Entasis Therapeutics Reports Second Quarter 2019 Financial Results and Provides Business Update
August 12 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 second quarter
financial results ended June 30, 2019 and provided a business
update.
“We continued to make steady progress across all our pipeline
programs in the first half of 2019,” commented Manos Perros,
President and Chief Executive Officer of Entasis Therapeutics.
“Earlier in April, we initiated the global ATTACK
(Acinetobacter Treatment
Trial Against
Colistin) Phase 3 pivotal trial evaluating a
fixed-dose combination of sulbactam plus durlobactam, or SUL-DUR
(ETX2514SUL), as a potential treatment for carbapenem-resistant
Acinetobacter baumannii infections. We also reported encouraging
topline data from the Phase 1 study of ETX0282 which is being
developed as a therapy for gram-negative infections caused by
multidrug-resistant (MDR) Enterobacteriaceae. We also
announced the addition of David Meek, current CEO of Ipsen S.A. as
Chairman of our board, who brings significant healthcare experience
and insight to the Company as we execute on our strategic
objectives.”
Second Quarter and Recent Business
Highlights
- In April, Entasis initiated the ATTACK Phase 3 pivotal clinical
trial to evaluate SUL-DUR for the treatment of patients with
pneumonia and bloodstream infections caused by carbapenem-resistant
A. baumannii. ATTACK is a global, two-part Phase 3 clinical trial
that will enroll a total of 300 patients. Topline results from the
study are expected to be available in second half of 2020.
- 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 is
evaluating the safety, tolerability and pharmacokinetics of ETX0282
either alone or in combination with cefpodoxime proxetil
(ETX0282CPDP) in healthy volunteers. Results demonstrated
that the plasma concentrations of the beta-lactamase inhibitor were
in the projected therapeutic range. ETX0282 was generally well
tolerated either alone or in combination with cefpodoxime proxetil,
with no serious adverse events reported.
- The Company strengthened its board with the appointment of
industry veteran, David Meek, as the Chairman of the Board of
Directors. Mr. Meek has over two decades of valuable healthcare
industry experience and is currently CEO and a Director of Ipsen
S.A.
- The Company also strengthened the management team with the
additions of Eric Kimble as Chief Commercial Officer, Elizabeth
Keiley as General Counsel and Andrew Dawson as Head of Human
Resources.
- At the American Society for Microbiology (ASM) Microbe
Conference, Entasis presented new findings supporting development
of the Company’s three clinical programs: SUL-DUR, zoliflodacin and
ETX0282CPDP. During the conference the Company presented data on
the pharmacokinetics and pharmacodynamics for SUL-DUR which formed
the basis of the dosing regimen tested in the Phase 2 clinical
trial and the ongoing ATTACK Phase 3 clinical trial.
Second Quarter Financial Results
The Company reported a net loss of $13.4 million for the quarter
ended June 30, 2019, compared to a net loss of $5.7 million for the
quarter ended June 30, 2018. The increase in net loss was primarily
related to an increase in research and development expenses and
decreases in other income.
Research and development expenses were $10.7 million for the
quarter ended June 30, 2019, compared to $9.5 million for the
quarter ended June 30, 2018. The increase in research and
development expenses was primarily attributable to clinical
development expenses, primarily related to the advancement of our
SUL-DUR product candidate.
General and administrative expenses were $3.4 million for the
quarter ended June 30, 2019 compared to $2.5 million for the
quarter ended June 30, 2018, as increased costs associated with
additional headcount were offset by lower legal costs.
As of June 30, 2019, cash, cash equivalents and short-term
investments were $59.5 million, compared to $74.6 million as of
March 31, 2019. 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), 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. 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 June 30, |
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Six Months Ended June 30, |
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2019 |
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2018 |
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2019 |
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2018 |
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Revenue |
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$ |
- |
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$ |
5,000 |
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$ |
- |
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$ |
5,000 |
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Operating
expenses: |
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Research
and development |
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10,677 |
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9,479 |
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21,679 |
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18,029 |
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General and
administrative |
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3,421 |
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2,548 |
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6,609 |
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5,766 |
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Total
operating expenses |
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14,098 |
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12,027 |
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28,288 |
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23,795 |
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Loss from
operations |
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(14,098 |
) |
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(7,027 |
) |
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(28,288 |
) |
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(18,795 |
) |
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Other income: |
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Grant income |
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372 |
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1,750 |
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1,201 |
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2,839 |
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Interest
income |
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417 |
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16 |
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908 |
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28 |
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Total other
income |
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789 |
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1,766 |
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2,109 |
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2,867 |
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Loss before income
taxes |
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(13,309 |
) |
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(5,261 |
) |
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(26,179 |
) |
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(15,928 |
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Provision for
income taxes |
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73 |
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472 |
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144 |
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472 |
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Net loss |
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$ |
(13,382 |
) |
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$ |
(5,733 |
) |
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$ |
(26,323 |
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$ |
(16,400 |
) |
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Net loss per
share—basic and diluted |
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$ |
(1.02 |
) |
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$ |
(453.60 |
) |
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$ |
(2.00 |
) |
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$ |
(1,297.57 |
) |
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Weighted average
common stock outstanding—basic and diluted |
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13,131,291 |
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12,639 |
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13,128,956 |
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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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June 30, |
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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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$ |
59,473 |
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$ |
85,092 |
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Other assets |
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7,016 |
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4,182 |
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Total
assets |
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$ |
66,489 |
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$ |
89,274 |
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Total
liabilities |
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$ |
8,649 |
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$ |
6,391 |
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Total
stockholders' equity |
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57,840 |
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82,883 |
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Total
liabilities and stockholders’ equity |
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$ |
66,489 |
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$ |
89,274 |
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