8-K

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):  May 12, 2022

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 May 12, 2022, vTv Therapeutics Inc. issued a press release to announce its financial results for the fiscal period ended March 31, 2022.  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 May 12, 2022, announcing financial results for the fiscal quarter ended March 31, 2022
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/ Richard S. Nelson
Name:	Richard S. Nelson
Title:	Interim Chief Executive Officer

Dated: May 12, 2022

EX-99.1

Exhibit 99.1

vTv Therapeutics Announces 2022 First Quarter Financial Results and Provides Corporate Update

HIGH POINT, N.C. – (GLOBE NEWSWIRE) – May 12, 2022 – vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for the first quarter ended March 31, 2022, and provided an update on the progress of its clinical programs.

Recent Achievements and Outlook

Corporate

• Strategic Focus. We are prioritizing the development of our lead program TTP399, a novel, oral liver selective glucokinase activator, as a potential treatment for patients with type 1 diabetes (“T1D”), as well as continuing to support our currently partnered programs. Given the strategic focus on these programs, we have paused our development activities in the United States on HPP737 while we evaluate strategic options for it. As part of this planned strategic focus, the Company has reduced its workforce. We are actively seeking to raise capital through licensing TTP399 in regions outside of North America and Europe and are also actively seeking licensing deals for HPP737 and other assets. We are currently in active discussions with respect to financing, partnering, and licensing transactions for the further development of TTP399.

Type 1 Diabetes

• Mechanistic Study of Ketoacidosis with TTP399.  In October 2021, we announced positive results from the Mechanistic study indicating no increased risk of ketoacidosis with TTP399 during acute insulin withdrawal in patients with T1D. 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 Simplici-T1 Study results. Full study results will be published in the Diabetes Obesity and Metabolism journal in conjunction with the 82^nd American Diabetes Association Scientific Sessions on June 6^th, 2022.  

• Pivotal Study Planning.  The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects withT1D and has engaged with the Food and Drug Administration (“FDA”) on the optimal clinical trial designs for these studies. The studies will recruit a total of approximately 1000 patients and at least one of the studies will be one year of treatment. The FDA and the company have agreed on the primary endpoint for the studies as the difference between placebo and TTP399-treated group in number of hypoglycemia events. These pivotal studies are expected to start in 3Q 2022.   

First Quarter 2022 Financial Results

• Cash Position: The Company’s cash position as of March 31, 2022, was $12.1 million compared to $13.4 million as of December 31, 2021.

• Revenue: Revenue in first quarter of 2022 was $2.0 million and relates to an increase in the transaction price for a license performance obligation, that was fully recognized due to the satisfaction of a development milestone under the amended license agreement with Huadong. The revenue for the fourth quarter of 2021 was immaterial.

• R&D Expenses: Research and development expenses were $3.1 million and $5.4 million in each of the three months ended March 31, 2022 and December 31, 2021, respectively. The changes are attributable to (i) decreases of $2.0 million for a license payment to Novo Nordisk for the completion of TTP399 phase 2 studies in Q4 2021, (ii) decreased severance costs of $0.7 million and payroll costs of $0.1 million in connection with the Company's restructuring plan that occurred in Q4 2021, (iii) decreased spending of $0.5 million related to the multiple ascending dose study for HPP737 offset by (iv) increases of $1.3 million due to manufacturing and analytical work related to chemistry manufacturing and control “CMC” for pivotal TTP399 studies, and the progression of TTP399 toxicology studies in Q1 2022.

• G&A Expenses: General and administrative expenses were consistent between periods at $5.3 million and $5.7 million for each of the three months ended March 31, 2022, and December 31, 2021. However, individual changes in the quarters are attributable to (i) lower payroll costs of $0.4 million and lower severance costs of $0.7 million due to the Company's restructuring plan that occurred in December 2021 and separation agreement with the Company's former CEO in Q1 2022, (ii) lower shared-based expense of $0.6 million due to the modification of awards related to the retirement and separation agreements with several key employees that occurred in Q4 2021, offset by (iii) higher other G&A operating costs of $0.2 million and (iv) increases of $1.1 million in legal expense.

• Other Income/(Expense): Other expense for the three months ended March 31, 2022, was $2.7 million and was driven by an unrealized loss related to the Company’s investment in Reneo Pharmaceuticals, Inc. (“Reneo”), aswellas gains related to a reduction in the fairvalueoftheoutstandingwarrantsto purchase shares of our own stock issued to a related party (“Related Party Warrants”). Other income for the three months ended December 31, 2021, was $1.6 million and was driven by changes in the fair value of our investment in Reneo, aswell as the gains related to a reduction in fair value of the Related Party Warrants.

• Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $9.4 million for the first quarter of 2022 compared to net loss before non-controlling interest of $9.5 million for the fourth quarter of 2021. The decrease in net loss before Non-Controlling Interest was attributable to (i) increases in other expense of $4.3 million driven by changes in the fair value of our investment in Reneo, aswellas the gains related to a reduction in the fairvalueoftheoutstandingwarrantsto purchase shares of our own stock issued to a related party, offset by (ii) lower R&D expenses of $2.3 million, and (iii) higher revenue of $2.0 million due to an increase in the transaction price for a license performance obligation, that was fully recognized due to the satisfaction of a development milestone under the amended license agreement with Huadong.

• Net Loss Per Share: Diluted net loss per share was ($0.10) for the three months ended March 31, 2022 compared to diluted net loss per share of ($0.11) for the three months ended December 31, 2021, based on weighted-average diluted shares of 66.9 million and 66.8 million for the three-month periods ended March 31, 2022 and December 31, 2021, respectively.

vTv Therapeutics Inc.

Condensed Consolidated Balance Sheets

(in thousands)

	March 31,			December 30,
	2022			2021
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	12,138		$	13,415
Accounts receivable		57			57
Prepaid expenses and other current assets		1,387			2,049
Current deposits		30			100
Total current assets		13,612			15,621
Property and equipment, net		255			278
Operating lease right-of-use assets		379			402
Long-term investments		5,939			9,173
Total assets	$	20,185		$	25,474
Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Deficit
Current liabilities:
Accounts payable and accrued expenses	$	12,474		$	8,023
Operating lease liabilities		191			184
Current portion of contract liabilities		35			35
Current portion of notes payable		—			256
Total current liabilities		12,700			8,498
Operating lease liabilities, net of current portion		441			492
Warrant liability, related party		770			1,262
Total liabilities		13,911			10,252
Commitments and contingencies
Redeemable noncontrolling interest		14,367			24,962
Stockholders’ deficit:
Class A Common Stock		669			669
Class B Common Stock		232			232
Additional paid-in capital		238,669			238,193
Accumulated deficit		(247,663	)		(248,834	)
Total stockholders’ deficit attributable to vTv Therapeutics Inc.		(8,093	)		(9,740	)
Total liabilities, redeemable noncontrolling interest and stockholders’ deficit	$	20,185		$	25,474

vTv Therapeutics Inc.

Condensed Consolidated Statements of Operations - Unaudited

(in thousands, except per share data)

	Three Months Ended
	March 31, 2022			December 31, 2021
Revenue	$	2,000		$	9
Operating expenses:
Research and development		3,133			5,402
General and administrative		5,348			5,716
Total operating expenses		8,481			11,118
Operating loss		(6,481	)		(11,109	)
Interest expense		(1	)		(6	)
Other (expense) income, net		(2,742	)		1,632
Loss before income taxes and noncontrolling interest		(9,224	)		(9,483	)
Income tax provision		200			—
Net loss before noncontrolling interest		(9,424	)		(9,483	)
Less: net loss attributable to noncontrolling interest		(2,417	)		(2,432	)
Net loss attributable to vTv Therapeutics Inc.	$	(7,007	)	$	(7,051	)
Net loss attributable to vTv Therapeutics Inc. common shareholders	$	(7,007	)	$	(7,051	)
Net loss per share of vTv Therapeutics Inc. Class A    Common Stock, basic and diluted	$	(0.10	)	$	(0.11	)
Weighted average number of vTv Therapeutics Inc.    Class A Common Stock, basic and diluted		66,942,777			66,785,550

vTv Therapeutics Inc.

Condensed Consolidated Statements of Operations

(in thousands, except per share data)

	Three Months Ended March 31,
	2022			2021
	(Unaudited)
Revenue	$	2,000		$	987
Operating expenses:
Research and development		3,133			3,103
General and administrative		5,348			2,164
Total operating expenses		8,481			5,267
Operating loss		(6,481	)		(4,280	)
Interest income		—			1
Interest expense		(1	)		—
Other expense, net		(2,742	)		(1,648	)
Loss before income taxes and noncontrolling interest		(9,224	)		(5,927	)
Income tax provision		200			15
Net loss before noncontrolling interest		(9,424	)		(5,942	)
Less:  net loss attributable to noncontrolling interest		(2,417	)		(1,701	)
Net loss attributable to vTv Therapeutics Inc.	$	(7,007	)	$	(4,241	)
Net loss attributable to vTv Therapeutics Inc. common shareholders	$	(7,007	)	$	(4,241	)
Net loss per share of vTv Therapeutics Inc. Class A Common    Stock, basic and diluted	$	(0.10	)	$	(0.08	)
Weighted average number of vTv Therapeutics Inc. Class A    Common Stock, basic and diluted		66,942,777			56,472,535

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. 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. In addition, we may not be able to successfully complete a successful financing, partnering or licensing transactions with respect to TTP399. 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:

IR@vtvtherapeutics.com.

or

Media:

PR@vtvtherapeutics.com

XML

Cover	May 12, 2022
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 12, 2022
Entity File Number	001-37524
Entity Registrant Name	vTv Therapeutics Inc.
Entity Central Index Key	0001641489
Entity Tax Identification Number	47-3916571
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	3980 Premier Drive
Entity Address, Address Line Two	Suite 310
Entity Address, City or Town	High Point
Entity Address, State or Province	NC
Entity Address, Postal Zip Code	27265
City Area Code	336
Local Phone Number	841-0300
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Class A common stock, par value $0.01 per share
Trading Symbol	VTVT
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false