Delaware

(State or other jurisdiction

of incorporation)

001-37524

(Commission File No.)

47-3916571
(IRS Employer
Identification No.)

3980 Premier Drive, Suite 310

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))

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Class A common stock, par value $0.01 per share

VTVT

NASDAQ Capital Market

Exhibit No.

Description

99.1

Press Release dated August 4, 2021, announcing financial results for the fiscal quarter ended June 30, 2021.

By:

/s/ Rudy C. Howard

Name:

Rudy C. Howard

Title:

Chief Financial Officer

•

Breakthrough Therapy Designation Type B Meeting.  As announced in April, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for TTP399 as an adjunctive therapy to insulin for the treatment of type 1 diabetes.  The Company held its first Type B meeting with the FDA pursuant to the Breakthrough Therapy designation to discuss the development of TTP399.

•

Mechanistic Study of Ketoacidosis with TTP399.  The Company completed enrollment in the mechanistic study of TTP399 in people with type 1 diabetes.  This phase 1 study is designed to assess the impact of TTP399 on ketone body formation, and therefore the risk of diabetic ketoacidosis, during a period of acute insulin withdrawal.  vTv expects to report topline results from this mechanistic study in late third quarter or early fourth quarter of 2021.

•

Pivotal Study Planning.  The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects with type 1 diabetes that are expected to begin in the first half of 2022.

•

Multiple Ascending Dose Study with HPP737.  The Company completed dosing healthy subjects in a phase 1 multiple ascending dose study to assess the safety, tolerability, and pharmacokinetic profile of HPP737, an oral PDE4 inhibitor.  We expect to report the results from this study in the third quarter.

•

Phase 2 Study Planning.  The Company is planning a phase 2 clinical trial of HPP737 in patients with psoriasis.  We are discussing the proposed study design with the FDA during the third quarter and expect to begin the study late in the fourth quarter of 2021 or

early in the first quarter of 2022.

•

vTv and Cantex Entered into a Strategic Licensing Agreement for Azeliragon.  In June, the Company announced a new strategic collaboration with Cantex Pharmaceuticals under which Cantex will continue the development of azeliragon for the treatment of the complications associated with cancer, including cachexia and pain from bone metastasis.  Cantex will be responsible for the development and commercialization of azeliragon and the companies will allocate profits under a tiered arrangement.

•

Reneo Dosed the First Patient in Phase 2b STRIDE Study.  In July, Reneo Pharmaceuticals dosed the first patient in the phase 2b STRIDE Study, designed to assess the efficacy and safety of REN001 for the treatment of patients with primary mitochondrial myopathies.  

•

$50 Million ATM Program. The Company added an additional $50 million of capacity to its at-the-market equity program with Cantor Fitzgerald to fund the ongoing and planned development of TTP399 and HPP737.

•

Registration of Additional Shares to Support Equity Line.  The Company registered an additional 9.4 million shares of Class A Common Stock to provide the continued flexibility to raise capital with share sales to Lincoln Park Capital under the Purchase Agreement entered into in November of 2020.

•

Cash Position: The Company’s cash position as of June 30, 2021, was $10.8 million compared to $8.4 million as of March 31, 2021.

•

Revenue: Revenue for the second quarter of 2021 was an insignificant amount.  For the first quarter of 2021 revenue was $1.0 million.  The revenue for the first quarter was non-cash and related to the recognition of revenue pertaining to the Huadong license agreement.

•

R&D Expenses: Research and development expenses were $2.4 million and $3.1 million for the three months ended June 30, 2021 and March 31, 2021, respectively.  This decrease of $0.7 million was driven primarily by the decreases in spending for the Elevage study as the analysis and close out of this study largely occurred in the first quarter as well as a decrease in spending for our study of HPP737 in psoriasis.

•

G&A Expenses: General and administrative expenses were consistent between periods at $2.2 million for each of the three months ended June 30, 2021 and March 31, 2021.

•

Other Income/(Expense): Other income for the three months ended June 30, 2021 was $3.8 million and was attributable to the changes in the fair value of our investment in Reneo Pharmaceuticals, Inc. which completed its initial public offering in the second quarter of 2021 as well as gains related to a reduction in fair value of the warrants to purchase shares of our own stock issued to a related party (the “Related Party Warrants”).  Other expense

for the three months ended March 31, 2021 was driven by losses related to an increase in the fair value of the Related Party Warrants.  

•

Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $0.8 million for the second quarter of 2021 compared to net loss of $5.9 million for the first quarter of 2021.

•

Net Loss Per Share: Diluted net loss per share was ($0.01) for the three months ended June 30, 2021 compared to diluted net loss per share of ($0.08) for the three months ended March 31, 2021, based on weighted-average diluted shares of 58.6 million and 56.5 million for the three-month periods ended June 30, 2021 and March 31, 2021, respectively.

June 30,

March 31,

2021

2021

(Unaudited)

(Unaudited)

Assets

Current assets:

Cash and cash equivalents

$

10,835

$

8,449

Accounts receivable, net

—

2

Prepaid expenses and other current assets

313

710

Current deposits

124

60

Total current assets

11,272

9,221

Property and equipment, net

322

344

Operating lease right-of-use assets

444

464

Long-term investments

9,622

6,725

Total assets

$

21,660

$

16,754

Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit

Current liabilities:

Accounts payable and accrued expenses

$

4,855

$

4,965

Operating lease liabilities

169

162

Current portion of contract liabilities

35

35

Current portion of notes payable

—

—

Total current liabilities

5,059

5,162

Contract liabilities, net of current portion

9

18

Operating lease liabilities, net of current portion

587

633

Warrant liability, related party

3,588

4,519

Other liabilities

50

50

Total liabilities

9,293

10,382

Commitments and contingencies

Redeemable noncontrolling interest

60,190

62,647

Stockholders’ deficit:

Class A Common Stock

602

576

Class B Common Stock

232

232

Additional paid-in capital

224,457

217,647

Accumulated deficit

(273,114

)

(274,730

)

Total stockholders’ deficit attributable to vTv Therapeutics Inc.

(47,823

)

(56,275

)

Total liabilities, redeemable noncontrolling interest and stockholders’ deficit

$

21,660

$

16,754

Three Months Ended

June 30, 2021

March 31, 2021

Revenue

$

9

$

987

Operating expenses:

Research and development

2,437

3,103

General and administrative

2,242

2,164

Total operating expenses

4,679

5,267

Operating loss

(4,670

)

(4,280

)

Interest income

—

1

Interest expense

—

—

Other income (expense), net

3,829

(1,648

)

Loss before income taxes and noncontrolling interest

(841

)

(5,927

)

Income tax provision

—

15

Net loss before noncontrolling interest

(841

)

(5,942

)

Less:  net loss attributable to noncontrolling interest

(233

)

(1,701

)

Net loss attributable to vTv Therapeutics Inc.

$

(608

)

$

(4,241

)

Net loss attributable to vTv Therapeutics Inc. common shareholders

$

(608

)

$

(4,241

)

Net loss per share of vTv Therapeutics Inc. Class A

   Common Stock, basic and diluted

$

(0.01

)

$

(0.08

)

Weighted-average number of vTv Therapeutics Inc.

   Class A Common Stock, basic and diluted

58,615,137

56,472,535

Three Months Ended June 30,

For the Six Months Ended June 30,

2021

2020

2021

2020

(Unaudited)

(Unaudited)

Revenue

$

9

$

—

$

996

$

8

Operating expenses:

Research and development

2,437

2,509

5,540

6,713

General and administrative

2,242

1,695

4,406

4,145

Total operating expenses

4,679

4,204

9,946

10,858

Operating loss

(4,670

)

(4,204

)

(8,950

)

(10,850

)

Interest income

—

—

1

12

Interest expense

—

(222

)

—

(390

)

Other income (expense), net

3,829

(565

)

2,181

(928

)

Loss before income taxes and noncontrolling interest

(841

)

(4,991

)

(6,768

)

(12,156

)

Income tax provision

—

—

15

—

Net loss before noncontrolling interest

(841

)

(4,991

)

(6,783

)

(12,156

)

Less:  net loss attributable to noncontrolling interest

(233

)

(1,623

)

(1,934

)

(4,064

)

Net loss attributable to vTv Therapeutics Inc.

$

(608

)

$

(3,368

)

$

(4,849

)

$

(8,092

)

Net loss attributable to vTv Therapeutics Inc. common

   shareholders

$

(608

)

$

(3,368

)

$

(4,849

)

$

(8,092

)

Net loss per share of vTv Therapeutics Inc. Class A

   Common Stock, basic and diluted

$

(0.01

)

$

(0.07

)

$

(0.08

)

$

(0.18

)

Weighted-average number of vTv Therapeutics Inc.

   Class A Common Stock, basic and diluted

58,615,137

45,661,221

57,549,755

44,561,886