Full Press Release Details
vTv Therapeutics Reports 2017 Fourth Quarter and Full Year Financial and Operational Results and Recent Highlights
HIGH POINT, N.C. - (BUSINESS WIRE) - Feb. 27, 2018 - vTv Therapeutics Inc. (Nasdaq:VTVT) today provided a corporate update and reported financial and operational results for the fourth quarter and full year that ended December 31, 2017.
"We made tremendous progress across the spectrum of our Alzheimer's and diabetes programs this past year, and look forward to continuing this momentum in 2018 as we anticipate reporting topline results in April from Part A of our Phase 3 STEADFAST study of azeliragon in patients with mild Alzheimer's disease," said Steve Holcombe, president and CEO of vTv Therapeutics. "Our unique and holistic approach to targeting Alzheimer's through the receptor for advanced glycation endproducts (RAGE) antagonist addresses three major pathologies believed to contribute to the disease: transport of a-beta to the brain, inflammation and the phosphorylation of tau protein. We're hopeful that results from the study will be a step toward finding a much-needed therapy for the Alzheimer's community and the millions of people suffering from this devastating disease."
Fourth Quarter 2017 Highlights
vTv Therapeutics Initiates Phase 1b/2 Study as Part of Industry Partnership with the Juvenile Diabetes Research Foundation (JDRF)
vTv Therapeutics and Hangzhou Zhongmei Huadong Pharmaceutical Co. Enter Licensing Agreement for GLP-1r Diabetes Program
vTv Therapeutics and Reneo Pharmaceuticals Enter Licensing Agreement for PPAR-delta Program
vTv Therapeutics Hosts Key Opinion Leader (KOL) Event on Current State of Clinical Development in Alzheimer's Disease
Upcoming Anticipated Milestones
Shelf Registration on Form S-3
Fourth Quarter 2017 Financial Results
Full Year 2017 Financial Results
vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets
| December 31, | September 30, | ||||||
| 2017 | 2017 | ||||||
| (Unaudited) | |||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 11,758 | $ | 20,488 | |||
| Restricted cash and cash equivalents | 162 | 281 | |||||
| Accounts receivable, net | 8,000 | - | |||||
| Prepaid expenses and other current assets | 442 | 725 | |||||
| Total current assets | 20,362 | 21,494 | |||||
| Restricted cash and cash equivalents, long-term | 2,500 | - | |||||
| Property and equipment, net | 283 | 310 | |||||
| Long-term investments | 2,480 | - | |||||
| Long-term deposits | 2,292 | 2,251 | |||||
| Total assets | $ | 27,917 | $ | 24,055 | |||
| Liabilities, Redeemable Noncontrolling Interest and Stockholders' Deficit | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued expenses | $ | 13,901 | $ | 10,120 | |||
| Deferred revenue | 8,757 | - | |||||
| Current portion of notes payable | 4,271 | 2,083 | |||||
| Total current liabilities | 26,929 | 12,203 | |||||
| Notes payable | 15,316 | 17,228 | |||||
| Deferred revenue, net of current portion | 4,497 | - | |||||
| Warrant liability, related party | 492 | - | |||||
| Other liabilities | 290 | 285 | |||||
| Total liabilities | 47,524 | 29,716 | |||||
| Commitments and contingencies | |||||||
| Redeemable noncontrolling interest | 131,440 | 130,642 | |||||
| Stockholders' deficit: | |||||||
| Class A Common Stock | 97 | 97 | |||||
| Class B Common Stock | 232 | 232 | |||||
| Additional paid-in capital | 127,682 | 127,036 | |||||
| Accumulated deficit | (279,058 | ) | (263,668 | ) | |||
| Total stockholders' deficit attributable to vTv Therapeutics Inc. | (151,047 | ) | (136,303 | ) | |||
| Total liabilities, redeemable noncontrolling interest and stockholders' deficit | $ | 27,917 | $ | 24,055 |
vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except per share data)
| Three Months Ended | |||||||
| December 31, 2017 | September 30, 2017 | ||||||
| Revenue | $ | 233 | $ | 15 | |||
| Operating expenses: | |||||||
| Research and development | 10,068 | 8,989 | |||||
| General and administrative | 2,937 | 2,567 | |||||
| Total operating expenses | 13,005 | 11,556 | |||||
| Operating loss | (12,772 | ) | (11,541 | ) | |||
| Interest income | 22 | 35 | |||||
| Interest expense | (852 | ) | (849 | ) | |||
| Other expense, net | (190 | ) | - | ||||
| Loss before income taxes and noncontrolling interest | (13,792 | ) | (12,355 | ) | |||
| Income tax provision | 800 | - | |||||
| Net loss before noncontrolling interest | (14,592 | ) | (12,355 | ) | |||
| Less: net loss attributable to noncontrolling interest | (10,281 | ) | (8,705 | ) | |||
| Net loss attributable to vTv Therapeutics Inc. | $ | (4,311 | ) | $ | (3,650 | ) | |
| Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | $ | (0.44 | ) | $ | (0.38 | ) | |
| Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | 9,693,254 | 9,693,254 |
vTv Therapeutics Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
| Three Months Ended December 31, (Unaudited) | For the Year Ended December 31, | ||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||
| Revenue | $ | 233 | $ | 38 | $ | 291 | $ | 634 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 10,068 | 11,099 | 39,640 | 45,748 | |||||||||||
| General and administrative | 2,937 | 2,252 | 11,333 | 9,906 | |||||||||||
| Total operating expenses | 13,005 | 13,351 | 50,973 | 55,654 | |||||||||||
| Operating loss | (12,772 | ) | (13,313 | ) | (50,682 | ) | (55,020 | ) | |||||||
| Interest income | 22 | 20 | 117 | 87 | |||||||||||
| Interest expense | (852 | ) | (394 | ) | (3,092 | ) | (398 | ) | |||||||
| Other expense, net | (190 | ) | (24 | ) | (190 | ) | (22 | ) | |||||||
| Loss before income taxes and noncontrolling interest | (13,792 | ) | (13,711 | ) | (53,847 | ) | (55,353 | ) | |||||||
| Income tax provision | 800 | - | 800 | - | |||||||||||
| Net loss before noncontrolling interest | (14,592 | ) | (13,711 | ) | (54,647 | ) | (55,353 | ) | |||||||
| Less: net loss attributable to noncontrolling interest | (10,281 | ) | (9,661 | ) | (38,503 | ) | (39,001 | ) | |||||||
| Net loss attributable to vTv Therapeutics Inc. | $ | (4,311 | ) | $ | (4,050 | ) | $ | (16,144 | ) | $ | (16,352 | ) | |||
| Net loss per share of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | $ | (0.44 | ) | $ | (0.42 | ) | $ | (1.67 | ) | $ | (1.71 | ) | |||
| Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | 9,693,254 | 9,693,254 | 9,693,254 | 9,545,527 |
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 diabetes as well as treatment of inflammatory disorders.
The STEADFAST study includes two statistically independent, identical, randomized, double-blind, placebo-controlled Phase 3 trials, investigating the efficacy of azeliragon as a potential treatment to slow the decline in cognition and functional activities for patients with mild Alzheimer's disease. The 18-month study targeted enrollment of 800 patients (400 each for Part A and B). Part A enrolled patients in the United States and Canada. Enrollment of Part B additionally included study sites in the United Kingdom, Ireland, Australia, New Zealand and South Africa. Subjects completing the STEADFAST study are eligible to enroll in a 24-month open-label extension trial. STEADFAST is being conducted following agreement with FDA under the Special Protocol Assessment (SPA) process and the azeliragon development program has been granted fast track designation. Enrollment of Part A was completed in September 2016 with data anticipated to read out in April 2018. Part B data is expected to read out in early 2019.
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.
Non-GAAP Financial Measures
To supplement our consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the U.S. ("GAAP"), we use non-GAAP earnings per fully exchanged share, which is a non-GAAP financial measure. Non-GAAP earnings per fully exchanged share is defined as net loss attributable to vTv Therapeutics Inc. including the loss attributable to the non-controlling interest and assuming the exchange of all the Class B common stock of vTv Therapeutics Inc. and an equal number of non-voting common units of vTv Therapeutics LLC ("vTv Units") for shares of Class A common stock of vTv Therapeutics Inc. We believe that this measure provides useful information to investors as it eliminates the variability of non-controlling interest resulting from the exchanges of Class B common stock and vTv Units into Class A common stock. This measure is not intended to be considered in isolation or as a substitute for, or superior to, financial measures prepared and presented in accordance with GAAP.
The following is a reconciliation of non-GAAP earnings per fully exchanged share, basic and diluted to its most directly comparable GAAP measure, net loss per share of vTv Therapeutics Class A common stock, basic and diluted and the computation of the components of this non-GAAP measure:
| Three Months Ended | |||||||
| December 31, 2017 | September 30, 2017 | ||||||
| Numerator: | |||||||
| Net loss attributable to vTv Therapeutics Inc. | $ | (4,311 | ) | $ | (3,650 | ) | |
| Reallocation of net income attributable to non-controlling interest from the assumed exchange of Class B shares (1) | (10,281 | ) | (8,705 | ) | |||
| Net loss before noncontrolling interest | $ | (14,592 | ) | $ | (12,355 | ) | |
| Denominator: | |||||||
| Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | 9,693,254 | 9,693,254 | |||||
| Assumed exchange of Class B Common Stock (1) | 23,119,246 | 23,119,246 | |||||
| Adjusted proforma fully exchanged weighted-average shares of Class A common stock outstanding, basic and diluted | 32,812,500 | 32,812,500 | |||||
| Adjusted proforma earnings per fully exchanged share, basic and diluted | $ | (0.44 | ) | $ | (0.38 | ) |
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||
| Numerator: | |||||||||||||||
| Net loss attributable to vTv Therapeutics Inc. | $ | (4,311 | ) | $ | (4,050 | ) | $ | (16,144 | ) | $ | (16,352 | ) | |||
| Reallocation of net income attributable to non-controlling interest from the assumed exchange of Class B shares (1) | (10,281 | ) | (9,661 | ) | (38,503 | ) | (39,001 | ) | |||||||
| Net loss before noncontrolling interest | $ | (14,592 | ) | $ | (13,711 | ) | $ | (54,647 | ) | $ | (55,353 | ) | |||
| Denominator: | |||||||||||||||
| Weighted-average number of vTv Therapeutics Inc. Class A Common Stock, basic and diluted | 9,693,254 | 9,693,254 | 9,693,254 | 9,545,527 | |||||||||||
| Assumed exchange of Class B Common Stock (1) | 23,119,246 | 23,119,246 | 23,119,246 | 23,266,973 | |||||||||||
| Adjusted proforma fully exchanged weighted-average shares of Class A common stock outstanding, basic and diluted | 32,812,500 | 32,812,500 | 32,812,500 | 32,812,500 | |||||||||||
| Adjusted proforma earnings per fully exchanged share, basic and diluted | $ | (0.44 | ) | $ | (0.42 | ) | $ | (1.67 | ) | $ | (1.69 | ) |
vTv Therapeutics Inc.
Mike Biega, 617-221-9660
Katie Engleman, 910-509-3977