Conference Call Today at
“We capped off 2018 with a strong finish, with the regulatory approvals
of XERAVA™ (eravacycline) for the treatment of complicated
intra-abdominal infections (cIAI) in both the U.S. and
Mr. Macdonald continued, “With respect to our pipeline, we expect to
complete our bronchopulmonary disposition study for TP-6076, targeted
against Acinetobacter baumannii and other multidrug-resistant
pathogens, later this year and look forward to presenting preclinical
data on our new acute myeloid leukemia (AML) pipeline candidate,
TP-2846, at the
Key Milestones for 2019
- Complete 400 formulary reviews for XERAVA by mid-year
- Present preclinical data on TP-2846 at the AACR Annual Meeting – 2Q 2019
Everest Medicines to begin Phase 3 clinical trial of eravacycline in
China– 2Q 2019
- Complete bronchopulmonary disposition study for TP-6076 – 2H 2019
Fourth Quarter and Recent Highlights
- Commercially Launched XERAVA for cIAI in the U.S.
The Company commercially launched XERAVA in the U.S. in
mid-October 2018. XERAVA is now available for use in hospitals and healthcare institutions for the treatment of a range of patients with empiric and confirmed cIAI. The salesforce is focusing on institutions responsible for treating 90 percent of patients with Gram-negative infections. Currently, three antimicrobial susceptibility tests (ASTs) have been approved for commercial use including the Eravacycline Mast Disk by Hardy Diagnostics; the Eravacycline MIC Strip by Liofilchem, Inc.; and the Sensititre Plate by Thermo Fisher Scientific, Inc.Previously, more than 200 healthcare institutions ordered ASTs for research-use-only purposes.
- Received Marketing Authorization from the
European Commission(EC) for XERAVA in the European Union(EU)
In September, the EC adopted the
July 2018positive opinion issued by the Committee for Medicinal Products for Human Useof the European Medicines Agency(EMA) to grant marketing authorization for XERAVA for the treatment of cIAI in adults in all EU member states as well as Iceland, Liechtensteinand Norway.
- Entered into Loan and Security Agreement with
Solar Capital Limited
November 2018, the Company entered into a loan agreement with Solar Capital Limited, providing up to $75 million, with $30 millionfunded at closing, which is being used to support the commercial launch of XERAVA and for general corporate purposes.
- Announced New Preclinical Data on TP-2846 for AML to be Presented
at the 2019 AACR Annual Meeting
February 2019, Tetraphase announced it will present three posters on TP-2846, the Company’s newly revealed pipeline candidate for AML, at the 2019 AACR Annual Meeting taking place March 29– April 3at the Georgia World CongressCenter in Atlanta. The poster presentations will include in vitro and in vivo data supporting TP-2846’s potential as a novel tetracycline antileukemia agent.
- Approval of Everest Medicines’ Investigational New Drug (IND)
Application for Eravacycline in cIAI by the
China National Medical Products Administration(NMPA)
June 2018, Everest Medicines, a C-Bridge Capital-backed biopharmaceutical company, which has the exclusive license to develop and commercialize eravacycline in China, Taiwan, Hong Kong, Macau, South Koreaand Singapore, submitted an IND application to the China NMPA, formerly the China FDA. The IND was approved by China NMPA, and Everest expects to begin enrolling patients in its Phase 3 study of eravacycline in cIAI in the second quarter of 2019.
- Presented XERAVA and TP-6076 Data at the
Infectious Disease Societyof America’s (IDSA) 2018 IDWeek
October 2018, the Company presented data related to XERAVA and TP-6076 at IDSA’s IDWeek. Among the data presented were results from a post-hoc analysis of XERAVA Phase 3 data, which showed high clinical cure and microbiological eradication rates with XERAVA among patients with cIAI and concurrent bacteremia. Data from a Phase 1 randomized, placebo-controlled, double-blind, multiple-ascending-dose study demonstrating positive safety, tolerability and pharmacokinetic results for the Company’s novel, fully synthetic tetracycline, TP-6076, were also presented.
- Presented XERAVA Data at the
American College of Clinical Pharmacy(ACCP) 2018 Global Conference
At the ACCP 2018
Global Conferencein October, the Company announced positive data from a post-hoc analysis of two Phase 3 trials of XERAVA in cIAI in higher-risk populations – obese patients and those with altered renal function. Similar clinical cure rates were observed for XERAVA in these populations across all classifications of renal function, further supporting that the drug is an effective empiric treatment for cIAI and may provide an alternative to antibiotics that require dosing modification in patients with altered renal function. XERAVA was also effective regardless of body mass index when dosed 1mg/kg IV every 12 hours, based on total body weight when compared to carbapenems.
Fourth Quarter and Full-Year 2018 Financial Results
For the fourth quarter of 2018, Tetraphase reported a net loss of
XERAVA product revenue for the fourth quarter and year ended
Total revenues were
Research and development (R&D) expenses for the fourth quarter of 2018
Selling, general and administrative (SG&A) expenses for the fourth
quarter of 2018 were
Conference Call and Webcast Information
Tetraphase will host a conference call today at
A replay of the conference call will be available from
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
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.
Please see full prescribing information for XERAVA.
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 our commercial launch of XERAVA in
the U.S. will be successful; our cash resources and the expected revenue
will be sufficient to fund our operations for the period anticipated;
our product candidates will succeed in clinical trials and even if the
clinical trials are successful, we may never achieve regulatory approval
of such product candidates and other clinical, regulatory and commercial
risk factors discussed in the "Risk Factors" section of our quarterly
report on Form 10-Q for the period ended
Tetraphase Pharmaceuticals, Inc.
|Condensed Consolidated Statement of Operations (Unaudited)|
|(In thousands, except per share data)|
|Three Months Ended||
|December 31,||December 31,|
|Product revenue, net||$||178||$||-||$||178||$||-|
|License and collaboration revenue||3,177||-||12,677||-|
|Cost of revenue - product||130||-||130||-|
|Cost of revenue - intangible asset amortization||98||-||98||-|
|Research and development||10,717||18,468||54,879||101,706|
|Selling, general and administrative||14,727||7,878||37,078||23,675|
|Loss from operations||(21,389)||(23,818)||(73,281)||(115,715)|
|Other income and expenses|
|Net loss per share-basic and diluted||$||(0.40)||$||(0.46)||$||(1.37)||$||(2.63)|
|Weighted-average common shares used in net loss per share-basic and diluted||53,652||51,415||52,514||43,582|
|Tetraphase Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets (Unaudited)|
|December 31,||December 31,|
|Cash and cash equivalents||$||107,776||$||136,411|
|Accounts receivable, net||2,274||4,653|
|Prepaid expenses and other current assets||2,674||6,382|
|Property and equipment, net||1,121||1,395|
|Intangibles assets, net||4,652||-|
|Other assets, noncurrent||699||199|
|Liabilities and Stockholders' equity|
|Accounts payable and accrued expenses||$||14,957||$||17,865|
|Other liabilities, noncurrent||8||105|
|Total stockholders' equity||79,682||130,410|
|Total liabilities and stockholders' equity||$||122,944||$||149,040|