On February 27, 2018 vTv Therapeutics Inc. (Nasdaq:VTVT) reported a corporate update and financial and operational results for the fourth quarter and full year that ended December 31, 2017 (Press release, vTv Therapeutics, FEB 27, 2018, View Source;p=RssLanding&cat=news&id=2335134 [SID1234524269]).
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"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)
Conducted with support from JDRF, the leading global organization funding type 1 diabetes (T1D) research, vTv Therapeutics initiated simplici-T1, an adaptive Phase1b/2 study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of vTv Therapeutics’ liver-selective glucokinase activator, TTP399, in type 1 diabetes. The study will evaluate whether TTP399 is well-tolerated when administered as an add-on to insulin therapy and can improve daily glucose profiles and HbA1c in people living with T1D.
vTv Therapeutics and Hangzhou Zhongmei Huadong Pharmaceutical Co. Enter Licensing Agreement for GLP-1r Diabetes Program
vTv Therapeutics successfully entered into a licensing agreement with Hangzhou Zhongmei Huadong Pharmaceutical Co., one of the largest pharmaceutical companies in China, for rights to develop and commercialize vTv Therapeutics’ GLP-1r agonist program, including TTP273, in China and other Pacific Rim countries. vTv Therapeutics received an $8 million upfront payment and is eligible for up to an additional $75 million in milestone payments related to development, regulatory and commercial milestones. In addition, vTv Therapeutics will be eligible to receive royalty payments on sales of commercialized products in the licensed territories. vTv will conduct a Phase 2 multi-region clinical trial, including sites in both the United States and China, to investigate the safety and efficacy of a lower dose of TTP273 in patients with type 2 diabetes.
vTv Therapeutics and Reneo Pharmaceuticals Enter Licensing Agreement for PPAR-delta Program
vTv Therapeutics granted Reneo Pharmaceuticals exclusive worldwide rights to research, develop and commercialize vTv Therapeutics’ selective peroxisome proliferator-activated receptor delta (PPAR-delta) program, including HPP593, in a global licensing agreement. Under the terms of the agreement, vTv Therapeutics received an upfront payment and is eligible to receive future development and commercialization milestones as well as royalties on sales of approved products. vTv Therapeutics also received shares of Reneo Pharmaceuticals’ common stock.
vTv Therapeutics Hosts Key Opinion Leader (KOL) Event on Current State of Clinical Development in Alzheimer’s Disease
vTv Therapeutics hosted a KOL presentation focused on the current state of clinical development in Alzheimer’s disease. The event featured two speakers with extensive experience in Alzheimer’s research and care: Dr. Howard Fillit, founding executive director and chief scientific officer of Alzheimer’s Drug Discovery Foundation, clinical professor of geriatric medicine, palliative care and neuroscience at Mt. Sinai School of Medicine; and Dr. Mary Sano, associate dean for clinical research, professor of psychiatry, founding member and director of the Alzheimer’s Disease Research Center at Mt. Sinai School of Medicine. vTv Therapeutics provided a brief overview of the company’s ongoing Phase 3 clinical development program for azeliragon, an orally bioavailable small molecule RAGE antagonist for patients with mild Alzheimer’s disease.
Upcoming Anticipated Milestones
vTv Therapeutics anticipates reporting topline data from Part A of the company’s Phase 3 STEADFAST Study in April 2018. Data from Part B are expected to read out in early 2019. The STEADFAST study is a single protocol within which vTv Therapeutics is conducting two statistically independent, identical, randomized, double-blind, placebo-controlled trials investigating the efficacy of azeliragon as a potential treatment of mild Alzheimer’s disease.
Shelf Registration on Form S-3
Today the Company filed a S-3 Registration Statement with the Securities and Exchange Commission to register Class A Common Stock. The Company has no current plans to issue securities under the Registration Statement.
Fourth Quarter 2017 Financial Results
Cash Position: Cash and cash equivalents as of December 31, 2017, were $11.8 million compared to $20.5 million as of September 30, 2017.
R&D Expenses: Research and development expenses were $10.1 million in the fourth quarter of 2017, compared to $9.0 million in the third quarter of 2017. The increase in research and development expense was primarily driven by increased enrollment in the open-label extension trial and higher consulting costs incurred related to the STEADFAST Study.
G&A Expenses: General and administrative expenses were $2.9 million and $2.6 million, for the fourth and third quarters of 2017, respectively. The increase in general and administrative cost was primarily due to the higher professional service fees incurred in the fourth quarter of 2017 related to our license agreements entered into in December 2017.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $14.6 million for the fourth quarter of 2017 compared to net loss before non-controlling interest of $12.4 million for the third quarter of 2017.
Net Loss per Share: GAAP net loss per share was $0.44 and $0.38 for the three months ended December 31, 2017 and September 30, 2017, respectively, based on weighted-average shares of 9.7 million in each period. Non-GAAP net loss per fully exchanged share was $0.44 and $0.38 for the three months ended December 31, 2017 and September 30, 2017, respectively, based on non-GAAP fully exchanged weighted-average shares of 32.8 million in each period.
Full Year 2017 Financial Results
R&D Expenses: Research and development expenses were $39.6 million in 2017, compared to $45.7 million in 2016. The decrease in research and development expense was primarily driven by decreases in clinical trial costs for TTP399 and TTP273 as both the AGATA and LOGRA studies were completed in 2016. Additionally, we saw decreases in the expense for azeliragon as a result of the completion of drug-drug interaction and other supporting studies in 2016 which were partially offset by increases in cost related to continuing enrollment in the open-label extension trial and increased cost of consultants engaged to assist with the STEADFAST Study.
G&A Expenses: General and administrative expenses were $11.3 million and $9.9 million, for the 2017 and 2016, respectively. The increase in general and administrative cost was primarily due to the higher professional service fees incurred in 2017 related to our license agreements entered into in December 2017 and increased compensation cost related to the grant of additional share-based compensation awards as well as the impact of additional personnel hired in both years.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $54.6 million for 2017 compared to net loss before non-controlling interest of $55.4 million for 2016.
Net Loss per Share: GAAP net loss per share was $1.67 and $1.71 for 2017 and 2016, respectively, based on weighted-average shares of 9.7 million and 9.5 million in each period, respectively. Non-GAAP net loss per fully exchanged share was $1.67 and $1.69 for 2017 and 2016, respectively, based on non-GAAP fully exchanged weighted-average shares of 32.8 million in each period.
vTv Therapeutics Inc.
Condensed Consolidated Balance Sheets
(in thousands)
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
September 30,
December 31, 2017 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 For the Year Ended
December 31, December 31,
(Unaudited)
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