“During the third quarter, Tetraphase achieved several key milestones that continue to set the stage for the potential approval and commercialization of intravenous (IV) eravacycline in 2018,” said
Mr. Macdonald continued, “For IV eravacycline in complicated urinary tract infections (cUTI), we completed enrollment in the phase 3 IGNITE3 trial, and expect top-line data to be available in the first quarter of 2018. Assuming a positive IGNITE3 outcome and upon approval of IV eravacycline in cIAI, we plan to file a supplemental NDA (sNDA) for cUTI.”
“Lastly, we recently announced an update on our oral eravacycline development program, including positive phase 1 results in healthy volunteers, and look forward to moving our optimized IV-to-oral regimen into a phase 2 clinical trial in cUTI patients in the first half of 2018,” Mr. Macdonald added. “With a strengthened balance sheet following a successful public offering in the third quarter, we will be able to execute on these important objectives for the eravacycline program and through our anticipated commercial launch."
Key 2018 Milestones
- Submit NDA for IV eravacycline for the treatment of cIAI (1Q)
- Report top-line phase 3 IGNITE3 data for IV eravacycline in cUTI (1Q)
- Initiate phase 2 clinical trial in cUTI patients for IV-to-oral eravacycline (1H)
- Complete phase 1 multiple-ascending dose studies for TP-271 and TP-6076 (1H)
- Potential approval of IV eravacycline for cIAI in US and
- Submit sNDA for IV eravacycline in cUTI (2H)
Third Quarter and Recent Highlights
- Announced positive top-line results from IGNITE4, the Company's phase 3 clinical trial evaluating the efficacy and safety of twice-daily IV eravacycline compared to meropenem for the treatment of patients with complicated intra-abdominal infections. The results of IGNITE4, which enrolled 500 patients, demonstrated statistical non-inferiority of eravacycline to meropenem for the primary efficacy endpoint of clinical response at the test-of-cure (TOC) visit.
- Announced that the MAA for IV eravacycline for the treatment of complicated intra-abdominal infections was submitted to and subsequently validated by the EMA. The MAA filing is based on data from the phase 3 IGNITE1 clinical trial in which eravacycline was well tolerated and demonstrated statistical non-inferiority to ertapenem using the primary endpoint of clinical response at the TOC visit.
- Announced completion of enrollment in IGNITE3, the Company’s ongoing phase 3 clinical trial evaluating the efficacy and safety of once-daily IV eravacycline compared to ertapenem in cUTI. The Company expects to report top-line data from this trial in the first quarter of 2018.
- Presented data at IDWeek 2017 from the first study of the Company’s recently completed phase 1 program designed to evaluate drug exposure of oral eravacycline in an IV-to-oral dosing regimen. These results, along with data from subsequent trials in this phase 1 program, have allowed for the identification of an optimized IV-to-oral dosing regimen using the current oral eravacycline formulation which the company plans to advance into a phase 2 clinical trial in patients with complicated urinary tract infections. This study is anticipated to begin in the first half of 2018.
- Successfully completed a public offering of shares of common stock with gross proceeds totaling approximately
Kamalam (Kam)Unninayar as Chief Financial Officer. Kam is an experienced financial executive with a track record of over two decades of financial leadership in the life sciences and consumer goods industries. Most recently, Kam spent over 11 years overseeing finance organizations at Thermo Fisher Scientific, a global leader in serving science.
Third Quarter 2017 Financial Results
Revenues during the third quarter of 2017 were
Research and development (R&D) expenses for the third quarter of 2017 were
General and administrative (G&A) expenses for the third quarter of 2017 were
For the third quarter of 2017, Tetraphase reported a net loss of
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.
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 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
|Tetraphase Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations (Unaudited)|
|(In thousands, except per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||28,777||17,190||83,237||44,459|
|General and administrative||5,600||4,858||15,797||14,870|
|Total operating expenses||34,377||22,048||99,034||59,329|
|Loss from operations||(30,310||)||(21,198||)||(91,896||)||(55,274||)|
|Other income (expense)|
|Other income (expense), net||302||88||620||255|
|Net loss per share-basic and diluted||$||(0.63||)||$||(0.58||)||$||(2.23||)||$||(1.50||)|
|Weighted-average number of common shares used in net loss per share|
|applicable to common stockholders-basic and diluted||47,347||36,692||40,942||36,640|
|Tetraphase Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets (unaudited)|
|September 30,||December 31,|
|Cash and cash equivalents||$||161,365||$||142,086|
|Prepaid expenses and other current assets||5,493||6,582|
|Property and equipment, net||1,424||1,054|
|Other assets, noncurrent||199||199|
|Liabilities and Stockholders' equity|
|Accounts payable and accrued expenses||$||21,781||$||10,240|
|Total deferred revenue||782||1,255|
|Other liabilities, noncurrent||119||162|
|Total stockholders' equity||149,364||140,053|
|Total liabilities and stockholders' equity||$||172,046||$||151,710|
Source: Tetraphase Pharmaceuticals, Inc.