Licensed Protease Inhibitor for Hepatitis C Virus Product Regimen Enanta Asset Economics* MAVYRET Logo 2-DAA (ABBV) glecaprevir (PI) Double-digit royalty on 50% of net sales Glecaprevir Sales (50% of MAVYRET®net sales) Royalty Rate (annual) Calendar 2023 HCV Royalties $
Slide 42: Financial Highlights
Company Logo Financial Highlights ($In millions except per share amounts) Fiscal Year EndedSept. 30, 2022 Fiscal Quarter Ended Mar. 31, 2023 TotalRevenues $86.2 $17.8 R&D Expenses $164.5 $43.5 G&A Expenses $45.5 $13.8 Net Loss $(121.8) $(37.7) Net Loss per Diluted Common Share $(5.91) $(1.79) Balanc
Slide 43: Key Catalysts 2023
Company Logo Key Catalysts 2023 Virology Respiratory Virology Liver SARS-CoV-2 EDP-235 (3CLpro): Report Phase 2 (SPRINT) data in May 2023 EDP-235 (3CLpro): Pursue partnership for Phase 3 study Respiratory Syncytial Virus EDP-938: Continue Phase 2 recruitment in high-risk patient populations EDP-323:
Slide 44: www.enanta.com
Company Logo www.enanta.com
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