- Reported Positive Data from a Phase 1b Study of EDP-514 in
NUC-Suppressed Chronic Hepatitis B Virus (HBV) Patients Supporting
Once Daily Dosing and Combination Approach
- On Track to Report Preliminary Data from a Phase 1b Study of
EDP-514 in Viremic Chronic HBV Patients in Q2 2021 and to Initiate
a Phase 1 Study of EDP-721 in Mid-2021
- IND-Enabling Studies of a Lead Oral Protease Inhibitor
Specifically Designed for SARS-CoV-2 Expected to Begin in Q2
2021
- Initiated RSVPEDs, a Phase 2 Study of EDP-938 in Pediatric
Patients with Respiratory Syncytial Virus (RSV) Infection
- Royalty Revenue for the Quarter was $20 Million
- Cash and Marketable Securities Totaled $400 Million at March
31, 2021
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage
biotechnology company dedicated to creating small molecule drugs
for viral infections and liver diseases, today reported financial
results for its fiscal second quarter ended March 31, 2021.
“This quarter was marked by meaningful progress, particularly as
we further our efforts to develop an all-oral regimen for chronic
HBV patients,” said Jay R. Luly, Ph.D., President and Chief
Executive Officer of Enanta Pharmaceuticals. “We are especially
pleased with the safety, tolerability, pharmacokinetic, and HBV RNA
data we announced today from our Phase 1b study in NUC-suppressed
patients, which reinforces our belief in EDP-514’s potential to
serve as the foundation of an oral combination treatment approach
to achieve a functional cure in patients with HBV. We also remain
on track for other key milestones in our HBV program later this
quarter, including reporting preliminary data from our Phase 1b
trial of EDP-514 in viremic chronic HBV patients and initiating a
Phase 1 study of EDP-721, our novel HBV RNA destabilizer. Looking
to the rest of our pipeline, we are excited to soon initiate
IND-enabling studies of a lead oral protease inhibitor specifically
designed to target SARS-CoV-2, with a goal of beginning a Phase 1
study in early 2022. Each milestone we achieve brings us closer to
our vision of being a leader in the discovery and development of
small molecule drugs for the treatment of viral infections and
liver diseases.”
Fiscal Second Quarter Ended March 31, 2021 Financial
Results
Total revenue for the three months ended March 31, 2021 was
$20.1 million and consisted of royalty revenue derived primarily
from worldwide net sales of AbbVie’s hepatitis C virus (HCV)
regimen MAVYRET®/MAVIRET® (glecaprevir/pibrentasvir), which
continued to be adversely impacted by the pandemic. For the three
months ended March 31, 2020, total revenue from royalties on
AbbVie’s net sales of HCV regimens was $27.6 million.
Research and development expenses totaled $41.5 million for the
three months ended March 31, 2021, compared to $32.6 million for
the three months ended March 31, 2020. The increase in research and
development expenses was primarily due to the timing of the
company’s clinical trials year over year.
General and administrative expenses totaled $8.3 million for the
three months ended March 31, 2021, compared to $6.9 million for the
three months ended March 31, 2020. The increase in general and
administrative expenses was due to increased headcount and
compensation expense.
Enanta recorded an income tax benefit of $7.1 million for the
three months ended March 31, 2021, compared to an income tax
benefit of $3.9 million for the same period of 2020. The income tax
benefit during the three months ended March 31, 2021 was due to the
provision of the CARES Act of 2020, which enables the Company to
carry back its projected current year tax loss to offset taxable
income in prior years.
Net loss for the three months ended March 31, 2021 was $22.0
million, or a loss of $1.09 per diluted common share, compared to a
net loss of $6.0 million, or a loss of $0.30 per diluted common
share, for the corresponding period in 2020.
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $400.4 million at March 31, 2021.
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 for the foreseeable
future.
Pipeline Programs and Near-Term Milestones
Virology
- HBV: Core Inhibitor EDP-514 and RNA Destabilizer EDP-721
- Positive preliminary data announced today from the Phase 1b
study of EDP-514 in NUC-suppressed chronic HBV patients. The 200 mg
and 400 mg doses were safe and well-tolerated, with
pharmacokinetics supportive of once daily dosing. The 800 mg cohort
is ongoing and final study results will be presented at a future
scientific conference.
- Preliminary data expected from the ongoing Phase 1b study of
EDP-514 in viremic chronic HBV patients in the second quarter of
2021.
- On track to initiate a Phase 1 clinical study of EDP-721 in
mid-2021. EDP-721 is an oral, potent and selective HBV RNA
destabilizer being developed for use in combination with other
mechanisms, with the goal of achieving an all-oral functional
cure.
- Presenting the discovery and preclinical characterization of
EDP-721 in a poster at the International Liver CongressTM,
sponsored by the European Association for the Study of the Liver
(EASL), in June.
- RSV: N-Protein Inhibitor EDP-938
- Due to ongoing COVID-19 mitigation measures, RSV, like
influenza, did not emerge during the usual late-fall and winter RSV
season in the Northern Hemisphere in 2020-2021. Enanta continues
its preparedness efforts to establish trial sites in North America,
Europe, the Asia-Pacific region, and the Southern Hemisphere.
- Continuing extensive efforts to double the number of clinical
sites globally for RSVP, a Phase 2b randomized, double-blind,
placebo-controlled study in 70 adult outpatients with
community-acquired RSV infection.
- Initiated RSVPEDs, a Phase 2 randomized, double-blind,
placebo-controlled study in 90 pediatric RSV patients, in March
2021.
- Continuing to activate sites for RSVTx, a Phase 2b randomized,
double-blind, placebo-controlled study in 200 adult hematopoietic
cell transplant recipients with acute RSV infection and symptoms of
upper respiratory tract infection.
- Respiratory Virology Discovery Initiatives – In 2021,
Enanta expects to identify two clinical development candidates
among its three discovery initiatives below:
- COVID-19
- IND-enabling studies of a lead oral protease inhibitor
specifically designed for SARS-CoV-2 are expected to begin later
this quarter, with the goal to have a candidate in a Phase 1 study
in early 2022.
- RSV L-Protein Inhibitor
- Optimization of leads with potent nanomolar activity against
both RSV-A and RSV-B is ongoing, with potential for use alone or in
combination with agents targeting other RSV mechanisms, such as
EDP-938, to possibly broaden the addressable treatment window or
patient population.
- Human Metapneumovirus (hMPV)
- Lead optimization on potent nanomolar hMPV inhibitors is
currently ongoing.
NASH
- Farnesoid X Receptor (FXR) Agonist EDP-305
- Continuing recruitment and dosing in ARGON-2 Phase 2b study of
EDP-305, with a blinded 12-week internal interim analysis on a
subset of patients to inform next steps, is expected in the third
quarter of 2021, rather than in mid-year.
- EDP-297, a Highly Potent and Targeted FXR Agonist
- Continuing recruitment and dosing in a Phase 1 study of
EDP-297, with data expected in mid-2021.
Upcoming Events and Presentations
- RBC Capital Markets Global Healthcare Conference (May 18-19,
2021)
- JMP Securities 2021 Life Sciences Conference (June 16-17,
2021)
- Raymond James Human Health Innovation Conference (June 21-23,
2021)
- The International Liver Congress™ 2021 sponsored by EASL (June
23-26, 2021)
- Enanta plans to issue its fiscal third quarter financial
results press release, and hold a conference call regarding those
results, on August 5, 2021.
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at 4:30
p.m. ET. To participate in the live conference call, please dial
(855) 840-0595 in the U.S. or (518) 444-4814 for international
callers. A replay of the conference call will be available starting
at approximately 7:30 p.m. ET on May 6, 2021, through 11:59 p.m. ET
on May 10, 2021 by dialing (855) 859-2056 from the U.S. or (404)
537-3406 for international callers. The passcode for both the live
call and the replay is 4283865. A live audio webcast of the call
and replay can be accessed by visiting the “Events and
Presentation” section on the “Investors” page of Enanta’s website
at www.enanta.com.
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 and liver diseases. Enanta’s research and development
efforts have produced clinical candidates for the following disease
targets: respiratory syncytial virus (RSV), non-alcoholic
steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also
conducting research in human metapneumovirus (hMPV) and emerging
coronaviruses, including SARS-CoV-2.
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 and now marketed by AbbVie as part of its
leading treatment for chronic HCV infection, is sold under the
brand names 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, NASH and HBV, as well as
discovery initiatives in SARS-CoV-2, RSV and 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 competitive treatments for RSV, HBV, HCV, COVID-19
and NASH; the discovery and development risks of Enanta’s programs
in RSV, HBV, NASH, hMPV and SARS-CoV-2; the competitive impact of
development, regulatory and marketing efforts of others in those
disease areas; 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 most recent Form 10-Q for the quarter ended
December 31, 2020, and 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.
ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS UNAUDITED (in thousands,
except per share amounts) Three Months Ended
Six Months Ended March 31, March 31,
2021
2020
2021
2020
Revenue
$
20,132
$
27,619
$
51,875
$
80,189
Operating expenses Research and development
41,506
32,610
78,171
65,388
General and administrative
8,326
6,884
15,703
13,805
Total operating expenses
49,832
39,494
93,874
79,193
Income (loss) from operations
(29,700
)
(11,875
)
(41,999
)
996
Other income, net
545
1,950
1,222
4,026
Income (loss) before income taxes
(29,155
)
(9,925
)
(40,777
)
5,022
Income tax benefit
7,110
3,920
10,404
2,416
Net income (loss)
$
(22,045
)
$
(6,005
)
$
(30,373
)
$
7,438
Net income (loss) per share Basic
$
(1.09
)
$
(0.30
)
$
(1.51
)
$
0.37
Diluted
$
(1.09
)
$
(0.30
)
$
(1.51
)
$
0.36
Weighted average common shares outstanding Basic
20,171
19,922
20,131
19,836
Diluted
20,171
19,922
20,131
20,692
ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS UNAUDITED (in thousands)
March 31, September 30,
2021
2020
Assets Current assets Cash and cash equivalents
$
77,126
$
87,131
Short-term marketable securities
298,821
299,518
Accounts receivable
20,132
23,492
Prepaid expenses and other current assets
32,140
26,696
Total current assets
428,219
436,837
Long-term marketable securities
24,493
32,634
Property and equipment, net
7,038
8,596
Deferred tax assets
345
345
Operating lease, right-of-use assets
6,972
7,020
Restricted cash
608
608
Other long-term assets
92
92
Total assets
$
467,767
$
486,132
Liabilities and Stockholders' Equity Current liabilities Accounts
payable
$
5,699
$
5,737
Accrued expenses and other current liabilities
15,744
14,159
Operating lease liabilities
5,175
4,261
Total current liabilities
26,618
24,157
Operating lease liabilities, net of current portion
2,644
3,838
Series 1 nonconvertible preferred stock
1,479
1,479
Other long-term liabilities
994
1,078
Total liabilities
31,735
30,552
Total stockholders' equity
436,032
455,580
Total liabilities and stockholders' equity
$
467,767
$
486,132
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210506006072/en/
Media and Investor Contact: Jennifer Viera 617-744-3848
jviera@enanta.com
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