- Initiated SPRINT (SARS-Cov-2 PRotease
INhibitor Treatment), a Phase 2 Study of EDP-235, an
Oral, 3CL Protease Inhibitor, in Non-Hospitalized, Symptomatic
Patients With Mild to Moderate COVID-19
- Initiated RSVHR, a Phase 2 Study of EDP-938, an Oral N-Protein
Inhibitor, in Adults at High Risk for Complications from
Respiratory Syncytial Virus (RSV)
- Began Dosing in a Phase 1 Study of EDP-323, a Novel, Oral
L-Protein Inhibitor Designed for the Treatment of RSV
- Royalty Revenue for the Quarter was $20.3 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 fourth quarter and year ended September 30, 2022.
“Our fiscal 2022 was a year of progress toward our vision of
transforming the lives of patients with curative therapies, and in
the past two months alone we began three new clinical trials to
advance our pipeline,” said Jay R. Luly, Ph.D., President and Chief
Executive Officer of Enanta Pharmaceuticals. “Most recently, the
initiation of SPRINT, a Phase 2 study of EDP-235, our lead 3CL
protease inhibitor, moves us further in developing a best-in-class
treatment for COVID-19 without ritonavir boosting and associated
drug-drug interactions. As new variants emerge that can evade
immunity arising from vaccination or previous infection, EDP-235
has the potential to fill the need for rapid treatment of COVID
infection as a once-daily, oral treatment. This quarter, we also
expanded our RSV clinical program with the initiation of RSVHR, a
Phase 2 study of EDP-938 in patients who are at high risk of
complications, a population where we believe that treatment with
EDP-938 has significant potential to show optimal efficacy and
clinical benefit. Additionally, we dosed our first subject with
EDP-323, our novel, oral therapeutic targeting the RSV L-protein
RNA polymerase. The further progression of our clinical studies and
expansion of our pipeline continues to enhance our robust position
in respiratory virology.”
Fiscal Fourth Quarter and Year Ended September 30, 2022
Financial Results
Total revenue of $20.3 million for the three months ended
September 30, 2022, consisted of royalty revenue derived from
worldwide net sales of AbbVie’s hepatitis C virus (HCV) regimen
MAVYRET®/MAVIRET®, compared to royalty revenue of $23.6 million for
the three months ended September 30, 2021. For the twelve months
ended September 30, 2022, total revenue was $86.2 million compared
to $97.1 million for the same period in 2021.
Research and development expenses were $34.8 million for the
three months ended September 30, 2022, compared to $48.9 million
for the three months ended September 30, 2021. For the twelve
months ended September 30, 2022, research and development expenses
were $164.5 million compared to $174.1 million in 2021. The
decreases in both periods were due to the timing and scope of the
company’s clinical trials.
General and administrative expenses totaled $12.6 million for
the three months ended September 30, 2022, compared to $8.4 million
for the three months ended September 30, 2021. For the twelve
months ended September 30, 2022, general and administrative
expenses were $45.5 million compared to $32.5 million in 2021. The
increases in both periods were due primarily to additional
headcount and stock compensation expense.
Enanta recorded an income tax expense of $0.01 million for the
three months ended September 30, 2022, and an income tax benefit of
$0.4 million for the twelve months ended September 30, 2022, which
are due primarily to the release of a state tax reserve. Enanta
recorded an income tax benefit of $8.8 million and $28.6 million
for the three and twelve months ended September 30, 2021,
respectively, due primarily to a federal net loss carryback
available in fiscal 2021 under the CARES Act of 2020. Enanta is
still due a refund of $28.7 million for the tax losses carried back
in 2021 to offset taxable income in prior years.
Net loss for the three months ended September 30, 2022, was
$26.3 million, or a loss of $1.27 per diluted common share,
compared to a net loss of $24.6 million, or a loss of $1.22 per
diluted common share, for the corresponding period in 2021. For the
twelve months ended September 30, 2022, net loss was $121.8
million, or a loss of $5.91 per diluted common share, compared to a
net loss of $79.0 million, or loss of $3.92 per diluted common
share for the corresponding period in 2021.
Enanta’s cash, cash equivalents and marketable securities
totaled $278.5 million at September 30, 2022. Enanta expects that
its current cash, cash equivalents and short-term and long-term
marketable securities, as well as its continuing royalty revenue,
will continue to be sufficient to meet the anticipated cash
requirements of its existing business and development programs into
the fourth quarter of fiscal 2024.
Financial Guidance for Fiscal Year 2023
- Research and Development Expense: $210 million to $230
million
- General and Administrative Expense: $46 million to $52
million
Pipeline Programs
COVID-19 (SARS-CoV-2)
- Enanta announced the initiation of SPRINT, a Phase 2 clinical
study of EDP-235, an oral, 3CL protease inhibitor, which has Fast
Track designation from the U.S. Food and Drug Administration (FDA).
The randomized, double-blind, placebo-controlled study is designed
to evaluate the safety, tolerability and antiviral activity of
once-daily doses of EDP-235 compared to placebo. SPRINT will enroll
approximately 200 non-hospitalized, symptomatic patients with mild
to moderate COVID-19, who are not at increased risk for developing
severe disease. During the study, patients will receive EDP-235
orally at a dose of 200 mg or 400 mg or placebo, once daily for
five days, and will be assessed for a further 28 days. The primary
objective of the study includes evaluation of safety and
tolerability, and key secondary objectives include analysis of
pharmacokinetics (PK) and multiple virology measures to guide dose
selection for other trials.
- EDP-235 is supported by positive topline data from a Phase 1
study which assessed the safety, tolerability, and PK of orally
administered single and multiple ascending doses of EDP-235 in
healthy adult subjects.
- Data from the Phase 1 study demonstrated EDP-235 was generally
safe and well-tolerated up to 400 mg for seven days, with strong
exposure multiples over the EC90, which is a measure of potency,
specifically the concentration of drug that results in 90%
inhibition of viral replication in vitro. EDP-235 200 mg taken once
daily with food resulted in mean trough plasma levels at steady
state that were 3-fold and 7-fold over the plasma-protein-adjusted
EC90 for the Alpha variant and Omicron variant, respectively, while
the 400 mg dose resulted in levels that were 6-fold and 13-fold
over the plasma-protein-adjusted EC90 for the respective variants.
These target exposure multiples were achieved without the need for
ritonavir boosting and its associated drug-drug interactions.
EDP-235 has good tissue distribution and is expected to drive these
multiples four times higher in lung tissue.
RSV
- EDP-938, an N-protein inhibitor with Fast Track designation
from the FDA, is being evaluated in a broad clinical development
program in multiple patient groups, including pediatric and
high-risk adult populations.
- In October 2022, Enanta announced the initiation of RSVHR, a
Phase 2b randomized, double-blind, placebo-controlled,
multi-center, global study 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 (COPD) or asthma. The study is designed to evaluate the
effect of EDP-938 compared with placebo on the progression of RSV
infection by assessment of clinical symptoms in non-hospitalized
adult subjects with up to 72 hours of respiratory tract infection
symptoms who test positive for RSV and negative for influenza and
SARS-CoV-2. Approximately 180 patients will be treated with 800 mg
of EDP-938 or placebo for five days and evaluated over a 28-day
period thereafter.
- Other ongoing studies include 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.
- Enanta will continue to monitor RSV infection trends during the
Northern Hemisphere season to evaluate timing for data readouts in
its ongoing RSV studies.
- Enanta is also evaluating EDP-323, a novel, oral, direct-acting
antiviral selectively targeting the RSV L-protein, for the
treatment of RSV.
- In October 2022, Enanta announced the first subject was dosed
in a Phase 1 study of EDP-323. This double-blind,
placebo-controlled, first-in-human study will enroll approximately
80 healthy subjects to evaluate the safety, tolerability, and PK of
EDP-323 with a single-ascending dose phase, including a two-part
food-effect cohort, and a multiple-ascending dose phase.
- 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.
- EDP-323 is also supported by promising preclinical data
presented this quarter at the 12th International RSV Symposium,
which showed that EDP-323 inhibited polymerase activity in vitro
and inhibited the virus-induced cytopathic effect of both RSV-A and
RSV-B strains. In a rodent RSV infection model, treatment with
EDP-323 was associated with improved lung histopathology and
dose-dependent reductions in pro-inflammatory cytokines.
Human Metapneumovirus (hMPV)
- hMPV is a pathogen that causes upper and lower respiratory
tract infections similar to RSV in young children and the elderly,
as well as in immunocompromised patients or those with COPD or
asthma.
- This quarter, Enanta presented new data at the 12th
International RSV Symposium, which highlighted several advances in
virus detection, quantification and growth methods for the
generation of an improved toolkit for in vitro characterization of
multiple hMPV strains across each of the four hMPV genetic
subgroups. This expanded in vitro characterization of genetically
distinct hMPV strains catalyzes the advancement of hMPV virology
and the development of direct-acting antivirals.
- Enanta’s goal is to select a development candidate for hMPV in
2023.
Hepatitis B Virus (HBV)
- Enanta remains committed to developing a cure for HBV patients
and is currently 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, which has Fast Track designation from the FDA, has
displayed a good safety profile and robust antiviral activity in
multiple HBV patient populations, with declines in HBV DNA among
the best published to date for core inhibitors.
Upcoming Events and Presentations
- Piper Sandler Healthcare Conference, November 29, 2022
- Evercore Healthcare Conference, November 30, 2022
- 41st Annual JP Morgan Healthcare Conference, January 10,
2023
- Enanta plans to issue its fiscal first quarter financial
results press release, and hold a conference call regarding those
results, on February 7, 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
https://ir.enanta.com/events-presentations or by clicking here. 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 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 in development for the following disease
targets: respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19)
and hepatitis B virus (HBV). Enanta is also conducting research in
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 program in hMPV. 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 vaccines
and 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-Q for the fiscal
quarter ended June 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
Twelve Months Ended
September 30,
September 30,
2022
2021
2022
2021
Revenue
$
20,317
$
23,575
$
86,160
$
97,074
Operating expenses Research and development
34,796
48,946
164,522
174,111
General and administrative
12,569
8,356
45,482
32,536
Total operating expenses
47,365
57,302
210,004
206,647
Loss from operations
(27,048
)
(33,727
)
(123,844
)
(109,573
)
Other income, net
714
333
1,656
1,994
Loss before income taxes
(26,334
)
(33,394
)
(122,188
)
(107,579
)
Income tax benefit (expense)
(14
)
8,795
433
28,583
Net loss
$
(26,348
)
$
(24,599
)
$
(121,755
)
$
(78,996
)
Net loss per share Basic
$
(1.27
)
$
(1.22
)
$
(5.91
)
$
(3.92
)
Diluted
$
(1.27
)
$
(1.22
)
$
(5.91
)
$
(3.92
)
Weighted average common shares outstanding Basic
20,755
20,221
20,603
20,171
Diluted
20,755
20,221
20,603
20,171
ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS UNAUDITED (in thousands)
September 30,
September 30,
2022
2021
Assets Current assets Cash and cash equivalents
$
43,994
$
57,206
Short-term marketable securities
205,238
186,796
Accounts receivable
20,318
23,576
Prepaid expenses and other current assets
13,445
14,188
Income tax receivable
28,718
37,255
Total current assets
311,713
319,021
Long-term marketable securities
29,285
108,416
Property and equipment, net
6,173
5,943
Operating lease, right-of-use assets
23,575
4,711
Restricted cash
3,968
608
Other long-term assets
696
92
Total assets
$
375,410
$
438,791
Liabilities and Stockholders' Equity Current liabilities Accounts
payable
$
6,000
$
9,540
Accrued expenses and other current liabilities
20,936
22,429
Operating lease liabilities
2,891
4,203
Total current liabilities
29,827
36,172
Operating lease liabilities, net of current portion
22,372
1,126
Series 1 nonconvertible preferred stock
1,423
1,506
Other long-term liabilities
454
558
Total liabilities
54,076
39,362
Total stockholders' equity
321,334
399,429
Total liabilities and stockholders' equity
$
375,410
$
438,791
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221121005683/en/
Media and Investor Contact: Jennifer Viera 617-744-3848
jviera@enanta.com
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