vtvt-8k_20190227.htm

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of Report (date of earliest event reported):  February 27, 2019

vTv Therapeutics Inc.
(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction

of incorporation)

001-37524

(Commission File No.)

47-3916571
(IRS Employer
Identification No.)

 

4170 Mendenhall Oaks Pkwy

High Point, NC 27265

(Address of principal executive offices)

 

(336) 841-0300

(Registrant’s telephone number, including area code)  

NOT APPLICABLE

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a‑12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 


Item 2.02 Results of Operations and Financial Condition

 

On February 27, 2019, vTv Therapeutics Inc. issued a press release to announce its financial results for the fiscal year ended December 31, 2018.  A copy of the press release is attached as Exhibit 99.1 to this current report on Form 8-K and is incorporated herein by reference.

 

The information in this report (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18, of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit No.

Description

99.1

Press Release dated February 27, 2019, announcing financial results for the fiscal year ended December 31, 2018

 

 



SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

VTV THERAPEUTICS INC.

By:

/s/ Rudy C. Howard

Name:

Rudy C. Howard

Title:

Chief Financial Officer

 

Dated: February 27, 2019

 

 

 

 

 

vtvt-ex991_6.htm

Exhibit 99.1

 

 

 

 

 

vTv Therapeutics Announces 2018 Fourth Quarter and Full Year Financial Results and Update

 

HIGH POINT, N.C. – (BUSINESS WIRE) – Feb. 27, 2019 – vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for the fourth quarter and year that ended December 31, 2018, and provided an update on recent achievements and upcoming events.

 

“We are excited about the therapeutic potential of azeliragon in patients with mild-Alzheimer’s Disease (AD) and type 2 diabetes and our progress to date with our Simplici-T1 trial in type 1 diabetics,” said Steve Holcombe, chief executive officer, vTv Therapeutics. “Our licensing partners also continue to advance our GLP-1R agonist, PPAR-delta, and PDE4 programs and we hope to see progress in each of these programs over the next year.”

 

Recent Achievements and Outlook

 

 

Initiated start-up activities for an adaptive Phase 2/3 clinical trial for azeliragon as a potential treatment of mild AD in patients with type 2 diabetes. Post-hoc subgroup analyses of our phase 3 STEADFAST Study identified that a population of mild-AD patients with type 2 diabetes experienced positive benefit. Based on these results, we have initiated start-up activities for an adaptive Phase 2/3 trial to evaluate azeliragon as a potential treatment of mild-AD in patients with type 2 diabetes. We are currently finalizing a protocol for the study, negotiating with clinical research organizations to support study conduct activities for the trial and beginning the site selection process.  We expect to initiate patient enrollment in this study in mid-2019. We plan to continue to develop azeliragon through internal efforts, based upon receipt of additional funding, or through future partnerships with other life science entities.

 

 

Simplic-T1 Study enrolling patients with type 1 diabetes. We have completed enrollment of the part 1 learning phase of the adaptive Phase 1/2 Simplici-T1 Study, a 12-week study to evaluate TTP399 as an add-on to insulin therapy for type 1 diabetics, and expect to report results for this portion of the study in June 2019. We have begun the start-up activities for the part 2 confirmatory phase and expect to report results for this portion of the study in the latter part of the first quarter of 2020. TTP399 has previously demonstrated statistically significant reductions in HbA1c levels in the AGATA Study, a phase 2 study in type 2 diabetes.

 

 

Financing Strategy. We are evaluating several financing strategies to fund the proposed clinical trial of azeliragon for the treatment of mild-AD in patients with type 2 diabetes, including direct equity investment and future public offerings of our common stock. The timing and availability of such financing are not yet known.

 


 


 

Fourth Quarter 2018 Financial Results

 

 

Cash Position: Cash and cash equivalents as of December 31, 2018, were $1.7 million compared to $3.8 million as of September 30, 2018.

 

 

R&D Expenses: Research and development expenses were $2.8 million in the fourth quarter of 2018 which were consistent with the $2.7 million of such expenses incurred in the third quarter of 2018.

 

 

G&A Expenses: General and administrative expenses were $2.1 million and $2.2 million in the fourth and third quarters of 2018, respectively.

 

 

Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $2.3 million for the fourth quarter of 2018 compared to net loss before non-controlling interest of $2.0 million for the third quarter of 2018.

 

 

Net Loss Per Share: GAAP net loss per share was $0.10 and $0.06 for the three months ended December 31, 2018 and September 30, 2018, respectively, based on weighted-average shares of 17.6 million and 12.3 million for the three month periods ended December 31, 2018 and September 30, 2018, respectively. Non-GAAP net loss per fully exchanged share was $0.08 and $0.06 for the three months ended December 31, 2018 and September 30, 2018, respectively, based on non-GAAP fully exchanged weighted-average shares of 40.7 million and 35.4 million for the three months ended December 31, 2018 and September 30, 2018, respectively.

 

Full Year 2018 Financial Results

 

 

R&D Expenses: Research and development expenses were $23.0 million and $39.6 million for the years ended December 31, 2018 and 2017, respectively. The decrease in research and development expenses was primarily driven by the termination of the STEADFAST and open label extension studies and related activities in the second quarter of 2018.

 

 

G&A Expenses: General and administrative expenses were $9.2 million and $11.3 million for the years ended December 31, 2018 and 2017, respectively. The decrease in general and administrative expenses was primarily due to decreases in expenses for share-based awards, incentive-based compensation and professional services.

 

 

Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $23.8 million and $54.6 million for the years ended December 31, 2018 and 2017, respectively.

 

 

Net Loss Per Share: GAAP net loss per share was $0.69 and $1.67 for the years ended December 31, 2018 and 2017, respectively, based on weighted-average shares of 12.4 million and 9.7 million for the years ended December 31, 2018 and 2017, respectively. Non-GAAP net loss per fully exchanged share was $0.69 and $1.67 for the year ended December 31, 2018 and 2017, respectively, based on non-GAAP fully exchanged weighted-average shares of 35.5 million and 32.8 million for the years ended December 31, 2018 and 2017, respectively.


 


 

vTv Therapeutics Inc.

Condensed Consolidated Balance Sheets

(in thousands)

 

 

December 31,

 

 

September 30,

 

 

2018

 

 

2018

 

 

 

 

 

 

(Unaudited)

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

1,683

 

 

$

3,766

 

Prepaid expenses and other current assets

 

666

 

 

 

1,006

 

Current deposits

 

1,124

 

 

 

1,124

 

Total current assets

 

3,473

 

 

 

5,896

 

Restricted cash and cash equivalents, long-term

 

2,500

 

 

 

2,500

 

Property and equipment, net

 

70

 

 

 

177

 

Long-term investments

 

2,480

 

 

 

2,480

 

Long-term deposits

 

36

 

 

 

36

 

Total assets

$

8,559

 

 

$

11,089

 

Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable and accrued expenses

$

7,702

 

 

$

8,965

 

Current portion of deferred revenue

 

1,752

 

 

 

6,747

 

Current portion of notes payable

 

9,383

 

 

 

9,597

 

Total current liabilities

 

18,837

 

 

 

25,309

 

Notes payable

 

6,330

 

 

 

8,611

 

Deferred revenue, net of current portion

 

1,067

 

 

 

595

 

Warrant liability, related party

 

2,436

 

 

 

382

 

Other liabilities

 

260

 

 

 

258

 

Total liabilities

 

28,930

 

 

 

35,155

 

Commitments and contingencies

 

 

 

 

 

 

 

Redeemable noncontrolling interest

 

62,482

 

 

 

19,912

 

Stockholders’ deficit:

 

 

 

 

 

 

 

Class A Common Stock

 

203

 

 

 

158

 

Class B Common Stock

 

232

 

 

 

232

 

Additional paid-in capital

 

150,595

 

 

 

144,617

 

Accumulated deficit

 

(233,883

)

 

 

(188,985

)

Total stockholders’ deficit attributable to vTv Therapeutics Inc.

 

(82,853

)

 

 

(43,978

)

Total liabilities, redeemable noncontrolling interest and stockholders’ deficit

$

8,559

 

 

$

11,089

 


 


 

vTv Therapeutics Inc.

Condensed Consolidated Statements of Operations - Unaudited

(in thousands, except per share data)

 

 

Three Months Ended

 

 

December 31, 2018

 

 

September 30, 2018

 

Revenue

$

4,522

 

 

$

3,375

 

Operating expenses:

 

 

 

 

 

 

 

Research and development

 

2,800

 

 

 

2,698

 

General and administrative

 

2,073

 

 

 

2,158

 

Total operating expenses

 

4,873

 

 

 

4,856

 

Operating loss

 

(351

)

 

 

(1,481

)

Interest income

 

14

 

 

 

13

 

Interest expense

 

(743

)

 

 

(822

)

Other (expense) income, net

 

(1,248

)

 

 

329

 

Loss before income taxes and noncontrolling interest

 

(2,328

)

 

 

(1,961

)

Income tax provision

 

 

 

 

 

Net loss before noncontrolling interest

 

(2,328

)

 

 

(1,961

)

Less:  net loss attributable to noncontrolling interest

 

(1,237

)

 

 

(1,165

)

Net loss attributable to vTv Therapeutics Inc.

$

(1,091

)

 

$

(796

)

Net loss attributable to vTv Therapeutics Inc. common shareholders

$

(1,830

)

 

$

(796

)

Net loss per share of vTv Therapeutics Inc. Class A

   Common Stock, basic and diluted

$

(0.10

)

 

$

(0.06

)

Weighted-average number of vTv Therapeutics Inc.

   Class A Common Stock, basic and diluted

 

17,635,159

 

 

 

12,305,949

 

 


 


 

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,

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Revenue

$

4,522

 

 

$

233

 

 

$

12,434

 

 

$

291

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

2,800

 

 

 

10,068

 

 

 

23,035

 

 

 

39,640

 

General and administrative

 

2,073

 

 

 

2,937

 

 

 

9,223

 

 

 

11,333

 

Total operating expenses

 

4,873

 

 

 

13,005

 

 

 

32,258

 

 

 

50,973

 

Operating loss

 

(351

)

 

 

(12,772

)

 

 

(19,824

)

 

 

(50,682

)

Interest income

 

14

 

 

 

22

 

 

 

61

 

 

 

117

 

Interest expense

 

(743

)

 

 

(852

)

 

 

(3,290

)

 

 

(3,092

)

Other expense, net

 

(1,248

)

 

 

(190

)

 

 

(592

)

 

 

(190

)

Loss before income taxes and noncontrolling interest

 

(2,328

)

 

 

(13,792

)

 

 

(23,645

)

 

 

(53,847

)

Income tax provision

 

 

 

 

800

 

 

 

200

 

 

 

800

 

Net loss before noncontrolling interest

 

(2,328

)

 

 

(14,592

)

 

 

(23,845

)

 

 

(54,647

)

Less:  net loss attributable to noncontrolling interest

 

(1,237

)

 

 

(10,281

)

 

 

(15,934

)

 

 

(38,503

)

Net loss attributable to vTv Therapeutics Inc.

$

(1,091

)

 

$

(4,311

)

 

$

(7,911

)

 

$

(16,144

)

Net loss attributable to vTv Therapeutics Inc. common shareholders

$

(1,830

)

 

$

(4,311

)

 

$

(8,650

)

 

$

(16,144

)

Net loss per share of vTv Therapeutics Inc. Class A Common

   Stock, basic and diluted

$

(0.10

)

 

$

(0.44

)

 

$

(0.69

)

 

$

(1.67

)

Weighted-average number of vTv Therapeutics Inc. Class A

   Common Stock, basic and diluted

 

17,635,159

 

 

 

9,693,254

 

 

 

12,449,236

 

 

 

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.

 

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. common shareholders 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, 2018

 

 

September 30, 2018

 

Numerator:

 

 

 

 

 

 

 

Net loss attributable to vTv Therapeutics Inc. common shareholders

$

(1,830

)

 

$

(796

)

Reallocation of net income attributable to non-controlling

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

 

(1,237

)

 

 

(1,165

)

Net loss before noncontrolling interest

$

(3,067

)

 

$

(1,961

)

Denominator:

 

 

 

 

 

 

 

Weighted-average number of vTv Therapeutics Inc.

   Class A Common Stock, basic and diluted

 

17,635,159

 

 

 

12,305,949

 

Assumed exchange of Class B Common Stock (1)

 

23,094,221

 

 

 

23,114,652

 

Adjusted proforma fully exchanged weighted-average

   shares of Class A common stock outstanding,

   basic and diluted

 

40,729,380

 

 

 

35,420,601

 

Adjusted proforma earnings per fully exchanged share,

   basic and diluted

$

(0.08

)

 

$

(0.06

)

 

 


 

 

Three Months Ended December 31,

 

 

Twelve Months Ended December 31,

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Numerator:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss attributable to vTv Therapeutics Inc. common  

   Shareholders

$

(1,830

)

 

$

(4,311

)

 

$

(8,650

)

 

$

(16,144

)

Reallocation of net income attributable to non-controlling

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

 

(1,237

)

 

 

(10,281

)

 

 

(15,934

)

 

 

(38,503

)

Net loss before noncontrolling interest

$

(3,067

)

 

$

(14,592

)

 

$

(24,584

)

 

$

(54,647

)

Denominator:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average number of vTv Therapeutics Inc.

   Class A Common Stock, basic and diluted

 

17,635,159

 

 

 

9,693,254

 

 

 

12,449,236

 

 

 

9,693,254

 

Assumed exchange of Class B Common Stock (1)

 

23,094,221

 

 

 

23,119,246

 

 

 

23,099,500

 

 

 

23,119,246

 

Adjusted proforma fully exchanged weighted-average

   shares of Class A common stock outstanding,

   basic and diluted

 

40,729,380

 

 

 

32,812,500

 

 

 

35,548,736

 

 

 

32,812,500

 

Adjusted proforma earnings per fully exchanged share,

   basic and diluted

$

(0.08

)

 

$

(0.44

)

 

$

(0.69

)

 

$

(1.67

)

(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.
IR@vtvtherapeutics.com

 

or


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