Tetraphase Pharmaceuticals Reports First Quarter 2017 Financial Results and Reviews Recent Highlights
May 04 2017 - 4:05PM
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical-stage
biopharmaceutical company developing novel antibiotics to treat
life-threatening multidrug-resistant (MDR) infections, today
reported financial results for the first quarter ended March 31,
2017 and provided an overview of recent achievements.
“We have continued to make significant advancements across all
of our development programs, particularly for IV eravacycline with
the early completion of enrollment of IGNITE4 in complicated
intra-abdominal infections (cIAI), and the initiation of IGNITE3 in
complicated urinary tract infections (cUTI), for which enrollment
is progressing well,” said Guy Macdonald, President and Chief
Executive Officer of Tetraphase. “Preparations are ongoing
for the submission of a Marketing Authorization Application (MAA)
to the European Medicines Agency (EMA) for the treatment of cIAI in
the third quarter of this year and we look forward to top-line data
from IGNITE4 also in the third quarter, which would support a
subsequent U.S. New Drug Application (NDA) filing.”
Mr. Macdonald added, “We also look forward to data from the
ongoing phase 1 clinical trials for oral eravacycline which are
designed to optimize the oral dosing regimen, and we continue to
anticipate providing an update on that program during the third
quarter of 2017.”
First Quarter and Recent Highlights
- Completed enrollment for the phase 3 IGNITE4 clinical trial of
IV eravacycline in patients with cIAI. IGNITE4 is designed to
evaluate IV eravacycline compared to meropenem and is expected to
enroll approximately 450 patients. The primary analysis will
be conducted using a 12.5% non-inferiority margin. Tetraphase
expects to report top-line results in the third quarter of
2017. Assuming a successful outcome, this study, along with
data from IGNITE1, would support an NDA filing for IV eravacycline
for cIAI.
- Initiated the phase 3 IGNITE3 clinical trial of IV eravacycline
in patients with cUTI. IGNITE3 is designed to evaluate IV
eravacycline compared to ertapenem and is expected to enroll
approximately 1,000 patients. The primary analysis will be
conducted using a 10% non-inferiority margin. Assuming a
positive outcome, the IGNITE3 clinical data are expected to support
a supplemental NDA (sNDA) submission for IV eravacycline in
cUTI.
- Presented data at ECCMID 2017, including in vitro data for
eravacycline demonstrating potent activity against drug-resistant
bacteria, specifically Gram-negative bacteria Acinetobacter
baumannii and Enterobacteriaceae, including carbapenem-resistant or
extended beta-lactamase producing phenotypes, as well as
Gram-positive bacteria Staphylococcus aureus and enterococci,
including methicillin- or vancomycin-resistant phenotypes.
Additionally, data presentations for TP-6076 highlighted its
potency against multidrug-resistant Acinetobacter baumannii and
carbapenem-resistant Enterobacteriaceae, with activity demonstrated
in clinical isolates that were pan-resistant to multiple antibiotic
classes.
- Awarded up to $4 million in research funding from the Combating
Antibiotic Resistant Bacteria Biopharmaceutical Accelerator
(CARB-X), an international, public-private partnership focused on
the discovery and development of new antimicrobial products to
address the threat of antibiotic resistance, for its pipeline
candidate TP-6076.
- Initiated a multiple-ascending dose study evaluating a 7-day
dose regimen of IV TP-6076 in healthy volunteers.
- Received Qualified Infectious Disease Product and Fast Track
designation from the FDA and initiated a single-ascending dose
study for the oral formulation of TP-271.
First-Quarter 2017 Financial Results
As of March 31, 2017, Tetraphase had cash and cash equivalents
of $128.2 million and 37.7 million shares outstanding. The
company expects that its cash and cash equivalents, as well as
expected revenue from its U.S. government awards, will be
sufficient to fund operations into the second half of 2018.
Revenues during the first quarter of 2017 were $1.5 million
compared to $2.0 million for the same period in 2016.
Revenues for each period consisted of contract and grant revenue
under the Company’s U.S. government awards for the development of
Tetraphase compounds for the treatment of diseases caused by
bacterial biothreat pathogens and for certain infections caused by
life-threatening multidrug-resistant bacteria. This decrease was
primarily due to the scope and timing of activities related to our
BARDA subcontract conducted during the quarter ended March 31,
2017, offset in part by an increase in clinical development
activities under our NIAID subcontract.
Research and development (R&D) expenses for the first
quarter of 2017 were $25.9 million compared to $13.5 million for
the same period in 2016. The increase in R&D expenses was
primarily due to increased costs related to our IGNITE3 and IGNITE4
phase 3 clinical studies for eravacycline.
General and administrative (G&A) expenses for the first
quarter of 2017 were $5.1 million compared to $5.3 million for the
same period in 2016.
For the first quarter of 2017, Tetraphase reported a net loss of
$29.5 million, or $0.79 per share, compared to a net loss of $16.7
million, or $0.46 per share, for the same period in 2016.
About Tetraphase Pharmaceuticals,
Inc.Tetraphase is a clinical-stage biopharmaceutical
company using its proprietary chemistry technology to create novel
antibiotics for serious and life-threatening bacterial infections,
including those caused by many of the multidrug-resistant (MDR)
bacteria highlighted as urgent public health threats by the CDC.
Tetraphase has created more than 3,000 novel tetracycline analogs
using its proprietary technology platform. Tetraphase's pipeline
includes three antibiotic clinical candidates: eravacycline, which
is in phase 3 clinical trials, and TP-271 and TP-6076, which are in
phase 1 clinical trials. Please visit www.tphase.com for more
company information.
Forward-Looking StatementsAny statements in
this press release about our future expectations, plans and
prospects, including statements regarding our strategy, future
operations, prospects, plans and objectives, and other statements
containing the words "anticipates," "believes," "expects," "plans,"
"will" and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including: whether results obtained in previous
clinical trials will be indicative of results obtained in future
clinical trials; whether eravacycline or any other clinical
candidate will advance through the clinical trial process on a
timely basis or at all; whether the results of the Company's
development efforts will warrant regulatory submission and whether
any such submissions will receive approval from the United States
Food and Drug Administration or equivalent foreign regulatory
agencies; whether, if any clinical candidate obtains approval, it
will be successfully distributed and marketed; and other factors
discussed in the "Risk Factors" section of our quarterly report on
Form 10-K, filed with the Securities and Exchange Commission on
March 13, 2017. In addition, the forward-looking statements
included in this press release represent our views as of May 4,
2017. We anticipate that subsequent events and developments will
cause our views to change. However, while we may elect to update
these forward-looking statements at some point in the future, we
specifically disclaim any obligation to do so.
Tetraphase Pharmaceuticals, Inc. |
Condensed Consolidated Statement of Operations
(Unaudited) |
(In thousands, except per share
data) |
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
Revenues |
$ |
1,485 |
|
|
$ |
1,962 |
|
|
|
Operating expenses |
|
|
|
|
|
Research
and development |
|
25,947 |
|
|
|
13,523 |
|
|
|
General
and administrative |
|
5,133 |
|
|
|
5,253 |
|
|
|
Total
operating expenses |
|
31,080 |
|
|
|
18,776 |
|
|
|
Loss from
operations |
|
(29,595 |
) |
|
|
(16,814 |
) |
|
|
Other income
(expense) |
|
|
|
|
|
Other
income (expense), net |
|
137 |
|
|
|
73 |
|
|
|
Net loss |
$ |
(29,458 |
) |
|
$ |
(16,741 |
) |
|
|
Net loss per
share-basic and diluted |
$ |
(0.79 |
) |
|
$ |
(0.46 |
) |
|
|
Weighted-average number
of common shares used in net loss per share |
|
|
|
|
|
applicable to common |
|
|
|
|
|
stockholders-basic and diluted |
|
37,093 |
|
|
|
36,598 |
|
|
|
Tetraphase Pharmaceuticals, Inc. |
Condensed Consolidated Balance Sheets
(unaudited) |
(In thousands) |
|
|
March 31, |
|
December 31, |
|
|
2017 |
|
|
2016 |
Assets |
|
|
|
Cash and
cash equivalents |
$ |
128,159 |
|
$ |
142,086 |
Accounts
receivable |
|
1,703 |
|
|
1,789 |
Prepaid
expenses and other current assets |
|
3,829 |
|
|
6,582 |
Property
and equipment, net |
|
1,467 |
|
|
1,054 |
Other
assets, noncurrent |
|
199 |
|
|
199 |
Total
assets |
$ |
135,357 |
|
$ |
151,710 |
|
|
|
|
Liabilities and
Stockholders' equity |
|
|
|
Accounts
payable and accrued expenses |
$ |
15,366 |
|
$ |
10,240 |
Total
deferred revenue |
|
851 |
|
|
1,255 |
Other
liabilities, noncurrent |
|
148 |
|
|
162 |
Total
stockholders' equity |
|
118,992 |
|
|
140,053 |
Total liabilities and
stockholders' equity |
$ |
135,357 |
|
$ |
151,710 |
Investor Contacts:
Tetraphase Pharmaceuticals
Teri Dahlman
617-600-7040
tdahlman@tphase.com
Argot Partners
Maeve Conneighton
206.899.4940
maeve@argotpartners.com
Media Contact:
Sam Brown Inc.
Mike Beyer
312-961-2502
Mikebeyer@sambrown.com
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