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)

☐

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))

Exhibit No.

Description

99.1

Press Release dated February 27, 2017, announcing financial results for the fiscal year ended December 31, 2016

By:

/s/ Rudy C. Howard

Name:

Rudy C. Howard

Title:

Chief Financial Officer

Exhibit No.

Description

99.1

Press Release dated February 27, 2017, announcing financial results for the fiscal year ended December 31, 2016

•

Part A of STEADFAST Study completed enrollment in the third quarter. The 18-month randomized, double-blind, placebo-controlled study is evaluating the potential of azeliragon to slow the cognitive and functional decline of patients with mild Alzheimer’s disease. Based on the completion of enrollment of Part A in September, the Company anticipates reporting topline data from this part of the study in early 2018. Enrollment of Part B continues, and is on track to be completed by mid-year of 2017. The STEADFAST Study is being conducted under a Special Protocol Assessment. Development of azeliragon has received fast track designation from the FDA.

•

Demonstrated a statistically significant reduction in HbA1c. In the 12-week LOGRA study conducted in 30 centers in the U.S., 174 patients with Type 2 diabetes on stable doses of metformin were randomized to receive either placebo or TTP273 at doses of 150 mg once or twice daily. Patients in each treatment arm had mean placebo-subtracted HbA1c differences of -0.86 percent and -0.71 percent, respectively. HbA1c increased by 0.15 percent in patients randomized to placebo. Although the study was not powered to demonstrate weight loss, trends were observed with patients losing on average 0.9 kg and 0.6 kg in the once and twice daily arms, respectively. Additionally, the compound was well-tolerated, with negligible incidences of nausea and vomiting across all arms of the study. Analyses of full study results will continue.

•

Topline results showed achievement of the primary endpoint of statistically significant change from baseline in HbA1c at 6 months with daily administration of 800 mg of TTP399. The Phase 2b AGATA (Add Glucokinase Activator to Target A1c) was a six-month, double-blind, placebo- and active-controlled parallel group trial in 190 patients with Type 2 diabetes on a stable dose of metformin. TTP399 was also found to be well-tolerated without increased incidences of hypoglycemia and hyperlipidemia compared to placebo. A manuscript with data from the study is in preparation and will be submitted for publication during the first quarter of 2017.    

•

Completion of Credit Facility Financing: In October, the Company closed a $25 million facility, the proceeds of which will be used to advance its strategic initiatives, as well as to provide further financial support to ongoing clinical trials.

•

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2016 were $51.5 million, compared to $51.1 million as of September 30, 2016. Cash used in the quarter for operations was offset by the proceeds from the borrowing of the first tranche under the Company’s credit facility received in October. vTv believes that cash and cash equivalents coupled with funds available from its credit facility will be sufficient to fund operations through the first quarter of 2018, which is when topline results from Part A of the STEADFAST Study are expected.

•

R&D Expenses: Research and development expenses were $11.1 million in the fourth quarter of 2016, compared to $11.2 million in the third quarter of 2016. The

decrease in research and development was primarily driven by decreases in costs associated with completion of the Company’s AGATA and LOGRA studies of $0.8 million and reduction in compound manufacturing costs for its diabetes and other programs of $0.6 million. Such decreases were offset by increases of $1.3 million related to the STEADFAST Study and the related open-label extension trial for azeliragon.

•

G&A Expenses: General and administrative expenses were $2.3 million in the fourth quarter of 2016, which is relatively consistent with expenses of $2.4 million in the third quarter of 2016.

•

Net Loss: Net loss was $13.7 million for the fourth quarter of 2016 compared to net loss of $13.5 million for the third quarter of 2016.

•

R&D Expenses: Research and development expenses were $45.7 million in 2016, compared to $29.6 million in 2015. The increase in research and development expense was primarily driven by an increase of $15.4 million in costs related to the Company’s azeliragon program caused by higher enrollment and related activities for the STEADFAST Study, higher compound manufacturing costs to support the study and higher costs associated with other supporting studies. Additionally, there were increases of $0.6 million in costs related to TTP273, as increases in clinical trial costs outweighed decreases in compound manufacturing costs, and increases of $1.5 million in other research and development costs driven primarily by higher compensation costs as headcount was increased in order to support ongoing clinical trials. Such increases were offset by a decrease in spending of $1.5 million for TTP399, as the AGATA study was completed in August 2016 and a decrease in the cost of compound manufacturing for the study, which primarily occurred in 2015.

•

G&A Expenses: General and administrative expenses were $9.9 million in 2016 compared to $9.1 million in 2015. The increase was primarily driven by a $2.1 million increase in compensation costs related to the addition of personnel to support compliance with public company requirements, offset by a $1.4 million decrease in legal and professional service expenses incurred in 2015 in connection with the Company’s IPO that year.

•

Net Loss: Net loss was $55.4 million for 2016 compared to a net loss of $41.1 million for 2015.

December 31,

September 30,

2016

2016

(Unaudited)

(Unaudited)

Assets

Current assets:

Cash and cash equivalents

$

51,505

$

51,058

Accounts receivable, net

—

—

Prepaid expenses and other current assets

612

1,058

Total current assets

52,117

52,116

Property and equipment, net

444

493

Other long-term assets

1,934

2,106

Total assets

$

54,495

$

54,715

Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit

Current liabilities:

Accounts payable and accrued expenses

$

11,413

$

10,156

Accounts payable and accrued expenses - related party

—

406

Deferred revenue

21

21

Total current liabilities

11,434

10,583

Notes payable

11,058

—

Other liabilities

433

225

Total liabilities

22,925

10,808

Commitments and contingencies

Redeemable noncontrolling interest

122,515

155,147

Stockholders’ deficit:

Class A Common Stock

97

97

Class B Common Stock

232

232

Additional paid-in capital

124,212

122,838

Accumulated deficit

(215,486

)

(234,407

)

Total stockholders’ deficit attributable to vTv Therapeutics Inc.

(90,945

)

(111,240

)

Total liabilities, redeemable noncontrolling interest and stockholders’ deficit

$

54,495

$

54,715

Three Months Ended

For the Year Ended December 31,

December 31, 2016

September 30, 2016

2016

2015

Revenue

$

38

$

38

$

634

$

519

Operating expenses:

Research and development

11,099

11,165

45,748

29,584

General and administrative

2,252

2,401

9,906

9,077

Total operating expenses

13,351

13,566

55,654

38,661

Operating loss

(13,313

)

(13,528

)

(55,020

)

(38,142

)

Interest income

20

21

87

40

Interest expense

(394

)

(1

)

(398

)

(108

)

Other (expense) income, net

(24

)

3

(22

)

(2,897

)

Loss before income taxes and noncontrolling interest

(13,711

)

(13,505

)

(55,353

)

(41,107

)

Income tax provision

—

—

—

—

Net loss before noncontrolling interest

(13,711

)

(13,505

)

(55,353

)

(41,107

)

Less:  net loss attributable to noncontrolling interest

(9,661

)

(9,512

)

(39,001

)

(13,609

)

Net loss attributable to vTv Therapeutics Inc.

$

(4,050

)

$

(3,993

)

$

(16,352

)

$

(27,498

)

Net loss per share of vTv Therapeutics Inc. Class A

   Common Stock, basic and diluted

$

(0.42

)

$

(0.41

)

$

(1.71

)

$

(3.32

)

Weighted-average number of vTv Therapeutics Inc.

   Class A Common Stock, basic and diluted

9,693,254

9,691,362

9,545,527

8,276,520