Entasis Therapeutics Reports Full Year 2019 Financial Results and Business Update
March 11 2020 - 4:05PM
Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX), a clinical-stage
biopharmaceutical company focused on the discovery and development
of novel antibacterial products, announced its full year 2019
financial results and business highlights.
“2019 marked a pivotal year for the Company as
we made great strides both advancing our clinical programs and
strengthening our leadership team,” stated Manos Perros, President
and Chief Executive Officer of Entasis Therapeutics. “We continued
to make significant progress across all of our clinical candidates
as we initiated two Phase 3 registration trials in 2019 and
reported encouraging topline data from our Phase 1 study of ETX0282
for Gram-negative infections caused by multidrug-resistant (MDR)
Enterobacteriaceae. In April, we launched the global ATTACK
(Acinetobacter Treatment
Trial Against
Colistin) Phase 3 registration trial, evaluating a
fixed-dose combination of sulbactam plus durlobactam (SUL-DUR) as a
potential treatment for carbapenem-resistant Acinetobacter
baumannii infections. We then achieved a second key milestone in
September with the advancement of zoliflodacin, a novel antibiotic
for the treatment of uncomplicated gonorrhea, into a Phase 3
registration trial.”
Dr. Perros added, “To further drive our
strategic initiatives, we bolstered our leadership team through the
additions of several key members of management. We appointed two
biopharmaceutical veterans, Dr. David Altarac as Chief Medical
Officer and Eric Kimble as Chief Commercial Officer, who combined
have nearly 50 years of industry experience. Additionally, we
strengthened our Board of Directors through the additions of David
Meek as the Chairman of the Board and Dr. Howard Meyer. We are
extremely excited to build upon our strong 2019 performance and
look forward to ATTACK and zoliflodacin Phase 3 registration trial
data readouts.”
Full Year 2019 and Recent
Highlights
- In April, we initiated the ATTACK Phase 3 registration trial to
evaluate SUL-DUR for the treatment of patients with pneumonia and
bloodstream infections caused by carbapenem-resistant Acinetobacter
baumannii. ATTACK is a global, two-part Phase 3 registration trial
set to enroll a total of approximately 300 patients. As
pre-planned, after randomization of approximately 40 patients into
the primary efficacy arm (Part A, which will include a total of 136
evaluable patients), the Data Safety Monitoring Board, or DSMB,
conducted a pre-specified pharmacokinetics assessment to confirm
our projected SUL-DUR exposures. Although we remain blinded
to treatment assignment, the DSMB has advised us to continue
enrollment without modification of the trial protocol and in
addition has allowed us to open the Part B arm of the trial, which
is an open-label treatment of approximately 80 patients with
Acinetobacter infections who are not otherwise eligible for the
randomized comparison. Due to the coronavirus outbreak in countries
where we are conducting the ATTACK registration trial, we now
anticipate topline results from the study to be available in early
2021. This is a change from our previous guidance of the second
half of 2020 as we anticipate some effect on the ATTACK trial
timeline from this epidemic, the extent of which we continue to
monitor and are working to mitigate.
- In September, the Global Antibiotic Research and Development
Partnership (GARDP) initiated the global Phase 3 registration trial
of zoliflodacin for the treatment of uncomplicated gonorrhea. The
randomized, open label trial will enroll approximately 1,000 adults
with urogenital gonorrhea at clinical trial sites in the United
States and internationally and will assess the safety and efficacy
of zoliflodacin versus the combination of azithromycin and
ceftriaxone, the current standard of care. GARDP is fully funding
and sponsoring the Phase 3 trial. In return, the Company has
provided them with exclusive commercial rights in low-income and
select middle-income countries. A data readout from the Phase 3
registration trial is expected in 2021.
- In June, the Company reported preliminary results from its
randomized, double-blind, placebo-controlled Phase 1 clinical study
of ETX0282, an oral beta-lactamase inhibitor, being developed to
combat multidrug-resistant Enterobacteriaceae. The trial was
designed to evaluate the safety, tolerability and pharmacokinetics
of ETX0282 either alone or in combination with cefpodoxime proxetil
(ETX0282CPDP) in healthy volunteers. Results from the Phase 1
clinical study demonstrated that plasma concentrations of the
beta-lactamase inhibitor were in the projected therapeutic range.
Additionally, ETX0282 was generally well tolerated either alone or
in combination with cefpodoxime proxetil, and no serious adverse
events were reported. Modified-release formulation efforts are now
ongoing.
- In December the Company selected ETX0462 as a clinical
candidate from its non-b-lactam penicillin binding protein
inhibitor (NBP) program. ETX0462 potentially represents a new
Gram-negative class of antibiotics and is initially being developed
for the treatment of multidrug-resistant Pseudomonas infections.
Data from the program will be presented at an upcoming medical
conference.
- The Company strengthened its management team with the
appointment of key industry leaders including Eric Kimble as Chief
Commercial Officer to build and oversee the Company’s global
commercialization strategy and product launch initiatives. Mr.
Kimble, who was appointed in April, has over 25 years of commercial
leadership experience in sales, marketing and commercial strategy,
and product launches from Cubist Pharmaceuticals, Biogen Inc. and
Merck & Co. In November, the Company also appointed David
Altarac, M.D., MPA as Chief Medical Officer. Dr. Altarac is a
recognized industry R&D leader and brings broad experience,
most recently as senior vice president and head of global
regulatory affairs, global drug safety and R&D quality and
compliance at Shire Plc.
Full Year 2019 Financial
Results
Entasis reported revenue of $7.0 million and
grant income of $2.3 million for the year ended December 31, 2019,
compared to revenue of $5.0 million and $5.3 million of grant
income for the year ended December 31, 2018. The revenue in 2019
was attributable to milestones achieved pursuant to the Company’s
collaboration agreement with Zai Lab (Shanghai) Co., Ltd.
The Company reported a net loss of $43.9 million
for the year ended December 31, 2019, compared to a net loss of
$33.0 million for the year ended December 31, 2018. The increase in
net loss was primarily due to increases in development expense and
general and administrative expense and a decrease in other income,
partially offset by the aforementioned increase in revenue year
over year.
Research and development expenses were $40.2
million for the year ended December 31, 2019, compared to $33.0
million for the year ended December 31, 2018. The increase in
research and development expenses was primarily attributable to
increases in clinical and manufacturing development expenses
related to the advancement of our SUL-DUR product candidate and
increased headcount, partially offset by decreases in preclinical
and clinical development expenses related to the advancement of our
ETX0282CPDP product candidate.
General and administrative expenses were $13.8
million for the year ended December 31, 2019, compared to $10.2
million for the year ended December 31, 2018. The increase was
driven by costs associated with additional headcount, director and
officer insurance costs, and VAT and other taxes associated with
the milestone revenue from our collaboration with Zai Lab
Limited.
As of December 31, 2019, cash, cash equivalents
and short-term investments were $41.0 million, compared to $85.1
million as of December 31, 2018. The Company believes its current
cash position provides a runway into the fourth quarter of
2020.
About EntasisEntasis is a
clinical-stage biopharmaceutical company focused on the discovery,
development and commercialization of novel antibacterial products
to treat serious infections caused by multidrug-resistant
Gram-negative bacteria. Entasis’ pathogen-targeted design platform
has produced a pipeline of product candidates, including
sulbactam-durlobactam (targeting Acinetobacter baumannii
infections), zoliflodacin (targeting Neisseria gonorrhoeae
infections), ETX0282CPDP (targeting Enterobacteriaceae infections)
and ETX0462 (targeting Pseudomonas infections). For more
information, visit www.entasistx.com.
Entasis Forward-looking
StatementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,”
“anticipate,” “estimate,” “intend” and similar expressions (as well
as other words or expressions referencing future events, conditions
or circumstances) are intended to identify forward-looking
statements. These forward-looking statements are based on Entasis’
expectations and assumptions as of the date of this press release.
Each of these forward-looking statements involves risks and
uncertainties. Actual results may differ materially from these
forward-looking statements. Many factors may cause differences
between current expectations and actual results, including
unexpected safety or efficacy data observed during non-clinical or
clinical studies, clinical site activation rates or clinical trial
enrollment rates that are lower than expected and changes in
expected or existing competition, changes in the regulatory
environment, failure of Entasis’ collaborators to support or
advance collaborations or product candidates and unexpected
litigation or other disputes. Many of these factors are beyond
Entasis’ control. These and other risks and uncertainties are
described more fully in the Entasis’ filings with the U.S.
Securities and Exchange Commission, including the section titled
“Risk Factors” contained therein. Forward-looking statements
contained in this announcement are made as of this date, and except
as required by law, Entasis assumes no obligation to update any
forward-looking statements contained herein to reflect any change
in expectations, even as new information becomes available.
Company Contact Kyle Dow Entasis Therapeutics
(781) 810-0114 kyle.dow@entasistx.com
Investor Relations ContactsTram Bui / James
SaliernoThe Ruth Group(646) 536-7035 /
7028tbui@theruthgroup.comjsalierno@theruthgroup.com
Media ContactKirsten ThomasThe Ruth Group(508)
280-6592kthomas@theruthgroup.com
(Financial Tables Follow)
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Entasis Therapeutics Holdings Inc. |
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Consolidated Statements of Operations |
|
Unaudited |
|
(in thousands, except share and per share data) |
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Year Ended December 31, |
|
|
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2019 |
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2018 |
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|
|
|
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Revenue |
|
|
|
|
|
|
|
$ |
7,000 |
|
$ |
5,000 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
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Research
and development |
|
|
|
|
|
|
40,166 |
|
|
33,046 |
|
General and
administrative |
|
|
|
|
|
|
13,770 |
|
|
10,161 |
|
Total operating expenses |
|
|
|
|
|
|
53,936 |
|
|
43,207 |
|
Loss from
operations |
|
|
|
|
|
|
|
(46,936) |
|
|
(38,207) |
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Other income: |
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Grant income |
|
|
|
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|
|
|
2,300 |
|
|
5,337 |
|
Interest income |
|
|
|
|
|
|
|
1,463 |
|
|
390 |
|
Total other income |
|
|
|
|
|
|
|
3,763 |
|
|
5,727 |
|
Loss before income
taxes |
|
|
|
|
|
|
|
(43,173) |
|
|
(32,480) |
|
Provision for
income taxes |
|
|
|
|
|
|
|
677 |
|
|
472 |
|
Net loss |
|
|
|
|
|
|
|
|
(43,850) |
|
|
(32,952) |
|
Dividends
declared |
|
|
|
|
|
|
|
- |
|
|
(9,142) |
|
Net loss attributable to common stockholders—basic and diluted |
|
$ |
(43,850) |
|
$ |
(42,094) |
|
Net loss per share—basic and diluted |
|
$ |
(3.33) |
|
$ |
(12.31) |
|
Weighted average
common stock outstanding—basic and diluted |
|
|
|
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13,160,357 |
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|
3,419,720 |
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Entasis Therapeutics Holdings Inc. |
Condensed Consolidated Balance Sheets |
Unaudited |
(in thousands) |
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December 31, |
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2019 |
|
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2018 |
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|
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Cash, cash
equivalents and short-term investments |
|
|
$ |
40,996 |
|
$ |
85,092 |
Other assets |
|
|
|
|
10,038 |
|
|
4,182 |
Total
assets |
|
|
|
$ |
51,034 |
|
$ |
89,274 |
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Total
liabilities |
|
|
$ |
8,877 |
|
$ |
6,391 |
Total
stockholders' equity |
|
|
|
42,157 |
|
|
82,883 |
Total
liabilities and stockholders’ equity |
|
|
$ |
51,034 |
|
$ |
89,274 |
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