Tetraphase Pharmaceuticals Reports Second Quarter 2016 Financial Results and Highlights Recent Progress
August 04 2016 - 4:52PM
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 second quarter ended June 30,
2016, and provided an overview of certain corporate achievements
and plans.
“During the second quarter, we finalized the protocol for
IGNITE4, our upcoming phase 3 clinical trial evaluating IV
eravacycline in patients with complicated intra-abdominal
infections (cIAI), and remain on track to initiate this trial early
in the fourth quarter of 2016,” said Guy Macdonald, Tetraphase's
President and Chief Executive Officer. “Based on discussions
with the FDA, we have designed IGNITE4 using a 12.5%
non-inferiority margin and a trial population of approximately 450
patients. We currently anticipate reporting top-line results from
IGNITE4 as early as the fourth quarter of 2017. In parallel,
we are also working to finalize the trial design for IGNITE3, our
phase 3 clinical trial evaluating once-daily IV eravacycline in
complicated urinary tract infections (cUTI), and we look forward to
providing details regarding the design and timing of IGNITE3 once
the protocol is completed.”
Dr. Patrick Horn, Tetraphase’s Chief Medical Officer, commented,
“Separately, we continue to advance development work on the oral
formulation of eravacycline. Early data from this phase 1
program indicate that the oral dosing regimen used in IGNITE2 leads
to lower systemic levels of eravacycline than expected. These
data also suggest that administration of oral eravacycline in a
fasted state results in increased drug exposure. With this
information now in hand, we have commenced further clinical testing
designed to evaluate several additional variables associated with
optimizing the oral eravacycline dosing regimen.”
“Along with the advancement of our clinical programs, we
continue to build the profile of eravacycline by testing it against
multidrug-resistant bacterial strains in vitro and, at ASM Microbe
and ECCMID we presented data showing eravacycline’s potent activity
against these difficult-to-treat pathogens, including
carbapenem-resistant enterobacteriaceae and Acinetobacter
baumannii,” added Dr. Horn. “We also recently confirmed that in in
vitro studies eravacycline retained its potent activity against
colistin-resistant clinical isolates expressing the mcr-1 gene,
which was just found in bacteria in the U.S. for the first time,
and we look forward to presenting these data at an upcoming medical
meeting.”
Second Quarter 2016 Financial Results
As of June 30, 2016, Tetraphase had cash and cash equivalents of
$178.3 million and 36.7 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 middle of 2018.
Revenues during the second quarter of 2016 were $1.2 million
compared to $3.3 million for the same period in 2015.
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. The decrease in
revenues was primarily due to the scope and timing of activities
related to our BARDA Contract conducted during the quarter ended
June 30, 2016.
Research and development (R&D) expenses for the second
quarter of 2016 were $13.7 million compared to $22.9 million for
the same period in 2015. The decrease in R&D expenses was
primarily due to lower costs related to our Phase 3 clinical
program for eravacycline.
General and administrative (G&A) expenses for the second
quarter of 2016 were $4.8 million compared to $6.5 million for the
same period in 2015. The decrease in G&A expenses was primarily
due to a decrease in stock-based compensation expense, as well as a
decrease in pre-commercialization activities for eravacycline.
For the second quarter of 2016, Tetraphase reported a net loss
of $17.2 million, or $0.47 per share, compared to a net loss of
$26.0 million, or $0.72 per share, for the same period in 2015.
Second Quarter and Recent Corporate
Highlights
- Presented data at the 26th European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID), including
preclinical data for eravacycline and TP-6076.
- Received guidance from the U.S. FDA confirming that one
additional positive phase 3 clinical trial will be required to
support a New Drug Application (NDA) submission for IV
eravacycline. Based on the FDA's guidance, Tetraphase plans
to conduct two additional pivotal phase 3 clinical trials: one in
cIAI (IGNITE4) to support the NDA filing and one in cUTI (IGNITE3)
that will form the basis of a supplemental NDA for IV
eravacycline.
- Finalized the clinical trial design for IGNITE4 to support an
NDA filing for IV eravacycline for cIAI. IGNITE4, the
Company’s planned phase 3 clinical trial evaluating the efficacy
and safety of twice-daily IV eravacycline compared to meropenem in
patients with cIAI, is expected to enroll approximately 450
patients and the primary analysis will be conducted using a 12.5%
non-inferiority margin. Tetraphase expects to initiate this
clinical trial early in the fourth quarter of 2016, with top-line
results expected as early as the fourth quarter of 2017.
- Presented data at the American Society of Microbiology (ASM)
Microbe 2016 Conference, including clinical and preclinical data
for eravacycline and preclinical data for TP-271, a novel,
broad-spectrum antibiotic candidate which is being developed to
combat respiratory disease caused by bacterial biothreats and
antibiotic-resistant public health pathogens, as well as bacterial
pathogens associated with community-acquired bacterial
pneumonia.
- Commenced patient dosing in a phase 1 clinical trial for
TP-6076, the lead candidate from the Company’s second-generation
antibiotic program which has demonstrated potent preclinical
activity against multidrug-resistant Gram-negative pathogens.
- Continued clinical testing designed to advance the development
of an oral dose formulation of eravacycline. During the
second quarter, Tetraphase completed preliminary clinical testing
which indicates that the overall efficacy results in IGNITE2 were
likely driven by underperformance of the oral formulation due to a
food effect. Preliminary clinical testing also suggests that
administration of oral eravacycline in a fasted state results in
increased drug exposure. Further clinical testing is now
underway to evaluate several additional variables associated with
increasing drug exposure and optimizing the oral eravacycline
dosing regimen.
- Added to the Russell Microcap® Index when the Russell
Investment Group reconstituted its family of U.S. indexes in late
June 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
preclinical studies and early or interim 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-Q, filed with the Securities and
Exchange Commission on August 4, 2016. In addition, the
forward-looking statements included in this press release represent
our views as of August 4, 2016. 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 Statements of
Operations (Unaudited) |
(In thousands, except per share
data) |
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
1,243 |
|
|
$ |
3,343 |
|
|
$ |
3,205 |
|
|
$ |
6,359 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
|
13,746 |
|
|
|
22,907 |
|
|
|
27,269 |
|
|
|
41,780 |
|
General and administrative |
|
|
4,759 |
|
|
|
6,489 |
|
|
|
10,012 |
|
|
|
11,393 |
|
Total operating expenses |
|
|
18,505 |
|
|
|
29,396 |
|
|
|
37,281 |
|
|
|
53,173 |
|
Loss from operations |
|
|
(17,262 |
) |
|
|
(26,053 |
) |
|
|
(34,076 |
) |
|
|
(46,814 |
) |
Other income
(expense) |
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
94 |
|
|
|
10 |
|
|
|
167 |
|
|
|
(216 |
) |
Net loss |
|
$ |
(17,168 |
) |
|
$ |
(26,043 |
) |
|
$ |
(33,909 |
) |
|
$ |
(47,030 |
) |
Net loss per
share-basic and diluted |
|
$ |
(0.47 |
) |
|
$ |
(0.72 |
) |
|
$ |
(0.93 |
) |
|
$ |
(1.38 |
) |
Weighted-average number
of common shares used in net loss per share applicable to common
stockholders-basic and diluted |
|
|
36,629 |
|
|
|
36,207 |
|
|
|
36,614 |
|
|
|
33,991 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tetraphase Pharmaceuticals, Inc. |
Condensed Consolidated Balance Sheets
(Unaudited) |
(In thousands) |
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
Assets |
|
|
|
Cash and cash equivalents |
$ |
178,311 |
|
|
$ |
205,912 |
|
Accounts receivable |
|
2,981 |
|
|
|
4,151 |
|
Prepaid expenses and other current
assets |
|
5,257 |
|
|
|
3,705 |
|
Property and equipment, net |
|
982 |
|
|
|
943 |
|
Other assets, noncurrent |
|
199 |
|
|
|
206 |
|
Total assets |
$ |
187,730 |
|
|
$ |
214,917 |
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
Accounts payable and accrued
expenses |
$ |
9,288 |
|
|
$ |
9,953 |
|
Deferred revenue |
|
1,195 |
|
|
|
909 |
|
Stockholders' equity |
|
177,247 |
|
|
|
204,055 |
|
Total liabilities and stockholders’
equity |
$ |
187,730 |
|
|
$ |
214,917 |
|
|
|
|
|
|
|
|
|
Investor Contacts:
Tetraphase Pharmaceuticals
Teri Dahlman
617-600-7040
tdahlman@tphase.com
Argot Partners
Maeve Conneighton
212-600-1902
maeve@argotpartners.com
Media Contact:
Sam Brown Inc.
Mike Beyer
312-961-2502
Mikebeyer@sambrown.com
Tetraphase Pharmaceuticals (NASDAQ:TTPH)
Historical Stock Chart
From Mar 2024 to Apr 2024
Tetraphase Pharmaceuticals (NASDAQ:TTPH)
Historical Stock Chart
From Apr 2023 to Apr 2024