-Company to Hold Conference Call Today at 4:30
PM ET-
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a
biopharmaceutical company focused on developing and commercializing
novel tetracyclines to treat serious and life-threatening
conditions including multidrug-resistant (MDR) infections, today
reported financial results for the first quarter ended March 31,
2019, provided an overview of recent achievements, and highlighted
key milestones for 2019.
“During the first quarter, interest in XERAVATM (eravacycline)
grew significantly among physicians in U.S. hospitals and
healthcare institutions,” said Guy Macdonald, President and Chief
Executive Officer of Tetraphase. “We are continuing to see hospital
sales driving XERAVA’s growth because of its broad spectrum of
coverage against Gram-positive and Gram-negative bacteria, as well
as anaerobes, making it particularly useful for first-line empiric
treatment of complicated intra-abdominal infections (cIAI). We are
especially pleased that XERAVA has been added to more than 200
formularies at top-prescribing hospitals, including some large
integrated delivery networks, and we are on track to complete 400
formulary reviews by mid-year.”
Mr. Macdonald continued, “Beyond XERAVA, we presented data on
TP-2846, our new candidate for treatment of acute myeloid leukemia
(AML), at the American Association for Cancer Research (AACR)
Annual Meeting last month. We are encouraged by TP-2846’s novel
mechanism of action, which we believe has the potential to treat
AML regardless of mutation status. We look forward to providing a
future update once toxicology studies are complete. Additionally,
we are awaiting the results of our bronchopulmonary disposition
study for TP-6076, targeted against Acinetobacter baumannii and
other MDR pathogens, which we expect to be completed in the second
half of this year.”
Key Milestones for 2019
- Complete 400 formulary reviews for
XERAVA by mid-year
- Complete bronchopulmonary disposition
study for TP-6076 – 2H 2019
- Announce next steps for TP-2846 and
TP-271 – 2H 2019
First Quarter and Recent Highlights
- Continued to Progress Launch of
XERAVA in U.S. Hospitals With High Antibiotic UsageThe
salesforce continues to focus on Tier 1 institutions, which are the
highest users of antibiotics defined by days of therapy and is now
also focusing their efforts on Tier 2 institutions. Together these
constitute approximately 90 percent of the Gram-negative market.
Beyond engaging with 100 percent of the Tier 1 institutions by the
end of 2018, the salesforce completed outreach to 100 percent of
Tier 2 institutions by the end of the first quarter of 2019. The
reorder rate for XERAVA was greater than 55 percent as of the end
of the first quarter and 400 formulary reviews are planned to be
complete by mid-year 2019.
- Presented New Preclinical Data on
TP-2846 for AML at the 2019 AACR Annual MeetingIn April,
Tetraphase presented three posters on TP-2846, the Company’s new
pipeline candidate for AML, at the 2019 AACR Annual Meeting. The
poster presentations included in vitro and in vivo data supporting
TP-2846’s potential as a novel tetracycline antileukemia agent with
a new mechanism of action. Data showed antiproliferative activity
against AML cell lines in vitro and in vivo in xenograft models,
and against bone marrow samples from AML patients in ex vivo
assays, including cell lines resistant to anthracyclines,
cytarabine and venetoclax.
- First Patient Dosed in Phase 3
Clinical Trial of Eravacycline for cIAI in ChinaEverest
Medicines Limited, which has the exclusive license to develop and
commercialize eravacycline in China, dosed the first patient in its
Phase 3 clinical trial of eravacycline for cIAI in China. The Phase
3, randomized, multicenter, double-blind, double-dummy,
parallel-group, controlled study is designed to evaluate the
efficacy, safety and tolerability of eravacycline versus ertapenem
for the treatment of cIAI in hospitalized adult patients.
- Presented XERAVA, TP-271 and TP-6076
Data at the 29th European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID)In April,
Tetraphase presented data at the 29th ECCMID including clinical
isolates from samples collected from European hospitals in 2017 and
in vitro activity of XERAVA and comparators against Gram-negative
and Gram-positive bacteria. In addition, the safety, tolerability
and pharmacokinetic results from the multiple-ascending dose study
of TP-271 were highlighted, as well as in vivo efficacy of TP-6076
in murine thigh and lung infection models challenged with
Acinetobacter baumannii.
- Sixteen Abstracts Selected for
Poster Presentations at Upcoming Medical MeetingsXERAVA, TP-271
and TP-6076 will be highlighted at upcoming meetings including the
22nd Annual Making a Difference in Infectious Diseases (MAD-ID)
Meeting; the 2019 Surgical Infection Society (SIS) Congress; and
American Society for Microbiology (ASM) Microbe 2019. Specifically,
five abstracts have been accepted for poster presentations at the
22nd MAD-ID Meeting including data on the efficacy of XERAVA in
high-risk cIAI subgroups, as well as on the efficacy of XERAVA
against Enterobacteriaceae and Acinetobacter baumannii, including
MDR isolates. Four posters will be presented at the SIS Congress
including surveillance data and factors that impact duration of
antibiotic therapy with XERAVA. Finally, at ASM Microbe 2019, seven
posters will be presented. This includes five posters on XERAVA,
one of which highlights the activity of cefiderocol,
ceftazidime-avibactam, and XERAVA against carbapenem-resistant E.
coli isolates from the U.S. Two additional posters on the
pharmacokinetics and efficacy of TP-6076 in animal models also will
be highlighted.
First Quarter 2019 Financial Results
As of March 31, 2019, Tetraphase had cash and cash equivalents
of $87.6 million and 53.7 million shares outstanding. The Company
expects that its cash and cash equivalents, as well as expected
revenue, will be sufficient to fund operations into the third
quarter of 2020.
For the first quarter of 2019, Tetraphase reported a net loss of
$19.5 million, or $0.36 per share, compared to a net loss of $21.6
million, or $0.42 per share, for the same period in 2018.
Total revenues were $1.3 million for the first quarter of
2019, compared to $1.9 million for the same period in
2018. Total revenues for the first quarter of 2019 consisted of
XERAVA product revenue of $341,000 as well government contract
revenue of $932,000. The decrease in total revenues for the first
quarter of 2019 compared to the same prior-year period was
primarily due to a decrease in government revenue offset in part by
XERAVA revenue.
Research and development (R&D) expenses for the first
quarter of 2019 were $6.7 million, compared to $18.1 million for
the same period in 2018. The decrease in R&D expenses for the
first quarter of 2019 compared to the same prior-year period was
primarily due to lower clinical trial costs associated with the
IGNITE Phase 3 clinical trial program, which concluded in the first
quarter of 2018, and lower license and milestone payments to
Harvard University, that occurred in the first quarter of 2018.
Selling, general and administrative (SG&A) expenses for the
first quarter of 2019 were $13.3 million, compared to $5.7 million
for the same period in 2018. This increase in SG&A expenses for
the first quarter of 2019 compared to the same prior-year period
was primarily due to an increase in commercial-related expenses for
XERAVA.
Conference Call and Webcast InformationTetraphase will
host a conference call today at 4:30 p.m. ET to discuss its
financial results and provide an update on the Company. The call
can be accessed by dialing 844-831-4023 (U.S. and Canada) or
731-256-5215 (international) and entering conference ID number
2794213. To access the live audio webcast, visit the “Investors —
Events & Presentations” section of the Tetraphase website at
www.tphase.com.
A replay of the conference call will be available from 7:30 p.m.
ET on Wednesday, May 8, 2019, through 7:30 p.m. ET on Wednesday,
May 15, 2019 by dialing 855-859-2056 (U.S. and Canada) and
404-537-3406 for (international) callers. The conference ID number
is 2794213. A replay of the webcast will be available by visiting
Tetraphase’s website.
About XERAVATMXERAVA (eravacycline for injection)
is a tetracycline class antibacterial indicated for the treatment
of complicated intra-abdominal infections (cIAI) in patients 18
years of age and older. It is approved for use in the U.S. and
Europe. XERAVA was investigated for the treatment of complicated
intra-abdominal infections (cIAI) as part of the Company’s IGNITE
(Investigating Gram-Negative Infections
Treated with Eravacycline) Phase 3 program. In the
first pivotal Phase 3 trial in patients with cIAI, twice-daily
intravenous (IV) XERAVA met the primary endpoint by demonstrating
statistical non-inferiority of clinical response compared to
ertapenem and was well-tolerated. In the second Phase 3 clinical
trial in patients with cIAI, twice-daily IV XERAVA met the primary
endpoint by demonstrating statistical non-inferiority of clinical
response compared to meropenem and was well-tolerated. In both
trials, XERAVA achieved high cure rates in patients with
Gram-negative pathogens, including resistant isolates.
XERAVATM Important Safety InformationXERAVA
is a tetracycline class antibacterial indicated for the treatment
of complicated intra-abdominal infections in patients 18 years of
age and older.
XERAVA is not indicated for the treatment of complicated urinary
tract infections.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of XERAVA and other antibacterial drugs,
XERAVA should be used only to treat or prevent infections that are
proven or strongly suspected to be caused by susceptible
bacteria.
XERAVA is contraindicated for use in patients with known
hypersensitivity to eravacycline, tetracycline-class antibacterial
drugs or to any of the excipients. Life-threatening
hypersensitivity (anaphylactic) reactions have been reported with
XERAVA.
The use of XERAVA during tooth development (last half of
pregnancy, infancy and childhood to the age of eight years) may
cause permanent discoloration of the teeth (yellow-gray-brown) and
enamel hypoplasia.
The use of XERAVA during the second and third trimester of
pregnancy, infancy and childhood up to the age of eight years may
cause reversible inhibition of bone growth.
Clostridium difficile associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents and may range
in severity from mild diarrhea to fatal colitis.
The most common adverse reactions observed in clinical trials
(incidence ≥ 3%) were infusion site reactions, nausea, and
vomiting.
XERAVA is structurally similar to tetracycline-class
antibacterial drugs and may have similar adverse reactions. Adverse
reactions including photosensitivity, pseudotumor cerebri, and
anti-anabolic action which has led to increased blood urea
nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and
abnormal liver function tests, have been reported for other
tetracycline-class antibacterial drugs, and may occur with XERAVA.
Discontinue XERAVA if any of these adverse reactions are
suspected.
To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase
Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full prescribing information for XERAVA.
About Tetraphase Pharmaceuticals, Inc.
Tetraphase Pharmaceuticals, Inc., is a biopharmaceutical company
using its proprietary chemistry technology to create novel
tetracyclines for serious and life-threatening conditions,
including bacterial infections caused by many of the
multidrug-resistant bacteria highlighted as urgent public health
threats by the World Health Organization and the Centers for
Disease Control and Prevention. The Company has created more than
3,000 novel tetracycline compounds using its proprietary technology
platform. Tetraphase's lead product XERAVATM is approved for the
treatment of complicated intra-abdominal infections by the U.S.
Food and Drug Administration and the European Medicines Agency. The
Company’s pipeline also includes TP-271 and TP-6076, which are in
Phase 1 clinical trials, and TP-2846, which is in preclinical
testing for acute myeloid leukemia. Please visit www.tphase.com for
more company information.
Forward-Looking Statements
Any statements in this press release about our future
expectations, plans and prospects, including statements regarding
our strategy, future operations, prospects, plans and objectives,
including our key milestones for 2019 and our anticipated cash
runway, 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 preclinical data is indicative of expected clinical data;
our cash resources and the expected revenue will be sufficient to
fund our operations in the future; our product candidates will
succeed in clinical trials; even if such clinical trials are
successful, whether we may ever achieve regulatory approval of such
product candidates; and other clinical, regulatory and commercial
risk factors discussed in the "Risk Factors" section of our annual
report on Form 10-K for the period ended December 31, 2018, filed
with the Securities and Exchange Commission on March 15, 2019. In
addition, the forward-looking statements included in this press
release represent our views as of May 8, 2019. 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, 2019 2018
Revenue: Product revenue, net $ 341 $ - Government revenue
932 1,891 Total revenues 1,273 1,891 Expenses: Cost
of revenue – product 164 - Cost of revenue – intangible asset
amortization 98 - Research and development 6,737 18,127 Selling,
general and administrative 13,314 5,705 Total
expenses 20,313 23,832 Loss from operations
(19,040) (21,941) Other income and expenses Interest income
507 365 Interest expense (955) - Net loss $ (19,488)
$ (21,576) Net loss per share-basic and diluted $ (0.36) $ (0.42)
Weighted-average common shares used in net loss per share-basic and
diluted 53,740 51,601
Tetraphase
Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets
(Unaudited) (In thousands) March
31, December 31, 2019 2018
Assets Cash and cash equivalents $ 87,559 $ 107,776 Accounts
receivable, net 1,818 2,274 Contract asset 3,000 3,000 Inventory
2,348 748 Prepaid expenses and other current assets 2,411 2,674
Property and equipment, net 1,116 1,121 Operating lease
right-of-use assets 5,896 - Intangibles assets, net 4,553 4,652
Other assets, noncurrent 699 699 Total assets $
109,400 $ 122,944
Liabilities and Stockholders'
equity Accounts payable and accrued expenses $ 11,949 $
14,971
Operating lease liabilities 6,019 - Loan payable 28,514 28,291
Total stockholders' equity 62,918 79,682 Total
liabilities and stockholders' equity $ 109,400 $ 122,944
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version on businesswire.com: https://www.businesswire.com/news/home/20190508005687/en/
Jennifer Vierajviera@tphase.com617-600-7040
Tetraphase Pharmaceuticals (NASDAQ:TTPH)
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