WATERTOWN, Mass., May 04, 2016 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today reported financial results for the first quarter ended March 31, 2016.
“We have remained in dialogue with the FDA this year regarding next steps for IV eravacycline, our lead antibiotic candidate for the treatment of patients with serious infections, particularly those caused by difficult-to-treat Gram-negative bacteria,” said Guy Macdonald, Tetraphase's President and Chief Executive Officer. “We expect to receive regulatory guidance from the FDA this quarter and look forward to providing an update once we have more clarity. We continue to plan for an additional phase 3 clinical trial for once-daily IV eravacycline in complicated urinary tract infections, and we recently commenced a phase 1 clinical trial as the first step to advance the oral development program for eravacycline.”
Mr. Macdonald continued, “For our other pipeline candidates, we have commenced patient dosing in a phase 1 clinical trial evaluating TP-271, a novel, broad-spectrum antibiotic candidate for the treatment of respiratory disease caused by bacterial biothreats. We are also working to advance TP-6076, our second-generation antibiotic candidate with potent activity against multidrug-resistant Gram-negative pathogens, into the clinic with a phase 1 clinical trial that is anticipated to start in the middle of this year.”
First Quarter 2016 Financial Results
As of March 31, 2016, Tetraphase had cash and cash equivalents of $189.9 million and 36.6 million shares outstanding. The company expects that its cash and cash equivalents, as well as expected revenue from its U.S. government awards, will be sufficient to fund operations into at least early 2018.
Revenues during the first quarter of 2016 were $2.0 million compared to $3.0 million for the same period in 2015. Revenues for each period consisted of contract and grant revenue under the Company’s U.S. government awards for the development of Tetraphase compounds for the treatment of diseases caused by bacterial biothreat pathogens and for certain infections caused by life-threatening multidrug-resistant bacteria. This decrease was primarily due to the scope and timing of activities related to our BARDA Contract conducted during the quarter ended March 31, 2016.
Research and development (R&D) expenses for the first quarter of 2016 were $13.5 million compared to $18.9 million for the same period in 2015. The decrease in R&D expenses was primarily due to lower costs related to our Phase 3 clinical program for eravacycline.
General and administrative (G&A) expenses for the first quarter of 2016 were $5.3 million compared to $4.9 million for the same period in 2015. The increase in G&A expenses was primarily due to an increase in stock-based compensation expense, as well as legal fees to support ongoing litigation.
For the first quarter of 2016, Tetraphase reported a net loss of $16.7 million, or $0.46 per share, compared to a net loss of $21.0 million, or $0.66 per share, for the same period in 2015.
First Quarter and Recent Corporate Highlights
- Continued discussions with the FDA regarding the next steps for the company's lead drug candidate, intravenous (IV) eravacycline. Tetraphase expects to receive regulatory guidance and provide an update during the second quarter of 2016.
- Presented data at the 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), including data for eravacycline and early-stage antibiotic candidate, TP-6076.
- Commenced patient dosing in a phase 1 clinical trial for IV TP-271, a novel, broad-spectrum antibiotic candidate which is being developed to combat respiratory disease caused by bacterial biothreats and antibiotic-resistant public health pathogens, as well as bacterial pathogens associated with community-acquired bacterial pneumonia. TP-271 is being developed with funding from the National Institutes of Health's National Institute of Allergy and Infectious Diseases.
- Initiated clinical testing designed to advance the oral development program for eravacycline.
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 MDR bacterial infections, including those caused by many of the MDR Gram-negative 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 its late-stage antibiotic candidate, eravacycline, as well as two additional antibiotic candidates, TP-271 and TP-6076. 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 preclinical studies and early or interim clinical trials will be indicative of results obtained in future clinical trials; whether eravacycline will advance through the clinical trial process; whether the results of the Company's development efforts will warrant regulatory submission and whether any such submissions will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if eravacycline obtains approval, it will be successfully distributed and marketed; whether our cash resources will be sufficient to fund our continuing operations for the period anticipated; and other factors discussed in the "Risk Factors" section of our quarterly report on Form 10-Q, filed with the Securities and Exchange Commission on May 4, 2016. In addition, the forward-looking statements included in this press release represent our views as of May 4, 2016. 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 Statements of Operations (Unaudited)|
|(In thousands, except per share data)|
|Three Months Ended|
|Research and development||13,523||18,873|
|General and administrative||5,253||4,903|
|Total operating expenses||18,776||23,776|
|Loss from operations||(16,814||)||(20,760||)|
|Other income (expense)|
|Other income (expense), net||73||(226||)|
|Net loss per share-basic and diluted||$||(0.46||)||$||(0.66||)|
|Weighted-average number of common shares used in net loss per share|
|applicable to common stockholders-basic and diluted||36,598||31,750|
|Tetraphase Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets (Unaudited)|
|March 31,||December 31,|
|Cash and cash equivalents||$||189,863||$||205,912|
|Prepaid expenses and other current assets||7,042||3,705|
|Property and equipment, net||948||943|
|Other assets, noncurrent||199||206|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||9,013||$||9,953|
|Total liabilities and stockholders’ equity||$||201,896||$||214,917|
Investor Contacts: Tetraphase Pharmaceuticals Teri Dahlman 617-600-7040 email@example.com Argot Partners Susan Kim 212-600-1902 firstname.lastname@example.org Media Contact: Sam Brown Inc. Mike Beyer 312-961-2502 Mikebeyer@sambrown.com