- Expects Topline Data From RSVP, a Phase 2b Study of EDP-938 in
Adults With Community-Acquired Respiratory Syncytial Virus (RSV),
This Quarter
- Received Fast Track Designation for EDP-235, an Oral 3CL
Protease Inhibitor Specifically Designed for the Treatment of
COVID-19; Expects Preliminary Data From a Phase 1 Study of EDP-235
This Quarter
- On Track to Initiate a Phase 1 Study of EDP-323, an RSV
L-Protein Inhibitor, in the Second Half of 2022
- Royalty Revenue for the Quarter was $18.7 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 second quarter ended March 31, 2022.
“We had a strong start to 2022, making meaningful strides to
advance our leadership in the development of therapeutics for viral
infections with important progress in our broad pipeline, most
notably in our clinical stage RSV and COVID-19 programs,” said Jay
R. Luly Ph.D., President and Chief Executive Officer of Enanta
Pharmaceuticals. “The progress we made lays the groundwork for an
important quarter to come, particularly as we soon approach
significant inflection points. During this quarter, we expect to
report topline data from our RSVP study, a Phase 2b trial designed
to confirm the results of the challenge study, in the setting of
community-acquired RSV infection in an otherwise healthy adult
population. We are also on track to announce preliminary data from
our COVID-19 Phase 1 study of EDP 235 this quarter which, if
positive, will allow us to move to the next phase of clinical
development in the second half of this year. Additionally, we plan
to initiate a Phase 2b study in adults at high-risk for serious RSV
infection by year end. With much to look forward to in the coming
months, we are excited to continue to advance our mission of
transforming the lives of patients by developing curative therapies
for viral diseases that have a global impact and high unmet
need.”
Fiscal Second Quarter Ended March 31, 2022 Financial
Results
Total revenue for the three months ended March 31, 2022 was
$18.7 million and consisted of royalty revenue derived primarily
from worldwide net sales of AbbVie’s hepatitis C virus (HCV)
regimen MAVYRET®/MAVIRET® (glecaprevir/pibrentasvir), as treated
patient volumes remain suppressed compared to pre-COVID levels. For
the three months ended March 31, 2021, total revenue from royalties
on AbbVie’s net sales of HCV regimens was $20.1 million.
Research and development expenses totaled $42.1 million for the
three months ended March 31, 2022, compared to $41.5 million for
the three months ended March 31, 2021. The increase was driven by
the timing of manufacturing and clinical trial costs associated
with the company’s virology and liver disease programs.
General and administrative expenses totaled $10.5 million for
the three months ended March 31, 2022, compared to $8.3 million for
the three months ended March 31, 2021. The increase in general and
administrative expenses was due to increased headcount and
stock-related compensation expense.
Enanta recorded no income tax expense for the three months ended
March 31, 2022, compared to an income tax benefit of $7.1 million
for the same period of 2021. Enanta recorded an income tax benefit
in 2021 due to the provision of the CARES Act of 2020, which
enabled the company to carry back its tax loss in the 2021 period
to offset taxable income in prior years. This provision does not
apply to periods ending after September 30, 2021.
Net loss for the three months ended March 31, 2022 was $33.6
million, or a loss of $1.63 per diluted common share, compared to a
net loss of $22.0 million, or a loss of $1.09 per diluted common
share, for the corresponding period in 2021.
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $322.5 million at March 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 for at least the next
two years.
Pipeline Update and Business Review
RSV
- EDP-938, an N-protein inhibitor with Fast Track designation by
the U.S. Food and Drug Administration (FDA), is being evaluated in
a broad clinical development program in multiple patient groups,
currently consisting of three Phase 2 trials: RSVP, RSVPEDs and
RSVTx.
- Enanta is on track to report topline data this quarter for
RSVP, a Phase 2b study designed to confirm the results of the
company’s challenge study, in the setting of community-acquired RSV
infection in an otherwise healthy adult population. These results
will provide additional information on the effect of EDP-938 on
symptoms and viral load in a low-risk adult population.
- Enanta plans to initiate an additional Phase 2b study in a
high-risk adult population, including the elderly or those with
asthma, chronic obstructive pulmonary disease, or congestive heart
failure, by year end.
- Recruitment is ongoing for 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. The company
expects these studies to continue into 2023.
- Enanta plans to initiate a Phase 1 study for EDP-323, a novel
oral, direct-acting antiviral selectively targeting the RSV
L-protein, in the second half of 2022. 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 their treatment windows.
- Data from the human challenge study of EDP-938 were published
this February in The New England Journal of Medicine.
COVID-19 (SARS-CoV-2)
- Enanta expects to report preliminary data this quarter for its
ongoing Phase 1 healthy volunteer study of EDP-235, an oral
inhibitor of coronavirus 3CL protease, or 3CLpro (also known as
Mpro or main protease) specifically designed for the treatment of
COVID-19. If supported by Phase 1 results, the company plans to
advance EDP-235 to the next stage of clinical development in the
second half of this year.
- In March, the FDA granted Fast Track designation for EDP-235,
further highlighting the urgent unmet need that exists for oral
COVID-19 treatments.
- Preclinical data demonstrate that EDP-235 potently blocks the
replication of SARS-CoV-2 in multiple cellular models, including
primary human airway epithelial cells with an EC90 of 33 nanomolar,
positioning EDP-235 among the most potent direct-acting antivirals
currently in development for SARS-CoV-2 infection, with the
potential for convenient once-daily dosing. Importantly, in
preclinical studies, EDP-235 has shown good exposure after oral
administration without ritonavir boosting and favorable
distribution into lung cells as well as other key target
tissues.
- Enanta also presented data highlighting EDP-235’s in vitro
pharmacology and molecular mechanism of action at the American
Society for Biochemistry and Molecular Biology 2022 Annual Meeting.
Preclinical data presented at the conference provided further
confirmation that EDP-235 is a potent inhibitor of SARS-CoV-2
3CLpro and shows potent antiviral activity against SARS-CoV-2
variants of concern, including Delta and Omicron. EDP-235 also
showed potent antiviral activity against most other pathogenic
human coronaviruses, potentially making it a pan-coronavirus
therapy.
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. 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.
Human Metapneumovirus (hMPV)
- Enanta is on track to select a clinical candidate for hMPV in
the second half of 2022. hMPV is a pathogen thatcauses 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.
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
844-467-7101 in the U.S. or 270-215-9353 for international callers.
A replay of the conference call will be available starting at
approximately 7:30 p.m. ET on March 9, 2022, through 11:59 p.m. ET
on March 16, 2022, 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 7061969. 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 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
programs include clinical candidates currently 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 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 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
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 December 31, 2021,
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.
ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS UNAUDITED (in thousands)
March 31, September 30,
2022
2021
Assets
Current assets
Cash and cash
equivalents
$
40,989
$
57,206
Short-term marketable securities
239,338
186,796
Accounts receivable
18,716
23,576
Prepaid expenses and other current assets
14,078
14,188
Income tax receivable
28,748
37,255
Total current assets
341,869
319,021
Long-term marketable securities
42,218
108,416
Property and equipment, net
4,815
5,943
Operating lease, right-of-use assets
17,216
4,711
Restricted cash
608
608
Other long-term assets
92
92
Total assets
$
406,818
$
438,791
Liabilities and Stockholders' Equity
Current liabilities Accounts
payable
$
5,985
$
9,540
Accrued expenses and other current liabilities
21,740
22,429
Operating lease liabilities
3,013
4,203
Total current liabilities
30,738
36,172
Operating lease liabilities, net of current portion
15,115
1,126
Series 1 nonconvertible preferred stock
1,506
1,506
Other long-term liabilities
876
558
Total liabilities
48,235
39,362
Total stockholders' equity
358,583
399,429
Total liabilities and stockholders' equity
$
406,818
$
438,791
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,
2022
2021
2022
2021
Revenue
$
18,716
$
20,132
$
46,364
$
51,875
Operating expenses
Research and development
42,087
41,506
90,636
78,171
General and administrative
10,476
8,326
19,984
15,703
Total operating expenses
52,563
49,832
110,620
93,874
Loss from operations
(33,847
)
(29,700
)
(64,256
)
(41,999
)
Other income, net
255
545
549
1,222
Loss before income taxes
(33,592
)
(29,155
)
(63,707
)
(40,777
)
Income tax benefit
—
7,110
—
10,404
Net loss
$
(33,592
)
$
(22,045
)
$
(63,707
)
$
(30,373
)
Net loss per share
Basic
$
(1.63
)
$
(1.09
)
$
(3.11
)
$
(1.51
)
Diluted
$
(1.63
)
$
(1.09
)
$
(3.11
)
$
(1.51
)
Weighted average common shares outstanding
Basic
20,551
20,171
20,473
20,131
Diluted
20,551
20,171
20,473
20,131
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220509005897/en/
Media and Investor: Jennifer Viera 617-744-3848
jviera@enanta.com
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