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
“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
Recent Highlights
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 (in thousands) |
||||||||
|
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) |
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Three Months Ended |
For the Year Ended |
|||||||||||||||
December 31, |
September |
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20170227006687/en/
Source:
vTv Therapeutics Inc.
Michael Gibralter, 646-378-2938
IR@vtvtherapeutics.com
or
Media:
Pure
Communications Inc.
Katie Engleman, 910-509-3977
Katie@purecommunicationsinc.com