Entasis Therapeutics Reports First Quarter 2020 Financial Results and Business Update
May 07 2020 - 04:05PM
Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX), a clinical-stage
biopharmaceutical company focused on the discovery and development
of novel antibacterial products, announced today its first quarter
2020 financial results and provided a business update.
“We are very pleased with the continued progress
made during the first quarter of 2020, despite the COVID-19
pandemic’s disruptions to clinical trials, the capital markets, and
many other facets of our industry,” commented Manos Perros,
President and Chief Executive Officer of Entasis Therapeutics. “Our
private placement with Innoviva, Inc. validates the hard work,
resilience and innovative pipeline of our organization. With the
proceeds, we are advancing our pipeline of novel Gram-negative
antibacterial product candidates and working to complete ATTACK
(Acinetobacter Treatment
Trial Against
Colistin), our global Phase 3 registration trial
evaluating a fixed-dose combination of sulbactam and durlobactam
(SUL-DUR) against Acinetobacter baumannii infections. We continue
to monitor the effects of the COVID-19 pandemic on our operations
and are taking action to mitigate their impact on our two Phase 3
data readouts in 2021.”
First Quarter 2020 and Recent
Highlights
- In April, the Company entered into a securities purchase
agreement with Innoviva, Inc. (NASDAQ:INVA), or Innoviva, to issue
and sell in a private placement up to 14,000,000 newly issued
shares of common stock and warrants with an exercise price of $2.50
per share. The private placement will occur in two tranches. The
first tranche closed on April 22, 2020 as Innoviva purchased
1,322,510 shares of common stock and warrants to purchase 1,322,510
shares of common stock for an aggregate purchase price of
approximately $3.3 million. At the closing of the second tranche,
anticipated in June, Innoviva will purchase the remaining
12,677,490 shares of common stock and an equal number of warrants
for an aggregate purchase price of approximately $31.7
million.
- The Company continues to advance its ATTACK Phase 3
registration trial to evaluate SUL-DUR for the treatment of
patients with pneumonia and bloodstream infections caused by
carbapenem-resistant Acinetobacter baumannii. ATTACK is a global,
two-part Phase 3 registration trial set to enroll a total of
approximately 300 patients. As previously announced, the
coronavirus outbreak in countries where we are conducting the
ATTACK registration trial is impacting patient recruitment, and we
anticipate topline data to be available in early 2021. The Company
is continuing to monitor the situation closely and is actively
taking steps to lessen the impact of the COVID-19 pandemic on the
trial timeline.
- The global Phase 3 registration trial of zoliflodacin for the
treatment of uncomplicated gonorrhea with the Global Antibiotic
Research and Development Partnership (GARDP) will enroll
approximately 1,000 patients with urogenital gonorrhea at clinical
trial sites in the United States and internationally. The trial
will assess the safety and efficacy of zoliflodacin versus the
combination of azithromycin and ceftriaxone, the current standard
of care. GARDP is fully funding and sponsoring the Phase 3 trial in
exchange for exclusive commercial rights in low-income and select
middle-income countries. Although enrollment progressed within the
first quarter of 2020, given the focus of our clinical trial sites
on addressing the immediate medical needs of patients due to the
COVID-19 pandemic, GARDP, with our full agreement, has made the
decision in late-March to temporarily suspend patient enrollment
into the Phase 3 registration trial at U.S. sites and new clinical
trial site activation in ex-U.S. regions. The Company is
working closely with GARDP to mitigate the impact of the temporary
suspension and still anticipates data readout from the Phase 3
registration trial in 2H 2021.
- The global outbreak of a novel strain of coronavirus (COVID-19)
has, and will likely continue to have, a significant impact on the
U.S. economy and businesses. The social distancing and stay-at-home
orders issued by national, state and local governments have
resulted in closures of offices and factories and disrupted supply
chains. The pandemic also has taxed healthcare systems both
in the U.S. and around the world, resulting in disruption to or
temporary suspension of clinical trials. As a result of these
changes, the timelines for completion of our clinical trials and
earlier-stage development programs may be impacted. Although
we are continuing to actively monitor and assess the effects of the
COVID-19 pandemic on our business and development programs, the
ultimate impact of the coronavirus pandemic is highly uncertain and
subject to change.
First Quarter 2020 Financial
Results
The Company reported a net loss of $15.3 million
for the quarter ended March 31, 2020, compared to a net loss of
$12.9 million for the quarter ended March 31, 2019. The increase in
net loss was primarily due to a decrease in other income and
increases in research and development and general and
administration expenses.
Research and development expenses were $11.6
million for the quarter ended March 31, 2020, compared to $11.0
million for the quarter ended March 31, 2019. The increase of $0.6
million was primarily due to increases in costs associated with
higher headcount offset by decreases in preclinical expenses.
General and administrative expenses were $3.8
million for the quarter ended March 31, 2020, compared to $3.2
million for the quarter ended March 31, 2019. The increase was
primarily due to costs associated with higher headcount.
As of March 31, 2020, cash, cash equivalents and
short-term investments were $27.5 million, compared to $41.0
million as of December 31, 2019. The Company believes its cash
position as of March 31, 2020 provides a cash runway into the
fourth quarter of 2020. Including the funding from Innoviva,
the Company forecasts operating capital into the middle 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 ContactsTram
Bui / James SaliernoThe Ruth Group(646) 536-7035 /
7028tbui@theruthgroup.com jsalierno@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 March 31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
11,623 |
|
|
$ |
11,002 |
|
General and administrative |
|
|
3,780 |
|
|
|
3,189 |
|
Total operating expenses |
|
|
15,403 |
|
|
|
14,191 |
|
Loss from operations |
|
|
(15,403 |
) |
|
|
(14,191 |
) |
Other income: |
|
|
|
|
|
|
Grant income |
|
|
13 |
|
|
|
829 |
|
Interest income |
|
|
124 |
|
|
|
492 |
|
Total other income |
|
|
137 |
|
|
|
1,321 |
|
Loss before income taxes |
|
|
(15,266 |
) |
|
|
(12,870 |
) |
Provision for income taxes |
|
|
— |
|
|
|
71 |
|
Net loss |
|
$ |
(15,266 |
) |
|
$ |
(12,941 |
) |
Net loss per share—basic and diluted |
|
$ |
(1.15 |
) |
|
$ |
(0.99 |
) |
Weighted average common stock outstanding—basic and diluted |
|
|
13,291,563 |
|
|
|
13,126,595 |
|
|
|
|
|
|
|
|
Entasis Therapeutics Holdings Inc. |
Condensed Consolidated Balance Sheets |
Unaudited |
(in thousands) |
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
Cash, cash equivalents and short-term investments |
|
$ |
27,466 |
|
$ |
40,996 |
Other assets |
|
|
7,194 |
|
|
10,038 |
Total assets |
|
$ |
34,660 |
|
$ |
51,034 |
|
|
|
|
|
|
|
Total liabilities |
|
$ |
6,956 |
|
$ |
8,877 |
Total stockholders' equity |
|
|
27,704 |
|
|
42,157 |
Total liabilities and stockholders’ equity |
|
$ |
34,660 |
|
$ |
51,034 |
|
|
|
|
|
|
|
Innoviva (NASDAQ:INVA)
Historical Stock Chart
From Feb 2024 to Mar 2024
Innoviva (NASDAQ:INVA)
Historical Stock Chart
From Mar 2023 to Mar 2024