CREATING SMALL MOLECULE DRUGS
FOR VIRAL INFECTIONS AND LIVER DISEASES
Corporate Overview
39th Annual J.P. Morgan Healthcare Conference
January 12, 2021
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 industry in which we operate. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "predict," "potential," "positioned," "seek," "should," "target," "will," "would," and other similar expressions that are predictions of or indicate future events and future trends, as well as other comparable terminology. These forward-looking statements include, but are not limited to, statements about overall trends, royalty revenue trends, research and clinical development plans and prospects, liquidity and capital needs and other statements of expectations, beliefs, future plans and strategies, anticipated events or trends, and similar expressions. These forward-looking statements are based on our management's current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management's beliefs and assumptions. These forward-looking statements are not guarantees of future performance or results and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this presentation may turn out to be inaccurate.
Please refer to the risk factors described or referred to in "Risk Factors" in Enanta's most recent Quarterly Report on Form 10-Q, and other periodic reports filed with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this presentation. These statements speak only as of the date of this presentation, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.
© ENANTA Pharmaceuticals, Inc. 2021 | 2
A Unique Approach to Drug Discovery
Using a proven, chemistry-driven approach to develop best-in-class small molecule drugs for virology and liver disease
Robust Clinical Stage Pipeline
RSV: Phase 2b in adult patients (RSVP)
Phase 2b in adult stem cell transplant patients (RSVPTx) Phase 2 in pediatric patients (RSVPEDs)
NASH: Phase 2b (ARGON-2)
Phase 1 (Follow-on FXR agonist) HBV: Two Phase 1b studies (core inhibitor)
Proven Track Record of Success
Strong Balance Sheet
Glecaprevir - HCV protease inhibitor in MAVYRET®/MAVIRET® $122M in fiscal 2020 royalties on HCV regimens
Strong balance sheet and royalties to fund robust pipeline $419M in cash at 9/30/20
© ENANTA Pharmaceuticals, Inc. 2021 | 3
Our Therapeutic Focus
RSV hMPV
COVID-19HBV
HCV NASH
Leveraging our core strength in Hepatitis C to become a leader in oral treatments for viral infections and liver diseases
Several new therapeutic areas with goal of building multiple approaches in each
© ENANTA Pharmaceuticals, Inc. 2021 | 4
Enanta Pipeline
PRODUCT CANDIDATE | DISCOVERY PRECLINICAL | PHASE 1 | PHASE 2 | PHASE 3 | MARKET |
Glecaprevir-containingpan-genotypic2-DAA combo
EDP-938EDP-938EDP-938
EDP-514EDP-514EDP-721
RSVP
RSVPEDs in Q1 2021
RSVTx
Viremic HBV patients
NUC-suppressed HBV patients
EDP-305
EDP-297
ARGON-2
* Fixed-dose combination contains glecaprevir and AbbVie's NS5A inhibitor, pibrentasvir. Marketed as MAVYRET (U.S.) and MAVIRET (ex-U.S.)
© ENANTA Pharmaceuticals, Inc. 2021 | 5
Our Therapeutic Focus
RSV hMPV
COVID-19HBV
HCV NASH
Leveraging our core strength in Hepatitis C to become a leader in oral treatments for viral infections and liver diseases
Several new therapeutic areas with goal of building multiple approaches in each
© ENANTA Pharmaceuticals, Inc. 2021 | 6
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 include:
- Premature babies
- Older adults, especially those 65 years and older
- People with chronic lung disease or certain heart problems
- People with weakened immune systems (e.g. HIV, organ transplant, chemotherapy)
RSV at a Glance
Children < 5 years | Adults > 65 years | |
33M global cases | ||
3M global hospitalizations | 177K US hospitalizations | |
120K global deaths | 14K US deaths | |
2.1M US outpatient visits | ||
Sources: Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, et al. The burden of respiratory syncytial virus infection in young children.New Engl J Med. 2009;360(6):588-98.; Falsey AR, Hennessey PA, Formica MA, Cox C, Walsh EE.Respiratory syncytial virus infection in elderly andhigh-riskadults.New Engl J Med. 2005;352(17):1749-59.; Shi et al.Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study.Lancet. 2017 Sep 2; 390(10098): 946-958.
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EDP-938:N-Protein Inhibitor for RSV
- EDP-938is the only N-inhibitor under clinical evaluation
- Non-fusionapproach directly targets viral replication vs. entry
- Granted Fast Track Designation by FDA
- Strong preclinical virological profile:
- Nanomolar inhibitor of both RSV-A and RSV-B activity
- Maintained antiviral potency across all clinical isolates tested
- Demonstrated high-barrier to resistance in vitro
- Synergy with other drug mechanisms (e.g. fusion and L inhibitors)
- Active against virus variants resistant to other mechanisms
- Robust in vivo efficacy data
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EDP-938 Development Program
Phase 1 Results
- Safe and well tolerated, no SAEs, AEs were mild
- At Phase 2 doses, mean trough levels 30x higher than EC90 of EDP- 938 against RSV-infected human cells
Phase 2a Challenge Study Results
- Primary and key secondary efficacy endpoints were achieved (p<0.001) at both dose levels after 5 days of dosing
- Primary endpoint: Reduction in area under the curve (AUC) viral load in the intent-to-treat-infected population (ITT-I)
- Secondary endpoint: Reduction in Total Symptom Score (TSS)
- Mean Ctrough concentrations were approximately >20-40x higher than EC90
- Well tolerated with safety profiles similar to placebo
- Consistent profile observed in >250 subjects exposed to EDP-938 for up to 7 days in Phase 1 and Phase 2a
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Robust Antiviral Effect
Rapid and Sustained Reduction in Viral Load in Both Active Arms Compared to Placebo (71%, 74% ↓ AUC; P<0.001)
Days After First Dose
Dosing Period
First Dose
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Robust Symptom Reduction
Rapid and Sustained Attenuation of RSV Symptoms in Both Active Arms Compared to Placebo (68%, 74% ↓ AUC; P<0.001)
Days After First Dose
Dosing Period
First Dose
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RSVP - A Phase 2b Study of EDP-938 in Adult Outpatients with RSV
Double-Blinded
Treatment Phase
5 days
•
Placebo (QD)
~70 Adults | 9 Day Follow-up | |
(≤75yo) | ||
EDP-938 800 mg (QD)* |
•
Day 1 | Day 5 | Day 14 |
Primary Objective:
Effect of EDP-938 on progression of RSV infection by assessment of clinical symptoms measured over the 14-day study period
Secondary Objective:
Antiviral efficacy, safety and PK of EDP-938
*Equivalent to 600mg suspension dosage form used in challenge study
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Enanta is Prepared for When RSV Returns
- Current RSV season in Northern Hemisphere has not begun due to continuing COVID-19 mitigation measures
- Modeling predicts large future outbreaks of RSV1
- Caused by an increase in susceptible RSV population, resulting from ongoing mitigation measures
- Assuming measures are reduced, a peak in infections are projected for the next RSV seasons
- Enanta is ready to move quicky upon RSV re-emergence
- Number of clinical sites more than doubled with expansion in EU and Asia-Pacific (total of ~150 sites globally)
- Updated guidance will be provided once RSV becomes prevalent again
Sources: 1.www.pnas.org/cgi/doi/10.1073/pnas.20131821172.https://www.cdc.gov/surveillance/nrevss/rsv/natl-trend.html;
Detection of RSV in the US in 20202
5000 | |||||||||
600 | 4000 | ||||||||
400 | 3000 | ||||||||
Antigen | PCR | ||||||||
200 | 2000 | ||||||||
1000 | |||||||||
Jan | April | Dec |
RSVP Clinical Trial Sites
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Two Additional Phase 2 Clinical Trials: RSVTx and RSVPEDs
Double-Blinded Treatment Phase
Planned for Q1 2021
~90 subjects
Age 28 days - 24 months Dosed in 4 age cohorts
5 days
Part 1: MAD in 4 age
cohorts
Part 2: Selected dose from Part 1 across 4 age cohorts
9 Day Follow-up
- Primary Objective, Part 1: Safety and PK of EDP-938
- Primary Objective, Part 2: Antiviral activity of EDP-938
Day 1 | Day 5 | Day 14 |
Double-Blinded Treatment Phase | ||||||||||
Initiated in Q4 2020 | 21 days | |||||||||
~200 adult HCT recipients | Placebo (QD) | |||||||||
28 Day Follow-up | ||||||||||
Age 18 - 75 years | ||||||||||
800 mg (QD) | ||||||||||
Day 1 | Day 21 Day 28 | Day 49 | ||||||||
- Primary Objective: Effect of EDP-938on development of LRTC in HCT subjects with acute RSV URTI
- Secondary Objectives: Viral load, progression to respiratory failure or all-causemortality, PRO, PK and safety
LRTC: lower respiratory tract complication; HCR: hematopoietic cell transplant; URTI: upper respiratory tract infection; PRO: patient reported outcomes; PK: pharmacokinetics
© ENANTA Pharmaceuticals, Inc. 2021 | 14
.
RSV L-Protein Inhibitor
- Enanta's newest RSV program
- RSV L-protein is a viral RNA-dependent RNA polymerase that contains multiple enzyme activities required for RSV replication
- Novel RSV L-protein inhibitor leads have nanomolar potency against RSV-A and RSV-B
- Not expected to have cross resistance to other classes of inhibitors
- Potential to be used alone or in combination with other RSV mechanisms, such as EDP-938
© ENANTA Pharmaceuticals, Inc. 2021 | 15
Human Metapneumovirus (hMPV)
Important cause of respiratory tract infections (RTIs), particularly in children, the elderly and immunocompromised individuals
• Paramyxovirus closely related | |
hMPV at a Glance | |
to RSV | |
- hMPV replication dependent on several viral proteins that form a multiprotein complex in cells
- Multiple potential targets for hMPV drug discovery
- No approved vaccine or therapeutics available
- Enanta nanomolar hMPV inhibitor leads under active optimization
Serious respiratory infections can occur in children under 5 years old
Second most common cause of lower RTIs in children (behind RSV)
Reinfection with hMPV occurs throughout life
Source: Epidemiology of Human Metapneumovirus; Jeffrey S. Kahn; Clinical Microbiology Reviews Jul 2006, 19 (3) 546-557; DOI: 10.1128/CMR.00014-06;https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1539100/
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SARS-CoV-2(COVID-19)
Caused by respiratory infection of a new highly pathogenic coronavirus, SARS-CoV-2
- SARS-CoV-2belongs to coronaviridae, a family of enveloped RNA viruses that includes SARS-CoV and MERS-CoV
- Despite vaccine and therapeutic progress, need an oral treatment for those infected with SARS-CoV-2, and potentially for mutated virus, or for future coronaviruses
- Enanta is leveraging years of antiviral drug discovery expertise to identify direct-acting antivirals
- Discovery efforts on multiple targets utilizing a combination of screening and drug design
- Potent molecules currently undergoing lead optimization
© ENANTA Pharmaceuticals, Inc. 2021 | 17
Our Therapeutic Focus
RSV hMPV
COVID-19HBV
HCV NASH
Leveraging our core strength in Hepatitis C to become a leader in oral treatments for viral infections and liver diseases
Several new therapeutic areas with goal of building multiple approaches in each
© ENANTA Pharmaceuticals, Inc. 2021 | 18
Hepatitis B Virus (HBV)
Potentially life-threatening liver infection caused by the hepatitis B virus
Current treatments rarely give true cures
- Interferon is ~10% effective, but with side effects
- Reverse-transcriptaseinhibitors effective at reducing viral load, but low cure rates (1% or lower) and treatment for life to improve cirrhosis or hepatocellular carcinoma (HCC) outcomes
HBV at a Glance
US | 850K - 2M people |
US, Japan, | |
Major | ~4.9M people |
EU Populations | |
Worldwide | ~290M people |
Estimated 15-25% of patients with chronic HBV infection will develop chronic liver diseases
including cirrhosis, HCC or liver decompensation
Sources: WHO, CDC, Datamonitor
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HBV Core Inhibitor EDP-514 Summary
- A novel core inhibitor that displays potent anti-HBV activity at multiple points in the HBV lifecycle
In vitro • Potent anti-HBV activity in HBV expressing stable cell lines
- Capable of preventing the establishment of cccDNA
- Potent pan-genotypic activity
In vivo • Favorable tolerability and pharmacokinetic profile
- Over 4-log reduction in HBV viral titers with 12 weeks of treatment in a chimeric liver mouse model
Fast Track designation by FDA
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EDP-514 is Efficacious in the Humanized Liver Mouse Model
- uPA/SCID mice were infected with genotype C HBV and dosed with EDP-514 for 12 weeks
Treatment | Follow-up | ||||||||||||||||
(Day 0-83) | (Day 84-112) | ||||||||||||||||
(copies/mL) | 1.0E+09 | ||||||||||||||||
1.0E+08 | |||||||||||||||||
Level | 1.0E+07 | ||||||||||||||||
HBV DNA | 1.0E+06 | ||||||||||||||||
1.0E+05 | |||||||||||||||||
Serum | 1.0E+04 | ||||||||||||||||
0 | 7 | 14 | 21 | 28 | 35 | 42 | 49 | 56 | 63 | 70 | 77 | 84 | 91 | 98 | 105 | 112 | |
Days |
Max. Viral DNA Log
Reduction at Day 77
Vehicle Control | -0.04 |
Entecavir Control | -2.21 |
EDP-514 25 mg/kg BID | -2.99 |
EDP-514 50 mg/kg BID | -3.61 |
EDP-514 75 mg/kg BID | -3.95 |
EDP-514 100 mg/kg BID | -4.43 |
© ENANTA Pharmaceuticals, Inc. 2021 | 21
EDP-514 Clinical Development Program
Phase 1 Study
Phase 1b Study
Part 1 Complete
- Healthy volunteer SAD/MAD study evaluated safety, tolerability and PK
- Generally safe and well tolerated over dose range for up to 14 days
- All reported TEAEs of mild severity
- PK profile supportive of once daily dosing with no food effect
Part 2 Ongoing
- NUC-suppressedpatients
- Evaluating safety, tolerability, PK and antiviral activity over 28 days
- 24 patients randomized to receive one of three multiple ascending doses of EDP-514 or placebo
- Preliminary data anticipated in 2Q 2021
Ongoing
- Viremic chronic HBV subjects not currently on therapy
- Evaluating the safety, tolerability, PK and antiviral activity over 28 days
- 24 patients randomized to receive one of three multiple ascending doses of EDP-514 or placebo
- Preliminary data anticipated in 2Q 2021
© ENANTA Pharmaceuticals, Inc. 2021 | 22
EDP-721: HBV RNA Destabilizer
- Small molecules that cause destabilization and ultimate degradation of HBV RNAs
- Result in reduction of HBsAg and other viral proteins in whole cell systems and animal models
- Potential to complement or replace injectable (siRNA/ASO) with oral agents
- EDP-721is an oral small molecule HBV RNA destabilizer with a robust preclinical profile
- Sub-nanomolarpotency in vitro; dose dependent HBsAg reductions in vivo
- HBV pan-genomic activity; additive to synergistic activity with nucleosides and core inhibitors
- EDP-721in combination with other agents may lead to a functional cure
-
-
-
High levels of HBsAg suppress immune responses through multiple mechanisms EDP-721 reduces HBsAg derived from both integrated viral DNA and cccDNA Sustained loss of HBsAg is regarded as a core component of a functional cure for HBV
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Combination Regimen: Potential for Functional Cure
- Combination of multiple antiviral agents can block different points in the HBV life cycle
- Potential to drive rapid and deep suppression of viral replication (EDP-514 + NUC) and suppression of sAg production (EDP-721)
- All-oralregimen of EDP-514,EDP-721, NUC has potential to lead to a functional cure for HBV
Integrated | EDP-721 | |||||
cccDNA | DNA | |||||
eAg | EDP-514 | |||||
Uncoating & Import | rcDNA | sAg | NUC | |||
Repair | ||||||
Transcription | X | Reverse | ||||
Core | Assembly | Transcription | ||||
pgRNA | Translation | |||||
sAg | Pol | |||||
X | ||||||
Nucleus | Recycling |
© ENANTA Pharmaceuticals, Inc. 2021 | 24
EDP-721In Vivo Activity
- Dose dependent decrease in HBsAg observed with EDP-721 in AAV-HBV mouse model
7 | AAV-HBV HBsAg Levels | |||||||
6 | Vehicle | |||||||
IU/mL | 5 | EDP-721 0.1 mg/kg QD | ||||||
HBsAg | ||||||||
4 | EDP-721 1 mg/kg QD | |||||||
10 | ||||||||
Log | EDP-721 10 mg/kg QD | |||||||
3 | ||||||||
2 | ||||||||
0 | 2 | 4 | 6 | 8 | 10 | 12 | 14 |
Day Post Treatment
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Efficacy of Anti-HBsAg Agents in AAV-HBV Mouse Model
Agent | Modality | Route of Admin. | Dose (mg/kg) | HBsAg Log Drop | |
@ d14 | |||||
EDP-721 | Small Molecule | PO | 10 | ~3 | |
VIR-22181 | siRNA | SC | 9 | ~3 | |
AB-7292 | siRNA | SC | 3 | ~2.5 | |
ARB-14672 | siRNA | IV | 0.3 | ~1 | |
ALG-1250973 | siRNA | SC | 5 | ~1 | |
ALG-0205724 | ASO | SC | 10 | ~1.5 | |
PAPD5/7 ASO5 | ASO | SC | 5 | ~1.5 |
Sources: 1 EASL 2020 SAT426; 2 EASL 2018 O2646; 3 Jeffries 2020; 4 AASL 2020 O84; 5 AASLD 2019 P704
© ENANTA Pharmaceuticals, Inc. 2021 | 26
Our Therapeutic Focus
RSV hMPV
COVID-19HBV
HCV NASH
Leveraging our core strength in Hepatitis C to become a leader in oral treatments for viral infections and liver diseases
Several new therapeutic areas with goal of building multiple approaches in each
© ENANTA Pharmaceuticals, Inc. 2021 | 27
Non-Alcoholic Steatohepatitis (NASH)
Leading cause of liver disease in western countries
- Associated with metabolic syndrome, diabetes and hypertension
- Dramatically increases risk of cirrhosis, liver failure and hepatocellular carcinoma
- By 2030 NASH will be the most frequent reason for liver transplants in the U.S.
Stages
of Liver
Damage
Sources:American Liver Foundation,GlobalLiver.org
NASH at a Glance
US | 2.5 - 16.3M people | |
Worldwide | 115M people | |
Worldwide in | ||
357M people | ||
2030 | ||
© ENANTA Pharmaceuticals, Inc. 2021 | 28
EDP-305: A Potent FXR Receptor Agonist
Farnesoid X Receptor (FXR)
- Nuclear hormone receptor
- Main regulator of bile acid levels in liver and small intestine
- Responds to bile acids by regulating transcription of key enzymes and transporters
- FXR agonists ameliorate pathologies in NASH models, including fibrosis
- Clinical validation of FXR agonist in NASH with 6-ECDCA (OCA)
EDP-305
- Non-bileacid
- Designed to take advantage of increased binding interactions with the receptor
- Highly selective for FXR vs other nuclear receptors
- Potent and differentiated effects on FXR- dependent gene expression vs OCA in preclinical models
- Robust efficacy seen in multiple fibrosis and NASH models
- Granted Fast Track Designation by FDA
© ENANTA Pharmaceuticals, Inc. 2021 | 29
EDP-305ARGON-1 Study Summary
Endpoints Met at Week 12 Using 2.5 mg Dose
Primary Endpoint:
ALT change
Secondary Endpoint:
Liver fat by MRI-PDFF
- Strong target engagement as shown by decrease in C4, and increase in FGF-19 and ALP
- Robust reduction in marker of liver injury (GGT)
- Generally safe for up to 12 weeks
- Majority of treatment emergent adverse events were mild to moderate
-
Incidence of treatment discontinuation
due to pruritus: 1.8% for 1 mg and 20.8% for 2.5 mg - Associated with small numeric absolute changes in lipids
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EDP-305:ARGON-2 Phase 2b Study
Treatment Duration
- 340 biopsy-proven NASH with fibrosis patients
72 weeks
Placebo (QD)
EDP-305 1.5 mg (QD)
EDP-305 2.0 mg (QD)
Day 1 Week 12
Internal Interim
Analysis
Primary Endpoint:
Improvement of fibrosis without worsening of NASH and/or NASH resolution without worsening of fibrosis
Week 72
- Includes 12-week internal interim analysis by mid-2021 (to generate dose information more quickly for potential combinations), as well as a prespecified powered IA when ~40% of subjects reach week 72 biopsy
- Two doses selected to provide strong target engagement and a balanced profile in terms of efficacy and tolerability
- 1.5 mg dose: designed to demonstrate stronger biomarker signals of efficacy than seen at 1.0 mg
- 2.0 mg dose: designed to demonstrate less pruritus than seen at 2.5 mg
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EDP-297: A Potent and Differentiated Follow-on FXR Agonist
- EDP-297preclinical profile shows:
- High target-tissuedistribution (liver and intestine) vs plasma and skin
- Potency greater than that published on any FXR agonist in clinical development today
- A highly potent andhighly targeted FXR agonist may allow for lower doses and reduced drug levels at non-targeted tissues
- Potential to reduce pruritus unless pruritus is FXR-mediated by FXR receptors in liver or intestine
- Initiated Phase 1 study in 3Q 2020; data expected in 2Q 2021
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EDP-297: Highly Potent with Excellent Target Tissue Distribution
FXR FL | Dose | Intestine / | Liver / | ||||
Compound | Activation | Plasma | Plasma | ||||
(mouse, po) | |||||||
EC50 (nM) | @ 4 hrs ~ Tmax | ||||||
OCA | Bile Acid | 1301 | 10 mg/kg | 160 | 26 | ||
cilofexor | Non-Bile Acid | 412 | 1 mg/kg | 0.6 | 0.9 | ||
EDP-305 | Non-Bile Acid | 8 | 1 mg/kg | 7 | 15 | ||
tropifexor | Non-Bile Acid | 0.43 | 1 mg/kg | 0.8 | 8 | ||
EDP-2974 | Non-Bile Acid | <0.1 | 1 mg/kg | 265 | 75 | ||
Enanta data except where noted:
- EC50 = 99 nM reported by Intercept
- Gilead data. Trauner et al Hepatology 2019
- EC50 = 0.26 nM reported by Novartis. Tully et al J. Med. Chem., 2019
- EDP-297is undetectable in mouse skin
© ENANTA Pharmaceuticals, Inc. 2021 | 33
Our Therapeutic Focus
RSV hMPV
COVID-19HBV
HCV NASH
Leveraging our core strength in Hepatitis C to become a leader in oral treatments for viral infections and liver diseases
Several new therapeutic areas with goal of building multiple approaches in each
© ENANTA Pharmaceuticals, Inc. 2021 | 34
Glecaprevir - Our Licensed Protease Inhibitor for Hepatitis C Virus
Product | Regimen | Enanta Asset | Economics* | ||||
2-DAA (ABBV) | glecaprevir (PI) | Double-digit royalty on 50% | |||||
of net sales | |||||||
Glecaprevir Sales | Royalty Rate |
(50% of MAVYRET net sales) | (annual) |
$2.5B | 20% |
17%
$1.0B
Calendar 2020 HCV Royalties
Q4 $TBD
Q3 $23.6M
Q2 $18.7M
$750M
14%
Q1 $27.6M
$500M
12%
10%
*Enanta also receives royalties on paritaprevir sales (30% of Viekira 3DAA sales, same tiers)
© ENANTA Pharmaceuticals, Inc. 2021 | 35
Financial Highlights
($ In millions) | Fiscal Year Ended | Fiscal Quarter Ended | |||
Sept. 30, 2020 | Sept. 30, 2020 | ||||
Total Revenues | $122.5 | $23.6 | |||
R&D Expenses | $136.8 | $36.7 | |||
G&A Expenses | $27.4 | $6.7 | |||
Net Income (Loss) | $(36.2) | $(29.3) | |||
Net Income (Loss) per | |||||
$(1.81) | $(1.46) | ||||
Diluted Common Share | |||||
Balance Sheet | |||||
Cash, Cash Equivalents | $419.3 | $419.3 | |||
and Marketable Securities | |||||
© ENANTA Pharmaceuticals, Inc. 2021 | 36
Key Catalysts 2021
Virology
NASH
RSV N-InhibitorEDP-938
-
Initiated RSVTx in 4Q 2020 Initiate RSVPEDs in Q1 2021
Resume recruitment for RSVP when RSV returns
hMPV, SARS-CoV-2 and RSV L-inhibitor
- Nominate two clinical development candidates
HBV Core Inhibitor EDP-514 and RNA Destabilizer EDP-721
- EDP-514Phase 1b in viremic HBV patients; preliminary data anticipated in 2Q 2021
- EDP-514Phase 1b in NUC-suppressed HBV patients; preliminary data anticipated in 2Q 2021
- Initiate Phase 1 with EDP-721 in mid-2021
FXR Agonists EDP-305 and EDP-297
- ARGON-2Phase 2b in NASH ongoing; 12-week interim analysis in mid-2021
- Phase 1 with EDP-297(follow-on FXR) ongoing with data expected in 2Q 2021
- Advance non-FXR compounds for NASH
© ENANTA Pharmaceuticals, Inc. 2021 | 37
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Enanta Pharmaceuticals Inc. published this content on 12 January 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 January 2021 14:27:05 UTC