Tobira Therapeutics Inc. Reports Second Quarter 2015 Financial Results

SOUTH SAN FRANCISCO, Calif., Aug. 11, 2015 /PRNewswire/ -- Tobira Therapeutics, Inc. (NASDAQ: TBRA), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel treatments for nonalcoholic steatohepatitis (NASH) and other serious immuno-inflammatory and fibrotic diseases, today reported business highlights and financial results for the second quarter of 2015.

"We successfully completed the transition to a public company, backed by a group of highly regarded investors, providing us with the financial resources needed to continue advancing cenicriviroc (CVC) as a platform for multiple high unmet need indications in liver, immuno-inflammatory and fibrotic diseases," said Laurent Fischer, M.D., Tobira's chief executive officer.

"In the second quarter of 2015, we made significant progress toward building clinical evidence for CVC in patients with non-alcoholic steatohepatitis (NASH). This includes completing enrollment in the CENTAUR Phase 2b study of CVC. With enrollment now complete, CENTAUR represents the largest NASH study enrolled to date. Furthermore, CENTAUR exclusively enrolled patients with NASH and liver fibrosis and incorporates potentially approvable surrogate endpoints. As we move into the second half of this year, we remain focused on strengthening the profile of CVC in NASH, including presenting combination therapy data, as we work towards reporting the primary endpoint of CENTAUR in the third quarter of 2016."

Second Quarter 2015 and Recent Business Highlights

• On May 4, successfully completed a financing and merger with Regado Biosciences. Subsequently commenced trading on the NASDAQ Capital Market under the ticker symbol TBRA.
• Completed patient recruitment in the CENTAUR study. CENTAUR is a global, double blind, placebo controlled, Phase 2b clinical trial evaluating the treatment effects of CVC versus placebo in patients with NASH and liver fibrosis. Target enrollment for the study was 252 patients. Final enrollment totaled 289 patients, which will provide the broadest data set in NASH patients at risk of progressive liver disease.
• Expanded the profile of CVC with completion of a Phase 1 study evaluating the pharmacokinetics and safety of CVC and the diabetes medication, pioglitazone, both when administered alone and in combination. Tobira is planning on presenting the positive results from this study at a medical meeting later this year.

Second Quarter 2015 Financial Results

• Research and development expenses in the second quarter of 2015 were $6.6 million compared to $3.1 million in the second quarter of 2014. The increase was primarily associated with the costs of running the CENTAUR Phase 2b clinical study.
• General and administration expenses in the second quarter of 2015 were $3.1 million compared to $1.9 million in the second quarter of 2014. The increase was primarily attributable to costs associated with the merger and being a publicly traded company.
• Cash used in operations in the second quarter of 2015 was $9.8 million.
• Net loss for the second quarter of 2015 was $11.0 million, or $0.99 per share compared with a net loss of $7.9 million, or $19.62 per share for the same period in 2014.

2015 Six-Month Results

• Research and development expenses were $12.3 million in the first six months of 2015, compared to $4.8 million in the first six months of 2014.
• General and administration expenses were $5.3 million in the first six months of 2015, compared to $2.7 million in the first six months of 2014.
• Cash used in operations in the first six months of 2015 was $15.8 million.
• Net loss for the first six months of 2015 was $18.0 million, or $3.14 per share compared with a net loss of $10.7 million, or $26.63 per share for the same period in 2014.

Cash, Cash Equivalents & Marketable Securities
As of June 30, 2015 Tobira had cash, cash equivalents, and investments in securities totaling $63.7 million. Tobira believes its existing cash and cash equivalents will fund the company into the second half of 2017.

Conference Call Information
The company will host a conference call today to review Tobira's business highlights and financial results for the second quarter of 2015 beginning at 1:30 p.m. Pacific Time /4:30 p.m. Eastern Time. Analysts and investors can participate in the conference call by dialing +1 (855) 638-8858 for domestic callers and +1 (707) 294-1299 for international callers, using the conference ID# 91340309. The webcast can be accessed live on the Investor Relations page of Tobira's website, http://ir.tobiratherapeutics.com, and will be available for replay for 30 days following the call.

About Cenicriviroc and Nonalcoholic Steatohepatitis
CVC is an oral, once-daily, potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are intricately involved in the inflammatory and fibrogenic pathways in NASH that cause liver damage and often lead to cirrhosis, liver cancer or liver failure. This mechanism differs from metabolic targets related to the pathogenesis of NASH. Tobira believes this novel approach will establish CVC as both a single-agent and as a cornerstone treatment in multi-therapy regimens for NASH, for which there is currently no approved drug.

CVC is currently being evaluated in Tobira's Phase 2b CENTAUR study (identifier NCT02217475) and the company expects to announce top line data from the study's primary endpoint in the third quarter of 2016. CENTAUR is comparing CVC to placebo in 289 patients with NASH and liver fibrosis, and includes endpoints identified as suitable for registrational studies in the findings of an FDA-AASLD workshop recently reported in Hepatology¹.

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