Tetraphase Pharmaceuticals Reports Third Quarter 2017 Financial Results and Highlights Recent Clinical and Corporate Achievem...
November 02 2017 - 8:00AM
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 third quarter ended September
30, 2017 and provided an overview of recent achievements.
“During the third quarter, Tetraphase achieved
several key milestones that continue to set the stage for the
potential approval and commercialization of intravenous (IV)
eravacycline in 2018,” said Guy Macdonald, President and Chief
Executive Officer of Tetraphase. “We submitted a Marketing
Authorization Application (MAA) for IV eravacycline in complicated
intra-abdominal infections (cIAI) to the European Medicines Agency
(EMA) which is now under review, and we successfully completed our
phase 3 IGNITE4 clinical trial, which, together with IGNITE1, will
form the basis of our New Drug Application (NDA) to the FDA in the
first quarter of 2018.”
Mr. Macdonald continued, “For IV eravacycline in
complicated urinary tract infections (cUTI), we completed
enrollment in the phase 3 IGNITE3 trial, and expect top-line data
to be available in the first quarter of 2018. Assuming a positive
IGNITE3 outcome and upon approval of IV eravacycline in cIAI, we
plan to file a supplemental NDA (sNDA) for cUTI.”
“Lastly, we recently announced an update on our
oral eravacycline development program, including positive phase 1
results in healthy volunteers, and look forward to moving our
optimized IV-to-oral regimen into a phase 2 clinical trial in cUTI
patients in the first half of 2018,” Mr. Macdonald added. “With a
strengthened balance sheet following a successful public offering
in the third quarter, we will be able to execute on these important
objectives for the eravacycline program and through our anticipated
commercial launch."
Key 2018 Milestones
- Submit NDA for IV eravacycline for the treatment of cIAI
(1Q)
- Report top-line phase 3 IGNITE3 data for IV eravacycline in
cUTI (1Q)
- Initiate phase 2 clinical trial in cUTI patients for IV-to-oral
eravacycline (1H)
- Complete phase 1 multiple-ascending dose studies for TP-271 and
TP-6076 (1H)
- Potential approval of IV eravacycline for cIAI in US and Europe
(2H)
- Submit sNDA for IV eravacycline in cUTI (2H)
Third Quarter and Recent Highlights
- Announced positive top-line results from IGNITE4, the Company's
phase 3 clinical trial evaluating the efficacy and safety of
twice-daily IV eravacycline compared to meropenem for the treatment
of patients with complicated intra-abdominal infections. The
results of IGNITE4, which enrolled 500 patients, demonstrated
statistical non-inferiority of eravacycline to meropenem for the
primary efficacy endpoint of clinical response at the test-of-cure
(TOC) visit.
- Announced that the MAA for IV eravacycline for the treatment of
complicated intra-abdominal infections was submitted to and
subsequently validated by the EMA. The MAA filing is
based on data from the phase 3 IGNITE1 clinical trial in which
eravacycline was well tolerated and demonstrated statistical
non-inferiority to ertapenem using the primary endpoint of clinical
response at the TOC visit.
- Announced completion of enrollment in IGNITE3, the Company’s
ongoing phase 3 clinical trial evaluating the efficacy and safety
of once-daily IV eravacycline compared to ertapenem in cUTI.
The Company expects to report top-line data from this trial in the
first quarter of 2018.
- Presented data at IDWeek 2017 from the first study of the
Company’s recently completed phase 1 program designed to evaluate
drug exposure of oral eravacycline in an IV-to-oral dosing regimen.
These results, along with data from subsequent trials in this phase
1 program, have allowed for the identification of an optimized
IV-to-oral dosing regimen using the current oral eravacycline
formulation which the company plans to advance into a phase 2
clinical trial in patients with complicated urinary tract
infections. This study is anticipated to begin in the first half of
2018.
- Successfully completed a public offering of shares of common
stock with gross proceeds totaling approximately $65.7
million.
- Appointed Kamalam (Kam) Unninayar as Chief Financial
Officer. Kam is an experienced financial executive with a
track record of over two decades of financial leadership in the
life sciences and consumer goods industries. Most recently, Kam
spent over 11 years overseeing finance organizations at Thermo
Fisher Scientific, a global leader in serving science.
Third Quarter 2017 Financial ResultsAs of
September 30, 2017, Tetraphase had cash and cash equivalents of
$161.4 million and 51.2 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 at least early 2019.
Revenues during the third quarter of 2017 were $4.1 million
compared to $0.9 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 increase was
primarily due to the scope and timing of activities related to our
government contracts conducted during the third quarter of
2017.
Research and development (R&D) expenses for the third
quarter of 2017 were $28.8 million compared to $17.2 million for
the same period in 2016. The increase in R&D expenses was
primarily due to conduct of our IGNITE3 phase 3 clinical trial.
General and administrative (G&A) expenses for the third
quarter of 2017 were $5.6 million compared to $4.9 million for the
same period in 2016. This increase was primarily due to an
increase in legal and headcount related costs.
For the third quarter of 2017, Tetraphase reported a net loss of
$30.0 million, or $0.63 per share, compared to a net loss of $21.1
million, or $0.58 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-Q, filed with the Securities and Exchange Commission on
November 1, 2017. In addition, the forward-looking statements
included in this press release represent our views as of November
2, 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 Statements of
Operations (Unaudited) |
(In thousands, except per share
data) |
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
Revenues |
$ |
4,067 |
|
|
$ |
850 |
|
|
$ |
7,138 |
|
|
$ |
4,055 |
|
Operating expenses |
|
|
|
|
|
|
|
Research
and development |
|
28,777 |
|
|
|
17,190 |
|
|
|
83,237 |
|
|
|
44,459 |
|
General
and administrative |
|
5,600 |
|
|
|
4,858 |
|
|
|
15,797 |
|
|
|
14,870 |
|
Total
operating expenses |
|
34,377 |
|
|
|
22,048 |
|
|
|
99,034 |
|
|
|
59,329 |
|
Loss from
operations |
|
(30,310 |
) |
|
|
(21,198 |
) |
|
|
(91,896 |
) |
|
|
(55,274 |
) |
Other income
(expense) |
|
|
|
|
|
|
|
Other
income (expense), net |
|
302 |
|
|
|
88 |
|
|
|
620 |
|
|
|
255 |
|
Net loss |
$ |
(30,008 |
) |
|
$ |
(21,110 |
) |
|
$ |
(91,276 |
) |
|
$ |
(55,019 |
) |
Net loss per
share-basic and diluted |
$ |
(0.63 |
) |
|
$ |
(0.58 |
) |
|
$ |
(2.23 |
) |
|
$ |
(1.50 |
) |
Weighted-average number
of common shares used in net loss per share |
|
|
|
|
|
|
|
applicable to common stockholders-basic and diluted |
|
47,347 |
|
|
|
36,692 |
|
|
|
40,942 |
|
|
|
36,640 |
|
|
|
|
|
|
|
|
Tetraphase Pharmaceuticals, Inc. |
Condensed Consolidated Balance
Sheets
(unaudited) |
(In thousands) |
|
|
September 30, |
|
December 31, |
|
2017 |
|
2016 |
Assets |
|
|
|
Cash and
cash equivalents |
$ |
161,365 |
|
$ |
142,086 |
Accounts
receivable |
|
3,565 |
|
|
1,789 |
Prepaid
expenses and other current assets |
|
5,493 |
|
|
6,582 |
Property
and equipment, net |
|
1,424 |
|
|
1,054 |
Other
assets, noncurrent |
|
199 |
|
|
199 |
Total
assets |
$ |
172,046 |
|
$ |
151,710 |
|
|
|
|
Liabilities and Stockholders'
equity |
|
|
|
Accounts
payable and accrued expenses |
$ |
21,781 |
|
$ |
10,240 |
Total
deferred revenue |
|
782 |
|
|
1,255 |
Other
liabilities, noncurrent |
|
119 |
|
|
162 |
Total
stockholders' equity |
|
149,364 |
|
|
140,053 |
Total liabilities and
stockholders' equity |
$ |
172,046 |
|
$ |
151,710 |
|
|
|
|
Investor Contacts:Tetraphase
PharmaceuticalsTeri Dahlman617-600-7040tdahlman@tphase.com
Argot PartnersMaeve
Conneighton206.899.4940maeve@argotpartners.com
Media Contact:Sam Brown Inc.Mike
Beyer312-961-2502Mikebeyer@sambrown.com
Tetraphase Pharmaceuticals (NASDAQ:TTPH)
Historical Stock Chart
From Aug 2024 to Sep 2024
Tetraphase Pharmaceuticals (NASDAQ:TTPH)
Historical Stock Chart
From Sep 2023 to Sep 2024