- Reported Positive Topline Data from Phase 1 Study of EDP-323,
an L-Protein Inhibitor in Development as an Oral, Once-Daily
Treatment for Respiratory Syncytial Virus (RSV); Expect to Initiate
Phase 2 Human Challenge Study in Early 4Q 2023.
- Cash and Marketable Securities Totaled $392.5 Million at June
30, 2023
- Royalty Revenue for the Quarter was $18.9 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 third quarter ended June 30, 2023.
“Our fiscal third quarter was marked by important progress in
our pipeline, most notably across our RSV and COVID-19 programs. In
RSV, we were pleased to report positive Phase 1 results for EDP-323
in healthy volunteers, demonstrating favorable safety,
tolerability, and pharmacokinetics. These data allow us to build
and progress our RSV portfolio through advancement of this second
oral RSV antiviral into a Phase 2 human challenge study, with a
goal of identifying potential applications for EDP-323 as a
monotherapy or combination approach. We believe our RSV antivirals
have significant promise and we are advancing our clinical programs
with a sense urgency given the substantial unmet need for RSV
treatments,” said Jay R. Luly Ph.D., President and Chief Executive
Officer of Enanta Pharmaceuticals. “Additionally, in our COVID-19
program, we presented further data in June from the SPRINT trial
where EDP-235 treatment resulted in a 1.0 log drop in viral load in
the subset of patients who had not been recently infected with
SARS-CoV-2 and were treated within three days of symptom onset.
With our robust pipeline, including EDP-938, the most advanced RSV
N-protein inhibitor in development, and our strong financial
position, we are poised to be a leader in the development of
therapeutics for life-threatening viruses.”
Fiscal Third Quarter Ended June 30, 2023 Financial
Results
Total revenue for the three months ended June 30, 2023 was $18.9
million and consisted of royalty revenue from worldwide net sales
of AbbVie’s hepatitis C virus (HCV) regimen MAVYRET®/MAVIRET®
(glecaprevir/pibrentasvir), compared to $19.5 million for the three
months ended June 30, 2022.
Research and development expenses totaled $43.0 million for the
three months ended June 30, 2023, compared to $39.1 million for the
three months ended June 30, 2022. The increase was primarily due to
the timing of clinical trial expenses in the company’s virology
programs.
General and administrative expenses totaled $12.6 million for
the three months ended June 30, 2023, compared to $12.9 million for
the three months ended June 30, 2022.
Enanta recorded income tax expense of $4.2 million for the three
months ended June 30, 2023 driven by the receipt of the $200.0
million from the royalty sale agreement which is taxable for
federal and state purposes. Enanta was able to utilize federal net
operating loss and research and development tax credit
carryforwards as well as a deduction for foreign derived intangible
income to substantially offset the taxable effect of the royalty
sale agreement. For the three months ended June 30, 2022, Enanta
recorded an income tax benefit of $0.4 million, which was due to
the release of a state tax reserve during the period.
Net loss for the three months ended June 30, 2023 was $39.1
million, or a loss of $1.86 per diluted common share, compared to a
net loss of $31.7 million, or a loss of $1.53 per diluted common
share, for the corresponding period in 2022.
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $392.5 million at June 30, 2023. In
April 2023, Enanta sold 54.5% of its ongoing royalties from AbbVie
on sales of MAVYRET®/MAVIRET® after June 30, 2023, for an upfront
payment of $200.0 million from OMERS, one of Canada’s largest
defined benefit pension plans. For financial reporting purposes,
the transaction will be treated as debt, with the upfront purchase
payment of $200.0 million recorded as a liability. Enanta will
continue to record 100% of the royalty earned as revenue and will
then amortize the debt liability proportionally as 54.5% of the
cash royalties are paid to OMERS, until a cap of 1.42 times the
purchase payment is met, after which point 100% of the cash
royalties will be retained by Enanta. Interest expense will be
recorded in Enanta’s consolidated statement of operations as other
expense based on an imputed interest rate.
Enanta expects that its current cash, cash equivalents and
marketable securities and its continuing portion of cash from
future royalty revenue, should be sufficient to meet the
anticipated cash requirements of its existing business and
development programs into the second half of fiscal 2027.
Updated Financial Guidance for Fiscal 2023
- Research and Development Expense: $165 million to $175
million
- General and Administrative Expense: $50 million to $55
million
- 54.5% of royalties on MAVYRET®/MAVIRET® sales in fiscal fourth
quarter will be paid to OMERS
Pipeline Update and Business Review
RSV
- EDP-938, an N-protein inhibitor with Fast Track designation
from the U.S. Food and Drug Administration (FDA), is supported by
data from a Phase 2 RSV human challenge study that demonstrated a
significant impact on viral replication and symptom reduction, and
is the only published study to show such an effect for an
N-inhibitor. EDP-938 also has a favorable and consistent safety
profile.
- Ongoing studies of EDP-938 include RSVPEDs, a Phase 2
randomized, double-blind, placebo-controlled study in hospitalized
and non-hospitalized pediatric RSV patients; RSVHR, a Phase 2b
randomized, double-blind, placebo-controlled study in adults with
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; and RSVTx, a Phase 2b,
randomized, double-blind, placebo-controlled study in adult
hematopoietic cell transplant recipients with RSV infection and
symptoms of upper respiratory tract infection.
- Enanta expects to complete enrollment in one or more of its
ongoing Phase 2 studies of EDP-938 in the upcoming Northern
Hemisphere RSV season and to report data in fiscal 2024, pending a
return to a normal pre-pandemic type of RSV season in the Northern
Hemisphere.
- In June, Enanta reported positive topline data from healthy
volunteers in its Phase 1 study of EDP-323, an oral, L-protein
inhibitor, for the treatment of RSV. EDP-323 has the potential to
be used alone or in combination with EDP-938 to address different
patient populations or extend the treatment window. Data
demonstrated favorable safety, tolerability, and pharmacokinetics
(PK) supportive of once-daily dosing, with good exposure multiples,
thereby supporting further clinical advancement of EDP-323.
- Enanta plans to initiate a human challenge study evaluating
EDP-323 early in the fourth quarter of 2023 and anticipates having
data results in the second quarter of 2024.
COVID-19 (SARS-CoV-2)
- Enanta announced additional analyses of SPRINT
(SARS-Cov-2 PRotease INhibitor
Treatment), its Phase 2 clinical trial of EDP-235, an oral,
3CL protease inhibitor in non-hospitalized, symptomatic adults with
mild or moderate COVID-19.
- These analyses demonstrated a virologic effect of EDP-235 in
the subset of patients who had not been recently infected, known as
nucleocapsid-negative patients, as measured by lack of antibodies
to the SARS-CoV-2 nucleocapsid. Specifically, in this
nucleocapsid-negative patient subset, an 0.8 log viral load decline
was observed at Day 5 with 400 mg of EDP-235 compared to placebo,
and a 1.0 log viral load decline in nucleocapsid-negative patients
who were treated within three days of symptom onset.
- These data build upon the positive topline SPRINT data
announced in May in which a dose-dependent improvement in symptoms
was observed with EDP-235 treatment compared to placebo, which
achieved statistical significance (p<0.05) in the 400 mg
treatment group at multiple time points, starting as early as one
day after the first dose. In a prespecified population consisting
of patients enrolled within three days of symptom onset, a
statistically significant improvement was observed with EDP-235 at
400 mg at all time points. Further, an analysis of a subset of
symptoms showed a two day shorter time to symptom improvement in
patients receiving EDP-235 400 mg who were enrolled within three
days of symptom onset (p<0.01). The study also demonstrated that
EDP-235 was generally safe and well-tolerated.
- Enanta plans to conduct all future COVID work in the context of
a collaboration. To that end, the company is focused on partnering
opportunities for progressing EDP-235 into Phase 3 trials and is
engaging in regulatory discussions regarding the registrational
pathway for such development of EDP-235.
Human Metapneumovirus (hMPV)/RSV
- Enanta’s research program targeting both hMPV and RSV with a
single agent is ongoing with optimization of 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 each virus. Enanta expects
to select a dual hMPV/RSV clinical candidate in the fourth quarter
of 2023.
Hepatitis B Virus (HBV)
- Enanta continues to monitor the HBV field to identify
alternative compounds for development in combination regimens with
a nucleoside reverse transcriptase inhibitor and EDP-514, its
potent core inhibitor, which received Fast Track designation from
the FDA.
Upcoming Events and Presentations
- Wells Fargo Securities Healthcare Conference, September 7,
2023
- H.C. Wainwright 25th Annual Global Investment Conference,
September 12, 2023
- Baird 2023 Global Healthcare Conference, September 13,
2023
- 2023 Cantor Global Healthcare Conference, September 26 – 28,
2023
- 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 20, 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
join by phone, participants can register for the call here. It is
recommended that participants register 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).
Glecaprevir, a protease inhibitor discovered by Enanta, is part
of one of the leading treatment regimens for curing chronic
hepatitis c virus 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 Nine Months
Ended June 30, June 30,
2023
2022
2023
2022
Revenue
$
18,892
$
19,479
$
60,272
$
65,843
Operating expenses Research and development
42,987
39,090
127,357
129,726
General and administrative
12,618
12,929
39,092
32,913
Total operating expenses
55,605
52,019
166,449
162,639
Loss from operations
(36,713
)
(32,540
)
(106,177
)
(96,796
)
Interest expense
(1,997
)
—
(1,997
)
—
Interest and investment income, net
3,866
393
6,696
942
Loss before income taxes
(34,844
)
(32,147
)
(101,478
)
(95,854
)
Income tax (expense) benefit
(4,221
)
447
(4,231
)
447
Net loss
$
(39,065
)
$
(31,700
)
$
(105,709
)
$
(95,407
)
Net loss per share Basic
$
(1.86
)
$
(1.53
)
$
(5.05
)
$
(4.64
)
Diluted
$
(1.86
)
$
(1.53
)
$
(5.05
)
$
(4.64
)
Weighted average common shares outstanding Basic
21,054
20,710
20,939
20,552
Diluted
21,054
20,710
20,939
20,552
ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS UNAUDITED(in thousands) June
30, September 30,
2023
2022
Assets Current assets Cash and cash equivalents
$
95,177
$
43,994
Short-term marketable securities
291,408
205,238
Accounts receivable
18,892
20,318
Prepaid expenses and other current assets
17,071
13,445
Income tax receivable
25,917
28,718
Total current assets
448,465
311,713
Long-term marketable securities
5,924
29,285
Property and equipment, net
12,014
6,173
Operating lease, right-of-use assets
23,968
23,575
Restricted cash
3,968
3,968
Other long-term assets
830
696
Total assets
$
495,169
$
375,410
Liabilities and Stockholders' Equity Current liabilities Accounts
payable
$
7,932
$
6,000
Accrued expenses and other current liabilities
18,196
20,936
Liability related to the sale of future royalties
36,693
—
Operating lease liabilities
5,368
2,891
Total current liabilities
68,189
29,827
Liability related to the sale of future royalties, net of current
portion
164,979
—
Operating lease liabilities, net of current portion
22,333
22,372
Series 1 nonconvertible preferred stock
1,423
1,423
Other long-term liabilities
426
454
Total liabilities
257,350
54,076
Total stockholders' equity
237,819
321,334
Total liabilities and stockholders' equity
$
495,169
$
375,410
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230807396248/en/
Media and Investor Contact: Jennifer Viera 617-744-3848
jviera@enanta.com
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Jul 2023 to Jul 2024