- Reported Positive Topline Data from Phase 2 SPRINT Clinical
Study of EDP-235, a 3CL Protease Inhibitor in Development as an
Oral, Once-Daily Treatment for COVID-19
- Strengthened Balance Sheet Through the Sale of 54.5% of Future
MAVYRET®/MAVIRET® Royalties for an Upfront Payment of $200
Million
- On Track to Report Phase 1 Data of EDP-323, an L-Protein
Inhibitor in Development as an Oral, Once-Daily Treatment for
Respiratory Syncytial Virus, in June
- Royalty Revenue for the Quarter was $17.8 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 second quarter ended March 31, 2023.
“At Enanta, we are focused on transforming the lives of patients
with curative therapies, by leveraging our previous successes in
the development of small molecules and our deep understanding of
virologic diseases,” said Jay R. Luly, Ph.D., President and Chief
Executive Officer of Enanta Pharmaceuticals. “This vision is
supported by positive topline data from our SPRINT Phase 2 study
announced today. With EDP-235 and Enanta’s entire pipeline, our
goal continues to be to develop cures for life-threatening viral
infections. Looking ahead, we are also eager to advance our
programs in respiratory syncytial virus with an upcoming data
readout for EDP-323, our L-protein inhibitor in development as a
once-daily oral treatment, next month. Further, the financial
flexibility we now have with the additional funding from our
royalty monetization allows us to continue to advance our robust
pipeline.”
Fiscal Second Quarter Ended March 31, 2023 Financial
Results
Total revenue for the three months ended March 31, 2023 was
$17.8 million and consisted of royalty revenue from worldwide net
sales of AbbVie’s hepatitis C virus (HCV) regimen MAVYRET®/MAVIRET®
(glecaprevir/pibrentasvir), compared to $18.7 million for the three
months ended March 31, 2022.
Research and development expenses totaled $43.5 million for the
three months ended March 31, 2023, compared to $42.1 million for
the three months ended March 31, 2022. The increase was primarily
due to the timing of clinical trial expenses in our virology
programs.
General and administrative expenses totaled $13.8 million for
the three months ended March 31, 2023, compared to $10.5 million
for the three months ended March 31, 2022. The increase was due to
increased stock-related compensation expense and legal fees
associated with our patent infringement suit against Pfizer.
Net loss for the three months ended March 31, 2023 was $37.7
million, or a loss of $1.79 per diluted common share, compared to a
net loss of $33.6 million, or a loss of $1.63 per diluted common
share, for the corresponding period in 2022.
Enanta’s cash, cash equivalents and short-term and long-term
marketable securities totaled $225.1 million at March 31, 2023,
before giving effect to its April 2023 sale of 54.5% of its ongoing
MAVYRET®/MAVIRET® royalties from AbbVie for an upfront payment of
$200 million from OMERS, one of Canada’s largest defined benefit
pension plans. Enanta expects that its current cash, cash
equivalents and marketable securities, as well as the royalty sale
and Enanta’s continuing portion of cash from future royalty
revenue, will be sufficient to meet the anticipated cash
requirements of its existing business and development programs into
calendar 2026.
Pipeline Updates
COVID-19 (SARS-CoV-2)
- Today, Enanta announced positive topline data from SPRINT
(SARS-Cov-2 PRotease INhibitor
Treatment), a double-blind, placebo-controlled Phase 2
clinical trial of EDP-235, the company’s oral, 3CL protease
inhibitor, in non-hospitalized, symptomatic adults with mild or
moderate COVID-19 who were not at high risk for severe disease. In
the trial, EDP-235 met the primary endpoint and was generally safe
and well-tolerated. A dose-dependent improvement in symptoms was
observed with EDP-235 treatment compared to placebo, which achieved
statistical significance (p<0.05) in the 400mg 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 3 days of symptom onset, a statistically
significant improvement was observed with EDP-235 at 400mg at all
time points. While no difference was observed in time to
improvement of 14 targeted COVID-19 symptoms, an analysis of a
subset of these symptoms showed a 2-day shorter time to improvement
in patients receiving EDP-235 400mg who were enrolled within 3 days
of symptom onset (p<0.01). No effect on virologic endpoints as
measured in the nose was detected due to the rapid viral decline in
the placebo arm of this highly immunologically-experienced,
standard risk population.
- Enanta will continue to evaluate data from SPRINT and is
focusing on partnership opportunities for Phase 3 and on the
potential for a different Phase 2 study in acute or long COVID that
could further demonstrate the efficacy of EDP-235.
- Enanta is advancing a research program focused on the discovery
and development of inhibitors of the SARS-CoV-2 papain-like
protease (PLpro) for the oral treatment of COVID-19. The company
continues to optimize inhibitors as it progresses this program
forward to select a development candidate.
Respiratory Syncytial Virus (RSV)
- Enanta is progressing a broad clinical program, aimed at
targeting populations at high-risk for RSV, and is evaluating
EDP-938, an N-protein inhibitor, with three ongoing clinical
trials. EDP-938 is supported by data from a previous clinical
challenge study showing that the compound significantly inhibited
replication of RSV, the only published study to show such an effect
for an N-inhibitor. EDP-938 also has a favorable and consistent
safety profile.
- Multiple ongoing studies 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
acute 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 acute RSV infection
and symptoms of upper respiratory tract infection.
- These three studies are expected to continue through 2023.
Enanta is monitoring RSV epidemiology to determine the impact on
trial enrollment and timing for data readouts.
- Enanta is on track to report topline Phase 1 data in June from
its ongoing study of EDP-323, a novel, oral, direct-acting
antiviral selectively targeting the RSV L-protein. This
double-blind, placebo-controlled, first-in-human study is designed
to enroll healthy subjects to assess EDP-323’s safety,
tolerability, and pharmacokinetics (PK). EDP-323 has the potential
to be used alone or in combination with EDP-938 to potentially
broaden the addressable patient populations or the treatment
window.
- In April, at ECCMID, Enanta reported preclinical data
highlighting EDP-323’s favorable preclinical PK properties,
excellent bioavailability with low plasma clearance, and favorable
target tissue distribution, supporting a once-daily, oral-dosing
regimen for RSV.
Human Metapneumovirus (hMPV)/RSV
- Enanta’s research program targeting both hMPV and RSV with a
single agent, which the company refers to as a dual inhibitor, is
ongoing. 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 mouse models of the respective viruses,
demonstrating significant reductions in viral load of each virus.
Enanta expects to select a dual hMPV/RSV inhibitor clinical
candidate in the fourth quarter of 2023.
Hepatitis B Virus (HBV)
- Enanta remains focused on identifying additional compounds
externally with different mechanisms of action to combine with
EDP-514, its potent core inhibitor, and a nucleoside reverse
transcriptase inhibitor. EDP-514 has displayed a good safety
profile and robust antiviral activity in multiple HBV patient
populations, with significant declines in HBV DNA among the best
published to date for core inhibitors.
Corporate
- In April, Enanta strengthened its balance sheet with the sale
to OMERS of 54.5% of Enanta’s future royalty payments from AbbVie
Inc. on worldwide sales of MAVYRET/MAVIRET. The upfront purchase
price paid to Enanta was $200 million. OMERS right to receive
royalty payments is based on net sales of the product beginning in
July 2023 through June 2032, with total payments capped at 1.42
times the purchase price. Enanta’s retains 45.5% of all royalties
until the cap is hit, at which point 100% of all further royalties
revert to Enanta.
Upcoming Events and Presentations
- JMP Securities Life Sciences Conference – May 16, 2023
- RBC Capital Markets Global Healthcare Conference – May 17,
2023
- Jefferies Global Healthcare Conference – June 7-9, 2023
- Enanta plans to issue its fiscal third quarter 2023 press
release, and hold a conference call regarding those results, on
August 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. 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).
Enanta receives 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 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.
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,
2023
2022
2023
2022
Revenue
$
17,795
$
18,716
$
41,380
$
46,364
Operating expenses Research and development
43,468
42,087
84,370
90,636
General and administrative
13,778
10,476
26,474
19,984
Total operating expenses
57,246
52,563
110,844
110,620
Loss from operations
(39,451
)
(33,847
)
(69,464
)
(64,256
)
Other income, net
1,837
255
2,830
549
Loss before income taxes
(37,614
)
(33,592
)
(66,634
)
(63,707
)
Income tax expense
(44
)
—
(10
)
—
Net loss
$
(37,658
)
$
(33,592
)
$
(66,644
)
$
(63,707
)
Net loss per share Basic
$
(1.79
)
$
(1.63
)
$
(3.19
)
$
(3.11
)
Diluted
$
(1.79
)
$
(1.63
)
$
(3.19
)
$
(3.11
)
Weighted average common shares outstanding Basic
21,035
20,551
20,882
20,473
Diluted
21,035
20,551
20,882
20,473
ENANTA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED
BALANCE SHEETS
UNAUDITED
(in thousands)
March 31, September 30,
2023
2022
Assets Current assets Cash and cash equivalents
$
73,178
$
43,994
Short-term marketable securities
136,906
205,238
Accounts receivable
17,795
20,318
Prepaid expenses and other current assets
14,484
13,445
Income tax receivable
28,774
28,718
Total current assets
271,137
311,713
Long-term marketable securities
15,040
29,285
Property and equipment, net
11,050
6,173
Operating lease, right-of-use assets
24,554
23,575
Restricted cash
3,968
3,968
Other long-term assets
696
696
Total assets
$
326,445
$
375,410
Liabilities and Stockholders' Equity Current liabilities Accounts
payable
$
11,761
$
6,000
Accrued expenses and other current liabilities
15,482
20,936
Operating lease liabilities
4,923
2,891
Total current liabilities
32,166
29,827
Operating lease liabilities, net of current portion
23,073
22,372
Series 1 nonconvertible preferred stock
1,423
1,423
Other long-term liabilities
408
454
Total liabilities
57,070
54,076
Total stockholders' equity
269,375
321,334
Total liabilities and stockholders' equity
$
326,445
$
375,410
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230508005587/en/
Media and Investors Contact: Jennifer Viera 617-744-3848
jviera@enanta.com
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