Tetraphase Pharmaceuticals Reports Fourth Quarter and Full-Year 2016 Financial Results and Highlights Key 2017 Milestones
March 08 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 fourth quarter and year-ended
December 31, 2016, highlighted key milestones for 2017 and provided
an overview of recent achievements.
“2016 marked a year of important progress for Tetraphase as we
advanced our phase 3 global development program for IV eravacycline
with initiation of IGNITE4 in complicated intra-abdominal
infections (cIAI), in which enrollment is proceeding well, and the
recent commencement of IGNITE3 in complicated urinary tract
infections (cUTI),” said Guy Macdonald, President and Chief
Executive Officer of Tetraphase. “We have laid the groundwork
for an event-driven 2017 and look forward to several important IV
eravacycline milestones, including the submission of a Marketing
Authorization Application (MAA) to the European Medicines Agency
(EMA) for the treatment of cIAI during the second half of the year
and top-line data from IGNITE4 during the fourth quarter, which
would support a subsequent NDA filing.”
Mr. Macdonald continued, “Beyond IV eravacycline, we are also
focused on completing the phase 1 clinical development of oral
eravacycline and expect to provide an update during the third
quarter of 2017, including next steps toward our goal of delivering
the first and only IV-to-oral antibiotic transition therapy for the
treatment of MDR gram-negative infections.”
Key Milestones for 2017
- Submit MAA for IV eravacycline to EMA for the treatment of cIAI
– 2H 2017
- Report top-line data from phase 3 IGNITE4 trial evaluating IV
eravacycline in cIAI – 4Q 2017
- Provide oral eravacycline development program update – 3Q
2017
- Report phase 1 single-ascending dose data for TP-271 –
mid-2017
- Report phase 1 single-ascending dose data for TP-6076 –
mid-2017
- Initiate phase 1 multiple-ascending dose trials for IV TP-271
and IV TP-6076 – 2017
Fourth Quarter and Recent Highlights
- Initiated 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 fourth 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 New Drug Application (sNDA) submission for IV
eravacycline in cUTI.
- Published results from IGNITE1 in the Journal of the American
Medical Association (JAMA) Surgery. In the phase 3 IGNITE1
trial, eravacycline was well tolerated and demonstrated statistical
non-inferiority to ertapenem in patients with cIAI.
- Presented data at IDWeek 2016, including in vitro data for
eravacycline demonstrating consistent and potent activity against
drug-resistant bacteria, including carbapenem-resistant
Enterobacteriaceae (CRE), Acinetobacter baumannii,
vancomycin-resistant enterococci (VRE) and methicillin-resistant
Staphylococcus aureus (MRSA), isolated from recent patients.
- Published data in Antimicrobial Agents and Chemotherapy (AAC)
demonstrating that eravacycline retained potency against E. coli
clinical isolates containing a plasmid expressing mcr-1 (ERV
MIC90=0.5 µg/mL; colistin MIC90=16 µg/mL).
- Continued clinical testing designed to advance the development
of an oral dose formulation of eravacycline. Additional
clinical testing is ongoing to evaluate variables associated with
increasing drug exposure and optimizing the oral eravacycline
dosing regimen.
- Continued to advance pipeline candidates, TP-271 and TP-6076,
with the completion of phase 1 single-ascending dose studies for
the IV formulations of both compounds.
- Received Qualified Infectious Disease Product and Fast Track
designation from the FDA for the oral formulation of TP-271 and
initiated a single-ascending dose phase 1 study of oral
TP-271.
- Promoted Larry Edwards to Chief Commercial Officer in January
2017. Larry joined Tetraphase as Vice President, Marketing in
2015 and this promotion recognizes Larry’s contributions in
providing strong leadership and direction in the commercial and
business development functions. Larry has exceptional
commercialization experience for early and late-stage hospital
infectious disease products. Prior to Tetraphase, he served
as Senior Director of Marketing, Gram Negative Franchise for
Cubist Pharmaceuticals from April 2014 through the Merck
acquisition, and previously at Merck & Company in infectious
disease global marketing leadership roles from 2007 to 2014 and
various sales positions of increasing responsibility from 1999 to
2007. Larry has a Masters of Business Administration from St.
Joseph's University and a Bachelors of Science in Business &
Healthcare Administration from Ohio University.
Fourth-Quarter and Full-Year 2016 Financial
Results
As of December 31, 2016, Tetraphase had cash and cash
equivalents of $142.1 million and 36.9 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 the
second half of 2018.
For the fourth quarter of 2016, Tetraphase reported a net loss
of $22.5 million, or $0.61 per share, compared to a net loss of
$18.1 million, or $0.50 per share, for the same period in 2015.
Revenues were $1.1 million compared to $2.5 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
fourth quarter of 2016. Research and development (R&D) expenses
for the fourth quarter of 2016 were $19.3 million compared to $15.0
million for the same period in 2015. The increase in R&D
expenses was primarily due to higher clinical trial costs for
eravacycline driven by the start-up activities of our IGNITE3 and
IGNITE4 clinical trials, and an increase in manufacturing activity.
General and administrative (G&A) expenses for the fourth
quarter of 2016 were $4.3 million compared to $5.6 million for the
same period in 2015. The decrease in G&A expenses was primarily
due to lower headcount-related costs.
For the year ended December 31, 2016, Tetraphase reported a net
loss of $77.5 million, or $2.11 per share, compared to a net loss
of $83.2 million, or $2.36 per share, for the same period in 2015.
Revenues were $5.1 million for the year ended December 31, 2016
compared to $11.7 million for the same period in 2015. As stated
above, 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 2016.
R&D expenses were $63.8 million for the year ended December 31,
2016 compared to $73.8 million for the same period in 2015. The
decrease in R&D expenses was primarily due to a net decrease in
development spending on the eravacycline program. G&A
expenses were $19.2 million for the year ended December 31, 2016
compared to $20.9 million for the same period in 2015. The decrease
in G&A expenses was primarily due to lower spending related to
pre-commercialization activities for eravacycline.
Conference Call InformationTetraphase will host
a conference call today at 4:30 pm Eastern Time. The call can be
accessed by dialing (844) 831-4023 (U.S. and Canada) or (731)
256-5215 (international) and entering passcode: 82825167. To access
the live audio webcast, or the subsequent archived recording, visit
the "Investor Relations — Events & Presentations" section of
the Tetraphase website at www.tphase.com. The webcast will be
recorded and available for replay on the Tetraphase website for 30
days following the call.
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 3, 2016. In addition, the forward-looking statements
included in this press release represent our views as of March 8,
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.
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Tetraphase Pharmaceuticals, Inc. |
Condensed Consolidated Statement of Operations
(Unaudited) |
(In thousands, except per share
data) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Year Ended |
|
|
December 31, |
|
December 31, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
1,090 |
|
|
$ |
2,471 |
|
|
$ |
5,145 |
|
|
$ |
11,686 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
19,305 |
|
|
|
15,016 |
|
|
|
63,764 |
|
|
|
73,768 |
|
General
and administrative |
|
|
4,341 |
|
|
|
5,587 |
|
|
|
19,211 |
|
|
|
20,916 |
|
Total
operating expenses |
|
|
23,646 |
|
|
|
20,603 |
|
|
|
82,975 |
|
|
|
94,684 |
|
Loss from
operations |
|
|
(22,556 |
) |
|
|
(18,132 |
) |
|
|
(77,830 |
) |
|
|
(82,998 |
) |
Other income
(expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense), net |
|
|
95 |
|
|
|
16 |
|
|
|
350 |
|
|
|
(191 |
) |
Net loss |
|
$ |
(22,461 |
) |
|
$ |
(18,116 |
) |
|
$ |
(77,480 |
) |
|
$ |
(83,189 |
) |
Net loss per
share-basic and diluted |
|
$ |
(0.61 |
) |
|
$ |
(0.50 |
) |
|
$ |
(2.11 |
) |
|
$ |
(2.36 |
) |
Weighted-average number
of common shares used in net loss per share applicable to common
stockholders-basic and diluted |
|
|
36,894 |
|
|
|
36,559 |
|
|
|
36,704 |
|
|
|
35,261 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Tetraphase Pharmaceuticals, Inc. |
Condensed Consolidated Balance Sheets
(unaudited) |
(In thousands) |
|
|
December 31, |
|
December 31, |
|
2016 |
|
2015 |
Assets |
|
|
|
Cash and
cash equivalents |
$ |
142,086 |
|
$ |
205,912 |
Accounts
receivable |
|
1,789 |
|
|
4,151 |
Prepaid
expenses and other current assets |
|
6,582 |
|
|
3,705 |
Property
and equipment, net |
|
1,054 |
|
|
943 |
Other
assets, noncurrent |
|
199 |
|
|
206 |
Total
assets |
$ |
151,710 |
|
$ |
214,917 |
|
|
|
|
Liabilities and Stockholders'
equity |
|
|
|
Accounts
payable and accrued expenses |
$ |
10,240 |
|
$ |
9,788 |
Total
deferred revenue |
|
1,255 |
|
|
909 |
Other
liabilities, noncurrent |
|
162 |
|
|
165 |
Total
stockholders' equity |
|
140,053 |
|
|
204,055 |
Total liabilities and
stockholders' equity |
$ |
151,710 |
|
$ |
214,917 |
|
|
|
|
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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