Entasis Therapeutics Reports First Quarter 2019 Financial Results and Provides Business Update
May 14 2019 - 7:30AM
Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX), a clinical-stage
biopharmaceutical company focused on the discovery and development
of novel antibacterial products, announced its first quarter
financial results ended March 31, 2019 and provided a business
update.
“We believe 2019 will be a transformative year for Entasis as we
advance our late-stage pipeline and expand our leadership team,”
commented Manos Perros, President and Chief Executive Officer of
Entasis Therapeutics. “To kick off the year, we recently initiated
our global Phase 3 trial for ETX2514SUL against
carbapenem-resistant Acinetobacter, for which we expect to have top
line data in 2020. The initiation of this trial represents a major
step forward for the Company. We also anticipate both the
initiation of our Phase 3 trial for zoliflodacin for uncomplicated
gonorrhea in collaboration with our partner Global Antibiotic
Research and Development Partnership (GARDP), and Phase 1 data
read-out of ETX0282CPDP, in mid-2019. With our first Phase 3
clinical trial underway, we have started to prepare our global
commercialization strategy by bolstering our organization with the
appointment of Eric Kimble as Chief Commercial Officer and
Elizabeth Keiley as General Counsel. We look forward to leveraging
their expertise as we advance towards commercialization.”
First Quarter and Recent Business
Highlights
- Recently, the Company launched its Phase 3 clinical trial of
ETX2514SUL, ATTACK (Acinetobacter
Treatment Trial
Against Colistin), as a potential
treatment for infections caused by carbapenem-resistant A.
baumannii. ATTACK is a two-part global study that will enroll a
total of 300 patients. The U.S. Food and Drug Administration (FDA)
has granted Qualified Infectious Disease Product (QIDP) and Fast
Track designations to ETX2514SUL.
- The Company strengthened its management team with the
appointment of Eric Kimble as Chief Commercial Officer to build and
oversee the Company’s global commercialization strategy and product
launch initiatives. Mr. Kimble 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 April, Elizabeth Keiley was appointed General Counsel and is
responsible for leading the Company’s legal, governance and
compliance initiatives. Ms. Keiley will be instrumental in
supporting our commercialization efforts while ensuring compliance
with applicable laws and regulations and the protection of Entasis’
intellectual property, including patents and FDA designation.
- Entasis presented promising findings from multiples studies
related to its clinical assets, ETX2514SUL and ETX0282CPDP, as well
as its preclinical non-beta-lactam PBP inhibitor (NBP) program at
the 29th European Congress of Clinical Microbiology &
Infectious Diseases (ECCMID) in Amsterdam, Netherlands. These data
presentations highlighted the Company’s pipeline of innovative
antimicrobial assets and their potential value as therapeutic
agents.
First Quarter Financial Results
The Company reported a net loss of $12.9 million for the quarter
ended March 31, 2019, compared to a net loss of $10.7 million for
the quarter ended March 31, 2018. The increase in net loss was
primarily related to an increase in research and development
expenses, partially offset by increases in other income.
Research and development expenses were $11.0 million for the
quarter ended March 31, 2019, compared to $8.6 million for the
quarter ended March 31, 2018. The increase in research and
development expenses was primarily attributable to preclinical and
clinical development expenses related to the advancement of our
ETX2514SUL product candidate.
General and administrative expenses remained flat at $3.2
million for the quarter ended March 31, 2019 compared to the
quarter ended March 31, 2018, as increased costs associated with
additional headcount were offset by lower legal costs.
As of March 31, 2019, cash, cash equivalents and short-term
investments were $74.6 million, compared to $85.1 million as of
December 31, 2018.
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 Contact
Kyle Dow Entasis Therapeutics (781) 810-0114
kyle.dow@entasistx.com
Investor Relations ContactsTram Bui / Janhavi
MohiteThe Ruth Group(646) 536-7035 /
7026tbui@theruthgroup.comjmohite@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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Condensed Consolidated Statements of
Operations |
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Unaudited |
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(in thousands, except share and per share
data) |
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Three Months Ended March 31, |
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2019 |
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2018 |
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Operating
expenses: |
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Research
and development |
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$ |
11,002 |
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$ |
8,550 |
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General and
administrative |
|
|
|
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|
3,189 |
|
|
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|
3,218 |
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Total
operating expenses |
|
|
|
|
|
|
|
14,191 |
|
|
|
|
11,768 |
|
|
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Loss from
operations |
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(14,191 |
) |
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(11,768 |
) |
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Other income: |
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Grant income |
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|
829 |
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|
1,089 |
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Interest
income |
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|
|
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|
492 |
|
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|
12 |
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Total other
income |
|
|
|
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|
|
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1,321 |
|
|
|
|
1,101 |
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Loss before income
taxes |
|
|
|
|
|
|
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(12,870 |
) |
|
|
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(10,667 |
) |
|
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Provision for
income taxes |
|
|
|
|
|
|
|
71 |
|
|
|
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- |
|
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Net loss |
|
|
|
|
|
|
|
$ |
|
(12,941 |
) |
|
$ |
|
(10,667 |
) |
|
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Net loss per
share—basic and diluted |
|
$ |
|
(0.99 |
) |
|
$ |
|
(844.01 |
) |
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Weighted average
common stock outstanding—basic and diluted |
|
|
|
|
13,126,595 |
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|
12,639 |
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Entasis Therapeutics Holdings Inc. |
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Condensed Consolidated Balance Sheets |
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Unaudited |
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(in thousands) |
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March 31, |
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December 31, |
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2019 |
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2018 |
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Cash, cash
equivalents and investments |
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$ |
74,555 |
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$ |
85,092 |
|
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Other assets |
|
|
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6,712 |
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|
4,182 |
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Total
assets |
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|
$ |
81,267 |
|
$ |
89,274 |
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Total
liabilities |
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$ |
10,693 |
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$ |
6,391 |
|
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Total
stockholders' equity |
|
|
|
70,574 |
|
|
82,883 |
|
|
Total
liabilities and stockholders’ equity |
|
|
$ |
81,267 |
|
$ |
89,274 |
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