Exhibit 99.1

 

 

 

vTv Therapeutics Announces Second Quarter 2018 Results and Update

 

HIGH POINT, N.C. – (BUSINESS WIRE) – August 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.

 

 

Contacts

Investors:
vTv Therapeutics Inc.
Mike Biega, 617-221-9660 
IR@vtvtherapeutics.com

 

or


Media:
Josh Vlasto, 212-572-5969 
PR@vtvtherapeutics.com

View differences made from one to another to evaluate Vtv Therapeutics Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 8-K Corporate News to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Vtv Therapeutics Inc..

Continue

Never Miss A New SEC Filing Again


Real-Time SEC Filing Notifications
Screenshot taken from Gmail for a new 10-K Annual Report
Last10K.com Member Feature

Receive an e-mail as soon as a company files an Annual Report, Quarterly Report or has new 8-K corporate news.

Continue

We Highlighted This SEC Filing For You


SEC Filing Sentiment Analysis - Bullish, Bearish, Neutral
Screenshot taken from Wynn's 2018 10-K Annual Report
Last10K.com Member Feature

Read positive and negative remarks made by management in their entirety without having to find them in a 10-K/Q.

Continue

Widen Your SEC Filing Reading Experience


Increased Reading Area for SEC Filings
Screenshot taken from Adobe Inc.'s 10-Q Quarterly Report
Last10K.com Member Feature

Remove data columns and navigations in order to see much more filing content and tables in one view

Continue

Uncover Actionable Information Inside SEC Filings


SEC Filing Disclosures
Screenshot taken from Lumber Liquidators 10-K Annual Report
Last10K.com Member Feature

Read both hidden opportunities and early signs of potential problems without having to find them in a 10-K/Q

Continue

Adobe PDF, Microsoft Word and Excel Downloads


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshots of actual 10-K and 10-Q SEC Filings in PDF, Word and Excel formats
Last10K.com Member Feature

Export Annual and Quarterly Reports to Adobe PDF, Microsoft Word and Excel for offline viewing, annotations and analysis

Continue

FREE Financial Statements


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshot of actual balance sheet from company 10-K Annual Report
Last10K.com Member Feature

Get one-click access to balance sheets, income, operations and cash flow statements without having to find them in Annual and Quarterly Reports

Continue for FREE

Intrinsic Value Calculator


Intrinsic Value Calculator
Screenshot of intrinsic value for AT&T (2019)
Last10K.com Member Feature

Our Intrinsic Value calculator estimates what an entire company is worth using up to 10 years of financial ratios to determine if a stock is overvalued or not

Continue

Financial Stability Report


Financial Stability Report
Screenshot of financial stability report for Coco-Cola (2019)
Last10K.com Member Feature

Our Financial Stability reports uses up to 10 years of financial ratios to determine the health of a company's EPS, Dividends, Book Value, Return on Equity, Current Ratio and Debt-to-Equity

Continue

Get a Better Picture of a Company's Performance


Financial Ratios
Available Financial Ratios
Last10K.com Member Feature

See how over 70 Growth, Profitability and Financial Ratios perform over 10 Years

Continue

Log in with your credentials

or    

Forgot your details?

Create Account