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Tetraphase Pharmaceuticals Reports First-Quarter 2014 Financial Results

Companies mentioned in this article: Tetraphase Pharmaceuticals, Inc.

WATERTOWN, Mass. -- (BUSINESS WIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical-stage biopharmaceutical company developing a portfolio of potent new antibiotics designed to be effective against multidrug-resistant (MDR) bacteria, today reported financial results for the quarter ended March 31, 2014. The Company's lead antibiotic candidate, eravacycline, is currently in Phase 3 development to treat MDR infections, including those caused by many of the MDR Gram-negative bacteria highlighted as urgent public health threats by the Centers for Disease Control and Prevention (CDC).

“During the first quarter, we made significant progress in advancing eravacycline through the final stages of clinical development,” said Guy Macdonald, Tetraphase President and Chief Executive Officer. “We now have both planned Phase 3 trials underway, each evaluating eravacycline for the treatment of a different indication – complicated intra-abdominal infections (IGNITE 1) and complicated urinary tract infections (IGNITE 2). Our focus is on execution of these trials and we anticipate three important eravacycline data milestones: the first, in mid-2014, top-line results from the lead-in portion of IGNITE 2, which will be the first data on the IV-to-oral step-down of eravacycline; the second, top-line results from the IGNITE 1 trial in the first quarter of 2015; and the third, top-line results from the pivotal portion of IGNITE 2 in mid-2015. We also increased our investment in the eravacycline program to support the achievement of these milestones and our goal of filing for regulatory approval of eravacycline in the U.S. by the end of 2015.”

First-Quarter 2014 Financial Results

For the first quarter of 2014, Tetraphase reported a net loss of $13.5 million, or $0.53 per share, compared to a net loss of $2.8 million, or $1.51 per share, for the same period in 2013.

Revenues for the first quarter of 2014 were $2.5 million compared to $2.7 million for the same period in 2013. Revenues for each period consisted of contract and grant revenue under three U.S. government awards for the development of Tetraphase compounds as potential countermeasures for the treatment of diseases caused by bacterial biothreat pathogens. These funds are received through subcontracts and a subaward from CUBRC Inc., an independent, not-for-profit research corporation that specializes in U.S. government-based contracts. These U.S. government awards consist of an award from the Biomedical Advanced Research and Development Authority (BARDA) for eravacycline development and two awards from the National Institute of Allergy and Infectious Diseases (NIAID) for the development of the Company’s preclinical compound TP-271.

Research and development (R&D) expenses for the first quarter of 2014 were $12.5 million, compared to $4.1 million for the same period in 2013. The increase in R&D expense during the first quarter of 2014 compared to the same period in the prior year was primarily due to an increase in expenses related to increased clinical activities and drug manufacturing associated with the Company’s two ongoing Phase 3 clinical trials for eravacycline.

General and administrative (G&A) expenses for the first quarter of 2014 were $3.2 million, compared to $1.2 million for the same period in 2013. The increase in G&A expense during the first quarter of 2014 compared to the same period in the prior year was primarily due to an increase in various general costs as a result of operating as a public company, as well as an increase in personnel-related costs to support clinical and pre-commercialization efforts on eravacycline, which included additional hiring and an increase in stock-based compensation.

As of March 31, 2014, Tetraphase had cash and cash equivalents of $89.0 million and 25.8 million shares outstanding.

First-Quarter and Recent Corporate Highlights

  • Surpassed the 50% enrollment mark in IGNITE 1, the ongoing Phase 3 clinical trial studying the safety and efficacy of intravenous (IV) eravacycline for the treatment of complicated intra-abdominal infections; top-line data from this study are expected in the first quarter of 2015.
  • Progressed enrollment in IGNITE 2, a Phase 3 clinical trial studying the safety and efficacy of oral and IV formulations of eravacycline for the treatment of complicated urinary tract infections; top-line data from the lead-in portion of this trial are expected in mid-2014.
  • Eravacycline granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in its IV and oral formulations and for both indications being pursued; Fast Track status is a process designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.
  • Strengthened the senior management team with the hiring of Craig Thompson as Chief Operating Officer.
  • Appointed Nancy J. Wysenski to the Company's Board of Directors, bringing broad experience in the commercial launch and marketing of pharmaceutical products.

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 multidrug-resistant (MDR) bacterial infections, including those caused by many of the MDR Gram-negative bacteria highlighted as urgent public health threats by the Centers for Disease Control and Prevention (CDC). Tetraphase's lead product candidate, eravacycline, is being developed as a broad-spectrum intravenous and oral antibiotic in the IGNITE program (Investigating Gram-negative Infections Treated with Eravacycline). Under this program, two Phase 3 clinical trials are ongoing: IGNITE 1 for the indication of complicated intra-abdominal infections (cIAI) and IGNITE 2 for complicated urinary tract infections (cUTI). Tetraphase has created more than 3,000 novel tetracycline analogs using its technology platform; in addition to eravacycline, Tetraphase has generated multiple preclinical antibiotic candidates that are currently being evaluated for clinical suitability. Please visit www.tphase.com for more company information.

Forward-Looking Statements

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 our cash resources will be sufficient to fund our continuing operations through the end of 2015; whether results obtained in preclinical studies and early clinical trials will be indicative of results obtained in future clinical trials; whether eravacycline will advance through the clinical trial process on a timely basis and 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; and other factors discussed in the “Risk Factors” section of our most recent quarterly report on Form 10-Q, filed with the Securities and Exchange Commission on May 12, 2014. In addition, the forward-looking statements included in this press release represent our views as of May 12, 2014. 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
March 31,
2014 2013
 
Revenues $ 2,457   $ 2,700  
Operating expenses
Research and development 12,504 4,098
General and administrative   3,171     1,225  
Total operating expenses   15,675     5,323  
Loss from operations   (13,218 )   (2,623 )
Other income (expense)
Interest income 5
Interest expense (334 ) (431 )
Other income   24     263  
Other expense, net   (305 )   (168 )
Net loss $ (13,523 ) $ (2,791 )
Net loss per share applicable to common stockholders-basic and diluted $ (0.53 ) $ (1.51 )
Weighted-average number of common shares used in net loss per share
applicable to common stockholders-basic and diluted   25,734     1,848  
     
Tetraphase Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands)
 
March 31, December 31,

     2014     

2013
 
Assets
Cash and cash equivalents $ 89,011 $ 102,712
Accounts receivable 2,017 1,706
Prepaid expenses and other current assets 1,547 1,002
Property and equipment, net 238 235
Other assets, noncurrent   230     231  
Total assets $ 93,043   $ 105,886  
 
Liabilities and stockholders’ equity
Accounts payable and accrued expenses $ 8,008 $ 7,171
Total term loan 9,372 10,815
Total deferred revenue - 92
Stockholder's equity   75,663     87,808  
Total liabilities and stockholders’ equity $ 93,043   $ 105,886  


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Contact:

Investors:
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Jennifer LaVin, 617-715-3591
jlavin@tphase.com
or
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or
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