- Completes Enrollment in SPRINT, a Phase 2 Clinical Study of
EDP-235, a 3CL Protease Inhibitor Designed as an Oral, Once-Daily
Treatment for COVID-19; Topline Data Expected in May
- Expects Phase 1 Data of EDP-323, an L-Protein Inhibitor in
Development as an Oral, Once-Daily Treatment for Respiratory
Syncytial Virus (RSV), in 2Q 2023
- Expands Robust Pipeline with New Research Programs Developing
SARS-CoV-2 Papain-Like Protease Inhibitors and Human
Metapneumovirus (hMPV)/RSV Dual-Inhibitors
- Revenue for the Quarter was $23.6 Million
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage
biotechnology company dedicated to creating small molecule drugs
for viral infections, today reported financial results for its
fiscal first quarter ended December 31, 2022.
“We begin 2023 in a strong position and poised for success with
multiple upcoming milestones across our pipeline. Notably, we are
excited to make important progress in our COVID-19 program with the
completion of enrollment in SPRINT, our Phase 2 clinical study of
EDP-235, a 3CL protease inhibitor specially designed as an oral,
once-daily treatment for SARS-CoV-2 infection,” said Jay R. Luly,
Ph.D., President and Chief Executive Officer at Enanta
Pharmaceuticals. “We look forward to a data readout of SPRINT in
May and, pending data, initiating a Phase 3 trial in the second
half of this year. Based on the high unmet need that still exists
for conveniently prescribed COVID-19 therapies, we are focused on
building out our COVID-19 portfolio, with the recent addition of a
research program developing SARS-CoV-2 papain-like protease
inhibitors. These inhibitors have the potential to be used alone or
in combination with 3CL protease inhibitors, such as EDP-235 or
other compounds, to provide a range of treatment options for
different patient populations. Beyond COVID-19, we look forward to
reporting topline data from the Phase 1 study of EDP-323, our RSV
L-protein inhibitor, next quarter, and we aim to select a dual
inhibitor clinical candidate that targets both hMPV and RSV in the
fourth quarter of this year. 2023 is gearing up to be a pivotal
year for Enanta, with multiple milestones expected that have the
potential to drive value for the company and move us closer to
bringing important therapies to patients in need.”
Fiscal First Quarter Ended December 31, 2022 Financial
Results
Total revenue for the three months ended December 31, 2022 was
$23.6 million and consisted primarily of $22.6 million of royalty
revenue from worldwide net sales of MAVYRET®/MAVIRET®, AbbVie’s
eight-week treatment for chronic hepatitis C virus (HCV). For the
three months ended December 31, 2021, total royalty revenue was
$27.6 million on AbbVie’s sales of MAVYRET/MAVIRET. The decline is
primarily a result of continued lower treated patient volumes due
to the COVID-19 pandemic.
Research and development expenses totaled $40.9 million for the
three months ended December 31, 2022, compared to $48.5 million for
the three months ended December 31, 2021. The decrease was
primarily due to the timing of drug supply manufacturing and
preclinical studies in the company’s virology program year over
year.
General and administrative expenses totaled $12.7 million for
the three months ended December 31, 2022, compared to $9.5 million
for the three months ended December 31, 2021. This increase was
primarily due to an increase in stock-based compensation expense
and in headcount.
Net loss for the three months ended December 31, 2022 was $29.0
million, or a loss of $1.39 per diluted common share, compared to a
net loss of $30.1 million, or a loss of $1.48 per diluted common
share, for the corresponding period in 2021.
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $241.4 million at December 31, 2022.
Enanta expects that its current cash, cash equivalents and
marketable securities, as well as its continuing royalty revenue,
will be sufficient to meet the anticipated cash requirements of its
existing business and development programs into the fourth fiscal
quarter of 2024.
Pipeline Updates
COVID-19 (SARS-CoV-2)
- Enanta announced today that enrollment is complete in SPRINT
(SARS-CoV-2 PRotease INhibitor
Treatment), a Phase 2 clinical study of EDP-235, a 3CL
protease inhibitor designed as an oral, once-daily treatment for
COVID-19. This randomized, double-blind, placebo-controlled study
is evaluating the safety, tolerability, and antiviral activity of
EDP-235 compared to placebo. SPRINT was designed to enroll
approximately 200 non-hospitalized, symptomatic patients with mild
to moderate COVID-19, who were not at increased risk for developing
severe disease. During the study, patients received EDP-235 orally
at a dose of 200 mg or 400 mg or placebo, once daily for five days,
and were assessed for a further 28 days. The primary objective of
the study is evaluation of safety and tolerability, and key
secondary objectives include analysis of multiple virology measures
and pharmacokinetics (PK) to guide dose selection for future
trials. Enanta is on schedule to report topline data from SPRINT in
May.
- EDP-235 is supported by a robust dataset demonstrating good
potency and PK profile, without the need for ritonavir boosting and
its associated drug-drug interactions.
- In January, Enanta announced new preclinical in vivo data on
EDP-235 highlighting the robust antiviral treatment effect and
prevention of COVID-19 transmission in a ferret model. Ferrets were
infected with SARS-CoV-2 and then subsequently received either
EDP-235 or vehicle. Results demonstrated that EDP-235 treatment of
SARS-CoV-2 infected animals resulted in a rapid, robust and
sustained decline in viral replication. Additionally, healthy
animals did not contract COVID-19 when moved into housing with
infected animals that were treated with EDP-235, whereas the
healthy animals that were moved into housing with vehicle-treated
infected animals did contract the virus. This study continues to
support the potential of EDP-235 as an efficacious therapy for
COVID-19, and also demonstrates its potential to reduce
transmission of the virus.
- In previously announced Phase 1 data, EDP-235 increased
approximately proportionally with ascending single and multiple
doses of EDP-235, with a half-life consistent with daily dosing,
resulting in a PK profile suitable for once-daily dosing. Data also
demonstrated that EDP-235 had strong exposure multiples over the
EC90, without the need for ritonavir.
- Enanta plans to present further details of the EDP-235 Phase 1
data, the ferret study and two other preclinical posters at the
International Conference on Antiviral Research (ICAR) 2023 in
March, as well as other preclinical data at the European Congress
of Clinical Microbiology and Infectious Diseases (ECCMID) in
April.
- In January, Enanta introduced a new research program focused on
the discovery and development of inhibitors of the SARS-CoV-2
papain-like protease (PLpro) for the oral treatment of COVID-19.
PLpro is another essential enzyme which plays an important role in
viral replication and, in addition, acts to suppress the innate
immune response. Inhibition of PLpro blocks viral replication and
has the potential to alleviate the suppression of the immune
response to SARS-CoV-2 infection. As this mechanism is distinct
from 3CL protease inhibition, it could potentially be used alone or
in combination with 3CL protease inhibitors. In preclinical
research, Enanta’s prototype PLpro inhibitors demonstrated
nanomolar potency against the Omicron variant in both biochemical
and cellular assays, and the company continues to optimize
inhibitors as it progresses this program forward toward development
candidate selection.
Respiratory Syncytial Virus (RSV)
- EDP-938, an N-protein inhibitor, is being evaluated in a broad
clinical development program in multiple high-risk patient groups,
including pediatric and high-risk adult populations.
- Ongoing studies include RSVHR, a Phase 2b randomized,
double-blind, placebo-controlled study recently initiated in adults
with acute RSV infection who are at high risk of complications,
including the elderly and/or those with congestive heart failure,
chronic obstructive pulmonary disease or asthma; RSVPEDs, a Phase 2
randomized, double-blind, placebo-controlled study in hospitalized
and non-hospitalized pediatric RSV patients; and RSVTx, a Phase 2b,
randomized, double-blind, placebo-controlled study in adult
hematopoietic cell transplant recipients with acute RSV infection
and symptoms of upper respiratory tract infection.
- These three studies are expected to continue through 2023 and
Enanta is monitoring RSV epidemiology to determine the impact on
trial enrollment and timing for data readouts.
- EDP-323, a novel, oral, direct-acting antiviral selectively
targeting the RSV L-protein, is being evaluated in a Phase 1 study.
This double-blind, placebo-controlled, first-in-human study is
designed to enroll approximately 80 healthy subjects to assess the
safety, tolerability, and PK of EDP-323. Enanta plans to present
preclinical PK data at ECCMID and expects to report topline data
from this Phase 1 study in the second quarter of 2023.
- EDP-323 has shown sub-nanomolar potency against RSV-A and RSV-B
in vitro and is not expected to have cross-resistance to other
classes of inhibitors. EDP-323 could be used as a monotherapy or in
combination with other RSV mechanisms, such as EDP-938, to
potentially broaden the addressable patient populations or the
treatment window.
Human Metapneumovirus (hMPV)/RSV
- In January, Enanta announced a new research program with
broader spectrum antivirals targeting both hMPV and RSV with a
single agent, which the company refers to as a dual-inhibitor. In
preclinical studies, Enanta’s prototype dual inhibitor maintained
nanomolar activity against multiple genotypes and strains of hMPV
and RSV in a range of cell types. Further, the dual-inhibitor
potently inhibited replication of both hMPV and RSV in a
dose-dependent manner in respective mouse models, demonstrating a
significant reduction in viral load of both viruses. Enanta expects
to select a dual hMPV/RSV clinical candidate in the fourth quarter
of 2023.
Hepatitis B Virus (HBV)
- Enanta remains focused on identifying additional compounds with
different mechanisms of action to combine with EDP-514, its potent
core inhibitor, and a nucleoside reverse transcriptase inhibitor.
EDP-514 has displayed a good safety profile and robust antiviral
activity in multiple HBV patient populations, with significant
declines in HBV DNA among the best published to date for core
inhibitors.
Upcoming Events and Presentations
- SVB Securities Global Biopharma Conference, February 14,
2023
- Oppenheimer 33rd Annual Healthcare Conference, March 14,
2023
- International Conference on Antiviral Research, March 13 – 17,
2023
- 33rd European Congress of Clinical Microbiology and Infectious
Diseases, April 15 – 18, 2023
- Enanta plans to issue its fiscal second quarter financial
results press release, and hold a conference call regarding those
results, on May 8, 2023.
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at 4:30
p.m. ET. The live webcast can be accessed under "Events &
Presentations" in the investors section of Enanta’s website. To
participate by phone, please register for the call here. It is
recommended that participants register a day in advance or at a
minimum of 15 minutes before the call. Once registered,
participants will receive an email with the dial-in information.
The archived webcast will be available on Enanta’s website for
approximately 30 days following the event.
About Enanta Pharmaceuticals, Inc.
Enanta is using its robust, chemistry-driven approach and drug
discovery capabilities to become a leader in the discovery and
development of small molecule drugs for the treatment of viral
infections. Enanta’s research and development programs include
clinical candidates for the following disease targets: respiratory
syncytial virus (RSV), SARS-CoV-2 (COVID-19) and hepatitis B virus
(HBV). Enanta is also conducting research on a single agent
targeting both RSV and human metapneumovirus (hMPV).
Enanta’s research and development activities are funded by
royalties from hepatitis C virus (HCV) products developed under its
collaboration with AbbVie. Glecaprevir, a protease inhibitor
discovered by Enanta, is part of one of the leading treatment
regimens for curing chronic HCV infection and is sold by AbbVie in
numerous countries under the tradenames MAVYRET® (U.S.) and
MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit
www.enanta.com for more information.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements,
including statements with respect to the prospects for advancement
of Enanta’s clinical programs in RSV, SARS-CoV-2 and HBV and its
preclinical dual-inhibitor program in hMPV/RSV. Statements that are
not historical facts are based on management’s current
expectations, estimates, forecasts and projections about Enanta’s
business and the industry in which it operates and management’s
beliefs and assumptions. The statements contained in this release
are not guarantees of future performance and involve certain risks,
uncertainties and assumptions, which are difficult to predict.
Therefore, actual outcomes and results may differ materially from
what is expressed in such forward-looking statements. Important
factors and risks that may affect actual results include: the
impact of development, regulatory and marketing efforts of others
with respect to competitive treatments for RSV, SARS-CoV-2 and HBV;
the discovery and development risks of Enanta’s programs in RSV,
SARS-CoV-2, HBV and hMPV; the competitive impact of development,
regulatory and marketing efforts of others in those disease areas;
any continuing impact of the COVID-19 pandemic on business
operations and clinical trials; Enanta’s lack of clinical
development experience; Enanta’s need to attract and retain senior
management and key research and development personnel; Enanta’s
need to obtain and maintain patent protection for its product
candidates and avoid potential infringement of the intellectual
property rights of others; and other risk factors described or
referred to in “Risk Factors” in Enanta’s Form 10-K for the fiscal
year ended September 30, 2022, and any other periodic reports filed
more recently with the Securities and Exchange Commission. Enanta
cautions investors not to place undue reliance on the
forward-looking statements contained in this release. These
statements speak only as of the date of this release, and Enanta
undertakes no obligation to update or revise these statements,
except as may be required by law.
Tables to Follow
ENANTA PHARMACEUTICALS,
INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
UNAUDITED (in thousands,
except per share amounts)
Three Months Ended
December 31,
2022
2021
Revenue
$
23,585
$
27,648
Operating expenses Research and development
40,902
48,549
General and administrative
12,696
9,508
Total operating expenses
53,598
58,057
Loss from operations
(30,013)
(30,409)
Other income, net
993
258
Loss before income taxes
(29,020)
(30,151)
Income tax benefit
34
36
Net loss
$
(28,986)
$
(30,115)
Net loss per share Basic
$
(1.39)
$
(1.48)
Diluted
$
(1.39)
$
(1.48)
Weighted average common shares outstanding Basic
20,816
20,388
Diluted
20,816
20,388
ENANTA PHARMACEUTICALS,
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
UNAUDITED (in
thousands)
December 31,
September 30,
2022
2022
Assets Current assets Cash and cash equivalents
$
42,223
$
43,994
Short-term marketable securities
172,247
205,238
Accounts receivable
22,585
20,318
Prepaid expenses and other current assets
17,946
13,445
Income tax receivable
28,703
28,718
Total current assets
283,704
311,713
Long-term marketable securities
26,939
29,285
Property and equipment, net
8,682
6,173
Operating lease, right-of-use assets
23,540
23,575
Restricted cash
3,968
3,968
Other long-term assets
701
696
Total assets
$
347,534
$
375,410
Liabilities and Stockholders' Equity Current liabilities Accounts
payable
$
4,352
$
6,000
Accrued expenses and other current liabilities
15,163
20,936
Operating lease liabilities
3,486
2,891
Total current liabilities
23,001
29,827
Operating lease liabilities, net of current portion
21,859
22,372
Series 1 nonconvertible preferred stock
1,423
1,423
Other long-term liabilities
414
454
Total liabilities
46,697
54,076
Total stockholders' equity
300,837
321,334
Total liabilities and stockholders' equity
$
347,534
$
375,410
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230207005225/en/
Media and Investors: Jennifer Viera 617-744-3848
jviera@enanta.com
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