Print PagePrint Page
E-mail PageE-mail Page
RSS FeedsRSS Feeds
X
Share Page
E-mail AlertsE-mail Alerts
IR ContactsIR Contacts

Press Release

Printer Friendly Version View printer-friendly version
<< Back
vTv Therapeutics Announces Second Quarter 2018 Results and Update

HIGH POINT, N.C.--(BUSINESS WIRE)--Aug. 3, 2018-- vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for the second quarter that ended June 30, 2018, and provided an update on recent achievements and upcoming events.

“Since our announcement regarding the topline results from Part B of the STEADFAST Study, we have continued to analyze the results from Parts A and B and are encouraged by our findings,” said Steve Holcombe, chief executive officer, vTv Therapeutics. “In addition, our other programs, including our glucokinase activator currently in clinical development for type 1 diabetes and our GLP-1R program that is being developed in partnership with Huadong Medicine for type 2 diabetes, continue to make steady progress.”

Recent Achievements and Outlook

  • Azeliragon data analysis continues in order to move development of the therapy forward in consultation with our scientific advisory board and the FDA.
  • SimplicT-1 Study enrolling patients with type 1 diabetes. The adaptive Phase 1/2 SimplicT-1 Study has begun dosing patients with type 1 diabetes in a 12 week study to evaluate TTP399 as an add-on to insulin therapy. TTP399 has previously demonstrated statistically significant reductions in HbA1c levels in the AGATA Study, a phase 2 study in type 2 diabetes.
  • Advancing PDE4 program with Newsoara. During the second quarter, vTv licensed rights to its PDE4 program to Newsoara Biopharma Co., Ltd. to further its development and potential commercialization in China and other Pacific Rim countries. Newsoara is developing vTv’s PDE4 compounds as a potential therapeutic for COPD, a chronic illness affecting nearly 100 million people in China.
  • Additional Investment by MacAndrews & Forbes Incorporated. MacAndrews & Forbes provided vTv an additional $10 million capital line.

Upcoming Events

vTv will participate in the following upcoming investor conferences:

  • H.C. Wainwright Annual Healthcare Conference, September 4-6, New York.

vTv will also participate in the following upcoming scientific conferences:

  • 11th Clinical Trials on Alzheimer’s Disease (CTAD), October 24-27, Barcelona.

Second Quarter 2018 Financial Results

  • Cash Position: Cash and cash equivalents as of June 30, 2018, were $1.2 million compared to $6.5 million as of March 31, 2018.
  • R&D Expenses: Research and development expenses were $8.6 million in the second quarter of 2018, compared to $8.9 million in the first quarter of 2018. The decrease in research and development expenses was primarily driven by the termination of the STEADFAST and open label extension studies during the second quarter of fiscal 2018.
  • G&A Expenses: General and administrative expenses were $2.7 million and $2.3 million, for the second quarter of 2018 and the first quarter of 2018, respectively. The change in general and administrative cost was driven by lower incentive compensation costs in the first quarter of 2018 related to a reduction in the expected probability of payment of the remaining amount of fiscal 2017 incentive bonuses.
  • Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $9.6 million for the second quarter of 2018 compared to net loss before non-controlling interest of $10.0 million for the first quarter of 2018.
  • Net Loss per Share: GAAP net loss per share was $0.31 and $0.30 for the three months ended June 30, 2018 and March 31, 2018, respectively, based on weighted-average shares of 10.0 million and 9.7 million for the three month periods ended June 30, 2018 and March 31, 2018, respectively. Non-GAAP net loss per fully exchanged share was $0.29 and $0.30 for the three months ended June 30, 2018 and March 31, 2018, respectively, based on non-GAAP fully exchanged weighted-average shares of 33.1 million and 32.8 million for the three months ended June 30, 2018 and March 31, 2018, respectively.

 

       

vTv Therapeutics Inc.

Condensed Consolidated Balance Sheets - Unaudited

(in thousands)

 

June 30, March 31,
2018 2018
 
Assets
Current assets:
Cash and cash equivalents $ 1,163 $ 6,535
Restricted cash and cash equivalents
Accounts receivable, net 2,270 210
Prepaid expenses and other current assets 264 471
Current deposits   2,311     2,256  
Total current assets 6,008 9,472
Restricted cash and cash equivalents, long-term 2,500 2,500
Property and equipment, net 202 241
Long-term investments 2,480 2,480
Long-term deposits   36     36  
Total assets $ 11,226   $ 14,729  
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit
Current liabilities:
Accounts payable and accrued expenses $ 13,144 $ 11,296
Current portion of deferred revenue 10,114 8,754
Current portion of notes payable   8,229     6,771  
Total current liabilities 31,487 26,821
Notes payable 10,863 13,091
Deferred revenue, net of current portion 603 2,436
Warrant liability, related party 201 517
Other liabilities   256     255  
Total liabilities 43,410 43,120
Commitments and contingencies
Redeemable noncontrolling interest 39,413 120,397
Stockholders’ deficit:
Class A Common Stock 109 97
Class B Common Stock 232 232
Additional paid-in capital 134,587 128,796
Accumulated deficit   (206,525 )   (277,913 )
Total stockholders’ deficit attributable to vTv Therapeutics Inc.   (71,597 )   (148,788 )
Total liabilities, redeemable noncontrolling interest and stockholders’ deficit $ 11,226   $ 14,729  
 
   

vTv Therapeutics Inc.

Condensed Consolidated Statements of Operations - Unaudited

(in thousands, except per share data)

 
Three Months Ended
June 30, 2018     March 31, 2018
Revenue $ 2,473 $ 2,064
Operating expenses:
Research and development 8,594 8,943
General and administrative   2,737     2,255  
Total operating expenses   11,331     11,198  
Operating loss (8,858 ) (9,134 )
Interest income 16 18
Interest expense (870 ) (855 )
Other income (expense), net   316     11  
Loss before income taxes and noncontrolling interest (9,396 ) (9,960 )
Income tax provision   200      
Net loss before noncontrolling interest (9,596 ) (9,960 )
Less: net loss attributable to noncontrolling interest   (6,524 )   (7,008 )
Net loss attributable to vTv Therapeutics Inc. $ (3,072 ) $ (2,952 )
Net loss per share of vTv Therapeutics Inc. Class A

Common Stock, basic and diluted

$ (0.31 ) $ (0.30 )
Weighted-average number of vTv Therapeutics Inc.

Class A Common Stock, basic and diluted

  10,049,831     9,699,721  
 
       

vTv Therapeutics Inc.

Condensed Consolidated Statements of Operations - Unaudited

(in thousands, except per share data)

 
Three Months Ended June 30,

For the Six Months Ended June 30,

2018     2017 2018     2017
Revenue $ 2,473 $ 13 $ 4,537 $ 43
Operating expenses:
Research and development 8,594 9,623 17,537 20,583
General and administrative   2,737     3,005     4,992     5,829  
Total operating expenses   11,331     12,628     22,529     26,412  
Operating loss (8,858 ) (12,615 ) (17,992 ) (26,369 )
Interest income 16 33 34 60
Interest expense (870 ) (832 ) (1,725 ) (1,391 )
Other income (expense), net   316         327      
Loss before income taxes and noncontrolling interest (9,396 ) (13,414 ) (19,356 ) (27,700 )
Income tax provision   200         200      
Net loss before noncontrolling interest (9,596 ) (13,414 ) (19,556 ) (27,700 )
Less: net loss attributable to noncontrolling interest   (6,524 )   (9,451 )   (13,532 )   (19,517 )
Net loss attributable to vTv Therapeutics Inc. $ (3,072 ) $ (3,963 ) $ (6,024 ) $ (8,183 )
Net loss per share of vTv Therapeutics Inc. Class A Common

Stock, basic and diluted

$ (0.31 ) $ (0.41 ) $ (0.61 ) $ (0.84 )
Weighted-average number of vTv Therapeutics Inc. Class A

Common Stock, basic and diluted

  10,049,831     9,693,254     9,875,743     9,693,254  
 

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.

About STEADFAST

The STEADFAST study, two independent and identical randomized, double-blind, placebo-controlled Phase 3 trials (Part A and Part B), was designed to investigate the safety and efficacy of azeliragon as a potential treatment for patients with mild Alzheimer’s disease. The 18-month study targeted enrollment of 800 patients (400 in each trial). The first trial enrolled patients in the United States and Canada who had a clinical diagnosis of mild Alzheimer's disease and an MRI consistent with this diagnosis. Enrollment of the second trial included study sites in the United Kingdom, Ireland, Australia, New Zealand and South Africa. Clinical trials involving azeliragon, including the Part B Study and the open-label extension study have been terminated based on the topline results from the Part A Study showing the trial failed to meet either of the co-primary endpoints. Topline efficacy results from the Part B Study were announced in June of 2018 showing that this trial also failed to meet either of the co-primary endpoints.

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
June 30, 2018     March 31, 2018
Numerator:
Net loss attributable to vTv Therapeutics Inc. $ (3,072 ) $ (2,952 )
Reallocation of net income attributable to non-controlling

interest from the assumed exchange of Class B shares (1)

  (6,524 )   (7,008 )
Net loss before noncontrolling interest $ (9,596 ) $ (9,960 )
Denominator:
Weighted-average number of vTv Therapeutics Inc.

Class A Common Stock, basic and diluted

10,049,831 9,699,721
Assumed exchange of Class B Common Stock (1)   23,094,221     23,115,631  
Adjusted proforma fully exchanged weighted-average

shares of Class A common stock outstanding,

basic and diluted

  33,144,052     32,815,352  
Adjusted proforma earnings per fully exchanged share,

basic and diluted

$ (0.29 ) $ (0.30 )
 
       
Three Months Ended June 30, Six Months Ended June 30,
2018     2017 2018     2017
Numerator:
Net loss attributable to vTv Therapeutics Inc. $ (3,072 ) $ (3,963 ) $ (6,024 ) $ (8,183 )
Reallocation of net income attributable to non-controlling

interest from the assumed exchange of Class B shares (1)

  (6,524 )   (9,451 )   (13,532 )   (19,517 )
Net loss before noncontrolling interest $ (9,596 ) $ (13,414 ) $ (19,556 ) $ (27,700 )
Denominator:
Weighted-average number of vTv Therapeutics Inc.

Class A Common Stock, basic and diluted

10,049,831 9,693,254 9,875,743 9,693,254
Assumed exchange of Class B Common Stock (1)   23,094,221     23,119,246     23,104,867     23,119,246  
Adjusted proforma fully exchanged weighted-average

shares of Class A common stock outstanding,

basic and diluted

  33,144,052     32,812,500     32,980,610     32,812,500  
Adjusted proforma earnings per fully exchanged share,

basic and diluted

$ (0.29 ) $ (0.41 ) $ (0.59 ) $ (0.84 )
 
(1)   Assumes the exchange of all outstanding Class B common stock, resulting in the elimination of the non-controlling interest and recognition of the net income attributable to non-controlling interests.
 

Source: vTv Therapeutics Inc.

vTv Therapeutics Inc.
Investors:
Mike Biega, 617-221-9660
IR@vtvtherapeutics.com
or
Media:
Josh Vlasto, 212-572-5969
PR@vtvtherapeutics.com