CORRECTING and REPLACING Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2017

News Archive

CORRECTING and REPLACING Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2017

WATERTOWN, Mass.–(BUSINESS WIRE)–May 8, 2017–
Seventh paragraph, second sentence of release dated May 8, 2017, should
read: “For the six months ended March 31, 2017, net loss was $10.4
million, or ($0.54) per diluted common share, compared to net income of
$24.5 million, or $1.28 per diluted common share…” (instead of $1.28
million per diluted common share).

The corrected release reads:

ENANTA PHARMACEUTICALS REPORTS FINANCIAL RESULTS FOR ITS FISCAL
SECOND QUARTER ENDED MARCH 31, 2017

Webcast and Conference Call today at 4:30 p.m. ET

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused 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, 2017.

Enanta’s cash, cash equivalents and short-term and long-term marketable
securities totaled $240.9 million at March 31, 2017. This compares to a
total of $242.2 million in such accounts at September 30, 2016. Enanta
expects that its current cash, cash equivalents and marketable
securities will be sufficient to meet the anticipated cash requirements
of its existing business and development programs for the foreseeable
future.

Fiscal Second Quarter Ended March 31, 2017 Financial Results

Total revenue for the three months ended March 31, 2017 was $9.0
million, compared to $13.0 million for the three months ended March 31,
2016. For the six months ended March 31, 2017, total revenue was $19.4
million, compared to $61.4 million for the same period in 2016. For the
three and six month periods ended March 31 2017, revenue consisted
exclusively of royalties earned on AbbVie’s worldwide net sales of HCV
regimens containing paritaprevir. For the 2016 six month period, revenue
consisted primarily of royalty revenues as well as a $30.0 million
milestone payment for the reimbursement approval of VIEKIRAX® in Japan.
Milestone payments and royalties have varied significantly from period
to period, and we expect that variability to continue in the future.

Research and development expenses totaled $13.0 million for the three
months ended March 31, 2017, compared to $9.1 million for the three
months ended March 31, 2016. For the six months ended March 31, 2017,
research and development expenses totaled $25.5 million compared to
$18.2 million for the same period in 2016. The increase in research and
development expenses was primarily due to increased preclinical and
clinical costs associated with the progression of Enanta’s wholly-owned
R&D programs in non-alcoholic steatohepatitis (NASH)/primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV).

General and administrative expenses totaled $5.5 million for the three
months ended March 31, 2017, compared to $4.4 million for the three
months ended March 31, 2016. For the six months ended March 31, 2017,
general and administrative expenses was $10.4 million, compared to $8.2
million for the same period in 2016. For the three month period, the
increase in general and administrative expenses was primarily due to
increases in stock-based compensation expense driven by increased
headcount. For the six month period, the increase was due to increased
headcount as well as achievement of milestones under existing
performance-based stock awards.

Enanta recorded an income tax benefit for the three months ended March
31, 2017 of $3.6 million compared to an income tax expense of $1.6
million for the same period in 2016. The Company’s estimated annual
effective tax rate for fiscal 2017 of 33.0 percent was slightly below
the statutory rate of 35.0 percent due to the availability of federal
research and development tax credits.

Net loss for the three months ended March 31, 2017 was $5.4 million, or
$(0.28) per diluted common share, compared to net loss of $1.6 million,
or ($0.09) per diluted common share, for the corresponding period in
2016. For the six months ended March 31, 2017, net loss was $10.4
million, or ($0.54) per diluted common share, compared to net income of
$24.5 million, or $1.28 per diluted common share, for the corresponding
period in 2016.

“With our second partnered protease inhibitor product, glecaprevir,
expected to launch starting in August as part of AbbVie’s new,
investigational G/P treatment for HCV, the prospects for additional
milestone and royalty payments to us for G/P are significant,” stated
Jay R. Luly, Ph.D., President and Chief Executive Officer, Enanta. “Any
such payments, coupled with our existing financial resources, will allow
us to advance our clinical program in NASH/PBC and also fund our
additional R&D programs, including our lead compound EDP-938 for RSV,
scheduled to begin clinical development later this year.”

Development Program and Business Review

Upcoming Events and Presentations

On June 25 at the XIX International Symposium on Respiratory Viral
Infections in Berlin, Germany, Enanta will present data on EDP-938, its
respiratory syncytial virus inhibitor candidate in an oral presentation
titled: “EDP-938, a Novel Non-Fusion Replication Inhibitor of
Respiratory Syncytial Virus, Demonstrates Potent Antiviral Activities
both In Vitro and In Vivo”.

Conference Call and Webcast Information
Enanta will host a
conference call and webcast today at 4:30 p.m. Eastern time. 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.
Eastern time on May 8, 2017, through 11:59 p.m. Eastern time on May 12,
2017 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 6851190. A live audio webcast of the call and replay can be
accessed by visiting the “Calendar of Events” section on the “Investors”
page of Enanta’s website at www.enanta.com.

About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on the following
disease targets: non-alcoholic steatohepatitis (NASH)/ primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV).

Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with AbbVie, include paritaprevir, currently
marketed in AbbVie’s HCV regimens, and glecaprevir (ABT-493), Enanta’s
second protease inhibitor product, which AbbVie is developing as part of
its investigational, pan-genotypic HCV regimen of
glecaprevir/pibrentasvir (G/P) now in registration in the U.S., the E.U.
and Japan and other jurisdictions. Royalties and any further milestone
payments from this collaboration will provide additional funding for
Enanta’s earlier development programs, including its Phase 1 FXR agonist
program for NASH/PBC, and its preclinical programs for HBV and RSV.
Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.

Forward Looking Statements
This press release contains
forward-looking statements, including statements with respect to the
prospects for AbbVie’s investigational G/P regimen in HCV and the
prospects for advancement of Enanta’s earlier stage programs in NASH/PBC
and 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: Enanta’s revenues in the
short-term are dependent upon the success of AbbVie’s continuing
commercialization efforts for its HCV treatment regimens containing
paritaprevir; Enanta’s longer-term revenues will be dependent upon the
success of AbbVie’s efforts to obtain regulatory approvals for G/P and
commercialize that regimen; competitive pricing, market acceptance and
reimbursement rates of AbbVie’s treatment regimens containing
paritaprevir or its G/P combination compared to competitive HCV products
on the market and product candidates of other companies under
development; the discovery and development risks of early stage
discovery efforts in other disease areas such as NASH, PBC,RSV and HBV;
potential competition from the development efforts of others in those
other disease areas; Enanta’s lack of clinical development experience;
Enanta’s need to attract and retain senior management and key scientific
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-K for
the fiscal year ended September 30, 2016 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.

1 Presumed NAFLD subjects in this study are obese subjects,
with or without pre-diabetes or type-2 diabetes.

     

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,
2017 2016 2017 2016
 
Revenue $ 8,959 $ 13,004 $ 19,376 $ 61,449
Operating expenses
Research and Development 13,004 9,143 25,530 18,176
General and administrative   5,461     4,426     10,398     8,244  
Total operating expenses   18,465     13,569     35,928     26,420  
Income (loss) from operations (9,506 ) (565 ) (16,552 ) 35,029
Other income, net   549     472     1,073     801  
Income (loss) before income taxes (8,957 ) (93 ) (15,479 ) 35,830
Income tax (expense) benefit   3,565     (1,552 )   5,107     (11,286 )
Net income (loss) $ (5,392 ) $ (1,645 ) $ (10,372 ) $ 24,544  
 
Net income (loss) per share
Basic $ (0.28 ) $ (0.09 ) $ (0.54 ) $ 1.30
Diluted $ (0.28 ) $ (0.09 ) $ (0.54 ) $ 1.28
 
Weighted average common shares outstanding
Basic 19,047 18,921 19,042 18,848
Diluted 19,047 18,921 19,042 19,225
 
           

ENANTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED
(in thousands)
 
March 31, September 30,
2017 2016
Assets
Current assets
Cash and cash equivalents $ 19,211 $ 16,577
Short-term marketable securities 156,362 193,507
Accounts receivable 8,959 12,841
Prepaid expenses and other current assets   6,059   9,231
Total current assets 190,591 232,156
Property and equipment, net 8,526 8,004
Long-term marketable securities 65,330 32,119
Deferred tax assets 13,903 8,390
Restricted cash   608   608
Total assets $ 278,958 $ 281,277
 
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable $ 4,056 $ 3,377
Accrued expenses and other current liabilities   5,098   4,512
Total current liabilities 9,154 7,889
Warrant liability 1,276 1,251
Series 1 nonconvertible preferred stock 162 159
Other long-term liabilities   2,355   2,042
Total liabilities   12,947   11,341
Total stockholders’ equity   266,011   269,936
Total liabilities and stockholders’ equity $ 278,958 $ 281,277
 

Source: Enanta Pharmaceuticals, Inc.

Investor Contact
Enanta Pharmaceuticals, Inc.
Carol
Miceli, 617-607-0710
cmiceli@enanta.com
or
Media
Contact

MacDougall Biomedical Communications
Kari Watson,
781-235-3060
kwatson@macbiocom.com

 

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2017

Webcast and Conference Call today at 4:30 p.m. ET

WATERTOWN, Mass.–(BUSINESS WIRE)–May 8, 2017–
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused 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, 2017.

Enanta’s cash, cash equivalents and short-term and long-term marketable
securities totaled $240.9 million at March 31, 2017. This compares to a
total of $242.2 million in such accounts at September 30, 2016. Enanta
expects that its current cash, cash equivalents and marketable
securities will be sufficient to meet the anticipated cash requirements
of its existing business and development programs for the foreseeable
future.

Fiscal Second Quarter Ended March 31, 2017 Financial Results

Total revenue for the three months ended March 31, 2017 was $9.0
million, compared to $13.0 million for the three months ended March 31,
2016. For the six months ended March 31, 2017, total revenue was $19.4
million, compared to $61.4 million for the same period in 2016. For the
three and six month periods ended March 31 2017, revenue consisted
exclusively of royalties earned on AbbVie’s worldwide net sales of HCV
regimens containing paritaprevir. For the 2016 six month period, revenue
consisted primarily of royalty revenues as well as a $30.0 million
milestone payment for the reimbursement approval of VIEKIRAX® in Japan.
Milestone payments and royalties have varied significantly from period
to period, and we expect that variability to continue in the future.

Research and development expenses totaled $13.0 million for the three
months ended March 31, 2017, compared to $9.1 million for the three
months ended March 31, 2016. For the six months ended March 31, 2017,
research and development expenses totaled $25.5 million compared to
$18.2 million for the same period in 2016. The increase in research and
development expenses was primarily due to increased preclinical and
clinical costs associated with the progression of Enanta’s wholly-owned
R&D programs in non-alcoholic steatohepatitis (NASH)/primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV).

General and administrative expenses totaled $5.5 million for the three
months ended March 31, 2017, compared to $4.4 million for the three
months ended March 31, 2016. For the six months ended March 31, 2017,
general and administrative expenses was $10.4 million, compared to $8.2
million for the same period in 2016. For the three month period, the
increase in general and administrative expenses was primarily due to
increases in stock-based compensation expense driven by increased
headcount. For the six month period, the increase was due to increased
headcount as well as achievement of milestones under existing
performance-based stock awards.

Enanta recorded an income tax benefit for the three months ended March
31, 2017 of $3.6 million compared to an income tax expense of $1.6
million for the same period in 2016. The Company’s estimated annual
effective tax rate for fiscal 2017 of 33.0 percent was slightly below
the statutory rate of 35.0 percent due to the availability of federal
research and development tax credits.

Net loss for the three months ended March 31, 2017 was $5.4 million, or
$(0.28) per diluted common share, compared to net loss of $1.6 million,
or ($0.09) per diluted common share, for the corresponding period in
2016. For the six months ended March 31, 2017, net loss was $10.4
million, or ($0.54) per diluted common share, compared to net income of
$24.5 million, or $1.28 million per diluted common share, for the
corresponding period in 2016.

“With our second partnered protease inhibitor product, glecaprevir,
expected to launch starting in August as part of AbbVie’s new,
investigational G/P treatment for HCV, the prospects for additional
milestone and royalty payments to us for G/P are significant,” stated
Jay R. Luly, Ph.D., President and Chief Executive Officer, Enanta. “Any
such payments, coupled with our existing financial resources, will allow
us to advance our clinical program in NASH/PBC and also fund our
additional R&D programs, including our lead compound EDP-938 for RSV,
scheduled to begin clinical development later this year.”

Development Program and Business Review

Upcoming Events and Presentations

Conference Call and Webcast Information
Enanta will host a
conference call and webcast today at 4:30 p.m. Eastern time. 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.
Eastern time on May 8, 2017, through 11:59 p.m. Eastern time on May 12,
2017 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 6851190. A live audio webcast of the call and replay can be
accessed by visiting the “Calendar of Events” section on the “Investors”
page of Enanta’s website at www.enanta.com.

About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on the following
disease targets: non-alcoholic steatohepatitis (NASH)/ primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV).

Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with AbbVie, include paritaprevir, currently
marketed in AbbVie’s HCV regimens, and glecaprevir (ABT-493), Enanta’s
second protease inhibitor product, which AbbVie is developing as part of
its investigational, pan-genotypic HCV regimen of
glecaprevir/pibrentasvir (G/P) now in registration in the U.S., the E.U.
and Japan and other jurisdictions. Royalties and any further milestone
payments from this collaboration will provide additional funding for
Enanta’s earlier development programs, including its Phase 1 FXR agonist
program for NASH/PBC, and its preclinical programs for HBV and RSV.
Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.

Forward Looking Statements
This press release contains
forward-looking statements, including statements with respect to the
prospects for AbbVie’s investigational G/P regimen in HCV and the
prospects for advancement of Enanta’s earlier stage programs in NASH/PBC
and 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: Enanta’s revenues in the
short-term are dependent upon the success of AbbVie’s continuing
commercialization efforts for its HCV treatment regimens containing
paritaprevir; Enanta’s longer-term revenues will be dependent upon the
success of AbbVie’s efforts to obtain regulatory approvals for G/P and
commercialize that regimen; competitive pricing, market acceptance and
reimbursement rates of AbbVie’s treatment regimens containing
paritaprevir or its G/P combination compared to competitive HCV products
on the market and product candidates of other companies under
development; the discovery and development risks of early stage
discovery efforts in other disease areas such as NASH, PBC,RSV and HBV;
potential competition from the development efforts of others in those
other disease areas; Enanta’s lack of clinical development experience;
Enanta’s need to attract and retain senior management and key scientific
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-K for
the fiscal year ended September 30, 2016 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.

1 Presumed NAFLD subjects in this study are obese subjects,
with or without pre-diabetes or type-2 diabetes.

     

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,
2017 2016 2017 2016
 
Revenue $ 8,959 $ 13,004 $ 19,376 $ 61,449
Operating expenses
Research and Development 13,004 9,143 25,530 18,176
General and administrative   5,461     4,426     10,398     8,244  
Total operating expenses   18,465     13,569     35,928     26,420  
Income (loss) from operations (9,506 ) (565 ) (16,552 ) 35,029
Other income, net   549     472     1,073     801  
Income (loss) before income taxes (8,957 ) (93 ) (15,479 ) 35,830
Income tax (expense) benefit   3,565     (1,552 )   5,107     (11,286 )
Net income (loss) $ (5,392 ) $ (1,645 ) $ (10,372 ) $ 24,544  
 
Net income (loss) per share
Basic $ (0.28 ) $ (0.09 ) $ (0.54 ) $ 1.30
Diluted $ (0.28 ) $ (0.09 ) $ (0.54 ) $ 1.28
 
Weighted average common shares outstanding
Basic 19,047 18,921 19,042 18,848
Diluted 19,047 18,921 19,042 19,225
 
           

ENANTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED
(in thousands)
 
March 31, September 30,
2017 2016
Assets
Current assets
Cash and cash equivalents $ 19,211 $ 16,577
Short-term marketable securities 156,362 193,507
Accounts receivable 8,959 12,841
Prepaid expenses and other current assets   6,059   9,231
Total current assets 190,591 232,156
Property and equipment, net 8,526 8,004
Long-term marketable securities 65,330 32,119
Deferred tax assets 13,903 8,390
Restricted cash   608   608
Total assets $ 278,958 $ 281,277
 
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable $ 4,056 $ 3,377
Accrued expenses and other current liabilities   5,098   4,512
Total current liabilities 9,154 7,889
Warrant liability 1,276 1,251
Series 1 nonconvertible preferred stock 162 159
Other long-term liabilities   2,355   2,042
Total liabilities   12,947   11,341
Total stockholders’ equity   266,011   269,936
Total liabilities and stockholders’ equity $ 278,958 $ 281,277
 

Source: Enanta Pharmaceuticals, Inc.

Investor Contact
Enanta Pharmaceuticals, Inc.
Carol
Miceli, 617-607-0710
cmiceli@enanta.com
or
Media
Contact

MacDougall Biomedical Communications
Kari Watson,
781-235-3060
kwatson@macbiocom.com

 

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2017

Webcast and Conference Call today at 4:30 p.m. ET

WATERTOWN, Mass.–(BUSINESS WIRE)–May 8, 2017–
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused 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, 2017.

Enanta’s cash, cash equivalents and short-term and long-term marketable
securities totaled $240.9 million at March 31, 2017. This compares to a
total of $242.2 million in such accounts at September 30, 2016. Enanta
expects that its current cash, cash equivalents and marketable
securities will be sufficient to meet the anticipated cash requirements
of its existing business and development programs for the foreseeable
future.

Fiscal Second Quarter Ended March 31, 2017 Financial Results

Total revenue for the three months ended March 31, 2017 was $9.0
million, compared to $13.0 million for the three months ended March 31,
2016. For the six months ended March 31, 2017, total revenue was $19.4
million, compared to $61.4 million for the same period in 2016. For the
three and six month periods ended March 31 2017, revenue consisted
exclusively of royalties earned on AbbVie’s worldwide net sales of HCV
regimens containing paritaprevir. For the 2016 six month period, revenue
consisted primarily of royalty revenues as well as a $30.0 million
milestone payment for the reimbursement approval of VIEKIRAX® in Japan.
Milestone payments and royalties have varied significantly from period
to period, and we expect that variability to continue in the future.

Research and development expenses totaled $13.0 million for the three
months ended March 31, 2017, compared to $9.1 million for the three
months ended March 31, 2016. For the six months ended March 31, 2017,
research and development expenses totaled $25.5 million compared to
$18.2 million for the same period in 2016. The increase in research and
development expenses was primarily due to increased preclinical and
clinical costs associated with the progression of Enanta’s wholly-owned
R&D programs in non-alcoholic steatohepatitis (NASH)/primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV).

General and administrative expenses totaled $5.5 million for the three
months ended March 31, 2017, compared to $4.4 million for the three
months ended March 31, 2016. For the six months ended March 31, 2017,
general and administrative expenses was $10.4 million, compared to $8.2
million for the same period in 2016. For the three month period, the
increase in general and administrative expenses was primarily due to
increases in stock-based compensation expense driven by increased
headcount. For the six month period, the increase was due to increased
headcount as well as achievement of milestones under existing
performance-based stock awards.

Enanta recorded an income tax benefit for the three months ended March
31, 2017 of $3.6 million compared to an income tax expense of $1.6
million for the same period in 2016. The Company’s estimated annual
effective tax rate for fiscal 2017 of 33.0 percent was slightly below
the statutory rate of 35.0 percent due to the availability of federal
research and development tax credits.

Net loss for the three months ended March 31, 2017 was $5.4 million, or
$(0.28) per diluted common share, compared to net loss of $1.6 million,
or ($0.09) per diluted common share, for the corresponding period in
2016. For the six months ended March 31, 2017, net loss was $10.4
million, or ($0.54) per diluted common share, compared to net income of
$24.5 million, or $1.28 million per diluted common share, for the
corresponding period in 2016.

“With our second partnered protease inhibitor product, glecaprevir,
expected to launch starting in August as part of AbbVie’s new,
investigational G/P treatment for HCV, the prospects for additional
milestone and royalty payments to us for G/P are significant,” stated
Jay R. Luly, Ph.D., President and Chief Executive Officer, Enanta. “Any
such payments, coupled with our existing financial resources, will allow
us to advance our clinical program in NASH/PBC and also fund our
additional R&D programs, including our lead compound EDP-938 for RSV,
scheduled to begin clinical development later this year.”

Development Program and Business Review

Upcoming Events and Presentations

Conference Call and Webcast Information
Enanta will host a
conference call and webcast today at 4:30 p.m. Eastern time. 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.
Eastern time on May 8, 2017, through 11:59 p.m. Eastern time on May 12,
2017 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 6851190. A live audio webcast of the call and replay can be
accessed by visiting the “Calendar of Events” section on the “Investors”
page of Enanta’s website at www.enanta.com.

About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on the following
disease targets: non-alcoholic steatohepatitis (NASH)/ primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV).

Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with AbbVie, include paritaprevir, currently
marketed in AbbVie’s HCV regimens, and glecaprevir (ABT-493), Enanta’s
second protease inhibitor product, which AbbVie is developing as part of
its investigational, pan-genotypic HCV regimen of
glecaprevir/pibrentasvir (G/P) now in registration in the U.S., the E.U.
and Japan and other jurisdictions. Royalties and any further milestone
payments from this collaboration will provide additional funding for
Enanta’s earlier development programs, including its Phase 1 FXR agonist
program for NASH/PBC, and its preclinical programs for HBV and RSV.
Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.

Forward Looking Statements
This press release contains
forward-looking statements, including statements with respect to the
prospects for AbbVie’s investigational G/P regimen in HCV and the
prospects for advancement of Enanta’s earlier stage programs in NASH/PBC
and 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: Enanta’s revenues in the
short-term are dependent upon the success of AbbVie’s continuing
commercialization efforts for its HCV treatment regimens containing
paritaprevir; Enanta’s longer-term revenues will be dependent upon the
success of AbbVie’s efforts to obtain regulatory approvals for G/P and
commercialize that regimen; competitive pricing, market acceptance and
reimbursement rates of AbbVie’s treatment regimens containing
paritaprevir or its G/P combination compared to competitive HCV products
on the market and product candidates of other companies under
development; the discovery and development risks of early stage
discovery efforts in other disease areas such as NASH, PBC,RSV and HBV;
potential competition from the development efforts of others in those
other disease areas; Enanta’s lack of clinical development experience;
Enanta’s need to attract and retain senior management and key scientific
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-K for
the fiscal year ended September 30, 2016 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.

1 Presumed NAFLD subjects in this study are obese subjects,
with or without pre-diabetes or type-2 diabetes.

     

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,
2017 2016 2017 2016
 
Revenue $ 8,959 $ 13,004 $ 19,376 $ 61,449
Operating expenses
Research and Development 13,004 9,143 25,530 18,176
General and administrative   5,461     4,426     10,398     8,244  
Total operating expenses   18,465     13,569     35,928     26,420  
Income (loss) from operations (9,506 ) (565 ) (16,552 ) 35,029
Other income, net   549     472     1,073     801  
Income (loss) before income taxes (8,957 ) (93 ) (15,479 ) 35,830
Income tax (expense) benefit   3,565     (1,552 )   5,107     (11,286 )
Net income (loss) $ (5,392 ) $ (1,645 ) $ (10,372 ) $ 24,544  
 
Net income (loss) per share
Basic $ (0.28 ) $ (0.09 ) $ (0.54 ) $ 1.30
Diluted $ (0.28 ) $ (0.09 ) $ (0.54 ) $ 1.28
 
Weighted average common shares outstanding
Basic 19,047 18,921 19,042 18,848
Diluted 19,047 18,921 19,042 19,225
 
           

ENANTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED
(in thousands)
 
March 31, September 30,
2017 2016
Assets
Current assets
Cash and cash equivalents $ 19,211 $ 16,577
Short-term marketable securities 156,362 193,507
Accounts receivable 8,959 12,841
Prepaid expenses and other current assets   6,059   9,231
Total current assets 190,591 232,156
Property and equipment, net 8,526 8,004
Long-term marketable securities 65,330 32,119
Deferred tax assets 13,903 8,390
Restricted cash   608   608
Total assets $ 278,958 $ 281,277
 
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable $ 4,056 $ 3,377
Accrued expenses and other current liabilities   5,098   4,512
Total current liabilities 9,154 7,889
Warrant liability 1,276 1,251
Series 1 nonconvertible preferred stock 162 159
Other long-term liabilities   2,355   2,042
Total liabilities   12,947   11,341
Total stockholders’ equity   266,011   269,936
Total liabilities and stockholders’ equity $ 278,958 $ 281,277
 

Source: Enanta Pharmaceuticals, Inc.

Investor Contact
Enanta Pharmaceuticals, Inc.
Carol
Miceli, 617-607-0710
cmiceli@enanta.com
or
Media
Contact

MacDougall Biomedical Communications
Kari Watson,
781-235-3060
kwatson@macbiocom.com

 

Enanta Announces Eight Weeks of Treatment with AbbVie’s Investigational, Pan-Genotypic, Ribavirin-Free HCV Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR Rates in Challenging-to-Treat Genotype 3 Chronic HCV Patients

WATERTOWN, Mass.–(BUSINESS WIRE)–Apr. 21, 2017–
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today reported
that AbbVie announced high SVR rates were achieved with 8 weeks of
treatment with its investigational, once daily, ribavirin-free,
pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) in patients with
challenging-to-treat genotype 3 (GT3) chronic hepatitis C virus (HCV)
infection. In results from AbbVie’s Phase 3 ENDURANCE-3 study, 95
percent (n=149/157) of GT3 chronic HCV-infected patients without
cirrhosis and who were new to treatment achieved sustained virologic
response at 12 weeks post-treatment (SVR12) following 8 weeks
of treatment with G/P.1 These results will be featured as an
oral presentation today at The International Liver Congress™ (ILC) 2017
in Amsterdam, The Netherlands.

In addition to evaluating 8 weeks of treatment with G/P, the ENDURANCE-3
study was designed to evaluate whether 12 weeks of G/P treatment is
non-inferior to 12 weeks of sofosbuvir plus daclatasvir (SOF+DCV), a
current standard of care for GT3 chronic HCV-infected patients.1
SVR12 rates of 95 percent were seen in both 8 weeks
(n=149/157) and 12 weeks (n=222/233) of treatment with G/P.1 Additionally,
12 weeks of treatment with G/P was demonstrated to be non-inferior to 12
weeks of treatment with SOF+DCV (97 percent, n=111/115).1

GT3 is the second most common genotype globally, accounting for 18
percent of patients worldwide and 26 percent of patients in Europe.2
Patients with GT3 HCV have more rapid disease progression, with the
highest rates of associated fibrosis, steatosis (fatty liver), and
hepatocellular carcinoma (HCC).3 Treatment guidelines with
current standards of care recommend 12 weeks of treatment in GT3
patients without cirrhosis and who are new to treatment.4

Full results from ENDURANCE-3 are the latest to be released from
AbbVie’s registrational studies in its G/P clinical development program,
designed to investigate a faster path to virologic cure* for all major
HCV genotypes (GT1-6) and with the goal of addressing areas of continued
unmet need.

In the ENDURANCE-3 study, no patients who received 8 weeks of G/P
discontinued treatment due to adverse events (AEs).1 AEs were
mostly mild (71 percent) in patients receiving both 8 and 12 weeks of
G/P. The most common AEs (≥10 percent) in patients receiving 8 weeks and
12 weeks of G/P were headache (20 and 26 percent), fatigue (13 and 19
percent) and nausea (12 and 14 percent), respectively and with patients
receiving 12 weeks of SOF+DCV treatment (headache 20 percent, fatigue 14
percent and nausea 13 percent).1

Authorization applications for G/P are currently under review by
regulatory authorities around the world. G/P has been granted
accelerated assessment by the European Medicines Agency, and priority
review designations by the U.S. Food and Drug Administration and
Japanese Ministry of Health, Labour and Welfare. G/P is an
investigational regimen and its safety and efficacy have not been
established.

The ENDURANCE-3 study will be featured in the official ILC press
conference on Friday, April 21 from 11:30 a.m. – 12:30 p.m. local time.

About the ENDURANCE-3 Study
ENDURANCE-3 is a Phase 3,
open-label, active-controlled study evaluating patients who are new to
treatment with HCV GT3 infection without cirrhosis. The study included
505 patients who were randomized to receive either 12 weeks of G/P (Arm
A, n= 233) or 12 weeks of SOF+DCV (Arm B, n=115), with subsequently
enrolled patients receiving 8 weeks of G/P (Arm C, n=157). The primary
endpoint was the percentage of patients achieving SVR12. The rate of
virologic failure was 1.7 percent (n=4/233) in Arm A, 0.8 percent
(n=1/115) in Arm B and 3.8 percent (n=6/157) in Arm C.

Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov.

About G/P
G/P is an investigational, pan-genotypic regimen
that is being evaluated by AbbVie as a potential cure in 8 weeks for HCV
patients without cirrhosis and who are new to treatment with
direct-acting antivirals (DAAs)**, who make up the majority of HCV
patients. AbbVie is also studying G/P in patients with specific
treatment challenges, such as patients with genotype 3 HCV, patients who
were not cured with previous DAA treatment and those with chronic kidney
disease, including patients on dialysis.

G/P is an investigational, once-daily regimen that combines two distinct
antiviral agents in a fixed-dose combination of glecaprevir (300mg), an
NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor.
G/P is dosed once-daily as three oral tablets.

*Patients who achieve a sustained virologic response at 12 weeks post
treatment (SVR12) are considered cured of hepatitis C.

**Patients who are treatment-naive or had prior treatment experience
with IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN).

About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on the following
disease targets: non-alcoholic steatohepatitis (NASH)/ primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV).

Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with AbbVie, include paritaprevir, part of
AbbVie’s currently marketed HCV regimens, and glecaprevir (ABT-493),
Enanta’s second protease inhibitor product, which AbbVie is developing
as part of its investigational, pan-genotypic HCV regimen of
glecaprevir/pibrentasvir (G/P) now in registration in the U.S., the E.U.
and Japan. Royalties and any further milestone payments from this
collaboration will provide additional funding for Enanta’s earlier
development programs, including its Phase 1 FXR agonist program for
NASH/PBC, and its preclinical programs for HBV and RSV. Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.

Forward Looking Statements
This press release contains
forward-looking statements, including statements with respect to the
prospects for AbbVie’s G/P 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 efforts of AbbVie (our collaborator developing glecaprevir)
to obtain regulatory approvals of its glecaprevir/pibrentasvir (G/P)
combination and commercialize it successfully; the regulatory and
marketing efforts of others with respect to competitive treatment
regimens for HCV; regulatory and reimbursement actions affecting G/P,
any competitive regimen, or both; the need to obtain and maintain patent
protection for glecaprevir 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-K for
the fiscal year ended September 30, 2016 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.

__________________________________________

1 Foster, GR et al. ENDURANCE-3: safety and efficacy of
glecaprevir/pibrentasvir compared to sofosbuvir plus daclatasvir in
treatment-naïve HCV genotype 3-infected patients without cirrhosis.
Presented at The International Liver Congress™ (ILC) in Amsterdam, The
Netherlands, April 19-23, 2017.

2 Petruzziello, A. et al. Global epidemiology of hepatitis C
virus infection: An up-date of the distribution and circulation of
hepatitis C virus genotypes. World J Gastroenterol. 2016; 22(34):
7824-7840

3 Asselah T, Thompson AJ, Flisiak R, Romero-Gomez M,
Messinger D, Bakalos G, et al. (2016) A Predictive Model for Selecting
Patients with HCV Genotype 3 Chronic Infection with a High Probability
of Sustained Virological Response to Peginterferon Alfa-2a/Ribavirin.
PLoS ONE 11(3): e0150569. doi:10.1371/journal.pone.

4 EASL Recommendations on Treatment of Hepatitis C 2016. J
Hepatol (2016), http://dx.doi.org/10.1016/j.jhep.2016.09.001.

Source: Enanta Pharmaceuticals, Inc.

Investor Contact
Enanta Pharmaceuticals, Inc.
Carol
Miceli, 617-607-0710
cmiceli@enanta.com
or
Media
Contact

MacDougall Biomedical Communications
Kari Watson,
781-235-3060
kwatson@macbiocom.com

 

Enanta Announces 99 Percent SVR12 Rate in Chronic HCV Patients with Compensated Cirrhosis Treated with AbbVie’s Investigational, Pan-Genotypic, Ribavirin-free Regimen of Glecaprevir/Pibrentasvir (G/P)

WATERTOWN, Mass.–(BUSINESS WIRE)–Apr. 20, 2017–
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today announced
that 99 percent (n=145/146) of chronic hepatitis C virus (HCV) infected
patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis
(Child-Pugh A) achieved sustained virologic response at 12 weeks
post-treatment (SVR12) with AbbVie’s investigational,
pan-genotypic, ribavirin-free regimen of glecaprevir/pibrentasvir (G/P).
This high SVR12 rate was seen following 12 weeks of G/P
treatment without ribavirin. Patients with specific virus strains
associated with resistance or with a high quantity of the virus in their
bloodstream before treatment initiation were not excluded from the
study. These new data, from the Phase 3 EXPEDITION-1 study, will be
featured as an oral presentation today at The International Liver
Congress™ (ILC) 2017 in Amsterdam, The Netherlands.

In the EXPEDITION-1 study, the majority of adverse events (AEs) were
mild, and no patients discontinued treatment due to an AE. The most
common (≥10 percent) AEs were fatigue and headache.

Approximately 130 to 150 million people worldwide are living with
chronic HCV, for whom the risk of cirrhosis of the liver is between
15-30% within 20 years.2 Treatment guidelines around the
world recommend that all patients with cirrhosis should be considered
for treatment, yet the treatment of specific patients with HCV and
compensated cirrhosis is still challenging.3,4

AbbVie is presenting additional data at ILC in patients with specific
treatment challenges, including in those with chronic kidney disease
(SAT-273), HIV-1 co-infection (LBP-522), post liver transplant, and post
renal transplant (LBO-03), as well as in patients who did not achieve SVR12
with previous direct-acting antiviral treatment (PS-156). Additional
information on the clinical trials for G/P is available at http://www.clinicaltrials.gov.

Authorization applications for G/P are currently under review by
regulatory authorities around the world. G/P has been granted
accelerated assessment by the European Medicines Agency, and priority
review designations by the U.S. Food and Drug Administration and
Japanese Ministry of Health, Labour and Welfare. G/P is an
investigational regimen and its safety and efficacy have not been
established.

About the EXPEDITION-1 Study
EXPEDITION-1 is a single arm,
multicenter, open-label study evaluating the efficacy and safety of 12
weeks of G/P in adults with GT1, 2, 4, 5 or 6 chronic HCV infection and
compensated cirrhosis (Child-Pugh A). The study enrolled 146 patients,
including those new to treatment or those who had prior treatment
experience with IFN-based treatments (IFN/pegIFN ± RBV, or sofosbuvir +
RBV ± pegIFN). The primary endpoint was the percentage of patients
achieving SVR12. SVR12 was achieved by 145/146 (99
percent) patients, with one GT1a-infected patient experiencing relapse.

No patients experienced ALT elevations equal to or above Grade 3. Of the
11 patients (7.5 percent) who experienced serious AEs, none were
considered treatment-related.

About G/P
G/P is an investigational, pan-genotypic regimen
that is being evaluated by AbbVie as a potential cure in 8 weeks for HCV
patients without cirrhosis and who are new to treatment with
direct-acting antivirals (DAAs)*, who make up the majority of HCV
patients. AbbVie is also studying G/P in patients with specific
treatment challenges, such as patients with genotype 3 HCV, patients who
were not cured with previous DAA treatment and those with chronic kidney
disease, including patients on dialysis.

G/P is an investigational, once-daily regimen that combines two distinct
antiviral agents in a fixed-dose combination of glecaprevir (300mg), an
NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor.
G/P is dosed once-daily as three oral tablets.

Additional information on AbbVie’s clinical trials for G/P is available
at www.clinicaltrials.gov.

*Patients who are treatment-naive or had prior treatment experience with
IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN).

About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on the following
disease targets: non-alcoholic steatohepatitis (NASH)/ primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV).

Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with AbbVie, include paritaprevir, part of
AbbVie’s currently marketed HCV regimens, and glecaprevir (ABT-493),
Enanta’s second protease inhibitor product, which AbbVie is developing
as part of its investigational, pan-genotypic HCV regimen of
glecaprevir/pibrentasvir (G/P) now in registration in the U.S., the E.U.
and Japan. Royalties and any further milestone payments from this
collaboration will provide additional funding for Enanta’s earlier
development programs, including its Phase 1 FXR agonist program for
NASH/PBC, and its preclinical programs for HBV and RSV. Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.

Forward Looking Statements
This press release contains
forward-looking statements, including statements with respect to the
prospects for AbbVie’s G/P 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 efforts of AbbVie (our collaborator developing glecaprevir)
to obtain regulatory approvals of its glecaprevir/pibrentasvir (G/P)
combination and commercialize it successfully; the regulatory and
marketing efforts of others with respect to competitive treatment
regimens for HCV; regulatory and reimbursement actions affecting G/P,
any competitive regimen, or both; the need to obtain and maintain patent
protection for glecaprevir 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-K for
the fiscal year ended September 30, 2016 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.

__________________________________________

1 Forns, X et al. EXPEDITION-1: Efficacy and Safety of
Glecaprevir/Pibrentasvir in Adults with Chronic Hepatitis C Virus
Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis. Presented
at The International Liver Congress™ (ILC) in Amsterdam, The
Netherlands, April 19-23, 2017.

2 Hepatitis C. World Health Organization. World Health
Organization, July 2016. Web. http://www.who.int/mediacentre/factsheets/fs164/en/

3 EASL Recommendations on Treatment of Hepatitis C 2016. J
Hepatol (2016), http://dx.doi.org/10.1016/j.jhep.2016.09.001.

4 Spach D, Scott J. Treatment of Hepatitis C in Patients with
Cirrhosis. Hepatitis C Online. http://cdn.hepatitisc.uw.edu/pdf/special-populations-situations/treatment-cirrhosis/core-concept/all
Published 2015. Accessed April 3, 2017.

Source: Enanta Pharmaceuticals, Inc.

Investor Contact
Enanta Pharmaceuticals, Inc.
Carol
Miceli, 617-607-0710
cmiceli@enanta.com
or
Media
Contact

MacDougall Biomedical Communications
Kari Watson,
781-235-3060
kwatson@macbiocom.com

 

Enanta Announces New Preclinical Data on its FXR Agonist EDP-305 for Non-Alcoholic Steatohepatitis (NASH) and Primary Biliary Cholangitis (PBC) at The International Liver Congress™ 2017

WATERTOWN, Mass.–(BUSINESS WIRE)–Apr. 19, 2017–
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today announced
new data from its lead FXR agonist candidate EDP-305 for NASH and PBC.
This new data is being presented during The International Liver
Congress™ (ILC) 2017, April 19-23, in Amsterdam.

Data from three poster presentations being presented at the Congress
will demonstrate that EDP-305 is a potent Farnesoid X Receptor (FXR)
agonist that has been shown to reduce expression of fibrogenic genes,
reduce fibrosis progression and improve non-alcoholic fatty liver
disease (NAFLD) activity scores (NAS) in a variety of preclinical models.

NAFLD is the accumulation of excessive fat in the form of triglycerides
in patients’ liver cells (steatosis) that is not caused by alcohol.
NAFLD is widely considered to be the liver expression of metabolic
disease associated with type 2 diabetes, insulin resistance, obesity,
and hyperlipidemia. A subgroup of NAFLD patients has liver cell injury
and inflammation in addition to excessive fat (steatohepatitis).
Progression of this condition leads to non-alcoholic steatohepatitis
(NASH). Patients with NASH can develop fibrosis and ultimately cirrhosis
of the liver, potentially leading to hepatocellular carcinoma or
requiring a liver transplant.

The first poster will be presented by Bryan C. Fuchs, Ph.D., Assistant
Professor of Surgery, Harvard Medical School, Massachusetts General
Hospital. Poster #THU-377, titled “A Novel Farnesoid X Receptor (FXR)
Agonist, EDP-305, Reduces Fibrosis Progression in Animal Models of
Fibrosis”
, demonstrates that EDP-305 reduced fibrosis progression in
a choline-deficient, high-fat-diet mouse model of NASH and a rat model
of PBC induced by bile duct ligation. Fibrosis progression was measured
by quantitative molecular imaging of collagen crosslinking and Type 1
collagen, markers that are sensitive to changes in fibrosis.

The second poster will be presented by Lijuan Jiang, Ph.D., Executive
Director DMPK and Bioanalysis, Enanta Pharmaceuticals, Inc. Poster
#FRI-363, titled “EDP-305, a Novel and Highly Potent Farnesoid X
Receptor (FXR) Agonist, Improves Liver Steatosis, Ballooning and
Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) in a
Diet-Induced Murine Model of Non-Alcoholic Steatohepatitis”
,
demonstrates that EDP-305 exerts beneficial pharmacological effects in a
dietary-induced NASH (DIN) mouse model that mimics the human NAFLD/NASH
physiological setting. In addition to reducing plasma and liver lipid
content, EDP-305 showed a significant decrease in hepatocyte ballooning,
and NAS in DIN mice, suggesting that EDP-305 may have potential
beneficial effects in treating NASH.

The third poster will be presented by Yury Popov, M.D., Ph.D., Staff
Scientist, Beth Israel Deaconess Medical Center and Assistant Professor
of Medicine, Harvard Medical School. Poster #SAT-459, titled “A Novel
FXR Agonist EDP-305 Potently Suppresses Liver Injury and Fibrosis in
Mouse Models of Biliary and Metabolic Liver Disease”
, demonstrates
that treatment with EDP-305 potently improved pre-established liver
injury and hepatic fibrosis in biliary (BALBc.Mdr2-/-) and metabolic
(MCD) models of liver disease in mice.

“The BALBc.Mdr2-/- mouse model may represent the most relevant model
that we have to evaluate the potential of new agents for the treatment
of primary sclerosing cholangitis (PSC). We are very encouraged by the
results we have observed with EDP-305 showing a very robust response in
this biliary disease model,” stated Yury Popov, M.D., Ph.D.

“The extensive preclinical profiling of EDP-305 in a variety of in
vitro
and in vivo models has given Enanta the confidence to
continue to advance EDP-305 in the clinic and to consider new areas,
such as PSC, for exploration,” stated Jay R. Luly, Ph.D., President and
CEO, Enanta. “We expect to present clinical data from our ongoing
clinical study in healthy volunteers and presumed NAFLD subjects and to
initiate NASH-enabling studies in the second half of this year, and also
to begin phase 2 studies in PBC in the fourth quarter of calendar 2017.
We are planning for phase 2 studies in NASH in early 2018.”

EDP-305 is currently in Phase 1 clinical development. Enanta’s ongoing
double-blind, placebo-controlled Phase 1a/b study is designed to
evaluate the safety, tolerability and pharmacokinetics of single
ascending doses (SAD) and multiple ascending doses (MAD) of EDP-305 in
healthy adults, and in adults with presumptive non-alcoholic fatty liver
disease (NAFLD) (obese, with or without pre-diabetes or type 2
diabetes). The study will enroll approximately 150 subjects and is
planned to evaluate at least 5 single and multiple dose cohorts, with
EDP-305 administered orally, once daily.

The current study includes subjects with presumptive NAFLD in order to
obtain initial safety data and additional data regarding the
relationship between EDP-305 plasma concentration levels and certain
pharmacological effects in the context of fatty liver disease. This
relationship will be explored by using biomarkers that are relevant to
the disease and to the activity of EDP-305, such as evaluation of
lipids, glucose, insulin resistance and specific markers of FXR activity.

About EDP-305, a Farnesoid X Receptor (FXR) Agonist
EDP-305
is a potent FXR agonist and Enanta’s lead product candidate being
developed for the treatment of NASH and PBC. EDP-305 represents a new
class of FXR agonists that has been designed to take advantage of
increased binding interactions with the receptor. Further, this non-bile
acid class contains steroidal and non-steroidal components, and does not
contain the carboxylic acid group normally present in other classes of
FXR agonists and natural bile acids that can lead to the formation of
taurine and glycine conjugates. EDP-305 has been granted Fast Track
Designation by the U.S. Food and Drug Administration and is currently in
Phase 1 clinical development.

About NAFLD, NASH, and FXR
Non-alcoholic fatty liver disease
(NAFLD) is the accumulation of excessive fat in the form of
triglycerides in patients’ liver cells (steatosis) that is not caused by
alcohol. NAFLD is widely considered to be the liver expression of
metabolic disease associated with type 2 diabetes, insulin resistance,
obesity, and hyperlipidemia. A subgroup of NAFLD patients has liver cell
injury and inflammation in addition to excessive fat (steatohepatitis).
Progression of this condition leads to non-alcoholic steatohepatitis
(NASH). Patients with NASH can develop fibrosis and ultimately cirrhosis
of the liver, potentially leading to hepatocellular carcinoma or
requiring a liver transplant. The Farnesoid X receptor (FXR) is a
nuclear receptor and a main regulator of bile acid levels in the liver
and small intestine. It responds to bile acids by regulating gene
transcription of key enzymes and transporters, many of which play
important roles in lipid metabolism, insulin resistance, inflammation,
and fibrosis.

About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on the following
disease targets: non-alcoholic steatohepatitis (NASH)/ primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV).

Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with AbbVie, include paritaprevir, part of
AbbVie’s currently marketed HCV regimens, and glecaprevir (ABT-493),
Enanta’s second protease inhibitor product, which AbbVie is developing
as part of its investigational, pan-genotypic HCV regimen of
glecaprevir/pibrentasvir (G/P) now in registration in the U.S., the E.U.
and Japan. Royalties and any further milestone payments from this
collaboration will provide additional funding for Enanta’s earlier
development programs, including its Phase 1 FXR agonist program for
NASH/PBC, and its preclinical programs for HBV and RSV. Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.

Forward Looking Statements Disclaimer
This press release
contains forward-looking statements, including statements with respect
to the prospects for Enanta’s further development of EDP-305. 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 development risks of
early stage discovery efforts in disease areas such as NASH, PBC and
PSC; the impact of development, regulatory and marketing efforts of
others with respect to competitive treatments for NASH, PBC and/or PSC;
regulatory and reimbursement actions affecting any competitive treatment
for NASH, PBC and/or PSC; Enanta’s lack of clinical development
experience; Enanta’s need to attract and retain senior management and
key scientific personnel; the need to obtain and maintain patent
protection for EDP-305 and Enanta’s other 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-K for the fiscal year ended September 30,
2016 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.

Source: Enanta Pharmaceuticals, Inc.

Investor Contact
Enanta Pharmaceuticals, Inc.
Carol
Miceli, 617-607-0710
cmiceli@enanta.com
or
Media
Contact

MacDougall Biomedical Communications
Kari Watson,
781-235-3060
kwatson@macbiocom.com

 

Enanta Pharmaceuticals to Host Conference Call on May 8 at 4:30 p.m. ET to Discuss Financial Results for its Fiscal Second Quarter Ended March 31, 2017

WATERTOWN, Mass.–(BUSINESS WIRE)–Apr. 18, 2017–
Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today announced
that it plans to report its financial results for its fiscal second
quarter ended March 31, 2017 after the U.S. markets close on May 8,
2017. Enanta management will host a conference call at 4:30 p.m. ET to
discuss these results and provide an update on Enanta’s research and
development pipeline.

Conference Call and Webcast Information

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.
Eastern time on May 8, 2017, through 11:59 p.m. Eastern time on May 12,
2017 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 6851190. A live audio webcast of the call and replay can be
accessed by visiting the “Calendar of Events” section on the “Investors”
page of Enanta’s website at www.enanta.com.

About Enanta

Enanta Pharmaceuticals is a research and development-focused
biotechnology company that uses its robust chemistry-driven approach and
drug discovery capabilities to create small molecule drugs for viral
infections and liver diseases. Enanta’s research and development efforts
are currently focused on the following disease targets: non-alcoholic
steatohepatitis (NASH)/ primary biliary cholangitis (PBC), respiratory
syncytial virus (RSV) and hepatitis B virus (HBV).

Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with AbbVie, include paritaprevir, part of
AbbVie’s currently marketed HCV regimens, and glecaprevir (ABT-493),
Enanta’s second protease inhibitor product, which AbbVie is developing
as part of its investigational, pan-genotypic HCV regimen of
glecaprevir/pibrentasvir (G/P) now in registration in the U.S., the E.U.
and Japan. Royalties and any further milestone payments from this
collaboration will provide additional funding for Enanta’s earlier
development programs, including its Phase 1 FXR agonist program for
NASH/PBC, and its preclinical programs for HBV and RSV. Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.

Source: Enanta Pharmaceuticals, Inc.

Investor Contact
Enanta Pharmaceuticals, Inc.
Carol
Miceli, 617-607-0710
cmiceli@enanta.com

 

Enanta Pharmaceuticals to Host Conference Call on May 8 at 4:30 p.m. ET to Discuss Financial Results for its Fiscal Second Quarter Ended March 31, 2017

WATERTOWN, Mass.–(BUSINESS WIRE)–Apr. 18, 2017–
Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today announced
that it plans to report its financial results for its fiscal second
quarter ended March 31, 2017 after the U.S. markets close on May 8,
2017. Enanta management will host a conference call at 4:30 p.m. ET to
discuss these results and provide an update on Enanta’s research and
development pipeline.

Conference Call and Webcast Information

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.
Eastern time on May 8, 2017, through 11:59 p.m. Eastern time on May 12,
2017 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 6851190. A live audio webcast of the call and replay can be
accessed by visiting the “Calendar of Events” section on the “Investors”
page of Enanta’s website at www.enanta.com.

About Enanta

Enanta Pharmaceuticals is a research and development-focused
biotechnology company that uses its robust chemistry-driven approach and
drug discovery capabilities to create small molecule drugs for viral
infections and liver diseases. Enanta’s research and development efforts
are currently focused on the following disease targets: non-alcoholic
steatohepatitis (NASH)/ primary biliary cholangitis (PBC), respiratory
syncytial virus (RSV) and hepatitis B virus (HBV).

Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with AbbVie, include paritaprevir, part of
AbbVie’s currently marketed HCV regimens, and glecaprevir (ABT-493),
Enanta’s second protease inhibitor product, which AbbVie is developing
as part of its investigational, pan-genotypic HCV regimen of
glecaprevir/pibrentasvir (G/P) now in registration in the U.S., the E.U.
and Japan. Royalties and any further milestone payments from this
collaboration will provide additional funding for Enanta’s earlier
development programs, including its Phase 1 FXR agonist program for
NASH/PBC, and its preclinical programs for HBV and RSV. Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.

Source: Enanta Pharmaceuticals, Inc.

Investor Contact
Enanta Pharmaceuticals, Inc.
Carol
Miceli, 617-607-0710
cmiceli@enanta.com

 

Enanta Pharmaceuticals Announces Data Presentations at The International Liver Congress™ 2017

WATERTOWN, Mass.–(BUSINESS WIRE)–Apr. 5, 2017–
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today announced
that several abstracts regarding Enanta’s wholly-owned EDP-305
development program for NASH and PBC, as well as abstracts regarding
AbbVie’s investigational, pan-genotypic regimen of
glecaprevir/pibrentasvir (G/P) for the treatment of chronic hepatitis C
virus (HCV) infection, have been accepted for presentation at The
International Liver Congress™ (ILC) 2017, April 19-23, in Amsterdam.

Three poster presentations will demonstrate that EDP-305 is a potent
Farnesoid X Receptor (FXR) agonist that has been shown to reduce
fibrosis progression and improve non-alcoholic fatty liver disease
(NAFLD) activity scores (NAS) in a variety of preclinical models.

In addition, several oral and poster presentations will report data from
AbbVie’s G/P clinical development program. G/P is an investigational,
pan-genotypic, once-daily regimen that combines two distinct
direct-acting-antiviral (DAA) agents, glecaprevir, Enanta’s second
protease inhibitor, and pibrentasvir, AbbVie’s NS5A inhibitor.

The following abstracts regarding EDP-305 and G/P will be presented
during the International Liver Congress:

Enanta Presentations: EDP-305 FXR Agonist:

Thursday, April 20

Poster Presentation, 08:00 – 18:00

Friday, April 21

Poster Presentation, 08:00 – 18:00

Saturday, April 22

Poster Presentation, 08:00 – 18:00

AbbVie Presentations: glecaprevir/pibrentasvir (G/P) for HCV:

Thursday, April 20

Oral Presentation, 15:15 – 15:30

Poster Presentations, 08:00 – 18:00

Late Breaking Poster April 20-22, 08:00 – 18:00

Friday, April 21

Oral Presentation, 08:30 – 08:45

Poster Presentations 08:00 – 18:00

Saturday, April 22

Oral Presentations

Poster Presentations, 08:00 – 18:00

The full ILC 2017 scientific program can be found at http://ilc-congress.eu/.

About G/P

G/P is an investigational, pan-genotypic regimen that is being evaluated
by AbbVie as a potential cure in 8 weeks for HCV patients without
cirrhosis and who are new to treatment with direct-acting antivirals
(DAAs), who make up the majority of HCV patients. AbbVie is also
studying G/P in patients with specific treatment challenges, such as
patients with genotype 3 HCV, patients who were not cured with previous
DAA treatment and those with chronic kidney disease, including patients
on dialysis.

G/P is an investigational, once-daily regimen that combines two distinct
antiviral agents in a fixed-dose combination of glecaprevir (300mg), an
NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor.
G/P is dosed once-daily as three oral tablets.

Additional information on AbbVie’s clinical trials for G/P is available
at www.clinicaltrials.gov.

About Enanta

Enanta Pharmaceuticals is a research and development-focused
biotechnology company that uses its robust chemistry-driven approach and
drug discovery capabilities to create small molecule drugs for viral
infections and liver diseases. Enanta’s research and development efforts
are currently focused on the following disease targets: non-alcoholic
steatohepatitis (NASH)/ primary biliary cholangitis (PBC), respiratory
syncytial virus (RSV) and hepatitis B virus (HBV).

Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with AbbVie, include paritaprevir, currently
marketed in AbbVie’s HCV regimens, and glecaprevir (ABT-493), Enanta’s
second protease inhibitor product, which AbbVie is developing as part of
its investigational, pan-genotypic HCV regimen of
glecaprevir/pibrentasvir (G/P) now in registration in the U.S., the E.U.
and Japan. Royalties and any further milestone payments from this
collaboration will provide funding for Enanta’s earlier development
programs, including its Phase 1 FXR agonist program for NASH/PBC, and
its preclinical programs for HBV and RSV. Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.

Forward Looking Statements Disclaimer

This press release contains forward-looking statements, including
statements with respect to the prospects for AbbVie’s G/P regimen for
HCV and the prospects for Enanta’s further development of EDP-305.
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 efforts of AbbVie (our
collaborator developing glecaprevir) to obtain regulatory approvals of
its glecaprevir/pibrentasvir (G/P) combination and commercialize it
successfully; the regulatory and marketing efforts of others with
respect to competitive treatment regimens for HCV; regulatory and
reimbursement actions affecting G/P, any competitive regimen, or both;
the development risks of early stage discovery efforts in HCV and in new
disease areas such as NASH; Enanta’s lack of clinical development
experience; Enanta’s need to attract and retain senior management and
key scientific personnel; the need to obtain and maintain patent
protection for glecaprevir and Enanta’s other 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-K for the fiscal year ended
September 30, 2016 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.

Source: Enanta Pharmaceuticals, Inc.

Investor Contact
Enanta Pharmaceuticals, Inc.
Carol
Miceli, 617-607-0710
cmiceli@enanta.com
or
Media
Contact

MacDougall Biomedical Communications
Kari Watson,
781-235-3060
kwatson@macbiocom.com

 

Enanta Pharmaceuticals to Present at the H.C. Wainwright 1st Annual NASH Investor Conference

Presentation to be Webcast on April 3 at 4:00 pm ET

WATERTOWN, Mass.–(BUSINESS WIRE)–Mar. 27, 2017–
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today announced
that Jay R. Luly, Ph.D., President and Chief Executive Officer, will
present at the H.C. Wainwright 1st Annual NASH Investor
Conference in New York on April 3 at 4:00 pm ET. Dr. Luly will present
an overview of Enanta’s wholly-owned research and development programs
with a focus on EDP-305, Enanta’s FXR agonist for non-alcoholic
steatohepatitis (NASH).

A live webcast and replay of the presentation will be accessible by
visiting the “Calendar of Events” section on the “Investors” page of
Enanta’s website at www.enanta.com.
The webcast replay will be available following the presentation and will
be archived for approximately 30 days.

About Enanta

Enanta Pharmaceuticals is a research and development-focused
biotechnology company that uses its robust chemistry-driven approach and
drug discovery capabilities to create small molecule drugs for viral
infections and liver diseases. Enanta’s research and development efforts
are currently focused on the following disease targets: non-alcoholic
steatohepatitis (NASH)/ primary biliary cholangitis (PBC), respiratory
syncytial virus (RSV) and hepatitis B virus (HBV).

Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with AbbVie, include paritaprevir, currently
marketed in AbbVie’s HCV regimens, and glecaprevir (ABT-493), Enanta’s
second protease inhibitor product, which AbbVie is developing as part of
its investigational HCV regimen of glecaprevir/pibrentasvir (G/P) now in
registration in the U.S., the E.U. and Japan. Royalties and any further
milestone payments from this collaboration will provide funding for
Enanta’s earlier development programs, including its Phase 1 FXR agonist
program for NASH/PBC, and its preclinical programs for HBV and RSV.
Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.

Source: Enanta Pharmaceuticals, Inc.

Investor Contact
Enanta Pharmaceuticals, Inc.
Carol
Miceli, 617-607-0710
cmiceli@enanta.com
or
Media
Contact

MacDougall Biomedical Communications
Kari Watson,
781-235-3060
kwatson@macbiocom.com