Entasis Therapeutics Reports Third Quarter 2020 Financial Results and Provides a Business Update
November 05 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 today its third quarter
2020 financial results and provided a business update.
“We made considerable progress during the quarter
despite the sustained headwinds of the COVID-19 pandemic, as we
continued to advance our Phase 3 registration clinical trials
addressing Acinetobacter infections and gonorrhea, further
delivered on our pipeline, and strengthened our balance sheet from
the closing of a $25 million private placement,” commented Manos
Perros, President and Chief Executive Officer of Entasis
Therapeutics.
“In addition to our operational progress in the
third quarter, we also presented at multiple investor conferences
and were pleased to present four posters on SUL-DUR at the virtual
IDWeek 2020 Conference, which included demonstration of its robust
activity against global multidrug resistant Acinetobacter baumannii
clinical isolates. We continue to be encouraged by our progress
toward achieving our objectives and believe we are optimally
positioned and well-funded as we conclude 2020 and look toward
2021.”
Third Quarter
2020 and Recent
Highlights
Business Highlights
- In August, the Company announced that it had entered into a $25
million private placement agreement with two healthcare investors.
The Company intends to use the net proceeds for the continued
support of the ongoing ATTACK Phase 3 registration clinical trial
as well as for working capital and other general corporate
purposes. ATTACK is a global Phase 3 registration trial evaluating
SUL-DUR for the treatment of patients with pneumonia and
bloodstream infections caused by Acinetobacter baumannii, including
carbapenem-resistant strains.
- In September, the Company presented
virtually at the H.C. Wainwright & Co. 22nd
Annual Global Investment Conference, the Cantor
2020 Virtual Global Healthcare Conference, and the Oppenheimer
Fall Healthcare Life Sciences & MedTech Summit. In August, the
Company presented at the 2020 Wedbush PacGrow Healthcare
Virtual Conference and at the Canaccord Genuity 40th Annual
Growth Conference.
SUL-DUR
- The Company continues with enrollment of the ATTACK Phase 3
registration clinical trial in 17 countries, and to-date has had
two pre-planned Data and Safety Monitoring Board reviews, including
one most recently in July 2020. Although the Company remains
blinded to the data, both reviews recommended continuation of the
trial without protocol modification. While not providing specific
guidance on the timing of top-line data from ATTACK due to the
unpredictability of the COVID-19 pandemic, the Company remains in
close contact with its contract research organization to optimize
the allocation of its resources and funded activities in an effort
to mitigate the impact on its trial sites and anticipated
timeline.
- During the virtual IDWeek 2020 held on October 21-25, the
company presented four posters highlighting SUL-DUR’s potential.
Two posters detailed findings demonstrating activity of SUL-DUR
against multidrug-resistant Acinetobacter clinical isolates from
the Middle East as well as global Acinetobacter
baumannii-calcoaceticus complex clinical isolates. In addition, a
retrospective review of serious infections caused by
carbapenem-susceptible and carbapenem-resistant Acinetobacter
baumannii-calcoaceticus complex was presented, which concluded that
such infections are associated with high mortality rates and that
carbapenem resistance appears to be a contributing factor. Lastly,
the Company highlighted the in vitro intrinsic microbiological
activity of durlobactam and combinations against multidrug
resistant Mycobacterium abscessus.
Zoliflodacin
- With patient enrollment and other trial activities resuming in
July 2020, the Company is continuing to support the Phase 3
registration clinical trial of zoliflodacin for the treatment of
uncomplicated gonorrhea with the Global Antibiotic Research and
Development Partnership (GARDP). The trial plans to enroll patients
with uncomplicated gonorrhea, including infections caused by
multidrug resistant strains of N. gonorrhoeae, at 14 clinical trial
sites across the United States, Netherlands, South Africa and
Thailand, and will assess the safety and efficacy of oral
zoliflodacin versus the combination of intramuscular ceftriaxone
plus oral azithromycin, the current standard of care. While not
providing specific guidance on the timing of top-line data from
this trial due to the unpredictability of the COVID-19 pandemic,
the Company and GARDP are working to optimize the allocation of
their resources and funded activities in an effort to mitigate the
impact on their trial sites and anticipated timeline.
- In August, the Company co-authored a review of recent progress
in adapting non-clinical models to facilitate research and
development of new agents for treating gonorrhea, based on the
November 2019 expert workshop organized by the Global Antibiotic
Research and Development Partnership (GARDP). The review was
featured in the peer-reviewed journal, Clinical Microbiology and
Infection.
Discovery
Research
- In October, the Company presented at the Boston Area
Antimicrobial Resistance Network (BAARN) Meeting 2020 an oral
presentation titled, “Antibacterial Drug Discovery: Competing
Methyl Efforts on Biochemical Potency and Cell Accumulation.”
Third Quarter 2020 Financial
Results
The Company reported a net loss of $11.1 million
for the quarter ended September 30, 2020, compared to a net loss of
$3.5 million for the quarter ended September 30, 2019. The increase
in net loss was primarily related to a decrease in revenue recorded
during the third quarter 2020 versus the same period last year.
Research and development expenses were $9.4 million
for the quarter ended September 30, 2020, compared to $7.6 million
for the quarter ended September 30, 2019. The increase of $1.8
million was driven primarily by increased spending related to our
SUL-DUR product candidate, increased personnel expenses associated
with higher headcount, salaries and stock-based compensation
expense, and increased spending related to our ETX0462 product
candidate. These increases were offset by decreased spending
related to our ETX0282 product candidate.
General and administrative expenses were $3.2
million for the quarter ended September 30, 2020, compared to $3.5
million for the quarter ended September 30, 2019. The decrease of
$0.3 million was driven primarily by decreases in VAT tax
associated with payments received from our collaboration with Zai
Lab.
As of September 30, 2020, cash, cash equivalents
and short-term investments were $61.2 million, compared to $50.8
million as of June 30, 2020.
Based on our current operating plan, we believe
that our existing cash, cash equivalents and short-term investments
will be sufficient to fund our operating expenses and capital
expenditure requirements into the fourth quarter of 2021.
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
ContactsJan Medina, CFA / James SaliernoThe Ruth
Group(646) 536-7035 / (646) 536-7028jmedina@theruthgroup.com /
jsalierno@theruthgroup.com
Media ContactKirsten ThomasThe
Ruth Group(508) 280-6592kthomas@theruthgroup.com
(Financial Tables Follow)
Entasis
Therapeutics Holdings Inc. |
Condensed
Consolidated Statements of Operations |
Unaudited |
(in
thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
- |
|
|
$ |
7,000 |
|
|
$ |
- |
|
|
$ |
7,000 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
9,387 |
|
|
|
7,606 |
|
|
|
31,249 |
|
|
|
29,286 |
|
General and administrative |
|
|
3,213 |
|
|
|
3,521 |
|
|
|
10,235 |
|
|
|
10,130 |
|
Total operating expenses |
|
|
12,600 |
|
|
|
11,127 |
|
|
|
41,484 |
|
|
|
39,416 |
|
Loss from
operations |
|
|
(12,600 |
) |
|
|
(4,127 |
) |
|
|
(41,484 |
) |
|
|
(32,416 |
) |
Other
income: |
|
|
|
|
|
|
|
|
|
|
|
|
Grant
income |
|
|
1,458 |
|
|
|
634 |
|
|
|
1,519 |
|
|
|
1,835 |
|
Interest
income |
|
|
9 |
|
|
|
332 |
|
|
|
170 |
|
|
|
1,240 |
|
Total other income |
|
|
1,467 |
|
|
|
966 |
|
|
|
1,689 |
|
|
|
3,075 |
|
Loss before
income taxes |
|
|
(11,133 |
) |
|
|
(3,161 |
) |
|
|
(39,795 |
) |
|
|
(29,341 |
) |
Provision
for income taxes |
|
|
- |
|
|
|
324 |
|
|
|
- |
|
|
|
467 |
|
Net
loss |
|
$ |
(11,133 |
) |
|
$ |
(3,485 |
) |
|
$ |
(39,795 |
) |
|
$ |
(29,808 |
) |
Net loss per
share—basic and diluted |
|
$ |
(0.37 |
) |
|
$ |
(0.27 |
) |
|
$ |
(1.97 |
) |
|
$ |
(2.27 |
) |
Weighted
average common stock outstanding—basic and diluted |
|
|
29,960,219 |
|
|
|
13,134,538 |
|
|
|
20,151,570 |
|
|
|
13,130,837 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Entasis
Therapeutics Holdings Inc. |
Condensed
Consolidated Balance Sheets |
Unaudited |
(in
thousands) |
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
Cash, cash
equivalents and investments |
|
$ |
61,190 |
|
$ |
40,996 |
Other
assets |
|
|
8,772 |
|
|
10,038 |
Total assets |
|
$ |
69,962 |
|
$ |
51,034 |
|
|
|
|
|
|
|
Total
liabilities |
|
$ |
7,726 |
|
$ |
8,877 |
Total
stockholders' equity |
|
|
62,236 |
|
|
42,157 |
Total liabilities and stockholders’ equity |
|
$ |
69,962 |
|
$ |
51,034 |
|
|
|
|
|
|
|
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