SAN DIEGO, May 7, 2013 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq:TSRX), a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for serious infections, announced today its financial results for the first quarter ended March 31, 2013.
"After successfully completing and reporting positive top-line results for our ESTABLISH 2 study, we are preparing to file our New Drug Application (NDA) for tedizolid later this year and, if approved, to potentially launch in the U.S. in the second half of 2014," said John Schmid, Chief Financial Officer at Trius.
At March 31, 2013, Trius had cash, cash equivalents and investments totaling $83.6 million. As of May 1, 2013, Trius had 47,872,124 shares outstanding.
For the first quarter of 2013, Trius reported a net loss of $17.3 million versus a net loss of $7.6 million in the comparable period in 2012. The increase in the net loss in the first quarter of 2013 was primarily due to lower collaboration revenues from our partnership with Bayer Pharma AG (Bayer) as well as from our federal contracts. In addition, we recognized a $2.0 million non-cash expense during the three months ended March 31, 2013 related to the valuation of our common stock warrant liability versus the non-cash benefit recognized during the comparable period in 2012. As a result, Trius reported a net loss per share of $0.38 for the first quarter of 2013 versus $0.22 in the first quarter of 2012.
Revenues for the three months ended March 31, 2013 were $1.7 million compared to $9.8 million for the same period in 2012. In the first quarter of 2012, the Company earned a $5.0 million milestone payment from Bayer, but received no similar payments in the current year. Federal contract revenues also decreased from the prior year due to reduced funding for our biodefense pathogen research programs.
Research and development expenses for the three months ended March 31, 2013 were $12.5 million compared to $16.8 million for the same period in 2012. The decrease in research and development expenses was primarily related to lower clinical trial and development costs for tedizolid phosphate.
General and administrative expenses for the three months ended March 31, 2013 increased to $4.5 million compared to $3.0 million for the same period in 2012. The increase in general and administrative expenses was primarily due to an increase in commercial activities for tedizolid phosphate in connection with launch planning.
Program Updates & Upcoming Events
In March 2013, Trius announced positive top-line data for its ESTABLISH 2 study, the second Phase 3 trial in acute bacterial skin and skin structure infection, or ABSSSI. Tedizolid achieved all primary and secondary efficacy outcomes after a short course of therapy using one-tenth the amount of total drug versus the comparator linezolid (Zyvox®). Patients receiving tedizolid also showed numerical improvements in key safety and tolerability measurements in the complete study population. We plan to file a New Drug Application (NDA) for tedizolid phosphate in the second half of 2013.
In January 2013, Trius completed a public offering of 7,169,135 shares of Trius common stock and raised net proceeds of $31.6 million.
Pending final agreement with regulatory authorities, Trius plans to initiate a Phase 3 program for the treatment of pneumonia in the second half of 2013 using the same 200 mg, once daily dose of tedizolid phosphate that is currently being tested to treat skin infections. In addition, the Company is progressing with enabling studies for an Investigational New Drug (IND) application for its Gyrase-B development candidate with potent activity against Gram-negative and Gram-positive bacterial pathogens. A Phase 1 clinical trial is expected to start in 2014.
About Trius Therapeutics
Trius Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for serious infections. The Company's lead investigational drug, tedizolid phosphate, is a new, novel antibiotic for the treatment of ABSSSI and serious Gram-positive infections, including those caused by methicillin-resistant staphylococcus aureus (MRSA). Trius has completed two Phase 3 ABSSSI trials for which it has Special Protocol Assessments with the FDA and has partnered with Bayer Pharma for the development and commercialization of tedizolid phosphate outside of the U.S., Canada and the European Union. In addition to the Company's tedizolid phosphate clinical program, Trius has initiated IND-enabling studies for its Gyrase-B development candidate with potent activity against Gram-negative bacterial pathogens including multi-drug resistant strains of E. coli, Klebsiella, Acinetobacter and Pseudomonas. For more information, visit www.triusrx.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trius' ability to successfully complete its ongoing clinical trials and development programs, the timing of Trius' NDA filing and commercial launch of tedizolid for the treatment of ABSSSI, the timing of the initiation of a Phase 3 program for tedizolid for the treatment of pneumonia and the timing of the initiation of a Phase 1 clinical trial for Trius' Gyrase-B development candidate. Risks that contribute to the uncertain nature of the forward-looking statements include: the accuracy of Trius' estimates regarding expenses, future revenues and capital requirements; the success and timing of Trius' preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; changes in Trius' plans to develop and commercialize its product candidates; Trius' ability to obtain additional financing; Trius' ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Trius' most recently filed SEC documents, including its Form 10-K, Forms 10-Q and other documents filed with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trius undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
| Trius Therapeutics, Inc. | ||
| Statements of Operations | ||
| (In thousands except per share data) | ||
|
Three Months Ended March 31, |
||
| 2013 | 2012 | |
| (Unaudited) | ||
| Revenues: | ||
| Collaboration and license fees | $ 1,198 | $ 6,821 |
| Contract research | 529 | 3,011 |
| Total revenues | 1,727 | 9,832 |
| Operating expenses: | ||
| Research and development | 12,545 | 16,846 |
| General and administrative | 4,504 | 3,004 |
| Total operating expenses | 17,049 | 19,850 |
| Loss from operations | (15,322) | (10,018 ) |
| Other income (expense): | ||
| Interest income | 11 | — |
| Fair value adjustment of stock warrant liability | (1,969) | 2,417 |
| Other income (expense) | — | (3) |
| Total other income (expense) | (1,958) | 2,414 |
| Net loss | $ (17,280) | $ (7,604 ) |
| Net loss per share, basic and diluted | $ (0.38) | $ (0.22 ) |
| Weighted-average shares outstanding, basic and diluted | 46,021 | 35,195 |
| Trius Therapeutics, Inc. | ||
| Balance Sheets | ||
| (In thousands except share and per share data) | ||
|
March 31, 2013 |
December 31, 2012 |
|
| (Unaudited) | ||
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $ 20,086 | $ 16,370 |
| Short-term investments, available-for-sale | 63,562 | 49,659 |
| Accounts receivable | 2,337 | 5,698 |
| Prepaid expenses and other current assets | 2,698 | 2,254 |
| Total current assets | 88,683 | 73,981 |
| Property and equipment, net | 820 | 990 |
| Restricted cash | 151 | 151 |
| Other assets | 164 | 152 |
| Total assets | $ 89,818 | $ 75,274 |
| Liabilities and stockholders' equity | ||
| Current liabilities: | ||
| Accounts payable | $ 5,046 | $ 6,761 |
| Accrued liabilities | 6,514 | 7,762 |
| Common stock warrant liability | 5,817 | 3,848 |
| Current portion of deferred revenue | 171 | 116 |
| Total liabilities | 17,548 | 18,487 |
| Stockholders' equity: | ||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized at March 31, 2013 and December 31, 2012; no shares issued and outstanding at March 31, 2013 and December 31, 2012 | — | — |
| Common stock, $0.0001 par value; 200,000,000 shares authorized at March 31, 2013 and December 31, 2012; 47,868,166 and 40,661,360 shares issued and outstanding at March 31, 2013 and December 31, 2012, respectively | 5 | 5 |
| Additional paid-in capital | 238,858 | 206,093 |
| Accumulated other comprehensive income | 7 | 9 |
| Accumulated deficit | (166,600) | (149,320) |
| Total stockholders' equity | 72,270 | 56,787 |
| Total liabilities and stockholders' equity | $ 89,818 | $ 75,274 |