Full Press Release Details
vTv Therapeutics Reports 2016 Fourth Quarter and Full Year Financial and Operational Results and Recent Highlights
Completed enrollment of Part A pivotal Phase 3 STEADFAST Study of azeliragon
in Alzheimer's Disease
Positive Phase 2 results for Type 2 diabetes therapies, TTP273 and TTP399
High Point, North Carolina (February 27, 2017) - 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, among other therapeutic areas, today provided a corporate update and reported financial and operational results for the fourth quarter and full year that ended December 31, 2016.
"2016 marked a year of substantial progress for vTv, as we achieved numerous milestones in the development of novel therapeutics for Alzheimer's disease and Type 2 diabetes," said Steve Holcombe, president and CEO of vTv Therapeutics. "Our Alzheimer's program continues to advance as planned, and we welcomed positive Phase 2 results from each of our oral, small molecule drug candidates in Type 2 diabetes."
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 the potential to delay progression of AD
Phase 2 LOGRA Study with TTP273 in Type 2 diabetes
TTP273: An investigational, orally-administered small molecule GLP-1R agonist
Phase 2b AGATA Study with TTP399 in Type 2 diabetes
TTP399: A novel, investigational, oral, liver-selective glucokinase activator (GKA)
Upcoming Anticipated Milestones
STEADFAST Study (azeliragon in Alzheimer's disease): Expect to complete enrollment in Part B of Phase 3 study in mid-2017.
Fourth Quarter 2016 Financial Results
Full Year 2016 Financial Results
vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets
| December 31, | September 30, | ||||||
| 2016 | 2016 | ||||||
| (Unaudited) | (Unaudited) | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 51,505 | $ | 51,058 | |||
| Accounts receivable, net | - | - | |||||
| Prepaid expenses and other current assets | 612 | 1,058 | |||||
| Total current assets | 52,117 | 52,116 | |||||
| Property and equipment, net | 444 | 493 | |||||
| Other long-term assets | 1,934 | 2,106 | |||||
| Total assets | $ | 54,495 | $ | 54,715 | |||
| Liabilities, Redeemable Noncontrolling Interest and Stockholders' Deficit | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued expenses | $ | 11,413 | $ | 10,156 | |||
| Accounts payable and accrued expenses - related party | - | 406 | |||||
| Deferred revenue | 21 | 21 | |||||
| Total current liabilities | 11,434 | 10,583 | |||||
| Notes payable | 11,058 | - | |||||
| Other liabilities | 433 | 225 | |||||
| Total liabilities | 22,925 | 10,808 | |||||
| Commitments and contingencies | |||||||
| Redeemable noncontrolling interest | 122,515 | 155,147 | |||||
| Stockholders' deficit: | |||||||
| Class A Common Stock | 97 | 97 | |||||
| Class B Common Stock | 232 | 232 | |||||
| Additional paid-in capital | 124,212 | 122,838 | |||||
| Accumulated deficit | (215,486 | ) | (234,407 | ) | |||
| Total stockholders' deficit attributable to vTv Therapeutics Inc. | (90,945 | ) | (111,240 | ) | |||
| Total liabilities, redeemable noncontrolling interest and stockholders' deficit | $ | 54,495 | $ | 54,715 |
Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except per share data)
| Three Months Ended | For the Year Ended December 31, | ||||||||||||||
| December 31, 2016 | September 30, 2016 | 2016 | 2015 | ||||||||||||
| Revenue | $ | 38 | $ | 38 | $ | 634 | $ | 519 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 11,099 | 11,165 | 45,748 | 29,584 | |||||||||||
| General and administrative | 2,252 | 2,401 | 9,906 | 9,077 | |||||||||||
| Total operating expenses | 13,351 | 13,566 | 55,654 | 38,661 | |||||||||||
| Operating loss | (13,313 | ) | (13,528 | ) | (55,020 | ) | (38,142 | ) | |||||||
| Interest income | 20 | 21 | 87 | 40 | |||||||||||
| Interest expense | (394 | ) | (1 | ) | (398 | ) | (108 | ) | |||||||
| Other (expense) income, net | (24 | ) | 3 | (22 | ) | (2,897 | ) | ||||||||
| Loss before income taxes and noncontrolling interest | (13,711 | ) | (13,505 | ) | (55,353 | ) | (41,107 | ) | |||||||
| Income tax provision | - | - | - | - | |||||||||||
| Net loss before noncontrolling interest | (13,711 | ) | (13,505 | ) | (55,353 | ) | (41,107 | ) | |||||||
| Less: net loss attributable to noncontrolling interest | (9,661 | ) | (9,512 | ) | (39,001 | ) | (13,609 | ) | |||||||
| Net loss attributable to vTv Therapeutics Inc. | $ | (4,050 | ) | $ | (3,993 | ) | $ | (16,352 | ) | $ | (27,498 | ) | |||
| Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | $ | (0.42 | ) | $ | (0.41 | ) | $ | (1.71 | ) | $ | (3.32 | ) | |||
| Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | 9,693,254 | 9,691,362 | 9,545,527 | 8,276,520 |
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.