Entasis Therapeutics Reports Full Year 2018 Financial Results and Provides Business Update
March 29 2019 - 6:30AM
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 2018
financial results and provided a business update.
“In 2018, we made tremendous progress on a number of fronts
which we believe have positioned the Company for continued
advancement in 2019,” commented Manos Perros, President and Chief
Executive Officer of Entasis Therapeutics. “We have a number of
important near-term milestones we are working toward, including the
imminent launch of our Phase 3 clinical trial of ETX2514SUL for
infections caused by carbapenem-resistant Acinetobacter baumannii
(A. baumannii). We also plan to initiate the Phase 3 clinical trial
of zoliflodacin for the treatment of Neisseria gonorrhoeae
infections, including drug-resistant strains, in collaboration with
the Global Antibiotic Research and Development Partnership (GARDP)
in mid-2019. In addition, we are developing ETX0282CPDP for the
treatment of complicated urinary tract infections caused by
multidrug-resistant Enterobacteriaceae, with data from the Phase 1
clinical trial expected in mid-2019.”
Fourth Quarter and Recent Business
Highlights
- Based on feedback from the Company’s end-of-Phase-2 meeting
with the U.S. Food and Drug Administration regarding the further
clinical development of ETX2514SUL for the treatment of infections
caused by carbapenem-resistant A. baumannii, the Company is in the
process of initiating the Phase 3 clinical trial for ETX2514SUL
with data expected to be available in the second half of 2020.
- Entasis entered into an agreement with bioMérieux and intends
to incorporate BIOFIRE® FILMARRAY® Instruments and the BIOFIRE®
FILMARRAY® Pneumonia Panel into its global Phase 3 clinical trial
of ETX2514SUL for enrollment optimization. This panel allows for
fast, accurate, and comprehensive syndromic testing for lower
respiratory tract infections and enables identification of 33
targets, including A. baumannii, either directly from sputum or
bronchoalveolar lavage samples.
- Entasis and its collaborator GARDP intend to initiate a Phase 3
clinical trial of zoliflodacin for the treatment of uncomplicated
gonorrhea in mid-2019 with data expected in 2021. The Phase 3
clinical trial will be funded and conducted by GARDP.
- The Company completed its initial public offering in September
2018 resulting in net cash proceeds of approximately $65.6 million.
The proceeds from this offering are being used to fund business
operations and further development of Entasis’ novel pipeline of
antibacterial candidates, including the Phase 3 clinical trial of
ETX2514SUL, the Phase 3 clinical trial of zoliflodacin, the Phase 1
clinical trial of ETX0282CPDP and the advancement of other
preclinical product candidates.
Full Year Financial Results
Entasis reported revenue of $5.0 million and grant income of
$5.3 million for the year ended December 31, 2018, compared to no
revenue and $1.4 million of grant income for the year ended
December 31, 2017. The revenue in 2018 was attributable to the
upfront payment from Zai Lab (Shanghai) Co., Ltd. following the
licensing of commercial rights to ETX2514SUL in Asia-Pacific
territories.
The Company reported a net loss of $33.0 million for the year
ended December 31, 2018, compared to a net loss of $29.9 million
for the year ended December 31, 2017. The increase in net loss was
primarily related to increases in research and development and
general and administrative expenses, partially offset by increases
in other income.
Research and development expenses were $33.0 million for the
year ended December 31, 2018, compared to $25.7 million for the
year ended December 31, 2017. The increase in research and
development expenses was primarily attributable to preclinical,
clinical and CMC development expenses related to the advancement of
ETX2514SUL and the Company’s NBP and other preclinical
programs.
General and administrative expenses were $10.2 million for the
year ended December 31, 2018, compared to $5.6 million for the year
ended December 31, 2017. The increase in general and administrative
expenses was primarily attributable to increased legal and
professional fees associated with the Company’s initial public
offering, as well as expenses of being a public company.
Entasis ended the year with $85.1 million in cash, cash
equivalents and short-term investments compared to $55.1 million as
of December 31, 2017. The increase was attributable to the proceeds
from the Company’s initial public offering in September 2018,
partially offset by cash used in operating activities. We believe
that our existing cash, cash equivalents and short-term
investments at December 31, 2018 will be adequate to satisfy our
capital needs into the fourth quarter of 2020 based on our current
operating plans, which includes top-line data read-out of the
ETX2514SUL Phase 3 clinical trial.
About Entasis
Entasis 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’
targeted-design platform has produced a pipeline of product
candidates, including ETX2514SUL (targeting A. baumannii
infections), zoliflodacin (targeting Neisseria gonorrhoeae), and
ETX0282CPDP (targeting Enterobacteriaceae infections). Entasis is
also using its platform to develop a novel class of antibiotics,
non-β-lactam inhibitors of the penicillin-binding proteins (NBPs)
(targeting Gram-negative infections). For more information, visit
www.entasistx.com.
Entasis Forward-looking
Statements
This 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. Forward-looking statements contained in this press
release include statements regarding (i) the progress, timing and
results of Entasis’ clinical trials; (ii) design of the Phase 3
clinical trial of ETX2514SUL, including plans to incorporate
BIOFIRE Instruments and Pneumonia Panels into this trial; (iii)
GARDP’s role in the Phase 3 clinical trial of zoliflodacin; and
(iv) use of proceeds from the initial public offering. 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 ContactKyle Dow Entasis Therapeutics
(781) 810-0114 kyle.dow@entasistx.com
Investor Relations ContactLee RothThe Ruth
Group646-536-7012lroth@theruthgroup.com
Media ContactKirsten ThomasThe Ruth Group(508)
280-6592kthomas@theruthgroup.com
Tables Follow
|
|
Entasis Therapeutics Holdings
Inc. |
Condensed Consolidated Statements of
Operations |
Unaudited |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
5,000 |
|
|
$ |
- |
|
Operating
expenses: |
|
|
|
|
|
|
Research
and development |
|
|
33,046 |
|
|
|
25,745 |
|
General
and administrative |
|
|
10,161 |
|
|
|
5,599 |
|
Total
operating expenses |
|
|
43,207 |
|
|
|
31,344 |
|
Loss from
operations |
|
|
(38,207 |
) |
|
|
(31,344 |
) |
Other income: |
|
|
|
|
|
|
Grant income |
|
|
5,337 |
|
|
|
1,396 |
|
Interest income |
|
|
390 |
|
|
|
25 |
|
Total
other income |
|
|
5,727 |
|
|
|
1,421 |
|
Loss before income
taxes |
|
|
(32,480 |
) |
|
|
(29,923 |
) |
Provision for income
taxes |
|
|
472 |
|
|
|
- |
|
Net loss |
|
|
(32,952 |
) |
|
|
(29,923 |
) |
Dividends declared |
|
|
(9,142 |
) |
|
|
- |
|
Net loss attributable
to common stockholders—basic and diluted |
|
$ |
(42,094 |
) |
|
$ |
(29,923 |
) |
Net loss per share
attributable to common stockholders—basic and diluted |
|
$ |
(12.31 |
) |
|
$ |
(13,795.76 |
) |
Weighted average common
stock outstanding—basic and diluted |
|
|
3,419,720 |
|
|
|
2,169 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Entasis Therapeutics Holdings
Inc. |
Condensed Consolidated Balance
Sheets |
Unaudited |
(in thousands) |
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
Cash, cash equivalents
and investments |
|
$ |
85,092 |
|
$ |
55,101 |
|
Other assets |
|
|
4,182 |
|
|
3,693 |
|
Total
assets |
|
$ |
89,274 |
|
$ |
58,794 |
|
|
|
|
|
|
|
|
Total liabilities |
|
$ |
6,391 |
|
$ |
9,871 |
|
Preferred stock |
|
|
- |
|
|
104,713 |
|
Total stockholders'
equity (deficit) |
|
|
82,883 |
|
|
(55,790 |
) |
Total
liabilities, preferred stock and stockholders’ equity
(deficit) |
|
$ |
89,274 |
|
$ |
58,794 |
|
|
|
|
|
|
|
|
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