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Share Name | Share Symbol | Market | Type |
---|---|---|---|
vTv Therapeutics Inc | NASDAQ:VTVT | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
1.20 | 4.64% | 26.965 | 8.50 | 50.34 | 26.965 | 24.80 | 25.89 | 3,777 | 05:00:09 |
TTP273 is an oral, small molecule GLP-1R agonist with best-in-class potential
Company Releases Q2 Earnings Results and Details Upcoming Program Milestones
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 announced the completion of enrollment of the company’s Phase 2 LOGRA (aLlosteric Oral Glp1 Receptor Agonist) study, a randomized, double-blind, placebo-controlled, parallel group trial of TTP273. TTP273 is an oral, small molecule GLP-1R agonist with best-in-class potential.
The previous Phase 1b trial of TTP273 showed robust effects on postprandial and fasting glucose. In this study, all doses of TTP273 were well tolerated with no serious adverse events or evidence of significant gastrointestinal side effects.
Last week, vTv announced positive topline results from a placebo and active-comparator-controlled Phase 2b clinical study of TTP399, a liver-selective glucokinase activator (GKA) under development for the treatment of Type 2 diabetes.
“Coming off the announcement of positive topline results from our GKA trial, we are pleased to report that enrollment of our GLP-1 trial has been completed,” said Steve Holcombe, President and CEO of vTv. “Earlier studies of this compound showed that TTP273 has the potential to provide enhanced glycemic control and weight loss without the burden of injections or gastrointestinal side effects seen with other GLP-1 biologic agents. We look forward to completing this trial and reporting results at the end of this year.”
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 are expected late this year.
Second Quarter Financials, Recent Highlights, and Upcoming Milestones
“We’re on the threshold of several important clinical milestones including completing enrollment in the next few weeks of Part A of our pivotal Phase 3 azeliragon trial in mild Alzheimer’s subjects. We will begin discussions with pharmaceutical companies regarding possible partnering opportunities for our successful GKA program while continuing to advance TTP399. We also expect to complete and then report the topline results of our phase 2 GLP-1R trial by the end of the year. This has been an exciting year as we continue to meet the key goals for our Alzheimer’s and diabetes programs,” Holcombe added.
Phase 3 STEADFAST Study with azeliragon in mild Alzheimer’s disease (AD)
Azeliragon: A novel, oral small molecule antagonist of the Receptor for Advanced Glycation Endproducts (RAGE) with best-in-class potential
Phase 2b AGATA Study with TTP399 in Type 2 diabetes
TTP399: A novel oral, liver-selective Glucokinase Activator (GKA) with first-in-class potential
Second Quarter 2016 Financial Results
9,156,686 shares outstanding as of June 30, 2016 and December 31, 2015,
respectively
97 92 Class B Common Stock, $0.01 par value; 100,000,000 shares authorized, 23,122,576and 23,655,814 shares outstanding as of June 30, 2016 and December 31, 2015,
respectively
232 237 Additional paid-in capital 122,137 117,686 Accumulated deficit (201,986) (195,985) Total stockholders’ deficit attributable to vTv Therapeutics Inc. (79,520) (77,970) Total liabilities, redeemable noncontrolling interest and stockholders’ deficit $ 66,783 $ 91,532 vTv Therapeutics, Inc. Condensed Combined Consolidated Statements of Operations - Unaudited (in thousands, except per share data) Three Months Ended June 30, For the Six Months Ended June 30, 2016 2015 2016 2015 Revenue $ 182 $ 110 $ 558 $ 160 Operating expenses: Research and development 12,149 5,702 23,484 13,478 General and administrative 2,672 2,297 5,253 4,292 Total operating expenses 14,821 7,999 28,737 17,770 Operating loss (14,639) (7,889) (28,179) (17,610) Other income (expense), net 22 (2,523) 42 (2,615) Loss before income taxes and noncontrolling interest (14,617) (10,412) (28,137) (20,225) Income tax provision — — — — Net loss before noncontrolling interest (14,617) (10,412) (28,137) (20,225) Less: net loss attributable to noncontrolling interest (10,160) — (19,828) — Net loss attributable to vTv Therapeutics Inc. $ (4,457) $ (10,412) $ (8,309) $ (20,225) Net loss per share of vTv Therapeutics Inc. Class A CommonStock, basic and diluted
$ (0.47) $ (0.88) $ — Weighted-average number of vTv Therapeutics Inc. Class ACommon Stock, basic and diluted
9,564,623 9,397,134 —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.
Forward-Looking Statements
This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160816005292/en/
InvestorsIR@vtvtherapeutics.comorMediavTv TherapeuticsNura Strong, 336-841-0300 X164Director, Business Developmentnstrong@vTvTherapeutics.com
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