BOULDER, Colo., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Nivalis Therapeutics, Inc. (NASDAQ:NVLS), a clinical-stage pharmaceutical company focused on treating people with cystic fibrosis (CF), today reported financial results and recent business highlights for the third quarter 2016. Nivalis continues to advance the clinical development of cavosonstat (N91115), a novel stabilizer of the cystic fibrosis transmembrane conductance regulator protein, or CFTR. "Our cavosonstat Phase 2 development programs continue to progress on schedule with data due by the end of this year for our add-on to Orkambi™ study and in the first quarter of 2017 for our add-on to Kalydeco™ study," said Jon Congleton, president and chief executive officer of Nivalis. "We continue to believe that cystic fibrosis requires multiple mechanisms to achieve optimal outcomes for people managing this disease. The cavosonstat add-on to Orkambi study will produce the first Phase 2 triple therapy data set aimed at validating this belief," Congleton added. Third Quarter Financial ResultsFor the third quarter ended September 30, 2016, Nivalis reported a net loss of $7.4 million, or ($0.48) per share, compared to a net loss of $6.1 million, or ($0.39) per share, in the same quarter of the prior year. The increased loss was primarily the result of higher costs associated with progressing cavosonstat in two Phase 2 clinical studies, including completing enrollment, as planned, in the study adding cavosonstat to Orkambi. Cash used in operating activities was $7.5 million during the third quarter and $21.1 million for the nine months year to date. As of September 30, 2016, Nivalis has $66.2 million in cash and marketable securities. Nivalis has no outstanding debt and there are 15.5 million shares of common stock issued and outstanding. Recent Business Highlights and Upcoming Milestones
- In early July, the Company completed enrollment of the Phase 2 clinical study in which cavosonstat is being evaluated for the treatment of CF patients, who have two copies of the F508del mutation, in combination with Orkambi. The 16-week (including a 4-week follow-up), double-blind, randomized, placebo-controlled, parallel group study is designed to investigate the efficacy and safety of two doses of cavosonstat, 200 mg and 400 mg twice daily, compared to placebo when added to Orkambi. A total of 138 patients were enrolled at 46 sites in the U.S., and topline results are expected by the end of this year. More information on this Phase 2 study is available on ClinicalTrials.gov, reference Identifier: NCT02589236.cavosonstat(N91115).
- In May 2016, Nivalis also began dosing patients in a second Phase 2 trial to evaluate the effect of cavosonstat in patients who have one copy of the F508del mutation and a second mutation that results in a gating defect in the CFTR protein. This proof-of-concept study is intended to evaluate the efficacy and safety of cavosonstat, 400mg twice daily, in adult patients who have these mutations and who are being treated with Kalydeco. This multicenter study will randomize approximately 20 CF patients to either cavosonstat with Kalydeco or placebo with Kalydeco. The primary efficacy endpoint is the within-group absolute change from baseline in ppFEV 1 in the cavosonstat treatment group. Data is expected in the first quarter of 2017. More information on this Phase 2 study is available on ClinicalTrials.gov, reference Identifier: NCT02724527.cavosonstat(N91115).
- This month, the Company announced that Cynthia Smith, chief commercial officer (CCO) of ZS Pharma, Inc., a subsidiary of AstraZeneca, has been appointed to the Company's Board of Directors. Ms. Smith has more than 20 years of broad leadership experience within the healthcare industry. Since 2013, Ms. Smith has served as CCO and a member of the executive team of ZS Pharma, where she led efforts to transition the company from the development stage to a commercial enterprise. Ms. Smith also served as vice president, market access and commercial development at Affymax, Inc., and has held various senior leadership positions in market access, corporate strategy, government relations and external affairs at Merck & Co.
|Nivalis Therapeutics, Inc.|
|Condensed Statements of Operations|
|(in thousands, except per share amounts)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||5,669||4,279||17,660||11,761|
|General and administrative||1,879||1,822||6,418||4,507|
|Loss from operations||(7,548||)||(6,101||)||(24,078||)||(16,268||)|
|Weighted average shares outstanding||15,504||15,451||15,476||7,322|
|Net loss per share - basic and diluted||$||(0.48||)||$||(0.39||)||$||(1.53||)||$||(2.22||)|
|Summary Balance Sheet Data|
|September 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||66,187||$||87,254|
|Property, plant and equipment, gross||1,729||1,669|
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