Research and development (R&D) expenses for the third quarter of 2016 ($17.2 million) were similar to the same period in 2015 ($17.0 million), which is reflective of spending patterns related to our phase 3 clinical program for eravacycline.General and administrative (G&A) expenses for the third quarter of 2016 were $4.9 million compared to $3.9 million for the same period in 2015. This increase was primarily due to a higher stock-based compensation expense and an increase in legal fees, offset by a decrease in pre-commercialization activities. For the third quarter of 2016, Tetraphase reported a net loss of $21.1 million, or $0.58 per share, compared to a net loss of $18.0 million, or $0.49 per share, for the same period in 2015. The net loss for the three and nine months ended September 30, 2016 includes stock-based compensation expense of $3.3 million and $10.3 million, respectively. Third Quarter and Recent Corporate Highlights
- Presented data at IDWeek 2016, including in vitro data for eravacycline demonstrating consistent and potent in vitro activity against drug-resistant bacteria, including carbapenem-resistant Enterobacteriaceae (CRE) , Acinetobacter baumannii, vancomycin-resistant enterococci (VRE) and methicillin-resistant Staphylococcus aureus (MRSA) , isolated from recent patients.
- Initiated the phase 3 IGNITE4 clinical trial of IV eravacycline in cIAI. Assuming a successful outcome, this study, along with data from IGNITE1, will support an NDA filing for IV eravacycline for cIAI. IGNITE4, compared to meropenem in patients with cIAI, is expected to enroll approximately 450 patients and the primary analysis will be conducted using a 12.5% non-inferiority margin. Tetraphase expects to have top-line results in the fourth quarter of 2017.
- Initiated patient dosing in a single-ascending dose phase 1 clinical trial evaluating the safety and pharmacokinetics of TP-6076 in healthy volunteers. TP-6076 is being developed for the treatment of serious and life-threatening bacterial infections, including those caused by pathogens otherwise resistant to current treatment options.
- Continued clinical testing designed to advance the development of an oral dose formulation of eravacycline. Additional clinical testing is ongoing to evaluate variables associated with increasing drug exposure and optimizing the oral eravacycline dosing regimen.
|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||17,190||16,972||44,459||58,752|
|General and administrative||4,858||3,937||14,870||15,329|
|Total operating expenses||22,048||20,909||59,329||74,081|
|Loss from operations||(21,198||)||(18,053||)||(55,274||)||(64,866||)|
|Other income (expense)|
|Other income (expense), net||88||9||255||(207||)|
|Net loss per share-basic and diluted||$||(0.58||)||$||(0.49||)||$||(1.50||)||$||(1.87||)|
|Weighted-average number of common shares used in net loss per share applicable to common stockholders-basic and diluted||36,692||36,463||36,640||34,824|
|Tetraphase Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets (Unaudited)|
|September 30,||December 31,|
|Cash and cash equivalents||$||162,076||$||205,912|
|Prepaid expenses and other current assets||6,692||3,705|
|Property and equipment, net||932||943|
|Other assets, noncurrent||199||206|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||10,011||$||9,953|
|Total liabilities and stockholders' equity||$||170,644||$||214,917|
Investor Contacts:Tetraphase PharmaceuticalsTeri Dahlman617firstname.lastname@example.orgArgot PartnersMaeve Conneighton212email@example.comMedia Contact:Sam Brown Inc.Mike Beyer312-961-2502Mikebeyer@sambrown.com