- Nominates EDP-235, an Oral Protease Inhibitor Specifically
Designed to Treat COVID-19, with a Phase 1 Study Planned for Early
2022
- On Track to Dose First Subject in a Phase 1 Study of EDP-721,
an Oral, Hepatitis B Virus (HBV) RNA Destabilizer
- Recently Reported Positive Preliminary Data from a Phase 1b
Study of EDP-514 in Viremic Chronic HBV Patients Supportive of Once
Daily Dosing and Demonstrating a Mean Reduction of 3.3 Logs in HBV
DNA
- Royalty Revenue for the Quarter was $21.6 Million
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 third quarter ended June 30, 2021.
“This was an important quarter for Enanta, and I am proud of the
work we have accomplished and the significant milestones we have
achieved to advance our clinical portfolio in key therapeutic
areas,” stated Jay R. Luly, Ph.D., President and Chief Executive
Officer of Enanta Pharmaceuticals. “We are excited today to
nominate EDP-235, our novel, potent, oral protease inhibitor
specifically designed to target SARS-CoV-2. As the COVID-19
pandemic continues to have a significant impact globally, we are
committed to leveraging our expertise in virology to progress this
program and initiate a Phase 1 clinical study in early 2022. We are
also pleased to be on track to dose our first subject this month in
the Phase 1 study of EDP-721, our oral HBV RNA destabilizer, which
we believe will be an important component of an all-oral,
functional cure for chronic HBV. This progress follows recent
positive data from two Phase 1b studies of our core inhibitor
EDP-514, one in chronic HBV patients already being treated with a
nucleoside reverse transcriptase inhibitor and the other in viremic
patients not currently on treatment. Looking toward the second half
of the year, we are excited to continue our progress and advance
several clinical candidates in our pipeline.”
Fiscal Third Quarter Ended June 30, 2021 Financial
Results
Total revenue of $21.6 million for the three months ended June
30, 2021 consisted of royalty revenue derived primarily from
worldwide net sales of AbbVie’s hepatitis C virus (HCV) regimen
MAVYRET®/MAVIRET®. This compared to total revenue of $18.7 million
for the three months ended June 30, 2020, which also consisted of
royalty revenue. AbbVie has stated that net sales of
MAVYRET/MAVIRET in the three months ended June 30, 2021 increased
compared to 2020, although a residual impact from the pandemic
continues.
Research and development expenses increased to $47.0 million for
the three months ended June 30, 2021, compared to $34.7 million for
the three months ended June 30, 2020. The increase was due to the
timing of the company’s clinical trials year over year.
General and administrative expenses totaled $8.5 million for the
three months ended June 30, 2021, compared to $6.8 million for the
three months ended June 30, 2020. The increase was due to an
increase in headcount and related compensation expense.
Enanta recorded an income tax benefit of $9.4 million for the
three months ended June 30, 2021 compared to an income tax benefit
of $7.1 million for the same period in 2020. These income tax
benefits were due to the provision of the CARES Act of 2020, which
enables the company through fiscal 2021 to carry back its projected
current year tax loss to offset taxable income in prior years.
Net loss for the three months ended June 30, 2021 was $24.0
million, or a loss of $1.19 per diluted common share, compared to
net loss of $14.3 million, or a loss of $0.71 per diluted common
share, for the corresponding period in 2020.
Enanta’s cash, cash equivalents and marketable securities
totaled $372.5 million at June 30, 2021. 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 for
at least the next two years.
Pipeline Program -- Recent Events and Near-Term
Milestones
Virology
- HBV: Core Inhibitor EDP-514 and HBV RNA Destabilizer
EDP-721
- On track to dose the first subject this month in a Phase 1
clinical study of EDP-721, an oral, potent and selective HBV RNA
destabilizer being developed for use in combination with other
mechanisms, with the goal of developing an all-oral regimen to
achieve a functional cure. Data are expected in the first half of
2022.
- Announced positive data from a Phase 1b study of EDP-514 in
viremic chronic HBV patients, which demonstrated that the 200 mg
and 400 mg doses were safe and well-tolerated through 28 days of
treatment, displayed pharmacokinetics supportive of once-daily
dosing, and resulted in mean HBV DNA reductions of 2.9 and 3.3
logs, respectively.
- Presented 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).
- COVID-19 (SARS-CoV-2): Protease Inhibitor EDP-235
- Nominated EDP-235, the company’s lead oral protease inhibitor
specifically designed for the treatment of COVID-19 and is on track
to initiate a Phase 1 study in early 2022.
- Respiratory Syncytial Virus (RSV): N-Protein Inhibitor
EDP-938
- While RSV, like influenza, did not emerge during the usual
late-fall and winter RSV season in the Northern Hemisphere in
2020-2021, the Centers for Disease Control and Prevention recently
issued a health advisory to notify clinicians and caregivers about
increased interseasonal RSV activity across parts of the Southern
United States. As RSV re-emerges, Enanta is continuing to establish
additional trial sites in North America, Europe, the Asia-Pacific
region, and the Southern Hemisphere.
- Given the recent re-emergence of RSV is not following any
normal seasonal pattern, it is very difficult to predict how
significant or sustained the new incidence of RSV will be moving
forward. Enanta is hopeful that enrollment in the RSVP study will
be complete during the Northern Hemisphere winter season if there
are no renewed social distancing interventions. Assuming this
enrollment occurs, the company would expect data in first half of
2022.
- For RSVTx and RSVPEDs, which were initiated more recently,
Enanta is monitoring the trends and will update as
appropriate.
- Respiratory Virology Discovery Initiatives – Having
recently nominated EDP-235 as a clinical development candidate,
Enanta’s goal in the second half of 2021 is to identify one more
clinical development candidate among the two discovery initiatives
below:
- RSV L-Protein Inhibitor
- Continuing to optimize leads with potent nanomolar activity
against both RSV-A and RSV-B.
- Human Metapneumovirus (hMPV)
- Continuing lead optimization on potent nanomolar hMPV
inhibitors.
Non-Alcoholic
Steatohepatitis
- Farnesoid X Receptor (FXR) Agonist EDP-305
- ARGON-2, a Phase 2b study of EDP-305, is on track for a planned
12-week internal interim analysis on a subset of patients in the
third quarter of 2021 to inform next steps.
- EDP-297, a Highly Potent and Targeted FXR Agonist
- Data are expected from the Phase 1 study of EDP-297 in the
third quarter of 2021.
Corporate
- Announced the planned retirement of Nathalie Adda, M.D., Senior
Vice President and Chief Medical Officer, in February 2022, with a
period of consulting thereafter.
Upcoming Events and Presentations
- H.C. Wainwright 23rd Annual Global Investment Conference
(September 13-14, 2021)
- Baird 2021 Global Healthcare Conference (September 14-15,
2021)
- Enanta plans to issue its fiscal fourth quarter and year-end
financial results press release, and hold a conference call
regarding those results, on November 22, 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 August 5, 2021, through 11:59 p.m. ET
on August 9, 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 5637368. A live audio webcast of
the call and replay can be accessed by visiting the “Events and
Presentations” section on the “Investors” page of Enanta’s website
at www.enanta.com.
About Enanta
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), hepatitis B virus
(HBV), non-alcoholic steatohepatitis (NASH) and SARS-CoV-2
(COVID-19). 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 sold by AbbVie in numerous countries as
part of its leading treatment for chronic HCV infection 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 research and development programs in RSV, HBV, NASH,
SARS-CoV-2 and hMPV, as well as future royalty revenue from sales
of AbbVie’s MAVYRET/MAVIRET regimen for HCV. 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
dependence of Enanta’s revenues in the short-term upon the
continued success of AbbVie’s sales of its MAVYRET/MAVIRET HCV
regimen; the impact of development, regulatory and marketing
efforts of others with respect to competitive treatments for RSV,
NASH, HBV, hMPV and SARS-CoV-2; treatment rates, competitive
pricing, and reimbursement rate actions affecting MAVYRET/MAVIRET
compared to competitive HCV products on the market; any continuing
impact of COVID-19 on AbbVie’s MAVYRET/MAVIRET sales; the discovery
and development risks of Enanta’s research and development programs
in RSV, NASH, HBV, 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; the realizability of our deferred tax assets; and other
risk factors described or referred to in “Risk Factors” in Enanta’s
most recent Form 10-Q for the quarter ended March 31, 2021, 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 Nine Months Ended
June 30, June 30,
2021
2020
2021
2020
Revenue
$
21,624
$
18,653
$
73,499
$
98,842
Operating expenses Research and
development
46,994
34,682
125,165
100,070
General and administrative
8,477
6,823
24,180
20,628
Total operating expenses
55,471
41,505
149,345
120,698
Loss from operations
(33,847
)
(22,852
)
(75,846
)
(21,856
)
Other income, net
439
1,445
1,661
5,471
Loss before income taxes
(33,408
)
(21,407
)
(74,185
)
(16,385
)
Income tax benefit
9,384
7,142
19,788
9,558
Net loss
$
(24,024
)
$
(14,265
)
$
(54,397
)
$
(6,827
)
Net loss per share Basic
$
(1.19
)
$
(0.71
)
$
(2.70
)
$
(0.34
)
Diluted
$
(1.19
)
$
(0.71
)
$
(2.70
)
$
(0.34
)
Weighted average common shares outstanding
Basic
20,201
20,020
20,155
19,897
Diluted
20,201
20,020
20,155
19,897
ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS UNAUDITED (in thousands)
June 30, September 30,
2021
2020
Assets Current assets Cash and cash
equivalents
$
4,601
$
87,131
Short-term marketable securities
252,223
299,518
Accounts receivable
21,624
23,492
Prepaid expenses and other current assets
12,137
13,655
Income tax receivable
30,570
13,041
Total current assets
321,155
436,837
Long-term marketable securities
115,706
32,634
Property and equipment, net
6,613
8,596
Deferred tax assets
345
345
Operating lease, right-of-use assets
5,917
7,020
Restricted cash
608
608
Other long-term assets
92
92
Total assets
$
450,436
$
486,132
Liabilities and Stockholders' Equity Current
liabilities Accounts payable
$
5,895
$
5,737
Accrued expenses and other current liabilities
17,695
14,159
Operating lease liabilities
5,034
4,261
Total current liabilities
28,624
24,157
Operating lease liabilities, net of current portion
1,637
3,838
Series 1 nonconvertible preferred stock
1,479
1,479
Other long-term liabilities
846
1,078
Total liabilities
32,586
30,552
Total stockholders' equity
417,850
455,580
Total liabilities and stockholders' equity
$
450,436
$
486,132
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210805005808/en/
Media and Investor Contact: Jennifer Viera Tel:
617-744-3848 jviera@enanta.com
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