vTv Therapeutics Reports Second Quarter 2017 Financial And Operational Results

HIGH POINT, N.C.--(BUSINESS WIRE)--vTv Therapeutics Inc. (vTv) (Nasdaq: VTVT) today provided a corporate update and reported financial and operational results for the second quarter ended June 30, 2017.

“With positive progress in our lead Alzheimer’s and diabetes programs, vTv is pleased to showcase another productive quarter,” said Steve Holcombe, president and CEO of vTv Therapeutics. “At the American Diabetes Association meeting in June, we presented important new updates from our Phase 2 clinical study of TTP273 that may meaningfully expand the treatment options for patients with Type 2 diabetes. We also completed enrollment of Part B of our Phase 3 STEADFAST Study in Alzheimer’s disease, and we are anticipating data from Part A early next year. If positive, those data position vTv Therapeutics to be the first biopharmaceutical company to bring an investigational therapy before the FDA that could potentially delay progression of clinical symptoms of Alzheimer’s disease.”

Second Quarter 2017 Recent Highlights

Phase 3 STEADFAST Study with azeliragon in mild Alzheimer’s disease (AD)

• Part B of the STEADFAST Study completed enrollment in the second quarter. The randomized, double-blind, placebo-controlled study is evaluating whether azeliragon can effectively slow the cognitive and functional decline of patients with mild Alzheimer’s disease over 18 months of treatment. The STEADFAST Study is being conducted under a Special Protocol Assessment and the azeliragon development program has Fast Track designation from the FDA.

2017 American Diabetes Association 77th Scientific Sessions

• In a poster presentation titled, “Is Less More? Learning to dose the oral, non-peptide GLP-1R Agonist, TTP273 in Type 2 Diabetics,” researchers from vTv reviewed results from a concentration/effect analysis on the LOGRA study showing that lower doses of TTP273 may show more pronounced effects for key efficacy endpoints, including a reduction in HbA1c, weight and fasting plasma glucose.

Upcoming Anticipated Milestones

STEADFAST Study (azeliragon in Alzheimer’s disease): Expected to report top-line results from Part A and B of this study in early 2018 and late 2018, respectively.

Second Quarter 2017 Financial Results

• Cash Position: Cash and cash equivalents as of June 30, 2017 were $32.5 million compared to $45.2 million as of March 31, 2017. vTv expects that its cash and cash equivalents will be sufficient to fund its operations through the receipt of top-line results for Part A of our STEADFAST Study, which are expected in early 2018.
• R&D Expenses: Research and development expenses were $9.6 million in the second quarter of 2017, compared to $11.0 million in the first quarter of 2017. The decrease in research and development expense was primarily driven by decreases in spending for the STEADFAST Study as enrollment finalized during the second quarter of 2017.
• G&A Expenses: General and administrative expenses were relatively consistent between the second and first quarters of 2017 and were $3.0 million and $2.8 million, respectively.
• Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $13.4 million for the second quarter of 2017 compared to net loss before non-controlling interest of $14.3 million for the first quarter of 2017.
• Net Loss per Share: GAAP Net loss per share was $0.41 and $0.44 for the three months ended June 30, 2017 and March 31, 2017, respectively, based on weighted-average shares of 9.7 million in each period. Non-GAAP earnings per fully exchanged share was $0.41 and $0.44 for the three months ended June 30, 2017 and March 31, 2017, respectively, based on non-GAAP fully exchanged weighted-average shares of 32.8 million in each period.