Entasis Therapeutics Reports Second Quarter 2020 Financial Results and Business Update
August 06 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 second quarter
2020 financial results and provided a business update.
“I’m pleased to report substantial progress
across a number of areas of the Company in the second quarter of
2020 despite significant adjustments to adapt our clinical trial
operations to the COVID-19 pandemic restrictions,” commented Manos
Perros, President and Chief Executive Officer of Entasis
Therapeutics. “First, our two ongoing Phase 3 registration
trials addressing carbapenem-resistant Acinetobacter infections and
uncomplicated gonorrhea due to Neisseria gonorrhea, two “CDC urgent
threats,” continue to make progress in enrolling patients. Each
trial, however, has been impacted by the COVID-19 pandemic as it
disrupts healthcare facilities and practitioners around the
world. As a result of the unpredictability of these
disruptions, at this time we cannot provide specific guidance when
each trial will be completed.”
“Second, we have strengthened our balance sheet
by completing the closing of the $35 million common stock and
warrant investment from Innoviva, Inc., which strategically
positions us to fund the ATTACK Phase 3 registration trial and
advance our pipeline. Third, we secured two non-dilutive funding
awards to support our pipeline of novel antibacterial programs. We
are pleased to continue our relationship with CARB-X, which, in
June, exercised a new option award under our existing arrangement
that will support development of ETX0462 to Phase 1-ready status.
ETX0462 is being developed to potentially address
multidrug-resistant Pseudomonas infections. Additionally, we
have been awarded a contract from the National Institute of Allergy
and Infectious Diseases (NIAID) that included an initial amount of
approximately $3 million and the potential to receive up to $15.5
million. We believe this contract further validates the potential
of our NBP platform to yield novel molecules with expanded
Gram-negative spectrum against antibiotic-resistant bacterial
pathogens. Finally, seven articles were published across our
clinical programs SUL-DUR, zoliflodacin, and ETX0282CPDP, including
a zoliflodacin article that was chosen as the Editors’ Choice in
the May 12, 2020 edition of ACS Infectious Disease. Taken together,
these accomplishments provide us with momentum to continue
executing on our business objectives in the second half of
2020.”
Second Quarter 2020 and Recent
Highlights
Business Highlights
- In June, the Company closed its
securities purchase agreement with Innoviva for gross proceeds of
$35 million. The stock purchase occurred in two tranches. The first
tranche was closed in April for an aggregate purchase price of
approximately $3.3 million. In the second tranche, which was
completed in June, Innoviva purchased 12,677,490 shares of common
stock and warrants for gross proceeds of approximately $31.7
million.
- In June the Combating
Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator
(CARB-X), a global non-profit partnership dedicated to accelerating
antibacterial research to tackle the global rising threat of
drug-resistant bacteria, exercised a new option under our existing
arrangement. The option provides non-dilutive support for
additional pre-clinical work to further develop ETX0462, our first
product candidate from our non-β-lactam inhibitor (NBP) platform,
to Phase 1-ready status.
- In June, the Company also received
a contract from the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health (NIH).
The contract initiated on July 1, 2020 and included an initial
award of approximately $3 million, with the potential to increase
up to $15.5 million. Proceeds from the contract will be used to
develop novel molecules from Entasis’ non-β-lactam inhibitor (NBP)
platform with expanded antimicrobial spectrum.
- In June, the Company presented at
the BMO virtual 2020 Prescriptions for Success Healthcare
Conference.
SUL-DUR
- The Company continues to advance
ATTACK, a global two-part Phase 3 registration trial evaluating
SUL-DUR for the treatment of patients with pneumonia and
bloodstream infections caused by carbapenem-resistant Acinetobacter
baumannii. The trial has now opened approximately 89 clinical sites
across 16 countries, and a July 2020 Drug and Safety Monitoring
Board review recommended continuation of the trial without protocol
modification. Despite the continued progress, the COVID-19 pandemic
continues to intermittently disrupt the operations of the ATTACK
global clinical trial sites. The timing, scope and duration of
these interruptions are unpredictable and, as a consequence, we
cannot accurately assess their impact on the expected timeline for
completion of the trial. Therefore, the Company is suspending
guidance on top-line data from this study. We will continue to
monitor the situation and provide updates as available.
- A publication from the Company
(Seifert H., et al. Antimicrob Chemother. 2020 Jun 9) and a
separate publication from our partner Zai Lab (Yang Q., et al.
Antimicrob Chemother. 2020 Jul 1;75(7)) highlighted the in vitro
potency of SUL-DUR against global isolates of carbapenem-resistant
Acinetobacter baumannii and clinical isolates of Acinetobacter
baumannii from China, respectively. In addition, the Company also
published Phase 1 results demonstrating that durlobactam was
generally safe and well tolerated when administered either alone or
in combination with sulbactam and/or imipenem-cilastatin (Lickliter
JD, Lawrence K, O'Donnell J, Isaacs R. Antimicrob Agents Chemother.
2020 Jun 23;64(7)).
Zoliflodacin
- The Company is continuing to
support the Phase 3 registration trial of zoliflodacin for the
treatment of uncomplicated gonorrhea in partnership with the Global
Antibiotic Research and Development Partnership (GARDP). The trial
is set to enroll approximately 1,000 patients with urogenital
gonorrhea at clinical trial sites in the United States and around
the world and will assess the safety and efficacy of zoliflodacin
versus the combination of azithromycin and ceftriaxone, the current
standard of care. In late-March, GARDP, with the Company’s
agreement, made the decision to temporarily suspend patient
enrollment into the Phase 3 registration trial at U.S. sites and
activation of new clinical trial sites in ex-U.S. regions due to
the COVID-19 pandemic. Although patient enrollment and other trial
activities resumed in July 2020, the Company is suspending guidance
on the timing of the Phase 3 data readout while it continues to
assess the potential impact of the COVID-19 pandemic on the global
clinical trial sites and patient enrollment.
- The Company published a review of
zoliflodacin’s full range of in vitro antibacterial activity
against Neisseria gonorrhea, as well as Chlamydia trachomatis,
Mycoplasma genitalium, Staphylococcus aureus (both
methicillin-susceptible and methicillin-resistant), and
Streptococcus spp. and reviewed the current state of clinical
development. The publication was selected as ACS Infectious Disease
Editors’ Choice (Bradford PA, Miller AA, O'Donnell J, Mueller JP.
ACS Infect Dis. 2020 Jun 12;6(6)).
ETX0282CPDP
- Following completion of initial
Phase 1 studies, the Company proceeded with development of an
extended release formulation aiming to optimize the safety and
projected efficacy of the combination product. Having achieved
preclinical proof-of-concept, the Company is now progressing with
development of an appropriate clinical formulation to be initially
evaluated in a Phase 1 clinical trial before progressing to
clinical studies in patients.
- The Company had three articles
published on its novel oral product candidate ETX0282CPDP.
The initial discovery of ETX0282, a novel orally available
β-lactamase inhibitor with broad spectrum activity was described
(Durand-Reville TF, et al. .J Med Chem. 2020 Jul 13). Additionally,
the Company had two ETX0282 publications highlighted in the ACS
Infectious Diseases “Special issue on Antibiotics.” From in
vitro, in vivo, and PK/PD analyses, the orally available
combination of ETX0282 and cefpodoxime-proxetil exhibited favorable
attributes for the potential treatment of ESBL- and
carbapenemase-producing uropathogens or Enterabacterales (O'Donnell
J, et al. ACS Infect Dis. 2020 Jun 12;6(6):1378-1388 and Miller AA,
et al. ACS Infect Dis. 2020 Jun 12;6(6):1389-1397).
Second Quarter 2020 Financial
Results
The Company reported a net loss of $13.4 million
for the quarter ended June 30, 2020, which is consistent with a net
loss of $13.4 million for the quarter ended June 30, 2019.
Research and development expenses were $10.2
million for the quarter ended June 30, 2020, compared to $10.7
million for the quarter ended June 30, 2019. The decrease of $0.5
million was primarily due to decreases in spending related to our
SUL-DUR product candidate and were partially offset by an increase
in personnel expenses associated with higher headcount, salaries
and stock-based compensation expense.
General and administrative expenses were $3.2
million for the quarter ended June 30, 2020, compared to $3.4
million for the quarter ended June 30, 2019. The decrease of $0.2
million was driven primarily by a decrease in legal and consulting
expenses and were partially offset by an increase in personnel
expenses associated with higher headcount.
As of June 30, 2020, cash, cash equivalents and
short-term investments were $50.8 million, compared to $27.5
million as of March 31, 2020 . In April, the Company also entered
into an agreement with Innoviva Inc. for the private placement of
$35 million. 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 second 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 the
impact of the COVID-19 pandemic, 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 ContactsJames SaliernoThe
Ruth Group(646) 536-7028jsalierno@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 June 30, |
|
Six Months Ended June 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
10,239 |
|
|
$ |
10,677 |
|
|
$ |
21,862 |
|
|
$ |
21,679 |
|
General and administrative |
|
3,241 |
|
|
|
3,421 |
|
|
|
7,021 |
|
|
|
6,609 |
|
Total operating expenses |
|
13,480 |
|
|
|
14,098 |
|
|
|
28,883 |
|
|
|
28,288 |
|
Loss from operations |
|
(13,480 |
) |
|
|
(14,098 |
) |
|
|
(28,883 |
) |
|
- |
(28,288 |
) |
Other income: |
|
|
|
|
|
|
|
|
|
|
|
Grant income |
|
48 |
|
|
|
372 |
|
|
|
62 |
|
|
|
1,201 |
|
Interest income |
|
36 |
|
|
|
417 |
|
|
|
159 |
|
|
|
908 |
|
Total other income |
|
84 |
|
|
|
789 |
|
|
|
221 |
|
|
|
2,109 |
|
Loss before income taxes |
|
(13,396 |
) |
|
|
(13,309 |
) |
|
|
(28,662 |
) |
|
|
(26,179 |
) |
Provision for income taxes |
|
- |
|
|
|
73 |
|
|
|
- |
|
|
|
144 |
|
Net loss |
$ |
(13,396 |
) |
|
$ |
(13,382 |
) |
|
$ |
(28,662 |
) |
|
$ |
(26,323 |
) |
Net loss per share—basic and diluted |
$ |
(0.78 |
) |
|
$ |
(1.02 |
) |
|
$ |
(1.89 |
) |
|
$ |
(2.00 |
) |
Weighted average common stock outstanding—basic and diluted |
|
17,095,140 |
|
|
|
13,131,291 |
|
|
|
15,193,351 |
|
|
|
13,128,956 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Entasis Therapeutics Holdings Inc. |
Condensed Consolidated Balance Sheets |
Unaudited |
(in thousands) |
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
Cash, cash equivalents and investments |
$ |
50,771 |
|
|
$ |
40,996 |
|
Other assets |
|
5,693 |
|
|
|
10,038 |
|
Total assets |
$ |
56,464 |
|
|
$ |
51,034 |
|
|
|
|
|
|
|
|
|
Total liabilities |
$ |
7,177 |
|
|
$ |
8,877 |
|
Total stockholders' equity |
|
49,287 |
|
|
|
42,157 |
|
Total liabilities and stockholders’ equity |
$ |
56,464 |
|
|
$ |
51,034 |
|
|
|
|
|
|
|
|
|
Entasis Therapeutics (NASDAQ:ETTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Entasis Therapeutics (NASDAQ:ETTX)
Historical Stock Chart
From Apr 2023 to Apr 2024