vTv Therapeutics Inc. (vTv) (Nasdaq: VTVT), a clinical-stage biopharmaceutical company engaged in the discovery and development of new orally administered treatments for Alzheimer's disease and diabetes, today provided a corporate update and reported financial and operational results for the third quarter ended September 30, 2016. "This was a very productive quarter as we continued the advancement of our Alzheimer's and diabetes programs," said Steve Holcombe, President and CEO of vTv. "We announced positive topline results from our AGATA study with our glucokinase activator TTP399. Enrollments were completed in Part A of our STEADFAST study with azeliragon in mild Alzheimer's disease patients and in our Phase 2 LOGRA Study with TTP273, an oral, small molecule GLP-1R agonist. We also recently closed on a $25 million credit facility, the proceeds of which will be used to advance our strategic initiatives as well as to provide further financial support to our ongoing clinical trials." Third Quarter Financials, Recent Highlights, and Upcoming Milestones Phase 3 STEADFAST Study with azeliragon in mild Alzheimer's disease (AD) Azeliragon: A novel, investigational, oral small molecule antagonist of the Receptor for Advanced Glycation Endproducts (RAGE) with first-in-class potential
About vTv Therapeutics vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of orally administered small molecule drug candidates to fill significant unmet medical needs. vTv has a pipeline of clinical drug candidates led by programs for the treatment of Alzheimer's disease and Type 2 diabetes as well as treatment of inflammatory disorders and the prevention of muscle weakness.
- Part A of STEADFAST trial completed enrollment in the third 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. Based on the completion of enrollment of Part A in September, the Company anticipates reporting topline data from this part of the study in early 2018. The Company is currently enrolling Part B. The STEADFAST Study is being conducted under a Special Protocol Assessment and the azeliragon development program has Fast Track designation from the FDA.
- Completed enrollment in our Phase 2 LOGRA study with data readout expected at the end of 2016. The LOGRA study is assessing the safety and efficacy of TTP273 in Type 2 diabetic subjects on stable doses of metformin. The study's primary endpoint is the change from baseline in HbA1c at 3 months, with secondary endpoints including body weight, plasma glucose, lipids insulin, lactate, C-peptide, glucagon and GLP.
- Topline results showed achievement of the primary endpoint of statistically significant change from baseline in HbA1c at 6 months of daily administration of 800 mg of TTP399. The reduction in HbA1c was dose-dependent and sustained throughout the duration of the study. TTP399 was also found to be well-tolerated without increased incidences of hypoglycemia and hyperlipidemia compared to placebo. A manuscript with data from the study is in preparation and will be submitted for publication to a major medical journal.
- Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2016 were $51.1 million, (not including the proceeds from the $25 million credit facility), compared to $63.8 million as of June 30, 2016. The Company expects that its cash, cash equivalents and marketable securities coupled with the funds available from its recently obtained credit facility will be sufficient to fund its operations through 2017.
- R&D Expenses: Research and development expenses were $11.2 million in the third quarter of 2016, compared to $12.1 million in the second quarter of 2016. The decrease in research and development was primarily driven by a decrease in compound manufacturing costs of approximately $1.2 million from the prior quarter based on the timing of this work for our azeliragon program.
- G&A Expenses: General and administrative expenses were $2.4 million in the third quarter of 2016, compared to $2.7 million in the second quarter of 2016. The decrease in general and administrative expenses for the quarter was primarily due to a decrease in professional service expenses.
- Net Loss: Net loss was $13.5 million for the third quarter of 2016 compared to net loss of $14.6 million for the second quarter of 2016.
|vTv Therapeutics, Inc. Condensed Consolidated Balance Sheets (in thousands)|
|September 30,||June 30,|
|Cash and cash equivalents||$||51,058||$||63,841|
|Prepaid expenses and other current assets||1,058||423|
|Total current assets||52,116||64,264|
|Property and equipment, net||493||561|
|Employee loans receivable - related party||3||24|
|Other long-term assets||2,103||1,934|
|Liabilities, Redeemable Noncontrolling Interest and Stockholders' Deficit|
|Accounts payable and accrued expenses||$||10,156||$||9,490|
|Accounts payable and accrued expenses - related party||406||312|
|Total current liabilities||10,583||9,823|
|Commitments and contingencies|
|Redeemable noncontrolling interest||155,147||136,250|
|Class A Common Stock||97||97|
|Class B Common Stock||232||232|
|Additional paid-in capital||122,838||122,137|
|Total stockholders' deficit attributable to vTv Therapeutics Inc.||(111,240||)||(79,520||)|
|Total liabilities, redeemable noncontrolling interest and stockholders' deficit||$||54,715||$||66,783|
|Condensed Consolidated Statements of Operations - Unaudited (in thousands, except per share data)|
|Three Months Ended|
|September 30, 2016||June 30, 2016|
|Research and development||11,165||12,149|
|General and administrative||2,401||2,672|
|Total operating expenses||13,566||14,821|
|Other income (expense), net||23||22|
|Loss before income taxes and noncontrolling interest||(13,505||)||(14,617||)|
|Income tax provision||—||—|
|Net loss before noncontrolling interest||(13,505||)||(14,617||)|
|Less: net loss attributable to noncontrolling interest||(9,512||)||(10,160||)|
|Net loss attributable to vTv Therapeutics Inc.||$||(3,993||)||$||(4,457||)|
|Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted||$||(0.41||)||$||(0.47||)|
|Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted||9,691,362||9,564,623|
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