Tetraphase Pharmaceuticals Reports Second Quarter 2017 Financial Results and Highlights Recent Achievements
August 02 2017 - 4:15PM
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,
2017 and provided an overview of recent achievements.
“Following the recently reported positive phase 3 data from the
IGNITE4 clinical trial, we now have two successfully completed
phase 3 clinical trials evaluating IV eravacycline in complicated
intra-abdominal infections (cIAI). We remain focused on the
execution of many significant upcoming milestones for the company,
including a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) this quarter and a New Drug
Application (NDA) submission to the U.S. Food and Drug
Administration (FDA) in the first quarter of 2018 for IV
eravacycline in cIAI,” said Guy Macdonald, President and Chief
Executive Officer of Tetraphase. “We are pleased to see enrollment
progressing well in the phase 3 IGNITE3 study in complicated
urinary tract infections (cUTI), and we look forward to completing
enrollment in that study early in the fourth quarter of 2017. If
successful, the IGNITE3 data will support a future supplemental NDA
filing for once-daily IV eravacycline in cUTI.”
“In late July, we strengthened the balance sheet through a
public offering of common stock, the gross proceeds of which are
$65 million and which will allow us to prepare for the commercial
launch of eravacycline. Finally, our phase 1 clinical programs
continue to advance. We plan to provide an update to our oral
eravacycline development program later this quarter, and we
anticipate completion of multiple-ascending dose studies for TP-271
and TP-6076 this year,” Mr. Macdonald concluded.
Second 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 intravenous (IV) eravacycline compared to meropenem for
the treatment of patients with complicated intra-abdominal
infections (cIAI). 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.
- Presented data at ASM Microbe 2017 including additional
supportive data generated for eravacycline demonstrating consistent
potency against drug-resistant bacteria in ongoing global
surveillance studies and positive data from phase 1
single-ascending dose studies for its two pipeline programs,
TP-6076 and TP-271.
- Successfully completed a public offering of 10,000,000 shares
of common stock with gross proceeds totaling $65 million.
Second Quarter 2017 Financial ResultsAs of June
30, 2017, Tetraphase had cash and cash equivalents of $118.2
million and 40.0 million shares outstanding. The company
expects that its cash and cash equivalents, proceeds from the July
public offering, as well as expected revenue from its U.S.
government awards, will be sufficient to fund operations into early
2019.
Revenues during the second quarter of 2017 were $1.6 million
compared to $1.2 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.
Research and development (R&D) expenses for the second
quarter of 2017 were $28.5 million compared to $13.7 million for
the same period in 2016. The increase in R&D expenses was
primarily due to conduct of our IGNITE3 and IGNITE4 phase 3
clinical trials.
General and administrative (G&A) expenses for the second
quarter of 2017 were $5.1 million compared to $4.8 million for the
same period in 2016.
For the second quarter of 2017, Tetraphase reported a net loss
of $31.8 million, or $0.83 per share, compared to a net loss of
$17.2 million, or $0.47 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
August 2, 2017. In addition, the forward-looking statements
included in this press release represent our views as of August 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 |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
Revenues |
$ |
1,586 |
|
|
$ |
1,243 |
|
|
$ |
3,071 |
|
|
$ |
3,205 |
|
Operating expenses |
|
|
|
|
|
|
|
Research
and development |
|
28,513 |
|
|
|
13,746 |
|
|
|
54,460 |
|
|
|
27,269 |
|
General
and administrative |
|
5,065 |
|
|
|
4,759 |
|
|
|
10,198 |
|
|
|
10,012 |
|
Total
operating expenses |
|
33,578 |
|
|
|
18,505 |
|
|
|
64,658 |
|
|
|
37,281 |
|
Loss from
operations |
|
(31,992 |
) |
|
|
(17,262 |
) |
|
|
(61,587 |
) |
|
|
(34,076 |
) |
Other income
(expense) |
|
|
|
|
|
|
|
Other
income (expense), net |
|
181 |
|
|
|
94 |
|
|
|
318 |
|
|
|
167 |
|
Net loss |
$ |
(31,811 |
) |
|
$ |
(17,168 |
) |
|
$ |
(61,269 |
) |
|
$ |
(33,909 |
) |
Net loss per
share-basic and diluted |
$ |
(0.83 |
) |
|
$ |
(0.47 |
) |
|
$ |
(1.63 |
) |
|
$ |
(0.93 |
) |
Weighted-average number
of common shares used in net loss per share |
|
|
|
|
|
|
|
applicable to common stockholders-basic and diluted |
|
38,273 |
|
|
|
36,629 |
|
|
|
37,686 |
|
|
|
36,614 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tetraphase Pharmaceuticals, Inc. |
Condensed Consolidated Balance
Sheets
(unaudited) |
(In thousands) |
|
|
June 30, |
|
December 31, |
|
2017 |
|
2016 |
Assets |
|
|
|
Cash and
cash equivalents |
$ |
118,214 |
|
$ |
142,086 |
Accounts
receivable |
|
2,682 |
|
|
1,789 |
Prepaid
expenses and other current assets |
|
5,117 |
|
|
6,582 |
Property
and equipment, net |
|
1,529 |
|
|
1,054 |
Other
assets, noncurrent |
|
199 |
|
|
199 |
Total
assets |
$ |
127,741 |
|
$ |
151,710 |
|
|
|
|
Liabilities and Stockholders'
equity |
|
|
|
Accounts
payable and accrued expenses |
$ |
19,042 |
|
$ |
10,240 |
Total
deferred revenue |
|
1,548 |
|
|
1,255 |
Other
liabilities, noncurrent |
|
134 |
|
|
162 |
Total
stockholders' equity |
|
107,017 |
|
|
140,053 |
Total liabilities and
stockholders' equity |
$ |
127,741 |
|
$ |
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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