“During the first quarter, we revised our eravacycline strategy to focus primarily on the commercialization of the IV formulation of the drug in complicated intra-abdominal infections (cIAI), for which we have submitted a New Drug Application (NDA) to the
Mr. Macdonald continued: “Beyond our U.S. strategy for IV eravacycline in cIAI, we also have a Marketing Authorization Application (MAA) under review with the European Medicines Agency (EMA) and expect an approval decision in cIAI in
Key Milestones for 2018
Potential approval of eravacycline in cIAI in U.S. – Q3 2018
Potential approval of eravacycline in cIAI in
Potential commercial launch of eravacycline in cIAI in the U.S. – Q4 2018
Complete phase 1 multiple ascending dose studies for TP-271 and TP-6076 – 2H 2018
First Quarter and Recent Highlights
- Presented data at ECCMID 2018 including an oral presentation of IGNITE4, the Company’s phase 3 study to evaluate the efficacy and safety of eravacycline versus meropenem in cIAI. This is the first time IGNITE4 data have been presented and the submission was awarded a “Best Rated Abstract” from ECCMID. Additionally, poster presentations included data regarding the in vitro activity of eravacycline and comparators against Gram-negative isolates from a large-scale global surveillance study, as well as the activity of TP-6076 against carbapenem-resistant Acinetobacter baumannii isolates.
- Entered into an exclusive licensing agreement with
Everest Medicines Limited, a biopharmaceutical company based in China, to develop and commercialize eravacycline for the treatment of cIAI and other indications in mainland China, Taiwan, Hong Kong, Macau, South Koreaand Singapore.
- Notified of a Prescription User Fee Act (PDUFA) goal date of
August 28, 2018for the FDA’s completion of its review of the NDA for IV eravacycline for the treatment of cIAI. The NDA submission includes data from the IGNITE1 and IGNITE4 phase 3 clinical trials, in which twice-daily IV eravacycline was well tolerated and achieved high clinical cure rates in patients with cIAI. Both studies demonstrated statistical non-inferiority of eravacycline to widely used comparators – ertapenem in IGNITE1 and meropenem in IGNITE4 – for the primary efficacy endpoint of clinical response at the test-of-cure visit.
Larry Edwards, Chief Operating Officer. Mr. Edwards joined Tetraphase in July 2015as vice president, marketing, served as vice president, commercial operations from January 2016to December 2016and as senior vice president, chief commercial officer from December 2016to February 2017. He has over 20 years of experience in the infectious disease area. Mr. Edwards is responsible for all phases of the launch of eravacycline, pending regulatory approval.
Larry Tsai, M.D., Chief Medical Officer. Dr. Tsai joined Tetraphase in 2014 as senior medical director and became vice president, clinical development in 2015. He has nearly 20 years of experience in clinical practice and development. Dr. Tsai has provided significant expertise to the clinical team throughout the IGNITE phase 3 program for eravacycline, as well as in the early clinical development of the Company’s pipeline programs.
- Announced top-line results from IGNITE3, the Company's phase 3 clinical trial evaluating the efficacy and safety of once-daily IV eravacycline compared to ertapenem for the treatment of patients with complicated urinary tract infections (cUTI), in which eravacycline did not achieve statistical non-inferiority to ertapenem. Given the IGNITE3 results, the Company ceased development of IV and oral eravacycline for the treatment of cUTI.
First Quarter 2018 Financial Results
Revenues during the first quarter of 2018 were
Research and development (R&D) expenses for the first quarter of 2018 were
General and administrative (G&A) expenses for the first quarter of 2018 were $5.7 million compared to
For the first quarter of 2018, Tetraphase reported a net loss of
Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of cIAI and other serious infections, including those caused by MDR pathogens that have been highlighted as urgent public health threats by both the
Eravacycline was investigated for the treatment of cIAI as part of the Company's IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) phase 3 programs. In IGNITE1, a pivotal phase 3 trial in patients with cIAI, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem, was well tolerated, and achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. The IGNITE1 data is serving as the basis of the MAA for IV eravacycline for the treatment of patients with cIAI now under review by the EMA. In IGNITE4, a second phase 3 clinical trial in patients with cIAI, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem, was well tolerated, and achieved high cure rates. The Company has used the results from IGNITE1 and IGNITE4 to support NDA submission for IV eravacycline in cIAI. To date, eravacycline has been administered to over 2,700 patients. Eravacycline is an investigational product and has not been approved for commercial use.
Tetraphase is a 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 MDR bacteria highlighted as urgent public health threats by the CDC. The Company has created more than 3,000 novel tetracycline analogs using its proprietary technology platform. Tetraphase's pipeline includes three antibiotic clinical candidates: eravacycline, which has completed phase 3 clinical trials and is under review for potential approval in complicated intra-abdominal infections by the
Any 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 the Company's regulatory submission will receive approval from the
|Tetraphase Pharmaceuticals, Inc.|
|Condensed Consolidated Statement of Operations (Unaudited)|
|(In thousands, except per share data)|
|Three Months Ended|
|Research and development||18,127||25,947|
|General and administrative||5,705||5,133|
|Total operating expenses||23,832||31,080|
|Loss from operations||(21,941||)||(29,595||)|
|Other income (expense)|
|Other income (expense), net||365||137|
|Net loss per share-basic and diluted||$||(0.42||)||$||(0.79||)|
|Weighted-average number of common shares used in net loss per share|
|applicable to common|
|stockholders-basic and diluted||51,601||37,093|
|Tetraphase Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets (unaudited)|
|March 31,||December 31,|
|Cash and cash equivalents||$||117,665||$||136,411|
|Prepaid expenses and other current assets||6,931||6,382|
|Property and equipment, net||1,362||1,395|
|Other assets, noncurrent||199||199|
|Liabilities and Stockholders' equity|
|Accounts payable and accrued expenses||$||9,723||$||17,865|
|Total deferred revenue||7,479||660|
|Other liabilities, noncurrent||131||105|
|Total stockholders' equity||112,037||130,410|
|Total liabilities and stockholders' equity||$||129,370||$||149,040|
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Source: Tetraphase Pharmaceuticals, Inc.