vTv Therapeutics Announces Second Quarter 2018 Results and Update

Aug. 3, 2018 11:30 UTC

HIGH POINT, N.C.--(BUSINESS WIRE)-- 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.
     

 

Contacts

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

 
 

Source: vTv Therapeutics Inc.

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