vtvt-8k_20211109.htm
false 0001641489 0001641489 2021-11-09 2021-11-09

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):  November 9, 2021

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.)

 

3980 Premier Drive, Suite 310

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))

Securities registered pursuant to Section 12(b) of the Act:

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

Indicate by check mark whether the registrant is an emerging growth company 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 November 9, 2021, vTv Therapeutics Inc. issued a press release to announce its financial results for the fiscal period ended September 30, 2021.  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 November 9, 2021, announcing financial results for the fiscal quarter ended September 30, 2021

104

Cover Page Interactive Data File (embedded within Inline XBRL document)

 



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: November 9, 2021

 

 

 

 

 

vtvt-ex991_20.htm

Exhibit 99.1

 

 

 

 

 

vTv Therapeutics Announces 2021 Third Quarter Financial Results and Provides Corporate Update

 

HIGH POINT, N.C. – (GLOBE NEWSWIRE) – November 9, 2021 – vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for the third quarter ended September 30, 2021, and provided an update on the progress of its clinical programs.

 

“We plan to refocus vTv’s strategy on TTP399.  TTP399 is unique and the most important product in our portfolio with strong equity value potential to our shareholders”, said Deepa Prasad, president and CEO, vTv Therapeutics. “Biotech is about innovation and meeting the unmet medical needs for patients.  TTP399 does exactly this in seeking to solve the unmet need for type 1 diabetic patients experiencing hypoglycemic episodes. We are excited the FDA supports our effort by granting us Breakthrough Therapy Designation. Hypoglycemia is the most common acute complication for type 1 diabetes with onset occurring quickly and often without warning. We believe TTP399 can address this critical unmet need for type 1 diabetic patients worldwide.

 

Recent Achievements and Outlook

 

Corporate

 

 

Leadership. On October 19, 2021, Deepa Prasad was appointed to the role of President and CEO, and joined the board of directors.  Deepa is a recognized healthcare leader with more than 20 years of experience across startup funding, operations, investment banking, and healthcare policy. Most recently, Deepa led investments in innovative life science companies as a managing director at West River Group.

 

 

Strategic Focus. We plan to implement a strategy to focus our efforts on the continued development of TTP399 as a potential treatment for patients with type 1 diabetes (“T1D”) and TTP273 as a potential treatment for patients with cystic fibrosis related diabetes, as well as continuing to support our currently partnered programs.  Given the strategic focus on these programs, we plan to pause our development activities in the United States on HPP737 while we evaluate strategic options for it. As part of this planned strategic focus, we are also evaluating cost reductions which may include reductions in our workforce.

 

 

Balance Sheet.  The Company strengthened its balance sheet during the quarter through utilization of the at-the-market equity program with Cantor Fitzgerald, ending the quarter with $19.6 million of cash, cash equivalents and marketable securities.

 

Type 1 Diabetes

 

 

Mechanistic Study of Ketoacidosis with TTP399.  In October 2021, the Company announced positive results from the mechanistic study of TTP399 in people with type 1 diabetes.  Patients with type 1 diabetes taking TTP399 experienced no increase in ketone levels relative to placebo during a period of acute insulin withdrawal, indicating

 


 

 

that treatment with TTP399 presents no increased risk of ketoacidosis.  In addition, patients taking TTP399 had improved fasting plasma glucose levels and experienced fewer hypoglycemic events relative to those taking placebo, consistent and supportive of the previously announced phase 2 SimpliciT1 Study results.  

 

 

Pivotal Study Planning.  The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects with type 1 diabetes and is engaged with the FDA on the optimal clinical trial designs for these studies.  The Company expects to begin these pivotal studies in the first half of 2022.  

Third Quarter 2021 Financial Results

 

 

Cash Position: The Company’s cash position as of September 30, 2021, was $19.6 million compared to $10.8 million as of June 30, 2021.

 

 

Revenue: Revenue for the third quarter of 2021 was $3.0 million, attributable to the satisfaction of milestones under the license agreements with Newsoara Biopharma Co., Ltd. and Reneo Pharmaceuticals, Inc. Revenue for the second quarter of 2021 was an insignificant amount.

 

 

R&D Expenses: Research and development expenses were $2.4 million in each of the three months ended September 30, 2021 and June 30, 2021, respectively.

 

 

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

 

 

Other Income/(Expense): Other expense for the three months ended September 30, 2021 was $0.2 million and was attributable to the 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”) offset by losses driven by the decrease in the fair value of our investment in Reneo Pharmaceuticals, Inc. (the “Reneo Investment”).  Other income for the three months ended June 30, 2021 of $3.8 million was driven by changes in value of the Reneo Investment and gains related to the reduction in fair value of the Related Party Warrants.

 

 

Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $1.5 million for the third quarter of 2021 compared to net loss before non-controlling interest of $0.8 million for the second quarter of 2021.

 

 

Net Loss Per Share: Diluted net loss per share was ($0.02) for the three months ended September 30, 2021 compared to diluted net loss per share of ($0.01) for the three months ended June 30, 2021, based on weighted-average diluted shares of 61.1 million and 58.6 million for the three-month periods ended September 30, 2021 and June 30, 2021, respectively.

                                                      


 

 

vTv Therapeutics Inc.

Condensed Consolidated Balance Sheets

(in thousands)

 

 

September 30,

 

 

June 30,

 

 

2021

 

 

2021

 

 

(Unaudited)

 

 

(Unaudited)

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

19,566

 

 

$

10,835

 

Accounts receivable, net

 

928

 

 

 

 

Prepaid expenses and other current assets

 

1,574

 

 

 

313

 

Current deposits

 

103

 

 

 

124

 

Total current assets

 

22,171

 

 

 

11,272

 

Property and equipment, net

 

300

 

 

 

322

 

Operating lease right-of-use assets

 

424

 

 

 

444

 

Long-term investments

 

8,539

 

 

 

9,622

 

Total assets

$

31,434

 

 

$

21,660

 

Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable and accrued expenses

$

4,663

 

 

$

4,855

 

Operating lease liabilities

 

176

 

 

 

169

 

Current portion of contract liabilities

 

35

 

 

 

35

 

Current portion of notes payable

 

636

 

 

 

 

Total current liabilities

 

5,510

 

 

 

5,059

 

Contract liabilities, net of current portion

 

9

 

 

 

9

 

Operating lease liabilities, net of current portion

 

540

 

 

 

587

 

Warrant liability, related party

 

2,260

 

 

 

3,588

 

Other liabilities

 

50

 

 

 

50

 

Total liabilities

 

8,369

 

 

 

9,293

 

Commitments and contingencies

 

 

 

 

 

 

 

Redeemable noncontrolling interest

 

44,610

 

 

 

60,190

 

Stockholders’ deficit:

 

 

 

 

 

 

 

Class A Common Stock

 

665

 

 

 

602

 

Class B Common Stock

 

232

 

 

 

232

 

Additional paid-in capital

 

236,557

 

 

 

224,457

 

Accumulated deficit

 

(258,999

)

 

 

(273,114

)

Total stockholders’ deficit attributable to vTv Therapeutics Inc.

 

(21,545

)

 

 

(47,823

)

Total liabilities, redeemable noncontrolling interest and stockholders’ deficit

$

31,434

 

 

$

21,660

 

 


                                                      


 

 

vTv Therapeutics Inc.

Condensed Consolidated Statements of Operations - Unaudited

(in thousands, except per share data)

 


 

Three Months Ended

 

 

September 30, 2021

 

 

June 30, 2021

 

Revenue

$

3,000

 

 

$

9

 

Operating expenses:

 

 

 

 

 

 

 

Research and development

 

2,382

 

 

 

2,437

 

General and administrative

 

2,221

 

 

 

2,242

 

Total operating expenses

 

4,603

 

 

 

4,679

 

Operating loss

 

(1,603

)

 

 

(4,670

)

Interest expense

 

(6

)

 

 

 

Other income, net

 

244

 

 

 

3,829

 

Loss before income taxes and noncontrolling interest

 

(1,365

)

 

 

(841

)

Income tax provision

 

100

 

 

 

 

Net loss before noncontrolling interest

 

(1,465

)

 

 

(841

)

Less:  net loss attributable to noncontrolling interest

 

(378

)

 

 

(233

)

Net loss attributable to vTv Therapeutics Inc.

$

(1,087

)

 

$

(608

)

Net loss attributable to vTv Therapeutics Inc. common shareholders

$

(1,087

)

 

$

(608

)

Net loss per share of vTv Therapeutics Inc. Class A

   Common Stock, basic and diluted

$

(0.02

)

 

$

(0.01

)

Weighted-average number of vTv Therapeutics Inc.

   Class A Common Stock, basic and diluted

 

61,073,280

 

 

 

58,615,137

 

 

 

 

 

 

 

 

 

 


                                                      


 

 

vTv Therapeutics Inc.

Condensed Consolidated Statements of Operations

(in thousands, except per share data)

 

 

Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

 

(Unaudited)

 

 

(Unaudited)

 

Revenue

$

3,000

 

 

$

7

 

 

$

3,996

 

 

$

15

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

2,382

 

 

 

1,768

 

 

 

7,922

 

 

 

8,481

 

General and administrative

 

2,221

 

 

 

1,071

 

 

 

6,627

 

 

 

5,216

 

Total operating expenses

 

4,603

 

 

 

2,839

 

 

 

14,549

 

 

 

13,697

 

Operating loss

 

(1,603

)

 

 

(2,832

)

 

 

(10,553

)

 

 

(13,682

)

Interest income

 

 

 

 

 

 

 

1

 

 

 

12

 

Interest expense

 

(6

)

 

 

(235

)

 

 

(6

)

 

 

(625

)

Other income (expense), net

 

244

 

 

 

814

 

 

 

2,425

 

 

 

(114

)

Loss before income taxes and noncontrolling interest

 

(1,365

)

 

 

(2,253

)

 

 

(8,133

)

 

 

(14,409

)

Income tax provision

 

100

 

 

 

 

 

 

115

 

 

 

 

Net loss before noncontrolling interest

 

(1,465

)

 

 

(2,253

)

 

 

(8,248

)

 

 

(14,409

)

Less:  net loss attributable to noncontrolling interest

 

(378

)

 

 

(720

)

 

 

(2,312

)

 

 

(4,784

)

Net loss attributable to vTv Therapeutics Inc.

$

(1,087

)

 

$

(1,533

)

 

$

(5,936

)

 

$

(9,625

)

Net loss attributable to vTv Therapeutics Inc. common

   shareholders

$

(1,087

)

 

$

(1,533

)

 

$

(5,936

)

 

$

(8,765

)

Net loss per share of vTv Therapeutics Inc. Class A

   Common Stock, basic and diluted

$

(0.02

)

 

$

(0.03

)

 

$

(0.10

)

 

$

(0.21

)

Weighted-average number of vTv Therapeutics Inc.

   Class A Common Stock, basic and diluted

 

61,073,280

 

 

 

48,238,285

 

 

 

58,737,170

 

 

 

45,796,298

 

 

About vTv Therapeutics

vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes and cystic fibrosis related diabetes. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease, renal disease, primary mitochondrial myopathy, and pancreatic cancer.

 

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.

 

 

 

Contacts

Investors:

Corey Davis
LifeSci Advisors
CDavis@LifeSciAdvisors.com

 

or


Media:

PR@vtvtherapeutics.com