Entasis Therapeutics Reports Third Quarter 2019 Financial Results and Provides Business Update
November 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 third quarter
financial results for the period ended September 30, 2019 and
provided a business update.
“We are extremely pleased by the continued
progress we have made advancing our pipeline during the third
quarter of 2019,” stated Manos Perros, President and Chief
Executive Officer of Entasis Therapeutics. “We reached another
pivotal milestone in September with the advancement of our second
program, zoliflodacin, a novel antibiotic for the treatment of
uncomplicated gonorrhea, into a Phase 3 clinical trial. In
addition to zoliflodacin, sulbactam-durlobactam (SUL-DUR) is being
studied in carbapenem-resistant Acinetobacter infections in the
ongoing ATTACK Phase 3 clinical trial.”
Dr. Perros added, “We also strengthened our
company with the additions of Dr. Howard Mayer to our board of
directors, effective August 5, 2019 and David Altarac, M.D., MPA as
Chief Medical Officer, effective November 4, 2019. Dr. Mayer brings
significant clinical expertise in the infectious and rare disease
space as well as operational leadership to both our board and
company. Dr. Altarac brings over 20 years of biopharmaceutical
R&D leadership and has led multiple new drug approvals and
product extensions in major markets. Overall, we remain committed
to executing our strategic initiatives and believe our skilled
leadership team, strong pipeline, and focused business plan
position us well in anticipation of our first Phase 3 data readout
from the ATTACK clinical trial during the second half of 2020.”
Third Quarter and Recent
Highlights
- In September, the Global Antibiotic
Research and Development Partnership (GARDP) initiated the global
Phase 3 pivotal 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. Our partner GARDP is fully funding and sponsoring the
trial, and in return we have provided them with exclusive
commercial rights in low to select middle income countries. A data
readout from the Phase 3 pivotal trial is expected in 2021.
- Entasis strengthened its board of
directors through the addition of industry veteran Howard Mayer,
M.D. Dr. Mayer has held positions in executive management at both
mid-sized and large pharmaceutical companies including Pfizer,
Bristol-Myers Squibb, Merck KGaA and Shire Plc, and brings a wealth
of experience leading and executing clinical programs, including
programs in the infectious disease space.
- In November, David Altarac, M.D.,
MPA joined the Company as Chief Medical Officer, concurrent with
the retirement of Dr. Robin Isaacs who has served as the Company’s
Chief Medical Officer since July 2015. Dr. Altarac is a recognized
industry R&D leader and brings broad experience from previous
roles, most recently as senior vice president and head of global
regulatory affairs, global drug safety and R&D quality and
compliance at Shire Plc.
- At IDWeek 2019, the Company
highlighted the latest advancements in the antibacterial activity
of our lead candidate SUL-DUR through two poster presentations. For
the first time, the Company described the robust in vitro and in
vivo antibacterial activity of SUL-DUR against Burkholderia
species, a challenging group of pathogens that have the potential
to cause serious respiratory infections, especially in patients
with cystic fibrosis. Dr. Perros, President and CEO, also
participated in an industry panel discussion on how to reinvigorate
antibiotic development in the current market environment. The
Company hosted an advisory panel on SUL-DUR and discussed aspects
of the pivotal ATTACK clinical trial and SUL-DUR’s potential for
the treatment of multidrug-resistant Acinetobacter infections.
- The Company bolstered its liquidity
by entering into a Common Stock Purchase Agreement with Aspire
Capital Fund, LLC. Under the agreement, the Company may issue and
sell shares of its common stock having an aggregate gross sales
price of up to $20.0 million. The Company has the sole discretion
to present Aspire with a purchase notice directing Aspire to
purchase up to 50,000 shares of common stock per business day.
Third Quarter Financial
Results
The Company reported a net loss of $3.5 million
for the quarter ended September 30, 2019, compared to a net loss of
$8.5 million for the quarter ended September 30, 2018. The decrease
in net loss was primarily due to milestone revenue of $7.0 million
from our collaboration with Zai Lab Limited in 2019 related to the
achievement of key milestones in our ATTACK clinical trial.
Research and development expenses were $7.6
million for the quarter ended September 30, 2019, compared to $8.1
million for the quarter ended September 30, 2018. The decrease in
research and development expenses was primarily attributable to
decreases in drug manufacturing costs, partially offset by
increases in clinical development expenses related to the
advancement of our SUL-DUR product candidate.
General and administrative expenses were $3.5
million for the quarter ended September 30, 2019, compared to $2.1
million for the quarter ended September 30, 2018, an increase
driven by costs associated with additional headcount and VAT taxes
associated with the milestone revenue from our collaboration with
Zai Lab Limited.
As of September 30, 2019, cash, cash equivalents
and short-term investments were $48.8 million, compared to $59.5
million as of June 30, 2019. The Company believes its current cash
position, together with earned milestones from our collaboration
with Zai Lab Limited, provides a cash runway into the fourth
quarter of 2020. Additionally, the Company signed a $20
million common stock purchase agreement with Aspire Capital Fund,
LLC on October 21, 2019.
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
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)
Entasis
Therapeutics Holdings Inc. |
Consolidated
Statements of Operations |
Unaudited |
(in
thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
Revenue |
$ |
7,000 |
|
|
$ |
- |
|
|
$ |
7,000 |
|
|
$ |
5,000 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
7,606 |
|
|
|
8,086 |
|
|
|
29,286 |
|
|
|
26,115 |
|
General and administrative |
|
3,521 |
|
|
|
2,075 |
|
|
|
10,130 |
|
|
|
7,840 |
|
Total operating expenses |
|
11,127 |
|
|
|
10,161 |
|
|
|
39,416 |
|
|
|
33,955 |
|
Loss from
operations |
|
(4,127 |
) |
|
|
(10,161 |
) |
|
|
(32,416 |
) |
|
|
(28,955 |
) |
Other
income: |
|
|
|
|
|
|
|
|
|
|
|
Grant income |
|
634 |
|
|
|
1,669 |
|
|
|
1,835 |
|
|
|
4,507 |
|
Interest income |
|
332 |
|
|
|
19 |
|
|
|
1,240 |
|
|
|
47 |
|
Total other income |
|
966 |
|
|
|
1,688 |
|
|
|
3,075 |
|
|
|
4,554 |
|
Loss before
income taxes |
|
(3,161 |
) |
|
|
(8,473 |
) |
|
|
(29,341 |
) |
|
|
(24,401 |
) |
Provision
for income taxes |
|
324 |
|
|
|
- |
|
|
|
467 |
|
|
|
472 |
|
Net
loss |
|
(3,485 |
) |
|
|
(8,473 |
) |
|
|
(29,808 |
) |
|
|
(24,873 |
) |
Dividends
declared |
|
- |
|
|
|
(9,142 |
) |
|
|
- |
|
|
|
(9,142 |
) |
Net loss
attributable to common stockholders—basic and diluted |
$ |
(3,485 |
) |
|
$ |
(17,615 |
) |
|
$ |
(29,808 |
) |
|
$ |
(34,015 |
) |
Net loss per
share—basic and diluted |
$ |
(0.27 |
) |
|
$ |
(20.33 |
) |
|
$ |
(2.27 |
) |
|
$ |
(113.22 |
) |
Weighted
average common stock outstanding—basic and diluted |
|
13,134,538 |
|
|
|
866,641 |
|
|
|
13,130,837 |
|
|
|
300,435 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Entasis
Therapeutics Holdings Inc. |
|
Condensed
Consolidated Balance Sheets |
|
Unaudited |
|
(in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
December 31, |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments |
$ |
48,810 |
|
|
$ |
85,092 |
|
Other
assets |
|
14,477 |
|
|
|
4,182 |
|
Total assets |
$ |
63,287 |
|
|
$ |
89,274 |
|
|
|
|
|
|
|
|
|
Total
liabilities |
$ |
8,393 |
|
|
$ |
6,391 |
|
Total
stockholders' equity |
|
54,894 |
|
|
|
82,883 |
|
Total liabilities and stockholders’ equity |
$ |
63,287 |
|
|
$ |
89,274 |
|
|
|
|
|
|
|
|
|
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