-Company to Hold Conference Call Today at 4:30 PM ET-
WATERTOWN, Mass.–(BUSINESS WIRE)–lt;a href="https://twitter.com/search?q=%24TTPH&src=ctag" target="_blank"gt;$TTPHlt;/agt; lt;a href="https://twitter.com/hashtag/antibioticresistance?src=hash" target="_blank"gt;#antibioticresistancelt;/agt;–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 Usage
The 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 Meeting
In 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 China
Everest 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 Meetings
XERAVA, 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 Information
Tetraphase 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 XERAVATM
XERAVA (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 Information
XERAVA
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 | ||||
Contacts
Jennifer Viera
jviera@tphase.com
617-600-7040